Medical Records for Animals Used in Research, Teaching ... - Aaalac

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1. endorse professional judgment and performance standards,both of which promote a higher level of care thanstrict engineering standards, without being overlyburdensome;2. establish clear authority over the medical recordprogram (i.e., Attending Veterinarian and IACUCoversight);3. differentiate between the medical record requirementsfor spontaneous medical conditions versus those thatwere induced (animal models); and4. provide guidance on the type of record that was outsidethe scope of this document.The Committee developed a draft public statement,which was reviewed by the ACLAM Board of Directors(BOD 1 ). During development of the public statement, theCommittee addressed a number of complex issues. Forexample,1. It was very challenging to write a “one size fits all”guidance document. The public statement was carefullyworded to ensure that it provided nonprescriptive guidanceon defining what constitutes a medical record, whodecides when the record is needed, how the records aremaintained, and what is included in the record.2. The Attending Veterinarian must have the authority toestablish and oversee a medical records program, andthe institution must support that authority.3. Documentation of experimentally induced disease (animalmodel) is a research record and is not necessarily apart of the medical record. The course of the diseasedevelopment is part of an experimental protocol that isreviewed and approved by an institutional animal careand use committee (IACUC 1 ), and the details of thatdisease are recorded in the research notes. Although thistype of information may be part of a research record, itmust be readily available for review by the veterinarystaff, as well as appropriate for internal (e.g., IACUC)or external (e.g., US Department of Agriculture[USDA 1 ]) oversight uses.4. A breeding record is not necessarily a medical record,although it may contain useful information regardingthe animal’s welfare.5. A reference to the research use of the animal should beincluded in the medical record.6. Use of an electronic signature was addressed, as was theneed for hand-written records that are “legible to someoneother than the writer.”After several revisions of the document, a final draft ofthe public statement was approved by the ACLAM BOD.This document was distributed to more than 700 ACLAMboard-certified laboratory animal medicine veterinarians forcomment. All comments were reviewed and addressed bythe committee, a final version was presented to and approvedby the BOD, and the public statement was releasedin October 2004.As noted in the conclusion of the ACLAM public statementon medical records (ACLAM 2004), “Medical recordsfor animals used in research, teaching and testing are a corecomponent of adequate veterinary care. They should documentinformation associated with management of clinicaldisease, diagnostic and therapeutic procedures performed,and preventive medical procedures. The methods by whichmedical records are developed and maintained should bedetermined by the institution, with the guidance and professionaljudgment of the Attending Veterinarian. Applicationof performance standards within the medical record programallows the veterinarian to effectively employ professionaljudgment, ensuring that the animal receives thehighest level of care available.”The following text is a copy of the ACLAM publicstatement on medical records, with references added inbrackets.ACLAM PUBLIC STATEMENTS: MedicalRecords for Animals Used in Research,Teaching and Testing 2IntroductionThe guidelines summarized below were prepared by theAmerican College of Laboratory Animal Medicine(ACLAM) to assist research facilities in their efforts to establishand maintain animal health medical records (medicalrecords). The professional guidance of the Attending Veterinarianor his/her designee in the development and oversightof a medical records program is essential in theapplication of these guidelines by an institution [FASS1999]. Application of performance standards within themedical record program allows the veterinarian to effectivelyemploy professional judgment, ensuring that the animalreceives the highest level of care available. TheAttending Veterinarian must receive institutional supportthrough the IACUC, Institutional Official, or other means,to assure compliance with the development and effectiveapplication of these guidelines for the medical recordsprogram.This document provides guidelines for maintenance ofclinical data for animals used in research, teaching and testing.Because of the potential volume of data generated inthese settings, there is a risk that critical information may bediluted. For this reason, the precise mechanism chosen tosummarize clinical data into a medical record is not prescribed.Each institution must establish its own standards ofperformance [Haskins and Eisele 1997]. The ACLAM recognizesthat varied approaches can be used to achieve the2 Reprinted with permission from the American College of Laboratory AnimalMedicine, State of Illinois.38 ILAR Journal
desired outcome of providing the highest quality of careavailable.ACLAM Position on Medical RecordsContent and ScopeEstablishing and maintaining appropriate medical records isa core component of adequate veterinary care [AVMA2002; Gaertner 2003]. Medical records provide documentationof the care given, and communicate that information toother professionals [APHIS 2000; CFR 2003; Osborne1983]. Medical record information may be retained in amedical record and/or research record, depending on howthe institution wishes to run its program.The institution, under the guidance of the AttendingVeterinarian, should determine the method(s) by whichmedical records are maintained. Medical records may takemany forms [Haskins and Eisele 1997] and have severalcomponents, such as written records, computerized records,sentinel animal reports, clinical pathology reports, qualityassurance reports, cage cards, and animal disposition reports.These components can be included in the medicaland/or research record, or can be linked and available. Themethod of record keeping should be designed to fit thespecific needs of each program of veterinary care.Oversight of the medical records must fall under thedirection of the Attending Veterinarian or his/her designeeand the IACUC. Individuals typically responsible for makingnotations in medical records include veterinary staff(veterinarians and/or veterinary technicians), animal husbandrystaff (animal care staff, managers, supervisors), andresearch staff (e.g., principal investigators, study directorsand/or research technicians).The ACLAM recognizes that many research animals,particularly rodents, can be obtained and maintained in astate of good health, without the necessity of a medicalrecord being created. When medical records for such animalsare indicated, group records may be acceptable andmay be more efficient than individual records [FASS 1999].Individual medical records should be maintained for animalsthat receive regular individual health evaluations, asdeemed appropriate by the institution [Suckow and Doerning2000].When a medical record is created, the informationshould be recorded so that the care and course of treatmentfor animals can be reconstructed, if necessary [Lees 1981].The medical record should also contain a sufficient amountof detail to determine the research use of the animal. However,clinical notations related to a disease that is experimentallyinduced in animals do not necessarily need to bemaintained in the medical record. Rather, it may be appropriatefor this information to be retained within researchrecords, but the information must be readily available forreview by the veterinary staff, as well as for appropriateinternal (e.g., IACUC) or external (e.g., USDA) oversightuses.Components of a Medical RecordWhen institutional representatives determine that a medicalrecord should be created, the record typically contains thefollowing types of information [APHIS 2000; NRC 1996]:1. Identification of the animal(s) or group(s),2. Clinical information such as results of physical examination,the behavior of the animal, and notations regardingobserved abnormalities, illnesses, and/orinjuries,3. Immunizations and other prophylactic treatments andprocedures as appropriate for the species,4. Documentation of diagnostic tests and interpretation,5. Reference to the research intervention, whereappropriate,6. Treatment prescribed and provided, the clinical response,and follow up,7. Surgery, anesthesia, analgesia and peri/post-operativecare,8. Control of pain and distress,9. Documentation of euthanasia or other disposition,10. Documentation of necropsy findings, if indicated.Medical records should be written to define and reflectthe current level of understanding of a health problem[FASS 1999]. The record should be refined as additionalinformation is acquired, and communicate the medical logicand case progression [Chavis and Hutton 1998; Lees 1981].Notations in the medical record should be made by individualswho have administered treatments, or made directobservations or evaluations of the animal(s) or their diagnosticresults, or their designee. Individuals typically responsiblefor making notations in the record includeveterinary staff (veterinarians and/or veterinary technicians),animal husbandry staff (animal care staff, managers,supervisors), and research staff (e.g., principal investigators,study directors and/or research technicians). All entries inthe record should be dated, indicate the originator of theentry (e.g., initials, signature, and electronic signature) andbe legible to someone other than the writer [CareFirst 2004].Facilities may wish to consider establishing a list thatsummarizes the animal’s medical history at a glance. Thismay be particularly valuable for animals that undergo amajor survival surgery and/or are reassigned to anotherproject. A copy of the medical record, or a pertinent summaryof that animal’s medical history, should follow theanimal upon reassignment [APHIS 2000].Types of Medical RecordsA. Individual Health RecordsIndividual health records should be maintained for animalsthat receive regular individual health evaluations, asdeemed appropriate by the institution [Haskins and EiseleVolume 48, Number 1 2007 39
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