CHAPTER 1 REVIEWER

(ROLES AND RESPONSIBILITIES)

To be effective CSSD tech, ones must understand his ROLES AND

RESPONSIBILITIES to be competent in performing SPD Functions.
-working in SPD on must take on multi-dimensional task and responsibilities that
require knowledge skills and understanding of the following:
- Decontamination, packaging and holding of sterile products;
- Processing and reprocessing of re-usable products or medical devices;
- Cleaning, testing, assembly and distribution of movable patient care equipment;
- Facility’s purchasing procedures and;
- Storage, handling and distribution of movable (patient products) as well as
inventory control and cost recovery systems.
Nature of work in STERILE PROCESSING DEPARTMENT means PATIENT AND
PERSONNEL SAFETY IS PARAMOUNT!!!

Roles of CSSD Technician

 Receives soiled items
 Decontaminates
 Cleans
 Disinfects
 Sterilize
 Assembles
Function of CSSD Technician
 To provide dependable and reliable services to enhance patient care.

ACRONYMS
3 Regulating Agencies that related to CSSD Tech
 EPA- Environmental Protection Agency
 FDA- Food and Drug Administration
 OSHA- Occupational Safety Health Administration
PROFESSIONAL ORGANIZATIONS
AAMI- Association for the Advancement of Medical Instrumentation
APIC- Association for Professionals in Infection Control and Epidermiology
IAHCSMM- International Association Healthcare Center Service Materiel Management
AORN- Association of perioperative Registered Nurses
SGNA- Society of Gastroenterology Nurses and Associates

SPD Certification/ Training Orgganizations

CBSPD- Certification Board for Sterile Processing and Distribution
 CSPDT – Certified Sterile Processing and Distribution Technician
IAHCSMM- International Association of Health Center Service Materiel Management
 CRST – Certified Registered Central Service Technician
ACCREDITING AGENCIES
JC- The Joint Commission
JCAHO – Joint Commission on Accreditation of Healthcare Organizations
HFAP- Healthcare Facilities Accreditation Program
AAASF- American Association Accreditation of Ambulance Surgery Facilities

IFU- Instruction For Use

HCS- Hazard Communication Standard
GHS- Globally Harmonized System of Classification and Labelling of Chemicals
SDS- Safety Data Sheets
MDR- Medical Device Reporting Regulation
PPE- Personnel Protective Equipment
SPD AREAS
Decontamination Area (Dirty Area)
Where soiled items are received and cleaned
Types of items transportation
Dedicated elevator (Clean items) Dumbwaiter (Dirty Items)
Sterilization Area
Where microorganisms sterilization is performed, sometimes different
rooms are required depending on the type of sterilization process (EO/steam).
High-level Disinfection Area
Where cleaned items are highly level disinfected and then passed to prep and
pack area.
Preparation and Packaging Area
Where cleaned items are inspected, assembled and packaged. (clean work
room)
Sterile Storage Area
Where sterile items are stored until needed.
Sterile Stores
Where items for patient care outside manufacturers are stored. Could be
separate in some area in sterile storage depending on the facility AKA “Medical
Supply Distribution”
Case Cart Area
Where sterile supplies (case/or sterile items from outside manufacturer) are
kept and picked for surgical cases.
Dispatch
Where sterile and clean are dispensed
Loaner Area
For the receipt and return of instruments borrowed for specialty procedures.
Patient Care Equipment Clean-Up Area
Where patient care equipment is cleaned and disinfected. A separated area
for storage of clean and disinfected area.

ABULATORY SURGERY FACILITY

The set-up is similar to but smaller than a hospital settings. Ambulatory
surgery centers (ASC) also known as outpatient surgery centers same day surgery
centers are healthcare facilities where surgical procedures requiring an overnight
hospital stay perform, such as surgery is commonly less complicated than requiring
an hospitalization.

Basic Concepts, Affecting the work in SPD- Work Flow, People Flow and
Traffic Control
Work Flow
-How the work progresses through the departments. It begins to
decontamination are soiled then progresses to the prep and pack.
FROM DIRTY TO CLEAN

Decontamination Tray Assembly Sterilization

Operating Room Store Room

People Flow
-How people move through the department. It begins in the clean areas, sterile
storage, sterilization and complete his/her tour in the decontamination areas (soiled).
FROM CLEAN TO DIRTY
Traffic Control
Controlling access to SPD, Traffic is restricted to departamental employees and
authorized personnel only, such as service representatives. Everyone must abide by the
 required dress code for the department and a supply of cover garments, head covers and
shoe covers is available for visitors.
ORGANIZATIONAL CHART
-The facility/ departamental organizational chart details the reporting and
accountability mechanisms for the titles within the department/administration.
SAMPLE OF OC

Chief Operating Officer

VP Nursing

Sterile Processing Manager

SPD Lead Technician SPD Processing Tech

SPD Inventory Tech

SPD Case Cart Tech

ETHICS
The discipline dealing with what is good and bad with moral duty and Obligation.
Ethical Actions
Are those that conform to accepted and professional standards of conduct
Morals
Deal with or relate to principles of right and wrong behavior (a set of moral
principles or values)
Unethical Professional Conduct
The failure to conform to moral standards or policies.
Professional Ethics
Principles of conduct governing an individual or group.
Ethical Issues or Work Ethics
Work Ethics
 Patient Confidentiality
Hospital Property
Sales Representative
Employees Safety
Employees Behavior
If you have knowledge about these things. Ethically, the right thing to do is to REPORT
IT!!!
REGULATIONS, STANDARDS and RECOMMENDED PRACTICES
Regulation
Is a principle rule or law designed to control or govern behavior. Compliance
with a regulation is MANDATORY!!!
Standard
Established norm determined by opinion, authority, research and other theory. not
legally required, but are recognized as good practice
Recommended Practices
Statements of sound principles of practice that are based upon scientific data and
opinions of experts, not legally required but reflect accepted practices.
DISASTERS
The Joint Commission requires that facilities to be prepared for injuries.
SPD plays important role in providing equipment needed in case of emergencies
1. Personnel must be aware of the locations of the disaster—related supplies
2. Actual Plan initation
3. Triaging are (isolate patient depending on how severe their case)
4. Anticipate the needs
TYPES OF DISASTERS
Internal (Fire, Water, Sewage)
External (Earthquakes, Tornadoes, Train Wrecks)
EPA- registers and regulates environmental disinfectants and peticides
Control emissions into the water and air (clean air act) (clean water act) (outside HC
facility)
EPA regulates the manufacture and sale of EO Gas (ethylene Oxide)
EO Gas (the only sterilant that directly regulated by EPA
FDA- to promote and protect public’s health by helping safe and effective products reach
the market in a timely way, also monitor the product for continued safety after they are in
use, and to help the public to get accurate science-based info needed to improve health.
Regulates ALL MEDICAL DEVICES as well as the manufacturing. Reprocessing of
Single- use Devices by healthcare facilities and 3rd party reprocessors.
Sterilization monitoring devices such as…
 Chemical Indicators (CI’s)
 Biological Indicators (Bi’s)
 Liquid Chemical Sterilants (LCS’s)
 Chemical High-level disinfectants (HLD’s) MUST BE MONITORED AND
CLEARED BY FDA
FDA does not regulate…
MDR report by healthcare facilities and manufacturers
 The reprocessing of opened but unused devices, peacemakers or hemodializers
and others
FDA do monitor and regulate ALL NEW MEDICAL DEVICES such as peacemakers
and hemodializers.
FDA requires medical device manufacturers provide healthcare facilities with specific
instructions on how to clean and sterilize those products. Information kept in (2)
separate binders for Decontamination Area and in Prep &Pack/Sterilization Area.
The information should be requested from manufacturer everytime devices is ordered or
purchased.
IFU= INSTRUCTION FOR USE
Devices manufacturers IFU’s must be followed exactly as written. Non-compliance
can…
 Create concern for patient safety
  Could compromise standard of care
 And create issues for the healthcare facilities
Must have 2 binders for IFU !!!
IFU- Obtained prior to purchase of device to verify the availability of processing
before it is in hand. Attained EVERYTIME a device is purchased.
MEDICAL DEVICE REPORTING (MDR)
Requires medical manufacturers and distributors to report;
 Serious device malfunction to the FDA
 Serious injuries and;
 Patient deaths
SEMI ANUALLY REPORTS must be submitted to FDA by healthcare facilities.
FDA- proposed a regulation that would prohibit the marketing of powdered surgeon’s
gloves, powdered patient examination gloves and absorbable.
OSHA- regulates occupational exposure to:
 Airborne Contaminants
 Blood-Borne Contaminants
 Communication of Workplace Hazards
Standards must be communicated to employees on their 1st day of work in the
department and copies must be made available for them. Retraining of standards to
employees are done annually and documented.
Establishes occupational exposure limits from sterilants and HLD’s such as;
 Ethylene Oxide
 Formaldehyde
Establishes Air Contaminants standards that covers HLD’s and Sterilants such as; (PEL)
 Glutaraldehyde
 Hydrogen Peroxide
 Ozone
STANDARD PRECAUTION!!!
-means to “TREAT EVERYTHING AS IF WERE INFECTIOUS” use of PPE is
required by OSHA. IT IS NOT AN OPTION!!!
(Decontamination AREA: All PPE’s must be laundered by facility thru OSHA)
OSHA requires personnel to wear appropriate PPE and engineering controls,
(Splash guards) when pouring out blood/ body fluids.

“SHARPS Container”- used to hold anything that can cut you. ( Sponge stick or
Forceps)
Containers- potentially infectious items, must be:
 Leak proof
 Puncture proof
 Rigid
 Covered
 Labeled
 Color red
LATEX ALLERGY
-It is reaction to certain proteins on later rubber. Involves skin redness, rash hives or
itching up to runny nose, sneezing, asthma, difficulty breathing and shock.
Irritant Contact Dermatitis- dry, itchy, irritated areas.

HAZARD COMMUNICATION STANDARDS

Requires facilities to obtain and make available to employees and SDS for each chemical
used in the workplace. ANNUAL REVIEW and updates of safety information also
known as your “RIGHT TO KNOW” STANDARD
Globally Harmonized Standard of Classification and Labelling of Chemicals
Standard format to follow. Also known as your “RIGHT TO UNDERSTAND”
STANDARD
NFPA (FIRE)
 BLUE- health hazard
 RED- Flammability
 YELLOW-Instability
 WHITE- Special Hazard Information
BLOOD BORNE PATHOGENS
(3) most common great concern to any healthcare worker
 HBV- Hepatitis B
 HCV- Hepatitis C
 HIV- Human Immunodeficiency Virus
EMERGENCY EYEWASH STANDARDS
-ability to flush both eyes at the same time.
-temperature of water [60’F- 100’F (15.5’C-37.7’C)] to prevent eyes from burning.
-tested regularly and document proper operation (weekly)- follow unit manufacturer
instruction
-Path of travel must be free from obstruction(no doors)
-drench water or water bottles are not allowed. Location must be on the same level as
chemicals.

STATE AND LOCAL AGENCIES

-In addition to federal regulations there may be state and local regulations as well
The stricter the regulation takes precedence.
CENTERS FOR DISEASES CONTROL AND PREVENTION (CDC)
Is a government agency, however not a regulatory agency but publishes
recommendations and guidelines such as;
 Hand Hygeine
 Isolation precautions
 Environmental Infection Control
 Disinfection and Sterilization
 Cough etiquette
HICPAC- Healthcare Infection Control Practices Advisory Committee
 Is a federal advisory committee made up of 14 external infection control,
strategies for infection surveillance, and the prevention and control.
HAI’s – Healthcare Associated Infections
-Issues recommendations, in the form of guidelines, resolutions, and information
communication, for preventing and controlling HAI’s
SPAULDING’S CLASSIFICATION OF MEDICAL DEVICES
CRITICAL
-Devices used and exposed to normally sterile areas of the body (inner part of the body)
SEMI CRITICAL
-devices that come in contact with intact mucous membranes during use. Either sterilized
or high level disinfected.
NON-CRITICAL
-devices only touch skin or contact with persons indirectly.
-Clean and disinfected with an intermediate-level disinfectant,sanitized with low level
disinfectant (soap and water only)
The Joint Commission (STANDARDS)
-Establishes accrediting standards and conducts on-site inspections to evaluate a
healthcare performance using “TRACER METHODOLOGY”
-Surveyors visit any and all department that have 1.direct 2. Indirect responsibilities for
patient care
-Training should be standardized to ensure all staff are safe and learning the same
information in the same manner
- Extend accreditation to receive payments from insurance companies such as Medicare
and Mediaid.
CMS- CENTER FOR MEDICARE AND MEDIAIDS SERVICES
-a facility could invariably close down indirectly
-Accreditation is valid for 3years
-Annual competency testing is required
-JC surveyors are trained to follow ANSI/AMMI standards
-cleaning,disinfection and sterilization processes
-Surveyors are also trained to ask healthcare workers…
-departamental workers
-departamental policies and procedures
-request for documentation
AAMI- ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL
INSTRUMENTATION
=Compliance is not legally required, however it develops concensus staandards for;
 Decontamination
 Disinfection
 Steam sterilization
 EO Disinfection
 Chemical Disinfection
 And other types of processing that are recognized as best practice withing SPD
-Also sets standards for sterilization equipment and products BI’s and CI’s
-AAMI standards are not law but recognized as best practice.
FACILITY AND DEPARTAMENTAL POLICIES AND PROCEDURES
POLICIES
Defined as “what one must do”. It is suggested that cleaning, disinfecting and
sterilization policies and procedures be standardized for all the systems facilities
PROCEDURES
-Defined as the steps that must be followed in the policy. (STEPS TAKEN)
POLICY AND PROCEDURE Manual
-are approved and reviewed by the infection prevention and control committee (CDC)
vary per institution and regularly update as specified by the facility and or the state
regulations (every 3 years)
It must include the following but not limited to:
1. Transport of soiled instruments
2. Dress Code
3. Decontamination
4. High Level Disinfection
5. Sterilization (all methods used)
 6. Packaging materials and methods
7. Processing of Patient Care Equipment and loaner instruments
8. Manufacturer’s IFU
9. Sterile Storage
10. Transport of clean/sterile items
REMINDER: Failure to comply could result to low quality of patient care.
Food and drinks are prohibited in any areas of SPD (Could contaminate clean and
sterile supplies/cups with cover are also not allowed. Food containing sweeteners
could attract bugs and vermin) STAFF BREAKROOM is the ONLY area where
food and drinks are allowed
Loaner Policy are strictly implemented.
LOANER INSTRUMENTS
-are instruments the facility did not purchased. They are most often are used for
specialty type surgery. Sterile Processing and Operating Room personnel in
collaboration with the vendors must work together to see that this inventory is
managed correctly to prevent costly delays in the OR ans so as to not impact on
patient safety. Loaners can be from another hospital.
Personnel’s Safety
-all facilities must make every effort to provide a safe and healthy workplace through
programs designed to reduce risks of injury and illness.
 Team effort
 Do your part
Many chemicals used in SPD can be Toxic
Most common injury in SPD;
Back injury (due to heavy lifting)
Followed by cuts and burns
FIRE SAFETY- what to do in case of FIRE
R – Remove/Rescue (get everyone out of the department)
A-alarm (pull alarm box)
C- contain (close all doors)
E- extinguish (use fire extinguisher)
When Operating a Fire Extinguisher, always remember to use
P- pull the pin
A- Aim the nozzle
S- squeeze the handle
S- sweep the stream over the base of the fire

Quality Assurance and Continuous Quality Improvement

-“most important to remember” Collection of Data and Identification of Issues are only
part of a quality assurance program
Results must be monitored

WE WILL FINISH STRONG!!! FUTURE CBSPD LET’S GO!!!