Form 0920- Facility Incident Reporting Form FOR POLIOVIRUS RELEASE

Facility Incident Reporting

Facility Incident Reporting Form

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

FOR POLIOVIRUS THEFT or LOSS

Facilities retaining poliovirus infectious materials must report any poliovirus containment breach to the U.S. CDC Emergency Operation Center (EOC)
at (770) 488-7100. After notifying the EOC, submit this form to the U.S. National Authority for Containment of Poliovirus (NAC) at
[email protected] within 12 hours of the incident. Form sections A and B must be reported within 12 hours of the incident, and any
information not available at the time of submission should be provided as a resubmission within 72 hours of the incident. The U.S. NAC may share
information about the incident to poliovirus containment oversight bodies and CDC Incident Response leadership to ensure appropriate measures are
implemented.
FORM INSTRUCTIONS
Fill out each section of the form as completely as possible. Provide a signature after all sections are complete. If you are unable to sign digitally; print,
sign manually, and scan the document to PDF format. If the form is opened using a web browser and features are unavailable, reopen with Adobe
Acrobat. Send the completed form to the U.S. NAC at [email protected]. Contact NAC for assistance at [email protected] or
404-718-5160.

A. FACILITY INFORMATION (REPORT WITHIN 12 HOURS)
Facility Name:
Department:
Address:
Zip:

State:

City:

FACILITY CONTACT INFORMATION
Form submitted by:

Name

Title

Email

Phone #

Format: (xxx) xxx-xxxx

B. INCIDENT INFORMATION (REPORT WITHIN 12 HOURS)
1. Date of incident discovery1:
(Date format: MM/DD/YYYY)

Time of incident discovery:

(Include time zone, Ex: 9:15 am EST)

Date of CDC/NAC notification:

(Date format: MM/DD/YYYY)

2.

Has the incident been reported to the facility biosafety officer?............................................

Yes

No

N/A

3.

Has the incident been reported to the facility Security Representative?...............................

Yes

No

N/A

4.

Has the incident been reported to the appropriate law enforcement agency?......................

Yes

No

N/A

5.

Incident type (e.g., theft or loss):

6.

At what biosafety level did the incident occur?

For theft, complete section C1. For loss, complete section C2.
If other, please describe:

1 The date of incident discovery is the date that the incident was discovered by facility staff.

Public reporting burden: CDC estimates the average public reporting burden for this collection of information as 45 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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Facility Incident Reporting

B. INCIDENT INFORMATION, CONTINUED (REPORT WITHIN 12 HOURS)
7. Briefly describe the details of incident. e.g.,location (bldg, room, etc.) and equipment (freezer, centrifuge, etc.):

8. Enter the material type, virus type, sample type, and if known, the amount of virus sample involved in the incident. If there is
a mixture of material types, enter a separate record for each material type in separate rows. If known, enter the viral concentration
(ml or g) and/or poliovirus strain associated with the incident.
Virus Type

Material Type

Sample Type

Submit Form

Conc.
(µg/ml or titer)

Amt. (ml or g)

Poliovirus Strain

Submit Sections A and B
within 12 hours

C. ADDITIONAL INCIDENT DETAILS (REPORT WITHIN 72 HOURS)
C1. THEFT OF MATERIAL
1. Type of theft: (choose all that apply)

Insider/Insider Assist

Forced Entry

2. Was the stolen poliovirus material recovered?

Yes

No

If yes, date of recovery:

3. Was there a potential exposure to humans?

Yes

No

Unsure

Undetermined

Unauthorized Access

(Date format: MM/DD/YYYY)

(If yes, also complete the Facility Incident Reporting Form for Release/Exposure-link)

Reporting to Local Law Enforcement
4. Has local law enforcement been notified?

Yes

No

Not yet

5. Local law enforcement agency:
6. Local law enforcement point of contact (title and name):
7. Local law enforcement point of contact information (phone/email):

C2. LOSS OF MATERIAL
1. Type of loss: (choose all that apply)

Sample loss in transit

Sample loss/discarded at
facility

Inventory/record keeping error

Unknown

Other:

2. Was there a potential exposure to humans?

Yes

No

Unsure

(If yes, also complete the Facility Incident Reporting Form for Exposure/Release-link)

3. Was the lost poliovirus material recovered?

Yes

No

Unsure

If yes, date of recovery:
(Date format: MM/DD/YYYY)

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Facility Incident Reporting

C. ADDITIONAL INCIDENT DETAILS, CONTINUED (REPORT WITHIN 72 HOURS)
Provide the date of the last inventory/audit performed:

(Date format: MM/DD/YYYY)

Note: Provide an approximate date if exact date is unknown.

Provide a full narrative of the incident, including steps taken immediately after the incident.

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Facility Incident Reporting

D. DECLARATION
By signing this document, I acknowledge that the data provided are correct and accurately reflect the reported incident. I
understand that the information provided on this form may be provided to WHO2 and appropriate CDC leadership and may
result in a public health event of international concern (PHEIC) in accordance with WHO International Health Regulations.3
E-signature after Sections A, B, and C are complete:

Accountable Individual:
( e.g., Laboratory Head,
Principal Investigator)

Submit Form

Name:
Title:
Date:

Submit Sections C and D
within 72 hours

DEFINITIONS (General definitions on Appendix A on CDC U.S. NAC website)
Accountable individual: A person responsible for poliovirus materials (e.g.,
Principal Investigator, Laboratory Director).
Accident/incident: Event that occurs with IM or PIM poliovirus which may
impact poliovirus containment. Events may result in the following:
•
•
•
•

Injury
Exposure or illness
Breach of containment
Other events resulting in property damage or disruption of facility
operations
• Accidents/incidents hereinto referred to as incidents.

Certificate of Participation (CP): A CP formalizes the eligibility of the facility to
engage in the GAPIII/GAPIV CCS process.
Date of incident discovery: Date incident was discovered by facility staff.
Facility: Any site (e.g., laboratory, repository, or vaccine production unit) owned
or operated by any level of government, academic institution, corporation,
company, partnership, society, association, firm, sole proprietorship or other
legal entity.
Global Action Plan (GAPIII/GAPIV): The WHO global action plan to minimize
poliovirus facility associated risk after type-specific eradication of wild
polioviruses and sequential cessation of OPV use (GAPIII/GAPIV). GAPIII/
GAPIV aligns the safe handling and containment of poliovirus infectious and
potentially infectious materials with the WHO Endgame Strategy.
Infectious material (IM): Clinical materials from confirmed wild poliovirus
(including VDPV) infections or OPV/Sabin; environmental sewage or water
samples that have tested positive for the presence of wild polioviruses or OPV/
Sabin strains.
Nucleic acids: Refers to RNA, cDNA and total nucleic acid, extracted from
poliovirus infectious materials (e.g., a virus isolate) or potentially infectious
materials (e.g., stool, respiratory specimen, sewage). Extraction methods not
validated to inactive poliovirus should be reported as inactivation failures for
these materials.
Poliovirus containment perimeter: Poliovirus-essential facility area(s) listed on
the PEF CP application.
Potentially Infectious Materials (PIM): All materials potentially contaminated with
any type or strain of WPV or OPV/Sabin poliovirus, or where the presence of
polioviruses cannot be ruled out.

PIM can include but is not limited to:
• Fecal or respiratory secretion samples and their derivatives (e.g.,
stool suspensions, extracted nucleic acids, etc.) collected for any
purpose in a geographic area where WPV/cVDPV is present or
OPV is being used at the time of collection
• Products of such materials (above) from PV-permissive cells or
experimentally infected polio-susceptible animals
• Uncharacterized enterovirus-like cell culture isolates derived from
human specimens from countries known or suspected to have
circulating WPV/VDPV or use of OPV at the time of collection
• Respiratory and enteric virus stocks derived from PV PIM and
handled under conditions conducive to maintaining the viability or
enabling the replication of incidental PV
• Environmental samples (e.g., concentrated sewage, wastewater)
collected from areas known or suspected to have circulating
WPV/VDPV or use of OPV at the time of collection.
Poliovirus containment breach: Loss of poliovirus containment at any level
which may result in potential infection to persons or potential spread in the
environment. Any facility accident involving IM or PIM poliovirus that may
potentially expose humans to any poliovirus through ingestion, inhalation, or
skin contact by release, exposure, theft, or loss.
Poliovirus Essential Facility (PEF): A facility designed by the US NAC as
serving a critical national or international function that involves the handling
and/or storage of needed poliovirus infectious or potentially infectious
material.
Poliovirus exposure: Any facility accident that potentially exposes humans to
any poliovirus.
Poliovirus release: Loss of primary containment of IM or PIM poliovirus
which may result in potential infection to persons or potential spread in the
environment.
Risk assessment: A qualitative or semi-qualitative process undertaken by
individuals with expertise in appropriate disciplines and backgrounds in
response to an identified hazard.
Sabin/OPV: Attenuated poliovirus strains (approved for use in oral polio
vaccines by national regulatory authorities, principally Sabin strains).
VDPV: Vaccine-derived poliovirus; Classified with wild polioviruses and
usually demonstrate 1–15% sequence differences from the parental OPV
strain; they may have circulated in the community (cVDPV) or have
replicated for prolonged periods in immunodeficient subjects (iVDPV) or be
ambiguous and of unknown origin (aVDPV).

2 The Regional and Global Containment Commissions for the Certification of Eradication of Poliovirus.
3 International Health Regulations (2005), Third edition. Geneva: World Health Organization; 2016. (https://apps.who.int/iris/bitstream/
handle/10665/246107/9789241580496-eng.pdf?sequence=1, accessed 28 July 2020)

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