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Standards Interpretation Frequently Asked Questions (FAQs)

Print Date: 3/1/2018 9:10:49 AM

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Hospital and Hospital Clinics

Emergency Management (EM)

Topic

Analysis - Hazard Vulnerability Analysis

Is there a requirement to have an hazard vulnerability analysis (HVA) for off-site facilities?

The need for site-unique hazard vulnerability analysis (HVA) depends upon whether the off-site facility has
different internal or external circumstances that would affect its ability to manage emergencies. If a site is in close
proximity to the main hospital facility, and participates in the main facility's emergency operations plan, then the
assessment may be to incorporate the off-site HVA with the main facility's HVA; the off-site facility must be
identified. If the off-site facility has its own vulnerabilities in the context of its ability to provide services, then those
vulnerabilities are to be assessed. If assessments determines that there are unique situations at an off-site
location, the organization is required to perform an HVA for that site. Although it is not uncommon for a unique
hazard vulnerability to be identified for a remote facility often the emergency operation plan is simply a
communications process of informing patients, staff, etc. that services are to be temporarily stopped since the off-
site facility does not provide emergency services or any other care that cannot be deferred. [EM.01.01.01]

Emergency Management - Committees

Is there a required composition of the Emergency Management Committee?

The Joint Commission has no prescribed make-up of the emergency management committee. The organization
should consider those positions or persons that have primary responsibility and expertise associated with the
phases of emergency management. This includes mitigation, preparedness, response and recovery activities.
For example, if the National Incident Management System (NIMS) is used, there should be representation at
least from the areas of command, command staff, operations, planning, logistics, and finance/administration. Just
like the hazard vulnerability analysis (HVA) is used to establish the content of an emergency operations plan, the
HVA can also be used to establish the expertise needed for the emergency management committee. Also, if the
community emergency operations structure requires certain representation in an emergency management
committee, then the organization should take that into consideration when setting up committee representation.
EM.01.01.01 requires leaders of the medical staff to participate in emergency management planning activities.
[EM.01.01.01]

Incident Command Structure - Emergency Management

Are organizations required to use National Incident Management System (NIMS) as an incident
command structure?

The Joint Commission has no standard that specifically addresses educational requirements for organizations
that use the National Incident Management Syste (NIMS) as an incident command structure. If the organization is
required to use NIMS by their state or local controlling authority, then per standard LD.04.01.01, the requirements
of that controlling authority with regard to NIMS implementation and educational requirements must be followed.
[EM.01.01.01]

Inventory - Emergency Management

How does an organization establish an emergency inventory?

An organization needs to establish a process to manage its emergency inventory, however there is no
requirement for centralization of the inventory. The Joint Commission recognizes that this could be problematic
with "just in time" purchasing and recognizes that it is important to use stock with a shelf-life. Tracking assets and
inventory for a year is recommended in order to accurately ascertain what the capabilities and needs are for the
organization. Many organizations consider emergency requirements when establishing par levels. Memorandums
of Understanding (MOUs) or other agreements may be formed with other entities to help the organization
maintain its inventory during an emergency. However, it is very important to test and/or document this along with
the other five critical areas during an exercise or actual event to look for areas of risk. If an event or exercise is
initiated, one of the initial responses should be for those entities holding emergency inventories to report
available inventories to the incident commander. [EM.01.01.01]

Meetings - Emergency Management

Are Emergency Management meetings required and what frequency must the occur?

The Emergency Management standards do not require meetings, either regularly scheduled or as needed.
Meetings are typically an effective method to coordinate EM activities. The standards require that there be
evidence of standards compliance for each of the applicable elements of performance. For example, some
standards require various levels of participation, communication, planning, etc., but there is no requirement that
these be accomplished in meetings. If the organization establishes meeting at regular intervals as policy, then the
organization is expected to adhere to that policy. [EM.01.01.01]

Plans - Emergency Management 96 Hour Plan

With respect to the 96-hour plan, are organizations expected to remain sustainable for that period of
time?

The health care organization is not required to remain fully functional for 96-hours, but is required to develop an
understanding of their capabilities and limitations in order to make effective decisions concerning the progressive
curtailment or stopping of services in an organized and prioritized way so as to maintain those services most
applicable to the emergency situation for as long as possible. The issues for analysis are to be high priority
issues identified in the hazard vulnerability analysis. The anticipated actions, emergency supply inventory, access
to emergency supplies capability, and emergency services are to be based upon that assessment process.
Exercises can be used to validate or adjust the sustainability plan. If any of the organization's controlling
authorities, such as a local/state/region/federal charter, requires the organization to remain open for a specified
period of time, then the organization is to comply. [EM.02.01.01]

Plans - Emergency Management Event Recovery/Continuity

Is there a required process for Emergency Management event recovery and continuity of operations?

The Joint Commission standard for an organization's recovery and continuity of operations is performance based.
The organization will use its emergency operations plan to define its response to emergencies and to help
position it for recovery after the emergency has passed. Various aspects of a recovery effort could take place
during an event or after an event. Recovery strategies and actions are designed to help restore the systems that
are critical to providing care, treatment, and services in the most expeditious manner possible. Emergency
operations plans are to be designed to provide optimum flexibility to restore critical services as soon as possible
to meet community needs. Recovery strategies are to maintain a focus on continuity of operations. For example;
smooth transition from emergency to regular supply chains; effective decoupling of services shared with other
entities during an event; use or return of stockpiled supplies; staff relief without affecting continuity of operations;
creating the most seamless environment possible for patients and patient care. In order to evaluate effectiveness,
the survey process will review the emergency operations plan, interview staff and review exercise evaluations.
[EM.02.01.01]

Plans - Emergency Operations Creation Participation

Are hospital leaders and medical staff required to participate in creating the Emergency Operations
Plan?
An actual medical staff or physician member, and an actual hospital senior leader is to participate in planning
activities prior to the development of the Emergency Operations Plan. Medical staff and hospital leadership will
be directly involved in the management of an implementation of the emergency operations plan, so their input is
essential to establish the expected capabilities and duties of these entities. It is also important for them to
understand the duties and capabilities for the staff that will support the emergency operations plan, and the
capabilities of community support entities. Many disaster scenarios involve patient care with regard to
management of current patients and managing influx of patients. Hospital leaders must have an understanding of
the command structure and how it functions. [EM.01.01.01]

Environment of Care (EC)

Topic

Automatic Transfer Switch (ATS) transfer time requirements - Testing

What is the requirement for testing essential electrical system transfer switches (automatic and manual)?

Transfer switches that are part of the essential electrical system are considered high-risk utility systems
equipment that have code-related (NFPA 99-2012 and NFPA 110-2010) testing requirements. There must be
documentation of the result of testing for each unique piece of equipment or device in order to demonstrate that
the testing has been completed as required. All automatic transfer switches are to be tested monthly. Testing
activities are to be conducted in accordance with the assessed maintenance strategies that best suit the unique
system design. Per NFPA 99-2012, the monthly generator load test must include a complete simulated cold start
along with automatic and manual transfer of all essential electrical system loads. It is a best practice, but not a
requirement, to initiate the load test with a different ATS each month.

According to NFPA 99-2012, 6.4.4.1.1, the essential electrical system must be maintained to supply emergency
power within 10 seconds of loss of normal power. If the 10-second criteria is not met during regular testing, the
organization must have a process to confirm on an annual basis that the 10-second criteria can be met.

Clinical Interventions - Utility System Disruptions

What are expectations relating to procedures that address emergency clinical interventions during utility
system disruptions?

During times of utility interruptions, clinical procedures and processes may need to be changed or modified due
to lack of utility support. In the event of power loss, HVAC system shut down, loss of running water, etc.
emergency clinical interventions may be required in order to continue to provide necessary patient care. As
various clinical interventions vary based on the needs of the organization, there must be assessment made
relative to the type of utility interruption, and written clinical procedures must be available for implementation
should a utility system disruption happen. Staff should be aware of these policies and how to access them in the
event of a utility system disruption.

Control Labeling - Emergency Shutdown

What is the requirement for mapping utility systems and identifying controls for utility system shutdown?

Utility systems maps (or drawings) are important tools to be used when trouble-shooting a system problem and to
isolate portions of the system when needed. They can be construction as-built drawings, but many facilities have
been altered in phases over several years, therefore the mapping requirements also include how the various
generations of these systems interconnect. Maps can be schematics, diagrams, tables, or other effective means
that identify the location/space where a control device or equipment resides. System equipment is to be
identified; for example, chillers, boilers, bulk oxygen tanks, emergency generators, water softeners, etc. When
mapping a utility system, source valves/controls, code required valves/controls and assessed critical
valves/controls are to be identified in accordance with their actual labeling in the field. When determining the
criticality of valves/controls for a system, a rule-of-thumb would be whether significant harm can be done if a
delay in securing would be caused by the need to reference a drawing, a valve labeling cross-reference list, etc.

Controlling Airborne Contaminants - Documentation

What is the requirement for documentation of indoor air quality and ventilation maintenance?

The Joint Commission requires no specific documentation or forms to be filled out for indoor air quality and
proper ventilation maintenance. Evidence of compliance with regard to the following criteria is required. Standard
EC.02.05.01 EP 15 requires the hospital to maintain appropriate pressure relationships, air-exchange rates,
filtration efficiencies, temperature and humidity for critical spaces. This includes implementing methods to
validate continuous compliance and implementing methods to maintain the infrastructure equipment that achieve
the criteria. Methods are established by the criteria described by EC.02.05.01 relative to systems being designed
appropriately, inventoried and assessed, and a maintenance strategy established/implemented based upon
manufacturers' recommendation or an alternate equipment maintenance (AEM) strategy. Frequencies of
maintenance and testing are determined by assessment of the particular circumstances of the installation.
Examples of air pressure relationship management could include periodic testing (like tissue/smoke test with
logged results), continuous indicators (like ball-in-tube, mounted mechanical or electronic manometer), remote
building automation system monitoring, etc. Air exchange rate management could include periodic air balance
tests, a building automation system with flow measurement capabilities, etc. Air filtration efficiencies are
maintained by regular evaluation and replacement of air handling unit and other system filters that serve these
critical spaces. Infrastructure equipment maintenance includes ventilation fan and distribution system
maintenance (AHU, exhaust/return fan systems), control and indicator maintenance/calibration, and critical space
structural integrity (doors, walls, etc.). The organization must document that the maintenance and testing
activities implemented were performed on the schedule established. For other spaces assessed to be less
critical, evidence of continuous compliant ventilation, temperature and humidity levels may not be required, but
are to be initially set-up properly when affected by new construction, alteration or renovation, and through
methods such as regular environmental rounding, occupant feedback and through maintenance activities.

Design Criteria - Clinical Sink in a Medical Surgical Unit

What is the requirement for design criteria on clinical sinks in medical/surgical units?

Standard EC.02.06.05 states that The Joint Commission uses the requirements of the 2014 edition of the FGI
Guidelines for Design and Construction of Hospitals and Outpatient Facilities. For a hospital medical/surgical unit,
clinical sink requirements are not dictated by how many are installed on a floor. Per 2.1-2.6.10, soiled workrooms
shall contain a flushing rim clinical service sink with a bedpan rinsing device. For soiled holding rooms, omission
of the flushing-rim clinical sink is permitted in rooms used only for temporary holding of soiled material. If a
flushing-rim clinical service sink is not provided in the soiled holding room, such a sink or an acceptable
alternative (e.g., a water closet with bedpan-rinsing device located in a patient toilet room) shall be provided
elsewhere on the nursing unit for the cleaning of bedpans.

Design Criteria - Clinical Sink in an Outpatient Setting

What is the requirement for design criteria on hand washing sinks in an outpatient setting?

Standard EC.02.06.05 states that The Joint Commission uses the 2014 edition of the FGI Guidelines for Design
and Construction of Hospitals and Outpatient Facilities. 3.1-3.2 requires a hand-washing station within general
purpose examination and observation rooms, special purpose examination rooms, and treatment rooms within
outpatient facilities. Also, 3.1-3.6.5 requires hand-washing stations in each room where hands-on patient care is
provided in outpatient facilities. For specific outpatient facility types, within examination and treatment rooms,
hand-washing sinks are required for primary care outpatient facilities (3.2), free-standing outpatient diagnostic
and treatment facilities (3.3), free-standing urgent care facilities (3.5), outpatient surgical facilities (3.7), office-
based procedure and operating rooms (3.8), endoscopy facilities (3.9), renal dialysis centers (3.10), outpatient
psychiatric centers (3.11), outpatient rehabilitation therapy facilities (3.12), and dental facilities (3.14).

Free-standing birthing centers (3.4) require hand-washing sinks in each birthing room.

Freestanding cancer treatment facilities (3.6) requirements do not mention examination rooms, only that the sinks
are located in, next to, or directly accessible to the nurse station.

These requirements are applicable for new facilities and when renovation is done to exiting facilities. Whether
sinks are required for existing exam rooms would be dependent upon the FGI requirements or the organization's
licensing authority requirements at the time of construction.

Design Criteria - Facility Guidelines Institute (FGI)

What is the requirement for organizations to use when assessing building design and construction
criteria?

In accordance with EC.02.06.05, The Joint Commission expects organizations to assess building design and
construction requirements based on local, state, and federal regulations and codes. Typically an organization's
controlling authority for this issue is their state health department licensing entity. The organization would have to
check their licensing rules to determine their criteria and whether retroactive compliance is allowed. When these
entities are silent on a particular design criteria, The Joint Commission recognizes the 2014 Facility Guidelines
Institute (FGI) Guidelines for Design and Construction of Hospitals and Outpatient Facilities for new construction
and renovation. The FGI allows requirements at the time of construction to be used, so the edition of the FGI
applicable at the time of construction would be used for existing configurations. If current requirements are more
strict, The Joint Commission would expect the organization to perform a gap analysis to validate that adequate
patient and staff safety, and process integrity can be maintained.

Electronic Cigarettes - Health Care Occupancy

What are the requirements for electronic cigarettes?

In accordance with standard EC.02.01.03, The Joint Commission environment of care standards prohibits
smoking, regardless of the type of smoking (tobacco, electronic, etc.). There are provisions for allowing smoking
in specific circumstances, which may include a designated smoking room with appropriate exhaust and fire safety
features. These locations are to be physically separated from care, treatment and service areas. The goal is to
manage the smoke in the environment (regardless if it is tobacco smoke or smoke from the electronic cigarette).
Fire safety is also a concern in the environment of care. EC.02.03.01 states that “if patients are permitted to
smoke, the organization takes measures to minimize fire risk (see also EC.02.01.03).” The issue is smoking as a
source of ignition, and does not distinguish from a tobacco-based or other smoking process. The organization
should include electronic cigarettes in their smoking policy. Electronic cigarettes, which typically contain lithium
type batteries used to generate heat, could be a fire hazard. If people see electronic cigarettes used, and are not
aware of their uniqueness, they may assume that smoking conventional cigarettes is allowed.

Emergency Call Button - Public Accessible Restroom

What are the requirements for an emergency call button in a public accessible restroom?

See the FGI Guidelines for Design & Construction of Hospital and Health Care Facilities (2014 edition) for
specific application of nurse call and call buttons. The requirements are not the same for different services that
may be provided - the level of risk to the patient determines location. If the restroom application is not in the
Guidelines, conduct a risk assessment to determine the need of a call button. Also, in a business occupancy, the
risk assessment may include the physical condition/ability/needs of the public that may use a public restroom.
Another consideration may be the organization's policy of response in a public setting (i.e., does the organization
provide assistance or contact EMS as first responder to a public occurrence?). In addition, the only guidance
provided for call cord length is for psychiatric hospitals, geriatric, Alzheimer's, or other dementia units where the
length is limited to six inches. All other locations should be assessed by the organization to determine an
appropriate height for patient use and patient safety relative to situations when one may fall to the floor.

Emergency Generator - Fuel Capacity

What is the minimum required on-site fuel supply necessary?

The minimum required on-site fuel supply is determined by the licensing authority (typically the state health
department). It is typically stated in hours, so the on-site fuel storage is based upon the peak building load
connected to the generator, not necessarily the full load capacity of the generator unless required by the licensing
authority. Seismic risk area generators are required to operate for a minimum of 96 hours without refueling.

Emergency Generator 4-hour Load Test

Can the generator load bank test be combined to meet the 36-month test as well as the 4-hour load
test?

The Joint Commission requires compliance with NFPA 110-2010. The testing for an annual load bank test and
the triennial exercise may be combined according to NFPA 110-2012, 8.4.9.7 where the first three hours of the
test is required to be not less than 30% of the emergency generator nameplate kW rating or the minimum
exhaust gas temperature. The last hour cannot be less than 75 percent of the emergency generator nameplate
kW rating.

Emergency Generator Monthly Test - 30% Threshold

When are annual emergency generator load tests required?

Any generator that serves the loads described in EC.02.05.03 are to be tested monthly with building (dynamic)
load for at least 30 continuous minutes. When using building load, if the test cannot achieve at least 30% of the
generator’s rated capacity or the minimum exhaust gas temperature during all monthly tests, they are required to
perform an annual test with a artificial load per the test procedure. The annual test is not a full load test… it’s a
stepped test at 50% for 30 minutes and 75% for one hour. The annual test requirement only applies to diesel
generators that cannot remain above the 30% threshold during the monthly tests. The annual test is not
applicable to natural gas or propane generators, but the monthly test still is applicable. It is important to note that
the stepped load test will be required as long a NFPA 110-2010 is used.

Emergency Power Systems - Testing and Inspecting

What is the requirement for testing the battery feature of egress lights?

Per NFPA 101-2012, 7.9, a functional test is required to be performed for all emergency egress and exit lighting
on a monthly basis for a period of not less than 30 seconds; regardless if the sole source of emergency power for
the egress light is a battery or if the egress lighting is powered solely by the essential electrical system. But the
annual 90-minute test applies only to battery-powered emergency lighting (egress lighting and exit signs). If there
is an emergency power source installed that can illuminate egress lights in less than 10-seconds, then the battery
feature of the lights is not required.

Emergency Power Systems - Types

What is the distinction between emergency generators, stored emergency power supply systems
(SEPSS), and UPS, and when is one used versus the other?
The loads defined by EC.02.05.03 require a reliable emergency power source. Stored-energy emergency power
supply systems (SEPSS) are one means to automatically supply emergency power to critical loads and
generators are another. Per NFPA 111, a SEPSS consists of an uninterruptible power systems (UPS), a rectifier
plant, or a motor generator powered by a stored electrical energy source; a transfer switch designed to monitor
preferred and alternate load power source and provide desired switching of the load; and all necessary control
equipment to make the system functional. Per NFPA 99, restoration of critical loads are required within 10
seconds. If an UPS is installed to condition power or supply power when normal power is interrupted until
emergency power from a generator, SEPSS, or normal power is re-established, the UPS is considered a bridging
device, and not a SEPSS. In this case, the UPS would be maintained according to the maintenance frequency
and strategy established by the organization.

Environment of Care / Safety Committee - Criteria

What are The Joint Commission standards with regards to Environment of Care Committee
requirements?

The Joint Commission standards do not require an environment of care (or safety) committee. Specific
tools used to maintain compliance, like a multidisciplinary committee or environmental tours, are no
longer specifically required. EC.01.01.01 requires an individual or individuals to manage risk,
coordinate risk reduction activities in the physical environment, collect deficiency information, and
disseminate summaries of actions and results. This is typically accomplished by a committee of
appropriately qualified and responsible personnel with expertise in the applicable portions of the
environment of care chapter, to include safety, security, hazardous material and waste, fire safety,
medical equipment management and utility systems management. Depending upon the size and
complexity of the organization, these duties may be performed by one person, multiple persons, or
persons assigned multiple duties. By identifying one or more individuals to coordinate and manage
risk assessment and reduction activities, organizations can be more confident that they have
minimized the potential for harm, and have effectively managed the required aspects of the
environment of care. The Leadership Chapter establishes reporting relationships between leadership
and responsible entities. If used, the make-up of the EOC committee, the frequency of meeting, the
agenda items, and the reporting requirements are to be assessed based upon the particular
circumstances of the organization in order to effectively monitor, analyze and improve the
environment. The organization must be able to demonstrate on-going activity throughout the
reporting period in order to remain aware of the dynamic circumstances of a health care organization,
to be able to assess situations and make needed changes, and to make an accurate evaluation of
effectiveness at the end of the reporting period. Although not prescriptive, if the responsible group
meets less frequently than quarterly, the survey process would likely require a satisfactory explanation
of how it can effectively manage the dynamic character of a health care organization. The survey
process will also validate that meetings are conducted in accordance with established policies, to
include established frequencies and attendance requirements.

Environment of Care Management Plan - Annual Evaluation

What is the annual evaluation requirement for Environment of Care management plans?

By evaluating the management plans, the organization can make sure that the plans remain relevant and useful
guides for managing the environment of care. A review of the plans’ scope includes a determination of whether
any new services, programs, or sites that were added in the past year (or the last 12-month period of evaluation)
need to be addressed by the plans or if new hazards have been introduced into the environment that now need to
be covered. A review of the plans’ effectiveness could be accomplished through a review of incident reports as
well as evaluation of other known issues such as problems identified in the critique of fire drills or environmental
tours. A review of the plans’ objectives would include a determination of whether the previous year’s objectives
were met and if any new objectives/improvements should be established to address problems identified in the
review of the plans’ effectiveness. An overall determination of plan performance effectiveness for the review
period is to be made.

Eye Wash Station and Emergency Showers - Design Criteria

What is the design and operational criteria for eye wash stations and emergency showers?

The Joint Commission references ANSI Z358-1 as a basis for evaluating eye wash station and emergency
shower design configurations and functionality. The need is based on the corrosive level noted of the material
being handled and the risk of exposure . However, a proactive, defensible, documented risk assessment process
that may deviate from Z358.1 is acceptable provided OSHA criteria is not compromised. Eyewash bottles are
acceptable as supplemental devices to eyewash stations (cannot replace) and should be employed through the
risk assessment process for applicability.

Fans - Patient Care Areas

Are fans allowed in patient care areas, laboratories, or other support areas in an organization?

There are no specific Joint Commission standards that prohibit the use of fans. While fans may be used for
additional comfort of the patient, such as those with respiratory distress or post cardiac surgery, they may
indicate to surveyors that a temperature control or ventilation problem exists, as described by EC.02.05.01.
Space temperature issues can impact equipment, patient testing results, and overall patient care. This concern
usually arises after adding equipment or use of the space without increasing the capability of space
cooling/ventilation. The organization should perform a risk assessment per EC.02.01.01 that includes the most
appropriate persons available to the organization. Examples of assessment concerns could include: risks
pertinent to the needs of the patient; ventilation and/or temperature concerns for equipment; airborne
particles/contamination that may impact patient care, procedure/treatment processes or equipment operation;
maintaining the cleanliness of fan blades/housing; possible tripping hazard(s) created by cords; etc. Infection
control should be a key element in the assessment process. The survey process will evaluate the risk
assessment for effectiveness and validate proper implementation of the resulting policy/practice. Adjustments to
the implemented process are to be made as needed.

Fire Drill - Transmission of Fire Alarm "After Hours"

What is the requirement for fire signal transmissions during fire drills?

NFPA 101-2012 18/19.7.1.4 requires transmission of a fire signal during a fire drill; this requires the fire alarm to
be activated. There is an allowance for a coded announcement to replace audible alarms for fire drills conducted
between the hours of 9 pm and 6 am in 18/19.7.1.7. This would allow audible annunciators to be silenced prior to
the fire drill, but there is no stated relaxation of the requirement to transmit the fire alarm signal. Activation of the
fire alarm between 9 pm and 6 am would allow for evaluation (critique) of fire safety equipment other than the
audible alarms, to include signal transmission to the fire department, visual annunciators, door releases, elevator
recall, etc.

Fire Extinguishers - Inspection Intervals

What is the requirement for fire extinguisher inspection intervals?

The Joint Commission requirement for inspection of fire extinguishers is once per calendar month. There is no
minimum and maximum requirement for the interval of days between monthly inspections, but best practice is to
maintain an interval as close to 30 days as reasonably possible.

Fire Extinguishers - Operating Rooms

What is the requirement for determining fire extinguisher types in operating rooms?

The 2010 edition of NFPA 10 Standard for Portable Fire Extinguishers is a mandatory reference in chapter 2 of
the 2012 edition of NFPA 99, Healthcare Facilities Code. The organization is to determine the appropriate fire
extinguisher based upon risk. Organizations are encouraged to research what is appropriate for their situation.
Possible considerations are that the water mist could be for surgical site fires, and the CO2 could be for drapes
and other combustibles in the OR. With regard to water mist, ECRI Institute has published information to indicate
that they may not be an appropriate extinguisher. Another consideration is to evaluate whether a close-by basin
of sterile water with a sponge to quench a surgical site fire might be most appropriate. A CO2 extinguisher may
be made available in the room for fires away from the surgical field. But again, a site-specific risk assessment
would be in order. See NFPA 99, Chapter 15 for further information regarding fire loss prevention in the operating
rooms.

Fire Extinguishment Systems - Testing and Cleaning

What is the requirement for testing kitchen automatic fire extinguishing systems and cleaning
requirements?

The Joint Commission has no specific checklist for semi-annual inspection tasks for these systems. Criteria is
found in NFPA 96-2011 where all actuation components, including remote manual pull stations, mechanical or
electrical devices, detectors, actuators, and fire-actuated dampers, shall be checked for proper operation during
the inspection in accordance with the manufacturer’s listed procedures. This includes annual fusible link
replacement. The organization must also be able to demonstrate on-going compliance with required system
design components described in LS.02.01.35, which includes proper portable fire extinguishers in the vicinity,
proper grease removal devices, fire alarm system activation, deactivation of the cooking fuel source and proper
operation of the exhaust system. Note that NFPA 101-2012 allows for no activation of the building fire alarm
system by the commercial cooking equipment extinguishing system when the kitchen is fully sprinkler protected.
Guidance for cleaning can be found in NFPA 96-2011, but The Joint Commission has no specific standard that
requires exact compliance. The organization is required to have a strategy in place for cleaning based upon an
assessment of manufacturer's requirements, risk levels and hospital experience as described in EC.02.05.01.
Generator - Monthly Load Test

What is the requirement for initiating and completing the monthly emergency generator load test?

The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical
power. There is typically a "test" switch on an automatic transfer switch that simulates a loss of normal power;
this results in automatic generator start-up and automatic ATS transfer to the generator as an emergency power
source. An organization may choose open (turn off) a circuit breaker that results in a loss of normal electrical
power. The result must be that the generator automatically starts-up and ATS automatically transfers to the
generator as an emergency power source. Either action will satisfy the requirements provided the generator runs
under load from a cold start for at least 30-continuous minutes. The generator will require an unloaded cool-down
period (typically 5-minutes), but this is not considered part of the at least 30-minute load test.

Grounds Maintenance - Safety

How does grounds maintenance activities apply to safety in the environment of care?

Grounds maintenance is to be in the context of safe ingress and egress to the health care facilities from where
customers enter the campus. For example, safe/effective vehicle access to parking areas, and safe/effective
pedestrian access to the facilities from parking lots, shuttle and bus stops. This would include lighting, signage,
surfaces, play areas, etc. Also evaluate exterior equipment that supports the health care organization such as
bulk medical gas tanks/manifolds, loading dock equipment, grounds equipment, etc. [EC.02.01.01]

Hazardous Material - Waste Inventory Program

What is the requirement for having a hazardous material inventory?

A hazardous material inventory is required by all employers in order to provide information to their employees
about hazardous materials to which they may be exposed to in their workplaces as stated in the OSHA Hazard
Communication Standard, 29 CFR 1910.1200 (see 29 CFR 1910, Subpart Z, Toxic and Hazardous Substances).
Any hazardous material or waste that is regulated by local, state, or federal law (including OSHA, EPA, DOT, etc)
are required to be part of your organization’s current inventory of hazardous materials and waste. This inventory
may either be consolidated into one document, or decentralized. Consumer products (such as turpentine,
gasoline or white out) that are used in a workplace in such a way that the duration and frequency of use are the
same as that of a consumer, are not required to be included in the hazardous material and waste inventory.
However, it is the responsibility of the employer to make the determination for their workplace by assessing the
exposure potential of the consumer products that staff may encounter and ensuring that the frequency and
duration of use are not greater than that of normal consumer use. A good rule-of-thumb would be, for a given
product, review the Safety Data Sheet (prior MSDS) and determine if the organization's method of use could
result in adverse exposure. If the SDS contains any storage or usage warnings, like special storage, special
cirteria for the use environment, critical emergency actions to take if exposed, etc. then those products should be
included in the hazardous materials inventory. Hazardous wastes are typically tracked by manifest, and that acts
as an inventory. [EC.02.02.01]

Inspection Reports - Fire Safety Format

What is the required format for fire safety system inspection reports?

The Joint Commission does not require a specific format for fire safety system inspection reports since there is
wide variation in the installed systems for the heath care organizations that TJC accredits. Standard EC.02.03.05
EP 28 requires the inventory of devices and equipment, name of the activity, the date of the activity, the required
frequency of the activity, the name and contact information (including affiliation) for the person who performed the
activity, and the NFPA testing standard used (including the edition and section). It is also required to note the test
results, because fire alarm and fire extinguishing systems are considered critical to a fire-safe environment and
there is to be a documented pass/fail indication (result of the activity) for functional tests associated with each
uniquely identified device or piece of equipment tested. This includes each audible and visual device, each
releasing device, each fire department connection, etc. Test results for input devices (detectors, pull stations,
etc.) are to be distinguishable from test results for output devices (annunciating devices, releases, AHU shut-
down, etc.) . There is to be documented evidence that each deficiency identified was corrected in a timely
manner. The report should be formatted so that the person presenting the report during a TJC survey is familiar
with the content. A common issue during the survey process is that the organization is not adequately familiar
with the content of the report and the configuration of their fire safety systems. An effective way to accomplish
this is for the testing entity to closely review the report with the organization's representative.

Ligature Risks - Assessing and Mitigating Risk For Suicide and Self-Harm

What are the Joint Commission expectations for identifying and managing ligature risks in the hospital
setting?

For inpatient psychiatric hospitals, inpatient psychiatric units in general acute care hospitals, and non-behavioral
health units DESIGNATED for the treatment of psychiatric patients (i.e. special rooms/safe rooms in Emergency
Departments or Medical Units):
 The requirements found in the Environment of Care (EC) chapter of the accreditation manual at
EC.02.06.01 require hospitals to establish and maintain a safe, functional environment. Element of
Performance # 1 states “Interior spaces meet the needs of the patient population and are safe and
suitable to the care, treatment, and services provided”. Therefore, ligature and self-harm risks must be
identified and eliminated. While risks are in the process of being eliminated, policies and procedures
must be developed and implemented to mitigate the harm posed by such risks. Mitigation plans must
include, at a minimum the following: :
• Ensuring that leadership and staff are aware of the current environmental risks
• Identifying patients’ risk for suicide or self-harm, then implement appropriate interventions based
upon risk.
• Ongoing assessments and reassessments of at-risk behavior as defined by the organization.
• Ensuring the proper training of staff to properly identify patients’ level of risk and implement
appropriate interventions
• Incorporating suicide risk and self-harm reduction strategies into the overall Quality
Assessment/Performance Improvement (QAPI) program - see LD.01.03.01 EP 21.
• If equipment poses a risk but is necessary for the safe treatment of psychiatric patients (i.e.
medical beds with side rails on a geriatric unit), the
organization must consider these risks in patients’ overall suicide/self-harm risk assessments,
then implement appropriate interventions to
diminish those risks

In non-behavioral health units (i.e. Emergency Rooms or Medical Inpatient Units) that are NOT DESIGNATED
specifically for the treatment of psychiatric patients; however, where psychiatric patients may temporarily reside,
ligature/self-harm environmental risks must also be identified.

All physical risks not required for the treatment of the patient that can be removed, must be removed.
Furthermore, an appropriate level of effective surveillance must be implemented if self-harm risks remain in the
environment. Organizational policies and procedures must adequately guide staff in the assessment of patients’
risk for suicide/self-harm and the implementation of interventions based upon the patients’ individual needs.

For non-inpatient programs surveyed under the Hospital Accreditation manual, an environmental risk assessment
should be completed. Based upon the results of that assessment, taking into account the individuals they serve,
the organization determines if any modifications to the environment should be made. Policies and procedures
should also be developed and implemented to address the immediate action to be taken by staff when a patient
is assessed to be at risk for suicide.

Additional Resources for assessing suicide risk:

Sentinel Event Alert # 56
Facility Guidelines Institute: Design Guide for the Built Environment of Behavioral Health Facilities
Suicide Risk Booster - available to accredited organizations via their Secure Extranet Site

Medical Equipment - Blanket Temperature Risk Assessment

What standards apply to the requirement for organizations to maintain blanket temperatures?

The Joint Commission standards are not prescriptive with regard to blanket temperature, unless the
organization's controlling authority for health care operations has requirements. The organization is to have an
effective process in place to manage blanket temperatures for the purpose used. As indicated by EC.02.01.01,
the hospital should identify safety risks associated with blanket warmer use, then take action to minimize or
eliminate those risks. Different applications for different types patients in different conditions likely will require
different blanket temperatures. Some form of temperature validation test (for example, by touch or thermometer)
is needed before a blanket is used by a patient. There is to be a policy that establishes safe criteria for evaluating
and applying warm blankets, and staff that apply blankets are to know that criteria. Staff knowledge should
include the effects of temperature and contact duration of blankets applied directly to the skin regardless of
whether the blanket is intended to contact the skin directly. The policy and implementation should be periodically
assessed for effectiveness and safety. Blanket warming equipment should be maintained in accordance with
manufacturer's recommendations or an effective alternate equipment maintenance strategy.

Medical Equipment - High-Risk Equipment

What is the requirement for high-risk medical equipment to have emergency power required?

Crash carts and defibrillators are to be considered high risk medical equipment, therefore it is critical and required
that they perform properly when needed. Unless direct (plugged) power is required to directly operate the crash
cart equipment or defibrillator, The Joint Commission has no standard that requires the charging of a crash
cart/defibrillator to be from an emergency electrical power source, although it would be considered a best
practice. Only a crash cart and defibrillator that requires connection to electrical power to operate (not to charge)
are required to be plugged into an emergency power receptacle. The organization could perform an assessment,
to include the elements described in EC.02.04.01, to determine the best strategy for their circumstances, then
resulting in a policy. For example, if the device is not plugged into emergency power for charging, and there is a
prolonged normal electrical power outage, there is to be a process in place to maintain the battery charge
through the outage. If the organization's policy is for the defibrillator to be connected to emergency power, then
The Joint Commission would expect the policy to be followed. [EC.02.04.03]

Medical Equipment - Initial Check

What is the requirement for safety, operational and functional checks to be performed on equipment?

There is to be a safety check to determine that the equipment is safe for the user and the patient; this is typically
an electrical safety check in accordance with NFPA 99 (1999) Chapter 7, but it may be something like a physical
integrity inspection for equipment such as patient lifts. There is to be an operational check to determine that the
equipment performs in accordance with manufacturer's design intentions. There is to be a functional check to
determine that the equipment will perform as intended for the organization's particular patient care needs. They
may or may not be the same tasks as long as safety, operational and functional criteria are satisfied. Any
equipment that has had major repairs or upgrades performed must have initial checks performed. Any equipment
transported between sites is required to have an initial check to ensure safety, operational and functional checks
are not compromised. [EC.02.04.03]

Medical Equipment - Inventory/High Risk Equipment/Maintenance Strategies

What equipment is required to be included in a medical equipment inventory and how is high-risk
equipment and maintenance strategies determined?

If using The Joint Commission accreditation process for CMS deemed status purposes, all medical equipment is
required to be on the medical equipment inventory. A risk assessment must first determine whether the medical
equipment serves a life support function and whether non-life support equipment is considered to be "high risk".
In the context of new standard EC.02.04.01, the term “high-risk” means those items for which there is a risk of
serious injury or even death to a patient or staff member should they fail. Although the term “high-risk” includes all
life support equipment, it applies more broadly to encompass other items that are technically not necessary to
support life but that would put the patient or staff member at risk if they fail, such as surgical robotics in the
operating room. Note: the term "high-risk equipment" is equivalent in scope and nature to the CMS term “critical
equipment”. In accordance with standard EC.02.04.01, to determine activities and frequencies of maintenance,
organizations must comply with manufacturers’ recommendations or with strategies of an alternative equipment
maintenance (AEM) program, as long as the AEM does not reduce safety and is based on accepted standards of
practice. An AEM strategy may include reduced or altered maintenance tasks, relaxed frequencies of
maintenance, run-to-fail strategies, etc. Assessments for AEM strategies must be documented in accordance
with EC.02.04.01. Trade organizations such as ASHE, AAMI, AORN, etc. may provide further information with
regard to establishing alternative equipment maintenance strategies. For medical equipment, accepted standards
may be found in the American National Standards Institute/Association for the Advancement of Medical
Instrumentation handbook ANSI/AAMI EQ56: 2013, Recommended Practice for a Medical Equipment
Management Program. High-risk medical equipment is required to be maintained at 100% of schedule.
[EC.02.04.01]

Medical Equipment - Sharps/Needle Boxes Risk Assessment

Are there specific requirements for the deployment of sharps/needle boxes or containers?

The Joint Commission does not specify criteria for sharps/needle boxes or container deployment and security.
The Joint Commission standards require that organizations conduct a comprehensive risk assessment in
accordance with standard EC.02.01.01 to determine the potential adverse impact of equipment, supplies and
other factors on the safety and health of patients, staff, and others. The standards also require that organizations
use the information from the risk assessment to implement procedures and controls to address the potential
adverse impact, such as access control or container security. The risk assessment should determine whether the
selected placement of containers pose a risk to the occupants of the vicinity. In addition to considering patient
population, it also is important to consider whether visitors (perhaps with small children) could access the
containers. Include input from infection control, risk management, and the safety officer in the risk assessment
process. The Centers for Disease Control (CDC), the National Institute for Occupational Safety and Health
(NIOSH) and the Americans with Disabilities Act (ADA) provide further guidance that may be useful.
[EC.02.01.01]

Medical Equipment - Storage of Needles and Syringes

What are the Joint Commission requirements regarding storage of needles and syringes?

While there are no standards that specifically address needle and syringe storage, such items should
be kept secure to protect from tampering or theft. A secure area may be described as “an area where
the staff is providing patient care, or staff is present and effectively ensures that access to the area or
storage device is restricted to authorized individuals, and patients and visitors are not allowed access
without the supervision or presence of a health care professional.”

Organizations are expected to implement a process to identify safety and security risks associated
with the environment of care that could affect patients, staff, and other individuals. Conducting a risk
assessment is a helpful way of identifying risks associated with various options being considered to
ensure safe storage of syringes and needles.

A proactive risk assessment examines a process in detail including sequencing of events, actual and
potential risks, and failure or points of vulnerability and that prioritizes, through a logical process,
areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or
services provided. The services provided, patient population served and applicable law and regulation
should be included in the assessment process. Based on risks identified, organizations may
determine that use of a locking device or storage unit may be needed to prevent unauthorized access
to these supplies.

The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk
assessment model that an organization may use. However, this specific approach is not mandated as
there are other risk assessment tools available that may better meet the needs of the organization.
Other examples may include a root cause analysis, failure mode and effect analysis,
plan/do/check/act process, etc., or combinations and variations

Medical Gas Shut-off Valve - Labeling

What is the requirement for labeling medical gas shut-off valves?

Each room served by the piped medical gas and vacuum zone valves is to be identified. Consecutive rooms
served, like "Procedure Rooms 1-6" can be used. General statements of area are not acceptable. Labeling of
medical gas and vacuum valves is to be in accordance with NFPA 99 (1999 edition). A zone shut-off valve with a
removable panel does not have to be labeled both on the valve and on the removable panel; just one location is
adequate. Hidden shut-off valves, such as those above the ceiling, are to be labeled on or near the valve; its
hidden location can be identified by a label, icon, etc., or on a utility systems map in accordance with
EC.02.05.01. [EC.02.05.09]

Minimizing Waterborne Pathogens - Ice Machines

What are the requirements for ice machines in health care settings?

Ice machines are considered utilities system components that require a maintenance strategy per The Joint
Commission standard EC.02.05.01 EP 1 through 7, and EP 14. Per these elements of performance, the
organization evaluates and determines maintenance activities and intervals of maintenance based upon
manufacturer's recommendations or an alternate equipment maintenance (AEM) program. Ice machines that
provide patient nutrition are high-risk utility system components since they have an infection control risk as
described within EC.02.05.01, where the organization is to minimize pathogenic biological agents in domestic
cold water systems. Therefore, the hospital should pay particular attention to evaluate the requirement for
infection prevention through activities such as supply water filtration, disinfection of ice machine internal parts,
cleanliness of ice machine bins, build-up of water deposits, etc. It is important for a hospital to know the quality of
their water service, the condition of their domestic water distribution system, and the design/condition of their ice
machine equipment in order to establish an effective maintenance strategy. If maintenance tasks and frequencies
are not established by manufacturer's recommendations, assessment described by EC.02.05.01 is to be used to
determine an AEM program to satisfy the organization's particular circumstances. Once established, schedule
maintenance is to be completed in accordance with EC.02.05.05. [EC.02.05.01]

NFPA 99 - Edition Adoption Date

What is the requirement for retroactive compliance with NFPA 99-1999?

Chapter 1 of NFPA 99 does not require retroactive compliance unless alteration has occurred or any of the
organization's controlling authorities require retroactive compliance. The 1999 edition was adopted by The Joint
Commission and CMS in 2003. There was no NFPA 99 edition prior to 1984. For the years between, use the
edition required by the organization's controlling authority for health care construction. In order to be relieved of
1999 edition requirements, the organization must know the applicable requirements of construction for their
facilities. [EC.02.05.01]

Operating Room - Temperature

Can temperatures be outside of established range in operating rooms?

NFPA 99-2012 requires the use of ASHRAE 170-2008, Ventilation Table 7-1, which has an allowance to exceed
minimum temperature ranges. If this exception is used, it is acceptable for it to be done by established policy,
without the requirement to log the issue. If the temperature is set below the established range, then there needs
to be an assessment that patient care will not be compromised by the low temperature level; specifically that the
low temperature will not adversely affect the relative humidity level.

Oxygen Cylinder - Storage Management

What are the requirements for oxygen cylinder storage and the segregation of full, empty, and partial
tanks?

Physical Storage of Cylinders

Storing oxygen cylinders, as per NFPA 99-2012, 11.6.5.2, is about managing empty cylinders. Those cylinders
defined as empty by the organization shall be segregated from all other cylinders that are intended for patient
care use. Full and partially full cylinders are permitted to be stored together, unless the organization's policy
requires further segregation.

Empty cylinders shall be marked as such by either individual tagging, as indicated by the integral gauge (and
defined by policy), or group signage, as appropriate. Organizations must assess cylinders without an integral
gauge in order to determine the capability to provide safe patient care delivery and implement the assessment
according to its policy.

For example, if a rack of twelve cylinders were in an area and four of the cylinders were determined to be empty,
they must be segregated from the other cylinders and labeled as empty per NFPA 99-2012, 11.6.5.2 and
11.6.5.3. If there was a rack designated for empty, the designation would accomplish the “marking” of the
cylinders by the nature of the labeled empty rack.

For those cylinders outside of protected storage

Up to 300 cubic feet (i.e. 12 E cylinders) of non-flammable medical gases may be stored outside of enclosures
within a smoke compartment (22,500 square feet). All cylinders shall be attached to a cylinder stand, properly
attached to equipment, or properly racked. NFPA 99-2012,11.3.3.4 states that individual small-size cylinders (A,
B, D, or E) available for immediate use in patient care areas shall not be considered in storage. Immediate use
includes the following:

emergency designated cylinders (i.e. crash cart)

designated to transport equipment that is not in storage
actively in-use

For the purpose of calculating the aggregate total, empty and immediate use cylinders will not be included in the
volume limitations noted in section 11.3; that is, full and partially full cylinders will be considered full for
aggregation purposes.

Piped Medical Gas/Vacuum Systems - Maintenance Strategy

What is the requirement for activities and intervals of testing for piped medical gas and vacuum
systems?

The Joint Commission standards are not prescriptive with regard to tasks and frequencies for piped medical gas
and vacuum systems. In accordance with EC.02.05.09, for each piped medical gas and vacuum system, the
source, distribution, inlets/outlets, and the alarms that protect the systems are to be maintained in a safe and
reliable condition. These are considered high-risk utility systems. In accordance with EC.02.05.01, the
organization is to develop a maintenance strategy based upon manufacturer's recommendation or an alternative
equipment maintenance (AEM) strategy. Issues such as system complexity, system age/condition, patient acuity,
etc. are to be used to assess maintenance strategies. NFPA 99 (1999 edition) Appendix C can be used as a
guide for establishing a maintenance strategy, but appendix material are not requirements unless adopted by a
controlling authority. The survey process will evaluate the maintenance strategy assessment process for
effectiveness, and validate that it has been properly implemented. [EC.02.05.09]

Plans - Business Occupancy Requirement

Are environment of care management plans required for business occupancies?

While plans are required to cover each of the Environment of Care (EC) and Emergency Management (EM)
chapters, the content of the organization's EC & EM plans and policies for those plans that address business
occupancies should be designed to meet the needs of the organization. These will vary based on the nature and
complexity of operations. Some standards may not apply to the business occupancy location at all, and this
needs to be noted. The intent is to assure reasonable programs are in place and designed to meet the needs of
the organization for all occupancies where patients are seen or treated. [EC.01.01.01]

Plans - Environment of Care Leadership Oversight

Is an organization's governing board required to approve Environment of Care management plans?

There is no specific Leadership or Environment of Care standard that requires the organization's governing body
to approve environment of care management plans. If the governing body determines that review of environment
of care management plans is their duty, then that must occur. There must be regular communication between the
governing body and hospital leadership with regard to safety and quality, which may include environment of care
issues.
Plans - Management Plans vs. Policies/Procedures

How are management plans different than policies and procedures?

Management plans are not operational policies, but provide a high-level framework for environment of care
management. In other words, management plans should be a roadmap/outline to describe how the standards
apply to the organization, and then describe how the organization will comply with the applicable standards. They
cover all facilities where patients are seen or treated. They identify how the organization will manage risks
through planning, implementation, and evaluation of results. They address scope, objectives, staff
responsibilities, and time frames for identified activities. They are used as a guide to maintain ongoing
environment of care standards compliance through meetings, reporting, data collection, communications, etc. so
that at the end of a 12-month period, the environment of care program can be effectively evaluated. Therefore,
environment of care management plans are to be reviewed annually. [EC.01.01.01]

Plans - Security Management Risk Assessment

What are the requirements for developing a security program/security management plan?

In accordance with standard EC.01.01.01, the organization is required to develop a security management plan
specific to their particular circumstances based upon assessment of risk as described in EC.02.01.01. Applicable
staff, the type of training, their level of training, required credentials, etc. are considerations. For example, a
forensic behavioral health environment would likely have different criteria than a geriatric health environment.
Based upon their duties, staff may be assessed to require physical restraint training, self-defense training,
situation de-escalation training, etc. Once the required skill-set and type/level of training is established, the
organization is to create applicable policies, implement the security program, assess for effectiveness, and adjust
the strategy if needed. Any requirements of another controlling authority, like a state entity, must be followed. The
survey process will evaluate the assessment process and, through tracer activities, validate implementation in
accordance with the established policy. The survey process may also include interview of patients, and their input
is considered when the security program is evaluated. (Note: See standard PC.03.05.17 for restraint and
seclusion training.) [EC.01.01.01]

Pre-construction Risk Assessment - Requirement

What is the requirement for an organization to have a pre-construction risk assessment?

Standard EC.02.06.05 requires the organization to have a pre-construction risk assessment process in place,
ready to be applied at any time if planned or unplanned demolition, construction or renovation occurs.
Additionally, organizations must have a process that allow for minor work tasks to be performed in established
locations or under particular low risk circumstances using predetermined levels of protective practices. The
assessment covers potential risks to patients, staff, visitors or assets for air quality, infection control, utility
requirements, noise, vibration and any other hazards applicable to the work. The Joint Commission does not
dictate a particular risk assessment and implementation process. Recommendations can be found in the 2014
FGI Guidelines for Design and Construction of Hospitals and Outpatient Facilities and the Centers for Disease
Control and Prevention (CDC).

Many organizations use an assessment matrix that applies the construction intensity to the risk level of the work
area, which results in particular protective practices to be implemented or an available menu of protective
practices to be implemented. This could include removing ceiling tile for inspections, control device operation,
minor repairs, etc. The area of the work would likely dictate the level of unprotected work allowed, for example,
an lower risk administrative or support services area versus a high risk sterile or critical care area. Staff and
contractors performing the work are to have working knowledge of the established criteria, to include why
protective measures are necessary. Some organizations choose to use a permit process, particularly when
contractors are performing work in their facilities, where for example, permits are prominently displayed on their
ladder or work area. It is recommended that occupant staff be aware of the general work guidelines, particularly
when using a permit process, in order to provide extra enforcement capability.

Pertinent work practices are to be used such as spraying ceiling tile with a liquid before removal, having a
portable vacuum or wet cloth handy when removing electrical covers, or using containment booth when working
above the ceiling at an isolated location. The task and the location of the work would dictate the level of
protection, if needed. The definition used for demolition, construction or renovation is less important than the
context of the work. Will the work result in an environmental risk to patients, staff or visitors? There can be
policies in place to manage regular inspection, maintenance and repair activities, with an assessment process
established for more complex or unusual activities. That assessment process can range from pre-established
practices to situations that require extensive analysis.

Refrigerator - Design Quality

What is The Joint Commission standard for specific design quality, criteria for both clinical and non-
clinical use of refrigerators?

The Joint Commission has no standard that requires organizations to use a specific design quality or criteria for
refrigerators. It is recognized that medication or laboratory refrigerators would likely require a significantly higher
level of design quality than a food refrigerator in order to maintain acceptable temperature ranges. Although not
specifically required, refrigerators marketed by manufacturers to be medical grade typically are designed for more
aggressive and precise temperature control, and are constructed of more durable components (like metal
construction, typically stainless steel). Through assessment of the product stored, the organization is to select the
most appropriate quality and functionality for refrigerators to meet patient care and their operational needs. One
caveat would be the use of dormitory-style units. The Joint Commission agrees with CDC recommendation not to
store vaccine in a dormitory-style (or bar-style), combined refrigerator/freezer unit under any circumstances. A
dormitory-style refrigerator is defined as a combination refrigerator/freezer unit that is outfitted with one exterior
door and an evaporator plate (cooling coil), which is usually located inside an ice maker compartment (freezer)
within the refrigerator. In performance testing, this type of unit demonstrated consistently unacceptable
performance, regardless of where vaccines were placed. It also exhibited the inability to maintain temperatures
and there were wide variations throughout the unit. There is no “good” vaccine storage area in this style unit.
These units pose a significant risk of freezing vaccine even when used for temporary storage. Reference:
http://www.cdc.gov/vaccines/recs/storage/toolkit/storage-handling-toolkit.pdf

Refrigerator Temperature - Patient Care Food Storage

What is the requirement or standard that addresses thermometers or temperature logs for refrigerators
or freezers used for food storage?

The Joint Commission does not specifically require temperature logs for refrigerators and freezers used for food
storage. Food and nutrition products are stored under proper conditions of sanitation, temperature, light,
moisture, ventilation, and security. Depending on the accreditation program, it may be addressed at PC.02.02.03
or in CTS.04.03.33. These variables must be monitored to assure proper storage. One means of compliance
could be a digital minimum/maximum thermometer with a built in alarm to monitor the temperature of the
refrigerator/freezer. With this device if the temperature goes outside the set range an alarm will sound. As a result
daily monitoring by staff would not need to occur. Periodic logging of temperatures where the appropriate range
of compliant temperatures is identified, and noting needed corrective action on the log is another available
alternative. Internal refrigerator temperature monitoring devices with remote alarming notification capability is also
available. Staff would need to demonstrate competence with whatever method is used. Selected equipment must
be properly maintained.

Specific to expiration dating and discarding unused food, organizations are expected to comply with the product
manufacturer's guidelines for safe storage as well as applicable law/regulation that may be defined by your local
authority having jurisdiction (i.e., local or state health department, etc.).

Refrigerator Temperature - Refrigerators Provided in Patient Rooms

When organizations provide refrigerators in patient rooms for personal use, is temperature monitoring
and log maintenance required for these refrigerators?

There are no standards that prescriptively require temperature monitoring or maintaining a temperature log for
refrigerators provided for personal patient use. However, a process is required to ensure the refrigerator
functions properly to ensure safe storage of its food contents. Use of a temperature monitoring is but one
approach the organization may choose to ensure the unit is functioning properly.

The Joint Commissions standards require that organizations store food and nutrition products, including those
brought in by patients or their families, using proper sanitation, temperature, light, moisture, ventilation, and
security (see PC.02.02.03). When nutritional products, such as breast milk or baby formula are stored in these
units, evidence-based guidelines from sources, such as the CDC, the formula manufacturer, etc., are to be
followed to ensure safe storage. Organizations should also have processes that address cleaning between
patients and maintenance responsibilities. Consulting with local/state board of health agencies is recommended
as there may be additional requirements to consider.

A risk assessment should be conducted to identify any risk points associated with this practice. Conducting a risk
assessment is a helpful way of identifying risks associated with various options being considered by the
organization. A proactive risk assessment examines a process in detail including sequencing of events, actual
and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for
improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.

The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment
model that an organization may use. However, this specific approach is not mandated as there are other risk
assessment tools available that may better meet the needs of the organization. Leadership responsible for
patient care practices, infection prevention and control, safe management of food and facilities maintenance
should be encouraged to participate in the risk assessment process.

Refrigerator Temperature - Temperature Logs - Non-patient Care

What is the requirement or standard that addresses thermometers or temperature logs in staff only
refrigerators?
There is no Joint Commission standard that requires thermometers in, or temperature logs for, staff only
refrigerators. Staff refrigerators are not usually in the equipment or utilities management program, but may have
be included in a maintenance program for the organization to keep them. It is recommended that you contact
your state or local health department as they may have a more strict requirement.

Regulated Waste - OSHA Definition

What is the definition of "regulated waste?"

Regulated Waste means liquid or semi-liquid blood or other potentially infectious materials; contaminated items
that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed;
items that are caked with dried blood or other potentially infectious materials and are capable of releasing these
materials during handling; contaminated sharps; and pathological and microbiological wastes containing blood or
other potentially infectious materials. Per OSHA, urine, feces, and other reasonably anticipated biological
components comprising human wastes are not included in the definition of "other potentially infectious materials"
unless "...visibly contaminated with blood". [EC.02.02.01]

Relative Humidity - Requirements

What are relative humidity requirements for critical spaces?

The Joint Commission expects organizations to have a process in place to demonstrate that proper humidity
(RH) levels are maintained. NFPA 99-2012 includes ASHRAE Standard 170-2008, Ventilation for Health Care
Facilities, and it applies to new facilities only. Existing spaces should be maintained as originally designed with
parameters identified by the organization. In April 2013, CMS issued a categorical waiver in its Survey and
Certification (S&C) letter 13-25-LSC & ASC that allowed the lower limit to 20% RH for anesthetizing locations
based on ASHRAE 170-2008, Addendum D. Note that Addendum D does not apply to sterile storage locations
that are not in the OR where a maximum of 60% RH is recommended in ASHRAE 170-2008. The organization
should develop its process using evidence-based guidance, including the manufacturers' instructions for use
(IFUs) to ensure that the supplies in these locations are not impacted at lower levels.

Please be aware that CMS also issued S&C letter 15-27 that advises organization to follow manufacturers'
recommendations for equipment and sterile supplies in the operating room (OR) environment to ensure that the
humidity levels in the ORs are compatible with the manufacturers' IFUs for the supplies and equipment in that
setting. Where the requirements of the equipment or supplies conflict with the space conditions, the organization
should take action to prevent an adverse condition. [EC.02.05.01]

Relocatable power taps - Definition

What is a Relocatable Power Taps (RPT)?

Relocatable power taps (RPT), sometimes called power strips, are not to be used with medical equipment in
patient care areas. Medical equipment is used to diagnose, treat, or monitor a patient, and makes physical or
electrical contact with the patient and/or transfers energy to or from the patient, and/or detects such energy
transfer to or from the patient. This includes critical areas such as operating rooms, recovery areas, intensive
care areas, and non-critical patient care areas such as patient rooms, diagnostic areas, exam areas. This applies
regardless of whether the RPT is hospital grade or not and the requirements are noted in NFPA 99-2012,
10.2.3.6. They may include supplementary over-current protection, switches and indicator lights, surge protection
capability, and in some cases connections for cable, communications, telephone or antenna. Relocatable power
taps may not be used as a substitute for adequate electrical outlets in a facility. RPTs may be used for non-
patient care equipment such as computers/monitors/printers, and in areas such as waiting rooms, offices, nurse
stations, support areas, corridors, etc. Precautions needed if RPTs are used include: ensuring they are never
“daisy-chained” (connecting one RPT to another), preventing cords from becoming tripping hazards; installing
internal ground fault and over-current protection devices and using power strips that are adequate for the number
and types of devices used. Overload on any circuit can potentially cause overheating and fire. The use of ground
fault circuit interruption (GFCI) may be required in locations near water sources to prevent electrocution of the
occupants.

Relocatable Power Taps - UL Requirements

Where can relocatable power taps (RPTs) be used and what are the UL requirements?

NFPA 99-2012 only considers the patient vicinity with regard to multiple outlet connections (power strips). So
within the scope of patient care areas, power strips providing power to patient care-related electrical equipment
must be Special-purpose Relocatable Power Taps (SPRPT) listed as UL 1363A or UL 60601-1, and power strips
providing power to non-patient-care-related electrical equipment must be Relocatable Power Taps (RPT) listed as
at least UL 1363. Although not enforced, CMS S&C 14-46 provides useful guidance for the use and management
of the SPRPTs and RPTs and areas where patient examination and treatment does not occur such as nurse
stations, store rooms, administration, materials management, food service, etc., but it would be prudent to use
power strips of a proven quality within health care facilities, like UL-1363 or better.

Risk Assessment - Staff Food and Drink

Are food, drink, and personal items for staff members allowed in patient care and staff work areas, such
as nurse stations, registration areas, etc?

The Joint Commission has no standard that specifically addresses staff food or drink in patient care or staff work
areas, to include nurse stations. Compliance with local or state authority is required, if applicable, per standard
LD.04.01.01. For example, a number of states prohibit staff food and drink in clinical areas, requiring that they be
consumed in break areas. Also, OSHA Bloodborne Pathogen Standard prohibits food and drink in areas where
contamination is likely. For example, if laboratory specimens are handled in area in question, the OSHA standard
would prohibit food and drinks as contamination might occur. Standard EC.02.01.01 requires the organization is
to establish a practice based upon assessment of their particular circumstances and any controlling authority
requirement. The environmental risk assessment process should consider issues like infection control (see
IC.01.03.01), aesthetics, clutter, image, etc. The organization's state and local health departments may also have
a specific position on this issue. The survey process will validate that the organization is complying with their
established policy through tracer activity. [EC.02.01.01] Based on the outcome of the risk assessment, each
organization is responsible for defining which areas are considered ‘patient care’ and ‘staff work areas’ to which
their policies apply.

Risk Assessments - How and When

How/when are risk assessments required to be performed?

The Joint Commission is not prescriptive in how risk assessments are to be performed. The Joint Commission
allows organizations to develop assessment methods that best suit their circumstances and preferences.
Organizations may use assessment tools that they consider appropriate to achieve an outcome that mitigates or
eliminates the risk. Examples are root cause analysis, failure mode and effect analysis, plan/do/check/act
process, etc.; or combinations and variations. Risk assessment results should be reported to the multi-
disciplinary team responsible for the Environment of Care Committee, and the Infection Control Committee if they
do not share representation. An organizational policy/practice should be generated, appropriate staff
trained/notified, and some method to assess effectiveness implemented. The survey process will review the risk
assessment and associated policy/practice for effectiveness, and the tracer process will validate proper
implementation. Some examples may be found in the Leading Practices area of the organization's Joint
Commission intranet website. [EC.02.01.01]

Safety Officer - Requirement

Is there a The Joint Commission standard that specifies a Safety Officer requirement?

There is no Joint Commission standard with a stated requirement for the position of Safety Officer. EC.01.01.01
requires the organization to identify an individual or individuals to perform specified risk reduction activities and
threat intervention responsibilities. It is important that all environment of care activities be effectively managed,
and that responsible staff have a clear understanding of their duties. Gaps in responsibility are to be identified
and corrected. From the Overview of the Environment of Care Chapter: The standards address the need to
identify someone to manage environmental risks as well as to intervene when situations threaten people or
property; both responsibilities may be assigned to one person. It is important to remember that the standards in
this chapter do not prescribe a particular structure (such as a safety committee) or individual (such as one
employee hired to be a safety officer) for managing the environment, nor do they prescribe how required planning
activities are conducted. Elements of the Human Resources chapter require the organization to insure that staff
are competent to perform their responsibilities. The organization defines the qualifications needed and
determines how staff will function within their organizational structure. Then the organization must properly orient,
then provide on-going education and training opportunities to staff in order for them to effectively perform their
duties. This must be validated through regular evaluation. The Joint Commission requires an organization to
comply with the staffing structure that they have established, and comply with the requirements of their other
controlling authorities as applicable. Organizations typically create an Environment of Care/Safety Committee to
manage EC activities, and typically identify a person, called the Safety Officer, to coordinate and take the lead in
the management of EC activities. But this is not a specific requirement as long as the organization can
demonstrate that environment of care activities are effectively coordinated from the perspective of assessment,
management, implementation, monitoring, analysis and program improvement. LD.04.01.05 applies specifically
to Emergency Management and the individual identified is typically (not required) called the Emergency
Management Coordinator. There is no requirement that this person be one-in-the-same as the individual(s)
identified by EC.01.01.01, nor must it be the same person designated as the Safety Officer (if the designation of
Safety Officer is used). [EC.01.01.01]

Safety/Security - Risk Assessment Frequency

How often are safety and security risk assessments required to be performed after the initial evaluation
is completed?

Environment of care standards do not require safety and security risk assessments to be done at any particular
frequency, but reassessment is to be done when significant changes to the environment of care occur. It is a
good practice to schedule assessments for high risk issues on a regular frequency in order to incorporate new
tools or knowledge that may have become available. Annual evaluation of safety and security management plans
are a requirement, so annual risk assessments are helpful tools to identify goals and objectives, and to recognize
changes that have occurred in the environment. Compliance with all elements of performance within the
EC.02.01.01 standard for safety and security issues lend themselves to the assessment process because
effective management depends upon analysis of the organization's particular circumstances. If an organizational
policy establishes frequencies of assessment, then the established schedule is to be followed. [EC.02.01.01]

Security - ID Badges

What are the requirements for ID badges?

The Joint Commission standard EC.02.01.01 requires that the organization identifies individuals entering its
facilities. The organization is expected to determine who requires identification and how the process is
implemented. If the policy requires all staff and independent practitioners to wear ID badges, then all staff
(including Physicians) would need to comply. Photo IDs, name on badges (first, last, both, one or the other, etc.)
may be necessary as some states have specific standards. There is no specific Joint Commission requirement
for photo identification, nor is there required badge information. Check with the local or state Authority Having
Jurisdiction for additional guidance. [EC.02.01.01]

Security - Pediatric Abduction

Are Infant/Child Abduction drills required?

The Joint Commission standards do not require infant/child abduction drills. The standards do require that the
organization identifies and implements security procedures that address handling of an infant or pediatric
abduction, as applicable. An exercise is one method to evaluate the effectiveness of the procedures regarding
this issue. It is up to the organization to determine the appropriate actions to ensure successful implementation of
the security procedures. Conduct a risk assessment through a multi-disciplinary group that includes OB, NICU,
Pediatrics and other staff, such as the Safety Officer, Security Officer, Emergency Room staff, foster care
personnel, direct child care staff, and the Risk Manager with each providing input in their area of expertise to
address actual and potential risks. [EC.02.01.01]

Security - Pediatrics Risk Assessment

What are the requirements for developing a security program/security management plan?

The Joint Commission has no specific standards for the security of pediatric inpatient units. There are many
available configurations, locking arrangements, security/access control systems, surveillance capabilities, etc.
available to achieve security for a wide range of risks associated with the pediatric population(s) served by a
health care organization. The organization is required to assess their unique circumstances and establish a safe
and secure environment in accordance with standard EC.02.01.01. Remember, to be secured, something or
someone must either be physically secured or under adequate surveillance. In all cases, locking arrangements
must comply with NFPA 101 Life Safety Code (2000 edition) requirements, or CMS categorical waiver 13-58 that
allows the 2012 edition of NFPA 101 to be used in certain pediatric security circumstances. Assessment
participants should include representation from the unit staff, hospital leadership, hospital security, hospital
maintenance, appropriate consultants, etc. Informational sources may include trade organizations, controlling
authority (like a state licensing entity) requirements/recommendations, reputable design sources, etc. Criteria
may include the physical layout, the number/arrangement of exits, the vulnerability of the patient population,
intended level of guardian/visitor access, community risk, etc. The organization is expected to implement the
assessed design, systems and operational practices, then analyze if the desired affect was achieved (see
EC.04.01.01, EC.04.01.03 and EC.04.01.05). The Joint Commission survey process will evaluate the
management of security in these areas for effectiveness, and validate that the organization is following their
established practices. Abduction and missing patient exercises are effective means to validate pediatric security
effectiveness. [EC.02.01.01]

Security - Risk Assessment

What does it mean to be secure?

The Joint Commission defines secure as locked in containers, in a locked room, or under adequate surveillance.
Organizations are to conduct a risk assessment regarding unique security issues in accordance with standard
EC.02.01.01. A course of action should be established that is both defensible and rational. The organization is
expected to implement the course of action, then analyze if the desired affect was achieved. [EC.02.01.01]

Soiled Utility Room Security - Risk Assessment

Are soiled utility rooms required to be locked?

The Joint Commission standards do not require soiled utility rooms to be locked. The Life Safety Code or the
2014 FGI Guidelines for Design and Construction of Hospitals and Outpatient Facilities have no prescriptive
locking requirements, therefore the organization should conduct a risk assessment per standard EC.02.01.01 to
determine whether locking is warranted. Criteria to evaluate may include the patient and public population within
the area (for example, geriatric patients or pediatric patient/visitors), versus risks that reside within the soiled
utility room (for example, trash/linen chutes access doors, hazardous materials and waste, dangerous equipment,
contaminated items, etc.). Surveillance is also a form of security, so the assessment can consider proximity to
staffed areas such as nurse stations. Include input from infection control, risk management, the safety officer, and
other regulatory agencies (such as state licensing rules) in the risk assessment process. Soiled utility rooms in
behavioral health units are to be locked. The survey process will evaluate the risk assessment for effectiveness
and validate proper implementation of the resulting policy/practice.

Storage - Use of Wooden and Plastic Pallets

Please clarify The Joint Commission’s position on the use wooden pallets for storage.

The Joint Commission has no standard that prohibits wood pallets in clean areas, to include store rooms and
supply break-down rooms. Wood pallets that are contaminated should be segregated based on condition, and
not introduced to patient care areas or areas that support patient care, like laboratories.

The organization should conduct a risk assessment, per IC.01.03.01, to determine the appropriateness of having
wood pallets within any area of clean storage. Wood pallets should not be used in sterile areas, to include sterile
storage areas, since their surfaces are not conducive to the level of cleanliness required in a sterile area; this
prohibition does not apply to sterile supply breakdown areas; plastic pallets would be acceptable in sterile storage
areas.

Large quantities of wood pallets should not be used in non-fire sprinklered areas. When conducting the risk
assessment, the organization should involve an infection control representative, as well as the primary occupant
of the area being evaluated.

Organizations should define their requirements, such as in a policy, that addresses the acceptable use of wooden
pallets. The organization is expected to adhere to its requirements and evaluate the assessed practice for
effectiveness and compliance. The survey process will review the established process for effectiveness and
tracer activity will validate proper implementation.

See also: Boxes and Shipping Containers

Temperature and Humidity - Monitoring Requirements

What are the monitoring requirements for temperature and humidity?

The Joint Commission has no prescriptive requirement for daily monitoring or logging of temperature and relative
humidity of a particular room type unless required by a controlling authority or by organizational policy. But rooms
that are considered critical, like those where invasive procedures are performed or where sterile items are stored,
are to be in constant compliance when being used for their intended purpose. Therefore some reliable strategy is
to be implemented to insure continuous compliance, such as daily readings, real-time indicating devices in the
space, alarming through a building automation system, etc. Room temperature and humidity monitoring can be
accomplished remotely by a building automation system, as long as there is a means to effectively identify an
adverse condition (like a person at the monitoring station, an alarming mechanism, a paging system, etc.). Daily
monitoring can also be accomplished at the room site, by the occupants, as long as there is a process to
periodically check readings (like a temperature/humidity reading device within the space). Daily monitoring would
be acceptable as long as the organization has assessed there to be a reasonable assurance that the snap-shot-
in-time selected represents compliant humidity and temperature levels throughout the operational day. Non-
continuous, periodically checked conditions are to be logged. All non-compliant conditions are to be documented
with corrective actions described. If the room is not in-use and is placed in a non-compliant mode, like for energy
conservation, then the room must be validated to be in compliance before a procedure begins; an energy
conservation mode must maintain proper relative humidity levels. For other rooms assessed to be less critical,
evidence of temperature and humidity levels may not be required, but are to be initially set-up properly when
affected by new construction, alteration or renovation, and through methods such as regular environmental
rounding, occupant feedback and through maintenance activities.

Temperature and Humidity - Monitoring Requirements for Sterile Supply Storage Areas

What are the requirements for temperature and humidity monitoring in areas in which sterile supplies are
stored ?

Centralized sterile supply storage, in procedural areas where large volumes of sterile supplies are kept, require a
program for management of proper temperature and relative humidity (RH) levels in accordance with the
Facilities Guidelines Institute (FGI) Guidelines for Design and Construction of Hospitals and Outpatient Facilities.
Examples of these centralized sterile storage areas include surgery suites, C-section suites, endoscopy suites
and cardiac catheterization suites. Some emergency departments may perform high-level trauma cases that
would require a significant storage of sterile supplies.

Examples of large volume centralized locations are sterile processing areas and central stores. Examples of
temperature and RH management include electronic monitoring through a building automation system and
manual monitoring by observation of a measurement device at the site, with some established process to contact
facilities management personnel to correct deficiencies (alarming, staff feedback).

Decentralized locations where small quantities of sterile items are stored close to treatment/procedure areas that
are outliers to areas described above can be managed through staff surveillance during the regular course of
performing their duties. Examples of these decentralized locations could include labor and delivery areas without
C-section procedures, imaging areas, emergency department (small storage), etc. Staging of sterile items outside
of procedure room (like an operating room) for a limited period of time would also apply.

Knowledgeable staff should examine sterile supplies before use, and should contact facilities management
personnel if space temperature and RH levels are determined to be inadequate. A process method for
temperature, relative humidity (RH) and sterile product management is required, but specific
measurement/documenting of temperature and RH is not prescriptive for decentralized sterile product
deployment.

For consistency, temperature and relative humidity management process decisions should be made based upon
the criteria stated above, not the type of sterile items stored or the packing method of sterile items stored.
However, if the organization assesses that the type of decentralized storage requires a more robust management
and monitoring process based on criticality, then methods described for centralized storage should be
implemented.

Deficiencies relating to temperature and relative humidity management are scored at EC.02.05.01 EP 15 (based
on the FGI edition used at the time design) for critical care areas designed to control airborne contaminants and
at EC.02.05.01 EP 16 for non-critical areas.

Organizations should determine the appropriate temperature and humidity (and ventilation) parameters based on
the design criteria at the time of construction (see also the note in EC.02.05.01 EP 15) For new, renovated, or
altered spaces, organizations that use the Joint Commission for deemed status purposes must use ASHRAE
170-2008 as referenced in NFPA 99-2012, Chapter 9, effective July 5, 2016. This document is included in the
2010 FGI Guidelines for Design and Construction of Health Care Facilities. Organizations that do not use the
Joint Commission for deemed status purposes would use ASHRAE 170-2013 as referenced in the 2014 FGI
Guidelines for new, renovated, or altered spaces.

Temperature and relative humidity requirements - Controlling Authority

What are compliance requirements for ventilation, temperature and relative humidity?

NFPA 99-2012, Chapter 9, requires ventilation, temperature, and relative humidity to comply with ASHRAE 170-
2008 for new, renovated, altered, or modernized areas of the facility. Existing spaces may remain as originally
designed provided evidence can be provided that the original parameters are being maintained. The Joint
Commission would expect the organization to perform a gap analysis to validate that adequate infection control,
space comfort, and process integrity can be maintained.

Testing Requirements - Business Occupancy / Lease Facility

What are the fire safety system testing requirements in business and leased facilities?

The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated.
This includes leased facilities and business occupancies where patients are seen or treated. In leased facilities,
the lease agreement should include a requirement for the availability of documentation associated with all
applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the
host organization to the leasing organization. Fire safety system maintenance requirements are found in
EC.02.03.05. This standard does not require hospitals to have the types of fire safety equipment and building
features described by the elements of performance, however if these types of equipment or features exist within
the building, then maintenance, testing, and inspection is be conducted and documented.

Under-Sink Storage - Risk Assessment

What is the requirement for under-sink storage?

The Joint Commission standards do not specifically address under-sink storage criteria, so a risk assessment is
to be performed to determine the organization's accepted practices, with a resulting policy established and
disseminated to staff for implementation. The survey process will access the policy for effectiveness and verify
through tracer activity that the policy is being followed. The conclusion of a risk assessment would generally need
to establish if anything stored under a sink could be damaged by a sink plumbing leak or the moist environment,
then under-sink storage of those items would be prohibited. Examples may be clean/sterile supplies (not
necessarily cleaning supplies), reagent and chemicals that could have an adverse reaction if exposed to
water/sewer/moisture, cleaned patient care equipment, etc. Trash bins located under sinks would typically not be
an issue. The organization should also determine if their local health department or state licensing/health
organization has any prohibitions.

Utilities - Electrical Panels Risk Assessment

Are electrical panels required to be locked?

The Joint Commission has no standard that requires electrical panels to be locked. The organization is to
conduct a risk assessment, per EC.02.01.01, to determine the most appropriate policies for their circumstances.
Generally, electrical panels in certain patient care areas, such as pediatrics, geriatrics and behavioral health
units, or public spaces and corridors not under direct supervision are to be secure. Although emergency power
panels should be given heightened scrutiny during the assessment process, there is not particular requirement to
treat them differently. Electrical panels located in secure areas that are accessible to authorized staff may not
need to be locked. If an electrical panel is found to be unlocked during the survey process, and the surveyor
evaluates that the condition to be at-risk, then the organization should share their risk assessment with the
surveyor. If the surveyor determines that the risk is still valid, then the organization would receive an
observation(s) under EC.02.06.01. [EC.02.01.01]

Utility Systems - High Risk - Reliable Generator - Weekly Inspection

What is The Joint Commission standard for performing weekly maintenance on generators?

NFPA 110 requirements for the weekly emergency generator inspection include an inspection of the prime mover,
fuel system, lubrication system, cooling system, exhaust system, battery system, and electrical distribution
system up to the automatic transfer switches. Running unloaded is not required.

Human Resources (HR)

Topic

Competency Assessment vs Orientation

The Human Resource (HR) chapter of the accreditation manuals include requirements for ‘orientation’
and ‘competency assessment’. How do these activities really differ from each other?

Orientation (HR.01.04.01)
The Joint Commission’s glossary defines orientation as "A process used to provide initial training and information
while assessing the competence of clinical staff relative to job responsibilities and the organization’s mission and
goals."

Orientation may be further described as an introductory program and/or activities intended to guide a person in
adjusting to new surroundings, employment, policies/procedures, essential job functions, etc. Each organization
is responsible for determining when and how long a person is considered to be in orientation.

The requirements found at HR.01.04.01 outline specific topics to be included in an employee’s orientation
process and documented. For example, orientation to Key Safety Content that must be completed before staff
provides care, treatment, and services often include:
• Fire Safety and response
• Infection prevention and control
• Emergency response (code blue, rapid response, etc.)
• Active shooter
• Bomb threats
• Personal safety
• Emergency Management (internal/external disaster plans)
• Medical equipment failure and reporting process
• Utility system disruptions and reporting process

Additional examples may include:

• Work schedule
• Employee attendance, time and resource management expectations
• Employee responsibilities in the event of an internal or external disaster
• Managing a patient’s pain
• Sensitivity to cultural diversity
• Patient Rights
• Code of conduct expectations
• Infection prevention and control
• Maintaining privacy and security of protected health information; sometimes referred to as HIPAA
training.

Competency (HR.01.06.01)
While not formally defined, competency may be described as a combination of observable and measurable
knowledge, skills, abilities and personal attributes that constitute an employee’s performance. The ultimate goal
is that the employee can demonstrate the required attributes to deliver safe, quality care.

Competency assessment timeframes may vary greatly based on the individual’s entry skill level and the
complexity of the task(s) the individual will be required to safely perform. For example, demonstrating
competency on performing a bedside glucometer test will take less time to achieve than caring for a patient who
has just undergone an open heart procedure that involves managing/monitoring complex equipment and highly
refined assessment skills.

Because of the variability involved in both the number and complexity of competencies an individual must be
deemed competent, organizations often give consideration to these factors rather than assigning a finite period of
time in which competency must be achieved, however, this would be an organizational decision.

While The Joint Commission does not define required competencies that must be completed, organizations
should consider the following:
• When determining competency requirements, consideration should be given to needs of its patient
population, the types of procedures conducted, conditions or diseases treated, and the kinds of
equipment it uses. Competency assessment then focuses on specific knowledge, technical skills, and
abilities required to deliver safe, quality care.

• Competency assessments for knowledge and technical skills intrinsic to an individual’s professional
education are generally not required. For example:
- Administration of oral, IM or sub-q medications may be intrinsic to professional education, but the
use of a programmable infusion pump for IV administration may be a required competency.

• Basic assessment skills, such as heart/lung sounds may be part of education, but assessment skills
required to care for patients on a neuro-surgical unit may require advanced competency assessments in
evaluating a patient’s neurological status.

• Basic infection prevention and control knowledge may be part of education, however, knowledge and
skills related to sterile technique, sterilization, and high-level disinfection would be
competencies expected of an OR Nurse, surgical assistants and sterile processing staff.

Survey activities will focus on the organization’s requirements, compliance with evidence-based guidelines,
standards of practice and regulatory requirements. The accreditation requirements that address orientation and
competency are found in the Human Resource (HR) chapter of the accreditation manual. Each Joint
Commission-accredited organization has a copy of the manual containing these requirements.

Contract Staff - Applicability of Human Resource Standards (HAP, CAH, AMB, OBS, NCC)

What are the expectations for complying with the Human Resource (HR) requirements when patient care
services are provided via a contractual agreement?

All standards in the Human Resource (HR) chapter apply to contract staff providing patient care, treatment or
services. A well-written contract should specify that the contract organization will provide only staff who are
qualified by education, training, licensure, and competence as defined by the organization. Simply contracting for
services provided by another Joint Commission accredited organization does not assure compliance with the HR
standards.
Examples of compliance may include (when applicable):
• The individual possesses the knowledge, experience and competence appropriate for his or her
assigned responsibilities.
• Current license, certification, or registration confirmed via primary source verification.
• Meets the educational and experience requirements defined by the organization.
• Completion of health screenings and criminal background checks as required by law, regulation and
organizational policy.
• Orientation to the policies and procedures, key safety content and specific job duties.

During a survey, the surveyor may ask to review files of contract staff to evaluate compliance. Only the
information needed to demonstrate compliance should be provided. Organizations are NOT required to maintain
redundant HR files on contracted staff or share the actual results of health screenings or criminal background
checks, only that such requirements have been completed.

Through the contractual agreement, organizations determine which entity is responsible for obtaining and
maintaining the required HR documentation. Accredited organizations are also required to monitor the provision
of the contracted services provided based on the defined performance expectations. The requirements that
address contracted services are found in the Leadership (LD) chapter of the accreditation manual at LD.04.03.09.

Examples of clinical contracted services may include, but are not limited to:
• Dialysis
• Pharmacy
• Dietary
• Environmental Services
• Laundry Services
• Agency/traveling staff (nurses, therapists, etc)
• Mobile imaging (CT,PET, MRI, etc)

The following FAQs may also be informative in assisting contract service providers understand verification
requirements:
Verification - Primary Source Verification - Definition
Verification - Education
Verification - Education - Transcripts
Criminal Background Checks - Requirements

What is the Joint Commission requirement for criminal background checks and for which type of
individual must it be performed?

Staff, students and volunteers who work in the same capacity as staff who provide care, treatment, and services,
would be expected to have criminal background checks verified when required by law and regulation and
organization policy. This means that if state law, regulation or organization policy requires background checks on
all employees, volunteers and students, Joint Commission expects them to be done on all three categories.

If state law requires background checks on only specified types of health care providers (e.g. nursing
assistants/child care workers), then Joint Commission would require background checks on only those specified
in state law (unless organization policy goes beyond state law). If state law requires background checks on all
"employees", the organization should seek an opinion from the state on what categories of health care workers
are considered "employees". If the state clearly does not consider volunteers or students to be employees, then
Joint Commission would not require background checks on them (unless organization policy goes beyond state
law and requires it).

If state law is ambiguous as to the definition of employee, the organization can define the scope of background
checks to fit its own definition. As such, they may include or exclude students and volunteers, and Joint
Commission would survey to organization's policy. In the absence of a state law on criminal background checks,
each organization can develop its own expectations, e.g., and organization elects to screen employees and not
students/volunteers. Joint Commission would evaluate compliance with the organization's internal policy only.
There would be no Joint Commission expectation that an organization check categories of providers beyond what
is required in their own policy, which must comply with law and regulation. All criminal background checks must
be documented by the organization.

Laboratory and Point-of-Care Testing Personnel - Evidence of Qualifications

For personnel performing laboratory or point-of-care testing, what is required for evidence of their
qualifications?

The Joint Commission standards require compliance with the personnel qualifications specified in the Centers for
Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA). These personnel
requirements differ depending on the complexity of testing an individual is performing, specifically waived,
moderate or high complexity testing. Moderate and high complexity are sometimes discussed together and
referred to as "non-waived" testing.

For waived testing, the federal regulations do not specify the education requirements and an organization may
establish its own. The organization must maintain evidence that the testing personnel meet the education
requirements established by their job descriptions.

For each individual performing non-waived testing, the organization must maintain evidence of education that
meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high
complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7),
respectively. The regulations require specific levels of education, experience or both. In general terms, high
complexity testing requires an Associate's degree or higher in a chemical, physical or biological science.
Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical,
physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that
may apply to some individuals.

When there is a State laboratory testing personnel license requirement, evidence of the individual's State license
is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas,
degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and
testing personnel. Note that a State license must be primary source verified per Joint Commission standard
HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the
Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation
is required.

Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN.
license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of
such credentials will not be considered a substitute for evidence of the education and experience required for
testing personnel, with the exception of nursing or other allied health licenses in states where non-waived
laboratory testing in specified in the regulatory scope of practice.

Per the Survey and Certification guidance provided by CMS CLIA to its State Agencies, "If a high school is
closed, it is possible for the individual to solicit documentation from the local school board or State Board of
Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
 Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school
diploma and above for moderate complexity)
HEW Certification
State laboratory personnel license
Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified
within the scope of practice

Laboratories may use third party services to verify staff credentials. This practice is acceptable if the third party
verifies ACADEMIC credentials and is able to provide documentation of such verification within one week of
request by the laboratory.

Non-licensed, Non-employee Individuals - Human Resource Requirements

What are The Joint Commission’s expectations regarding non-licensed, non-employee individuals in
health care organizations, including health care industry representatives (HCIRs)?

The Joint Commission, similar to organization's themselves, has expectations regarding anyone entering a health
care organization. In order to maintain patient safety, accredited health care organizations need to be aware of
who is entering the organization and their purpose at the organization (EC.02.01.01, EP 7). Accredited health
care organization leaders need to also make sure they oversee operations and that responsibilities are assigned
for administrative and clinical direction of programs, services, sites, and departments (LD.04.01.05, EPs 1 and 3);
this includes processes for knowing who is entering the organization and their purpose.

There are additional expectations for non-licensed, non-employees that have a direct impact on patient care.
Some examples of these individuals are HCIRs in procedure rooms/operating rooms providing guidance to the
surgeon, HCIRs providing training to staff on equipment use, and surgical assistants brought in by surgeons.
Additional requirements related to these individuals include:

Taking steps to ensure that patient rights are respected, including communication, dignity, personal privacy
(RI.01.01.01, EPs 4, 5, and 7), and privacy of health information (IM.02.01.01, EPs 1 and 2) Obtaining
informed consent in accordance with organization policy (RI.01.03.01, EPs 1, 2, and 13)
Implementation of infection control precautions (IC.02.01.01, EP 1)
Implementation of the patient safety program (LD.04.04.05, EP 1)
For non-employees brought into the organization by licensed independent practitioners, organizations must
also address qualifications (HR.01.02.05 EP 7) and performance (HR.01.07.01 EP 5 of these individuals.

Privileging - National Practitioner Databank

Can organizations use the National Practitioner Data Bank's (NPDB) "Continuous Query" (aka Proactive
Disclosure Service) opion for re-privileging?

Use of National Practitioner Data Bank's "Continuous Query" (aka Proactive Disclosure Service) by an
organization is acceptable for the ongoing NPDB information after the organization obtains an initial NPDB query
for each practitioner. To demonstrate compliance, the organization would need to have record of a baseline query
and then share with the surveyors that no updates have been received from the NPDB. There does not need to
be documentation in the record that no further communication has been received. As with any NPDB information,
the organization would review the information received or confirm that no new information had been received,
whenever they are granting a new privilege or renewing existing privileges.

Scribe - Compliance with Joint Commission Standards - Update

Do the Joint Commission standards allow organizations to utilize scribes?

*** The use of scribes in healthcare settings is currently under review. Any updates or changes will be published
in future editions of the Perspectives Newsletters and/or via the Joint Commission Online newsletter. ***

Verification - Education

HR.01.02.05 EP 3 requires that "The organization verifies and documents that the applicant has the
education and experience required by the job responsibilities." Does this mean that verification via
primary source is required?

No, primary source verification of education is not required at this element of performance. Organizations are
required to verify and document education and experience only when specific minimum requirements are written
into the job description. For example, if the Nurse Manager job description specifically requires the incumbent to
possess a Master’s Degree in Nursing (MSN), the organization must verify the individual has this credential.
Organizations determine how verification and documentation of education and experience will be managed.
Examples may include, but are not limited to:

Review of an original diploma or certification that demonstrates completion of an education course or

degree, then retaining a copy as documentation of this education. Organizations also determine if
documentation will be retained as ‘paper’ or in an electronic format, such as a scanned document.
Alternatively, such a document could be reviewed (but not copied) and then a note of attestation by the
person reviewing the document could be entered into an HR file. The date the document was reviewed
should be documented.
Use of an external service, such as a Credentials Verification Organization (CVO). The glossary of the
accreditation manual contains a definition of a CVO.

Verification - Education - Transcripts

HR.01.02.05 EP 3 requires that "The organization verifies and documents that the applicant has the
education and experience required by the job responsibilities". Does this mean that organizations are
required to obtain transcripts as part of the education verification process?

There is no requirement that organizations obtain transcripts as part of the education verification process. Such a
requirement would be an organizational decision.
The FAQ titled "Verification - Education" provides examples of ways organizations may verify education.

Verification - Primary Source Verification - Definition

What is Primary Source Verification and to whom does it apply ?

Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license,
certification or registration to practice a profession when required by law or regulation. It is the responsibility of
the accredited organization to complete PSV, not the licensed individual. The glossary of The Joint Commission
Accreditation Manual defines PSV as:

"Verification of an individual practitioner’s reported qualifications by the original source or an approved

agent of that source. Methods for conducting primary source verification of credentials include direct
correspondence, documented telephone verification, secure electronic verification from the original
qualification source, or reports from credentials verification organizations (CVOs) that meet Joint
Commission requirements. See also credentials verification organization (CVO)." The definition of a CVO
may be found in the glossary of the accreditation manual.

Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is
identical to the information at the primary source are referred to as a ‘designated equivalent source’. The glossary
of the accreditation manual provides examples of such sources. Organizations are responsible for determining
what method will be used to document that PSV was completed and must include the date the verification was
conducted, who conducted the verification, what was specifically verified and the results of the verification. At the
time of survey, surveyors evaluate compliance with completing primary source verification of licensure,
certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was
complete by the organization does not meet the intent of the requirement.

The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at
HR.01.01.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also
requires PSV of the applicant’s relevant training and current competence. These requirements are found at
MS.06.01.03 EP 6 and MS.06.01.05 EP 2.

Infection Prevention and Control (IC)

Topic

Boxes and Shipping Containers

What is The Joint Commission's position on managing cardboard or corrugated boxes and shipping
containers ?

Fire Safety: Cardboard in storage quantities (recommend consultation with your Fire Marshal) should be placed
in hazardous areas protected per LS.02.01.30 and cannot obstruct the means of egress in accordance with
standard LS.02.01.20. Containers that are contaminated should be removed based upon the cleanliness
requirements of the storage area. Many suppliers have paper or cardboard distribution boxes that are designed
for use in laboratory, pharmacy, patient care areas or sterile storage areas.

Infection Prevention and Control: The organization should conduct a risk assessment in accordance with
standard IC.01.03.01 to determine the appropriateness of having the container type used in a particular area.
This could include where to load or unload supplies, criteria for content break-down areas, and what level of
packaging to keep within the area in question. The risk assessment could also address the use of boxes that
came out of the shipping container where box labeling is essential to proper use (for example, expiration dates,
contents, ingredients, directions for use, etc.).

When conducting the risk assessment, the organization should involve infection control personnel as well as the
primary occupant of the area being evaluated. A course of action should be determined, a policy generated, staff
trained and the process implemented. The organization is expected to assess whether the desired affect was
achieved, and adjust accordingly. Use of evidence-based guidelines may support and guide generated policy
and procedures specific to this topic.

Here is an example for consideration from AAMI ST:79

5.2.1 General Considerations
• Clean or sterile items to be transported to central processing and storage areas within the facility should be
removed from their external shipping containers before they enter the storage areas of the department. Any
instructions for use accompanying the items should be kept with the items.

Rationale: External shipping containers have been exposed to unknown and potentially high microbial
contamination. Also, shipping cartons, especially those made of a corrugated material, serve as generators of
and reservoirs for dust.
Also, The Joint Commission standard LD.04.01.01 expects the organization to comply with other controlling
authority(s) (for example, local or state health departments). Governmental entities (like the CDC or FDA), trade
organizations, and other evidence-based guidelines are good assessment criteria resources for areas such a
laboratory, pharmacy, sterile processing, food service, etc. The survey process will check to make sure there is a
policy in place, and whether the policy is effective through policy review and tracer activities.

Contact Precautions - Gowns

Do Joint Commission surveyors expect healthcare workers to wear a gown whenever entering the room
of a patient on contact precautions?

Joint Commission standard IC.01.05.01 EP 1 states: "When developing infection prevention and control activities,
the organization uses evidence-based national guidelines or, in the absence of such guidelines, expert
consensus." The guideline that addresses contact precautions is published by the CDC's Healthcare Infection
Control Practice Advisory Committee (HICPAC).

Recommendation V.B.3.b.i. from the HICPAC guideline states, "Wear a gown whenever anticipating that clothing
will have direct contact with the patient or potentially contaminated environmental surfaces or equipment in close
proximity to the patient. Don gown upon entry into the room or cubicle. Remove gown and observe hand hygiene
before leaving the patient-care environment."

Joint Commission surveyors will expect healthcare workers to wear a gown if their "clothing will have direct
contact with the patient or potentially contaminated environmental surfaces or equipment in close proximity to the
patient". The difficulty lies in "anticipating" when this may occur. For example, it is very probable that a nurses'
aide preparing to perform a bed bath will have contact as described above, and therefore a gown would be
expected. However, one of a large group of residents performing rounds with an attending physician would have
a lower likelihood of clothing contamination.

Each organization may decide what guidance to provide to its healthcare workers within the parameters provided
by HICPAC. However, The Joint Commission would encourage organizations to consider the high morbidity and
mortality of healthcare-associated infections in our nation when deciding what constitutes "anticipated contact" in
each facility. Additionally, organizations may want to discourage non-essential personnel from entering the rooms
of patients on isolation precautions.

Endotracheal Tubes - Clean, Disinfect and Store

Endotracheal Tubes - How to clean, disinfect and store this device.

Devices such as endotracheal tubes (ETT's) may be exposed to potentially infectious material during indicated
use, and can become contaminated through direct contact with the patient's skin, mucous membranes,
secretions and blood. An ETT interferes with normal patient defenses allowing pathogens direct access to the
lung. To reduce the risk of infection, the importance of standardizing the process of reprocessing as indicated,
with a minimum high level disinfection (IC.02.02.01 EP 2) or sterilization (if a single use device is not used and
manufacturer's instructions for use is adhered to), and storage is emphasized.

Cleaning and Disinfecting:

ETT's are most commonly obtained as sterile single use devices. As defined, single use devices are intended for
one time use, on a single patient, during a single procedure. If an ETT or Laryngeal Mask Airway (LMA) is
not designed by the manufacturer as a single use device, it is considered a semi-critical item and therefore would
require using the process for disinfection and sterilization of semi-critical items as designated by the CDC as
"high-level" disinfection. Please refer to the CDC and HICPAC document entitled Guidelines for Disinfection and
Sterilization in Healthcare Facilities, 2008.In addition, the CDC's Healthcare Infection Control Practices Advisory
Committee (HICPAC) states ETT's are "semi critical" items. Please refer to the CDC and HICPAC's document
entitled Guidelines for Preventing Healthcare-Associated Pneumonia, 2003.The last page of the guideline lists
ETT's as semi critical items.

Recommendation IIIA1b states how semi critical items must be processed and packaged:
"Whenever possible, use steam sterilization (by autoclaving) or high-level disinfection by wet heat pasteurization
at >158oF (>70oC) for 30 minutes for reprocessing semi critical equipment or devices (i.e., items that come into
direct or indirect contact with mucous membranes of the lower respiratory tract) that are not sensitive to heat and
moisture (see examples in Appendix). Use low-temperature sterilization methods (as approved by the Office of
Device Evaluation, Center for Devices and Radiologic Health, FDA) for equipment or devices that are heat- or
moisture-sensitive (307;309;310;314;315). After disinfection, proceed with appropriate rinsing, drying, and
packaging, taking care not to contaminate the disinfected items in the process (308;310). CATEGORY IA"

Storage (IC.02.02.01 EP 4):

ETT's should be kept free from contamination until the time of use. Once opened, there is potential for
microorganisms to settle on the device the longer it remains open and unused. Increased handling of the opened
unused device increases the chances of contamination. Ensure that the storage area provides protection from
dust, moisture, temperature and humidity extremes. Refer to the CDC and HICPAC document entitled Guidelines
for Disinfection and Sterilization in Healthcare Facilities, 2008.

Pre-opening of Endotracheal tubes (ETT):

Currently available evidence-based guidelines do not include recommendations for or against the pre-opening of
ETT's prior to use for any length of time. Related scientific articles to date that address pre-opening ETT's and
the risk of contamination with potentially harmful organisms while left opened for days, are limited. Until evidence
exists that is supported by well-designed clinical studies, an organization may: conduct a risk assessment, and
refer to appropriate professional organizations that address this issue in their position statements, weigh the risk
versus the benefits of having pre-opened ETT's given the absence of firm evidence that pre-opened ETT's are
advantageous or best practice, utilize a consistent process throughout their organization based on expert clinical
consensus that is documented in policy and procedure.

Joint Commission surveyors will evaluate processes related to ETT's to ensure that they are safe for patient use.
They will check that ETT's are:

A single use device, or if not a single use device, are processed via either high-level disinfection or
sterilization, according to manufacturer's instructions for use (IFU's).
Packaged as a sterile single use device. If the ETT is not a single use device, CDC and HICPAC guidelines
do not specify one method in which ETT's should be packaged. An example of an acceptable packaging
method would be a peel pack post steam sterilization.
Stored in a way that would prevent recontamination. Examples of noncompliant storage would include
unwrapped or opened ETT's in an anesthesia drawer, as well as unwrapped or opened ETT's on top of or
within a code cart.
If the organization pre-opens ETT's (refer to the above section on pre-opening of ETT's) a consistent
process is demonstrated and is reflected by policy and procedure.

Health Screening - Licensed Independent Practitioner

Are non-employed physicians and other licensed independent practitioners included in the health
requirements specified in IC.02.03.01 EPs 1, 2 and 3? Do we need to screen them for TB infection as
well as immunity to other diseases?

For IC.02.03.01 EP 1, the standard requires that screening "is available". For employees, and others to
whom the HR standards apply, health screenings are a requirement under HR.01.02.05 EP 5 (HAP and
CAH). For non-employed physicians and other licensed independent practitioners, screenings must be
made available, but each organization may decide whether these screenings are mandatory. The health
status of an applicant for medical staff privileges is also addressed under MS.4.20 EP 6 (HAP and CAH).
For IC.02.03.01 EP 2, treatment or referral is initiated if the organization becomes aware of any individual,
including non- employed physicians and other licensed independent practitioners, who "have, or are
suspected of having, an infectious disease that puts others at risk". (Active surveillance is not required for
either EP 2. Action is needed only if the organization becomes aware of such an exposure).
For IC.02.03.01 EP 3, treatment or referral is initiated if the organization becomes aware of any individual,
including non- employed physicians and other licensed independent practitioners, who "have been
occupationally exposed to an infectious disease". (Active surveillance is not required for either EP 3. Action
is needed only if the organization becomes aware of such an exposure).
When making a decision as to how to address these issues, organizations are encouraged to consider the
following factors:

Physicians are specifically included by the CDC in the documents entitled "Immunization of Health-Care
Workers" and "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care
Settings, 2005". IC.01.05.01 EP 1 requires the use of "evidence-based national guidelines or, in the
absence of such guidelines, expert consensus".
Many states require such screenings for all healthcare workers, including physicians and licensed
independent practitioners.
Biologically, all persons providing services in healthcare organizations are equally capable of transmitting
disease.
Legal and ethical considerations exist related to potential outbreak situations.

Instrument Reprocessing - Immediate Use Steam Sterilization (IUSS)

What are important considerations associated with Immediate-Use Steam Sterilization?

Immediate-Use Steam Sterilization (IUSS), formerly termed “flash” sterilization, is described as “the
shortest possible time from the item being removed from the sterilizer to the aseptic transfer onto the
sterile field”. IUSS items are not intended to be stored for future use.

Considerations for IUSS:

• Review and adhere to manufacturer instructions for use (IFU) to determine if the device or
instrument may be reprocessed via IUSS. If so, follow the
IFUs regarding cycle type, temperature setting, exposure time, and drying times.
• IUSS does not imply that reprocessing steps, such as appropriate cleaning and transport, may
be omitted. ,.
• Items are to be reprocessed in approved/validated containers/trays suitable for IUSS.
• IUSS should not be used for mere convenience, or due to limited instruments or equipment for
the number of cases/procedures performed.
• Evidence-based guidelines should be adopted to minimize the use of IUSS. Scenarios when
IUSS may be appropriate include:

o When a specific instrument is needed for an emergency procedure.

o When a non-replaceable instrument has been contaminated and needs to be replaced to
the sterile field immediately.
o When an item has dropped on the floor and is needed to continue a surgical procedure.

Identifying Gaps and Risk reduction strategies to consider:

• When ‘loaner’ trays or instruments (including those brought in by a provider) are used, establish an
agreement with the vendor/provider requiring that delivery
occurs sufficiently in advance of scheduled case(s)
to allow complete reprocessing of trays by the organization. Such a requirement is an example of a
performance expectation to include in a contract (see
LD.04.03.09).
• Develop policies, procedures, staff orientation and competencies based on evidence-based guidelines.
• Regular rounding by Leadership experienced in sterilization practices to all areas where instruments
are used and reprocessed is critical. Such rounds should include:

o Review of manufacturer’s IFUs for both the device used for IUSS as well as the
equipment/instruments being reprocessed to ensure compliance with
their guidelines.
o Allowing sufficient time to actually observe reprocessing activities, including a review of any
documentation requirements.
 o Soliciting questions/concerns from staff responsible for performing IUSS and implement plans
to reduce/eliminate concerns.

• Ensure there is a defined, evidence-based process in place for the premature release of items, to
include documentation of IUSS.
• When limited resources are identified, work with Leadership to develop a plan to ensure sufficient
resources are available to support the delivery of safe, quality of care (see LD.03.03.01).
• Ensure that sterilization practices, in all locations, have been fully incorporated into the organization’s
Quality Assessment Performance Improvement (QAPI) activities (see LD.01.03.01 EP 21 and
PI.01.01.01 EP 4).

• Evaluate the IUSS process in all locations that it is being performed. Surveyors evaluate compliance
based on the evidence-based guidelines, policies, procedures, practices and competencies adopted by
the organization (see IC.02.02.01 EP 2).

• Conducting a risk assessment is a helpful way of identifying risks and gaps in compliance with
evidence-based guidelines and product manufacturer’s instructions for use. A proactive risk
assessment examines a process in detail including sequencing of events, actual and potential risks, and
failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement
based on the actual or potential impact (that is, criticality) of care, treatment, or services provided. The
introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment
model that an organization may use. However, this specific approach is not mandated as there are other
risk assessment tools available that may better meet the needs of the organization.

Resources:
• The Association for Professionals in Infection Control and Epidemiology (APIC)
• The Association of periOperative Registered Nurses (AORN)
• The Association for the Advancement of Medical Instrumentation (AAMI).
• CDC Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008.

Instrument Reprocessing - Point-of-Use and Pre-Cleaning Expectations

What is meant by pre-cleaning at point-of-use in decentralized locations for sterilization reprocessing?

'Pre-cleaning' is described as the means of removal of visible gross blood, body fluids, and/or bio-burden in order
to prevent hardening of debris or the development of biofilm due to processing delays.
• Applies to surgical instruments, devices, supplies that, based on manufacturer instructions for use, are
intended to be reprocessed (meaning they are not single-use disposable items).
• When there are delays in the cleaning/decontamination reprocessing steps gross soil should be
removed at the point of use.
• Pre-cleaning at the point-of-use is required when soiled items cannot be immediately contained and
transported to a decontamination area or soiled utility area. ‘Immediately’ is described as ‘without delay’.
• Pre-cleaning at the point-of-use requires that visible bio-burden is removed from the instruments prior to
transport to a decontamination area where pre-cleaning or preparation for transport to a reprocessing
area occurs.
• IF a product is selected for pre-cleaning purposes, determine compliance based on the manufacturer’s
IFU.
• WHEN there are delays in instruments reaching decontamination in central sterile processing, items
must be pre-cleaned and remain moist while awaiting transport to decontamination.
• Use of pre-cleaning product or other acceptable method to keep instruments moist applies when there
are delays in transporting instruments.

Identifying Gaps to Ensure Compliance:

• Evaluate pre-cleaning practices at the point-of-use. The evaluation should be based on the evidence-based
guidelines adopted by the organization.
Surveyors evaluate compliance based on the guidelines on which leadership has based policies, procedures,
practices and competencies.
• If a product is selected for pre-cleaning purposes, follow manufacturer instructions for use. For example, if the
instructions for use state that hinged
instruments are to be in the open position before application, the practice should be consistent with this
recommendation.
'Immediately' vs 'delays' are important concepts to understand and clarify in the pre-cleaning at point-of-use
process step to promote standardization, frontline staff compliance, and education. For example:
• Instruments from the ER are picked up and transported to central sterile processing at the end of each
day. Since there will be a delay with instruments reaching decontamination in central sterile processing,
items must be pre-cleaned and remain moist while awaiting transport to decontamination.
• Due to high volumes of instruments requiring reprocessing, instruments may wait hours in
decontamination to be cleaned/decontaminated. Instruments are therefore pre-cleaned and transported
moist, to prevent hardening of debris or the development of biofilm due to processing delays.
.
Conducting a risk assessment is a helpful way of identifying risks and gaps in compliance with evidence-based
guidelines and product manufacturer’s instructions for use. A proactive risk assessment examines a process in
detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that
prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is,
criticality) of care, treatment, or services provided. The introductory section of the Leadership (LD) chapter
provides an example of a pro-active risk assessment model that an organization may use. However, this specific
approach is not mandated as there are other risk assessment tools available that may better meet the needs of
the organization.

Examples of organizations that promulgate nationally recognized infection and communicable disease control
guidelines, and/or recommendations include, but not limited to:
• the Association of periOperative Registered Nurses (AORN), Published online January 2017, doi:
10.6015/psrp.15.01.615
• the Association for the Advancement of Medical Instrumentation (AAMI).
• CDC Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008. Cleaning, page 73.
• the Association for Professionals in Infection Control and Epidemiology (APIC),

Laryngoscopes Blades and Handles - How to clean, disinfect and store these device

Laryngoscopes – Blades and Handles - How should we clean, disinfect and store these devices? How
will the surveyors evaluate this process?

Devices such as laryngoscope blades and handles, may be exposed to potentially infectious material during
indicated use, and can become contaminated through direct contact with the patient's skin, mucous membranes,
secretions and blood. To reduce the risk of infection, the importance of standardizing the reprocessing and
storage of the laryngoscope's blade and handle is emphasized (for non-disposable laryngoscopes).

Cleaning - Laryngoscope Blades:

Equipment used for intubation such as laryngoscope blades should be properly cleaned using the process for
disinfection and sterilization of semi-critical items as designated by the CDC as "high-level" disinfection. Please
refer to the CDC and HICPAC document entitled Guidelines for Disinfection and Sterilization in Healthcare
Facilities, 2008.
In addition, the CDC's Healthcare Infection Control Practices Advisory Committee (HICPAC) states laryngoscope
blades are "semi critical" items, which should be sterilized or subjected to high-level disinfection before reuse."
Read CDC and HICPAC's document entitled Guidelines for Preventing Healthcare-Associated Pneumonia,
2003.The last page of the guideline lists laryngoscope blades as semi-critical items. Recommendation IIIA1b
(pages 57-58) states how semi-critical items must be processed and packaged:
"Whenever possible, use steam sterilization (by autoclaving) or high-level disinfection by wet heat
pasteurization at 158F (70c) for 30 minutes for reprocessing semi-critical equipment or devices (i.e., items
that come into direct or indirect contact with mucous membranes of the lower respiratory tract) that are
not sensitive to heat and moisture (see examples in Appendix). Use low-temperature sterilization methods
(as approved by the Office of Device Evaluation, Center for Devices and Radiologic Health, FDA) for
equipment or devices that are heat- or moisture-sensitive (307;309;310;314;315). After disinfection,
proceed with appropriate rinsing, drying, and packaging, taking care not to contaminate the disinfected
items in the process (308;310). CATEGORY IA"

Cleaning - Laryngoscope Handles:

Laryngoscope handles are considered contaminated after use and must be processed prior to use with the next
patient. Some manufacturers suggest a low-level surface disinfectant be utilized on the surface of the handle,
while others may recommend high level disinfection or sterilization. As is the case with all medical devices, the
manufacturer's indications for use (IFU) must be followed. Also check with your state for additional law or
regulation; we are aware of at least one state that requires additional processing.

Storage:
Laryngoscopes should be kept free from contamination until the time of use. Once opened, there is potential for
microorganisms to settle on the equipment the longer it remains open and unused. In addition, increased
handling of the opened unused blade increases the probability of contamination. Ensure that the storage area
provides protection against dust, moisture, temperature and humidity extremes. Please refer to the CDC and
HICPAC document entitled Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008.

Storing laryngoscope blades individually eliminates the potential for contaminating multiple blades if
packaged together, and therefore having to reprocess several unused blades as opposed to the one that
was used. An option would be to contain the individual blade in a closed plastic bag, placed in a clean
 storage location or if steam sterilized, a peel-pack may be used.
When testing the light source and blade use proper hand hygiene and partially remove the blade from the
package, attach to the light source, and test.
Following testing, insert the blade back into the package and return to a clean storage location
(manipulation of the blade onto the light source/handle can be tested without actually removing the blade
from the bag or pack without touching the blade itself).
Institute this practice to all areas where laryngoscopes are used. Examples are: code carts, anesthesia
carts, and difficult airway boxes or carts.

Surveyor Evaluation:
Joint Commission surveyors will evaluate processes related to laryngoscope blades/handles to ensure that they
are safe for use on the next patient. Surveyors will check for the following:

Laryngoscope blades are processed via either high-level disinfection or sterilization.

Laryngoscope handles, the organization is following the manufacturer's instructions-for-use for
cleaning/disinfection guidance.
Laryngoscope blades/handles are packaged in some way. Note: CDC and HICPAC guidelines do not
specify the manner in which laryngoscope blades should be packaged.
The organization demonstrates a consistent process applied to all appropriate areas as reflected by
organization policy and procedure.
Laryngoscope blades/handles are stored in a way that would prevent contamination.

Examples of compliant storage include, but are not limited to, a peel pack post steam sterilization, or
containment within a closed plastic bag.
Examples of noncompliant storage would include unwrapped blades in an anesthesia drawer, as well
as unwrapped blades on top of or within a code cart.

Laundering - Guidelines For Surgical Scrubs or other Surgical/Procedural Attire

Does the Joint Commission require employers to commercially launder surgical scrubs and other
surgical attire?

For surgical scrubs or other surgical attire not visibly contaminated, organizations can choose between home
laundering (acceptable per CDC/HICPAC) or a healthcare-accredited laundry facility (recommended per AORN).
For all visibly contaminated clothing, the employer must be responsible for laundering per OSHA standards. Your
organization should develop a policy addressing how they will manage this process and what guidelines they are
following which will drive our survey process.

IC.01.05.01 EP 1 requires organizations to follow evidence-based national guidelines. The two main
guidelines regarding this topic do not agree, therefore an organization may choose one or the other:

CDC/HICPAC Recommendation Laundry and Bedding I. Employer Responsibilities A. Employers

must launder workers' personal protective garments that are contaminated with blood or other
potentially infectious materials. (OSHA: 29 CFR 1910.1030). There is no stated guidance on garments
that are not contaminated with blood or other potentially infectious materials.
AORN’s 2015 Guideline for Surgical Attire Recommendation II States: All individuals who enter the
semi-restricted and restricted areas should wear scrub attire that has been laundered at a health care-
accredited laundry facility or disposable scrub attire provided by the facility and intended for use within
the perioperative setting.

LD.04.01.01 EP 2 requires compliance with law and regulation. The OSHA Blood borne Pathogen Act
requires all visibly contaminated clothing, including scrubs or personally owned items, be laundered by the
employer at no cost to the employee. See section 1910.1030(d)(3)(iv).

For laundering of all other textiles, such as patient linens, etc., organizations must comply with local and state
health requirements, industry standards and/or guidelines published by professional organizations that focus on
safe management of healthcare linen services.

Linen Managment - Developing Requirements for Covering, Storage and Transport

Does The Joint Commission have specific requirements that address linen management, such as
covering, storage and transport?

No, requirements for managing linen are not defined within The Joint Commission standards. Organizations are
expected to develop their linen cleaning, storage and management requirements in accordance with evidence-
based sources (see IC.01.05.01 EP 1) such as the CDC, the National Association of Institutional Linen
Management and/or the local or state authority having jurisdiction.

For example, the CDC's guidelines state, "Clean linen should be transported and stored by methods that will
ensure its cleanliness." According to the NAILM, (National Association of Institutional Linen Management) the
carts or hampers that deliver laundered linens must be cleaned prior to accepting processed linens. A clean liner
within the cart is acceptable, and the linens should be covered. The guidelines state: "Carts that are going to be
used to store linens on patient-care areas (hallways) must have covers on them during transportation and
storage time. The covers shall protect the linens at all time during storage. They cannot be removed or adjusted
in a manner that will expose linens to common traffic. Open carts that are going to be used just to dispense linens
on patient- care areas need not be covered for this purpose. They cannot be used to store linens on the floors."

If an organization is unsure whether their linen management processes are compliant with such guidelines,
conducting a risk assessment is a helpful way of identifying risks associated with various options being
considered by the organization. A proactive risk assessment examines a process in detail including sequencing
of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical
process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or
services provided.

The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment
model that an organization may use. However, this specific approach is not mandated as there are other risk
assessment tools available that may better meet the needs of the organization.

Offsite Interpretive Reading Providers - Applicability of Infection Control Standards

How do the IC standards apply to interpretive reading providers? We have no contact with patients or
specimens-what do we need to do?

The focus of the IC standards is prevention of transmission of infectious disease. If no patient or specimen
contact occurs, no transmission is possible. While a risk assessment would not be required, if performed it would
reveal no risk at all. As such, no surveillance or reporting would be required, even for staff.

If the organization receives back contaminated equipment, then all IC standards apply.

Please note, however, that interpretive reading services do play a critical role in disease detection and
communication. Under IC.02.01.01 EPs 8-11, these services bear the responsibility for notification of infectious
disease-related results, especially those for which the differential diagnosis might necessitate isolation or public
health action. Examples would be a radiology study showing a right upper lobe cavity lesion (suspicious for
pulmonary tuberculosis), or mediastinal widening (suspicious for inhalation anthrax). Pathology studies would
include those that identify pathogens considered reportable to a public health authority.

Therefore, interpretive reading providers must have clearly defined processes for communication of such results.
An agreement should be in place with each organization for which services are provided. It should specify which
results are to be communicated urgently, whom should be notified, and in what time frame. It is expected that
many organizations will choose to have their infection control practitioner notified in addition to the provider who
orders the test.

Employee health programs (IC.02.03.01 EPs 1-3) may or may not be required. If your organization determines
that one is not needed, please check with your state's health department or healthcare licensing act, which may
have further regulations.

In conclusion, Teleradiology services will only be evaluated for compliance with IC.02.01.01 EPs 8-11, as
delineated above. They are encouraged, but not required, to incorporate practices for hand hygiene (please see
NPSG.07.01.01). IC.02.03.01 may or may not be applicable, as stated above.

Self-Contained High Level Disinfection Units - Semi-Critical Devices

What are the Joint Commission recommendations regarding Glutaraldehyde User Station's (GUS),
disinfection soak station's (or similar self-contained high level disinfection units which often use 0.55%
ortho-phthalaldehyde) for disinfecting devices ( such as vaginal probes and other endo-cavity probes)
utilized in various settings ( such as radiology, outpatient procedure rooms in hospital, and ambulatory
care settings). Specifically, are there any specific requirements for ventilation, use and processing
locations (shared or separate) and can the unit share space with a sterilizer?
This response is specific to the use of self-contained high level disinfection (HLD) units and does not apply to
reprocessing of instruments, such as endoscopes, bronchoscopes or TEE probes. In addition, the Joint
Commission does not endorse or promote any specific brand, product, process or device for performing HLD or
sterilization. Such decisions are the responsibility of the organization's leadership, giving consideration to the
scope of services provided, patient population served and accepted evidence-based guidelines, law and
regulation.

Disinfection strategies vary widely for semi- critical devices (such as vaginal probes, endocavity probes). Based
on the device and product(s) used for reprocessing, it would be expected that organizations follow the
manufacturer's recommendations to ensure safe, effective use.

This response addresses the environment where Glutaraldehyde User Station's (GUS) disinfection soak stations
(or similar self-contained high level disinfection units, such as those using 0.55% ortho-phthalaldehyde) are used.
The primary intent is that the 'process' for cleaning and disinfection of probes is consistent with current evidence-
based practices (that is recommended by AAMI, CDC, etc.) for such devices as well as following
recommendations from the product's manufacturer for both the device used for reprocessing as well as the
device being reprocessed.

The Joint Commission and OSHA require that health care facilities protect workers and patients from known
risks. Since all high-level disinfectants by definition are toxic, and their fumes are known irritants, workers and
patients need protection from exposure. Proper handling and use of high-level disinfectants falls under The Joint
Commission's Environment of Care Standard 02.02.01 EP 9 which states "The organization minimizes risks
associated with selecting, handling storing, transporting, using and disposing hazardous gases and vapors."

The Joint Commission Infection Control Standard IC.02.02.01 EP2 may be scored if the high level disinfectant is
not being properly used, including improper efficacy testing, frequency for changing the solutions in the unit not
following policy, or dilution ratio requirements not being followed.

The Joint Commission expects organizations to use evidence-based national guidelines, such as the ANSI/ AAMI
ST58:2013 "Chemical Sterilization and High-level Disinfection in Health Care Facilities". This document includes
the following requirements:

Chemical sterilants should be used in an area that is properly ventilated.

When general room ventilation is not adequate, a self-contained, freestanding system* or a local exhaust
hood should be installed to capture chemical vapor during processing.
When an outside exhaust system is not available, a ductless fume hood* can be used to deliver vapor to a
filter system that chemically inactivates the vapor; then clean, filtered air is returned to the room.
Filters for these systems should be replaced in accordance with the manufacturer's recommendations.
*A ductless fume hood is simply a freestanding system that captures the toxic fumes and vapors and
returns clean air to the room. Other names for ductless fume hoods are vapor control systems and
disinfection soak stations.

Practitioners should consult the labels of proprietary products for specific instructions. They should also consult
instrument manufacturers regarding compatibility of these agents with probes. Many of the chemical disinfectants
are potentially toxic and many require adequate precautions such as proper ventilation, personal protective
devices (gloves, face/eye protection, etc.) and thorough rinsing before reuse of the probe. Specific questions
pertaining to device cleaning and the self contained high level disinfection units:

What is the normal sequence of operations regarding device processing, including room environments?

After the patient is removed from the room the device is either processed in the room or removed from
the room in a covered container and brought to a separate room where the GUS (Glutaraldehyde
User Station) disinfection soak station (or similar self-contained high level disinfection unit, such as
those using 0.55% ortho-phthalaldehyde) is located. The processing procedure does not determine
the pressure differentials of the room (i.e. negative pressure), but the pressure differentials are
established by The Facility Guidelines Institute (FGI) 2014 Guidelines for Design & Construction of
Hospitals and Outpatient Facilities and the identified use of the room. For example, a soiled utility
room is required to be maintained under negative pressure, whether or not the GUS is in the room. A
clean utility room is required to be maintained under positive pressure, whether or not the GUS is in
the room.
The cleaning and disinfecting process should follow national guidelines (such as CDC guidelines)
where staff should wear appropriate Personal Protective Equipment (PPE) and follow manufacturers'
recommendations to process the device.
Store the device in a manner that will protect from damage or contamination and that is consistent
with national guidelines and manufacturers' recommendations such as hanging vertically in a cabinet
and storing in a clean environment.
 Is it acceptable to rinse the probes under tap water after Cidex disinfection OR should sterile water be
used?

There is no current recommendation to use sterile or filtered water rather than tap water for rinsing
semi -critical equipment that contact mucous membranes. The Joint Commission would expect the
organization to conduct a risk assessment to determine the quality of their rinse media.

Storage - Use of Wooden and Plastic Pallets

Please clarify The Joint Commission’s position on the use wooden pallets for storage.

The Joint Commission has no standard that prohibits wood pallets in clean areas, to include store rooms and
supply break-down rooms. Wood pallets that are contaminated should be segregated based on condition, and
not introduced to patient care areas or areas that support patient care, like laboratories.

The organization should conduct a risk assessment, per IC.01.03.01, to determine the appropriateness of having
wood pallets within any area of clean storage. Wood pallets should not be used in sterile areas, to include sterile
storage areas, since their surfaces are not conducive to the level of cleanliness required in a sterile area; this
prohibition does not apply to sterile supply breakdown areas; plastic pallets would be acceptable in sterile storage
areas.

Large quantities of wood pallets should not be used in non-fire sprinklered areas. When conducting the risk
assessment, the organization should involve an infection control representative, as well as the primary occupant
of the area being evaluated.

Organizations should define their requirements, such as in a policy, that addresses the acceptable use of wooden
pallets. The organization is expected to adhere to its requirements and evaluate the assessed practice for
effectiveness and compliance. The survey process will review the established process for effectiveness and
tracer activity will validate proper implementation.

See also: Boxes and Shipping Containers

Information Management (IM)

Topic

Abbreviation List - Options

Is a list of acceptable abbreviations required?

No. The requirements found at IM.02.02.01 do not require organizations to maintain a list of acceptable
abbreviations. Developing and maintaining a list of acceptable abbreviations would be an organizational
decision. IM.02.02.01 EP 2 requires that organizations use 'standardized' abbreviations. Any reasonable
approach to standardizing abbreviations, acronyms, and symbols is acceptable. Examples may include:

Standardized abbreviations developed by the individual organization.

Use of a published reference source. However, if multiple abbreviations, symbols or acronyms are used for
the same term, the organization identifies what will be used to eliminate any ambiguity.
A decision that individuals who work in the organization may use any abbreviation, acronym, or symbol that
is not on the list of unacceptable abbreviations. However, if multiple abbreviations, symbols, or acronyms
exist for the same term, the organization identifies what will be used to eliminate ambiguity.

Medical Record - Security

We contract with an after hours cleaning service. Our medical records are stored in an unlocked area or
on open shelves with in a secure area. The after hours cleaning crew members sign confidentiality
statements. Is this acceptable or should we store the records under lock and key?

The Joint Commission standards require organizations to comply with applicable law and regulation to ensure the
privacy and integrity of protected health information (PHI) are maintained. When an organization's staff is not
present to monitor medical records storage areas, alternative approaches must be employed to protect privacy
and confidentiality of this information. Keeping such information secure when staff is not present generally
requires a process that includes a locking mechanism. Use of alternative approaches, such as a signed
confidentiality statement in lieu of a locking mechanism, should be thoroughly evaluated by the organization’s
legal and risk management leadership to determine if such approaches comply with regulatory requirements
(CMS, state law/regulation, etc.).
The requirements found in the Information Management (IM) chapter of the Accreditation Manual apply to both
paper and electronic medical records. Organizations should work with their Information Technology (IT)
leadership to determine strategies for ensuring the security of electronic medical records. At the time of the
survey, compliance with the requirements found at IM.02.01.01 which require organizations to maintain the
privacy and confidentiality of information will be evaluated.

Conducting a risk assessment is a helpful way of identifying risks associated with various options being
considered by the organization. A proactive risk assessment examines a process in detail including sequencing
of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical
process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or
services provided.

The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment
model that an organization may use. However, this specific approach is not mandated as there are other risk
assessment tools available that may better meet the needs of the organization. Other examples may include a
root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and
variations.

Leadership (LD)

Topic

Contracted Services - Applicability to Joint Commission Standards

Do the standards for contracted services apply if the contracted organization is Joint Commission
accredited or certified?

Yes. Organizations are expected to demonstrate compliance with all accreditation or certification requirements for
their respective program.

Contracted Services - Organization's Responsibilities

What are our responsibilities related to services provided by our contracted organization?

Leaders must oversee contracted services to make sure that they are provided safely and effectively. The only
contractual agreements subject to the requirements at Standard LD.04.03.09 are those for the provision of care,
treatment, and services provided to the hospital's (organization's) patients. This standard does not apply to
contracted services that are not directly related to patient care, treatment, or services. The EPs do not prescribe
the methods for evaluating contracted services; leaders are expected to select the best methods for their hospital
(organization) to oversee the quality and safety of services provided through contractual agreement. Examples of
sources of information that may be used for evaluating contracted services include the following:

Review of information about the contractor's Joint Commission accreditation or certification status.
Direct observation of the provision of care.
Audit of documentation, including medical records.
Review of incident reports.
Review of periodic reports submitted by the individual or hospital providing services under contractual
agreement.
Collection of data that address the efficacy of the contracted service.
Review of performance reports based on indicators required in the contractual agreement.
Input from staff and patients.
Review of patient satisfaction studies.
Review of results of risk management activities

In the event that contracted services do not meet expectations, leaders take steps to improve care, treatment,
and services. In some cases, it may be best to work with the contractor to make improvements, whereas in other
cases it may be best to renegotiate or terminate the contractual relationship. When the leaders anticipate the
renegotiation or termination of a contractual agreement, planning needs to occur so that the continuity of care,
treatment, and services is not disrupted.

Laboratory Director Of Record - Definition

Please explain the title of 'Laboratory Director'.

Laboratory Director (LD) is the title afforded by regulation given to the individual whose name appears on the
laboratory service's CLIA certificate. This individual is the Laboratory Director of record for Centers for Medicare
and Medicaid Services (CMS) and Joint Commission purposes and they are responsible for all testing performed
by the laboratory service. For non-waived testing, this individual is typically a pathologist. Other physicians or
laboratory professionals may qualify if they have the prerequisite education and years of experience required by
the federal regulations†. For waived testing, there are no federally defined qualifications for the Laboratory
Director. In all cases, individual states may also have applicable regulations and licensure requirements for the
Laboratory Director.

For the purposes of accreditation and CLIA records, the title of Laboratory Director should not be confused with
the job description title of "Laboratory Director", sometimes given to an individual who provides administrative
oversight of the laboratory. This is often an experienced laboratory professional with a Bachelor's or Master's
degree. The Laboratory Director of record may delegate in writing a variety of oversight activities to the
administrative director, including technical responsibilities, in accordance with their qualifications and as permitted
by regulation.

Qualifications for the Laboratory Director of record for non-waived testing are described in the Clinical Laboratory
Improvement Amendments under Subpart M: "Personnel for Nonwaived Testing," 493.1351 - 493.1495.

Laboratory Test Complexity - Waived, Moderate and High

How can I verify the test complexity designation for a particular laboratory test?

Commercial test systems are evaluated by the Food and Drug Administration (FDA) and assigned one of the
three following complexity designations: Waived Moderate High Moderate and High complexity are often referred
to as "non-waived" testing. The complexity designation may be printed in the manufacturer's package insert. It
can also be searched online in the FDA's database:

Pain Management - Leadership Responsibilities for Educating Staff and Practitioners -

LD.04.03.13 EP 3

The revised pain management standards require organizations to provide staff and licensed independent
practitioners (LIP) with educational programs and resources regarding pain management and safe use
of opioid medication. Are there specific resources that must be available and what options may be
considered for delivering this information?

Each organization determines what educational resources and programs to have readily available to staff and
licensed independent practitioners, giving consideration to staff needs, services provided and patient population
served. Educational resources available to staff may include online resources and/or clinical guidelines that
include content related to safe opioid prescribing, modalities of treatment, multi-modal pain management*, patient
assessment and reassessment criteria.

* Multimodal analgesia may be described as combining 2 or more analgesic agents or techniques that act by
different mechanisms to provide analgesia resulting in improved pain relief while use of fewer opioids.

Resources:
R3 Report: Pain assessment and management standards for hospitals
Joint Commission Statement on Pain Management
Sentinel Event Alert Issue 49: Safe use of opioids in hospitals

Pain Management - Leadership Responsibilities for Monitoring and Perfomance Improvement

Acitivities - LD.04.03.13 EP 1

The new requirement states that leadership is responsible for developing, implementing and monitoring
performance improvement activities specific to pain management. Does having a policy meet the intent
of this requirement?

No, simply having a policy does not meet the intent of leadership engagement in quality assessment and
performance monitoring activities regarding pain management and opioid prescribing practices. Active leadership
engagement ensures the implementation of safe and effective practices, sustainable improvements and
accountability across disciplines and services involved in pain assessment, management and opioid prescribing
practices.

Each organization determines whether an individual 'leader' will be assigned this responsibility or if a 'team'
model would provide more comprehensive oversight of pain management practices. Evaluating the scope of
services provided and patient populations served will help determine which model would be most effective. If the
'team' approach is adopted, organizations would determine if the responsibilities would be assumed by an
existing team (committee, etc.), or if a separate team would be more effective.
Compliance is determined based on the organization's ability to demonstrate active leadership engagement and
how pain assessment and safe opioid prescribing has been identified as an organizational priority. Survey
activities may include: staff interviews, review of applicable meeting minutes, discussions with leadership,
practitioners, governing body members, Performance Improvement data, etc.

Resources:
R3 Report: Pain assessment and management standards for hospitals
Joint Commission Statement on Pain Management
Sentinel Event Alert Issue 49: Safe use of opioids in hospitals

Pain Management - Leadership Responsibilities for Providing Information on Available

Resources - LD.04.03.13 EP 4

The revised pain management standards require the organization to provide information to staff and
licensed independent practitioners (LIP) on available services for consultation and referral of patients
with complex pain management needs. Does this mean internal or external services - or both?

Available sources for consultation and referral may be include 'internal' resources, such as an organization's
outpatient pain management program, addictions treatment programs, or external community resources. The
intent of this requirement is to ensure that staff and LIPs are knowledgeable about available services and
resources to which patients can be referred to for continuing care at the time of discharge. Compliance with this
requirement is determined through interviews with staff, LIPs patients, etc.

Resources:
R3 Report: Pain assessment and management standards for hospitals
Joint Commission Statement on Pain Management
Sentinel Event Alert Issue 49: Safe use of opioids in hospitals

Pain Management - Leadership Responsibilities for Providing Non-pharmacologic Modalities for

Managing Pain - LD.04.03.13 EP 2

One of the new pain management elements of performance requires that organizations provide non-
pharmacologic pain treatment modalities. To what specifically does this refer and is there evidence-
based literature to support the efficacy of these non-pharmacologic modalities?

Organizations are required to provide non-pharmacologic pain treatment modalities relevant to its patient
population and assessed needs of the patient. These modalities serve as a complementary approach for pain
management and may potentially reduce the need for opioid medication in some circumstances.

Additionally, it is important to have non-pharmacologic pain treatment modalities available for patients that refuse
opioids or for whom physicians believe may benefit from complementary therapies. Non-pharmacologic
strategies include, but are not limited to transcutaneous electrical nerve stimulation, physical modalities (i.e.:
acupuncture therapy, chiropractic therapy, osteopathic manipulative treatment, massage therapy, and physical
therapy) relaxation therapy, music therapy, aromatherapy, cognitive behavioral therapy, etc. The level of evidence
for these therapies is highly variable, and it is evolving. Therefore, our standards do not mandate that any specific
complementary options are provided, but allow organizations to determine what modality(s) to offer.

Organizations should ensure that patient preferences for pain management are considered, and, when a patient’s
preference for a safe non-pharmacologic therapy cannot be provided, provide education to patients on where the
treatment may be accessed post-discharge. There is not an expectation that the hospital will fulfill any and all
requested non-pharmacologic therapies during the inpatient stay.

Resources:
R3 Report: Pain assessment and management standards for hospitals
Joint Commission Statement on Pain Management
Sentinel Event Alert Issue 49: Safe use of opioids in hospitals

Pain Management - Leadership Responsibility for Providing Access to Prescription Drug

Monitoring Program (PDMP) databases - LD.04.03.13 EP 6
Please explain what is meant by the requirement that "The hospital facilitates practitioner and
pharmacist access to the Prescription Drug Monitoring Program (PDMP) databases". Does this mean
that the organization is required to access the PDMP for every patient receiving opioids?

Facilitating access to the PDMP means that leadership has implemented systems and processes that support
both ease of access and consistent access to the PDMP when required.
Examples may include:

shortcuts on designated computer desktops to the PDMP database

links from the organization's intranet site and/or electronic health record (EHR)
staff and practitioner education that includes access to and when the PDMP is to be queried
demonstration/return demonstration
periodic monitoring of compliance as defined
periodic refreshers with staff, as defined by the organization
creating prompts in an electronic medical record (when state law requires accessing before hospital
discharge ).For example, the state of Massachusetts requires a 'Mass PAT' check before writing
prescriptions to be filled at a retail location for a schedule II or III narcotic or a benzodiazepine at
discharge from the inpatient setting or Emergency Department.

Each organization determines who is responsible for accessing the PDMP. This may vary based on different
patient care settings.
The requirement does NOT apply to patients receiving short term opioid medications DURING the hospital
encounter. For example, opioids administered for a day or two following a surgical or invasive procedure. During
survey, compliance with accessing the PDMP may be evaluated during tracer activities, interviews with staff,
practitioners, pharmacists, etc.

NOTE: This element of performance is only applicable in states that have a fully functioning Prescription Drug
Monitoring Program (PDMP).

Resources:
R3 Report: Pain assessment and management standards for hospitals
Joint Commission Statement on Pain Management
Sentinel Event Alert Issue 49: Safe use of opioids in hospitals

Pain Management - Leadership Responsibilties for Identifying Available Opioid Treatment

Programs for Referral - LD.04.03.13 EP 5

How do organizations demonstrate compliance with the requirement that states "The hospital identifies
opioid treatment programs that can be used for patient referrals" ?

Clinicians encountering patients dealing with possible opioid abuse or dependence need readily
accessible, accurate information about available resources to which patients can be referred for
treatment. It can be challenging for individual clinicians or departments to maintain current information
about provider availability in the community, therefore leadership can play a role by identifying
community resources, then communicating this information to staff and practitioners. To assist
organizations, the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) has a
directory of opioid treatment programs.

Compliance may be determined through interviews with leadership, staff, practitioners and patients,
review of an organization's discharge and referral processes, discharge information provided to patients
to support ongoing care following discharge, etc.

Resources:
R3 Report: Pain assessment and management standards for hospitals

Pain Management - Leadership Responsiblity: Patient Monitoring Following Sedation or

Anesthesia- LD.04.03.13 EP 7
Does The Joint Commission have any recommendations or standards concerning the monitoring of post-
operative patients on opiates (and/or on opiates combined with other pain medications)? Specifically, we
are wondering if continuous pulse oximetry is generally recommended for the first 24 hours post-
operatively…or recommended in certain situations only post-operatively, such as patients with additional
risk factors for respiratory depression.

Decisions on monitoring requirements to detect post-procedure drug-induced respiratory depression are

determined by the clinical team responsible for providing care and based on evidence-based guidelines,
accepted standards of practice, etc. Leadership commitment is required to ensure that appropriate equipment is
available to monitor patients deemed highest risk (that is, patients with sleep apnea, patients receiving
continuous intravenous opioids, patients on supplemental oxygen, etc.).

The requirements found in the Provision of Care (PC) chapter at PC.03.01.01 through PC.03.01.07 speak
specifically to sedation and anesthesia care. Because of the vast variations from one entity to the next, these
standards require organizations to develop policies, procedures, assessment/reassessment requirements, staff
qualifications and competency, education and training, etc., requirements based on the services provided and
patient populations served by the organization.

Organizations are encouraged to convene a group of clinicians that are involved in the pain assessment, pain
management, and safe opioid prescribing to discuss and re-evaluate the organization’s approach to pain
assessment and management.
Participants may include members of the medical staff, nursing, pharmacists, social workers, etc.

Review of evidence-based guidelines will assist leadership and the medical staff in developing policies, protocols,
metrics and other quality indicators, etc. During survey, clinicians may be asked to describe how they identify a
patient that is high risk and how they would manage and monitor that patient.

References to consider:
American Society of Anesthesiology
Anesthesia Patient Safety Foundation
American Pain Society
The American Society for Pain Management Nursing
The American Pain Society Guideline on Management of Postoperative Pain (2016)
Responsible, Safe, and Effective Prescription of Opioids for Chronic Non-Cancer Pain: American Society of
Interventional Pain Physicians (ASIPP) Guidelines (2017).

Resources:
R3 Report: Pain assessment and management standards for hospitals
Joint Commission Statement on Pain Management
Sentinel Event Alert Issue 49: Safe use of opioids in hospitals

Publications/Resources - Environment of Car, Emergency Management and Life Safety.

What are some other resources and publications helpful with compliance?

Publications and other sources available to accredited organization that may be helpful with environment of care,
emergency management and life safety compliance:

Joint Commission Resources publishes Environment of Care News (the official TJC environment of care,
emergency management and life safety news source), The Joint Commission Perspectives (the official
newsletter of TJC), and E-Alerts.
Accredited organizations may access the TJC Leading Practices Library on the intranet.
Other publications for purchase are available through Joint Commission Resources.
Frequently Asked Questions for various standards can be found on the Joint Commission web site.
For additional detail concerning specific standards, see The Joint Commission Physical Environment Portal
(JCPEP), which is a partnership with The American Society for Healthcare Engineering.
A helpful source for clarification of terms found in the standards chapters is the Glossary section of the
organization's applicable accreditation manual.

Records and Documentation - Format/Availability

What form of documentation is acceptable by The Joint Commission, electronic or paper? How quickly
must documentation be accessible during a survey?
The Joint Commission surveyors will accept evidence of standards compliance in either a paper format or an
electronic format. In either case, the documentation must be organized or accessible in such a way as to allow for
timely review. As with electronic medical records, a review of environment of care, emergency management and
life safety documentation can be done by, for example, viewing a computer screen or a wall projection. A person
from the organization must be available and have knowledge on how to efficiently navigate the electronic format.

The timeliness of accessibility to required documentation is at the surveyor's discretion and is an evaluative
determination. If the organization demonstrates a consistent pattern where requested documents are not readily
available, then a Leadership finding (LD.04.01.05) may be made. If an asked-for document is incomplete and
requires some time to retrieve additional documentation, then the surveyor will likely provide additional time
(LD.04.01.05).

The 2017 Accreditation Survey Activity Guide (SAG) for Health Care Organizations, available to organizations via
their secure extranet site or our website, includes a list of the documents required to be available to the survey
team. Organizations may find it helpful to conduct 'mock surveys' that include evaluating timely access and
availability of these documents.

Regarding Medical Records:

There is no prescribed, required or recommended format for medical records. At the time of survey, medical
records are evaluated for content, based on the applicable accreditation Elements of Performance (EP), not
format. Organizations operating in a high-bred environment (both paper and electronic) or are in the process of
migrating to an EMR platform may wish to consider having a 'super-user' available to staff during the survey to
assist in navigating the record to locate information requested by the surveyor.

Effective January 2017:

The following information regarding changes to the clarification process for 2017 were communicated to
organizations on December 22, 2016. “Findings of ‘lack of required documentation at the time of survey’ will no
longer be eligible for the clarification process. When an organization does not have required documentation
available at the time of survey, the organization can expect that the surveyor will give the organization a
reasonable amount of time to produce missing documents. If the documentation is provided within the time frame
agreed upon by the organization and surveyor, the organization will be compliant for document availability.
However, if the documentation is not provided, the organization is not compliant and an RFI is created. The RFI
remains in the survey report. Following the survey, the organization will need to provide ESC that the required
documentation is addressed through corrective actions."

Records and Documentation - Retention

How long are records and/or documentation required to kept ?

Retention of medical records is generally determined by state and/or federal law. Organizations should work with
their legal and risk management leadership to determine state-specific medical record retention requirements.
Likewise, legal and risk management leadership should determine retention requirements for documents NOT
considered part of the permanent patient medical record. Examples of documents not considered part of the
patient's medical record may include, but are not limited to:

Crash cart daily checks

Temperature monitoring logs,
Human Resource/employee file documents,
meeting agendas and minutes,
sign-in sheets for attendance at meetings,
educational events,
Etc.

From a survey perspective, organizations are required to have records available during the survey process that
goes back to their last full survey. Compliance with more stringent requirements of local/state/federal controlling
authorities is also expected.

Scribe - Compliance with Joint Commission Standards - Update

Do the Joint Commission standards allow organizations to utilize scribes?

*** The use of scribes in healthcare settings is currently under review. Any updates or changes will be published
in future editions of the Perspectives Newsletters and/or via the Joint Commission Online newsletter. ***

Texting - Use of Secure Text Messaging for Patient Information

Can secure text messaging be used to communicate patient information ?

Yes. Healthcare providers may text patient information (except for patient care orders) as long as a secure text
messaging platform is used. Several text messaging platform specifications and recommendations for texting
policies and procedures are included in The Joint Commission’s May 2016 Perspectives article.

Key features of secure text messaging platforms include:

• Secure sign-on process
• Encrypted messaging
• Delivery and read receipts
• Date and time stamp
• Customized message retention time frames

Organizations are also advised to do the following:

• Develop an attestation documenting the capabilities of their secure text messaging platform
• Assess compliance with texting policies and procedures
• Develop a risk-management strategy and perform a risk assessment
• Conduct training for staff, licensed independent practitioners, and other practitioners on applicable
policies and procedures

Texting - Use of Secure Text Messaging for Patient Orders

Can secure text messaging be used to communicate patient care orders?

No. After extensive discussion weighing the pros and cons of using secure text messaging platforms to place
orders, The Joint Commission and the Centers for Medicare & Medicaid Services (CMS) concluded that the use
of secure text messaging for patient care orders is not permitted (see The Joint Commission’s December 2016
Perspectives article for additional information).

CMS reiterated their position on texting in a December 28, 2017, memorandum stating that CMS does not permit
the texting of orders by physicians or other health care providers, regardless of the platform used. This
information is available at the following website:
https://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-18-10.pdf

Life Safety (LS)

Topic

Alcohol based hand rub dispensers - Placement In Waiting Areas

What is the requirement regarding placement of alcohol-based hand rub dispensers in health care
occupancies?

The Joint Commission allows the installation of alcohol-based hand rub (ABHR) dispensers in corridors and
rooms provided the requirements of NFPA 101 (2000 edition) Tentative Interim Amendment 00-1 are met.
Additionally, TJC has decided to accept the NFPA 101 (2012 edition) criteria of the ABHR dispenser being at
least 1 inch from an ignition source since it offers more specificity and clarity than the TIA 00-1 content.
[LS.02.01.30]

Alcohol-based Hand Wipes - Requirements

What is the criteria regarding alcohol-based hand wipes?

The requirements for alcohol-based hand wipes are that same as for alcohol-based hand rub (liquid) products.
These requirements can be found in the Tentative Interim Amendment section of the 2000 edition of NFPA 101
Life Safety Code and applicable CMS S&C letters. The 10-gallon limit per smoke compartment is applicable to
the aggregate of all alcohol based products mounted in unprotected locations within a smoke compartment. For
consistency, the volume of the alcohol-based wipes container (typically ounces converted to gallons) would be
used in the aggregate calculation. [LS.02.01.30]

CMS Categorical Waiver - TJC Traditional Equivalency

When and how do CMS categorical waivers apply to TJC standards?

The Joint Commission recognizes CMS Categorical Waivers (CW) (S&C 13-25-LSC & ASC) where certain
specific elements of the 2012 edition of NFPA 101 Life Safety Code can be implement under specified
circumstances. Only S&C 13-25 applies since the adoption of NFPA 101-2012 and NFPA 99-2012, effective July
5, 2016. The organization must strictly comply with the provisions of the CMS waiver document. The S&C letters
require the organization to notify the survey team for any applicable CW at the beginning of the survey (the
entrance conference). In addition, TJC requires a statement of invocation for any applicable CW in the Additional
Comments field of the Basic Building Information of the Statement of Conditions when the CW is related to NFPA
101 Life Safety Code. For any CW relating to an Environment of Care requirement, the organization is to
document invocation of the CW in their EC Committee meeting minutes or in the applicable management plan(s).
When documenting invocation of a CW, the CW must be identified (S&C letter/subject), the locations of
applicability, and there is to be an attestation that the organization has reviewed and is in compliance with the
referenced content of the of the applicable NFPA code. These categorical waivers will replace any TJC traditional
equivalencies granted to an organization that are covered by these categorical waivers, therefore no waiver
application is required. The survey process will field-validate proper CW invocation. Those properly applied NFPA
code sections defined by the CW (in the CMS S&C letter) will be recognized. (For more information, see the
November 2013 edition of Joint Commission Perspectives.)

CMS Waiver Process - Maintenance of Documents

Where and how do I get a copy of my organization's approved waivers?

The Joint Commission made a process change in 2010 to document equivalency approvals or denials in the
History/Audit Trail section under the PFI tab of the eSOC. Outside of the documentation in the SOC, the Joint
Commission does not maintain documentation of approved or denied equivalencies. It is the responsibility of the
organization to maintain approved equivalency documents. The organization should document them in the
"Additional Comments" field of the Basic Building Information (BBI) in the electronic Statement of Conditions for
the applicable building(s). The surveyor will review the BBI content, ask for the waiver document, then field
validate its proper implementation. If a Categorical Waiver is used, no submission is required. The organization
would review the appropriate CMS S&C letter and implement the CW as instructed. The organization would then
document the CW invocation in the Additional Comments field of the BBI for the applicable building(s). (see the
Frequently Asked Question concerning proper invocation of a Categorical Waiver) If a Traditional Equivalency
(CMS uses the term Waiver) is needed, instructions for submission (or re-submission) are in the eSOC > PFI tab
> left-side column of selections.

Combustible Postings - Managing Volume

What is the requirement for managing the volume of combustible postings?

The Joint Commission uses the following to manage combustible posting volume in a health care environment.
NFPA 101 (2000 edition) 10.2.5 Trim and Incidental Finish, where postings (considered Class C materials) are
not to be in excess of 10% of the aggregate wall and ceiling areas of any room or space. For example if the wall
and ceiling surface area of a particular room or corridor is 1000 sq-ft, then combustible postings should be limited
to 100 sq-ft in the aggregate. The 2012 edition of NFPA 101 provides more refined guidance, and the
requirements of 18/19.7.5.6 can be used if the organization invokes CMS Categorical Waiver 12-21. There
postings are considered combustible decorations. (see the Frequently Asked Question concerning proper
invocation of a Categorical Waiver) [LS.02.01.70]

Containers - Clean Waste

Are 96-gallon recycling containers allowed for clean waste use within a health care occupancy?

Recycling containers used for clean waste (e.g., bottles, cans, paper) pose a lower fire risk than trash containing
grease, oil, or flammable liquids. Allowing the size of container used for recycling to increase will reduce the
number of trash receptacles and hazardous storage areas required, which will reduce undue cost burden. In the
2012 LSC, the NFPA began allowing containers used solely for recycling clean waste or for patient records
awaiting destruction outside a hazardous storage area to be a maximum capacity of 96-gallons. Accordingly, The
Joint Commission permits CMS Categorical Waiver 13-58, item 7 Clean Waste & Patient Record Recycling
Containers to increase the size of containers used solely for recycling clean waste or for patient records awaiting
destruction when located outside of a hazardous storage area to be a maximum of 96-gallons, but only if in
compliance with sections 18/19.7.5.7.2 of the 2012 LSC. These recycle containers for clean waste or patient
records awaiting destruction are to be labeled with FM Approval Standard 6921, Containers for Combustible
Waste. (see the Frequently Asked Question concerning proper invocation of a Categorical Waiver) [LS.02.01.70]

Containers - Hazardous Areas

Is it acceptable to have containers that are designed with a capacity greater than 32 gallons in a
healthcare or ambulatory occupancy?

In accordance with Life Safety Code NFPA 101 Chapters 18/19 there are restrictions on deployment of soiled
linen and trash collection receptacles in health care occupancies. When located outside of hazardous protected
rooms, container capacity is not to exceed 32 gallons, and when there are multiple containers, the density of
soiled linen or trash is not to exceed 0.5 gallons per square foot. Container size and density restrictions are not
required within hazardous rooms. Within health care occupancies (not in ambulatory health care occupancies),
the organization has the option to invoke CMS Categorical Waiver 13-58, item 7 Clean Waste & Patient Record
Recycling Containers to increase the size of containers used solely for recycling clean waste or for patient
records awaiting destruction when located outside of a hazardous storage area to be a maximum of 96-gallons,
but only if in compliance with sections 18/19.7.5.7.2 of the 2012 LSC. These recycle containers for clean waste or
patient records awaiting destruction are to be labeled with FM Approval Standard 6921, Containers for
Combustible Waste. (see the Frequently Asked Question concerning proper invocation of a Categorical Waiver)
[LS.02.01.70]

Corridor Door - 5-ft-lb Closure Exception

What is the requirement for corridor doors using the "5-ft-lb closure exception?"

In accordance with standard LS.02.01.30, The Joint Commission uses the Life Safety Code NFPA 101 (2000
edition) 19.3.6.3.2 for existing health care occupancy corridor doors. Positive latching is required or allowance to
use 5 ft-lb of force to keep the door closed. There must be a maintenance strategy in place to maintain/validate
the 5 ft-lb closure criteria, and the closure force must be applied during all conditions, even a loss of power. This
5 ft-lb criteria does not apply to new health care occupancies defined by 18.3.6.3 where positive latching
hardware is required. For both new and existing health care occupancies, positive latching is not required for
toilet rooms, bathrooms, shower rooms, sink closets, and similar auxiliary spaces that do not contain flammable
or combustible materials. Roller latches are prohibited in all applications. [LS.02.01.30]

Corridor Door - Gaps

What is the minimum gap requirement for smoke resistant corridor doors?

The Joint Commission allows gaps not exceeding 1/8 inch for meeting edges of door pairs as acceptable for a
smoke resistant corridor door. Life Safety Code NFPA 101 (2012 edition) 18/19.3.6.3 simply requires that the
door is smoke resistant. The 1/8 inch gap criteria is TJC criteria for uniform, consistent application to be used by
surveyors and organizations when evaluating smoke resistant door assemblies. The door undercut is not to
exceed 1 inch. Gaskets may be used to reduce or close the gap and can also be used if the door is not a fire
rated door.

Dampers - Requirements

What are the requirements for the installation of fire and smoke dampers?

Use NFPA 90A-2012 Installation of Air Conditioning and Ventilating Systems to determine the requirements for
fire and smoke dampers. There is a useful Figure A.5.3 in the Annex of NFPA 90A.

Doors - Protective Plates

What are the requirements addressing protection plates on fire rated doors?

The Joint Commission uses NFPA 80-2010 where 6.4.5 Protection Plates states that: Factory-installed protection
plates shall be installed in accordance with the listing of the door. Field-installed protection plates shall be labeled
and installed in accordance with their listing. Labeling is not required where the top of the protection plate is not
more than 16 in. (406 mm) above the bottom of the door. No labeling is required if the plate is factory installed,
but labeling is required for field installed protective plates greater than higher 16 in. from the bottom of the door.
Per NFPA 80, Door Protection Plate is defined as: Protective material applied to the face of a door and generally
made of approximately 0.05-in. (1.2-mm) thick brass, bronze, aluminum, or stainless steel or 1/8-in. (3.2-mm)
thick laminated plastic.

Evacuation Maps - Posting Requirements

Are evacuation maps required to be posted in health care organizations?

Evacuation maps (deployed within the hospital) are not the same as life safety floor plans (a maintenance and
evaluation tool) required by the Joint Commission Statement of Conditions. Evacuation maps are typically user-
friendly diagrams with exit routes shown. Neither Joint Commission standards nor the NFPA 101 Life Safety
Code require that evacuation maps be posted in hospitals or other health care occupancies. However, there have
been cases where the local or state fire marshals have required such maps. If another authority having
jurisdiction (AHJ) mandates the posting of such maps, then the Joint Commission would expect compliance with
that AHJ.

Exit Signage - Internal Illumination

What are the requirements for photoluminescent Exit signs?

NFPA 101 (2000 edition) 18/19/20/21.2.10 requires marking the means of egress in health care and ambulatory
health care occupancies in accordance with 7.10. Photoluminescent Exit Signs, per 7.10.7, are categorized as
internally illuminated signs, therefore the listing requirements in 7.10.7.1 are applicable, so UL 924 compliance
and the stated lettering specifications are compliance requirements. Additionally, the requirements of 7.10.7.2 are
applicable to Photoluminescent Exit Signs. Annex A provides additional information to assist in selecting a
product. [LS.02.01.20, LS.03.01.10]

Exit Signage - No Exit

What circumstances require the use of "No Exit" signs?

There are circumstances when a No Exit sign is an effective means of providing clarity to the means of egress.
The Annex A guidance for NFPA 101 (2000) is helpful. "The likelihood of occupants mistaking passageways or
stairways that lead to dead-end spaces for exit doors and becoming trapped governs the need for No Exit signs."
[LS.02.01.20]

Exit Stairwell -Items In Stairwells

What are the restrictions on items being mounted or installed in exit enclosures such as stairwells?

The Joint Commission uses the 2000 edition of NFPA 101 Life Safety Code. For consistency, no equipment is
allowed in an exit enclosure (exit stairwell) that could interfere with its function as an area of refuge in accordance
with section 7.1.3.2.3. This would include systems such a security cameras and access control devices, and
evacuation chairs/sleds. But TJC allows for organizations to submit their particular circumstance for approval by
using the Traditional Equivalency process (see instructions in the electronic Statement of Conditions > PFI tab >
left side list of options). Using this process, TJC can validate on a case-by-case basis that the exit enclosure will
not be compromised. In accordance with 7.1.3.2.1, systems in an exit enclosure are limited to systems that
support the functionality of the exit enclosure in new health care and ambulatory health care occupancies.
Properly protected system penetrations into existing (prior to March 2003) exit enclosures are acceptable as long
as they were part of the original construction and no alterations have since been made. [LS.02.01.20,
LS.03.01.20]

Fire Rated Assemblies - Compliance

What is considered an assembly within a fire rated door system?

Fire rated door systems are considered assemblies. As an assembly, the door, hardware and frame are to be in
accordance with NFPA 80. If a component of a fire rated assembly is changed, then the change must result in the
overall assembly being compliant. Just because a component, in and of itself, has the appropriate rating
designation, it may not mean that the design of the resulting assembly of components has been accepted by the
testing authority as compliant. As long as the component replaced is listed for use with the door in question, then
the door assembly is compliant. If not, then the resulting altered assembly must be validated by a field study of
the assembly by a qualified entity.

Fire Rated Assemblies - Vision Panels

What is the requirement for proper fire rated vision panels?

If wired glass is used, and the vision opening is sized correctly according to NFPA 101-2012, Table 8.3.4.2 (does
not exceed the area and dimension limits), then the wired glass is considered to be compliant. If glazed glass is
used, regardless of whether the vision opening is sized correctly, the glass is to be labeled since that is the only
way to determine if it is fire rated glass.

Fire Sprinkler System - "Fully Sprinklered"

What constitutes a facility being considered "fully sprinklered?"

In accordance with NFPA 13-2010, a mandatory reference of NFPA 101 Life Safety Code, certain exclusions for
fire sprinkler coverage can be applied. As long as the facility sprinkler system is installed in accordance with all
applicable provisions of NFPA 13 as it relates to the applicable occupancy chapter of NFPA 101 Life Safety Code
(2012 edition), then the facility, or the smoke compartment within the building, is considered to be fully
sprinklered.

Fire Watch - Cameras Instead of Personnel

Can a fire watch be established solely with cameras?

The Joint Commission would not allow cameras to be used instead of on-site fire watches performed by
personnel. Cameras can be used as a supplement to fire watches by personnel, but not as a sole substitute.
Cameras cannot replace human smell and hearing senses, and sight scanning and focusing abilities to identify
smoldering, fire and smoke development in their early stages.

Fire Watch Requirements - Fire Alarm/Sprinkler Testing

Are "fire watches" required for all instances in which portions of fire protection system is deficient?

The requirement for a fire watch is described in LS.01.02.01. The Life Safety Code (NFPA 101-2012 edition),
Sections 9.6.1.6 and 9.7.6 (reference to NFPA 25), require fire department notification and implementation of a
fire watch any time either the fire alarm system is out of service for more than 4 hours in any 24-hour period, or
an automatic fire sprinkler system is out of service for more than 10 hours in a 24-hour period . The organization
must still evaluate whether Interim Life Safety Measures are needed, with an emphasis on occupant notification
of the risk. All fire watch activities are required to be documented.

Free-Standing Emergency Department - Occupancy

What type of occupancy is a free-standing emergency department?

The Joint Commission defines the occupancy based on the definitions found in the NFPA 101 (2000) Life Safety
Code. If the free standing Emergency Department is not capable of rendering four or more patients incapable of
self-preservation in an emergency or is not capable providing general anesthesia to four or more patients, then it
may be classified as a business occupancy in accordance with the LSC. If the render/anesthetize rule is
applicable, the ED is classified as an ambulatory health care occupancy. If the facility provides housing on a 24-
hour basis, it is classified as a health care occupancy (hospital). An ED that is open on a 24/7 basis does not
dictate that it is a health care occupancy. [LS.01.01.01]

ILSM - grouping of PFI's for assessment

Does an ILSM assessment have to be accomplished for every Plan For Improvement?

There is no requirement for there to be a single Interim Life Safety Measures assessment applied to a single Plan
for Improvement. An ILSM assessment can consider multiple PFIs by, for example, common location or common
deficiency type. The ILSM assessment must identify the PFIs being assessed. If ILSM's are implemented, the
validation documentation must demonstrate that the risks identified by the PFI's are being mitigated. In many
cases, combining PFIs for a single ILSM assessment is the most appropriate method to create an effective risk
mitigation strategy (ILSM) for a group of identified life safety code deficiencies (PFI's). Examples could include,
grouping all deficiency types found within a smoke compartment, or grouping one deficiency type found on one
floor. [LS.01.02.01]

ILSM - Policy Scope

What must an Interim Life Safety Measure policy contain?

In order to evaluate and implement an effective plan for Life Safety code deficiency mitigation, an Interim Life
Safety Measure policy must consist of the following:

State that the process is applicable to both construction related situations, and situations of non-compliance
with the Life Safety Code.
State circumstances that would require ILSM assessment, to include a statement that at all Statement of
Condition, Plans for Improvement (PFI’s) are to be assessed for ILSM.
Describe how the organization will respond to situations described in LS.01.02.01.
Describe how occupants are to be protected by using the available menu of interim life safety measures
described in LS.01.02.01, as applicable to the situation.
Describe the ILSM assessment process, to include an assessment tool to document which measure(s) will
be implemented, or no ILSM needed if that is the assessment result.
Describe the ILSM implementation process, to be effective throughout the duration of the deficiency(s), and
to include an implementation tool to document each implemented ILSM for the duration of its application.
[LS.01.02.01]

ILSM - Policy Timeframes

In terms of correcting a Life Safety Code deficiency, what is the definition of "immediate?"

The context of "immediate" is to allow for a fire-safe facility, either by correction of the identified Life Safety Code
deficiency, or by implementing mitigating activities to compensate for the deficiency. The Joint Commission allows
the organization to use their professional judgement and their knowledge of their facility's unique circumstances
to determine the timeline associated with "immediate." That judgement would determine the timeline on
"immediate" based upon the criticality and severity of the identified deficiency.

ILSM - Temporary Construction Barriers

Do plastic sheets constitute acceptable temporary barriers in and around construction areas?

Unrated flammable plastic sheets, do not constitute acceptable temporary barriers. Even though flammable
plastic sheets taped across an opening may form a dust seal, they are incapable of controlling fire. The only thing
they can do is keep air and patriculate from moving to unwanted locations. Therefore, they are good for infection
control, and on a limited basis, for resisting smoke passage caused by a fire, friction or welding/brazing in the
construction zone. But these sheet types do nothing to stop the fire itself. The Joint Commission standards
require that temporary construction partitions be smoke tight and built of noncombustible or limited combustible
materials (sheet rock, gypsum board) that will not contribute to the development or spread of fire." Insure that
evidence of "limited combustibility" can be furnished if questioned during survey or other inspection. The Joint
Commission position is that plastic sheet barriers of a limited combustible type (rated material) can be used for a
short term applications. In addition, if the project includes any high risk construction activities (i.e., torch cutting,
welding, burning, open flame, etc.), non-combustible barriers should be erected.

Interior finishes - Plywood

When can plywood be used as an interior finish?

The Joint Commission uses NFPA 101 (2000) Life Safety Code where 19.3.3.2 allows for non-treated plywood
(Class C) in existing installations if the space is sprinklered and separated from the exit access corridor. New
installations, whether in new health care occupancies or new installations in existing health care occupancies, in
unoccupied spaces such as information technology equipment closets are to use fire-retardant-treated plywood
(Class A). Both instances can be painted. The substrate is the primary driver for the finish class, not its cover
(paint). The paint supplier should be consulted to validate the paint used is compatible with the application to
achieve the desired finish class. For example, latex paint, being water-based, has a low flame spread rating once
dried. At least one label should be kept visible if FRT plywood is used. [LS.02.01.30]

Life Safety Code - CMS Minimum Requirement

What is the minimum requirement to be compliant with the Centers for Medicare/Medicaid Services?

Compliance with the 2000 edition of NFPA 101 Life Safety Code is a minimum requirement per the Centers for
Medicare/Medicaid Services. If an organization has structural or system protections over and above LSC
requirements, it is assumed that their authority having jurisdiction made those requirements as evidence by
approving construction plans and specifications, and by providing the organization with a certificate of occupancy.
It is not within the purview of The Joint Commission to relax any additional requirements. That approval must
come from the organization's AHJ. Therefore if additional LSC structural and system protections are installed, the
organization is required to inspect and maintain those systems on-time in accordance with TJC standards. So if
life safety floor plans identify protections above basic NFPA 101 (2000 edition) requirements, then organization
would be required to maintain those protections. [LS.01.01.01]

Life Safety Code Floor Plans - Business Occupancies

Are Life Safety Code floor plans required for business occupancies?

If the buildings are classified as Business occupancies as defined by the 2012 edition of NFPA 101 Life Safety
Code, then a Statement of Conditions (SOC) is not used. An SOC, when required, consists of a Basic Building
Information tool and life safety floor plans. But it is prudent, if possible, to have a document that depicts the Life
Safety Code features of any building, particularly those buildings where patients are treated, even if the building
is classified as a Business occupancy. [LS.01.01.01]

Life Safety Code Inspections - Fire Safety Inspections

Are building fire safety or Fire Marshall inspections an annual requirement?

The inspections described within LS.01.01.01 are not an annual requirement, but the time-frame must be
determined by the organization. If the Fire Marshal, or another authority performs the assessment, that is
acceptable. The requirement is to maintain those inspection documents when inspections occur for Joint
Commission review during the survey process. The primary purposes are to have a periodic evaluation of the
organization's facilities and to determine if the organization acts upon identified deficiencies in a timely manner. If
the organization has a qualified inspection source (for example, an insurance carrier), they are encouraged, but
not required to utilize those inspection services on a regular or periodic basis (for example, annually).

Life Safety Floor Plan Content - General Requirements

What are Life Safety floor plans, why are they significant, and what is the required content?

Accurate and complete life safety floor plans are required to be available at the time of any survey conducted by
The Joint Commission in order for the organization's facilities to be effectively evaluated. Life safety floor plans
are to include all Life Safety Code, 2012 edition, features that have an impact on any health care, ambulatory or
behavioral health residential occupancy. The concept is to have a comprehensive document that consolidates all
construction phases of the facility over its history, to allow for LSC compliance through maintenance strategies,
identification of deficiencies, inspection and training. All content is not required to be on each floor's drawing; a
drawing package is acceptable. Per standard LS.01.01.01, life safety floor plans are to consist of at least:

a legend that clearly identifies features of fire safety;

areas of the building that are fully sprinklered (if the building is partially sprinklered; areas covered, not
individual sprinkler heads);
locations of all hazardous storage areas (both fire rated barrier types and smoke resistive barrier types);
 locations of all fire-rated barriers; locations of all smoke barriers;
suite boundaries, including the sizes of the identified suites;
locations of designated smoke compartments;
locations of chutes and vertical (elevator and utility) shafts; and
any approved equivalencies or waivers.

Note that if a non-occupied floor, or a floor occupied by another entity affects the Life Safety Code integrity of the
accredited organization, then those affected features, like chutes and vertical shafts that pass through those
spaces, are to be part of the life safety floor plan package.

Life Safety Floor Plan Content - Hazardous Materials

What method is required to identify hazardous storage areas on life safety floor plans?

There is no specific method of identifying rooms that store hazardous materials on life safety floor plans. There is
to be a distinctive identification method that can be readily distinguished when viewing the plans, either in an
electronic format or a hardcopy format. For example, an icon or a legend. If the organization has new and
existing health care occupancies, then there is to be a method to distinguish the different structural protections
associated with each occupancy type. For example, a hatched floor for existing health care room's smoke
resistive walls, and distinctive line types for new health care room fire rated walls. In any case, the goal is to
provide an effective tool for the organization to inspect and maintain the Life Safety Code features of their
applicable facilities, and to provide surveyors with accurate criteria to evaluate. [LS.01.01.01]

Means of Egress - Computers on Wheels

How long can computers on wheels be in corridors? Are they allowed to charge in the corridors?

Computers on wheels may be in the egress access corridors provided they are "in use" and addressed in a fire
plan (i.e., move them from the corridor in an emergency situation). "In use" would refer to anything in the
corridors that is idle for less than 30 minutes. The computers on wheels may be stored and charged in corridor
alcoves provided the corridor width is not compromised at any time. Computers on wheels are not considered
medical emergency equipment and do not apply to the provisions of NFPA 101-2012, 18/19.2.3.4.

Means of Egress - Corridor Storage/Clutter

Can items be stored in areas designated as egress access corridors?

Items cannot be stored in corridors that are designated as egress access corridors as defined by NFPA 101 Life
Safety Code (2012 edition) no matter how wide the corridor. Corridor alcoves can be used for storage as long as
the stored items do not infringe into the corridor. Dead-end corridors may be used for storage or sitting areas as
long as it occupies less than 50 square feet of space, and does not inhibit egress. Wheeled items that are in-use
(rule-of-thumb of less than 30-minutes) can reside in an egress access corridor. Only crash carts, designated as
emergency medical equipment permanently in-use, can be stored in corridors. Isolation carts and chemotherapy
carts, when associated with a specific patient, are also considered permanently in-use, therefore can be in the
corridor. However, equipment considered in-use must be removed from an egress corridor in the event of an
emergency. If the area can be designated a suite (see NFPA 18/19.2.5), then effective management of items in
the suite are to be managed to achieve unobstructed movement within the suite since the corridor is considered
an intervening room. If the hospital is a mixed occupancy, and the corridor in question is within an occupancy
other than a health care or ambulatory health care occupancy, refer to the appropriate occupancy chapter of the
Life Safety Code for direction. [LS.02.01.20, LS.03.01.20]

Means of Egress - Dead-end Corridor Storage

Can dead-end corridors be used for storage or other uses?

Up to a 50 square feet footprint can be used for non-combustible storage at a dead-end of an egress access
corridor. This would include items such as equipment, work stations, computers on wheels, sitting areas, etc. at
the end of a corridor as long as it does not impede the means of egress from rooms that open to the corridor or
entry into a stairwell exit. There is no need to invoke CMS Categorical Waiver 12-21 for these circumstances.
[LS.02.01.20, LS.03.01.20]

Means of Egress - Locking Doors

What are the requirements with regards to locking doors within a required means of egress?

Per LS.02.01.20, (therefore NFPA 101 (2000 edition) 18/19.2.2.2.4) doors within a required means of egress
shall not be equipped with a latch or lock that requires the use of a tool or key from the egress side. The
allowable exceptions are unique and have specific required features. Mixing and matching of these features is
not compliant. Exception No. 1: Door-locking arrangements without delayed egress shall be permitted in health
care occupancies, or portions of health care occupancies, where the clinical needs of the patients require
specialized security measures for their safety, provided that staff can readily unlock such doors at all times. (See
18/19.1.1.1.5 and 18/19.2.2.2.5.) Exception No. 2: Delayed-egress locks complying with 7.2.1.6.1 shall be
permitted, provided that not more than one such device is located in any egress path. Exception No. 3: Access-
controlled egress doors complying with 7.2.1.6.2 shall be permitted. With regard to Exception 1, per CMS S&C
letter 13-58 item 4 Doors, "clinical needs of the patients" in 18/19.2.2.2.4 applies to areas with a risk of patient
elopement like psychiatric units. Areas containing patients that require specialized protective measures for their
safety, and areas where patients pose a security risk are not applicable to the 2000 edition of NFPA 101. But the
organization may choose to invoke CMS Categorical Waiver 13-58-LSC-4 for this issue as long as the locking
arrangements are in compliance with NFPA 101 (2012 edition) 18/19.2.2.2.2 through 18/19.2.2.2.6, as applicable.
(see the Frequently Asked Question concerning proper invocation of a Categorical Waiver) [LS.02.01.20]

Means of Egress - Suite-to-Suite Exit/Suite Direct Exit to Stairwell

What is the requirement for suite-to-suite exits or suite direct exit to a stairwell?

The organization may invoke CMS Categorical Waiver 13-58, item 5 Suites, where NFPA 101 (2012 edition) is
used to evaluate patient care sleeping and non-sleeping suite compliance. Per 18/19.2.5.7, where two exits or
more exist, one can be suite-to-suite, directly to an exit stairwell or directly to the outside. One of the other egress
arrangements must be directly to an egress access corridor or to a horizontal exit. It is important to validate that
all of the requirements of NFPA 101 (2012) 18/19.2.5.7 are adhered to before invocation of the categorical
waiver, which requires suite-to-suite separation barriers to be in accordance with proper corridor wall construction
described in 18/19.3.6. (see the Frequently Asked Question concerning proper invocation of a Categorical
Waiver) [LS.02.01.20]

NFPA 101 2000 - References For Life Safety Code/Environment of Care Compliance

What references are used by CMS and TJC for Life Safety Code and Environment of Care compliance?

The Centers for Medicare/Medicaid Services (CMS) requires compliance with the NFPA 101-2012 and NFPA 99-
2012, including the mandatory references in each edition, for fire safety construction and operations criteria.
Additional information relative to applicable NFPA references also is provided with many of the elements of
performance in accreditation manuals. Variations in adopted code editions required to be followed by other of the
organization's controlling authorities (like their state health care licensing entity) can be handled by either
reconciling the requirements of the code editions and complying with the most strict requirements. For other
federal organizations like the Veterans Administration, the Department of Defense, the Indian Health Service,
etc., those entities decide the NFPA code editions that they will use and TJC will survey to those standards. For
non-CMS deemed organizations, like a state institution, they must arrange with TJC for the editions of NFPA to
be used; if no previous arrangement, the 2012 edition of NFPA 101 is used.

NFPA 101 2012 - Edition Adoption Date

When did The Joint Commission adopt the 2012 edition of NFPA 101, Life Safety Code?

The Joint Commission adopted the 2012 edition of NFPA 101 Life Safety Code on July 5, 2016 when CMS
adopted it. The Joint Commission will a adopt later edition of NFPA 101 and its Chapter 2 mandatory references
when CMS receives approval to adopt it through the legislative process.

Notification/Fire Watch - Unplanned Outage

When does the fire watch start and end for an impairment of a fire safety system?

If there is an impairment of a fire alarm or sprinkler system (see EC.02.03.05 for related systems), the clock starts
at the time of the impairment. If the system is restored within the four hours for fire alarm systems or 10 hours
(cumulative) for fire sprinkler systems, the clock stops. The time-frame noted for each system is a cumulative
period of time over 24 hours rather than an individual occurrence.

Plan For Improvement (PFI) - Scope/Quantity

What is the purpose and management requirements of the Plan For Improvement (PFI) process?

The Plan For Improvement process is to be used to identify only Life Safety Code (NFPA 101 - 2012 edition)
deficiencies, and any deficiencies associated with mandatory references found in Chapter 2 of NFPA 101- 2012
edition. The number or lack of PFIs, and the nature of the PFIs are unique to the organization's circumstance.
The PFI process was created to allow organizations to self assess for LSC deficiencies and create a plan for
correction or equivalency. All PFIs must have an associated Interim Life Safety Measures assessment to
determine if mitigating activities (for example, additional surveillance, fire-fighting equipment, training/awareness,
etc.) are needed to compensate for the structural or system deficiency defined by the PFI. The Joint Commission
will entertain requests to extend projected completion dates if warranted. Failure to make progress in accordance
with the established schedule for a previously accepted PFI, or failure to document ILSM assessment for a PFI
may result in an accreditation with follow-up survey decision. Surveyors evaluate both closed and currently open
PFIs for content. Surveyors check both closed and open PFIs during building tour to evaluate how well the
organization is managing the PFI process. It is important that PFI scopes are specific to the deficiency and
identify the location of the deficiency. General statements of deficiency scope and location of a deficiency are not
acceptable. Documenting PFI designated deficiencies on floor plans, spreadsheets, or other detailed means may
be a helpful tools to achieve the specificity required. [LS.01.01.01]

Polyurethane Expandable Foam - Use Of

Is it acceptable to use fire rated polyurethane expandable foam?

An organization should be cautious in its decision to use fire rated polyurethane expandable foam. The product
must be fire rated for the application, which includes the fire rating duration (1, 2, etc. hour fire rating), the
building type (classified for commercial and industrial use is acceptable, but not for residential use), and must be
UL rated. When used, the organization is to maintain a copy of the product specification (preferably a used
container with a remnant of the product) for surveyor review and inspection.

Smoke alarms - Physician/Staff Sleeping Rooms

What is the requirement for smoke alarms in non-patient sleeping rooms?

While The Joint Commission does not survey for the requirements of Chapter 28/29 Hotels and Dormitories of
the Life Safety Code, the principals contained those chapters are used to accommodate a non-patient overnight
stay condition, therefore, a single-station smoke alarm is required in all staff/physician sleeping rooms in
accordance with 9.6.2.10. Single station operated smoke alarm is required, not a smoke detector that relies upon
activation of the fire alarm system. Therefore per 9.6.2.10.4, alarms shall sound only within the individual area,
and not activate the building fire alarm system unless otherwise permitted by the AHJ, and remote annunciation
is permitted.

Smoke Barrier Door - Latching Hardware

What are the requirements for latching hardware on smoke barrier doors?

NFPA 101 (2000 edition) Chapters 18/19/20/21 do not require positive latching hardware for smoke barrier doors
in health care and ambulatory health care occupancies. But if latching hardware is installed on smoke barrier
doors, they are to be maintained to operate as intended/designed. Also, if the door does not latch, it is an
indication that the door has not fully closed, which is a requirement of a smoke barrier door, regardless of
whether it has latching hardware or not. [LS.02.01.30, LS.03.01.30]

Smoke Barrier Wall - Penetrations

What are the requirements for penetrations in smoke barrier walls?

In accordance with Life Safety Code NFPA 101 (2012 edition) Chapter 18/19, for a smoke barrier wall in a health
care occupancy, the wall must be maintained as smoke-resistant. This includes ensuring all types of penetrations
are properly sealed to maintain the smoke-resistant features of the smoke barrier wall.

Sprinklers - 18-inch Rule

What is the basic premise behind the "18-inch rule for fire sprinkler head clearance"?

The 18-inch rule does not apply to a non-sprinkled space. If the space is sprinkled, picture a horizontal plane
parallel to the ceiling, below ceiling level at the discharge of the ceiling mounted sprinkler heads. Then picture a
parallel horizontal plane 18 inches below that sprinkler head discharge plane. Nothing, to include shelving, racks,
storage, etc., can be within 18 inches of the sprinkler head discharge plane unless against a perimeter wall.
There is to be no obstructions to sprinkler discharge pattern development. Perimeter wall shelving and storage
are allowed from floor to ceiling level. Sprinkler heads cannot be within 4 inches on a vertical plane from a wall,
perimeter shelving or other vertical obstruction. The 2010 edition of NFPA 13 has many intricacies with regard to
fire sprinkler spray pattern obstructions, but The Joint Commission uses the criteria defined above for simplicity
and clarity.

Statement of Conditions - Building Assessment

What is the guidance for completing the building assessment (Part 3) of the Statement of Conditions?

The Part 3 building assessment has not been a requirement of the Statement of Conditions since the electronic
Statement of Conditions was established in 2007. The applicable components of the Life Safety Chapter are to
be used to assess the organization's health care, ambulatory health care, and behavioral health residential
facilities. Note that the Life Safety Chapter does not apply to business occupancies where patients are seen or
treated, but the applicable fire safety portions of the Environment of Care Chapter apply (see EC.02.03.01, .03
and .05). The Part 3 assessment is no longer available in electronic form. [LS.01.01.01]

Statement of Conditions - Basic Building Information - Adding a Site/Building

How do organizations add sites or buildings to existing Statement of Conditions?

Once a new site (address) has been added to your Joint Commission E-App (General Application), within a few
days a new site will automatically appear in your electronic Statement of Conditions, on the Sites and Building
page. Once the site appears, or if the new building is at an existing site, a Building can be created by selecting
Manage SOC. Then select the health care occupancy type; this will dictate which form will open to enter Basic
Building Information data. Note that there is no BBI content for a business occupancy where patients are seen or
treated, just its designation as a business occupancy on the Sites and Buildings list. If the site is not downloaded
to your eSOC within four days, please contact your Account Executive. [LS.01.01.01]

Statement of Conditions - Responsibility to Maintain

Who is required to have direct access to the electronic Statement of Conditions?

LS.01.01.01 requires that the hospital assign an individual(s) to assess compliance with the Life Safety Code and
manage the Statement of Conditions (SOC) when addressing survey-related deficiencies, therefore that person
must be competent to perform those duties. Although The Joint Commission has no requirement for that
responsible person to have direct access to the SOC and those duties can be performed in conjunction with a
non-qualified person with access, direct access by the responsible person would provide an efficient method of
maintaining on-going SOC accuracy. [LS.01.01.01]

Medical Staff (MS)

Topic

Continuing Medical Education - Documentation

Are copies of the certificates of attendance at continuing education programs (CME) required to be
obtained and placed in the credentialing file as proof of attendance

Documentation of attendance can be done in several different ways, including but not limited to:

obtaining copies of program certificates,

obtaining a copy of the information submitted with a license renewal application when CME's are required
by the state, or
obtaining an attestation statement from the Licensed Independent Practitioner which attests to his/her
attendance at CME programs that relate to their area of practice, with the stipulation that proof of
attendance and program content will be submitted upon request.

Credentialing - Expedited MEC Function

As part of the expedited credentialing process, can the responsibilities of the Medical Executive
Committee (MEC) be delegated to the chairman of the committee?

No. There is no expediting or delegation of the responsibilities of the MEC. The expedited credential process
outlined in the standards relates only to the governing body function, and allows the governing body to appoint a
committee of two or more members of the governing body to review and approve applications between regularly
scheduled governing body meetings

Credentialing and Privileging - Admitting Privileges - Maxillofacial Surgeons

Can an oral and maxillofacial surgeon independently admit a patient with a pre-existing condition that is
controlled by medication?

An oral and maxillofacial surgeon with appropriate privileges may independently admit a patient with a preexisting
medical condition that is controlled at the time of admission, provided that the name of the medical practitioner
responsible for managing the pre-existing medical condition is entered into the record. If patients admitted for oral
and maxillofacial surgery remain on medications or treatments for their pre-existing condition during their stay,
either the oral and maxillofacial surgeon or other medical practitioner must have appropriate privileges to
prescribe the medications or treatment. If the medical condition of patient admitted for oral and maxillofacial
surgery becomes unstable or uncontrolled or if a new medical condition arises, that medical condition must be
managed by a physician with appropriate privileges. The National Patient Safety Goal for medication
reconciliation would apply to these patients and may need to be performed by someone other than the oral and
maxillofacial surgeon.

Credentialing and Privileging - Consultants

Does The Joint Commission require licensed independent practitioners (LIP) that provide consultative
services to be credentialed or privileged?

Yes, consultants that evaluate patients, then recommend care, treatment, or services are required to be
credentialed and privileged. Compliance with the organization's process for monitoring a practitioner’s
professional performance, clinical/technical skills, etc. is also required.

The Joint Commission describes a consultant as an LIP who was asked to evaluate a patient and provide
consultation, by the way of an order from another LIP. The consultant’s findings are entered into the medical
record and may be used by other practitioners to determine the ongoing course of care, treatment, or services.

Additionally, the requirements found at RC.02.01.01 EP 2 require that the medical record contain documentation
of any consultation reports. Therefore, organizations need to ensure that consultants have been identified as
authorized to make entries into the medical record (see RC.01.02.01 EP 1).

Credentialing and Privileging - Hospital-Based Behavioral Health Care Settings Surveyed Under
the Behavioral Health Care Manual

Can Hospital-Based Behavioral Health settings surveyed under the Comprehensive Accreditation
Manual for Behavioral Health Care have a separate verification of competence/approval of clinical
responsibilities process or must they be integrated with the hospital’s medical staff and credentialing and
privileging process?

The organizations are free to decide whether to have a separate process or whether to integrate with the
hospital's medical staff and processes. Whichever approach is selected the approach must meet the intent for the
standards in the manual under which the organization is being surveyed and when the practitioner is receiving
privileges/authorization/clinical responsibilities in multiple settings using a single credentialing and privileging
process, it must be clear as to what the practitioner is allowed to do in each setting.
The term "hospital-based" means that the services are under the auspices of the hospital, meet the Joint
Commission rules for functional and organization integration and are tailored with the hospital's accreditation
survey, regardless of where the services are physically housed.

Credentialing and Privileging - Peer References

Who can provide a peer reference for independent or non-independent practitioners such as nurse
practitioners, physician assistants, and psychologists, midwives, and social workers when there is no
other similar practitioner on staff?

The definition of a peer (see MS.06.01.05 EP 2, 8) is someone from the same discipline. For example, physicians
for physicians, dentists for dentists, podiatrists for podiatrists, etc. It does not have to be someone in the same
specialty (orthopedist, etc.). To be able to provide a reference the peer must be familiar with the individual's
actual performance. For the nurse practitioner, physician assistant, and psychologist, or social worker ideally this
should be another individual from the same discipline and the organization should attempt to obtain such
references. This could be someone within the same organization or someone from outside the organization.

In situations where there is no nurse practitioner, physician's assistant, psychologist, or social worker who could
provide a peer reference it is acceptable for a physician or D.O with essentially equal qualifications, who is
familiar with the allied health practitioner's performance, to provide the reference. For example, an internist could
provide a reference for a physician assistant, an anesthesiologist could provide a reference for a nurse
anesthetist, and a psychiatrist could provide a reference for a psychologist and a psychologist with similar
responsibilities could provide a reference for a social worker.

Credentialing and Privileging - Requirements for Physician Assistants and Advanced Practice
Registered Nurses

Since Physician Assistants (PA) and Advanced Practice Registered Nurses (APRN) are not physicians,
are organizations required to credential and privilege them via the requirements found in the Medical
Staff (MS) chapter of the accreditation manual?

Yes, any provider recognized by state law – and providing services as a ‘Licensed Independent Practitioner
(LIP)’** are required to be granted privileges prior to providing such care, treatment or services. While Physician
Assistants (PA) are generally not recognized by law/regulation as ‘independent practitioners’, they are subject to
the same credentialing and privileging requirements (see MS.06.01.01 - MS.06.01.09).
Examples of Care, Treatment or Services subject to the Medical Staff requirements may include, but are not
limited to:
• Writing orders for medications, tests, and procedures
• Interpreting tests and treatments
 • Performing history and physicals
• Wound debridement
• Central line insertions
• Assisting with interventional or surgical procedures

The requirements for conducting a Focused Professional Practice Evaluation (FPPE - MS.08.01.01) and an
Ongoing Professional Practice Evaluation (OPPE - MS.08.01.03) also apply to these practitioners.
When an APRN or PA functions in a limited role, such as an educator, and not directing care as an independent
practitioner, the Medical Staff requirements would not apply.

Additional Resources:
Click here to return to the list of FAQs available on our website.
The Leading Practice Library (available only to Joint Commission-accredited organizations via their secure
Extranet site).

** It is the responsibility of the individual organization to determine, based on law/regulation, if the APRN or PA
meet the following definition of a Licensed Independent Practitioner: “An individual permitted by law and by the
organization to provide care, treatment, and services without direction or supervision. A licensed independent
practitioner operates within the scope of his or her license, consistent with individually granted clinical privileges.
When standards reference the term licensed independent practitioner, this language is not to be construed to limit
the authority of a licensed independent practitioner to delegate tasks to other qualified health care personnel (for
example, physician assistants and advanced practice registered nurses) to the extent authorized by state law or
a state's regulatory mechanism or federal guidelines and organizational policy.”

Focused Professional Practice Evaluation (FPPE) - New Privileges

What is the requirement for new privileges?

Every hospital with a CCN number must collect data for FPPE related to a practitioner’s performance within its
own hospital.
Any additional information received from another hospital can be used as supplemental information but not in lieu
of collecting hospital specific data.

See also:
What is the intent of the Focused Professional Practice Evaluation requirement?

Focused Professional Practice Evaluation (FPPE) - Components of Design Process

Focused Professional Practice Evaluation (FPPE)- Four Required Components

Focused Professional Practice Evaluation (FPPE) - Peer Review

Focused Professional Practice Evaluation (FPPE) - Monitoring Timeline

Focused Professional Practice Evaluation (FPPE) - Components of Design Process

Must the process be pre-defined for new privileges or can it be determined for each specific applicant for
the new privilege?

Yes. You must predefine the FPPE process. You may predetermine criteria specific to physicians who have
previous experience and privileges from another organization which may differ from those physicians requesting
privileges with limited experience. The process must be implemented consistently. The components for design
are listed in MS.08.01.01 and would include, but not be limited to: criteria for conducting performance evaluations
method for establishing the monitoring plan specific to the requested privilege method to determining the duration
of performance monitoring circumstances under which monitoring by an external source is required.

See also:
What is the intent of the Focused Professional Practice Evaluation requirement?

Focused Professional Practice Evaluation (FPPE)- Four Required Components

Focused Professional Practice Evaluation (FPPE) - Peer Review

Focused Professional Practice Evaluation (FPPE) - Monitoring Timeline

Focused Professional Practice Evaluation (FPPE) - New Privileges

Focused Professional Practice Evaluation (FPPE) - Intent

What is the intent of the Focused Professional Practice Evaluation requirement?

Focused professional practice evaluation is a process whereby the organization evaluates the privilege-specific
competence of the practitioner who does not have documented evidence of competently performing the
requested privilege at the organization. This process may also be used when a question arises regarding a
currently privileged practitioner's ability to provide safe, high quality patient care. Focused professional practice
evaluation is a time-limited period during which the organization evaluates and determines the practitioner's
professional performance.

See also:

Focused Professional Practice Evaluation (FPPE) - Components of Design Process

Focused Professional Practice Evaluation (FPPE)- Four Required Components

Focused Professional Practice Evaluation (FPPE) - Peer Review

Focused Professional Practice Evaluation (FPPE) - Monitoring Timeline

Focused Professional Practice Evaluation (FPPE) - New Privileges

Focused Professional Practice Evaluation (FPPE) - Monitoring Timeline

What is the duration of the monitoring?

The Joint Commission does not define the duration of monitoring FPPE. A different approach could include high
volume vs. low volume privileges or high risk vs. low risk privileges. For example, performing a focused review for
a defined number of admissions such as the first 5, 10, 20, etc., or a defined number of procedures, such as 5,
10, 20, etc., or for a short period of time such as 1 month or 3 months. For an infrequently performed privilege
numbers might work better than a time period especially if the privilege isn't performed in that time period.

See also:

What is the intent of the Focused Professional Practice Evaluation requirement?

Focused Professional Practice Evaluation (FPPE) - Components of Design Process

Focused Professional Practice Evaluation (FPPE)- Four Required Components

Focused Professional Practice Evaluation (FPPE) - Peer Review

Focused Professional Practice Evaluation (FPPE) - New Privileges

Focused Professional Practice Evaluation (FPPE) - New Privileges

What is the requirement for new privileges?

A period of focused review is required for all new privileges. This includes all privileges for new applicants and all
newly requested privileges for existing practitioners. There is no exemption for board certification, documented
experience, or reputation. All applicants for new privileges must have a period of focused review.

The data source used for the FPPE process is limited to practitioner activities performed at the organization
where privileges have been requested. This would include activities performed at any location that falls under the
organization’s single CMS Certification Number (CCN). For example, if an organization operates two hospitals
that fall under the same CCN number, data from both hospital locations may be used. In the case of a multi-
hospital system where each hospital operates independently under its own CCN number, data for the FPPE
evaluation from these separate entities cannot be used.

See also:
What is the intent of the Focused Professional Practice Evaluation requirement?

Focused Professional Practice Evaluation (FPPE) - Components of Design Process

Focused Professional Practice Evaluation (FPPE)- Four Required Components

Focused Professional Practice Evaluation (FPPE) - Peer Review

Focused Professional Practice Evaluation (FPPE) - Monitoring Timeline

Focused Professional Practice Evaluation (FPPE) - Peer Review

Is this really just the process that was historically called Peer Review?

If an organization's current "peer review" process includes the criteria to be used for identified performance issue,
defined triggers that indicate the need for performance monitoring and the four required components it would
meet the intent for the existing focused professional practitioner evaluation.

See also:
Focused Professional Practice Evaluation (FPPE) - Performance Criteria vs Triggers

Credentialing and Privileging - Peer References

Focused Professional Practice Evaluation (FPPE) - Performance Criteria vs Triggers

What is the distinction between performance criteria and triggers and are there any examples?

The standard requires that criteria be developed and used for evaluating the performance of practitioners. This
criteria addresses issues affecting the provision of safe, quality patient care. Triggers can be single incidents or
evidence of a clinical practice trend.
Examples of triggers may include:

infection rates,
sentinel events,
perhaps complaints, and
other events that are not sentinel.

Criteria for performance issues might include but not be limited to:

small number of admissions or procedures over an extended period of time that raise the concern of
continued competence,
a growing number of longer lengths of stay than other practitioners,
returns to surgery,
frequent or repeat readmission suggesting possibly poor or inadequate initial management/treatment,
patterns of unnecessary diagnostic testing/treatments,
failure to follow approved clinical practice guidelines (This may or may not indicate care problems, but why
is there a variance?)
frequent or repeat readmission suggesting possibly poor or inadequate initial management/treatment,
patterns of unnecessary diagnostic testing/treatments, and
failure to follow approved clinical practice guidelines (This may or may not indicate care problems, but why
is there a variance?)

Focused Professional Practice Evaluation (FPPE) - Predefined Process

Must the process be defined in writing or defined in the medical staff bylaws?

There is no requirement that it be in the medical staff bylaws. The process would need to be pre-defined as EP 4
requires that focused professional practice evaluation be consistently implemented in accordance with the criteria
and requirements defined by the organized medical staff. Since the process must be consistently implemented
(EP 4), the organization may wish to put it in writing.

Focused Professional Practice Evaluation (FPPE)- Four Required Components

Are there any required components for design of the focused evaluation process?

The four required components for design of the process are:

 criteria for conducting performance evaluations,
method for establishing the monitoring plan specific to the requested privilege,
method to determining the duration of performance monitoring, and
circumstances under which monitoring by an external source is required.

See also:
What is the intent of the Focused Professional Practice Evaluation requirement?

Focused Professional Practice Evaluation (FPPE) - Components of Design Process

Focused Professional Practice Evaluation (FPPE) - Peer Review

Focused Professional Practice Evaluation (FPPE) - Monitoring Timeline

Focused Professional Practice Evaluation (FPPE) - New Privileges

History and Physical - Content

What specific elements or content must be included in the history and physical?

It is the responsibility of the organized medical staff to determine the minimum required content of medical
histories and physical examinations. This requirement is found in the Medical Staff (MS) chapter of the
accreditation manual at MS.03.01.01 EP 6. The required content should be pertinent, relevant and include
sufficient information necessary to provide the care, treatment and services required to address the patient's
condition, planned care and assessed needs. The required content may vary by setting or level of care,
treatment, and services. Therefore, the specific content could be different based on populations, or setting of
care, treatment or services. The organized medical staff is also responsible for defining the scope of the medical
history and physical examination when required for non-inpatient services (see MS.03.01.01 EP 11).

The medical history and physical examination must be completed and documented by a physician, oro-
maxillofacial surgeon, or other qualified licensed individual in accordance with State law and hospital policy. The
glossary of the accreditation manual provides a formal definition for "physician".

Other qualified licensed individuals are those licensed practitioners who are authorized in accordance with their
State scope of practice laws or regulations to perform an H&P and who are also formally authorized by the
hospital to conduct an H&P. Other qualified licensed practitioners could include nurse practitioners and physician
assistants. The glossary of the accreditation manual provides a formal definition for "licensed independent
practitioner". More than one qualified practitioner can participate in performing, documenting, and authenticating
an H&P for a single patient. When performance, documentation, and authentication are split among qualified
practitioners, the practitioner who authenticates the H&P will be held responsible for its contents.

Joint Commission-accredited organizations have a copy of the accreditation manual that contains the standards
referenced above.
Additional, applicable accreditation requirements include:

Medical Staff (MS): MS.01.01.01 EP 16

Provision of Care (PC): PC.01.02.03 EP 4
Record of Care (RC): RC.01.03.01 EP 4
Record of Care (RC): RC.02.01.03 EP 3

History and Physical - Delegation to Non Licensed Independent Practitioners

Can the responsibility for performing the admission history and physical examination be delegated to a
practitioner such as an advanced practice nurse or physician's assistant who may not recognized by the
state in which they practice as a licensed independent practitioner?

Typically, this delegation is limited to the physician's assistant or the advance practice nurse practitioner.
However, before allowing the responsibilities of a Licensed Independent Practitioner to be performed by a
practitioner not recognized by the state as a Licensed Independent Practitioner, the organization must determine
- and be able to demonstrate - whether state laws and regulations and professional practice acts allows such
delegation and under what circumstances.

The glossary of the accreditation manual defines a Licensed Independent Practitioner as "An individual permitted
by law and by the organization to provide care, treatment, and services without direction or supervision. A
licensed independent practitioner operates within the scope of his or her license, consistent with individually
granted clinical privileges. When standards reference the term licensed independent practitioner, this language is
not to be construed to limit the authority of a licensed independent practitioner to delegate tasks to other qualified
health care personnel (for example, physician assistants and advanced practice registered nurses) to the extent
authorized by state law or a state's regulatory mechanism or federal guidelines and organizational policy".

If it is determined that state law and regulation and professional practice acts allow delegation of the Licensed
Independent Practitioner history and physical examination, the exam can be delegated, provided:

The organization has appropriate policies and procedures.

Such delegation meets pertinent requirements for the type of history and physical examination required by
the organization.
The practitioner to whom completion of the H & P was delegated has received specific training to perform
an appropriate history and physical examination.
The organization has defined and verified that such practitioners have the appropriate competence to
perform a history and physical examination as defined by organization policy and procedures or other
documents.
The medical history and physical examination is performed under the supervision of, or through appropriate
delegation by, a specific qualified physician who countersigns in accordance with law, regulation and
organizational policy, and retains accountability for the patient's medical history and physical examination.
The person is specifically permitted by the organization to perform the history and physical either, as part of
the supervising/delegating physician's privileges, or through an specific alternate process, such as that
utilized by the organization for allied health practitioners.

History and Physical - Medical Student

Is it acceptable for a medical student to perform and document a history and physical in the medical
record?

A medical student has no legal status as a provider of health care services, therefore, a medical History and
Physical (H&P) conducted by a medical student would not fulfill the requirements. A practitioner who has been
granted privileges by the hospital to do so is required to perform patient medical history and physical
examinations and required updates.

Organizations that use Joint Commission accreditation for deemed status purposes may find it helpful to review
the CMS Conditions of Participation that address practitioner responsibilities for completing H & Ps. The
organization’s individual responsible for accreditation and regulatory compliance should have access to the CMS
State Operations Manual (SOM) that contains this information. It is also available by searching the internet.

Under certain circumstances, and as permitted by state law and policy, the organized medical staff may choose
to delegate or allow individuals who are not Licensed Independent Practitioners to perform part or all of a
patient’s medical history and physical examination under the supervision of, or through appropriate delegation by,
a specific qualified doctor of medicine or osteopathy who is accountable for the patient’s medical history and
physical examination. The definition of an LIP can be found in the glossary of the organization's accreditation
manual.

The following FAQ provides additional detail and clarification regarding delegation:
History and Physical - Delegation to Non Licensed Independent Practitioners

History and Physical - Non-Credentialed Practitioners

Can the organization utilize a history and physical that has been performed by someone who is not
privileged by the organization?

The organization can have a policy that would permit the use of a history and physical examination performed by
any practitioner permitted by state law. In this situation a practitioner who is privileged by the organization (see
MS.03.01.01 EP 8), as permitted by state law and organization policy and familiar with the organization's policy
for the defined minimal content of the history (see MS.03.01.01 EP 6) and physical must:

review the history and physical examination document;

determine if the information is compliant with the organization's defined minimal content;
obtain missing information through further assessment update information and findings as necessary, which
may include, but are not limited to:
inclusion of absent or incomplete required information,
 a description of the patient's condition and course of care since the history and physical examination
was performed, and
a signature and date on any document with updated or revised information as an attestation that it is
current.

History and Physical - Outpatient Procedures

Do patients receiving non-inpatient services such as outpatient surgery, therapy services, laboratory and
x-ray service require a history and physical?

In the hospital manual, MS.03.01.01 states "the organized medical staff defines the scope of the medical history
and physical examination when required for non-inpatient services". The intent is that the medical staff could
define only certain circumstances, such as certain type of outpatient surgeries or procedures such as
angiograms, that might require a history and physical.
The medical staff can also define the scope of the assessment. For example, the pertinent relevant history for
outpatient surgery for a detached retina might be defined to include only, the history of the trauma or activity that
resulted in the detachment, the patient's history of cardiac and respiratory history and current medications to
determine appropriate choice of anesthesia, and an assessment of the current condition of the retina and the
patient's current vital signs. The pertinent, relevant history for an angiogram might be defined to include a history
of cardiovascular problems including chest pain or tightness, medication history, and appropriate lab work.
However, any procedure that involves anesthesia or surgery services requires an history and physical to be
completed and on the medical record.

History and Physical - Podiatrists and Dentists

Can Podiatrists and Dentists perform the entire history and physical for a patient admitted for inpatient
and outpatient care?

The requirement found at MS.03.01.01 EP 8 requires that the history and physical be performed by a practitioner
who has been granted privileges to do so and must be completed and documented by a physician or other
qualified licensed individual in accordance with State law and hospital policy. In all cases the practitioners
included in the definition of a physician (see accreditation manual glossary) must be legally authorized to practice
within the State where the hospital is located and providing services within their authorized scope of practice.

Each organization must determine, based on state-specific law and regulation (Scope of Practice), the extent to
which a Dentist or Podiatrist may complete a history and physical. Typically the Dentist or Podiatrist is only
authorized to perform aspects of the History and Physical that are applicable to either Dentistry or Podiatry.

Medical Staff Governance - Medical Staff Policies versus Organizational Policies

Do the requirements found in the Medical Staff (MS) chapter at MS.01.01.01 require the organized
Medical Staff to have a separate set of policies apart from existing hospital-wide policies and procedures
that already apply to all individuals and departments that provide patient care, treatment, and services?

There are no standards that require the medical staff to create policies that duplicate existing organizational
policies, as long as it is clear that such policies also apply to the activities of the medical staff – whether
employees of the organization or not. There should be evidence that the medical staff participated in the
review/approval of such policies.

There are, however, requirements that are specific to the structure, functions and accountabilities of the medical
staff that should be defined in medical staff rules, regulations or policies. These documents create a system of
rights, responsibilities, and accountabilities between the organized medical staff and the governing body, and
between the organized medical staff and its members.

The requirements found at MS.01.01.01 Elements of Performance (EP) 5 – 7 address requirements specific to
medical staff and governing body compliance and enforcement of the bylaws, rules, and regulations, and
policies. A few examples of such policies may include:
• Required elements of a medical history, such as a psychological history, body systems review, past
procedures, allergies, co-morbidities, etc.
• The detailed steps for credentialing and re-credentialing
• Responsibilities for oversight of professional graduate education program participants
• Medical staff health screening requirements
• On-call coverage requirements

The term ‘policy’ is defined as “a principle or method that is developed for the purpose of guiding decisions and
activities related to governance, management, care, treatment, and services. A policy is developed by
organization leadership, approved by the governing body of the organization, and maintained in writing.” For the
purposes of ‘policies’ as referenced in the medical staff chapter, policies are documents other than medical staff
bylaws. However, when such documents are adopted by the organized medical staff and approved by the
governing body, pursuant to the provisions of Standard MS.01.01.01, these documents have the same force and
effect as the medical staff bylaws.

Use of rules, regulations, and policies may be used to define those requirements that are subject to more
frequent changes in the environment, law/regulation, expectations and functions of the medical staff. The
advantage of such documents is that changes may be delegated to the MEC if so defined in the bylaws (see
MS.01.01.01 EP 20). Therefore, review, revisions, and approvals can be more expeditious than changes to
bylaws as such changes cannot be delegated (see MS.01.01.01 EP 2).

When developing medical staff documents, organizations need to be mindful that there are requirements specific
to the medical staff governance and framework that MUST be contained within the bylaws. These are defined in
the Medical Staff chapter at MS.01.01.01 EP 12 - 37.

Medical Staff Involvement -'Medical Staff Bylaw and Amendment Approval Meeting

Is a formal meeting of the organized medical staff required to obtain adoption/approval of the medical
staff bylaws and revisions of amendments?

There is no current medical staff standard requiring a meeting of the medical staff.

Ongiong Professional Practice Evaluation (OPPE) - Data Collection Guidelines and Frequency

Are there any guidelines for collecting information for frequency and evaluation?

The organization may choose to use the methodologies for collecting information outlined at MS.08.01.03 for
ongoing professional practice evaluation: periodic chart review, direct observation, monitoring of diagnostic and
treatment techniques, discussion with other individuals involved in the care of each patient including consulting
physicians, assistants at surgery, nursing, and administrative personnel.

Frequency for conducting the Ongoing Professional Practice Evaluation (OPPE):

The frequency of such evaluation can be defined by the organized medical staff, but must occur more frequently
than every 12 months. For example, three months, six months, nine months, etc., would be acceptable. Nine
months may not be practical since you would have two complete sets of data and one incomplete set at the two
year renewal. Completing the OPPE every 12 months would be considered periodic, and therefore, not
compliant. For consideration, many organizations use eight months so they will have three complete sets of data
at the two year renewal and they can assess for patterns or trends from one set to the next.

Ongoing Professional Practice Evaluation (OPPE) - Intent

What is the intent of the requirement for Ongoing Professional Practice Evaluation?

(Maintaining Privileges)
The Ongoing Professional Practice Evaluation (OPPE) is defined as: "A document summary of ongoing data
collected for the purpose of assessing a practitioner’s clinical competence and professional behavior. The
information gathered during this process is factored into decisions to maintain, revise, or revoke existing
privilege(s) prior to or at the end of the two-year license and privilege renewal cycle."

The OPPE requirements apply to all practitioners granted privileges via the medical staff processes, including
allied health practitioners, such as Physician Assistants, Advanced Practice Nurses, etc. OPPE allows
organizations to identify professional practice trends that impact the quality and safety of patient care. It is the
responsibility of the organization's medical staff to determine the criteria used in the ongoing professional practice
evaluation.

In addition to privilege-specific criteria or data, additional examples may include:

Review of operative and other clinical procedure(s) performed and their outcomes
Pattern of blood and pharmaceutical usage
Requests for tests and procedures
Length of stay patterns
Morbidity and mortality data

Examples of data sources may include:

 Periodic chart review
Direct observation
Monitoring of diagnostic and treatment techniques
Discussion with other individuals involved in the care of each patient

If there is uncertainty regarding the practitioner’s professional performance, the organized medical staff should
follow the course of action defined in the medical staff bylaws, policies, rules/regulations for further evaluation of
the practitioner.

Related FAQs:
OPPE - Data Collection Guidelines and Frequency
OPPE - Low Volume Practitioners - Data Use From Another Organization
OPPE - Medical/Cognitive Specialties

Ongoing Professional Practice Evaluation (OPPE) - Low Volume Practitioners - Data Use From
Another Organization

Can organizations use data from outside organizations in lieu of collecting their own data to accomplish
the Ongoing Professional Practice Evaluation (OPPE)? Can outside data be used for low volume
practitioners?

For practitioners who have been granted clinical privileges at an organization, every organization must collect
data for the ongoing professional practice evaluation (OPPE) related to performance within its own organization.
Any information received from another organization can only be used as supplemental information and not in lieu
of collecting organization specific data or evaluating performance within the organization. Prior to obtaining or
sharing information between organizations, even with the practitioner’s consent, organizations should obtain legal
advice on whether such sharing would affect the protections provided by any applicable State peer review
statute.

The OPPE standard will not fully address the issue of the low or no volume practitioner. Organizations must
collect data, even data showing zero performance. At each review point, e.g. quarterly or every six months, the
medical staff and governing body would use the data, however, limited, to determine whether to continue, limit, or
revoke any existing privileges. At the two year reappointment if the organization determines it has insufficient
practitioner specific data, then per standard MS.07.01.03 EP 2 "Upon renewal of privileges, when insufficient
practitioner-specific data are available, the medical staff obtains and evaluates peer recommendations."

Ongoing Professional Practice Evaluation (OPPE) - Medical/Cognitive Specialties

Medical and Cognitive specialties (internal medicine, family practice, psychiatry, med specialties ...) are
very tough to identify meaningful data that can be evaluated. Is there any guidance that The Joint
Commission can offer to assist organized medical staffs?

Cognitive specialties (internal medicine, family practice, psychiatry, med specialties ...) are very difficult to identify
meaningful data that can be evaluated. The most difficult is probably psychiatry due to the confidential nature of
psychiatry, if is often not possible to observe the provision off care, treatment, and services by the psychiatrist. It
is important to start with the type of privileges that are granted.

Medical specialties in addition to managing medical conditions, also often perform procedures. The Joint
Commission Resources Publication "Credentialing, Privileging, Competency, and Peer Review: Examples of
Compliance for the Medical Staff" has some excellent detailed privilege forms for a wide variety of specialties
including but not limited to: internal medicine, family practice, OB/GYN, cardiac, cardiovascular disease, clinical
psychology, dentistry, emergency medicine, gastroenterology, medical imaging.

As you look at the way the privileges are detailed you can begin to identify data to collect including, but not
limited to, numbers of activities, length of stay, complications, management of complications, reasons for
readmissions, use of diagnostics, medications or other modalities, etc.

Other data to be considered would include, but not be limited to:

compliance with The Joint Commission Core Measures (for the applicable practitioners)
compliance with organization specific clinical practice guidelines
medication prescribing practices, e.g., number of times a drug is prescribed, appropriateness to diagnosis,
appropriateness of dosing, appropriateness of medication monitoring practices
use of diagnostic, i.e., appropriateness, overuse/underuse, appropriateness of therapeutic interventions in
response to diagnostic testing result
 patient readmissions either inpatient or outpatient for the same diagnosis/problem which may such
inadequate or inappropriate initial treatment
patient complaints

Primary Source Verification - Licensed Independent Practitioners Education

When credentialing licensed independent practitioners, can verification of a current licensure suffice for
verification of the education in lieu of performing primary source verification of the education since a
defined level of education is required to receive the license, e.g., a medical license requires completion
of medical school, a dental license requires completion of dental school, a podiatric license requires
completion of podiatric school, etc.?

The issues that can relate to verification vary and include but are not limited to: the date of the education the
name of the educational institution and its reputation the location of the educational institution. If the date of the
education is important to know to determine how the practitioner has kept current with changes in their field, then
primary source verification would be required. For example, if the education was at some time in the distant past,
e.g., twenty or thirty years, then additional information on subsequent training might need to be obtained before
granting privileges or assigning job responsibilities. If it is important to the organization to be able to market the
educational status of their practitioners, e.g., having graduates of specific institutions, then primary source
verification would be required. If it is important to know the location of the school. e.g., U.S. vs. foreign to
determine if there could be a difference in level of the education or possible language barrier issues that need to
be considered, then primary source verification would be required. If none of these issues are of importance then,
verification of licensure alone could suffice of evidence that the individual had completed the requisite education.
In addition, there may be an occasion when the educational institution is no longer in existence and the
information does not appear on the AMA profile or ECFMG. In those instances verification of licensure would
suffice since the licensing board would have had to verify the education before granting the license.

Privileges - Administration of Moderate Sedation

Are specific privileges to administer sedation required?

While privileges are required to administer sedation (see MS.3.01.01 EP 2), it is not required that criteria for
competence to perform "moderate" sedation be included in a separately delineated privilege. For example,
competency criteria for "moderate" sedation may be defined and included in procedure-based privileges. Thus, a
clinical privilege for endoscopy could be defined as including the use of sedation.

Organizations decide whether to use privileging as an appropriate approach to take based on the education,
training, and experience of the clinicians requesting authorization perform procedures using sedation. Individuals
who are privileged to administer sedation must be able to rescue patients at whatever level of sedation or
anesthesia is achieved either intentionally or unintentionally, e.g., when the patient slips from moderate into deep
sedation or from deep sedation into full anesthesia.

Organization must define how it will determine that the individuals are competent to perform the required types of
rescue. Acceptable examples may include, but are not limited to, ACLS certification, a satisfactory score on a
written examination developed in concert with the department of anesthesiology (see LD.04.01.05 EP 7), a mock
rescue exercise evaluated by an anesthesiologist, etc.

Privileging - National Practitioner Databank

Can organizations use the National Practitioner Data Bank's (NPDB) "Continuous Query" (aka Proactive
Disclosure Service) opion for re-privileging?

Use of National Practitioner Data Bank's "Continuous Query" (aka Proactive Disclosure Service) by an
organization is acceptable for the ongoing NPDB information after the organization obtains an initial NPDB query
for each practitioner. To demonstrate compliance, the organization would need to have record of a baseline query
and then share with the surveyors that no updates have been received from the NPDB. There does not need to
be documentation in the record that no further communication has been received. As with any NPDB information,
the organization would review the information received or confirm that no new information had been received,
whenever they are granting a new privilege or renewing existing privileges.

Privileging - Organ Procurement Team

Is a health care organization required to perform credentials review and grant clinical privileges to
members of transport teams and donor surgical teams for clinical intervention provided in the health care
organization?

No. Transport Teams, such as for Neonatal ICU patients, trauma victims, long-term care facility residents, or burn
patients, and Donor Surgical Teams, often contain licensed independent practitioners who would otherwise
require clinical privileges to work within the facility. These teams often consist of individuals who are on rotational
assignments, who may only infrequently visit the health care organization for a very brief period of time for the
specific purpose of transporting a patient. They often cover large territories and a large number of health care
organizations.

Their work is too limited to undergo effective performance improvement activity review at each site that is
meaningful for the renewal of clinical privileges. The Teams work as part of the health care organization's plan for
continuity of care.

The patient, although still in the health care organization, is transferred to the responsibility of the Team. When
that occurs, the responsibility for the performance of the members of the Team as it applies to the patient and as
required by Joint Commission standards, passes to the Team.

Teams work in health care organizations on the basis of some form of agreement, whether a contract,
memorandum of understanding, or regional governmental authority. It is the health care organization's
responsibility to ensure that the agreement provides for qualified individuals who are properly authorized by their
organizations.

Note: While this answer provides an exception to the usual procedures required for credentials review,
privileging, competency, and job descriptions, it does not remove the health care organization from its obligation
to ensure that it enters into agreements that comply with Joint Commission standards.

Privileging Process - Core or Bundle - CMS Position

Is the Joint Commission aware of any issue that CMS might have with the use of core/bundle
privileging?

In November 2004 CMS issued their position on privileging which addresses the concept of core/bundle
privileging and remains current as of 2016. It is in line with the Joint Commission expectation.

Privileging Process - Core or Bundle - Definition and Implementation

Are they any specific issues with using the core/bundle privileging format?

Yes. The definition of the activities that are being covered by the core/bundle terminology, and the
implementation of an evaluation to determine that the applicant can be granted each of the activities listed the
core privileges.

Definition: The core/bundled privilege must be clearly and accurately defined to reflect specific
activities/procedures/privileges to be included in the core terminology, and those activities/procedures/privileges
that are outside the core. The core/bundled privilege must be clearly and accurately defined to reflect only
activities/procedures/privileges actually performed at the organization. The core/bundled privilege must be clearly
defined to reflect activities that the organization believes a majority applicants should be able to perform.

Implementation: Before the core/bundle is granted the organization must evaluate each applicant's education,
training and current competence to perform each activity listed in the core/bundle, and any that are assigned
outside the core/bundle. It cannot be assumed that every applicant can do every activity listed. There needs to be
a clearly defined method for the applicant to request deletion of specific activities if they don't wish for them to be
granted. If organization's evaluation determines that the applicant is not competent to perform certain activities,
then the organization must modify the core/bundle that is granted to the applicant. In accordance with the medical
staff standards the applicant and all appropriate internal and/or external persons or entities (as defined by the
organization and applicable law) are notified as to the granting decision, i.e., whether the full core/bundle or a
modified bundle has been granted. If the core/bundle was modified, the notification must detail the specific
modifications.

Note: The expectation for the evaluation of each applicant's education, training, and current competence to
perform each specific activity would be the same if the organization were to use a "laundry list" format for the
applicant to select activities

Privileging Process - Core or Bundle - Endorsement

Does the Joint Commission endorse or recommend the use of the core/bundle privileging format.

Joint Commission's credentialing and privileging standards in all accreditation manuals do not reference the
concept of core privileges nor do they suggest or promote a particular format for granting privileges.

Reappointment and Re privileging - Due Dates

Is the reappointment/re privileging date due on the same date or same month of the previous
appointment/reappointment or privileging?
Reappointment/re privileging is due no later than the same date from the previous appointment or reappointment.
For example if the accreditation manual requires reappointment every two years and the reappointment period is
July 15, 2015 through July 14, 2017, the reappointment date would be July 15, 2017.

Reappointment and Re privileging - Governing Body Approval Date

Must reappointment/re privileging dates match the governing body approval dates or can the governing
body approve effective periods in advance?

No. The reappointment/re-privileging dates do not need to match the governing body approval dates. The
governing body should be approving effective periods in advance of the expiration date. For example, in May, the
board would approve all June reappointment/re privileging effective periods and in June the board would be
approving all July reappointment/re privileging effective periods. It would not be necessary to keep changing the
effective period to match the date the board actually met and approved the appointment/reappointment or
privileges.

Verification - Primary Source Verification - Definition

What is Primary Source Verification and to whom does it apply ?

Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license,
certification or registration to practice a profession when required by law or regulation. It is the responsibility of
the accredited organization to complete PSV, not the licensed individual. The glossary of The Joint Commission
Accreditation Manual defines PSV as:

"Verification of an individual practitioner’s reported qualifications by the original source or an approved

agent of that source. Methods for conducting primary source verification of credentials include direct
correspondence, documented telephone verification, secure electronic verification from the original
qualification source, or reports from credentials verification organizations (CVOs) that meet Joint
Commission requirements. See also credentials verification organization (CVO)." The definition of a CVO
may be found in the glossary of the accreditation manual.

Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is
identical to the information at the primary source are referred to as a ‘designated equivalent source’. The glossary
of the accreditation manual provides examples of such sources. Organizations are responsible for determining
what method will be used to document that PSV was completed and must include the date the verification was
conducted, who conducted the verification, what was specifically verified and the results of the verification. At the
time of survey, surveyors evaluate compliance with completing primary source verification of licensure,
certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was
complete by the organization does not meet the intent of the requirement.

The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at
HR.01.01.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also
requires PSV of the applicant’s relevant training and current competence. These requirements are found at
MS.06.01.03 EP 6 and MS.06.01.05 EP 2.

Medication Management (MM)

Topic

Antimicrobial Stewardship - Examples - Standard MM.09.01.01 EPs 1, 3, 5, 6, and 7

When examples are provided within an EP, are these example considered to be part of the requirement?

No. The examples that are provided in EPs 1, 3, 5, 6, and 7 are not Joint Commission requirements and are provided to assist
organizations during their review of the antimicrobial stewardship standard based on the care, treatment, and services provided.

Antimicrobial Stewardship – Accountability Document - Standard MM.09.01.01 EP 1

What is an accountability document, which is used as an example of leadership commitment?

An accountability document is any organizational document describing the formal chain of responsibility for the antimicrobial
stewardship program.

Antimicrobial Stewardship – Core Element Documentation - Standard MM.09.01.01 - EP 5

What type of documentation is needed for MM.09.01.01 EP 5, the required core elements of the antimicrobial stewardship
program?

The organization needs to have a document indicating how each core element is addressed in its antimicrobial stewardship program
This information can be located in a separate document or can be included in other antimicrobial stewardship documents (see
MM.09.01.01, EP 1). This documentation does not have to be provided in a lengthy format but needs to describe how the core
elements are addressed in the antimicrobial stewardship program.

Antimicrobial Stewardship – Data Collection, Analysis, and Reporting - Standard MM.09.01.01 EP 7

What type of antimicrobial stewardship data should organizations collect, analyze, and report?

The Joint Commission is not requiring any specific antimicrobial stewardship data in Standard MM.09.01.01. The organization must
determine the antimicrobial stewardship data it will collect, analyze, and report. The CDC’s Core Elements of Hospital Antibiotic
Stewardship Programs at https://www.cdc.gov/getsmart/healthcare/pdfs/core-elements.pdf and The Core Elements of Antibiotic
Stewardship for Nursing Homes at https://www.cdc.gov/longtermcare/prevention/antibiotic-stewardship.html provide examples of
measures that can be used to collect antimicrobial stewardship data and should be considered by organizations.

Additionally, the National Quality Partners Playbook on Antibiotic Stewardship in Acute Care provides examples of basic, intermedia
and advanced measures.
(http://www.qualityforum.org/Publications/2016/05/National_Quality_Partners_Playbook__Antibiotic_Stewardship_in_Acute_Care.as

Antimicrobial Stewardship – Education Requirements for Staff and Licensed Independent Practitioners - Standard
MM.09.01.01 EP 2

Will Joint Commission surveyors review human resource records and medical staff credentialing and privileging records to
determine if antimicrobial resistance and antimicrobial stewardship education was provided by the organization?

Joint Commission surveyors will not be reviewing staff or medical staff/licensed independent practitioner records on education receiv
regarding antimicrobial resistance and antimicrobial stewardship. Joint Commission surveyors will inquire about the type of educatio
provided by the organization during the Medication Management System Tracer (or other system tracers). During patient tracers,
surveyors may ask staff and licensed independent practitioners about the education they have received. Providing written material
such as the organization’s antibiogram will meet the educational requirement of MM.09.01.01, EP 2.

Antimicrobial Stewardship – Improvement Opportunities - Standard MM.09.01.01 EP 8

Are there any specific improvement opportunities that surveyors will look for regarding the organization’s antimicrobial
stewardship program?

During the survey, organizations need to identify improvement opportunities based on their collected and analyzed data. Surveyors w
ask the organization to discuss the antimicrobial stewardship improvement opportunities it has identified and the actions taken to
improve its program. This information should be documented. If the data demonstrates that antimicrobial stewardship improvements
are not necessary, the organization should share this data with the surveyor.

Antimicrobial Stewardship – Multidisciplinary Protocol Requirements - Standard

Do organizations need to have multidisciplinary protocols for each example in MM.09.01.01, EP 6?

The examples of protocols are provided for organizations to consider based on the care, treatment, and services delivered and are n
requirements.

Antimicrobial Stewardship – Multidisciplinary Team Requirements - Standard MM.09.01.01, EP 4

If an organization does not have an infectious disease physician on the antimicrobial stewardship multidisciplinary team w
receive a Requirement for Improvement (RFI)?

This depends on the availability of infectious disease physicians to serve in this capacity. The Joint Commission is aware that the
composition of this multidisciplinary team may vary based on the type of organization being surveyed as well as the geographic
location of the organization. This is the reason MM.09.01.01, EP 4 indicates that the four practitioners listed should be on the
multidisciplinary team “when available in the setting.” However, it would not be acceptable for an organization to have a team
consisting of only a pharmacist and a nurse when physicians and other licensed independent practitioners are available in the
organization (e.g., an infectious disease consultation team exists).
Note: Some organizations such as critical access hospitals and nursing care centers may not have the Medication Management
System Tracer. In these cases, antimicrobial stewardship will be evaluated during other scheduled activities, such as Orientation to t
Organization, Data Use System Tracer, and Individual Patient Tracers.

Antimicrobial Stewardship – Organizational Priority - Standard MM.09.01.01 EP 1

How will surveyors evaluate that an organization’s leaders have established antimicrobial stewardship as an organizationa
priority?

During the Leadership Session, leaders should be prepared to discuss how they have established antimicrobial stewardship as an
organizational priority. Surveyors may ask to review documents related to antimicrobial stewardship such as strategic plans, budget
plans, and performance improvement plans.

Emergency Cart - Medication Security

Please clarify the issue related to medication security on emergency carts. Is the use of a breakaway tag that includes a
numeric identification number and a defined process to monitor cart integrity considered an acceptable approach to
maintaining security of emergency carts strategically located and readily available for use in emergent situations in patient
care areas staffed 24/7.

The Joint Commission requires that medications are stored in a secure manner to prevent tampering, theft or diversion in accordanc
with law and regulation. Considering the intended nature and use of emergency carts, organizations must balance security with the
requirement that emergency medications and their associated supplies are readily available (see MM.03.01.03 EP 2) when needed.

While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) th
could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be
interpreted as 'not readily accessible for use' (see PC.02.01.11 EP 2). When security devices are used, the intent would be to use a
appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access
the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is
acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.

It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available fo
securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes t
best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE
Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.

Emergency Cart - Security

Is it acceptable to position emergency carts secured with a breakaway lock in strategic locations, such as a trauma room i
an emergency department or an alcove on a nursing unit or any area staffed 24/7 even though these carts may not be und
constant visual surveillance by staff 100 % of the time ?

Since emergency departments and nursing units are staffed 24/7, yes, it would be acceptable to place emergency carts in these
locations as long as there was a defined process in place to monitor the integrity of the breakaway lock and cart contents. Constant
visual surveillance of emergency carts is not required when such systems are in place. However, if there is evidence of tampering or
diversion, or if medication security otherwise becomes a problem, the hospital is expected to evaluate its current emergency cart
security policies and procedures, then implement the necessary systems and processes to ensure that the problem is corrected, an
that patient health and safety are maintained. NOTE: Emergency carts containing medication located in departments that are not
staffed 24/7 must be secured in a locked location.

Formulary - Adding New Medication

How do we monitor patient response to a newly added medication before we make it available for dispensing or ordering?

Standard MM.02.01.01, EP 3 requires that before you add a medication to your list or formulary, you are sure that either staff and
licensed Independent Practitioners are trained on the effects of the medication and monitoring requirements. In addition, the
organization must have access to appropriate laboratory or other diagnostic testing which may be required to monitor effectiveness.

Formulary - Strength and Dosage

Must formulary listings (or the list of medications available for dispensing and administration) include strength and dosage
form)?

Yes. The formulary should be a resource for prescribers and staff to know which products, strengths and dosage forms are available
within the organization.

Medication - Concentrated KCL definition

What is considered "concentrated" in terms of potassium chloride? We have 100ml bags of potassium chloride in strength
of 20 and 40 mEq. The bag label states that it is concentrated. Must these be kept out of patient care areas? What is
considered concentrated in terms of sodium chloride?

For potassium chloride, strengths of 2 mEq/ml or greater (specifically, vials of 20mEq/10ml and 40mEq/20ml) are considered
concentrated. The bags noted above are not considered concentrated and may be stored in patient care areas. For sodium chloride
NACL, strengths greater than 0.9% are considered concentrated.

Medication - Licensed Independent Practitioner Controlled - Pharmacy Review

 When medications are administered under Licensed Independent Practitioner (LIP) control, must there be a retrospective
Pharmacy review when the Pharmacy is open?

No. MM 05.01.01 EP 3 does not address situations in which medications are ordered, prepared, and administered under LIP control
Organizations should, however, consider the requirements at MM 08.01.01 in evaluating it's medication management system and
assess risk points by randomly sampling and reviewing LIP controlled orders for the items listed at MM.05.01.01 EP 4.

Medication - Sterile Compounding - Compounding Staff Competency Requirements

What competencies are required for personnel compounding medications in the Main Pharmacy or Satellite Pharmacy are
?

The following items are expected to be completed for all compounding staff:
• Media fill testing (representing the highest complexity level of compounding performed)
• Gloved fingertip sampling (initial and ongoing testing)
• Written didactic testing
• Evaluation of hand washing and donning PPE

The listed items are expected with the following time frames:

Low-Risk and Medium-Risk* Sterile Compounding: Annually for staff performing (defined as every 12 months +/- one month.)
High-Risk Sterile Compounding*: Every 6 months

* NOTE: Sterile compounding risk levels are adapted from USP 797

Medication - Sterile Compounding - Exending Beyond Use Dates (BUD) with Closed System Transfer Devices
(CSTD)

Can a Closed System Transfer Device be utilized to extend the beyond use date of a single dose container ?

The Joint Commission would evaluate compliance with the use of a closed system transfer device (CSTD) based on the FDA approv
indications of a device. Based on feedback received directly from the FDA, the extension of a beyond use date beyond 6 hours for
single dose vial has not been approved as an indication.

The Joint Commission is aware of published articles which supports the use of these devices to extend beyond use dating longer tha
the 6 hours allowed for a single dose vial. However, this has not been approved by the FDA and is not supported as a standard of
practice.

Medication - Sterile Compounding - Low Volume Hazardous Medication Preparation

Our Organization compounds a small quantity of hazardous medications. Are there any special requirements we should
follow ?

Ideally, hazardous medications would be compounded in a negative pressure environment. However, if an organization prepares a
volume of hazardous drugs, the use of two tiers of containment is acceptable in a non-negative pressure area. An example of 2-tie
containment would be the use of a closed system transfer device utilized within a biological safety cabinet or compounding aseptic
containment isolator.

Medication - Sterile Compounding - Nurse Competency Requirements

Are we required to do Finger Tip Testing and Media Fill Testing on nurses who compound emergent-use items outside of t
pharmacy ?

No, immediate-use Compounding is reserved for situations where an immediate/urgent need for medications is present and a delay
waiting for the pharmacy to compound items could delay care and for items with limited stability once compounded. Therefore, The
Joint Commission will not evaluate staff performing this type of compounding with an expectation that they have Finger Tip and Med
Fill testing completed as a component of their competencies.

Medication - Sterile Compounding - Personal Protective Equipment (PPE) Requirements with Compounding
Isolators

What Personal Protective Equipment (PPE) should be worn when compounding sterile products in a Compounding Asept
Isolator (CAI) or Compounding Aseptic Containment Isolator (CACI) ?
The same personal protective equipment expected in a clean room when compounding in a laminar workflow bench are required wh
utilizing a CAI or CACI unless the manufacturer has written information based on validated environmental testing that any
component(s) of PPE or personnel cleansing are not required. This includes double gloving for the preparation of hazardous
medications.

Medication - Sterile Compounding - Primary Engineering Control (PEC) Testing/Certification Requirements

What testing is required for our Primary Engineering Controls (Laminar Air Flow Work Bench; Compounding Aseptic Isolat
Biological Safety Cabinets, etc.) ?

The following items are expected to be tested at a minimum with a frequency not to exceed 6 month intervals. Lack of testing of the
items will result in non-compliance with Joint Commission standards.
• ISO level of the primary engineering control
• Viable particle testing surface of the primary engineering control
• Viable particle testing air within the primary engineering control
• HEPA filter leak test of the primary engineering control
• Evidence of remediation/retesting if assessed levels were not in compliance with those listed in USP 797

Medication - Sterile Compounding - Secondary Engineering Control (SEC) Testing/Certification Requirements

What testing is required for our Secondary Engineering Controls ?

The following items are expected to be tested at a minimum with a frequency not to exceed 6 month intervals. Lack of testing of the
items will result in non-compliance with Joint Commission standards.
• Air exchanges per hour of the buffer area
• Pressure differential (between buffer area/ante area; ante area/non-classified area)
• ISO level of the buffer area and ante area
• Viable particle testing surface of the buffer area and ante area
• Viable particle testing air—HEPA filter leak test of HVAC HEPA filter system
• Evidence of remediation/retesting if assessed levels were not in compliance with those listed in USP 797

Medication - Sterile Compounding - Segregated Compounding Area (SCA)

Our hospital has a segregated compounding area in the Emergency Department with an IV hood. Are there any restriction
on what medications can be compounded in that area ?

Organization may utilize a segregated compounding area to prepare items classified as Low Risk Level Compounding as long as the
beyond use date does not extend beyond 12 hours. Low Risk items are defined as those items prepared in an ISO 5 environment
which:
1. The compounding involves only transfer, measuring, and mixing manipulations using not more than three commercially
manufactured packages of sterile products and not more than two entries into any one sterile container or package (e.g., bag
vial) of sterile product or administration container/device to prepare the CSP.

2. Manipulations are limited to aseptically opening ampules, penetrating disinfected stoppers on vials with sterile needles and
syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other steril
products, and containers for storage and dispensing.

Medication - Sterile Compounding - Testing/Certification Remediation Requirements for Primary and Secondary
Engineering

If our Primary Engineering Control or Secondary Engineering Control certification/testing reports show a value outside of
acceptable limits, what should we do ?

Organizations are required to develop a remediation program to address the identified issue which must include retesting the tested
components which were out of range. The remediation process should include an overall review of compliance with procedures
including those of compounding staff, cleaning processes and products, and air filtration efficiency. These should be evaluated to
identify any potential adverse impact affecting testing results.

Medication - Sterile Compounding - Unit Dose Alcohol Swabs

Can an alcohol swab be utilized on more than one vial septum or bag injection entry point ?

The current standard of practice does not allow for alcohol swabs to touch another object prior to its use when cleaning a critical poi
(i.e. vial septum, ampule neck, or injection entry port on an IV bag). If this is identified during a survey, it will be scored as non-
compliant with Joint Commission Standards as an infection control risk.
Medication - Sterile Compounding - Using Primary and Secondary Engineering Controls with Testing/Certification
Failures

Can we still use our Primary Engineering Control if it fails its testing/certification ?

It is up to the organization to determine whether or not the compounding space is acceptable to continue producing sterile
compounded medication products. Factors should include the pathogenicity of the organism grown in the positive growth viable
sample; complexity level of the compounded product; any known/potential associated hospital acquired infections; and guidance fro
the infection control practitioner.

Medication Administration - Incorporating Patient Preference Into Medication Administration Practices

Are there circumstances when a provider may write PRN medication orders that allow variation in administration based on
patient preference such as in the following examples ? Example 1: Orders are written to administer ‘acetaminophen for mi
pain’ and ‘hydromorphone for moderate pain’. However, due to the side effects of hydromorphone, the patient requests to
take the acetaminophen even though pain was reported as ‘moderate’. Example 2: A post-partum patient has PRN pain
medications written as follows: morphine for severe pain, hydromorphone written for moderate pain and acetaminophen
written for mild pain. New moms who report moderate or severe pain may request to take the acetaminophen as they do n
want to take the other medications as they are breastfeeding.

The practice described may be acceptable as long as an organization has determined that:

1. That the medication order is written in a manner that supports deferring to patient preference when:
a. Requesting a lesser potent medication. (Potency should be established with an evidence based tool i.e. morphine
equivalents).
b. Requesting a lesser prescribed dose in a range order.
c. Requesting a less intrusive route of administration if both routes are prescribed by the provider.

2. The medication is administered in accordance with orders from the Licensed Independent Practitioner (MM.05.01.07 EP 5).

3. The inclusion of patient preference into the medication order cannot subsequently create a therapeutic duplication with other
prescribed medications.

4. The organization’s medication management policy (see MM.04.01.01 EP 1) identifies this type of medication order as deemed
acceptable, and defines all required elements of such orders.

5. The use of a protocol is not required. However if an organization chooses to utilize a protocol, the review and approval process
must comply with the requirements found at MM.04.01.01 EP 15. The medical record must contain evidence of an order to impleme
the protocol as well as the protocol itself.

6. That implementing such orders or protocols is not outside of the RN scope of practice as defined by state law/regulation,

7. The medical record must accurately reflect that the lesser potent medication was administered based on patient
preference (RC.02.01.01 EP 2). It is NEVER acceptable to administer a medication of stronger potency based on patient preference

8. Each organization is responsible for determining how such orders are to be entered into the medical record. However, the followin
is an example for consideration:
Acetaminophen 325 mg 2 tablets po every 4 hours prn mild pain.
Hydromorphone 2 mg 1 tablet po every 4 hours prn moderate pain. May administer less potent prescribed medication based
patient request per the organization’s medication management policy (MM.04.01.01).

The policy must be explicit in that such an order is ONLY for administration of a different (lesser) agent, not changing the dosage
ordered of the same medication. If the policy allows a lower dose of the same medication than ordered, it would not be accepted as
compliant.

Medication Administration - Range Orders

Does The Joint Commission prohibit the use of ‘range’ or ‘double-range’ orders?

No, there are no Joint Commission standards that prohibit the use of range orders as long as such orders are permitted by the
organization’s medication management policy (see MM.04.01.01). In addition, range orders may be a component of other order typ
such as taper orders and titration orders, unless prohibited by hospital policy.
The glossary of the accreditation manual describes a ‘range order’ as “Orders in which the dose or dosing interval varies over a
prescribed range, depending on the situation or the individual’s status.”
Example of range orders may be:
Hydromorphone 2mg tablets 1 – 2 tablets PO every 4 hours prn mild pain.
Morphine 2 mg to 4 mg IV every 4 hours prn severe pain.

Example of a double-range order may be:

Hydromorphone 2mg tablets 1 – 2 tablets PO every 4 – 6 hours prn mild pain.
Morphine 2 mg to 4 mg IV every 4 - 6 hours prn severe pain.

Organizations are responsible for determining the implementation process for how range orders are entered into the medical
record and that staff are properly trained to ensure consistent implementation. It is also the responsibility of the organization’s
leadership and medical staff to determine how these orders are interpreted. For example, if an order is written ‘Morphine 2mg-4mg
every 6 hours’ and the patient is given 2mg, must the nurse wait until the 6 hours has passed to give another dose or may they give
remaining 2mg if the pain is not adequately controlled prior to the 6-hour interval ?

Compliance with applicable law/regulation, recommendations from professional organizations (state pharmacy boards, ISMP, etc) a
evidence-based resources should be incorporated into applicable policies, procedures, etc.

Medication Administration - Titration Orders

Does The Joint Commission require specific elements for titration orders when such orders are permitted by an organizati
and what other quality or safety advances should be considered ?

Titration orders are generally defined as those in which the medication dose is either progressively increased or decreased in respon
to the patient’s status. Organizations are required to define, by policy, if titration orders are deemed acceptable for use. The elemen
of performance found in the Medication Management (MM) chapter at MM.04.01.01 outline the policy requirements.

Required elements for medication titration orders:

Medication name
Medication route
Initial or starting rate of infusion (dose/min)
Incremental units the rate can be increased or decreased
Frequency for incremental doses (how often dose(rate) can be increased or decreased
Maximum rate (dose) of infusion
Objective clinical endpoint (RASS score, CAM score, etc)

For example, a titrated medication order would say:

Start [medication name] drip at 10 mcg/kg/min. Increase by 5 mcg/kg/min every 5 minutes until desired patient
response and/or numeric target (e.g. RASS =3) is achieved. Maximum rate of 60 mcg/kg/min.

Goals when developing requirements for safe administration:

• Compliance with manufacturer’s Instructions For Use (IFU) for safe administration
• Consistent administration practices among nurses and other practitioners
• Ensure the patient response is achieved/sustained
• Nursing not placed in a position of making dosing/administration decisions that may conflict with their scope of prac
• Documentation accurately reflects order changes, patient assessments, etc.

The organization’s clinical and pharmacy leadership are encouraged to reach out to their state’s pharmacy and/or nursing
boards to determine if any additional requirements need to be considered.

Medication Order - Content

Does every medication order need to contain a diagnosis, condition, or indication-for-use?

No. Standard MM.04.01.01 requires that a diagnosis, condition, or indication for use exists for each medication ordered. The indicat
can be anywhere in the medical record and need not be part of the order itself. For example, the indication may be part of the medic
history, in the form of lab values, diagnoses, progress note entries, etc. However, standard MM.04.01.01. EP 3 requires organizatio
policy to designate when an indication for use is required as an element of a specific medication order. For example, an order writte
as 'Acetaminophen 650 mg po q4h prn for fever greater than 101' clearly defines the indication when it would be appropriate to
administer this medication.

Medication Security - Anesthesia Cart

Can an anesthesia cart containing medication be left unlocked in an OR suite between cases?
If the individual operating room is part of a larger OR unit that is manned at all times in a fashion which monitors access to the
operating room and assures constant surveillance of the anesthesia cart to prohibit access by unauthorized individuals - locking of th
cart between cases would not be required. After hours when the OR unit is not manned in a like manner, the carts must be properly
secured. Whether the carts are locked or unlocked, they must be stored in a secured area which prohibits access and tampering by
unauthorized individuals (e.g., in a separate locked room or in the secured OR unit where unauthorized access is prohibited.)

Medication Selection and Procurement - Managing Medication Shortages

What are The Joint Commission requirements for managing medication shortages?

Organizations are required to establish a process for communicating medication shortages to Licensed Independent Practitioners (L
and staff who participate in medication management (MM.02.01.01). Examples of ‘staff’ may include those responsible for ordering,
preparing, stocking, storing and administering medications. Each organization determines the most effective means of communicatin
this information to key constituents.

While not required, organizations may wish to consider several different means of communicating this information. Examples may
include emails, medical staff newsletters, daily staff briefings and huddles, alerts posted in dictation/documentation stations often us
by LIPs, medication dispensing stations, etc. Periodic assessment of the effectiveness of the communication process should be
conducted to ensure compliance with organizational requirements.

The timeframe for receiving notice of medication shortages is often short and preparing for shortages can be time-consuming and
difficult, therefore, advanced planning is crucial. If the organization intends to automatically substitute medications during times of
shortage, organizations are required to develop written medication substitution protocols. Such protocols must be approved by
leadership and the medical staff. The intent of these protocols is to allow for automatic substitutions which would be utilized if the
ordering practitioner had not indicated an alternative medication to an individual patient order. If providers are expected to determin
and order an alternative medication or dosage form, then the protocol would not be required.

If the substitution is made to items located in floor stock or crash carts, where an individual might retrieve a product different than wh
would be typically used, an approved substitution protocol would also be required. This would apply to substituting: dosage form;
route; concentration (strength); or medication. Staff education should be conducted for those assigned to those areas affected by
medication shortages and where the substitution may occur.

To ensure reduction of risk from variations introduced as a result of shortages, compliance with substitution practices should be
included when evaluating the effectiveness of all medication management systems (see MM.08.01.01). One example may be to
review medication errors/adverse drug events to determine if a medication shortage was directly or indirectly associated with the
event. The focus of this evaluation would be to identify performance improvement opportunities and implement risk reduction
strategies that can be applied to subsequent shortages. Organizations may also find it helpful to develop a safety checklist that
addresses each step of medication management systems when dealing with medication shortages.

Additional Resources:
Individual State Pharmacy Boards

Medication Storage - Concentrated Electrolytes - Storage in Patient Care Areas

Does The Joint Commission allow concentrated electrolytes to be stored outside of the pharmacy in patient care areas?

Under limited circumstances, it may be necessary to store concentrated electrolytes in specific patient care areas. Such decisions
should be based on the results of a robust risk assessment followed by implementation of appropriate safeguards that address all
identified risk points. As a general rule, concentrated electrolytes are not be kept in patient care areas where access is not urgently
needed.

Concentrated electrolytes may be described as solutions manufactured and distributed with the intention of being diluted prior to
administration. Examples include but not limited to: Hypertonic Premix Saline Solution 3%; Sodium Chloride 23.4% solution;
Potassium Chloride 2mEq/ml, Sodium Bicarbonate 8.4%, and Magnesium Sulfate 50%. When these solutions are available on a
patient care unit, the risk is significant that accidental administration may occur without first diluting, especially during an emergency
Examples of clinical areas where stocking concentrated electrolytes may be indicated include: crash carts located in intensive care
units, the emergency department, procedural or interventional suites, emergency response medication boxes, cardio-plegia solution
the operating room for use during cardiac surgery, etc.

The foundation for conducting a proactive risk assessment would be based on the services provided and patient population served i
each respective patient care area being considered for storage of such solutions. If it is determined that they are required, leadershi
would need to designate the appropriate locations for storage (i.e. emergency carts, automated medication dispensing cabinets,
dialysis unit, etc.) as well as which concentrated electrolytes would be appropriate. The population served by each storage device o
storage location should also be evaluated as such storage areas may serve a mixed patient population.

A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or
points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact
(that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an
organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may
better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis,
plan/do/check/act process, etc., or combinations and variations.

When an organization determines that concentrated electrolytes will be stored outside of the pharmacy, appropriate safeguards mus
be developed to prevent inadvertent administration of these medications without proper dilution. Examples of strategies to prevent
errors may include:
• Segregation from all other medications stored in the device or area.
• Determine an appropriate par level of the medication so that the amount maintained on the unit does not exceed the amou
necessary to meet patient care needs over a limited time period (for example, one day).
• A system for regularly checking and restocking to par level by pharmacy staff. .
• Prominent warning labels applied to the drug container.
• Restricted access to concentrated electrolyte medications and solutions to specially qualified staff.

Applicable Accreditation Standards::

Medication Management (MM)
MM.01.01.03 – High-risk High-alert medication
MM.03.01.01 – Safe medication storage practices
MM.03.01.03 – Management of emergency medications
MM.08.01.01 – Evaluation of medication management systems
HR.01.05.03 – Staff education

Leadership (LD)
LD.01.03.01 – Performance Improvement activities reflect the complexity of the organization and involved all departments an
services.

Performance Improvement (PI)

PI.01.01.01 – Medication errors, Adverse drug reactions.

Additional resources:
Standards BoosterPak: MM.03.01.01 (available only to Joint Commission-accredited organizations via their secure Extranet
site).
Individual State Pharmacy Boards
Institute for Safe Medication Practices
Institute for Healthcare Improvement

Medication Storage – Utilizing Literature to Extend Expiration Dating

Can an organization utilize published scientific information to determine medication stability when considering alternative
storage practices and expiration (beyond use) dates?

Medication storage practices and conditions are required to be in accordance with the original product manufacturer’s instructions
(MM.03.01.01 EP 2). When storage conditions for medication are not addressed in the original package insert, a pharmacist should
consulted to determine the appropriateness of alternate storage conditions, changes to the expiration date and the stability of the
medication. The Joint Commission is aware of published resources that may provide alternative stability data which may not reflect t
which is stated by the manufacturer. However, these publications and tests are not required to be validated by the FDA and therefo
may not be consistent with the strenuous testing required.

Expiration dating is based on stability testing under specified conditions as part of the U.S. Food and Drug Administration’s (FDA)
approval process. This is determined from results of rigorous analytical and performance testing, and are specific for a particular
formulation in its container and at stated exposure conditions of illumination and temperature. It is possible that a medication could
become unusable prior to its expiration date if it has been subjected to conditions that are inconsistent with the manufacturer’s pack
insert stated requirements.

The Joint Commission is also aware that the FDA has allowed extensions of certain medication expiration dates beyond what is liste
on product labeling. The applicability of this must be approved by the FDA and established by the manufacturer with an assurance t
the LOT number utilized for patient care is within the approved lot numbers of the medication.

NOTE: This FAQ only addresses the stability of the product and NOT the sterility. An organization should ensure that alternate
packaging and storage is consistent with National Standards to ensure appropriate sterility, such as USP 797.

Multi-Dose Injectable Products – Labeling and Storing

How should multi-dose vials be managed once opened/punctured?

Multi-dose, sterile injectable products are to be discarded 28 days after first use unless the manufacturer specifies otherwise (shorte
longer). Manufacturers are allowed by the FDA to publish extended dating within the package insert if they have conducted FDA
approved testing beyond the minimum 28-day requirement. Only guidelines published within the package insert are considered
appropriate.

Once the container has been punctured, an updated expiration date must be determined and applied to the container (MM.03.01.01
EP 7). If the manufacturer's original expiration date is shorter than the revised expiration date then the shorter date must be used.
For example, if the printed manufacturer’s expiration date on an injectable medication container states 7/1/2017 and the revised 28-
expiration from original vial puncture is 7/6/2017, then the 7/1/2017 date should be the expiration date of the container since it is bef
the revised date.
If sterility is questioned or compromised, the multi-dose container should be discarded regardless of the date. Labeling the multi-dos
container with only the date opened will not meet the intent of this requirement. These guidelines apply to all sterile, multi-dose
containers of injectable medications unless otherwise stated in the product package insert.

See also:
Multi-Dose Vials - Vaccine 28 Day Rule

Multi-Dose Vials - Definition

What types of vials are considered to be “multi-dose?'

According to Safe Injection Practices Coalition (2010): A multi-dose vial is a bottle of liquid medication (injectable) that contains more
than one dose of medication and is approved by the Food and Drug Administration (FDA) for use on multiple persons. A new, sterile
needle and syringe should always be used to access the medication in a multi-dose vial. The reuse of needles or syringes to access
multi-dose vial medication can result in contamination of the medicine with microbes that can be spread to others when the medicine
used again.

While there is not a specific Joint Commission standard that prohibits the use of multi-dose vials for more than one patient,
organizations must comply with the original product manufacturer’s intended use. For example:
• Single dose/single patient use
• Multi-dose/single patient use
• Multi-dose/multi-patient use

Policies, procedures and practices regarding the use of multi-dose vials should incorporate evidence-based practices, such as those
published by the CDC (Safe Practices for Medical Injections) and the Safe Injection Practices as developed by the “One and Only
Campaign”. Links to additional resources are provided below.

Additional Resources:
Review the One and Only Campaign website
The Center for Disease Control and Prevention websites:
Frequently Asked Questions (FAQs) regarding Safe Practices for Medical Injections
Safe Injection Practices to Prevent Transmission of Infections to Patients

Multi-Dose Vials - Punctured or Opened Discard Date

When do multi-dose vials that have been punctured or opened need to be discarded?

Multi-dose vials are to be discarded 28 days after first use unless the manufacturer specifies otherwise (shorter or longer).
Manufacturers are only required by law to test the effectiveness of the bacteriostatic agent used in the multi-dose vial for a period of
days. Manufacturers are allowed by the FDA to provide extended dating in the package insert if they have conducted testing beyond
the 28 days. Multi-dose pens, such as those used to inject medications such as insulin and Byetta must also follow these guidelines

Multi-Dose Vials - Punctured or Opened New Expiration Date

Does the multi-dose vial need to be labeled with a new expiration date once it is opened or punctured?

Yes. Standard MM.03.01.01 requires that all stored medications are labeled with the expiration date. The Joint Commission defines
expiration date as "the last date that the product is to be used". The manufacturer's expiration date is based on the fact that the prod
has not been opened. Once the vial cap is removed or the vial is punctured, the manufacturer's expiration date is no longer valid and
revised date (also called the "beyond use date" in pharmaceutical terminology) needs to be determined. To be in compliance with
MM.03.01.01, The Joint Commission requires organizations to re-label multi-dose vials with a revised expiration date once the multi-
dose vial is opened or punctured. If the manufacturer's original expiration date is shorter than the revised expiration date then the
shorter date must be used. Also, if sterility is questioned or compromised the multi-dose vials should be discarded regardless of the
date. Labeling the multi-dose vial with the date opened will not meet the intent of this requirement.

Multi-Dose Vials - Vaccine 28 Day Rule

Do vaccines need to follow the 28 day rule?

Currently, vaccines are exempted from this requirement. The CDC Immunization Program states that vaccines are to be discarded p
the manufacturer's expiration date. The Joint Commission is applying this approach to all vaccines (whether a part of the CDC or sta
immunization program or purchased by healthcare facilities) with the understanding that the vaccines are stored and handled
appropriately (correct temperature is maintained, frequency of temperature checks, etc.). Following the guidelines provided in the
package insert is very important to assure integrity of the vaccine.

The CDC has excellent resources regarding the use, storage and handling of vaccines.

Refrigerator/Freezer - Medication Temperature Logs

Are we required to maintain temperature logs for medication storage refrigerators and freezers?

The Joint Commission does not specifically require temperature logs for refrigerators and freezers used for medication storage.
Standard MM.03.01.01, EP2 requires that medications are stored according to manufacturer's recommendations. Additionally,
EC.01.01.01 requires that organization describes its processes to maintain and monitor equipment performance.

If your organization chooses to use temperature monitoring to achieve this, the process must be effective to ensure appropriate
temperatures are being maintained within the required ranges for all medications stored. Organization should also have a defined
process outlining disposition of medication from a refrigerator or freezer which has deviated from the recommended temperature
range.

The frequency of temperature monitoring (daily, continuous, etc.) is determined by the organization and in a manner consistent with
medication manufacturer's safe storage guidelines.

For temperature log retention requirements, see the FAQ titled "Records and Documentation - Retention" under the Leadership.

Sample Medications - Applicability of Standards

What issues must our organization consider relating to sample medications?

The following issues must be considered:

Patient-specific medication information must be available in some fashion (MM.01.01.01).

Medication must be safely stored (MM.03.01.01).
Medication orders or prescriptions are clear and accurate (MM.04.01.01).
The patient record contains information that reflects the patients care, treatment or services (RC.02.0.01).
Medications are labeled (MM.05.01.09).
The organization follows a process to retrieve recalled or discontinued medications (MM.0501.17).
The organization monitors patients to determine the effects of their medications (MM.07.01.01).
The organization responds to actual or potential adverse drug events, significant adverse drug reactions, and medication errors
MM.07.01.03).
The organization provides patient education and training based on each patient's needs and abilities (PC.02.03.01).

National Patient Safety Goals (NPSG)

Topic

Anticoagulation Therapy - Applicable Anticoagulants

What anticoagulants are included under NPSG.03.05.01?

The only anticoagulant drugs included currently under the requirement are warfarin, unfractionated heparin, and
low molecular weight heparins. Eventually, other anticoagulants may be added to the list in the future. However,
there is nothing that prevents an organization from including any other anticoagulant in their management
program. Such an approach is encouraged but not required.

Anticoagulation Therapy - Heparin for Subcutaneous Administration and Line Flushes

Does NPSG.03.05.01 include anticoagulant drugs that are not used for therapeutic purposes, such as
line maintenance? What about subcutaneous heparin?

No, the requirement only applies to patient's receiving "anticoagulation therapy". Thus, it only applies to patients
receiving these drugs for therapeutic purposes, and not for flushes, etc.

Anticoagulation Therapy - Management Program Definition

For NPSG.03.05.01 EP 1, what is meant by a "defined anticoagulant management program"?

The term "defined anticoagulant management program" means a program, specified in writing, for individualizing
anticoagulation therapy for each patient that involves the use of standardized practices and patient involvement,
and which is specifically designed to reduce the risk of adverse drug events associated with the use of heparin
(unfractionated), low molecular weight heparin (LMWH), warfarin, and other anticoagulants.

Anticoagulation Therapy - Not Dispensed or Administered

How does NPSG.03.05.01 relate to my organization if we do not dispense or administer anticoagulants?
Sometimes we will monitor or provide education on anticoagulation therapy, but we do not administer
anticoagulants.

For the purposes of NPSG.03.05.01 "providing anticoagulation therapy" means dispensing or administering
anticoagulants. If you do not dispense or administer anticoagulants then the requirement does not apply to your
organization. Additionally, NPSG.03.05.01 does not apply for those organizations that are only monitoring (i.e.
drawing labs and assessing for bleeding) or providing education on anticoagulation therapy

Anticoagulation Therapy - Prophylactic Treatment

Does NPSG.03.05.01 apply to prophylactic treatment? We often use therapeutic doses of heparin as an
infusion for DVT prophylaxis after orthopedic surgery.

NPSG.03.05.01 applies to those situations when anticoagulant is administered therapeutically and not
prophylactically regardless of the medication type (warfarin, heparin, low molecular weight heparin, etc.).
However, if it is usual practice for patients to be kept on therapeutic ranges of anticoagulant for several days as a
prophylactic strategy then NPSG.03.05.01 is applicable.

Catheter-Associated Urinary Tract Infection (CAUTI) - Surveillance

My facility performs a risk assessment every year as required by IC.01.03.01. We consider a wide range
of infection risks, and we rank them per IC.01.03.01 EP 5. Our risk assessment shows CAUTI is a very
low patient risk; there are many other higher priorities. Must I perform surveillance for CAUTI because of
the NPSG.07.06.01 even though my risk assessment does not identify it as a priority?

NPSG.07.06.01 was a new goal on catheter-associated urinary tract infection (CAUTI) that was published in the
July 2011 edition of Perspectives. Reasons for this goal are captured in the following quote from the Perspectives
article: "The Joint Commission's Patient Safety Advisory Group, a group of external national experts on patient
safety issues, recommended that NPSG.07.06.01 for CAUTIs be considered for adoption. CAUTI is the most
frequent type of health care-acquired infection (HAI), and represents as much as 80% of HAIs in hospitals. The
frequency of CAUTIs creates a patient safety and quality concern."

The Joint Commission recognizes that a variety of surveillance approaches are appropriate for various types of
infections. For example, NPSG.07.04.01 on catheter-associated bloodstream infection requires that all catheters
be monitored; EP 4 states surveillance must be "hospital-wide, not targeted". However, NPSG.07.03.01 on multi-
drug resistant organisms allows for the risk assessment to drive surveillance, hence EP 4 says surveillance may
be "targeted rather than hospital-wide". In a similar fashion, NPSG.07.05.01 on surgical site infection allows
organizations to determine which surgeries to monitor, and EP 5 states, "Surveillance may be targeted to certain
procedures based on the hospital's risk assessment."

NPSG.07.06.01 on CAUTI does not specify either hospital-wide or targeted surveillance. In fact, it does not
specifically require that surveillance for CAUTI be performed at every accredited hospital. Rather, it allows for
each organization to decide, based on its risk assessment (IC.01.03.01) whether CAUTI is a priority warranting
surveillance. Having said this, The Joint Commission urges organizations to review the scientific literature and
consensus-based guidelines when considering CAUTI surveillance. One summary of the epidemiology of CAUTI
that bears consideration is the following excerpt from the CDC/HICPAC document entitled "Guideline for
Prevention of Catheter-Associated Urinary Tract Infections 2009".

Urinary tract infections are the most common type of healthcare-associated infection, accounting for more than
30% of infections reported by acute care hospitals. Virtually all healthcare-associated UTIs are caused by
instrumentation of the urinary tract. Catheter-associated urinary tract infection (CAUTI) has been associated with
increased morbidity, mortality, hospital cost, and length of stay. In addition, bacteriuria commonly leads to
unnecessary antimicrobial use, and urinary drainage systems are often reservoirs for multidrug-resistant bacteria
and a source of transmission to other patients."

CDC or WHO - Artificial Nails and Gels

The CDC guidelines say that health care personnel should not wear artificial nails and should keep
natural nails less than one quarter inch long if they care for patients at high risk of acquiring infections
(e.g. patients in intensive care units or in transplant units). The WHO guidelines prohibit artificial nails
and extenders for all healthcare workers. Will Joint Commission actually be requiring this?

Each organization must follow the IA, IB and IC recommendations from the guideline it chooses (CDC or WHO).
Therefore, if WHO is chosen, no direct care providers should have artificial nails or extenders. If CDC is chosen,
providers in high-risk areas must not wear artificial nails.

Many organizations following CDC guidelines have chosen to expand the ban on artificial nails, nail gels, gel
colors, etc., to all care providers in the interest of safety. Regarding the length of natural nails, each organization
may choose its own approach since the level of recommendation in both the CDC and WHO guidelines is "II",
thereby making compliance optional.

In addition to the CDC and WHO, organization's requirements should incorporate evidence-based guidelines for
specialized and/or procedural areas. AORN, AAMI and APIC are additional examples of resources for such
guidelines.

Central Line Associated Bloodstream Infections (CLABSI) - Documentation

Please explain the documentation icons for NPSG.07.04.01 EPs 6 and 12. What will surveyors expect to
see?

NPSG.07.04.01 EP 6 requires use of "a catheter checklist and a standardized protocol for central venous
catheter insertion" The checklist or protocol is not required to be a part of the patient's medical record. A simple
indication that the checklist or protocol was completed, perhaps via a checkbox or brief note, is sufficient.
NPSG.07.04.01 EP 12 requires use of a "standardized protocol to disinfect catheter hubs and injection ports
before accessing the ports". This is not a patient-specific documentation requirement. Surveyors will ask to see
each organization's protocol; this may be in the form of a policy, protocol, etc.

Central Line Associated Bloodstream Infections (CLABSI) - Whole House Surveillance

Must we perform surveillance on all central lines, or is targeted surveillance okay?

Infection surveillance must be performed on all central lines; these lines carry significant risk of morbidity and
mortality regardless of circumstances. Limiting surveillance to certain types of lines, patient care units or service
lines is not allowable under NPSG.07.04.01.

Hand Hygiene - Alcohol-based Hand Products

Do we have to use alcohol-based hand products?

Accredited organizations are required to provide health care workers with a readily accessible alcohol-based
hand product. However, use of such a product by any individual health care worker is not required. The
guidelines describe when this type of cleaner may be used instead of soap and water. If a healthcare worker
chooses not to use it, then soap and water should be used instead.

Hand Hygiene - CDC and WHO Web Sites

Where can I find the current Center for Disease Control and Prevention (CDC) hand hygiene and World
Health Organization (WHO) guidelines?

View the CDC report. Download the WHO report.

Hand Hygiene - CDC or WHO - Categories for Recommendation Implementation

Does Joint Commission require implementation of all the recommendations in the CDC or WHO hand
hygiene guidelines?

Each of the CDC and WHO hand hygiene recommendations is categorized on the basis of the strength of
evidence supporting the recommendation. All "category I" recommendations (including categories IA, IB, and IC)
must be implemented. Category II recommendations should be considered for implementation but are not
required for accreditation purposes. Category IA recommendations are strongly supported by well-designed
experimental, clinical, or epidemiological studies; category IB recommendations are supported by certain
experimental, clinical, or epidemiological studies and a strong theoretical rationale; category IC recommendations
are required by regulation; category II recommendations are supported by suggestive clinical or epidemiological
studies or a theoretical rationale. The CDC also includes among its recommendations several "unresolved
issues" for which it makes "no recommendation."

Hand Hygiene - CDC or WHO - Choosing Guidelines

May we "pick and choose" some recommendations from CDC and some from WHO, or must we decide
to follow one of the guidelines in its entirety?

Scientific guidelines are designed to function as a cohesive whole. Following parts of a guideline is not as
efficacious as compliance with the entire document. Therefore, accredited organizations must choose to follow all
IA, IB and IC recommendations from either CDC or WHO. Of course, the Joint Commission would encourage
organizations to go "above and beyond" by complying with additional recommendations from either document as
long as compliance has been achieved with all level I recommendations from either CDC or WHO.

Hand Hygiene - CDC or WHO - Nutrition Services

Is there an expectation for individuals passing patient trays at mealtime to use alcohol-based hand rub
between each room?

If the person passing the food tray has, or is likely to have, direct contact with the patient, the answer is yes
because both the CDC and WHO guidelines state that hand hygiene is required after direct contact (category IB).
Both guidelines also say that individuals should decontaminate hands after contact with inanimate objects in the
immediate vicinity of the patient, but this is identified as a Category II by the CDC recommendation. As such,
while compliance with the CDC Guidelines is recommended for individuals passing meal trays who do not make
direct contact with the patients, it is not required. In contrast, the WHO guidelines require hand hygiene after
contact with the patient's environment (category IB).

Hand Hygiene - Corridor Dispensers of Alcohol-based Hand Products

What are the "conditions" that have to be met to be able to install alcohol-based hand rub (ABHR)
dispensers in egress corridors?

Location conditions and permissible volume specifications for gel ABHR dispensers to be installed in egress
corridors are as follows:

The corridor width is 6 feet or greater and dispensers are at least 4 feet apart.
The dispensers are not installed over or directly adjacent to an ignition source such as an electrical outlet or
switch. Adjacent is defined as being at least 6 inches from the center of the dispenser to an ignition source.
In locations with carpeted floor coverings, dispensers installed directly over carpeted surfaces are permitted
only in sprinklered smoke compartments.
Each smoke compartment may contain a maximum aggregate of 10 gallons (37.8 liters) of ABHR gel in
dispensers and a maximum of 5 gallons (18.9 liters) in storage.
The maximum individual dispenser fluid capacity is 0.3 gallons (1.2 liters) for dispensers in rooms,
corridors, and areas open to corridors.
The maximum dispenser size for individual dispensers in areas designated as suites of rooms is 0.5 gallons
(2.0 liters).

The situation is a little different with respect to foam ABHR products because all of the testing upon which the
NFPA and CMS decisions were based was done on the gel product, not on foam. However, industry experts and
CMS have indicated that small-quantity ABHR foam dispensers may be handled the same as for ABHR gel.
Therefore, pending further review, both The Joint Commission and CMS will allow any ABHR foam installation
that meets the location criteria stated above for ABHR gel. Volumes of ABHR foam are based on suppliers'
recommendations and in no case exceed the permissible volumes for ABHR gel as defined above. In the event
that subsequent testing demonstrates a safety concern relating specifically to foam dispensers in egress
corridors, The Joint Commission reserves the right to modify its position on the acceptability of such installations.
In that event, previously installed dispensers would be subject to the newer restrictions; that is, they would not be
"grandfathered," and noncompliant installations would have to be removed.

Hand Hygiene - Monitoring

What are the changes regarding hand hygiene requirements beginning in 2018 ?

Effective January 1, 2018, for all accreditation programs:

Any observation by surveyors of individual failure to perform hand hygiene in the process of direct patient care
will be cited as a deficiency resulting in a Requirement for Improvement (RFI) under Infection Prevention and
Control (IC) Standard IC.02.01.01, EP 2: “The [organization] uses standard precautions,
including the use of personal protective equipment, to reduce the risk of infection.” Surveyors also will continue
surveying an organization’s hand hygiene program to National Patient Safety Goal NPSG.07.01.01. (see also the
December 2017 issue of the Perspectives Newsletter).

It is a good idea to think of NPSG.07.01.01 EPs 2 and 3 as a basic outline for a required performance
improvement project. EP 2 requires each accredited organization formulate a goal for hand hygiene, and EP 3
requires organizations to improve compliance based on the goal set in EP 2. Each organization should customize
its goals and improvement efforts to meet its unique needs. Please note that there is no specific requirement as
to how measurement must occur other than it must occur according to CDC or WHO guidelines.

Measurement: Organizations must perform an accurate baseline assessment of hand hygiene in order to identify
opportunities for improvement. Please note that participants in the Center for Transforming Healthcare Hand
Hygiene Project found that their actual hand hygiene rates were significantly lower than they had previously
estimated. For more information, visit the Center for Transforming Healthcare Web site. In particular, please view
page four of the storyboard presentation. The Joint Commission recognizes that hand hygiene measurement is a
challenge. In an effort to provide assistance, we have co-authored a monograph on this topic along with several
other infection prevention leadership organizations: "Measuring Hand Hygiene Adherence: Overcoming the
Challenges".
Goal Formation: After establishing an accurate baseline, each accredited organization must formulate a goal for
improvement. The Joint Commission previously required that each organization have a hand hygiene goal of at
least 90%; that requirement is no longer in place. Rather, each organization must formulate a goal to improve
over past performance.

Improving compliance: After measurement and goal formation, interventions to achieve improvement must be
implemented. Per EP 1, these interventions must be designed utilizing either CDC or WHO guidelines. If the goal
is not met, interventions should be redesigned based on an analysis of causative factors. If the goal is met, it
should be adjusted to foster higher levels of compliance.

Ligature Risks - Assessing and Mitigating Risk For Suicide and Self-Harm

What are the Joint Commission expectations for identifying and managing ligature risks in the hospital
setting?

For inpatient psychiatric hospitals, inpatient psychiatric units in general acute care hospitals, and non-behavioral
health units DESIGNATED for the treatment of psychiatric patients (i.e. special rooms/safe rooms in Emergency
Departments or Medical Units):
The requirements found in the Environment of Care (EC) chapter of the accreditation manual at
EC.02.06.01 require hospitals to establish and maintain a safe, functional environment. Element of
Performance # 1 states “Interior spaces meet the needs of the patient population and are safe and
suitable to the care, treatment, and services provided”. Therefore, ligature and self-harm risks must be
identified and eliminated. While risks are in the process of being eliminated, policies and procedures
must be developed and implemented to mitigate the harm posed by such risks. Mitigation plans must
include, at a minimum the following: :
• Ensuring that leadership and staff are aware of the current environmental risks
• Identifying patients’ risk for suicide or self-harm, then implement appropriate interventions based
upon risk.
• Ongoing assessments and reassessments of at-risk behavior as defined by the organization.
• Ensuring the proper training of staff to properly identify patients’ level of risk and implement
appropriate interventions
• Incorporating suicide risk and self-harm reduction strategies into the overall Quality
Assessment/Performance Improvement (QAPI) program - see LD.01.03.01 EP 21.
• If equipment poses a risk but is necessary for the safe treatment of psychiatric patients (i.e.
medical beds with side rails on a geriatric unit), the
organization must consider these risks in patients’ overall suicide/self-harm risk assessments,
then implement appropriate interventions to
diminish those risks

In non-behavioral health units (i.e. Emergency Rooms or Medical Inpatient Units) that are NOT DESIGNATED
specifically for the treatment of psychiatric patients; however, where psychiatric patients may temporarily reside,
ligature/self-harm environmental risks must also be identified.

All physical risks not required for the treatment of the patient that can be removed, must be removed.
Furthermore, an appropriate level of effective surveillance must be implemented if self-harm risks remain in the
environment. Organizational policies and procedures must adequately guide staff in the assessment of patients’
risk for suicide/self-harm and the implementation of interventions based upon the patients’ individual needs.

For non-inpatient programs surveyed under the Hospital Accreditation manual, an environmental risk assessment
should be completed. Based upon the results of that assessment, taking into account the individuals they serve,
the organization determines if any modifications to the environment should be made. Policies and procedures
should also be developed and implemented to address the immediate action to be taken by staff when a patient
is assessed to be at risk for suicide.

Additional Resources for assessing suicide risk:

Sentinel Event Alert # 56
Facility Guidelines Institute: Design Guide for the Built Environment of Behavioral Health Facilities
Suicide Risk Booster - available to accredited organizations via their Secure Extranet Site

Methicillin Resistant Staphylococcus (MRSA) - Screening

Is MRSA screening required for all patients? If not, are there certain high-risk patients that must be
screened?

NPSG.07.03.01 EP 7 states, "Implement policies and practices aimed at reducing the risk of transmitting
multidrug-resistant organisms. These policies and practices meet regulatory requirements and are aligned with
evidence-based standards (for example, the Centers for Disease Control and Prevention (CDC) and/or
professional organization guidelines)." Please refer to the CDC/HICPAC guideline entitled "Management of
Multidrug-Resistant Organisms In Healthcare Settings, 2006". See also, IC.01.05.01 EP 1 which requires that,
"When developing infection prevention and control activities, the hospital uses evidence-based national
guidelines or, in the absence of such guidelines, expert consensus."

The HICPAC guideline lists two sets of interventions, designated as "general" and "intensified, tier 2".
Tier 2 interventions are not recommended of all facilities, but rather just those that meet criteria listed in
the guideline. These criteria include failure to decrease MDRO rates as well as the first occurrence of an
epidemiologically significant organism. Screening, also known as active surveillance cultures (ASC), is
listed under the category of "intensified interventions" (recommendation V.B.5.b).

Therefore, unless an organization meets the criteria for "intensified, tier 2" interventions, Joint
Commission surveyors would not expect these to be in place. Consequently, active surveillance cultures
are not required at all accredited facilities. However, please note that LD.04.01.01 EP 2 requires
compliance with applicable law and regulation. Many state legislatures have enacted law or regulation
that requires active surveillance cultures for particular patient populations. The Joint Commission would
expect these to be done per LD.04.01.01.

Multiple Drug-resistant Organism - Surveillance

Must we perform surveillance on all MDROs, or is targeted surveillance okay?

Targeted surveillance is allowable for MDROs. Please see NPSG.07.03.01 EP 4, which states, "implement a
surveillance program for multidrug-resistant organisms based on the risk assessment." Therefore, if an
organization's risk assessment shows that risk is greatest for certain organisms, patient care units or service
lines, the surveillance program may be targeted to focus resources on those high-risk issues.

Suicide Risk Reduction - Applicability in a Hospital Setting

In our hospital, we do not have a psychiatric unit but we do admit patients that have psychiatric disorders
along with their medical conditions. Does this requirement apply to us?

NPSG.15.01.01 applies to all patients in organizations surveyed under the BHC (behavioral) standards, all
patients in psychiatric hospitals, and to any patient in a general hospital with a primary diagnosis or primary
complaint of an emotional or behavioral disorder, regardless of registration status (IP, OP, ED, Obs, etc). At this
time, suicide risk assessment of patients with secondary diagnoses or secondary complaints of emotional or
behavioral disorders is encouraged but not required. For purposes of this requirement, the phrase "emotional or
behavioral disorders" refers to any DSM diagnosis or condition, including those related to substance abuse. The
phrase "being treated" is interpreted in terms of the patient's diagnosis or presenting "complaint." The nature of
the treatment is really not the issue. Additional information regarding assessing suicide risk has been published
in our Sentinel Event Alerts:

Detecting and Treating Suicide Ideation in All Settings

Inpatient Suicides: Recommendations For Prevention
A Follow-up Report on Preventing Suicide: Focus on medical/surgical units and the Emergency Department

Suicide Risk Reduction - Applicability in a Hospital's Emergency Department

What is the expectation for a patient brought to our general hospital Emergency Department for a
psychiatric-related condition when the patient will most likely be transferred to a psychiatric facility?

The requirement under this safety goal is that a suicide risk assessment will be done in the receiving Emergency
Department and appropriate precautions will be taken. There are several cases in The Joint Commission's
sentinel event database of suicides in emergency departments while the patients were awaiting transfer.
Additional information regarding assessing suicide risk has been published in our Sentinel Event Alerts:

Detecting and Treating Suicide Ideation in All Settings

Suicide Risk Reduction - Crisis Hotline

NPSG.15.01.01 EP 3 says, "The hospital provides information such as a crisis hotline to individuals at
risk for suicide and their family members.." Does this mean we have to provide our own crisis hotline?

No. Actually, it means that organizations must provide information about the availability of a crisis hotline (not
necessarily its own) or other resources, and how to access them if needed. This would be required for any
patients identified as "at risk" based on the assessment process as you have conducted it.
Additional information regarding assessing suicide risk has been published in our Sentinel Event Alerts:

Detecting and Treating Suicide Ideation in All Settings

Inpatient Suicides: Recommendations For Prevention
A Follow-up Report on Preventing Suicide: Focus on medical/surgical units and the Emergency Department

Suicide Risk Reduction - Hospital Applicability Sample Scenarios

For each of the following general hospital scenarios, would a suicide risk assessment be required?

A patient seen in the Emergency Department for a fracture sustained in the act of attempting suicide:
This patient has already identified him/herself as "at risk" by virtue of the suicide attempt. A risk assessment is
not necessary. Treatment of the fracture and the emotional condition is needed. As the patient recovers, an
assessment of the degree of ongoing risk for suicide is required in order to plan the appropriate continuing care.

A patient admitted to the ICU for detoxification:

Detoxification is a medical treatment. At the time of admission to the ICU, the primary diagnosis is medical.
However, as the patient recovers, the primary diagnosis will shift to the underlying psychiatric or substance abuse
problem. When the patient is able a suicide risk assessment will be required. A patient admitted to OB in active
labor, has history of severe post-partum depression after a previous childbirth: The decision to do a suicide risk
assessment and when to do it would be left to the responsible practitioner. It would not be required under
NPSG.15.01.01, however, this type of patient represents a high risk.

Additional information regarding assessing suicide risk has been published in our Sentinel Event Alerts:

Detecting and Treating Suicide Ideation in All Settings

Inpatient Suicides: Recommendations For Prevention
A Follow-up Report on Preventing Suicide: Focus on medical/surgical units and the Emergency Department

Suicide Risk Reduction - Screening vs. Comprehensive Assessment

For psychiatric hospitals and residential treatment facilities, are we required to screen all individuals
admitted and to conduct a more detailed risk assessment, as appropriate, or to conduct a thorough
suicide risk assessment for every individual who presents for admission?

The details of the risk assessment process, when required, are left to the individual organization to decide. A two-
stage process-for example, screening followed by a comprehensive assessment, as appropriate-is acceptable.
Additional information regarding assessing suicide risk has been published in our Sentinel Event Alerts:

Detecting and Treating Suicide Ideation in All Settings

Inpatient Suicides: Recommendations For Prevention
A Follow-up Report on Preventing Suicide: Focus on medical/surgical units and the Emergency Department

Surgical Site Infections (SSI) - Surveillance and Resources

Are organizations required to conduct surveillance on all surgical procedures, or is targeted surveillance
acceptable ?

No, there is no requirement that all surgical procedures must be included in an organization’s surveillance for
surgical site infections (SSI). Organizations may choose to target SSI surveillance based on the results of a risk
assessment. If an organization's risk assessment shows that risk is greatest for certain procedures or settings,
the surveillance program may be targeted to focus resources on those high-risk procedures.

Organizations may wish to consider conducting periodic risk assessments to ensure that the scope of the
targeted procedures included in surveillance activities remains current. Conducting a risk assessment is a helpful
way of identifying risks associated with various procedures performed. A proactive risk assessment examines a
process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability
and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that
is, criticality) of care, treatment, or services provided.

The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment
model that an organization may use. However, this specific approach is not mandated as there are other risk
assessment tools available that may better meet the needs of the organization. Other examples may include a
root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and
variations.

The risk assessment should focus on all components of the surgical continuum, including – but not limited to -
staff knowledge and competency, adoption of – and compliance with - evidence-based guidelines for
reprocessing of instruments, policies and procedures, surgical attire, practitioner engagement, and patient
education. Compliance with any state-specific reporting requirements should also be evaluated. From a quality
and safety perspective, ensure that surgical procedures performed in all locations have been integrated into the
organization-wide quality assessment and performance improvement (QAPI) program.

Additional Resources:
The Center for Transforming Healthcare: Surgical Site Infections Project
Preventing infections in ASCs: It's All about Teamwork: Infographic
Reducing Colorectal Surgical Site Infections
Compendium of Strategies to Prevent Healthcare-Associated Infections in Acute Care Hospitals
Video: Tackling Surgical Site Infections
The Joint Commission’s Implementation Guide for NPSG.07.05.01 on Surgical Site Infections
Educating Patients About Surgical Site Infections: Complying with NPSG.07.05.01
CDC: Prevention of Surgical Site Infection, 2017

Available to accredited organizations via their secure Extranet site: High-level Disinfection and Sterilization
BoosterPak

Test Results - Chronic Critical Values - Repeat Results

When a repeat test value is still critical but is showing improvement, does it still need to be considered a
"critical result" and reported in that time frame?

This is a matter of definition and each organization can define for itself the circumstances under which a test
result is considered "critical." It is permissible to define "critical results" differently for repeat tests. For example,
this may be represented as different "panic value" limits for repeat tests or may be based on the direction of
change in the subsequent test results. The default, however, should be to treat the repeat result as a critical
result.

Test Results - Chronic Critical Values Definition

When a patient has a chronic condition, such as end stage renal failure, and the lab values are "critical"
by our hospital's definition but are expected - or "normal" - for that particular patient, the lab and nursing
staff find themselves calling the same physician several times a day to report these values when it really
isn't necessary. Can we develop a policy for patients with certain chronic conditions that will allow the
physician to define the "critical" levels of the lab values that should be reported for a specific patient?

Each health care organization may define for itself what the "critical values" are. Provisions may be made for
certain patient-specific situations in which values that would be "critical" for most patients are not critical for a
particular patient or for patients with a particular diagnosis. The parameters must be objectively defined and are
known to all staff who are involved in the process of reporting values.

Transfusion Administration - Applicability to RhoGAM®

Does NPSG.01.03.01 apply to administration of RhoGAM®?

No. RhoGAM® is classified as a drug by the FDA, not a blood product.

Transfusion Administration - Identification Related to Blood Matching

Does NPSG.01.03.01 apply to the receipt of blood or blood products from the blood bank, or only to the
transfusion itself?

While optimal identification is encouraged at all stages of the blood matching process, this goal applies only to
the transfusion process itself.

Transfusion Administration - Qualified Transfusionist /Second Individual

Are there any specifications on who must be identified as the qualified transfusionist (EP 2) and the
second individual (EP 3)?

The determination of who may transfuse blood and blood products is made by each accredited organization
under consideration of law and regulation as well as competence. The second qualified individual can be any
staff member that the organization determines to be qualified; it need not be a qualified transfusionist.

Two Patient Identifiers - Active Involvement of the Patient or Responsible Caregiver

Are there any exceptions for active involvement of the patient or responsible caregiver? What if the
patient is sleeping? Does this mean the patient's nurse needs to help identify non-communicative or
confused patients whenever other healthcare workers, such as lab and respiratory therapy, use two
patient identifiers?

NPSG.01.01.01 The primary purpose of this requirement is to ensure the safety of patients during their care,
including prevention of medication, diagnostic and treatment errors. For those patients who are sleeping, are
non-communicative or are confused, each organization decides how they will assess these patients and when
active involvement of the patient or responsible caregiver is necessary. Such decisions and expectations must be
clearly communicated to staff, and should be based on promotion of patient safety, not convenience or workflow.

Two Patient Identifiers - Applicability to Nutrition Services

Does NPSG .01.01.01 apply to the delivery of patient meals and snacks?

At a minimum, it applies whenever the patient/resident requires a special diet or the meal/snack that is being
delivered is part of a special diet. It may be easier to implement this requirement consistently by applying it to all
patients/residents receiving diets or snacks.

Two Patient Identifiers - Armband For Patient Identification

What do you mean by two patient identifiers? NPSG.01.01.01

For those patients with armbands, we're thinking patient name and ID number compared to the order/MAR would
be the two identifiers. Yes, that is acceptable. The two identifiers may be in the same location, such as a
wristband. It is the person-specific information that is the "identifier," not the medium on which that information
resides. Acceptable identifiers may be the individual's name, an assigned identification number, telephone
number, or other person-specific identifier. Electronic identification technology coding, such as bar coding or
RFID, that includes two or more person-specific identifiers (not room number) will comply with this requirement.
Please remember that active patient involvement is also required in NPSG.01.01.01 EP 1.

Two Patient Identifiers - Armband Not Attached

Is it acceptable practice to lay the patient armband on the bedside table or tape it to the bed if the patient
is alert and is able to state their identifying information? NPSG.01.01.01

Although The Joint Commission does not require the use of arm bands for patient/resident identification, if you do
choose to use arm bands as a means of conveying patient/resident identification information, the band must be
attached to the patient/resident at all times. Simply placing it on the bedside table or taping it to the bed would not
be acceptable if there is any reliance on the information contained on it.

Two Patient Identifiers - Intent

What is the intent of the requirement for using two identifiers? NPSG.01.01.01

The intent here is two-fold: first, to reliably identify the individual as the person for whom the service or treatment
is intended; second, to match the service or treatment to that individual. Therefore, the two patient/client/resident-
specific identifiers must be directly associated with the individual and the same two identifiers must be directly
associated with the medications, blood products, specimen containers (such as on an attached label), other
treatments or procedures.

Two Patient Identifiers - Laboratory Not Accredited By The Joint Commission

NPSG.01.01.01 EP 2 says "Containers used for blood and other specimens are labeled in the presence
of the patient." Our hospital is Joint Commission accredited but we have another accrediting agency for
our lab. Does this requirement apply to us?

Yes. For any specimen collection that occurs in an accredited organization, NPSG.01.01.01 applies. Pre-labeling
of specimen containers, also known as batch processing, is a common approach which is assumed to improve
efficiency but can increase the risk for patient/treatment/specimen mis-identification. Pre-labeling can be done on
a patient-specific basis, but if not performed in the presence of the patient it will not be acceptable under this
requirement

Two Patient Identifiers - Orders for Care/Critical Test Values

Does the two-identifier requirement apply to orders for care? Does it apply to reporting critical test
results? NPSG.01.01.01

Yes, to both questions. These are important, safety-related aspects of patient care, which for purposes of this
requirement, fall under the EP for the use of two identifiers for "other treatments or procedures".

Two Patient Identifiers - Outpatient Setting

A lot of our outpatients-those who come for a lab draw and other simple procedures, our home health
patients and our ambulatory care patients-do not have an armband. Would asking them their name and
comparing it to any paperwork we have constitute two identifiers? NPSG.01.01.01

No. In the requirement for using two identifiers, the term "identifier" refers to the specific items of information by
which the care recipient can be identified rather than the source of the information. So, comparing the individual's
stated name with the name on the requisition would be one identifier. Examples of a second identifier for a care
recipient without an armband might be date of birth, social security number, home address, or phone number.

Two Patient Identifiers - Same Identifiers Throughout the Organization

Do the same two identifiers have to be used throughout the organization? NPSG.01.01.01

No. Ideally a standardized or similar approach would be used throughout the organization; however different
identifiers may be used in different settings as long as their use is consistent with the intent of this requirement as
stated above. However, the identifiers should be consistent within each setting, not just whatever the individual
practitioner or staff person wishes to use

Two Patient Identifiers - Temporary Names

How would you identify an injured ER patient who was unresponsive and could not communicate with
others? NPSG.01.01.01

Such patients are usually assigned a temporary "name" (e.g., John Doe) and an emergency department number
or medical record number. These identifiers could then be used to identify the patient and match against
specimen labels, medications ordered for the patient, or blood product labels. In this process, formal identification
of the patient should occur as soon as possible and once confirmed this identifying information should be used
instead of the temporary identification

Two Patient Identifiers - What is meant by two patient identifiers

What do you mean by two patient identifiers? NPSG.01.01.01

The glossary of the accreditation manual defines a patient identifier as "Information directly associated with an
individual that reliably identifies the individual as the person for whom the service or treatment is intended.
Acceptable identifiers may be the individual's name, an assigned identification number, telephone number, or
other person-specific identifier."

The two identifiers may be in the same location, such as a wristband. It is the person-specific information that is
the “identifier,” not the medium (source) on which that information resides. Electronic identification technology
coding, such as bar coding or RFID, that includes two or more person-specific identifiers (not room number) will
comply with this requirement.

Prior to providing care, treatment or services (see NPSG.01.01.01), compare the two patient identifiers against a
source document. Examples of source documents may include, but are not limited to: orders, medication
administration records, etc.

It is the responsibility of each organization to determine which patient identifiers are to be used prior to
administering care. While standardization of the identifiers used is beneficial, there are settings and situations
when variations may need to be employed. For example, in an outpatient setting where ID bands may not be
used as an information source, an infant or toddler, an unresponsive patient, etc. Again, the organization is
responsible for determining how accurate patient identification will be completed in these types of situations.
Surveyors determine compliance based on the organization's requirements.

Two Patient Identifiers - Written Orders/ Computerized Prescriber Orders

Does the two-identifier rule apply to writing orders for treatment? What about computerized prescriber
order entry (CPOE) systems?

Yes; the requirement for two identifiers applies to writing orders, including use of CPOE. A common "wrong
patient" error is the recording of orders in the wrong patient's record. In most cases, the error is recognized by
another caregiver; however, there are a significant number of such cases in which the error is not recognized and
the patient receives an inappropriate treatment. Similarly, "wrong patient orders" can be an unintended
consequence of using some CPOE systems that do not provide adequate safeguards including at least two
identifiers to assure correct patient identification before accepting orders (1).
1. Ross Koppel, PhD; Joshua P. Metlay, MD, PhD; Abigail Cohen, PhD; Brian Abaluck, BS; A. Russell Localio,
JD, MPH, MS; Stephen E. Kimmel, MD, MSCE; Brian L. Strom, MD, MPH. Role of Computerized Physician
Order Entry Systems in Facilitating Medication Errors. JAMA. 2005;293:1197-1203.

Universal Protocol - Pre procedure Verification

Patients involved in large surgeries such as open heart surgery are typically taken from their room
directly into the operative room for preparation and line insertion which require a significant amount of
time. The surgeon would leave after the verification and then return when the patient is prepared and
prior to anesthesia. Would it be acceptable to complete the pre-procedure verification process (see
UP.01.01.01) in the operating room rather than a pre-procedure holding area?

Yes, in cases where the patient is not held in a pre-procedure area for preparation, it would be acceptable to
complete the verifications and checklist in the operating room. Hospitals should identify the timing and location of
the preprocedure verification and site marking based on what works best for their own unique circumstances. The
frequency and scope of the pre-procedure verification process will depend on the type and complexity of the
procedure.

Keep in mind that the final time-out (see UP.01.03.01) must occur immediately prior to making the incision with
involvement of all immediate members of the procedure team. The final time-out participants MUST include, for
example, the individual performing the procedure, the anesthesia providers, the circulating nurse, the operating
room technician(s), and other active participants who will be participating in the procedure from the beginning.

The Universal Protocol is based on the following principles:

Wrong-person, wrong-site, and wrong-procedure surgery can and must be prevented.

A robust approach using multiple, complementary strategies is necessary to achieve the goal of always
conducting the correct procedure on the correct person, at the correct site.
Active involvement and use of effective methods to improve communication among all members of the
procedure team are important for success.
To the extent possible, the patient and, as needed, the family are involved in the process. Consistent
implementation of a standardized protocol is most effective in achieving safety.

Universal Protocol - Pre procedure Verification Checklist

Please explain what is meant by the requirement to ‘match the items that are to be available in the
procedure area to the patient’ found at UP.01.01.01 EP 3.

The requirements found at UP.01.01.01 define a series of progressive steps taken to reduce the risk of errors
associated with operative and invasive procedures.

EP 1 requires that a pre-procedure process is defined by the organization to verify the correct procedure, for the
correct patient, at the correct site. It is up to the organization to determine when this information is collected,
such as at the time of scheduling or pre-admission testing, and by which team member. Whenever possible,
consideration should be given to involving the patient in this process.

EP 2 requires a standardized pre-procedure verification list of items that, at a minimum, are - or may be required
- at the time of the operative or invasive procedure. Activities to address such items may start days – or perhaps
weeks – prior to the actual procedure. Such activities may include ordering medical devices, implants or special
equipment, ordering blood products, and/or obtaining copies of reports or radiographic images to ensure their
availability at the time of the procedure. Working from a standardized verification list reduces variability and thus
the potential for error. The location of the standardized list is determined by the organization. For example, in a
policy/procedure, a pre-procedure checklist that may become part of the patient medical record, etc.

EP 3 is the process of comparing information about the patient and procedure with the items identified in EP 2
that are required to proceed with the procedure. The final verification process generally occurs before the patient
leaves the pre-procedure area or enters the procedure room. Missing information, supplies or discrepancies are
addressed before starting the procedure.

Additional Information:
- The Joint Commission Tools and Resources: Universal Protocol
- Pre-procedure Verification FAQ
- Organizations accredited by The Joint Commission also have access to the Leading Practice Library (LPL) via
their secure Extranet site. The LPL contains examples of policies, procedures, checklists, etc., that organizations
may find helpful when developing their own requirements.

Performance Improvement (PI)

Topic

Data Collection - Discrepencies Between Pre-operative and Post-operative diagnoses

The requirement found at PI.01.01.01 EP 5 requires organizations to collect data on “All significant
discrepancies between preoperative and post-operative diagnoses, including pathologic diagnoses.”
Please provide examples of such data.

Although the accreditation manual does not provide a definition for the term “significant” as it relates to
PI.01.01.01 EP 5, providing the following examples may help clarify the expectations of this requirement:

Surgery scheduled for a cyst removal and post-operatively was determined to be a malignant tumor
Exploratory laparotomy performed with a diagnosis of "acute abdomen" - no pathology found, but the
patient was then diagnosed with C-Diff,
A patient scheduled for an appendectomy for "acute appendicitis" and the appendix was normal on
pathology exam; etc.

An organization's pathology services, medical staff and organizational leadership would determine additional
examples of such discrepancies to track. Consideration should be given to the scope of services provided and
patient population served by the organization.

Pain Management - Performance Improvement: Data Collection, Analysis and Implementing

Change - PI.01.01.01 EP 18

One of the new pain management standards requires organizations to analyze data collected on pain
assessment and pain management to identify areas that need change to increase safety and quality for
patients. Would the results of the Hospital Consumer Assessment of Healthcare Providers and Systems
(HCAHPS) used by CMS be sufficient to meet this requirement?

No, HCAHPS alone would not be sufficient to meet this requirement. The hospital and medical staff together
determine what quality metrics are collected, giving consideration to the patient population served and pain
management challenges that may be unique to each hospital. HCAHPS data is limited to patients discharged
from an inpatient encounter. Organizations should include data from outpatient programs involved in pain
management as well. Examples may include interventional pain management and chronic pain management
programs. Depending on the analysis of data, organizations may need to modify or add quality metrics in order to
keep them current as changes in patient demographics and/or services provided by the organization change.

Examples of data may include monitoring the duration and dose of opioid(s) being prescribed, use of Naloxone,
patterns and trends of opioid-induced respiratory depression, practitioner ordering practice patterns, etc. A
recommended article is Frederickson TW, et al. Reducing Adverse Drug Events elated to Opioids
Implementation Guide. Philadelphia: Society of Hospital Medicine, 2015.

Resources:
R3 Report: Pain assessment and management standards for hospitals
Joint Commission Statement on Pain Management
Sentinel Event Alert Issue 49: Safe use of opioids in hospitals

Provision of Care, Treatment, and Services (PC)

Topic

Emergency Cart - Medication Security

Please clarify the issue related to medication security on emergency carts. Is the use of a breakaway tag
that includes a numeric identification number and a defined process to monitor cart integrity considered
an acceptable approach to maintaining security of emergency carts strategically located and readily
available for use in emergent situations in patient care areas staffed 24/7.

The Joint Commission requires that medications are stored in a secure manner to prevent tampering, theft or
diversion in accordance with law and regulation. Considering the intended nature and use of emergency carts,
organizations must balance security with the requirement that emergency medications and their associated
supplies are readily available (see MM.03.01.03 EP 2) when needed.

While organizations are responsible for ensuring the security of the contents of an emergency cart, use of
devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and
supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11
EP 2). When security devices are used, the intent would be to use an appropriate device that allows the
organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency
supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is
acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.

It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various
options available for securing emergency cart contents. The results of the risk assessment will enable leaders to
make decisions and design processes that best serve the delivery of safe, quality emergency care while
maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication
located in departments that are not staffed 24/7 must be secured in a locked location.

Emergency Cart - Security

Is it acceptable to position emergency carts secured with a breakaway lock in strategic locations, such
as a trauma room in an emergency department or an alcove on a nursing unit or any area staffed 24/7
even though these carts may not be under constant visual surveillance by staff 100 % of the time ?

Since emergency departments and nursing units are staffed 24/7, yes, it would be acceptable to place
emergency carts in these locations as long as there was a defined process in place to monitor the integrity of the
breakaway lock and cart contents. Constant visual surveillance of emergency carts is not required when such
systems are in place. However, if there is evidence of tampering or diversion, or if medication security otherwise
becomes a problem, the hospital is expected to evaluate its current emergency cart security policies and
procedures, then implement the necessary systems and processes to ensure that the problem is corrected, and
that patient health and safety are maintained. NOTE: Emergency carts containing medication located in
departments that are not staffed 24/7 must be secured in a locked location.

Fall Reduction Program - Definition of a Fall (HAP/CAH)

Is there a standard definition of a patient/resident fall or does each organization need to define it?

No, the glossary of the accreditation manual does not provide an official definition of a 'fall'. For consideration, a
fall may be described as an unintentional change in position coming to rest on the ground, floor, or onto the next
lower surface (e.g. onto a bed, chair or bedside mat). The fall may be witnessed, reported by a patient, an
observer, or identified when the patient is found on the floor or ground. Falls include any fall whether it occurred
at home, out in the community, in an acute hospital, or ambulatory setting. Organizations are encouraged to
check with their state to determine if any law/regulation exists that formally define a 'fall' within the individual
state.

Additional Resources:
Zero falls ? It's Possible.
Sentinel Event Alert: Preventing Falls and Fall-related Injuries in Health Care Facilities
Targeted Solutions Tools for Preventing Falls

Fall Reduction Program - Resources

Where can I find additional information on how to design a fall reduction program? For example, what
are some of the risk factors we should be looking for? What are some steps that can be taken to reduce
falls/injuries?, etc.

Online and published resources include:

The Preventing Falls Targeted Solutions Tool® (TST®) is now available. The TST is an online resource that
provides a step-by-step process to assist Joint Commission accredited health care organizations in
 measuring performance, identifying barriers to excellent performance, and implementing the Center's
proven solutions that are customized to address specific barriers. TST® modules are also available for
improving hand hygiene, hand-off communications, and safe surgery. Accredited organizations can access
the TST® and solutions free of charge on their secure Joint Commission Connect extranet. Staff at Joint
Commission accredited organizations can request access via the website.
Zero falls ? It's Possible.
Sentinel Event Alert 55: Preventing falls and fall-related injuries in health care facilities.
The National Guideline Clearinghouse (enter "fall prevention" in the search field).
Guideline for the prevention of falls in older persons. American Geriatrics Society, British Geriatrics Society,
and American Academy of Orthopaedic Surgeons Panel on Falls Prevention. J Am Geriatr Soc. 2001
May;49(5):664-7.
AHRQ: Which fall prevention practices do you want to use?
AHRQ: How do you measure fall rates and fall prevention practices?
NCBI: Assessment and Management of Fall Risk in Primary Care Settings
NCBI: List of general resources

History and Physical - Authentication Time Frame

Do The Joint Commission standards require that a dictated and transcribed history and physical be
authenticated within 24 hours in order to be considered complete?

No. It is the responsibility of each organization to determine the time frame in which a dictated and
transcribed History and Physical must be authenticated. Determining the timeframe is based on applicable
state/federal regulatory requirements (CMS, etc.). The Joint Commission standards do not define this time
frame.

Each patient must have a history and physical performed and entered into the medical record within 24
hours AFTER inpatient admission (inpatient) or registration (outpatient) . This includes weekend and holidays.
. When there is a transcription delay, a handwritten note signed, dated and timed by the licensed independent
practitioner, should be entered into the medical record within 24 hours. The note should contain pertinent findings
and sufficient information that allows clinicians to manage the patient and guide the plan of care.

Accreditation requirements that apply to H & Ps and updates include:

Medical Staff (MS): MS.01.01.01 EP 16

Medical Staff (MS): MS.03.01.01 EP 6, 7, 10, 11
Provision of Care (PC): PC.01.02.03 EP 4
Record of Care (RC): RC.01.03.01 EP 4
Record of Care (RC): RC.02.01.03 EP 3

Organizations accredited by The Joint Commission have a manual that contains a copy of these requirements.

History and Physical - Content

What specific elements or content must be included in the history and physical?

It is the responsibility of the organized medical staff to determine the minimum required content of medical
histories and physical examinations. This requirement is found in the Medical Staff (MS) chapter of the
accreditation manual at MS.03.01.01 EP 6. The required content should be pertinent, relevant and include
sufficient information necessary to provide the care, treatment and services required to address the patient's
condition, planned care and assessed needs. The required content may vary by setting or level of care,
treatment, and services. Therefore, the specific content could be different based on populations, or setting of
care, treatment or services. The organized medical staff is also responsible for defining the scope of the medical
history and physical examination when required for non-inpatient services (see MS.03.01.01 EP 11).

The medical history and physical examination must be completed and documented by a physician, oro-
maxillofacial surgeon, or other qualified licensed individual in accordance with State law and hospital policy. The
glossary of the accreditation manual provides a formal definition for "physician".

Other qualified licensed individuals are those licensed practitioners who are authorized in accordance with their
State scope of practice laws or regulations to perform an H&P and who are also formally authorized by the
hospital to conduct an H&P. Other qualified licensed practitioners could include nurse practitioners and physician
assistants. The glossary of the accreditation manual provides a formal definition for "licensed independent
practitioner". More than one qualified practitioner can participate in performing, documenting, and authenticating
an H&P for a single patient. When performance, documentation, and authentication are split among qualified
practitioners, the practitioner who authenticates the H&P will be held responsible for its contents.

Joint Commission-accredited organizations have a copy of the accreditation manual that contains the standards
referenced above.
Additional, applicable accreditation requirements include:

Medical Staff (MS): MS.01.01.01 EP 16

Provision of Care (PC): PC.01.02.03 EP 4
Record of Care (RC): RC.01.03.01 EP 4
Record of Care (RC): RC.02.01.03 EP 3

History and Physical - Prenatal Record

Can the prenatal record be used as the history and physical for the obstetrical patient?

It is recognized that the prenatal patient is a special situation in that, in and of itself, the prenatal course of care is
a planned, systematic updating of the history and physical performed at the first visit and throughout the
pregnancy. As such, the entire prenatal record can be utilized as the history and physical, provided it is updated
to reflect the patient's condition upon admission.

History and Physical - Update Requirements

When is an update to a history and physical required?

When a history and physical (H & P) is completed within 30 days PRIOR TO inpa ent
admission or registra on of the pa ent, an update is required within 24 hours AFTER the
pa ent physically arrives for admission/registra on but prior to surgery or a procedure
requiring anesthesia services. For example, if an H & P was completed in a physician’s office
at 3:00 pm today for a procedure to be performed at 9:00 am tomorrow, an update would
be required AFTER the pa ent arrives for the procedure tomorrow morning but prior to the
9:00 am procedure me. The 24 hour me frame starts when the pa ent physically presents
for admission/registra on. NOTE: The term 'registra on' generally applies to pa ents
scheduled for same day or outpa ent procedures. Any H & P completed greater than 30
days prior to inpa ent admission or registra on cannot be updated and a new H & P must
be completed.
Accreditation requirements that apply to H & Ps and updates include:

Medical Staff (MS): MS.01.01.01 EP 16

Medical Staff (MS): MS. 03.01.01 EP 6, 7, 10, 11
Provision of Care (PC): PC.01.02.03 EP 4
Record of Care (RC): RC.01.03.01 EP 4
Record of Care (RC): RC.02.01.03 EP 3

History and Physical - Update Requirements When Procedures are Performed During Inpatient
Stay

What are the requirements for updating a history and physical when surgery or a procedure requiring
anesthesia services is performed at a later point during an admission?

If the history and physical (H & P) is completed as required (see PC.01.02.03 EP 4), then a
surgical procedure or other procedure requiring anesthesia services is to be completed at a
later point during the admission, an update to the H & P is not required as the daily progress
notes serve as the updates. The medical staff is responsible for determining who is
responsible for entering daily progress notes as well as the required contents of such notes.
To summarize, a properly executed history and physical is valid for the en re length of stay.
Any changes to the pa ent’s condi on would be documented in the daily progress notes. A
new H & P or update to the H & P is not required when the pa ent
remains con nuously hospitalized. If the pa ent has been discharged, then readmi ed, there
must be a valid history and physical (no greater than 30 days) and updated within 24 hours after re-
admission/registration but prior to a surgical procedure or other procedure requiring anesthesia.

Accreditation requirements that apply to H & Ps and updates include:

Medical Staff (MS): MS.01.01.01 EP 16

Medical Staff (MS): MS.03.01.01 EP 6, 7, 10, 11
Provision of Care (PC): PC.01.02.03 EP 4
Record of Care (RC): RC.01.03.01 EP 4
Record of Care (RC): RC.02.01.03 EP 3

Medical Record - Preferred Language

Are organizations required to use the term “preferred” language in order to comply with Standards
RC.02.01.01, EP 1 (medical record contains the patient’s communication needs, including preferred
language for discussing health care) and PC.02.01.21, EP 1 (identification of the patient’s
communication needs, including the patient’s preferred language for discussing health care)? My
organization is collecting the patient’s “primary” language – does this meet The Joint Commission’s
requirement for the collection of “preferred” language?

The intent of the Joint Commission requirement to collect the patient's preferred language is to record the
language the patient would like to use when discussing health care. The term "preferred" language is consistent
with the Centers for Medicare & Medicaid Services Meaningful Use criteria, the Office of Minority Health's
National Standards for Culturally and Linguistically Appropriate Services (CLAS), and the Institute of Medicine's
Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement report.

The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR)
and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR
as the language that a Limited English Proficient individual identifies as the language he or she uses to
communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language
and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language
the patient wants to use to communicate with his or her provider.*

Regardless of the term used by the organization, the goal is to identify the language needs of the patient to
determine whether an interpreter is required at the patient-level or whether language access services need to be
modified at the organization-level. If an organization collects "primary" language, and its policies and staff
describe that as the language the patient wants to use to communicate with his or her provider, the organization
would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an
alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR,
that would also be acceptable as long as the organization's policies and staff were able to describe the
information being collected as the patient's language for discussing health care.

*Of note, The Joint Commission's rationale behind collecting language data is to identify patients that may be
limited English proficient and need language access services, not necessarily to document the native or first
language of the patient. Although some organizations may choose to collect additional language data based on
their services and/or patient population, the intent of the Joint Commission requirement is to determine the
language the patient is comfortable using to communicate health care information, which may differ from the
patient's native language.

(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human
Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.

Additional Resources:
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care

Medical Record - Spiritual Assessment

Does the Joint Commission specify what needs to be included in a spiritual assessment?

No. Your organization would define the content and scope of spiritual and other assessments and the
qualifications of the individual(s) performing the assessment. Examples of elements that could be but are not
required in a spiritual assessment include the following questions directed to the patient or his/her family:

Who or what provides the patient with strength and hope?

Does the patient use prayer in their life?
How does the patient express their spirituality?
How would the patient describe their philosophy of life?
What type of spiritual/religious support does the patient desire?
What is the name of the patient's clergy, ministers, chaplains, pastor, rabbi?
What does suffering mean to the patient?
What does dying mean to the patient?
What are the patient's spiritual goals?
Is there a role of church/synagogue in the patient's life?
How does your faith help the patient cope with illness?
How does the patient keep going day after day?
What helps the patient get through this health care experience?
How has illness affected the patient and his/her family?

The requirements that address spiritual needs and practices are found in the accreditation manual. For example:

PC.02.02.13 addresses providing care, to the extent possible, that accommodates spiritual needs during
end-of-life care
RI.01.01.01 addresses patient's right to access religious and other spiritual services

Your organization's Accreditation Coordinator has access to the manual containing these requirements.

Medication Administration - Incorporating Patient Preference Into Medication Administration

Practices

Are there circumstances when a provider may write PRN medication orders that allow variation in
administration based on patient preference such as in the following examples ? Example 1: Orders are
written to administer ‘acetaminophen for mild pain’ and ‘hydromorphone for moderate pain’. However,
due to the side effects of hydromorphone, the patient requests to take the acetaminophen even though
pain was reported as ‘moderate’. Example 2: A post-partum patient has PRN pain medications written as
follows: morphine for severe pain, hydromorphone written for moderate pain and acetaminophen written
for mild pain. New moms who report moderate or severe pain may request to take the acetaminophen as
they do not want to take the other medications as they are breastfeeding.

The practice described may be acceptable as long as an organization has determined that:

1. That the medication order is written in a manner that supports deferring to patient preference when:
a. Requesting a lesser potent medication. (Potency should be established with an evidence based tool
i.e. morphine equivalents).
b. Requesting a lesser prescribed dose in a range order.
c. Requesting a less intrusive route of administration if both routes are prescribed by the provider.

2. The medication is administered in accordance with orders from the Licensed Independent Practitioner
(MM.05.01.07 EP 5).

3. The inclusion of patient preference into the medication order cannot subsequently create a therapeutic
duplication with other prescribed medications.

4. The organization’s medication management policy (see MM.04.01.01 EP 1) identifies this type of medication
order as deemed acceptable, and defines all required elements of such orders.

5. The use of a protocol is not required. However if an organization chooses to utilize a protocol, the review and
approval process must comply with the requirements found at MM.04.01.01 EP 15. The medical record must
contain evidence of an order to implement the protocol as well as the protocol itself.
6. That implementing such orders or protocols is not outside of the RN scope of practice as defined by state
law/regulation,

7. The medical record must accurately reflect that the lesser potent medication was administered based on
patient preference (RC.02.01.01 EP 2). It is NEVER acceptable to administer a medication of stronger potency
based on patient preference.

8. Each organization is responsible for determining how such orders are to be entered into the medical record.
However, the following is an example for consideration:
Acetaminophen 325 mg 2 tablets po every 4 hours prn mild pain.
Hydromorphone 2 mg 1 tablet po every 4 hours prn moderate pain. May administer less potent prescribed
medication based on patient request per the organization’s medication management policy
(MM.04.01.01).

The policy must be explicit in that such an order is ONLY for administration of a different (lesser) agent, not
changing the dosage ordered of the same medication. If the policy allows a lower dose of the same medication
than ordered, it would not be accepted as compliant.

Moderate Sedation - Medication

Does the Joint Commission define what medications are considered under the standards for moderate
or deep sedation? For example: Chloral hydrate for sedation of children, Brevitol, Propofol, Ketamine.

The Joint Commission standards do not identify specific medication. Rather, any medication which is used for the
purpose of inducing moderate sedation, or any medication, which when used results in a level of moderate
sedation would be subject to the standards for moderate or deep sedation.

Nursing Assessments - Licensed Practical Nurse

Can a Licensed Practical Nurse (LPN) perform assessments?

The hospital standards are specific to only a Registered Nurse (RN) performing the nursing assessment within 24
hours after admission. It may be possible for an LPN to collect the data and then have an RN review the data and
complete the assessment to determine the patient's needs and developing the plan of care.

An LPN may collect data if allowed by the nurse scope of practice act as defined by the state’s Nurse Practice
Act, however, the RN must complete the nursing assessment. Based on the Nurse Practice Act, it may be
possible for an LPN to perform partial or full assessment in only specific situations, such as personal care and
support services.

The Nurse Practice Act varies from one state to the next, therefore, organizations need to work with their nursing
leadership and legal counsel to determine the scope of practice as defined by state-specific law and regulation.
The Joint Commission does not define the scope of practice for any discipline.

Nutritional and Functional Screening - Requirement

When is it required to perform a nutritional, functional, and pain assessment or screen? Is this
required in the Emergency Room, Outpatient Settings and Hospital Owned or Sponsored Physician
Office Practices on ALL patients and at ALL encounters?

The standards for nutritional and functional screening clearly state that these are performed when warranted by
the patient's needs or condition. Your organization would define in writing the criteria that identify when these
screenings and more in-depth assessment are performed. When applicable for the patient's condition, these
screenings must be completed within 24 hours after inpatient admission.

It is not required that nutritional or functional screening are completed for all patients at all encounters if it has not
been defined by the organization's policy, a licensed independent practitioner with appropriate clinical privileges
has determined that it is not necessary in emergency situations, or it is not warranted by the patient's needs or
condition.

A comprehensive pain assessment would be conducted consistent with the scope of care, treatment and services
and the patient's condition. Nutritional, functional or pain screening may be performed at the first visit for primary
care, an ambulatory clinic or office practice. Thereafter, the screens and assessment would be needed only as
appropriate to the reason the patient is presenting for care or services.

Orders - Cancelling and Rewriting Orders Following a Procedure or Transition of Care

Is there a Joint Commission standard that requires all orders to be cancelled, then rewritten following a
procedure or when a patient is transferred from one level of care to another?

No, there is no specific accreditation requirement that states all orders must be canceled, then rewritten following
a procedure or when a patient is transferred from one level of care to the next. Such a requirement would be an
organizational decision, or unless specifically required by individual state law/regulation.
Organizations are expected to have a process in place to ensure that the orders used following a procedure or
transition of care are the most recent and reflect the current assessed needs of the patient. The requirement
found at PC.02.01.03 EP 7 requires that care, treatment, and services are provided using the most recent patient
order(s).

During transitions of care, there must be a process in place to ensure coordination of care among care providers
– also referred to as "hand off communication". The following requirements are found in the Provision of Care
(PC) chapter of the accreditation manual: PC.02.02.01 EP 1 states "The hospital has a process to receive or
share patient information when the patient is referred to other internal or external providers of care, treatment,
and services" and PC.02.02.01 EP 2 states "The hospital’s process for hand-off communication provides for the
opportunity for discussion between the giver and receiver of patient information. Note: Such information may
include the patient’s condition, care, treatment, medications, services, and any recent or anticipated changes to
any of these."

Conducting a risk assessment allows organizations to identify risk points associated with these processes, and to
ensure that such processes do not include any summary (blanket) orders for resuming medication (see
MM.04.01.01 EP 8). A proactive risk assessment (sometimes referred to as an FMEA) examines a process in
detail, including sequencing of events, actual and potential risks, and failure or points of vulnerability. Risk points
are then prioritized through a logical process, then process improvements - based on the actual or potential
impact (that is, criticality) on quality and safety – are implemented to reduce or eliminate risk. The introductory
section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an
organization may use. However, this specific approach is not mandated as there are other risk assessment tools
available that may better meet the needs of the organization.

Pain Management - Patient and Family Education - PC.01.02.07 EP 8

Who is responsible for educating the patient and family on discharge plans related to pain management?

It is the responsibility of each organization to determine who is qualified and responsible to educate the patient
and family at discharge regarding the pain management plan, side effects of treatment, impact on activities of
daily living, safe use, storage, and disposal of opioids when prescribed. PC.01.02.07 EP 8 requires written
documentation that the patient and family were educated on these requirements. Each organization determines
where this information will be documented in the medical record.

Resources:
R3 Report: Pain assessment and management standards for hospitals
Joint Commission Statement on Pain Management
Sentinel Event Alert Issue 49: Safe use of opioids in hospitals

Pain Management - Screening versus Assessment - PC.01.02.07 EP 1

What is the difference between “screening” vs “assessing” pain and what is the expectation?

A ‘screening’ is a process for evaluating the possible presence of a problem. An 'assessment' gathers more
detailed information through collection of data, observation, and physical examination. Assessments are
completed individuals deemed qualified through education, training, licensure, etc., to conduct such
evaluations. Pain assessment tools are generally evidence-based and often include, at a minimum, an evaluation
of pain intensity, location, quality, and associated symptoms. An accurate pain screening and assessment is the
foundation on which an individualized, effective pain management plan is developed.

For example, a pain 'screening' may be used to determine if the patient has pain or not. If the patient answers
“yes”, a comprehensive pain assessment would be indicated. If the patient answers “no” no further pain
assessment would be expected, unless required by organizational policy.
Organizations are responsible for ensuring that appropriate screening and assessment tools are readily available
and used appropriately. The tools required to adequately assess pain may differ depending on a patient’s age,
condition, and ability to understand and should be evidence-based. For example, adult intensive care unit (ICU)
patients who are unable to self-report and pediatric patients require the use of alternative assessment tools.
Hospitals are required to have defined criteria that they will use to screen, assess and reassess pain that are
consistent with the patient’s age, condition, and ability to understand. Organizations determine where this criteria
is located and any documentation requirements when such screenings or assessments are completed.

Resources:
R3 Report: Pain assessment and management standards for hospitals
Joint Commission Statement on Pain Management
Sentinel Event Alert Issue 49: Safe use of opioids in hospitals

Restraint and Seclusion - Enclosure Beds, Side Rails and Mitts

Is an enclosure bed, side rails, or hand mitts a restraint?

Enclosure Bed/Side Rails

The determination as to whether or not side rails would be considered a restraint is based on “intent.” Therefore:

if the intent of raising the side rails is to prevent a patient from voluntarily getting out of bed or attempting to
exit the bed, the side rails would be considered a restraint.
If the intent of raising the rails is to prevent the patient from inadvertently falling out of bed, then it is not
considered a restraint. Also, if a patient does not have the physical capacity to get out of bed regardless if
side rails are raised or not, then the use of side rails is not considered a restraint.

Use of an enclosure bed or net bed that preventions the patient from freely exiting the bed is considered a
restraint. An exception is the use of an enclosed crib for infants and/or toddlers.

Hand Mitts
Hand mitts would be considered a restraint if:
1) The mitts are pinned or otherwise attached to the bed/bedding or wrist restraints are used in conjunction,
and/or
2) The mitts are applied so tightly that the patient's hands or finger are immobilized, and/or
3) The mitts are so bulky that the patient's ability to use their hands is significantly reduced, and/or
4) The mitts cannot be easily removed intentionally by the patient in the same manner it was applied by staff
considering the patient's physical condition and ability to accomplish the objective.

If the mitts meet any of the above criteria, it would be considered a restraint.

Restraint and Seclusion - Telemedicine

Is the use of a telemedicine link allowed for use by the LIP who conducts the in-person evaluations of an
individual in restraint or seclusion?

No. A telemedicine link does not fulfill the in-person requirement for the evaluation by an LIP of the individual in
restraint or seclusion. The in-person evaluation must be in-person (face-to-face) and completed by a physician,
clinical psychologist, or other licensed independent practitioner responsible for the care of the patient. A trained
registered nurse or a physician assistant may conduct the in-person evaluation. This evaluation must be
completed within one hour of the initiation of restraint or seclusion used for the management of violent or self-
destructive behavior that jeopardizes the physical safety of the patient, staff, or others.

Restraint or Seclusion - Role of Medical Student

Can residents or house staff write orders and/or evaluate a patient for restraint or seclusion for
behavioral health reasons?

Joint Commission standards require that a licensed independent practitioner order restraint or seclusion when
applied for behavioral health reasons, and conduct a face-to-face evaluation of a patient in restraint or seclusion.
However, under the following four conditions a physician in a graduate medical education program (i.e.,
residency) may perform these activities. These activities, as all other patient care activities performed by the
participants in graduate medical education programs, are to be appropriately supervised. Four requirements must
be met for a resident to order restraint or seclusion for behavioral health reasons, or conduct the required face-to-
face evaluation of a patient in restraint or seclusion:
 State law permits residents to perform these two activities under the auspices of a graduate medical
education program.
The graduate medical education program has provided relevant education and training for the resident in
performing these two activities. [Graduate medical education programs accredited by the Accreditation
Council on Graduate Medical Education would be expected to be in compliance with this requirement; the
organization should be able to demonstrate compliance with any residency review committee citations
related to this requirement.]
In the judgment of the graduate medical education program, the resident is able to competently perform
these two activities.
The health care organization in which the resident provides patient care permits residents to perform these
two activities.

Sedation and Anesthesia - Pre-Induction Assessment - Documentation

Where must the findings be documented?

The organization is free to determine its documentation format, e.g., using a separate assessment document or
requiring the pre-induction assessment findings be the first entry on the procedure record.

Sedation and Anesthesia - Pre-Induction Assessment - Required Elements

What are the required elements of the assessment?

The standard does not specify the required elements or the assessment, rather it is the responsibility of the
organization as part of the assessment planning standard. Typically the assessment includes, vital signs, status
of the airway and response to any pre-procedure medications.

Sedation and Anesthesia - Rescue Requirements

Is the availability of an on demand "cardio-respiratory code team" acceptable in lieu of the person who is
permitted to administer moderate or deep sedation being able to perform the rescues required by the
sedation and anesthesia standards? .

No. These standards require that individuals who administer moderate or deep sedation must also be competent
to perform the rescues described in these standards. A "code team" would only be considered as an additional
resource.

Test Category - Monitoring Devices

Are the following devices considered laboratory tests - breathalyzers, continuous glucose monitoring
systems, pulse oximeters, and transcutaneous bilirubin meters?

These analyzers are approved by the FDA as monitoring devices and are not considered laboratory tests.
Therefore, they are not regulated by the Joint Commission's specific laboratory standards. As monitoring devices,
they should at a minimum be managed following manufacturer's guidelines. This includes performance of
calibration, controls, and maintenance, as applicable. Written policies and procedures should be readily available
to the staff using the equipment. In addition, staff should have evidence of training and competence, as required
by the HR standards.

Record of Care, Treatment, and Services (RC)

Topic

Authentication - Licensed Independent Practitioner Authority

Is it acceptable for one LIP to authenticate on behalf of another LIP?

Organizations would need to develop policies and procedures, consistent with law and regulation, which define
the circumstance and mechanisms under which one LIP could authenticate for another LIP. For example,
consistent with Joint Commission standards and CMS Conditions of Participation (CoP), it would be acceptable
for an organization to develop and implement a policy that allows a LIP to give a verbal order that has been
transcribed by a nurse or other authorized individual, and allows another LIP to implement and authenticate the
verbal order when the original LIP is unavailable. It would not be consistent with Joint Commission standards and
CMS Conditions of Participation (CoP) for an LIP to authenticate another LIP's transcribed progress note
because, he/she cannot authenticate that his/her colleague dictated a complete, accurate, and final progress
note.
History and Physical - Content

What specific elements or content must be included in the history and physical?

It is the responsibility of the organized medical staff to determine the minimum required content of medical
histories and physical examinations. This requirement is found in the Medical Staff (MS) chapter of the
accreditation manual at MS.03.01.01 EP 6. The required content should be pertinent, relevant and include
sufficient information necessary to provide the care, treatment and services required to address the patient's
condition, planned care and assessed needs. The required content may vary by setting or level of care,
treatment, and services. Therefore, the specific content could be different based on populations, or setting of
care, treatment or services. The organized medical staff is also responsible for defining the scope of the medical
history and physical examination when required for non-inpatient services (see MS.03.01.01 EP 11).

The medical history and physical examination must be completed and documented by a physician, oro-
maxillofacial surgeon, or other qualified licensed individual in accordance with State law and hospital policy. The
glossary of the accreditation manual provides a formal definition for "physician".

Other qualified licensed individuals are those licensed practitioners who are authorized in accordance with their
State scope of practice laws or regulations to perform an H&P and who are also formally authorized by the
hospital to conduct an H&P. Other qualified licensed practitioners could include nurse practitioners and physician
assistants. The glossary of the accreditation manual provides a formal definition for "licensed independent
practitioner". More than one qualified practitioner can participate in performing, documenting, and authenticating
an H&P for a single patient. When performance, documentation, and authentication are split among qualified
practitioners, the practitioner who authenticates the H&P will be held responsible for its contents.

Joint Commission-accredited organizations have a copy of the accreditation manual that contains the standards
referenced above.
Additional, applicable accreditation requirements include:

Medical Staff (MS): MS.01.01.01 EP 16

Provision of Care (PC): PC.01.02.03 EP 4
Record of Care (RC): RC.01.03.01 EP 4
Record of Care (RC): RC.02.01.03 EP 3

History and Physical - Dictated not Transcribed

Does a dictated history and physical examination that has not yet been transcribed and attached to the
medical record, meet the intent of the standards?

The answer is NO except in emergencies*. The intent of the standards related to Operative or Other High-Risk
Procedures and/or the Administration of Moderate or Deep Sedation foresees the continuous evaluation of the
patient's status throughout the peri-operative period. Standard RC.02.01.03 is specific in the requirement that the
patient's medical history and physical examination are recorded in the medical record before an operative or
other high-risk procedure is performed (EP 3). The mere existence of a dictated history and physical that has not
been transcribed and entered in the patient's medical record is not in compliance with the intent of the standards
as essential information needed to further assess and manage the patient is absent.
*In an emergency, when there is no time to record the complete history and physical examination, a progress or
admission note describing a brief history and appropriate physical findings and the preoperative diagnosis is
recorded in the medical record before surgery.

Medical Record - Authentication Date/Time

Must signatures and dates on documentation such as verbal orders, histories and physicals,
consultations, and discharged summaries, also include the time of the signature and dating?

If the required timeframe defined by the organization specifies a signature within a specified number of hours,
then the signature and date must include the time of the signature and dating to ensure compliance.

Medical Record - Authentication Time Frame

Do the standards specify the time frame for authentication of documentation?

The Joint Commission standards do not specify the time frame for authentication of documentation. The
organization is free to determine the time frame for completion of authentication. The timeframe must comply with
any applicable laws or regulations. If the organization is silent on the issue for specific types of documentation,
the time frame defaults to the time frame that the organization adheres to for completion of the medical record.
For example, RC.01.02.01 in the AMCAH, CAMH, CAMNCC, and CAMBHC while requiring the organization to
establish a time frame for completion of the medical record, specifically limits the time frame to no more than 30
days.
Medical Record - Laboratory Requirements

Our hospital information system captures data from our laboratory system and provides the results in
several other hardcopy and electronic formats accessed by our physicians, such as the physician portal,
flash reports, remote web access, etc. Do all these different reports need to conform to the standards
surveyed during the biennial laboratory survey?

In respect to laboratory electronic health records (EHR), the determination of whether a hospital information
system is considered an agent of the laboratory to deliver laboratory reports to the authorized user remains
unchallenged in practice. The Joint Commission's longstanding position is that the laboratory, an integrated and
essential service within a hospital, has an obligation to ensure the laboratory report, whether hardcopy or
electronic, appears in the organization's patient medical record in the intended format and with all required
elements. To ensure patient safety and correct interpretation by the end user, it is our further opinion that all
alternate distribution versions of the laboratory report (such as portals) derived from the data in the medical
record also appear to the end user in the intended format and with all required elements, even if these alternate
versions are not considered a part of the patient's permanent medical record.

Other supporting clinical applications in the patient record that may extract, manipulate and redisplay laboratory
results in other formats and that do not represent the official or an alternate distribution version of the laboratory
report in the record are not subject to the CLIA requirements. Examples include physician notes, wishbone
diagrams to support decision making, and nursing flow sheets, all of which may readily integrate laboratory report
data for various purposes and in which requiring the presence of all the CLIA required fields may be limiting to
innovation and functionality. As such, these supporting clinical applications are not required to contain all of the
required elements of the official or alternate distribution versions of the laboratory report. However, each
supporting clinical application should be assessed by the organization for inclusion of any and all fields necessary
to ensure clarity and proper interpretation by the end user. This assessment should include review by
representatives from both the laboratory and the intended end users. At a minimum, it is recommended that the
analyte' s name and units of measure always be included with the discrete laboratory result(s), either individually
or in title for aggregated data. The date and time of collection may also be necessary in a majority of uses. The
use of hyperlinks and hover capabilities to connect the extracted data to the original source laboratory report is
strongly encouraged. And lastly, healthcare professionals and software developers must consider the implications
associated with corrected laboratory reports and how to manage their effect on all supporting clinical applications
that rely upon the original and corrected laboratory results.

As the area of information technology is rapidly changing, please note that this interpretation could change in the
future based upon updated regulations, case examples, and other pertinent developments associated with the
implementation of the electronic medical record in a healthcare organization.

Medical Record - Patient Race and Ethnicity Data Collection

Are there specific categories for race and ethnicity that hospitals should use in order to comply with
Standard RC.02.01.01, EP 28 (The medical record contains the patient’s race and ethnicity)?

RC.02.01.01 (The medical record contains the patient's race and ethnicity) does not specify which categories of
race and ethnicity should be collected. The intent is to collect data in order to identify health care disparities, and
hospitals have the flexibility to determine which categories of race and ethnicity are appropriate to their patient
population.
While the Joint Commission standards do not specify categories for the collection of race and ethnicity data,
many state reporting entities and payors do specify these requirements. Organizations are encouraged to use the
race and ethnicity categories from the Office of Management and Budget (OMB) and US Census Bureau, and to
consult resources such as the Institute of Medicine report Race, Ethnicity, and Language Data: Standardization
for Health Care Quality Improvement (2) and the Health Research and Educational Trust Disparities Toolkit (3).

These resources recommend the collection of Hispanic ethnicity and the following race categories: Black or
African American, White, Asian, American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, and
Some other race. However, organizations also have the flexibility to collect granular ethnicity categories as
applicable to the population served. For example, if your organization has a large Asian population, you may
want to consider collecting additional ethnicity categories such as Chinese, Japanese, Filipino, etc. Race and
ethnicity data may be collected in either a 1- or 2-question format. While the preferred method of data collection
is to ask the Hispanic ethnicity question first, followed by the recommended race categories, it is acceptable to
combine Hispanic ethnicity and race into the same question.

Resources:
1. The Joint Commission: Advancing Effective Communication, Cultural Competence, and Patient- and Family-
Centered Care: A Roadmap for Hospitals. Oakbrook Terrace, IL: The Joint Commission, 2014

2. Ulmer C., McFadden B., Nerenz D.: Race, Ethnicity, and Language Data: Standardization for Health Care
Quality Improvement. Washington, DC: The National Academies Press, 2009. Available at
http://books.nap.edu/openbook.php?record_id=12696.

3. Hasnain-Wynia R., et al.: Health Research and Educational Trust Disparities Toolkit. Chicago, IL: Health
Research & Educational Trust, 2007. Available at http://www.hretdisparities.org.

Medical Record - Preferred Language

Are organizations required to use the term “preferred” language in order to comply with Standards
RC.02.01.01, EP 1 (medical record contains the patient’s communication needs, including preferred
language for discussing health care) and PC.02.01.21, EP 1 (identification of the patient’s
communication needs, including the patient’s preferred language for discussing health care)? My
organization is collecting the patient’s “primary” language – does this meet The Joint Commission’s
requirement for the collection of “preferred” language?

The intent of the Joint Commission requirement to collect the patient's preferred language is to record the
language the patient would like to use when discussing health care. The term "preferred" language is consistent
with the Centers for Medicare & Medicaid Services Meaningful Use criteria, the Office of Minority Health's
National Standards for Culturally and Linguistically Appropriate Services (CLAS), and the Institute of Medicine's
Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement report.

The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR)
and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR
as the language that a Limited English Proficient individual identifies as the language he or she uses to
communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language
and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language
the patient wants to use to communicate with his or her provider.*

Regardless of the term used by the organization, the goal is to identify the language needs of the patient to
determine whether an interpreter is required at the patient-level or whether language access services need to be
modified at the organization-level. If an organization collects "primary" language, and its policies and staff
describe that as the language the patient wants to use to communicate with his or her provider, the organization
would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an
alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR,
that would also be acceptable as long as the organization's policies and staff were able to describe the
information being collected as the patient's language for discussing health care.

*Of note, The Joint Commission's rationale behind collecting language data is to identify patients that may be
limited English proficient and need language access services, not necessarily to document the native or first
language of the patient. Although some organizations may choose to collect additional language data based on
their services and/or patient population, the intent of the Joint Commission requirement is to determine the
language the patient is comfortable using to communicate health care information, which may differ from the
patient's native language.

(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human
Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.

Additional Resources:
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care

Operative and High Risk Procedure Reports - Documenting Blood Loss and Specimens

The requirement found at RC.02.01.03 EP 6 lists the required elements that are to be included in the
operative or other high-risk procedure report. The word ‘any’ precedes both estimated blood loss (EBL)
and specimen(s) removed. Does this mean that even if there was no blood loss or specimen(s)
associated with a procedure that the practitioner must indicate ‘no EBL’ or ‘no specimens’ in the report?

No. If there was no blood loss and/or no specimens removed, there is no requirement for the proceduralist to
document those two items, unless the organization specifically requires this level of documentation. The word
“any” was specifically chosen to reflect the need to only document those items when applicable to the procedure
performed.

Organizations are encouraged to monitor compliance for completion of post-procedure notes based on
organizational requirements. For example, if there is no requirement to document 'no EBL' or 'no
specimens', individuals reviewing records for compliance should determine if the omission was appropriate
based on the procedure performed, or an oversight on the part of the practitioner.

Operative and High Risk Procedure Reports - Timeframe of Dictation or Written

In what timeframe must an operative or other high-risk procedure report be dictated and placed in the
medical record?
The report must be written or dictated immediately after an operative or other high risk procedure. An
organization's policy, based on state law, would define the timeframe for dictation and placement in the medical
record.

Most importantly, there needs to be sufficient information in the record immediately after surgery or other high risk
procedure to manage the patient throughout the post procedure period. This information could be entered as the
operative report or as a hand-written progress note. If the operative or procedural report is not placed in the
medical record immediately following the procedure, then a progress note must be immediately entered after the
procedure to provide pertinent information to the next provider of care.

'Immediately after surgery or procedure' is defined as "upon completion of procedure, before the patient is
transferred to the next level of care". This is to ensure that pertinent information is available to the next caregiver.
If the practitioner performing the operation or high-risk procedure accompanies the patient from the operating
room to the next unit or area of care, the report can be written or dictated in the new unit or area of care.

If the progress note option is used (see RC.02.01.03 EP 7), it must contain, at a minimum, comparable
operative/procedural report information. The minimum required elements include; the name of the primary
surgeon and assistants procedures performed and description of each procedure findings any estimated blood
loss, any specimens removed, and the post operative diagnosis.

Patient race and Ethnicity - Data Collection

Can the patient’s race and ethnicity data be collected in the same question?

Race and ethnicity data may be collected in either a 1- or 2-question format. Although The Joint Commission
does not specify which categories to use when collecting the patient's race and ethnicity information, the
monograph Advancing Effective Communication, Cultural Competence, and Patient- and Family-Centered Care:
A Roadmap for Hospitals (1) provides guidance to help hospitals collect these data elements (pages 36-37).
Hospitals are encouraged to use the race and ethnicity categories from the Office of Management and Budget
(OMB) and US Census Bureau, and to consult resources such as the Institute of Medicine report Race, Ethnicity,
and Language Data: Standardization for Health Care Quality Improvement (2) and the Health Research and
Educational Trust Disparities Toolkit (3). These resources recommend the collection of Hispanic ethnicity and the
following race categories: Black or African American, White, Asian, American Indian or Alaska Native, Native
Hawaiian or Other Pacific Islander, and Some other race. However, organizations also have the flexibility to
collect granular ethnicity categories as applicable to the population served. For example, if your organization has
a large Asian population, you may want to consider collecting additional ethnicity categories such as Chinese,
Japanese, Filipino, etc.

While the preferred method of data collection is to ask the Hispanic ethnicity question first, followed by the
recommended race categories, it is acceptable to combine Hispanic ethnicity and race into the same question.

Resources:
1. The Joint Commission: Advancing Effective Communication, Cultural Competence, and Patient- and Family-
Centered Care: A Roadmap for Hospitals. Oakbrook Terrace, IL: The Joint Commission, 2014
2. Ulmer C., McFadden B., Nerenz D.: Race, Ethnicity, and Language Data: Standardization for Health Care
Quality Improvement. Washington, DC: The National Academies Press, 2009. Available at
http://books.nap.edu/openbook.php?record_id=12696.
3. Hasnain-Wynia R., et al.: Health Research and Educational Trust Disparities Toolkit. Chicago, IL: Health
Research & Educational Trust, 2007. Available a http://www.hretdisparities.org.

Texting - Use of Secure Text Messaging for Patient Information

Can secure text messaging be used to communicate patient information ?

Yes. Healthcare providers may text patient information (except for patient care orders) as long as a secure text
messaging platform is used. Several text messaging platform specifications and recommendations for texting
policies and procedures are included in The Joint Commission’s May 2016 Perspectives article.

Key features of secure text messaging platforms include:

• Secure sign-on process
• Encrypted messaging
• Delivery and read receipts
• Date and time stamp
• Customized message retention time frames

Organizations are also advised to do the following:

• Develop an attestation documenting the capabilities of their secure text messaging platform
• Assess compliance with texting policies and procedures
• Develop a risk-management strategy and perform a risk assessment
• Conduct training for staff, licensed independent practitioners, and other practitioners on applicable
policies and procedures

Texting - Use of Secure Text Messaging for Patient Orders

Can secure text messaging be used to communicate patient care orders?

No. After extensive discussion weighing the pros and cons of using secure text messaging platforms to place
orders, The Joint Commission and the Centers for Medicare & Medicaid Services (CMS) concluded that the use
of secure text messaging for patient care orders is not permitted (see The Joint Commission’s December 2016
Perspectives article for additional information).

CMS reiterated their position on texting in a December 28, 2017, memorandum stating that CMS does not permit
the texting of orders by physicians or other health care providers, regardless of the platform used. This
information is available at the following website:
https://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-18-10.pdf

Rights and Responsibilities of the Individual (RI)

Topic

Confidentiality Agreement - Media

Standard RI.01.03.01, EP 3 states "Before engaging in the production of recordings, films, or other
images of patients, anyone who is not already bound by the hospital's confidentiality policy signs a
confidentiality statement to protect the patient's identity and confidential information. " Does this mean
that we need to have media sign a confidentiality agreement even if the patient has consented to be
filmed/recorded?

No. RI.01.03.01 EP 3 is only applicable in those circumstances in which filming/recording intended for external
use is being done without patient consent. In that situation, the party filming the images should sign a
confidentiality agreement indicating that they will not show the film/photos until consent is obtained from the
patient. If consent is not obtained, the identity of the patient will be masked or the film will be destroyed. If the
patient has specifically consented to being filmed/recorded prior to the commencement of filming, the media or
party doing the filming does not need to sign a separate confidentiality agreement.

Language Access Services - Bilingual Provider (physician, nurse, etc.) Serving as an Interpreter
for a Fellow Provider

If the bilingual provider (physician, nurse, etc.) serves as an interpreter for a fellow provider (i.e., the
patient and provider speak different languages and a bilingual provider is facilitating communication
between them), does the requirement found at HR.01.02.01 EP 1 apply?

Yes, since the bilingual provider is serving as an interpreter to bridge the communication between a fellow
provider and a patient, then the requirement at HR.01.01.01, EP 1 applies, and the organization is required to
have defined qualifications for individuals that provide interpreting services.

Additional Resources:
The Joint Commission’s Advancing Effective Communication, Cultural Competence, and Patient- and Family-
Centered Care: A Roadmap for Hospitals (see page 38).

Language Access Services - Practitioners Communicating Directly with Patients

Are there any Joint Commission standards that prohibit a bilingual practitioner (nurse, physician, etc)
from communicating directly with a patient in their preferred language while providing care without the
presence of an interpreter?

There are no standards that prohibit a bilingual practitioner from communicating directly with a patient in another
language while providing care, treatment or services. However, it is recommended that the organization has a
process to make sure that communication with the patient in the non-English language is effective and meets the
patient’s needs. For example, the organization can determine if a language proficiency assessment is necessary
to make sure the bilingual provider is able to communicate effectively or may consider using an interpreter to
validate the patient's understanding of the information provided by the bilingual provider and communicate further
information as needed.

Additional Resources:
The American Medical Association’s Promoting Appropriate Use of Physicians’ Non-English Language Skills in
Clinical Care: A White Paper of the Commission to End Health Care Disparities provides guidance for physicians
on the appropriate use of their non-English language skills when caring for patients with limited English
proficiency.
Medical Record - Spiritual Assessment

Does the Joint Commission specify what needs to be included in a spiritual assessment?

No. Your organization would define the content and scope of spiritual and other assessments and the
qualifications of the individual(s) performing the assessment. Examples of elements that could be but are not
required in a spiritual assessment include the following questions directed to the patient or his/her family:

Who or what provides the patient with strength and hope?

Does the patient use prayer in their life?
How does the patient express their spirituality?
How would the patient describe their philosophy of life?
What type of spiritual/religious support does the patient desire?
What is the name of the patient's clergy, ministers, chaplains, pastor, rabbi?
What does suffering mean to the patient?
What does dying mean to the patient?
What are the patient's spiritual goals?
Is there a role of church/synagogue in the patient's life?
How does your faith help the patient cope with illness?
How does the patient keep going day after day?
What helps the patient get through this health care experience?
How has illness affected the patient and his/her family?

The requirements that address spiritual needs and practices are found in the accreditation manual. For example:

PC.02.02.13 addresses providing care, to the extent possible, that accommodates spiritual needs during
end-of-life care
RI.01.01.01 addresses patient's right to access religious and other spiritual services

Your organization's Accreditation Coordinator has access to the manual containing these requirements.

Organ Donation - Patient Wishes

Are hospitals required to ask patients about their wishes concerning organ donation?

No. Hospitals and critical access hospitals are not required to ask patients about their organ donation wishes
unless it is required by law/regulation, organization policy/procedure or Organ Procurement Organization (OPO)
agreement. If organ donation is specified in the patient's advance directive or verbally expressed by the patient,
there should be documentation of the patient's wishes according to the organization's policy and procedure. The
organization must honor the patient's wishes within the limits of the law or hospital capacity. Some organizations
may not be capable of fully honoring the patient's wishes since they do not have the capability of sustaining life.
The patient may need to be transferred and this should be in accordance with law/regulation and any applicable
OPO agreement.

Videotaping or Filming - Consent Before Taping

Do hospital staff have to get a patient's consent to film or videotape their care while it is being provided?

If conscious, the patient should be able to provide or deny consent to be filmed or videotaped in advance.
However, in the emergency department situation, there may be times when it would be desirable to film, but it is
not feasible to obtain consent. In a situation where the patient is comatose or otherwise unable to provide
informed consent and no surrogate decision maker is available, the hospital may film or videotape patient care
activities. However the organization must have a written policy stating that informed consent is required before
the patient's film or videotape can be used for any purpose. In addition, anyone who films or videotapes must
sign an appropriate confidentiality commitment

Videotaping or Filming - Consent Not Provided

If informed consent has not yet been obtained, does the health care organization have to control or
sequester the film or videotape from being used for educational purposes until informed consent is
obtained?
Yes, the film or videotape must remain in the physical possession of the health care organization and not be
released to anyone else or used for educational or other purposes until appropriate informed consent is obtained.
This means anyone who is not an employee of the health care organization who performs filming or videotaping
cannot have the organization's film or tape or copy of the film or tape until consent is obtained.

Videotaping or Filming - Consent Not Provided by Patient's Portion

What happens if consent is not given to use an individual patient's portion of the film or videotape?

The expectation is that the health care organization retains control of the film or videotape until consent is
obtained. If consent is not given, then the patient is either removed from the film or videotape or the film or
videotape are destroyed.

Videotaping or Filming in the Emergency Room - Consent

Can staff of a health care organization film or videotape patient care activities in the Emergency
Department?

Yes. It is appropriate to film or videotape patient care activities in the emergency room, provided patients -- or
their family members or surrogate decision makers -- give informed consent. In a situation where the patient is
comatose or otherwise unable to give informed consent and no surrogate decision maker is available, the
hospital may film or videotape itself or retain another to film or videotape patient care activities within a policy
stating informed consent is required before that patient's film or videotape can be used for any purpose. Anyone
who films or videotapes must sign an appropriate confidentiality commitment.

Transplant Safety (TS)

Topic

Tissue - Adverse Reactions

What is The Joint Commission looking for in adverse tissue reaction policies?

Policies addressing the investigation of adverse tissue reactions should define two essential processes:

Reporting Potential Disease Transmission From the Donor Source Facility to the Patient:

The Joint Commission encourages facilities to develop reporting policies comparable to the "look back"
procedures required for investigation of potential disease transmission in blood products. For example,
this would include receipt of notification from the donor facility, determination of disposition, quarantine of
donations in inventory from the indicated source, disposal, and notification of the recipient(s). The policy
should specifically address HIV, HTLV-I/II, HBV and HCV, as well as other transmissible diseases, such
as bacteria or fungus. Policies should define the timeframe for notification, the number of attempts
required, and the notification procedure when the patient is deceased. References for policy development
include the Centers for Medicare and Medicaid Services Conditions of Participation for Hospitals [42 CFR
482.27(c)(4-8)] and the FDA's Guidance for Industry for blood establishments with regards to patient
notification for HIV and HCV, respectively.

Reporting Adverse Patient Reactions to the Donor Source Facility:

Similar to The Joint Commission requirements for suspected transfusion reactions, organizations need to
develop policies and procedures for suspected tissue reactions. The process should be detailed and
address criteria for identifying a suspected adverse tissue reaction, initial reporting internally, documented
investigation of the complication, and prompt reporting to the donor source facility. When developing their
process, organizations should keep in mind that symptoms of an adverse reaction could present as an
acute or chronic condition (ex. fever versus hepatitis). Other examples of adverse reactions or
complications could include, but are not limited to, infection (viral, bacterial, fungal), graft failure, or
immune response to the tissue. Organization's can work with their donor source facilities to establish their
reporting policies. Interested organizations may wish to review the FDA regulations for Current Good
Tissue Practice or participate inMedWatch, the FDA's reporting system for adverse events, product use
errors and product quality problems associated with medical products.

Tissue - Standards Applicability

What tissue products are surveyed under the standards in the Transplant Safety chapter?

The tissue standards apply to human and non-human cellular based products and any product classified as
tissue by state law, regulation or the FDA, even if it is acellular (containing no cells). Acellular dermal matrix,
bone putty, and cancellous chips are examples of acellular products classified by the FDA as tissues,
therefore, the tissue standards do apply based on FDA classification.
Products that are derived from human or non-human tissue and cellular materials, but rendered acellular at the
time of use for the patient, are not surveyed under the tissue standards. Albumin and gamma globulin are
examples of products derived from cellular products but rendered acellullar through the manufacturing
process. They are acellular at the time of patient use are not classified by the FDA as tissues, therefore, the
tissue standards do not apply. Please check the manufacturer's package insert for the product's composition. If
the FDA classification is not noted on the package insert, it may be necessary to research the product on the
FDA website to determine classification. A list of common tissue and cell products can also be found in the
Transplant Safety chapter of the accreditation manual on pages TS-7 and TS-8.

The tissue standards do not apply to products that do not meet the above description, including those that have
tissue-like names or are otherwise associated with tissue usage. Examples include medical devices (acellular),
medications, blood derivatives and combination products. These items may also require tracking to support
patient notification in the event of a recall or investigation for an unexpected adverse event. However, the Joint
Commission standards do not specify the same level of stringent documentation as is required for tracking tissue
products.

Tissue Implants - Traceability of Records

How do we determine if our record keeping permits traceability of implanted tissue?

The organization will need to be able to trace the chain of events or "audit trail" related to implanted tissue for
both reporting and investigational purposes. Records should permit bidirectional tracing of any tissue in order to:

Report potential disease transmission to the recipient when notified by the donor source facility
Report adverse patient reactions to the donor source facility
Investigate the chain of events, e.g. who handled the tissue, how it was transported, stored and processed,
dates and times of such activities.

An organization could become aware of the potential for an adverse event from either the donor facility or the
recipient. For example, the donor facility may notify the organization of a suspected infectious disease associated
with a particular tissue source. The organization would need to promptly identify and notify all recipients and
quarantine any implicated tissue not yet implanted. Alternatively, the patient's physician might notify the infection
control nurse of a post-op infection associated with the tissue implant. Procedures and records should allow the
organization to determine the tissue's unique identifier and enable reporting of the event to the source facility. In
addition, records should facilitate an investigation to determine if the post-op infection could be related to the
organization's storage or handling processes, e.g. use of sterile reconstitution supplies, OR procedures, storage
temperatures, expiration dates, etc.

Tissue Source Facilities - Licensing and Registration Verification

What is The Joint Commission looking for in regards to verification of registration and licensing of tissue
suppliers?

The source facility should be registered with the US Food and Drug Administration (FDA) and licensed by the
state, if the state in which the implanting organization resides requires licensure.

Annual registration is required by the FDA each December for all tissue suppliers who recover, screen, test,
process, label, package, or distribute tissues. Suppliers are expected to be compliant with the FDA regulations
that apply to their operations. Healthcare organizations that only receive and store tissues for implantation or
transplantation within their facility are not required to be registered with the FDA. Licensing is state dependent.
As of March 2007, five states require licensing, which include New York, Florida, California, Georgia, and
Maryland.

The Joint Commission standards can be met by requesting from the source facility copies of their current state
license (when applicable) and FDA registration and keeping them on file. For FDA registration, the supplier's
registration status may also be checked annually by using the FDA's online database.

Waived Testing (WT)

Topic

Glucose Testing - Patient/Resident/Client

If a patient/resident/client performs a glucose test on his/her own personal glucose meter, can the results
be used for treatment decisions?

Yes, if the medical staff/leaders are informed of such a process, understands the risks, and the process is
approved in written policy by the organization's leadership. Such a practice bears similarities to use of a
reference laboratory. When using a reference laboratory, organizations must verify that the laboratory is
compliant with applicable law and regulation. This is evidenced by having a current CLIA certificate and a
successful biennial inspection. When using a patient/resident/client's result from self-testing, the healthcare
provider does not have the same types of assurance provided by compliant reference laboratories, such as
adequate competency, successful quality control or proper equipment maintenance. The following processes are
not specific Joint Commission requirements and are only provided as examples of how organizations have dealt
with these concerns in practice. Verify competency by either confirming the patient/resident/client has been
previously trained or observing the patient/resident/client perform their first test. Require the
patient/resident/client to perform quality control, if available for the meter, each day results are used. Correlate
the patient/resident/client's first glucose result with testing by a main laboratory. Confirm all critical and nonlinear
instrument values with testing by the main laboratory.

Independent Practitioners -Waived Testing Competency

Are competency assessments required for licensed independent practitioners (LIP's) performing waived
testing?

When a licensed independent practitioner (LIP) performs waived testing that does not involve an instrument,
there is no Joint Commission requirement for documentation of competency when the test is a logical part of his
or her specialty and the organization has specifically privileged the provider to perform the test(s). Through the
medical staff credentialing process, individual practitioners may be privileged for those specific waived tests
appropriate** to their scope of practice and no further assessment of skills or documentation of competence is
required. At the discretion of the Director of Laboratory Services designated on the CLIA certificate or by
organizational policy, more stringent competency requirements may be implemented. When a licensed
independent practitioner (LIP) performs waived testing that involves an instrument, competence to perform
testing must be documented after training prior to performing patient tests and annually thereafter. Any two of the
following four procedures may be used for competence assessment:

Performance of a test on a blind specimen.

Periodic observation of routine work by the supervisor or qualified designee.
Monitoring of each user's quality control performance.
Use of a written test specific to the test assessed.

** The appropriateness of the waived tests to the scope of practice is determined through the mechanisms of the
credentialing process.

Laboratory Director Of Record - Definition

Please explain the title of 'Laboratory Director'.

Laboratory Director (LD) is the title afforded by regulation given to the individual whose name appears on the
laboratory service's CLIA certificate. This individual is the Laboratory Director of record for Centers for Medicare
and Medicaid Services (CMS) and Joint Commission purposes and they are responsible for all testing performed
by the laboratory service. For non-waived testing, this individual is typically a pathologist. Other physicians or
laboratory professionals may qualify if they have the prerequisite education and years of experience required by
the federal regulations†. For waived testing, there are no federally defined qualifications for the Laboratory
Director. In all cases, individual states may also have applicable regulations and licensure requirements for the
Laboratory Director.

For the purposes of accreditation and CLIA records, the title of Laboratory Director should not be confused with
the job description title of "Laboratory Director", sometimes given to an individual who provides administrative
oversight of the laboratory. This is often an experienced laboratory professional with a Bachelor's or Master's
degree. The Laboratory Director of record may delegate in writing a variety of oversight activities to the
administrative director, including technical responsibilities, in accordance with their qualifications and as permitted
by regulation.

Qualifications for the Laboratory Director of record for non-waived testing are described in the Clinical Laboratory
Improvement Amendments under Subpart M: "Personnel for Nonwaived Testing," 493.1351 - 493.1495.

Laboratory Test Complexity - Waived, Moderate and High

How can I verify the test complexity designation for a particular laboratory test?

Commercial test systems are evaluated by the Food and Drug Administration (FDA) and assigned one of the
three following complexity designations: Waived Moderate High Moderate and High complexity are often referred
to as "non-waived" testing. The complexity designation may be printed in the manufacturer's package insert. It
can also be searched online in the FDA's database:

Medical/Clinical Record - Reference Ranges

Do reference ranges have to be on the same page (printed or electronic) as the laboratory result?

No. While it is preferred to have the reference range documented on the same page and adjacent to the
laboratory result, the requirement is flexible enough to accommodate different information management systems
when it is impractical to do so. For both waived and non-waived testing, two criteria must be met when reference
ranges are not supplied on the same page along with the laboratory result: The reference range must be located
elsewhere within the permanent medical/clinical record. The result must have a notation directing the reader to
the location of the reference range(s) in the medical/clinical record.

Proficiency Testing - Requirement

Is proficiency testing required for waived tests?

The Joint Commission standards do not require participation in proficiency testing for those test systems
classified by the FDA as waived complexity. Some organizations may voluntarily participate in proficiency testing
as good practice or use proficiency testing as part of their competency assessment program. The Joint
Commission will survey each organization according to its own policies relative to proficiency testing for waived
testing.

Provider Performed Microscopy Procedures (PPMP) - Resources

Where can I find further information on PPMP testing?

Joint Commission requirements for Provider Performed Microscopy Procedures (PPMP) are located in the
laboratory program manual*. PPMP is specified in the federal regulations as a subset of moderately complex
tests. On-site review by an accrediting agency is not federally required, however, Joint Commission laboratory
surveyors will review a sampling of these services. Federal requirements for PPMP testing may be found in the
Clinical Laboratory Improvement Amendments (CLIA), which are located in the Code of Federal Regulations at
42CFR493.
*Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

Qualifications - Color-blind Testing

Is employee color-blind testing required?

The Joint Commission standards do not specifically require either visual acuity or color-blind testing for
employees. The HR standards require assessment of the employees' abilities to fulfill the expectations of their job
descriptions. Color-blind testing may be utilized as part of an organization's initial or ongoing competency
assessment program, but other mechanisms that evaluate an individual's ability to interpret colorimetric
determinations would also be acceptable.

Refrigerator Storage - Reagents, Medications, Specimens

Can laboratory reagents be stored in a refrigerator that also contains medications or laboratory
specimens?

Yes. Laboratory reagents may be stored in the same refrigerator as medications or laboratory specimens. In both
cases, there should be distinctly marked and separated areas in the refrigerator to minimize any risk of
contamination from spills. Sealed containers may be used as a further measure to prevent contamination.
Preferably, medications should be stored on upper shelves and laboratory reagents on lower shelves.
Conversely, laboratory reagents should be stored on upper shelves with laboratory specimens on lower shelves.
Temperature monitoring and security requirements may be different for medications and laboratory reagents. The
organization should follow the more stringent policy when these are stored together.

Testing - Rapid Group Strep A Strep Culture Follow-up

Is it required to perform culture follow-up on all negative rapid Group A Strep screens?

The manufacturer's package insert recommends that all negative rapid Group A Strep screens be followed-up
with a culture. The Joint Commission surveys compliance with following these manufacturer instructions. Thus,
culture follow-up should be performed unless the laboratory has performed a study that justifies discontinuing
such testing.

An acceptable study consists of age-specific (adults vs. children) parallel testing that demonstrates acceptable
correlation of results from rapid testing against cultures for the laboratory's setting. The study may be simple (20 -
100 samples) and rely upon existing data. Correlations tend to be better for the adult population as compared to
children as specimens are easier to collect and they have a higher colonization rate. Specimens from children
have a higher potential for a false negative rapid test (low colonization, difficult collection) and a higher risk of
further disease (such as rheumatic or scarlet fever), thus culture follow-up is recommended for this population.

This approach is consistent with the American Pediatric Association Guidelines (Pediatric Redbook 2002), the
IDSA Guidelines for Dx and Management of GAS and current recommendations for acute pharyngitis from the
Centers for Disease Control:

Adults: http://www.cdc.gov/getsmart/campaign-materials/info-sheets/adult-acute-pharyngitis.pdf
Pediatrics:http://www.cdc.gov/getsmart/campaign-materials/info-sheets/child-pharyngitis.pdf

A laboratory will be considered compliant if an age based study was performed and the laboratory director and
physicians have considered these guidelines in developing the approved laboratory policy.

Tests - Professional or Home Use (Glucose Meters, Etc.)

How do we know if a particular waived test or instrument, such as a glucose meter, is approved for
professional use?

Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or
both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint
Commission accredited organization.

To determine if a test is approved for professional use, the information can sometimes be found in the
manufacturer's package insert or by calling the manufacturer directly. You may also check the 510(k) summary
that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically
through the following website: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/

Follow the following steps to determine if the test is intended for professional use:

1. Enter the name of the device in the search field.

2. Locate the device in the list produced by the search.
3. Click on the "Summary" for the device to open the 510(k) document.
4. Read the 510(k) summary, particularly the section titled "Intended Use".
5. If there is language indicating the instrument may be used in professional settings or by healthcare
professionals, it meets the standards requirement.

Urine Drug Testing - Behavioral Health Care Facility

What does Joint Commission require if urine drug screens are performed in a behavioral health care
facility?

All organizations that perform urine drug testing must obtain the federally required CLIA* license and abide by
applicable Joint Commission standards. This is required even if the organization uses the test as a screen and
then refers the sample to another laboratory for confirmatory testing. To determine which CLIA license is
appropriate, it is first necessary to know the test complexity assigned by the FDA for the test system being used,
which may be either waived**, moderate, or high, based upon several factors. The test complexity may be
obtained by contacting the manufacturer or locating the information in the package insert. It may also be
searched at the following FDA web database.

The level of complexity then determines which CLIA license is required and the subsequent criteria which apply
for various aspects of testing, such as inspection, personnel qualifications, and quality control. These
requirements apply both to organizations that choose to provide the testing and to those organizations that are
required to provide the testing by law and regulation. For clarity, the Joint Commission standards do not require
organizations to perform urine drug testing.

For a urine drug test classified as waived, the following applies:

The organization must have a current Certificate of Waiver (COW) obtained from their state CLIA office.
The testing is surveyed under the waived testing standards in the PC chapter (PC.16.10 to PC.16.60) of the
Comprehensive Accreditation Manual for Behavioral Health Care (CAMBHC).
The testing is reviewed during the organization's routine triennial survey.

For moderately complex urine drug testing, the requirements are different:

The organization must have a current license for moderate complexity testing obtained from their state
CLIA office.
The CLIA license must have the following specialty/subspecialty listing: Chemistry/Toxicology.
 The testing is surveyed under the standards in the Comprehensive Accreditation Manual for Laboratories
and Point-of-Care Testing (CAMLAB), which are more stringent than the waived testing standards.
The testing is reviewed during a biennial survey, which is separate from the organizational triennial survey.

For moderately complex testing, organization's must fill out a separate application to request a biennial laboratory
survey. Alternatively, an allowance from this requirement may be granted on a case by case basis under Joint
Commission's "One Test Rule". An organization may formally request an exemption from the Joint Commission
laboratory survey if it is performing only one moderately complex laboratory test and the organization can provide
evidence of a state CLIA inspection every two years.

*Clinical Laboratory Improvement Act, a section of the federal Center for Medicare & Medicaid Services (CMS)
regulations
**Note: A test designated as CLIA waived does not mean it is CLIA exempt.

Waived Test - Screening or Definitive

How is it determined if a waived test is screening or definitive?

Within an organization, waived testing must be defined as either screening or definitive. The intention of the
requirement is for the organization to promote a uniform standard of care and set expectations as to when
confirmatory testing should be performed. A test is considered definitive when the organization determines that a
clinical treatment decision or diagnosis may be made based upon the result. An example of a definitive test result
would be blood sugar results determined to be reliable and accurate. Although a test may be considered
definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment.
Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may
be within the linear (i.e. reportable) range of the glucose analyzer. A test is considered screening when an
organization determines that additional information from testing or other procedures would be required to make a
treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A
Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics. When a
test is considered screening, the organization's policies should state that additional information must be obtained
through further testing or other procedures before any treatment or diagnostic decisions are made. For the
purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure,
if it is required.

Waived Testing -Laboratory Director Qualifications

What are the suggested minimum qualifications for the Laboratory Director on a CLIA Certificate of
Waiver?

For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical
Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and
experience required to oversee the specific laboratory testing performed. The Joint Commission further
recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA
regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have
applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is
legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory
Director should seek professional advice regarding the necessity of additional professional liability insurance.

Waived Testing- Screening or Definitive

How is it determined if a waived test is screening or definitive?

Within an organization, waived testing must be defined as either screening or definitive. The intention of the
requirement is for the organization to promote a uniform standard of care and set expectations as to when
confirmatory testing should be performed.

A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis
may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding
scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude
performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be
ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e.
reportable) range of the glucose analyzer.

A test is considered screening when an organization determines that additional information from testing or other
procedures would be required to make a treatment decision or diagnosis. An example of this would be a
physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining
whether or not to administer antibiotics.

When a test is considered screening, the organization's policies should state that additional information must be
obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For
the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written
procedure, if it is required.
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