WSR 00-17-181

PROPOSED RULES

DEPARTMENT OF HEALTH


[ Filed August 23, 2000, 11:21 a.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 00-10-111.

Title of Rule: WAC 246-976-320 and 246-976-390, air ambulance standards.

Purpose: The proposed rule change will require all air ambulance services to be accredited by the Commission on Accreditation of Medical Transport Services (CAMTS), or another accrediting organization approved by the department as having equivalent requirements as CAMTS for aeromedical transport, before they are licensed and verified. A provisional license will be granted to those new services requesting licensure that are ineligible to apply for CAMTS accreditation based upon stated CAMTS requirements. The requirement will ensure public safety, meet patients' needs and assure conformity between Washington air ambulance standards and the current national standards.

Statutory Authority for Adoption: RCW 18.73.140.

Statute Being Implemented: RCW 18.73.140.

Summary: Per RCW 18.73.140 and WAC 246-976-320 and 246-976-390, the Office of Emergency Medical and Trauma Prevention (OEMTP) licenses and verifies all air ambulance services to provide trauma care in the state of Washington.

Reasons Supporting Proposal: The current standards do not meet the needs of ensuring adequate public safety standards. DOH staff does not have the technical expertise to conduct the evaluation of air ambulance services to meet nationally recognized public safety standards. Requiring accreditation of air ambulance services provides assurance that the service meets national public safety standards. The accreditation is done by professionals who are qualified to determine air ambulance safety. In addition, compliance with accreditation standards is done on a continual basis by the accrediting organization. Their accreditation standards are periodically revised to reflect the dynamic, changing environment of medical transport with considerable input from all disciplines of the medical profession.

Name of Agency Personnel Responsible for Drafting: Christopher Blake, 2725 Harrison Avenue N.W., Olympia, WA, (360) 705-6739; Implementation and Enforcement: Jack Cvitanovic, 2725 Harrison Avenue N.W., Olympia, WA, (360) 705-6712.

Name of Proponent: Department of Health, governmental.

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

Explanation of Rule, its Purpose, and Anticipated Effects: The proposed rule change will require all air ambulance services to be accredited by the Commission on Accreditation of Medical Transport Services (CAMTS), or another accrediting organization approved by the department as having equivalent requirements as CAMTS for aeromedical transport, before they are licensed and/or verified. The requirement will ensure public safety, meet patients' needs and assure conformity between Washington air ambulance standards and the current national standards.

Proposal Changes the Following Existing Rules: The proposed rule change will require all air ambulance services to be accredited by the Commission on Accreditation of Medical Transport Services (CAMTS), or another accrediting organization approved by the department as having equivalent requirements as CAMTS for aeromedical transport, before they are licensed and verified. A provisional license will be granted to those new services requesting licensure that are ineligible to apply for CAMTS accreditation based upon stated CAMTS requirements.

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

Small Business Economic Impact Statement

     Background: Under current regulations (RCW 18.73.140 and WAC 246-976-320 and 246-976–390), the Department of Health (DOH) licenses and verifies air ambulance services to provide EMS and trauma care in the state of Washington. The proposed rule change requires all air ambulance services to be accredited by the Commission on Accreditation of Medical Transport Services (CAMTS) before they can be licensed. A provisional license will be granted to those new services requesting licensure that are ineligible to apply for CAMTS accreditation based upon stated CAMTS requirements. The CAMTS requirement will ensure public safety, meet patient's needs and assure conformity between Washington air ambulance standards and the current national standards.

     The OEMTP uses negotiated rule making while developing all proposed rules and proposed rule changes. This is a process where representatives of the agency and interested parties affected by a possible rule, including city and county representatives, seek to reach a consensus on the terms of the proposed rule and on the process by which it will be negotiated. Numerous committees and public work sessions are used in the initial development and in all revisions of the rules. Several statutory and other EMS and Trauma Care Committees participate in the drafting and reviewing of the proposed rules and proposed rule changes. The committees specifically involved in these proposed rule changes include: The Steering Committee for EMS and Trauma, and the Licensing and Certification Committee. Members of the above listed committees represent such associations as the Washington State Fire Commissioners' Association, Washington Ambulance Association, Washington State Firefighters' Association, Washington State Hospital Association, American College of Surgeons, Emergency Nurses' Association, Law Enforcement of Washington, Association of Neurological Surgeons, Washington State Medical Association Standards Committee, the public sector and the citizens of Washington state.

     Rule-making Requirements of the Regulatory Fairness Act (Chapter 19.85 RCW): The Regulatory Fairness Act, RCW 19.85.030 requires the department to conduct a small business economic impact statement (SBEIS) for proposed rules that have more than minor impact on small businesses. The OEMTP conducted the following SBEIS to meet this requirement.

     Cost of Compliance: Currently nine air ambulance services are licensed in the state of Washington, three of which are CAMTS-accredited: Airlift Northwest, Northwest Medstar and Critical Air. One air ambulance service, Med-Flight, is currently in the process of becoming CAMTS-accredited. The department assumes that the proposed rule would impose no new costs on these four services. Of the remaining five air ambulance services, four provide only scheduled, nonemergency services. This leaves only one service that provides nonscheduled, emergency care, which is not currently accredited by CAMTS. The department estimated the cost for the five services to become accredited.

     CAMTS accreditation lasts for three years. The fee depends on factors specific to the applicant.1 These fees are paid directly to CAMTS, not the Department of Health. Full accreditation is granted for a three-year period of time. Reaccreditation costs the same as the initial accreditation with the exception that a service may receive a $1500 discount if the service remains relatively unchanged.

Number of transports in most recent year Total number of sites where aircraft or ground units are based
<350 $3500 1 site $1500
350 – 500 $4000 >1 sites $2500
501 – 750 $4500 Number of dedicated transport vehicles (more than 1 transport per month)
751 – 1000 $5000 1 $500
1001 – 1500 $5500 2-3 $750
>1500 $6000 4-5 $1000
>5 $2000

     Generally, preparation for a CAMTS accreditation inspection takes four to six months. CAMTS accredited services in Washington state have reported that assembling the application materials usually takes between twenty-four and forty-eight hours of staff time. The department assumed that the service director spends about eight hours with the clerical staff spending an additional twenty-four hours. Assuming a director's hourly wage rate of $38.202 and clerical staff of $17.50, the total cost of applying for CAMTS accreditation approximates $725. In addition, there is the cost associated with accompanying CAMTS inspectors. The site survey can last from one to two days depending on the size of the service. The service director will need to be present for the entire inspection, while the medical director, chief flight nurse and lead pilot will need to spend about one hour with the inspector. The department assumes costs for hourly wage rates of the medical director, chief flight nurse and lead pilot of $41.80, $32.00, and $31.79, respectively.2 The total cost to services resulting from CAMTS inspections (not including the inspection fee) is about $410.

     In addition, services face ongoing costs associated with quarterly committee meetings as required by CAMTS. The size of the committee will vary according to the size of the service, but must have representatives from all of the service's areas of discipline. The department's analysis considers a committee with members representing medical staff, pilot staff, and communications staff that meets once a quarter for three hours with an hour of preparation time. Using the hourly wages listed above of $32.00 for the chief flight nurse and $31.79 for the lead pilot, as well as $20.68 for a communications specialist, the department estimated the cost of conducting four meetings a year for all three committees at $4054.56.

     The department does not anticipate any additional equipment costs as a result of using CAMTS's standards. CAMTS assesses an ambulance service's ability to provide transportation to patients with consideration given to the service's mission statement and the scope of care that the service seeks to provide to the area. As long as the service's equipment is consistent with the type of service being provided, there should not be any additional equipment costs.

     The department estimated the following costs for the various services to become CAMTS accredited.


Aeronaut-ical Services, Inc. Airlift Northwest Air-Medical Services, Inc. Ballard Services, Inc. Critical Air Medicine Island Air Lifeline Ambulance, Inc. Med-

Flight

Northwest Medstar
# of Employees 54 65 32 20-30 10 5 10 30 56
# of Transports in Most Recent Year 15 (1998) 3841 82 2 223 12 115 350 2871
Total Number of Sites 2 4 1 1 1 1 1 1 2
Total # of Dedicated Transport Vehicles 2 6 1 1 1 2 1 1 5
Initial Application Fee $300 $300 $300 $300 $300 $300 $300 $300 $300
Fee For # Of Transports in Most Recent Year $3500 $6000 $3500 $3500 $3500 $3500 $3500 $4000 $6000
Fee For Total # Of Sites Where Aircraft Or Ground Units Are Based $2500 $2500 $1500 $1500 $1500 $1500 $1500 $1500 $2500
Fee For Total # Of Dedicated Transport Vehicles $750 $2000 $500 $500 $500 $750 $500 $500 $1000
Total Fees $7050 $10,800 $5800 $5800 $5800 $6050 $5800

    

$6300 $9800
Annualized Fees $2350 $3600 $1933 $1933 $1933 $2017 $1933 $2100 $3267
Annual Personnel Costs $4500 $4500 $4500 $4500 $4500 $4500 $4500 $4500 $4500
Total Annual Cost $6850 $8100 $6433 $6433 $6433 $6517 $6433 $6517 $7767
Cost Per Transport $457 $2 $78 $3217 $29 $543 $56 $18 $3

     Conclusion: As the chart above indicates the one unaccredited service with more than fifty employees, Aeronautical Services, Inc. has a cost per transport that falls in the middle of that for the four small unaccredited services. This clearly indicates that there is not a disproportionate impact between large and small businesses. Therefore, the department determined that mitigation for small businesses is not required by the Regulatory Fairness Act.

     The department firmly believes, after extensive review and analysis, that the CAMTS accrediting process most efficiently assures that proper safety standards and patient needs are met and in addition, it provides conformity between Washington standards and current national standards.


1 Listed fees to become CAMTS accredited were obtained from the CAMTS Web site, accessed April 2000. Available at http://www.camts.org.

2 Hourly wage rates were drawn from Rau, W., "1999 Medical Crew Survey," AirMed, Sept-Oct, 1999, 27-33 and Rau, W., "1999 Air Crew Survey," AirMed, Sep-Oct, 1999, 27-33. The reported wage figures were inflated by 25% to account for nonwage benefits. Also, the "flight physician" wage was used as a proxy for the medical director and communications staff information was obtained through the Washington State Employment Security Department.

A copy of the statement may be obtained by writing to Tami Schweppe, DOH, EMS and Trauma, P.O. Box 47853, Olympia, WA 98504-7853.

RCW 34.05.328 applies to this rule adoption. This proposed rule is a significant legislative rule because it establishes, alters or revokes any qualification or standard for the issuance suspension or revocation of a license or permit.

Hearing Location: Highline Schools Administration Building, 15675 Ambaum Boulevard S.W., Burien, WA, on Thursday, September 28, 2000, at 9:00 a.m.

Assistance for Persons with Disabilities: Contact Tami Schweppe by September 20, 2000, TDD (800) 833-6388, or (360) 705-6748.

Submit Written Comments to: Janet Griffith, Director, P.O. Box 47853, Olympia, WA 98504-7853, fax (360) 705-6706, by September 20, 2000.

Date of Intended Adoption: October 24, 2000.

August 14, 2000

M. C. Selecky

OTS-4122.3


AMENDATORY SECTION(Amending WSR 00-08-102, filed 4/5/00, effective 5/6/00)

WAC 246-976-320
Air ambulance services.

(1) Air ambulance services must:

     (a) Comply with all regulations in this chapter pertaining to ambulance services and vehicles, except that WAC 246-976-290 and 246-976-300 are replaced for air ambulance services by subsection (((2))) (4)(b) and (c) of this section;

     (b) Comply with the standards in this section for all types of transports, including inter-facility and prehospital transports;

     (c) Be in current compliance with all state and Federal Aviation Administration statutes and regulations that apply to air carriers, including, but not limited to, those regulations that apply to certification requirements, operations, equipment, crew members, and maintenance, and any specific regulations that apply to air ambulance services;

     (d) Air ambulance services must provide a physician director who is practicing medicine in the response area of the aircraft, as identified in the state EMS/TC plan.

     (2) Air ambulance services currently licensed or seeking relicensure after July 31, 2001, must have and maintain accreditation by the Commission on Accreditation of Medical Transport Services or another accrediting organization approved by the department as having equivalent requirements as CAMTS for aeromedical transport. Until August 1, 2001, subsections (4), (5), and (6) of this section apply to air ambulance services currently licensed or seeking relicensure.

     (3) Air ambulance services requesting initial licensure that are ineligible to attain accreditation because they lack a history of operation at the site, must meet the criteria of subsections (4), (5), and (6) of this section and within four months of licensure must have completed an initial consultation with CAMTS or another accrediting organization approved by the department as having equivalent requirements as CAMTS for aeromedical transport. A provisional license will be granted for no longer than two years at which time the service must provide documentation that it is accredited by CAMTS or another accrediting organization approved by the department as having equivalent requirements as CAMTS for aeromedical transport.

     (4) Air ambulance services must provide:

     (a) A physician director who is:

     (i) Practicing medicine in the response area of the aircraft, as identified in the state EMS/TC plan;

     (ii) Trained and experienced in emergency, trauma, and critical care;

     (iii) Knowledgeable of the operation of air medical services; and

     (iv) Responsible for supervising and evaluating the quality of patient care provided by the air medical flight personnel;

     (b) Sufficient air medical personnel on each response to provide adequate patient care, specific to the mission, including:

     (i) One specially trained, experienced registered nurse or paramedic; and

     (ii) One other person who must be a physician, nurse, physician's assistant, respiratory therapist, paramedic, EMT, or other appropriate specialist appointed by the physician director.      If an air ambulance responds directly to the scene of an incident, at least one of the air medical personnel must be trained in prehospital emergency care;

     (c) Aircraft that, when operated as air ambulances:

     (i) Are configured so that the medical attendants can access the patient to begin and maintain advanced life support and other treatment;

     (ii) Allow loading and unloading the patient without excessive maneuvering or tilting of the stretcher;

     (iii) Have appropriate communication equipment to insure internal crew and air-to-ground exchange of information between flight personnel and hospitals, medical control, the flight operations center, and air traffic control facilities;

     (iv) Are equipped with:

     (A) Appropriate navigational aids;

     (B) Airway management equipment, including:

     (I) Oxygen;

     (II) Suction;

     (III) Ventilation and intubation equipment, adult and pediatric;

     (C) Cardiac monitor/defibrillator;

     (D) Supplies, equipment, and medication as required by the program physician director, for emergency, cardiac, trauma, pediatric care, and other missions; and

     (E) The ability to maintain appropriate patient temperature; and

     (v) Have adequate interior lighting for patient care arranged so as not to interfere with the pilot's vision;

     (d) If using fixed-wing aircraft, pressurized, multi-engine aircraft when appropriate to the mission;

     (e) If using helicopter aircraft:

     (i) A protective barrier sufficiently isolating the cockpit, to minimize in-flight distraction or interference;

     (ii) Appropriate communication equipment to communicate with ground EMS/TC services and public safety vehicles, in addition to the communication equipment specified in (c)(iii) of this subsection.

     (((3))) (5) All air medical personnel must:

     (a) Be certified in ACLS;

     (b) Be trained in:

     (i) Emergency, trauma, and critical care;

     (ii) Altitude physiology;

     (iii) EMS communications;

     (iv) Aircraft and flight safety; and

     (v) The use of all patient care equipment on board the aircraft;

     (c) Be familiar with survival techniques appropriate to the terrain;

     (d) Perform under protocols.

     (((4))) (6) Exceptions:

     (a) If aeromedical evacuation of a patient is necessary because of a life threatening condition and a licensed air ambulance is not available, the nearest available aircraft that can accommodate the patient may transport.      The physician ordering the transport must justify the need for air transport of the patient in writing to the department within thirty days after the incident.

     (b) Excluded from licensure requirements those services operating aircraft for primary purposes other than civilian air medical transport, but which may be called into service to initiate an emergency air medical transport of a patient to the nearest available treatment facility or rendezvous point with other means of transportation.      Examples are: United States Army Military Assistance to Safety and Traffic, United States Navy, United States Coast Guard, Search and Rescue, and the United States Department of Transportation.

[Statutory Authority: Chapters 18.71, 18.73, and 70.168 RCW.      00-08-102, § 246-976-320, filed 4/5/00, effective 5/6/00.      Statutory Authority: RCW 43.70.040 and chapters 18.71, 18.73 and 70.168 RCW.      93-01-148 (Order 323), § 246-976-320, filed 12/23/92, effective 1/23/93.]


AMENDATORY SECTION(Amending WSR 00-08-102, filed 4/5/00, effective 5/6/00)

WAC 246-976-390
Verification of trauma care services.

(1) The department will:

     (a) Publish procedures for verification.      Verification will expire with the period of licensure.      The application for verification will be incorporated in the application for licensure;

     (b) Verify prehospital trauma care services in the following categories:

     (i) Aid service: Basic, intermediate and advanced (paramedic) life support;

     (ii) Ground ambulance service: Basic, intermediate and advanced (paramedic) life support;

     (iii) Air ambulance service: After July 31, 2001, the department will consider that an air ambulance service has met the requirements of subsections (4), (6), and (9) of this section if it has been accredited by CAMTS or another accrediting organization approved by the department as having equivalent requirements as CAMTS for aeromedical transport;

     (c) Review the minimum response times for verified prehospital trauma services at least biennially, considering data available from the trauma registry and with the advice of the steering committee;

     (d) Forward applications for verification for aid and ground ambulance services to the appropriate regional council for review and comment;

     (e) Approve an applicant to provide verified prehospital trauma care, based on satisfactory evaluations as described in this section;

     (f) Notify the regional council and the MPD in writing of the name, location, and level of verified services;

     (g) Renew approval of a verified service upon reapplication, if the service continues to meet standards established in this chapter and verification remains consistent with the regional plan.

     (2) The department will identify minimum and maximum numbers of prehospital services, based on the approved regional and state plans.      The department will:

     (a) Establish and review biennially the minimum and maximum number of prehospital services based upon distribution and level of service identified for each response area in the approved regional plan.

     (b) Evaluate an applicant for trauma verification based upon demonstrated ability of the provider to meet standards defined in this section 24-hours every day.

     (c) Verify the trauma capabilities of a licensed prehospital service if it determines that the applicant:

     (i) Proposes services that are identified in the regional plan for ground services, or the state plan for air ambulance services, in the proposed response areas.

     (ii) Agrees to operate under approved regional patient care procedures and prehospital patient care protocols.

     (3) Regional council responsibilities regarding verification are described in WAC 246-976-960.

     (4) To apply for verification, a licensed ambulance or aid service must submit application on forms provided by the department, including:

     (a) Documentation required for licensure specified by WAC 246-976-260(2);

     (b) A policy that a trauma training program is required for all personnel responding to trauma incidents.      The program must meet learning objectives established by the department and be approved by the MPD;

     (c) Documentation that the provider has the ability twenty-four hours every day to deliver personnel and equipment required for verification to the scene of a trauma within the agency response times identified in this section; and

     (d) Documentation that the provider will participate in an approved regional quality assurance program.

     (5) Verified aid services must provide personnel on each trauma response including:

     (a) Basic life support: At least one individual, first responder or above;

     (b) Intermediate life support:

     (i) At least one ILS technician; or

     (ii) At least one IV/airway technician; or

     (iii) At least two individuals, one IV technician and one airway technician.

     (c) Advanced life support - Paramedic: At least one paramedic.

     (6) Verified ambulance services must provide personnel on each trauma response including:

     (a) Basic life support: At least two certified individuals -- one EMT plus one first responder;

     (b) Intermediate life support:

     (i) One ILS technician, plus one EMT; or

     (ii) One IV/airway technician, plus one EMT; or

     (iii) One IV technician and one airway technician;

     (c) Advanced life support - Paramedic: At least two certified individuals -- one paramedic and one EMT.

     (7) Verified BLS vehicles must carry equipment identified in WAC 246-976-300, Table C.

     (8) Verified ILS and paramedic vehicles must provide equipment identified in Table D, in addition to meeting the requirements of WAC 246-976-300:

TABLE D: EQUIPMENT FOR VERIFIED TRAUMA SERVICES

(NOTE: "ASST" MEANS ASSORTMENTS)

AMBULANCE AID VEHICLE
PAR ILS PAR ILS
AIRWAY MANAGEMENT
Airway Adjuncts
Adjunctive airways, per protocol 1 1 1 1
Laryngoscope handle, spare batteries 1 1 1 1
Adult blades, set 1 1 1 1
Pediatric blades, straight (0,1,2) 1ea 1ea 1ea 1ea
Pediatric blades, curved (2) 1ea 1ea 1ea 1ea
McGill forceps, adult & pediatric 1 1 1 1
ET tubes, adult (±1/2 mm) 1ea 1ea 1ea 1ea
ET tubes, pediatric, with stylet
Uncuffed (2.5 - 5.0 mm) 1ea 1ea 1ea 1ea
Cuffed or uncuffed (6.0 mm) 1ea 1ea 1ea 1ea
End-tidal CO2 detector 1ea 1ea 1ea 1ea
Oxygen saturation monitor 1ea 1ea 1ea 1ea
Suction
Portable, powered 1 1 1 1
PATIENT ASSESSMENT AND CARE
Sphygmomanometer
Adult, large 1 1 1 1
Pediatric 1 1 1 1
TRAUMA EMERGENCIES
IV access
Administration sets
Adult 1 1 1 1
Pediatric, w/volume control 4 4 2 2
Catheters, intravenous (14-24 ga) asst asst asst asst
Needles
Hypodermic asst asst asst asst
Intraosseous, per protocol 2 2 1 1
Sharps container 1 1 1 1
Syringes asst asst asst asst
Glucose measuring supplies Yes Yes Yes Yes
Pressure infusion device 1 1 1 1
Medications according to local patient care protocols

     (9) Verified air ambulance services must meet equipment requirements described in WAC 246-976-320.

     (10) Verified aid services must meet the following minimum agency response times for all major trauma responses to response areas as defined by the department and identified in the regional plan:

     (a) To urban response areas: Eight minutes or less, eighty percent of the time;

     (b) To suburban response areas: Fifteen minutes or less, eighty percent of the time;

     (c) To rural response areas: Forty-five minutes or less, eighty percent of the time;

     (d) To wilderness response areas: As soon as possible.

     (11) Verified ground ambulance services must meet the following minimum agency response times for all major trauma responses to response areas as defined by the department and identified in the regional plan:

     (a) To urban response areas: Ten minutes or less, eighty percent of the time;

     (b) To suburban response areas: Twenty minutes or less, eighty percent of the time;

     (c) To rural response areas: Forty-five minutes or less, eighty percent of the time;

     (d) To wilderness response areas: As soon as possible.

     (12) Verified air ambulance services must meet minimum agency response times as identified in the state plan.

[Statutory Authority: Chapters 18.71, 18.73, and 70.168 RCW.      00-08-102, § 246-976-390, filed 4/5/00, effective 5/6/00.      Statutory Authority: RCW 43.70.040 and chapters 18.71, 18.73 and 70.168 RCW.      93-01-148 (Order 323), § 246-976-390, filed 12/23/92, effective 1/23/93.]

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