How To Support A Research Program
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1 Medical Support for Biomedical Research James M Schmitt, MD, MS Medical Director, Occupational Medical Service, NIH Sept. 8, 2011
2 Overview 1.Relevant guidelines 2.Medical support basics 3.The NIH as a customer 4.Medical support services at NIH The Animal Exposure Program Allergies Work related injuries Biological Surety Program 2
3 Guidelines and Regulations OH&S in the Care and Use of Research Animals (NRC 1997) OH&S in the Care and Use of Nonhuman Primates (NRC 2003) Guide for the Care and Use of Laboratory Animals 8 th Ed, (NRC 2011) Biosafety in Microbiological and Biomedical Laboratories 5 th Ed, 2009 Americans with Disabilities Act of 1990 Americans with Disabilities Act Amendments Act of 2008 OSHA regulations (29 CFR, Part 1910) 3
4 Medical Support Services: the Basics 4
5 Purpose To promote a safe and healthy workplace through the provision of work-related medical services Recognition This is one more support service. It must: balance management needs and employee rights, while routinely demonstrating respect for those we seek to serve. 5
6 Alternative Approaches for Medical Support Occupational Medicine (OM) Medical services designed to meet workrelated needs, may include emergency medical care and health promotion. Focused, a challenge to keep current. Employee Health (EH) More expansive, less tailored. Includes a wider range of non-emergent personal healthcare services. 6
7 Prevention Primary avoid the injury (by removing the hazard, utilizing barriers, training) Secondary early detection and treatment of an injury Tertiary minimizing long-term consequences of an injury 7
8 Where does this group fit in the organization? Environmental Health and Safety (EHS) Student Health Facilities (if responsible for EHS) Human Resources Contracted (on- and off-site) Regardless, the service needs to be readily accessible to employees. 8
9 Essential Partners Occupational safety and health specialists Investigators, subject matter experts Veterinary resources Human resources Other support services (facility mgmt) Employees Senior management - support 9
10 Understanding the Environment Interaction with partners A description of the workplace Identified health hazards Animals used in research Relevant literature Committees Institutional Biosafety Committee Institutional Animal Care and Use Committee IC Safety and Health Committees 10
11 What Is Medical Surveillance? Careful monitoring to detect early clinical evidence of injury and permit early treatment, and to prevent further injury. Medical support services for biomedical research rarely meet this definition. The timely evaluation of occupational injuries and appropriate sharing of selected, related information is perhaps our most effective option. The speaker s opinion 11
12 Medical Surveillance Requirements 1. A test that is: Reliable, Acceptable, Sensitive (few false negatives ), Specific (few false positives ), and Capable of detecting an injury in time to make a difference. 12
13 Medical Surveillance Requirements (cont.) 2. A plan for the systematic collection and analysis of data. 3. An understanding of the prevalence of the finding in the community is essential for a meaningful analysis of the data. 4. A strategy for communicating the results of the analysis in a timely fashion with those that need to know. 13
14 Medical Surveillance Requirements (cont.) The Guide (p.22-23) states: Periodic medical evaluations are advisable for personnel in specific risk categories. For example, personnel required to use respiratory protection the medical surveillance program should promote the early diagnosis of allergies Zoonoses surveillance should be part of an occupational health and safety program. Those with nonhuman primate contact should be routinely screened for tuberculosis. Only screening for TB meets the definition for medical surveillance 14
15 Confidentiality of Medical Information OM as public health in a workplace. Dual responsibility to the employee (patient) and employer (public). Must protect the confidentiality of the employee's medical information, while providing necessary information to the employer to assist in the maintenance of a safe workplace. 15
16 Medical Evaluations and Services Preplacement medical evaluations Routine, periodic medical evaluations For-cause medical evaluations Occupational injuries and illnesses Incapacity personal injury or illness and intoxication Serum storage 16
17 Preplacement Medical Evaluation A rote baseline physical exam does not offer sufficient value to recommend it. An opportunity to: Discuss personal medical and immunization history, Review workplace health hazards, Describe first aid and emergency medical care, Provide work-related immunizations, and Offer relevant counseling. 17
18 Routine, Periodic Medical Evaluations In general, routine medical evaluations are not warranted. Work with BSL-3 and -4 agents and toxins are an exception to that general statement. 18
19 For-Cause Medical Evaluations All suspected occupational injuries and illnesses must be reported. OSHA General Duty Clause OSHA 300 log Workers Compensation Personal injuries and illnesses that compromise a worker s ability to perform occupational duties safely warrant appropriate medical evaluation. 19
20 Serum Storage Routine storage of serum is rarely useful. Work with BSL-3 and -4 agents and toxins may constitute an exception to that assertion. Serum stored at the time of report of a potential exposure to a biologic hazard (acute specimen) and 6-8 weeks following the incident (convalescent specimen) have proven clinically useful. 20
21 The NIH as a Customer 21
22 The NIH The world s largest biomedical research facility. Its mission: To seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illnesses and disability. How it is organized: 27 Institutes and Centers (ICs) each with its own specific research agenda. 22
23 The NIH (cont.) Annual budget: $31.2 B Extramural program more than 80% is awarded via competitive grants to more than 325,000 researchers at over 3,000 universities, medical schools and other research institutions. Intramural program 10% supports NIH researchers. Approximately $1.2 B spent on animal research activities by 24 ICs. Locations MD (Bethesda, Poolesville, Frederick, Baltimore), MT, NC, and field stations 23
24 The NIH (cont.) The workforce 18,700 badged federal employees 18,300 badged contractors and visitors An average of 22,000 workers on the main campus any given day More than 20% hold at least one doctoral degree Approximately 20% are foreign born Approximately 10-20% turnover per year 24
25 The NIH (cont.) Research animals 1.7 M used in % Mice 3.5% Rats 13.5% Fish and frogs 0.3% Guinea pigs, rabbits, and hamsters 0.3% Nonhuman primates Over 125 human pathogens studied More than 2,500 research laboratories Approximately 25 BSL-3 and 8 BSL-4 25
26 Medical Support at NIH 26
27 Medical Support at NIH Approach: OM (rather than EH) design, implement, and reassess services intended to address occupational health concerns of the NIH community. Organization: a component of the Division of Occupational Health and Safety. Eligibility: principally for federal workers Contractors receive: care for medical emergencies and work injuries, unique services (e.g., anthrax vaccine, Biological Surety Program), and flu shots. 27
28 Medical Support at NIH (cont.) Staffing: MDs (2), Allergist (.1), PAs/NPs (4), RNs (8), PT (.5), Lab tech (1), EAP counselors (3), Workers Comp specialist (1). Locations: Hours: MD (Bethesda, Frederick, Baltimore), MT. 7:30-5:00, 24/7 on-call for life-threatening injuries and illnesses Computer support customized 28
29 Medical Support at NIH (cont.) Animal Exposure Program (AEP, no S ) Eligibility: federal workers with access to research animals or their living quarters Participation and compliance are mandatory (mandatory minimum requirements for compliance are defined) Subdivided by type of animal contacted (small, large, nonhuman primate [NHP], and viable NHP tissue) Enrollment and compliance reported online and in real time 29
30 Medical Support at NIH (cont.) Medical elements of the AEP provided for all participants on enrollment: Review of position responsibilities and medical and immunization history, Tdap booster dose, if warranted, Other occupationally-indicated immunizations, and Counseling: allergies, zoonoses, agent/toxin-specific, requirement to report all work injuries, first aid, and accessing emergency care for occupational injuries 30
31 Medical Support at NIH (cont.) Additional medical elements of the AEP Large animal: occupationally indicated testing (ex: toxoplasmosis antibody testing for women of child bearing capacity) NHP: rubeola screening and immunization (if clinically warranted), enrollment in the TB Surveillance Program, wallet cards NHP tissues: offered voluntary enrollment in the TB Surveillance Program Recall: only for AEP participants with access to NHPs without evidence of prior infection with mtb; annual testing 31
32 Medical Support at NIH (cont.) Other relevant medical services Work-related allergy clinic Care for work-related injuries Biological Surety Program Allergies: no surveillance Rely on counseling, training, and self reporting Allergy testing and care provided onsite 32
33 Medical Support at NIH (cont.) Care for work-related injuries All injuries must be reported All reported to safety for investigation Provide complete care for more than 80% of work-related injuries sustained by federal workers and all injuries involving potential exposure exotic or highly pathogenic agents. Consult as needed with SMEs and infectious disease specialists Plan and drill for incidents involving BSL-3 and -4 agents 33
34 Medical Support at NIH (cont.) Biological Surety Program (BSP) Eligibility: federal and contract workers with access to select agents and toxins in designated facilities (DF) or unrestricted access to the critical infrastructure of a DF Participation and compliance is mandatory Design: layered services similar to AEP (BSL-3, agent-specific, BSL-4) We have gent-specific procedures for select agents and toxins studied Annual drills involving: labs, H&S, transport, medical, and hospital services 34
35 Questions? 35
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