BEFORE THE BOARD OF VETERINARY MEDICINE

                                DEPARTMENT OF LABOR AND INDUSTRY

                                                   STATE OF MONTANA

 

In the matter of the amendment of ARM 24.225.301 definitions, 24.225.514 patient medical records and recordkeeping, 24.225.550 unprofessional conduct, 24.225.709 continuing education, 24.225.904 certified euthanasia technicians – license requirements, 24.225.907 board-approved training program criteria, 24.225.910 certified euthanasia technician examinations – written and practical, 24.225.920 application for certified euthanasia agencies, 24.225.921 inspections – initial and annual, 24.225.925 continuing education – certified euthanasia technicians, 24.225.950 unprofessional conduct; the adoption of New Rule I certified euthanasia agency operation standards, New Rule II change of attorney-in-fact, New Rule III closure of a certified euthanasia agency or loss of DEA permit; and the repeal of 24.225.901 definitions, 24.225.926 termination of certified euthanasia technician employment and retirement of certificate

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NOTICE OF PUBLIC HEARING ON PROPOSED AMENDMENT, ADOPTION, AND REPEAL

 

TO: All Concerned Persons

 

            1. On April 7, 2020, at 1:00 p.m., a public hearing will be held in the Small Conference Room, 301 South Park Avenue, 4th Floor, Helena, Montana, to consider the proposed amendment, adoption, and repeal of the above-stated rules.

 

            2. The Department of Labor and Industry (department) will make reasonable accommodations for persons with disabilities who wish to participate in this public hearing or need an alternative accessible format of this notice. If you require an accommodation, contact the Board of Veterinary Medicine no later than 5:00 p.m., on March 31, 2020, to advise us of the nature of the accommodation that you need. Please contact Lucy Richards, Board of Veterinary Medicine, 301 South Park Avenue, P.O. Box 200513, Helena, Montana 59620-0513; telephone (406) 841-2394; Montana Relay 1 (800) 253-4091; TDD (406) 444-2978; facsimile (406) 841-2305; or dlibsdvet@mt.gov (board's e-mail).

 

            3. The rules proposed to be amended are as follows, stricken matter interlined, new matter underlined:

 

            24.225.301 DEFINITIONS (1) "Animal" means any member of the animal kingdom other than humans, whether living or dead.

            (2) "Approved euthanasia and restraint drugs" means those substances as defined in 37-18-602, MCA, and ARM 24.225.930 which are approved by the board for euthanizing animals under subchapter 9 of these rules.

            (3) "Attorney-in-fact" means the individual given power of attorney by a certified euthanasia agency as designated on the agency's DEA permit application.

            (4) "Drug Enforcement Administration" or "DEA" means the United States Department of Justice agency responsible for enforcing narcotics laws.

            (1) (5) "Emergency" shall mean means any instance in which an animal has a condition that threatens its life and immediate treatment is required to sustain life.

            (6) "Encounter" means an in-person visit, telephone conversation, or any telehealth interactions between the licensee and a client.

            (2) (7) "For remuneration or hire" shall mean means direct or indirect payment for the services rendered. This includes not only monetary payments but also payment by giving or receiving of material goods or services.

            (3) (8) "Occasional case" means the practice of veterinary medicine in this state no more than three days in any calendar year by a veterinarian actively licensed and in good standing in another state or jurisdiction who is supervised by a veterinarian licensed in this state practices veterinary medicine in this state no more than three days in any calendar year who is supervised by a veterinarian licensed in this state. As per 37-18-104, MCA, veterinarians meeting this definition are exempt from licensing requirements.

            (9) "Patient" means any animal or group of animals receiving veterinary care from a licensee.

            (4) (10) "Support personnel" shall mean means any person employed by a licensed veterinarian who assists a licensed veterinarian in the practice of veterinary medicine. The term does not include embryo transfer technicians.

            (5) (11) "Veterinarian/client/patient relationship" or "VCPR" exists when all of the following conditions have been met:

            (a) the veterinarian both the veterinarian and client acknowledge the veterinarian has assumed the responsibility for making clinical judgments regarding the health of the animal(s) and the need for medical treatment, and the client has agreed to follow the veterinarian's instructions allow the veterinarian to assume that responsibility;

            (b) the veterinarian has sufficient knowledge of the animal(s) to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s). This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by:

            (i) virtue of an a physical examination of the animal(s); or

            (ii) remains the same.

            (c) the veterinarian is available for follow-up evaluation in the event of adverse reactions or failure of the treatment regimen or the veterinarian has made reasonable arrangements for follow-up care.

            (6) remains the same but is renumbered (12).

 

            AUTH: 37-18-202, 37-18-603, MCA

            IMP:     37-18-102, 37-18-104, 37-18-603, MCA

 

REASON:  The board determined it is reasonably necessary to amend this rule to consolidate all definitions into a single location.  Definitions located in ARM 24.219.901 are being moved to this rule at (1), (2), and (4) for simplicity and better organization, and to eliminate duplicative definitions.

            Additionally, the board is defining "attorney-in-fact" at (3) as it applies to the application process and operating requirements for a certified euthanasia agency. This is not a commonly understood term by applicants and licensees and the definition will address repeated questions to staff.

            The board is defining "encounter" at (6) and "patient" at (9) to align with the proposed changes to recordkeeping requirements in ARM 24.225.514.

            The board is updating the definition of VCPR in (11) to align more closely with national standards.  It is also reasonably necessary to add the term "physical" to (11)(b)(i) to address questions from the public and licensees regarding the specific type of examination required to initiate a VCPR.

            Additional amendments provide consistency, simplicity, better organization, and ease of use for the reader.  The board is clarifying the definitions at (8) and (10) to address confusion from the public and licensees and numerous questions to staff.

            The board is updating the authority and implementation citations to accurately reflect all statutes implemented through the rule and provide the complete and current sources of the board's rulemaking authority.

 

            24.225.514 PATIENT MEDICAL RECORDS AND RECORDKEEPING STANDARDS (1) The required standards of practice of veterinary medical record-keeping are as follows:

            (a) (1) Patient medical records, either written or electronic, shall be maintained for every animal accepted and treated by a veterinarian as:

            (a) an individual patient; by a veterinarian, and for

            (b) every animal group (e.g., herd, litter, flock) treated by a veterinarian. These records shall be maintained and stored in an orderly manner lending itself to retrieval.

            (2) Patient medical records:

            (a) must be maintained for a minimum of three years after the last visit by the patient;

            (b) are the property of the practice and the practice owner where the records were prepared;

            (c) must be legibly written;

            (d)  must be maintained and stored in an orderly, legible manner for easy retrieval by the veterinarian;

            (e) must be safeguarded against loss, tampering, or use by unauthorized persons, readily available; and

            (f) must contain sufficient information to permit any authorized veterinarian to proceed with the care and treatment of the patient by reading the medical record.

            (3) In no case do the requirements in this rule eliminate the requirement to maintain drug records as specified by state and federal law and other rules in this chapter.

            (b) (4)  When appropriate, licensees Veterinarians may substitute the words "herd," "flock," or other collective term in place of the word "patient" when appropriate of this section.

            (5) Records to be maintained on these animals Patient medical records may be kept in a daily log or in the billing records, provided the records meet the requirements of this rule that the treatment information that is entered is adequate to substantiate the identification of these animals and the medical care provided. In no case does this eliminate the requirement to maintain drug records as specified by state and federal law and board rules.

            (c) (6)  The following data shall be clearly noted Patient medical records must include, but are not limited to the following:

            (a) patient identification, including description, sex (if readily determinable), breed, and age;

            (b) presenting complaint and relevant patient history;

            (c) client identification, including name, address, and phone number;

            (d) a record of every encounter and consultation regarding the patient;

            (i) name, address, and phone number of owner or agent;

            (ii) description, sex (if readily determinable), breed, and age of or description of group;

            (iii) date animal or group was seen, admitted, and discharged;

            (iv) (e)  results of any part of a physical examination, including but not limited to weight, temperature, pulse, and respiration, and condition, and diagnoses suspected;

            (f) all written records and notes, radiographs, sonographic images, video recordings, photographs, or other imaging and laboratory reports;

            (v) all medication, treatment, prescriptions, or prophylaxis given, including amount and frequency for both inpatient and outpatient care; and

            (g) treatments or intended treatment plans, or both, including:

            (i) medications; and

            (ii) amounts of medications administered, dispensed, or prescribed including amount and frequency for both inpatient and outpatient care;

            (vi) (h) diagnosis or tentative diagnosis, including diagnostic and laboratory tests or techniques utilized, and the results of each;

            (i) when pertinent, a prognosis; and

            (j) any authorizations, details of conversations, releases, waivers, discharge instructions, or other related documents.

            (d) (7) Veterinarians who practice with other veterinarians shall indicate by recognizable means on each patient's or animal group's medical record any treatment the licensee has performed, or which the licensee veterinarian has directed support personnel to perform.

            (e) (8) All radiographs referenced in (6) shall be permanently labeled to identify:

            (a)  the veterinarian or premises, or business name of the practice;

            (b)  the patient,;

            (c)  the owner,;

            (d)  the date the radiograph was taken,; and

            (e)  anatomical orientation of the radiograph.

            (f) Medical records of both individual and group patients shall be maintained for a minimum of three years after the last visit.

            (g) Consent forms, if used, should be part of the medical record.

            (h) Veterinary medical records and images are the property of the practice and the practice owner.

            (9)  Information within veterinary patient medical records is privileged and confidential, and may not be released to anyone other than the except the following:

            (a) owner of the patient,;

            (b) persons authorized by the owner, or;

            (c) other veterinarians involved with the treatment and care of the patient; or

            (d) as required by (12).

            (10) Information within patient medical records must be released upon consent of the owner or authorized person(s). Consent may be in written, electronic, or other form of waiver, and must be documented in the patient's medical file record. Confidentiality is waived under the conditions of (j) (12).

            (i) (11) When requested by the owner, or person(s) authorized by the owner, as per (h) (9), copies or summaries of the veterinary medical records and images must be provided by the veterinarian within a reasonable time period, and as promptly as required by medical necessity. The veterinary practice may charge a reasonable fee for the preparation of summaries and copying of the records and images.

            (j) remains the same but is renumbered (12).

            (i) and (ii) remain the same but are renumbered (a) and (b).

            (iii) (c)  upon request for statistical or scientific research, as long as the information is abstracted and de-identified; or

            (iv) (d)  upon request of public health officials, animal health officials, federal, state, or local officials, or agricultural authorities when it is deemed necessary to protect the welfare of the animal, and/or to protect public health and safety; or

            (e)  in response to a complaint filed with the board.

            (k) A veterinarian who reasonably and in good faith reports or discloses records in accordance with (j) shall not be considered to be engaging in unprofessional conduct.

            (l) remains the same but is renumbered (13).

            (m) (14) A veterinarian-practice owner terminating practice, retiring, relocating, or selling a practice shall:

            (a)  notify clients within 30 days by local newspaper, in writing, or via other electronic means that they are no longer available to patients, and shall;

            (b)  offer clients the opportunity to obtain a copy of their veterinary records,; and shall

            (c) specify who the new records owner is, and when applicable, and where the patient medical records can be obtained. A failure Failure to comply with this subsection may lead to disciplinary action.

            (n) (15) A veterinarian may not remove, copy, or use any part of any veterinary patient medical records without the express permission of the practice owner or as stated in (h) per (9) and (10).

            (o) (16) If a veterinarian, based upon his or her the veterinarian's medical opinion, is willing to dispense medication, then the veterinarian must also provide a prescription in place of said medication should the owner request a prescription. If a veterinarian, based upon his or her medical opinion, is not willing to dispense medication, then the licensee should deny a request for a prescription.

 

            AUTH: 37-1-131, 37-1-319, 37-18-202, MCA

            IMP:     37-1-131, 37-1-316, 37-1-319, MCA

 

REASON: Based on recommendations and concerns from the screening panel and department, the board concluded that licensees' recordkeeping practices vary widely and that licensees are reporting confusion about recordkeeping requirements. Therefore, the board determined it is reasonably necessary to update and standardize this rule and ARM 24.225.550 to better align the recordkeeping and unprofessional conduct rules with current national standards of practice.

            Authority citations are being amended to provide the complete sources of the board's rulemaking authority.

 

            24.225.550 UNPROFESSIONAL CONDUCT (1) remains the same.

            (a) violation of any state or federal statute or administrative rule regulating the practice of veterinary medicine, including any statute or rule defining or establishing standards of patient care or professional conduct or practice, or any rules established by any health agency or authority of the state or a political subdivision of those entities;

            (b) remains the same.

            (c) incompetence, negligence, or use of any practice or procedure in the practice of the profession, which creates an unreasonable risk of physical harm or serious financial loss to the client failing to provide care in a competent and humane manner consistent with prevailing standards of practice for the species of animal and the professed area of expertise of the veterinarian.  Licensees must meet the currently accepted standards of practice for the profession of veterinary medicine as described under:

            (i) Title 37, chapter 18, MCA;

            (ii) ARM Title 24, chapter 225; and

            (iii)  as otherwise found to be accepted within the profession as gauged by the reasonable conduct of other professionals engaged in the practice of veterinary medicine;

            (d) remains the same.

            (e) dispensing or prescribing a veterinary prescription drug or veterinary feed directive drug without a valid veterinarian/client/patient relationship VCPR;

            (f) failure to cooperate with an investigation authorized by the Board of Veterinary Medicine by respond to a request from the board, including:

            (i) not furnishing any papers or documents in the possession of and under the control of the licensee related to a complaint; or

            (ii) not furnishing in writing a full and complete explanation covering the matter contained in the a complaint; or

            (iii) not responding to subpoenas issued by the board or the department, whether or not the recipient of the subpoena is the accused in the proceedings.

            (g) through (j) remain the same.

            (k) willful or repeated violations of rules established by any health agency or authority of the state or a political subdivision thereof;

            (l) and (m) remain the same but are renumbered (k) and (l).

            (n) violation of the veterinarian/client/patient relationship by making public any information about, or photos of, the owner or patient, without consent of the owner or person(s) authorized by the owner;

            (m) making public any information without consent as per ARM 24.225.514;

            (o) (n)  violation of professional ethical standards by making public false or misleading negative information about another veterinarian's professional standing or reputation; or

            (p) (o)  identifying oneself as a member of an American Veterinary Medical Association (AVMA)-recognized specialty organization if such certification has not been awarded and maintained, or using terms implying a specialty in a false and misleading manner;

            (p) failure to disclose records in accordance with ARM 24.225.514 in a reasonable period of time;

            (q) failure to report to the proper authorities cruel or inhumane treatment to animals, if the licensee has direct knowledge of the cruel or inhumane treatment;

            (r) failure to refer if a client requests a referral; or

            (s) failure to obtain the client's consent before placing an animal under anesthesia, performing any surgical procedure, or transporting the animal to another facility, except in emergency situations.

 

            AUTH: 37-1-131, 37-1-136, 37-1-319, MCA

            IMP:     37-1-131, 37-1-136, 37-1-141, 37-1-316, 37-1-319, MCA

 

REASON: The board determined it is reasonably necessary to amend this rule by adding to the actions considered as unprofessional conduct based on recommendations and concerns from the department counsel. The board, through its screening panel, has encountered difficulty reviewing and processing complaints under the current rule. To better protect public health, safety, and welfare, the board is amending this rule to enable the board to more clearly set forth the actions considered by the board as unprofessional conduct and enable the board to better address future complaints.

            The board is updating the authority and implementation citations to accurately reflect all statutes implemented through the rule and provide the complete and current sources of the board's rulemaking authority.

 

            24.225.709 RENEWALS AND CONTINUING EDUCATION (1)  Nonsurgical embryo transfer technicians are required to obtain a total of ten continuing education (CE) hours prior to renewal on November 1.

            (2)  No more than five of the ten hours may be obtained through online courses.

            (3)  Continuing education requirements will not apply until after the licensee's first renewal.

            (4)  Licensees are responsible for selecting quality programs that focus on protecting the health, safety, and welfare of the public and contribute to nonsurgical embryo transfer technicians' professional knowledge and competence.  Acceptable CE activities:

            (a)  directly relate to the scope of practice of nonsurgical embryo transfer as defined in board statutes and rules;

            (b)  review existing concepts and techniques;

            (c)  convey information beyond the basic professional education;

            (d)  update knowledge on the practice and advances in nonsurgical embryo transfer; and/or

            (e)  reinforce professional conduct or ethical obligations of the licensee.

            (5)  All licensees shall affirm an understanding of their recurring duty to comply with CE requirements as a part of annual license renewal.

            (6)  The board may randomly audit up to 50 percent of renewed licensees.

            (7) All CE must be documented to show proof of completion.  The licensee is responsible for maintaining these records for one year following the renewal cycle reporting period and for making those records available upon board request.  Documentation must include the following information:

            (a) licensee name;

            (b) course title and description of content;

            (c) presenter or sponsor;

            (d) course date(s); and

            (e) number of CE hours earned.

            (8) Licensees found to be in noncompliance with CE requirements may be subject to administrative suspension.  Licensees may not apply CE hours used to complete delinquent CE requirements for the next education reporting period.

            (9)  Any CE hours required by disciplinary order do not apply toward the ten hours that are required annually under this rule.

            (10)  A licensee may request a hardship exemption from CE requirements due to certified illness or undue hardship.  Requests will be considered by the board.

            (1) A person certified as an embryo transfer technician under these rules must renew the certificate before the date set by ARM 24.101.413.

            (2) The certificate shall be issued by the department upon payment of a fee fixed by the board and on presentation of evidence satisfactory to the board that the certificate holder has ten credit hours of continuing education in embryo transfer during the preceding year.

            (3) New certificate holders shall be granted the renewal the first year without attending the educational programs.

            (4) The board may waive, revise, or suspend continuing education requirements or particular program requirements for applicants who cannot fulfill those requirements because of individual hardship.

            (5) A certificate holder may be granted a grace period of three months after the renewal date set by ARM 24.101.413 in which to fulfill continuing education requirements. This grace period will be granted only upon written request to the board, payment of the renewal fee, and payment of the late penalty fee. A certificate valid for the duration of the grace period will be issued only to a person granted a grace period. At the conclusion of the grace period, verification of CE compliance shall be submitted to the board, prior to the issuance of a full license.

            (6) It is the responsibility of the certificate holder to maintain proof of the certificate holder's continuing education attendance. The board will randomly audit two percent of the renewed licensees and all licensees requesting a grace period.

            (7) Continuing education programs attended during a license year or grace period cannot be used for the next year.

            (8) Proposed continuing education programs must be approved in advance by the board.

            (9) Persons exempt from these provisions are licensed veterinarians and new certificate holders applying for their first renewal.

 

            AUTH: 37-1-319, 37-18-202, MCA

            IMP:     37-1-131, 37-1-141, 37-1-306, 37-1-319, 37-18-104, MCA

 

REASON:  The board is amending this rule to align with and further facilitate the department's standardized application, renewal, and audit procedures, and streamline the rule for better organization and ease of use. As part of the standardization, the board is placing the responsibility on embryo transfer technicians to select quality continuing education (CE) programs that contribute to their knowledge and competence. Following amendment, the board will no longer approve programs as the licensees must choose CE that meets the education objectives described in this rule. The board is removing renewal provisions as they are adequately addressed in the department's standardized renewal procedure.

            The board determined it is necessary to restrict in (2) the number of hours that may be earned through online courses as some of the continuing education (CE) areas for nonsurgical embryo transfer are better learned in person.

            Following a recommendation by department legal staff, the board is adding (5) to align the affirmation of CE requirements at renewal with the provisions of 37-1-306, MCA. The amendments fall within standardized department procedures that licensees with mandatory CE affirm an understanding of their CE requirements, as part of a complete renewal application, instead of affirming CE completion.

            The board is adding (6) to allow flexibility in conducting random CE audits. Currently, the board randomly audits two percent of all renewed licensees per reporting period. The new language will allow the board to respond to staffing and budget issues by adjusting the number of licensees audited, while remaining consistent with the statutory maximum of 50 percent in 37-1-306, MCA.

            The board is clarifying in (8) that licensees not in compliance with CE may be subject to administrative suspension per 37-1-321, MCA, and in accordance with standardized department audit processes.  To address licensee and staff questions, (9) is intended to clarify that any CE required pursuant to a licensee's disciplinary action is independent of regular CE requirements.

            The board is eliminating the provisions for licensees to request CE grace periods to align CE and renewal requirements with standardized department procedures.  Under the standardized audit processes, licensees are provided with adequate time to cure any audit deficiencies and the grace period is no longer necessary. Licensees may still request hardship exemptions.

            Authority and implementation citations are being amended to accurately reflect all statutes implemented through the rule and provide the complete sources of the board's rulemaking authority.

 

            24.225.904 APPLICATION REQUIREMENTS AND QUALIFICATIONS FOR CERTIFICATION AND ENDORSEMENT AS A CERTIFIED EUTHANASIA TECHNICIANS – LICENSE REQUIREMENTS (1) Application for certification licensure as a certified euthanasia technician (CET) must be made on forms prescribed by the department. Completed applications include appropriate fees and required documentation.

            (2) Applications Applicants for an original license must include:

            (a) be at least 18 years of age;

            (b) have completed a euthanasia training program as described in ARM 24.225.907;

            (c) have passed both a written and practical euthanasia training and exam as described in ARM 24.225.910 within 36 months of the application date; and

            (d) provide verification of any professional license(s) the applicant has ever held in any state or jurisdiction.

            (a) a current, within two years, photograph of the applicant, certified by a notary;

            (b) documentation of successful completion of a board-approved training program taken within three years from the application date;

            (c) documentation of successful completion of a board-approved written and practical examination;

            (d) verification of all current employment at certified agencies;

            (e) Montana Department of Justice background check verifying that the applicant has no previous criminal convictions involving dangerous drugs and/or controlled substances, domestic violence, or animal cruelty;

            (f) verification from any other state or province where the applicant is certified as a euthanasia technician, that the applicant has never had certification revoked, suspended, or denied;

            (g) verification that applicant is at least 18 years of age or an emancipated minor; and

            (h) payment of the proper application fee.

            (3) The board may allow submission of a current euthanasia technician license from another state or province to meet the requirements of (2)(b) and (c), if the board determines that the other state's or province's standards for the euthanasia certification are substantially equivalent to or greater than the standards of this state.

            (4) An application shall remain active for one year from the date it is received at the board office. An applicant who, for any reason, fails or neglects to complete the licensing process within one year shall be required to file another application and submit another application fee.

            (3) Applicants for licensure currently licensed as a certified euthanasia technician in another jurisdiction must:

            (a) hold a current, active license in good standing to practice euthanasia in another state or jurisdiction whose standards at the time of application are substantially equivalent to Montana standards; and

            (b) provide verification of any professional license(s) the applicant has ever held in any state or jurisdiction.

            (4) Incomplete applications will automatically expire one year from the date the fee was received. If an application expires, the applicant must reapply and pay all appropriate fees.

 

            AUTH: 37-1-131, 37-18-202, 37-18-603, MCA

            IMP:     37-1-131, 37-1-304, 37-18-603, MCA

 

REASON: The board determined it is reasonably necessary to amend this rule to eliminate outdated, redundant, and unnecessary provisions, and provide consistency, simplicity, better organization, and ease of use for the reader. It is reasonably necessary to amend this rule and replace "certification" for "licensure" of euthanasia technicians. The department and board have always viewed the two terms synonymously, and the board is now updating the rule to utilize a single term.

            To address licensee questions and confusion, the board is removing the requirement that an applicant be employed at a certified euthanasia agency (CEA) to qualify for a CET license. A CET can only euthanize animals at a CEA. However, statute allows an individual to be an actively licensed CET regardless of whether or not that person is currently engaging in the practice at a CEA. The CEA, through the attorney-in-fact who holds power of attorney, is the individual that is authorized to obtain approved euthanasia drugs using its DEA permit. A CET would only be able to obtain and store approved euthanasia drugs if that person were also the individual with power of attorney at a CEA.

            The board is amending this rule to no longer require background checks for certified euthanasia technicians. Following a review of the rules and implemented statutes, staff determined the board lacks the statutory authority to require a background check on CET applicants.

            Implementation citations are being amended to accurately reflect all statutes implemented through the rule.

 

            24.225.907 BOARD-APPROVED TRAINING PROGRAM CRITERIA (1) To qualify for approval under ARM 24.225.904, a euthanasia training program must:

            (a) be conducted by a qualified instructor;

            (b) include but not be limited to instruction in:

            (1) Training courses for euthanasia technicians must include instruction on the following topics:

            (i) (a) proper dosage, and handling, and storage of approved euthanasia and restraint drugs listed in ARM 24.225.930;

            (ii) (b) maintaining human safety when conducting animal euthanasia and proper injection techniques;

            (iii) remains the same but is renumbered (c).

            (iv) (d) proper animal handling techniques to ease trauma and stress;

            (v) remains the same but is renumbered (e).

            (vi) (f) proper euthanasia and restraint drug storage and security precautions per state and federal regulations;

            (vii) proper record keeping; and

            (g) state and federal recordkeeping requirements for euthanasia and restraint drugs; and

            (viii) (h)  appropriate verification of how to verify and record death of the animal; and

            (c) issue a certificate of approval containing:

            (i) name of applicant;

            (ii) name of instructor;

            (iii) title of course;

            (iv) date of course;

            (v) number of hours; and

            (vi) presentation format.

 

            AUTH: 37-1-131, 37-18-202, 37-18-603, MCA

            IMP:     37-1-131, 37-18-603, MCA

 

REASON: The board is amending this rule and ARM 24.225.910 to eliminate outdated, redundant, and unnecessary provisions, and provide consistency, simplicity, better organization, and ease of use for licensees, staff, educators, program administrators, and the public. Since applicants must take a course and pass an examination, the board is standardizing these two rules to reflect the same sets of criteria for course instruction and the material on which applicants are tested.

            Additionally, the board is strengthening the language in (1) to make it clear that course material must include instruction regarding relevant state and federal laws pertaining to recordkeeping and storage of euthanasia and restraint drugs. The board concluded that to better protect the public, an understanding of those laws is a key certification requirement for CET applicants.

            The board is relocating the provisions on examination passage from ARM 24.225.910 to the license application rule, ARM 24.219.904. Implementation citations are being amended to accurately reflect all statutes implemented through the rule.

 

            24.225.910 CERTIFIED EUTHANASIA TECHNICIAN EXAMINATIONS – WRITTEN AND PRACTICAL TEST CRITERIA (1) A board-approved written and practical test for CETs must include:

            (a) Montana regulations governing CETs;

            (b) state and DEA drug record keeping requirements including disposal of out-of-date drugs and reporting of loss or theft of drugs;

            (c) human safety in administration of animal euthanasia;

            (d) pharmacology of sodium pentobarbital, xylazine, and acepromazine;

            (e) proper dosage and injection techniques of approved euthanasia and restraint drugs;

            (f) animal anatomy; and

            (g) verification of death.

            (1) The written and practical examinations for euthanasia must test on all criteria taught as part of the required training course in ARM 24.225.907.

            (2) A passing score on the written portion of the examination of 70 percent is required Seventy percent is the passing score for the written examination.

            (3) The practical examination will be graded by the instructor on a pass or fail basis.  The practical exam must consist of a hands-on demonstration by the individual showing the individual can conduct euthanasia by:

            (a) safely and effectively restraining an animal; and

            (b) administering the required euthanasia and restraint drugs.

            (3) A passing score on the practical test will be determined by the successful completion of hands-on demonstrations, which indicate that the applicant has been properly trained in procedures, which enable the applicant safely and effectively to restrain and perform humane euthanasia with restraint drugs and sodium pentobarbital. The practical examination will be graded on a pass/fail basis. The practical test shall be administered by the board-approved course provider.

            (4) Applicants who fail to achieve a passing score on any portion of the exam will not be eligible for certification.

 

            AUTH: 37-1-131, 37-18-202, 37-18-603, MCA

            IMP:     37-1-131, 37-18-603, MCA

 

REASON: See REASON for ARM 24.225.907. Implementation citations are being updated to accurately reflect all statutes implemented through the rule.

 

            24.225.920 APPLICATION FOR CERTIFIED EUTHANASIA AGENCIES

            (1) Application for licensure as a certified euthanasia agency must be made on forms prescribed by the department. Completed applications include appropriate fees and required documentation.

            (2) Applicants for licensure as a certified euthanasia agency must:

            (a) complete a power of attorney form appointing an attorney-in-fact for purposes of DEA orders;

            (b) pass an initial inspection by a board-designated inspector as described in ARM 24.225.921; and

            (c) provide verification of any professional license(s) the applicant has ever held in any state or jurisdiction.

            (3) Incomplete applications will automatically expire one year from the date the fee was received. If an application expires, the applicant must reapply and pay all appropriate fees.

            (1) A certified euthanasia agency (CEA) may purchase and possess controlled substances approved for the purpose of euthanasia. The application for initial certification as a CEA must be made on forms provided by the department.

            (2) Applications must include:

            (a) documentation of passage of an inspection by a board-approved inspector;

            (b) a copy of completed application sent to the DEA to possess and store controlled substances approved by the board for the purpose of euthanasia, DEA number to be reported to board when issued;

            (c) a list of all CETs or veterinarians employed by the agency with the day, month, and year that each individual began employment;

            (d) indication of which CET is responsible for all aspects of euthanasia at the agency;

            (e) completed power of attorney form as required by the DEA; and

            (f) payment of the proper fee.

            (3) An application will remain active for one year from the date it is received at the board office. An applicant who fails or neglects to complete the licensing process within one year shall be required to file a new application and submit another application fee.

 

            AUTH: 37-1-131, 37-18-202, 37-18-603, MCA

            IMP:     37-1-131, 37-18-603, 37-18-604, MCA

 

REASON: The board determined it is reasonably necessary to amend this rule to align with current standardized department procedures for licensure application processing.  The board is further amending this rule to eliminate outdated, redundant, and unnecessary provisions, and provide consistency, simplicity, better organization, and ease of use for licensees, staff, educators, program administrators, and the public.

            The board is amending this rule to clarify the application requirements regarding submission of power of attorney forms for purposes of DEA orders. The new language in (2)(a) which references the power of attorney form and "attorney-in-fact" will work in conjunction with the new definition for "attorney-in-fact" in ARM 24.225.301.

            The board is also removing the requirement that a copy of the DEA permit application be submitted as part of the board's application. The DEA permit is more appropriately addressed in NEW RULE I on CEA operating requirements.

            Because the attorney-in-fact is the person with authority under the DEA permit to obtain and store euthanasia drugs, the board only needs to know the attorney-in-fact as part of the initial application process, not persons licensed as CET or veterinarians. Lastly, all CETs are qualified to perform euthanasia per statutory authority, so it is not necessary to require applicants specify which CET is responsible for all aspects of euthanasia.

            The board is updating the implementation citations to accurately reflect all statutes implemented through the rule.

 

            24.225.921 CERTIFIED EUTHANASIA AGENCY INSPECTION CRITERIA - NOTIFICATION OF DEFICIENCIES AND CORRECTIONS INSPECTIONS – INITIAL AND ANNUAL (1)  Applicants must pass an initial inspection of the facility by a board-designated inspector prior to a license being issued.

            (a)  Results of the inspection will be provided to the licensee.

            (b)  If there are any items of noncompliance, the attorney-in-fact must submit a written response to the board which addresses those items of noncompliance.  The response must be received by the department within ten days of the attorney-in-fact receiving notification of noncompliance.

            (c)  If issues of noncompliance are not corrected within ten days of the attorney-in-fact receiving notice of noncompliance, a report of noncompliance will be reviewed by the board at the next regularly scheduled board meeting following the initial inspection.  For good cause the board may order a re-inspection, the cost of which will be paid by the applicant.

            (2)  A board-designated inspector will conduct annual on-site inspections of all existing certified euthanasia agency facilities.

            (a)  Inspections may be conducted with or without advance notice to the licensee.

            (b)  Results of the inspection will be provided to the licensee.

            (c)  If there are any items of noncompliance, the attorney-in-fact must submit a written response to the board which addresses those items of noncompliance.  The response must be received by the board within ten days of the licensee receiving notification of noncompliance.

            (d)  A report of significant noncompliance will be reviewed by the board screening panel per the department's standard compliance process.

            (3) If the inspector determines that an item of noncompliance substantially affects the public health, safety, or welfare, or jeopardizes animals under the control of the certified euthanasia agency, the inspector must immediately inform law enforcement and the board, which may summarily suspend the licensee's certificate pursuant to 2-4-631, MCA, and applicable Montana law.

            (1) An inspection of a CEA must be conducted annually by the board or a person authorized by the board with its full authority.

            (2) The inspection must include:

            (a) verification that the area and equipment is appropriate for animal euthanasia;

            (b) verification of the correct security, storage, disposal, and labeling of euthanasia and restraint drugs;

            (c) verification of correct drug record-keeping;

            (d) appropriate sanitation; and

            (e) any other condition that the board determines is relevant to the proper euthanasia of animals.

            (3) If the inspector determines that a deficiency substantially affects the public health, safety, or welfare, or jeopardizes animals under the control of the CEA, the inspector must immediately inform law enforcement and the board, which may summarily suspend the CEA's certificate pursuant to 2-4-631, MCA, and applicable Montana law. If a less serious deficiency is found after inspection, it must be communicated to the agency and the board in writing. The CEA must correct any such deficiency within 30 days from the date of the inspection. If a second inspection is required, a second inspection fee must be paid by the agency.  Failure to sufficiently correct a noted deficiency will be addressed as a disciplinary matter by the screening panel of the board, and the board may notify the DEA.

 

            AUTH: 37-1-131, 37-18-202, 37-18-603, MCA

            IMP:     37-1-131, 37-18-603, MCA

 

REASON:  The board determined it is reasonably necessary to amend this rule to remove outdated, redundant, and unnecessary provisions and add clarifying language where needed to address questions, and provide consistency, simplicity, better organization, and ease of use for licensees.

            Currently the rule does not specify the different processes for initial inspection for certification and annual inspection once a CEA has been licensed so the board is amending this rule to address questions in this area.  The board also determined it is reasonably necessary to clarify for the public, applicants, current licensees, and department staff what the process is for noncompliance using department inspections standards and processes for noncompliance.

            The board is reducing the number of days that the attorney-in-fact has to respond and address noncompliance from 30 days from the inspection to ten days from notification of the deficiencies.  The board concluded that ten days is a reasonable amount of time given the risk to public safety since CEA are obtaining and storing euthanasia and restraint drugs on the premises.

            The board is moving provisions on actual inspection criteria to NEW RULE I since inspection criteria are based on operating criteria instead of the reverse.

            The board is updating the implementation citations to accurately reflect all statutes implemented through the rule.

 

            24.225.925 RENEWALS CONTINUING EDUCATION – CERTIFIED EUTHANASIA TECHNICIANS (1)  Certified euthanasia technicians are required to obtain continuing education (CE) hours prior to renewal on May 30 every three years after the first year of licensure.  The CE must be obtained within the twelve months between the second and third renewals.

            (2) Approved CE to meet board requirements consists of both:

            (a) a euthanasia training program as described in ARM 24.225.907; and

            (b) passing both a written and practical euthanasia training exam as described in ARM 24.225.910.

            (3)  All licensees shall affirm an understanding of their recurring duty to comply with CE requirements as a part of annual license renewal.

            (4)  The board may randomly audit up to 50 percent of renewed licensees.

            (5) All CE must be documented to show proof of completion.  The licensee is responsible for maintaining these records for one year following the renewal cycle reporting period and for making those records available upon board request.  Documentation must include the following information:

            (a) licensee name;

            (b) course title and description of content;

            (c) presenter or sponsor;

            (d) course date(s); and

            (e) number of CE hours earned.

            (6) Licensees found to be in noncompliance with CE requirements may be subject to administrative suspension.  Licensees may not apply CE hours used to complete delinquent CE requirements for the next education reporting period.

            (7)  Any CE hours required by disciplinary order do not apply toward the CE that are required annually under this rule.

            (8)  A licensee may request a hardship exemption from CE requirements due to certified illness or undue hardship.  Requests will be considered by the board.

            (1) CETs must recertify on a form or by a method approved by the board on or before the date set by ARM 24.101.413 of every year, beginning in 2005. The certification renewal application must include:

            (a) verification of satisfactory completion of a board-approved euthanasia course and examination documenting continued competency taken within the 36 months immediately preceding the current renewal deadline date;

            (b) verification of current employment at a CEA; and

            (c) payment of the proper fee.

            (2) CEAs must renew certification on a form or by a method approved by the board on or before the date set by ARM 24.101.413 of every year, beginning in 2005. The renewal application must include:

            (a) verification of completion of satisfactory inspection within 12 months of the current renewal deadline date;

            (b) a list of currently employed CETs or veterinarians with day, month, and year that each individual began employment and indication of which CET is responsible for all aspects of euthanasia at the agency;

            (c) the proper fee; and

            (d) verification of current DEA registration.

            (3) Renewal notices will be sent as specified in ARM 24.101.414.

            (4) A CET's or CEA's renewal certificate shall be valid for one year following the renewal date of the previously held certificate.

            (5) The fee for any certificate holder who fails to recertify or submit the proper fee prior to the renewal date must pay the late penalty fee specified in ARM 24.101.403. Certification renewal forms may not be processed until all required documentation is received in the board office and all fees are paid.

            (6) The provisions of ARM 24.101.408 apply.

 

            AUTH: 37-1-131, 37-1-319, 37-18-202, 37-18-603, MCA

            IMP:     37-1-131, 37-1-306, 37-1-319, 37-1-141, 37-18-603, MCA

 

REASON:  The board is amending this rule to align with and further facilitate the department's standardized application, renewal, and audit procedures, and streamline the rule for better organization and ease of use for the reader.

            Following a recommendation by department legal staff, the board is adding (3) to align the affirmation of CE requirements at renewal with the provisions of 37-1-306, MCA. The amendments fall within standardized department procedures that licensees with mandatory CE affirm an understanding of their CE requirements, as part of a complete renewal application, instead of affirming CE completion.

            The board is amending (4) to allow flexibility in conducting random CE audits. Currently, the board randomly audits two percent of all renewed licensees for each reporting period. This amendment will allow the board to respond to staffing and budget issues by adjusting the number of licensees audited, while remaining consistent with the statutory maximum of 50 percent in 37-1-306, MCA.

            The board is clarifying in (6) that licensees not in compliance with CE may be subject to administrative suspension per 37-1-321, MCA, and in accordance with standardized department audit processes.  To address licensee and staff questions, (7) is intended to clarify that any CE required pursuant to a licensee's disciplinary action is independent of regular CE requirements.

            The current rule does not allow CET to request a CE hardship exemption.  The board is adding that option to be consistent with the other CE rules.

            The board is updating the authority and implementation citations to accurately reflect all statutes implemented through the rule and provide the complete and current sources of the board's rulemaking authority.

 

            24.225.950 UNPROFESSIONAL CONDUCT (1) remains the same.

            (a) violation of any state or federal statute or administrative rule regulations regulating the practice of animal euthanasia, including any statute or rule defining or establishing standards of animal euthanasia or professional conduct or practice;

            (b) and (c) remain the same.

            (d) possession, use, addiction to, diversion, or distribution of controlled substances in any way other than for legitimate euthanasia purposes, or violation of any drug law and use of euthanasia and restraint drugs for any purpose other than animal euthanasia as described in these rules;

            (e) violation of any state or federal drug laws;

            (e) remains the same but is renumbered (f).

            (f) (g) failure to maintain sanitary facilities or apply sanitary procedures for euthanizing animals meet the certified euthanasia agency operation standards described in these rules, including but not limited to maintaining sanitary conditions and appropriate records of euthanasia and restraint drugs;

            (g) (h) practicing as a CEA or as a CET if a certificate is retired, expired, terminated, revoked, or suspended;

            (h) (i) willful or repeated violations of rules regarding euthanasia established by any health agency or authority of the state or a political subdivision thereof;

            (i) remains the same but is renumbered (j).

            (j) (k) failure of a certified euthanasia agency to have current DEA registration;

            (k) failure to report to the board termination or change of employment for a CET within ten days;

            (l) use of unapproved drugs or methods for euthanasia; or

            (m) euthanasia of an animal for which the CET certified euthanasia technician has not received training; or

            (n) failure to store euthanasia or restraint drugs or other controlled substances used in the euthanasia of animals in compliance with established DEA requirements.

 

            AUTH: 37-1-131, 37-1-319, 37-18-202, 37-18-603, MCA

            IMP:     37-1-131, 37-1-316, 37-1-319, 37-18-603, 37-18-604, 37-18-605, MCA

 

REASON:  It is reasonably necessary to amend this rule to remove outdated, redundant, and unnecessary provisions and add clarifying language where needed to address questions, and provide consistency, simplicity, better organization, and ease of use for the public, licensees, and department staff.

            The board is amending this rule to clarify that the drugs specifically referred to are euthanasia drugs, which are the types of drugs that CEA and CET working at CEA are allowed to possess under these particular scopes of practice.  See the REASON for the repeal of ARM 24.219.926 for the striking of (1)(k).

            The board is updating the implementation citations to accurately reflect all statutes implemented through the rule.

 

            4. The proposed new rules are as follows:

 

            NEW RULE I CERTIFIED EUTHANASIA AGENCY OPERATION STANDARDS (1) A certified euthanasia agency cannot operate unless:

            (a) a license has been issued by the board;

            (b) the licensee has a current DEA permit, including a DEA number; and

            (c) the certified euthanasia agency has a designated attorney-in-fact.

            (2) Certified euthanasia agencies must:

            (a) have a designated area for euthanasia that can hold at least two people;

            (b) maintain the euthanasia area in a clean and sanitary condition at all times;

            (c) have bright, even light in the euthanasia area;

            (d) have proper ventilation in the euthanasia area;

            (e) have a table or work area for handling animals during euthanasia;

            (f) have a designated surface or cabinet to store equipment;

            (g) display the facility license and licenses of all licensed staff in a conspicuous place so they can be seen by members of the public.  Personal addresses on licenses may be covered;

            (h) have sufficient materials on-site for euthanasia, including, but not limited to:

            (i) medical quality needles;

            (ii) disposal container for used sharps as defined in 75-10-1003, MCA, that meets the requirements in 75-10-1005, MCA;

            (iii) syringes;

            (iv)  first aid kit;

            (v) electric clippers;

            (vi) stethoscope;

            (vii) humane restraint devices;

            (viii) towels; and

            (ix) disinfectant;

            (i) comply with all state and federal laws pertaining to storage of approved euthanasia and restraint drugs; and

            (j) comply with all state and federal laws pertaining to recordkeeping requirements for approved euthanasia and restraint drugs.

 

            AUTH: 37-1-131, 37-18-202, 37-18-603, MCA

            IMP:     37-1-131, 37-18-603, 37-18-604, MCA

 

REASON:  The board determined it is reasonably necessary to clarify the operating criteria for CEA in rule.  Currently the criteria are scattered throughout ARM 24.225.921 and the application rules or are listed only in the board's inspection checklist.  Locating the requirements in a single rule provides additional clarity and transparency for the public, applicants, current licensees, and department staff.

 

            NEW RULE II CHANGE OF ATTORNEY-IN-FACT (1) When there is a change of the appointed attorney-in-fact, the certified euthanasia agency must:

            (a) comply with any DEA notification requirements concerning the change of the attorney-in-fact; and

            (b) complete a department power of attorney form appointing a new attorney-in-fact.  The form must be submitted to the board within ten days of the change.

 

            AUTH: 37-1-131, 37-18-202, 37-18-603, MCA

            IMP:     37-1-131, 37-18-603, 37-18-604, MCA

 

REASON:  Based on information that department staff obtained during inspections and to address licensee confusion, the board is adopting this new rule to clarify what needs to occur when a CEA has a change of attorney-in-fact.  Through the power of attorney, the attorney-in-fact is responsible for all the euthanasia drugs obtained and held on the premises under the DEA permit.  A CEA must have an attorney-in-fact in order to obtain and hold drugs.

 

            NEW RULE III CLOSURE OF A CERTIFIED EUTHANASIA AGENCY OR LOSS OF DEA PERMIT (1) The designated attorney-in-fact must notify the board within ten days of closure of a certified euthanasia agency.

            (2) As part of the notification in (1) the designated attorney-in-fact must:

            (a) provide current contact information for the attorney-in-fact including but not limited to a mailing address and telephone number; and

            (b) verify that all euthanasia and restraint drugs and records are managed according to state and federal laws pertaining to these types of substances.  The verification must confirm:

            (i) all euthanasia and restraint drugs, including controlled substances, have been either:

            (A) destroyed; or

            (B) transferred to an authorized person(s), including the name and address of the person(s) to whom the euthanasia and restraint drugs were transferred;

            (ii) for controlled substances, the following:

            (A) the date of transfer; and

            (B) the name and amount of controlled substances transferred; and

            (iii) the return of DEA registration and all unused DEA 222 forms (order forms) to the DEA.

            (3) The designated attorney-in-fact must notify the board within ten days if a certified euthanasia agency loses its existing DEA permit and comply with the requirements in (2)(b).

 

            AUTH: 37-1-131, 37-18-202, 37-18-603, MCA

            IMP:     37-1-131, 37-18-603, 37-18-604, MCA

 

REASON:  The board has determined it is reasonably necessary to clearly delineate licensees' obligation to notify the board when a CEA closes and/or loses its DEA permit.  Information obtained by staff has shown that most licensees are unaware of all the steps needed to remain in compliance with state and federal drug laws if they close and/or lose their DEA permit.  Locating the requirements in this new rule provides additional clarity and transparency of requirements and processes for the public, applicants, current licensees, and department staff.

 

            5. The rules proposed to be repealed are as follows:

 

            24.225.901 DEFINITIONS

 

            AUTH: 37-18-202, 37-18-603, MCA

            IMP:     37-18-603, MCA

 

REASON: The board is repealing this rule as all relevant provisions are being relocated to ARM 24.225.301.

 

            24.225.926 TERMINATION OF CERTIFIED EUTHANASIA TECHNICIAN EMPLOYMENT AND RETIREMENT OF CERTIFICATE

 

            AUTH: 37-1-131, 37-18-202, 37-18-603, MCA

            IMP:     37-18-603, MCA

 

REASON: The board is repealing this rule as unnecessary. A CET can only euthanize animals at a certified euthanasia agency. However, statute allows an individual to be an actively licensed CET regardless of whether that person is currently engaging in the practice at a CEA. The CEA through attorney-in-fact who holds power of attorney is authorized to obtain approved euthanasia drugs using its DEA permit. A CET would only be able to obtain and store approved euthanasia drugs if that person were also the individual with power of attorney at a CEA.

 

            6. Concerned persons may present their data, views, or arguments either orally or in writing at the hearing. Written data, views, or arguments may also be submitted to the Board of Veterinary Medicine, 301 South Park Avenue, P.O. Box 200513, Helena, Montana 59620-0513, by facsimile to (406) 841-2305, or e-mail to dlibsdvet@mt.gov, and must be received no later than 5:00 p.m., April 10, 2020.

 

            7. An electronic copy of this notice of public hearing is available at http://boards.bsd.dli.mt.gov/vet (department and board's web site). Although the department strives to keep its web sites accessible at all times, concerned persons should be aware that web sites may be unavailable during some periods, due to system maintenance or technical problems, and that technical difficulties in accessing a web site do not excuse late submission of comments.

 

            8. The board maintains a list of interested persons who wish to receive notices of rulemaking actions proposed by this board. Persons who wish to have their name added to the list shall make a written request that includes the name, e-mail, and mailing address of the person to receive notices and specifies that the person wishes to receive notices regarding all board administrative rulemaking proceedings or other administrative proceedings. The request must indicate whether e-mail or standard mail is preferred. Such written request may be sent or delivered to the Board of Veterinary Medicine, 301 South Park Avenue, P.O. Box 200513, Helena, Montana 59620-0513; faxed to the office at (406) 841-2305; e-mailed to dlibsdvet@mt.gov; or made by completing a request form at any rules hearing held by the agency.

 

            9. The bill sponsor contact requirements of 2-4-302, MCA, do not apply.

 

            10. Regarding the requirements of 2-4-111, MCA, the board has determined that the amendment of ARM 24.225.301, 24.225.514, 24.225.550, 24.225.709, 24.225.904, 24.225.907, 24.225.910, 24.225.920, 24.225.921, 24.225.925, and 24.225.950 will not significantly and directly impact small businesses.

            Regarding the requirements of 2-4-111, MCA, the board has determined that the adoption of New Rules I through III will not significantly and directly impact small businesses.

            Regarding the requirements of 2-4-111, MCA, the board has determined that the repeal of ARM 24.225.901 and 24.225.926 will not significantly and directly impact small businesses.

            Documentation of the board's above-stated determinations is available upon request to the Board of Veterinary Medicine, 301 South Park Avenue, P.O. Box 200513, Helena, Montana 59620-0513; telephone (406) 841-2394; facsimile (406) 841-2305; or to dlibsdvet@mt.gov.

 

            11. Lucy Richards, Executive Officer, has been designated to preside over and conduct this hearing.

 

	BOARD OF VETERINARY MEDICINE PAUL MCCANN, DVM, PRESIDENT
/s/ DARCEE L. MOE Darcee L. Moe Rule Reviewer	/s/ THOMAS K. LOPACH Thomas K. Lopach, Interim Commissioner DEPARTMENT OF LABOR AND INDUSTRY

 

 

            Certified to the Secretary of State March 3, 2020.