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Overview of Animal Surgery Regulations and Guidelines

To UMass-Amherst Animal Researchers performing surgery on vertebrates:

This is a reminder to all labs, performing surgery on vertebrates, regarding personnel and surgical procedures. There are protocol requirements, and minimum guidelines, that your research staff and you must follow to maintain compliance with the laboratory animal welfare regulations. Review the material below and share it with all persons in your lab who are involved with animal surgery, as part of new student/employee training and/or during a lab meeting, for example.

All aspects of the lab animal care and use regulations on the subject of surgical precautions and procedures parallel the standards of the veterinary profession. The conduct of, and records for, lab animal surgery are inspected and reviewed by the IACUC and federal regulators.

The Director of Animal Care, Steve Plouff, and the Campus Veterinarian, Andre Darrigrand, DVM, are available to discuss or review with your lab staff the measures and supplies needed to meet these regulations. Surgery forms (for you to use as is, or modify to your needs) are available from the Animal Care Office and are posted on this website.

Basically, the regulatory compliance issues boil down to these items:

Protocol: Ensure all animal use, such as surgical procedures and related information, is well described in your protocol. Related information that must be noted includes all personnel involved and location where surgical procedures are performed.

Surgery: Conduct aseptic techniques during surgery according to veterinary surgical standards and as specified in the laws. Maintain the designated surgery area (whether temporary or permanent), as well as other animal use areas, neatly. (One way of assessing this is to ask: “would I want my pet to undergo surgery or procedures here, and under these conditions?”)

Training: Document in your protocol and train all persons handling animals and performing surgery. Ensure that adequate assistance and supervision are available during procedures and during post-op times.

Records: Document the surgeries on some form of surgical record that includes all information that is logical for noting each animal's status and is required by law. Maintain these records where they are safe but accessible.

In addition, the surgery areas and records are inspected by the USDA inspector and the Institutional Animal Care and Use Committee, and are part of the upcoming semi-annual inspections.

Sections on subsequent pages include:

A. Protocol requirements
B. Regulatory Wording and Website References
C. References, on line and in our library

Please share this information with all members of your lab.

A. Protocol requirements : note the bolded words that include aspects that are federal requirements. All these updates/explanations/changes can be done using Appendix A (addendum form for the protocol) . These may be submitted for committee review by campus mail or email; if the latter, the signature page must be submitted by campus mail or in person.

All persons handling the animals, and performing or assisting with animal surgery and postoperative care, must be identified in your approved protocol for this animal use . If there are new members of your lab, it is your responsibility to submit an addendum to ensure that the names and training of these persons are included with the protocol materials in the IACUC files. The qualification aspect must be addressed so that there is a clear statement about the experience and training of these persons .

New surgical techniques must also be presented in addenda and reviewed and approved by the IACUC .

Be sure that you are conducting surgery in the location(s) noted in your protocol.

B. Regulatory Wording . Note that the bolded words that include requirements that are considered “standards of practice”.

1. Surgery

Animal Welfare Act wording:

“Activities that involve surgery include appropriate provision for pre-operative and post-operative care of the animals in accordance with established veterinary medical and nursing practices . All survival surgery will be performed using aseptic procedures, including surgical gloves, masks, sterile instruments, and aseptic techniques . Major operative procedures on non-rodents will be conducted only in facilities intended for that purpose which shall be operated and maintained under aseptic conditions. Non-major operative procedures and all surgery on rodents do not require a dedicated facility, but must be performed using aseptic procedures. Operative procedures conducted at field sites need not be performed in dedicated facilities, but must be performed using aseptic procedures.”

Public Health Service Policy wording (excerpted from the 1996 NRC Guide for the Care and Use of Laboratory Animals):

“Appropriate attention to pre-surgical planning, personnel training, aseptic and surgical technique, animal well-being, and animal physiologic status during all phases of a protocol will enhance the outcome of surgery.” (page 60)

“Aseptic technique is used to reduce microbial contamination to the lowest possible practical level. The contribution and importance of each practice varies with the procedure. Aseptic technique includes preparation of the patient, such as hair removal and disinfection of the operative site; preparation of the surgeon, such as the provision of decontaminated surgical attire, surgical scrub, and sterile surgical gloves; sterilization of instruments, supplies, and implanted materials and the use of operative techniques to reduce the likelihood of infection .” (page 62)

“ Pre-surgical planning should specify the requirements of post-surgical monitoring, care, and record-keeping, including the personnel who will perform these duties. The investigator and veterinarian share responsibility for ensuring that post-surgical care is appropriate. An important component of post-surgical care is observation of the animal and intervention as required during recovery from anesthesia and surgery. The intensity of monitoring necessary will vary with the species and the procedure and might be greater during the immediate anesthetic-recovery period than later in postoperative recovery. During the anesthetic-recovery period, the animal should be in a clean, dry area where it can be observed often by trained personnel. Particular attention should be given to thermoregulation, cardiovascular and respiratory function, and postoperative pain or discomfort.” (page 63)

Massachusetts Practice Act (for veterinarians) wording:

“A veterinarian shall maintain a medical record for each patient.

(a) patient's age, if known;

(b) patient's sex'

(d) the type of anesthesia;

(e) treatment;

(f) surgery, if performed;

(g) names and dosages of drugs and/or medications used or prescribed;

(h) any other pertinent information gathered.”

“ Drugs and medications which have expired shall not be left on shelves or retained for use or dispensing. ”

[ Note: The USDA considers these regulations applicable and relevant to researchers performing animal surgery [typically regarded as the realm of veterinary surgeons] and has used these regulations for the basis for non-compliance citations, even though these particular regs were originally written to apply to licensed veterinarians. Policy 3 of the USDA policies now includes comments about drug expiration dates and the use of medical grades of drugs.]

2. Training

Animal Welfare Act wording:

“ Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures .”

“Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training , including the proper and humane care and use of laboratory animals.”

Public Health Service Policy wording:

“Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals.
(Article XIII of U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training)

C. The regulatory text concerning surgery and all other research and teaching animal use
is located at the following sites:

Animal Welfare Act: This covers the species such as hamsters, gerbils, and rabbits. This regulation is enforced by the USDA by means of unannounced inspections. Policy 3 includes regulations requiring the use of medical grade drugs.

Website references: http://www.aphis.usda.gov/
http://www.aphis.usda.gov/ac/policy/policy3

Public Health Service Policy : This covers all vertebrate animals. The NIH enforces these regulations through documentation (Animal Welfare Assurance, and other documents) and selected site visits to institutions. Compliance is especially critical for all labs receiving any DHHS/PHS/NIH/DOD funding, but it is the practice and philosophy here that we are consistent across the board for all animals involved in teaching and research regardless of funding sources. Enforcement is through NIH Office of Laboratory Animal Welfare (OLAW). Wording of the Policy is in the Policy handbook, and the specifics are in the Guide. The website contains these as well as many supporting documents, commentary and “help areas” to facilitate compliance.

Website references: http://grants.nih.gov/grants/olaw/olaw.htm
http://www.nap.edu/readingroom/

Massachusetts Practice Act: This describes requirements for licensed veterinarians in this state. The USDA (see Animal Welfare Act above) considers that these also apply to those non-veterinarians performing surgery on animals comparable or similar to that performed in veterinary practice.

Website references: http://www.state.ma.us/reg/boards/#v
http://www.state.ma.us/reg/boards/vt/default.htm

3. References, on line from other institutions and in our library:

Here are some on-line surgery references from other institutions, and some in our library.

http://oacu.od.nih.gov/ARAC/surguide.htm

http://researchnet.asu.edu/animal_care/

http://www.uiowa.edu/~vpr/research/animal/rod_surg.htm

http://www.vet.ohio-state.edu.docs/ular/rodsurg.html

http://www.mc.uky.edu/dlar/resources/sop/rodsuruk.htm

http://www.miami.edu/research/training/Rodent_Survival_Surgery.html

http://www.olar.uiuc.edu/Policies/rodentsurg.html

http://www.fsu.edu/~FSULAR/aseptic.html

http://www.mediasales.psu.edu/latest/rodentqu.html (This is a self- assessment page.)

In the library:

Disease Mechanisms in Small Animal Surgery. (1993) ed. by M. Joseph Bojrab. Lea and Febiger. Philadelphia.(call # SF991.D57 1993, Morrill Biological Sciences Library) (Note particularly Chapter 9.)

Frye, F.L. (1994) Reptile Clinician's Handbook: a compact clinical and surgical reference. Krieger. Malabar. FL. (call # SF997.5.R4 F78 1994, reference section, Morrill Biological Sciences Library)

The Biology, Husbandry and Health Care of Reptiles. (1997) ed and compiled by L. Ackerman. T.F.H. Publications. Neptune City, NJ. (call # SF515.B56 1997, reference section, Morrill Biological Sciences Library)

The IACUC Handbook. (2000) ed, by J. Silverman, M.A. Suckow, and S. Murthy. CRC Press. New York. (call # HV 4709 I23 2000, DuBois/University Library)

Waynforth, H.B. (1980) Experimental and Surgical Technique in the Rat. Academic Press. Boston(call #: QL737.R666 W38, Morrill Biological Sciences Library)




Research Home Animal Care Home FAQs & Safety Sheets PHS Policy Info IACUC Policies Protocol Forms, Record Keeping Forms & Cage ID Tags Surgery Regulations Animal Welfare Act Useful Links		Overview of Animal Surgery Regulations and Guidelines To UMass-Amherst Animal Researchers performing surgery on vertebrates: This is a reminder to all labs, performing surgery on vertebrates, regarding personnel and surgical procedures. There are protocol requirements, and minimum guidelines, that your research staff and you must follow to maintain compliance with the laboratory animal welfare regulations. Review the material below and share it with all persons in your lab who are involved with animal surgery, as part of new student/employee training and/or during a lab meeting, for example. All aspects of the lab animal care and use regulations on the subject of surgical precautions and procedures parallel the standards of the veterinary profession. The conduct of, and records for, lab animal surgery are inspected and reviewed by the IACUC and federal regulators. The Director of Animal Care, Steve Plouff, and the Campus Veterinarian, Andre Darrigrand, DVM, are available to discuss or review with your lab staff the measures and supplies needed to meet these regulations. Surgery forms (for you to use as is, or modify to your needs) are available from the Animal Care Office and are posted on this website. Basically, the regulatory compliance issues boil down to these items: Protocol: Ensure all animal use, such as surgical procedures and related information, is well described in your protocol. Related information that must be noted includes all personnel involved and location where surgical procedures are performed. Surgery: Conduct aseptic techniques during surgery according to veterinary surgical standards and as specified in the laws. Maintain the designated surgery area (whether temporary or permanent), as well as other animal use areas, neatly. (One way of assessing this is to ask: “would I want my pet to undergo surgery or procedures here, and under these conditions?”) Training: Document in your protocol and train all persons handling animals and performing surgery. Ensure that adequate assistance and supervision are available during procedures and during post-op times. Records: Document the surgeries on some form of surgical record that includes all information that is logical for noting each animal's status and is required by law. Maintain these records where they are safe but accessible. In addition, the surgery areas and records are inspected by the USDA inspector and the Institutional Animal Care and Use Committee, and are part of the upcoming semi-annual inspections. Sections on subsequent pages include: A. Protocol requirements B. Regulatory Wording and Website References C. References, on line and in our library Please share this information with all members of your lab. A. Protocol requirements : note the bolded words that include aspects that are federal requirements. All these updates/explanations/changes can be done using Appendix A (addendum form for the protocol) . These may be submitted for committee review by campus mail or email; if the latter, the signature page must be submitted by campus mail or in person. All persons handling the animals, and performing or assisting with animal surgery and postoperative care, must be identified in your approved protocol for this animal use . If there are new members of your lab, it is your responsibility to submit an addendum to ensure that the names and training of these persons are included with the protocol materials in the IACUC files. The qualification aspect must be addressed so that there is a clear statement about the experience and training of these persons . New surgical techniques must also be presented in addenda and reviewed and approved by the IACUC . Be sure that you are conducting surgery in the location(s) noted in your protocol. B. Regulatory Wording . Note that the bolded words that include requirements that are considered “standards of practice”. 1. Surgery Animal Welfare Act wording: “Activities that involve surgery include appropriate provision for pre-operative and post-operative care of the animals in accordance with established veterinary medical and nursing practices . All survival surgery will be performed using aseptic procedures, including surgical gloves, masks, sterile instruments, and aseptic techniques . Major operative procedures on non-rodents will be conducted only in facilities intended for that purpose which shall be operated and maintained under aseptic conditions. Non-major operative procedures and all surgery on rodents do not require a dedicated facility, but must be performed using aseptic procedures. Operative procedures conducted at field sites need not be performed in dedicated facilities, but must be performed using aseptic procedures.” Public Health Service Policy wording (excerpted from the 1996 NRC Guide for the Care and Use of Laboratory Animals): “Appropriate attention to pre-surgical planning, personnel training, aseptic and surgical technique, animal well-being, and animal physiologic status during all phases of a protocol will enhance the outcome of surgery.” (page 60) “Aseptic technique is used to reduce microbial contamination to the lowest possible practical level. The contribution and importance of each practice varies with the procedure. Aseptic technique includes preparation of the patient, such as hair removal and disinfection of the operative site; preparation of the surgeon, such as the provision of decontaminated surgical attire, surgical scrub, and sterile surgical gloves; sterilization of instruments, supplies, and implanted materials and the use of operative techniques to reduce the likelihood of infection .” (page 62) “ Pre-surgical planning should specify the requirements of post-surgical monitoring, care, and record-keeping, including the personnel who will perform these duties. The investigator and veterinarian share responsibility for ensuring that post-surgical care is appropriate. An important component of post-surgical care is observation of the animal and intervention as required during recovery from anesthesia and surgery. The intensity of monitoring necessary will vary with the species and the procedure and might be greater during the immediate anesthetic-recovery period than later in postoperative recovery. During the anesthetic-recovery period, the animal should be in a clean, dry area where it can be observed often by trained personnel. Particular attention should be given to thermoregulation, cardiovascular and respiratory function, and postoperative pain or discomfort.” (page 63) Massachusetts Practice Act (for veterinarians) wording: “A veterinarian shall maintain a medical record for each patient. (a) patient's age, if known; (b) patient's sex' (c) patient's breed or description; (d) the type of anesthesia; (e) treatment; (f) surgery, if performed; (g) names and dosages of drugs and/or medications used or prescribed; (h) any other pertinent information gathered.” “ Drugs and medications which have expired shall not be left on shelves or retained for use or dispensing. ” [ Note: The USDA considers these regulations applicable and relevant to researchers performing animal surgery [typically regarded as the realm of veterinary surgeons] and has used these regulations for the basis for non-compliance citations, even though these particular regs were originally written to apply to licensed veterinarians. Policy 3 of the USDA policies now includes comments about drug expiration dates and the use of medical grades of drugs.] 2. Training Animal Welfare Act wording: “ Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures .” “Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training , including the proper and humane care and use of laboratory animals.” Public Health Service Policy wording: “Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals. (Article XIII of U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training) C. The regulatory text concerning surgery and all other research and teaching animal use is located at the following sites: Animal Welfare Act: This covers the species such as hamsters, gerbils, and rabbits. This regulation is enforced by the USDA by means of unannounced inspections. Policy 3 includes regulations requiring the use of medical grade drugs. Website references: http://www.aphis.usda.gov/ http://www.aphis.usda.gov/ac/policy/policy3 Public Health Service Policy : This covers all vertebrate animals. The NIH enforces these regulations through documentation (Animal Welfare Assurance, and other documents) and selected site visits to institutions. Compliance is especially critical for all labs receiving any DHHS/PHS/NIH/DOD funding, but it is the practice and philosophy here that we are consistent across the board for all animals involved in teaching and research regardless of funding sources. Enforcement is through NIH Office of Laboratory Animal Welfare (OLAW). Wording of the Policy is in the Policy handbook, and the specifics are in the Guide. The website contains these as well as many supporting documents, commentary and “help areas” to facilitate compliance. Website references: http://grants.nih.gov/grants/olaw/olaw.htm http://www.nap.edu/readingroom/ Massachusetts Practice Act: This describes requirements for licensed veterinarians in this state. The USDA (see Animal Welfare Act above) considers that these also apply to those non-veterinarians performing surgery on animals comparable or similar to that performed in veterinary practice. Website references: http://www.state.ma.us/reg/boards/#v http://www.state.ma.us/reg/boards/vt/default.htm 3. References, on line from other institutions and in our library: Here are some on-line surgery references from other institutions, and some in our library. http://oacu.od.nih.gov/ARAC/surguide.htm http://researchnet.asu.edu/animal_care/ http://www.uiowa.edu/~vpr/research/animal/rod_surg.htm http://www.vet.ohio-state.edu.docs/ular/rodsurg.html http://www.mc.uky.edu/dlar/resources/sop/rodsuruk.htm http://www.miami.edu/research/training/Rodent_Survival_Surgery.html http://www.olar.uiuc.edu/Policies/rodentsurg.html http://www.fsu.edu/~FSULAR/aseptic.html http://www.mediasales.psu.edu/latest/rodentqu.html (This is a self- assessment page.) In the library: Disease Mechanisms in Small Animal Surgery. (1993) ed. by M. Joseph Bojrab. Lea and Febiger. Philadelphia.(call # SF991.D57 1993, Morrill Biological Sciences Library) (Note particularly Chapter 9.) Frye, F.L. (1994) Reptile Clinician's Handbook: a compact clinical and surgical reference. Krieger. Malabar. FL. (call # SF997.5.R4 F78 1994, reference section, Morrill Biological Sciences Library) The Biology, Husbandry and Health Care of Reptiles. (1997) ed and compiled by L. Ackerman. T.F.H. Publications. Neptune City, NJ. (call # SF515.B56 1997, reference section, Morrill Biological Sciences Library) The IACUC Handbook. (2000) ed, by J. Silverman, M.A. Suckow, and S. Murthy. CRC Press. New York. (call # HV 4709 I23 2000, DuBois/University Library) Waynforth, H.B. (1980) Experimental and Surgical Technique in the Rat. Academic Press. Boston(call #: QL737.R666 W38, Morrill Biological Sciences Library)


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