Semiannual Program Review^1^

Use this checklist and the *Guide for the Care and Use of Laboratory
Animals*, (1996 edition) to review the program of animal care and use.
This document is intended to aid Animal Care and Use Committees (ACUCs)
during the semiannual program review process. It can be used as a whole
or in parts to focus the discussion and intensify the detail of the
review.

Name of Reviewed Unit:

This review covers the period from:

Reviewers:

**[INSTRUCTIONS:]{.underline}**

Indicate your response by circling the appropriate symbol. Make comments
in the margin on the right side or use the back of the page. Comments
will become a part of the official program review. Answer to the best of
your knowledge. Forms do not need to be typed, but please write or print
legibly.

**Y** = Yes

**N** = No (Any "No" should be accompanied by a clarifying comment or
explanation.)

**?** = Unable to determine

**X** = Not Applicable

> ^1^ This checklist is intended to aid ACUCs during semiannual program
> review. It is not meant as a replacement for the "Semiannual Program
> Review Checklist" and is not to be submitted with the semiannual
> report. It is meant as a guide to assist ACUCs to ensure that all
> aspects of the program are reviewed.

**[General Requirements]{.underline}**

YN?X Does the institution devote sufficient resources to conduct the
animal care and use program?

YN?X Is there a functioning animal care and use committee?

YN?X Is there at least one trained and experienced veterinarian
associated with the program and is he authorized by formal agreement to
guide the program of animal care and use?

Are appropriate records maintained?

YN?X for each protocol with a record of the committee's action and date
of expiration?

YN?X for each committee meeting?

YN?X for each facility and program review?

YN?X of any outside evaluations?

YN?X regarding any complaints?

YN?X for all other pertinent information?

**[Monitoring the Care and Use of Animals]{.underline}**

*Institutional Animal Care and Use Committee*

Is membership in accordance with the Public Health Service Policy and
the Animal Welfare Regulations?

YN?X Veterinarian

YN?X One practicing scientist experienced in research involving animals

YN?X One public member not an animal user or affiliated with the
institution

YN?X One non-scientist

YN?X At least one additional member

YN?X Are the members of the IACUC appointed in writing by the
Institutional Official (IO)?

YN?X Does the committee have access to the appropriate resources
including administrative support sufficient to conduct the duties as
required?

Are procedures and policies in place to conduct the following activities
of the IACUC:

YN?X Does the committee meet at least once every six months as required?

YN?X Are minutes of these meeting written and filed for future review?

YN?X Are facilities inspected at least once every six months?

YN?X Is the program for the care and use of animals evaluated at least
once every six months?

YN?X Are the ARAC Guidelines on Classifying Deficiencies followed during
semiannual program review?

YN?X Is the ARAC Guideline on IC Collaborations Involving Animals
Outside NIH Animal Facilities being practiced?

YN?X Is the ARAC Guideline on Communications Among Collaborating ICs and
ACUCs being practiced?

Are reports submitted as required:

YN?X To the Institutional Official; Is a written report, signed by a
majority of the IACUC members, sent to the IO every six months?

YN?X To USDA (Annually)

YN?X To OPRR; at least every 12 months through the IO

YN?X To AAALAC (Annually)

YN?X In these reports are deficiencies listed as either minor or major
and is a plan and timeline for correction set forth?

YN?X Are procedures in place to receive and deal with complaints
regarding animal care and use?

YN?X Do procedures for dealing with complaints meet ARAC Guidelines?

*Animal Care and Use Protocols*

YN?X Has an animal study proposal (ASP) form been developed which asks
the appropriate questions for the review process? (See Page 10 of
Guide).

YN?X Are all elements of the NIH ASP form ( see Attachment 1, NIH Policy
Manual 3040-2) included in the form?

YN?X Is the ARAC Guideline on Significant Changes to ASPs practiced?

Has special consideration and careful review and justification been made
for the following?

YN?X Prolonged restraint.

YN?X Multiple major survival surgeries.

YN?X Food or fluid restriction. (See Page 12 of Guide and ARAC Guideline
on Diet Control in Behavioral Studies)

YN?X Use of wire bottom caging in rodents.

YN?X Use of inflammatory agents - Complete Freund's Adjuvant (See ARAC
Guideline)

YN?X LD50 testing ( See IRAC Recommendation)

YN?X Oocyte harvesting in *Xenopus laevis* (See ARAC Guideline)

YN?X Toe clipping of animals (See ARAC Guideline)

YN?X Ascites production in Mice (See ARAC Guideline)

YN?X Alleviation of pain and distress in rodents (See ARAC Guideline)

YN?X Endpoints in animal studies (See ARAC Guideline)

YN?X Survival bleeding in of mice and rats (See ARAC Guideline)

YN?X Genotyping of rodents (See ARAC Guideline)

*Veterinary Care (see separate section)*

YN?X Is there an attending veterinarian that has been given direct or
delegated authority to ensure that humane needs are met and are
compatible with scientific requirements.

YN?X Is there adequate staffing to ensure timely provision of veterinary
care?

*Personnel Qualifications and Training*

YN?X Is the animal care staff trained?

YN?X Is the research staff trained?

YN?X Does the ACUC have a process to track training and maintain records
of training of animal care staff?

YN?X Does the ACUC have a process to track training and maintain records
of training of research staff?

**[Hazard Identification and Risk Assessment]{.underline}**

YN?X Are inherent dangers identified and evaluated? Bites, chemical
cleaning agents, allergens, zoonotic diseases, etc.

Is the extent and level of participation in the program based on:

YN?X The type of hazard present?

YN?X Exposure intensity, duration , and frequency?

YN?X Susceptibility of the individual?

YN?X History of problems in the work place?

**[Personnel Training (OHSaP)]{.underline}**

YN?X Is there an appropriate training program?

YN?X Are there clear and defined procedures for conducting the duties of
the animal care and use program?

**[Personal Hygiene]{.underline}**

Is personal hygiene encouraged by:

YN?X Providing protective clothing such as uniforms and lab coats?

YN?X Emphasis on hand washing?

YN?X Prohibiting eating, drinking, using tobacco, or applying cosmetics
in the vivarium?

YN?X Is a sign in place instructing personnel of this prohibition?

YN?X Is a place provided for doing prohibited activities (break room).

YN?X Are hand washing facilities available?

**[Facilities, Procedures, and Monitoring]{.underline}**

YN?X Are there appropriate facilities, procedures, and monitoring
programs in place for the OHSaP?

YN?X Is safety equipment properly maintained and routinely calibrated?

**[Animal Experimentation Involving Hazards]{.underline}**

YN?X Are procedures in place to identify and manage animal experiments
that involve the use of hazardous agents such as biological agents,
chemicals, carcinogens, and volatile anesthetics?

**[Personal Protection]{.underline}**

YN?X Is the appropriate personal protective equipment provided to
employees?

YN?X Is use of this equipment mandatory?

YN?X Is the ARAC Guideline on Minimum Protective Clothing being
practiced as applicable?

**[Medical Evaluation and Preventive Medicine for
Personnel]{.underline}**

Do personnel participate in a medical evaluation and are there
appropriate preventive medical programs for :

YN?X government employees?

YN?X contract employees?

YN?X Are tetanus vaccinations given at appropriate intervals?

YN?X Are other vaccinations given as required?

YN?X Is there a pre-employment physical exam or health history taken and
does this aspect of the program involve a medical doctor?

YN?X Are there any periodic medical exams required? If so, are exams
accomplished as scheduled?

YN?X Does the research staff participate in the medical evaluation and
preventive medicine program?

**[Physical Environment]{.underline}**

*Microenvironment and Macroenvironment*

YN?X Has consideration been given to the actual environment surrounding
the animal as opposed to consideration only for the larger area such as
a room?

*Housing*

YN?X Is housing appropriate to the species involved?

YN?X Is caging in good repair?

YN?X Where possible have wire bottom cages for rodents been eliminated?

*Space Recommendations*

YN?X Is the space provided for animals in accordance with the Animal
Welfare Regulations and the Guide?

YN?X Do all animals have enough space to turn around and to express
normal postural adjustments?

YN?X Do all animals have ready access to food and water.

YN?X Do all animals have enough clean bedded or unobstructed area to
move and rest?

YN?X Are animals housed in compatible groups where appropriate?

YN?X Do cats have a raised resting surface?

*Temperature and Humidity*

YN?X Are temperatures maintained in accordance with the Guide, page 32?

YN?X Is humidity controlled to between 30-70% RH?

YN?X Are extremes of temperature or humidity kept to a minimum?

YN?X Are temperature and humidity monitored and is a record maintained?

*Ventilation*

YN?X Has the system been reviewed by a qualified mechanical engineer?
(Recommended Practice)

YN?X Do animal rooms meet the general standard of 10-15 fresh-air
changes per hour?

YN?X If not, what other mitigating factors have been considered which
make the general standards invalid?

YN?X Have Minimal ventilation rates been established?

YN?X Have unwanted drafts been eliminated?

YN?X Have static-pressure differentials been evaluated?

YN?X Is all of the animal-area air exhausted or recirculated only to
animal areas so as to avoid contamination of people areas?

YN?X Have you made any husbandry changes to control ventilation and air
quality in static filter-top cages?

YN?X Are animal rooms free of excessive odors indicative of a high level
of toxic gases?

YN?X Do you avoid recycled air within the animal areas of the facility?

YN?X Is recycled air returned to only the same room or area?

YN?X Is recycled air HEPA filtered?

YN?X Is recycled air treated to remove toxic gases and odors?

YN?X Are proper temperatures and humidity maintained?

YN?X Does the HVAC system have periodic maintenance and evaluation?

*Illumination*

Have the following factors been considered with regards to lighting?

YN?X Length of photo period

YN?X Photo intensity

YN?X Quality of light

YN?X Distribution of light

YN?X Are light timers used to control photo periods?

YN?X Is timer performance checked periodically including an after normal
hours check?

YN?X Have light levels been evaluated?

> Date
>
> Note: 12-30 ft. candles is recommended

*Noise*

YN?X Are species separated by noise level?

YN?X Has equipment been evaluated for the production of sound outside
normal human hearing but which may effect animals?

YN?X Within your facility do you avoid noise above 85dB?

YN?X Are normal operations conducted so as to minimize noise which may
affect animals?

**[Behavioral Management]{.underline}**

*Structural Environment*

YN?X Does the environment enhance animal well-being as appropriate to
the species?

*Social Environment*

YN?X Are social animals given the opportunity to interact with other
members of the species?

YN?X If housed, is there an enrichment program for non-human primates?

*Activity*

YN?X Do animals (especially higher animals such as dogs, pigs, cats and
primates) have the opportunity to exhibit species - typical activity
patterns?

YN?X Are higher animals given the opportunity to interact with humans as
appropriate?

YN?X Are dogs given the opportunity for additional exercise as required
by USDA Reg.?

YN?X Are other animals given the opportunity to exercise as applicable.
(Pens, runs, pastures, exercise lots, etc.)?

**[Husbandry]{.underline}**

*Food*

YN?X Is food appropriate to the species?

YN?X Is food of high quality and free of contaminants?

YN?X Have the procedures and practices of the feed vendor been
evaluated?

YN?X Is shelf life data available and is feed rotated to assure food
does not become stale? Generally food is good for 3-6 months.

YN?X Is stored feed protected from vermin?

YN?X Is feed stored off the floor?

YN?X Are storage conditions monitored?

YN?X Are feeds stored below 70^o^F?

YN?X Are purified and chemically defined diets stored below 39^o^F?

YN?X Are special autoclavable diets used when required and is the date
of autoclaving recorded so that diets are rotated and used quickly?

YN?X Is the transfer of feed-storage containers between areas that pose
different risks of contamination avoided?

YN?X Are storage containers cleaned regularly?

YN?X Is the feed of some animals restricted as appropriate? Rabbit,
pigs, dogs, cats, NH primates, etc.

YN?X Are "treats" used for enrichment as appropriate?

YN?X Is care taken to assure that the balance of the diet is not altered
by excessive treats?

YN?X If food is fed on the floor of a shoebox cage, is this approved in
the ASP or in an SOP?

YN?X Are food treats included in an SOP?

YN?X Are food restriction studies conducted in accordance with ARAC
guidelines?

*Water*

YN?X Do animals have access to potable drinking water?

YN?X Periodically do you monitor (review reports) for pH, hardness, and
microbial and chemical contamination as required by the scientific
studies being conducted?

YN?X Are watering devices checked daily?

YN?X Do you avoid refilling water bottles?

YN?X If bottles are refilled are they returned to the same cage?

YN?X Are water restriction studies conducted in accordance with ARAC
guidelines?

YN?X If water is treated with acid or chlorine, are the chemical levels
being monitored?

*Bedding*

YN?X Do you avoid softwood (pine is a softwood) bedding in those studies
that may be effected by the aromatic hydrocarbons they contain?

YN?X Is cedar avoided in all cases?

YN?X Do you evaluate procedures of the bedding vendor?

YN?X Are bedding materials stored in such a way that they are protected
from contamination and vermin?

YN?X If autoclaved, is bedding dried before use or storage?

*Sanitation*

YN?X Is bedding changed often enough to keep animals clean and dry?
Usually twice a week for rodents and rabbits in standard caging is
appropriate.

YN?X Are pens and runs not using bedding flushed with water at least
once daily?

YN?X Are animals kept dry during cage cleaning as appropriate?

YN?X Are cages and accessories such as tops sanitized at least once
every other week?

YN?X Are solid bottom cages sanitized at least once a week?

YN?X Are bottles and sipper tubes sanitized at least once a week?

YN?X Are cages treated with acid to remove urine scale as necessary?

YN?X Is the effectiveness of the method of sanitization verified by use
of systems such as RODAC plates?

YN?X Are automatic watering systems flushed periodically?

YN?X Are cages autoclaved where appropriate?

YN?X Are autoclaves monitored by systems such as kilits^7^?

YN?X Are cleaning implements dedicated to areas of similar contamination
risk?

YN?X Are worn cleaning implements replaced as required?

YN?X Are implements stored in a manner that will facilitate drying and
minimize contamination?

*Waste Disposal*

YN?X Are Medical Pathological Waste boxes used as required?

YN?X Is conventional, biological, and hazardous waste removed and
disposed of regularly and safely?

YN?X Are adequate numbers of properly labeled waste receptacles
strategically placed throughout the facility?

YN?X Are receptacles leak proof and equipped with tight-fitting lids?

YN?X Are containers cleaned often and regularly?

YN?X Are waste storage areas tidy and free of vermin and insects?

YN?X Are procedures in place for the safe handling of hazardous waste?
See page 45 of Guide.

YN?X Are adequate numbers of sharps containers made available and
disposed of when ¾ full?

YN?X Are recapped needles found in the sharps containers?

*Pest Control*

YN?X Is there a regularly scheduled and documented program of pest
control and monitoring?

YN?X Have steps been taken to eliminate harborage (places bugs like to
live such as cracks, dark and dirty spaces, and areas of trash and
debris) and prevent entry?

YN?X Are the use of chemical pesticides limited and controlled?

YN?X If pesticides are used, is it done in consultation with
investigators and its use documented?

YN?X If traps are used, are they checked frequently to assure humane
euthanasia after capture?

*Emergency, Weekend, and Holiday Care*

YN?X Are animals cared for by qualified personnel each and every day?

YN?X Is emergency veterinary care available each and every day?

YN?X Do police and fire agencies have telephone numbers of key
personnel?

YN?X Is there a disaster plan and are key personnel included as official
responders to emergencies that involve animals?

YN?X Is there adequate staffing of animal husbandry personnel to ensure
daily care of all animals?

**[Population Management]{.underline}**

*Identification and Records*

YN?X Are all animals identified in some manner?

Does identification, including cage cards and animal records associated
with the animal's ID, include the following:

YN?X Source of animals

YN?X Strain of stock

YN?X Name and location of responsible P.I.

YN?X Pertinent dates

YN?X Protocol number

YN?X Number of animals

YN?X Age or weight

YN?X Sex

YN?X Are clinical records for individual animals (chronic dogs, cats,
pigs, rabbits, NH primates) available as required?

YN?X Are clinical records available near the animals for which they
apply?

*Genetics and Nomenclature*

YN?X Are founding populations of in-house outbred breeding colonies
large enough to ensure the long-term heterogeneity of the colony or are
other steps taken to ensure heterogeneity?

YN?X Are in-house inbred breeding programs monitored to ensure continued
homozygosity?

YN?X Are steps taken to prevent and/or identify contamination resulting
from mutation and/or mismating?

YN?X Are transgenic animals managed using standard genetic-management
procedures, including the maintenance of detailed records and genetic
monitoring to verify the presence and zygosity of transgenes?

**[General requirements for adequate veterinary care]{.underline}**

YN?X Is there a program of preventive medicine?

YN?X Is there a program for the surveillance, diagnosis, treatment, and
control of natural diseases or conditions?

YN?X Is there a program to manage diseases or conditions induced by
experimental conditions?

YN?X Is the veterinarian involved in the selection and use of
anesthetics and analgesics?

YN?X Is there a program for the management of surgery and post operative
care?

YN?X Is there a program for the assessment of animal well-being
including daily observation of all animals?

YN?X Is there a program to provide for the humane euthanasia of all
animals?

YN?X Is there frequent communication between the veterinarian and lay
personnel regarding the condition of animals and aspects of care and
treatment?

Does the veterinarian provide guidance as follows:

YN?X To scientific investigators regarding the use of animals?

YN?X To other persons involved in the care and use of animals?

YN?X With respect to the surgical and post operative care program?

**[Animal Procurement and Transportation]{.underline}**

YN?X Are all animals obtained lawfully?

YN?X If dogs or cats are used and obtained from a Class B dealer, are
steps taken to assure that animals are not pets or stolen?

YN?X Are steps taken to minimize the use of endangered species?

YN?X Are vendors evaluated for quality of the animals they supply?

YN?X Is transportation consistent with ARAC guidelines and Clinical
Center transportation policy?

YN?X Are transportation vehicles clean and does transportation minimize
the spread of disease and stress of the animals?

YN?X Are animal shipments inspected for compliance with procurement
specifications and signs of clinical disease?

YN?X Are rodents imported and exported according to ARAC guidelines?

YN?X Is there an appropriate quarantine program for animals that are not
from a known specific-pathogen-free facility?

YN?X Are animals stabilized prior to use in research projects?

YN?X Is the Central Animal Procurement System used for animal ordering?

YN?X Is ordering and receiving of animals coordinated with the
appropriate animal care personnel to assure that appropriate facilities
are available for housing?

**[Preventive Medicine]{.underline}**

*Quarantine, Stabilization, and Separation*

YN?X Does the veterinarian or delegated person evaluate the health and
pathogen status of newly received animals.

YN?X If non-human primates are used are they quarantined?

YN?X Are steps taken to separate species with a different
microbiological profile?

YN?X Are animals given a period of stabilization before being used? (2
days)

YN?X Are animals separated by species?

YN?X Is the ARAC Guideline on Housing Multiple Species of Large
Laboratory Animals being practiced as applicable?

*Surveillance, Diagnosis, Treatment, and Control of Disease*

YN?X Are all animals observed daily (weekends and holidays) by trained
personnel to identify disease or injury?

YN?X Are methods in place for disease surveillance and diagnosis?

YN?X Are the ARAC Guidelines for Prevention and Control of Tuberculosis
in Nonhuman Primates being practiced as applicable?

YN?X Is there a program in place for the reporting of unexpected deaths,
signs of illness, or other deviations from normal?

YN?X Is timely care or euthanasia provided to diseased or injured
animals?

YN?X Are facilities available for the diagnosis of disease?

YN?X Is there a program in place to monitor for sub-clinical diseases
especially in rodents?

YN?X Are transplantable tumors, hybridomas, cell lines, and other
biological materials screened for disease agents?

**[Surgery]{.underline}**

YN?X Is a program in place for aseptic surgery where applicable? SOP's,
etc.

YN?X Is the ARAC Guideline for Survival Rodent Surgery followed as
applicable?

YN?X Is there a program for the continuing and thorough assessment of
surgical outcomes? Is corrective action taken as appropriate?

YN?X Is the ability of the surgical team assessed by the ACUC? Is
training provided as needed?

YN?X Are antibiotics appropriately used?

YN?X For nonsurvival surgery, does the surgeon clip the hair around the
surgical site, wear gloves, and use clean instruments?

For survival surgery, are the following practices followed except as
exempted:

YN?X Routine preparation of patient?

YN?X Routine preparation of surgeon?

YN?X Routine use of surgical attire as appropriate?

YN?X Use of sterile gloves?

YN?X Sterilization of instruments and implants, etc.? (Not alcohol!!)

YN?X Aseptic operative techniques?

YN?X Is the effectiveness of sterilization monitored by indicators or
other methods?

YN?X Is nonrodent survival surgery conducted in an authorized location
dedicated to the use and are the appropriate number of dedicated rooms
available for different aspects of surgery?

YN?X Is the surgical area kept clean or thoroughly cleaned prior to
surgical use?

YN?X Is a record of surgery and postoperative care maintained?

**[Pain, Analgesia, and Anesthesia]{.underline}**

YN?X Is the use of analgesics and anesthetics considered by the IACUC
and the veterinarian?

YN?X If neuromuscular blocking (NMB) agents are used are they
specifically justified by the investigator and approved by the IACUC?

YN?X Are appropriate amounts of anesthetics first defined on procedures
that do not use NMB agents?

**[Euthanasia]{.underline}**

YN?X Are methods consistent with AVMA recommendations and appropriate to
the species?

YN?X If the scientific protocol causes a disease or condition, does the
protocol have specific criteria for intervention by euthanasia before
the condition leads to death?

YN?X If death is an unavoidable end point, is it justified on scientific
grounds?

YN?X Are individuals trained in the method of euthanasia to be used?

YN?X Is CO2 administered from a compressed gas cylinder with the use of
a flow meter?

YN?X Are flow rates posted for each system?

YN?X Are the ARAC Guidelines on Euthanasia of Mouse and Rat Fetuses and
Neonates being practiced?

YN?X Are the ARAC Guidelines for Euthanasia of Rodents Using CO2 being
practiced?

**SPECIAL NOTES TO BE PROVIDED BY THE FACILITIES MANAGEMENT**

Name of Animal Facility:

Please indicate or attach information on the following items for the six
month period covered by this review (see instructions for covered
period):

1.  In-service training you have conducted since the last review.

> Total staff including supervisory: Total hours of instruction:
>
> Total number of classes given: Average attendance:

2.  Outside continuing education classes attended by members of your
    staff. (List or attach sheet.)

3.  Indicate any change(s) in personnel and list
    certification/registration level of new individuals of new
    individuals.

> Persons no longer employed:
>
> New hires during the reporting period: Certification/Registration
> Level:

4.  Indicate any change(s) in the certification and registration of
    other members of your staff.

5.  Indicate any additional information that may be helpful or
    interesting regarding your facility and its operation.