DAR File No. 43258

Health, Family Health and Preparedness, Emergency Medical Services

Rule R426-4

Operations

Notice of Proposed Rule

(Amendment)

DAR File No.: 43258
Filed: 10/15/2018 09:30:32 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

These rule changes update language to be consistent with Title 26-8a, amend terms for personnel certification to license, and remove language for air ambulance licensing.

Summary of the rule or change:

These proposed rule changes update language to be consistent with Title 26-8a by changing the term "licensed" to include individuals, and delete language for the licensure of air ambulance providers since a new rule (R426-10, also published in the November 11, 2018 Bulletin) is being concurrently submitted to address those requirements.

Statutory or constitutional authorization for this rule:

• Section 26-8a

Anticipated cost or savings to:

the state budget:

These proposed rule changes are not expected to have any fiscal impact on state government revenues or expenditures because they are for the changing of terminology, and documentation for licensed ambulance providers. State expenditures and staff time are not affected.

local governments:

These proposed rule changes are not expected to have any fiscal impact on local governments' revenues or expenditures because these amendments do not put any additional constraints on affected parties. These rule changes include updates to language, punctuation, references, formatting, and deletion of air ambulance language.

small businesses:

These proposed rule changes are not expected to have any fiscal impact on the one small business that is a licensed ground ambulance provider because these amendments do not put any additional constraints on affected parties. These rule changes include updates to language, punctuation, references, formatting, and deletion of air ambulance language.

persons other than small businesses, businesses, or local governmental entities:

These proposed rule changes are not expected to have any fiscal impact on persons other than small businesses, businesses, or local governmental entities, because these amendments do not put any additional constraints on affected parties. These rule changes include updates to language, punctuation, references, formatting, and deletion of air ambulance language.

Compliance costs for affected persons:

These proposed rule changes are not expected to have any fiscal impact on affected persons.

Comments by the department head on the fiscal impact the rule may have on businesses:

After conducting a thorough analysis, it was determined that these rule amendments will not result in fiscal impact to businesses.

Joseph K. Miner, M.D. Executive Director.

The full text of this rule may be inspected, during regular business hours, at the Office of Administrative Rules, or at:

Health
Family Health and Preparedness, Emergency Medical Services
3760 S HIGHLAND DR
SALT LAKE CITY, UT 84106

Direct questions regarding this rule to:

• Guy Dansie at the above address, by phone at 801-273-6671, by FAX at 801-273-4165, or by Internet E-mail at gdansie@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

12/03/2018

This rule may become effective on:

12/10/2018

Authorized by:

Joseph Miner, Executive Director

Appendix 1: Regulatory Impact Summary Table*

Fiscal Costs	FY 2019	FY 2020	FY 2021
State Government	$0	$0	$0
Local Government	$0	$0	$0
Small Businesses	$0	$0	$0
Non-Small Businesses	$0	$0	$0
Other Person	$0	$0	$0
Total Fiscal Costs:	$0	$0	$0
Fiscal Benefits
State Government	$0	$0	$0
Local Government	$0	$0	$0
Small Businesses	$0	$0	$0
Non-Small Businesses	$0	$0	$0
Other Persons	$0	$0	$0
Total Fiscal Benefits:	$0	$0	$0
Net Fiscal Benefits:	$0	$0	$0

 

*This table only includes fiscal impacts that could be measured. If there are inestimable fiscal impacts, they will not be included in this table. Inestimable impacts for State Government, Local Government, Small Businesses and Other Persons are described in the narrative. Inestimable impacts for Non-Small Businesses are described in Appendix 2.

 

Appendix 2: Regulatory Impact to Non-Small Businesses

This rule change is not expected to have any fiscal impacts on large businesses revenues or expenditures, because the amendments do not require any additional constraints on affected parties. The rule changes include updates to language, punctuation, references, formatting, and deletion of air ambulance language.

 

I approve publication of this proposed amendment to rule R426-4 Emergency Medical Services. Operations. Joseph Miner, MD

 

 

R426. Health, Family Health and Preparedness, Emergency Medical Services.

R426-4. Operations.

R426-4-100. Authority and Purpose.

[This rule is established under Title 26, Chapter 8a. It establishes standards for the operation of EMS providers licensed or designated under the provisions of the Emergency Medical Services System Act.](1) This rule is establishes standards for the operation of licensed ground EMS providers or designated EMS providers under the provisions of the Utah Emergency Medical Services System Act.

 

R426-4-200. Licensed Ground Ambulance and [ QRV ] Designated QRU Staffing.

(1) While responding to a call, each permitted QRV shall be staffed by at least one individual [certified]licensed at or above the provider's designated level of service.

(2) While responding to a call, each licensed ground ambulance shall be staffed with the following minimum complement of [certified]licensed personnel for the service level described:

(a) Basic Life Support ambulance: two EMTs, AEMTs, or paramedics, or any combination thereof[.];

(b) AEMT ambulance: one AEMT and one EMT, AEMT, or paramedic[.];

(c) EMT-IA ambulance: one EMT-IA and one EMT, AEMT, or Paramedic[.];

(d) Paramedic ambulance: one paramedic and one EMT, AEMT, EMT-IA, or paramedic[.];

(e) Paramedic (non-transport): one paramedic[.];

(f) Paramedic inter-facility: one paramedic and one EMT, AEMT, EMT-IA, or paramedic[.];

(g) Paramedic tactical: one paramedic.

(3) A paramedic ground ambulance or paramedic provider shall deploy two paramedics to the scene of 911 calls for service requiring Advanced Life Support response, unless otherwise determined by local selective medical dispatch system protocols.

(4) When providing care, responders not in a [Department approved ]uniform shall display upon request their level of medical [certification]licensure.

(5) Each licensed or designated provider shall maintain a personnel file for each [certified]licensed individual. The personnel file [must]shall include records documenting the individual's qualifications, training, certification s, licensure, immunizations, and continuing medical education.

(6) A[n] licensed individual may perform only to his [certified service]licensed EMS provider level, even if the licensed EMS or designated provider is licensed or designated at a higher level.

 

[R426-4-210. Air Ambulance Staffing.

(1) Air ambulance provider shall have at least one medical attendant who is a licensed PA, RN, or MD/DO. This attendant shall be the primary medical attendant. The second medical attendant shall be a Paramedic, PA, Respiratory Therapist, RN, or MD/DO.

(2) Air ambulance providers shall operate only within their accreditation standards designation.

(3) Air ambulance providers shall notify the Department if the air ambulance provider changes its specialty designation through its accrediting agency.]

 

R426-4-300. Permits and Inspections.

(1) A licensed ground ambulance[,] or designated[QRV or air ambulance] EMS provider shall only use vehicles for which the provider has obtained a permit from the Department. All new ground ambulances shall meet current State approved specifications and standards. Department policy for ground ambulances will be posted on the Bureau of Emergency Medical Services and Preparedness’s website.

[(a) Ground ambulances must meet Federal General Services Administration Specification for ground ambulances as of the date of manufacture. New ground ambulance vehicles must meet current state approved specifications for ground ambulances.

(b) QRVs shall meet the Department requirements.]

(2) A permit issued by the Department is valid for one year.

(3) The provider shall display the current permit location on vehicle in a location easily visible at ground level from outside of the vehicle.

(4) Permits and decals are not transferable to other vehicles.

(5) Each [permit holder]licensed ambulance and designated provider shall annually provide proof upon request that every operator of an emergency vehicle has successfully completed an emergency vehicle operator's course approved by the Department [for all emergency vehicle operators].

 

[R426-4-310. Air Ambulance Shall Meet Federal Aviation Regulations.

Air Ambulance providers shall meet all Federal Aviation Regulations specific to their operations.]

 

R426-4-400. [ Ground Ambulance and QRV ] Licensed Ground Ambulance and Designated QRU Provider Operations.

(1) Each licensed ground ambulance provider or [QRV]designated QRU provider shall notify the Department of the permanent location of its ground ambulances and QRVs. The [ground ambulance provider or QRV]licensed ground EMS provider or designated QRU provider shall notify the Department in writing whenever it changes the permanent location for any [ground ambulance or QRV]permitted vehicles.

(2) Each [ground ambulance provider or QRV]licensed ground ambulance provider or designated QRU provider shall maintain each operational permitted vehicle on a premise suitable to make it available for immediate use, in good mechanical repair, properly equipped, and in a sanitary condition.

(3) Each [ground ambulance provider or QRV]licensed ground ambulance provider or designated provider shall maintain each operational vehicle in a clean condition with the interior being thoroughly cleaned after each use in accordance with OSHA standards and the provider's exposure control plan.

(4) Each [ground ambulance provider or QRV]licensed ground ambulance provider or designated provider shall equip each operational vehicle with adult and child safety restraints. To the point practicable and feasible, all occupants [must]shall be safely restrained during operation.

(5) Each [ground ambulance provider or QRV]licensed ground ambulance provider or designated provider shall assure that each emergency vehicle operator who may drive the emergency vehicle:

(a) is at least 18 years of age;

(b) possesses a valid driver license;

(c) successfully passed the provider's criminal background check within the prior four years; and

(d) successfully completed a department approved emergency vehicle operator's course or refresher course within the past two years.

(6) The Department shall verify annually that licensed ground ambulance providers or designated providers are in compliance with this requirement.

 

R426-4-500. Scene and Patient Management.

(1) Designated [E]emergency medical service dispatch centers shall use a selective medical dispatch system to determine which [EMS service provider]licensed ambulance provider will be notified for patient transport.

(2) When responding to a medical emergency call, EMS personnel shall follow protocols approved by the service provider's medical director, and act within their scope of practice.

(3) EMS personnel shall establish communication with on-line medical control as soon as reasonable.

(4) Licensed Paramedic tactical [service]provider may only function at the invitation of the local or state public safety authority. When called upon for assistance, the licensed tactical paramedic provider shall immediately notify the local emergency medical service dispatch center to coordinate patient transportation.

 

R426-4-600. Pilot Projects.

(1) A person who proposes to undertake a research or study project which requires waiver of any rule [must]shall have a project director who is a physician licensed to practice medicine in Utah, and shall submit a written proposal to the Department for presentation to the EMS Committee for recommendation.

(2) The proposal shall include the following:

(a) [A]a project description that describes the[:]

([i]b) need for project;

([ii]c) project goal;

([iii]d) specific objectives;

([iv]e) approval by the provider off-line medical director;

([v]f) methodology for the project implementation;

([vi]g) geographical area involved by the proposed project;

([vii]h) specific rule or portion of rule to be waived;

([viii]i) proposed waiver language;[and]

([ix]j) evaluation methodology[.];

([b]k) [A]a list of the EMS providers and hospitals participating in the project; and

([c]l) a signed statement of endorsement from the participating hospital medical directors and administrators, the director of each participating licensed paramedic and ambulance [licensee]provider, other project participants, and other parties who may be significantly affected.

([d]3) If the pilot project requires the use of additional skills, a description of the skills to be utilized by the field EMS licensed personnel and provision for training and supervising the field EMS licensed personnel who are to utilize these skills, including the names of the field EMS licensed personnel.

([e]4) The name and signature of the project director attesting to his or her support and approval of the project proposal.

([3]5) If the pilot project involves human subjects' research, the applicant [must]shall also obtain Department Institutional Review Board approval.

([4]6) The Department or Committee, as appropriate, may require the applicant to meet additional conditions as it considers necessary or helpful to the success of the project, integrity of the EMS system, and safety to the public.

([5]7) The Department or Committee, as appropriate, may initially grant project approval for one year. The Department or Committee, as appropriate, may grant approval for continuation beyond the initial year based on the achievement and satisfactory progress as evidenced in written progress reports to be submitted to the Department at least 90 days prior to the end of the approved period. A pilot project may not exceed three years[;].

([6]8) [t]The Department or Committee, as appropriate, may only waive a rule if:

(a) the applicant has met the requirements of this section;

(b) the waiver is not inconsistent with statutory requirements;

(c) there is not already another pilot project being conducted on the same subject; and

(d) it finds that the pilot project has the potential to improve pre-hospital medical care.

([7]9) Approval of a project allows the field EMS licensed personnel listed in the proposal to exercise the specified skills of the participants in the project. The project director shall submit the names of field EMS licensed personnel not initially approved to the Department.

([8]10) The Department or Committee, as appropriate, may rescind approval for the project at any time if:

(a) [T]those implementing the project fail to follow the protocols and conditions outlined for the project;

(b) it determines that the waiver is detrimental to public health; or

(c) it determines that the project's risks outweigh the benefits that have been achieved.

([9]11) The Department or Committee, as appropriate, shall allow the licensed or designated EMS provider involved in the study to appear before the Department or Committee, as appropriate, to explain and express its views before determining to rescind the waiver for the project.

([10]12) At least six months prior to the planned completion of the project, the medical director shall submit to the Department a report with the preliminary findings of the project and any recommendations for change in the project requirements.

 

R426-4-700. Confidentiality of Patient Information.

(1) Licensed or designated EMS [P]providers and all licensed EMS personnel shall not disclose patient information except as necessary for patient care or as allowed by statute or rule.

 

R426-4-800. [Ground Ambulance and QRV]Permitted Vehicle Supply Requirements.

(1) In accordance with the [licensure]licensed EMS provider level or designation type and level, the [ground ambulance or QRV]each permitted vehicle shall carry [on each vehicle ]the quantities of supplies, medications, and equipment as described in the Department inspection requirements. The vehicle requirements shall be approved by the State EMS Medical Director and the State EMS Committee.

(2) Medical directors for licensed or designated providers are responsible to provide protocols, training, and quality assurance for all medications used by [certified]licensed individuals performing duties for their respective licensed or designated provider.

(3) If a licensed or designated EMS provider desires to carry different equipment, supplies, or medication from the vehicle supply requirements, the provider shall submit a written request from the certified off-line medical director to the Department requesting the waiver. The request shall include:

(a) a detailed training outline;

(b) protocols;

(c) proficiency testing;

(d) supporting documentation;

(e) local EMS Council or committee comments; and

(f) a detailed letter of justification.

(4) All non-disposable equipment shall be designed and constructed of materials that are durable and capable of withstanding repeated cleaning. The provider shall:

(a) [shall ]clean the equipment after each use in accordance with OSHA standards;

(b) [shall ]sanitize or sterilize equipment prior to reuse;

(c) [shall ]not reuse equipment intended for single use;

(d) [shall ]clean and change linens after each use; and

(e) [shall ]store or secure all equipment in a readily accessible and safe manner to prevent its movement.

(5) The provider shall have all equipment tested, maintained, and calibrated according to the manufacturer's standards.

(6) The provider shall document all equipment inspections, testing, maintenance and calibrations. Testing or calibration conducted by an outside service shall be documented. Such inspections, testing and calibration shall be performed monthly. All testing documentation shall be maintained and available for Department review upon request.

(7) A provider required to carry any of the following equipment shall perform monthly inspections to ensure proper functionality:

([i]a) defibrillator, manual, or automatic;

([ii]b) autovent;

([iii]c) infusion pump;

([iv]d) glucometer;

([v]e) flow restricted, oxygen-powered ventilation devices;

([vi]f) suction equipment;

([vii]g) electronic Doppler device;

([viii]h) automatic blood pressure/pulse measuring device;

([ix]i) pulse oximeter; and,

([x]j) any other electronic, battery powered, or critical care device.

(8) The licensed or designated EMS provider shall perform monthly inspections to ensure proper functionality of all equipment that require consumable[s:]items, power supplies, electrical cables, pneumatic power lines, hydraulic power lines, or related connectors.

(9) Unless otherwise authorized by the State EMS Medical Director, a licensed or designated EMS provider shall store all medications according to the manufacturers' recommendations,[:

(a) for]including temperature control and packaging requirements[; and].

(10) All medication known or suspected to have been subjected to temperatures outside the recommended temperature range shall be return to the supplier for replacement.

[(b) return to the supplier for replacement of any medication known or suspected to have been subjected to temperatures outside the recommended range.]

([10]11) The Department shall maintain and publish requirements for ground ambulances , [and ]QRVs, and other designated providers on the Department's website.

 

[R426-4-900. Air Ambulance Equipment Standards.

Air ambulance providers must maintain minimum quantities of supplies and equipment for each air ambulance transport in accordance with its accreditation designation. The air ambulance medical director shall oversee and determine the protocols and provide training to support the medications.

 

R426-4-1000. Air Ambulance Operational Standards.

(1) An air ambulance pilot may refuse transport to any individual who the pilot considers to be a safety hazard to the air ambulance or any of its passengers.

(2) Air ambulance providers shall provide a patient care record to the receiving hospital as soon as practical, but no longer than 24 hours after completion of the transport.

(3) Air ambulance providers shall maintain a personnel file which shall include staff qualifications and training.

(4) All air ambulance providers shall have an operational manual or policy and procedures manual available for all air ambulance personnel.

(5) All air ambulance provider records shall be available for inspection by representatives of the Department.

(6) Air ambulances shall be equipped to allow air ambulance provider personnel to be able to:

(a) Communicate with hospital emergency medical departments, flight operations centers, air traffic control, ground ambulance providers, and law enforcement agencies;

(b) Communicate with other air ambulances while in flight;

(c) Have the ability to override any radio or telephone transmission in the event of an emergency.

(7) The management of the air ambulance provider shall be familiar with the federal regulations related to air ambulance providers.

(8) Each air ambulance provider shall have a safety committee, with a designated safety officer. The committee shall meet at least quarterly to review safety issues and submit a written report to the air ambulance provider's management and maintain a copy on file at the air ambulance provider's office.

(9) Air ambulance providers shall have a quality management team and a program implemented by this team to assess and improve the quality of patient care provided by the air ambulance provider.]

 

KEY: emergency medical services

Date of Enactment or Last Substantive Amendment: [September 24, 2015]2018

Authorizing, and Implemented or Interpreted Law: 26-8a