This document contains information concerning animal use in human clinical facilities (e.g., MRI or PET Clinics). The use of animals in facilities also used by human patients carries special risks relating to exposure of patients to animal allergens or pathogens, as well as the increased potential for visibility of the animal procedures to members of the general public.
The following guidelines are intended as a general framework for individual clinical facilities to develop and implement their own Standard Operating Procedures (SOPs) for the use of animals. Additional requirements or limitations may be placed on the clinical facility by the Hospital Director or other regulatory or accrediting bodies such as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) or the Centers for Disease Control and Prevention (CDC).
Although the Principal Investigator is ultimately responsible for the proper conduct of all procedures involving animals, close collaboration with the clinical facility manager is essential to ensure adherence to the SOPs established for each facility. The Principal Investigator is responsible for ensuring that the human clinical facility has received approval for the proposed procedures by the Institutional Biosafety Committee and Radiation Safety Officer, as applicable.
In accord with PHS Policy IV.B.2, USDA Animal Welfare Act Regulations (AWARs) §2.31(c)(2), and the Guide for the Care and Use of Laboratory Animals (the Guide, p. 25), all human clinical areas used for animal procedures shall be subject to semiannual inspection by the ARC.
In general, human clinical areas should not be used if a suitable dedicated animal facility is available. Animals should not be treated in operating rooms or other patient-care areas where invasive procedures are performed (e.g., cardiac catheterization laboratories or invasive nuclear medicine areas). When use of a human clinical area is necessary, the use of this facility must conform to the following:
Infection Control Measures
Investigators and clinical managers are expected to minimize the potential that clinical employees and patients will come into contact with animal saliva, dander, urine, or feces. It is recommended that investigators schedule the animal procedure for the last procedure of the day in the area, at a time when human patients are not scheduled to be in the vicinity.
All personnel must practice hand hygiene after any animal contact.
- Wash hands with soap and water, especially if hands are visibly soiled or contaminated with proteinaceous material.
- Use either soap and water or alcohol-based hand rubs when hands are not visibly soiled or contaminated.
After the procedures have been performed, all surfaces including the countertops, floors, equipment, and any other areas of the procedure room where animals were used must be thoroughly cleaned and disinfected. If reusable medical or surgical instruments are used in animal procedures, future use of these instruments should be limited to animals only.
Investigators are expected to comply with all applicable federal, state, and local laws concerning medical waste disposal, protection of the environment, and pollution control to dispose animal waste, trash, and debris, as described in their facility's SOPs.
Whenever possible, the clinical area should be designed so that access to the facility is through an inconspicuous entrance, rather than through the patient lobby.
Rooms used for animal procedures should be properly ventilated to minimize the spread of animal particulate matter or pathogens to other areas of the clinical facility. Rooms should be maintained at negative pressure relative to the corridor. Air from these rooms should not recirculate elsewhere in the facility.
All doors and interior window shades in the clinical room must be closed to avoid view and/or intrusion of the conduct of the procedures. If the clinical facility is located such that the procedures can be observed from the outside (e.g., on the ground floor), exterior window shades must also be closed.
Requirements for Personnel
Patients and non-essential employees must not be present in the immediate vicinity when animal procedures are ongoing.
Employees participating in the animal procedure must be listed on the approved ARC protocol. Individuals who will have hands-on contact with conscious animals must complete all animal user certification requirements. Completion of all components of the certification program may not be necessary for personnel who will only have contact with unconscious animals; however, investigators should consult the ARC administrative staff (310-206-6308 or firstname.lastname@example.org) to determine specific training requirements for these individuals.
Finally, annual submission of a Medical History Questionnaire (MHQ) to the Occupational Health Facility (OHF) is mandatory for all employees, including those who will assist in the procedures but will not have direct contact with the animals.
Source: Centers for Disease Control and Prevention, Guidelines for environmental infection control in health-care facilities: recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC), MMWR 2003;52 (No. RR-10):28-30.
Approved 3/22/04; Revised 2/8/10; Updated 1/18/11
Replaces ARC Policy on Animal Transport and Use in Clinical and Public Access Areas 12/00