6 Colo. Code Regs. § 1015-3-5-5

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

Section 6 CCR 1015-3-5-5 - Application for Colorado Licensing, Licensing Processes, And Base Locations

5.1 Mandatory Requirements for All Applicants Seeking Colorado Licensure

5.1.1 All applicants must:

A) Demonstrate compliance with applicable federal, state and local laws and regulations to operate an air ambulance service in Colorado, including but not limited to, laws and regulations governing medical personnel and emergency medical service providers, licensing and certifications, and professional liability insurance. Applicants are not required to prove compliance with those provisions of federal law that govern activities preempted by the Federal Aviation Act, 49 U.S.C. § 40101, et seq., or the federal "Airline Deregulation Act of 1978"49 U.S.C. § 41713(b)(1).

B) Submit to the Department a completed application form and the application fee as set forth in section 6 of these rules.

C) Upon request, submit to the Department copies of the air ambulance service's written policy and procedure manual, operation/medical protocols, and other documentation the Department may deem necessary.

D) Submit a copy of air ambulance service license(s) concurrently issued and on file with other states.

E) Provide the Department with results of any investigations, disciplinary actions, or exclusions that impact or have the potential to impact the quality of medical care provided to patients as requested by the Department.

F) For an air ambulance service that is not granted qualified immunity under the Colorado Governmental Immunity Act, section 24-10-101et seq., C.R.S., shall provide proof of professional malpractice and liability insurance for injuries to persons in amounts of at least $1,000,000 for each individual claim and a total of $3,000,000 for all claims made against the air ambulance service or its medical personnel from an insurance company authorized to write liability insurance in Colorado or through a self-insurance program.

1) The air ambulance service shall provide the Department with a copy of its certificate of insurance demonstrating compliance with this section or proof of financial viability if self-insured; and

G) Any air ambulance service that is granted qualified immunity under the Colorado Governmental Immunity Act, section 24-10-101 et seq, C.R.S, shall provide proof of professional malpractice and liability insurance coverage, or proof of self-insurance to the maximum extent required by section 24-10-114, C.R.S.

H) Provide proof of worker's compensation coverage as required by Colorado law.

I) 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.

J) Provide a statement signed and dated contemporaneously with the application stating whether, within the previous ten (10) years of the date of application, the applicant has 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.

1) Been convicted of a felony or misdemeanor involving moral turpitude under the laws of any state or of the United States. A guilty verdict, a plea of guilty or a plea of nolo contendere (no contest) accepted by the court is considered a conviction.

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

3) 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.

K) If applicable, provide any statement regarding the information requested in paragraph (J) to include the following:

1) 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.

2) 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.

3) 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.

5.1.2 Air ambulance service licenses are not transferable.

5.1.3 The Department has the authority to conduct an inspection or reinspection of the medical aspects of the air ambulance service operation including equipment and documentation, at any time it deems necessary to ensure compliance with these rules and to protect the public health and medical safety.

5.1.4 The applicant shall provide accurate and truthful information to the Department during inspections, investigations and licensing activities.

5.2 Mandatory Reporting Requirements for all Existing Licensees

5.2.1 Except for requiring proof of compliance with those provisions of federal law that govern activities preempted by the Federal Aviation Act, 49 U.S.C. § 40101, et seq., or the federal "Airline Deregulation Act of 1978"49 U.S.C. § 41713(b)(1), all licensed air ambulance services must notify the Department:

A) At least thirty (30) calendar days prior to the effective date of the change of any name of the air ambulance service and submit a new air ambulance service application and applicable fees.

B) At least thirty (30) calendar days prior to the effective date of any change of ownership, pursuant to section 5.8, the new owner or operator must file for and obtain an air ambulance license from the Department prior to beginning operations.

C) Within five (5) calendar days when there has been a reduction or loss of insurance coverage.

D) Within sixty (60) calendar days of all other changes in insurance coverage.

E) Within seven (7) calendar days of knowing about any of the following events impacting patient medical care occurring on or during transport onto or off of an air ambulance, report to the Department and the approved accreditation organization, if applicable:

1) Invasive procedure performed on the wrong site.

2) Wrong other procedure performed on a patient.

3) Unintended retention of a foreign object in a patient after an invasive procedure.

4) Immediately post procedure death in an American society of anesthesiologists class I patient.

5) Patient death or serious injury associated with the use of contaminated drugs, devices, or biologics provided by the service.

6) Patient death or serious injury associated with the use or function of a device in which the device is used in a manner other than as intended.

7) Patient death or serious injury associated with intravascular air embolism.

8) Release of a patient of any age, who is unable to make decisions, to other than an authorized person.

9) Patient suicide, attempted suicide, or self-harm that results in serious injury.

10) Patient death or serious injury associated with any medication error.

11) Patient death or serious injury associated with any unsafe administration of blood products.

12) Maternal death or serious injury associated with labor or delivery in a low-risk pregnancy.

13) Death or serious injury of a neonate associated with labor or delivery in a low-risk pregnancy.

14) Patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology, or radiology test results.

15) Patient or staff death or serious injury associated with an electric shock in the course of patient care.

16) Any incident in which systems designated for oxygen or other gas to be delivered to a patient contains no gas, the wrong gas, or are contaminated by toxic substances.

17) Patient or staff death or serious injury associated with a burn incurred from any source in the course of patient care.

18) Patient death or serious injury associated with the use of physical restraints during the course of patient care.

19) Death or serious injury of a patient or staff associated with the introduction of a metallic object into the MRI area.

20) Any instance of care ordered by or provided by someone impersonating a licensed health care provider.

21) Any instance of alleged unlawful sexual behavior on a patient or staff member, as defined by section 18-3-401et seq., C.R.S.

22) Patient or staff death or serious injury resulting from a physical assault.

23) Appropriating or possessing without authorization medications, supplies, equipment, or personal items of a patient or employer.

5.3 State Licensing Process.

5.3.1 With respect to those applicants seeking to acquire licensure pursuant to this section, the Department shall review the applicant's fitness to provide appropriate medical care as a licensed air ambulance service. The Department shall determine by on-site inspection or other appropriate investigation the applicant's compliance with applicable statutes and regulations concerning the medical aspects of the air ambulance service. The Department shall consider the information contained in the air ambulance service's application and may request access to and consider other information concerning the medical aspects of the air ambulance service operation including, without limitation, aspects related to patient care, such as:

A) Whether the applicant has legal status to provide the medical and related patient care services for which the license is sought as conferred by articles of incorporation, statute or other governmental declaration,

B) The applicant's previous compliance history, including compliance with requirements of other states or accreditation organizations where the applicant was licensed or accredited within the previous 5 years,

C) The applicant's policies and procedures as delineated in section 9 of these rules,

D) The applicant's quality improvement plans, other quality improvement documentation as may be appropriate, and accreditation reports,

E) Credentials of patient care staff,

F) Interviews with staff, and

G) Other documents deemed appropriate by the Department.

5.3.2 Where an air ambulance service is licensed and subject to inspection, certification, or review by other agencies, states or accrediting organizations, the air ambulance service shall provide and/or release to the Department, upon request, any correspondence, reports or recommendations concerning the air ambulance service applicant that were prepared by such organizations.

5.3.3 The applicant shall provide, upon request, access to such individual patient records as the Department requires for the performance of its licensing and regulatory oversight responsibilities.

5.3.4 An applicant shall provide, upon request, access to or copies of reports and information required by the Department including, but not limited to, medical staffing reports, statistical information, and such other records pertaining to medical and patient care objectives as the Department requires for the performance of its licensing and regulatory oversight responsibilities.

5.3.5 the Department shall not release to any unauthorized person any information defined as confidential under state law or the Health Insurance Portability and Accountability Act of 1996, codified at 42 U.S.C. section 300gg, 42 U.S.C. 1320d et seq., and 29 U.S.C. section 1181, et seq.

5.3.6 As it relates to the medical aspects of the operation of an air ambulance service, the Department may conduct an inspection of the air ambulance service and its aircraft to assure compliance with these rules, and as needed, the Department may conduct complaint and other investigations of an air ambulance service.

5.3.7 The applicant shall submit to the Department the applicable fee(s) set forth in section 6 of these rules.

5.4 Licensure through Accreditation by Organization Approved by Department.

5.4.1 In addition to meeting the requirements in 5.1, applicants that are currently accredited by an organization approved by the Department pursuant to section 5.5 may receive an air ambulance license upon completion of the documentation and payment of fees that are required by the Department. The air ambulance service shall authorize the accrediting organization to submit directly to the Department copies of any documentation within the accrediting organization's control concerning its evaluation of the air ambulance service's compliance with the organization's standards during the previous accreditation cycle. Such documentation shall include but is not limited to, surveys, inspections, final audit reports, plans of correction, and the most recent letter of accreditation showing the service has received accreditation status.

5.4.2 As it relates to the medical aspects of the operation of an air ambulance service, the Department may conduct an inspection of the air ambulance service and its aircraft to assure compliance with these rules and, as needed, the Department may conduct complaint and other investigations of an air ambulance service accredited by an organization approved by the Department.

A) Any air ambulance service licensed under this section shall immediately notify the Department in the event that it receives any notice that its accreditation has been withdrawn, revoked, suspended or modified, or that it is no longer accredited by the accreditation organization approved by the Department.

B) If the licensed air ambulance service voluntarily surrenders its accreditation, or is notified by the accrediting organization that the service's accreditation is at risk of being revoked, suspended, withdrawn, preliminarily denied, deferred, or modified in any way-such as being placed on probation, placed under review or under special review, or placed on-hold--the licensed service must provide the Department within one (1) business day with information describing the circumstances the accrediting organization states for the reason(s) for the possible action. The Department may:

1) Initiate appropriate actions it deems necessary to evaluate the licensed service's performance;

2) Elect to revoke or summarily suspend the service's Colorado license that is based on the accreditation in section 5.4; and/or

3) Require the licensed service to immediately apply for state licensure through the process set forth in section 5.3.

C) If the licensed air ambulance service's accreditation has been withdrawn or revoked, the licensed service must provide the Department with information describing the circumstances the accrediting organization states for the reason(s) for the action. The service shall immediately cease operations. If the air ambulance service wishes to continue to operate it must submit an application and receive a state license as set forth in section 5.3, before it may continue to operate under these rules as a licensed air ambulance service.

1) The Department may allow the service to continue operating under a provisional license as described in section 5.6, below.

2) If the Department allows the service to operate under a provisional license, the provisional license period shall begin on the date of the accreditation withdrawal or revocation. In no event shall the service be allowed to operate under a provisional license for more than one hundred eighty (180) days.

5.4.3 If the Department deems it necessary, the Department may request, and the applicant shall provide, any of the information set forth in section 5.2.

5.4.4 The Department shall publish a list of the accrediting organizations that it has approved on its website.

5.4.5 The applicant shall submit to the Department the applicable fee(s) set forth in section 6 of these rules.

5.4.6 If the licensed air ambulance has made a timely and sufficient application for renewal of the license, the existing license shall not expire until the Department has acted upon the renewal application.

5.5. Requirements for Approval of Accreditation Organization

5.5.1 To be approved by the Department as an acceptable accreditation organization for the purposes of section 5.4, the accrediting organization must meet the following minimum standards:

A) Has standards that are equivalent to or exceed the standards in this chapter.

B) Provides accreditation for no more than three consecutive years without an updated inspection and reaccreditation.

C) Has a multidisciplinary board of directors with members consisting of, at a minimum, individuals who are medical transport professionals and related health professionals that:

1) Seek input and guidance from national professional medical organizations in the development of its standards, and

2) Assure that the organization allows for multidisciplinary input in the development and implementation of its standards and review processes.

D) Uses trained site-surveyors with experience in medical transport at the level of accreditation and license.

E) Assures that air ambulance services with identified deficiencies will implement corrective action or improvement plans to correct any deficiencies.

F) Has an open process that encourages and accepts comments on its accreditation standards.

G) Provides transparency to the public on its standards and procedures.

H) Maintains insurance (general liability, medical professional liability, directors & officers and travel) and be able to present its current certificates of insurance to the Department.

I) In addition to its right to conduct independent inspections of equipment and documentation pursuant to section 5.1.3 of these rules, allows a Department representative to accompany accreditation surveyors on site surveys or during any accreditation inspections at the request of the Department.

J) Has a clear conflict of interest policy.

5.6 Provisional License.

5.6.1 The Department may issue a provisional license to an applicant for an initial license to operate an air ambulance service if:

A) The applicant is temporarily unable to conform to all the minimum standards required under title 25, part 3.5 and these rules;

B) The operation of the applicant's air ambulance service will not adversely affect patient care or the health, safety and welfare of the public; and

C) The applicant air ambulance service demonstrates it is making its best efforts to achieve compliance with the applicable rules.

5.6.2 A provisional license issued by the Department shall be valid for a period not to exceed ninety (90) calendar days, except that the Department may issue a second provisional license for the same duration and shall charge the same fee as for the first provisional license. If the licensee has made a timely and sufficient application for renewal of the provisional license, the existing license shall not expire until the Department has acted upon the renewal application. The Department may not issue a third or subsequent provisional license to the applicant, and in no event shall a service be provisionally licensed for a period to exceed one hundred eighty (180) calendar days.

5.6.3 The applicant shall submit to the Department the applicable fee(s) set forth in section 6 of these rules.

5.7 Conditional License

5.7.1 The Department may impose conditions or limitations upon a license prior to issuing an initial or renewal license or during an existing license term. If the Department imposes conditions or limitations on a license, the licensee shall immediately comply with all conditions or limitations until and unless said conditions are overturned or stayed on appeal.

A) If conditions or limitations are imposed at the same time as an initial or renewal license, the applicant shall pay the applicable initial or renewal license fee plus the conditional fee as set forth in section 6 of these rules. If conditions or limitations are imposed during the license term, the licensee shall pay the conditional fee and the conditions or limitations shall run concurrently with the existing license term. If the conditions are renewed in whole or in part for the next license term, the licensee shall pay the applicable renewal fee along with the conditional fee in effect at the time of renewal.

B) If the Department imposes conditions or limitations of continuing duration that require only minimal administrative oversight, it may waive the conditional fee after the licensee has complied with the conditions or limitations for a full license term.

5.7.2 Unless consented to by the air ambulance service, a limitation imposed prior to issuance of an initial or renewal license shall be treated as a denial. A modification of an existing license during its term, unless consented to by the air ambulance service, shall be treated as a revocation.

5.8 Change of Ownership/Management

5.8.1 When a currently licensed air ambulance service anticipates a change of ownership, the current licensee shall notify the Department within the specified time frame and the prospective new licensee shall submit an application for change of ownership along with the requisite fees and documentation within the same time frame. The time frame for submittal of such notification and documentation shall be at least thirty (30) calendar days before a change of ownership involving any air ambulance service.

5.8.2 in general, the conversion of an air ambulance service's legal structure, or the legal structure of an entity that has a direct or indirect ownership interest in the air ambulance service is not a change of ownership unless the conversion also includes a transfer of at least 50 percent of the licensed air ambulance service'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 5.8.3.

5.8.3 The Department shall consider the following criteria in determining whether there is a change of ownership of an air ambulance service that requires a new license:

A) Sole proprietors:

1) The transfer of at least 50 percent of the ownership interest in an air ambulance service 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.

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

B) Partnerships:

1) 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.

2) 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:

1) 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.

2) 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.

3) 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:

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

2) 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.

3) 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.

5.8.4. 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 air ambulance service, the action shall be considered a change of ownership that requires a new license.

5.8.5 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 days 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 air ambulance service, including administrators, directors, managers and management contractors.

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

2) 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.

D) The name, address and business telephone number of every person identified in section 5.8.5 and the individual designated by the applicant as the chief executive officer of the entity.

1) 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 air ambulance service.

E) Proof of professional liability insurance obtained and held in the name of the license applicant as required by section 5.1.1 & (G) of these rules. 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 Colorado; 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 paragraph (C) of 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.

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

K) Any statement regarding the information requested in paragraph (J) shall include the following, if applicable:

5.8.6 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.

5.8.7 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.

5.9 Base Locations in Colorado

5.9.1 If an air ambulance service has a base located within Colorado, the air ambulance service shall at all times:

A) Maintain or have readily available records of operation;

B) Have security measures in place to protect the air ambulance from tampering and the unauthorized access to medical equipment and supplies, 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;

C) Display its Colorado air ambulance service license within a building at the base location;

D) Display its drug enforcement agency registration in the building where controlled substances, if any, are stored;

E) Maintain a current post-accident incident plan;

F) Comply with applicable state and local building and fire codes;

G) Maintain or have readily available documentation of the professional certifications and/or licenses and continuing education documentation for staff responsible for providing patient care.

5.9.2 An air ambulance service that has a base location in Colorado is not eligible for out of state licensure recognition pursuant to section 4 of these rules.

6 CCR 1015-3-5-5

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

47 CR 10, May 25, 2024, effective 6/14/2024