Tenn. Comp. R. & Regs. 1200-12-01-.05

Current through October 22, 2024

Section 1200-12-01-.05 - AIR AMBULANCE STANDARDS

All air ambulance service providers and crew members operating in Tennessee must comply with Chapter 140 of Title 68 of the Tennessee Code Annotated and this Rule. Failure to comply shall subject the service provider and/or its personnel to disciplinary action pursuant to T.C.A. 68-140-511.

(1) Definitions - As used in this Rule, the following terms shall have the following meanings:

(a) "Air Medical Communications Specialist" means any person employed by an air ambulance service coordinating acknowledgement of medical requests, medical destination, and medical communications during an air medical response and patient transfer.

(b) "Medical Crew Member" means any person employed by an air ambulance service for the purpose of providing care to patients transported by and receiving medical care from an air ambulance service.

(c) "Special Medical Equipment" means any device which shall be approved by the air ambulance service medical director for the medical care of an individual patient on an air ambulance.

(d) "Specialty Crew Member" means any person the air ambulance service medical director assigns for a regular medical crew member for a specialty mission.

(e) "Specialty Mission" means an air ambulance service assignment necessitating the medical director to substitute special medical care providers and/or equipment to meet the specified needs of an individual patient.

(f) "Utilization Review" means the critical evaluation of health care processes and services delivered to patients to ensure appropriate medical outcome, safety and cost effectiveness.

(2) Medical Equipment and Supplies. The medical director for the emergency medical service shall ensure that the following medical equipment and supplies are provided on each fixed-wing or helicopter flight mission:

(a) Litter or stretcher with at least three sets of restraining straps;

(b) An installed and a portable suction apparatus, each of which has the capacity to deliver adequate suction, including sterile suction catheters and a rigid suction tip for both adult and pediatric patients;

(c) Bag/valve/mask resuscitator(s) with clear masks and an oxygen reservoir with connections capable of achieving 95% fraction inspired oxygen to provide resuscitation for both adult and pediatric patients;

(d) Airway devices for adult and pediatric patients including the following:

1. Oropharyngeal airways;

2. Endotracheal tubes;

3. Laryngoscope with assorted blades and accessory items for intubation; and,

4. Alternative advanced airway devices as approved by the service medical director;

(e) Resuscitation board suitable for cardiac compression, unless a rigid stretcher or spine board is employed for patient transfer;

(f) Medical oxygen equipment on board capable of adjustable flow from 2 to 15 liters per minute including the following:

1. Masks and supply tubing capable of administering variable oxygen concentrations from 24% to 95% fraction inspired oxygen for both adult and pediatric patients;

2. Medical oxygen to allow for treatment during 150% of estimated transport time; and,

(g) Sanitary supplies including the following:

1. Bedpan (fixed-wing flight mission only);

2. Urinal (fixed-wing flight mission only);

3. Towelettes (fixed-wing flight mission only);

4. Tissues (fixed-wing flight mission only);

5. Emesis bags;

6. Plastic trash disposable bags; and,

7. Non-latex gloves;

(h) Sheets and blankets for each patient transported;

(I) Patient assessment devices for adult and pediatric patients, including:

1. Flashlight and/or penlight;

2. Stethoscope and Doppler stethoscope;

3. Sphygmomanometer and blood pressure cuffs;

4. Electro-cardiographic monitor/recorder and defibrillator, with transcutaneous pacemaker, having a back-up power source;

5. Pulse oximetry;

6. Capnography, both continuous and portable;

7. Transport ventilator; and

8. Clinical thermometer or temperature strips;

(j) Trauma supplies, including:

1. Sterile dressings;

2. Roller bandages;

3. Device for chest decompression;

4. Surgical airway device as approved by medical direction; and

5. Semi-rigid immobilization devices;

(k) Intravenous fluids and administration devices;

(l) Appropriate medications including the advanced life support medications described in Rule 1200-12-01-.03; and

(m) Neonatal transport equipment that shall conform to the standards adopted in the Tennessee Perinatal Care System Guidelines for Transportation, Tennessee Department of Health, Women's Health and Genetics Section, Fifth Edition, 2006 or successor publication.

1. Isolette shall be capable of being opened from its secured position within the aircraft.

(n) In order to help ensure patient comfort and medical care as well as the safety of patients, crew members and ground personnel, each air ambulance the Board currently permits shall have an environmental control system with factory-installed or FAA approved add-on air conditioner and heater by March 31, 2014.

1. Any air medical aircraft newly permitted by the Board after the effective date of this rule shall have an air conditioner and heater.

2. In the event of a non-functioning air conditioner and/or heater, the aircraft operator shall be required to follow environmental performance criteria including, but not limited to, temperature ranges as approved by the Board.

(3) In addition to the medical equipment and supplies required on either a fixed wing or helicopter flight mission as described in paragraph (2) above, the medical director for the emergency medical service shall ensure that the following medical equipment and supplies are provided on each helicopter flight mission:

(a) Medical oxygen equipment capable of adjustable flow from 2 to 15 liters per minute which shall include:

1. Portable medical oxygen system with a usable supply of at least 300 liters of oxygen; and

2. A backup source of oxygen that shall be delivered via a non-gravity dependent delivery source which may be the required portable tank if it is carried in the patient care area during flight;

(b) Trauma supplies, including:

1. Lower extremity traction device; and

2. Semi-rigid cervical collars.

(4) Each air ambulance service shall offer its instruction materials to other EMS providers within its response area to familiarize them with its requirements for control of helicopter access and ground to air communications on the scene.

(5) Air Ambulance Personnel Qualifications and Duties

(a) Medical Director Qualifications and Duties

1. Each helicopter air ambulance service shall employ a Medical Director who is responsible for providing medical direction for the helicopter air ambulance service.

2. The Medical Director for a helicopter air ambulance service must be a physician having the following qualifications:

(i) Currently licensed in the State of Tennessee;

(ii) Board certified or eligible for Board certification by a professional association or society in General or Trauma Surgery, Family Practice, Internal Medicine, Pediatrics, Emergency Medicine, or Aerospace Medicine;

(iii) Certification in Advanced Cardiac Life Support (unless Board certified or eligible for Board certification in Emergency Medicine);

(iv) Certification in Advanced Trauma Life Support; and

(v) Certification in Pediatric Advanced Life Support or equivalent (unless Board certified or eligible for Board certification in Emergency Medicine), including the following:

(I) Certification in a Neonatal Resuscitation Program; and

(II) Possess adequate knowledge regarding altitude physiology/stressors of flight.

3. Duties of the Medical Director for a helicopter air ambulance service shall include the following:

(i) Active involvement in the Quality Improvement process;

(ii) Active involvement in the hiring, training and continuing education of all medical personnel for the service; and

(iii) Responsibility for on-line medical control or involved in orienting and collaborating with physicians providing on-line medical direction according to the policies, procedures and patient care protocols of the medical transport service.

4. The service Medical Director shall establish mission specific and clinical procedures. He shall require each medical crew member to complete and maintain documentation of initial and annual training in such procedures, which shall at least include didactic and hands-on components for the following clinical procedures:

(i) Pharmacological Assisted Intubation - Adult and Pediatric;

(ii) Emergency cricothyrotomy;

(iii) Alternative airway management - Adult and Pediatric;

(iv) Chest decompression; and

(v) Intraosseous Access - Adult and Pediatric.

(b) The medical crew shall include:

1. Each patient transported by a fixed-wing ambulance shall be accompanied by either a physician, a registered nurse, or an EMT-P licensed in the State of Tennessee.

2. Each transport of patients by a helicopter air ambulance shall require staffing by a regular medical crew which as a minimum standard shall consist of one Registered Nurse licensed in the State of Tennessee and another licensed medical provider (i.e., EMT-P, Respiratory Therapist, Nurse, or Physician licensed in the State of Tennessee). The composition of the medical team may be altered for specialty missions upon order of the medical director of the air ambulance service.

3. On a fixed-wing flight mission only, the air ambulance service medical director may allow transport of patients in the presence of only one medical professional; the minimum level of licensure in such a situation would be that of EMT-P.

(c) Medical crew training and qualifications

1. The service medical director shall make a determination that each regular medical crew member serving on an air ambulance is physically fit for duty by ensuring the service has documentation that each regular crew member has had a pre-employment and annual medical examination.

2. A Registered Nurse serving as a medical crew member on an air ambulance shall meet the following qualifications:

(i) Have three years of registered nursing experience in critical care nursing, or two years fulltime flight paramedic experience and one year critical care nursing experience;

(ii) Possess a current Tennessee nursing license, unless exempted by T.C.A. § 63-7-102(8);

(iii) Obtain certification as an Emergency Medical Technician within twelve (12) months of employment; and

(iv) Obtain advance nursing certification within twelve (12) months of employment through one of the following programs:

(I) Certified Emergency Nurse; or

(II) Critical Care Registered Nurse; or

(III) Certified Flight Registered Nurse.

3. An EMT-Paramedic serving as a medical crew member on an air ambulance shall meet the following qualifications:

(i) Possess a current Tennessee EMT-P license and have three years experience as an EMT-P in an advanced life support service;

(ii) Obtain advanced paramedic certification within twenty-four (24) months of employment through one of the following programs:

(I) Critical Care Paramedic; or

(II) Certified Flight Paramedic.

4. Each medical crew member on an air ambulance shall have and maintain certification in Advanced Cardiac Life Support, Pediatric Advanced Life Support or equivalent (Emergency Nursing Pediatric Course, PEPP), and in neonatal resuscitation.

5. Each medical crew member on an air ambulance shall attend and maintain training in one of the following:

(i) Trauma Nurse Advanced Trauma Course;

(ii) International Trauma Life Support;

(iii) Prehospital Trauma Life Support; or,

(iv) Trauma Nurse Core Course.

(d) Each fixed wing air ambulance service shall have an air medical consultant who shall be a physician licensed within the jurisdiction of the base of operations and shall advise on the restrictions and medical requirements for patient transport.

(e) Each helicopter air ambulance service shall have a Medical Control Physician who shall be available to provide on line medical control continuously via radio or telephone who shall be board certified or eligible for board certification by a professional association or society in General or Trauma Surgery, Internal medicine, Pediatrics, Emergency Medicine, Family Practice, or Aerospace Medicine.

(f) Air Medical Communications specialist qualifications and duties:

1. Each air medical communications specialist shall meet the following qualifications:

(i) At a minimum, be licensed as an Emergency Medical Technician; or

(ii) Be a higher level licensed health care professional with at least two years of emergency medical or emergency communications experience; and

2. Have initial and recurrent training for medical coordination and telecommunications.

3. Air medical communications specialists shall be certified through the National Association of Air Medical Communication Specialists (NAACS) or obtain such certification within twelve (12) months of employment.

(i) Air medical communication specialists shall coordinate helicopter air ambulance service flights.

4. Air medical communications specialists shall not be required to work more than sixteen (16) hours in any one twenty-four (24) hour period.

(g) Duty time for medical crew members on an air ambulance shall not exceed twenty-four (24) consecutive hours or more than forty-eight (48) hours within a seventy-two (72) hour period. The air ambulance service shall provide the medical flight crew adequate rest and meal time. Personnel must have at least eight (8) hours of rest with no work-related interruptions prior to any scheduled shift of twelve (12) hours or more in the air transport environment.

(6) Flight Coordination

(a) Each air ambulance service operations office director shall maintain an Operations Manual detailing policies and procedures and shall ensure that it is available for reference in the operations office. Personnel shall be familiar and comply with policies contained within the manual which shall include:

1. Criteria for medical conditions including indications or contraindications for transfer;

2. Procedures for call verification and advisories to the requesting party;

3. Radio and telephone communications procedures;

4. Policies and procedures for accidents and incidents;

5. Procedures for informing the requesting party of operations procedure, ambulance arrival, termination of mission and delayed responses, including the following:

(i) Estimated Time of Arrival includes time of operations acceptance to time of landing on scene; and

(ii) Any deviation from ETA greater than 5 minutes will be reported to the requesting agency;

6. Procedures shall be established for communications failure or overdue transports;

7. Emergency protocols for alerting search and rescue; and

8. Utilization of the Air Medical Communication Safety Questionnaire (as approved by the board).

(7) Telecommunications

(a) The operations center for an air ambulance service operating in Tennessee shall include radio and telephone equipment to enable personnel to contact the helicopters and crew. Telecommunications devices shall include the following:

1. EMS Communications on the established frequencies of 155.205 MHz, 155.340 MHz, and/or upon such specific channels or frequencies as may be designated within each region as approved and published as a supplement to the State EMS Telecommunications Plan;

2. Direct telephone circuits accessible by air communication; and

3. Recording equipment for both telephone and radio messages and instant message recall.

(8) Helicopter Air Ambulance Response and Destination Guidelines and Procedures.

(a) Medical necessity shall govern air ambulance service response, including medical responsibility and destination coordination, to emergency medical situations.

(b) Medical Necessity.

1. The medical director for the helicopter air ambulance service shall determine whether there is a medical necessity to transport a patient by air ambulance. Medical necessity will be met if the following conditions occur:

(i) At the time of transport the patient has an actual or anticipated medical or surgical need requiring transport or transfer that would place the patient at significant risk for loss of life or impaired health without helicopter transport; or

(ii) Patient meets the criteria of the trauma destination guidelines; or

(iii) Available alternative methods may impose additional risk to the life or health of the patient; or,

(iv) Speed and critical care capabilities of the helicopter are essential; or,

(v) The patient is inaccessible to ground ambulances; or,

(I) Patient transfer is delayed by entrapment, traffic congestion, or other barriers; or,

(II) Necessary advanced life support is unavailable or subject to response time in excess of twenty (20) minutes.

(vi) Specialty Missions with specialized medical care personnel, special medical products and equipment, emergency supplies, and special assistance for major casualty incidents or disasters, or mutual aid to other aero medical services are medically necessary when their availability might lessen aggravation or deterioration of the patient's condition.

(c) The incident commander or his designee will coordinate the transfer of medical responsibility to the medical flight crew by emergency services responsible for the patient at the scene of the incident.

1. If a helicopter air ambulance lands on a scene and it is determined through patient assessment and coordination between ground and air medical personnel that it is not medically necessary to transport the patient by helicopter, the appropriate ground EMS agency will transport the patient.

2. Interfacility transfers shall not be initiated unless an appropriate physician at the receiving facility has accepted the patient for transfer.

(d) Patient destination shall be established pursuant to Rule 1200-12-01-.21.

(9) Records and Reports

(a) The air ambulance service shall maintain records including the following:

1. A record for each patient transported including:

(i) Name of the person transported;

(ii) Date of transport;

(iii) Origin and destination of transport;

(iv) Presenting illness, injury, or medical condition necessitating air ambulance service;

(v) Attending and medical personnel;

(vi) Accessory ground ambulance services;

(vii) Medical facilities transferring and receiving the patient;

(viii) Documentation of treatment during transport; and

(ix) A copy shall be provided to the receiving facility.

2. Each air ambulance service shall report the number of air ambulance transfers performed annually on the form provided for such purposes to the Division of Emergency Medical Services.

(b) Each air ambulance service shall retain patient records for at least ten years.

(10) Utilization Review (UR)

(a) The air ambulance service management shall ensure appropriate utilization review process based on:

1. Chart review of medical benefits delivered to a random sample of patients, including the following:

(i) Timeliness of the transport as it relates to the patient's clinical status;

(ii) Transport to an appropriate receiving facility;

(iii) On scene transports (Rotor Wing) - the following types of criteria are used in the triage plan for on-scene transports:

(I) Anatomic and physiological identifiers;

(II) Mechanism of injury identifiers;

(III) Situational identifiers;

(IV) Pediatric and Geriatric Patients;

(iv) Specialized medical transport personnel expertise available during transport are otherwise unavailable;

2. Structured, periodic review of transports shall be performed at least semi-annually and result in a written report; and

3. The service shall list criteria used to determine medical appropriateness. It will maintain records of such reviews for two years.

(11) Quality Improvement (QI)

(a) The service shall have an established Quality Improvement program, including, at a minimum, the medical director(s) and management.

(b) The service shall conduct an ongoing Quality Improvement program designed to assess and improve the quality and appropriateness of patient care provided by the air medical service.

(c) The service shall have established patient care guidelines/standing orders. The QI committee and medical director(s) shall periodically review such guidelines/standing orders.

(d) The Medical Director(s) is responsible for ensuring timely review of patient care, utilizing the medical record and pre-established criteria.

(e) Operational criteria shall include at least the following quantity indicators:

(i) Number of completed transports;

(ii) Number of air medical missions aborted and canceled due to weather; and

(iii) Number of air medical missions aborted and canceled due to patient condition and use of alternative modes of transport.

(f) For both QI and utilization review programs, the air ambulance service shall record procedures taken to improve problem areas and the evaluation of the effectiveness of such action.

(g) For both QI and utilization review programs, the air ambulance service shall report results to its sponsoring institution(s) or agency (if applicable) indicating that there is integration of the medical transport service's activities with the sponsoring institution or agency (if applicable).

(12) Compliance. Compliance with the foregoing regulations shall not relieve the air ambulance operator 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.

(13) Separation of Services. Air ambulance service shall constitute a separate class of license and authorization from the Board and Department.

Tenn. Comp. R. & Regs. 1200-12-01-.05

Original rule filed March 20, 1974; effective April 19, 1974. Amendment filed November 30, 1984; effective February 12, 1985. Amendment filed February 4, 1988; effective March 20, 1988. Amendment filed June 28, 1988; effective August 12, 1988. Amendment filed August 11, 1993; effective October 25, 1993. Amendment filed January 7, 1997; effective March 23, 1997. Repeal and new rule filed January 7, 1997; effective March 23, 1997. Repeal and new rule filed June 30, 2011; effective September 28, 2011. Amendment filed October 4, 2012; effective January 2, 2013.

Authority: T.C.A. §§ 4-5-202, 4-5-204, 68-140-304, 68-140-307, 68-140-504, and 68-140-507.