The National Institutes of Health (NIH), Office of Research Services (ORS), Division of Occupational Health and Safety (DOHS) contracted an 8(a) Prime Contractor to provide safety and health consulting support services in the Safety Engineering Activity (SEA) Office. CRC conducted 49% of the scope of the contract. Our company has served as a subcontractor for this contract and previous contracts of similar size and scope for the client since 2000. We have supported three 8(a) prime contractors for this engagement.
Breadth of Scope
The National Institutes of Health serves under the U.S. Department of Health and Human Services (DHHS) and fosters fundamental creative discoveries, innovative research strategies and their applications as a basis for ultimately protecting and improving public health. The National Institutes of Health is a campus located in Bethesda, MD (similar to a university) that is comprised on over 60 buildings, parking garages and trailers. In addition, there are four satellite campuses: Rocky Mountain Laboratory located in Hamilton, MT; Integrated Research Facility (IRF) located in Frederick, MD; National Institutes of Health Animal Center located in Poolesville, MD and Bayview Research Center located in Baltimore, MD. CRC has offices located within the Division of Occupational Health and Safety located at the National Institutes of Health Main Campus in Building 13 that are adjacent to the NBBTP office and provides support on an as-needed basis the Main Campus and the four satellite campuses.
The work provided by CRC in support of the NIH is niche and requires full-time safety engineers, communications specialists, biosafety professionals, and subject matter experts to provide program management services for SEA. Programs managed by CRC that immediately affected the NIH and the affiliated biosafety and research community included:
- National Biosafety and Biocontainment Training Program (NBBTP) training support and mentorship
- Biosafety standards, policies, and guidelines development (NIH BSL-3 Certification Requirements and Checklist; NIH BSL-4 Certification Requirements and Checklist; Standard ANSI: Testing and Performance Verification Methodologies For Ventilation Systems for Biological Safety Level (BSL-3) and Animal Biological Safety Level (ABSL-3) Facilities; NIH Design Requirements Manual)
- Program management
- Meeting management
- Public health communications and training
- Digital and information solutions
- BSL-3/BSL-4 consulting
As noted by the assessing official on our most recent Contractor Performance Assessment Report (CPAR) evaluation, “The contract [has] successfully met all the project deadlines assigned to them and [has] become an excellent resource for the NIH Division of Occupational Health and Safety. In addition, the contractor staff have demonstrated at all times a great work ethic, professionalism and respect to the government colleagues…Contractor has provided exceptional quality in support of the NIH DOHS.”
Biosafety Standards, Policies, and Guidelines Development
CRC managed the delivery and updates to integral biosafety standards, policies, and guidelines that impact the biosafety community worldwide. We highlight this experience to demonstrate our in-depth knowledge and experience regarding biosafety. CRC’s biosafety and biocontainment SMEs represented the DOHS on revision committees in the past and now as revisions are proposed for the NIH Design Requirements Manual. This is an industry standard used nationally and internationally. As part of this document there is a variance process. CRC reviewed all biosafety and safety-related variances. Our review assessed the applicable codes, guidelines, and regulations cognizant of their intent. We evaluated compensatory protection features, materials, impact on operational procedures, performed risk assessments and economic impact, analyzed industry effects, evaluated if the equivalent achieves equivalent risk reduction, and determined if the variance ensured lasting and reasonable compliance.
CRC’s biosafety and biocontainment Subject Matter Experts (SMEs) designed, developed, and implemented the NIH BSL-3 Certification Requirements and Checklist. This document is published and used widely in the biomedical and bio-research industry. The Department of Defense (DOD) has adopted the document for commissioning their laboratories as required in Department of the Army Pamphlet 385–69, Safety Standards for Microbiological and Biomedical Laboratories (UNCLASSIFIED). CRC maintained the NIH BSL-3 Certification Requirements document and has expanded later versions to include similar internal certification requirements and checklists for ABSL-3 laboratories and BSL-4 laboratories. As we have reviewed and updated the checklists annually, they have become more detailed in later versions and increasingly risk-based.
CRC’s contract responsibility for biosafety and biocontainment consulting also included representing the DOHS on revision committees in the past and now as revisions are proposed for the NIH Design Requirements Manual. This is a biosafety industry standard used nationally and internationally. As part of this document there is a variance process. As the DOHS project manager and lead technical representative for this process, CRC had the variance reviewed by safety personnel within the division who have subspecialties to reach consensus for recommendation on the variance approval.
BSL-3/BSL-4 Consulting
Our biosafety, engineering, owner advocacy, program management, and psychological support services included mechanical, industrial, and safety engineering plan reviews and related site assessments/audits, engineering system validation, maximum and high containment lab certification support, occupational health, safety and biosafety/microbiological consultation, risk communication consultation and training, as well as program and management support. CRC’s Mechanical, Industrial and Safety Engineering Personnel managed the annual certification of the NIH high and maximum containment laboratories. These facilities had high/maximum containment systems with requirements similar to those required in sterile compounding pharmacies. If a facility could not successfully achieve the certification, CRC assisted with identifying and rectifying issues (i.e. eliminate airflow reversals) which typically revolved around the HVAC system. The facilities included:
- Integrated Research Facility at Fort Detrick (High and Maximum Containment)
- Integrated Research Facility at Rocky Mountain Laboratory (High and Maximum Containment)
- Special Clinical Studies Unit (High Containment Inpatient Unit)
- W. “Bill” Young Center for Biodefense and Emerging Infectious Diseases (High Containment)
- Louis Stokes Laboratories (High Containment)
In addition to annual certification testing, CRC performed a quarterly pressure decay test at the Integrated Research Facility at Fort Detrick.
CRC’s Mechanical, Industrial, and Safety Engineering Personnel imparted their expertise in a multitude of disciplines. Our Team identified, through plan reviews, safety and health issues that may arise due to the construction and/or renovation of biomedical research facilities, the pilot plant and, most recently, the sterile compounding pharmacy to be located in the Clinical Center. The Engineering Personnel evaluated plans with safety and health specialists, facility personnel, program personnel, NIH management, and contractors to ensure compliance with all applicable guidelines, standards, and requirements. To ensure the safety of NIH staff and the local community, we provided support for validating engineering systems in newly constructed or renovated biomedical research facilities and other special environments, including BSL-3, ABSL-3, BSL-4, and ABSL-4 laboratories, inpatient isolation wards, and the sterile compounding pharmacy.
CRC’s professional engineers and biosafety subject matter experts reviewed design documents at planned intervals, (15%, 35%, 65%, 95%, 100%), and issued comments to the A/E firm through coordination with the Office for Research Facilities (ORF) to ensure that the laboratory was constructed to meet all applicable guidelines, regulations, and standards. During the plan review, our Team’s engineering personnel assessed the building hardening and biosurety initiatives and provided recommendations to strengthen the security of accesses to building systems and security of entering and exiting of laboratories that contain agents with bioterrorism potential. We also served as an Owner’s Advocate for high containment and maximum containment laboratories and biomedical research projects. The Owner’s Advocate approach was a cost saving and risk management proponent to ensure that the occupational safety and health policies and procedures were achieved with each construction project. CRC provided the full spectrum of Occupational Health and Safety and Biosafety Consulting necessary to support DOHS Safety Engineering Services required.
The Occupational Health and Safety and Biosafety Personnel worked with the safety engineer(s), safety and health specialists, facility personnel, program personnel, NIH management, and contractors during and after the commissioning process to assist with plan reviews and validation testing of the facility’s systems to identify safety and health issues specific to high containment laboratories and biomedical research laboratory facilities. Working closely with the Engineering Personnel, the Occupational Health and Safety and Biosafety Personnel reviewed plans and identified safety and health issues. We reviewed, commented, and made suggestions on the proposed workflow to include personnel, materials, waste, maintenance access, etc. for the laboratories. The Occupational Health and Safety and Biosafety Personnel reviewed floor plans and identified design issues regarding support areas, equipment, biosecurity, biorisk management systems, biosecurity, operations, maintenance, constructability, validation, and certification. We also made recommendations on how to lower energy and operating costs. Laboratory best design practices were implemented when we reviewed plans for high containment laboratories and biomedical research laboratory facilities.