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Based on medical record review, document review and interview, it was determined the Governing Body failed to maintain oversight of the Quality Assessment and Performance Improvement (QAPI) program to ensure the quality of care provided to cardiothoracic surgery and cardiac intervention patients was consistent with prevailing standards of medical care.

These failures may have placed patients at risk for serious harm and death.

Findings revealed:

The Quality and Patient Safety Plan for 2021 states: "The Hospital Governing Body (Board of Directors) has the responsibility for the safety and quality of the hospital's performance."

Review of the cardiothoracic surgery meeting minutes and a list of mortalities from November 2020 to August 2021 revealed there were 21 mortalities for cardiothoracic surgery and cardiac interventions.

Review of the board meeting minutes from August 6, 2020 to August 5, 2021 revealed there were five (5) meeting minutes in which the quality assessment committee did not report all activities, findings and corrective actions to the governing body relating to the increasing mortality rates and complications in cardiothoracic surgery and cardiac intervention services for 2021.

See detailed findings at A 273, A 283, and A 286.

These findings were confirmed during an interview with Staff H, President of the Hospital on 9/28/2021 at approximately 2:55 PM.

Based on medical record reviews, document reviews and interviews, in 15 of 20 medical records reviewed, it was determined the facility failed to utilize its Quality Assessment and Performance Improvement (QAPI) program to identify, analyze and track complications and mortalities in cardiothoracic surgery and cardiac intervention services and implement corrective actions to improve the quality of care and health outcome of patients.

These failures may have placed patients at risk for serious harm and death.

Findings include:

The Quality Performance Committee did not present a QAPI plan with specific indicators to assess the quality of care provided to Cardiothoracic Surgery and Cardiac Intervention patients.

See detailed findings at A 273.

There was no evidence that the facility collected data for all incidents, occurrences, and adverse events for each department.

There was no documented evidence that mortality and peer reviews conducted by Cardiothoracic Surgery and Cardiac Intervention Services were used to identify opportunities for improvement.

See detailed findings at A 283.

The facility did not review all cardiothoracic surgery mortalities, and did not track, trend, and analyze mortalities and complication rates and implement quality improvement measures.

See detailed findings at A 286.

Based on document review and interviews, it was determined that Cardiothoracic Surgery and Cardiac Intervention Services failed to develop a written QAPI plan with specific indicators to monitor the performance of services provided to patients.

Findings include:

The facility's Quality and Patient Safety Plan for 2021 did not describe a process for collection, review and analysis of patient incidents and occurrences.

Review of the facility's Quality and Patient Safety Plan for 2021 revealed no documented evidence of the scope of QAPI plan for the Cardiothoracic Surgery and Cardiac Intervention Services. The department's QAPI plan activities were limited to outcome indicators which were mortality and peer reviews.

There was no documented evidence that data collected on mortalities and peer reviews were analyzed and tracked.

For example:
Review of six (6) Cardiothoracic Surgery peer review meeting minutes from September 3, 2020 to July 12, 2021, revealed a total of 37 peer reviews for complications and mortalities as follows:

September 2020 - 7 reviews
October 2020 - 2 reviews
November 2020 - 7 reviews
April 2021 - 10 reviews
June 2021 - 5 reviews
July 2021 - 6 reviews

It was identified that 16 of the 37 reviews were attributed to one provider. In addition, review of a list titled unexpected death with treatable serious complications revealed four (4) of the seven mortalities were attributed to another provider.

There was no evidence that the facility identified these trends and tracked or analyzed these findings to determine causation and implement corrective actions to improve outcomes and the care provided to patients.

During an interview on 9/23/2021 at 11:50 AM, Staff E, Nuvance Health Chief Quality Officer acknowledged findings and stated that there is room for improvement.

Based on document review and interviews, it was determined the facility failed to utilize its Quality Assessment and Performance Improvement (QAPI) program to identify opportunities for improvement in Cardiothoracic Surgery and Cardiac Intervention Services and implement actions aimed at performance improvement.

Findings include:

Review of the Quality Performance and Improvement minutes for 10/12/2020 - 8/12/2021, showed no evidence of thorough reviews, discussions and analysis of incidents and events that occurred in the cardiothoracic surgery and cardiac intervention services.

In the following three (3) of eight (8) peer reviews where it was identified that there was room for improvement, there was no documented evidence of corrective action plans and implementation of measures to improve the quality of care provided to patients:

Review of the Cardiothoracic Peer Review Committee meeting minutes of 9/3/20 revealed a 34-year-old patient with a history of intravenous drug abuse and anemia presented with a forearm abscess status post Incision and Drainage and Septic Shock. The patient's hospitalization was complicated by Aortic Valve Endocarditis, a splenic stroke, and a small right frontal stroke. The patient was taken to the operating room (OR) on 10/1/20 for Aortic Valve Repair (AVR) and Repair of Aorto-Mitral curtain. The patient was taken back to the OR twice on post-operative (POD) #1 for mediastinal exploration. Bleeding was found with the initial exploration and a clot evacuated on re-exploration. POD #4, the patient was noted to have an intracranial bleed. The peer review noted "standard of care met-room for improvement." The follow-up action noted "no further action."

Cardiothoracic surgery meeting minutes on 4/01/21revealed discussion on a case where a patient underwent Coronary Artery Bypass Grafting (Procedure to improve blood flow to the heart) x 4 with Mitral (heart) Valve Repair. The discussion was "should the chest have been left open or not. Difficult operation due to small stature ...standard of care was met, with room for improvement."

There was no documentation of the areas that needed improvement. The case was closed with no corrective actions implemented.

Review of the Cardiothoracic Peer Review committee meeting minutes for 7/12/21 revealed a discussion of a patient who was scheduled for a repeat Percutaneous Intervention (PCI) and had a perforation during wiring in the catheterization lab. An Aortic Valve Repair was done but the patient expired in the OR.

The minutes noted "tough case, valiant effort. Case discussed in Cath lab peer review as well." The standard of care was not met with room for improvement. The committee recommended having more discussion with cardiology.

There was no documentation of discussions with cardiology. The case was closed with no further action taken.

During an interview on 9/23/2021 at 11:30 AM, Staff D, Performance Improvement Specialist stated that there is an issue with under reporting in some departments. The Cardiac Surgery Department does not enter all safety and adverse events into the Midas reporting system. These events should be entered by the physicians, nurses, and managers, but it is not always done.

There was no evidence that these three incidents were entered in the Midas reporting system for tracking, trending, and corrective actions.

Based on medical record review, document review, and interview, in three (3) of 12 medical records reviewed, it was determined the facility failed to track, trend, review and analyze mortality data for providers and implement quality improvement measures (Medical record #s 2, 3 and 4).

Findings include:

The facility's Quality and Safety Plan 2021, states: "Patterns and trends in performance will be closely analyzed by the department chairs and quality partners for causality and opportunities for improvement."

Review of the "CTS (Cardiothoracic Surgery) Mortality Surgical Case Log" for 8/1/2020 to 8/31/2021 showed 14 deaths from 2/04/2021 to 7/23/2021.

There was no documented evidence that patterns and trends in performance was closely analyzed by the Cardiothoracic Surgery Chair and quality partners for causality and opportunities for improvement as indicated in the facility's Quality and Safety Plan for 2021.

Three (3) of the 14 mortalities were not reviewed to determine the quality of care provided to these patients and identify opportunities for improvement.

Medical record #2: This is a 78-year-old frail patient who was admitted to the facility on 3/31/2021 with "recurrent severe mitral valve regurgitation after undergoing a MitraClip procedure in 2019. She had many problems and was deemed to be a high risk for surgical valve replacement at that time. After the clip the patient had several admissions/evaluations for congestive symptoms and Atrial Fibrillation with RVR." She was short of breath with activity and a recent test showed severe valve leaking and Pulmonary Hypertension. Her previous medical history included Congestive Heart Failure (CHF), Coronary Artery Disease (CAD-blockages in the blood vessels in the heart), severe pulmonary hypertension (PHTN) and Transient Ischemic Attacks (TIAs). The patient underwent multiple procedures during the surgery including Coronary Artery Bypass Grafting x 1, Closure of Atrial Septal Defect and Mitral Valve Replacement.

The patient developed complications (tamponade) which began early in the perioperative period in the intensive care unit (ICU), and she was taken back to the OR where coagulopathy (condition resulting in excessive bleeding or clotting) and some surgical bleeding was noted. She continued to have multiple complications in the postoperative period, and she expired on 4/13/2021.

Medical record #3: This is an 86-year-old patient who was admitted on 2/16/2021 with a history of persistent Atrial Fibrillation, valvular heart disease with Mitral Valve Endocarditis, pacemaker, Severe Mitral Regurgitation and Tricuspid Regurgitation who presented with dyspnea (difficulty breathing) with minimal exertion. On 2/22/2021 at 8:00 AM the patient underwent Mitral Valve Replacement, Tricuspid Valve Repair, and extensive Left Atrial cryoMaze (procedure to block electric activities). At 6:00 PM on 2/22/2021, the patient was taken back to the operating room (OR) for Mediastinal (chest) Re-exploration and Evacuation/control of hemorrhage (500 cc blood/clots noted). Prior to the procedure the patient had ventricular fibrillation (abnormal heart rhythm) and manual compressions and resuscitative measures were successful. After the procedure the patient subsequently was noted to have multiorgan failure with oxygen saturation in 30-40's despite oxygen (FiO2) of 100%. Resuscitative measures were futile, and she expired at 8:00 PM on 2/22/2021.

Medical record #4: This was an 81-year-old patient who was admitted to the facility on 3/18/2021 who underwent a mechanical Aortic Valve Repair/Replacement (AVR) 25 years earlier and had done well who was now experiencing progressive shortness of breath with exercise. He had coronary stents (device that opens clogged heart vessel) and in-stent re-stenoses in the past. The patient had developed significant disease recurrence and he was referred for a re-do heart surgery. The patient underwent a Re-do sternotomy, Exposure of Greater Saphenous vein (GSV - longest vein in the body, left lower extremity) and an Off-pump Coronary Artery Bypass Grafting (CABG) x 2 on 3/18/21.

On post op day (POD) #1, in the morning while getting out of bed to a chair, the patient developed rapid supraventricular tachycardia (SVT-rapid heart rate) or Atrial Fibrillation (AF-abnormal heart rhythm) with rapid ventricular response (RVR) as high as 180 with Hypertension (high blood pressure) and increasing shortness of breath requiring oxygen. The patient was treated; however, 4:00 AM on 3/20/2021 (POD #2), he was found unresponsive on the floor in the intensive care unit (ICU). Resuscitative measures were implemented but they were subsequently unsuccessful. The patient was pronounced dead at 5:12 AM on 3/20/2021.

The hospital Quality and Improvement Performance meetings from 10/12/2020 to 8/12/2021, Division of Cardiology Committee minutes for November 2020 and July 1, 2021 did not show the discussion or review of these deaths.

During interview on 9/24/2021 at 10:20 AM, Staff F, Senior VP, System Chair for Heart & Vascular Institute acknowledged the number of deaths and stated that he believes standard of care was met. He also stated that "We don't discuss all issues in our QA meetings, our minutes might be lacking in some of what's going on, and that is something we need to work on". He also said that he did not identify any outliers or quality of care issues that "raised a red flag," however there is some room for improvement on the selection criteria of patients.