WSR 13-08-083

PROPOSED RULES

DEPARTMENT OF HEALTH


[ Filed April 3, 2013, 9:14 a.m. ]

     Original Notice.

     Preproposal statement of inquiry was filed as WSR 12-14-098 and 12-23-044.

     Title of Rule and Other Identifying Information: Chapter 246-827 WAC, Medical assistants, proposing a new chapter for the implementation of the medical assistant credential as authorized by chapter 18.360 RCW.

     Proposed amendments to WAC 246-826-990 Health care assistant -- Fees and renewal cycle, to establish procedures to transition health care assistant (HCA) credentials to new medical assistant (MA) credentials.

     Hearing Location(s): Department of Health, Point Plaza East, Room 152/153, 310 Israel Road S.E., Tumwater, WA 98501, on May 7, 2013, at 9:00 a.m.

     Date of Intended Adoption: May 14, 2013.

     Submit Written Comments to: Brett Cain, P.O. Box 47852, Olympia, WA 98504, e-mail http://www3.doh.wa.gov/policyreview/, fax (360) 236-2901, by May 7, 2013.

     Assistance for Persons with Disabilities: Contact Cece Zenker at (360) 236-4633 by May 1, 2013, TTY (800) 833-6388 or 711.

     Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed rules create new chapter 246-827 WAC. The rules establish requirements for obtaining an MA credential, supervision of MAs, MA tasks, and related requirements. This proposal also amends WAC 246-827-990 to describe how the department will transfer an HCA credential active on July 1, 2013, to one of three corresponding credentials: Medical assistant-certified (MA-C), medical assistant-hemodialysis technician (MA-H), or medical assistant-phlebotomist (MA-P).

     Reasons Supporting Proposal: Rule making is necessary to create enforceable standards for the medical assistant credentials. ESSB 6237 grants the department authority to establish education and training standards. It also grants the department authority to limit the drugs that an MA-C may administer based on risk, class, or route. Rules are also necessary to establish administrative procedures and administrative requirements to establish the medical assistant credentials. Rules setting the fees for these credentials were adopted in November 2012.

     Statutory Authority for Adoption: Chapter 153, Laws of 2012, chapter 18.360 RCW, and RCW 43.70.280.

     Statute Being Implemented: Chapter 153, Laws of 2012.

     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, Implementation and Enforcement: Brett Cain, 111 Israel Road S.E., Tumwater, WA 98504, (360) 236-4766.

     A small business economic impact statement has been prepared under chapter 19.85 RCW.

Small Business Economic Impact Statement

     Section 1. What is the scope of the proposed rule package? ESSB 6237, enacted in 2012 and codified as chapter 18.360 RCW, establishes the medical assistant profession. The bill directed the secretary of the department of health (department) to adopt rules setting the minimum qualifications to obtain a medical assistant credential.

     As directed by ESSB 6237, the medical assistant credential will replace the current HCA credentials under chapters 18.135 RCW and 246-826 WAC. On July 1, 2013, the department plans to begin transferring the HCA credentials of approximately 17,000 individuals to a new medical assistant credential, and on that date the department will stop issuing new HCA credentials.

     The proposed rules create new chapter 246-827 WAC, Medical assistants. This proposal also amends WAC 246-827-990 Health care assistant -- Fees and renewal cycle, to describe how the department will transfer an HCA credential active on July 1, 2013, to one of three corresponding credentials: MA-C, MA-H, or MA-P.

     The proposed rules establish certification requirements for MA-C, MA-H and MA-P, and registration requirements for one new category of medical assistant. Medical assistants may only work under the delegation and supervision of a Washington state licensed physician, osteopath, naturopath, optometrist, physician's assistant, osteopathic physician's assistant, advanced registered nurse practitioner, or registered nurse. The proposed rules clarify standards for a health care practitioner to delegate tasks to a medical assistant, and the level of supervision the health care practitioner must provide when delegating tasks.

     ESSB 6237 directs the department to set minimum requirements to obtain a medical assistant credential. Because the bill does not prescribe these requirements, the department must adopt rules to establish enforceable standards. The proposed rules specify the minimum qualifications to obtain credential as MA-C, MA-H, or MA-P. The rules also set medication administration and injection limitations for MA-Cs based on risk, class, and route.

     The proposal also establishes the minimum requirements for a health care practitioner, clinic, or group practice to endorse an individual as a medical assistant-registered (MA-R). This is a new credential created by ESSB 6237; there is no corresponding health care assistant credential. An MA-R endorsement is not transferable from one practitioner or practice setting to another. The proposed rules describe what an MA-R must do to maintain his or her credential when changing employment from an endorsing provider, clinic or group practice, and starting work with another.

     Assumptions: ESSB 6237, passed during the 2012 legislative session, creates four medical assistant credentials in Washington state. The law has been codified as chapter 18.360 RCW and is effective July 1, 2013. RCW 18.360.020 states that anyone practicing as a medical assistant must obtain a credential from the Washington state department of health (department). The law (RCW 18.360.050) also sets the scope of practice for the different categories of medical assistants. Therefore, some uncredentialed assistive personnel may be required to obtain a credential to perform the tasks they currently perform as they are tasks that are included in the scope of the new medical assistant credential.

     Because of the unique tasks that their unlicensed assistive personnel perform, the department has identified that podiatrists will likely be required to have currently unlicensed staff member credentialed as a medical assistant-registered under the proposed rules. There are no minimum training qualifications to obtain a medical assistant-registered credential. For the purposes of this small business economic impact statement (SBEIS), the department assumes that each licensed podiatrist operates as an independent business, and each podiatrist will endorse one medical assistant-registered and pay the credentialing fee of $90 every two years. The average cost per podiatry business would be $45 per year. This average cost per business is below the threshold required for analyzing the small business economic impact to podiatry businesses.

     As a result, the remainder of this analysis focuses on economic impacts to optometry businesses.

     The medical assistant law provides that current health care assistants will transition to one of the new categories of medical assistant. Optometrists are not approved supervisors and delegators for health care assistants. They are supervisors and delegators for medical assistants under the new law. Also, their unlicensed personnel, including optometric technicians and optometric assistants, currently administer prescription eye drops. Under ESSB 6237 and the proposed rules, the administration of drugs may only be performed by medical assistant-certified.

     Because these unlicensed assistive personnel administer medication and perform other tasks included in the scope of medical assistant-certified, this analysis assumes that each optometry office in Washington state will be required to hire a medical assistant-certified. It is also assumed that current unlicensed optometry assistive personnel may not have the training required to obtain a medical assistant-certified credential when these rules are scheduled to take effect on July 1, 2013. Therefore, for the purposes of this SBEIS, [the] department assumes that each optometry office will hire one full-time medical assistant-certified.

     Wage data: Optometry assistants are classified as medical assistants by the United States Bureau of Labor Statistics. According to the Washington state employment security department, medical assistants in Washington earn an average of $16.761 per hour with an average annual salary of $34,190. The department polled optometry businesses regarding current optometry assistant wages and reported wages of $11.50 to $19 (a mean of $16.25) an hour with an average annual salary of $33,1502.

     Section 2. Which businesses are impacted by the proposed rule package? What are their North American Industry Classification System (NAICS) codes? What are their minor cost thresholds?


NAICS Code (4, 5 or 6 digit) NAICS Business Description # of Businesses in WA Minor Cost Threshold = 1% of Average Annual Payroll Minor Cost Threshold = 0.3% of Average Annual Receipts
621320 Optometrists' offices (e.g., centers, clinics) 507 $1,806 $1,930

     Section 3. What is the average cost per business of the proposed rule? This analysis assumes that optometry businesses will need to employ one state credentialed medical assistant-certified as of the date these rules take effect, currently scheduled for July 1, 2013. It also assumes that there would be insufficient time before these rules take effect for an optometrist to have one of his/her optometry assistants obtain the training required in the proposed rules to become a medical assistant-certified.

     It is also noted that optometrists may be able to reduce nearly all of the cost impacts of these rules by the licensed optometrists performing administration of prescription eye drops themselves, and having one or more of their other optometry assistive personnel obtain a medical assistant-registered credential. If this option is chosen, the average annual cost per business would be $45 per year for state credentialing for each optometry assistive personnel who obtains a medical assistant-registered credential.


Cost Category Description Cost
Reporting $0
Recordkeeping $0
Training $0
Professional Services (e.g., engineers, lawyers) $0
Equipment (type) $0
Supplies (type, amount) $0
Labor (show hours multiplied by cost per hour) Medical assistant-certified - 2040 (hrs. per year) x 16.76 $34,190
Optometric assistant - 2040 (hrs. per year) x 16.25 $33,150
Administration $0
Lost Sales or Revenue $0
Other n/a
Total Average Cost3 Difference in cost of employing a qualified medical assistant-certified compared to cost of employing an optometric assistant $34,190 minus

$33,150, equals

$1,040

     Section 4. Does the rule impose more than minor costs on impacted businesses?


Average cost per optometry business $1,040
Minor cost threshold - 1% payroll $1,806
Minor cost threshold - .03% of receipts $1,930

     Does the average cost per business exceed both of the minor cost thresholds? No.

     Section 5. Does the rule have a disproportionate impact on small businesses? After research and consultation with three member[s] of the Washington state board of optometric physicians, it has been determined that there are large businesses (having more than fifty employees) operating in Washington state who employ optometrists as primary care providers. This may include businesses such as Group Health, Costco, Providence, Wal-Mart, Clarus Eye Centre, among others. These large businesses may have greater capacity or more options for absorbing the impact of the rules. Group Health, for example, may have a health care assistant already on staff whose credential will transfer to medical assistant-certified credential and may assist in performing administration of prescription eye drops.

     Is the average cost per employee for small businesses more than the average cost per employee for the largest businesses? Yes.

     Section 6. Did the department make an effort to reduce the impact of the rule?

     The department made every effort to reduce the impact of this rule on health care providers. The department worked diligently to assure that stakeholders throughout the state were involved in the design and implementation of the rules.


Did the department reduce, modify, or eliminate substantive regulatory requirements?

ESSB 6237 creates four medical assistant credentials in Washington state. The bill was passed during the 2012 legislative session and has been codified as chapter 18.360 RCW. The law is effective July 1, 2013. RCW 18.360.020 states that no person may practice as a medical [assistant] unless they are certified or registered under RCW 18.360.040. RCW 18.360.050 sets the scope of practice for the different categories of medical assistants.

Did the department simplify, reduce, or eliminate recordkeeping and reporting requirements;

RCW 18.360.040 requires that registrations based on an endorsement to perform specific medical tasks signed by a supervising health care practitioner must be filed with the department. The law mandates a certain level of recordkeeping and reporting.

Did the department reduce the frequency of inspections?

Discipline action taken by the department is complaint-driven. The department does not routinely inspect health care practitioner offices or clinics.

Did the department delay compliance timetables?
The law mandates that the rules be effective July 1, 2013. The law does not currently allow for the department to delay compliance. Persons performing medical assisting duties after June 30, 2013, must obtain a medical assistant credential from the department.
However, a bill has been introduced in the 2013 Washington state legislature that would allow medical assistants-registered to administer eye drops and topical ointments. If passed, an optometrist would not need to employ a medical assistant-certified. The bill would also allow the department to delay adoption of the medical assistant-registered rules only, to give time to implement the bill.

Did the department reduce or modify fine schedules for noncompliance?

Persons performing medical assistant duties after June 30, 2013, must obtain a medical assistant credential from the department. Nonlicensed persons acting as medical assistants after the above date may be subject to unlicensed practice laws under the Uniform Disciplinary Act, chapter 18.130 RCW. There is no language in the law that allows the department to modify fine schedules.

Did the department create or implement any other mitigation techniques?

The law provides that a medical assistant-certified credential is required to administer medications. The department may not by rule allow medical assistants-registered to administer medications. The department worked diligently to assure that stakeholders throughout the state were involved in the design and implementation of the rules.

     Section 7. Did the department involve small businesses in the rule development process? Stakeholders from both the Optometric Physicians of Washington and the Washington State Podiatric Medical Association attended rules workshops held by the department.

     Section 8. Will businesses have to hire or fire any employees because of the requirements in the rule? The department's analysis concludes that optometrists in Washington state who do not have other qualified staff persons to administer prescription eye drops will be required to either hire a new medical assistant-certified or require their current unlicensed assistive staff person to obtain the medical assistant-certified credential. Washington state podiatrists may need to reallocate staff duties and require some assistive staff to obtain the medical assistant-registered credential.

1 Data taken [from] the Washington state employment security department https://fortress.wa.gov/esd/employmentdata/reports-publications/occupational-reports/occupations-in-demand.

2 Data from poll of several Washington state optometry businesses.

3 Calculation assumes optometry offices replace once [one] current unlicensed optometric assistant with one medical assistant-certified to comply with the medical assistant law.

     A copy of the statement may be obtained by contacting Brett Cain, 111 Israel Road S.E., Tumwater, WA 98501, phone (360) 236-4766, fax (360) 236-2901, e-mail brett.cain@doh.wa.gov.

     A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Brett Cain, 111 Israel Road S.E., Tumwater, WA 98501, phone (360) 236-4766, fax (360) 236-4766 [236-2901], e-mail brett.cain@doh.wa.gov.

April 3, 2013

Mary C. Selecky

Secretary

OTS-5230.2


AMENDATORY SECTION(Amending WSR 11-20-092, filed 10/4/11, effective 12/1/11)

WAC 246-826-990   Health care assistant fees and renewal cycle.   (1) Certificates must be renewed every two years as provided in WAC 246-826-050 and chapter 246-12 WAC, Part 2.

     (2) ((If a health care assistant who holds a current active credential leaves employment with a facility or practitioner and returns to employment with a facility or practitioner that previously employed the health care assistant, and more than two years has passed since that health care assistant's employment with the previous facility or practitioner ended, the health care assistant must complete a new credential application and pay the application fee. However, that health care assistant is not required to pay the late renewal penalty and the expired credential reissuance fee.)) On July 1, 2013, all active certified health care assistant credentials will expire and be renewed as medical assistant credentials pursuant to RCW 18.360.080 and 43.70.280. The department will issue a medical assistant credential to a person who had an active health care assistant credential as of June 30, 2013. No fee will be required of the credential holder for this transition.

     (3) The following nonrefundable fees will be charged:


Title of Fee Fee
Initial certification $113.00
Renewal 113.00
Expired credential reissuance 55.00
Recertification 108.00
Late renewal penalty 55.00
Duplicate certificate 30.00

[Statutory Authority: RCW 43.70.110, 43.70.250, and 2011 1st sp.s. c 50. 11-20-092, § 246-826-990, filed 10/4/11, effective 12/1/11. Statutory Authority: RCW 43.70.110, 43.70.250, 2008 c 329. 08-15-014, § 246-826-990, filed 7/7/08, effective 7/7/08. Statutory Authority: RCW 18.135.030. 07-20-100, § 246-826-990, filed 10/2/07, effective 11/2/07. Statutory Authority: RCW 43.70.250, [43.70.]280 and 43.70.110. 05-12-012, § 246-826-990, filed 5/20/05, effective 7/1/05. Statutory Authority: RCW 43.70.250 and 18.135.030. 03-24-071, § 246-826-990, filed 12/1/03, effective 3/1/04. Statutory Authority: RCW 43.70.280. 98-05-060, § 246-826-990, filed 2/13/98, effective 3/16/98. Statutory Authority: RCW 43.70.250. 91-13-002 (Order 173), § 246-826-990, filed 6/6/91, effective 7/7/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-826-990, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 43.70.250. 90-04-094 (Order 029), § 308-175-140, filed 2/7/90, effective 3/10/90. Statutory Authority: RCW 18.135.030. 87-23-022 (Order PM 689), § 308-175-140, filed 11/12/87.]

OTS-5292.4


NEW SECTION
WAC 246-827-0010   Definitions.   The following definitions apply throughout this chapter unless the context clearly indicates otherwise:

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

     (2) "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, an osteopathic physician assistant licensed under chapter 18.57A RCW, or an optometrist licensed under chapter 18.53 RCW.

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

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

     (5) "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 practitioners only.

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

     (a) Medical assistant-certified;

     (b) Medical assistant-registered;

     (c) Medical assistant-hemodialysis technician; and

     (d) Medical assistant-phlebotomist.

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

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

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GENERAL
NEW SECTION
WAC 246-827-0100   Applicability.   A person shall obtain a medical assistant credential from the secretary in order to practice as a medical assistant. "Practice as a medical assistant" means the person assists a health care practitioner by providing direct patient health care including treatment, self-care instruction, patient education, and administration of medication. A person employed by a health care practitioner or facility is not practicing as a medical assistant as defined in this chapter if he or she only performs the following tasks:

     (1) Accounting;

     (2) Insurance reimbursement;

     (3) Maintaining medication and immunization records;

     (4) Obtaining and recording patient history;

     (5) Preparing and maintaining examination and treatment areas;

     (6) Reception;

     (7) Scheduling;

     (8) Telephone and in person screening limited to intake and gathering of information; or

     (9) Similar administrative tasks.

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NEW SECTION
WAC 246-827-0110   Delegation and supervision.   (1) The medical assistant functions in a dependent role when providing direct patient care under the delegation and supervision of a health care practitioner.

     (2) "Delegation" means direct authorization granted by a health care practitioner to a medical assistant to perform the functions authorized in RCW 18.360.050 which fall within the scope of practice of the health care practitioner and the training and experience of the medical assistant.

     (3) A medical assistant may only accept delegated tasks when:

     (a) The health care practitioner follows the requirements of RCW 18.360.060;

     (b) The task can be performed without requiring the exercise of judgment based on clinical knowledge;

     (c) The results of the task are reasonably predictable;

     (d) The task can be performed without a need for complex observations or critical decisions;

     (e) The task can be performed without repeated clinical assessments; and

     (f) The task, if performed improperly, would likely not present life-threatening consequences or the danger of immediate and serious harm to the patient.

     (4) A medical assistant may not accept delegation of acts that are not within his or her scope of practice.

     (5) A medical assistant is responsible and accountable for his or her practice based upon and limited to:

     (a) Scope of his or her education or training;

     (b) Scope of practice set forth in law and applicable sections of this chapter;

     (c) Demonstration of competency to the delegating health care practitioner;

     (d) Written documentation of competency as required by this rule and the health care employer's policies and procedures. The documentation will be maintained by the health care employer.

     (6) A medical assistant who has transitioned from a health care assistant credential as of July 1, 2013, may not accept delegated tasks unless he or she has received the necessary education or training to safely and competently perform the task.

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NEW SECTION
WAC 246-827-0120   General standards.   (1) The medical assistant shall have the ability to read, write, and converse in the English language.

     (2) The medical assistant shall have knowledge and understanding of the laws and rules regulating medical assistants, including chapter 18.130 RCW, Uniform Disciplinary Act.

     (3) The medical assistant shall function within his or her scope of practice.

     (4) The medical assistant shall obtain instruction from the delegating health care practitioner and demonstrate competency before performing new or unfamiliar duties which are in his or her scope of practice.

     (5) The medical assistant shall demonstrate a basic understanding of the patient's rights and responsibilities.

     (6) The medical assistant must respect the client's right to privacy by protecting confidential information and may not use confidential health care information for other than legitimate patient care purposes or as otherwise provided in chapter 70.02 RCW, the Uniform Health Care Information Act.

     (7) The medical assistant shall comply with all federal and state laws and regulations regarding patient rights and privacy.

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NEW SECTION
WAC 246-827-0130   U.S. armed forces equivalency.   An applicant with relevant military training or experience satisfies the training or experience requirements of this chapter unless the secretary determines that the military training or experience is not substantially equivalent to the standards of this state.

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MEDICAL ASSISTANT CREDENTIALS
NEW SECTION
WAC 246-827-0200   Medical assistant-certified -- Training and examination.   Certification requirements - Applicants 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 approved through the U.S. Department of Education, which includes a minimum of seven hundred twenty clock hours of training in medical assisting skills, including a clinical externship of no less than one hundred sixty hours;

     (c) A registered apprenticeship program administered by a department of the state of Washington 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; or

     (d) The secretary may approve an applicant who submits documentation that he or she completed postsecondary education with a minimum of seven hundred twenty 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 one hundred sixty hours.

     (2) Pass one of the following examinations within three years prior to submission of an initial application for this credential:

     (a) Certified medical assistant examination through the American Association of Medical Assistants (AAMA);

     (b) Registered medical assistant certification examination through the American Medical Technologists (AMT);

     (c) Clinical medical assistant certification examination through the National Healthcareer Association (NHA); or

     (d) National certified medical assistant examination through the National Center for Competency Testing (NCCT).

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NEW SECTION
WAC 246-827-0220   Medical assistant-certified -- Application -- Interim certification.   (1) Application requirements - Applicants for a medical assistant-certified credential shall submit the following:

     (a) Completed application on forms provided by the department;

     (b) Proof of completion of high school education or its equivalent;

     (c) Proof of successful completion of the required education or approved training program;

     (d) Proof of successful completion of an approved examination under WAC 246-827-0200(2), completed within three years prior to submission of an initial application for this credential;

     (e) Proof of completing seven clock hours of AIDS education as required by chapter 246-12 WAC, Part 8;

     (f) Any fee required in WAC 246-827-990; and

     (g) Fingerprint cards for national fingerprint based background check pursuant to RCW 18.130.064(2), if requested by the department.

     (2) An applicant who has met all the requirements in this subsection (2), except passage of the examination, may be issued an interim certification.

     (a) A person who has an interim certification possesses the full scope of practice of a medical assistant-certified.

     (b) A person who has an interim certification must notify their employer any time they fail any of the examinations listed in WAC 246-827-0200(2).

     (c) A person's interim certification expires upon issuance of the medical assistant-certified credential or one year after issuance of the interim certification, whichever occurs first.

     (d) A person cannot renew an interim certification.

     (e) A person is only eligible for an interim certification upon initial application.

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NEW SECTION
WAC 246-827-0230   Medical assistant-certified -- Activities allowed or prohibited.   A medical assistant-certified may perform functions authorized in RCW 18.360.050(1) under the delegation and supervision of a health care practitioner as described in WAC 246-827-0110. The delegation and direction must be for functions within the scope of the medical assistant-certified and the medical assistant-certified must be able to safely and competently perform the function.

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NEW SECTION
WAC 246-827-0240   Medical 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 authorized in this section. Drugs 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 administration shall not be delegated when:

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

     (b) Complex observations or critical decisions are required;

     (c) A patient is unable to physically ingest or safely apply a medication independently or with assistance; or

     (d) A patient is unable to indicate awareness that he or she is 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 schedule II controlled substances, chemotherapy agents or experimental drugs.

     (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 when authorized by the delegating health care practitioner. Drugs shall be administered only by unit or single dosage or by a dosage calculated and verified by a health care practitioner. A medical assistant-certified shall only administer drugs by 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 category, route and level of supervision:


Drug Category Routes Permitted Level of Supervision Required
Controlled substances, schedule III, IV, and V Oral, topical, rectal, otic, ophthalmic, or inhaled routes Immediate supervision
Subcutaneous, intradermal, intramuscular, or peripheral intravenous injections Direct visual supervision
Other legend drugs Intravenous injections Direct visual supervision
All other routes Immediate supervision

     (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.

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NEW SECTION
WAC 246-827-0300   Medical assistant-registered -- Application.   Registration requirements - Applicants for a medical assistant-registered credential shall submit the following:

     (1) A completed application on forms provided by the department;

     (2) Proof of completion of high school education or its equivalent;

     (3) An endorsement signed by a health care practitioner;

     (4) Proof of completing seven clock hours of AIDS education as required by chapter 246-12 WAC, Part 8;

     (5) Any fee required in WAC 246-827-990; and

     (6) Fingerprint cards for national fingerprint based background check pursuant to RCW 18.130.064(2), if requested by the department.

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NEW SECTION
WAC 246-827-0310   Medical assistant-registered -- Endorsement.   (1) A medical assistant-registered shall have a current attestation, signed by a health care practitioner, of his or her endorsement to perform specific tasks that is filed with the department.

     (2) The medical assistant-registered shall only perform the tasks listed in his or her current attestation of endorsement filed with the department.

     (3) An endorsement is valid as long as the medical assistant-registered is continuously employed by the same health care practitioner, clinic or group practice.

     (4) A medical assistant-registered shall submit a new attestation of endorsement to the department within thirty days if the tasks listed on the current attestation change.

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NEW SECTION
WAC 246-827-0320   Medical assistant-registered -- Credential termination.   The medical assistant-registered credential terminates when the medical assistant-registered separates employment with the endorsing health care practitioner, clinic or group practice. The medical assistant-registered shall notify the department within thirty days of separation of employment. A person shall submit a new initial medical assistant-registered application as described in WAC 246-827-0300 upon new or additional employment.

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NEW SECTION
WAC 246-827-0330   Medical assistant-registered -- Collection of specimens.   In order to collect a blood specimen, a medical assistant-registered may perform a finger or heel stick.

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NEW SECTION
WAC 246-827-0400   Medical assistant-phlebotomist -- Certification and training.   Certification requirements - Applicants for a medical assistant-phlebotomist credential must meet the following requirements:

     (1) Successful completion of an approved phlebotomy program through an accredited postsecondary school or college; or

     (2) Successful completion of a phlebotomy training program. The phlebotomy training program must be approved by a health care practitioner who is responsible for determining the content of the training and for ascertaining the proficiency of the trainee. The phlebotomy training program must include the following:

     (a) Training to include evaluation and assessment of knowledge and skills to determine entry level competency in the following areas:

     (i) Responsibilities to be delegated which include ethical implications and patient confidentiality;

     (ii) Patient identification process;

     (iii) Procedure requesting process, including forms used, accessing process, and collection patterns;

     (iv) Materials to be used;

     (v) Anatomic considerations for performing such functions as venipuncture, capillary finger collection, and heel sticks;

     (vi) Procedural standards and techniques for blood collection;

     (vii) Common terminology and practices such as medical classifications, standard diagnoses, test synonyms, background information on procedures, and interferences;

     (viii) Physical layout of the work place, including patient care areas; and

     (ix) Safety requirements including infection prevention and control, dealing with a client who has an infectious disease, and the handling and disposal of biohazardous materials.

     (b) Direct visual supervision by a health care practitioner or a delegated and certified medical assistant-phlebotomist to the trainee to ensure competency in the following:

     (i) Practice technique in a simulated situation;

     (ii) Observe and perform procedures on patients until the trainee demonstrates proficiency to be certified at the minimum entry level of competency. The trainee must have adequate physical ability, including sufficient manual dexterity to perform the requisite health care services. The number of specific procedures may vary with the skill of the trainee.

     (c) Documentation of all phlebotomy training, duties, and responsibilities of the trainee must be completed, signed by the supervising health care practitioner and the trainee, and placed in the trainee's personnel file.

     (d) A trainee must complete the training program and submit an application within ninety days of starting the phlebotomy training program to continue to perform procedures on patients.

     (e) Training programs that meet the requirements described in this subsection are approved by the secretary.

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NEW SECTION
WAC 246-827-0410   Medical assistant-phlebotomist -- Application.   Application requirements - Applicants for a medical assistant-phlebotomist credential shall submit the following:

     (1) A completed application on forms provided by the department;

     (2) Proof of completion of high school education or its equivalent;

     (3) Proof of successful completion of an accredited phlebotomy program or successful completion of a phlebotomy training program as attested by the phlebotomy training program's supervising health care practitioner;

     (4) Proof of completing seven clock hours of AIDS education as required by chapter 246-12 WAC, Part 8;

     (5) Any fee required in WAC 246-827-990; and

     (6) Fingerprint cards for national fingerprint based background check pursuant to RCW 18.130.064(2), if requested by the department.

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NEW SECTION
WAC 246-827-0420   Medical assistant-phlebotomist -- Supervision -- Requirements for performing arterial invasive procedures and line draws.   (1) The delegating health care practitioner does not need to be present when a medical assistant-phlebotomist is performing capillary or venous procedures to withdraw blood, but must be immediately available for consultation by phone or in person within a reasonable period of time.

     (2) A medical assistant-phlebotomist may only perform arterial invasive procedures or line draws after the following education and training is completed and documented. A medical assistant-phlebotomist's training and education must be documented on a checklist, signed by the delegating health care practitioner and the medical assistant-phlebotomist, and placed in the medical assistant-phlebotomist's personnel file. The medical assistant-phlebotomist shall complete:

     (a) Education to include anatomy, physiology, concepts of asepsis, and microbiology;

     (b) Training to perform arterial invasive procedures for blood withdrawal and line draws, including theory, potential risks, and complications;

     (c) Anatomic considerations for performing such functions as arterial puncture, line draws, and use of local anesthetic agents;

     (d) Observation of the arterial invasive procedure and line draws; and

     (e) Successful demonstration of the arterial invasive procedure and line draws under direct visual supervision of a health care practitioner.

     (3) Upon successful completion of the training described in subsection (2) of this section, a medical assistant-phlebotomist may only perform:

     (a) Arterial invasive procedures for blood withdrawal while under the immediate supervision of a supervising health care practitioner; and

     (b) Line draws if the intravenous fluid is stopped and restarted by a health care practitioner under the immediate supervision of a supervising health care practitioner.

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NEW SECTION
WAC 246-827-0500   Medical assistant-hemodialysis technician -- Qualifications and training.   (1) Applicants for a medical assistant-hemodialysis technician credential must complete the following requirements:

     (a) Proof of a high school diploma or equivalent;

     (b) Basic math skills including the use of fractions and decimal points;

     (c) Either:

     (i) Complete a hemodialysis training program as described in subsection (3) of this section; or

     (ii) Have a national credential as a hemodialysis technician which is substantially equivalent to the hemodialysis training program described in subsection (2) of this section.

     (2) The hemodialysis training program may be facility based or a state recognized training facility or institution of higher education specific to training hemodialysis technicians that meets the following requirements:

     (a) The training program must:

     (i) Be approved by the program or facility medical director and governing body;

     (ii) Be under the direction of a registered nurse;

     (iii) Be focused on the operation of kidney dialysis equipment and machines;

     (iv) Include interpersonal skills, including patient sensitivity training and care of difficult patients; and

     (v) Provide supervised clinical experience opportunities for the application of theory and for the achievement of stated objectives in a patient care setting. The training supervisor must be physically accessible to the hemodialysis technician when the hemodialysis technician is in the patient care area.

     (b) The training program must cover the following subjects:

     (i) Principles of dialysis and fluid management;

     (ii) Care of patients with kidney failure, including interpersonal skills;

     (iii) Dialysis procedures and documentation, including initiation, proper cannulation techniques, use of central catheters, monitoring, and termination of dialysis;

     (iv) Use and care of hemodialysis accesses;

     (v) Common laboratory testing procedures and critical alert values;

     (vi) Possible complications of dialysis and dialysis emergencies;

     (vii) Water treatment and dialysate preparation;

     (viii) Infection control;

     (ix) Use of hazardous chemicals;

     (x) Safety;

     (xi) Dialyzer reprocessing, if applicable; and

     (xii) Use of medications used in dialysis and their side effects.

     (c) The medical assistant-hemodialysis technician applicant, upon completion of the hemodialysis training program, must demonstrate competency of the following:

     (i) Dialysis procedures and documentation, including initiation, proper cannulation techniques, central catheter techniques, monitoring, and termination of dialysis;

     (ii) Operation of hemodialysis equipment;

     (iii) Calculation of patient fluid removal and replacement needs;

     (iv) Preparation and mixture of additives to hemodialysis concentrates as required by facility procedure based on patient prescription;

     (v) Preparation and administration of heparin and sodium chloride solutions and intradermal, subcutaneous, or topical administration of local anesthetics during treatment in standard hemodialysis doses;

     (vi) Provide initial response to patient complications and emergencies prior to, during, and after treatment per facility procedures including, but not limited to, the administration of normal saline per facility protocol;

     (vii) Use and care of hemodialysis vascular accesses;

     (viii) Administration of oxygen; and

     (ix) Initiation of cardiopulmonary resuscitation.

     (d) Technicians who perform monitoring and testing of the water treatment system must complete a training program that has been approved by the facility medical director and governing body.

     (e) The training program may accept documentation of a medical assistant-hemodialysis technician's successful completion of training objectives in another dialysis facility or accredited academic institution if it is substantially equivalent to the core competencies described in this subsection. The dialysis facility that accepts the documentation assumes responsibility for confirming the core competency of the medical assistant-hemodialysis technician.

     (f) Upon successful completion of the hemodialysis training program, an authorized representative of the hemodialysis training program will sign an attestation of completion of the training described in this subsection. The attestation shall include documentation of the satisfactory completion of a skills competency checklist equivalent to, or exceeding the competencies required by these rules.

     (g) Training programs that meet the requirements described in this subsection are approved by the secretary.

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NEW SECTION
WAC 246-827-0510   Medical assistant-hemodialysis technician -- Application.   Applicants for a medical assistant-hemodialysis technician credential shall submit the following:

     (1) A completed application on forms provided by the department;

     (2) Proof of high school education or equivalent;

     (3) Proof of successful completion of an approved training program or proof of national credential as a hemodialysis technician;

     (4) Proof of completing seven clock hours of AIDS education as required by chapter 246-12 WAC, Part 8;

     (5) Current cardiopulmonary resuscitation certification;     (6) Any fee required in WAC 246-827-990; and

     (7) Fingerprint cards for national fingerprint based background check pursuant to RCW 18.130.064(2), if requested by the department.

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NEW SECTION
WAC 246-827-0520   Conditions for performing hemodialysis.   (1) A medical assistant-hemodialysis technician trained by a federally approved end-stage renal disease facility may perform the following dialysis tasks:

     (a) Venipuncture for blood withdrawal;

     (b) Administration of oxygen as necessary by cannula or mask;

     (c) Venipuncture for placement of fistula needles;

     (d) Connection to vascular catheter for hemodialysis;

     (e) Intravenous administration of heparin and sodium chloride solutions as an integral part of dialysis treatment;

     (f) Intradermal, subcutaneous or topical administration of local anesthetics in conjunction with placement of fistula needles; and

     (g) Intraperitoneal administration of sterile electrolyte solutions and heparin for peritoneal dialysis.

     (2) A medical assistant-hemodialysis technician may perform the dialysis tasks described in subsection (1) of this section, under the following supervision:

     (a) In a renal dialysis center under immediate supervision of a registered nurse; or

     (b) In the patient's home if a physician and a registered nurse are available for consultation during the dialysis.

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CREDENTIAL STATUS
NEW SECTION
WAC 246-827-0600   Credential renewal.   A medical assistant credential must be renewed every two years on the medical assistant's birthday as provided in WAC 246-12-030.

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NEW SECTION
WAC 246-827-0610   Expired credential -- Return to active status.   (1) A person holding an expired medical assistant credential may not practice until the credential is returned to active status.

     (2) If the medical assistant credential has expired for less than three years, he or she shall meet the requirements of chapter 246-12 WAC, Part 2.

     (3) If the medical assistant credential has been expired for three years or more, and he or she is currently practicing as a medical assistant in another state or U.S. jurisdiction, he or she shall (a) meet the requirements of chapter 246-12 WAC, Part 2, and (b) provide verification of a current unrestricted active medical assistant credential in another state or U.S. jurisdiction which is substantially equivalent to the qualifications for his or her credential in the state of Washington.

     (4) If a medical assistant-certified, a medical assistant-hemodialysis technician, or a medical assistant-phlebotomist credential has been expired for three years or more and the person does not meet the requirements of subsection (3) of this section, he or she shall comply with chapter 246-12 WAC, Part 2, and demonstrate competence in one of the following ways:

     (a) A medical assistant-certified must successfully pass an examination as identified in WAC 246-827-0200 within six months prior to reapplying for the credential.

     (b) A medical assistant-phlebotomist must complete the training requirements of WAC 246-827-0400 within six months prior to reapplying for the credential.

     (c) A medical assistant-hemodialysis technician must complete the training requirements of WAC 246-827-0500 within six months prior to reapplying for the credential.

     (5) If the medical assistant-registered credential has expired, he or she must also submit a new application as provided for in WAC 246-827-0300.

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NEW SECTION
WAC 246-827-0620   Inactive status.   A medical assistant-certified, a medical assistant-hemodialysis technician, or a medical assistant-phlebotomist may obtain an inactive credential as described in chapter 246-12 WAC, Part 4.

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NEW SECTION
WAC 246-827-0630   Retired volunteer medical worker credential.   A medical assistant-certified, a medical assistant-hemodialysis technician, or a medical assistant-phlebotomist may obtain an initial retired volunteer medical worker credential as described in chapter 246-12 WAC, Part 12. To change a retired volunteer medical assistant credential to active status the person must follow the requirements of WAC 246-12-450.

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