Comprehensive Risk-Based Laboratory Inspection Program

Boston University
Boston Medical Center

Comprehensive Risk-Based Laboratory Inspection Program

Prepared by:
Environmental Health and Safety

December 2014

704 Commonwealth Avenue
Boston, Massachusetts 02215
(617) 353-4094

85 E. Newton Street, M-470
Boston, Massachusetts 02118
(617) 638-8830

1. Introduction

Research laboratories use a variety of hazardous materials (e.g., chemical, biological, radiological), and potentially hazardous procedures and equipment (e.g., centrifuges, x-rays, lasers) that carry the potential for causing physical injuries (e.g., via pressurized vessels, vacuum systems) or general fire or life safety hazards (e.g., via flammable materials, electrical/electronic equipment).

All of these substances, equipment, and activities are governed by an array of regulations that have been promulgated by local, state, and/or federal agencies. Many of these regulations require oversight provisions that mandate:

• The submission of an application for review and approval (e.g., biological materials use);
• The tracking of activities post-approval (e.g., environmental health and safety surveillance) and periodic reviews, audits, and inspections;
• Maintenance of detailed inventories of hazardous materials (e.g., chemical or radiological), animals, and controlled substances;
• Training programs for individuals engaged in research activities; and
• Unannounced inspections by regulatory agencies.

2. Purpose and Scope

2.1. The purpose of the laboratory safety inspection program is to ensure that appropriate service is being provided to assist laboratories in complying with Federal, State, Municipal and Institutional requirements. Each laboratory area will receive, at a minimum, one laboratory safety inspection per year from the Office of Environmental Health and Safety (OEHS), which will support this goal. All inspections are conducted with either the Principal Investigator or his or her assigned Laboratory Safety Coordinator present. Following the inspection, EHSEnvironmental Health & Safety will issue a report containing the findings, identifying the responsible party, proposing a corrective action, and giving a target date for the corrective action to be completed.

3. References

3.1. Regulations

3.1.1. 29 CFR 1910.1450 – Occupational Exposure to Hazardous Chemicals In Laboratories
3.1.2. 29 CFR 1910.1030 – Occupational Exposure to Bloodborne Pathogens
3.1.3. Biosafety in Microbiological and Biomedical Laboratories, 5th Edition
3.1.4. NIHNational Institutes of Health Guideline for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
3.1.5. Boston Fire Prevention Code
3.1.6. NFPA 101 Life Safety Code
3.1.7. NFPA 45 Laboratories Using Chemicals
3.1.8. City of Boston Laboratory Registration Ordinance
3.1.9. Boston Public Health Commission Laboratory Regulation
3.1.8. 105 CMR 480.000 Minimum Requirements for the Management of Medical or Biological Waste (State Sanitary Code Chapter VIII)
3.1.9. Boston Public Health Commission Recombinant DNA Technology: Use Regulation
3.1.10. Boston Public Health Commission Disease Surveillance and Reporting Regulation
3.1.11. 105 CMR 700.000: Implementation of M.G.L. c.94C (controlled substances)
3.1.12. 42 CFR Part 73 Possession, 7 CFR Part 331 and 9 CFR Part 121, Use and Transfer of Select Agents and Toxins
3.1.13. 49 CFR DOT Hazardous Materials Transportation
3.1.14. IATA Dangerous Transportation

3.2 BU Policies

3.2.1. Chemical Hygiene Plan
3.2.2. Biosafety Manual
3.2.3. Institutional Animal Care and Use Committee
3.2.4. Institutional Biosafety Committee
3.2.5. Laboratory Safety Committees
3.2.6. Radiation Safety Committee
3.2.7. Controlled Substance Program
3.2.8. Integrated Pest Control

3.3 Other SOP

3.3.1. IBCInstitutional Biosafety Committee The IBC is an instituti... Biological Use Authorization Review
3.3.2. Biological Use Authorization Site Assessment

3.4 Supplementary Documents

3.4.1. IBC Approval Summary Form
3.4.2. Lab Inspection Deficiency Form
3.4.3. BUA Site Assessment Form
3.4.4. PIPrincipal Investigator View Boston University's policy on... Pre Inspection Report
3.4.5. Chemical Inventory Report

4. Definitions

4.1 Tier Levels: The OEHS has established a system in order to evaluate the hazards and risks of each laboratory on the Boston University/Boston University Medical Campus (BU/BUMCBoston University Medical Campus) campus. Each laboratory is assigned a tier based upon laboratory hazards, biological hazards, and the laboratory’s performance. Tier levels are assessed and documented (See Appendix I) during laboratory inspections conducted by the OEHS and assigned as follows:

Tier 3:

• Biosafety level 3 (BSL-3) laboratories are automatically included in this category
• Labs that routinely use significant quantities or varieties of chemicals included in the BU High Hazard Chemical Program or biological agents identified by the Laboratory Acquired Infection (LAI) Subcommittee of the IBC
• Labs with current radiation permits
• Labs that use Schedule 1 controlled substances
• Labs that conduct high-risk experiments
• Labs that have been found to have multiple deficiencies and compliance issues that require close oversight from OEHS
• Labs in which frequent student turnover necessitates regular training and/or EHS support
• These laboratories are inspected quarterly; the Category B checklists will be used on the following schedule: Q1 Biological Safety; Q2 Controlled Substance; Q3 Chemical Safety; Q4 Fire and General Safety. Category A checklists will be used each quarter

Tier 2:

• Labs that routinely use any chemical included in the BU High Hazard Chemical Program, biological agents identified by the Laboratory Acquired Infection (LAI) Advisory Subcommittee of the IBC, risk group 2 (RG-2) biological agents in large volumes
• Labs that routinely employ processes or procedures that are determined by OEHS to constitute a potentially significant hazard, including mechanical or physical hazards
• Labs that use non-Schedule 1 controlled substances
• Labs that have been found to have some deficiencies and compliance issues that require more regular oversight from OEHS
• Labs in which intermittent student turnover necessitates additional training and/or EHS support
• These laboratories are inspected semi-annually; the Category B checklists will be used on the as follows: from Biological Safety, Controlled Substance, Chemical Safety and Fire and General Safety two Category B checklists will be selected for each of the two semi-annual inspections. Any combination may be used at the discretion of the assigned Safety Specialist according to the needs of the inspection; no Category B checklist may be repeated in any 12-month period. Category A checklists will be used at both semi-annual inspections

Tier 1:

• Labs that do not routinely use any chemical included in the BU High Hazard Chemical Program, biological agents identified by the Laboratory Acquired Infection (LAI) Advisory Subcommittee of the IBC, risk group 2
• (RG-2) biological agents in large volumes, or routinely employ processes or procedures that are determined by OEHS to constitute a potentially significant hazard
• Tier 1 laboratories are free of deficiencies and compliance issues and do not require additional oversight from OEHS
• These laboratories are inspected annually; the Category A and all Category B checklists will be used at the annual inspection

Tier determinations may be modified in two ways. A laboratory may be designated as a higher tier by changes to research procedures concurrent with IBC approval, update of chemical inventory to include qualifying chemicals, or observation of deficiencies and compliance issues as noted by OEHS. A laboratory may be designated as a lower tier by changes to research procedures concurrent with IBC approval, update of chemical inventory to remove qualifying chemicals, or by two consecutive inspection cycles during which observed deficiencies and compliance issues are resolved and do not recur. Any change in tier designation will be communicated to the Principle Investigator (PI) prior to commencement of the modified inspection schedule.

4.2. RIMSResearch Information Management System Learn more and acc... – The Research Information Management System, an online application for collection and management of data for various compliance requirements

4.3. Oversight Committees – Committees with provide oversight for various safety or compliance-related issues. Examples include the Institutional Biosafety Committee (IBC), the Laboratory Safety Committee (LSCLaboratory Safety Committee), the Intuitional Animal Care and Use Committee (IACUCInstitutional Animal Care and Use Committee IACUC oversee...), the Radiation Safety Committee (RSCRadiation Safety Committee The Radiation Safety Committee...), and the Institutional Review Board (IRB)

4.4. Principal Investigator (PI) – A faculty member or person with equivalent position who is in charge of and has overall responsibility to ensure the safety of the laboratory facility and its personnel

4.5. Laboratory Safety Coordinator (LSC) – A person appointed by the PI to supervise and be in charge of the daily laboratory operations, to ensure safety and compliance with safety, and to serve as a liaison with EHS

5. Procedures and Instructions

5.1. Frequency – Several oversight agencies have requirements that inspections be performed routinely and at least annually. The major categories of inspections are: biological safety, chemical safety, fire and life safety, radiation safety, and controlled substances. Therefore, at BU and BUMC, the program is designed to perform at least one comprehensive inspection annually for each laboratory based on the risk assessment.

5.2. Ownership – EHS staff members are assigned to specific schools, departments, and/or principal investigators (PIs). These assignments encompass all PIs, administrators, and other groups, this procedure primarily focuses on the PIs who are actively performing research and/or teaching, as well as the laboratories in which these activities are ongoing.

5.3. Scheduling Inspections – At a minimum at the start of each inspection period each DSA will notify PI’s and LSC’s of the content of the inspection. Since every group is different and some groups have more turnover than others, the DSA may decide to send detailed information, locations of documents, etc. prior to the inspection. DSA’s are expected to build a working relationship with the laboratories for which they are responsible. In this way, depending upon the preference of the PI and/or LSC, the DSA will either schedule an exact time to inspect, give an approximate timeframe, or visit the lab unannounced.

5.4. Pre-Inspection Preparation – Prior to arriving at the lab there are a number of items the DSA will review, including but not limited to: reviewing protocols, reviewing chemical inventories, checking training records, noting open deficiencies for reassessment, and assessing repetitive deficiencies. The PI pre-inspection report, and IBC and IACUC protocols are the principal sources for this information.

5.5. Inspection Process – The DSA will begin by discussing the above information and reviewing paperwork, records etc. with the lab prior to the physical walkthrough. Then a physical walkthrough will be conducted using the inspection checklist provided in Appendix 1.

5.6. Reporting – At the conclusion of each inspection, a report is issued to the individual responsible (i.e., the PI, laboratory safety coordinator, etc.) outlining any findings, along with recommendations for corrective actions, if necessary. The responsible individual is required to provide a response outlining the actions taken to remedy the findings and to prevent their reoccurrence.

EHS will also report any relevant changes in personnel or research status to the appropriate committees for follow-up (e.g. IBC, LSC, etc.) Depending on the nature of the findings, EHS may re-visit the laboratory to confirm that any corrective actions have been implemented, or follow up on specific issues at the time of the next scheduled meeting with the laboratory safety coordinator. See section 7 for proper follow up and assessment of deficiencies.

6. Roles & Responsibilities

6.1. Environmental Health and Safety (EHS) Research Safety (RS) staff

6.1.1. Conduct comprehensive safety inspections of research facilities per this protocol.

6.1.2. Assist Principal Investigators, Laboratory Safety Coordinators and other responsible parties in addressing and correcting findings identified during the inspection.

6.1.3. Inform laboratories of potentially hazardous situations and assist inmitigating the hazard.

6.1.4. Report laboratories that continuously conduct unsafe practices or continued noncompliance for re-assessment and tier adjustment.

6.1.5. Report laboratories that are required to submit registrations or amendments to the IBC.

6.2 The Principal Investigator

6.2.1. Ensure that the laboratories under his or her supervision are safe and in compliance with Federal, State, Municipal and Institutional requirements.

6.2.2. Ensure that findings identified during the inspection are addressed.

6.2.3. Provide the appropriate information regarding the laboratory in RIMS.

6.2.4 Be available or designate a Laboratory Safety Coordinator to the Research Safety staff to answer questions and address issues before, during, and after the inspection visit.

6.2.5. Ensure that corrective actions are implemented in a timely manner.

6.2.6. Report to EHS and any relevant oversight committees when corrective actions have been implemented.

6.2.7. Ensure that all members of the lab have completed their training requirements.

6.3 Oversight Committees

6.3.1. Provide oversight of programs in the Committee’s technical area (i.e., biosafety, chemical safety, etc.).

6.3.2. Review inspection reports of laboratories that continue to be in noncompliance with applicable regulations and BU policies and implement disciplinary actions as necessary.

6.4 Laboratory Safety Coordinator

6.4.1. As designated by the PI, be available to answer questions and address issues before, during, and after the inspection visit.

6.4.2 Ensure that corrective actions are implemented in a timely manner.

6.4.3 Communicate with the PI and other laboratory researchers about the findings of the inspection and any corrective actions that must be implemented.

7. Special Requirements- Deficiencies and Follow-up

Once a deficiency is identified an assessment will be made. Deficiencies may be categorized as “high risk” “moderate risk” or “low risk” depending on several variables. An example of this would be improper PPE; while this may be low or moderate risk while working with non-high-hazard chemicals, it also has the potential to be an immediate danger to life and health (IDLH) if handling high-hazard chemicals (HHC).

Definitions:

Immediately Dangerous to Life and Health (IDLH) – A deficiency that may cause death or severe disability as found.
High Risk – A deficiency that has the ability to cause death or severe injury if it is not remedied in a timely manner or is recurrent. High risk of environmental or building impact may also make a deficiency “high risk.”
Moderate Risk – A deficiency that has the potential to cause harm or injury but is not severe or life threatening. The risk of moderate fines, building damage, environmental impact may also fall under “moderate risk.”
Low Risk – A deficiency that will generally not cause harm to the user or environment, but may pose minor fines and/or do not comply with BU policy. Paperwork and minor labeling issues are examples of “low risk.”
Frequency – If a single type of deficiency is noted repeatedly or frequently, it may result in an increase in the categorization of the risk. Observance of the same low risk deficiency in three consecutive inspections (including follow-up visits) will result in re-categorization of that deficiency as a moderate risk. Observance of the same moderate risk deficiency in two consecutive inspections (including follow-up visits) will result in re-categorization of that deficiency as a high risk. Observance of the same high-risk deficiency in two consecutive inspections (including follow-up visits) will result in re-categorization of that deficiency as IDLH.

Actions:

Corrective actions will take place in accordance to the categories above. If any deficiency or hazard falls in the IDLH or high-risk category, immediate corrective actions must occur. Depending on the deficiency this may include resolving the issue at the time of the inspection, immediately notifying Facilities while remaining present at location, or stopping all work and/or evacuating until corrective actions can be taken. A report will also be forwarded to the Laboratory Safety Committee or the IBC, as appropriate, for review and follow-up.

If a deficiency falls into the moderate risk category, corrective actions must take place in a timely manner. Within 2 weeks of the initial inspection visit, EHS will conduct an unannounced follow-up visit to the laboratory to confirm that appropriate services are being provided and to assist the laboratory in addressing any open corrective items. The follow-up visit allows Research Safety staff to confirm that corrective actions are being implemented and consult with the Principal Investigator and/or Laboratory Safety Coordinator.

A deficiency that falls into the low risk category does not require immediate remediation. These deficiencies will be communicated during the inspection and noted in the RIMS inspection report. These deficiencies will be re-examined during the next inspection or follow-up visit.

8. Forms –See Appendices

9. Training-See Laboratory Safety Training Program

10. Records Management- All records of inspections are saved in the RIMS

11. Program Revision History- This document as well as the inspection checklist will be reviewed at least annually by the research safety division.

12. Appendices

Appendix I: Risk assessment worksheet (tier assignment)

Appendix II: Complete inspection checklist

Category A checklist
Category B checklist – Biological
Category B checklist – Controlled Substance
Category B checklist – Chemical
Category B checklist – Fire and General Safety