Prior to conducting the review, it would be helpful to assemble the
following documents:

1.  Last copy of the Security Inspection (Internal and external
    conducted by OIG, CDC, VISN, etc.)

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1.  A copy of security related training records

2.  Record of inventory (select agents and toxins, or hazardous agents)

3.  Agent specific training records

4.  Records of access to the BSL -3 research laboratory

5.  A copy of Certificate of Registration, if applicable (All
    Certificates of Registration must be maintained and renewed when
    applicable as required by CDC or APHIS.)

> A list of acronyms is found in Appendix A. A list of general
> references is found in Appendix B.

+---+----------------------------------+---+-----------------------------+
|   | **ISSUES**                       | * | **COMMENTS**                |
|   |                                  | * |                             |
|   |                                  | 1 |                             |
|   |                                  | - |                             |
|   |                                  | 5 |                             |
|   |                                  | \ |                             |
|   |                                  | * |                             |
|   |                                  | * |                             |
|   |                                  | * |                             |
+===+==================================+===+=============================+
| * | Facility is located away from    |   |                             |
| * | public access points and common  |   |                             |
| 1 | use areas                        |   |                             |
| . |                                  |   |                             |
| * |                                  |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | All views of exterior entry are  |   |                             |
| * | unobstructed                     |   |                             |
| 2 |                                  |   |                             |
| . |                                  |   |                             |
| * |                                  |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | Area is clearly marked as        |   |                             |
| * | restricted                       |   |                             |
| 3 |                                  |   |                             |
| . |                                  |   |                             |
| * |                                  |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | No windows present or windows    |   | See VHA Handbook 1200.06,   |
| * | meet specifications in VA        |   | 7.e.(2)(j)                  |
| 4 | requirements                     |   |                             |
| . |                                  |   |                             |
| * |                                  |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | Video surveillance systems are   |   |                             |
| * | in place                         |   |                             |
| 5 |                                  |   |                             |
| . |                                  |   |                             |
| * |                                  |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | Doors are self-closing           |   |                             |
| * |                                  |   |                             |
| 6 |                                  |   |                             |
| . |                                  |   |                             |
| * |                                  |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | Doors are secured at all times   |   |                             |
| * |                                  |   |                             |
| 7 |                                  |   |                             |
| . |                                  |   |                             |
| * |                                  |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | Access into areas from overhead  |   |                             |
| * | is prevented                     |   |                             |
| 8 |                                  |   |                             |
| . |                                  |   |                             |
| * |                                  |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | Access is only by keycard or a   |   |                             |
| * | system that is equal to, or      |   |                             |
| 9 | exceeds, the security of a       |   |                             |
| . | keycard system                   |   |                             |
| * |                                  |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | Audible security alarms are      |   | Note: With appropriate      |
| * | present and regularly tested     |   | justification, silent       |
| 1 |                                  |   | alarms or strobe lights may |
| 0 |                                  |   | be used.                    |
| . |                                  |   |                             |
| * |                                  |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | Security devices are fully       |   |                             |
| * | integrated with medical center   |   |                             |
| 1 | security system                  |   |                             |
| 1 |                                  |   |                             |
| . |                                  |   |                             |
| * |                                  |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | Security codes are changed       |   | Unless changed              |
| * | quarterly                        |   | electronically and          |
| 1 |                                  |   | automatically at frequent   |
| 2 |                                  |   | intervals and at least      |
| . |                                  |   | quarterly                   |
| * |                                  |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | Control of access on a 24 hour,  |   |                             |
| * | 7 days a week schedule,          |   |                             |
| 1 | including weekends and holidays  |   |                             |
| 3 |                                  |   |                             |
| . |                                  |   |                             |
| * |                                  |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | Entry and exit control rosters   |   |                             |
| * | are maintained and reviewed      |   |                             |
| 1 | weekly; findings documented      |   |                             |
| 4 |                                  |   |                             |
| . |                                  |   |                             |
| * |                                  |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | The number of people authorized  |   |                             |
| * | access to the BSL-3 is kept to   |   |                             |
| 1 | the minimum consistent with      |   |                             |
| 5 | operational and security         |   |                             |
| . | requirements, including routine  |   |                             |
| * | cleaning, maintenance, and       |   |                             |
| * | repairs                          |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | Strangers/personnel without      |   |                             |
| * | badges are challenged            |   |                             |
| 1 |                                  |   |                             |
| 6 |                                  |   |                             |
| . |                                  |   |                             |
| * |                                  |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | Security for all containers,     |   |                             |
| * | refrigerators, freezers,         |   |                             |
| 1 | cabinets, or other areas where   |   |                             |
| 7 | hazardous agents are stored must |   |                             |
| . | be provided to ensure control at |   |                             |
| * | all times                        |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | Telephone is located inside the  |   |                             |
| * | laboratory                       |   |                             |
| 1 |                                  |   |                             |
| 8 |                                  |   |                             |
| . |                                  |   |                             |
| * |                                  |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | Hazardous Agents Control Program |   |                             |
| * | is in place:                     |   |                             |
| 1 |                                  |   |                             |
| 9 | -   Monitor and evaluate program |   |                             |
| . |                                  |   |                             |
| * | -   Appointed Responsible        |   |                             |
| * |     Official (RO) ensures that   |   |                             |
|   |     the research security        |   |                             |
|   |     programs are in compliance   |   |                             |
|   |     with current regulatory      |   |                             |
|   |     requirements                 |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | Security plan is based on a      |   |                             |
| * | site-specific risk assessment    |   |                             |
| 2 | for agents that are present      |   |                             |
| 0 |                                  |   |                             |
| . |                                  |   |                             |
| * |                                  |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | Security plan includes all       |   |                             |
| * | required elements of the VHA     |   |                             |
| 2 | Handbook and has been signed by  |   |                             |
| 1 | staff as designated by the       |   |                             |
| . | Facility                         |   |                             |
| * |                                  |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | VA police participated in the    |   |                             |
| * | development of security policies |   |                             |
| 2 |                                  |   |                             |
| 2 |                                  |   |                             |
| . |                                  |   |                             |
| * |                                  |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | Facility security standards are  |   |                             |
| * | reviewed annually                |   |                             |
| 2 |                                  |   |                             |
| 3 |                                  |   |                             |
| . |                                  |   |                             |
| * |                                  |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | Emergency Preparedness and       |   |                             |
| * | Incident Response Plan exists    |   |                             |
| 2 | and                              |   |                             |
| 4 |                                  |   |                             |
| . | -   Has been distributed to      |   |                             |
| * |     personnel                    |   |                             |
| * |                                  |   |                             |
|   | -   Is reviewed annually         |   |                             |
|   |                                  |   |                             |
|   | -   Drill conducted annually     |   |                             |
|   |                                  |   |                             |
|   | -   Reassessment done after each |   |                             |
|   |     incident                     |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | Vulnerability assessment is in   |   |                             |
| * | place and conducted by           |   |                             |
| 2 | multidisciplinary team annually  |   |                             |
| 5 |                                  |   |                             |
| . |                                  |   |                             |
| * |                                  |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | Human Resources has conducted a  |   |                             |
| * | background check on all          |   |                             |
| 2 | personnel authorized access to   |   |                             |
| 6 | BSL-3 facilities, and personnel  |   |                             |
| . | status is reviewed semiannually  |   |                             |
| * | by R&D Committee                 |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | Access is not permitted for      |   | If BSL-3 laboratory has     |
| * | those individuals deemed in the  |   | non-exempt quantities of    |
| 2 | USA Patriot Act to be restricted |   | select agents or toxins.    |
| 7 | from shipping, receiving,        |   |                             |
| . | transporting, or possessing      |   |                             |
| * | biological select agents         |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | Individuals who have access to   |   | Applies to laboratories     |
| * | select agents or toxins have     |   | with non-exempt quantities  |
| 2 | undergone a security risk        |   | of select agents or toxins. |
| 8 | assessment by the Attorney       |   |                             |
| . | General                          |   |                             |
| * |                                  |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+
| * | All security related training    |   |                             |
| * | requirements are met in          |   |                             |
| 2 | compliance with VHA Handbook     |   |                             |
| 9 | 1200.06                          |   |                             |
| . |                                  |   |                             |
| * |                                  |   |                             |
| * |                                  |   |                             |
+---+----------------------------------+---+-----------------------------+

**ACRONYMS**

APHIS Animal and Plant Health Inspection Service

BMBL Biological in Microbiological and Biomedical Laboratories

BSL Biological Safety Level

CDC Centers for Disease Control and Prevention

ESP Equivalent Security Provided

IIP Installation In Progress

OIG Office of Inspection General

OSHA Occupational Safety and Health Administration

PCA Plans for Corrective Action

RO Responsible Official

SAT Select Agents or Toxins

USDA United States Department of Agriculture

VISN Veterans Integrated Service Network

**References**

-   Title 42 CFR Part 73.11

-   VA Directive 0730 -- Security and Law Enforcement

-   VA Directive and Handbook 0710, Personnel Suitability and Security
    Program

-   VHA Handbook 1200.06, "Control of Hazardous Agents in VA Research
    Laboratories," October 21, 2005

-   Biosafety in Microbiological and Biomedical Laboratories (BMBL),
    Section VI, 5^th^ Edition, February 2007.

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