No. 43259 (New Rule): Rule R426-10. Air Ambulance Licensure and Operations

(New Rule)

DAR File No.: 43259
Filed: 10/15/2018 09:37:59 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this new rule is to implement new air ambulance requirements based on national model rules for federal compliance, standardization for providers with other state rules, and to reflect best practices in the industry.

Summary of the rule or change:

This new rule will consolidate past air ambulance rules with a format and requirements based on model rules developed by the National Association of State EMS Officials. The requirements in this new rule have been vetted to regulatory federal agencies for compliance with federal regulations. This new rule also implements best practices of the air ambulance industry. The rule contains licensing and operational requirements previously contained in R426-3 and R46-4.

Statutory or constitutional authorization for this rule:

• Section 26-8a

Anticipated cost or savings to:

the state budget:

This proposed rule is not expected to have any fiscal impact on state government revenues or expenditures because it will not increase regulatory requirements or increase staff workload.

local governments:

Local governments do not license air ambulance providers. They do not have any regulatory requirements or authority over air ambulance providers.

small businesses:

No small businesses are licensed to operate an air ambulance in Utah.

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

This new rule is not expected to have any fiscal impact on persons other than small businesses, businesses, or local governmental entities, because this rule does not put any additional constraints on them.

Compliance costs for affected persons:

This proposed rule is not expected to have any fiscal impact on affected persons, such as patients or hospitals, who normally pay for EMS services.

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

Businesses will experience a fiscal impact because of the requirements set out in this rule; however, the impact cannot be estimated since current licensed providers exceed the requirements set out in this rule.

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 [e-mail]

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

RULE TEXT

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

There are six licensed air ambulance providers operating and based in Utah. This number is based on current licenses per Utah Department of Health data. These businesses will experience a fiscal cost because of increased requirements described in this new rule. The full impact to these non-small businesses cannot be estimated because currently licensed air ambulance providers exceed the effective rule requirements, and will meet the new requirements without addition impacts. However, these new requirements are more costly than past requirements. Also, actual cost data from air ambulance providers is not available for comparisons. Non-fiscal impacts will include better efficiencies or possible cost savings for non-small businesses affected. This is due to rule or regulatory standardization states for air ambulance providers licensed in multiple states.

 

I approve publication of this proposed new rule R426-10 Air Ambulance Licensure and Operations. Joseph Miner, MD

 

 

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

R426-10. Air Ambulance Licensure and Operations.

R426-10-100. Authority and Purpose.

(1) This rule is established for the licensing requirements and operations for air ambulance providers.

 

R426-10-200. Air Ambulance Service Application and Licensure.

(1) No person, either as owner, agent or otherwise, shall furnish, operate, conduct, maintain, advertise or otherwise be engaged in the provision of emergency medical care using an air ambulance unless currently licensed by the State of Utah Department of Health. The state retains the right to conduct air ambulance service investigations per state law.

(2) The following shall be complied with to obtain a State of Utah air ambulance license:

(a) A person from another state shall not provide emergency medical services aboard an air ambulance within the state unless that person complies with the requirements under this chapter. This requirement applies to any person that provides patient care within the State of Utah.

(b) Applicants desiring to be licensed or to renew its license for an air ambulance service shall submit the applicable fees and application on Department-approved forms prior to being issued a license to operate.

(c) Applicants shall submit a copy of air ambulance service license(s) concurrently issued and on file with other states.

(d) Applicants shall provide information about individual aircraft that will be used while providing medical care licensed under this Chapter to the state for physical inspection of medical compliance.

(e) Applicants shall provide results to the Department from the prior 10 years of any investigations, disciplinary actions, or exclusions with the potential to impact the quality of medical care provided to patients. Such investigations, disciplinary actions, or exclusions that shall be reported apply to all current and prior legal names of the entity and all other names used by the entity to provide health care services (see R426-10-600, Change of Ownership/Management) and any person or entity who had direct or indirect ownership of at least 50% interest in the air ambulance service within the prior 10-year period.

(f) Applicants shall identify an air ambulance service medical director pursuant to requirements found in R426-5-2400. The medical director shall be responsible for medical direction and oversight regarding credentialing air medical providers, clinical practice, and all patient care issues. Personnel changes in medical director shall be reported to the Department within 30 days.

(g) Applicants shall submit all required fees, when applicable.

(h) When the name or ownership of the air ambulance service changes, an air ambulance service license application shall be submitted to the Department at least 30 days prior to the effective date of the change.

(i) Air ambulance services shall provide emergency information about the service to the Department. This information shall be used by the Department to provide effective communications and resource management, in the event of a statewide or localized disaster or emergency situation. The information is included in the initial and renewal application for certification of air ambulance services.

(j) Air ambulance permits and licenses are not transferable.

(k) Duplicate air ambulance permits and licenses can be obtained by submitting a written request to the Department. The request shall include a letter signed by the licensee certifying that the original permit and license has been lost, destroyed or rendered unusable.

(l) Each licensed air ambulance provider shall obtain a new air ambulance inspection and subsequent permit or certification from the Department prior to returning an air ambulance to service following a modification, change or any renovation that results in a change to the stretcher placement or seating in the air ambulance interior configuration to ensure the aircraft meets patient care requirements.

(m) The licensed air ambulance service shall file an amended list of aircraft that are used to provide service within the state to the Department within 30 days after an air ambulance is added or removed permanently from service.

(n) The licensure period for all licensed air ambulance services shall be for 4 years.

(o) Licensure authorizes the air ambulance provider only to provide emergency medical care using an air ambulance, and does not constitute authority to provide air transportation. Such authority shall be obtained from the Federal Aviation Administration and United States Department of Transportation.

(p) The following regulations shall not relieve the licensed air ambulance provider from compliance with other statutes, rules, or regulations in effect for medical personnel and emergency medical services, involving licensing and authorizations, insurance, prescribed and proscribed acts and penalties.

 

R426-10-300. Exceptions to Air Ambulance Service Application and Licensure.

(1) This rule does not apply to the following:

(a) An air ambulance or air ambulance service operated by an agency of the United States government.

(b) Services that provide rescue and evacuation equipment and aircraft owned and operated by a governmental entity whose primary role is not to transport patients by air ambulance, and who is not receiving payment for such services.

(c) Evacuation and rescue equipment used and owned by the department of public safety in air, ground, or water evacuation.

 

R426-10-400. Air Ambulance Service Deemed Status.

(1) The Department may grant deemed status for state license to an air ambulance provider that has received accreditation from a Department recognized accreditation service. An air ambulance provider who has deemed status may receive a license if they meet all of the requirements for application and licensure.

(2) To be recognized by the Department as an approved accreditation organization for the purposes of this section, the accrediting organization shall meet the following minimum standards:

(a) Publish standards that are equivalent to or exceed the standards in this chapter.

(b) Publish standards which address every component of a medical transport service that could potentially impact the quality of care and patient safety with respect to communications centers, pilots, drivers, maintenance, patient care providers, and administrative support.

(c) Provide evidence of timely reviews of applications from providers seeking accreditation.

(d) Procedures for random site visits, audits, and other strategies utilized to ensure an accredited provider or a provider seeking accreditation is adhering to the accreditation standards.

(e) Publish policies for the

(i) initial accreditation requirements;

(ii) the tenure of accreditation, not to exceed three (3) years;

(iii) the requirements for reaccreditation; and

(iv) the accreditation decision making process.

(f) Uses trained accreditation personnel with experience in medical transport at the level of accreditation and license for the level of accreditation being sought.

(g) A formal training program that educates accreditation auditors in consistent interpretation of standards and policies of the accreditation agency.

(h) Publish the required qualifications for accreditation personnel who conduct site surveys. Such qualifications must demonstrate an extensive depth of experience with and knowledge of the air ambulance industry.

(i) Policies and standards that recognize the special circumstances of medical transport services that serve rural areas.

(j) Demonstrate that accreditation standards are updated on a regular basis to stay current with changes in healthcare and air medical transportation.

(k) Provide definition of all sentinel events including near misses. The accrediting agency shall outline the processes for notifying the Department of such events and the process for investigating and instituting corrective measures for such events.

(l) Provide information about the Board of Directors. Members of the Board of Directors shall have experience in the air medical transport industry. The Board of Directors shall include broad representation by members of relevant national organizations that are engaged in the development, training, and oversight of critical care and air medical patient transportation.

(m) Clearly outline the Conflict of Interest Policy that excludes Board members or other accreditation agency representatives from participating in accreditation decisions, site surveys, or other processes when a real or potential conflict of interest exists.

(n) Publish fees for providers seeking accreditation.

(o) Provide documentation of the process that allows and encourages input, suggestions, and review by outside individuals and agencies related to its standards, policies, and procedures.

(p) Explain the procedure for a corrective action plan when an audit uncovers areas that are out of compliance.

(q) Demonstrate a continuous quality improvement process that reviews the application process, site surveys, accreditation decisions, and accreditation standards. The process must include measures to achieve improvement, fairness, and transparency.

(r) Maintain insurance (General liability, Medical Professional Liability, Directors & Officers and Travel) and be able to present their current certificates of insurance to the state licensing agency.

(s) Comply with all applicable Health Insurance Portability and Accountability Act (HIPAA) regulations, including any necessary requirements of a Business Associate entity.

(t) Allow a Department representative to be present during site surveys, investigations, and any other on-site visit performed in the Utah.

(u) Provide simultaneous notification to the Department of an air ambulance provider's accreditation decisions, corrective action, any changes in accreditation status, and sentinel event reports; and

(v) List the accrediting agency's involvement in research to improve the air medical transportation industry.

(3) A current list of recognized accreditation organizations is available on the Department's website.

 

R426-10-500. Air Ambulance Service Compliance with State Licensure Requirements.

(1) Deemed status recognition is intended to streamline the licensure process for air ambulance services by preventing duplicative documentation.

(2) The Department reserves the right to verify and inspect all equipment and documentation at any time to ensure that the air ambulance service maintains full compliance with requirements related to the air ambulance service licensure.

 

R426-10-600. Licensed Air Ambulance Provider Change of Ownership and Management.

(1) When a currently licensed air ambulance provider anticipates a change of ownership, the current licensed air ambulance provider shall notify the Department within thirty (30) calendar days before a change of ownership. A licensed air ambulance provider who is seeking a new license, shall submit an application for change of ownership along with the requisite fees and documentation within thirty (30) calendar days.

(2) The conversion of a licensed air ambulance provider's legal structure, or the legal structure of an entity that has a direct or indirect ownership interest in the licensed air ambulance provider is not a change of ownership unless the conversion also includes a transfer of at least 50 percent of the licensed air ambulance provider's direct or indirect ownership interest to one or more new owners. Specific instances of what does or does not constitute a change of ownership are set forth below in section (4).

(3) The Department shall consider the following criteria in determining whether there is a change of ownership of a licensed air ambulance provider that requires a new license:

(a) Sole proprietors:

(i) The transfer of at least 50 percent of the ownership interest in a licensed air ambulance provider from a sole proprietor to another individual, whether or not the transaction affects the title to real property, shall be considered a change of ownership.

(ii) Change of ownership does not include forming a corporation from the sole proprietorship with the proprietor as the sole shareholder.

(b) Partnerships:

(i) Dissolution of the partnership and conversion into any other legal structure shall be considered a change of ownership if the conversion also includes a transfer of at least 50 percent of the direct or indirect ownership to one or more new owners.

(ii) Change of ownership does not include dissolution of the partnership to form a corporation with the same persons retaining the same shares of ownership in the new corporation.

(c) Corporations:

(i) Consolidation of two or more corporations resulting in the creation of a new corporate entity shall be considered a change of ownership if the consolidation includes a transfer of at least 50 percent of the direct or indirect ownership to one or more new owners.

(ii) Formation of a corporation from a partnership, a sole proprietorship or a limited liability company shall be considered a change of ownership if the change includes a transfer of at least 50 percent of the direct or indirect ownership to one or more new owners.

(iii) The transfer, purchase, or sale of shares in the corporation such that at least 50 percent of the direct or indirect ownership of the corporation is shifted to one or more new owners shall be considered a change of ownership.

(d) Limited liability companies:

(i) The transfer of at least 50 percent of the direct or indirect ownership interest in the company shall be considered a change of ownership.

(ii) The termination or dissolution of the company and the conversion thereof into any other entity shall be considered a change of ownership if the conversion also includes a transfer of at least 50 percent of the direct or indirect ownership to one or more new owners.

(iii) Change of ownership does not include transfers of ownership interest between existing members if the transaction does not involve the acquisition of ownership interest by a new member. For the purposes of this subsection, "member" means a person or entity with an ownership interest in the limited liability company.

(4) Management contracts, leases or other operational arrangements:

(a) If the owner of an air ambulance service enters into a lease arrangement or management agreement whereby the owner retains no authority or responsibility for the operation and management of the licensed air ambulance provider, the action shall be considered a change of ownership that requires a new license.

(5) Each applicant for a change of ownership shall provide the following information:

(a) The legal name of the entity and all other names used by it to provide health care services. The applicant has a continuing duty to notify the Department of all name changes at least thirty (30) calendar day prior to the effective date of the change.

(b) Contact information for the entity including mailing address, telephone and facsimile numbers, e-mail address and website address, as applicable.

(c) The identity of all persons and business entities with a controlling interest in the licensed air ambulance provider, including administrators, directors, managers and management contractors.

(i) A non-profit corporation shall list the governing body and officers.

(ii) A for-profit corporation shall list the names of the officers and stockholders who directly or indirectly own or control five percent or more of the shares of the corporation.

(iii) A sole proprietor shall include proof of lawful presence in the United States in compliance with section 24-76.5-103(4), C.R.S.

(d) The name, address and business telephone number of every person identified in R426-10-600 as ownership or management and the individual designated by the applicant as the chief executive officer of the entity. If the addresses and telephone numbers provided above are the same as the contact information for the entity itself, the applicant shall also provide an alternate address and telephone number for at least one individual for use in the event of an emergency or closure of the licensed air ambulance provider.

(e) Proof of professional liability insurance obtained and held in the name of the license applicant. Such coverage shall be maintained for the duration of the license term and the Department shall be notified of any change in the amount, type or provider of professional liability insurance coverage during the license term.

(f) Articles of incorporation, articles of organization, partnership agreement, or other organizing documents required by the secretary of state to conduct business in Utah; and by-laws or equivalent documents that govern the rights, duties and capital contributions of the business entity.

(g) The address of the entity's physical location and the name(s) of the owner(s) of each structure on the campus where licensed services are provided if different from those identified in elsewhere in this section.

(h) A copy of any management agreement pertaining to operation of the entity that sets forth the financial and administrative responsibilities of each party.

(i) If an applicant leases one or more building(s) to operate as a licensed air ambulance service, a copy of the lease shall be filed with the license application and show clearly in its context which party to the agreement is to be held responsible for the physical condition of the property.

(j) A statement signed and dated contemporaneously with the application stating whether, within the previous ten (10) years, any of the new owners have been the subject of, or a party to, one of more of the following events, regardless of whether action has been stayed in a judicial appeal or otherwise settled between the parties.

(i) Been convicted of a felony or misdemeanor involving crimes as described in R426-5-3100 under the laws of any state of the United States.

(ii) Had a state license or federal certification denied, revoked, or suspended by another jurisdiction.

(iii) Had a civil judgment or a criminal conviction in a case brought by federal, state or local authorities that resulted from the operation, management, or ownership of a health facility or other entity related to substandard patient care or health care fraud.

(iv) Certifies whether it is presently or has ever been debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from participation in a Contract by any governmental department or agency, whether international, national, state, or local, and certifies it is in compliance with Utah Code Ann. Section 63G-6a-904 et seq. and OMB guidelines at 2 C.F.R. 180 which implement Executive Order Nos. 12549 and 12689. Notification to the Department within thirty (30) days must occur if debarred, suspended, proposed for debarment, declared ineligible or voluntarily excluded from participation in any contract by any governmental entity during the tenure of the license.

(k) Any statement regarding the information requested in this section of rule shall include the following, if applicable:

(i) If the event is an action by federal, state or local authorities; the full name of the authority, its jurisdiction, the case name, and the docket, proceeding or case number by which the event is designated, and a copy of the consent decree, order or decision.

(ii) If the event is a felony or misdemeanor conviction involving moral turpitude, the court, its jurisdiction, the case name, the case number, a description of the matter or a copy of the indictment or charges, and any plea or verdict entered by the court.

(iii) If the event involves a civil action or arbitration proceeding, the court or arbiter, the jurisdiction, the case name, the case number, a description of the matter or a copy of the complaint, and a copy of the verdict, the court or arbitration decision.

(6) The existing licensee shall be responsible for correcting all rule violations and deficiencies in any current plan of correction before the change of ownership becomes effective. In the event that such corrections cannot be accomplished in the time frame specified, the prospective licensee shall be responsible for all uncorrected rule violations and deficiencies including any current plan of correction submitted by the previous licensee unless the prospective licensee submits a revised plan of correction, approved by the Department, before the change of ownership becomes effective.

(7) If the Department issues a license to the new owner, the previous owner shall return its license to the Department within five (5) calendar days of the new owner's receipt of its license.

 

R426-10-700. Air Ambulance Service Insurance Requirements.

(1) Applicants for licensure shall demonstrate liability coverage for injuries to persons and for loss or property damages resulting from negligence by the service or medical crew. A license holder shall immediately notify the Department and cease operations if the coverage required by this section is cancelled or suspended.

(2) The Department shall not issue an air ambulance license to an air ambulance provider unless the applicant for a license or the licensee has evidence of medical professional liability insurance that requires the insurer to compensate for injuries to persons or unintentional damage to property.

(a) Applicants shall provide a copy of the current certificates of insurance demonstrating coverage for each air ambulance medical crew member that demonstrates, at a minimum, aggregate limits of $1,000,000 per claim made and a total of $3,000,000 for all claims made against the provider during the policy year.

(3) Worker's compensation coverage is required as defined by the State of Utah regulating bodies.

 

R426-10-800. Base Locations.

(1) A base location is the physical address where the crew, medical equipment and supplies, and the air ambulance are located. This will be designated by where the licensee operates and maintains or makes readily available records of operations.

(2) The Department may conduct announced and unannounced inspections at any locations where a licensed air ambulance provider operates at any time, including nights or weekends to determine compliance with these rules and regulations.

(3) Each base location shall have readily available at all times the following:

(i) Security measures in place that protects medical supplies and equipment onboard the air ambulance from tampering and unauthorized access, including pharmaceuticals. This would include direct visual monitoring or closed circuit television or the air ambulance must be in a secured location with locked perimeter fencing or hangar.

(ii) State license or certificate of operation prominently displayed within the building.

(iii) Evidence of medical professional liability insurance.

(iv) Drug Enforcement Agency Registration shall be prominently displayed within those buildings that store controlled substances.

(v) Current Post-Accident Incident Plan.

(vi) Documentation showing the professional certifications and licenses of all flight crew members.

(4) The facility shall be clean and free of debris at all times and shall be compliant with all state and local building and fire codes.

 

R426-10-900. Number and Type of Air Ambulances.

(1) Air ambulance providers shall provide a list of all air ambulances to be licensed and inspected for medical compliance by the Department, including tail number (N-Number) and designation of (rotor or fixed wing) capabilities.

 

R426-10-1000. Capabilities of Medical Communications.

(1) A licensed air ambulance provider shall have a communications network available consisting of reliable equipment designed to afford clear communications related to the number and condition of patients among all stakeholders within the system.

(2) The communication center shall demonstrate and maintain voice communications linkage with the radios and other allowable communication devices used in the air ambulance for the declared service area.

(3) Licensed air ambulance providers shall have two-way communications equipment available that allows for or has the following:

(a) Real-time patient tracking that shall be maintained and documented every 15 minutes including the time the air ambulance returns to service following transport.

(b) Appropriate wireless communications capabilities with dispatch centers, local first responders, to include fire, EMS, and law enforcement.

(c) Communications with medical referral and receiving facilities to exchange patient information and consult with medical control that shall be capable of communications exclusive of the air traffic control system.

(d) A dedicated telephone number for the air ambulance service dispatch center.

(4) The licensed air ambulance provider base station or communications network shall be manned during all phases of patient treatment and transport.

(5) An emergency plan for communications during power outages and in disaster situations shall be established.

(6) A policy for delineating methods for maintaining medical communications during power outages and in disaster situations.

 

R426-10-1100. Coordination of Medical Communications.

(1) All licensed air ambulance providers shall have flights coordinated by designated medical dispatchers or communications specialists.

(3) Communication specialists are required for processing requests, initiating responses, telecommunications, and assessing the capability for utilizing emergency medical dispatch protocols approved by the Department.

(4) Air ambulance communications specialists shall have training commensurate with the scope of responsibility given them by the particular licensed air ambulance provider.

(5) The following requirements shall apply to all air ambulance communications centers:

(a) Establish and maintain policies and procedures based on state or nationally accepted emergency medical dispatch standards and state or nationally accepted EMS clinical guidelines to aid in directing the daily operation of the air ambulance communications center.

(b) Coordinate air ambulance deployment activities and communications with primary 911 PSAP call centers and appropriate medical facilities.

(c) Require its communications specialists to satisfy performance standards that are based on state or nationally accepted emergency medical dispatch standards and state or nationally accepted EMS clinical guidelines.

(6) At a minimum, the air ambulance communications center's performance standards shall measure a communication specialist's ability to:

(a) Deploy the appropriate medical resources within the prescribed timeframe established by the communications center's standard operating procedures.

(b) Provide pertinent information to the appropriate 911 PSAP call center and receive updated information about the incident from the responding units or medical facilities.

(c) Establish a quality assurance review process that is executed with consistency and objectivity in accordance with internal standards developed by the licensed air ambulance provider.

 

R426-10-1200. Communications Specialists Personnel Qualifications.

(1) Communication specialists shall have appropriate training pertaining to EMS and medical transportation communications related to the provision of health care and receive certification within (1) year.

 

R426-10-1300. Pre-arrival and Hand-Off Communications to Hospitals or Emergency Patient Receiving Facilities.

(1) All licensed air ambulance providers shall have a plan in place to transmit significant clinical data to hospital or emergency patient receiving facility medical personnel prior to arrival.

(2) Licensed air ambulance providers shall start the process for transferring responsibility of patient care during patient transport to reduce the communication load on patient arrival to the facility as early as possible. Transfer of care documentation shall be part of the EMS record.

(3) Information transmitted to the hospital or the emergency patient receiving facility prior to arrival shall include:

(a) patient information;

(b) chief complaint;

(c) brief patient history;

(d) condition of patient;

(e) treatment provided; and

(f) estimated time of arrival.

(4) Information at the time of patient hand-off shall include a copy of the patient care report to the hospital or emergency patient receiving facility within 24 hours after the end of the patient transport. If a completed patient care report cannot be left at the facility at the end of the patient transfer to the hospital or emergency patient receiving facility, an abbreviated patient encounter form containing information essential to continued patient care shall be provided.

(5) Abbreviated Patient Encounter form shall include:

(a) patient information;

(b) chief complaint;

(c) brief patient history;

(d) allergies (if known);

(e) time and date of onset of symptoms;

(f) pertinent physical findings;

(g) patient medications (if known);

(h) vital signs;

(i) air medical treatment, including medications administered, IV fluids, procedures performed, and oxygen delivery; and

(j) transfer of care (name of air medical crew member to the receiving healthcare professional legibly included in documentation).

 

R426-10-1400. Data Collection, Submission and Call Volume.

(1) All licensed air ambulance providers shall have a system in place to collect, submit, monitor, and track all flight requests This information shall be submitted to the Department.

(2) All licensed air ambulance providers shall:

(a) Report the specified state minimum data set, as required by the Department for every request that results in the dispatch of an air ambulance, whether emergency prehospital, inter-hospital transport, aborted flight, cancellation of requested service, death on scene (non-transport), or refusal of care as requested by the Department.

(b) Provide a yearly call volume report or EMS agency status report documenting the number of flights made within that calendar year. This report shall contain the number of flights organized by emergency prehospital, inter-hospital transport, aborted flight, cancellation of requested service, death on scene, non-transport, or refusal of care to assist efforts related to evaluating patient care and the improvement of the EMS system.

 

R426-10-1500. Temporary Air Ambulance Use.

(1) A licensed air ambulance provider shall notify the Department when it temporarily removes a permitted air ambulance from service, or replaces it with a substitute air ambulance.

(2) Upon receipt of notification, the Department may issue a temporary permit for the operation of said air ambulance, as required by the Department.

 

R426-10-1600. Medical Operations Policies and Procedures.

(1) A detailed manual of policies and procedures shall be available for reference in the flight coordination office and available for inspection by the Department to assist with EMS system planning and resource coordination efforts.

(2) Personnel shall be familiar and comply with policies contained within the manual, which shall include all of the following:

(a) procedures for acceptance of requests, referrals, and/or denial of service for medically related reasons;

(b) a written description of the geographical boundaries and features for the service area, and a copy of the service area map;

(c) scheduled hours of operation;

(d) criteria for the medical conditions and indications or medical contraindications for flight;

(e) medical communication procedures, including but not limited to medically-related dispatch protocol, call verification, and advisories to the requesting party, to include procedures for informing requesting party of flight procedures, anticipated time of aircraft patient arrival, or cancellation of flight;

(f) criteria regarding acceptable destinations based upon medical needs of the patient;

(g) non-aviation safety procedures for medical crew assignments and notification, including rosters of medical personnel;

(h) written policy that ensures that air medical personnel shall not be assigned or assume cockpit duties concurrent with patient care duties and responsibilities;

(i) written policy that directs air ambulance personnel to honor a patient request for a specific service or destination when the circumstances will not jeopardize patient safety;

(j) medical communications procedures;

(k) flight cancellation and referral procedures;

(l) mutual aid procedures;

(m) a written plan that addresses the actions to be taken in the event of an emergency, diversion, or patient crisis during transport operations;

(n) patient tracking procedures that shall assure air/ground position reports at intervals not to exceed fifteen (15) minutes (inflight) and forty-five (45) minutes while landed on the ground;

(o) policy for delineating methods of maintaining medical communications during power outages and in disaster situations; and

(p) written procedures governing the licensed air ambulance provider's medical complaint resolution process and protocols. At a minimum, the licensed air ambulance provider shall designate personnel responsible for its dispute resolution process and provide the protocols it shall follow when investigation, tracking, documenting, reviewing, and resolving the complaint. The licensed air ambulance provider's complaint resolution procedures shall emphasize resolution of complaints and problems within a specified period of time.

 

R426-10-1700. Medical Transport Plans.

(1) To ensure proper patient care and the effective coordination of statewide emergency medical and trauma services, all licensed air ambulance providers shall have an integrated medical transport plan for each air ambulance permitted by the Department that describes the following:

(a) base location;

(b) hours of operation;

(c) emergency (dispatch) and non-emergency (business) contact information;

(d) description of primary and secondary service areas;

(e) medical criteria for utilization;

(f) description of medical capabilities (including availability of specialized medical transport equipment);

(g) communications capabilities including (but not limited to) radio frequencies and talk groups;

(h) procedures for communicating with the air medical crew; and

(i) mutual aid or backup procedures when the service is not available.

 

R426-10-1800. Coordination with Regional and State Disaster Preparedness Plans.

(1) To ensure coordinated response to local, regional, or statewide disaster, all licensed air ambulance providers shall participate in regional and state disaster preparedness advisory groups, including preparedness planning meetings and scheduled exercises.

 

R426-10-1900. Medically Related Dispatch Protocols.

(1) When air ambulance transport is indicated, requests shall be coordinated through the local Public Safety Answering Point (PSAP) or 911 call center as part of an integrated response, whenever possible in order for the PSAP to be able to coordinate communications among all entities involved in the response.

 

R426-10-2000. Ethical Practices and Conduct.

(1) All licensed air ambulance providers shall have and follow a written code of conduct that demonstrates ethical practices including business, clinical operations, marketing and professional conduct.

(2) Licensed air ambulance providers are subject to disciplinary action, or may be denied licensure for unethical practices or conduct which includes but shall not be limited to the following:

(a) misrepresentation of the availability or level of medical or patient related services offered or provided; and

(b) failing to take appropriate action in safeguarding the patient from incompetent or inappropriate health care practices of emergency medical services personnel.

 

R426-10-2100. Continuous Quality Improvement (QI) Program.

(1) Licensed air ambulance providers shall establish a quality management team and a program implemented by this team to assess and improve the quality and appropriateness of patient care provided by the air ambulance services.

(2) The program shall include:

(a) development of protocols, standing orders, training, policies and procedures;

(b) approval of medications and techniques permitted for field use by service personnel in accordance with regulations of the Department;

(c) direct observation, field instruction, in-service training, or other means available to assess the quality of field performance; and

(d) Participation in local and regional performance improvement activities.

(3) All licensed air ambulance providers shall have a written policy that outlines a process to identify, document, and analyze sentinel events, adverse medical events, or potentially adverse events with specific goals to improve patient medical safety and/or quality of patient care.

(4) Policies shall include the following:

(a) review of events should address the effectiveness and efficiency of the organization, its support systems, as well as that of individuals within the organization;

(b) when a sentinel event is identified, a method of information gathering shall be developed, and shall include outcome studies, chart review, case discussion, or other methodology;

(c) findings, conclusions, recommendations, and actions shall be made and recorded including follow-up which also shall be determined, recorded, and performed; and

(d) training and education needs, individual performance evaluations, equipment or resource acquisition, patient medical safety and risk management issues shall be integrated with the continuous quality improvement process.

(5) All licensed air ambulance providers shall have a written policy outlining a utilization review process.

 

R426-10-2200. Staffing and Medical Personnel Requirements.

(1) At a minimum a licensed air ambulance provider shall have the following medical personnel:

(a) Medically qualified Utah licensed, or certified, individuals appropriate to the scope and mission of the licensed air ambulance provider, or EMS personnel recognized under an interstate compact of which Utah is a member. Acceptable medical personnel include, but are not limited to physicians(MD/DO), paramedics, registered nurses(RN), registered nurse practitioners(RN-P), advanced practice nurses, physician assistants(PA), respiratory therapists(RRT), or other allied health professionals.

(b) 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.

 

R426-10-2300. Air Ambulance Staffing and Personnel Qualifications.

(1) Each patient transport by a licensed air ambulance provider requires a minimum of two (2) medically qualified staff who are licensed or certified according to Utah or providers recognized under an interstate compact, REPLICA, who provide direct patient care, plus a vehicle operator.

(2) The composition of the medical team may be amended for specialty missions upon approval and credentialing by the licensed air ambulance provider's medical director:

(a) The licensed nurse shall have appropriate specialty certification within two (2) years of hire and must have pre-hire experience in the medications and interventions necessary for the service's scope of care. The licensed nurse also shall have three (3) years critical care experience, which is no less than 4000 hours experience in an ICU or emergency department.

(b) The paramedic shall have a FP-C or CCP-C within (2) years of hire in addition to at least (3) years (minimum of 4000 hours) of advanced life support experience.

(c) The RRT shall have a minimum of 4000 hours of emergency department or ICU experience and appropriate specialty certification within two (2) years of hire.

(3) Medical personnel shall have cognitive, affective, and psychomotor abilities sufficient to meet the clinical needs for the type of patient missions served.

(4) A licensed air ambulance provider shall have a plan to assess and document the competency and proficiency of the personnel who provide medical services.

 

R426-10-2400. Air Ambulance Personnel Training Requirements.

(1) All licensed air ambulance providers shall have a documented, structured educational program required for all air ambulance personnel, including the medical director.

(2) The educational program shall at a minimum contain program orientation; initial and recurrent training which adheres to the services scope of care, patient population, mission statement and medical direction.

(3) Each medical crew member shall complete and document training in mission specific procedures related to patient care as established by the licensed air ambulance provider's medical director and such federal, state, or local agencies with authority to regulate licensed air ambulance providers. Documentation showing completion of all initial and recurrent training may be required by the Department for license renewal.

(4) Clinical experiences shall include but are not limited to the following:

(a) experiences specific to the mission statement and scope of care of the medical transport service;

(b) measurable objectives developed and documented for each experience listed below reflecting hands-on experience versus observation only;

(c) care of patients in the air medical environment including the impact of altitude and other stressors;

(d) advanced airway management;

(e) applicable medical device specific training (Automatic Implantable Cardioverter Defibrillator (AICD), Extracorporeal Membrane Oxygenation (ECMO), Intra-Aortic Balloon Pump (IABP), Left Ventricular Assist Device (LVAD), medication pumps, ventilators, etc.);

(f) cardiology;

(g) mechanical ventilation and respiratory physiology for adult, pediatric, and neonatal patients as it relates to the mission statement and scope of care of the medical transport service specific to the equipment;

(h) high risk obstetric emergencies;

(i) basic care for pediatrics, neonatal and obstetrics;

(j) emergency/critical care for all patient populations to include special needs population;

(k) hazardous materials recognition and response;

(l) management of disaster and mass casualty events;

(m) infection control and prevention; and

(n) ethical and legal issues.

 

R426-10-2500. Medical Staff and Patient Safety Welfare.

(1) Medical personnel scheduling and individual work schedules shall demonstrate strategies to minimize duty-time fatigue, length of shift, number of shifts per week, and day-to-night rotation.

(2) On-site scheduled shifts for a period to exceed twenty-four (24) hours are not acceptable under most circumstances.

(3) The following criteria shall be met for shifts scheduled more than twelve (12) hours:

(a) medical personnel are not required to routinely perform any duties beyond those associated with the transport services;

(b) medical personnel are provided with access to and permission for uninterrupted rest after daily medical personnel duties are met;

(c) the physical base of operations includes an appropriate place for uninterrupted rest;

(d) medical personnel shall have the right to call "time out" and be granted a reasonable rest period if the team member (or fellow team member) determines that he or she is unfit or unsafe to continue duty, no matter the shift length;

(e) there shall be no adverse personnel action or undue pressure to continue in a "time-out" circumstance;

(f)licensed air ambulance management shall monitor transport volumes and personnel's use of a "time out" policy;

(g) licensed air ambulance providers shall utilize a fatigue risk management tool that is widely recognized in the industry; and

(h) shifts extended over several days may be scheduled to address long commutes at programs with low volumes.

(4) The licensed air ambulance provider shall clearly demonstrate and document it meets this above criteria for shifts over twelve (12) hours.

(5) Provide at least (10) hours of rest in each twenty-four (24) hour period.

(6) If the location of the base is remote and one-way commutes are more than two (2) hours, transportation time shall be considered.

(7) Licensed air ambulance providers shall utilize a fatigue risk management tool that is widely recognized in the industry.

(8) Scheduling of on-call shifts shall be evaluated to address fatigue in a written policy based on monitoring of duty times by managers, quality management tracking, and fatigue risk management.

(9) The license air ambulance provider shall establish safety and infection control protocol that comply with the Occupational Safety and Health Administration (OSHA) Standards.

(10) The licensed air ambulance provider shall have an appropriate dress code that addresses mission specific hazards as well as jewelry, hair, and other personal items that may possibly be used by medical personnel that may interfere with patient care.

 

R426-10-2600. Air Ambulance Service Medical Director Qualifications.

(1) A licensed air ambulance provider's medical director who oversees the practice of the emergency medical services during patient transport shall be familiar with Utah state medical standards practices, and licensing requirements.

(2) A licensed air ambulance provider's medical director shall be a Utah licensed physician in good standing to supervise the medical care provided in an air medical environment.

(3) The medical director shall also:

(a) be board certified or board-eligible in EMS, emergency medicine, or other appropriate critical care specialty that services the patient population involved;

(b) have experience in the care of patients consistent with the licensing and mission profile of the air ambulance provider's service;

(c) designate other medical physician specialists for direction outside medical director's area of practice as appropriate to the licensed air ambulance provider's service mission profile;

(d) have access to medical specialists for consultation regarding patients whose illness and care needs are outside the medical director's area of practice;

(e) have a current DEA registration; and

(f) have current credentials achieved through active participation in patient care and continuing medical education activities appropriate for the role of a licensed air ambulance provider's medical director.

(4) The licensed air ambulance provider's medical director shall have familiarity in the following areas:

(a) care of patients in the air medical environment, including the impact of altitude and other patient stressors, in-flight assessment and care, monitoring capabilities, and limitations of the flight environment;

(b) hazardous materials recognition and response;

(c) management of disaster and mass casualty events;

(d) infection control and prevention;

(e) advanced resuscitation and care of adult, pediatric and neonatal patients with both traumatic and non-traumatic diagnoses;

(f) quality improvement theories and applications;

(g) principles of adult learning;

(h) capabilities and limitations of care in air ambulance;

(i) applicable federal, state, and local law, rules and protocols related to air ambulance providers and state trauma rule guidelines;

(j) air ambulance dispatch and communications; and

(k) ethical and legal issues related to air medical transport.

(5) The licensed air ambulance provider's medical director roles and responsibilities shall include:

(a) oversight of medical care provided by the air medical service provider;

(b) ensure competency and currency of all medical personnel;

(c) active engagement in the evaluation credentialing, initial training, and continuing education of all personnel who provide patient care;

(d) development and approval of written patient care guidelines, policies and protocols, including, but not limited to, those addressing the adverse impact of altitude on patient physiology and stressors of transport; and

(e) active engagement in quality management, utilization review, and safety reviews.

 

R426-10-2700. Patient Compartment General Standards.

(1) A licensed air ambulance provider shall ensure that a permitted air ambulance has the following:

(a) a climate control system to prevent temperature variations that would adversely affect patient care;

(b) the air ambulance shall have an adequate interior lighting system so that patient care can be given and the patient's status monitored;

(c) for each place where a patient may be positioned, at least one electrical power outlet or other power source that is capable of operating all electrically powered medical equipment without compromising the operation of any electrical air ambulance equipment;

(e) a back-up source of electrical power or batteries capable of operating all electrically powered life-support equipment for at least one hour;

(f) an appropriate power source which is sufficient to meet the requirements of the complete specialized equipment package without compromising the operation of any electrical air ambulance equipment;

(g) an entry that allows for patient loading and unloading without excessive maneuvering and without compromising the operation of monitoring systems, intravenous lines, or manual or mechanical ventilation;

(h) If an isolette is used during patient transport, the operator shall ensure that the isolette is able to be opened from its secured in-flight position in order to provide full access to the patient;

(i) adequate access and necessary space to maintain the patient's airway and to provide adequate ventilatory support by an attendant from the secured, seat-belted position within the air ambulance;

(j) a configuration that allows for rapid exit of personnel and patients that will not allow obstruction from stretchers and medical equipment;

(k) an interior of the air ambulance that is sanitary and in good working order during use;

(l) secure positioning of cardiac monitors, defibrillators, and external pacers so that displays are visible to medical personnel; and

(m) provision for medications that maintains temperatures within manufacturer recommendations. Glass containers shall not be used unless required by medication specifications and be properly vented.

(2) Each air ambulance operator shall ensure that all medical equipment is appropriate to the air medical service's scope and mission and maintained in working order according to the manufacturer's recommendations.

(3) All permitted air ambulances shall be equipped to provide patient care according to approved medical protocols.

 

KEY: emergency medical services, air

Date of Enactment or Last Substantive Amendment: 2018

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

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