RULES AND REGULATIONS
STATE BOARD OF VETERINARY MEDICINE
[ 49 PA. CODE CH. 31 ]
Responsibility to Clients and Patients
[40 Pa.B. 3952]
[Saturday, July 17, 2010]The State Board of Veterinary Medicine (Board) amends § 31.21 (relating to Rules of Professional Conduct for Veterinarians) to read as set forth in Annex A. The final-form rulemaking amends Principle 7 (relating to responsibility to clients and patients) to specify two exceptions to the existing regulation that veterinarians may choose whom they will serve. First, the final-form rulemaking requires a veterinarian to provide euthanasia to relieve the suffering of an animal physically presented to the veterinarian's facility during the veterinarian's business hours. Second, the final-form rulemaking requires a veterinarian to provide notice and a reasonable time to secure alternative services should a veterinarian decide to discontinue treatment of an animal.
In addition, the final-form rulemaking clarifies an existing provision regarding protecting the personal privacy of clients. The final-form rulemaking also requires veterinarians to practice in accordance with current advancements in veterinary medicine and acceptable and prevailing standards of care, including with respect to drugs used by a veterinarian. Finally, the final-form rulemaking requires veterinarians to utilize analgesic drugs and therapies in accordance with current veterinary medical knowledge and acceptable and prevailing standards of practice.
Effective Date
The final-form rulemaking will be effective upon publication in the Pennsylvania Bulletin.
Statutory Authority
Section 21(11) of the Veterinary Medicine Practice Act (act) (63 P. S. § 485.21(11)) provides that the Board ''shall suspend or revoke'' a licensee or certificateholder who ''depart[s] from or fail[s] to conform to the standards of acceptable and prevailing veterinary medical practice.'' The Board's amendments to subsections (d) and (f) are consistent with this provision.
Section 21(12) of the act provides that the Board ''shall suspend or revoke'' a licensee or certificate holder who is found guilty of ''[e]ngaging in practices in connection with the practice of veterinary medicine which are in violation of the standards of professional conduct as defined herein or prescribed by the rules of the board.'' Section 5(2) of the act (63 P. S. § 485.5(2)) authorizes the Board to ''[a]dopt rules and regulations of professional conduct appropriate to establish and maintain a high standard of integrity, skills and practice in the profession of veterinary medicine.'' The Board's amendments to subsections (a), (c) and (e) update the Board's rules of professional conduct and set forth standards to maintain high standards of integrity, skills and practice in the profession.
Summary of Comments and the Board's Response
The Board received comments from Tom Garg, VMD, and the Pennsylvania Veterinary Medical Association (PVMA). Dr. Garg opined that the proposed standards were very reasonable; however, he voiced concern with subsection (e). The first issue raised was whether a client who gave oral consent for euthanasia of a pet being treated at a veterinary facility would find it inappropriate and insensitive for the veterinarian to later ask the client to provide written consent. In addition, Dr. Garg questioned what would happen if the client later refused to return the euthanasia consent form (if it was mailed to the client) or refused to sign the consent form. The Board agrees that many clients would find it insensitive to be asked to provide written consent after a beloved pet had been euthanized. The Board has replaced the proposed requirement with a requirement that the veterinarian document, in the patient's veterinary medical record, a client's oral consent to euthanasia or other treatments that have significant potential risks.
Second, Dr. Garg noted that in an emergency/critical care practice where critically ill patients are continually being reevaluated, it would not be feasible to obtain written consent each time the treatment plan is revised, as the animal's owner is rarely present. Dr. Garg accurately noted that the use of a broad consent form at the outset of treatment would not be obtaining truly informed consent. Section 31.21, Principle 7(e) was not intended to stifle the provision of veterinary care to patients. The Board added language to this subsection to indicate that the subsection does not preclude a veterinarian from obtaining general consent to treat that is effective whenever circumstances require veterinary medical intervention in the best interests of the patient and within parameters previously discussed with the client.
PVMA wrote in support of the requirement that veterinarians provide euthanasia to an animal that is physically presented to the veterinarian, noting that the requirement was consistent with the American Veterinary Medical Association's professional veterinary medical ethics and in the best interest of the welfare of suffering animals. PVMA questioned how ''reasonable attempts'' to contact an owner would be interpreted and who would establish the definition. The Board added a definition for both a ''reasonable attempt'' to determine the identity of an animal's owner and for a ''reasonable attempt'' to contact the owner. Specifically, the new provision provides that a reasonable attempt to contact the owner includes telephoning or using another contact method found on the animal's tag or microchip.
PVMA next asked who defines what are ''significant'' potential risks of treatment options. The treating veterinarian would be responsible for determining the significant potential risks that need to be explained to a client. The adjective ''significant'' is intended to limit the list of potential risks that shall be discussed to those that are statistically significant either in frequency or severity. It would be impossible for a health care provider to discuss every potential risk of every treatment; the provision requires veterinarian address with clients those risks that are generally recognized by the veterinary medical community as significant risks. The Board added the words ''reasonably anticipated'' to further describe the significant potential risks that must be explained to clients.
PVMA next commented on subsection (f), stating that the '' 'acceptable and prevailing standards of veterinary medical practice' can vary from region to region, general vs. specialty practice, [and so forth]. These terms should be spelled out to prevent subject interpretation.'' The Board disagrees that the acceptable and prevailing standards of veterinary medical practice, as this phrase is used in the act and Chapter 31, can vary from region to region or type of practice. The General Assembly created only one Statewide Board and the act provides for only one standard of practice that is acceptable and prevailing across this Commonwealth. Every practitioner of the healing arts—whether veterinarian, physician, dentist or podiatrist—is required to maintain current knowledge of the generally accepted treatments and precautions within their fields. It is impossible for any licensing board to ''spell out'' the acceptable and prevailing standards of practice in the healing professions for two primary reasons: first, the standards are too extensive; and second, because the acceptable and prevailing standard is, by definition, always changing.
Regarding subsection (g), PVMA questioned what would be a ''reasonable period of time.'' The Board added an explanatory statement that the reasonableness of the time period will be based on the nature of the animal's condition and the transfer shall be sufficiently timely to accommodate the animal's veterinary medical needs. Thus, if the animal were in critical condition, the veterinarian should fax the records immediately; however, if the animal is well and stable, a longer time, up to the 3-day period for release of records to clients, would be acceptable.
Finally, PVMA questioned whether a client shall provide a written release for medical records as currently required under § 31.22 (relating to recordkeeping). Section 31.22(8) requires a veterinarian to release records to an animal owner within 3 business days of receipt of the client's written request. Subsection (h) refers to a transfer of the records from one veterinarian to another veterinarian; this request may be oral.
PVMA also raised the following concerns: (1) what is the protocol when a person adopts an animal and the original owner cannot be located or does not respond to contact attempts; (2) what protection does the veterinarian have when releasing those records; and (3) what recourse does the new owner have in obtaining the records. As to the first inquiry, the Board is not clear how an animal could be adopted if the animal's owner cannot be located or does not respond to contact attempts. If an animal is abandoned at a veterinary facility, the veterinarian shall follow the abandonment provisions in section 601(c) of the Dog Law (3 P. S. § 459-610(c)). In this case, ownership of the animal would be asserted by the humane society. In some cases, by agreement with the humane society, the veterinarian retains possession of the animal and the humane society transfers ownership of the animal to the veterinarian. In this case, the veterinarian either releases the records to the humane society or, if the veterinarian becomes the animal's owner, may release the animal's records to a new adopter. Regarding the second inquiry, the abandonment provisions in section 601(c) of the Dog Law provide the protection. The third question appears to be answered in the response to the first question.
The House Professional Licensure Committee (HPLC) submitted two comments. First, the HPLC requested an explanation ''as to how to reconcile the conflict between the need of a veterinarian to obtain oral consent or a signature of an owner to perform humane euthanasia for an animal and the lack of need for client consent for euthanasia when a client cannot be contacted.'' The Board does not view the provision that requires a veterinarian to obtain an owner's consent for treatment as conflicting with the provision that allows a veterinarian to provide treatment without an owner's consent if the owner cannot be identified or contacted. There is not a conflict because, in the latter case, there is effectively no owner from whom to obtain consent to treatment.
In the vast majority of cases, the animal's owner brings the animal to a veterinarian for treatment. Euthanasia is a treatment that may be provided by a veterinarian in certain cases. Owner consent is required for treatment; however, an animal may urgently require care in some cases when the owner is unknown or cannot be contacted. The Board's provision allows veterinarians to provide care in these limited cases and sets forth guidelines for the provision of care in these cases. A case such as this might arise when a law enforcement officer or good Samaritan brings an injured animal to a veterinarian. The Board's provision requires the veterinarian to check the animal for tags, a tattoo and to scan for a microchip to attempt to identify the animal's owner and obtain consent for treatment (which may include euthanasia). In some cases the animal does not have identification and an owner cannot be determined, or if an owner is identified, the owner cannot be contacted to obtain consent to treatment. In this case, Principle 7(b), which requires veterinarians to ''consider first the welfare of the animal for the purpose of relieving suffering and disability while causing a minimum of pain or fright'' would guide the veterinarian's actions. Principle 7(a)(1) authorizes the veterinarian to provide treatment to the animal without the owner's consent. The veterinarian is bound by the standards of acceptable and prevailing veterinary medical practice in the type of treatment that the veterinarian shall provide. In cases when euthanasia is medically necessary to relieve an animal's suffering, the provision allows a veterinarian to provide euthanasia.
Second, the HPLC inquired as to how standards that veterinarians are to follow are determined to be ''acceptable and prevailing.'' The standards are identified through expert testimony, learned treatises, textbooks and peer-reviewed professional journals, just as they are determined in other fields of the healing arts.
The Independent Regulatory Review Commission (IRRC) also submitted comments. IRRC asked the Board to submit information regarding the widespread acceptance that the use of analgesia is the acceptable and prevailing standard of care, which had been detached from the Regulatory Analysis Form prior to submission of the proposed rulemaking. This information is being provided to IRRC as an attachment to the Regulatory Analysis Form.
Regarding subsection (a)(1), IRRC recommended using either ''humane euthanasia'' or ''euthanasia'' throughout the final-form rulemaking. As the concept of humane is integral to ''euthanasia,'' the Board deleted the repetitive word from subsection (a)(1). IRRC next recommended that the Board provide a clear standard for what a ''reasonable attempt'' would be in subsection (a)(1). The Board added language to address the concern. IRRC also inquired as to the meaning of ''proper veterinary medical judgment'' as used in subsection (a)(1) and (2). The Board intended that veterinarians act in accordance with the acceptable and prevailing standards of veterinary medical practice, as is required by the act.
Next, regarding subsection (a)(2), IRRC asked what type of notice would be required to be given to a client prior to terminating the veterinarian-client-patient relationship and suggested that the notice be in writing. The Board adopted the suggestion.
Regarding subsection (c), IRRC questioned under what circumstances a veterinarian would obtain or need a person's Social Security number or confidential health information and requested an explanation of why it would be necessary for a veterinarian to request, possess and document a person's Social Security number, sensitive financial information or confidential health information. Subsection (c) does not require a veterinarian to request, possess or document this information; rather, subsection (c) requires a veterinarian who does have this information to protect it. By way of further answer, a veterinarian may have a client's Social Security number if the client applies for Care Credit through the veterinarian. A veterinarian may have confidential health information about a client if the veterinarian is caring for an emotional support animal or assistance animal. Finally, a veterinarian may have sensitive financial information, such as a client's credit card information, if the client has provided this information to pay for services.
IRRC echoed PVMA's questions about defining the acceptable and prevailing standard of veterinary medical practice in subsections (d) and (f). Section 21(11) of the act authorizes the Board to discipline a licensee for the ''departure from, or failure to conform to, the standards of acceptable and prevailing veterinary medical practice, in which case actual injury need not be established.'' Virtually identical language exists in nearly every healthcare profession's practice act. For example, section 7(a)(10) of the Optometric Practice and Licensure Act (63 P. S. § 244.7(a)(10)) states that the State Board of Optometry may discipline a licensee for the ''[f]ailure to conform to, the acceptable and prevailing standards of optometric practice in rendering professional service to a patient. Actual injury to a patient need not be established''; section 15(a)(8) of the Osteopathic Medical Practice Act (63 P. S. § 271.15(a)(8)) states that the State Board of Osteopathic Medicine may discipline a licensee for ''any departure from, or the failure to conform to, the standards of acceptable and prevailing osteopathic medical practice. Actual injury to a patient need not be established''); section 5(a)(12) of the Pharmacy Act (63 P. S. § 390-5(a)(12)) states that the State Board of Pharmacy may discipline a licensee for ''the departure from, or failure to conform to, the standards of acceptable and prevailing pharmacy practice, in which case actual injury need not be established''; and section 41(8) of the Medical Practice Act of 1985 (63 P. S. § 422.41(8)) states that the State Board of Medicine may discipline a licensee for ''departure from or failing to conform to an ethical or quality standard of the profession . . . actual injury to a patient need not be established.'' Section 41(8)(i) of the Medical Practice Act of 1985 further explains the deviation from a standard of the profession by stating that ''the accepted standard of care for a practitioner is that which would normally be exercised by the average professional of the same kind in this Commonwealth under the circumstances.'' The Board has already further defined the ''acceptable and prevailing standards of care'' as used in subsection (d) by stating that abiding by these standards ''includ[es] using current proven techniques, drugs and scientific research that may affect treat- ment decisions'' and to ''practice in accordance with . . . pharmacologic properties, indications and contraindications of drugs and biologics.'' The Board believes these provisions further clarify the statutory phrase.
Next, IRRC raised issues with subsection (e). First, IRRC suggested deleting the word ''significant'' from the phrase ''significant potential risks,'' stating that the word ''significant'' was vague. The Board intended the word ''significant'' to modify and limit the word ''risks,'' thus adding clarity to the vague term ''risks.'' Veterinarians are required to conform their professional conduct to the acceptable and prevailing standards of practice; this requirement extends to veterinarians' conversations with clients regarding treatment options. Potential risks are significant and shall be disclosed to clients if the risks are generally accepted in the veterinary medical community to be significant and if a majority of practitioners acting on this generally accepted knowledge would disclose the risks to clients. Second, IRRC questioned the requirement for written consent to euthanasia, particularly if oral consent is first obtained. IRRC agreed with commentators that to request a signature after an animal had been euthanized was unrealistic and awkward. As previously discussed, the Board deleted this provision.
Regarding subsection (g), IRRC asked who determines what is a reasonable period of time to forward records to a new veterinarian and suggested that the final-form rulemaking set a finite time limit. The Board declines to set a finite time limit because the time is wholly dependent on the condition of the animal. As an outside period, the Board believes that guidance is already found in § 31.22, which gives a veterinarian a maximum of 3 business days to provide copies of records to a client. The Board added a provision regarding this maximum time period.
Fiscal Impact and Paperwork Requirements
The final-form rulemaking should not have financial impact on licensees, the Board or any other State entity. The final-form rulemaking will not have fiscal impact on the public. There are not additional paperwork requirements associated with the final-form rulemaking.
Sunset Date
The Board continuously monitors its regulations. Therefore, a sunset date has not been assigned.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on September 2, 2009, the Board submitted a copy of the notice of proposed rulemaking, published at 39 Pa.B. 5438 (September 19, 2009), to IRRC and to the HPLC and the Senate Consumer Protection and Professional Licensure Committee (SCP/PLC) for review and comment.
Under section 5(c) of the Regulatory Review Act, IRRC, the HPLC and the SCP/PLC were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Board has considered all comments from IRRC, the HPLC, the SCP/PLC and the public.
Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on May 5, 2010, the final-form rulemaking was approved by the HPLC. On June 2, 2010, the final-form rulemaking was deemed approved by the SCP/PLC. Under section 5.1(e) of the Regulatory Review Act, IRRC met on June 3, 2010, and approved the final-form rulemaking.
Findings
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) and the regulations promulgated thereunder, 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and all comments were considered.
(3) This final-form rulemaking is necessary and appropriate for administering and enforcing the authorizing act identified in this preamble.
Order
The Board, acting under its authorizing statute, orders that:
(a) The regulations of the Board, 49 Pa. Code Chapter 31, are amended by amending § 31.21 to read as set forth in Annex A, with ellipses referring to the existing text of the regulation.
(b) The Board shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General as required by law.
(c) The Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(d) This order shall take effect immediately upon publication in the Pennsylvania Bulletin.
ROBIN J. BERNSTEIN, Esq.,
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 40 Pa.B. 3471 (June 19, 2010).)
Fiscal Note: Fiscal Note 16A-5722 remains valid for the final adoption of the subject regulation.
Annex A
TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND OCCUPATIONAL AFFAIRS
CHAPTER 31. STATE BOARD OF VETERINARY MEDICINE
PROFESSIONAL CONDUCT § 31.21. Rules of Professional Conduct for Veterinarians.
* * * * * Principle 7. Responsibility to clients and patients.
(a) Except as provided in this subsection, veterinarians may choose whom they will serve, but may not neglect an animal with which the veterinarian has an established veterinarian/client/patient relationship.
(1) During a veterinarian's regular business hours, a veterinarian may not refuse to provide euthanasia to relieve the suffering of an animal that is physically presented to the veterinarian at the veterinarian's facility. A veterinarian may provide euthanasia for an animal under this paragraph without a veterinarian/client/patient relationship if the owner is unknown or cannot be contacted. If the owner is unknown, the veterinarian shall make a reasonable attempt to determine the identity of the animal's owner, including, at a minimum, checking the animal for a tag, tattoo or microchip. If the owner is known or identified, the veterinarian shall make a reasonable attempt to contact the owner, including, at a minimum, telephoning or using another contact method found on the animal's tag or microchip, and obtain consent to euthanasia or treatment. If the owner cannot be identified or cannot be contacted, the veterinarian shall exercise proper veterinary medical judgment to determine whether to provide euthanasia or other veterinary medical care to the animal.
(2) If a veterinarian deems it necessary to discontinue the treatment of an animal with which the veterinarian has a veterinarian/client/patient relationship, the veterinarian shall give written notice to the client of his intention to withdraw and provide reasonable time, based on the condition of the animal and the availability of alternative veterinary medical services, to allow the client to obtain necessary veterinary care for the animal.
(b) Veterinarians shall consider first the welfare of the animal for the purpose of relieving suffering and disability while causing a minimum of pain or fright.
(c) Veterinarians and their staffs shall protect the personal privacy of clients, unless the veterinarians are required by law to reveal the confidences or it becomes necessary to reveal the confidences to protect the health and welfare of an individual, the animal or others whose health and welfare may be endangered. Personal information that should be protected under this section includes a client's Social Security number and sensitive financial information and confidential health information about the client. Veterinary medical records of a client's animals shall be released to the Board or its agents upon demand, as set forth in section 27.1(b)(1) of the act (63 P. S. § 485.27a(b)(1)). Any portion of a veterinary medical record relevant to public health shall be released to public health or law enforcement officials upon demand. Veterinary medical records shall be released to the general public only with the written consent of the client, subpoena or court order.
(d) Veterinarians shall practice in accordance with current advancements and acceptable and prevailing standards of care in veterinary medicine, including using current proven techniques, drugs and scientific research that may affect treatment decisions. Veterinarians shall practice in accordance with advancements and acceptable and prevailing standards of veterinary medical practice in this Commonwealth related to the pharmacologic properties, indications and contraindications of drugs and biologics.
(e) Veterinarians shall explain the benefits and reasonably anticipated significant potential risks of treatment options to clients. When the client or client's agent is present, veterinarians shall document, by signature, the client's consent for euthanasia and other treatments that have significant potential risks. If the client is not present to provide a signature, veterinarians shall attempt to contact the owner by telephone or other established means to obtain oral consent and shall document the oral consent in the animal's veterinary medical record. This subsection does not preclude a veterinarian from obtaining general consent to treat that is effective whenever circumstances require veterinary medical intervention in the best interests of the patient within parameters previously discussed with the client.
(f) Veterinarians shall serve as patient advocates especially regarding the alleviation of pain and suffering, consistent with the acceptable and prevailing standards of veterinary medical practice. Veterinarians shall utilize analgesic drugs, dosages, treatment intervals and combination therapies proven to be safe and effective in different species and in various conditions of age, illness or injury in accordance with current veterinary medical knowledge and acceptable and prevailing standards of veterinary medical practice in this Commonwealth.
(g) If a client desires to consult with another veterinarian about the same case, the first veterinarian shall readily withdraw from the case, indicating the circumstances on the veterinary medical record of the animal, and shall forward copies of the animal's veterinary medical records in a reasonable period of time to other veterinarians who request them. For purposes of this subsection and subsection (h), the reasonableness of the period of time shall be based on the nature of the animal's condition and the transfer shall be sufficiently timely to accommodate the animal's veterinary medical needs, but may not be longer than 3 business days after the client makes the request.
(h) If a client requests referral to another veterinarian or veterinary hospital, the attending veterinarian shall honor the request and facilitate the necessary arrangements, which includes forwarding copies of the veterinary medical records of the animal in a reasonable period of time to the other veterinarian or veterinary hospital.
* * * * *
[Pa.B. Doc. No. 10-1276. Filed for public inspection July 16, 2010, 9:00 a.m.]
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