6 Colo. Code Regs. § 1015-3-5-9

Current through Register Vol. 47, No. 11, June 10, 2024

Section 6 CCR 1015-3-5-9 - General Medical Operational Requirements for Air Ambulance Services Licensed by the Department

9.1 Policies and Procedures

9.1.1 To assess the adequacy of patient care, every applicant or licensee shall make available for reference and inspection a detailed manual of its policies and procedures. Service personnel shall be familiar and comply with policies contained within the manual. The manual shall include:

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) Field triage criteria for all trauma patients;

F) 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 arrival, and cancellation of flight;

G) Criteria regarding acceptable destinations based upon medical needs of the patient;

H) Non-aviation safety procedures for medical crew assignments and notification, including rosters of medical personnel;

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

J) 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;

K) On-ground medical communications procedures;

L) Flight referral 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) Written procedures governing the air ambulance service's medical complaint resolution process and protocols. At minimum, the air ambulance service shall designate personnel responsible for its dispute resolution process and provide the protocols it shall follow when investigating, tracking, documenting, reviewing and resolving the complaint. The service's complaint resolution procedures shall emphasize resolution of complaints and problems within a specified period of time; and

P) Policy for delineating methods for maintaining medical communications during power outages and in disaster situations.

9.1.2. To ensure proper patient care and the effective coordination of statewide emergency medical and trauma services, services that respond to incident scenes and/or support disaster response shall provide aircraft safety and landing zone procedures in a written format to all fire, rescue, ems, public safety, law enforcement agencies and medical facility personnel who interface with the medical service that includes but is not limited to the following:

A) The identification, designating and preparation of appropriate landing zones;

B) Provider safety in and around the aircraft;

C) Air to ground communications; and

D) crash recovery procedures

9.2. Each licensed air ambulance service shall complete and submit to the Department a profile that includes information to be used by the Department to provide effective communications, planning and coordination of statewide emergency medical and trauma services.

9.2.1 All air ambulance service agencies licensed in Colorado shall provide the Department with the required data and information as specified below in a format determined by the Department or in an alternate media acceptable to the Department.

9.2.2 Air ambulance service agencies shall provide organizational profile data in a manner designated by the Department.

9.2.3 Agencies shall update organizational profile data whenever changes occur and at least annually.

9.3 Medical Transport Plans

9.3.1 To ensure proper patient care and the effective coordination of statewide emergency medical and trauma services, all air ambulance services shall have an integrated medical transport plan for each air ambulance licensed 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

I) Mutual aid or backup procedures when the service is not available

9.4 Medically-Related Dispatch Protocols

9.4.1 When air ambulance transport is indicated, requests shall be appropriately coordinated after consultation with the requesting party. All air ambulance services shall maintain communication with all appropriate entities involved in the response, including the receiving facility.

9.5 Medical Communications

9.5.1 An air ambulance service shall have a two-way wireless communication system with reliable equipment that will allow clear voice communication among and between all agencies necessary for the safe and effective transport and medical care of the patient and crew.

9.5.2 An air ambulance service's two-way communication equipment system shall allow for or have:

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

B) Appropriate wireless communications capabilities with local first responders, to include fire, rescue, emergency medical services (EMS), and law enforcement as published in the State EMS Telecommunications Plan.

C) A system of communications, exclusive of the air traffic control system, that must be capable of communications with medical services (EMS), and law enforcement as published in the State EMS Telecommunications Plan.

D) Dedicated telephone number for the air ambulance service dispatch center.

E) The air ambulance service communications center must be staffed during all phases of patient treatment and transport.

F) An emergency plan for communications during power outages and in disaster situations.

9.6 Medical Personnel

9.6.1 At a minimum an air ambulance service must have the following medical personnel:

A) An air ambulance service medical director who oversees the practice of emergency medical services during patient transport for a Colorado licensed service must be familiar with Colorado state medical standards, practices, and licensing requirements. Therefore, except as provided in section 9.6.1 , a medical director must be a Colorado licensed physician in good standing to supervise the medical care provided in an air medical environment. The medical director must also:

1) Be board certified or board-eligible in EMS, emergency medicine, or other specialty serving the patient population involved;

2) Have experience in the care of patients consistent with the licensing and mission profile of the air ambulance service;

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

4) Have a current DEA registration; and

5) Have current credentials achieved through active participation in patient care and continuing medical education activities appropriate for the role of an air ambulance service medical director.

B) For air ambulance services operating pursuant to section 4 of these rules, the medical director who is licensed and in good standing, without restrictions or conditions, in the state in which the service is based, and who is exempt from Colorado licensure requirements pursuant to section 12-36-106(3)(b), C.R.S., may supervise the medical care provided to a patient in an air medical transport that either originates or terminates in Colorado. Under these circumstances the medical director must:

1) Be board certified or board-eligible in EMS, emergency medicine, or other specialty serving the patient population involved;

2) Have experience in the care of patients consistent with the licensing and mission profile of the air ambulance service;

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

4) Have a current DEA registration; and

5) Have current credentials achieved through active participation in patient care and CME activities appropriate for the role of an air ambulance service medical director.

C) An air ambulance service medical director who oversees the practice of emergency medical services during transport of a patient that originates and terminates in Colorado must be a Colorado licensed physician in good standing that meets the requirements set forth in section 9.6.1(A).

D) Medically qualified Colorado licensed, or certified, individuals appropriate to the scope and mission of the air ambulance service, or providers recognized under an interstate compact of which Colorado is a member. Acceptable medical personnel include, but are not limited to physicians, certified emergency medical services providers, registered nurses, registered nurse practitioners, advanced practice nurses, physician assistants, respiratory therapists, or other allied health professionals.

9.6.2 Each patient transport by a licensed air ambulance service shall be staffed by a minimum of two (2) medical personnel who are licensed or certified according to Colorado and/or providers recognized under an interstate compact of which Colorado is a member who provide direct patient care, plus a vehicle operator.

A) One of the medical personnel must be the primary care provider, who, as the team leader with a higher level of license, is ultimately responsible for the patient.

1) The primary care provider may be a licensed nurse, a resident or staff physician, or a paramedic.

2) If the primary care provider is a licensed nurse, s/he must have CEN, CCRN, CFRN or CTRN [or equivalent national certification] within two (2) years of hire and must have pre-hire experience in the medications and interventions listed necessary for the service's scope of care. The licensed nurse must also have three (3) years critical care experience, which is no less than 4000 hours experience in an ICU or an emergency department.

3) If the primary care provider is a paramedic, s/he must have pre-hire experience in the medications and interventions listed necessary for the service's scope of care. The paramedic must also have 3 years critical care experience, which is no less than 4000 hours experience in an ICU or an emergency department.

B) If the second medical provider is a paramedic, then the paramedic must have a FP-C or CCP-C, or Colorado critical care endorsement, or equivalent required within two (2) years of hire, along with three (3) years (minimum of 4000 hours) of advanced life support experience.

C) If the second medical provider is a registered respiratory therapist (RRT), the RRT is required to have a minimum of 4000 hours of emergency department or ICU experience.

D) The composition of the medical team may be altered for specialty missions and teams upon approval and credentialing by the air ambulance service medical director.

E) The medical team must demonstrate affective and psychomotor education sufficient to meet the clinical needs for the type of patient served in an air ambulance medical environment without restrictions.

F) Medical personnel shall operate only within their scope of practice, including an emergency medical service provider acting in accordance with a waiver granted pursuant to Chapter Two, 6 CCR 1015-3.

9.6.3 Training Requirements

A) An air ambulance service shall have a training and educational program that is required for all medical air ambulance personnel, including the medical director.

B) At a minimum, the training and educational program shall contain program orientation, initial and recurrent training which is consistent with the air ambulance service's scope of care, patient population, mission statement and medical direction. The air ambulance service shall document that its air ambulance medical personnel have completed training, met the learning objectives and have ongoing clinical experience in the following:

1) Care of patients in the air medical environment including the impact of altitude and other stressors;

2) Advanced airway management;

3) 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.;

4) Cardiology;

5) 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;

6) High risk obstetrical emergencies and obstetrics care;

7) Pediatrics and neonatal care;

8) Emergency/critical care for all applicable patient populations, including special needs populations;

9) Hazardous materials recognition and response;

10) Management of disaster and mass casualty events;

11) Infection control and prevention; and

12) Ethical and legal issues.

C) The air ambulance service medical director shall have familiarity in the following areas:

1) 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;

2) Hazardous materials recognition and response;

3) Management of disaster and mass casualty events;

4) Infection control and prevention;

5) Advanced resuscitation and care of adult, pediatric and neonatal patients with both traumatic and non-traumatic diagnoses;

6) Quality improvement theories and applications;

7) Principles of adult learning;

8) Capabilities and limitations of care in an air ambulance;

9) Applicable federal, state and local law, rules and protocols related to air medical services and state trauma rule guidelines;

10) Air medical dispatch and communications; and

11) Ethical and legal issues.

9.6.4 Air Ambulance Service Medical Director Roles and Responsibilities

A) The air ambulance service medical director roles and responsibilities shall include:

1) Responsibility for oversight of medical care provided by the air medical service and ensure competency and currency of all medical personnel;

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

3) Development and/or approval of written patient care guidelines (when available), policies and protocols including but not limited to those addressing the adverse impact of altitude on patient physiology and stresses of transport; and

4) Active engagement in quality management, utilization review and patient care and safety reviews.

9.7 Medical Equipment

9.7.1 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. Medical equipment shall be available on the aircraft to meet the local/state protocols for ems providers in which the service intends to operate and in line with the mission of the air ambulance service.

A) Required equipment

1) Isolation equipment including isolation goggles and masks or mask/shield combination, isolation gowns and isolation gloves

2) High particulate filter washes (HEPA filter or n95 mask-assorted sizes)

3) Containers (bags) for infectious medical waste

4) Sharps container

5) Disinfectant/germicidal cleaners, wipes or solutions

6) Waterless hand cleaner

7) Airway equipment, consisting of:

a. Complete set of oropharyngeal airway devices: adult and pediatric,

b. Complete set of nasopharyngeal airway devices: adult, pediatric, and infant

c. Complete set of intubation equipment-adult, pediatric, and infant

8) Syringes, assorted sizes

9) Magill forceps (adult and pediatric sizes)

10) Thermometer

11) Intubation equipment

14) Pediatric weight based drug tape, chart or wheel

15) Water soluble lubricant

16) End-tidal CO2 monitor

17) Advanced airway procedure kit, as applicable

18) Appropriate medications as defined by clinical guidelines or per medical treatment guidelines.

19) ECG monitor/defibrillator and appropriate adult and pediatric pads, including external pacemaker pads (secure positioning of cardiac monitors, defibrillators, and external pacers so that displays are visible to medical personnel)

20) Pulse oximeter with adult and pediatric probes

21) Spare batteries as appropriate for powered medical devices

22) Ventilator as approved by medical director

23) Bandages and dressings

24) Suction equipment including tubing

a. Wall mounted suction unit

b. Portable suction unit powered or hand operated

25) Pharyngeal hard tip suction

26) Soft tip suction catheter set

a. Adult sizes

b. Pediatric sizes

27) Suction bags or replaceable reservoirs

28) Sterile gloves

29) Oxygen equipment - oxygen flow capable of being stopped at the oxygen source from inside the air ambulance and measurement of the liter flow and quantity of oxygen remaining is accessible to air medical personnel while in flight:

a. Main oxygen source

b. Wall mounted oxygen flow meter 0-15 l/min. minimum

i. Oxygen equipment shall be furnished capable of adjustable flow from 0 to 15 liters per minute. Masks and supply tubing for adult and pediatric patients shall allow administration of variable oxygen concentrations from 24% to 95% fraction inspired oxygen. Medical oxygen shall be provided for 150% of the scheduled flight time by a unit secured within the air ambulance.

30) Compressed air as appropriate (each gas outlet clearly marked for identification)

31) Portable oxygen cylinder with portable variable flow regulator 0-15 l/min. Minimum

32) Bag-valve-mask with reservoir to provide one hundred per cent oxygen flow (adult, pediatric and infant sizes)

33) Oxygen masks (adult, pediatric and infant sizes)

34) Nasal cannulas (adult and pediatric sizes)

35) Nebulizer and appropriate connecting tubing

36) Adjunct equipment

a. Trauma shears

b. Stethoscope (adult and pediatric)

c. Tourniquets

37) Blood pressure cuffs: (large adult, adult, pediatric, infant)

38) Patient hearing protection

39) Assorted tape

40) Exam gloves

41) Obstetrical kit

42) Nasogastric tubes (adult and pediatric)

43) Patient restraints

44) Pediatric restraining system

45) Intravenous equipment, including but limited to:

a. Alcohol, chlorhexidine, or betadine skin cleanser (preferably prep pads)

b. IV administration sets

c. IV infusion pump tubing

d. IV catheters, assorted sizes 24-14

e. Intraosseous needles

f. IV solutions, per protocol

46) Needles, assorted sizes

47) Associated adjunct equipment

a. Invasive line set-up

b. Pressure bags

48) One or more cots/stretchers capable of being secured in the aircraft that meet the following criteria:

a. Accommodates an adult of a height and weight appropriate for the capacity of the air ambulance, and restraining devices or additional appliances available to provide adequate restraint of all patients including those under 60 pounds or 36 inches in height.

b. The head of the primary stretcher is capable of being elevated up to 30 degrees. The elevating section shall not interfere with or require that the patient or stretcher securing straps and hardware be removed or loosened.

c. Sturdy and rigid enough that it can support cardiopulmonary resuscitation. If a backboard or equivalent device is required to achieve this, such device will be readily available.

d. A pad or mattress impervious to moisture and easily cleaned and disinfected according to occupational safety and health administration (OSHA) blood borne pathogen requirements (29 C.F.R § 1910.10302016).

e. A supply of linen for each patient.

49) Survival kit for all medical crew members and patient

9.8 Patient Compartment

9.8.1 An applicant or licensee shall ensure that an air ambulance has the following:

A) A climate control system to prevent temperature variations that would adversely affect patient care.

B) 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.

D) A back-up source of electrical power or batteries capable of operating all electrically powered life-support equipment for at least one hour.

E) An appropriate power source that is sufficient to meet the requirements of the complete specialized equipment package without compromising the operation of any electrical air ambulance equipment.

F) 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.

G) If an isolette is used during patient transport, an isolette that is able to be opened from its secured in-flight position in order to provide full access to the patient.

H) Adequate access and necessary space to maintain the patient's airway and to provide adequate ventilator support by an attendant from the secured, seat-belted position within the air ambulance.

I) A configuration that allows for rapid exit of personnel and patients, without obstruction from stretchers and medical equipment.

J) An interior that is sanitary and in good working order at all times.

K) Appropriate storage for medications that maintains temperatures within manufacturer recommendations. Glass containers shall not be used unless required by medication specifications and properly vented. Medications, fluids and controlled substances shall be securely maintained by air ambulance licensees in compliance with local, state, and federal drug laws.

L) Secure positioning of cardiac monitors, defibrillators, and external pacers so that displays are visible to medical personnel.

9.9 Data Collection and Submission

9.9.1 All services shall have a system in place to collect, submit, monitor, and track all flight requests that result in patient transport. This information shall be submitted and made readily available to the Department upon request.

9.9.2 Colorado licensed air ambulance services shall submit data and information as required in 6 CCR 1015-3, Chapter Three Rules Pertaining to Emergency Medical Services Data and Information Collection and Record Keeping and section 18 of these rules, to the extent data collection and submission serve a medical or quality improvement purpose.

9.10 Continuous Quality Improvement Program

9.10.1 Air ambulance services 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 service. The program shall include:

A) Development of protocols, standing orders, training, policies, 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 quality of field performance.

9.10.2 All services 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. Goals 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. This shall include outcome studies, chart review, case discussion, or other methodology.

C) Findings, conclusions, recommendations and actions shall be made and recorded. Follow-up, if necessary, shall be determined, recorded, and performed.

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

9.10.3 All services shall have a written policy outlining a utilization review process.

9.11 Medical Staff and Patient Safety Welfare

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

9.11.2 On-site shifts scheduled for a period to exceed twenty-four (24) hours are not acceptable under most circumstances. The following criteria must 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 service.

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 must 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. There must be no adverse personnel action or undue pressure to continue in this circumstance.

E) Management must monitor transport volumes and personnel's use of a "time out" policy.

9.11.3 Shifts extended over several days may be scheduled to address long commutes at programs with low volumes. The program must clearly demonstrate and document it meets the above criteria for shifts over twelve (12) hours. In addition:

A) A program's base averages less than one (1) transport per day.

B) Provides at least ten (10) hours of rest in each twenty-four (24) hour period.

C) Location of the base or program is remote and one-way commutes are more than two (2) hours.

D) Fatigue risk management tools are utilized.

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

9.11.5. Physical well-being is promoted through:

A) Protective clothing and dress code pertinent to:

1) Mission profile such as turn-out gear available at scene for medical personnel who assist with heavy extrication

2) Safe operations, which shall include:

a. Boots or sturdy footwear,

b. Appropriate outerwear to protect the provider from adverse environmental conditions and

c. If medical crews and vehicle operators respond to night scenes, the ambulance medical crew members must wear high visibility reflective vests or Department of Transportation-approved clothing that meets industry standards.

3) In addition to the mandatory requirements in 9.11.5(A), safe operations may include:

a. Wearing reflective material or striping on uniforms for night operations; and

b. Flame retardant clothing (strongly encouraged for rotor wing services according to a risk assessment)

9.11.6. The air ambulance service shall establish an infection control protocol that complies with occupational safety and health administration (OSHA) standards, including 29 C.F.R. § 1910.1030 (2016), 29 C.F.R. § 1910.132 (2016), and 29 C.F.R. 1910.134 (2016).

9.11.7 The air ambulance services shall have an appropriate dress code that addresses jewelry, hair and other personal items of medical personnel that may interfere with patient care.

6 CCR 1015-3-5-9

37 CR 12, June 25, 2014, effective 5/21/2014

37 CR 12, June 25, 2014, effective 7/15/2014

37 CR 22, November 25, 2014, effective 12/15/2014

38 CR 24, December 25, 2015, effective 1/14/2016

40 CR 10, May 25, 2017, effective 7/1/2017

40 CR 20, October 25, 2017, effective 1/1/2018

40 CR 21, November 10, 2017, effective 1/1/2018

41 CR 23, December 10, 2018, effective 1/14/2019

43 CR 22, November 25, 2020, effective 1/1/2021

44 CR 23, December 10, 2021, effective 12/30/2021

45 CR 10, May 25, 2022, effective 6/14/2022