Background:

I. Health Care Assistants.

A certified health care assistant is authorized to provide assistance to certain licensed health care practitioners, such as physicians, nurses, and naturopaths. A licensed health practitioner may delegate certain functions to the health care assistant such as administering skin tests, injections, and performing blood withdrawals.

Each health care assistant is certified by the facility in which they are employed, or by the practitioner who delegates functions to the health care assistant, pursuant to standards adopted by the Department of Health (DOH) in rule. The facility or practitioner must submit a roster of certified health care assistants to the DOH.

Health care assistants are divided into seven different categories based on differing educational, training, and experiential requirements. The different tasks each category of health care assistant may perform are as follows (all health care assistants may administer vaccines):

Category A: venous and capillary invasive procedures for blood withdrawal;
Category B: arterial invasive procedures for blood withdrawal;
Category C: intradermal, subcutaneous, and intramuscular injections for diagnostic agents and the administration of skin tests;
Category D: intravenous injections for diagnostic agents;
Category E: intradermal, subcutaneous, and intramuscular injections and the administration of skin tests;
Category F: intravenous injections for therapeutic agents; and
Category G: hemodialysis.

II. Medical Assistants.

Medical assistants are assistive personnel who provide administrative or clinical tasks under the supervision of other health care practitioners. Although a variety of national organizations certify medical assistants, they are currently not a credentialed health profession in Washington.

In 2011 the DOH completed a sunrise review of a proposal to credential medical assistants. In its report, the DOH supported credentialing medical assistants, but also made recommendations regarding clarifying the current health care assistant credential. The DOH made the following recommendations:

Blend the existing health care assistant categories with a medical assistant certification.
- Categories C and E would be replaced with a certified medical assistant credential.
- Categories A and B would be replaced with a certified phlebotomist credential.
- Category G would be replaced with a certified hemodialysis technician credential.
Remove the requirement that a credential holder obtain a new credential every time he or she leaves a facility or delegator.
Require the following qualifications for new applicants:
- Certified medical assistants must complete a medical assistant training program and pass an examination (both the program and the exam must be approved by the Secretary of Health).
- Certified phlebotomists must meet the same qualifications as category A and B health care assistants.
- Certified hemodialysis technicians must meet the same qualifications as category G health care assistants.
"Grandfather" current health care assistants in the following manner:
- Category C or E health care assistants would become medical assistants upon renewal and submission of a practice arrangement plan.
- Category A or B health care assistants would become phlebotomists upon renewal.
- Category G health care assistants would become hemodialysis technicians upon renewal.
- More research is necessary to determine what should be done with category D and F health care assistants.
Set parameters around medication administration for medical assistants.
Set parameters around office medical equipment usage for medical assistants.

Include criteria that identify the nature of the tasks a medical assistant can perform.

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Summary of Substitute Bill:

I. New Professions Created.

Four new professions are created: medical assistant-certified, medical assistant-registered, medical assistant-hemodialysis technician, and medical assistant-phlebotomist. No person may practice as one of the new professions unless he or she is appropriately certified or registered.

II. Qualifications for Certification/Registration.

A person meets the qualifications for certification as a medical assistant-certified if he or she satisfactorily completes a medical assistant training program approved by the Secretary of Health (Secretary), passes an examination approved by the Secretary, and meets any additional qualifications established by the Secretary in rule.

A person meets the qualifications for registration as a medical assistant-registered if he or she:

is endorsed by a health care practitioner, clinic, or group practice, that meets qualifications established by the Secretary; and
has a current attestation of his or her endorsement to perform specific medical tasks signed by a supervising health care practitioner filed with the DOH. A medical assistant-registered may only perform the medical tasks listed on the attestation.

A person meets the qualifications for certification as a medical assistant-hemodialysis technician if he or she meets qualifications adopted by the Secretary in rule. The qualifications must be equivalent to the current qualifications for hemodialysis technicians certified as health care assistants.

A person meets the qualifications for certification as a medical assistant-phlebotomist if he or she meets qualifications adopted by the Secretary in rule.

III. Scope of Practice.

A medical assistant-certified may perform the following tasks delegated by, and under the supervision of, a health care practitioner:

fundamental procedures: wrapping items for autoclaving, sterilization procedures, disposing of biohazardous materials, and practicing standard precautions;
clinical procedures: performing aseptic procedures, preparing of and assisting in sterile procedures, taking vital signs, preparing patients for examination, capillary blood withdrawal, venipuncture, and intradermal, subcutaneous, and intramuscular injection, and observing and reporting patients' signs or symptoms;
specimen collection: capillary puncture and venipuncture, obtaining specimens for microbiological testing, and instructing patients in the proper technique to collect urine and fecal specimens;
diagnostic testing: electrocardiography, respiratory testing, and tests waived under the federal Clinical Laboratory Improvement Amendments (CLIA) program (the DOH may update this list by rule based on changes to the CLIA program);
patient care: telephone and in-person screening limited to intake and gathering of information without requiring the exercise of judgment based on medical knowledge, obtaining vital signs, obtaining and recording patient history, preparing and maintaining examination and treatment areas, preparing patients for, and assisting with, examinations, procedures, treatments, and minor office surgeries, maintaining medication records, and screening and following up on test results; and
administering medications that are (1) administered only by unit or single dosage or by a dosage calculated by a health care practitioner, (2) administered pursuant to a written order, and (3) limited to legend drugs, vaccines (including combination vaccines), and schedule III-IV controlled substances as authorized by a health care practitioner under the scope of his or her license. The Secretary may, by rule, limit the drugs that may be administered by a medical assistant-certified based on risk, class, or route.

A medical assistant-registered may perform the same tasks as a medical assistant-certified, except a medical assistant-registered may notperform the following:

aseptic procedures;
blood withdrawal or injections;
diagnostic testing;
preparing patients for, and assisting with, routine and specialty examinations, procedures, treatments, and minor office surgeries; and
the administration of medications.

A medical assistant-hemodialysis technician may, under the delegation and supervision of a health care practitioner, perform hemodialysis and administer vaccines, drugs, and oxygen pursuant to rules adopted by the Secretary.

A medical assistant-phlebotomist may, under the delegation and supervision of a health care practitioner, perform capillary, venous, and arterial invasive procedures for blood withdrawal and administer vaccines pursuant to rules adopted by the Secretary.

The following health care practitioners are authorized to delegate to, and supervise, a medical assistant:

a physician or an osteopathic physician; and
acting within the scope of his or her license:
- a podiatric physician and surgeon;
- a registered nurse;
an advanced registered nurse practitioner;
a naturopath;
a physician assistant; and
an osteopathic physician assistant.

Prior to delegating a task to a medical assistant, a health care practitioner must determine:

that the task is within the scope of practice of the health care practitioner;
that the task is indicated for the patient;
the appropriate level of supervision;
that no law prohibits the delegation;
that the medical assistant is competent to perform the task;
that the task itself is one that should be appropriately delegated considering that:
- the task can be performed without the exercise of judgment based on medical knowledge;
- results of the task are reasonably predictable;
- the task can be performed without a need for complex observations or critical decisions;
- the task can be performed without repeated medical assessments; and
- the task, if performed improperly, would not result in life-threatening consequences or the danger of immediate and serious harm to the patient.

IV. Portability.

A medical assistant-certified, medical assistant-hemodialysis technician, or a medical assistant-phlebotomist credential is transferable among different practice settings. A medical assistant-registered credential is not transferable to other practice settings.

V. Exemptions.

The following persons are exempt from certification or registration as a medical assistant:

another health care practitioner acting within the scope of his or her license;
a person performing functions in the discharge of official duties on behalf of the federal government;
a person trained by a federally approved end-stage renal disease facility who performs end-stage renal dialysis in the home setting; and
a person participating in an externship as part of an approved medical assistant training program under the direct supervision of an on-site health care provider.

Any medical assistant may perform blood withdrawal procedures in the residences of research study participants when the procedures have been authorized by the institutional review board of a comprehensive cancer center or nonprofit degree-granting institution of higher education and are conducted under the general supervision of a physician.

VI. Health Care Assistants.

Certified health care assistants are converted to medical assistants upon renewal of their certifications in the following manner:

a category C, D, E, or F health care assistant will automatically become a medical assistant-certified;
a category G health care assistant will automatically become a medical assistant-hemodialysis technician; and
a category A or B health care assistant will automatically become a medical assistant-phlebotomist.

The health care assistant credential is eliminated effective July 1, 2016.

Until July 1, 2016, the DOH must consider medical assistants and health care assistants as one profession for purposes of calculating licensing fees.

Staff Summary of Public Testimony:

(In support) Medical assistants are a vital part of many medical practices—they can perform a variety of procedures that do not require medical judgment. Medical assistants are an important part of medical homes and specialty clinics. Medical assistants are one of the fastest growing professions in Washington. This bill will protect the public from sub-standard medical assistant services while increasing the availability of medical services (including primary care) without compromising quality. This bill will increase safety for Washington citizens. Medical assistants are recognized by a variety of national organizations and are becoming subject to more educational requirements. This legislation closely tracks the DOH's sunrise review. Medication administration is limited to situations that do not require clinical judgment. Another safeguard in this bill is that a delegator must be sure of the medical assistant's competency prior to delegation. Health care assistants should remain a separate profession, but they should be combined for purposes of setting fees. The scope of drugs authorized by this bill should be expanded to include certain schedule II controlled substances. The current medical assistant scope of practice has been in turmoil because of changing interpretations by the DOH—this bill does not expand this existing scope of practice. The medical assistant scope should evolve with technological changes.

(With concerns) Medical assistants, who are often confused with nurses, should be regulated, but in a manner more closely reflective of the DOH sunrise review. Delegation inflation is a concern. Medical assistants should not be able to administer medications or respiratory tests without more training.

(Opposed) There should be more education standards in this bill. The new credential should be portable. The scope of practice in this bill is broad and goes beyond low-risk tasks. The drugs that may be administered should be stated in the bill. The provisions of the bill authorizing standing orders may result in unsupervised practice by medical assistants. The difference between health care assistants and medical assistants should be clarified. This bill is confusing with respect to whether the medical assistants are registered or certified.