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Based on staff interview and document review, the facility failed to ensure the medical staff were accountable to the governing body for the quality of the medical care provided to the patients for one of 10 patient records reviewed (Patient #1). This had the potential to affect all patients presenting to the cath lab. The cath lab performed 736 diagnostic and 536 non-surgical coronary revascularizations in the cath lab in the last 12 months.

Findings include:

Review of the medical record for Patient #1 revealed arrival on 12/04/23 to the emergency department (ED) at 11:11 AM by ambulance. The patient was breathing and unresponsive. The patient lost pulses as he was transferred from the ambulance cot to the ED cot. A STEMI (ST-elevation myocardial infarction) alert and Code Blue were called and CPR (cardiopulmonary resuscitation) was started at 11:13 AM. Chest compressions were done manually at first and then a Lucas Device (automatic chest compression device) was placed and took over all chest compressions. ROSC (return of spontaneous circulation) was achieved but the patient lost pulses again and CPR was reinitiated. At 11:24 AM, a foley catheter was placed and the patient was intubated. At 11:37 AM, Patient #1 was taken to the cath lab emergently with the Lucas Device doing chest compressions. At 11:53 AM, ECMO (extracorporeal membrane oxygenation) was initiated. At 12:03 PM, the CPR ended. Patient #1 was transferred to another facility for additional care later that day.

Review of the staff list for the cath lab revealed there were six Registered Nurses (RN) and five Radiologic Technologists (Rad Techs) in the cath lab.

On 01/23/24 from 1:18 PM to 3:20 PM, seven cath lab staff (Staff F, G, H, I, J, K, and L) were interviewed individually. The staff collectively stated that training could be better, and that it was not well defined. The staff stated there had only been one instance of a Lucas Device in the cath lab so far. They stated they had not worked with the Lucas Device before and had not had any training on it. They all stated they had not had education on the ECMO process as to what their role was, what to monitor for specifically, how to provide care, and what to document. They reported there had been a few ECMO cases in the cath lab lately.

Personnel files were reviewed for Staff G, H, J, and S. The personnel files lacked documentation of any education on Lucas Devices or ECMO.

On 01/24/24 at 2:00 PM, Staff O verified the cath lab staff had not received education on the Lucas Device. Staff O stated that last year the staff had attended a Cardiogenic Shock lecture which included information on ECMO in general, but not specific to their position.

This deficiency represents non-compliance investigated under Substantial Allegation OH00149142.