The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

HENDRY REGIONAL MEDICAL CENTER 524 W SAGAMORE AVE CLEWISTON, FL 33440 June 19, 2019
VIOLATION: PERIODIC EVALUATION & QA REVIEW Tag No: C0330
Based on medical record review, policy and procedure review, interview with clinical and administrative staff, and observations, the hospital failed to develop, implement, and maintain an effective, ongoing Quality Assurance (QA)program. The hospital's QA program failed to ensure that the program reflected the hospital's services and focused on health outcomes and the prevention and reduction of medical errors. The hospital failed to maintain and demonstrate evidence of its QA program as evidenced by:

1. The hospital failed to have an effective Quality Assurance program with on-going monitoring and data collection, identification of data analysis, identification of corrective actions, evaluation of corrective action with measures to improve quality on a continuous basis for 1 (for Patient #1) of 3 adverse incidents reviewed. This has the potential for another adverse incident to occur due to a lack of patient vital signs and cardiac monitoring in the Emergency Department (ED). Refer to Standard at C-336.

2. The Quality Assurance Committee failed to document the outcomes of the actions they had taken or reassess the effectiveness of root cause analysis action plan resulting in a potential for a similar incident to reoccur due to a lack of staff failing to appropriately reassess and monitor patients in the ED. Refer to Standard at C-343.
VIOLATION: QA - QUALITY OF PATIENT CARE Tag No: C0336
Based on observation, interview, and record review the hospital failed to have an effective Quality Assurance program with on-going monitoring and data collection, identification of data analysis, identification of corrective actions, evaluation of corrective action with measures to improve quality on a continuous basis for 1 (for Patient #1) of 3 adverse incidents reviewed. This has the potential for another adverse incident to occur due to a lack of patient vital signs and cardiac monitoring in the Emergency Department (ED).

The findings included:

Review of the Emergency Department (ED) record dated 10/31/19 showed Patient #1 had a history of gastro-intestinal bleed and cirrhosis of the liver. On 10/31/18 he walked into the facility with a complaint of "Nausea, Vomiting (blood)". He was assessed by nursing staff at 6:58 p.m., with initial vital signs of blood pressure (BP) 167/93, heart rate (HR) 118, respiration rate (RR) of 18, and an oxygen saturation (O2 sat) of 95%. The nursing Triage note reads, "In the last 24 hours, unknown amount of vomiting episodes occurred. The symptoms developed spontaneously. There is no history of abdominal surgery or diabetes. There is associated abdominal pain. Note: Patient states he began spitting up blood and has abdominal pain ..."

From the time Patient #1 entered room #10 in the ED on 10/31/19 at 6:58 p.m., until the time Patient #1 expired at 10:05 p.m., the nursing staff completed only two more sets of vital signs on the patient.
At 8:07 p.m., Patient #1's vitals were recorded as BP 183/110, HR 111, RR 15, O2 sat 96% on 3 liters of oxygen via nasal cannula with a pain of 3 on a scale of 0-10.
At 8:44 p.m., Patient #1's vitals are recorded as BP 111/61, HR 121 [rapid], RR 30 [fast], and 02 sat 87% [low].

In an interview on 6/18/19 at 9:30 a.m., the Risk Manager (RM) said she developed a timeline of events that occurred prior to patient #1's death by viewing recorded video footage taken in the ED on 10/31/19, and interviewing staff members. The RM explained the following events were noted to have occurred: At 8:50 p.m., the patient was taken off the cardiac monitor and the monitor was placed on standby mode. Patient #1 was assisted via wheelchair by Registered Nurse (RN) Staff A to the restroom. The medical record shows while in the restroom, Patient #1 had a bowel movement of "loose black stool" (an indicator of blood).
At 8:58 p.m., Patient #1 was assisted back to bed by RN Staff A. According to the RM, RN Staff A placed the monitor leads on Patient #1 but failed to take the cardiac monitor off stand-by mode. No vital signs were recorded due to the cardiac monitor being on stand-by. From 8:44 p.m., to 9:56 a.m., Patient #1 had no assessment of cardiac rhythm, vital signs, or oxygen saturation levels due to the cardiac monitor being placed on stand-by mode. The facility staff failed to look and the central telemetry (it would have shown room 10 was on standby), and RN Staff A failed to reassess the cardiac status of Patient #1 for 1 hour and 12 minutes when he was found to have expired.

The medical record shows the physician initially assessed Patient #1 on 10/31/19 at 7:02 p.m. The impression of the physician was Patient #1 had an of upper GI bleeding likely from varices (swollen veins), anemia (low blood cells) with falling hemoglobin (a blood protein) compared to last lab value, cirrhosis with ascites (excess fluid in the abdomen). The physician's plan is recorded as transferring Patient #1 to a higher level of care. On 10/31/19 at 8:38 p.m., the ER physician had another hospital accepting Patient #1 for transfer. The physician was sending the patient to the higher level of care via medical helicopter transportation. A transportation log shows the helicopter company was contacted at 9:00 p.m., and the estimated time of the transport arriving was 2.5 hours.

Review of the findings of the root cause analysis identified human error in patient care. The analysis and actions initiated by quality assurance focuses on the cardiac monitor being placed on standby, and failure of staff in attempting resuscitation efforts on the patient when he was a full code.

There was no documentation of any data collection or action plan for not not notifying the MD of the abnormal vital signs taken at 8:44 p.m., prior to the patient being taken off the cardiac monitor and taken to the restroom. There was no documentation or follow-up regarding the frequency of vital signs, or the lack of staff failing to do vital signs for 1 hour and 12 minutes after the last set of abnormal vital signs were obtained.

The Quality Assurance program initiated a new policy of never placing the patient's cardiac monitor on standby until they were discharged . The program never identified or initiated any action for the contributing factor that none of the ED staff looked at the central telemetry monitor for 1 hour and 12 minutes on 10/31/18 prior to Patient #1 expiring.

The quality assurance program failed to identify and document the factor of the 2.5 hour delay in transportation. According to the ER physician, the Chief Nursing Officer (CNO), and the RM, transportation issues were a concern for months prior to this incident and issues continued after the incident occurred. These concerns were never identified or addressed by the quality assurance program.

There was no follow-up with auditing the plan initiated by the quality assurance program. The plan was initiated in January 2019 and was to be completed in May of 2019. The audits identified in the plan for ensuring staff connected patients back on telemetry and never placed patients on standby were never completed. There was no reassessment to ensure the plan was effective.

In an interview on 6/18/19 at 11:00 a.m., the RM verified there had been an on-going issue with transportation of patients to a higher level of care from the ED for about 6 months due to the emergency medical service (EMS) contracted with the facility walking out on there contract. The Quality Assurance program did not address the transportation issues.

In an interview on 6/18/19 at 3:45 p.m., the CNO verified there had not been any action regarding frequency of vital signs or standards of frequency of vital signs for patients with GI bleeds or on continuous cardiac monitoring. The CNO verified there had been no documented education or audits of staff members failing to visually observe the telemetry monitor for a patient on a cardiac monitor or with a GI bleed.

On 6/18/19 at 4:00 p.m., observation of the central telemetry monitor in the ED was observed with RN Staff B. A monitor was observed flashing yellow with statement "low heart rate". RN Staff B verified the flashing was the system alarming. RN Staff B verified she could not audibly hear the alarm. RN Staff C said the reason the monitor was alarming for a heart rate of 70 was the telemetry had been on a pediatric patient and is now on a adult patient. She said the staff assigned to the patient had failed to changed the settings on the telemetry for the alarms to an adult setting.
On 6/18/19 at 4:02 p.m., Patient #4 was observed lying in a room marked with a placard outside the door marked "Pediatric". The patient was an adult male with telemetry leads attached. The patient confirmed the telemetry monitor had been alarming for "quite a while."

In an interview on 6/18/19 at 4:30 p.m., the CNO said Patient #4 was placed on the cardiac monitor at 3:07 p.m. The CNO verified the ED staff should not be allowing the cardiac monitor to be alarming for 43 minutes with no action.

In an interview on 6/19/19 at 1:14 p.m., the Radiology Director (RD) said he had not completed any training with staff regarding removing the cardiac monitor. He said he had told his staff to allow the ED nurses to remove the telemetry until April of 2019. The CNO and the RD both said the radiology staff were retrained in April of 2019 when staff competencies were completed. The RD verified there had not been any audits conducted to ensure staff performance. The CNO verified the only audits completed by the facility was with Code Blue performance. She said every Code Blue in the facility was reviewed.

In an interview on 6/19/19 at 2:00 p.m., the RM said she had been concerned about the not being an actual person monitoring telemetry in the ED. She said the CNO had told her it was not the standard of care.

In an interview on 6/19 18 at 2:37 p.m., the ED physician said he had not been informed of Patient #1 having abnormal vital signs. The ED physician said he is dependent on nursing staff to inform him of changes in cardiac status because he does not have a telemetry monitor visible to where he sits. The ED physician verified the helicopter was 2.5 hours out and it was a long time to have to wait. He said the facility went for 6 months where they had a horrible time with transporting critically ill patients due a lack of available EMS transportation.

In an interview on 6/19/19 at 3:50 p.m., the CNO and the RM verified the issues with transport for the ER had never been addressed in Quality Assurance.
VIOLATION: QA - DOCUMENTATION Tag No: C0343
Based on observation, interview, and record review the Quality Assurance Committee failed to document the outcomes of the actions they had taken or reassess the effectiveness of root cause analysis action plan resulting in a potential for a similar incident to reoccur due to a lack of staff failing to appropriately reassess and monitor patients.

The findings included:

Review of the Emergency Department (ED) records for Patient #1 revealed a history of gastro-intestinal (GI) bleed and cirrhosis of the liver. On 10/31/18 he walked into the facility with a complaint of "Nausea, Vomiting (blood)". The patient was assessed by nursing staff at 6:58 p.m., with initial vital signs of blood pressure (BP) 167/93, heart rate (HR) 118, respiration rate (RR) of 18 and an oxygen saturation (O2 sat) of 95%. The nursing Triage note read, "In the last 24 hours, unknown amount of vomiting episodes occurred. The symptoms developed spontaneously. There is no history of abdominal surgery or diabetes. There is associated abdominal pain. Note: Patient states he began spitting up blood and has abdominal pain ...".
From the time Patient #1 entered room #10 in the ED on 10/31/19 at 6:58 p.m., until the time Patient #1 expired at 10:05 p.m., the nursing staff completed two more sets of vitals on the patient. At 8:07 p.m., Patient #1's vitals were recorded as BP 183/110, HR 111, RR 15, O2 sat 96% on 3 liters of oxygen via nasal cannula with a pain scale of 3 out of 10. At 8:44 p.m., Patient #1's vitals are recorded as BP 111/61, HR 121, RR 30, and 02 sat 87%.

In an interview on 6/18/19 at 9:30 a.m., the Risk Manager (RM) said at 8:58 p.m., Patient #1 was assisted back to bed by Registered Nurse (RN) Staff A. RN Staff A placed the monitor leads on Patient #1 and failed to take the cardiac monitor off stand-by. There were no vital signs recorded due to the cardiac monitor being on stand-by. From 8:44 p.m., to 9:56 p.m., Patient #1 had no assessment of cardiac rhythm, vital signs, or oxygen saturation levels due to the cardiac monitor being placed on stand-by, facility staff failing to look and the central telemeter (it would have clearly read room 10 was on standby), and RN Staff A failing to reassess the cardiac status of Patient #1 for 1 hour and 12 minutes when he was found to have expired.

The facility completed a root cause analysis and the findings were documented on a diagram on 11/8/19.
On 11/12/2018 a root cause action plan was completed show the recommended actions to be taken were outlined as: "1. Educate all ED staff on critical importance of reassessment of patient when returning to ED suite - visual inspection to ensure patient call light in reach, placed back on monitor, and patient's needs met. 2. Director or Designee will do minimum of 30 audits per month for a minimum of 120 days to validate staff compliance... 5. Image Director/Supervisor will educate/train all existing staff on reporting, removing, and replacing ED patients on monitor-and the documentation... 6. Imaging Director/Supervisor will audit staff's performance for compliance on a monthly basis for a minimum of 120 days." The findings of the root cause were that bedside monitors would only be placed in standby mode when patient is discharged from the ED-or has left for transfer to a higher level of care. The action plan included educating staff on this new policy and the ED Director/Designee would audit 30 episodes of care to validate compliance per month for 120 days.
The action plan compliance had a completion date of May 2019.

The action plan failed to address the lack documentation of the physician being informed of abnormal vital signs, and/or the actions taken to reassess the patient at the time of the vitals were taken, following a standard of care for frequency of vital signs for a patient with an active GI bleed and having continuous cardiac monitoring, failure of facility staff to visually monitor the telemetry for 1 hour and 7 minutes, the nurse failing to reassess the patients cardiac status for 1 hour and 7 minutes, and, documentation of the reason for a delay in flight transportation.

Observation on 6/18/19 at 10:20 a.m., the ED telemetry monitor had yellow flashing on the monitor of two telemetry units. There was no audible alarm sound noted at that time.

Observation on 6/18/19 at 4:00 p.m., the central telemetry monitor in the ED with RN Staff B, a monitor was flashing yellow with statement "low heart rate". RN Staff B verified the flashing was the system alarming. RN Staff B verified she could not audibly hear the alarm. RN Staff C said the reason the monitor was alarming for a heart rate of 70 was the telemetry had been on a pediatric patient and is now on a adult patient. She said the staff assigned to the patient had failed to change the settings on the telemetry for the alarms to adult settings.

In an interview on 6/18/19 at 4:30 p.m., the CNO said Patient #4 was placed on the cardiac monitor at 3:07 p.m. The CNO verified the ED staff should not be allowing the cardiac monitor to be alarming for 43 minutes with no action.

In an interview on 6/19/19 at 1:14 p.m., the Radiology Director (RD) said he had not completed any training with staff regarding removing the cardiac monitor. He said he had told his staff to allow the ED nurses to remove the telemetry until April of 2019. The CNO and the RD both said the radiology staff were retrained in April of 2019 when staff competencies were completed. The RD verified there had not been any audits conducted to ensure staff performance. The CNO verified the only audits completed by the facility was with code blue performance. She said every code blue in the facility was reviewed.

The facility would be unable to assess the effectiveness of the action plan until audits listed in the action plans were completed.