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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 §482.13, 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 review, the facility failed to ensure a safe environment of care for patients. Specifically, the facility failed to ensure an air medical transportation company used to transport patients with basic medical and critical care needs was licensed in the state of Colorado to meet the needs of the patients during the air transport. Document review showed 2 of 3 records reviewed of patients transferred out of the facility by air medical transport, (Patient #4 and Patient #5) used the unlicensed air transport company.

Based on interviews and document review, the facility failed to ensure a safe environment of care for patients. Specifically, the facility failed to ensure an air medical transportation company used to transport patients with basic medical and critical care needs, was licensed in the State of Colorado. Document review showed 2 of 3 records reviewed of patients transferred out of the facility by air medical transport, (Patient #4 and Patient #5) used the unlicensed air transport company.

Findings include:

Facility policies:

The Discharge Planning policy read, the patient would be evaluated throughout the hospitalization to identify needs of the patient prior to discharge. Patients were screened to determine post discharge needs with focus on prevention of the risk of adverse health outcomes after discharge due to lack of discharge planning. Included the determination of the appropriate discharge destination and what was required for a seamless and safe transition from the hospital to the discharge destination.

The Patient Rights and Responsibility policy read the patients' right to receive quality care, be involved in and understand the planning of their care, and to be treated in a safe setting.

Reference:

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 ensure the air medical transport company used to transfer patients was licensed within the State of Colorado to ensure the care provided was safe.

a. Interviews with staff revealed inconsistencies in understanding the requirements of the air medical transport company qualifications and licensure during air medical flight transportation, which put patients with basic and critical medical conditions at risk.

i. On 2/2/21 at 3:41 p.m., an interview was conducted with Doc Line Registered Nurse (RN) #1. RN #1 stated transportation set up meant the transport company had accepted responsibility to handle the patient's medical needs during transport. She stated medical needs included intravenous (IV) fluid infusions or any treatments the patient needed during transport to support the patients level of care.

ii. On 2/2/21 at 5:10 p.m., an interview was conducted with Life Line Transport Emergency Medical Technician (EMT) #2. EMT #2 stated the provider requested the level of transport a patient needed. EMT #2 stated the facility assisted outside facilities as needed for transport needs. When assisting other facilities with transport, they required information to be shared pertinent to the patients' care including but not limited to diagnosis, IV infusions, and special equipment needed during the flight. The information was used to determine the type of aircraft needed for out of state or international dispositions both into and out of the facility. EMT #2 stated he was aware of licensure specific to certain counties or regions, but could not provide specific information for air medical transport companies' licensure in the State of Colorado or how to verify it. EMT #2 stated the facility assumed the air medical transport company would not agree to provide care if they were not licensed to provide the level of medical care the patient needed. EMT #2 stated there were multiple risks involved if an unlicensed air medical transport company was used to transport a patient with critical care needs which included patient decompensation, equipment failure and even death of the patient.

iii. On 2/3/21 at 9:41 a.m., an interview was conducted with the Manager of RN Care Managers (Manager) #8. Manager #8 stated RN Care Managers who needed to arrange air transportation would not use a specific company since there were no current contracts with an air medical transport company. Leadership need to be involved in these situations. The air medical transport company chosen would depend on the availability of the company to provide the service in a timely manner. The patient information was provided to the company and the company then verified their ability to care for the patient during the flight. When asked about licensure of air medical transport companies, Manager #8 stated she was not aware of how to verify licensure of these companies.

iv. On 2/3/21 at 1:00 p.m., an interview was conducted with Vice President (VP) #7. VP #7 stated it was important to understand the patients' care needs to verify the air medical transport company could meet the specific needs of critical patients during transport which included the maintenance of IV infusions and cardiac monitoring. VP #7 stated not verifying the qualifications of the air transport company would put critically ill patients at risk of not receiving the care they needed during the air transport.

v. On 2/4/21 at 12:18 p.m., an interview was conducted with the Chief Medical Officer of Revenue Cycle (CMO) #6. CMO #6 stated the facility had no current contracts with air medical transport companies. CMO #6 stated they presumed if a company accepted the air medical transport of a critically ill patient, the company would be licensed. CMO #6 stated if the facility had a contract with a company, they would not go through primary source verification like they would for physician privileging, to create the contract. CMO #6 stated the reason physicians were under increased scrutiny was due to regulations requiring the verification of various physician licensure and certifications. CMO #6 stated it was the facilities responsibility to discontinue the use of a contracted service once they became aware of a lapse in licensure. CMO #6 stated there were reasons rules were put into place as it was dangerous to use a company operating without a license. CMO #6 stated there was not a process at the facility for primary source verification of the licensure of air medical transport companies.

vi. On 2/4/21 at 1:46 p.m., a follow up interview was conducted with VP #7. VP #7 stated it was important for ambulance service companies to be licensed to legally operate in certain areas, the licensure requires the company to meet patient safety guidelines. VP #7 stated the requirements encompass configuration of aircraft, the type and amount of training and personnel requirements. VP #7 stated risks associated with an unlicensed company would be personnel who were unqualified with inadequate safety training to care for the patient during the flight.

b. Record review of Patient #4 revealed she was transported by an unlicensed air medical transport company on 7/29/20 to an out of state rehabilitation facility. Patient #4 recently had surgery on her brain and was unable to support herself while seated upright due to weakness on one side of her body. Patient #4 had medical needs during transport as she was at risk for falling and therefore needed to be transported on a stretcher for safety.

i. On 2/4/21 at 11:29 a.m., an interview was conducted with Provider #5. Provider #5 stated Patient #4 and her family requested post hospitalization inpatient physical and occupational therapies in a different state. He stated the preferred method of travel for the post neurosurgical patient, was to travel by air. Provider #5 stated his preference for air travel versus ground transportation was by air because if a neurological emergency occurred during transportation, the aircraft would land at a major city with neurological services for the patient nearby. Provider #5 stated Patient #4 required assistance with care during her flight due to her inability to walk or independently sit upright, secondary to weakness of her limbs on one side of her body.

c. Record review of Patient #5 revealed he was transported by an unlicensed air medical transport company to his home state on 12/1/20 for extensive inpatient chemotherapy treatment following a new cancer diagnosis. Patient #5 had continuous IV fluids and critical care monitoring needs during the flight.

i. On 2/4/21 at 9:53 a.m., an interview was conducted with Care Manager (CM) #3. CM #3 facilitated Patient #5's discharge needs which coordinated with insurance in arranging the air medical transport. CM #3 stated she was not aware Patient #5 would require IV fluid management during the flight. CM #3 stated all medical orders were faxed to the air medical transport company and they had accepted Patient #5. CM #3 stated Patient #5 had a very short amount of time to begin his chemotherapy. When asked how the facility knew the air medical transport company could provide the level of care Patient #5 required, CM #3 stated the air medical transport company was approved by Patient #5's medical insurance, therefore she did not verify the transport company's license to operate in the State of Colorado.

ii. On 2/4/21 at 11:01 a.m., an interview was conducted with Provider #4. Provider #4 stated Patient #5 needed to begin an intensive, structured, month long inpatient chemotherapy treatment upon his return to his home state. Provider #4 stated Patient #5 was at risk for toxicity and infection and the timeline for Patient #5 to remain stable was tight. Provider #4 stated Patient #5 required close monitoring throughout the flight. Provider #4 stated a six hour commercial flight was not an option for Patient #5, since he needed an ambulance level of care. Provider #4 stated the patient needed continuous IV fluids to prevent disseminated intravascular coagulation (DIC), an increase in blood clot formation. Patient #5 was too high risk to be transported in a non-monitored setting. Provider #4 stated the critical medical needs of Patient #5, made air medical transport the only safe way for Patient #5 to travel. Provider #4 stated he was not familiar with the licensure requirements and hoped the air transport company could provide the level of care they had attested too when they accepted the transport.