SAMPLE SEMIANNUAL PROGRAM & FACILITY REVIEW CHECKLIST

Introduction

Many institutions have sought guidance on how to conduct adequate semiannual reviews of institutional programs and facilities for the care and use of animals as required by the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy).  This PHS Policy requirement, found at IV.B.1.&2., states that, at least once every six months, the Institutional Animal Care and Use Committee (IACUC) will review the institution's program  for humane care and use of animals and inspect all of the institution's animal facilities.  The Guide for the Care and Use of Laboratory Animals (Guide) contains the standards and benchmarks to be used as a basis for evaluation.

This sample checklist is a tool designed to assist IACUCs in conducting thorough semiannual reviews.  The sample checklist covers the major topics  of the Guide, and the requirements of the PHS Policy.  Endnotes are included to reference specific United States Department of Agriculture (USDA) regulatory requirements that differ from the PHS Policy.

This checklist does not replace the Guide; it should be utilized in  conjunction with the Guide which contains the standards, recommendations, and descriptions of desired outcomes necessary to evaluate and inspect an animal care and use program.

This checklist is provided only as a suggestion.  USE OF THIS CHECKLIST IS NOT MANDATORY. OLAW encourages institutions to try this checklist, to amend it as necessary to reflect institutional programs and needs, or to develop their own checklist. 

OLAW is interested in your comments on the usefulness of this checklist and any suggestions for revision.  We consider this document to be dynamic, subject to change as  institutions provide feedback on their experiences with it.  Suggestions or comments about this checklist should be sent to: olaw@od.nih.gov. 

InstructionS FOR CHECKLIST

The IACUC has a mandate to review at least once every six months the institution’s program for the  care and use of animals using the Guide as a basis for evaluation.  The program review section is titled  Sample Semiannual Program Review Checklist.  This program review section is further divided into Institutional Policies and Responsibilities that corresponds to Chapter One of the Guide, and Veterinary Medical Care that corresponds to Chapter Three of the Guide.  It is recommended that the program review section be completed during an IACUC meeting.

The IACUC is also charged with inspecting at least once every six months all of the institutions animal facilities, including satellite facilities, using the Guide as a basis for evaluation.  The second half is titled  Sample Semiannual Facility Inspection Checklist and corresponds to Chapters Two and Four of the Guide.  This section is further divided into: animal housing and support areas; cagewash; aseptic surgery; and procedure areas, non-survival surgeries, laboratories, and rodent surgeries.  Because these are physical aspects of a program that require visual observation to evaluate, it is recommended that this section be completed during an inspection of facilities.  There is an additional page on which to record observations during the facility inspection.

A table is provided, titled Sample Semiannual Program and Facility Review Report.  It is intended to suggest a format for the IACUC to organize and track information regarding deficiencies, and plans and schedules for correction.  Some IACUCs  may wish to attach the table to the report to the Institutional Official.

                 SAMPLE SEMIANNUAL PROGRAM REVIEW CHECKLIST 
 			  INSTITUTIONAL POLICIES AND RESPONSIBILITIES
	
DATE:	*A	M	S	
1.  IACUC Membership and Functions				
- institution provides training and resources to assist IACUC members in understanding and 
  evaluating issues brought before the committee				
- at least 5 members, appointed by CEO				
- members include veterinarian, scientist, non-scientist, and non-affiliated non-lab animal user				
	- responsible for oversight and evaluation of institution's program				
	- reports to Institutional Official (IO)				
	- conducts semiannual evaluations of institutional animal care and use program				
	- conducts semiannual inspections of institutional animal facilities				
	- reviews and investigates concerns about animal care and use at institution				
	- procedures for review, approval and suspension of animal activities				
	- procedures for review & approval of significant changes to approved activities				
	- policies for special procedures (e.g. restraint, multiple survival surgery, fluid restriction)				
2.  IACUC Records and Reporting Requirements				
Reports to Institutional Official (IO)				
	- reports of semiannual program reviews & facility inspections are submitted to IO				
	- include minority IACUC views				
	- describe departures from Guide or PHS Policy and reasons for departure				
	- distinguish significant from minor deficiencies				
	- include plan and schedule for correction of each deficiency identified				
Reports to Office of Laboratory Animal Welfare (OLAW)				
	- reports include any minority IACUC views				
	- annual report to OLAW documents program changes & dates of IACUC semiannual review				
	- promptly advises OLAW of serious/ongoing Guide  deviations or PHS Policy noncompliance				
	- promptly advises OLAW of any suspension of activity by the IACUC				
Reports to United States Department of Agriculture (USDA)				
	- annual report contains required information				
	- reporting mechanism in place for IACUC-approved exceptions to the regulations and standards				
	- reports within 15 days failure to adhere to timetable for correction of deficiencies				
	- reports suspension of activity by the IACUC to USDA and any Federal funding agency				
Records				
	- minutes of IACUC meetings and semiannual reports maintained for 3 years				
	- IACUC review documentation maintained for 3 years after end of study				
	- IACUC review of activities involving animals includes all required information				
3.  Veterinary Care (See also next section - Veterinary Medical Care)				
	- institutional arrangement for veterinarian with training or experience in lab animal medicine				
	- veterinary access to all animals				
	- provision for backup veterinary care				
	- must provide guidance on handling, immobilization, sedation, analgesia, anesthesia, euthanasia				
	- must provide guidance/oversight on surgery programs and oversight of postsurgical care				
	- veterinary authority to oversee all aspects of animal care and use 				
*A = acceptable; M = minor deficiency; S = significant deficiency (is or may be a threat to animal health or safety)	

              SAMPLE SEMIANNUAL PROGRAM REVIEW CHECKLIST 
		       INSTITUTIONAL POLICIES AND RESPONSIBILITIES (cont.)
	
DATE:	*A	M	S	
4.  Personnel Qualifications and Training				
	- institution has established and implemented an effective training program				
	- includes professional/management/supervisory personnel				
	- includes animal care personnel				
	- includes research investigators, instructors, technicians, trainees, students				
Training program content				
	- humane practices of animal care (e.g. housing, husbandry, handling)				
	- humane practices of animal use (e.g. research procedures, use of anesthesia, pre- & post-operative care)				
	- research/testing methods that minimize numbers necessary to obtain valid results				
	- research/testing methods that minimize animal pain or distress				
	- use of hazardous agents, including access to OSHA chemical hazard notices where applicable				
5.  Occupational Health and Safety of Personnel				
Institutional program for a safe and healthy workplace				
	- program is established and implemented				
	- covers all personnel who work in laboratory animal facilities				
	- based on hazard identification and risk assessment				
	- personnel training (e.g. zoonoses, hazards, pregnancy/illness/immunosuppression precautions)				
	- personal hygiene procedures (e.g., work clothing, eating/drinking/smoking policies)				
	- procedures for use, storage & disposal of hazardous biologic, chemical, and physical agents				
	- specific procedures for personnel protection (e.g., shower/change facilities, injury prevention)				
Program for medical evaluation and preventive medicine for personnel				
	- pre-employment evaluation including health history				
	- immunizations as appropriate (e.g. rabies, tetanus) & tests				
	- zoonosis surveillance as appropriate (e.g. Q-fever, tularemia, Hantavirus, plague)				
	- procedures for reporting and treating injuries, including bites etc.				
Special precautions for personnel who work with primates 				
	- tuberculosis screening includes all exposed personnel				
	- training and implementation of  procedures for bites & scratches				
	- education regarding Cercopithecine herpesvirus 1 (Herpes B)				
Notes:	

	

	

	

*A = acceptable; M = minor deficiency; S = significant deficiency (is or may be a threat to animal health or safety)	

                SAMPLE SEMIANNUAL PROGRAM REVIEW CHECKLIST	
 				            VETERINARY MEDICAL CARE
	
DATE:	*A	M	S	
1.  Preventive medicine/animal procurement & transportation				
	- evaluation of animal vendors				
	- procedures for lawful animal procurement, evaluation of animals, & transport				
	- procedures for quarantine, stabilization				
	- policies on separation by species, source, health status				
	- policies for isolation of sick animals				
	- program of surveillance, diagnosis, treatment and control of disease				
	- availability of diagnostic resources for preventive health program				
	- provision for emergency, weekend and holiday veterinary care				
2.  Surgery				
	- procedures for monitoring surgical anesthesia and analgesia				
	- pre-surgical plan (e.g. identify space, supplies, conduct pre-op exam, define post-op care )				
	- appropriate training or experience of personnel in surgery & anesthesia				
	- major procedures distinguished from minor				
	- use of effective aseptic procedures for survival surgery				
	- implemented procedures for use of surgical facility				
	- implemented procedures for using/scavenging volatile anesthetics				
	- effective procedures for sterilizing instruments & monitoring expiration dates on sterile packs				
	- documentation of post-operative monitoring and care				
3.  Pain, distress, analgesia, and anesthesia				
	- guidelines for assessment and categorization of pain				
	- IACUC guidelines for avoiding unnecessary pain and distress				
	- appropriate anesthetics, analgesics, tranquilizers used for each species				
	- special precautions for the use of paralytics				
	- veterinary input in the choice of drugs				
4.  Euthanasia				
	- compliance with current AVMA Panel on Euthanasia unless approved by the IACUC				
	- guidance provided on appropriate methods for each species				
	- training available for personnel in humane methods of euthanasia				
5.  Drug storage and control				
	- safe, secure, storage arrangement				
	- record keeping meets regulations				
	- procedures exist for ensuring drugs are within expiration date				
Notes:	

	

	
 *A = acceptable; M = minor deficiency; S = significant deficiency (is or may be a threat to animal health or safety)	

SAMPLE SEMIANNUAL FACILITY INSPECTION CHECKLIST
ANIMAL HOUSING & SUPPORT AREAS
  
        DATE:
	
Location:	animal areas separate from personnel areas, separation of species, separation by disease status	
Construction:	corridors, doors, windows, floors, drainage, walls, ceilings, HVAC, power & lighting, noise	
Room/cage:	temperature, humidity, ventilation, illumination, noise control	
Cage/run :	sanitation, cleaning tools, food/water access, security, safety, allows undisturbed observation,
			size, rationale for Guide/ USDA exceptions, meets physiologic, behavioral, social needs	
Sheltered or outdoor housing (barns, corrals, pastures, islands): 
			weather protection, ventilation & sanitation of shelters (no waste/moisture build-up),
			animal acclimation, social compatibility, roundup/restraint procedures, security	
Behavioral management:     environmental enrichment, social grouping, animal activity	
Food:		feeding schedule & procedures, contamination, vendor quality control ,
			storage in sealed containers, expiration date labeling, vermin control, rotation of stocks
Water:	            ad libitum unless justified, QC procedures
Bedding:	species appropriate, keeps animals dry, QC procedures, minimizes scientific variables
Sanitation:	frequency of bedding change (note Guide exceptions), cleaning & disinfection, monitoring
Waste disposal:    procedures for collection, storage & disposal of waste; hazardous waste; animal carcasses
Pest control:    regularly scheduled, documented program including control of rodent pests & insecticide use
Emergency, weekend, & holiday animal care:     provision for accessible contact information, monitoring 
                       of backup systems, veterinary care, a disaster plan that takes into account both personnel and
                       animals               
Animal identification and records:     cage/rack cards contain required information, clinical records 
                       accessible and appropriate
Genetics and nomenclature:     appropriate genetic records & monitoring procedures, use of standardized 
                       nomenclature
Storage:	food and bedding, supplies, drugs & biologics, waste material, hazardous material, carcasses 
Personnel:	locker rooms, administration and training
Specialized space:	receiving, quarantine, isolation, necropsy, radiography, diet preparation 	
	
  LOCATION	 *A	M	S							NOTES	

					

					

					

					

  		 *A = acceptable; M = minor deficiency; S = significant deficiency (is or may be a threat to animal health or safety)	

SAMPLE SEMIANNUAL FACILITY INSPECTION CHECKLIST
CAGEWASH

DATE:	

Construction:
	- doors, windows, floors, drainage, walls, ceilings (see Guide)	
	- convenient to animal areas/waste disposal	
	- ease of access (including door size) facilitates use	
	- sufficient space for workload	
	- safety precautions/clothing/equipment used for bedding disposal/prewash/acid wash	
	- traffic flow clean to dirty with no contamination of clean equipment by dirty equipment	
	- insulation and/or sound attenuation present as needed	
	- utilities are appropriate	
	- ventilation meets heat and humidity load and Guide requirements	
	- safety features (SOP’s, warning signs, eyewash station) are in use	
	- cagewash temperatures are monitored & records are available	
	- appropriate clean cage storage 
	
LOCATION	 *A	M	S                                             NOTES	

					

					

					

					

					

					

					

					
		*A = acceptable; M = minor deficiency; S = significant deficiency (is or may be a threat to animal health or safety)       			

SAMPLE SEMIANNUAL FACILITY INSPECTION CHECKLIST 
ASEPTIC SURGERY

DATE:	

General Considerations:	
	- location minimizes traffic/contamination	
	- functional components (surgical support, animal preparation, surgeon scrub, operating room,
	  postoperative recovery) are designed and separated (physically or otherwise) according to the Guide	
	- appropriate drug storage, control, expiration date monitoring	
	- safe sharps disposal system	
	- adequate records of anesthesia and perioperative care	
	- aseptic procedures in use for all survival surgery	
Operating Room: 	
	- effective contamination control procedures	
	- effective cleaning procedures/dedicated tools	
	- interior surfaces smooth and impervious to moisture	
	- HVAC system meets Guide requirements	
	- lighting safe and appropriate	
	- outlets safe and appropriate	
	- scavenging of anesthetic gases implemented	
	- warning signs posted where needed	
	- fixed equipment is sanitizable	
Surgical support:
	- facility for washing, sterilizing, storing instruments & supplies	
	- autoclave monitoring procedures are implemented	
	- storage of autoclaved materials maintains sterility	
	- cold sterilization procedures are appropriate 	
Animal preparation:	contains large sink to facilitate cleaning of animal and operative site	
Surgeon scrub:	outside operating room, non-hand-operated sink	
Postoperative recovery: allows adequate observation, easily cleaned, supports physiologic functions, 
                                      minimizes risk of injury	
Dressing area:             place for personnel to change	
	
LOCATION	 *A	M	S	                                            NOTES	

					

					

					

		*A = acceptable; M = minor deficiency; S = significant deficiency (is or may be a threat to animal health or safety)       			

			SAMPLE SEMIANNUAL FACILITY INSPECTION CHECKLIST 
		          PROCEDURE AREAS, NON-SURVIVAL SURGERIES, LABORATORIES, 
						        RODENT SURGERIES

DATE:	
	
General concerns:	
	- drug storage, control, and expiration dates	
	- sharps disposal	
	- anesthetic monitoring	
	- gas cylinders immobilized	
	- scavenging of anesthetic gases	
	- warning signs	
	- carcass disposal	
	
Additional concerns for survival surgery (rodent or minor procedures only):	
	- rodent survival surgery clean and uncluttered, not used for anything else during surgery	
	- records of perioperative care	
	- aseptic procedures	
	- autoclave monitoring procedures	
	- storage of autoclaved materials	
	- cold sterilization procedures are appropriate	
	
  LOCATION	*A	M	S							NOTES	

					

					

					

					

					

					

		* A = acceptable; M = minor deficiency; S = significant deficiency (is or may be a threat to animal health or safety)	

			SAMPLE SEMIANNUAL FACILITY INSPECTION CHECKLIST 
			     [Use this  page when additional space is needed for facility inspection comments]

DATE:	
				
  LOCATION	*A	M	S						notes	

					

					

					

					

					

					

					

					

					

					

					

		 *A = acceptable; M = minor deficiency; S = significant deficiency (is or may be a threat to animal health or safety)	

						SAMPLE Semiannual Program & Facility Review Report	

DATE:		
	
Members in Attendance:		

Deficiency
Category
(S or M)	

*	

Location	
Deficiency 
& Plan for Correction	
Responsible       Party	
Correction Schedule
& Interim Status	
 Date
 Complete	

							

							
 S = significant deficiency, M = minor deficiency  (a significant deficiency is or may be a threat to animal health or safety)	
*Check if repeat deficiency	

Endnotes - Selected USDA Regulatory Requirements that Differ from the PHS Policy