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Hospital Safety Promotion & Disaster Preparedness

ROJoson's Advocacy on Hospital Safety Promotion Program

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WPRO Safe Hospital Checklist


QI-BD-5 Self-assessment of Hospital / Department Safety Promotion and Disaster Preparedness
Program Using the International Patient Safety Goals and Standards of Joint Commission
International (JCI)[4th ed] and Accreditation Canada International

Philippines DOH Safe Hospital Checklist


Posted on November 21, 2011 by reyojoson

Audit Checklist for Safe Hospital Initiative

Using Philippine Indicators

Structural, Non-structural, and Functional Indicators

(DOH-HEMS, 2nd edition, 2009)

(for use in preparing for internal and external quality audits)

(for use in self-assessment and in audit)


Structural Indicators of a Safe Hospital

Instruction:

Encircle the thumbs-up sign (means Yes or complies completely with what is asked for) and
thumbs-down sign (means No or may not comply completely with what is asked for) when
assessing the hospital or health facility according to the following indicators. Use the Remarks
column to write essential observations when doing the assessment, especially when the result is
No..
1. Buildings must be located in highly
suitable sites and away from areas that will
diminish its accessibility and threaten its Remarks
operations in times of emergencies.
1.1 Not at the edge of a slope Y N
1.2 Not close to a seismic fault line: Y N

1.2.1 High Risk (Zone 1): 5kms and nearer


to the fault line

1.2.2 Medium Risk (Zone 2): over 5kms-


10kms to the fault line

1.2.3 Low Risk (Zone 3) : over 10kms -


15kms to the fault line
1.3 Not near the foot of a mountain Y N
1.4 Near bodies of water (creeks, rivers, sea) Y N
provided with water barrier (i.e. rip-rap, dikes,
other forms)
1.5 Not on a reclaimed site Y N
1.6 Not in flood-prone areas Y N
1.7 Not within typhoon zone: Y N

1.7.1 High Risk: 250kph

1.7.2 Medium Risk: 200kph

1.7.3 Low Risk: 175kph


1.8 Not near active volcano Y N
2. The design of the hospital structural
system must strictly conform with the
requirements of the National Structural
Code of the Philippines (NSCP, 2001);
especially for wind and earthquake design
(per structural computations).
2.1 Foundation Y N
2.2 Columns Y N
2.3 Beams Y N
2.3.1 Underside of arches, balconies or Y N
overhangs free from structural cracks and
falling cement plasters
2.3.1 Other fixtures such as ceiling liner are Y N
properly fastened or attached
2.4 Floor and Roof Slabs Soffit or the Y N
underside of floor slab has no cracks and leaks
2.5 Trusses Y N
2.6 Walls and Partitions Y N
2.7 Shear Walls Y N
2.8 Roof System:
2.8.1 Roofing completely and securely Y N
fastened, welded, riveted, or cemented
2.8.2 Considered roof cover and insulation Y N
materials, slope, type of connection, condition,
thickness at least gauge 24 or 26
2.8.3 Considered regional location, e.g. in Y N
Bicol areas it should be heavily fastened or
anchored
3. The shape and form of the hospital
building must be simple and regular.
3.1 Hospital form is:
3.1.1 Square Y N
3.1.2 Rectangular Y N
3.1.3 Triangular Y N
3.1.4 Circular Y N
3.1.5 Irregular Y N
3.2 Building form (Elevations)

3.2.1 Top heavy Y N


3.2.2 Use of cantilevers Y N
3.2.3 Unbalanced massing Y N
3.2.4 Unbalanced loading Y N
4. The hospital structural system must be
continually checked and reviewed during
construction and the entire period of
occupancy. Structural design of building
constructed before 2001 should have
undergone any of the following:
4.1 Peer review using Association of Y N
Structural Engineers of the Philippines (ASEP)
guidelines
4.2 Undergone rapid evaluation using DPWH Y N
Guidelines
4.3 Issued with structural certification by Y N
qualified structural engineer
5. Cracks on the hospital structural system
must be immediately investigated and
addressed especially if they appear after an
earthquake. Major structural cracks or
visible damages does not appear on any of
the following structural members:
5.1 Foundation (Investigate for any settlement, Y N
tilting of building)

5.2 Columns (Investigate end and midpoint Y N


columns)

5.3 Beams (Investigate end support and mid- Y N


span)

5.4 Floor slabs Y N


5.5 Trusses (Investigate sagging, movement, Y N
corrosion, rotting)

5.6 Walls and partitions Y N


5.7 Shear Walls Y N

6. As-Built/As Found plans of all hospital


buildings must be kept on record; Readily
available and complete set of as-built
construction drawings for reference
purposes.
6.1 Architectural plans Y N
6.2 Structural Plans including structural Y N
computations
6.3 Electrical Plans including electrical Y N
computations
6.4 Sanitary Plans Y N
6.5 Mechanical Plans Y N
6.6 Electronics and Communications Plans Y N
7. Building Permit and Occupancy Permit
issued by the building official are
prerequisites for the start and occupancy
respectively of any new building construction
or renovation. Should be complete with
necessary building permits and occupancy
permits.
7.1 Building Permit per Project Y N
7.2 Occupancy Permit per Project Y N
7.3 Fire Safety Permit Y N
7.4 Elevator Permit where applicable Y N
7.5 Generator Permit where applicable Y N
7.6 Other Permits as needed Y N

Non-structural Indicators of a Safe Hospital

Instruction:

Encircle the thumbs-up sign (means Yes or complies completely with what is asked for) and
thumbs-down sign (means No or may not comply completely with what is asked for) when
assessing the hospital or health facility according to the following indicators. Use the Remarks
column to write essential observations when doing the assessment, especially when the result is
No..
1. Safety of Ceilings

Remarks
1.1 Ceiling materials such as fiber cement , Y N
gypsum board, or glass securely fastened
1.2 Ceilings made of wood are coated/treated with Y N
fire retardant paints and termite-controlled
1.3 Ceiling materials not made of asbestos Y N
1.4 Ceiling accessories or light fixtures adequately Y N
fastened and supported
2. Safety of Doors and Entrances
2.1 Doors securely attached to jambs Y N
2.2 Any glass panel in doors is transparent wired Y N
glass mounted in steel frames
2.3 In the event of power failure, power-operated Y N
doors may be opened manually to permit exit travel
2.4 Doors are either double swing or swing-out:
2.4.1 Double swing main doors, Y N
ER/OR/DR/ICU/Nursery/Radiology/ patients
rooms, Dietary, kitchen, laundry, linen and other
support areas
2.4.2 Swing-out toilets and exit doors Y N
2.5 Each single door with a width of not less than Y N
112 cm. and not more than 122 cm. (Note: if power
operated doors in the event of power failure the
door may be opened manually to permit exit travel)
2.6 Doors in rooms below 30 persons occupant Y N
load capacity single door 112 cm wide
2.7 Doors in rooms more than 30 persons occupant Y N
load capacity (conference rooms, function
rooms),112 cm wide, remotely located from each
other, swing out
2.8 Smoke partition doors located along hallways Y N
and corridors should be double swing, per groups
of rooms/section, for compartmentation
2.9 In high rise buildings/structures, the interior Y N
vertical exit stairwell/staircase, is a pressurized fire
exit or smoke proof fire exit, suitably sealed
against smoke, heat and fire
2.10 Locks installed on patient wards so arranged Y N
that they can be locked only from the corridor side.
Such locks arranged to permit exit from room by a
simple operation without the use of key
2.11 Any device or alarm installed to restrict the Y N
improper use of a means of egress so designed and
installed that it cannot, even in case of failure,
impede or prevent emergency use of such means of
egress
2.12 With manual door closer Operating Room Y N
(OR), Intensive Care Unit (ICU), Recovery Room
(OR), Delivery Room (DR), Labor Room (LR),
Isolation Rooms (IR) and other sterile areas
2.13 A door designed to be kept normally closed Y N
as a means of egress, such as a door to a stair or
horizontal exit, provided with a reliable self
closing mechanism, and shall not at any time be
secured in the open position. A door designed to be
kept normally closed shall bear a sign as follows:
FIRE EXIT, KEEP DOOR CLOSED
3. Safety of Windows and Shutters
3.1 Windows have wind and sun protection Y N
devices (e.g. sun baffles)
3.2 Window grilles to secure the safety of the Y N
patient, provided with fire exit opening
3.3 Windows are leak-proof Y N
3.4 Windows which could be mistaken for doors Y N
have protective barriers or railings
3.5 All glass panels or windows are made of Y
tempered glass or with appropriate thickness or N
provided with protective films
4. Safety of Walls, Divisions and Partitions
4.1 Exterior walls meet the fire resistance rating of Y N
2 hours
4.2 Interior walls made of fire-resistive materials Y N
and from floor to floor
4.3 Smoke-proof stairs, lobbies and vestibules are Y N
made of non-combustible materials
4.4 Partitions for fire zones are fire-resistive, floor- Y N
to-floor and compartmented
5. Safety of Exterior Elements (cornices,
ornaments, faade, plastering etc.)
5.1 Securely fastened on walls Y N
5.2 Hanging lighting fixtures properly anchored Y N
5.3 Electrical wires and cables properly Y N
fastened/secured
6. Safety of Floor Coverings
6.1 Non-slippery floor without crevices in all Y N
clinical/service areas
6.2 Durable floor materials Y N
6.3 Fire-resistive interior floor materials Y N
7. Safety of Lifeline Facilities
7.1 Electrical System
7.1.1 Electrical system must conform with the Y N
Philippine Electrical Code (PEC) requirements for
health facilities except for some provisions as may
be required by the end-users
7.1.2 Emergency generator has the capacity to Y N
meet 100% of hospital demand (provision for back-
up electrical system to include aircon units, and
stockrooms)
7.1.3 Generator housing or power house made Y N
of reinforced concrete
7.1.4 Generator housing or power house Y N
elevated from the ground line
7.1.5 Generators and other vibrating equipment Y N
can be fixed by special brackets which allow some
movement but prevent them from overturning
7.1.6 Non-vibrating and silent type generators Y N
7.1.7 Exhaust system made of critical type Y N
silencer or hospital grade
7.1.8 Provided with generator automatic Y N
transfer switch (ATS)
7.1.9 Protected control panel, with electrical Y N
surge suppressor
7.1.10 Ground fault circuit interrupters (GFCIs) Y N
provided in outlets in bath/shower rooms and in
wet or damp locations
7.1.11 All convenience outlets (COs) provided Y N
with grounding pole/type
7.1.12 Ducting system/conduits Polyvinyl Y N
Chloride (PVC) for power and lighting; Rigid Steel
Conduit (RSC) or Intermediate Metal Conduit
(IMC) for fire alarm and detection systems,
telephone, intercom, Closed-circuit (CCTV), Cable
TV (CATV), computer network data lines
7.1.13 Adequate lighting in all areas of the Y N
hospital
7.1.14 Exterior electrical system installed Y N
underground
7.1.15 Functional electrical and emergency lights Y N
with battery back-up in all areas
7.1.16 Energy-saving Compact Flourescent Y N
Lighting (CFL)
7.1.17 Non-mercury bulb/lights Y N
7.1.18 Automatic monitoring system installed Y N
(Extension wires/cord unplugged when not in use)
7.1.19 All non-current carrying metallic parts of Y N
the electrical system, i.e. electrical enclosures,
boxes, gutters, ducts, trays, etc. adequately
grounded
7.1.20 Perimeter/Exterior lighting system Y N
installed in the hospital grounds
7.1.21 All electrical systems/rooms protected Y N
with appropriate chemical type automatic fire
suppression units
7.1.22 Explosion-proof switch and outlets for Y N
hazardous areas
7.1.23 Antennas and lightning rods protection Y N
terminals with bracing/support for safety
7.1.24 Lightning arrester provided Y N
7.2 Communication System
7.2.1 Radios have back-up direct current power Y N
source (battery)
7.2.2 Presence of back-up communication Y N
system
7.2.3 Communication equipment and cables Y N
secured with anchors and braces
7.2.4 Alarm signalling system arranged so that Y N
the normal operation of any required alarm
initiating device will automatically transmit an
alarm to the nearest fire station or to such other
outside assistance as may be available
7.2.5 Exterior communication systems installed Y
underground
N

7.3 Domestic Water Supply System


7.3.1 Water storage tank has sufficient reserve Y N
to satisfy the hospital demand for 3 days at all
times
7.3.2 Water storage tank has safe location and Y N
support system
7.3.3 Alternate water source provided: deep Y N
well, mobile water storage tank, or fire truck
delivery
7.3.4 Fusion-weld pipes or galvanized iron Y N
pipes, valves, and fittings are free from breakage,
leaks and free from harmful agents
7.4 Medical and Industrial Gases (oxygen,
nitrous oxide, etc.) System
7.4.1 Hospitals using pipe-in medical gas Y N
should have minimum storage of 3 days
7.4.2 Hospitals using individual cylinders Y N
should have minimum storage of 3 days
7.4.3 Tanks, cylinders and related equipment Y N
anchored
7.4.4 Alternative sources of medical gases Y N
available
7.4.5 Medical gases appropriately located and Y N
secured from theft, vandalism and pilferage
7.4.6 Ensured the safety of medical gas Y N
provided with an audio-visual alarm distribution
system (valves, pipes, fittings)
7.4.7 Functional pressure gauge and fittings Y N
7.4.8 Use of standard copper tubings for Y N
medical gas
7.4.9 Undergoes regular testing procedures Y N
7.4.10 Medical gas pipes embedded in walls are Y N
provided with pipe sleeves
7.4.11 Non-interchangeable piping connection Y N
7.4.12 Provided zone/shut off valves in case of Y N
leaks, (example in case of fire at the OR complex,
zone valve can be shut off)
7.4.13 Secured back-up oxygen tanks in case of Y N
emergency patient evacuation
7.4.14 Industrial gases located outside the Y N
building and provided with automatic shut off
device (e.g. LPG)
7.4.15 Tanks bear an intact safety seal from the Y N
supplier
7.4.16 Explosion venting system provided Y N
outside the building for hazardous processes or
storage area, such as boiler room, motor pool,
electrical rooms, and housekeeping rooms.
7.4.17 Automatic gas leak detection system Y N
interconnected with the automatic fire alarm
system
7.5 Fire Suppression System
7.5.1 Detection, alarm and extinguishing Y N
systems are interconnected/ interphased
7.5.2 Fire Alarm system is a combination of Y N
automatic and manual system
7.5.3 Fire alarm system is monitored by Fire Y N
Service Station or Accredited monitoring agency
7.5.4 Heat and Smoke Detection installed in all Y N
areas
7.5.5 Smoke detectors must be spaced not Y N
further apart than nine meters on center and more
than four and six-tenths (4.6) from any wall
7.5.6 Each room provided with portable fire Y N
extinguishers
7.5.6.1 For general services areas, ABC fire Y N
extinguishers used
7.5.6.2 For electronic and electrical equipment, Y N
Carbon Dioxide (CO2), Hydrochloro-fluorocarbon
(HCFC),or Fluoroethane 36 used
7.5.7 Provided with wet standpipe system with Y N
complete accessories for building more than 5-
storey
7.6 Emergency Exit System
7.6.1 Every floor of the building must have at Y N
least 2 emergency exits remote from each other
7.6.2 Revolving Doors and Elevators are not Y N
considered emergency exits
7.6.3 Fire Exit Doors are fire resistive, swing- Y N
out type, self-enclosing, and with panic bar
hardware (of 7 kilograms or less pressure)
7.6.4 The floors of beams of egress are Y N
illuminated at all points including angles and
intersections of corridors and passageways,
landings of stairs and exit doors with bulbs of not
less than one thousandth (0.001) lumens per square
centimetre
7.6.5 Illumination system of the exits is not Y N
battery-operated
7.6.6 Emergency lighting facilities maintain the Y N
specified degree of illumination in the event of
failure of the normal lighting for a period of at least
half of an hour
7.6.7 Illuminated EXIT signs distinctive in Y N
color, reliable source, located just above the door
frame
7.6.8 Size of Exit Signs plainly legible letters Y N
not less than fifteen centimetres high with the
principal strokes of letters not less than nineteen
millimeters wide
7.6.9 Luminous directional exit signs located Y N
one foot above floor level leading to the nearest
fire escape route
8. Heating, Ventilation and Air Conditioning
(HVAC) Systems in Critical Areas
8.1 Provide adequate bracing for pipes and ducts Y N
8.2 Leak-free pipes, valves, and fittings Y N
8.3 Anchored central heating and/or hot water Y N
equipment
8.4 Anchored air-conditioning equipment Y N
8.5 Safety enclosures or guards for rotating parts Y N
of HVAC equipment
8.6 Fire-stopping materials for all pipes and ducts Y N
9. Medical and Laboratory Equipment and
Supplies used for Diagnosis and Treatment
9.1 With color coded sign: For priority in saving Y N
during evacuation
9.2 Medical Equipment in operating rooms and Y N
recovery rooms
9.2.1 Equipment in the operating room must be Y N
anchored or fastened
9.2.2 Lamps, equipment for anesthesia and Y N
surgical tables are secured and that table on cart
wheels are locked
9.3 Radiological Equipment and Other
Support Devices on the Radiology Department
(X-ray units, ultrasound scanners, CT scanners,
MRI scanners)
9.3.1 Heavy and movable equipment anchored Y N
or bolted on the floor (X- ray machine) or to the
wall
9.3.2 Available steel frames for securing of Y N
equipment
9.3.3 Adequately shielded room (radiation Y N
protection, radio-frequency, magnetic fields, etc.)
9.3.4 Air conditioned room with controlled Y N
humidity
9.3.5 Safe from flooding Y N
9.4 Laboratory Equipment and Other Support
Devices for the Laboratory Department/
Services
9.4.1 Supplies and contents of laboratories Y N
secured on shelves and in racks. (Anchor the
cabinets to the walls and strap the shelves)
9.4.2 Safe and secured storage of culture Y N
organisms/media
9.4.3 Available standard decontamination area Y N
(fixed/mobile)
9.4.4 Waste water connected to neutralization Y N
tank before disposal to sewerage treatment plant
9.4.5 Fume hood provided (depends on level of Y N
laboratory)
9.4.6 Material Safety Data Sheet (MSDS) Y N
available for all chemical substance
9.5 Medical Equipment in Emergency Rooms
9.5.1 Each bed is provided with wheel lock or Y N
anchor
9.5.2 Equipment and accessories needed for Y N
treatment and placed near the bed are supported,
anchored or fixed
9.5.3 Supplies and contents of medical cabinets Y N
secured on shelves and in racks. (Anchor and strap
the shelves to the wall)
9.6 Medical Equipment in ICU Areas
9.6.1 Each bed is provided with wheel lock or Y N
anchor
9.6.2 Equipment and accessories are supported, Y N
anchored or fixed
9.6.3 Anchor bolts should be provided on the Y N
walls in appropriate locations so that the equipment
can be removed and fixed in a safe place when not
in use
9.7 Medical Equipment in the Pharmacy
Departments
9.7.1 Supplies and contents of pharmacy Y N
cabinets are secured on shelves and in racks.
(Anchor the cabinets to the walls)
9.7.2 Proper storage for hazardous materials free Y N
from leaks
9.7.3 Air-conditioned room or well ventilated Y N
9.8 Medical Equipment in the Sterilization
Units
9.8.1 Supplies and contents of sterilization unit Y N
cabinets should be secured on shelves and in racks.
(Anchor the cabinets to the walls)
9.8.2 Heavy and movable equipment anchored or Y N
bolted to the floor or to the wall (ex. autoclave)
9.9 Medical Equipment in the Wards
9.9.1 Each bed is provided with wheel lock or Y N
chains
9.9.2 Equipment and accessories must be Y N
supported, anchored or fixed
9.9.3 Equipment on roller trolleys must have Y N
proper anchoring system using hooks and chains,
and can be attached to beds or walls (ECG,
monitors, suction units, ventilators, incubators, BP
monitors, resuscitation equipment, etc.)
9.9.4 Patients charts must be secured (especially Y N
if you have to evacuate that ward in times of
emergencies) for proper / continuous management
of patients
9.10 Equipment and Other Support Devices in
Nuclear Medicine Department and Radiation
Therapy Units (including Chemical/Poisoning)
9.10.1 Adequately shielded room Y N
9.10.2 Air conditioned room Y N
9.10.3 Proper storage, handling and disposal of Y N
chemicals and radioactive materials and wastes
9.10.4 Equipment and accessories needed for Y N
treatment and placed must be supported, anchored
or fixed
9.10.5 Use of Proper Personal Y N
Protective Equipment (PPE)
9.10.6 Available standard decontamination area Y N
(fixed/mobile)
9.10.7 Waste water connected to delay to decay Y N
tank before disposal to sewerage treatment plant
9.10.8 Use of Proper Illumination Y N
9.10.9 Independent circuit breaker Y N

9.10.10 Has a separate facility for the processing Y N


of the reagents/ chemical substance, radio-
pharmaceuticals and other diagnostic kits
9.10.11 Asbestos free Y N

9.10.12 Proper anchorage of equipment and the Y N


materials used for the attachments do not cross
react with the chemical agents
9.10.12 Presence of the following safety Y N
equipment:

Shields Y N
Protective clothing Y N
Tools for remote handling Y N
Containers for radioactive materials Y N
Dose rate monitors with alarm Y N
Contamination meters Y N
Signs, labels, records Y N
Emergency kits Y N

9.10.14 Security
Y
Provided with Close Circuit TV Y N
(CCTV) cameras with recorder
Roving guard available Y N
Secured entrance and exit points Y N N
Provided with equipment for Y N
inspection such as metal detectors

10. Safety of Personnel and Patients


10.1 Available PPEs for universal precaution Y N
(gloves, masks, gowns)
10.2 Available sterilizing unit for equipment Y N
and supplies
10.3 Available Information Education Y N
Communication (IEC) materials for patients and
personnel on what to do during
emergencies/disasters
Functional Indicators of a Safe Hospital

Instruction:

Encircle the thumbs-up sign (means Yes or complies completely with what is asked for) and
thumbs-down sign (means No or may not comply completely with what is asked for) when
assessing the hospital or health facility according to the following indicators. Use the Remarks
column to write essential observations when doing the assessment, especially when the result is
No.
1. Site and Accessibility

Remarks
1.1 Hospital is located along/ near good roads Y N
and adequate means of transportation and readily
accessible to the community and reasonably free
from undue noise, smoke, dust, foul odor, flood,
and not located near railroads, freight yards,
childrens playgrounds, airports, industrial
plants, disposal plants.
1.2 The location of the hospital shall comply Y N
with all zoning regulations and ordinances
1.3 There shall be no road obstructions leading Y N
to the hospital
1.4 There should be access to more than one Y N
road (alternative routes)

1.5 There should be access to more than one Y N


road (alternative routes)
1.6 There should be separate ingress and egress Y N
routes
1.7 Well paved access roads should be properly Y N
identified/labelled
1.8 Available, safe and well lighted parking lots Y N
1.9 Provide available parking lots for the Y N
disabled near the main entrance
1.10 Available covered walk way, to Y N
interconnect service areas
1.11 Directional signages are available and Y N
properly fastened
1.12 Outdoor stairs must have enclosed and Y N
protected openings
1.13 All entrances, especially main and Y N
emergency entrances, shall be provided with
canopies for protection from the elements
1.14 Provide entrance ramps using ratio of 1:12 Y N
1.15 Secured and controlled of entry points Y N
2. Internal Circulation and Inter-
Operability
2.1 Proper zoning of areas Y N
2.1.1 Departments most closely linked to the Y N
community are located nearest to the entrance
(OPD, ER,)
2.1.2 Departments that receive their Y N
workload from the wards or inner zones should
be located closer to these zones (Radiology,
Laboratory)
2.1.3 In-patient departments should be in the Y N
inner zones
2.2 General service areas are located in separate Y N
structures such as power plant, boilers, water
storage facilities, laundry area, and pump house
2.3 Areas to be converted to spaces for patients Y N
during disasters properly identified with
adequate lighting, electrical outlets, water supply
and toilets/bathrooms
2.4 Diagnostic areas with heavy equipment are Y N
preferably at the ground floor but are safe from
flooding
2.5 Nurses at the Stations can oversee the wards Y N
and are accessible to the patients
2.6 Gender sensitive wards (female, male) and Y N
sanitary toilets
2.7 Morgue is located separately from the Y N
service areas
2.8 Corridors, hallways and aisles are 2.45 Y N
meters in width
2.9 Use of ramps as access to 2nd and 3rd floors Y N
only
2.10 Use of elevators as access for 4th floor Y N
and above
2.11 Use of stairways with safe and adequately
Y N
secured balusters and railings
3. Basic Equipment and Supplies
3.1 Basic equipment should be available per Y N
ward at least two sets
3.2 Basic equipment should be available at Y N
treatment area at least two sets
3.3 Basic emergency supplies available Y N
3.4 Diagnostic and therapeutic basic equipment Y N
are functional and properly labelled
3.5 Stock pile of medical supplies good for at Y N
least one week
3.6 Basic PPEs are available at the ER Y N
3.7 PPEs are available in all service areas Y N
4. Hospital Emergency Preparedness,
Response and Recovery Plan approved by the
Chief of Hospital / Director, disseminated,
tested and updated
4.1 Operational Plan and Contingency Plans
for Internal or External Disasters
4.1.1 The hospital has available, accessible, Y N
tested, updated and disseminated Hospital
Emergency Preparedness, Response and
Recovery Plan which contains Hazard
Prevention and Mitigation Plan, Vulnerability
Reduction Plan and Capacity Development Plan.
4.1.2 The hospital has contingency plans Y N
for medical treatment during different types of
disasters such as Typhoon, Floods, Earthquake,
Fire, Disease outbreaks, Emerging and Re-
emerging Infections/Diseases, Biological,
Chemical, Radio-nuclear terrorism, Control of
Infections acquired during hospitalization,
pathogens with epidemic potential, etc.
5. Hospital Emergency Management
Systems, Procedures and Protocols written
and attached/incorporated in the Plan 4.1
5.1 SOP/Guidelines on infection control Y N
5.2 Decontamination procedures/ guidelines Y N
5.3 SOP for internal and external referral of Y N
patients
5.4 Emergency response procedure/ Y N
guidelines
5.5 Treatment guidelines/protocols Y N
5.6 Special administrative procedures for Y N
disasters
5.7 Procedures for resource mobilization (funds, Y N
logistics, human resources) to include shifting of
duties during emergencies or disasters
5.8 SOP for admission to Emergency Y N
Department during emergency/disaster
5.9 Procedures to expand services, spaces and Y N
beds, in case of surge of patients
5.10 Procedures to protect patients records Y N
5.11 Procedures for regular safety inspection Y N
of equipment by appropriate authority and
preventive maintenance
5.12 Procedures for hospital epidemiologic Y N
surveillance
5.13 Procedures for preparing sites for Y N
temporary placement of dead bodies for forensic
medicine
5.14 Procedures for transport and logistic Y N
support
5.15 SOP/guidelines for food and supplies of Y N
hospital staff during emergency
5.16 Measures to ensure well being of Y N
additional personnel mobilized during
emergency
5.17 Guidelines for mental health and psycho- Y
N
social support
5.18 Guidelines on drills / simulation exercises Y N

Fire Y N
Other disasters Y N

5.19 SOP for handling of volunteers especially Y N


during emergencies/disasters
5.20 SOP for hospital security system during Y N
emergencies or disasters
5.21 Health care waste management program Y N
during emergencies or disasters
5.22 Fire Safety Program Y

5.22.1 There must be an organized Y N


Fire Brigade which has
undergone seminar/training on Fire
Drill/ Fire Evacuation Drill/
Earthquake Drill
5.22.2 Conduct of regular Fire Drills/ Y N
Fire Evacuation Drill
5.22.3 Conduct of fire mitigation Y N
prevention and suppression training
N
5.22.4 Fire fighting equipment
available
5.22.5 Conduct of preventive Y N
maintenance of fire fighting
equipment
5.22.6 Available Fire Exit Plan and Y N
provision of Fire exit/evacuation plan
in conspicuous places at every floor
level

5.23 Users/Operations manual for all medical Y N


equipment
6. Availability of Back-up System for the
following critical services
6.1 Back-up generators Y N
6.2 Alternate source of drinking Y N
water
6.3 Fuel reserves Y N
6.4 Medical gases Y N Y N
6.5 Wastewater Treatment Y N
6.6 Solid Waste Treatment Y N

7. Human Resources
7.1 Organization of Hospital
Disaster Committees and Emergency Operation
Center
7.1.1 Crisis Management Committee Y N
Committee lower than the Executive
Committee, with technical expertise, who could
give advice to the Executive Committee
regarding crisis/ emergency/ disaster
management
7.1.2 Emergency Response Team led Y N
by a designated Hospital Emergency
Management Coordinator and composed of
Physicians, Nurses, Emergency Management
Technician (EMT) trained staff, Paramedics,
trained Ambulance Driver on
emergency/disaster
7.1.3 Health Emergency Planning Y N
Group Responsible for the development of
Health Emergency Preparedness, Response and
Recovery Plan and other hospital response plans
7.1.4 Safety Committee headed by a Y N
Safety Officer. The committee is in charge of
promoting safety in the hospital from all types of
hazards
7.1.5 Hospital Operation Center N
headed by the Hospital Emergency Management
Coordinator, in charge of monitoring incidents Y
of emergency or disaster, dispatching of
response teams, mobilizing other resources for
emergency, operational 24 hours a day and
seven days a week. It has a designated office or
unit with personnel equipped with
communication facilities, and computer system,
directories, withalternate communication system
in case the system bogs down

7.2 Capability Building of Personnel


7.2.1 100% of health workers trained Y N
in Basic Life Support and Cardio-pulmonary
Resuscitation
7.2.2 100% of health workers trained Y N
in Standard First Aid
7.2.3 Emergency Room medical staff Y N
trained in Advance Cardiac Life Support and
Pediatric Advance Cardiac Life Support
7.2.4 Hospital Responders trained in Y N
Emergency Medical Responders Course Incident
Command System (ICS), Mass Casualty
Incident (MCI)
7.2.5 Hospital managers are trained in Y N
Hospital Emergency Incident Command System
(HEICS)

7.3 Drills and Exercises


7.3.1 Conducts of Fire drills at least Y N
twice a year
7.3.2 Conducts of simulation drills or Y N
exercises at least once a year
8.Monitoring and Evaluation

8.1 Conducts post-incident evaluation of


Y N
emergencies or disasters responded to
Additional Non-Structural Indicators for Hospitals with Special Functions

Instruction:

Encircle the thumbs-up sign (means Yes or complies completely with what is asked for) and
thumbs-down sign (means No or may not comply completely with what is asked for) when
assessing the hospital or health facility according to the following indicators. Use the Remarks
column to write essential observations when doing the assessment, especially when the result is
No.

1. Hospital For Highly Infectious Diseases Remarks

1.1 Isolation Room/ Biological


Unit/Negative Pressure Room
1.1.1 Closed, air tight windows and N
Y
doors
1.1.2 Glass transparent doors for the Y N
ante room and the room of the patient, tightly
closed
1.1.3 Automatic shut off doors, swing type Y N

of the ante room and the room of the patient,


tightly closed
1.1.4 Leak proof ceiling, windows and Y N
doors
1.1.5 With signage ISOLATION Y N
1.2 Divisions/Partitions
1.2.1 Isolation room has an ante room N
for dressing with Personal Protective Equipment Y
(PPE)
1.2.2 Ante room has lavatory and PPE Y N
rack
1.3 Floor Covering Y
1.3.1 Reinforced concrete Y N
1.3.2 Non-slippery floor tiles without crevices Y N
1.4 Attachments
1.4.1 Heating, Ventilation and Air Conditioning
(HVAC)
No air-conditioning Y N
Y N
No electric fan Y N

1.4.2 Pipes/Medical Gases N


Y
Closed, built in pipes
1.4.3 Fixtures and Equipment N

No nebulizer Y N
No Oxygen tank; to be used only in Y N
life and death situation
No suction machine (dedicated) Y N
Minimized dedicated equipment: Y N
only life saving equipment
Lavatory of ante room with foot Y N Y
operated trash bin, soap dispenser,
and disinfectant dispenser; while the
faucet is sliding that can be operated/
opened by pushing of the elbow
Color coded trash bins Y N
Refrigerator near the Nurses Station Y N
for storage of biological specimens
and culture media

1.4.4 Electrical Lighting


Well lighted Y N
Back-up emergency lights Y N Y N

1.5 Lifeline Facilities (Critical Systems)


1.5.1 Communication System Y
Dedicated 2 telephone lines for Y N N
inside and outside communication
1.5.2 Water Supply System Y

Safe and adequate water supply in Y N


all areas
Water tank storage has sufficient Y N
reserve to N

satisfy the hospital demand for three


days
Water containers for storage in the Y N
ante room

1.5.3 Medical Gases, pipes (oxygen, nitrous


oxide, etc.)

Sufficient storage for minimum of Y N


15 day supply
Securely anchored tanks, cylinders Y N
and related equipment
Protection of medical gas tanks Y N
and/or cylinders and related
equipment Y N
Functional pressure gauge Y N
Leak proof Y N
Medical gas pipes not embedded in Y N
walls
Individualized piping system Y N
Automatic shut off mechanism in Y N
case of leaks

1.5.4 Emergency Exit System


Y N
Exclusive Emergency Exit Y N
Illuminated EXIT signs Y N
distinctive in color

(Reliable source five thousand


lumens

(0.005) per square centimeters


Provide luminous directional exit Y N
signs located one foot or below floor
level

1.6 Heating, Ventilation and Air


Conditioning Systems

1.6.1 Negative pressure room Y N


1.6.2 Exhaust system with filter that Y N
Y N
exits

into the open air far from human


activity
1.6.3 Airtight Y N

2. Operating Room and Recovery Room

2.1 Medical and Laboratory Equipment and


Supplies used for Diagnosis and Treatment
2.1.1 Medical Equipment in Operating
Room and Recovery Room
Dedicated equipment mounted on Y N
rollers or roller trolleys must be
anchored or fastened near the
Y N
operating table during operations
and can be removed afterwards
Lamps, equipment for anesthesia and Y N
surgical tables are secured and table
or cart wheels are locked
Equipment on roller trolleys must Y N
have proper anchoring system using
hooks and chains, and can be
attached to beds or walls (ECG,
monitors, suction units, ventilators,
incubators, BP monitors,
resuscitation equipment, etc.)

2.1.2 Safety of Radiology Equipment

Dedicated portable mobile X ray Y N


machine that is battery operated

3. Laboratory Room (P3 Laboratory and


Bio-safety and Bio-security)

3.1 Safety of Laboratory Equipment

3.1.1 Safe washing area Y N


3.1.2 Available standard Y N
decontamination area, (fixed/mobile)
3.1.3 Hospitals maintain lab as per Y N
their category (Category 3)
3.1.4 Manual on collection, Y N Y N
transport, storage, and handling of
specimen

3.2 Safe Laboratory Room


3.2.1 Adequate Facilities

Good and proper ventilation Y N Y N


Non-slip surfaces (floor & working Y N
areas)
Hand-washing facilities Y N

3.2.2 Safety Equipment


Personal Protective Equipment Y N
Gowns Y N
Goggles Y N
Mask Y N
Gloves Y N
Safety devices on laboratory Y N Y N
Safety Laboratory Equipment Y N
Biosafety Cabinet Class II

3.2.2 Emergency Equipment

Fire extinguishers Y N
Emergency showers Y N Y N
Eye wash station Y N

3.2.3 Appropriate Procedures

Good housekeeping Y N
Personal hygiene (handwashing) Y N Y N
Laboratory safety protocol Y N

3.2.4 Proper Storage Area


(secured/anchored)

Properly stored ordinary Y N


reagents/chemicals Y N
Non-corrosive building materials for Y N
acid

containing chemicals and reagents


Dedicated storage for pathogenic Y N
organisms accessible only to
responsible people

3.2.6 Proper Laboratory Holding Y


P3 laboratory negatively Y N
pressurized environment for highly
N
contagious organisms

3.2.7 Decontamination Area Y

N
Fixed autoclave Y N
Mobile autoclave Y N

3.2.8 Knowledgeable Workers

Y N
Experienced Y N
Trained Y N

IF POSSIBLE: All laboratory doors should be


labeled with emergency contact information. If
an accident occurs during office hours,
respondents need to know the names and
telephone numbers of people responsible for
laboratory operations. Properly trained and
experienced laboratory workers have the
greatest ability to control laboratory risks.
4. Emergency Room

4.1 Safety of Medical Equipment in Emergency


Room

4.1.1 Separate ER Y N Y N
4.1.2 Dedicated supplies and Y N
equipment for diagnosis and
treatment
4.1.3 Disposable PPEs (masks, Y N
goggles, gowns, caps, gloves,
booties)

5. Security and Safety


5.1 Provision of Close Circuit TV Y N
(CCTV) cameras with recorder
5.2 Secured entrance and exit points Y N
5.3 Available appropriate PPEs Y N
(gloves, N95 masks, goggles, gowns,
Y
booties, caps)
N
5.4 Available dedicated sterilizing Y N
equipment and supplies
5.5 Dedicated staff assigned in Y N
Isolation Room/Biological Unit
5.6 Signages for restricted areas Y N

Additional Functional Indicators for Highly Infectious Diseases

Instruction:

Encircle the thumbs-up sign (means Yes or complies completely with what is asked for) and
thumbs-down sign (means No or may not comply completely with what is asked for) when
assessing the hospital or health facility according to the following indicators. Use the Remarks
column to write essential observations when doing the assessment, especially when the result is
No.

Y N
1. Site and Accessibility Remarks
1.1 Properly identified/labeled Y N
Isolation

Room/Biological Unit
1.2 Directional signages available and Y N
properly fastened
1.3 Admitted cases have separate Y N
entrance to the Isolation room/ER
from the rest of the hospital patients
and personnel
2. Internal Circulation and Inter-Operability
2.1 There is a dedicated Isolation Y N
Room/ Biological Unit for highly
infectious cases (i.e. SARS, Avian
Flu)
2.2 There is a dedicated Y N
ER/Consultation Room for highly
infectious patients away from the
usual ER and OPD
2.3 Presence of decontamination areas Y N
near the entrance at the ER, at the
laboratory, and at the Isolation
Room/Biological Unit
2.4 Nurses at the Stations can oversee Y N
Y N
the patients inside the Isolation
Room/Biological Unit
2.5 Gender based wards (female, Y N
male) and common sanitary toilets
2.6 Observe proper zoning: Isolation Y N
Room/Biological Unit must be
secured, regulated, and located in the
hospital away from the busy wards
2.7 Identified safe perimeter for Y N
patients and personnel with proper
signage (3 meters away from the door
of Isolation Room/ Biological Unit)

3. Equipment and Supplies Y N


3.1 Dedicated equipment and supplies Y N
for the Isolation Room/Biological
Unit/ER
3.2 Dedicated portable X ray, Y N
ventilators, diagnostic and treatment
tools (i.e Stethoscope, laryngoscope,
BP apparatus, etc)
3.3 Laboratory has bio-safety cabinet Y N
with hood
3.4 Available special PPEs like N95 Y N
masks, goggles, caps, gowns, gloves,
booties, all of which are disposable
3.5 Hand lotion and disinfectants Y N
3.6 Proper waste disposal materials Y N
/supplies

4. Hospital Plans
4.1 Hospital Contingency Plan for Y N
Highly Infectious Disease Outbreak

4.2 Hospital Contingency Plan for Y N


Y N
Bioterrorism
4.2.1 SOP/Guidelines on Infection Y N
Control
4.2.2 Decontamination Procedures/ Y N
Guidelines
4.2.3 Bio-safety and Bio-security Y N
Guidelines

5. Hospital Emergency Management Policies,


Guidelines, Procedures, and Protocols
5.1 SOP for internal referral of Y N
patients
5.2 Treatment Guidelines/Protocols Y N Y N
for Emerging/Re-emerging Infections
5.3 Procedures for hospital Y N
epidemiologic Surveillance
5.4 Procedures for preparing sites for Y N
temporary placement of dead bodies
for highly infectious disease
5.5 SOP/Guidelines for food and Y N
supplies of dedicated hospital staff
during emergency

6. Hospital Systems

6.1 Logistics Management System

6.1.1 System for prioritizing hospital Y N


personnel to be given prophylactic/
therapeutic drugs for highly infectious
diseases in times of drug scarcity

6.1.2 Surveillance System

Established hospital disease Y N


surveillance system for the patients
and personnel
Y N

6.1.3 Water Supply System

Presence of adequately safe water at Y N


all times even during emergency for
hygienic purpose, for flushing toilets
and other utilities
Presence of alternate source of water Y N
in case the main supply is cut off
Identified agencies responsible for Y N
timely restoration of water service
Supplementary pumping system in Y N
case system fails or services disrupted

6.1.4 Electrical System


Presence of emergency power Y N
generator or alternative power for
emergency lighting and operation of
essential equipment

6.1.5 Security System

Dedicated security personnel Y N


Tightened security of the Isolation Y N
Room/Biological Unit, being a
restricted area
Only authorized personnel are allowed Y N
to enter
Separate entrance or access route Y N
With proper signages Y N

6.1.6 Transportation and Communication System

Available back-up communication Y N


facilities (cellular phone, handheld
radios satellite communication
facilities,etc)
Dedicated ambulance for highly Y N
infectious patients with glass separator
between the driver and the patient
compartment equipped with proper
decontamination/disinfection supplies
and materials

6.1.7 Public Information System

Presence of established Public Y N


Information Center where public can
go to request information concerning
family members
Public Information Center is Y N
coordinated by a social worker and
staffed by personnel or volunteers
Available public awareness and public Y N
education campaign with advisories,
IECs, warning messages
Designated spokesperson for risk Y N
communication
Procedures for communicating with Y N
the public and media

6.1.8 Hospital Emergency Incident Command


System (HEICS)

The Chief of Hospital as the Incident Y N


commander and other staff to fill up
the position of the Incident Command
Structure
System of activating and deactivating Y N
the Incident Command System
System of activating the Hospital Y N
Response Plan
Hospital Early Warning and Code Y N
Alert System in order for hospital to
prepare and mobilize resources in
response to early warning signs or
signals
System of recalling of staff and Y N
positioning them for possible response
to emergencies
System of activating and deactivating Y N
the Code Alert System

6.1.9 Information Management System

Preparation of a census of admitted Y N


patients and those referred to other
hospitals
Proper recording and reporting using Y N
standard forms
Ways of sharing information with Y N
proper authorities
7. Operational Plan and Contingency Plans for N
internal or external disasters
7.1 The hospital must have available, Y N
accessible, tested, updated and
disseminated Hospital Emergency
Preparedness, Response and Recovery
Plan and Contingency Plan for Highly
Infectious Diseases (SARS, AI) This Y
plan includes the developed systems,
guidelines, SOPs and protocols for
emergency management
7.2 Procedures to activate and Y N
deactivate the plan

8. Plans for the Operation, Preventive N


Maintenance, and Restoration of Critical
Services
8.1 Electrical supply and back-up Y N

generators
8.2 Drinking water supply Y N
Y
8.3 Fuel reserves
8.4 Medical gases Y N
8.5 Standard and back-up Y N
communication systems
8.6 Wastewater Treatment Y N
8.7 Solid waste Treatment Y N
8.8 Fire suppression system Y N
9. Human Resources

9.1 Organization of Hospital Disaster Committees


and Emergency Operation Center

Y N
9.1.1 Crisis Management Committee Y N
9.1.2 Dedicated trained and Y N
competent staff in managing highly
infectious cases
9.1.3 Dedicated trained and Y N
competent security personnel
9.1.4 Dedicated trained and Y N
competent Ambulance drivers
9.1.5 Dedicated trained and Y N
competent maintenance/utility
personnel
9.1.6 Dedicated trained and Y N
competent Safety Committee members
9.1.7 Dedicated trained, competent, Y N
and active Infection Control
Committee
9.1.8 Hospital Operation Center staff Y N
to be headed by the Hospital
HEMS Coordinator, to be operational
24 hours a day and seven days a week

9.2 Capability Building of Personnel

9.2.1 100% of staff trained on Y N


management of highly infectious
diseases

10. Availability of medicines, supplies,


instruments, and other equipment dedicated
for highly infectious diseases (SARS, AI)
10.1 Emergency Medicines at the Y N

Emergency Room and in the critical


service

areas (OR, RR, ICU, NICU, etc) Y N


10.2 Items for treatment and other Y N
supplies
10.3 Instruments for emergency Y N
procedures
10.4 Medical gases Y N
10.5 Ventilators Y N
10.6 Electro-medical equipment Y N
10.7 Life support equipment
10.8 Personal Protective equipment Y N
for epidemics (disposable)
10.9 Crash cart for cardio-pulmonary Y N
arrest
10.10 Triage tags and other supplies Y N
for managing mass casualties
11. Monitoring and Evaluation

11.1 Conduct of post-incident Y N


Y N
evaluation of emergencies or disasters
responded
11.2 Conduct of drills Y N

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Procedure for handling of returned Material/products


1.0 PURPOSE
To Lay down systematic procedure to establish handling of returned material/ products from market.

2.0 SCOPE
This method is applicable for the handling of returned material/products from market.

3.0 RESPONSIBILITY
Production Head / Tech. Director/ Head Quality Assurance

4.0 ACCOUNTABILITY
Head Quality Assurance

5.0 PROCEDURE

5.1 Any material or goods (Finished products &/or intermediates) returned from the market shall be stored in a
separate area dedicated for storage of returned goods.

5.2 Record all the details in Returned Goods Record, as per the Annexure-II.

5.3 Inform the Quality Assurance department for evaluation of the returned goods.

5.4 The Quality Assurance chemist shall evaluate the returned goods for the following:
(a) Check the COA and other documents with the returned consignment.
(b) Condition of the Packaging, carton and container.
(c) Labeling details.

If the returned materials has exceeded the labeled expiry period &/or the condition of the packaging, carton,
5.5 container and storage condition of the material before returning/ shipping are doubtful, then destroy the
material as per the XXX/SOP/QA/014 for control sample destruction.

If none of the above condition is apparent, then sample the material as per the XXX/SOP/QA/013 for
sampling of the FG.
5.6
Analyze the sample as per the current approved product specification. If the product meets appropriate
product specification, then the returned material/ product may be considered for reprocessing as per the SOP
5.7 for reprocessing, provided the subsequent product meets the product specification.

In case the sample fails to meet the product specification, destroy the material/product as per the SOP for
destruction, and initiate failure investigation.
5.8
Identify the batches manufactured during the same period &/or manufactured by using the same RMs.
Extend the investigation to these batches also.
5.9
Refer flow chart for handling of the returned material/ products as per Annexure I.

5.10

6.0 REFERENCES
NIL
7.0 ANNEXURES

Annexure No. Title of Annexure Format No.


Annexure I FLOW CHART OF HANDLING OF RETURNED MATERIAL/PRODUCT QA/033/F01-00
Annexure II RETURNED MATERIAL/ PRODUCT RECORD QA/033/F02-02

8.0 ABBREVIATIONS

Abbreviations Full Forms


SOP Standard Operating Procedure
QA Quality Assurance
COA Certificate of Analysis
FG Finished good
9.0 DISTRIBUTION

Master Copy Head Quality Assurance Department


Controlled office Copy No. 1 Head Quality Assurance Deptt.

10.0 REVISION HISTORY


Revision Effective Reason for Authorized By
S.No. Details of Change
No. Date Revision (sign & Date)
Annexure I
W CHART OF HANDLING OF RETURNED MATERIAL/PRODUCT
Annexure II
RETURNED MATERIAL/ PRODUCT RECORD
Reason for Condition
Returned Product details
Return
Name Batch No. A. R. No. Mfg. Date Exp. Date Quantity