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Washington
State University
Institutional
Animal Care and Use Committee
Guidelines
for Maintaining Animal Care & Medical Records for Research &
Teaching Animals
Background
Information:
USDA
Regulatory Enforcement and Animal Care (REAC) standards and information
presented by the Public Health Service (PHS/NIH) have emphasized
a need for proper documentation of animal care. More specifically,
the emphasis has been on the record keeping practices for animals
under treatment/observation when a variation from normal health
and/or behavior exists.
The
USDA regulations involving
animal care ask that daily observations be made of all animals to
assess their health and well-being. The regulations allow this observation
to be accomplished by someone other than a veterinarian provided
that a mechanism is in place to communicate problems of animal
health and well-being to the veterinarian on a timely basis.
The
PHS has informally (at meetings via case reports demonstrating programmatic
deficiencies) recommended that institutions assure internal controls
are in place and adequate in regards to animal care records. Case
examples used by the PHS to emphasize this need have dealt with
inadequate post-surgical monitoring and treatment or inadequate
medical care/observation of animals with variations from normal
when performed by the investigators or other designated individuals.
The PHS notes that if portions of the responsibilities for treatment/observation
are delegated to the investigator, there should be documentation
in place to ensure care is provided and the care provided conforms
with standard veterinary practice. In addition, it is stressed that
records of care and treatment (i.e., medical records) be maintained
in a manner that is readily accessible to the attending veterinarian
and animal care staff.
USDA
veterinary inspectors and Association
for the Assessment and Accreditation of Animal Care (AAALAC) site
visit teams routinely review research and teaching animal records
when on the WSU campus.
Animal
welfare regulations require good documentation. Accrediting and
federal regulatory organizations are placing increased emphasis
on research and teaching animal records. Detailed information about
experimental procedures performed, any drug or research compound
administered (including dose & route of administration), collection
of blood and other biologic samples, monitoring animals for possible
sequellae to procedures, veterinary medical diagnostics and treatments
and method of euthanasia or final disposition of the animal is expected.
The
absence of adequate records almost ensures an unfavorable outcome
should the records or care provided be challenged, even though the
care rendered may not have been substandard.
The
documentation required includes:
- A
daily record/entry of animal well-being
or evidence of such daily observation. This is needed for both
normal and "abnormal" (e.g., post-surgical or ill animal)
animal(s).
- For
normal animals, documentation is routinely accomplished by providing
verification that someone (e.g., animal care staff, research staff
or individual able to recognize signs of abnormality) has observed
the animal(s) and that no evidence of illness, injury, or abnormal
behavior was noted. This documentation is most often provided
in the form of a "checkoff" list.
-
When providing daily care to or observation of an abnormal research
or teaching animal, or administering directed care, documentation
should meet certain standards. The intent is a need to document
that the circle of veterinary care is complete.
-
For an abnormal animal, a daily documentation of the animal(s)
condition should be available for review.
Documentation
required for an abnormal animal (one showing signs of
illness, injury or other departure from normal health and well-being)
includes:
- Pertinent
history
- Examination
findings
- Tentative
/ provisional diagnosis
- Corrective
measures (diagnostic and treatment plan) being taken as the result
of this variation from normal health or behavior.
- Daily
assessment of the animal's condition and/or progress over the
duration of the treatment/observation period.
- The
author of all entries made on the record must be identified. If
daily assessment is being performed by a lay person (animal care
staff, research staff member, etc.) under the direction of a veterinarian,
the record must reflect the guidance provided by the veterinarian
and a daily assessment of the animal's condition by or direct
involvement of the veterinarian providing primary care concerning
diagnosis, treatments or planning. It is necessary to document
that veterinary oversight and authority is in place regarding
the veterinary care of animals.
- Record
of veterinary care given or directed to include daily
treatment provided as well as dosages, routes and frequency of
administration of any drugs/medications administered.
- Records
of diagnostic laboratory services that are performed in order
to facilitate veterinary medical care and can include gross and
microscopic pathology, clinical pathology, hematology, clinical
chemistry, microbiology, serology and parasitology.
- Resolution
of the problem (e.g., diagnosis, treatment, return to a normal
state, euthanasia).
For
small animals or farm animals maintained in a vivarium, treatment
record(s) must be maintained in a manner that allows for immediate
access (e.g., in or adjacent to the room where the animals are housed).
This is especially critical for animals in the post-operative period
or those displaying any abnormality. Having the record in such a
location accomplishes several functions.
- It
explains the condition of the animals to animal care staff (a
sedated animal may otherwise be thought to be ill)
- It
assures animal care staff, the WSU Attending Veterinarian and
USDA Animal Welfare inspectors that the animal care/treatment
is being provided
- It
informs animal care staff how recently the investigator has seen
the animal. This knowledge helps them decide whether or not there
is a need to contact the investigator or the Attending Veterinarian
to inform him or her of the present condition of the animal.
For
large animal or farm species maintained in a farm environment, the
records must also be readily accessible from the facility manager
or the veterinary medicine teaching hospital files.
Although
individual records are desirable, a composite post-operative record
may be used for a group of rodents. Such a record might have a list
of the animal numbers and entries made that would include a notation
that the animal had been checked, any abnormal observations and
a list of any therapeutics given including drugs, doses, and routes
of administration.
Records
must be kept that sutures/wound clips have been removed, the post-operative
record requires no further entries, but should continue to be kept
in the area where the animals are housed. When the study is completed
and the animals are euthanized, the record may either be kept by
the investigator or discarded.
There
is no one format that would suit all situations and as such, this
policy does not require nor recommend a standard form to be used
in each instance. Suffice it to say, the record(s) should be readily
available and should contain all clinical information pertaining
to the animal with sufficient information being provided to justify
the tentative diagnosis and warrant the actions taken and/or treatment
provided. Sparse, incomplete or sloppy records make it difficult
to ascertain what happened and why.
Information
and examples from a number of sources that provide guidelines and
a summary of the items that individuals/organizations feel are important
to documenting animal care provided are available from the Office
of the Campus Veterinarian (335-6246).
Approved
by IACUC: 01/21/97 |
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