641—144.4(147A) Service program levels of care and staffing standards.
	144.4(1) An air ambulance service program seeking authorization shall:
	a. 	Apply for authorization at the following levels:
	(1)	EMT-Basic.
	(2)	Paramedic specialist.
	(3)	Critical care transport.
	b. 	Conduct all air ambulance service flights under a minimum of FAR rules, Part 135.
	c. 	Maintain an adequate number of aircraft and personnel to provide 24-hour-per-day, 7-day-per-week coverage. The number of aircraft and personnel to be maintained shall be determined by the service and shall be based upon, but not limited to, the following:
	(1)	Number of calls;
	(2)	Service area and population; and
	(3)	Availability of other services in the area.
	d. 	Staff fixed-wing ambulances, at a minimum on each flight request, with the following staff while a patient is being transported:
	(1)	One health care provider who is certified or licensed in the state from which the aircraft launches and is certified as an EMT-Basic or higher level; and
	(2)	One FAA-certified commercial pilot who is appropriately rated in the aircraft being used for the transport.
	e. 	Staff rotorcraft ambulances, at a minimum on each flight request, with the following staff while a patient is being transported:
	(1)	Two health care providers who are certified or licensed in the state from which the aircraft launches, one of whom must at a minimum be certified as a paramedic specialist; and
	(2)	One FAA-certified commercial pilot who is appropriately rated in the aircraft being used for the transport.
	f. 	Train medical crew members in the following areas:
	(1)	Patient care limitations in flight.
	(2)	Altitude physiology.
	(3)	Appropriate utilization of air medical services.
	(4)	Communication system.
	(5)	Aircraft operations and safety.
	(6)	Emergency safety and survival.
	(7)	Prehospital scene response and safety.
	(8)	Crew resource management.
	(9)	Program flight risk assessment procedures.
	g. 	Apply to the department to receive approval to provide critical care transportation based upon appropriately trained staff and approved equipment.
	h. 	Ensure that the health care provider with the highest level of certification (on the transporting service) attends the patient, unless otherwise established by protocol approved by the medical director.
	144.4(2) Air ambulance service program operational requirements. Air ambulance service programs shall:
	a. 	Complete and maintain a patient care report concerning the care provided to each patient. Services shall provide, at a minimum, a verbal report upon delivery of a patient to a receiving facility and shall provide a complete PCR within 24 hours to the receiving facility.
	b. 	Ensure that personnel duties are consistent with the level of certification and the service program’s level of authorization.
	c. 	Maintain current personnel rosters and personnel files. The files shall include the names and addresses of all personnel and documentation that verifies EMS provider credentials including, but not limited to:
	(1)	Current provider level certification.
	(2)	Current course completions/certifications/endorsements as may be required by the medical director.
	d. 	If requested by the department, notify the department in writing of any changes in personnel rosters.
	e. 	Have a medical director and 24-hour-per-day, 7-day-per-week on-line medical direction available.
	f. 	Ensure that the appropriate service program personnel respond as required in this rule and that personnel respond in a reasonable amount of time.
	g. 	Notify the department in writing within seven days of any change in service director or ownership or control or of any reduction or discontinuance of operations.
	h. 	Select a new or temporary medical director if for any reason the current medical director cannot or no longer wishes to serve in that capacity. Selection shall be made before the current medical director relinquishes the duties and responsibilities of that position.
	i. 	Within seven days of any change of medical director, notify the department in writing of the selection of the new or temporary medical director who must have indicated in writing a willingness to serve in that capacity.
	j. 	Implement a continuous quality improvement program for patient transport missions to include as a minimum:
	(1)	Medical audits.
	(2)	Skills competency.
	(3)	Flight safety procedures.
	(4)	Appropriateness of air medical response.
	(5)	Review of flight risk assessment.
	(6)	Loop closure requiring physician review of patient transport missions.
	k. 	Document an equipment maintenance program to ensure proper working condition and appropriate quantities.
	144.4(3) Air ambulance equipment and vehicle standards.
	a. 	All air ambulance service programs shall carry equipment and supplies in quantities as determined by the medical director and appropriate to the service program’s level of care and available medical crew member personnel, and as established in the service program’s approved protocols.
	b. 	Pharmaceutical drugs may be carried and administered by appropriate staff upon completion of training and pursuant to the service program’s established protocols approved by the medical director.
	c. 	All pharmaceuticals shall be maintained in accordance with the rules of the state board of pharmacy.
	d. 	Accountability for drug exchange, distribution, storage, ownership, and security shall be subject to applicable state and federal requirements. The method of accountability shall be described in the written pharmacy agreement. A copy of the written pharmacy agreement shall be submitted to the department.
	e. 	Each aircraft shall be equipped and maintained in accordance with FAA operating requirements.
	f. 	Each aircraft shall be equipped with a survival kit.
	144.4(4) Communications and flight dispatch program.
	a. 	Each service program shall maintain a telecommunications system between the medical crew member and the source of the service program’s medical direction and other appropriate entities.
	b. 	All telecommunications shall be conducted in an appropriate manner and on a frequency approved by the Federal Communications Commission and the department.
	c. 	A flight-following policy shall be adopted. This policy shall at a minimum contain the following:
	(1)	Minimum time between communications with aircraft and its monitoring center;
	(2)	Documentation of communications with flight;
	(3)	Lost communications procedures; and
	(4)	Overdue aircraft procedures.
	d. 	Flight programs shall provide staff or contract with a flight dispatch system for receiving flight requests. Communication specialists shall be trained in the following:
	(1)	Flight operations;
	(2)	Aviation weather;
	(3)	Aviation maintenance;
	(4)	Flight following;
	(5)	Flight risk assessment;
	(6)	Flight service minimum safety standards; and
	(7)	Overdue aircraft procedures.
	144.4(5) Flight risk assessment policy.
	a. 	Each service shall have a flight risk assessment policy in accordance with current FAA guidelines.
	b. 	Flight risk assessment policies shall mandate adherence to policy for all flights.
	c. 	Flight risk assessment policies shall address other flight services being requested, en route, or having been denied request to same incident.
	144.4(6) Air ambulance service program—incident and accident response and reports.
	a. 	Air medical services shall have a policy in place outlining missing/overdue/accident issues. This policy will contain at a minimum the following:
	(1)	Overdue aircraft procedures; and
	(2)	Postincident action plans.
	b. 	Incidents of fire or other destructive or damaging occurrences or theft of a service program aircraft, vehicle, equipment, or drugs shall be reported to the department within 48 hours following the occurrence of the incident.
	c. 	A report relating to an accident resulting in personal injury, death or property damage shall be submitted to the department within seven days following an accident involving a service program aircraft or vehicle. A complete FAA/NTSB accident report shall be submitted to the bureau of EMS upon completion of the report.
	144.4(7) Reportable patient data—adoption by reference.
	a. 	The department shall prepare compilations for release or dissemination on all reportable patient data entered into the EMS service program registry during the reporting period. The compilations shall include, but not be limited to, trends and patient care outcomes for local, regional, and statewide evaluations. The compilations shall be made available to all service programs submitting reportable patient data to the registry.
	b. 	Access and release of reportable patient data and information.
	(1)	The data collected by and furnished to the department pursuant to this subrule are confidential records of the condition, diagnosis, care, or treatment of patients or former patients, including outpatients, pursuant to Iowa Code section 22.7. The compilations prepared for release or dissemination from the data collected are not confidential under Iowa Code subsection 22.7(2). However, information which individually identifies patients shall not be disclosed, and state and federal law regarding patient confidentiality shall apply.
	(2)	The department may approve requests for reportable patient data for special studies and analysis provided that the request has been reviewed and approved by the deputy director of the department with respect to the scientific merit and confidentiality safeguards and the department has given administrative approval for the proposal. The confidentiality of patients and the EMS service program shall be protected.
	(3)	The department may require entities requesting the data to pay any or all of the reasonable costs associated with furnishing the reportable patient data.
	c. 	To the extent possible, activities under this subrule shall be coordinated with other health data collection methods.
	d. 	Quality assurance.
	(1)	For the purpose of ensuring the completeness and quality of reportable patient data, the department or an authorized representative may examine all or part of the patient care report as necessary to verify or clarify all reportable patient data submitted by a service program.
	(2)	Review of a patient care report by the department shall be scheduled in advance with the service program and completed in a timely manner.
	e. 	“Iowa Trauma Patient Data Dictionary” is available through the Iowa Department of Public Health, Bureau of Emergency Medical Services, Lucas State Office Building, Des Moines, Iowa 50319-0075, or the bureau of EMS website (idph.iowa.gov/BETS/Trauma/data-registry).
	f. 	“Iowa EMS Patient Registry Data Dictionary” identified in 641—paragraph 136.2(1)“c” is incorporated by reference for inclusion criteria and reportable patient data to be reported to the department. For any differences which may occur between the adopted reference and this chapter, the administrative rules shall prevail.
	g. 	 “Iowa EMS Patient Registry Data Dictionary” identified in 641—paragraph 136.2(1)“c” is available through the Iowa Department of Public Health, Bureau of Emergency Medical Services, Lucas State Office Building, Des Moines, Iowa 50319-0075, or the bureau of EMS website (idph.iowa.gov/BETS/EMS/data-registry).
	144.4(8) An air ambulance service program shall:
	a. 	Submit reportable patient data identified in subrule 144.4(7) via electronic transfer. Data shall be submitted in a format approved by the department.
	b. 	Submit reportable patient data identified in subrule 144.4(7) to the department for each calendar quarter. Reportable patient data shall be submitted no later than 90 days after the end of the quarter.
	144.4(9) The patient care report is a confidential document and shall be exempt from disclosure pursuant to Iowa Code subsection 22.7(2) and shall not be accessible to the general public. Information contained in these reports, however, may be utilized by any of the indicated distribution recipients and may appear in any document or public health record in a manner which prevents the identification of any patient or person named in these reports.
	144.4(10) Implementation. The director may grant waivers from the requirements of this chapter for any air medical service. Waivers shall be reasonably related to undue hardships which existing services experience in complying with this chapter. Services requesting waivers shall be subject to other applicable rules adopted pursuant to Iowa Code chapter 147A. Nothing in this chapter shall be construed to require any service to provide a level of care beyond minimum basic care standards.
[ARC 8662B, IAB 4/7/10, effective 5/12/10; ARC 5528C, IAB 3/24/21, effective 4/28/21]