Biological Safety Manual – Chapter 07: Occupation Health Support for Biomedical Research
The occupational health provider is integral in the promotion of a workplace culture of safety in biomedical and microbiological research. An occupational health program that supports staff with access to biological hazards, such as infectious agents or toxins, should aim to alleviate the risk of adverse health consequences due to potential exposures to biohazards in the workplace. Health services should be risk-based and tailored to meet the needs of individual staff and the research institution based on risk assessments. Ideally, the program focuses on work-related healthcare to avoid potential conflicts of interest. An institution must carefully consider available options for implementing robust occupational health support as an essential component of its risk management strategy.1,2
Table of Contents
- Framework for Occupational Health Support of Biomedical Research
- Basic Concepts for Providing Work-Related Healthcare in a Research Setting
- Practical and Regulatory Requirements for Occupational Health Programs
- Risk-based Design of Occupational Health Services
- Pre- and Post-Exposure Communications
- Occupational Health and Risk Management
- Elements of an Occupational Health Program Supporting Biomedical Research
- Preplacement Medical Evaluations
- Periodic Medical Evaluations
- Occupational Health Support for Occupational Injuries and Potential Exposures
- Clinically-Oriented, Post-Exposure Risk Assessment
- Post-Exposure Follow-Up Care and Testing
- Occupational Health Support for Occupational Illnesses
- Occupational Health Support of Staff in High and Maximum Biocontainment
I. Framework for Occupational Health Support of Biomedical Research
A. Basic Concepts for Providing Work-Related Healthcare in a Research Setting
Occupational health services that support a biomedical research community should be based on detailed risk assessments of hazards in the workplace.3 See Chapter 2 of UNC-Chapel Hill’s Biological Safety Manual for additional information regarding Biological Risk Assessments. Services should complement the hierarchy of exposure controls and provide relief in case of potential exposure to a hazard.4 Medical countermeasures such as vaccines, wound decontamination, or pharmaceutical agents may reduce the risk of harm, but they do not eliminate it (e.g., vaccine failure or antibiotic resistance).5,6
Different elements of occupational health support may be indicated at various stages of employment, ranging from anticipatory risk mitigation (e.g., preplacement evaluation or vaccination) to incident-driven medical measures such as post-exposure immuno- or chemoprophylaxis. A change in a staff member’s health status suggestive of a Laboratory-associated infection (LAI) requires clinical care and an interdisciplinary investigation into a possible antecedent occupational exposure. At each juncture, the healthcare provider must take care to tailor services to mitigate the individual staff member’s risk for harm.1,7
Before research involving biological hazards begins, stakeholders should have plans in place for providing occupational health support for staff commensurate with the potential health risks of the proposed work (i.e., pathogens, activities, and work environment or facility).8 An institution may require, as a condition of employment, its staff to participate in relevant occupational health programs designed to reduce risks associated with research on biological agents that may pose grave threats to human health and society (high-consequence pathogens).9 The provider may consider establishing contact with subject matter experts (SMEs) for consultation on procedural and clinical elements of the program, especially agent-specific occupational exposure and illness response plans concerning high-consequence pathogens or bioengineered infectious particles whose pathogenic potential is not established.10,11
Continual collaboration among stakeholders is key to optimal protection of biomedical research staff. The designated occupational healthcare provider should work with institutional safety staff, principal investigators (PIs), and clinically-oriented SMEs (i.e., infectious diseases specialists) to ensure optimal work-related health care of laboratorians and their support staff.
B. Practical and Regulatory Requirements for Occupational Health Programs
Occupational health services may be administered through a variety of arrangements and may be employer- or community-based provided they are readily available, allow timely evaluation, and appropriate treatment. Regardless of employment status, all workers should have access to a comparable level of care and occupational health services based on their risk of occupational hazard exposure. Contractors, students, volunteers, and visitors should receive work-related occupational health services through their employer or sponsor equivalent to those provided by the host institution for its employees.
The designated occupational health provider should be familiar with the nature of hazards in the work environment and the controls used to prevent exposures. The program should have the means to implement promptly any indicated pre- and post-exposure medical measures and related counseling. The provider should ensure that services rendered remain consistent and conform to current practices such as recommended immunization schedules and infection control.12-14 Expanded discussions of principles of standard occupational health practices are available in authoritative texts.15,16
The provider should be aware of and abide by guidance or regulations including but not limited to the following:
- NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines);
- Title 42 of the Code of Federal Regulations, Part 73;
- Relevant Occupational Safety and Health Administration (OSHA) standards;
- The Americans with Disabilities Act (ADA) of 1990 and related regulations;
- The Pregnancy Discrimination Act of 1978; and
- Patient confidentiality laws including Health Insurance Portability and Accountability Act of 1996 (HIPAA).17-24
C. Risk-based Design of Occupational Health Services
The scope of an occupational health program should match the clinical and research portfolio of the institution it supports. Institutional biosafety and security policies may require additional occupational health support. Work with microbes that are not associated with disease in healthy adults (RG1) likely requires minimal occupational health support, although the provider should be aware of other non-biological hazards that may be present in the laboratory. Staff with access to RG2, RG3, or RG4 biological agents should be provided with occupational health services that stand to decrease the risk of potential harm. The program will need to commit resources that are likely proportionate to the severity of potential health risks of these agents and the residual risk of exposure after implementation of applicable controls. This consideration becomes especially pronounced for programs that support RG3 and RG4 pathogen research where the elevated cost of emergency preparedness reflects the need to mitigate a wide range of risks, including those associated with high-impact, low-probability events.25-27
With increasingly widespread applications of advances in bioengineering, occupational medical staff must be prepared to adapt established practices to evolving workplace hazards.28-30 The principles of expert risk-based occupational health support for work with naturally occurring biological agents apply to work with genetically modified organisms, designer biologics, or novel genetic constructs. For example, viral vectors deployed in gene therapy or vaccinology may be engineered to incorporate safety features at the genomic level to decrease infectivity or virulence. However, even highly genetically altered particles should not be presumed to be risk-free to staff who are exposed to them, as illustrated by the replacement of first-generation lentiviral platforms with third- or fourth-generation HIV-derived vectors.31 Until immediate and long-term health risks of genetically modified organisms or synthetic constructs are better characterized (e.g., insertional mutagenesis), the provider must appreciate that an agent’s genome-level safety features may not fully protect exposed staff from potential health risks. The NIH Office of Science Policy provides guidance on assessing and mitigating potential harm from recombinant nucleic acids, genetically modified organisms, or entirely new constructs with varying capacity to infect human cells.17,32
Staff may require additional occupational health services besides those targeting biological agents under scientific investigation. For example, researchers engaged in human subjects research activities or animal care and veterinary staff who support the use of laboratory animals should receive all applicable medical care and counseling.33 Laboratory animals may become zoonotic disease vectors when a staff member is exposed to an infected animal’s body fluids or tissues (e.g., Macacine alphaherpesvirus 1 [B virus] or Simian immunodeficiency virus [SIV]).34,35 In turn, susceptible research animals must be protected from reverse zoonotic transmission of human pathogens. For example, Measles morbillivirus or Mycobacterium tuberculosis (Mtb) may devastate non-human primates (NHPs) and cause substantial losses.36
Other potential hazards may add to the complexity of pertinent occupational health support; some with established risk factors such as:
- Human-derived materials;
- Chemical, physical, or environmental hazards; and
- Others with less well-circumscribed risk to staff (e.g., hazards Section VII associated with field research or outbreak response).
OSHA provides general guidance on safety and health in a laboratory environment such as respiratory protection and hearing conservation.19,37,38 The occupational health program should collaborate with institutional biosafety, management, and subject matter experts to customize services that complement risk mitigation in biomedical research
D. Pre- and Post-Exposure Communications
All biomedical research laboratories should maintain a laboratory-specific biosafety manual that specifies the steps all staff should take immediately after an incident. An effective incident response, including medical care of affected staff, relies on the coordinated execution of the plan and concise, prompt communications.39 Laying the foundation for proper post-exposure risk mitigation begins before an occupational exposure occurs (e.g., with risk awareness training in the workplace and targeted preplacement occupational health evaluations). Incident response protocols should describe requisite notifications at the time of a potential exposure, including how to access medical care.40 All staff should identify and work to remove barriers to prompt, qualified post-exposure medical care. Community-based medical care of a staff member after a potential occupational exposure may require additional steps to ensure optimal assessment and treatment of the staff member, including connecting the healthcare provider with SMEs.
E. Occupational Health and Risk Management
The designated occupational health program should design a quality assurance program to monitor internal operations and interdisciplinary processes with a healthcare component.41 Each occupational health support offering and procedure should be reviewed regularly with respect to the most current practice guidelines and relevance to the research supported. The occupational health program is uniquely positioned to contribute to the institution’s ongoing risk management activities. For example, prevention of future exposures should be informed by the collection and analysis of work-related injury and illness statistics.42,43
II. Elements of an Occupational Health Program Supporting Biomedical Research
- Preplacement Medical Evaluations
- Periodic Medical Evaluations
- Occupational Health Support for Occupational Injuries and Potential Exposures
- Clinically-Oriented, Post-Exposure Risk Assessment
- Post-Exposure Follow-Up Care and Testing
- Occupational Health Support for Occupational Illnesses
- Occupational Health Support of Staff in High and Maximum Biocontainment
A. Preplacement Medical Evaluations
Supervisors should inform all workers about workplace hazards and exposure controls and refer newly hired staff with proposed access to biological hazards (e.g., biological agents, human subjects, laboratory animals, or their respective body fluids or tissues) to the occupational health program for a risk-based preplacement medical evaluation.1,19 The healthcare provider must review staff members’ personal and occupational health history in light of the supervisors’ input on potential hazards and minimum functional requirements of the position.
This standard review includes the following:
- Past and current medical conditions and treatment;
- Present use of medications (prescription and non-prescription);
- Allergies and adverse reactions to medicines, vaccines, animals, and other environmental allergens; and
- A complete immunization history, including serology results, when appropriate, or relevant prior infections.
The provider should discuss agent-specific risk factors and incidental hazards (e.g., zoonotic infections, toxic chemicals, or laboratory animal allergens), and the provider should dispense information on health conditions that might increase susceptibility to infection and complications after an occupational exposure. The provider should ensure staff members’ familiarity with the need for standard first aid after an exposure, and the need to promptly report work-related injuries and illnesses. The importance of exposure prevention should be emphasized while cautioning against overreliance on medical countermeasures for curbing work-related health risks. For example, minimizing exposure to likely allergens (e.g., animal proteins or latex) is paramount to the control of occupational allergies. Sensitization to specific allergens may not be reversible even with treatment. Staff should be directed to supervisors and safety professionals for training and proper use of applicable exposure control strategies, including personal protective equipment (PPE).8 The provider should also advise staff on steps to take in cases of potentially work-related illness(es), such as signs or symptoms suggestive of an LAI or an occupationally-acquired allergy.
The occupational health program should offer only those services that constitute effective medical support related to workplace hazards and duties. For example, testing for immunity to a specific pathogen is rarely indicated as a condition for employment. Pre-immunization serology should be performed in accordance with established risk-based guidelines.13,44 Serum banking, the practice of collecting and storing frozen serum samples, is of questionable value to the care of research or clinical laboratory staff; it should not be offered routinely without a clear indication. An exception may be made if a risk assessment suggests that work conditions are likely to lead to unrecognized exposures, especially to pathogens with long latency periods or with the potential for subclinical infection. If serum banking is utilized, the provider must implement it with the requisite precautions to ensure accurate retrieval, proper storage and disposal, patient privacy, and observance of applicable ethics standards.1,45 Serum sampling and short-term storage should be considered on a case-by-case basis with properly designed testing strategies for post-incident screening of potentially exposed staff or investigation of possible LAIs.1
The Advisory Committee on Immunization Practices (ACIP) provides expert adviceon the most effective immunization strategies against vaccine-preventable diseases. The occupational health program should utilize ACIP guidelines for routine administration of vaccines and offer any licensed vaccine indicated to provide risk-based agent-specific immune protection.1,13,44
With few exceptions, acceptance of vaccinations that are medically indicated should not be a precondition of employment in biomedical research laboratories. However, under specific legal situations, an institution may be able to exclude a worker who declines to receive a potentially protective licensed vaccine against a virulent pathogen strain from working directly with that agent. Each institution must determine the best risk management strategy for its laboratory-based workforce. The healthcare provider should counsel staff who refuse recommended immunization against a vaccine-preventable disease and document the staff members’ lack of protection in the medical record.
C. Periodic Medical Evaluations
In most cases, there is no medical basis for requiring periodic medical evaluations for the vast majority of staff solely because they work with biological hazards. Institutions may require specific work groups to participate in periodic medical evaluations provided it is justified by a substantial risk of exposure to biohazards. The possibility of increased health risks due to potential changes in staff health status should not serve as a basis for requiring workers in biomedical research to be subjected to periodic medical evaluations; rather, staff should be offered the chance to seek medical advice when such changes occur. Staff with specific concerns, such as working with biohazards while immunocompromised or the effects of hazards on their reproductive capacity, should be directed to seek confidential medical counseling with a qualified clinician.
Screening programs for work-related infections of staff, such as post-exposure medical surveillance, contact investigations, or research settings associated with evidently elevated exposure risk to specific pathogens, should also be risk-based. Periodic testing, ostensibly to detect unrecognized workplace exposures, should be avoided unless there is an unusual constellation of risk factors that could preclude the timely recognition of LAIs. For example, a workplace risk assessment may conclude that there is sufficient residual exposure risk to Mtb, an easily transmissible agent with a low infectious dose and long latent period, to warrant surveillance of staff to avoid dire health consequences for unknowingly infected staff and their contacts.
Before an occupational health program endeavors to screen asymptomatic staff without a recognized exposure to a specific pathogen, the provider should do the following:
- Justify the benefit of such testing;
- Clearly define criteria for interpretation of results; and
- Develop plans for further investigation of indeterminate and positive test results.
Any medical surveillance must meet requisite criteria.46-49
D. Occupational Health Support for Occupational Injuries and Potential Exposures
In case of a potential hazard exposure, the staff member must immediately perform proper first aid and follow all established agent-specific protocols. All occupational injuries, including potential exposures to a biohazard, should be reported to the occupational healthcare provider immediately. The provider should notify the supervisor and safety staff if the staff member has not already done so.
The provider must take a sufficiently detailed account of the incident to quickly determine its clinical significance. The primary source of information is typically the affected staff member. Collateral sources include safety professionals investigating the incident, the supervisor or PI, and others with knowledge of the circumstances of the incident or source materials involved. The following key factors in this step include:
- Exposure controls used at the time of the incident and work activities performed leading up to it;
- The mechanism of the potential exposure (e.g., percutaneous injury, splash to mucous membranes or skin, inhalation of an infectious aerosol);
- The nature of the potential biohazard (e.g., animal body fluid, culture medium, contaminated fomite) and inoculum size (concentration, volume);
- Characteristics of agent(s) known or suspected to be involved (e.g., species, strain); transmission in natural infection or LAI; minimum infectious or lethal dose to humans; incubation period; drug susceptibility or resistance;
- Agent viability (i.e., inactivation by chemical or physical means prior to incident) and genetic modifications (to enhance viral vector safety); and
- First aid performed at the workplace (e.g., duration and cleansing agent used, time elapsed from exposure to initiation).
The two most critical determinants that diminish the risk of infection are the immediate and adequate cleansing of the affected body area and avoidance of delays in starting appropriate post-exposure prophylaxis (PEP). When in doubt, the provider should repeat first aid. The provider should take a pertinent health and social history focused on mitigating the risk of adverse health consequences for the affected staff member and the community due to the potential exposure. This should include factors that may affect the individual’s susceptibility to infection with the pathogen of concern, barriers to adherence to proposed medical management, and the potential for exposure of others during the incident or close contacts. Prior agent-specific immunization does not obviate the need for a post-exposure medical evaluation because vaccination may not fully protect against disease. PEP should be offered whenever such treatment may prevent or ameliorate illness. The provider may consult clinical specialists who have experience with the biological agents of concern. If need be, the staff member should be transferred to a medical facility that can provide the necessary level of care.10 The occupational health program should ensure adequate medical support is available for incidents where multiple staff may have been exposed.
E. Clinically-Oriented, Post-Exposure Risk Assessment
In case of an occupational hazard exposure, the clinician’s first priority is mitigating against the risk of further harm to the affected staff member. The occupational health program may contribute further by documenting lessons learned from each incident, thereby decreasing the chances for future exposures. To achieve both goals, it may help to distinguish between a potential biohazard and specific pathogens of concern and to stratify the risk of exposure (RoE) and risk of adverse health consequences or disease (RoD) separately.1,50 It may be unknown at the time of an incident whether the source material (hazard) involved harbors any potentially harmful biological agents. Some biological materials (i.e., animal or human body fluids and tissues) may present a mixed hazard with more than one specific pathogen of concern, each warranting separate RoE and RoD estimates. The RoE to a pathogen informs agent-specific subsequent clinical decision-making (e.g., initiating treatment to lower the initial RoD).
The following two conditions must be met for a biohazard exposure to occur:
- A biohazard must be present (i.e., released from containment by aerosolization, splash, spill, or mishandling of a contaminated object); and
- The staff member must come into direct contact with the biohazard.
The provider must determine whether a pathogen may have been transmitted to the staff member and the mechanism of exposure is compatible with transmission of an agent of concern. Whenever the possibility of transmission of a specific biological agent cannot be excluded, the provider must estimate the level of RoD.
Risk factors for infection, illness, and potential for complications include:
- Circumstances of the incident;
- Characteristics of the biological agents involved;
- Host factors such as immune function or pre-exposure vaccination; and
- The utilization of post-exposure medical countermeasures.
Generally, initial estimates of RoE and RoD levels will correlate. Post-exposure medical measures such as immediate wound decontamination and PEP may lower the initial RoD estimate but they cannot eliminate the possibility of an LAI.
F. Post-Exposure Follow-Up Care and Testing
The provider should counsel each staff member who reports a potential occupational exposure on the significance of the incident and clearly communicate the following:
- The post-exposure care plan, including treatment options;
- Alternatives to treatment;
- Testing procedures; and
- Interpretation and implications of laboratory results.
When PEP is recommended, the staff member should be followed closely for signs of an LAI, compliance with treatment, and possible adverse medication effects. Staff exposed to infectious agents for which there is no effective PEP must receive appropriate post-incident care tailored to the agent involved and the worker’s personal health. Staff may be asked to adhere to an agent-specific monitoring protocol to facilitate early detection of a symptomatic LAI. The provider may recommend isolation of a staff member to avoid secondary transmission during the prodromal phase associated with pathogens that may render a person infectious prior to the onset of symptoms (e.g., influenza).
The optimal post-exposure testing strategy for evidence of infection depends on the following:
- The pathogen of concern;
- Potential spectrum of illness;
- Performance of available commercial assays; and
- The affected worker’s host risk factors.
Awaiting test results, including pregnancy testing, should not delay initiation of clinically indicated and appropriately selected PEP. Certain PEP protocols, such as antiretroviral regimens, may justify targeted baseline laboratory testing.51 A serum specimen collected at the time of the incident may be useful for exposure-related surveillance; however, screening for pre-existing infection with an agent of concern should not be conducted routinely. When there are no signs or symptoms of an LAI, subsequent laboratory or imaging studies to assess if transmission occurred should be avoided in most cases. However, when there is clinical value in detecting acute infections that may remain asymptomatic for prolonged periods, post-exposure testing strategies should aim for early detection. For example, nucleic acid testing for Hepacivirus C (HCV) even before antibodies may be present or screening for latent Mtb infection could lead to timely recognition of the need for treatment of an LAI.
For serologic assays, comparison of results from paired serum samples, collected at appropriate time points, constitutes more reliable laboratory evidence of recent infection than results of screening of a single serum specimen. Ideally, the provider performs serial serological assays, simultaneously testing aliquots of baseline serum and samples collected when specific immune markers are assumed to become detectable. The clinician may consider blinding the testing facility to the times the samples were obtained. Documented seroconversion, or a significant increase in antibody titer (at least four-fold) associated with a compatible clinical syndrome, is usually highly suggestive of acute infection. The typical timing of serial serum collections in each case may be modified by circumstances of the exposure, the agent’s characteristics, host factors, and medical countermeasures taken. For example, screening too soon may fail to detect low levels of early immune markers. Repeat screening at appropriate intervals may be indicated when seroconversion may be delayed; for example, repeat screening may be indicated due to the nature of the agent (e.g., human retroviruses), the immediate use of PEP (e.g., B virus), or the affected staff members’ immune system function. If a staff member is to be screened with a non-commercial assay based on expert consensus, the provider should submit samples from uninfected source(s) as negative controls, positive control samples, whenever possible, and blind the testing facility to sources and timing of sample collection. The provider should caution the exposed staff member that the clinical utility of such assays is not the same as licensed tests and must be interpreted with extreme caution.
Post-exposure occupational health care of an affected staff member may be informed by establishing whether the biological material involved harbored specific pathogens of concern. The provider should work with the principal investigator, veterinarian, or clinician responsible for the source material to determine if testing appropriate samples could help establish if a specific infectious agent was present. Negative results may not indicate the absence of a specific infectious agent and should be interpreted with caution.
G. Occupational Health Support for Occupational Illnesses
Staff in biomedical research and clinical laboratories should be encouraged to seek timely care for illnesses attributable to their work. Full implementation of laboratory exposure controls at recommended Biosafety Levels clearly reduces the chance of LAIs.26,52 However, there is little evidence to corroborate the effectiveness of biocontainment practices in preventing occupational exposures due to underreporting and a lack of centralized data-sharing on biological hazard exposures and LAIs.53 The true incidence of LAIs remains unknown and, although increased adherence to safer work practices in biomedical and microbiological laboratories has eliminated many opportunities for occupational exposures, staff remain at risk for LAIs.52,54 Historically, staff with proven LAIs often did not recall an antecedent exposure. Unexpectedly, serious illnesses have resulted from exposures that were deemed trivial at the time of the incident or were not recognized as an LAI at initial presentation.55-57 Research and clinical laboratorians who work with human pathogens, or access spaces where such agents are handled, should maintain an awareness of the timing of a febrile illness in light of their work activities. They should be encouraged (e.g., at preplacement or post-exposure medical evaluations) to have a low threshold for contacting the designated occupational health provider with the earliest signs and symptoms that could be compatible with an LAI.
The provider must conduct a risk assessment for any acutely ill staff member who handled a potential pathogen during a time span prior to the onset of symptoms equal to the pathogen’s range of incubation period.
In addition to a focused clinical history, the interview should include an inquiry into the following:
- Recent work with biological materials;
- Potential breaches of exposure controls;
- Adherence to biosafety practices;
- Sick contacts at work and outside; and
- Other plausible exposure opportunities to infectious agents (e.g., hobbies or travel).
Clinicians should be aware that in cases of occupational exposures, a pathogen’s typical incubation period or initial clinical presentation may differ markedly from naturally acquired infections (e.g., due to disparate exposure mechanisms or an agent’s genetic modifications). Prior vaccination or infection with certain pathogens may also affect the clinical course of an LAI with a related infectious agent (e.g., tick-borne encephalitis or dengue). Close-working relationships among all stakeholders and ready access to expert medical care are absolutely essential to an adequate LAI response.
Risk stratification of a possible LAI follows the same considerations as a post-incident evaluation except in a retrospective fashion and with increased emphasis on risk for the ill staff member’s close contacts who may be subject to contemporaneous workplace exposure or secondary transmission. The occupational health program should be prepared to work with supervisors and biosafety professionals to conduct workplace contact investigations or case finding, taking care to balance the needs for privacy protection and infection control. An LAI that meets criteria for a reportable disease requires notification of public health authorities.
Additional workplace hazards and ergonomic conditions in the laboratory environment may give rise to work-related health conditions that may diminish staff’s ability to work safely with human pathogens such as work-related musculoskeletal disorders or occupationally acquired allergies. In most cases, allergies to laboratory animals develop within the first year of occupational exposure to the allergens. Of the 20 to 30% of workers who become allergic to animal proteins, 5% may progress to asthma that may, rarely, threaten workers’ lives and livelihood due to anaphylaxis.1,7 The occupational health program should be prepared to evaluate and treat these conditions to ensure a safe return of staff to full duty.
H. Occupational Health Support of Staff in High and Maximum Biocontainment
Adequate occupational health support of research in Biosafety Level (BSL)-3 and BSL-4 laboratories may pose special challenges for occupational health providers.58 BSL-3, BSL-4, and associated animal facilities (i.e., ABSL-3, ABSL-4, and the high containment facilities described for open penned or loose-housed animals in Appendix D of the BMBL) are designed to minimize the risk of exposure to high-consequence biological agents for workers, the community, and the environment.59,60 BSL-3 or BSL-4 researchers who participate in field research or outbreak response involving RG3 or RG4 pathogens may need additional occupational health services due to increased exposure risks.61
The same principles of incident and illness response outlined above apply to potential hazard exposures and LAIs in a BSL-3 or BSL-4 laboratory environment, but with an increased concern for public health and potential harm to society if RG3 or RG4 agents were to be released, diverted, or intentionally misused. See Chapter 6 of the Biological Safety Manual or additional information about laboratory biosecurity. A staff member with access to RG3 or RG4 pathogens who develops an unexplained acute febrile illness should seek medical consultation at the earliest onset of symptoms.
Supervisory staff may encourage RG3 and RG4 agent researchers to contact the designated medical provider in case of a possible LAI, rather than seeking care from a community-based medical provider who may be less familiar with hazards involved. Depending on risk, a fever watch for the duration of the incubation period, with calls to the occupational health program in the event of a fever, may be a useful component of institutional emergency preparedness. Advance planning for appropriate care in case of an occupational exposure or possible LAI is a fundamental component of an occupational health program supporting research of RG3 or RG4 pathogens.9 The designated medical provider may forge liaisons with clinical programs capable of the requisite advanced level of care for patients infected with high-consequence pathogens.10,50,62 Incident and illness response plans should also include timely and appropriate notification of local health authorities as warranted by the circumstances in each case.
Occupational health support for a biomedical research community should consist of select, expert services tailored to address the risks identified for the individual staff member and the institution and commensurate with the scope of work involving potential biological hazards. The strength of an occupational health program supporting staff in laboratories or animal care facilities where such biological materials are present depends on sound coordination with each component of the institution’s occupational safety and health operations. The occupational healthcare provider has a vital role in the health, safety, and security of staff in the biomedical research environment and the establishment of a robust culture of safety.
- Schmitt JM. Occupational medicine in a biomedical research setting. In: Wooley DP, Byers KB, editors. Biological Safety: Principles and Practices. 5th ed. Washington (DC): ASM Press; 2017. p. 511–17.
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- Wooley DP, Fleming DO. Risk assessment of biological hazards. In: Wooley DP, Byers KB, editors. Biological Safety: Principles and Practices. 5th ed. Washington (DC): ASM Press; 2017. p. 95–104.
- Centers for Disease Control and Prevention [Internet]. Atlanta (GA): The National Institute for Occupational Safety and Health (NIOSH); c2015 [cited 2019 Mar 6]. Hierarchy of Controls. Available from: https://www.cdc.gov/niosh/topics/hierarchy/default.html
- Wiedermann U, Garner-Spitzer E, Wagner A. Primary vaccine failure to routine vaccines: Why and what to do?. Hum Vaccin Immunother. 2016;12(1):239–43.6.
- Wilde H. Failures of post-exposure rabies prophylaxis. Vaccine. 2007;25(44):7605–9.
- Schmitt JM, Wilson DE, Raber JM. Occupational Safety and Health. In: Weichbrod RH, Thompson GA, Norton JN, editors. Management of animal care and use programs in research, education, and testing. 2nd ed. Boca Raton (FL): CRC Press; 2018. p. 279–318.
- Delany JR, Pentella MA, Rodriguez JA, Shah KV, Baxley KP, Holmes DE; Centers for Disease Control and Prevention. Guidelines for biosafety and laboratory competency: CDC and the Association of Public Health Laboratories. MMWR Suppl. 2011;60(2):1–23.
- Federal Select Agent Program [Internet]. Atlanta (GA); Riverdale (MD): Centers for Disease Control and Prevention; Animal and Plant Inspection Service; c2018 [cited 2019 Mar 6]. Occupational Health Program. Available from: https://www.selectagents.gov/compliance/guidance/occupational-health/index.htm
- Jahrling P, Rodak C, Bray M, Davey RT. Triage and management of accidental laboratory exposures to biosafety level-3 and -4 agents. Biosecur Bioterror 2009;7(2):135–43.
- Fischman ML, Goldstein DA, Cullen MR. Emerging Technologies. In: Rosenstock L, Cullen MR, Brodkin CA, Redlich CA, editors. Textbook of Clinical Occupational and Environmental Medicine. 2nd ed. Philadelphia: Elsevier Saunders; 2005. p. 263–71.
- Kim DK, Riley LE, Hunger P. Advisory Committee on Immunization Practices recommended immunization schedule for adults aged 19 years or older—United States, 2018. MMWR Morb Mortal Wkly Rep. 2018;67(5):158–60.
- Centers for Disease Control and Prevention [Internet]. Atlanta (GA): National Center for Immunization and Respiratory Disease; c2019 [cited 2019 Mar 6]. ACIP Vaccine Recommendations and Guidelines. Available from: https://www.cdc.gov/vaccines/hcp/acip-recs/index.html
- Centers for Disease Control and Prevention [Internet]. Atlanta (GA): National Center for Emerging and Zoonotic Infectious Diseases, Division of Healthcare Quality Promotion; c2016 [cited 2019 Mar 6]. Infection Control. Available from: https://www.cdc.gov/infectioncontrol/index.html
- Menckel EWA, Westerholm P, editors. Evaluation in occupational health practice. 1st ed. Oxford: Butterworth-Heinemann; 1999.
- Levy BS, Wegman DH, editors. Occupational Health: Recognizing and Preventing Work-related Disease and Injury. 4th ed. Philadelphia: Lippincott Williams & Wilkins; 2000.
- National Institutes of Health. NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). Bethesda (MD): National Institutes of Health, Office of Science Policy; 2019.
- Federal Select Agent Program [Internet]. Atlanta (GA); Riverdale (MD): Centers for Disease Control and Prevention; Animal and Plant Health Inspection Service; c2017 [cited 2019 Mar 6]. Select Agents Regulations. Available from: https://www.selectagents.gov/regulations/index.htm
- Occupational Safety and Health Administration. Laboratory Safety Guidance. OSHA 3404-11R. Washington (DC): U.S. Department of Labor; 2011.
- Bloodborne pathogens, 29 C.F.R. Part 1910.1030 (1992).
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