Form 0920- Global Action Plan (GAP) Poliovirus Containment Poliovir

FORM APPROVED
OMB NO. 0920-XXXX
EXP DATE: xx/xx/20xx

Global Action Plan (GAP) Poliovirus Containment
Poliovirus- Essential Facility Assessment Checklist
The Poliovirus-Essential Facility (PEF) Assessment Checklist is used to aid facilities preparing for an audit to obtain a poliovirus
(PV) containment certification. Facility information for U.S. laboratories retaining PV 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),
World Health Organization (WHO)) as relevant to WHO Global Action Plan to minimize poliovirus facility-associated risk after typespecific eradication. Note that as of May 2022, wild PV type 1 (WPV1) and type 3 (WPV3) infectious materials used or
stored in containment areas must be included.
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 WHO Containment Certification Scheme (CCS).
Poliovirus containment certification in the United States is a multi-step process overseen by the U.S. NAC.

Contents
SECTION 1: REQUIRED DOCUMENT SUBMISSION CHECKLIST
SECTION 2: FACILITY INFORMATION
SECTION 3: FACILITY SELF ASSESSMENT QUESTIONNAIRE
SECTION 4: FACILITY EVALUATION CHART

Public reporting burden: CDC estimates the average public reporting burden for this collection of information as 1.0 hours 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: FACILITY DOCUMENTS
Facility documents used for the development of an audit plan.
Document

Align to GAP Requirements
(Yes / In Progress / No)

An organizational chart outlining the Biorisk management-related
roles and responsibilities.
Biorisk management related documents (policies) and records.
A register of applicable laws, standards, and guidelines.
Biosafety/Biosecurity manuals and associated procedures.
Accident/Incident records relevant to poliovirus containment.
The list of contracted services, companies, and individuals.
Risk Assessments (e.g., those relating to emergency preparedness,
procedural controls, the design and operation of the facility and
equipment, decontamination measures, security measures, and
maintenance).
A map/floor plan, including any relevant support areas (e.g.,
ventilation areas, effluent treatment plant, storage areas, waste
handling/storage locations).

SECTION 2: FACILITY INFORMATION
1. Facility Assessment Completion Date:
2. Containment certificate(s) desired (Check all that apply):
Interim Certificate of Containment (ICC) ☐ Certificate of Containment (CC) ☐
3. Facility Name:
4. Office/Dept.:
5. Facility Physical Address:
6. Additional Offsite Address:
7. Individuals with key roles in the GAP biorisk management system have been designated as follows:
Role

Name

Senior manager
Biorisk management advisor (e.g.,
BSO)
Scientific manager (e.g., PI)
Occupational health professional
Facility manager
Security manager
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Role

Name

Animal care manager (if applicable)
Laboratory representative
Quality manager
Emergency response manager
SECTION 3: FACILITY ASSESSMENT QUESTIONAIRE
The following checklist reports PEF progress for GAP containment to assist the facility in preparation for a future NAC audit. In addition, the
completed questionnaire will be requested by the NAC to assist in developing an audit plan and determining readiness for Stage 1 audit. For each
question below, please indicate “yes” or “no” to report the PEF’s status on GAP and US NAC policy topics. If the topic is anticipated to be an ICCNC, please indicate “no”. Provide any additional information in the remarks section.
Element 1 - Biorisk Management System
Y
1.

2.
3.

1a. Has an internal audit for GAP been completed? If so, please
add the date in the Remarks column.
Does the facility have a system to capture audit nonconformances?
Are there preventative primary safeguards (i.e., facility
management, facility design and construction, and immunization
of personnel) in place to reduce the likelihood of the release of
poliovirus material?
Is the Biorisk management system reviewed at a predefined
frequency (e.g., biannually) to ensure suitability, adequacy, and
effectiveness?

5.

Are key performance indicators (i.e., audits and incident reporting)
in place to monitor the biorisk management system?

6.

Does the facility have a document control system in place?

8.
9.

Remarks

Does your facility have an internal audit process?

4.

7.

N

6a. Are controls in place for the review, update, and reapproval of
documents?
Is a communication system defined to ensure relevant and
current information that can potentially affect staff and others? Is
the communication system and its delivery to relevant personnel
effective?
Are the processes for selection and evaluation of
suppliers/contractors aligned with GAP?
Are continual improvement processes in place for various
elements in GAP?

10. Is general safety included in the GAP biorisk management
system?
11. Is there change management process in place and is it
documented?
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Element 2 - Risk Assessment and Control
Y
1.
2.

N

Remarks

N

Remarks

Is there general safety training for physical hazards associated with
the work in the facility? (e.g., general laboratory safety, chemical,
and fire safety)
Is there a hazard plan in place?

3.

Are biological hazards identified and assessed in relation to the
potential dangers to humans and the environment?

4.

Is there a risk management system established in the facility?
4a. Has the system been aligned to GAP with personnel
responsible and accountable for the implementation?
4b. Is compliance with the risk management system reviewed at
least annually?

5.

Has the facility conducted a risk assessment for GAP derogations?
5a. Are risk assessments for GAP derogations peer- reviewed?

6.

Has the facility defined the process used to identify the need for a
new risk assessment or the need to review an existing one?
Element 3 - Worker Health Program
Y

1.

2.
3.
4.
5.

6.

Does the facility ensure that the risk to worker health, and that of
other personnel whose health could be directly impacted by
exposure to biological agents and toxins, is managed effectively,
including through preventive and protective measures?
Has a vaccination policy been defined and implemented based on
risk and exposure?
Does the facility verify immunization and poliovirus protective
immunity for essential personnel?
Does the facility verify immunization records for support staff,
visitors, and contractors that enter poliovirus containment area?
Has the facility established a system to effectively manage medical
and/or environmental emergencies, including but not limited to
identifying potentially infected workers and providing immediate
medical care to exposed, ill or injured workers?
Has the facility implemented the U.S. NAC Policy for Occupational
Health Programs at U.S. Poliovirus-essential facilities?

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Element 4 - Competence and Training
1.

Y

N

Remarks

Y

N

Remarks

N

Remarks

Are qualifications, experience and aptitudes related to biorisk
considered as part of the employee recruitment process?
1a. Has the process been aligned with GAP requirements/and or
guidance?

2.

Are the requirements and procedures for biorisk-related training of
personnel identified, established, documented, and maintained?

3.

Have competency levels been defined and documented for staff?

4.
5.
6.

7.

3a. Are records maintained to show staff members have obtained
and demonstrated required levels of competency?
Does the facility have a process to identify roles and individuals
that require a back-up ensuring the integrity of the facility is not
compromised through short- or long-term absence?
Are there measures put in place for personnel who are no longer
employed at the facility (e.g., remove access to the facility,
computerized records, and data)?
Does the facility have an established program to address risk
associated with human behavior, as it pertains to health and safety,
including the management of how workers interact with the facility
and its equipment?
6a. Has the program been aligned to the GAP biorisk management
system?
Has the program implemented a Personnel Reliability Program as
outlined in the U.S. NAC Policy for U.S. Poliovirus-essential facilities
to Control Security of Poliovirus Materials and Information?
Element 5 - Good Microbiological Practice and Procedure

1.

Is a site-specific biosafety manual in place? (Based on risk
assessments focused on hazards associated with
poliovirus/poliovirus containing materials)

2.

Are appropriate resources (including time and equipment) available
to ensure good microbiological techniques are implemented and
effective?

3.

Is training in good microbiological techniques provided (i.e.,
annually, biannually)?
Element 6 - Clothing and Personal Protective Equipment (PPE)
Y

1.
2.
3.

Was adequate information used in selecting PPE (e.g. risk
assessments, review and analysis of tasks and employee feedback)
Are containment areas labeled with the appropriate level of PPE
required?
Is suitable equipment made available, used, and maintained
appropriately within the facility?

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Element 7 - Security

1.

Are controls in place for the physical security of cultures,
specimens, samples and potentially contaminated materials or
waste, determined as part of the risk assessment process?

2.

Are policy and procedures in place to identify sensitive
information?
Does the facility have a process in place to ensure that suppliers,
contractors, visitors, and subcontractors adhere to the established
management systems’ requirements and do not compromise the
facility’s biorisk management?

3.

4.

Y

N

Remarks

Y

N

Remarks

Y

N

Remarks

3a. Is the process documented and reviewed periodically?
Has the program implemented poliovirus material and information
security measures as outlined in the U.S. NAC Policy for U.S.
Poliovirus-essential facilities to Control Security of Poliovirus
Materials and Information?
Element 8 - Facility Physical Requirements

1.

Is there a formal process to commission new facilities and
decommission existing facilities?

2.

Does the facility design process identify and incorporate all
relevant legislative requirements, recognized standards, guidelines,
industry good practices and facility-specific risk assessments?

3.

Does the poliovirus containment area meet current GAP physical
feature requirements? (excluding any final containment
requirements at this time)
Element 9 - Equipment and Maintenance

1.
2.
3.

4.

Is a maintenance program for the poliovirus-essential facility and
equipment documented and aligned to GAP?
Are equipment control procedures documented and aligned to
GAP? (e.g., equipment inventory and calibration)
Does the facility ensure calibration and certification is scheduled
and conducted as required by the manufacturer’s requirements
and/or at other specified intervals as identified by risk
assessments?
Does the facility ensure competent and independent process
mechanisms are used when validating equipment?

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Element 10 - Poliovirus Inventory and Information
Y
1.

2.
3.

N

Remarks

Does the facility have a risk assessed based inventory process with
controls in place?
1a. Has the poliovirus inventory management system been aligned
to the U.S. NAC Policy for Poliovirus-Essential Facilities to Manage
Inventory?
Is there a documented process for intra-facility and inter-facility
transfers of poliovirus?
Has the facility conducted an inventory audit?
3a. Are the physical inventory and associated records reviewed at
least annually?

4.

Is the storage area equipped with back-up emergency power source
and with recording alarms systems to monitor freezers?
Element 11 - Waste Management, Decontamination, Disinfection and Sterilization

1.

Y

N

Remarks

Y

N

Remarks

Does the facility have an established program for appropriate
waste management for poliovirus materials?
1a. Has the facility identified and documented all contaminated or
potentially contaminated waste streams?

2.
3.

Are SOPs validated and shown to be effective against poliovirus
prior to their use?
Have inactivation protocols been validated in accordance with the
NAC Policy for U.S. Facilities to Inactivate Poliovirus Materials?
Element 12 - Transport Procedures

1.

2.

Does the facility have an established program for transfers and
transport of poliovirus, both inside and outside the facility
containment perimeter?
1a. Are transfers documented?
Does the facility report poliovirus material transfers to US NAC
consistent with NAC Policy for U.S. Facilities to Transfer Poliovirus
Materials?

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Element 13 - Emergency Response and Contingency Planning

1.
2.

Y

N

Remarks

Y

N

Remarks

Does the facility have a risk assessed based emergency plan in
place and are biological risks considered?
In the event of an emergency, are adequate contingency measures
in place to ensure the safety and security of continued operations?

3.

Are emergency plans effectively communicated to all employees
and relevant third parties, and tested with the goal of making
everyone aware of their obligations?

4.

Has the facility implemented the U.S. NAC Policy for Emergency
Response and Exposure Management Plans at U.S. Poliovirusessential facilities?
4a. Have PV-specific drills and exercises been conducted?
Element 14 - Accident/Incident Investigation

1.

2.
3.

Has facility defined criteria for what constitutes a significant
poliovirus exposure?
1a. Has a poliovirus post-exposure response plan been
established?
Are personnel responsible for maintaining the accident/incident
reporting system been identified?
Are documented procedures established and maintained to define,
record, analyze and learn from accidents and incidents involving
poliovirus?

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SECTION 4: FACILITY EVALUATION CHART
The following table provides a summary of progress for GAP containment. This information will assist the
NAC in developing an audit plan and determining readiness for a Stage 1 certification audit.

Element

Documented

(Yes or No)

Monitored
(Yes or No)

Element

Element 1
Biorisk Management System

Element 8
Facility Physical Requirements

Element 2
Risk Assessment and
Control

Element 9
Equipment and Maintenance

Element 3
Worker Health Program

Element 10
Poliovirus Inventory and
Information

Element 4
Competence and Training

Element 11
Waste Management,
Decontamination,
Disinfection and
Sterilization

Element 5
Good
Microbiological
Practice and
Procedure
Element 6
Clothing and Personal
Protective Equipment

Element 7
Security

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Documented

(Yes or No)

Monitored
(Yes or No)

Element 12
Transport
Procedures
Element 13
Emergency Response and
Contingency Planning

Element 14
Accident and Incident
Investigation

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Declaration of Validity

I hereby declare that to the best of my knowledge the information contained within this questionnaire
is true and accurate. I understand that the information may be used in the evaluation process to
assess the named organization's suitability as a Poliovirus-Essential Facility

Signature:

Signature:

Principal Investigator

Completed By

Completed By:

Date:

Job Position:

Telephone:

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