IBC Policy 360 - Facility Inspection and Review

Adopted August 27, 2026

I. Policy Purpose

This policy establishes procedures for the periodic inspection of laboratories and other facilities in conducting IBC regulated activities and for periodic review of the Institutional Biosafety Committee's (IBC) overall biosafety program. These procedures are intended to verify ongoing compliance with the NIH Guidelines, applicable federal and state regulations, and to confirm that the Committee's oversight practices remain effective and current.

II. Policy Definitions

BMBL refers to the current edition of the Biosafety in Microbiological and Biomedical Laboratories, published by the CDC. The BMBL provides recommended guidance and best practices for the safe handling of biological hazards in laboratory settings.

NIH Guidelines means the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules; the set of regulations detailing safety practices and containment procedures for research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules.

r/sNA refers to recombinant or synthetic nucleic acid molecules. These molecules are subject to the federal NIH Guidelines cited above.

Regulated Activities include any research, teaching, and/or contracted service activity with r/sNAs or biological hazards conducted by SIUC faculty, staff, volunteers, and students.

Facility Inspection means an on-site evaluation of a laboratory or other space in which regulated activities occur, conducted to verify that engineering controls, work practices, signage, and administrative safeguards match those described in the approved MUA and comply with the NIH Guidelines and BMBL.

Corrective Action Plan (CAP) means a written plan, submitted by a Principal Investigator (PI) in response to inspection findings, describing the specific steps and timeline the laboratory will follow to resolve identified deficiencies.

Program Review means a periodic, comprehensive evaluation of the IBC's overall biosafety program, including MUA records, committee composition and member training, inspection records and CAP resolution, incident and noncompliance reports, and standard operating procedures, undertaken to confirm the effectiveness of institutional biosafety oversight.

III. Policy Statement

All laboratories and other facilities in which regulated activities are conducted under an approved MUA are subject to periodic inspection by the Biological Safety Officer (BSO), in coordination with the Office of Research Compliance (ORC), to verify ongoing compliance with the approved MUA, the NIH Guidelines, and applicable biosafety standards.

Deficiencies identified during an inspection must be corrected within the timeframe specified in this policy; uncorrected or serious deficiencies may result in suspension of the MUA and referral for investigation under Policy 510 (Investigation of Noncompliance).

In addition to individual facility inspections, the IBC's overall biosafety program will undergo a periodic Program Review to ensure the Committee's policies, procedures, and oversight practices remain effective, current, and consistent with the NIH Guidelines.

IV. General Procedures

A. Facility Inspections and Frequency

An initial facility inspection is required before regulated activities may begin at a new laboratory location and before an MUA involving a new facility is granted final approval.

Following initial approval, laboratories are reinspected on the following schedule, unless the Committee determines that risk factors warrant more frequent inspection:

• Annually for laboratories conducting work with r/sNAs or biological hazards requiring Biosafety Level 2 (BSL-2) or higher containment, work with Select Agents, or work involving experiments under Sections III-A through III-D of the NIH Guidelines.
• At least once every three years for laboratories conducting only low-risk activities, such as those falling under Sections III-E and III-F of the NIH Guidelines, consistent with the MUA renewal cycle described in Policy 320.

An inspection outside the routine schedule is also required whenever a laboratory:

• relocates to a new physical space;
• adds a new agent, material, or procedure that changes the laboratory's risk profile or required containment level;
• is amended to change biosafety level; or
• has been the subject of a reportable incident under Policy 500.

B. Conduct of the Inspection

Inspections are conducted by the BSO or a designee, and may include IBC committee members, ORC and CEHS staff, or other subject matter experts as appropriate. Routine re-inspections are ordinarily scheduled in advance with the PI or a laboratory designee; the BSO may also conduct unannounced walkthroughs to assess general safety compliance and physical conditions.

The inspection evaluates, at a minimum:

• consistency between activities observed in the laboratory and the activities and containment levels described in the approved MUA;
• required engineering controls (e.g., biological safety cabinet certification, autoclave validation, restricted access, signage and biohazard labeling);
• laboratory-specific biosafety practices, PPE use, and waste decontamination and disposal procedures;
• availability and currency of the laboratory's biosafety manual, standard operating procedures, and required training records; and
• any other item identified in the current IBC inspection checklist, which is maintained by the ORC and aligned with the containment requirements of the BMBL and the NIH Guidelines corresponding to the laboratory's biosafety level.

The inspection methodology combines document review, physical observation of the space and equipment, and discussion with the PI and laboratory personnel present.

C. Findings and Corrective Action

If a deficiency poses an immediate risk to personnel, public health, or the environment, the BSO, in consultation with the IBC Chair, may exercise emergency shutdown authority consistent with Policy 220.

Following the inspection, the BSO/ORC provides the PI with a written report identifying any deficiencies. For any deficiency identified, the PI must submit a Corrective Action Plan (CAP) to the ORC within 15 business days of receiving the inspection report, describing the corrective steps to be taken and the anticipated timeline for completion. The BSO, IBC Chair, and ORC reviews the CAP and verifies its completion, which may include a follow-up inspection.

Deficiencies are reported to the full Committee at their next ordinal meeting. Deficiencies that remain uncorrected beyond the agreed timeline or that recur across inspection cycles, may be referred for investigation under Policy 510.

Inspection reports and CAPs are maintained by the ORC as part of the laboratory's MUA file.

D. Program Review

In addition to individual facility inspections, the IBC's overall biosafety program undergoes a comprehensive Program Review annually using the Institutional Biosafety Committee Self-Assessment Tool or other tool agreed upon by the Institutional Official.

The Program Review is conducted by the ORC in consultation with the Chair and BSO, and evaluates:

• the timeliness and adequacy of MUA review and approval, including adherence to review categories described in Policy 320;
• the completeness of facility inspection records and the resolution of associated CAPs;
• committee composition, quorum practices, and member training;
• consistency of institutional policies with current NIH Guidelines, BMBL, and other applicable federal guidance.

The ORC summarizes the results of the Program Review in a written report. Where the review identifies gaps in policy or practice, the Chair brings recommended revisions to the full Committee for consideration.

E. Reporting to the Committee

The BSO reports a summary of facility inspection activity and any significant or unresolved findings to the Committee at each regularly scheduled meeting. The results of each Program Review are reported to the full Committee and to the IO.