WSR 12-01-072

PROPOSED RULES

DEPARTMENT OF HEALTH


[ Filed December 19, 2011, 12:24 p.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 10-19-035.

Title of Rule and Other Identifying Information: Chapter 246-926 WAC, amending and adding new sections for licensure requirements for cardiovascular invasive specialists.

Hearing Location(s): Department of Health, Room 152/153, 310 Israel Road S.E., Tumwater, WA 98501, on January 31, 2012, at 10:00 a.m.

Date of Intended Adoption: February 14, 2012.

Submit Written Comments to: Susan Gragg, Department of Health, P.O. Box 47852, Olympia, WA 98504-7852, web site http://www3.doh.wa.gov/policyreview/, fax (360) 236-2901, by January 31, 2012.

Assistance for Persons with Disabilities: Contact Susan Gragg by January 23, 2012, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The department of health is proposing rules to implement the new cardiovascular invasive specialist profession created by SHB 2430 (chapter 92, Laws of 2010), now codified in chapter 18.84 RCW. The proposed rules will establish enforceable standards of practice, education and examination requirements, and licensing fees.

Reasons Supporting Proposal: The proposed rules will protect patients by setting the practice standards for the cardiovascular invasive specialist profession and licensing appropriately educated and trained individuals.

Statutory Authority for Adoption: RCW 18.84.040, 43.70.250, SHB 2430 (2010).

Statute Being Implemented: Chapter 18.84 RCW, SHB 2430 (2010).

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: Susan Gragg, Program Manager, P.O. Box 47852, Olympia, WA 98504-7852, (360) 236-4941.

No small business economic impact statement has been prepared under chapter 19.85 RCW. The proposed rule would not impose more than minor costs on businesses in an industry.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Susan Gragg, Program Manager, P.O. Box 47852, Olympia, WA 98504-7852, phone (360) 236-4941, fax (360) 236-2901, e-mail susan.gragg@doh.wa.gov.

December 15, 2011

Mary C. Selecky

Secretary

OTS-4476.3


AMENDATORY SECTION(Amending WSR 10-10-043, filed 4/27/10, effective 5/28/10)

WAC 246-926-020   Definitions.   The definitions in this section apply throughout this chapter unless the context clearly requires otherwise.

(1) "ARRT" means the American Registry of Radiologic Technologists.

(2) "Cardiovascular invasive specialist" means a person certified under chapter 18.84 RCW to assist in cardiac or vascular catheterization procedures.

(3) "Department" means the department of health.

(((3))) (4) "Direct supervision" means the appropriate licensed practitioner is on the premises and is quickly and easily available.

(a) For a diagnostic, therapeutic, or nuclear medicine radiologic technologist, the appropriate licensed practitioner is a physician licensed under chapter 18.71 or 18.57 RCW.

(b) For a radiologist assistant, the appropriate licensed practitioner is a radiologist.

(((4))) (5) "General supervision" for a radiologist assistant means the procedure is furnished under the supervising radiologist's overall direction and control. The supervising radiologist must be on-call or be available for consultation.

(((5))) (6) "Hospital" means any health care institution licensed pursuant to chapter 70.41 RCW.

(((6))) (7) "Nursing home" means any health care institution which comes under chapter 18.51 RCW.

(((7))) (8) "Personal supervision" ((for a radiologist assistant)) means the supervising ((radiologist)) physician must be in the room during the performance of the procedure.

(((8))) (a) For a cardiovascular invasive specialist, the supervising physician is a physician licensed under chapter 18.71 or 18.57 RCW.

(b) For a radiologist assistant, the supervising physician is a radiologist.

(9) "Radiological technologist" means a person certified under chapter 18.84 RCW.

(((9))) (10) "Radiologist" means a licensed physician licensed under chapter 18.71 or 18.57 RCW and certified by the American Board of Radiology or the American Osteopathic Board of Radiology.

(((10))) (11) "Radiologist assistant" means an advanced-level diagnostic radiologic technologist certified under chapter 18.84 RCW.

(((11))) (12) "Registered X-ray technician" means a person who is registered with the department, and who applies ionizing radiation at the direction of a licensed practitioner.

(((12))) (13) "Unprofessional conduct" as used in this chapter means the conduct described in RCW 18.130.180.

[Statutory Authority: RCW 18.84.040. 10-10-043, 246-926-020, filed 4/27/10, effective 5/28/10; 06-01-104, 246-926-020, filed 12/21/05, effective 1/21/06. Statutory Authority: RCW 18.84.040 and 18.130.070. 92-05-010 (Order 237), 246-926-020, filed 2/7/92, effective 2/19/92. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as 246-926-020, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 18.130.070. 89-14-092 (Order PM 842), 308-183-010, filed 6/30/89.]


AMENDATORY SECTION(Amending WSR 10-10-043, filed 4/27/10, effective 5/28/10)

WAC 246-926-180   Parenteral procedures for a diagnostic or therapeutic radiologic technologist((s)), or a cardiovascular invasive specialist.   (1) A certified diagnostic or therapeutic radiologic technologist may administer diagnostic and therapeutic agents under the direct supervision of a physician licensed under chapter 18.71 or 18.57 RCW. Diagnostic and therapeutic agents may be administered via intravenous, intramuscular, or subcutaneous injection. In addition to direct supervision, before the radiologic technologist may administer diagnostic and therapeutic agents, the following guidelines must be met:

(a) The radiologic technologist has had the prerequisite training and thorough knowledge of the particular procedure to be performed;

(b) Appropriate facilities are available for coping with any complication of the procedure as well as for emergency treatment of severe reactions to the diagnostic or therapeutic agent itself, including readily available appropriate resuscitative drugs, equipment, and personnel; and

(c) After parenteral administration of a diagnostic or therapeutic agent, competent personnel and emergency facilities must be available to the patient for at least thirty minutes in case of a delayed reaction.

(2) A cardiovascular invasive specialist may administer diagnostic and therapeutic agents during cardiac or vascular catheterization procedures under the personal supervision of a physician licensed under chapter 18.71 or 18.57 RCW. Parenteral administration includes, but is not limited to, procedures involving arteries and veins.

(3) A certified radiologic technologist or cardiovascular invasive specialist may perform venipuncture under the direct supervision of a physician licensed under chapter 18.71 or 18.57 RCW.

[Statutory Authority: RCW 18.84.040. 10-10-043, 246-926-180, filed 4/27/10, effective 5/28/10; 06-01-104, 246-926-180, filed 12/21/05, effective 1/21/06. Statutory Authority: RCW 43.70.040. 92-19-060 (Order 302), 246-926-180, filed 9/11/92, effective 10/12/92; 91-02-049 (Order 121), recodified as 246-926-180, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 18.84.040. 89-01-015 (Order PM 802), 308-183-170, filed 12/9/88.]


NEW SECTION
WAC 246-926-400   Cardiovascular invasive specialist scope of practice.   (1) A cardiovascular invasive specialist assists in cardiac or vascular catheterization procedures in the role of either:

(a) A monitoring technologist, who documents every action during a catheterization procedure and monitors the patient's status, reporting any irregularities to the surgical team;

(b) A circulating technologist, who provides assistance to the surgical team from outside the sterile field; or

(c) A sterile/scrub technologist, who directly assists the physician during the catheterization procedure.

Except as provided in subsection (8) of this section, no cardiovascular invasive specialist shall perform the tasks of more than one role during any individual procedure. All intraprocedure tasks in any role must be performed under personal supervision.

(2) The preprocedure tasks a cardiovascular invasive specialist may perform in any role include:

(a) Prepare sterile table and necessary supplies;

(b) Verify patient identification;

(c) Verify or facilitate patient consent;

(d) Verify history and physical information to include:

(i) Chief complaint;

(ii) History of present illness;

(iii) Current medications;

(iv) Laboratory results;

(v) Test reports, as necessary, such as X rays and/or electrocardiograms (ECG);

(vi) Past medical history;

(vii) Family and social history; and

(e) Obtain blood samples as allowed under WAC 246-926-180(3).

(3) The intraprocedure and post-procedure tasks a cardiovascular invasive specialist may perform in the role of a monitoring technologist include:

(a) Operate physiologic monitoring and recording equipment;

(b) Capture and input data for procedural calculations;

(c) Monitor, identify, measure, and record information from electrocardiograms (ECG), intracardiac electrograms, and pressure waveforms;

(d) Document each step and action during a procedure; and

(e) Inform the physician and team members of noted abnormalities.

(4) The intraprocedure tasks a cardiovascular invasive specialist may perform in the role of a sterile/scrub technologist include:

(a) Administer local anesthetic as allowed under WAC 246-926-180;

(b) Gain arterial/venous access;

(c) Insert and flush vascular sheath;

(d) Assist with insertion and manipulation of guidewires, catheters, and pacing leads;

(e) Assist with implantation of leads and devices for implantable devices, such as pacemakers or implantable cardioverter-defibrillators (ICDs);

(f) Close implantable device pockets;

(g) Assist in ablation of intracardiac lesions;

(h) Assist with performing intracardiac mapping;

(i) Assist with performing intracardiac lead extraction;

(j) Assist with obtaining invasive hemodynamic data, cardiac outputs, and blood samples;

(k) Inject contrast as allowed under WAC 246-926-180 for visualizing cardiovascular anatomical structures either manually or with the aid of a mechanical contrast device;

(l) Administer medications related to cardiac or vascular catheterization as directed by the physician;

(m) Assist with obtaining tissue samples for biopsy; and

(n) Operate intravascular ultrasound/intracardiac echocardiography (IVUS/ICE), fluoroscopy, and other imaging modalities.

(5) The intraprocedure tasks a cardiovascular invasive specialist may perform in the role of a circulating technologist include:

(a) Maintain sterile field and equipment supply;

(b) Set-up and operate ancillary equipment to include:

(i) Contrast injectors;

(ii) IVUS/ICE;

(iii) Fractional flow reserve/coronary flow reserve (FFR/CFR);

(iv) Atherectomy/thrombectomy devices and consoles;

(v) Intra-aortic balloon pump;

(vi) Percutaneous ventricular assist devices;

(vii) Pacemakers, automated implantable cardioverter defibrillators (AICD), and temporary pacemakers;

(viii) Pacemaker and AICD programmers;

(ix) Ablation devices;

(x) Intracardiac mapping devices;

(xi) Lead extraction devices;

(xii) Electrophysiologic stimulators;

(xiii) Other diagnostic, interventional, and mechanical support devices;

(xiv) Activated coagulation time (ACT) and other coagulation studies;

(xv) Whole blood oximetry; and

(xvi) Arterial blood gas (ABG).

(6) The post-procedure access site tasks a cardiovascular invasive specialist may perform in the role of either circulating technologist or sterile/scrub technologist include the following:

(a) Manually remove vascular sheath/catheter;

(b) Secure retained sheath/catheter;

(c) Use compression devices;

(d) Use vascular closure devices; and

(e) Instruct patient on care of site.

(7) The post-procedure patient care tasks a cardiovascular invasive specialist may perform in any role include the following:

(a) Monitor and assess patient ECG, vital signs, and level of consciousness;

(b) Identify, monitor, and compress rebleeds and/or hematomas;

(c) Assess distal pulses; and

(d) Document patient chart as appropriate.

(8) On an individual case basis and at the sole discretion of the physician, a cardiovascular invasive specialist may assume the dual role of monitoring and circulating technologist during an individual procedure. Such dual role approval shall be documented in the patient chart.

(9) Nothing in this chapter shall be interpreted to alter the scope of practice of any other credentialed health profession or to limit the ability of any other credentialed health professional to assist in cardiac or vascular catheterization if such assistance is within the profession's scope of practice.

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NEW SECTION
WAC 246-926-410   Requirements for cardiovascular invasive specialist certification.   (1) Applicants for certification as a cardiovascular invasive specialist must meet the following requirements:

(a) Graduate from an educational program accredited by the Commission on Accreditation of Allied Health Education Programs (CAAHEP) utilizing the standards and criteria established by the Joint Review Committee on Education in Cardiovascular Technology (JRC-CVT); and

(b) Obtain a passing score on the national Registered Cardiovascular Invasive Specialist (RCIS) examination administered by Cardiovascular Credentialing International (CCI).

(2) Individuals who have been certified or registered with one of the following national organizations shall be considered to have met the education and training requirements:

(a) CCI through the RCIS examination;

(b) CCI through the Registered Cardiac Electrophysiology Specialist (RCES) examination;

(c) Heart Rhythm Society (HRS) through the North American Society of Pacing and Electrophysiology (NASPE) examination; or

(d) ARRT through the Cardiac Interventional Radiographer (RTR-CI) post-primary examination, the Vascular Interventional Radiographer (RTR-VI) post-primary examination, or the Cardiovascular Interventional Radiographer (RTR-CV) post-primary examination.

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NEW SECTION
WAC 246-926-420   Alternate certification process -- Time limited.   Until July 1, 2012, the department shall issue a cardiovascular invasive specialist certification to applicants who meet the following requirements:

(1) Hold a current health care credential issued by the department that has been in good standing for at least the last five consecutive years; and

(2) Document qualifying prior experience. Such qualifying experience must:

(a) Be in cardiac or vascular catheterization functions as defined in WAC 246-926-400;

(b) Have been obtained in the last five years;

(c) Include at least one thousand hours per year; and

(d) Be documented on forms prepared by the department and attested to by the catheterization laboratory lead technologist, manager, or director.

(3) If an individual certified through this section allows his or her certification to expire for more than one year, he or she must then meet the education and examination requirements under WAC 246-926-410 before being issued a new certification.

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AMENDATORY SECTION(Amending WSR 10-19-071, filed 9/16/10, effective 10/15/10)

WAC 246-926-990   Radiologist assistants; diagnostic, therapeutic, and nuclear medicine radiologic technologists; cardiovascular invasive specialists; X-ray technicians -- Certification and registration fees and renewal cycle.   (1) Certificates and registrations must be renewed every two years on the practitioner's birthday as provided in chapter 246-12 WAC, Part 2.


Title of Fee Fee
(2) The following nonrefundable fees will be charged for certified diagnostic, therapeutic, and nuclear medicine radiologic technologists:
Application $150.00
Renewal 105.00
Late renewal penalty 50.00
Expired certificate reissuance 80.00
Certification of registration or certificate 15.00
Duplicate registration or certificate 15.00
(3) The following nonrefundable fees will be charged for registered X-ray technicians:
Application 105.00
Renewal 103.00
Late renewal penalty 50.00
Expired reissuance 50.00
Certification of registration or certificate 15.00
Duplicate registration or certificate 15.00
(4) The following nonrefundable fees will be charged for certified radiologist assistants:
Application 150.00
Renewal 150.00
Late renewal penalty 75.00
Expired reissuance 75.00
Certification of registration or certificate 15.00
Duplicate registration or certificate 15.00
(5) The following nonrefundable fees will be charged for cardiovascular invasive specialists:
Application 150.00
Renewal 105.00
Late renewal penalty 75.00
Expired reissuance 75.00
Certification of registration or certificate 30.00
Duplicate registration or certificate 30.00

[Statutory Authority: RCW 43.70.110, 43.70.250, and 2010 c 37. 10-19-071, 246-926-990, filed 9/16/10, effective 10/15/10. Statutory Authority: RCW 18.84.040. 10-10-043, 246-926-990, filed 4/27/10, effective 5/28/10. Statutory Authority: RCW 43.70.110, 43.70.250 and 2008 c 329. 08-16-008, 246-926-990, filed 7/24/08, effective 7/25/08. Statutory Authority: RCW 18.84.040. 06-01-104, 246-926-990, filed 12/21/05, effective 1/21/06. Statutory Authority: RCW 43.70.250, [43.70.]280 and 43.70.110. 05-12-012, 246-926-990, filed 5/20/05, effective 7/1/05. Statutory Authority: RCW 43.70.250. 99-08-101, 246-926-990, filed 4/6/99, effective 7/1/99. Statutory Authority: RCW 43.70.280. 98-05-060, 246-926-990, filed 2/13/98, effective 3/16/98. Statutory Authority: RCW 18.84.040 and 18.84.100. 92-05-010 (Order 237), 246-926-990, filed 2/7/92, effective 2/19/92. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as 246-926-990, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 18.84.040. 89-01-015 (Order PM 802), 308-183-180, filed 12/9/88.]

Washington State Code Reviser's Office