SAN DIEGO STATE UNIVERSITY ENVIRONMENTAL HEALTH AND SAFETY ANIMAL CONTACT/EXPOSURE MONITORING PROGRAM AN OCCUPATIONAL HEALTH PROGRAM POLICIES AND REGULATIONS The US Public Health Service (PHS) regulations require an effective Occupational Health and Safety Program for the care and use of animals in research or education. As part of that program, the regulations further require to have an effective Occupational Health Program. It is the policy of San Diego State University to comply with all pertinent Federal, State and local statutes, standards and regulations regarding provision of personnel health programs for individuals who have contact with or are exposed to animals in the course of their employment, research or education. Therefore, participation in the SDSU Animal Contact/Exposure Monitoring Program is thus mandatory for all faculty, staff, students and volunteers who work in the SDSU animal facilities; work directly with animals or animal tissues, body fluids or wastes; work in close proximity to animals; or work with hazardous agents or conditions in animal research or education. Their contact or exposure to animals may increase their risks of an occupational illness from zoonotic disease, animal bites and scratches, or animal allergy in the course of their employment, research or teaching. Therefore, the purpose and goal of the Animal Contact/Exposure Monitoring Program is to identify, evaluate, manage, and reduce potential health hazards and risks of exposure to illness associated with the care and use of animals, their derived products, and their tissues at SDSU. The SDSU Animal Contact/Exposure Monitoring Program is intended to comply with the recommendations made by the Committee on Occupational Safety and Health in Research Animal Facilities and the Institute for Laboratory Animal Resources. These recommendations have been published in the Guide of the Care and Use of Laboratory Animals, (National Research Council; National Academy Press; Washington D.C.; 1996) and Occupational Health and Safety in the Care and Use of Research Animals (National Research Council; National Academy Press; Washington DC; 1977). OVERVIEW Hazard Identification and Risk Assessment are critical components of an effective Occupational Health Program which involves the identification of health hazards and ensures the potential risks associated with an individual’s contact or exposure to animals, animal tissues, hazardous agents and conditions in animal research or instruction are minimized. The Initial (preplacement / pre-assignment) Health History Evaluation establishes a baseline of an individual’s EHS, SDSU Page 1 Rev. 10/2013 health condition that could potentially increase exposure or risk to hazards inherent in animal research or instruction. Subsequent updates and Periodic Health Evaluations are then performed to assess an individual’s changing risks. In many cases, an Initial Risk Assessment is all that is necessary. For some individuals however, an Initial Health History Evaluation and Periodic Health Evaluation may be required as well. PURPOSE The purpose of an occupational health and safety program is to reduce the risk of exposure to the health hazard (illness and injury) associated with the use of animals, their derived products and their tissues in research, teaching and employment consistent with the overall institutional focus on maintaining a safe and health workplace. This program is designed to help protect researchers, staff, students, and volunteers from the risk of possible infection by animalassociated organisms or other agents associated with animal research. It is also designed to help prevent development of laboratory animal related allergies or to help slow progression of existing allergies. There is a risk associated with working with live vertebrate animals in a way that increases exposure to zoonotic diseases, animal related physical injury, or allergy. PROGRAM INFORMATION Individuals who work in SDSU laboratory animal facilities; work directly with animals or animal tissues; work with hazardous agents or conditions in animal research or education; or work in close proximity with animals are required to participate in the Animal Contact/Exposure Monitoring Program. This program is provided at no cost to the employee. Principal Investigators and supervisors are responsible for ensuring that all personnel (including employees, students, colleagues, collaborators, and volunteers) involved with their IACUCapproved project are given the program information and forms. They are also responsible for providing the hazard information relating to their animal contact/exposure as part of the program. The Institutional Animal Care and Use Committee (IACUC) verifies that all personnel listed on new and continuing Animal Protocol Form (APF) are registered with the SDSU Animal Contact/Exposure Monitoring Program. The program involves completion of one or more of the following elements: Risk Assessment, Initial Health History Evaluation, and Periodic Health Evaluation. The IACUC notifies the Principal Investigator (PI) and supervisor of any personnel who have not completed the program and are not thus cleared for animal contact. In addition, PIs or supervisors who do not respond to IACUC’s requirement for personnel participation in the Animal Contact/Exposure Monitoring Program may have their approval rescinded by the IACUC. The extent of medical coverage under the program is based upon risk assessment by an occupational medicine physician. Individuals in this program are evaluated by an occupational EHS, SDSU Page 2 Rev. 10/2013 health physician with respect to the type and extent of his/her animal contact, and are advised on the inherent risks involved with the animal research and the recommended medical services in an effort to provide a healthy and safe work environment. ELEMENTS OF THE PROGRAM 1. Hazard Identification and Risk Assessment A Risk Assessment Form (RAF) is required to be filled out by faculty, staff, students, volunteers, visitors, etc. who are listed on the Animal Protocol Form (APF), work in SDSU laboratory animal facilities; work directly with animals or animal tissues; work with hazardous agents or conditions in animal research or education; or work in close proximity with animals. Students who are not listed on the APF but have exposure to animals while participating in a teaching exercise will not normally be required to enroll in the Animal Contact and Exposure Monitoring Program. Students will be provided information about any health considerations relative to the species with which they will be exposed. The supervisor or PI can provide assistance as needed in filling out this form. The supervisor and PI will sign this form attesting to the accuracy of information regarding animal exposure or contact. This form is submitted to IACUC through EHS to evaluate exposure risk and determine whether the Medical History Questionnaire (MHQ) must be completed. This risk assessment shall involve consideration of the following factors: animal contact; exposure intensity; exposure frequency; physical and biological hazards presented by the animal; hazardous properties of the agents used in the animal research protocols or teaching activities; and hazard control measures available. The University recognizes that hazard identification and risk assessment must be a continuing process in each animal use unit. Everyone who had filled out the Risk Assessment Form (RAF) will be informed of potential hazard and risk of exposure when working in SDSU laboratory animal facilities; working directly with animals or animal tissues; working with hazardous agents or conditions in animal research or education; or working in close proximity with animals. EHS will notify the individual either of the following: EHS, SDSU A risk assessment that indicates no Medical History Questionnaire (MHQ) is necessary; or Page 3 Rev. 10/2013 A risk assessment that indicates a Medical History Questionnaire (MHQ) is necessary to complete and submit and evaluated by a license occupational health physician, and if applicable, any required medical evaluation, examination, and medical clearance. Upon completion of the Medical History Questionnaire (MHQ), the questionnaire must be submitted directly to a licensed health care provider (LHCP) to evaluate health risks and whether a medical evaluation is needed. The risk assessment shall include susceptibility of individuals and occupational health history of individuals. An updated Risk Assessment Form (RAF) must be completed and submitted if there are changes to the type and frequency of exposure to animals, or changes in exposure to hazardous materials used with the animals. All Risk Assessment Forms (RAF) will be maintained by EHS. 2. Initial Health History Evaluation / Preplacement Medical History Evaluation The Medical History Questionnaire (MHQ) is completed by faculty, staff, students, volunteers, visitors, etc. who work in SDSU laboratory animal facilities; work directly with animals or animal tissues; work in close proximity with animals; or work with hazardous agents or conditions in animal research or teaching. Individuals who have contact or exposure to (including working within the “air space” or “breathing their air”) non-human primates (including unfixed tissue, blood and bodily fluids of these animals), or experimentally or naturally infected animals with Risk Group 3 agents (ABSL 3), or whose work involves animal husbandry or veterinary care with any species must enroll in the Animal Contact/Exposure Monitoring Program by completing the Medical History Questionnaire (MHQ). Anyone who had filled out the Risk Assessment Form (RAF) but does not work with the types of animals/materials mentioned above are made aware of the MHQ and have the option of filling out the Medical History Questionnaire (MHQ). In particular, individuals with known latex or animal allergies, are pregnant or plan to become pregnant, have chronic medical conditions or with existing medical conditions that create an animal contact health risk but do not work with the types of animals/materials mentioned above are encouraged to complete the Medical History Questionnaire (MHQ). The Medical History Questionnaire (MHQ) deals with anticipated or actual exposure to animals at work, immunization status with regard to rabies and tetanus, susceptibility or EHS, SDSU Page 4 Rev. 10/2013 occupational health history of the employee, and any existing medical conditions that create an animal contact health risk. Individuals with known latex or animal allergies, are pregnant or plan to become pregnant, or have chronic medical conditions are asked to disclose these conditions in the Medical History Questionnaire (MHQ). Such conditions can increase the risk or severity of animal exposure. The completed Medical History Questionnaire (MHQ) is sent directly to Sharp Rees Stealy (SRS) and reviewed by an Occupational Medicine physician at SRS for health risks and determine whether a medical evaluation and/or examination is needed. After completion of the medical review of the information provided in the Medical History Questionnaire (MHQ), the occupational health physician notifies EHS in a timely manner regarding: approval to work with the animal species or materials specified on the risk assessment form, or need to complete a medical evaluation and/or examination. An updated Medical History Questionnaire (MHQ) must be completed and submitted if there is a change to an individual’s health status. 3. Periodic Medical/Health Evaluation and Examination If the occupational health physician determines based on risk assessment and medical history that medical evaluation is warranted, the enrollee will schedule an appointment with the occupational health physician for a medical evaluation and for receipt of other procedures and services. However, if an individual declines the additional medical services, he/she will be notified of his/her right for reassessment of risk at any time in the future and the enrollee will be advised to discuss the risks of animal contact when next seen by his/her physician. For participants who do not wish to utilize the medical services offered by the program, and are not required by their position to obtain immunizations/testing, there is a Medical Evaluation Declination Form, which allows them to opt out of the medical services offered by the program. The Risk Assessment Form (RAF) and Medical History Questionnaire (MHQ) must be submitted prior to submitting the Medical Evaluation/Examination Declination Form. The IACUC and PI/supervisor will be informed of the declination. The IACUC and PI/supervisor will determine if the declination places the participant in an unsafe work environment and will address that issue directly with the participant. EHS, SDSU Page 5 Rev. 10/2013 After completion of the medical evaluation, the occupational health physician notifies: EHS in a timely manner regarding approval, disapproval or accommodations required for the individual to work with the animal species specified on the risk assessment form. Employees of medical follow-ups and surveillance recalls e.g. tetanus booster, rabies antibody titer. Records documenting status of entry medical evaluation and recommendations regarding surveillance recalls schedules will be prepared and maintained by the occupational health physicians. Occupational Health Physician will determine frequency of the period medical evaluation. Health provider recommendations for immunizations/tests will be based on the functional requirements of the positions, the type of animal contact, and the individual’s medical history. Any person declining to obtain recommended inoculations or testing will be required to sign the Medical Evaluation/Examination Declination Form. The IACUC and PI/supervisor will be informed of the declination. The IACUC and PI/supervisor will determine if the declination places the participant in an unsafe work environment and will address that issue directly with the participant. In some cases, immunizations or tests are required for a position and cannot be declined. For example, those working with (or in the rooms with) non-human primates must have biannual TB screenings (TST). Also, those working with the rabies virus must have the rabies immunizations and subsequent titers. Periodic medical/health evaluations and examinations are also designed and provided to help monitor for occupational exposure, injury, or illness that may have occurred. 4. Post Exposure Evaluation Concerns and symptoms of inhaled and contact allergies to lab animals should be reported as soon as they are noted. Personnel reporting illnesses potentially related to their work with animals should immediately contact their supervisor and contact Sharp Rees Stealy at (619) 644-6600 and see an occupational health physician during normal working hours or proceed to Sharp Rees Stealy Urgent Care for emergency after hours. Note: The IACUC or PI/supervisor will be notified of all declination forms. They will determine if the declination places the participant in an unsafe work environment and will address that issue directly with the participant. EHS, SDSU Page 6 Rev. 10/2013 REQUIREMENTS FOR COMPLETION As noted above, participation in the Animal Contact/Exposure Program is mandatory for all employees, students, visitors, and volunteers who work in SDSU laboratory animal facilities; work directly with animals or animal tissues; work with hazardous agents or conditions in animal research or teaching; or work in close proximity with animals. An employee, student or visitor is at an increased risk if they are exposed to these materials in a way that gives them an increased risk of an occupational illness such as zoonotic disease, physical injury or allergy. An individual has successfully met this requirement when he/she has registered in the Program by completing the Risk Assessment Form and has received from EHS either: 1. A risk assessment that indicates no medical questionnaire is necessary; or 2. A risk assessment that indicates a medical history questionnaire is necessary to complete and submit and evaluated, and if applicable, any required medical evaluation, examination, and medical clearance. Generally at the conclusion of a health history and any prescribed medical evaluation, the medical professional determines the individual to be either: a. Medically eligible to perform the stated activities without restriction b. Medically eligible to perform the stated activities with additional requirements (e.g. respiratory protection or vaccination) or c. Medically ineligible to perform the stated activities. ELIGIBILITY Individuals covered by the occupational health program (Animal Contact and Exposure Program) include faculty, staff, students, volunteers and visitors who work with vertebrate animals or in close proximity to/with them, or who handle certain animal tissues, body fluids or wastes, or work with hazardous agents or conditions in animal research or teaching. Therefore, faculty and staff employees including students, volunteers and visitors are required to participate in the Animal Contact/Exposure Monitoring Program by completing the Risk Assessment Form if they have duties that: 1. Have direct contact or are involved in the direct care of live animals, including small or large animals or nonhuman primates (NHP). 2. Are within the “air space” of the NHP or infectious animal and breathing their air. 3. Work with non-fixed NHP or infectious animal tissue including blood. EXAMPLES OF ELIGIBLE PARTICIPANTS Those involved in the direct care of animals (including part time employees) Research investigators and their technical staff EHS, SDSU Page 7 Rev. 10/2013 Instructors Students having animal contact through research projects Others having direct contact with animal tissue, fluids or wastes Relevant personnel involved in animal facilities maintenance, custodial services, security Some visitors Students who are only exposed to animals in a classroom setting are not required to participate in the Animal Contact and Exposure Program. Short term visitors from other institutions should provide to IACUC and EHS evidence of current participation in a medical surveillance program at their home institution. Without such documentation, visitors will be required to participate in the SDSU Animal Contact/Exposure Program. Certain animal contact/projects pose little or no health risk to individuals and are exempt from enrolling in the Animal Contact/Exposure Program (not required to fill out the Medical History Questionnaire but the Risk Assessment Form is still required to be completed and submitted). Exemption is granted to those who are involved or work with outdoor observation studies of animals at a distance. Individuals with isolated one-time contact or incidental animal contact (e.g. participation in training sessions) are also exempt. The following exemptions are also granted after submission of the Risk Assessment Form: 1. Personnel who work solely with standard animal biological products obtained from vendors, such as organs, tissues, cells, or antibodies, may be exempt from program participation. A written request and current animal health report from the vendor must be provided to the IACUC veterinarian for review and approval in order to qualify for this exemption. 2. Personnel whose contact is limited to in-vitro work with animals, tissues, fluids or wastes that have been sterilized chemically or via autoclaving. All these individuals are advised of specific health risks, precautions and recommendations through the Notice Regarding Possible Risks Associated with the Use of Animals in Research or Education and are required to complete and submit the Risk Acknowledgment Form, but are not required to formally enroll in the Risk Assessment, Medical History, Medical Evaluation and Examination portion of the Animal Contact/Exposure Monitoring Program. The primary responsible party (principal investigators, research director, student research coordinator, etc.) shall be responsible for assuring compliance with the notification requirements for these individuals. It is their responsibility to ensure that all personnel who have animal contact be enrolled in the Animal Contact/Exposure Monitoring Program before they begin working or contacting animals. Failure to enroll in the program may result in delay of approval for new or renewal APF submissions as well as significant changes to existing EHS, SDSU Page 8 Rev. 10/2013 protocols. If IACUC determines that an individual working in an animal research area is not enrolled in the Monitoring Program, the protocol or individuals may be suspended from animal work until such time has been completed. IDENTIFICATION, PARTICIPATION AND ENROLLMENT Supervisors identify any potential workplace health hazards including potential exposure or contact with research animals as part of this Occupational Health Program. Faculty, staff, and student employees including volunteers who work in SDSU laboratory animal facilities; work directly with animals or animal tissues; work with hazardous agents or conditions in animal research; or work in close proximity with animal must participate in the Program by completing the Risk Assessment Form (RAF). Members of IACUC or visitors who will perform facility inspections must also participate by completing the Risk Acknowledgement Form. However, students whose contact or exposure to animals or animal tissue is limited to classroom activities only however, are not required to participate. The RAF is sent to the enrollee’s supervisor for validation. Once approved at this level, the responses on the RAF are evaluated by the Environmental Health and Safety Department (EHS) to determine based on risk of exposure whether the Medical History Questionnaire (MHQ) must be completed and submitted to Sharp Rees Stealy Occupational Medicine or Student Health Services (SHS). If so, the information provided on the completed MHQ will be reviewed by Sharp Rees Stealy Medical Services (SRS) or Student Health Services (SHS). If clinical evaluation or medical examination, periodic medical evaluation and examination or medical intervention i.e. immunization is required, the enrollee will be notified of the requirements and must meet the requirements in order to become compliant with the Program. Initial Health History Evaluations/ Pre-placement Medical History Evaluation (completion and review of Medical History Questionnaire MHQ) are mandatory for animal care or veterinary care staff, for those individuals who have contact or exposure to (including working within the “air space” and “breathing their air”) non-human primates (including unfixed tissue, blood and bodily fluids of these animals) or experimentally or naturally infected animals with Risk Group 3 agents (ABSL 3). OCCUPATIONAL INJURY OR ILLNESS RESPONSE AND REPORTING PROCEDURE Every animal holding facility and animal research laboratory will maintain an injury log to include the date, time, type of injury, and date of employee referral for treatment. Employees and students shall promptly report all work-related injuries and illnesses to their immediate EHS, SDSU Page 9 Rev. 10/2013 supervisors for instructions on procedures for obtaining first aid or medical treatment. The injured/ill employee or student should report their claim to HR or Office of Risk Management within 3 working days of a major incident or within 5 working days of a minor incident, per procedures established by HR. Individuals, who experience an injury, illness, bites, scratch, or allergy symptoms related to working with animals, must promptly report the event to their Supervisor or Principal Investigator (PI) and must complete and submit an Incident/Accident Report Form whether the injured person receives medical treatment or not. When an injury or illness occurs and medical treatment is necessary, the individual and/or the supervisor must phone the SDSU Workers’ Compensation Office and complete the Supervisor Injury and Illness Form and Workers’ Compensation Claim Form (DWC -1). If medical treatment is needed, Sharp Rees Stealy (SRS) or Student Health Services (SHS) should be used. If SRS or SHS is closed or emergency treatment is necessary, visit SRS Urgent Care or go to the nearest Emergency Department. In the event that treatment is provided somewhere other than Sharp Rees Stealy or Student Health Services, employees and students must schedule an appointment with SRS and non-employee students should schedule an appointment with SHS for an evaluation before returning to work or the lab. The Incident/Accident Report Form must be submitted to EHS within 7 days of all injuries or incidences, or filling of Workmans’ Comp Claim to assist EHS in understanding and analyzing the causes of accidents and enhance the ability to take action to prevent recurrence. FACULTY, STAFF, STUDENT AND VOLUNTEER RESPONSIBILITIES When notified that a medical evaluation is required, a faculty, staff, student or volunteer animal handler must be seen by SRS or SHS as soon as possible to retain his/her access to animal facilities and continued authorization to use animals in research. If an animal handler does not promptly seek medical evaluation, IACUC will notify the animal handler, the Principal Investigator, and the Department Chair. Failure to complete the required Occupational Health Program registry and/or receive required medical evaluation at SRS or SHS will lead to suspension of an animal handler’s facility and animal access and/or revocation of IACUC protocol approval. Short term visitors from other institutions should provide to IACUC evidence of current participation in a medical monitoring program (occupational health program) at their home institution. Without such documentation, visitors will be required to participate in the SDSU Occupation Health Program. Individuals involved in isolated one-time, nonrecurrent exposures shall be informed of potential dangers and medical precautions, but are not required to participate in the program. The primary responsible party (principal investigator, research director, student research coordinator, etc.) shall be responsible for assuring compliance with the modification requirements for these individuals. EHS, SDSU Page 10 Rev. 10/2013 INSTITUTIONAL AND IACUC RESPONSIBILITIES All live vertebrate animal work conducted by SDSU faculty, either at on-campus or off-campus sites, must be approved by the IACUC. Moreover, the OHSP as a component of the animal care and use program is included in the IACUC’s semiannual program reviews. The IACUC has the responsibility to verify that individuals are enrolled in the Occupational Health Program before they are allowed to work with animals. Individuals will not be granted access to animal areas until they are enrolled in the Program. Whenever a new protocol or an annual protocol review is submitted, the list of all personnel working on the project will be reviewed by Research Affairs and compared with the occupational health registry database to ensure all individuals with contact/exposure are enrolled or have reviewed their information within the past year. If individuals associated with a new protocol are not enrolled, the protocol will not be approved by the IACUC. If individuals associated with an ongoing protocol are not enrolled, they will be asked to cease work until enrolled. In the case of ongoing failure to enroll, the IACUC will consider suspending approval of a protocol. Refusal to comply with any of this policy or the accompanying procedures may result in denial of faciliites access, a hold being placed on protocols for animal ordering, or withdrawal of protocol authorization or participation. ENVIRONMENTAL HEALTH AND SAFETY RESPONSIBILITIES The Environmental Health and Safety Department and the Institutional Animal Use and Care Committee (IACUC) jointly oversee the Animal Contact Program. The Program requirements are based on the type and frequency of exposure to animals. Employee identification and tracking will be managed jointly by IACUC and EHS. Sharp Rees Stealy Medical Group and SDSU Student Health Services are the medical provider for the program and maintains the medical records. EHS provides consultation to researchers, instructors, students, and staff on matters relating to occupational health and safety. EHS may also investigate or oversee investigation of accidents or incidents involving occupational health and safety to determine probable cause and/or the extent of compliance with IACUC and animal care and use guidelines. The EHS website contains material and linkages pertaining to initial and periodic training on occupational health and safety issues. LICENSED HEALTH CARE PROVIDER (LHCP) The LHCP through Sharp Rees Stealy Medical Group provides medical services and counseling associated with initial medical evaluation and surveillance recalls (e.g., annual reviews, tetanus EHS, SDSU Page 11 Rev. 10/2013 boosters, rabies antibody titers). With initial medical evaluations, the LHCP will notify the PI, director or supervisor in a timely manner when the medical evaluation and medical examinations have been completed and will indicate in the notification approval, non-approval or accommodations required for enrollees to work with the animal species specified in the Risk Assessment Form. The LHCP is responsible for notifying enrollees of medical follow-ups or surveillance recalls. Records documenting status of initial medical evaluations and surveillance recalls are maintained by the LHCP. TRAINING Supervisors, Principal Investigators and Instructors of individuals at increased risk must provide training and information about availability of medical evaluations and treatment, health and physical hazards such as zoonoses, allergies, animal bites, and methods for preventing and treating them. The value of universal precautions, personal hygiene and personal protective clothing and equipment will also be provided. Other considerations, such as precautions to be taken by individuals who are pregnant, planning to be pregnant, immune-compromised or have other significant medical conditions should also be addressed and discussed. EHS, SDSU Page 12 Rev. 10/2013