Form 0920- Personal Protective Equipment Survey for Laboratories

[CPR] U.S. National Authority for Containment of Poliovirus Data Collection Tools

Att6 - Global Action Plan (GAP) Poliovirus Containment Poliovirus-Essential Facility Questionnaire_Final

Att 7 _Personal Protective Equipment Survey for Laboratories

OMB: 0920-1424

Document [pdf]
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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

PAPR

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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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