National Institutes of Health

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 NIH 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 National Biosafety and Biocontainment Training Program (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 training support and mentorship for the NBBTP.

CRC was selected to oversee the development, management, and administration of the NBBTP. CRC managed the onset of the NBBTP and monitored a subcontractor’s progress, a non-profit entity, to eventually take control of the administration and management of NBBTP. CRC developed and established the NBBTP in order to provide a working model of the program. This model contained the technical components, administrative components, and practical approach to successfully implement all aspects of the program for the first two years. The model was approved by the Program Director (the Director, Division of Occupational Health and Safety [DOHS], Office of Research Services [ORS]) prior to implementation.

Our organization provided all necessary personnel, technical support, management, and supervision to plan and implement a comprehensive biosafety fellowship program for the NIH. To maintain a fully functional and effective training program, CRC oversaw and directed the NBBTP’s administrative functions and utilized best practices to optimize outcomes in all aspects of the program. Using a collaborative process with DOHS, National Institute for Allergy and Infectious Diseases (NIAID), and subcontractors, CRC provided staffing and support to produce the first class of NBBTP graduates.

Functional Model for the Development, Implementation and Management of the NBBTP

CRC developed a comprehensive curriculum organized around the central concepts of biosafety and high-level biocontainment. This was achieved through education and training in the areas of occupational health, biological sciences, applied biosafety, biosecurity, and core competencies to support the Fellows’ training and educational experience. Existing training and educational materials were identified and used where available. CRC developed a specialized training module to fill gaps in the existing body of information where no training and educational materials existed. In order to meet this requirement, CRC drew upon expertise across a wide array of subject matter experts. Utilizing recognized national leaders in the field of biocontainment and biosafety, CRC developed and produced the deliverable for this task. CRC submitted for approval a course outline for a two-year training fellowship. This included study areas comprised of formal course work on a series of topical lectures over two years, on-the-job training, developmental training, practicums, fellowship projects, publications, and credentialing. CRC provided the following as final deliverables as part of this activity:

• A comprehensive outline of training subjects that comprised the initial two-year curriculum. Identified and proposed a team of recognized subject matter experts for approval. Identified the subject area for which individual(s) experts were responsible.
• A schedule and timeline, for review and approval, that provided clear milestones for the development, review/approval, and completion of training materials for each subject area.
• All training material for content and editorial review and approval.
• All printing and reproduction services required to provide training materials and documents, in required area, to support Fellowship students and other interested parties. All printing was of professional quality and was approved before the final printing was performed.

Curriculum for Education, Training, and Skill Development to Enable and Qualify Biosafety Professionals to Manage and Operate High Level Biocontainment Laboratories

CRC implemented the training and education paradigm that, within the constraints of a two-year fellowship program, provided the training and education experience necessary for biosafety professionals to manage and operate high level biocontainment laboratories. CRC provided qualified instruction that included providing training/instructional venues, course materials, and laboratory materials. In addition, CRC provided all instruction through recognized and approved experts in the subject areas. Training and education was both didactic and practical, encompassing the bioresearch environment at NIH and other venues.  CRC incorporated learning opportunities intended to provide the broadest experience in the biomedical research environment.  This was not only from within this structured curriculum, but lectures, seminars, classes at the NIH, universities, and training programs. CRC gave a proposed list of extra-curricular learning opportunities and a mechanism to track, locally and nationally, all relevant training, and notify all Fellows in sufficient time to enable them to participate.

CRC provided highly qualified faculty for instruction and guidance purposes. Faculty were recognized experts in an area(s) of biosafety and biocontainment and were familiar with the curriculum developed by CRC. CRC addressed the availability of such individuals and had in place contingency plans in the event some faculty became unavailable to teach during the time they were scheduled. The faculty was made available not only for instruction but also to provide professional guidance to the Fellows, continuing quality improvement of the curriculum, and input and support for practicums and Fellowship applied biosafety projects. Applied biosafety projects were coordinated through CRC and approved by the Director. Once a project including Developmental Assignments (DAs) was identified and approved, CRC made all arrangements necessary to facilitate a successful learning experience. CRC ensured that all necessary training materials, guidance, and preparation were available to the Fellows in order to successfully complete future testing and credentialing of each Fellow.

Administrative Organization that Provided Financial, Logistical, and Physical Support Services Necessary to Operate the Training Program

CRC developed and implemented an administrative structure and organization that provided effective, transparent management of all aspects of the training program. These activities included:

• Developed and implemented a financial oversight/management organization internal to the program, including regular quarterly reports on the status of expended funds, funds to be expended in the next quarter, and an updated financial report for the two-year training cycle.
• Administrative and HR support services for all Fellows including, but not limited to, financial support, travel, extra-curricular training, support equipment, etc.
• Coordination of all the activities of visiting faculty, including logistical arrangement for each lecturer.
• Organized and provided office space and amenities for Fellows, faculty, and administrative offices for program administration.
• Developed a recruitment plan, organized, and facilitated a national/international promotional program to attract the best, most qualified applicants and increased the stature and reputation of the program within and outside the professional biosafety community.
• Developed both an immediate and a long term strategy for obtaining ongoing financial support and funding to ensure the continuation of the Fellowship training program. The ultimate goal was that the NBBTP became a self-sustaining entity. CRC planned for three cycles of two-year Fellowships under this contract. 

Scientific Advisory Board (SAB)

CRC developed and implemented a program oversight and evaluation strategy to ensure the highest level of training and performance and to assess current and future training requirements. Our organization organized the SAB consisting of biosafety/containment experts from outside the training program. This committee met regularly (three times per year), as directed by the NBBTP Program Director, to review the curriculum, assess level of instruction, plan for future training requirements, and review and evaluate the management of the program from an administrative prospective. CRC scheduled all meetings, prepared meeting minutes, and arranged travel for the SAB. CRC presented to the SAB the following:

• Progress of each Fellow to ensure they were receiving the level of instruction necessary to complete the program within the two-year cycle.
• Progress of Fellows post-program completion to assess the training received with respect to the demands of the biosafety, high containment environment.
• Provided continuous quality improvement during all training cycles to ensure all aspects of the training product was of the highest quality feasible and met the changing demands of this emerging discipline.

Application Development

CRC outlined the application process and drafted an accompanying flowchart detaining all stages of the application review process. Unbiased eligibility requirements were established in collaboration with DOHS. A final application packet was provided.

Recruitment of Fellows

CRC developed the first NBBTP recruitment plan to attract the best, most qualified applicants, and increased the reputation of the NBBTP within and outside the professional biosafety community. As part of the recruitment plan, CRC identified exhibitions and job fairs to recruit eligible applicants. CRC designed and produced an exhibition booth as well as marketing collateral to advertise the program. Responsible for attending scientific and industry-related conferences, CRC staffed personnel to provide potential applicants with program information. Application materials and eligibility requirements were developed by CRC. All recruitment materials were made available on the NBBTP website. CRC also recruited applicants via Listservs, professional development training activities, and via its biosafety professional network.

Vetting and Selection of Fellows

CRC compiled applications and transcripts. Each candidate’s reference was verified. A checklist was used to verify that each candidate met all submission requirements. Professional references were contacted. A final packet for eligible candidates was presented the Program Director and the SAB.

NBBTP Training Support and Mentorship

CRC supported the NBBTP through the development and provision of training and mentorship for the Fellows, including professional development courses:

• Biosafety and Biocontainment Training, Kansas State University
• BSL-3 Operations and Maintenance I, Kent State University
• BSL-3 Operations and Maintenance II, University of California-Irvine (UCI)
• BSL-4 Operations and Maintenance Course, IRF-Frederick

CRC provided annually the following courses in support of the NBBTP:

• Fundamentals of Engineering Part 1
• Fundamentals of Engineering Part 2
• Design Review Course
• Engineering Practicum

Being in such close proximity to the Fellows gave CRC’s SMEs the opportunity to mentor the Fellows. CRC provided the following support to the Fellows:

• Helped define Fellows’ training goals at the outset and evaluated them at regular intervals throughout the training
• Met with Fellows regularly, one-on-one, to discuss their progress towards these goals
• Listened to each Fellow’s ideas
• Provided constructive and timely feedback on their work
• Supported Fellow’s growth through encouraging training opportunities and professional development
• Introduced Fellows to biosafety and scientific colleagues, so that Fellows could begin to develop networks of their own
• Provided career advice and reviewed Fellows’ resumes
• Served as a professional reference