DEPARTMENT OF HEALTH

[Filed November 2, 2024, 2:09 p.m.]

Preproposal statement of inquiry was filed as WSR 24-14-096.

Title of Rule and Other Identifying Information: Medical assistant medication administration requirements and apprenticeship programs. The department of health (department) is proposing rule amendments to WAC 246-827-0010, 246-827-0200, and 246-827-0240 to align with statutes updated by ESHB 1073 (chapter 134, Laws of 2023) and ESSB 5983 (chapter 248, Laws of 2024) and to ensure that the rules are current and align with best practices. The department is also proposing new WAC 246-827-0340 to address the medication administration requirements for the medical assistant-registered (MA-R) credential.

Hearing Location(s): On December 18, 2024, at 9:00 a.m., at the Washington State Department of Health, Town Center 2, Room 166/167, 111 Israel Road S.E., Tumwater, WA 98501; or via Zoom. Register in advance for this webinar https://us02web.zoom.us/webinar/register/WN_-tzxOMYUR3yDXF7vp1jrqg. After registering, you will receive a confirmation email containing information about joining the webinar. The department will be offering a hybrid public hearing. Participants may attend virtually or in person at the physical location. You may also submit comments in writing.

Date of Intended Adoption: December 26, 2024.

Submit Written Comments to: Becky McElhiney, P.O. Box 47852, Olympia, WA 98504-7852, email https://fortress.wa.gov/doh/policyreview, fax 360-236-2850, beginning the date and time of this filing, by December 18, 2024, at 11:59 p.m.

Assistance for Persons with Disabilities: Contact Becky McElhiney, phone 360-236-4766, fax 360-236-2901, TTY 711, email medical.assistants@doh.wa.gov, by December 4, 2024.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: In 2023, the legislature passed ESHB 1073 which updated the supervision requirements and the scope of practice for medical assistants in RCW 18.360.050. The department is proposing amendments to medical assistant rules to align with the updates in RCW 18.360.050 and establish requirements for medication administration by an MA-R credential. The ESHB 1073 amendments to RCW 18.360.050 significantly expanded the scope of practice for the MA-R credential, specifically for medication administration. A new rule section is necessary to provide guidance regarding routes and supervision levels related to these tasks. The department is also proposing updates to the medical assistant-certified (MA-C) medication administration rules to align with ESHB 1073.

In 2024, the legislature passed ESSB 5983 which amended RCW 18.360.050 and lowered the supervision level required for MA-Cs and MA-Rs to provide treatment for known or suspected syphilis infections from "immediate or direct" visual supervision to "telemedicine" supervision. The department is proposing updates to the medication administration rules for MA-C and adding rule language in the new MA-R section to align with this supervision requirement change.

The department is also proposing an update to the MA-C training and certification requirements that clarify the types of apprenticeship programs that are accepted to meet training requirements.

Reasons Supporting Proposal: The proposal aligns rules with RCW 18.360.050 and provides clarity to licensees and the public regarding requirements for medication administration, supervision, and training requirements for medical assistants.

Statutory Authority for Adoption: RCW 18.360.030, ESHB 1073 (chapter 134, Laws of 2023), and ESSB 5983 (chapter 248, Laws of 2024).

Statute Being Implemented: RCW 18.360.010, 18.350.040, and 18.360.050.

Rule is not necessitated by federal law, federal or state court decision.

Name of Proponent: Department of health, governmental.

Name of Agency Personnel Responsible for Drafting: Becky McElhiney, 111 Israel Road S.E., Tumwater, WA 98501, 360-236-4766; Implementation and Enforcement: James Chaney, 111 Israel Road S.E., Tumwater, WA 98501, 360-236-2831.

A school district fiscal impact statement is not required under RCW 28A.305.135.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Becky McElhiney, P.O. Box 47852, Olympia, WA 98504-7852, phone 360-236-4766, fax 360-236-2850, TTY 711, email medical.assistants@doh.wa.gov.

This rule proposal, or portions of the proposal, is exempt from requirements of the Regulatory Fairness Act because the proposal:

Is exempt under RCW 19.85.025(4).

Explanation of exemptions: The proposed rules impact individual licensees and not small businesses.

Scope of exemption for rule proposal:

Kristen Peterson, JD

for Umair A. Shah, MD, MPH

AMENDATORY SECTION(Amending WSR 23-16-004, filed 7/19/23, effective 8/19/23)

WAC 246-827-0010Definitions.

The following definitions apply throughout this chapter unless the context clearly indicates otherwise:

(1) "Controlled substance" has the same meaning as RCW 69.50.101.

(2)"Direct visual supervision" means the supervising health care practitioner is physically present and within visual range of the medical assistant.

(((2)))(3)"Forensic blood draw" means a blood sample drawn at the direction of a law enforcement officer for the purpose of determining its alcoholic or drug content by a person holding one of the credentials listed in RCW 46.61.506, including a medical assistant-certified, medical assistant-phlebotomist, or forensic phlebotomist.

(((3)))(4)"Health care practitioner" means a physician licensed under chapter 18.71 RCW; an osteopathic physician and surgeon licensed under chapter 18.57 RCW; or acting within the scope of their respective licensure, a podiatric physician and surgeon licensed under chapter 18.22 RCW, a registered nurse or advanced registered nurse practitioner licensed under chapter 18.79 RCW, a naturopath licensed under chapter 18.36A RCW, a physician assistant licensed under chapter 18.71A RCW, or an optometrist licensed under chapter 18.53 RCW.

(((4)))(5)"Hemodialysis" is a procedure for removing metabolic waste products or toxic substances from the human body by dialysis.

(((5)))(6)"Immediate supervision" means the supervising health care practitioner is on the premises and available for immediate response as needed.

(((6)))(7) "Immediately available" means the supervising health care practitioner is available to arrive on the premises in a reasonable amount of time or for an immediate audio or video telephone consultation.

(8)"Legend drug" means any drug which is required by any applicable federal or state law or regulation to be dispensed on prescription only or is restricted to use by health care practitioners only.

(((7)))(9)"Medical assistant" without further qualification means a person credentialed under chapter 18.360 RCW as a:

(a) Medical assistant-certified;

(b) Medical assistant-registered;

(d) Medical assistant-phlebotomist.

(((8)))(10)"Medical assistant-hemodialysis technician" means a patient care dialysis technician trained in compliance with federal requirements for end stage renal dialysis facilities.

(((9)))(11) "Medication" means a legend drug, over-the-counter drug, vaccine, or Schedule III through V controlled substance.

(12)"Secretary" means the secretary of the department of health or the secretary's designee.

(((10)))(13)"Telemedicine supervision" means the delivery of direct patient care under supervision by a health care practitioner provided through the use of interactive audio and video technology, permitting real-time communication between a medical assistant at the originating site and a health care practitioner off premises. "Telemedicine" does not include the use of audio-only telephone, facsimile, or electronic mail.

"Telemedicine supervision" also includes supervision of a medical assistant-certified or medical assistant registered through telemedicine technology for administering intramuscular injections for the purpose of treating a known or suspected syphilis infection in accordance with RCW 18.360.050.

AMENDATORY SECTION(Amending WSR 23-16-004, filed 7/19/23, effective 8/19/23)

WAC 246-827-0200Medical assistant-certified—Training and examination.

An applicant for a medical assistant-certified credential must meet the following requirements:

(1) Successful completion of one of the following medical assistant training programs:

(a) Postsecondary school or college program accredited by the Accrediting Bureau of Health Education Schools (ABHES) or the Commission of Accreditation of Allied Health Education Programs (CAAHEP);

(b) Postsecondary school or college accredited by a regional or national accrediting organization recognized by the U.S. Department of Education, which includes a minimum of 720 clock hours of training in medical assisting skills, including a clinical externship of no less than 160 hours;

(c) ((A registered))An apprenticeship program ((administered by a department of the state of Washington))registered and approved by the Washington state apprenticeship and training council unless the secretary determines that the apprenticeship program training or experience is not substantially equivalent to the standards of this state. The apprenticeship program shall ensure a participant who successfully completes the program is eligible to take one or more examinations identified in subsection (2) of this section;

(d) The secretary may approve an applicant who submits documentation that they completed postsecondary education with a minimum of 720 clock hours of training in medical assisting skills. The documentation must include proof of training in all of the duties identified in RCW 18.360.050(1) and a clinical externship of no less than 160 hours; or

(e) The secretary may approve an applicant who submits documentation that they completed a career and technical education program approved by the office of the superintendent of public instruction with a minimum of 720 clock hours of training in medical assisting skills. The documentation must include proof of training in all of the duties identified in RCW 18.360.050(1) and a clinical externship of no less than 160 hours.

(2) Pass a medical assistant certification examination, approved by the secretary, within the preceding five years of submitting an initial application or currently hold a national medical assistant certification with a national examining organization approved by the secretary. A medical assistant certification examination approved by the secretary means an examination that:

(a) Is offered by a medical assistant program that is accredited by the National Commission for Certifying Agencies (NCCA); and

(b) Covers the clinical and administrative duties under RCW 18.360.050(1).

AMENDATORY SECTION(Amending WSR 13-12-045, filed 5/31/13, effective 7/1/13)

WAC 246-827-0240Medical assistant-certified—Administering medications and injections.

A medical assistant-certified shall be deemed competent by the delegating health care practitioner prior to administering any ((drug))medication authorized in this section. ((Drugs))Medications must be administered under a valid order from the delegating health care practitioner and shall be within the delegating health care practitioner's scope of practice. The order must be in written form or contained in the patient's electronic health care record.

(1) ((Drug))Medication administration shall not be delegated when:

(a) The ((drug))medication may cause life-threatening consequences or the danger of immediate and serious harm to the patient;

(b) Complex observations or critical decisions are required;

(d) A patient is unable to indicate awareness that ((he or she is))they are taking a medication.

(2) To administer medications, the delegator shall ensure a medical assistant-certified receives training concerning: Dosage, technique, acceptable route(s) of administration, appropriate anatomic sites, expected reactions, possible adverse reactions, appropriate intervention for adverse reaction, and risk to the patient. The delegator must ensure a medical assistant-certified is competent to administer the medication.

(3) A medical assistant-certified is prohibited from administering:

(a) Schedule II controlled substances, chemotherapy agents, or experimental drugs; or

(b) Medications through a central intravenous line.

(4) Except as provided in subsection (1) of this section, a medical assistant-certified may administer controlled substances in schedules III, IV, and V or other ((legend drugs))medications when authorized by the delegating health care practitioner. ((Drugs))Medications shall be administered only by unit or single dosage or by a dosage calculated and verified by a health care practitioner. For the purposes of this section, a combination or multidose vaccine shall be considered a unit dose. A medical assistant-certified shall only administer ((drugs by))medications under the level of supervision based on the route as described in subsection (5) of this section.

(5) A medical assistant-certified may only administer medications by the following ((drug))medication category, route and level of supervision:

((Drug))Medication Category	Routes Permitted((*))	Level of Supervision Required
Controlled substances, schedule III, IV, and V	Oral, topical, rectal, otic, ophthalmic, or inhaled routes	Immediate supervision
Controlled substances, schedule III, IV, and V	Intramuscular injections	Immediate supervision
	Subcutaneous, intradermal, ((intramuscular,)) or peripheral intravenous injections	Direct visual supervision
((Other))Legend drugs (excluding those prohibited by subsection (3)(a) of this section)	((All other routes))Peripheral intravenous injections	((Immediate))Direct visual supervision
	All other routes	Immediate supervision
Over-the-counter medications	All routes per manufacturer's instructions	Immediate supervision
	((Peripheral intravenous injections	Direct visual supervision))
Vaccines	Oral, inhaled, subcutaneous, or intramuscular routes	Immediately available or telemedicine supervision

((*	A medical assistant-certified is prohibited from administering medications through a central intravenous line.

(6) A medical assistant-certified may not start an intravenous line. A medical assistant-certified may interrupt an intravenous line, administer an injection, and restart at the same rate.))

(6) A medical assistant-certified may:

(a) Start an intravenous line for diagnostic or therapeutic purposes under the immediate supervision of a health care practitioner.

(b) Interrupt an intravenous line and restart at the same rate under the immediate supervision of a health care practitioner.

(c) Administer intravenous injections for diagnostic or therapeutic agents under the direct visual supervision of a health care practitioner.

(d) Administer intramuscular injections for the purposes of treating a known or suspected syphilis infection without immediate supervision if a health care practitioner is providing supervision through interactive audio or video telemedicine technology in accordance with RCW 18.360.010 (12)(c)(ii).

WAC 246-827-0340Medical assistant-registered—Administering medications and injections.

A medical assistant-registered shall be deemed competent by the delegating health care practitioner prior to administering any medication authorized in this section. Medications must be administered under a valid order from the delegating health care practitioner and shall be within the delegating health care practitioner's scope of practice. The order must be in written form or contained in the patient's electronic health care record.

(1) Medication administration shall not be delegated when:

(a) The medication may cause life-threatening consequences or the danger of immediate and serious harm to the patient;

(b) Complex observations or critical decisions are required;

(d) A patient is unable to indicate awareness that they are taking a medication.

(2) To administer medications, the delegator shall ensure a medical assistant-registered receives training concerning: Dosage, technique, acceptable route(s) of administration, appropriate anatomic sites, expected reactions, possible adverse reactions, appropriate intervention for adverse reaction, and risk to the patient. The delegator must ensure a medical assistant-registered is competent to administer the medication.

(3) A medical assistant-registered is prohibited from administering:

(a) Schedule II controlled substances, chemotherapy agents, or experimental drugs; or

(b) Medications through a central intravenous line.

(d) Medications through intravenous injection.

(4) Except as provided in subsection (1) of this section, a medical assistant-registered may administer controlled substances in schedules III, IV, and V or other medications when authorized by the delegating health care practitioner. Medications shall be administered only by unit or single dosage or by a dosage calculated and verified by a health care practitioner. For the purposes of this section, a combination or multidose vaccine shall be considered a unit dose. A medical assistant-registered shall only administer medications under the level of supervision based on the route as described in subsection (5) of this section.

(5) A medical assistant-registered may only administer medications by the following medications category, route, and level of supervision:

Medication Category	Routes Permitted	Level of Supervision Required
Controlled substances, schedule III, IV, and V	Intramuscular injections	Immediate supervision
Legend drugs (excluding those prohibited by subsection (3)(a) of this section)	Intramuscular injections	Immediate supervision
Over-the-counter medications	All routes per manufacturer's instructions	Immediate supervision
Vaccines	Oral, inhaled, subcutaneous, or intramuscular routes	Immediately available or telemedicine supervision

(6) A medical assistant-registered is prohibited from starting an intravenous line. A medical assistant-registered may interrupt an intravenous line.

(7) A medical assistant-registered may administer intramuscular injections for the purposes of treating a known or suspected syphilis infection without immediate supervision if a health care practitioner is providing supervision through interactive audio or video telemedicine technology in accordance with RCW 18.360.010 (12)(c)(ii).