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Based on observation, document review, and interview it was determined that the Hospital failed to ensure an effective governing body, that is legally responsible for the conduct and operations of the hospital. Therefore, the Condition of Participation 42 CFR 482.12 Governing Body was not met, as evidenced by:

A. Based on document review and interview, it was determined the Hospital failed to ensure the Quality Assurance Performance Improvement (QAPI) program was measured, tracked and monitored throughout the Hospital. This failure puts the patients, staff and community members at great harm.

Findings include:

1. During the entrance conference on 11/16/21 at approximately 9:15 AM, the adverse event log, complaint/grievance log and the complaint and grievance policy were requested. The adverse event log nor the policy was not provided as of 11/18/21. On 11/16/21 at approximately 3:00 PM, the complaint and grievance log was reviewed, The logs lacked documentation of any complaint/grievances since 3/2021.

2. The Code Blue Committee meeting minutes dated 2/24/21 and 8/31/21 were reviewed on 11/16/21. The meeting minutes dated 2/24/21 noted " ... did not have the electronic code blue or rapid response audit tools. These are used to document variances that occurred during the event."

3. The Medical Executive Committee meeting minutes dated 10/5/21 were reviewed on 11/17/2021 at 11:00 AM. The minutes noted "7.1.1.3... Unable to collect and report data on several indicators due to loss of reports with new EHR (Electronic Health Record).

4. During an interview on 11/16/21 at approximately 3:00 PM, E#7 (Quality Registered Nurse Abstractor) stated "There are no quality checks. This new electronic health record (implemented May 2021 created by E#18 (Chief Executive Officer, Doctor of Information Technology) does not allow us to capture data. We can get a few raw numbers like the number of admissions but nothing else. We couldn't even bill because the electronic health record couldn't pull codes for billing. Oh, yeah and they fired all the coders. Patient Safety and Risk Management is not being followed up on. The Adverse Event reporting system, no one has access to it to review data, so we can't track or monitor adverse events. We have no other process in place for this. The Managers are acting as Director and working the floor and are tasked so heavily, they can't look at data even if they could access the database."

B. Based on document review, interview and observation, it was determined the Governing Body failed to maintain responsibility and oversight for the staffing and operations of the Hospital. This failure puts the patients, staff and community members at great harm.

1. On 11/18/21 at approximately 9:15 AM, the monthly "Resuscitation/Code Blue and Rapid Response Utilization" reports were reviewed from January 2021 to September 2021. E#3 stated, "there were no codes in October 2021." The "Concurrent Resuscitation/Code Review" forms noted the following:
a) Pt #8, admitted on 6/2/21, Diagnoses: Hypotension and End Stage Renal Disease. The review form dated 6/3/21 noted "Quality Management Issues- not enough (staff) to do CPR (cardiopulmonary resuscitation) for sustained length of time... on going code blue X (times) 3..." and was transferred to the ICU. The "Code Blue Log 2021" was reviewed on 11/18/21 at approximately 8:45 AM. The log noted Pt #8 "pronounced (expired) @ (at) last code that was called @ 0506 (5:06 AM)."
b) Pt #9, admitted on 7/23/21, Diagnosis: COVID 19 positive. The review form dated 7/24/21 noted "airway: multiple intubation attempts- 5 attempts by ER MD (Emergency Room Medical Doctor) and anesthesia 1 attempt." The code blue record noted "code blue called:
9:18 AM- due to patients decline in respiratory status. Transferred patient to ICU from med- surg floor... 9:57 AM- ER MD had 5 failed attempted intubations ... .10:00 AM- Intubated by anesthesia ...."
The "Code Blue Review" (attachment noted by the House Supervisor) noted "Dr. attempted to get pt transferred to Hospital #1 for higher level of care. Hospital #1 had no beds... Hospital #2 was contacted and would call back... crash cart taken into room by staff and there was no resuscitation bag on cart....This patient could have been transferred out of the ED before the decompensation occurred." The "Code Blue Log 2021" was reviewed on 11/28/21 at approximately 8:45 AM. The log noted Pt #9 "Life flighted to Hospital #2 at 12:16 PM."

2. During a tour of 2nd floor - medical surgical unit on 11/16/21 at approximately 12:55 PM, the following was not conducted:
a) 8 of 30 twice a day crash cart checks
b) 4 of 15 daily cleaning of the crash cart and defibrillator

3. During an interview on 11/18/21 at approximately 9:00 AM, E#3 verbally agreed the crash cart checks and cleaning were not conducted and should have been.

4. The Staffing Sheets dated 9/1/21 through 11/16/21 were reviewed on 11/17/21 at approximately 11:15 AM. The staffing sheets noted on 10/7/21, an "Emergency Department RN went with a HDU (Hemodialysis Unit) patient to the ICU" although the ICU was reported as "closed." The patient was stabilized until transferred to an acute care hospital for a higher level of care.

5. The staffing sheet dated 11/11/21 noted 1 Registered Nurse was scheduled in the ED during the 7 PM (11/11/21) to 7 AM (11/12/21) shift. The staffing sheet dated 11/12/21 noted at 5:04 AM "Rapid/Rapid/Code Blue ED #1 on vent (ventilator) trying to find placement."

6. The staffing sheets dated 11/3/21, 11/5/21,11/9/21 and 11/10/21 were reviewed on 11/17/21 at approximately 11:35 AM. The sheets noted E#8 (Director of Nursing) was working 7 AM- 7 PM shift as a floor nurse and no other House Supervisor was on the schedule. The staffing sheet dated 11/10/21 noted E#8 worked 7 AM to 11 PM.

7. During an interview on 11/17/21 at approximately 11:30 PM, E#8 stated "I'm not the Chief Nursing Officer. We don't have one. I am the House Supervisor when I am here, usually until around 4:00 PM, then the House Supervisors come in and work through the night. I've been working a lot of hours on the floor. I know E#13(Operating Room Manager) and E#15 (Emergency Manager) work a lot and fill in any gaps in coverage needed. We (medical surgical unit) focus on our post-surgical patients. We do a lot of ortho (Orthopedic) cases here. If there is a Pneumonia, Sepsis or Cardiac patient, we will ship them out and keep the ortho patients. We do have staffing issues"

8. The Board of Trustees meeting minutes dated 7/14/2021 were reviewed on 11/16/21. The meeting minutes noted "ICU Update ... Nurses have been pulled from ICU to work in the ER (emergency room). ICU is closed due to lack of staff ..."
The Board of Trustees meeting minutes dated 9/29/21 were reviewed on 11/16/21. The meeting minutes noted "Chairman's Report Letters of resignation were received from... (Chairman)... (Vice Chairman) ... and... " (Retired Community Member), effective September 2021 ....7.0 Administration Update Staff Layoffs Update: Recently, there were 26 staff layoffs with 2 people resigning... These layoffs are due to the hospital and clinics needing to right size to the patient volumes/financials. Nursing Staff Shortage; ICU is closed due to lack of staff. There are also 6 uncovered spots in the next shifts in the next month in the ED... Billing Systems... Still work to be done across hospital for billing glitches... EMR (Electronic Medical Record) system still contains some glitches... Roles and Responsibility of the Hospital Board...... the Joint Commission requires a governing body/advisory board to be in place at the hospital... will send the regulations to the Board members..."

9. The Medical Executive Committee meeting minutes dated 10/5/21 noted "7.1.1.3... Unable to collect and report data on several indicators due to loss of reports with new EHR... 7.1.1.7 Nursing Updates... ICU staff are filling vacancies in the ED. Must go on trauma bypass if one nurse staffed in ED."

10. The "Hospital Termination List" dated 3/1/21 through 11/17/21 noted 128 employees were terminated. The following Nurses were terminated:
a) 12 ICU Registered Nurses plus 1 ...
b) 12 Emergency Department Nurses (5 full time nurses and 8 prn nurses employed as of 11/16/21)
c) 5 Medical Surgical Unit Nurses plus 7 quit (6 full time nurses and 4 prn nurses employed as of 11/16/21)

11. The Organizational Chart dated 11/10/21 noted "COO (Chief Operating Officer) ????????". The Hospital lacked a Director for the Emergency Department, Surgical Services, Nutrition Services, Materials Management, Accounting, Informational Technology, Imaging, Health Information Management, Case Management and lacked an Exercise Physiologist in the rehabilitation unit.

12. During an interview on 11/16/2021 at approximately 11:35 AM, E#3 (Quality Coordinator and Medical Staff Coordinator) stated the Hospital was purchased in May 2020. E#3 stated "Within a few weeks (of the purchase) we didn't have any access to our policies, except for our paper copies, because policy stat (electronic policy software) was no longer kept. The Physician credentialing software "Premier" was taken away and a lot of data was lost. They (new owners) got rid of the Medical Staff Coordinator, so I was assigned to take it over. I had no training and no guidance... The Chief Quality Officer and I tried to piece it together, but she/he was let go 3 weeks ago" The Organizational Chart was reviewed with E#3 on 11/17/21 at approximately 2:15 PM. E#3 stated the following employees turned in their resignation this week: Infection Control/Employee Health Nurse, Informational Technology Director, Case Manager, 2 Med/Surg nurses and on 11/18/21 at approximately 8:30 AM, 2 more nurses resigned. E#3 stated the Education/Informatics nurse will assume the role of the Infection Control/Employee Health nurse (unknown qualifications), the Laboratory Director is in an interim position and the lab has a new lab system in place and they are having problems generating reports and implementing the reports into the electronic health record.

13. During an interview on 11/16/21 at approximately 3:00 PM, E#7 (Quality Registered Nurse Abstractor) stated "They (new owners) are cutting key staff that provide patient safety. They fill holes with unqualified people. The Director of Nursing (E#8) works shifts all the time because there is no coverage. We have a decreased volume (of patients) because we have no staff. We are capped at 6 patients right now. They are just cutting all of our resources. With no Charge Nurse, no Unit Secretary and only 1 CNA (Certified Nursing Assistant) there is no one available to answer the phone. Now they have done away with our code blue (life resuscitating procedure which requires qualified staff from other units) button and now they have to stop and dial the phone to get the code blue team. Patient Safety and Risk Management is not being followed up on. The Managers are acting as Directors and working the floor and are tasked so heavily."

14. During an interview on 11/18/21 at approximately 10:45 AM, E#19 (Infection Control Coordinator) stated "My last day is tomorrow. There is no House Supervisor during the day. E#8 is supposed to be the House Supervisor, but she/he is usually taking patients. There is not enough staff to



An Immediate Jeopardy (IJ) was identified for Complaint #IL00139941/2111224. The immediate jeopardy (IJ) began on 11/18/2021, due to the Facility's failure to ensure an effective governing body, that is legally responsible for the conduct and operations of the hospital and was identified on 11/18/2021 at 42 CFR 482.12 Governing Body. The IJ was announced on 11/19/21 at 11:15 AM, during a meeting with E#47, Chief Quality Officer, Berwick, Pennsylvania; E#48, Chief Executive Officer; E#49, Consultant; E#3, Quality Coordinator; E#7, Clinical Data Abstrator; E#1, Director of Operations; E#50, Consultant Quality, Pontiac, Michigan and was not removed by the survey exit date of 11/19/2021.