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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.12, GOVERNING BODY, was out of compliance.

A-0085 The governing body must be responsible for services furnished in the hospital whether or not they are furnished under contracts. The governing body must ensure that a contractor of services (including one for shared services and joint ventures) furnishes services that permit the hospital to comply with all applicable conditions of participation and standards for the contracted services. Based on interviews and document reviews, the facility's governing body failed to ensure services were provided in compliance with all applicable conditions of participation and standards for contracted services. Specifically, the facility used an unlicensed contracted air ambulance service to transport patients who were not medically cleared for commercial transportation. This failure was identified in 2 out of 2 patient records who required air ambulance. (Patient #2 and #3).

Based on interviews and document reviews, the facility's governing body failed to ensure services were provided in compliance with all applicable conditions of participation and standards for contracted services. Specifically, the facility used an unlicensed contracted air ambulance service to transport patients who were not medically cleared for commercial transportation. This failure was identified in 2 out of 2 patient records who required air ambulance. (Patient #2 and #3).

Findings include:

Facility policy:

The Contract Policy read, organizations must monitor contracted services just as they monitor employees and that every contract for patient care services includes written performance measures that must be monitored. The policy further read The Joint commission standards, CMS regulations, state governing laws and state agencies require that organizations ensure that patient care, treatment and services through contractual agreements are provided safely and effectively. Organizations must monitor contracted services just as they monitor employees.

References:

According to the Colorado Department of Public Health and the Environment Air ambulance licensing and recognition, air ambulance services are licensed and regulated by the Colorado Department of Public Health and Environment. A license is required when patients are transported from any point within Colorado, to any point within or outside of Colorado.

According to the Code of Colorado Regulations Health Facilities and Emergency Medical Services Division EMERGENCY MEDICAL SERVICES 6 CCR 1015-3, 1.3 An air ambulance service may be authorized to operate in Colorado by either: A) Holding an accreditation by an accrediting organization approved by the Department and complying with section 5.1; B) Meeting the standards set forth in these rules (sections 5.1 and 5.3); or C) An air ambulance service may obtain a recognition instead of license if it picks up patients within the state of Colorado for out of state transport no more than 12 times per calendar year as set forth in section 4.

Colorado Revised Statues (C.R.S 25-29-101) 25-29-103 Denver health and hospital authority (2) the authority shall be governed by an eleven-member board of directors. The board shall be responsible for the operation of the health system.

1. The facility failed to ensure the Governing Body monitored and verified the contracted air ambulance service was appropriately licensed in the state in which services were provided.

This failure resulted in the facility using an unlicensed contracted air ambulance service to transport patients from March 2020 to January 2021.

Document Review

a. According to the contracted agreement between the air ambulance service and the facility, the air ambulance service would comply with all applicable federal and state laws and regulations.

Review of the contract between the facility and contracted air ambulance service was initiated on 1/21/2016 and automatically renewed yearly every March 31st. As of 2/4/21, the facility continued to use, and had a contract with, the air ambulance service.

b. Online license verification revealed the contracted air ambulance service's license expired on 3/19/20.

c. Governing Board meeting minutes were reviewed from 2/27/20 to 12/17/20. There was documentation contracted services or contract review was performed.

d. The facility provided documentation of use of the air ambulance service which indicated the service was used 16 times from 4/1/20 to 12/31/20. Additionally, after review of Patient #2's medical record it was identified the air ambulance service was still being utilized on 1/19/21.

e. Review of patient #2's medical record revealed she was admitted for anorexia and severe malnutrition. Patient #2's treatment team documented patient #2 required ongoing hospitalization for weight restoration and medical stability. The medical record revealed the contracted air ambulance service transported Patient #2 to her home on 1/19/21 after their license expired. This use of the air ambulance service was not listed on documentation the facility provided of the number of uses of the unlicensed contracted air ambulance service for admissions and discharges.

f. Review of Patient #3's medical record revealed she was admitted for severe malnutrition. On 10/19/20, Patient #3 was transported to a treatment facility in another state using the contracted air ambulance service after their license expired.

g. On 2/2/21 at 9:28 a.m., an interview was conducted with Social Worker (SW #4). SW #4 stated the air ambulance service was not frequently used, but was used more since the COVID-19 pandemic began. SW #4 stated she did not know if the facility had a contract with the air ambulance service.

Interviews

h. On 2/3/21 at 1:52 p.m., another interview was conducted with SW #4. SW #4 stated the unlicensed contracted air ambulance service was the only one she was told to use if patients were not cleared for commercial air transportation by a physician. SW #4 stated the facility used the contracted air ambulance service because the patient population who were transported had severe health concerns and were not medically cleared to use commercial transport.

i. On 2/3/21 at 2:52 p.m., an interview was conducted with the Acute Medical Director (Director #3). Director #3 stated he was not responsible for verifying licenses of contracted services such as air ambulances. Director #3 stated the facility should not use a contracted ambulatory service if they were not licensed by the State of Colorado. Director #3 stated the use of the contracted air ambulance service was to ensure a safe environment for patient transport. Director #3 stated this was important because patients using the air ambulance service may struggle with basic self-care or have behavioral issues which present a danger to themselves or others.

j. On 2/3/21 at 3:25 p.m., an interview was conducted with Chief Operations Officer (COO #2). COO #2 did not know the contracted air ambulance service did not have a current license, but was aware of how to verify licensure. COO #2 stated the contract was automatically renewed annually, but stated it was not the COO's responsibility to check licensure status annually. COO #2 stated most contracts were approved by the governing body, but was uncertain whether the governing body approved the contract with the ambulatory air service in 2016. COO #2 stated it was important contracted services have current state licensure because the facility must comply with state and local law. COO #2 stated contracting with an unlicensed air ambulance service was a patient safety concern and would be out of compliance with the Centers of Medicare and Medicaid services (CMS).

k. On 2/4/21 at 9:58 a.m., an interview was conducted with the General Counsel for the facility (Counsel #1). Counsel #1 stated facility contract required the vendor to comply with applicable laws and regulations. Counsel #1 stated the contract with the air ambulance service was last reviewed in 2016, but did not know if the contract had been reviewed since then because the contract automatically renewed annually. Counsel #1 stated the facility had the ability to verify state licensure of the contracted air ambulance services, but that was not a typical process. Counsel #1 stated the board of directors very rarely got involved in a contract, but the board of directors approved the contract policy.

Counsel #1 stated it was disconcerting the contracted air ambulance service was used to transport patients from the facility after their state issued license expired. Counsel #1 stated this was a patient safety issue. Counsel #1 stated the facility planned on reaching out to the air ambulance service regarding the licensing issue and would terminate the contract if they did not quickly get licensed. Counsel #1 stated the facility would begin using an electronic management system next summer which should help enable the facility to track licensure better. Counsel #1 stated the manual system for tracking the facility was using was not easy to manage.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.13, PATIENT RIGHTS, was out of compliance.

A-0144 The patient has the right to receive care in a safe setting. Based on interviews and document reviews, the facility failed to protect the patient's right to receive care in a safe environment. Specifically, the facility used an air ambulance company which was unlicensed and therefore did not meet state regulations. This failure was identified in 2 out of 2 patient records (Patient #2 and Patient #3).

Based on interviews and document reviews, the facility failed to protect the patient's right to receive care in a safe environment. Specifically, the facility used an air ambulance company which was unlicensed and therefore did not meet state regulations. This failure was identified in 2 out of 2 patient records (Patient #2 and Patient #3).

Findings include:

Facility policies:

The Patient Rights and Responsibilities policy read, patients have a right to get care in a safe setting that is free from neglect, exploitation, and verbal, mental, or physical abuse.

The Contract policy read, organizations must monitor contracted services just as they monitor employees and that every contract for patient care services includes written performance measures that must be monitored. The facility must maintain a list of all active contracts. The policy further read it was the Legal Department's role to review legal aspects of the contract which includes governing law.

References

According to the Colorado Department of Public Health and the Environment Air ambulance licensing and recognition, air ambulance services are licensed and regulated by the Colorado Department of Public Health and Environment. A license is required when patients are transported from any point within Colorado, to any point within or outside of Colorado.

According to the Code of Colorado Regulations Health Facilities and Emergency Medical Services Division EMERGENCY MEDICAL SERVICES 6 CCR 1015-3, 1.3 An air ambulance service may be authorized to operate in Colorado by either: A) Holding an accreditation by an accrediting organization approved by the Department and complying with section 5.1; B) Meeting the standards set forth in these rules (sections 5.1 and 5.3); or C) An air ambulance service may obtain a recognition instead of license if it picks up patients within the state of Colorado for out of state transport no more than 12 times per calendar year as set forth in section 4.

1. The facility failed to follow state regulations and provide care in a safe setting by transporting patients via an unlicensed air ambulance service.

a. The facility provided documentation of use of the air ambulance service which indicated the service was used 16 times from 4/1/20 to 12/31/20. Additionally, after review of Patient #2's medical record it was identified the air ambulance service was still being utilized on 1/19/21.

b. Review of Patient #3's medical record revealed she was admitted for anorexia and severe malnutrition. According to the Discharge Summary dated 10/18/21 by Patient #3's attending physician, the treatment team decided Patient #3 required ongoing hospitalization for weight restoration and medical stability. Patient #3 required total parenteral nutrition (TPN, a method of getting nutrition into the body through a vein), total feeding (TF), continuous telemetry monitoring and continuous observation for her safety. Patient #3's had a diagnosis of anorexia with severe malnutrition with chronic mood dysregulation and was uncooperative with treatments and needed significant staff intervention and support.

Despite the patient requiring extensive continuous monitoring, the facility used an unlicensed air ambulance service to transport Patient #3 on 10/19/20.

c. Review of Patient #2's medical record revealed she was admitted for anorexia and severe malnutrition. Patient #2's treatment team decided Patient #2 required ongoing hospitalization for weight restoration and medical stability. According to the Discharge Summary dated 1/15/21 by Patient #2's physician, Patient #2 was non-compliant with treatments and was diagnosed with psychosis.

Although Patient #2 required continuous monitoring during transport, the facility transported Patient #2 using an unlicensed air ambulance service on 1/19/21.

d. On 2/2/21 at 2:48 p.m., an interview was conducted with the Nurse Manager of the acute unit (Manager #5). Manager #5 stated the air ambulance service was used for patients who were unsafe to fly commercial from the facility. Manager #5 stated the air ambulance service was given report of the patient condition, had access to patient records and was aware of the specific needs of the patient population on the acute care unit. Manager #5 stated the air ambulance service had a medical team with nurses who could administer medication on board and were able to intervene if there was an emergency. Manager #5 stated the social workers' team was responsible for arranging the air ambulance service. Manager #5 stated she was unaware if the air ambulance service was licensed or how the license was verified.

e. On 2/3/21 at 2:52 p.m., an interview was conducted with the Acute Medical Director (Director #3). Director #3 stated the air ambulance service was used to ensure patient safety because they required medical and/or behavioral services during transport such as monitored blood sugars, acute interventions, or care for behavioral behaviors where patients posed a risk to themselves or others. Such patients were inappropriate for commercial transportation and were instead transported through the air ambulance service. Director #3 was unaware whether the air ambulance service was licensed and stated ensuring licensure was not his responsibility. Director #3 stated that if an air ambulance service was not licensed, the facility should not use the service to transport the facility's high-risk patients.

f. Review of the contract between the facility and the contracted air ambulance service revealed it was initiated on 1/21/16 and automatically renewed yearly every March 31st.

g. On 2/3/21 at 3:25 p.m., an interview was conducted with Chief Operation Officer (COO #2). COO #2 stated she reviewed contracts from an operational point of view. COO #2 stated the contract with the air ambulance service was auto-renewed, which meant the contract was extended every year for a five year period. COO #2 was responsible for quarterly reviews of contracts. COO #2 stated it was important that air ambulance service were licensed in the State of Colorado because it was required by state and local law. COO #2 stated using an unlicensed air ambulance service to transport patients presented a patient safety risk.

h. On 2/4/21 at 9:58 a.m., an interview was conducted with General Counsel for the facility (Counsel #1). Counsel #1 state he was responsible for overseeing the legal department and risk management department. Counsel #1 stated contracts should require the vendor to comply with laws and regulations. Counsel #1 stated the assigned contract administrator was responsible for the contract. Counsel #1 also stated transporting a patient with an unlicensed air ambulance service posed multiple risks to patients.

Counsel #1 stated the facility's legal team knew how to verify licensure with the State of Colorado and recently became aware the air ambulance service was not licensed. Counsel #1 stated it was disconcerting the service had not maintained their license per their contract. Counsel #1 stated the facility planned on reaching out to the air ambulance service regarding the licensing issue and would terminate the contract if they did not quickly get licensed.

i. On 2/4/21 at 12:30 p.m., an interview was conducted with Chief Quality Officer (Officer #5). Officer #5 stated he understood the importance of patient safety during transportation. Officer #5 stated the facility started using the air ambulance service to ensure patient safety after a patient died on a flight with a different company. Officer #5 stated the use of an unlicensed air ambulance service created an unsafe environment for the facility's patients.