16.2.19 NMAC

TITLE 16 OCCUPATIONAL AND PROFESSIONAL LICENSING

CHAPTER 2 ACUPUNCTURE AND ORIENTAL MEDICINE PRACTITIONERS

PART 19 EXPANDED PRACTICE CERTIFICATIONS

16.2.19.1 ISSUING AGENCY: New Mexico Board of Acupuncture and Oriental Medicine.

[16.2.19.1 NMAC - Rp, 16.2.19.1 NMAC, 6/16/2015]

16.2.19.2 SCOPE: All doctors of oriental medicine who are certified for expanded practice or who are applicants for certification for expanded practice, as well as all educational programs and students enrolled in an educational program.

[16.2.19.2 NMAC - Rp, 16.2.19.2 NMAC, 6/16/2015]

16.2.19.3 STATUTORY AUTHORITY: This part is promulgated pursuant to the Acupuncture and Oriental Medicine Practice Act, Section 61-14A-8.1 NMSA 1978.

[16.2.19.3 NMAC - Rp, 16.2.19.3 NMAC, 6/16/2015]

16.2.19.4 DURATION: Permanent.

[16.2.19.4 NMAC - Rp, 16.2.19.4 NMAC, 6/16/2015]

16.2.19.5 EFFECTIVE DATE: June 16, 2015, unless a later date is cited at the end of a section.

[16.2.19.5 NMAC - Rp, 16.2.19.5 NMAC, 6/16/2015]

16.2.19.6 OBJECTIVE: This part lists the certification requirements for each of the following expanded practice categories: basic injection therapy, injection therapy, intravenous therapy and bioidentical hormone therapy.

[16.2.19.6 NMAC - Rp, 16.2.19.6 NMAC, 6/16/2015]

16.2.19.7 DEFINITIONS:

A. The definitions in this section are in addition to those in the act and 16.2.1.7 NMAC.

B. The following definition applies to the rules and the act: “educational course” is a comprehensive foundation of studies, approved by the board leading to demonstration of entry level competence in the specified knowledge and skills required for the four respective certifications in expanded practice; an educational course is not an educational program as this term is used in the act and the rules and as defined in 16.2.1 NMAC.

C. The following definitions are from 16.19.36 NMAC for clarification of regulations for doctors of oriental medicine, certified in expanded practice;

(1) “Air changes per hour” (ACPH) means the number of times a volume of air equivalent to the room passes through the room each hour.

(2) “Ante-area” means an ISO Class 8 or better area where personnel hand hygiene and garbing procedures, staging of components, order entry, CSP labeling, and other high-particulate generating activities are performed. It is also a transition area that:

(a) provides assurance that pressure relationships are constantly maintained so that air flows from clean to dirty areas; and

(b) reduces the need for the heating, ventilating, and air-conditioning (HVAC) control system to respond to large disturbances.

(3) “Aseptic Technique” means proper manipulation of preparations to maintain sterility

(4) "ASHP" American society of health-systems pharmacists.

(5) “Beyond-use date” (BUD) means the date, or as appropriate, date and time, after which a compounded preparation is not to be used and is determined from the date and time the preparation is compounded.

(6) “Biological safety cabinet” (BSC) means a ventilated cabinet that provides ISO Class 5 environment for CSP’s, provides personnel, preparation, and environmental protection having an open front with inward airflow for personnel protection, downward high-efficiency particulate air (HEPA)-filtered laminar airflow for preparation protection, and HEPA-filtered exhausted air for environmental protection.

(7) “Buffer area” means an area where the primary engineering control (PEC) is physically located. Activities that occur in this area include the staging of components and supplies used when compounding CSP’s.

(8) “Certification” means independent third-party documentation declaring that the specific requirements have been met.

(9) “Cleanroom” means a room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. Microorganisms in the environment are monitored so that a microbial level for air, surface, and personnel gear are not exceeded for a specified cleanliness class.

(10) “Closed system vial-transfer device” means a vial-transfer system that allows no venting or exposure of substances to the environment.

(11) “Compounded sterile preparations” (CSP’s) include, but are not limited, to the following dosage forms which must be sterile when administered to patients:

(a) parenteral preparations;

(b) aqueous bronchial and nasal inhalations;

(c) injections (e.g. colloidal dispersions, emulsions, solutions, suspensions);

(d) irrigations for wounds and body cavities;

(e) ophthalmic drops and ointments; and

(12) “Compounding aseptic isolator” (CAI) means an enclosed ISO Class 5 environments for compounding pharmaceutical ingredients or preparations. It is designed to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer processes. Air exchange into the isolator from the surrounding environment should not occur unless the air has first passed through a microbial retentive filter (HEPA minimum).

(13) “Critical area” means an ISO Class 5 environment.

(14) “Critical site” means a location that includes any component or fluid pathway surfaces (e.g., vial septa, injection ports, beakers) or openings (e.g., opened ampules, needle hubs) exposed and at risk of direct contact with air (e.g., ambient room or HEPA filtered), moisture (e.g., oral and mucosal secretions), or touch contamination. Risk of microbial particulate contamination of the critical site increases with the size of the openings and exposure time.

(15) “Direct compounding area” (DCA) means a critical area within the ISO Class 5 primary engineering control (PEC) where critical sites are exposed to unidirectional HEPA-filtered air, also known as first air.

(16) “Disinfectant” means an agent that frees from infection and destroys disease-causing pathogens or other harmful microorganisms but may not kill bacterial and fungal spores. It refers to substances applied to inanimate agents, usually a chemical agent, but sometimes a physical one.

(17) “Home care” means health care provided in the patient’s home (not a hospital or skilled nursing facility) by either licensed health professionals or trained caregivers. May include hospice care.

(18) “Immediate use” means administration begins not later than one hour following the start of the compounding procedure. Use of Immediate use products is reserved to those events in which delay in preparation would subject the patient to additional risk due to delay in therapy and meeting USP/NF <797> (Immediate-Use CSP Provision) criteria.

(19) “ISO 5” means air containing no more than 100 particles per cubic foot of air of a size at least 0.5 micron or larger in diameter (3520 particles per cubic meter).

(20) “ISO 7” means air containing no more than 10,000 particles per cubic foot of air of a size at least 0.5 micron or larger in diameter (352,000 particles per cubic meter).

(21) “ISO 8” means air containing no more than 100,000 particles per cubic foot of air of a size at least 0.5 micron or larger in diameter (3,520,000 particles per cubic meter).

(22) “Laminar airflow” means a non-turbulent, non-mixing streamline flow of air in parallel layers.

(23) “Laminar airflow workbench” (LAFW) means a ventilated cabinet for compounding of sterile preparations. Provides preparation protection with high-efficiency particulate air (HEPA) filtered laminar airflow, ISO Class 5. Airflow may be horizontal (back to front) or vertical (top to bottom) in direction.

(24) “Media-fill test” means a test used to qualify aseptic technique of compounding personnel or processes and to ensure that the processes used are able to produce sterile preparation without microbial contamination. During this test, a microbiological growth medium such as soybean-casein digest medium is substituted for the actual drug product to simulate admixture compounding. The issues to consider in the development of a media-fill test are media-fill procedures, media selection, fill volume, incubation, time, and temperature, inspection of filled units, documentation, interpretation of results, and possible corrective actions required.

(25) “Multiple-dose container” means a multiple-unit container for articles or preparations intended for parenteral administration only and usually containing antimicrobial preservatives. Once opened or entered, a multiple dose container with antimicrobial preservative has a BUD of 28 days unless otherwise specified by the manufacturer.

(26) “Negative pressure room” means a room that is at a lower pressure than the adjacent spaces and therefore, the net flow of air is into the room.

(27) “Parenteral product” means any preparation administered by injection through one or more layers of skin tissue.

(28) “Personal protective equipment” (PPE) means items such as gloves, gowns, respirators, goggles, face shields, and others that protect individual workers from hazardous physical or chemical exposures.

(29) “Plan of care” means an individualized care plan for each patient receiving parenteral products in a home setting to include the following:

(a) description of actual or potential drug therapy problems and their proposed solutions;

(b) a description of desired outcomes of drug therapy provided;

(c) a proposal for patient education and counseling; and

(d) a plan specifying proactive objective and subjective monitoring (e.g. vital signs, laboratory test, physical findings, patient response, toxicity, adverse reactions, and noncompliance) and the frequency with which monitoring is to occur.

(30) “Positive pressure room” means a room that is at a higher pressure than the adjacent spaces and, therefore, the net airflow is out of the room.

(31) “Preparation” means a CSP that is a sterile drug or nutrient compounded in a licensed pharmacy or other healthcare-related facility pursuant to the order of a licensed prescriber; the article may or may not contain sterile products.

(32) “Product” means a commercially manufactured drug or nutrient that has been evaluated for safety and efficacy by the FDA. Products are accompanied by full prescribing information, which is commonly known as the FDA-approved manufacturer’s labeling or product package insert.

(33) “Quality assurance” means a program for the systematic monitoring and evaluation of the various aspects of a service or facility to ensure that standards of quality are being met.

(34) “Quality control” means a system for verifying and maintaining a desired level of quality in a preparations or process, as by planning, continued inspection, and corrective action as required.

(35) “Single-dose container” means a single-dose, or a single-unit, container for articles or preparations intended for parenteral administration only. It is intended for a single use. Examples of single-dose containers include prefilled syringes, cartridges, fusion-sealed containers, and closure-sealed containers when so labeled.

(36) “Secondary engineering control” means the ante area and buffer area or cleanroom in which primary engineering controls are placed.

(37) “Segregated compounding area” means a designated space, either a demarcated area or room, that is restricted to preparing low-risk level CSP’s with twelve (12)-hour or less BUD. Such area shall contain a device that provides unidirectional airflow of ISO Class 5 air quality for preparation of CSP’s and shall be void of activities and materials that are extraneous to sterile compounding.

(38) “Standard operating procedure” (SOP) means a written protocol detailing the required standards for performance of tasks and operations within a facility.

(39) “Sterile” means free from bacteria or other living microorganisms.

(40) “Sterilization by filtration” means passage of a fluid or solution through a sterilizing grade membrane to produce a sterile effluent.

(41) “Sterilizing grade membranes” means membranes that are documented to retain one hundred percent of a culture of 107 microorganisms of a strain of Brevundimonas (Pseudomonas) diminuta per square centimeter of membrane surface under a pressure of not less than 30 psi. Such filter membranes are nominally at 0.22 mm or 0.2 mm porosity, depending on the manufacturer’s practice.

(42) “Unidirectional flow” means airflow moving in a single direction in a robust and uniform manner and at sufficient speed to reproducibly sweep particles away from the critical processing or testing area.

(43) “USP 797” United States Pharmacopeia Chapter <797> Pharmaceutical Compounding.

(44) “Sterile Preparations” - This general Chapter provides procedures and requirements for compounding sterile preparations. General Chapter <797> describes conditions and practices to prevent harm to patients that could result from microbial contamination, excessive bacterial endotoxins, variability in intended strength, unintended chemical and physical contaminants, and ingredients of inappropriate quality in compounded sterile preparations.

(45) “USP/NF standards” means United States pharmacopeia/national formulary.

[16.2.19.7 NMAC - Rp, 16.2.19.7 NMAC, 6/16/2015]

16.2.19.8 EXPANDED PRACTICE CERTIFICATION GENERAL PROVISIONS: The four categories of expanded practice certification authorized by Section 61-14A-8.1. NMSA 1978 and defined in 16.2.19 NMAC that include, basic injection therapy, injection therapy, intravenous therapy and bioidentical hormone therapy shall all include the following provisions:

A. a doctor of oriental medicine enrolled in an educational course shall be authorized to perform the techniques and shall have the prescriptive authority, for the duration of the course, to administer and compound the substances that are authorized in the expanded practice formulary for which he is studying under the supervision of the board approved teacher for that educational course; under other circumstances the student shall not be authorized to obtain, prescribe or dispense such substances;

B. upon receipt of a current copy of CPR/BLS card the board shall annually renew the expanded practice certifications of a doctor of oriental medicine in good standing if the licensee has completed all continuing education required by 16.2.9 NMAC;

C. all expanded practice and prescriptive authority certifications shall automatically terminate when licensure as a doctor of oriental medicine:

(1) is placed on inactive status as specified in 16.2.15 NMAC;

(2) expires as specified in 16.2.8 NMAC; or

(3) is suspended, revoked or terminated for any reason as defined in 16.2.12 NMAC;

D. Proof of completion of an ASHP course relative to USP 797 is required for the first time renewal of basic injection therapy.

E. an expanded practice certification that is revoked or terminated shall not be reinstated; the doctor of oriental medicine must reapply for expanded practice certification as a new applicant;

F. all expanded practice certifications that were automatically terminated due to inactive status, expiration or suspension as specified in Subsection E of 16.2.19.8 NMAC, shall be automatically reinstated when licensure as a doctor of oriental medicine is reinstated, provided that:

(1) all fees required by 16.2.10 NMAC have been paid;

(2) all continuing education requirements specified in 16.2.9 NMAC have been completed; and

(3) all other relevant, reinstatement provisions, required by board rule, have been completed;

G. each year the board may review the expanded practice formularies for necessary amendments; when new substances are added to a formulary, appropriate education in the use of the new substances shall be approved and required by the board and the board of pharmacy for doctors of oriental medicine applying for new certification or as continuing education for renewal of the applicable expanded practice certification or certifications;

H. a doctor of oriental medicine certified for a category of expanded practice under 16.2.19 NMAC that authorizes the use of testosterone, a controlled substance, and any other drug that is classified as a controlled substance, shall register with the federal DEA (drug enforcement agency) prior to obtaining, prescribing, administering, compounding or dispensing the controlled substance;

I. a doctor of oriental medicine certified for expanded practice, when prescribing, shall use prescription pads printed with their name, address, telephone number, license number and their specific expanded practice certifications; if a doctor of oriental medicine is using a prescription pad printed with the names of more than one doctor of oriental medicine, the above information for each doctor of oriental medicine shall be on the pad and the pad shall have a separate signature line for each doctor of oriental medicine; each specific prescription shall indicate the name of the doctor of oriental medicine for that prescription and shall be signed by the prescribing doctor of oriental medicine;

J. a doctor of oriental medicine certified for expanded practice shall always, when diagnosing and treating a patient, use the skill and care ordinarily used by reasonably well-qualified doctors of oriental medicine similarly certified and practicing under similar circumstances, giving due consideration to the locality involved; failure to comply with this fundamental requirement may result in denial, suspension or revocation of licensure or certification, or other disciplinary measures, pursuant to the provisions of the act, Section 61-14A-17 NMSA 1978, and the Uniform Licensing Act, Section 61-1-1 NMSA 1978, et seq.;

K. when a doctor of oriental medicine is certified for injection therapy, this certification automatically supersedes his certification for basic injection therapy; and

L. the provisions for certification transition from extended prescriptive authority (Rx1) and expanded prescriptive authority (Rx2) to the expanded practice categories specified in 16.2.19 NMAC.

[16.2.19.8 NMAC - Rp, 16.2.19.8 NMAC, 6/16/2015; A, 10/22/2024]

16.2.19.9 EXPANDED PRACTICE CERTIFICATION BOARD REQUIREMENTS:

A. The board shall have final authority for certification of all applicants.

B. The board shall notify the applicant in writing by mail postmarked no more than 30 days after the receipt of the initial application as to whether the application is complete or incomplete and missing specified application documentation.

C. The board shall notify the applicant in writing by mail postmarked no more than 30 days after the notice of receipt of the complete application sent out by the board, whether the application is approved or denied.

D. If the application is denied, the notice of denial shall state the reason the application was denied.

E. the board shall maintain a list of each doctor of oriental medicine who is certified for each expanded practice category and shall notify the New Mexico board of pharmacy of all such certified licensees;

F. The board shall have the authority to deny, suspend, revoke or otherwise discipline an expanded practice certification, in accordance with the Uniform Licensing Act, Sections 61-1-1 to 61-1-31 NMSA 1978, for reasons authorized in the act and clarified in 16.2.12 NMAC.

[16.2.19.9 NMAC - Rp, 16.2.19.9 NMAC, 6/16/2015; A, 10/22/2024]

16.2.19.10 EXPANDED PRACTICE SCOPE OF PRACTICE: (from 16.2.2.10 NMAC):

A. In addition to the scope of practice outlined in 16.2.2 NMAC for a doctor of oriental medicine in New Mexico, the scope of practice for those certified in expanded practice shall include certification in any or all of the following modules: (Section 61-14A-8.1B NMSA1978) basic injection therapy, injection therapy, intravenous therapy and bio-identical hormone therapy as specified in 16.2.19 NMAC.

B. The scope of practice for those doctors of oriental medicine certified in expanded practice shall also include the expanded practice and prescriptive authority defined in Section 61-14A-8.1C NMSA1978.

[16.2.19.10 NMAC - Rp, 16.2.19.10 NMAC, 6/16/2015]

16.2.19.11 BASIC INJECTION THERAPY CERTIFICATION: The board shall issue, to a doctor of oriental medicine, certification for basic injection therapy upon completion of the course prerequisites including 30 hours of Pharmacology as specified in 16.2.18.9 and the following requirements.

A. The doctor of oriental medicine shall be a doctor of oriental medicine in good standing.

B. The doctor of oriental medicine shall submit to the board the completed application.

C. The doctor of oriental medicine shall pay the application fee for expanded practice certification specified in 16.2.10 NMAC.

D. The doctor of oriental medicine shall submit, with the application, proof of successful completion of the basic injection therapy educational course specified in 16.2.18 NMAC.

[16.2.19.11 NMAC - Rp, 16.2.19.11 NMAC, 6/16/2015; A, 10/22/2024]

16.2.19.12 INJECTION THERAPY CERTIFICATION: The board shall issue to a doctor of oriental medicine, certification for injection therapy, upon completion of the following requirements.

A. The doctor of oriental medicine shall be a doctor of oriental medicine in good standing.

B. The doctor of oriental medicine shall submit to the board the completed application.

C. The doctor of oriental medicine shall pay the application fee for expanded practice certification specified in 16.2.10 NMAC.

D. The doctor of oriental medicine shall submit, with the application, proof of:

(1) current certification by the board for basic injection therapy; or

(2) any course combining basic injection therapy and injection therapy, as they are specified in the board’s rules, or otherwise in accordance with law, must be completed within two years of the start of the course.

E. The doctor of oriental medicine shall submit, with the application, proof of successful completion of the injection therapy educational course approved by the board.

[16.2.19.12 NMAC - Rp, 16.2.19.12 NMAC, 6/16/2015; A, 10/22/2024]

16.2.19.13 INTRAVENOUS THERAPY CERTIFICATION: The board shall issue to a doctor of oriental medicine, certification for intravenous therapy, upon completion of the course prerequisites including board certification in basic injection therapy, and three hours of college level biochemistry, and the following requirements.

A. The doctor of oriental medicine shall be a doctor of oriental medicine in good standing.

B. The doctor of oriental medicine shall submit to the board the completed application.

C. The doctor of oriental medicine shall pay the application fee for expanded practice certification specified in 16.2.10 NMAC.

D. The doctor of oriental medicine shall submit, with the application, proof of successful completion of an intravenous therapy educational course approved by the board.

[16.2.19.13 NMAC - Rp, 16.2.19.13 NMAC, 6/16/2015; A, 10/22/2024]

16.2.19.14 INTRAVENOUS THERAPY EXPANDED PRACTICE CERTIFICATION: The board shall only issue certification to applicants after successful completion of the intravenous therapy expanded practice course, and successful completion and documentation of a practicum to include 300 hours under the supervision of a board approved physician and 150 individual patients to be completed within two years of completion of the coursework.

[16.2.19.14 NMAC - N, 6/16/2015]

16.2.19.15 BIOIDENTICAL HORMONE THERAPY CERTIFICATION: The board shall issue to a doctor of oriental medicine, certification for bioidentical hormone therapy, upon completion of the following requirements:

A. the doctor of oriental medicine shall be a doctor of oriental medicine in good standing;

B. the doctor of oriental medicine shall submit to the board the completed application;

C. the doctor of oriental medicine shall pay the application fee for expanded practice certification specified in 16.2.10 NMAC; and

D. the doctor of oriental medicine shall submit, with the application, proof of successful completion of the bioidentical hormone therapy educational course approved by the board.

[16.2.19.15 NMAC - Rp, 16.2.19.14 NMAC, 6/16/2015; A, 10/22/2024]

16.2.19.16 EXPANDED PRACTICE CERTIFICATION RENEWAL: If a doctor of oriental medicine certified for expanded prescriptive authority does not complete all expanded prescriptive authority continuing education requirements specified in 16.2.9.9 NMAC before the end of the 60 day grace period, the expanded prescriptive authority certification is expired, and that licensee shall not be certified for expanded prescriptive authority until the continuing education is completed. Provided that all other renewal requirements have been received by the board, such a licensee shall continue to be licensed as a doctor of oriental medicine and is authorized for that scope of practice but shall not be authorized for the relevant expanded prescriptive authority scope of practice. For an expired expanded prescriptive authority certification, if a properly completed application for certification renewal, including proof of completion of the required expanded prescriptive authority continuing education, is received at the board office within one year of the last regular renewal date, the expanded prescriptive authority certification shall be renewed if all the requirements of late certification renewal during the 60 day grace period provided by Section 61-14A-15 NMSA 1978 are completed, in addition to the requirements of 16.2.8.11 NMAC, and the licensee also pays the fee for expired certification renewal specified in 16.2.10 NMAC. The licensee must notify the board of the correct current mailing address and of any address changes within ten (10) days of the change. A doctor of oriental medicine who fails to renew an expired license by the next July 31 annual license renewal date or who fails to complete any required continuing education specific to his prescriptive authority certification shall be required to reapply as a new applicant for expanded practice, certification the expired license number of any doctor of oriental medicine certified in expanded practice who fails to renew in a timely manner in accordance with board rules. The board will promptly report to the board of pharmacy when the expired license is renewed or reinstated.

[16.2.19.16 NMAC - Rp, 16.2.19.15 NMAC, 6/16/2015]

16.2.19.17 TRANSITION PROVISIONS:

A. A doctor of oriental medicine, previously certified for extended prescriptive authority including prolotherapy, (Rx1) as of the effective date of this section, shall be automatically certified for basic injection therapy and prolotherapy using previously taught and appropriate injection routes and only substances listed in Paragraph (1) of Subsection F of 16.2.20.8 NMAC under the provisions of 16.2.19.11 NMAC.

B. A doctor of oriental medicine, previously certified for the expanded prescriptive authority (Rx2) as of the effective date of this section, shall be automatically certified for:

(1) injection therapy under the provisions of 16.2.19.12 NMAC basic injection therapy certification is automatically superseded by injection therapy certification;

(2) intravenous therapy under the provisions of 16.2.19.13 NMAC; and

(3) bioidentical hormone therapy under the provisions of 16.2.19.15 NMAC.

[16.2.19.17 NMAC - Rp, 16.2.19.16 NMAC, 6/16/2015, A, 10/22/2024]

16.2.19.18 LICENSE DESIGNATION: The designation for expanded practice shall follow the license number on the license and shall reflect the respective modules of certification: Rx basic injection, Rx injection, Rx intravenous, Rx hormones.

[16.2.19.18 NMAC - Rp, 16.2.19.17 NMAC, 6/16/2015]

16.2.19.19 ULTRASOUND CREDENTIALING: A licensed doctor of oriental medicine may utilize musculoskeletal diagnostic ultrasound and ultrasound guidance of procedures with the RMSK credential from the alliance for physician certification & advancement or APCA, or the registered musculoskeletal sonographer credential from ARDMS, the American registry of diagnostic medical sonography. A licensed doctor of oriental medicine (DOM) who wishes to practice diagnostic musculoskeletal ultrasound and ultrasound guidance of procedures shall register with the board of acupuncture and oriental medicine (BAOM) to be provisionally credentialed to practice diagnostic musculoskeletal ultrasound and ultrasound guided procedures upon completion of a minimum of 30 hours in BAOM approved courses. Within 36 months of provisional credentialing, the doctor of oriental medicine shall submit to the BAOM proof of scheduling for RMSK testing with APCA or registered musculoskeletal sonographer testing with ARDMS. If the provisional credentialing period is continued to 36 months without ARDMS RMSK or APCA RMSK credentialing, the provisionally credentialed DOM shall submit proof of 30 hours of continuing education in courses approved by the BAOM. Provisional credentialing shall lapse within 48 months of initial provisional credentialing. Ultrasound credentialing does not require certification in expanded practice.

[16.2.19.19 NMAC - Rp, 16.2.19.18 NMAC, 6/16/2015; A, 10/22/2024]

History of repealed material.

16.2.19 NMAC, Expanded Practice Certifications, filed 10-29-2009, repealed 6/16/2015.