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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 §482.11 Condition of Participation: Compliance with Federal, State, and Local Laws, was out of compliance.

A-0020 Condition of Participation: Compliance with Federal, State and Local Laws.

Based on document review and interviews, the facility failed to ensure state law requirements were met. Specifically, the facility failed to ensure state regulations for patient event reporting were met.

Findings include:

Policy:

The Events Reportable to the State policy read, its purpose was to ensure timely reporting of all reportable occurrences, as required by the Colorado Department of Public Health and Environment (CDPHE). The facility will report all reportable occurrences within one business day following a reportable occurrence. Reportable occurrences include unexplained deaths, brain injuries, spinal cord injuries, life-threatening complications of anesthesia, life-threatening transfusion errors/reactions, severe burns, missing persons, physical abuse, verbal abuse, sexual abuse, neglect, misappropriation of property, diverted drugs, and malfunction/misuse of equipment. Risk Management in consultation with others, including legal counsel, determines whether an event is a reportable occurrence. Risk Management or designee submits all reportable occurrences through the Colorado Health Facilities Web Portal or by contacting CDPHE directly. An initial report will be submitted within one business day of the occurrence and final reports will be submitted within five days of the initial report. Risk Management works with CDPHE to ensure that all requested follow-up information is provided timely.

Reference:

The Health Facilities and Emergency Medical Services Division (HFEMSD) Occurrence Reporting Manual read, any occurrence that results in any of the following serious injuries to a patient: life-threatening complications of anesthesia. Section 25-1-124-(2)(b)(II), C.R.S. Two elements are needed: the occurrence (event) as a result of anesthesia and life-threatening complication/reaction.

1. The facility failed to ensure life-threatening complications of anesthesia were reported to the state agency as an occurrence.

A. Document review

i. Patient #2's medical record was reviewed. On 2/26/24 at 1:40 p.m., Patient #2 received medication for the induction of anesthesia. Patient #2 suffered a cardiac arrest (a condition where the heart stops beating unexpectedly, preventing blood from circulating properly and reaching the brain and other organs) during airway intubation (a medical procedure that involves inserting a tube into a patient's airway to help them breathe). A code blue (an emergency call used to alert staff to help with a medical emergency, usually cardiac and/or respiratory arrest) was called and Patient #2 was resuscitated. Patient #2 sustained an anoxic brain injury and passed away six days later.

ii. A review of the Events Reportable to the State policy read, the facility will report all reportable occurrences within one business day following a reportable occurrence. Reportable occurrences included life-threatening complications of anesthesia.

iii. A review of the HFEMSD Occurrence Manual, referenced above, revealed serious injuries to a patient, such as life-threatening complications of anesthesia, were to be reported to the state agency.

iv. A review of the state agency's occurrence reporting database on 11/12/24 (more than eight months after Patient #2's event) revealed no occurrences had been reported concerning the life-threatening complications of anesthesia which resulted in serious harm and death to Patient #2.

B. Interview

i. On 11/14/24 at 2:58 p.m., an interview was conducted with the director of risk management (Director) #1. Director #1 stated events listed in the state agency occurrence manual were required to be reported to the state agency. Further, Director #1 stated Patient #2's life-threatening complications of anesthesia had not been reported to the state agency as required by facility policy and state regulations.