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pdfFORM APPROVED
OMB NO. 0920-XXXX
EXP DATE: xx/xx/20xx
Global Action Plan (GAP) Poliovirus Containment
Poliovirus-Essential Facility Questionnaire
Your facility has submitted a Certificate of Participation to the U.S. National Authority for Containment (NAC) of Poliovirus and
committed to containment of poliovirus (PV) materials in accordance with the World Health Organization (WHO) Containment
Certification Scheme (CCS). Poliovirus containment certification in the United States is a multi-step process overseen by the
U.S. NAC.
The Poliovirus-Essential Facility (PEF) Questionnaire is used to collect additional information on the poliovirus materials held by
your facility, your work activities, and facility features. Facility information for U.S. laboratories retaining poliovirus materials will
be maintained by the U.S. NAC but may be shared upon request with regional and international health authorities (Pan
American Health Organization (PAHO), WHO) as relevant to WHO Global Action Plan to minimize poliovirus facility-associated
risk after type-specific eradication.
Contents
SECTION 1: PARENT FACILITY INFORMATION
SECTION 2: PRINCIPAL INVESTIGATOR (PI) WORK DETAILS
SECTION 3: PRINCIPAL INVESTIGATOR (PI) GENERAL WORK DETAILS
3a: INFECTIOUS MATERIAL (IM)
3b: POTENTIALLY INFECTIOUS MATERIAL (PIM) (If applicable)
3C: SPECIES SPECIFIC ANIMAL WORK (If applicable)
SECTION 4: FACILITY ENTRY REQUIREMENTS
SECTION 5: LABORATORY/STORAGE AREA INFORMATION
SECTION 6: VALIDATION
Public reporting burden: CDC estimates the average public reporting burden for this collection of information as 1.5 hours/minutes per
response, including the time for reviewing instructions, searching existing data/information sources, gathering and maintaining the
data/information needed, and completing and reviewing the collection information unless it displays a currently valid OMB control number.
Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this
burden to CDC/ATSDR Information Review Office; 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-XXXX).
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SECTION 1: PARENT FACILITY INFORMATION
1. Application Date:
2. Containment certificate(s) desired:
3. Facility Name:
4. Office/Dept.:
5. Facility Address:
6. Additional Offsite Address:
Facility Contacts
7. Name
8. Facility Title
9. Work Phone
10. Work Email
Principal
Investigator
Biosafety officer
Institution
Representative
11. Facility Key Roles: Individuals with key roles in the biorisk management system have been designated as follows:
Role
Name
Co-investigator
Senior manager
Biorisk management advisor
Scientific manager
Occupational health professional
Facility manager
Security manager
Emergency Manager
Lab manager
Animal care manager
Biorisk management advisor
Quality management system professional
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12. Poliovirus Materials* Onsite
iWPV1
iVDPV1
iWPV2
iVDPV2
iWPV3
iVDPV3
piWPV1
piVDPV1
piWPV2
piVDPV2
piWPV3
piVDPV3
Other/new poliovirus strains (e.g., S19)
Other
iOPV1
iOPV2
iOPV3
piOPV1
piOPV2
piOPV3
mOPV1
mOPV2
mOPV3
mOPV (1 & 3)
mOPV (1, 2, & 3)
nOPV1
nOPV2
nOPV3
Bivalent nOPV (1 & 3)
Bivalent nOPV (1, 2, & 3)
* Prefix of 'i' indicates infectious material whereas 'pi' indicates potentially infectious materials; 'm' indicates monovalent vaccine; 'n' indicates
a novel vaccine.
13. Poliovirus Strains
VirusType
Example: WPV1
Strain
Mahoney
14. Poliovirus funding source(s):
15. Justification for critical national or international function:
SAFEGUARDS
16. Immunization/Secondary safeguards (Pol3 Immunization coverage estimates):
17. Population and demographic characteristics within a 100 km radius of PEF, including any pockets of susceptible individuals:
18. Occupational health requirements for PV containment areas (check all that apply):
A. Staff
PV childhood immunization records
Adult IPV booster
PV proof of immunity
Other required immunizations:
Other:
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Medical clearance for respirator
Respirator fit test
Tuberculosis skin test
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B. Visitors
PV childhood immunization records
Adult IPV booster
PV proof of immunity
Other required immunizations:
Other:
Medical clearance for respirator
Respirator fit test
Tuberculosis skin test
19.Environmental/Tertiary safeguards (closed sanitation system with at least secondary or greater treatment of PEF effluents):
SECURITY SYSTEMS AND PRACTICES
20. Facility is located on a secure site with perimeter control (e.g., perimeter fence) ...........................................................................
21. Facility perimeter is subject to constant monitoring (e.g., through use of alarms, security personnel) ............................................
22. Facility ensures two-person system with second individual within the containment perimeter or in close
proximity during PV work
23. Facility building(s) are equipped with intrusion detection system where PV containment areas are located ...................................
24. Facility building(s) are equipped with video surveillance where PV containment areas are located ................................................
25. Facility has a security plan or procedure that identifies appropriate security controls for PV as determined
by risk assessment
26. Facility has defined and implemented a personnel reliability policy ................................................................................................
26a. Personnel reliability policy requires verification of references .........................................................................................
26b. Personnel reliability policy requires verification of criminal history ..................................................................................
26c. Personnel reliability policy requires verification of education ...........................................................................................
27. Visitor Identification Required ........................................................................................................................................................
BIORISK MANAGEMENT SYSTEM
28. Management systems and practices, regulations, or standards implemented for PV work:
Clinical Laboratory Improvement Amendments (CLIA)
Good Laboratory Practice (GLP)
International Standardards Organization (ISO)
Good Microbiological Practice (GMP)
Quality Management System (QMS) (if selected, briefly describe):
Other:
29. Management review process and frequency for PEF:
30. Internal audit process and frequency for PEF:
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31. Risk assessment process for PV work and PEF site (e.g., facility, security, emergency response):
32. PV work has been reviewed by institutional biosafety committee or equivalent: .................................
Yes
No
N/A
33. PV animal work has been reviewed by institutional animal care and use committee or equivalent: .....
Yes
No
N/A
34. Notification and coordination with state and local agencies that support emergency response plans for the PEF:
GAP ELEMENTS
35. ICC/CC Facility: Indicate PEF processes aligned to GAP elements (check all that apply):
A. Laboratory processes
Planning
Purchasing
Personnel
Facilities
Other:
Equipment
Testing
Quality Assurance/Quality Control
Inventory
Shipping
Decontamination
Management Review
B. Support processes
Quality Managment System (QMS)
Environmental Health and Safety
Training
Other:
Occupational Health
Security
Emergency Response
Maintenance
Contractors/Supplies
35. ICC/CC Facility: Facility has identified nonconformities to the following GAP element(s) that will be resolved during an interim
certificate of containment (ICC-NCs)? ................................................................................................................... Yes
If yes, check all that apply:
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Element 1 - Biorisk Management System
Element 8 - Facility Physical Requirements
Element 2 - Risk Assessment and Control
Element 9 - Equipment & Maintenance
Element 3 - Worker Health Programme
Element 10 - Poliovirus Inventory & Information
Element 4 - Competency/Training
Element 11 - Waste Mgnt, Decon, Disinfect, & Sterilize
Element 5 - Good Microbiological Practice Procedure
Element 12 - Transport Procedures
Element 6 - Clothing & Personal Protective Equipment
Element 13 - Emer Response & Contingency Planning
Element 7 - Security
Element 14 - Accident/Incident Investigation
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SECTION 2: LABORATORY/STORAGE AREA INFORMATION
Information regarding laboratory and storage areas including infrastructure and operation management. If more than one area was
declared, information is displayed for each.
Location 1
Building:
Room:
1. Campus:
1a. Room Use: .........................................................................................................
Lab space
Storage
Yes
1b. Dedicated space: ...............................................................................................................................................
No
(CP Only/ICC/CC)
1c. Location used during what phase of CCS? .....................................................................................................
1d. PV materials used in this space:
iWPV1
iVDPV1
iWPV2
iVDPV2
iWPV3
iVDPV3
piWPV1
piVDPV1
piWPV2
piVDPV2
piWPV3
piVDPV3
Other/new poliovirus strains (e.g., S19)
Other
iOPV1
iOPV2
iOPV3
piOPV1
piOPV2
piOPV3
mOPV1
mOPV2
mOPV3
mOPV (1 & 3)
mOPV (1, 2, & 3)
nOPV1
nOPV2
nOPV3
Bivalent nOPV (1 & 3)
Bivalent nOPV (1, 2, & 3)
2. Building construction date:
3. Room construction/renovation date:
4. PV facility support system renovations since construction:
5. Total area of the suite/room (sq ft):
6. Designated safety level for the PV containment area (e.g., BSL-2, A/BSL-3):
7. Number of rooms in the containment area:
8. Number of individuals with direct access to poliovirus material:
9. Number of individuals with access to the containment area:
10.Poliovirus immunization verified for all individuals entering containment area:
Yes
11. Floor plan on file with NAC: ...............................................................................................................................
No
Note: Floor plan for each room should include as applicable: points of entry and/or egress for personnel, locations of equipment including but not
limited to: sink, shower, autoclave, BSC including type (e.g., Class II, Type A2; Class III). Note, for equipment (e.g., autoclave, emergency
shower) located outside of the containment laboratory, provide separate floor plan showing location of equipment relative to the PV2 laboratory.
12. PV laboratory personal protective equipment (PPE):
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Gloves
Scrubs
Eye/face protection
Dedicated lab shoes
Disposable wrap-around gown
Safety glasses
Respirator
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Tyvek suit or coverall
Face or surgical mask
Shoe Covers
Other:
13. Will facility supply PPE to visitors for entry to the PV laboratory? .........................................................................
Yes
No
Facility Physical Requirements for Location 1
Information regarding the physical requirements of the facility. If more than one area was declared, information is displayed for each.
Facility Physical Features
Reference
Feature Area
14.
8.3.2
Facilities are poliovirus dedicated laboratories, OR
15.
8.3.2
Facilities are non-dedicated laboratories. Non-dedicated facilities must demonstrate effective
segregation and decontamination procedures between work with poliovirus and other pathogens to
prevent cross-contamination.
16.
8.3.3
Containment perimeter is sealable for fumigation and with sealed penetrations to prevent uncontrolled
outward airflow irrespective of the choice of primary containment.
17.
NAC policy
Facility is equipped with a single door.
18.
NAC policy
Facility is equipped with two doors between public areas and PV containment area.
19.
8.3.5
Facility controls entry into the containment perimeter through a double-door personnel airlock.
20.
8.3.5
Features include alarms, interlocking doors or an equivalent system to ensure that more than one
door cannot be opened at a time.
21.
8.3.5
Anterooms and airlocks are within the containment perimeter and sealable for fumigation.
22.
8.3.6
Containment area marked with biohazard signs
23.
8.3.8
Facility controls exit from containment perimeter with appropriate steps to prevent exposure to
contaminated PPE or personnel (e.g., change area).
24.
8.3.9
Exits are clearly marked.
25.
8.3.15
Containment area equipped with vision panel(s) for visual monitoring of activities
Feature Area Comments: Lorum ipsum. Now is the time for all good men to come to the aid of their country.
Primary Containment Devices
Reference
Feature Area
26.
8.3.4
Containment area equipped with Class II biosafety cabinet(s)
27.
8.3.4
Containment area equipped with fully functional Class III biosafety cabinet(s) or similar isolators.
28.
8.3.15
Containment area has closed systems that have been leak tested and validated (e.g., manufacturing
processes and transfer of intermediates for use in vaccine production).
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Primary Containment Devices
Reference
29.
8.3.16
Feature Area
Containment area equipped with other primary containment devices (e.g., flexible film isolators, local
exhaust ventilation)
Feature Area Comments:
Decontamination Systems
Reference
Feature Area
30.
8.3.12
Containment area equipped with single door autoclave
31.
8.3.12
Containment area equipped with a dedicated pass-through autoclave. Autoclave has the following
features:
31a.
8.3.12
• Bioseal
31b.
8.3.12
• Interlocking doors to prevent opening the clean side prior to cycle completion
31c.
8.3.12
• Sterilization of air discharge
31d.
8.3.12
• Cycle recording mechanisms and alarms
32.
8.3.12
Containment area equipped with a material airlock/decontamination chamber sealable for fumigation
33.
8.3.12
Containment area equipped with a dunk tank containing sufficient active compound to inactivate
poliovirus
34.
NAC policy
Facility uses a tissue digester to dispose of PV animal waste (if applicable)
35.
NAC policy
Facility uses an incinerator to dispose of biohazardous waste
Feature Area Comments:
HVAC Systems
Reference
Feature Area
36.
8.3.10
36a.
NAC policy
37.
8.3.10
37a.
8.3.10
• Exhaust air is HEPA filtered
37b.
8.3.10
• Dedicated exhaust for PV area
37c.
8.3.10
• Dedicated supply for PV area
37d.
8.3.10
• Shared supply for PV area with supply-side HEPA filters directly on containment perimeter
37e.
8.3.10
• Backflow protection on supply air
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Controlled air system maintains inward directional airflow.
• Visual monitoring device, which confirms directional airflow, provided at the laboratory entry
Ventilation system features:
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HVAC Systems
Reference
Feature Area
37f.
8.3.10
• Ductwork sealable for fumigation
37g.
8.3.10
• Monitors/alarms to ensure directional airflow can be readily validated
Feature Area Comments:
Sinks and Showers
Reference
Feature Area
38.
NAC policy
39.
8.3.7
Containment area equipped with a hands-free or automated hand washing sink.
40.
8.3.7
Sinks located within and near exit of containment perimeter.
41.
8.3.8
Containment area equipped with a personnel exit shower.
42.
8.3.8
Containment area equipped with a personnel walk-through exit shower.
43.
8.3.8
Containment area equipped with an emergency shower.
Containment area equipped with a hand washing sink.
Feature Area Comments:
Effluent Decontamination
Reference
Feature Area
44.
8.3.11
All effluents from within the containment perimeter are decontaminated with a validated inactivation
procedure (e.g., EDS, chemical treatment of collected laboratory effluents)
45.
8.3.11
Effluent decontamination includes handwash
46.
8.3.11
Effluent decontamination includes shower/emergency shower water
47.
8.3.11
Effluent decontamination includes eyewash
48.
8.3.11
Effluent decontamination includes unsterilized autoclave condensate
49.
8.3.11
Backflow prevention is implemented on all liquid services/utilities passing across the polio
containment boundary and via measures to prevent release through traps, sinks and shower drains.
50.
8.3.11
Effluent treatment system is dedicated to PV containment area
51.
8.3.11
Non-dedicated effluent treatment system has appropriate measures for cross-contamination risk
based on risk assessment
52.
8.3.13
Kill-tank rooms or equivalent meet all construction, sealing, and HVAC requirements of the primary
containment space
53.
8.3.13
Kill-tank rooms or equivalent have an anteroom/personnel airlock for controlled entry
54.
8.3.13
Kill-tank rooms have appropriate spill risk mitigation measures. Such mitigations include:
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Effluent Decontamination
Reference
Feature Area
54a.
8.3.13
• Berms
54b.
8.3.13
• Leak detection systems or alarms
54c.
8.3.13
• Sump pumps
Feature Area Comments:
Security
Reference
Feature Area
55.
7.1.1
Security controls limit access to PV containment area to only authorized persons
56.
7.3.1
Authorized persons are in compliance with personnel reliability policies
57.
NAC policy
58.
7.1.1
59.
NAC policy
Lock(s) fail secure and allow egress only
60.
NAC policy
PV area(s) are enclosed by a permanent barrier from floor to ceiling, with entry doors that can be
securely locked
61.
NAC policy
Material used in the construction of the permanent barrier is of sufficient strength and thickness that it
cannot be readily or easily removed, penetrated, or bent
62.
NAC policy
Walls are permanent construction, floor to ceiling
63.
7.1.1
63a.
7.1.1
• Electronic records (e.g., proximity card system)
63b.
7.1.1
• Paper records (e.g., sign in log)
63c.
7.1.1
• Closed circuit television or video records
63d.
7.1.1
• None
64.
7.1.1
PV containment area equipped with video surveillance
65.
7.1.1
PV containment area equipped with intrusion detection system
66.
8.3.9
PV containment perimeter is equipped with emergency exit and/or other perimeter doors (not
authorized for employee entrance)
67.
8.3.9
Emergency exit doors from the containment perimeter are alarmed
68.
NAC policy
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Entry door(s) to PV area has a magnetic lock or an UL approved lock and lock cylinder which are
rated as burglary resistant
Locked door uses two-factor access control measure (e.g., card access system with personal access
code)
Entries into PV containment area are recorded
External hardware is removed (or lock cores sealed) on all fire exits and other perimeter doors could
provide access to the PV area
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Security
Reference
69.
8.3.9
Feature Area
PV containment perimeter is not equipped with emergency exit or other perimeter door(s) that could
provide entrance into containment
Feature Area Comments:
Storage Area
Reference
Feature Area
70.
10.5.3
PV material stored outside of the PV containment laboratory under appropriate containment conditions
71.
10.5.2
PV material stored in dedicated freezer(s)
72.
10.5.5
PV material storage area has recording and alarm systems to monitor freezers
73.
10.5.5
PV material storage area equipped with a back-up emergency power source
Feature Area Comments:
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SECTION 3: PRINCIPAL INVESTIGATOR GENERAL WORK
Completed for each principal investigator using or storing PV infectious or potentially infectious materials. If work activities differ by
poliovirus type (PV1, PV2, PV3), complete a separate Section 2 to report type-specific work.
PI ID ###
PRINCIPAL INVESTIGATOR (PI): [PI_Name]
SECTION 3a: INFECTIOUS MATERIAL (IM)
1.Material type used or stored: .....................................................................................................................................
2. Material use schedule: (Daily, weekly, quarterly, annually, storage only) .......................................................
3. Work activities include:
Animal Work
Immunology assays
Viral propagation
Antigen production
Inoculating specimens into PV permissive cells
Viral cloning
Antiviral efficacy assays
Nucleic acid detection or sequencing methods
Viral genetic modification
Antiviral resistance assays
Nucleic acid extraction methods
Viral concentration/purification
Other:
None (Storage only)
Not applicable
4. Estimated routine range of PV working concentrations [infectious units/mL]:
≤10^3
10^4-10^6
10^7-10^9
>10^9
Unknown
501ml-1L
1-10L
Not applicable for PIM
5. Estimated routine range of PV working volumes used:
≤10ml
11-100ml
101-500ml
>10L
None (Storage only)
6. Estimated maximum range of PV concentration used or stored [infectious units/ml]: ...........................................
7. Materials are removed from the containment laboratory (for any reason) ............................................
If yes, purpose for removal:
Yes
No
Yes
No
Procedures performed in another location outside of containment perimeter
Decontamination
Transfer to another facility
Other:
8. Materials inactivated for future work ....................................................................................................
If yes, inactivation method(s) and parameters used:
Method
Extraction
Parameters
Fixation
Heat
Irradiation
Other
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SECTION 3b: POTENTIALLY INFECTIOUS MATERIAL (PIM)
1. Material type used or stored: ...................................................................................................................................
2. Material use schedule: (Daily, weekly, quarterly, annually, storage only) ...............................................................
3. Work activities include:
Animal Work
Immunology assays
Viral propagation
Antigen production
Inoculating specimens into PV permissive cells
Viral cloning
Antiviral efficacy assays
Nucleic acid detection or sequencing methods
Viral genetic modification
Antiviral resistance assays
Nucleic acid extraction methods
Viral concentration/purification
Other:
None (Storage only)
Not applicable
4. Estimated routine range of PV working concentrations [infectious units/mL]:
≤10^3
10^4-10^6
10^7-10^9
>10^9
Unknown
501ml-1L
1-10L
Not applicable for PIM
5. Estimated routine range of PV working volumes used:
≤10ml
11-100ml
101-500ml
>10L
None (Storage only)
6. Estimated maximum range of PV concentration used or stored [infectious units/ml]: ...........................................
7. Materials are removed from the containment laboratory (for any reason) ............................................
If yes, purpose for removal:
Yes
No
Yes
No
Procedures performed in another location outside of containment perimeter
Decontamination
Transfer to another facility
Other:
8. Materials inactivated for future work ....................................................................................................
If yes, inactivation method(s) and parameters used:
Method
Extraction
Parameters
Fixation
Heat
Irradiation
Other
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SECTION 3c: PRINCIPAL INVESTIGATOR SPECIES SPECIFIC ANIMAL WORK
Information regarding animal species used in the PI’s work plan. Please answer each question; if more than one animal species is used,
provide information for each species. Complete section 3 for each poliovirus type if different type-specific (PV1, PV2, PV3) work activities
are performed.
SPECIES: [SpeciesType]
1. PV type used or stored: ......................................................................................................
2. Estimated frequency of animal work: .................................................................................................
3. Estimated routine range of animals used in a single experiment: ...............................................................
4. Containment device(s) used for manipulation of infected animals:
Class II BSC
Class III BSC
Inward Air Flow
Other:
Glove Box
Downdraft Table
5. Poliovirus infected animals housed in a separate room from other animals: ......................................................
Yes
No
6. Animal caging method(s) used:
Conventional caging
Ventilated containment caging system
7. Personal protective equipment (PPE) worn in PV animal laboratory:
Scrubs
Gloves
Safety Glasses
Disposable wrap-around gown
Face or surgical mask
Tyvek suit or coverall
Conventional caging within inward flow
ventilated enclosure
Eye/face protection
Respirator
Shoe Covers
Dedicated Lab Shoes
PAPR
Other:
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SECTION 4: VALIDATION
I declare that the information given in this form has been review by me and is, to the best of my knowledge, complete and correct.
I understand that any willful misrepresentation of fact would render _______________________________________[FacilityName]
liable to disqualification from the GAP Containment Certification Scheme (CCS).
INSTITUTION
REPRESENTATIVE
Printed name:
Signature:
Date:
BIOSAFETY
OFFICER
Printed name:
Signature:
Date:
PRINCIPAL
INVESTIGATOR
Printed name:
Signature:
Date:
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| File Type | application/pdf |
| File Modified | 2023-11-03 |
| File Created | 2023-09-19 |