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Based on observation, interview, and record review, the hospital failed have an effective governing body (GB) legally responsible for the conduct of the hospital as an institution as evidenced by:

1. Failure to ensure nursing services were provided to safely meet the needs of patients (Refer to A395, A397, and A398).

2. Failure to carry out an effective, system-wide quality assessment and performance improvement (QAPI) program in identifying and developing performance measure projects focusing on nursing care pertaining to high risk and high volume hospital setting to ensure patient safety (Refer to A283).

An interview with the administrator (ADM) was conducted on 5/16/24 at 4:55 p.m. The ADM stated the medical executive committee (MEC, also known as GB) had the oversight of hospital operation.

The Professional Staff Bylaws for the Hospital, approved 3/19/24, indicated the board of directors as the governing body had the ultimate responsibility for the proper functioning of the hospital and for all related matters.

The cumulative effect of these systemic problems resulted in the governing body's inability to govern the hospital effectively and therefore was not in compliance with the Condition of Participation for Governing Body in ensuring safe delivery of patient care.

Based on interview and record review, the hospital failed to develop an effective, ongoing, hospital wide, data driven quality assessment and performance improvement (QAPI) program for nursing services in high risk high volume setting as there were no performance measures addressing:

1. Continuous supervision of patients residing in a high risk setting. Patient 1 was not continuously supervised in the telemetry unit (hospital floor that monitors patient's heart rhythm and rate, respiratory rate, and oxygen saturation using an electronic device) and registered nurses did not timely attend to the patient when he was off his telemetry monitor (Refer to A395).

2. Tracking and evaluating staff performance in adhering to hospital policies and procedures to provide safe patient care. Registered nurses did not use or timely activate Vocera (devise used between caregivers to timely communicate and attend to patient needs), and a staff member did not correctly follow escalation notification process when a patient concern arose (Refer to A398).

3. Ensure registered nurses were provided orientation and deemed competent (documentation of nurses' clinical knowledge, skills, abilities, and behaviors to ensure provision of safe and effective care to patients) by the time of patient assignment to their respective nursing units (Refer to A397).

These cumulative failures resulted in the hospital's inability to provide quality health care as required by the QAPI Program Condition of Participation and placed patients at health risk.

Based on interview and record review the hospital failed to identify and develop performance measure projects focusing nursing services pertaining to high risk and high volume setting in the hospital to ensure patient safety. This failure resulted in a missed opportunity to prevent unnecessary harm and improve patient care.

Findings:

Review of Patient 1's record indicated he had physician's order to be continuously supervised in the telemetry unit (hospital floor that monitors a patients' heart rhythm and rate, respiratory rate, and oxygen saturation with an electronic device).

During an interview on 5/15/24 at 11:15 a.m., the assistant nurse manager (ANM) D stated registered nurses on the telemetry unit were required to use Vocera (devise used between caregivers to timely communicate and attend to patient needs), the nurse assigned to Patient 1 did not turn it on. Patient 1 was found in the bathroom, and later died.

During an interview on 5/15/24 at 12:10 p.m., the clinical nurse educator (CNE) F stated a competency checklist for Vocera communication system was not developed because it was considered a piece of equipment and not necessary.

During an interview on 5/16/24 at 8:30 a.m. the monitor technician (MT) stated when she was unable to contact the primary (assigned) nurse by Vocera on the first incident, she used the chat system (online tool to allow user to communicate in real time via text or video chat), then the second incident of the Patient 1 being off monitor and she could not find anyone to check Patient 1.

During an interview on 5/16/24 at 2:30 p.m., the clinical director of quality services (CDQ) stated the hospital do not use the chat system to contact a nurse, it was not part of the escalation process.

During an interview on 5/16/24 at 4:05 p.m., the nurse manager (NM) H stated after Patient 1's incident, the hospital learned about problems in the telemetry unit, such as not all nurses were consistently logged on to Vocera and she acknowledged performance measure projects were not developed.

Review of two of two sampled travel registered nurses personnel files who were assigned patient care lacked sufficient orientation and competencies (documentation of nurses' clinical knowledge, skills, abilities, and behaviors to ensure provision of safe and effective care to patients).

Review of the Medical Executive Committee Meeting Minutes from 8/7/23 to 3/4/24 did not address performance measure projects addressing high risk high volume potential problems such as continuous patient monitoring, communication systems (equipment and escalation process) and staff competencies.

Review of the Hospital Quality and Patient Safety Program Description policy, dated 1/26/24, Under Patient Safety, indicated the hospital was to implement activities to include ensuring actual and potential hazards associated with high risk processes and patient care populations were identified, assess with the ultimate objective of ensuring patients are free from unnecessary harm, ensure staff possess the knowledge and competence to safely perform required duties and improve system safety performance, operate and maintain a safe environment of care as well as evaluate, and utilize equipment that promoted the efficiency and effectiveness with which safe healthcare was provided.

Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation for Nursing Services was met as evidenced by:

1. One of 30 sampled patients (Patient 1) was not continuously supervised in the telemetry unit (hospital floor that monitors patient's heart rhythm and rate, respiratory rate, and oxygen saturation using an electronic device) in accordance with physician's order. Patient 1 disconnected himself a second time from his telemetry monitor, Patient 1 was not timely attended and was found to be in respiratory distress. Patient 1 had a low heart rate and he subsequently died. (Refer to A395)

2. Hospital policies were not followed for patient care. Registered nurses did not use or timely activate Vocera (devise used between caregivers to timely communicate and attend to patient needs), the used of Vocera was not consistently tracked, and the process of ensuring notification (escalation) of patient concern was not followed (Refer to A398).

3. Two of two sampled travel registered nurses personnel files who provided patient care lacked competencies (documentation of nurses' clinical knowledge, skills, abilities, and behaviors to ensure provision of safe and effective care to patients) and sufficient orientation (Refer to A397).

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality health care and placed patients at health risk.

Based on interview and record review the hospital failed to supervise a patient's health status for one of 30 sampled patients (Patient 1). Patient 1 was not continuously supervised in the telemetry unit (hospital floor that monitors patient's heart rhythm and rate, respiratory rate, and oxygen saturation using an electronic device) in accordance with physician's order. When Patient 1 disconnected himself a second time from his telemetry monitor he was not promptly attended by a registered nurse. Patient 1 was found to be in respiratory distress, low heart rate and he subsequently died.

Findings:

Review of Patient 1's record indicated he had a physician's order dated 3/15/24 at 3:53 p.m. to initiate cardiac monitoring when admitted to the telemetry unit (hospital floor that monitors a patients' heart rhythm and rate, respiratory rate, and oxygen saturation with an electronic device).

During an interview on 5/14/24 at 11:15 a.m., the assistant nurse manager (ANM) D stated on approximately 3/18/24 at 12:22 a.m., Patient 1 had his telemetry leads (device that connects electrode from the patient to a telemetry unit for continuous monitoring) off and it was replaced in five minutes. At 12:33 a.m. Patient 1's leads were off again and when he was found at 12:45 a.m. a code blue (hospital emergency code that indicates a patient needs immediate medical attention, usually due to cardiac (heart) or respiratory arrest) was called. The ANM stated the registered nurse (TRN, travel nurse A) assigned to Patient 1 did not log in to Vocera (devise used between hospital staff to timely communicate and attend to patient needs).

During an interview on 5/16/24 at 9 a.m., registered nurse (RN) C stated she was assigned to provide care to Patient 1 on 3/17/24 at 7 p.m. At 11 p.m. she gave a hand off (report) to the incoming nurse (TRN A) and continued working as a relief in higher class (charge nurse). RN C recalled she reconnected Patient 1's telemetry monitor when she was informed it was disconnected (first incident) and later when she walked down the hall with TRN A, she found Patient 1 down in the bathroom appearing pale and with agonal breathing (gasping for air). RN C did not remember if TRN A had a Vocera.

During an interview on 5/16/24 at 8:30 a.m. the monitor technician (MT) stated she asked the charge nurse to check on Patient 1 when there was no Vocera response from the assigned nurse when the patient was off monitor. When Patient 1 was off monitor the second time there was again no Vocera response from the assigned nurse and she could not find anybody to check on the patient.

Review of Patient 1's Discharge Summary dated 3/18/24 at 6:50 a.m. indicated the patient was found down on the bathroom floor with bradycardia (slow heart rate), hypotensive (low blood pressure) and in pulseless electrical activity (PEA, type of irregular heart rhythm that occurs when the heart's electrical activity was too weak to pump blood or maintain a heartbeat) and was declared dead on 3/18/24 at 1 a.m.

Review of Standard of Care for Telemetry Units policy, revised 10/2022, under Cardiovascular system indicated to monitor continuous cardiac electrical activity.

Based on interview and record review the hospital failed to ensure two of two sampled contracted (travel) registered nurses received sufficient orientation and had completed competencies(documentation of a nurse's clinical knowledge, skills, abilities, and behaviors to ensure provision of safe and effective care to patients) adequate for telemetry unit (hospital floor specializing in monitoring patients' heart rhythm and rate, respiratory rate, and oxygen saturation using an electronic device) for which they were assigned patients. This failure had the potential for patients not receiving quality care and placed them at health risk.

Findings:

During an interview on 5/15/24 at 11:15 a.m., the assistant nurse manager (ANM) D stated Patient 1 disconnected his telemetry leads (device that connects electrode from the patient to a telemetry unit for continuous monitoring) twice on the night shift (11 p.m. to 7 a.m.) on 3/17/24, the nurse assigned to Patient 1 was not contacted to check on the patient, and on the second incident the patient was found in the bathroom with agonal breathing (gasping breath) and later died. The ANM stated registered nurses on the telemetry unit were required to use Vocera and the the nurse assigned to Patient 1 at the time did not turn it on.

1. Review of travel registered nurse (TRN) A's personnel file indicated she had a contractual assignment as a registered nurse to work in the intensive care unit (ICU) from 2/27/24 to 5/25/24. The file did not contain competency as an telemetry or ICU nurse from the contracting company.

Review of TRN A's Initial Registered Nurse (RN) Core Competency form, dated from 3/5/24 to 3/6/24, indicated the preceptor/supervisor/educator did not consistently date and or initial all sections of the approximate 30 page form.

Review of the RN Initial Competency Intensive Care Unit form other than indicating TRN A's name was left blank. None of the competencies addressed the use of Vocera (devise used between caregivers to timely communicate and attend to patient needs). The telemetry competency for TRN A was requested and not provided.

Review of TRN A's record indicated the nurse worked in the medical-surgical unit on 3/7/24, 3/11/24, and was assigned to patients in the telemetry unit on 3/17/24.

During an interview on 5/15/24 at 12:10 p.m., the clinical nurse educator (CNE) F stated a competency checklist for Vocera communication system was not developed because it was a piece of equipment and not necessary.

During an interview on 5/15/24 at 12:30 p.m., clinical nurse educator (CNE) E who reviewed the personnel file stated the Core Competency form was not complete, ideally the preceptor should have date and initial each sections and note discussion indicating the nurse understood the process. CNE E acknowledged an ICU or telemetry competency was not conducted for TRN A.

During a concurrent interview and record review on 5/15/24 at 1:07 CNE E the "Orientation Schedule -ICU Traveler" was reviewed, the document indicated on 3/1/24 Travel Nurse (TRN) A was scheduled to orient on the sixth floor telemetry unit from 9 am-11 am., CNE E was not able to provide evidence of the sixth floor telemetry unit orientation.

2. Review of TRN B's personnel file indicated she had a contractual assignment as a registered nurse to work in the telemetry unit from 1/2/24 and she was currently employed.

During an interview on 5/16/24 at 4:14 p.m. the Human resouce representative stated TRN B had renewed her contract and was currently providing patient care in the telemetry unit.

A request for TRN B's telemetry competency was requested and not provided.

Review of the Orientation, Training, Education and Competency policy, revised 11/2022, indicated a registered nurse shall be considered competent.... The manager/designee evaluates individual competency on an ongoing basis. In the event of staff member temporary assignment to another unit or patient population, skills/knowledge competencies required on the assigned unit or patient population were assessed and validated prior to independent assignment. "Documentation of orientation, training, education and/or competency was part of the employee record ...".

Based on interview and record review the hospital failed to ensure policies and procedures were followed for patient care. Registered nurses did not use or timely activate Vocera (devise used between caregivers to timely communicate and attend to patient needs) when providing patient care, the use of Vocera were not consistently tracked, and the process of ensuring notification (escalation) of patient concern were not followed. These failures placed patients at health risk.

Findings:

1. During an interview on 5/15/24 at 11:15 a.m., the assistant nurse manager (ANM) D stated Patient 1 disconnected his telemetry leads (device that connects electrode from the patient to a telemetry unit for continuous monitoring) twice on the night shift (11 p.m. to 7 a.m.) of 3/17/24, the nurse assigned to Patient 1 was unable to be contacted by Vocera to check on the patient. On the second incident the patient was found in the bathroom with agonal breathing (gasping breath) and he later died. The ANM D stated registered nurses on the telemetry unit were required to use Vocera and the the nurse assigned to Patient 1 did not turn it on.

Review of the undated Vocera Phone Workflow Roles and Responsibilities form, indicated Vocera phone assignments to the nurses was to be completed by the oncoming/out going unit assistance at shift change. The nurse was to log in to their Vocera upon receipt.

2. During an interview on 5/16/24 at 8:30 a.m., the monitor technician (MT) stated Patient 1 had his telemetry leads off twice on the night shift of 3/17/24, she tried but was unable to contact the nurse (primary) assigned by Vocera to check on the patient. The MT stated on the second incident she used the chat system (online tool to allow user to communicate in real time via text or video chat) twice and there was still no response from the nurse and she could not contact another nurse.

During an interview on 5/16/24 at 2:30 p.m., the clinical director of quality services (CDQ) stated we do not use the chat system to contact a nurse, and it was not part of the escalation process.










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3. During a concurrent observation, interview, and record review on 5/14/24 at 11:20 a.m. with nurse manager (NM) L and ANM I, the "Staff Assignment Premier and the Phone/Patient Nurse Assignment Form" were reviewed. The Assistant manager stated, the ANM matches the staff assignment, and the phone/patient nurse assignment and signs it off. During the concurrent interview and observation, the staff assignment failed to include registered nurse (RN) G, the ANM I confirmed RN G should have been on the staff assignment.

During an interview on 5/16/24 at 4:05 p.m., the nurse manager stated after Patient 1's incident, the hospital learned not all nurses were consistently logged on.

During a concurrent interview and record review on 5/16/24 at 4:30 p.m. with ANM M the "Nursing Assignment - 6th Floor", dated 3/17/24 and "Vocera user activity details" for 3/17/24 and 3/18/24 was reviewed. Review of the documents with ANM M, there was no evidence that indicated three of 12 Scheduled Registered Nurses (TRN A, RN J, RN K) were signed onto the Vocera device on 3/17/24 7 p.m. to 7 a.m. shift. The ANM M stated, "there was no indication they were signed into Vocera, they should have been signed in".

During a review of the facility's policy and procedure titled, "Clinical Alarm Notification Systems (CANS) NCAL Regional Policy", dated 10/25/2023, indicated "RN will ensure that phone is correctly programmed with assigned patients, and all required alarms are audible (red, yellow and inoperative).

Review of Monitor Technician Skills Assessment form, dated 03/2019, indicated a skill/responsibility was to follow a chain of command if unable to reach primary registered nurse. Under guidelines/expectations, it indicated any concerns with phone or telemetry monitor performance was to be escalated to the unit assistant nurse manager, nurse manager or designee.