HospitalInspections.org

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Item #1: Failure to Implement the Hospital's Immediate Jeopardy Removal/Serious Safety Event Plan

Based on interview and document review, the hospital's governing body failed to ensure that its hospital leadership implemented the hospital's Immediate Jeopardy/Serious Safety Event Removal Plans and removed conditions creating danger to patient's receiving care in the hospital's Emergency Department.

Failure to implement corrective action plans to ensure removal of conditions creating an unsafe environment puts patients at risk of harm and death.

Findings included:

1. Document review of the hospital document titled, Grays Harbor Community Hospital Immediate Jeopardy: Care in a Safe Environment Removal Plan," approved 01/28/20 at 9:00 AM, showed the following:

a. The hospital stated Implementation Date of the removal plan was 01/28/21 at 12:00 PM.

b. Beginning no later than 01/27/21, a staff member shall be assigned and present for continuous monitoring of the Emergency Department (ED) patient monitoring system.

c. The staff member shall be trained in the use of the patient monitoring system.

d. The staff member will have no other assigned duties.

e. The corrective action shall remain in place, until troubleshooting of the monitoring system and any identified repairs have been completed.

2. On 03/03/21 at 6:05 AM- 7:30 AM, during interview with Investigator #5, Emergency Department Staff (Staff #512, #513, #514, #515, and #516) stated that the hospital did not provide qualified staff to monitor the hospital's Hemodynamic/Telemetry patient monitoring system in the Emergency Department.

Staff reported that staff shortages and the inability to monitors the monitors and provide adequate care to high risk suicide and restrained patients were reported to hospital leadership, reported through the Quantros Incident Reporting System, and reported electronically to the Department Director and the Chief Nursing Officer through Assignment Despite Objection Forms.

3. On 03/03/21 at 8:00 AM, Investigator #5 and the Emergency Room Director (Staff #517) reviewed the ED shift and staffing report sheets from 02/01/21 to 02/24/21. The review showed that there were no staff assigned or available to provide continuous monitoring of the hemodynamic/cardiac telemetry system for 23 of 24 days reviewed. The review showed the hospital had not implemented the Immediate Jeopardy/Serious Safety Event Removal Plans and failed to ensure patients received safe care in the Hospital's Emergency Department.

4. On 03/03/21 at 10:35 AM, Investigator #5 interviewed the Chief Executive Officer (Staff #510) and the Director of Quality and Risk (Staff #508) related to the hospital's failure to implement its Immediate Jeopardy/Serious Safety Event Removal Plan in the Emergency Department. Staff #510 stated that the hospital leadership was not aware that there were not staff to provide continuous monitoring in the Emergency Department per the hospital's removal plan.

Investigator #5 requested interview with the Chief Nursing Officer. Staff #510 stated that the CNO (Staff #518) had previously been out on medical leave and was not available for interview.

5. Staff #508 stated that the hospital had purchased additional monitoring equipment and on 02/25/21, moved the Emergency Department monitoring to the Medical /Telemetry Department. He stated that it had not been conveyed to him that the hospital was not able to provide staff to monitor the monitors in the Emergency Department.

Item #2 Governing Body Oversight

Based on observation, document review, and interview, the hospital's governing body failed to provide effective oversight of the hospital.

Failure to provide effective oversight for patient rights, quality improvement, nursing services and medical staff and failure to provide adequate staff puts patients at risk of harm from inconsistent and inadequate treatment.

Findings included:

1. Failure to ensure that the Governing Body received periodic evaluations of the medical staff's quality of patient care services.

Cross Reference A0049

2. Failure to ensure that the hospital had an effective system in place to evaluate and ensure that contracted patient care services were provided to patients in a safe and effective manner

Cross Reference: A0084

3. Failure to ensure review and resolution of patient grievances went through the Board of Directors or a Grievance Committee.

4. Failure to provide a safe and appropriately functioning clinical alarm system (a full spectrum of alarm systems that are triggered by physiological monitoring of the patient or by variations in measure parameters of medical equipment directly applied to the patient) for patients in the hospital's Emergency Department (ED), Critical Care Unit (CCU), and Medical/Tele Units as evidenced by the cardiac/hemodynamic monitoring system failure to capture hemodynamic data, failure to capture critical alarm data, failure to ensure that historical data could be retrieved, and failure to ensure audible alarm features were functional.

5. Failure to ensure a safe and effective process for ordering and documenting medications for patients boarded (Boarding is the practice of holding patients in the Emergency Department or another temporary location while awaiting transfer to another facility, admissions placement or discharge) in the hospital's Emergency Department (ED)

6. Failure to follow the hospital's policy and procedure for ordering restraints for management of patients exhibiting violent or self-destructive behavior.

7. Failure to follow the hospital's policy and procedure for ordering restraints for management of patients exhibiting nonviolent or non-self-destructive behavior.

8. Failure to ensure that hospital staff members released patients from restraints at the earliest opportunity.

9. Failure to ensure that hospital staff members assessed and monitored patients while in restraints as directed by the hospital's restraint policy.

Cross Reference: A0115

10. Failure to ensure that there was an effective process in place to ensure staff completed an Incident Reports when an error, potential adverse events, and provider practice concern were identified. Failure to systematically collect, aggregate, and analyze quality indicator data as part of the hospital's overall quality program as defined in its policy and procedure.

11. Failure to ensure that there was an effective process in place to identify patient harm events that require an RCA (Root Cause Analysis) and therefore failure to conduct an RCA's for potential patient harm events that included provider practice concerns, infections, and medication errors.

12. Failure to provide oversight of the hospital's quality program in order to ensure the quality program reflected the complexity of the organization and services and included all hospital departments and services. Failure of the Governing Body to be responsible for the quality of care provided to patients across service lines including contracted services.

13. Failure of the Governing Body to provide oversight to ensure full implementation of the quality assessment and performance improvement (QAPI) plan including the development and implementation of a systematic process to report, monitor, evaluate, and improve the quality of patient care services through systematic data collection, analysis, and implementation and monitoring of quality activities.

14. Failure to ensure that there was an effective process in place to ensure staff completed Incident Reports when errors, potential adverse events, and provider practice concerns were identified. Failure to systematically collect, aggregate, and analyze quality indicator data as part of the hospital's overall quality program as defined in its policy and procedure.

15. Failure to ensure that there was an effective process in place to identify patient harm events that require an RCA (Root Cause Analysis) and therefore failure to conduct RCA's for potential patient harm events that included provider practice concerns, infections, and medication errors.

Cross Reference A0263

16. Failure to ensure that the medical staff operated in compliance with rules and by-laws approved by the governing body.

Cross Reference A0347

17. Failure to ensure the hospital had sufficient qualified staff to provide monitoring of the Clinical Alarm System in the Emergency Department.

18. Failure to ensure the hospital had sufficient nursing personnel to assess and monitor patients at risk of Suicide.

19. Failure to ensure the hospital had sufficient personnel to assess and monitor patients at risk of Elopement.

20. Failure to develop and implement Emergency Department (ED) policies and procedures that define Standards of Care/Standards of practice to direct ED staff when and how to assess, reassess, and care for patients held for an extended length of time in the ED.

Cross Reference A0395

Due to the scope and severity of deficiencies detailed under 42 CFR 482.13 Patient's Rights, 42 CFR 482.21 Condition of Participation for Quality Assessment and Performance Improvement, 42 CFR 482.23 Nursing Services, and the Condition of Participation for Governing Body was NOT MET.

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Based on interview and review of hospital documents, the hospital's governing body failed to ensure that it received periodic evaluations of the medical staff's quality of patient care services.

Failure by the governing body to monitor and oversee the quality of medical services provided to the hospital's patient population puts patients at risk of substandard care and adverse outcomes.

Findings included:

1. Document review of a policy titled "Incident Reports", #QUR301, revised 11/27/17, showed that any event not consistent with routine care or an unexpected outcome, will be reported by entering an Electronic Quality Memo (QM), also referred to as Quantros. The Quantros report is then sent to the Quality Department for investigation.

2. On 01/15/21 at 11:45 AM, Investigator #4 reviewed a sample of 7 medical records (Patient #401, #402, #405, #406, #407, #408, and #409) with the Director of Quality, Risk, and Compliance (Staff #404). The 7 medical records were chosen based on incident reports, staff concerns, and patient logs for the past 4 months. Of the 7 medical records reviewed, 3 medical records (Patient #401, #402, and #405) had documented patient harm events that were not reported in the incident reporting system (Quantros).

3. On 01/21/21 at 3:15 PM, Investigator #4 interviewed the Director of Quality, Risk, and Compliance (Staff #404). Staff #404 confirmed that no Quantros entries were received regarding 3 documented patient harm events in the Cardiac Cath Lab (Patient #401, #402, and #405).

4. On 01/19/21 at 2:05 PM, Investigator #4 interviewed the Chief Medical Officer (Staff #405) regarding the medical staff peer review process. Staff #405 stated that incident reports are screened by the Quality Department and medical staff concerns are further reviewed by the Medical Staff Peer Review Committee.

5. On 01/19/21 at 2:05 PM, Investigator #4 interviewed the Chief Medical Officer (Staff #405) regarding the 3 patient incidents (Patient #401, #402, and #405) from the last 4 months involving a medical staff member (Staff # 401) and poor patient outcomes. Staff #405 stated that she was not made aware of these incidents.

6. On 01/28/21 at 11:15 AM, Investigator #4, #5, and #9 met with the Governing Body. The Governing Body confirmed that they were not aware of any medical staff peer review concerns before our investigation. When asked how medical staff peer review is used in medical staff and service contract review and renewal, the Governing Body stated that they are not currently involved in contract review.

7. The hospital failed to aggregate and present patient care data related to provider practice to governing body.

Cross Reference A0347
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Based on interview, document review, review of the hospital's quality and performance improvement program, and review of Governing Body documents, the Governing Body failed to ensure that the hospital had an effective system in place to evaluate and ensure that contracted patient care services were provided to patients in a safe and effective manner for 2 of 2 contracts reviewed.

Failure to develop a coordinated process to oversee the performance of all patient care services and departments risks provision of improper or inadequate care and adverse patient outcomes.

Findings included:

1. Document review of the hospital's policy titled, "Contractual Arrangement Standards," policy number COM006, revised 09/09/13, showed that the policy did not address performance review for contracted services.

2. On 01/26/20 at 2:30 PM, Investigator #5 and the Quality and Risk Director (Staff #508) reviewed 2 clinical contracts (CardioSolutions LLC and Northwest Emergency Physicians). The review showed that 2 of 2 clinical contracts had not received a performance review.

3. On 01/22/21 at 2:00 PM, Investigators declared an Immediate Jeopardy/Serious Safety Event related to the hospital's failure to have a systematic process to report, monitor, evaluate, and improve the quality of patient care services through systematic data collection, analysis, and implementation and monitoring of quality activities in hospitals' Cardiac Cath Lab as evidenced by a failure to ensure that there was an effective process in place to ensure staff completed an Incident Report when an error, potential adverse event, or provider practice concern was identified.

During the investigation, it was determined that:

a. The Cardiac Cath Lab staff had been reporting provider care concerns, infections, and medication errors including potential adverse events to the contracted company.

b. Cardiac Cath Lab staff and management had not been reporting incidents through the hospitals incident reporting system per the hospital's policy.

c. The contracted company had not reported issues reported to them by staff to the hospital as defined in the hospital's contract.

d. The Cardiac Cath Lab was not integrated into the hospital's quality program.

The Quality and Risk Director (Staff #508) stated that the hospital had not conducted a contract review for the contracted company providing Cardiac Cath services to the hospital.

4. On 01/27/21, Investigator #5 reviewed 2 clinical contracts including CardioSolutions who provides all clinical services for the hospital's Cardiac Cath Lab, as well as Northwest Emergency Physicians, which provides staff in the Emergency Department. Investigator #5 found no evidence that the contracted services had been reviewed for quality and performance.

5. On 01/28/21 at 10:00 AM, Investigator #5, the Quality and Risk Director (Staff #508) and the Quality Committee reviewed the hospital's Quality Program and associated Quality Committee Documents. Investigator #5 found no evidence that the hospital's clinical contracts were reviewed as part of the Hospitals Quality Program.

6. At the time of the observation, Staff #508 stated that contracted service review was not reported through the local hospital's quality committee or through the hospital's governing body and verified that the 2 contracts reviewed by the Investigator had not received a quality performance review by the hospital.

7. On 01/28/21 at 11:02 AM, Investigator #5, the Quality and Risk Director (Staff #508), the Chief Executive Officer (Staff #509), and the hospital's Board of Directors, reviewed the Governing Body minutes and discussed the Governing Body's role and responsibilities for the hospital. Investigator #5 found no evidence that the hospital's Governing Body provided oversight for quality improvement review or activities for services furnished under contract or arrangement.

8. At the time of the review, the Chief Executive Officer (Staff #501) stated that there was not a process in place for reporting performance evaluation for contracted services to the hospital's Governing Body. Staff #508 stated that the hospital would be implementing a new program for clinical contract review.



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Based on observation, interview, and document review, the hospital failed to protect and promote patients' rights related to care in a safe setting.

Failure to protect and promote each patient's rights by providing for care in a safe setting risked patient harm. The cumulative effects of these systemic problems resulted in the hospital's inability to provide for patient safety, resulting in a declaration of immediate jeopardy.

Findings included:

1. Failure to ensure review and resolution of patient grievances went through the Board of Directors or a Grievance Committee.

Cross Reference: A0119

2. Failure to provide a safe and appropriately functioning clinical alarm system (a full spectrum of alarm systems that are triggered by physiological monitoring of the patient or by variations in measure parameters of medical equipment directly applied to the patient) for patients in the hospital's Emergency Department (ED), Critical Care Unit (CCU), and Medical/Telemetry Units as evidenced by the cardiac/hemodynamic monitoring system failure to capture hemodynamic data, failure to capture critical alarm data, failure to ensure that historical data could be retrieved, and failure to ensure audible alarm features were functional.

3. Failure to ensure a safe and effective process for ordering and documenting medications for patients boarded (Boarding is the practice of holding patients in the Emergency Department or another temporary location while awaiting transfer to another facility, admissions placement or discharge) in the hospital's Emergency Department (ED)

Cross Reference A0144

4. Failure to follow the hospital's policy and procedure for ordering restraints for management of patients exhibiting violent or self-destructive behavior.

Cross Reference: A0171

5. Failure to follow the hospital's policy and procedure for ordering restraints for management of patients exhibiting nonviolent or non-self-destructive behavior.

Cross Reference: A0173

6. Failure to ensure that hospital staff members released patients from restraints at the earliest opportunity.

Cross Reference: A0174

7. Failure to ensure that hospital staff members assessed and monitored patients while in restraints as directed by the hospital's restraint policy.

Cross Reference: A0175

Due to the scope and severity of deficiencies cited under 42 CFR 482.13, the Condition of Participation for Patient Rights was NOT MET.

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Based on document review and interview, the hospital failed to ensure review and resolution of patient grievances went through the Board of Directors or a Grievance Committee.

Failure to review and approve resolution of grievances by the Governing Body or a grievance committee instead of an individual risks incomplete or inadequate evaluation of all aspects of the grievance issue.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Patient Grievance," policy number QUR102, last revised 09/25/17, showed that the Board of Directors delegates the responsibility for the operation of the grievance process to the Hospital Grievance Committee. The Committee consists of the Patient Advocate, Director of Quality, Risk, & Compliance, Medical Staff Services Supervisor, Patient Accounts Director, and the Utilization Review Coordinator. The committee meets a least quarterly.

2. On 01/28/21 at 8:00 AM, Investigator #3 reviewed the Board of Directors Regular Committee and Board Quality, Safety and Compliance Committee meeting minutes for 2020 (past twelve months). The investigator could find no evidence in the minutes that patient grievances or complaints had been presented or reviewed.

3. On 01/28/21 at 3:30 PM, Investigator #3 interviewed the Director of Quality, Risk, and Compliance (Staff #302) about the grievance investigation and resolution process. Staff #302 stated that the hospital did not have a grievance committee and that the current hospital policy did not reflect the current process. Staff #302 stated that grievances are assigned, investigated and reported to the Board Quality, Safety, and Compliance Committee by himself. The investigator asked Staff #302 to show evidence that grievances were presented to the board. Staff #302 acknowledged and confirmed that the grievances presented to the board were not well documented in the meeting minutes.
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Item #1 Safe and Functioning Clinical Monitoring Equipment

Based on observation, interview, and document review the hospital failed to provide a safe and appropriately functioning clinical alarm system (a full spectrum of alarm systems that are triggered by physiological monitoring of the patient or by variations in measure parameters of medical equipment directly applied to the patient) for patients in the hospital's Emergency Department (ED), Critical Care Unit (CCU), and Medical/Telemetry Units as evidenced by the cardiac/hemodynamic monitoring system failure to capture hemodynamic data, failure to capture critical alarm data, failure to ensure that historical data could be retrieved, and failure to ensure audible alarm features were functional.

Failure to ensure an appropriately functioning clinical alarm system is in place puts patients at risk of delayed care, harm, and death.

Findings included:

1. Document review of the hospital's policy titled, "Physiologic Monitor Alarms, Continuous," policy number PS-149, revised 05/22/19, showed the following:

a. All patients placed on a continuous physiologic monitor will have the appropriate alarm(s) activated to ensure patient safety.

b. Alarms will not be disabled.

c. Alarms will be individualized (set and changed) to meet the patient's unique clinical circumstance by the Registered Nurse (RN) or by the Respiratory Therapist (RT) and by the specific equipment or as ordered by the medical provider.

d. Alarms will be set so that if there is a significant change in the patient's condition or abnormality in the operating condition of the piece of equipment applied to the patient will trigger an alarm.

e. Alarms will be audible and/or visual to appropriate staff to promptly notify them of a changing patient condition.

f. Alarm volumes shall be sufficiently loud and/or distinctive to be heard over noise commonly present in the units where the devices are used.

g. Users shall examine whether an alarm is sufficiently audible within the environment for which it is used.

2. On 01/20/21 at 4:10 PM, during interview with Investigator #5, a Monitor Tech (Staff #506) stated that the Telemetry monitoring system does not function properly and that the system "drops" data (periods of monitoring not recorded) and therefore they are unable to retrieve information from the system when a change in condition is identified. She stated that you could view the information live but you could not retrieve the information from the system. She stated in addition, the system will "discharge" a patient at random, and that staff have to go into the "discharged Patient" area of the system to pull the patients telemetry information. She stated that the system issues have been occurring for a very long time. Staff #506 stated that from 8:00 PM until 6:00 AM the CCU telemetry monitors are "pushed/diverted" to the Med/Telemetry Department. She stated that CCU staff are responsible to monitor their own telemetry during this time but the Monitor Technician (MT) in the Med/Telemetry are a "second pair of eyes."

3. At this time, Staff #506 provided Investigator #5 with samples of telemetry monitoring strips for current admitted patients. Investigator #5 observed "black outs" on the strips where there was no hemodynamic or cardiac data recorded. At this time, Investigator #5 also observed that there were no audible sounds coming from the monitoring system for the CCU patients being monitored by the medical/tele staff.

4. On 01/20/21 at 4:30 PM, Staff #506 verified that there were no audible alarm sounds for critical alarms triggered for patients in the CCU monitored by the medical/telemetry staff.

5. On 01/20/21 at 4:30 PM, the Clinical Data Abstractor (Staff #507) verified the systems failure to capture cardiac and hemodynamic data.

6. On 01/20/21 at 10:00 PM, the Director of Quality and Risk (Staff #508) verified the issues with the "blackouts" of the strips and verified that staff are unable to retrieve past cardia rhythms but that he was not aware of the random discharging of patients from the system.

Patient #501

7. Document review of hospital quality documents showed that on 01/12/21, staff reported that the telemetry monitoring system failed to alarm for Patient #501 who was suffering from Hypoxia in the Critical Care Unit (CCU) Room #9. The patient went into cardiac/respiratory arrest, failed return of spontaneous circulation (ROSC), and died.

8. On 01/20/21 at 9:30 PM, during interview with Investigator #5, a Registered Nurse (RN) Staff #501 stated that on 01/12/21 staff had intubated (inserted a tube into the trachea for ventilation) the patient in CCU Room #5 and put the patient on a respirator. Upon exiting the room Staff #501 noted that the cardiac/telemetry monitor showed that Patient #501, located in CCU Room #9, was hypoxic (deficiency in the amount of oxygen reaching the tissues) and had significant cardiac rhythm changes. She noted at this time that the telemetry monitoring system was not audibly alarming the critical events. Hospital staff started emergency life saving measures, but patient #501 failed to return of ROSC and died.

Staff #501 stated that after Patient #501 in CCU Room #9 had died, staff exited the patient room and entered the nurses station where they observed on the monitoring system that the patient in CCU Room #5 (Patient #504) who was ventilated on a respirator (A ventilator is a machine that provides mechanical ventilation by moving breathable air into and out of the lungs, to deliver breaths to a patient who is physically unable to breathe, or breathing insufficiently) was hypoxic with an oxygen saturation of 60%. Staff immediately responded with emergency measures and the patient returned to normal oxygen saturations. Staff #501 stated that the monitoring system also failed to alarm hypoxia for the Patient #504 in CCU Room #5 as well.

Staff #501 stated that most of the patients in the CCU are Covid-19 patients. She stated that the core staff in the CCU is 2 nurses and that there was no staff to monitor the clinical alarm system. She stated that when staff are in these isolation rooms with the doors closed, they were unable to hear critical alarms.

9. At this time, Investigator #5 observed that CCU Room #9 had been removed from service, but CCU Room #5 had a patient in the room who was being monitored by the hospital's clinical monitoring system.

10. On 01/21/21 at 2:28 PM, during interview with Investigator #5, a Provider (Staff #509) stated that after Patient #501 had died and staff returned to the nurses station she observed that the monitoring system showed that the Patient #504 located in CCU Room #5 had an oxygen saturation of 60%. She stated that the clinical alarm system did not sound to alert staff to the medical emergency in Room #5.

11. On 01/21/21 at 4:30 PM, a Registered Nurse (RN) Staff #510 verified that the clinical alarm monitoring system did not audibly alarm warning staff of the critical alarms for Patients #501 and #504. He stated that when he pushed on the "alarm watch" button the alarms started working.

12. Currently, the hospital is unable to determine if the alarm failures are a result of equipment malfunction or human error.

Patient #902

13. Document review showed that on 12/29/20 at 5:42 PM, Patient #902 was transferred by ambulance to the Emergency Department (ED) with complaints of chest pain, nausea and dizziness. Document review of the medical record showed the following:

a. The patient had a history of atrial fibrillation (irregular, often rapid heart rate), congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), and diabetes mellitus.

b. Initial vitals taken during triage: weight 82.6 kg/182 pounds, blood pressure 147/77, pulse 92 beat per minute, respirations 20, and reported pain 2 out of 10.

c. Prior to the patient's arrival to the ED, the Emergency Medical Staff (EMS) had identified the patient was experiencing an ST-elevation myocardial infarction (STEMI), which triggers the need for a life-saving team and equipment upon arrival. An initial electrocardiography (EKG) obtained on arrival to the ED
did not show signs of STEMI criteria and the provider cancelled the STEMI code.

d. At 9:48 PM, an order was placed to admit the patient to the hospital. The patient remained in ED Room #5 pending the availability of a bed within the hospital. The ED provider consulted with the hospital's cardiologist (Staff #910) and ordered cardiac monitoring for Patient #902.

e. At 9:55 PM, nursing notes documented repositioning the patient and giving her a teddy bear that was on the counter.

f. From 9:56 PM until 11:02 PM Patient #902's cardiac monitoring telemetry alarmed noting changes in the cardiac rhythm 16 times, including consistent Ventricular Tachycardia beginning at 10:30 PM.

g. At 10:52 PM, a period of 22 minutes after the patient went into a ventricular tachycardia heart rhythm (a type of abnormal heart rhythm, or arrhythmia. It occurs when the lower chamber of the heart beats too fast to pump well and the body doesn't receive enough oxygenated blood), Staff #907 entered the patient's room to prepare to transport the patient to her hospital room upstairs. Staff #907 found the patient gray and unresponsive, with a heart rate of 40. The ED provider was notified, and an ultrasound of the heart was obtained.

h. At 11:02 PM, the patient was pronounced dead.

14. On 01/20/21 at 2:25 PM, during an interview with Investigator #9, the Director of Emergency Services (Staff #901) verified the finding and stated that she was not able to determine if the alarms were audible or silenced by staff. She stated that due to the layout of the Emergency Department and the alarm monitors, it is not possible to hear the alarms unless sitting directly in front of the monitor at the nurse's station. She stated that the patient's telemetry monitors were not continuously monitored as the monitors were monitored by the charge nurse who also had patients and was responsible for triaging new patients.

15. On 01/21/21 at 12:15 PM, during an interview with Investigator #9, the Director of Quality and Risk (Staff #904) verified that the video tapes dated 12/29/20 from 10:00 PM to 11:02 PM showed that staff entered Patient #902's room at 9:55 PM and re-entered again at 10:52 PM. Staff #904 verified that based on the angle of the video cameras and review of the alarm system data, they are unable to confirm if staff silenced the alarms or if the alarms did not function.

16. At the time of the finding, the hospital was unable to determine if the event was related to equipment malfunction or staff error.

Patient #905

17. On 01/25/21, Investigator #9 reviewed the medical record for Patient #905. The review showed the following:

a. On 01/23/21 at 6:49 PM, Patient #905 was transferred to the Emergency Department (ED) via ambulance with abdominal distension and difficulty breathing. The patient had a history of transient ischemic attacks (TIA), hypertension (high blood pressure), and dementia.

b. Initial vitals taken during triage showed a blood pressure of 85/52, a pulse of 65 beats per minute, and a respiration rate of 25 breaths per minute. The patient was placed in ED Room #1 on cardiac monitoring.

c. At 7:45 PM, the Patient's blood pressure was 67/41. Surveyor #9 found no evidence that any alarms were triggered or documented on the alarm history.

d. At approximately 7:50 PM, a review of telemetry monitoring data showed that there were gaps in time where the telemetry monitoring system failed to capture data for the patient's heart rhythm, respirations, and oxygen saturation.

e. At 8:45 PM, Patient's blood pressure was 66/41 with a pulse of 47. No alarms were triggered or documented on the alarm history.

f. At 9:05 PM, provider notes showed that the patient returned from CT scan with a reported heart rate of 18 beats per minute. No alarms were triggered or documented in the alarm history.

g. The patient's daughter was at bedside and stated that patient advanced directives are DNR/DNI (Do not resuscitate/Do not intubate). Time of death was pronounced at 9:06 PM.

18. On 01/25/21 at 1:50 PM, Investigator #9 reviewed the patients cardiac alarm history. The documentation showed that the cardiac telemetry monitoring alarm history was completely blank. No alarms were documented for the patient throughout admission from 1/23/21 at 6:49 PM to the patient's expiration at 8:06 PM.

19. On 01/25/21 at 1:50 PM, during an interview with Investigator #9, the Director of Emergency Services (Staff #901) verified that the alarm history for Patient #905 was missing any data or record of alarms and that based on a review of the patient's vitals and cardiac rhythm monitoring, several alarms should have been triggered.

20. On 01/25/21 at 2:30 PM, during an interview with Investigator #9, the Cardiac Monitoring Vendor Space Labs (Staff #908) verified that the alarm history for Patient #905 was missing all the alarm data. He was unable to verify if the absence of the alarm history signified that the alarms did not trigger. Staff #908 stated "it is some sort of glitch in the system."

Patient #903

21. On 01/25/21, Investigator #9 reviewed the medical record for Patient #903. The record review showed the following:

a. On 01/12/21 at 11:51 PM, Patient #903 was transferred to the hospital's Emergency Department (ED) via ambulance with shortness of breath, dry cough, and abdominal pressure.

b. The patient had a history of seizures, tachycardia (rapid heart rate), CHF (chronic heart failure), heroin and methamphetamine use.

c. Initial vital signs taken during triage showed the patient's blood pressure of 110/92, a heart rate of 118 beats per minute, a respiratory rate of 28, and a reported pain 6 out of 10. The patient was placed in Room #4 on cardiac monitoring.

d. On 01/13/21 at 1:04 AM, nursing documentation showed that the patient was sleeping, and respirations noted.

e. At 2:21 AM, nursing documentation showed that the patient was watching TV and had no reports of distress.

f. At 3:08 AM, nursing documentation showed that the patient was alert, sitting up and yelling for pain medication. The notes showed that the patient stated that she used heroin every two hours stating, "I need something."

g. At 3:24 AM, after the staff finished with a medical emergency in another patient room (Room #5), they entered Patient #903's room (Room #4) and found Patient #903 unresponsive and initiated a code blue (medical emergency).

22. On 01/26/21 at 9:30 AM, during an Interview with Investigator #9, the Director of Emergency Services (Staff #901) verified that there was no staff available to watch the cardiac telemetry monitors during the medical emergency in Room #5. Staff #901 stated that it is the responsibility of the charge nurse to monitor the telemetry system, however the charge nurse is responsible for their own patient assignment, triaging new patient's presenting to the emergency room, responding to medical emergencies (code blue), and is therefore unable to provide for continuous monitoring of the telemetry monitoring system. Staff #901 stated that she was unable to verify if the alarms were triggered during the emergencies or if they did not alarm.

23. On 01/26/21 at 3:00 PM, Investigator #5 inspected the hospital's Emergency Department (ED). Investigator #5 noted that the centralized cardiac monitoring system utilized to monitor current Emergency Room department patients was not attended or monitored by a staff member.

24. On 01/26/21 at 3:30 PM, during interview with Investigator #5, the ED Charge Nurse (Staff #509) verified that the monitors were not continuously monitored. She stated that monitoring of the telemetry system for patients in the emergency room was a function of the charge nurse role, but that the charge nurses were also responsible to take a patient assignment, complete triage on new patient's arriving to the ED, manage code blues (medical emergencies), and manage flow throughout the ED and therefore they could not provide continuous monitoring.

System Failure Notification

25. On 01/25/21 at 10:00 AM, during interview with Investigator #5, the Director of Quality and Risk (Staff #508), Staff #508 stated that Spacelabs was investigating aspects of the system failures to determine if the failures were related to hardware and software problems, hospital server problems, equipment failures, and/or staff errors. Staff
#508 stated that because staff had not been entering incident reports through the hospital's electronic incident reporting system (QANTROS) until they received education as part of the previous declarations of Immediate Jeopardies/Serious Safety Events called on 01/22/21, the hospital was unaware of the scale of the clinical monitoring system malfunction.

26. On 01/26/21, document review of the hospitals Quality data showed that from 01/22/21 at 4:30 PM through 01/25/21 at 7:00 AM (period of a 62.5 hours) staff reported 39 incidents of clinical alarm system malfunctions for patients currently admitted to the hospital. The malfunctions included:

a. One Thousand One Hundred and Twenty-Six (1,126) occurrences of clinical alarm system failure to capture cardiac rhythms on current admitted patients.

b. The clinical alarm system failure to alarm for a patient in Emergency Room #1 with an oxygen saturation of 85%. Staff reported that the monitor was not functioning appropriately (turning off and on) and required staff to "jiggle" the monitor to get it to function.

c. Failure of the monitors in ED Room #1 and #10 to function. The monitoring screens were black, and staff were unable to view or hear and the monitor in Room #1 was turning off and on at random.

d. Failure of the system to take vital signs as programed.

e. Failure of the Telemetry boxes to capture patient data

f. Failure to pull data from transport boxes to main system

g. Failure to be able to see heart monitor reading on "any" of the patients located in the CCU.

27. On 01/26/21 at 1:00 PM, Investigators declared an Immediate Jeopardy/Serious Safety Event related to the hospital's failure to ensure a safe and effective system was in place to provide hemodynamic monitoring for patients in the hospital's Emergency Department (ED). Critical Care Unit (CCU), and Medical/Telemetry Units as evidenced by the monitoring system's failure to capture hemodynamic data, failure to capture critical alarm data, failure to ensure that historical data could be retrieved, and failure to ensure audible alarm features were functional.

Item #2 Electronic Orders for Medication Administration

Based on observation, document review, and interview, the hospital failed to ensure a safe and effective process for ordering and documenting medications for patients boarded (Boarding is the practice of holding patients in the Emergency Department or another temporary location while awaiting transfer to another facility, admissions placement or discharge) in the hospital's Emergency Department (ED).

Failure to ensure a safe process is in place for ordering and documenting medication could lead to medication omissions and errors and cause patient harm and death.

Findings included:

1. Document review of the hospital's policy titled, "Patient Standards of Care in the Emergency Department," policy number ED-088, revised 08/29/18, showed that the policy did not address medication administration and documentation guidelines for the provision of care to patients in the Emergency Department (ED).

2. On 01/21/21, Investigator #9 and the Director of Emergency Services (Staff #901), reviewed the medical record for Patient #901 who was a boarder patient in the hospital's ED from 12/10-31/20. The review showed the following:

a. Diabetic Point of Care Testing results showed that from 12/10/20 to 12/30/20 the patient's fasting blood glucose results were out-of-normal range as defined by the hospital's protocols.

b. The patient did not receive his insulin Levemir on 12/14/20, 12/15/20, 12/16/20, 12/17/20, and 12/18/20.

c. The Medication Administration Record (MAR) showed that the order for the Levemir dropped off the MAR after 12/13/20 and staff did not document any further Levemir administrations. On 12/19/20 a provider wrote an order to re-start the medication.

d. Review of the Patient's medical record found no nursing notes or provider notes documenting the lapse in medication administration.

3. On 01/27/21 at 12:37 PM, Investigators #4, #5, and #9 interviewed the Chief Nursing Officer (Staff #902) regarding care of patients boarding in the ED. During the interview, Staff #902 stated that there is currently no policy guiding care, treatment and services for patients boarding in the ED.

4. On 01/28/21 at 9:52 AM during interview with Investigator #9, an ED Nurse (Staff #903), reported that because of the Emergency Department Charting limitations, some of the medications designated with "ED" drop off the Medication Administration Records (MAR) after four hours. Staff #903 stated that this was the case with Patient #901's medications for diabetes management. Staff #903 stated that this often results in patients not receiving required medications in the Emergency Department. Additionally, Staff #903 reported that there is not a way to order daily blood glucose monitoring checks, such as the standard "before meals and at bedtime (ACHS)" through the Emergency Department Charting system.

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Based on interview, record review, and review of hospital policies and procedures, the hospital failed to ensure that orders for restraints to manage violent or self-destructive behavior did not exceed four hours for adults, as demonstrated by 1 of 4 patient records reviewed (Patients #303).

Failure to follow established procedures for restraints risks physical and psychological harm, loss of dignity, and violation of patient rights.

Findings included:

1. Document review of the hospital policy and procedure titled, "Management of Restraints and Seclusion," policy number PS-012, last revised 12/10/20, showed that use of a restraint requires an order from a provider. Restraint orders for emergency behavior management is time limited to four hours for patients greater than 18 years of age.

2. On 03/03/21 at 1:00 PM, Investigator #3 and the Quality Management Data Analyst (Staff #301) reviewed the medical records of four patients who were placed in behavioral management restraints during their care at the hospital. The review showed:

a. Patient #303, a 35-year-old patient, was admitted to the Emergency Department (ED) on 02/27/21 for psychological evaluation by the police after swinging a knfie and threatening neighbors and herself. Upon arrival to the ED, the patient was agitated and was immediately placed in four-point restraints at 7:15 PM. The medical record showed that the provider wrote an order for restraints due to violent behavior at 7:24 PM on 02/27/21. A renewal order for an additional 4-hour period was written at 11:38 PM on 02/27/21. No further orders were written for restraints. The patient was released from restraints at 6:57 AM on 2/28/21, a period of 3 hours and 19 minutes after the current restraint order had expired due to time limits.

3. At the time of the record review, Investigator #3 interviewed the Quality Management Data Analyst (Staff #301) about the hospital's policy for ordering and renewing behavioral management restraints. Staff #301 confirmed that staff had not followed the hospital's policy for restraint orders being written every 4 hours as required.

THIS IS A REPEAT CITATION, PREVIOUSLY CITED ON 11/09/20.
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Based on record review, interview, and document review, staff failed to follow the hospital's policy and procedure for ordering restraints for management of patients exhibiting nonviolent or non-self-destructive behavior for 1 of 4 patient records reviewed (Patients #302).

Failure to follow established procedures for restraints risks physical and psychological harm, loss of dignity, and violation of patient rights.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Management of Restraints and Seclusion," policy number PS-012, last revised 03/14/19, showed that for a non-violent/non-destructive patient, the provider must be notified prior to applying restraints. Daily, the provider will see and assess the patient before writing a new restraint order. The provider will annotate on the order the indication for continued need for restraints.

2. On 01/27/21 at 11:00 AM, Investigator #3 and the Quality Management Data Analyst (Staff #301) reviewed the medical records of four patients who have been placed in restraints during their stay at the hospital. The review showed that Patient #302 was a 72-year-old who was admitted to the critical care unit with respiratory failure. The physician ordered restraints for the patient on 01/21/21 at 5:32 PM for protection of life-saving lines and tubes. Staff discontinued the patient's restraints on 01/24/21 at 8:46 AM. Despite discontinuation of the restraints, a provider continued to write orders for four consecutive days (01/24/21, 01/25/21, 01/26/21, and 01/27/21).

3. On 01/27/21 at 1:30 PM, Investigator #3 and the Quality Management Data Analyst (Staff #301) interviewed the hospitalist (Staff #303) on duty in the critical care unit who had written the restraint orders for the past three days. When asked by the investigator why renewal orders for restraints were written, the hospitalist (Staff #303) stated that he was unaware that the patient's restraints had been discontinued earlier.
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Based on record review, interview, and review of hospital policies and procedures, the hospital failed to ensure that patients were released from restraints at the earliest possible time for 1 of 4 patients reviewed (Patients #303).

Failure to remove patients from restraints at the earliest possible time risks loss of dignity, loss of personal freedom, and psychological and physical harm to the patient.

Findings included:

1. Review of the hospital's policy and procedure titled, "Management of Restraints and Seclusion", Policy # PS-012, last revised 12/10/20, showed that restraint will be in accordance with an order from a provider and will end at the earliest possible time. The use of restraints for behavior management must be limited to the duration of the emergency safety situation regardless of the length of the order.

2. On 03/03/21 at 1:00 PM, Investigator #3 and a Quality Management Data Analyst (Staff #301), reviewed the medical records of four patients who were placed in behavioral management restraints during their care at the hospital. The review showed the following:

a. Patient #303, a 35-year-old patient, was admitted to the Emergency Department (ED) on 02/27/21 for psychological evaluation by law enforcement after swinging a knife and threatening neighbors and herself. Upon arrival to the ED, the patient was agitated and was immediately placed in four-point restraints at 7:15 PM. The patient was later released from restraints at 6:57 AM on 02/28/21. While in restraints, the medical record showed that the patient's condition improved and the patient's behavior was described as "sleeping" from 02/28/21 at 2:45 AM to 02/28/21 at 6:57 AM, a period of 4 hours and 12 minutes. A nursing note written at the time the patient was released from restraints showed that the patient was "cooperative after sleep." No other documentation could be found that supported the continued use of restraints for that period.

3. At the time of the record review, Investigator #3 interviewed the Quality Management Data Analyst (Staff #301) about the use of restraints. Staff #301 confirmed that staff had not followed the hospital's restraint policy and procedure while caring for Patient #303.
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Based on record review, interview, and review of hospital policies and procedures, the hospital failed to ensure that hospital staff members assessed and monitored patients while in restraints as directed by the hospital's restraint policy, as demonstrated by 4 of 8 patient records reviewed (Patient #301, #303, #304, #305).

Failure to follow approved policies and procedures for restraint use risks physical and psychological harm, loss of dignity, and violation of patient rights.

Findings included:

1. Review of the hospital's policy and procedure titled, "Management of Restraints and Seclusion," number PS-012, last revised 12/10/20, showed that patients restrained for violent/self-destructive behavior would be assessed every fifteen minutes for type of restraint, patient behavior/effect of restraint, circulation, assistance or offering of fluids, nutrition, and elimination, range of motion, and evaluation for restraint removal. Monitoring of patients in restraints for behavioral management will be through continuous, in-person observation.

2. On 01/27/21 at 11:00 AM, Investigator #3 and the Quality Management Data Analyst (Staff #301) reviewed the medical records of four patients who have been placed in restraints during their stay at the hospital. The review showed that Patient #301 was a 37-year-old who presented to the Emergency Department (ED) with a chief complaint of shortness of breath. While in the ED, the patient suffered a cardiac arrest and subsequently was intubated. In addition, a central venous line, urinary catheter, and nasogastric tube was placed.

The patient was placed in restraints on 01/13/21 at 3:40 AM for protection of life-saving tubes. Patient #301 remained in restraints until her transfer to a higher level of care facility on 01/12/21 at 5:28 PM. The patient's record lacked evidence that she was assessed every two hours between 01/13/21 at 7:40 AM and 01/12/21 at 5:28 PM, a period of 9 hours and 48 minutes.

3. At the time of the review, Investigator #3 interviewed the Quality Management Data Analyst (Staff #301) who confirmed that the record lacked evidence or documentation that the patient had been assessed every two hours as directed by hospital policy.

4. On 03/03/21 at 1:00 PM, Investigator #3 and a Quality Management Data Analyst (Staff #301), reviewed the medical records of four patients who were placed in behavioral management restraints during their care at the hospital. The review showed the following:

a. Patient #304 was a 47-year-old patient admitted to the Emergency Department (ED) on 02/18/21 for psychological evaluation after the designated crisis responder requested the police bring the patient to the hospital. Upon arrival to the ED, the patient was aggressive and agitated toward the hospital staff. The patient was placed in four-point restraints at 8:00 PM with several police officers at the bedside. The patient was released from restraints at 7:09 AM on 02/19/21. The review showed that the patient's behavior, offering of fluids, nutrition, and elimination were not documented or assessed between 8:00 PM on 02/18/21 and 10:45 PM on 02/18/21, a period of 2 hours and 45 minutes. The investigator could find no assessment or documentation that circulation checks were performed during the length of the restraint episode, a period of 11 hours and 9 minutes. A nursing note written at the time that the restraints were released showed that both feet "are reddened and have petechiae".

b. Patient #303 was a 34-year patient admitted to the Emergency Department (ED) on 02/23/21 for psychological evaluation after the designated crisis responder requested the police bring the patient to the hospital. Upon arrival to the ED, the patient was combative, agitated, and physically assaulted a staff member. The patient was immediately placed in four-point restraints at 9:45 PM. The patient was later released from restraints at 4:00 PM on 02/24/21. The review showed no assessment or documentation that circulation checks were performed as required by hospital policy for the length of the restraint episode (a period of 18 hours and 15 minutes).

c. Patient #303 was a 35-year-old patient admitted to the Emergency Department (ED) on 02/27/21 for psychological evaluation after being brought in by the police following an incident in which the patient was swinging a knife and threatening neighbors and herself. Upon arrival to the ED, the patient was agitated and was immediately placed in four-point restraints at 7:15 PM. The patient was later released from restraints at 6:57 AM on 02/28/21. The review showed no assessment or documentation that circulation checks were performed as required by hospital policy for the length of the restraint episode (a period of 11 hours and 42 minutes).

d. Patient #305 was a 28-year-old patient admitted to the Emergency Department (ED) on 02/27/21 for psychological evaluation after the designated crisis responder requested the police bring the patient to the hospital. The patient initially agreed to voluntary psychiatric hospitalization.

On 03/01/21 at 1:31 PM, the patient threatened to leave. A nursing note dated 1:55 PM on 03/01/21 showed that the patient eloped out the ambulance doors and that the hospital social worker (Staff #304) called the police to bring the patient back. The patient was brought back by the police and the hospital social worker informed the patient that he was now on involuntary hold until the designated crisis responder could evaluate him.

The patient became agitated, was medicated with multiple medications and then placed in behavior management restraints at 2:30 PM on 03/01/21. A nursing note dated 2:40 PM on 03/01/21 showed that the patient untied himself from the restraints and eloped out the ambulance bay doors. The behavioral restraint note documentation was marked yes for one to one nursing and close observation.

The investigator found no evidence to support that the patient remained under continuous observation as required by hospital policy.
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Based on observation, interview, and review of quality documents, the hospital failed to develop a hospital-wide quality assessment and performance improvement program (QAPI) to monitor, evaluate, and improve quality of patient care services through systematic data collection, analysis, implementation of process improvement, and monitoring of those plans post implementation to ensure sustained improvements in clinical care with oversight of the hospital's Governing Body.

Failure to systematically collect and analyze hospital-wide performance data limited the hospital's ability to identify problems and formulate action plans. This reduced the likelihood of sustained improvements in clinical care and patient outcomes.

Findings included:

Interview, record review, and review of the hospital's quality documents showed the following:

1. Failure to ensure that there was an effective process in place to ensure staff completed an Incident Report when errors, potential adverse events, and provider practice concerns were identified. Failure to systematically collect, aggregate, and analyze quality indicator data as part of the hospital's overall quality program as defined in its policy and procedure.

Cross Reference A0273

2. Failure to ensure that there was an effective process in place to identify patient harm events that require an RCA (Root Cause Analysis) and therefore failure to conduct RCA's for potential patient harm events that included provider practice concerns, infections, and medication errors.

Cross Reference A0286

3. Failure of the Governing Body to provide oversight to ensure full implementation of the quality assessment and performance improvement (QAPI) plan, including the development and implementation of a systematic process to report, monitor, evaluate, and improve the quality of patient care services through systematic data collection, analysis, and implementation and monitoring of quality activities.

Cross Reference: A0309

Due to the scope of the deficiencies cited under 42 CFR 482.21; the Condition of Participation for Quality Assurance Performance Improvement was NOT MET.

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Based on interview and document review, the hospital failed to ensure that there was an effective process in place to ensure staff completed an Incident Reports when an error, potential adverse events, and provider practice concern were identified.

Failure to ensure that there was an effective process in place to ensure staff completed an Incident Report when an error, potential adverse events, and provider practice concern were identified limited the hospital's ability to identify problems and formulate action plans. This reduced the likelihood of sustained improvements in clinical care and patient outcomes.

Findings included:

1. Document review of the hospital's policy titled, "Incident Reports," policy number QUR301, revised 11/27/17, showed:

a. An electronic Quality Memo (QM) is to be completed to report all occurrences of actual or potential injury to patient and non-patients.

b. The employee, staff member, or physician who is involved in, witnesses, discovers, or has an occurrence reported to them are responsible for reporting the event by the end of their shift.

c. Sentinel or serious adverse events as well as near misses will undergo a root cause analysis to identify issues that may have contributed to the process failure.

d. Medical Staff occurrences, including adverse outcomes or Quality Care concerns will be referred to the QUR Committee. Contact problems, documentation issues or other concerns will be referred to the Department Chair for investigation, discussion and forwarded to QUR as appropriate.

Document review of a contract titled "CardioSolutions Master Services Agreement", #11190344v9/71356.15, showed that CardioSolutions is to notify the hospital of any investigations initiated by CardioSolutions.

Document review of a policy labeled "Quality Assurance for Cardiac Cath Lab", #CATH-9002, effective 04/14/20, showed that any event that causes a patient to undergo additional surgical intervention, such as a pacemaker explantation, required a cardiologist peer review and report to the Cardiac Quality Assurance Committee.

Patient #401

2. On 01/19/21, Investigator #4 reviewed the medical record for Patient #401. The document review showed the following:

a. On 10/23/20 at 5:06 AM, Patient #401 was brought to the cardiac catherization lab (a hospital procedure room where doctors perform procedures to diagnose and treat heart disease) for an emergency cardiac catherization (procedure where a long tube called a catheter is inserted into a blood vessel and threaded to the heart to diagnose and/or treat a blockage).

b. At 5:22 AM, the patient's heart stopped and a Code Blue (a call for help by intercom system in hospital when someone's heart has stopped beating) was called and Cardiopulmonary Resuscitation (CPR) was initiated.

c. At 5:28 AM, the cardiologist (Staff #401) declared the patient deceased and CPR was stopped.

d. From 5:30 AM to 5:47 AM, the Provider performed an invasive cardiac catherization on the deceased patient (Patient #401).

3. On 01/19/21 from 11:00 AM to 2:00 PM, Investigator #4 interviewed 3 Cardiac Cath Lab Staff (Staff #12, #13, and #15). Staff #412 stated that she immediately reported the incident involving Patient #401 to her manager but did not complete a Quantros Incident Report (the hospital's internal quality reporting system). Staff #413 also stated that he reported Patient #401's incident to his manager but was not aware of the hospital's Quantros reporting system.

4. On 01/19/21 at 11:45 AM, Investigator #4 interviewed the Cardiac Cath Lab Manager (Staff#411). Staff #411 confirmed that 2 staff members (Staff #412 and #413) reported their concerns on the day of the event. Staff #411 asked for and received written statements from Staff #412 and Staff #413 and forwarded their concerns to the Field Operations and Quality Manager (Staff #409).

5. On 01/19/21 at 12:10 PM, Investigator #4 interviewed the CardioSolutions Field Operations and Quality Manager (Staff #409). Staff #409 confirmed that on 10/23/20 he received 2 written complaints regarding Patient #401's care. Staff #409 stated that he forwarded the complaints to their contracted agency's Regional Chief Medical Officer and Chief Medical Officer for review.

6. On 01/29/21 at 4:00 PM, Investigator #4 interviewed the Clinical Data Abstractor (Staff #408) regarding Patient #401's case not being reported to the Quality Department and then forwarded to the Peer Review Committee as described in the hospital's contract. Staff #408 stated that the concerns regarding Patient #401's care were brought to the Quality Department via email.

7. Document review of an email correspondence from 10/27/20 to 11/13/20 showed a request from the Director of Emergency Services (Staff #406) for a peer review of Patient #401's care in the Cardiac Cath Lab. Staff #406 reported in her email to the Quality Improvement Specialist Registered Nurse (RN) (Staff #407) that on 10/23/20 several Emergency Department (ED) staff members attended Patient #401's Code Blue in the Cardiac Cath Lab and had verbalized concerns regarding Patient #401's medical care.

8. On 01/15/21 at 1:20 PM, Investigator #4 interviewed the Director of Risk, Quality, and Compliance (Staff #404). Staff #404 stated that he was not notified of the investigation by CardioSolutions regarding Patient #401. Therefore, the hospital was unaware of the event and investigation and peer review processes were not initiated.

9. On 01/19/21 at 2:05 PM, Investigator #4 interviewed the Chief Medical Officer (Staff #405). Staff #405 confirmed that she was not aware of the concerns reported to CardioSolutions or the concerns reported by staff regarding Patient #401's medical care.

Patient #402

10. On 01/19/21, Investigator #4 reviewed the medical record for Patient #402. The document review showed the following:

a. On 10/23/20, Patient #402 was brought to the cardiac catherization lab (a hospital procedure room where doctors perform procedures to diagnose and treat heart disease) to have a temporary pacemaker (a device implanted in the body to keep heart rate) removed and a permanent pacemaker placed secondary to a diagnosed heart block (heart problem that lowers your heart rate, sometimes to unsustainable low heart rates).

b. The medical record showed that on 10/23/20 at 4:34 PM, a Cardiologist's (Staff #401) operative report, showed that the patient had a fever at the time of the permanent pacemaker placement.

11. On 01/19/21 at 1:10 PM, during interview with Investigator #4, the Cath Lab Technician (Staff #416) who assisted with the pacemaker placement stated that it is not common practice to place a pacemaker when someone has a fever or other signs of infection and that he notified the Cardiologist (Staff #402) of Patient #402's fever prior to the procedure. He stated that the Cardiologist (Staff #402) replied that he places pacemakers in patients with fevers, he just uses Vancomycin (strong antibiotic to treat certain types of bacterial infections).

12. Document review of a logbook labeled "Cardiac Cath Lab Patient Log," showed that on 10/23/20, Patient #402 had a pacemaker placed, and then on 10/31/20 the pacemaker was removed due to an infection.

13. Document review of Patient #402's medical record and operative report dated 10/31/20, showed the Cardiologist (Staff #401) performed a pacemaker explantation (removal of the pacemaker device) secondary to an infection. Staff #401's operative report contradicts his prior documentation by stating that he was removing the temporary pacemaker that was placed on 10/20/20 by another Cardiologist (Staff #417). The operative report dated 10/31/20 failed to mention that Staff #401 had removed the temporary pacemaker on 10/23/20, per his own documentation, and replaced it with a permanent pacemaker.

14. On 01/19/21 at 11:45 AM, Investigator #4 interviewed the Cath Lab Manager (Staff #411). Staff #411 stated that he was aware of Patient #402's pacemaker infection and reported his concerns to his direct supervisor for CardioSolutions (Staff #409). The Cath Lab Manager (Staff #411) stated that he was not aware of, or was not invited to, an active quality assurance committee for the hospital. He stated that there was a STEMI (heart attack interventions) meeting but that his involvement included only providing STEMI statistics requested via email from the Chief Nursing Officer (Staff #410) every quarter.

15. On 01/20/20 at 3:40 PM, Investigator #4 interviewed the Chief Nursing Officer (Staff #410). Staff #410 stated that she was unaware of Patient #402's pacemaker infection and explantation. Staff #410 also stated that the required quality data and concerns are discussed at the quarterly STEMI meetings. Investigator #4 requested the meeting minute documentation, but Staff #410 stated that meeting minutes and attendance are not documented, and she was unable to provide any evidence of the meeting, or process improvement activities.

16. On 01/20/20 at 3:30 PM, Investigator #4 interviewed the Director of Surgical Services and Infection Preventionist (Staff #418). Staff #418 stated that she was unaware of Patient #402's infection or return to surgery. When asked what mechanism there was to notify her of infections in the cardiac Cath lab, she reported that there was no way for her to capture that data unless cardiac Cath lab employees called her personally to tell her.

17. On 01/21/21 at 3:15 PM, Investigator #4 interviewed the Director of Risk, Quality, and Compliance (Staff #404). Staff #404 stated that he was not notified of the investigation by CardioSolutions regarding Patient #402. He stated that hospital staff did not enter Quantros incident reports related to the provider practice concerns, the hospital acquired infection, or the return to surgery for Patient #402, and therefore, the hospital was unaware of the events and investigation and peer review processes were not initiated.

Patient #904 #1

18. On 01/21/21, Investigator #9 reviewed the medical record for Patient #904. The record review showed the following:

a. On 01/05/21 at 7:57 AM, Patient #904 was transferred to the hospital's Emergency Department (ED) via ambulance. The patient had been found down and unconscious at home. His wife called paramedics, then performed cardiopulmonary resuscitation (CPR) until the paramedics arrived, who continued to perform CPR for 15 minutes. The paramedics gave the patient two electrical shocks from the defibrillator and the patient regained an effective rhythm. The patient's electrocardiogram (EKG) results showed a right bundle-branch block (physiologic electrical conduction system of the heart is altered or interrupted).

b. The record showed that the Cath Lab was contacted, and the patient was transferred to the Cath Lab for a procedure.

19. On 01/21/21 at 12:56 PM, during an interview with Investigator #4, Investigator #5, and Investigator #9, the Cath Lab Tech (Staff #909) stated that during the procedure for Patient #904, the medical provider (Staff #910) stated that the patient was in PEA (Pulseless Electrical Activity) and proceeded to perform aggressive pericardial thumps. Staff #909 voiced his concern to the provider that the patient had a cardiac rhythm, a blood pressure, and was awake. Staff #909 stated that multiple staff in the room at the time voiced concerns and repeatedly requested the provider cease performing the pericardial thumps.

20. Staff #909 stated that he did not fill out an incident report, but that he had reported the provider care concerns to his manager (Staff #503).

21. On 01/21/21 at 1:45 PM, during interview with Investigator #5, the Cath Lab Manager (Staff #503) stated that he reported the incident to Cardio Solutions but did not complete a hospital incident report.

Patient #904 #2

22. On 01/22/21 at 8:17 AM, during an interview with Investigator #4, Investigator #5, and Investigator #9, the Cath Lab Tech (Staff #911) stated that during the angioplasty procedure for Patient #904, the medical provider (Staff #910) was having difficulty with moving the balloon past the occlusion and asked Staff #911 to hold the guide lines. In order to maintain a sterile field, Staff #911 continued to hold the guidelines in each hand. The medical provider (Staff #910) reached around Staff #911 and retrieved the nitroglycerin syringe and administered the medication into the coronary arteries. The provider (Staff #910) stated twice that he was injecting nitroglycerin into the patient's coronary arteries for Cath lab staff to document. After each administration, the patient developed arrythmias that required emergency intervention.

After the conclusion of the procedure, and after the provider had left the room, staff discovered that the provider had injected lidocaine into the coronary vessels and not nitroglycerin.

23. At the time of the interview, Staff #909 stated that he did not fill out an incident report, but that he reported the provider care concerns to his manager (Staff #503).

24. On 01/21/21 at 1:45 PM, during interview with Investigator #5, the Cath Lab Manager (Staff #503) verified that the patient coded (a medical emergency) after each medication administration. He stated that he reported the incident to CardioSolutions, but did not complete a hospital incident report. He stated that once he reported the incident to his Corporate office it was "out of (his) hands."

25. On 01/21/21 at 3:15 PM, during interview with Investigator #5 and #9, the Director of Risk, Quality, and Compliance (Staff #404) stated that hospital staff had not entered Quantros incident reports related to the provider practice concerns, or the medication error for Patient #904, and therefore, the hospital was unaware of the events and investigation and peer review processes were not initiated.

26. On 01/22/21 at 2:00 PM, Investigators declared an Immediate Jeopardy/Serious Safety Event related to the hospital's failure to have a systematic process to report, monitor, evaluate, and improve the quality of patient care services through systematic data collection, analysis, and implementation and monitoring of quality activities in hospitals' cardiac Cath lab as evidenced by a failure to ensure that there was an effective process in place to ensure staff completed an Incident Report when an error, potential adverse event, or provider practice concern was identified.

Clinical Alarm System Failure

27. On 01/25/21 at 10:00 AM, during interview with Investigator #5 related to the failures identified with the hospital's clinical alarm system, the Director of Quality and Risk (Staff #508), stated that Spacelabs was investigating aspects of the system failures to determine is the failures were related to hardware and software problems, hospital server problems, equipment failures, and/or staff errors. Staff #508 stated that because staff had not been entering incident reports through the hospital's electronic incident reporting system (QANTROS) until they had received education as part of the previous declarations of Immediate Jeopardy's/Serious Safety Events called on 01/22/21 the hospital was unaware of the scale of the clinical monitoring system malfunction.

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Item #1 Patient Harm Event Identification and Investigation

Based on interview and document review, the hospital failed to ensure that there was an effective process in place to identify patient harm events that required an RCA (Root Cause Analysis) and therefore failed to conduct RCA's for potential patient harm events that included provider practice concerns, infections, and medication errors.

Failure to implement a systematic process for the identification, analysis, implementation and monitoring of quality activities and reporting of incidence and adverse events puts patients at risk of serious injury or death and limited the hospital's ability to improve patient care outcomes.

Findings included:

1. Document review of the hospital's policy titled, "Incident Reports," policy number QUR301, revised 11/27/17, showed that an Adverse event is defined as medical errors that healthcare facilities could and should have avoided. Adverse events are further defined as serious reportable events that may result in patient death or serious disability. A Sentinel event is defined as an occurrence involving death or serious physical or psychological injury or risk thereof. Sentinel or serious adverse events, as well as near misses, will undergo a root cause analysis to identify issues that may have contributed to the process failure.

Patient #402

2. On 01/19/21, Investigator #4 reviewed the medical record for Patient #402. The document review showed that on 10/23/20, Patient #402 was brought to the cardiac catherization lab (a hospital procedure room where doctors perform procedures to diagnose and treat heart disease) to have a temporary pacemaker (a device implanted in the body to keep heart rate) removed and a permanent pacemaker placed secondary to a diagnosed heart block (heart problem that lowers your heart rate, sometimes to unsustainable low heart rates).

a. The medical record showed that on 10/23/20 at 4:34 PM, a Cardiologist's (Staff #401) operative report, showed that the patient had a fever at the time of the permanent pacemaker placement. On 10/31/20 the pacemaker was removed due to an infection.

b. Document review of Patient #402's medical record and operative report dated 10/31/20, showed the Cardiologist (Staff #401) performed a pacemaker explantation (removal of the pacemaker device) secondary to an infection.

2. On 01/20/20 at 3:40 PM, Investigator #4 interviewed the Chief Nursing Officer (Staff #410). Staff #410 stated that she was unaware of Patient #402's pacemaker infection and explantation.

3. On 01/20/20 at 3:30 PM, Investigator #4 interviewed the Director of Surgical Services and Infection Preventionist (Staff #418). Staff #418 stated that she was unaware of Patient #402's infection or return to surgery. When asked what mechanism there was to notify her of infections in the cardiac Cath lab, she reported that there was no way for her to capture that data unless cardiac Cath lab employees called her personally to tell her.

4. On 01/21/21 at 3:15 PM, Investigator #4 interviewed the Director of Risk, Quality, and Compliance (Staff #404). Staff #404 stated that he was not notified of the investigation by CardioSolutions regarding Patient #402. He stated that hospital staff did not enter Quantros incident reports related to the provider practice concerns, the hospital acquired infection, or the return to surgery for Patient #402, and therefore, the hospital was unaware of the events, a hospital investigation was not initiated, nor was an RCA was not completed to identify system failures

Patient #904

5. On 01/21/21, Investigator #9 reviewed the medical record for Patient #904. The record review showed that on 01/05/21 at 7:57 AM, Patient #904 was transferred to the hospital's Emergency Department (ED) via ambulance. The patient had been found down and unconscious at home and was resuscitated by paramedics. The patient was transferred to the hospital's cardiac cath lab for a cardiac catheterization.

6. On 01/22/21 at 8:17 AM, during an interview with Investigator #4, Investigator #5, and Investigator #9, the Cath Lab Tech (Staff #911) stated that during the angioplasty procedure for Patient #904, the medical provider (Staff #910) was having difficulty with moving the balloon past the occlusion and asked Staff #911 to hold the guide wires. In order to maintain a sterile field, Staff #911 continued to hold the guidelines in each hand. The medical provider (Staff #910) reached around Staff #911 and retrieved the nitroglycerin syringe and administered the medication into the coronary arteries. The provider (Staff #910) stated twice that he was injecting nitroglycerin into the patient's coronary arteries for Cath lab staff to document. After each administration, the patient developed arrythmias that required emergency intervention. The patient was transferred by helicopter to a higher level of care from the cath lab.

After the conclusion of the procedure, and after the provider had left the room, staff discovered that the provider had injected lidocaine into the coronary vessels and not nitroglycerin.

7. At the time of the interview, Staff #909 stated that he did not fill out an incident report, but that he had reported the provider care concerns to his manager (Staff #503).

8. On 01/21/21 at 1:45 PM, during interview with Investigator #5, the Cath Lab Manager (Staff #503) verified that the patient coded (a medical emergency) after each medication administration. He stated that he reported the incident to CardioSolutions, but did not complete a hospital incident report. He stated that once he reported the incident to his Corporate office it was "out of (his) hands."

9. On 01/21/21 at 3:15 PM, during interview with Investigator #5 and #9, the Director of Risk, Quality, and Compliance (Staff #404) stated that hospital staff had not entered Quantros incident reports related to the provider practice concerns, or the medication error for Patient #904, and therefore, the hospital was unaware of the events, did not initiate an investigation, and did not perform an RCA to identify system failures.

10. On 01/22/21 at 2:00 PM, Investigators declared an Immediate Jeopardy/Serious Safety Event related to the hospital's failure to have a systematic process to report, monitor, evaluate, and improve the quality of patient care services through systematic data collection, analysis, and implementation and monitoring of quality activities in the hospitals' cardiac Cath Lab as evidenced by a failure to ensure that there was an effective process in place to ensure staff completed an Incident Report when an error, potential adverse event, or provider practice concern was identified.

11. On 01/25/21 at 10:00 AM, during interview with Investigator #5, related to hospitals alarm failures and patients deaths related to the potentially malfunctioning telemetry monitoring system, the Director of Quality and Risk (Staff #508) stated that Spacelabs was investigating aspects of the system failures to determine is the failures were related to hardware and software problems, hospital server problems, equipment failures, and/or staff errors. Staff #508 stated that because staff had not been entering incident reports through the hospital's electronic incident reporting system (QANTROS) until they received education as part of the previous declarations of Immediate Jeopardies/Serious Safety Events called on 01/22/21 the hospital was unaware of the scale of the clinical monitoring system malfunction. The hospital had not completed an RCA related to events to identify system failures.

12. On 01/29/21 at 4:00 PM, Investigator #4 interviewed the Clinical Data Abstractor (Staff #408) regarding Patient #401's case not being reported to the Quality Department and then forwarded to the Peer Review Committee. Staff #408 reported that the concerns regarding Patient #401's care were brought to the Quality Department via email. Staff #408 stated that she completed an initial screening and sent an email to the Director of Emergency Services (Staff #406) instructing her to enter an incident report if she felt the incident needed further review.

An email correspondence from 10/27/20 to 11/13/20 showed a request from the Director of Emergency Services (Staff #406) for a peer review of Patient #401's care in the Cardiac Cath Lab. Staff #406 reported in her email to the Quality Improvement Specialist Registered Nurse (RN) (Staff #407) that several Emergency Department (ED) staff members attended Patient #401's Code Blue in the Cardiac Cath Lab on 10/23/20 and had verbalized concerns regarding Patient #401's medical care.

Item #2 Planned Maintenance to ensure Safe Equipment Functioning

Based on record review and interview, the hospital facilities staff failed to complete preventive maintenance for 37 pieces of equipment including life supporting equipment, located in the hospital's Critical Care Unit.

Failure to complete preventive maintenance activities risks failure to identify inadequate functioning equipment that could place patients and staff at risk of harm including death.

Findings included:

1. Document review of the hospital's policy titled, "Medical Equipment Management Plan," policy number EOC0006, revised 03/15/19, showed the following:

a. Grays Harbor Community Hospital contributes to a safe environment for patients and staff through the management of medical equipment. This management plan includes proper selection, acquisition, recording, tracking, safe handling, maintenance, and retiring of medical equipment.

b. The Biomedical Engineering Department is responsible to execute service maintenance and inspection procedures including maintaining an accurate and comprehensive service record for each listed device to include all user complaints made against the device as well as all repairs and maintenance actions performed.

c. Provide documentation, upon request, to clinical departments of ownership detailing all work performed on a Medical Device.

d. Planned Maintenance: The Plant Services CMMS work order system will be used to manage and document all Medical Equipment service activities including Planned Maintenance (PM).

e. The Director of Plant Services, or designated Biomedical Engineer Technician, will manage the work order generation and completion process.

f. Maintenance of all Medical Equipment is performed in a timely manner per policy and Life Support (Risk Level 1) equipment must maintain 100% monthly completion.

2. Document review of the hospital's planned maintenance records showed that hospital staff had not documented planned maintenance for 32 pieces of equipment located in the Critical Care Unit as directed by hospital policy including:

a. External Pacemaker-Medtronic(1)

b. Blood pressure monitor-Colin Medical (2)

c. CO2 (carbon dioxide) monitor module-SpaceLabs (4)

d. Hyper/Hypothermia Unit-Cincinnati Lab (1)

e. Multifunctional Monitor Tower -SpaceLabs (11)

f. Multiparameter Transport Monitor-SpaceLabs (1)

g. Multiparameter Module-SpaceLabs (8)

h. Fluid Warmer-Smith Medical (1)

i. Endoscopy Light Source-Olympus (1)

j. Patient Ceiling Lift-ARJO (2)

k. Mattress Overlay Pump-Stryker (1)

l. Patient Forced Air Warmer Unit-Smiths Medical (2)

m. Patient Scale-Scaletronix (1)

n. Patient move assist (Hovermat)-Hovertech (1)

3. On 01/27/21 at 4:10 PM, Investigator #5 interviewed the Director of Plant Service (Staff #511) related to the clinical monitoring equipment failures identified in the hospital's Critical Care Unit and Medical Telemetry Unit, the hospital's process for planned maintenance and equipment malfunction reporting processes, and response related to failures.

Staff #511 and Investigator #5 reviewed the hospital's planned maintenance records for equipment located in the hospital's Emergency Department, Women's and Children Department and the Critical Care Unit.

Staff #511 found no evidence in the hospital's planned maintenance and repair system "Facility Dude" that staff had completed planned maintenance for 37 pieces of equipment in the hospital's Critical Care Unit since 09/2019.

Staff #511 stated that the hospital had a "backup" excel spreadsheet to track planned maintenance. Document review of the spreadsheet showed the staff last documented PM on 08/10.

4. At the time of the observation, Staff #511 verified the finding and stated that staff struggled with the "Facility Dude" program.

5. On 01/28/20 at 12:05 PM, Staff #511 reported that the "Facility Dude" Program was set up correctly and should have executed a work order for the planned maintenance. He stated that there was a breakdown in the software program. He stated that planned maintenance was completed on the equipment as evidenced by the sticker affixed to the equipment. Staff #511 was unable to provide documentation required by hospital policy or evidence of passing, failing, or work completed for planned maintenance of the 37 pieces of equipment in the Critical Care Unit.

Cross Reference: A0144
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Based on observation, document review, interview, and review of hospital's quality programs, the hospital's Executive Leadership and Governing Body failed to provide oversight to ensure full implementation of the quality assessment and performance improvement (QAPI) plan including the development and implementation of a systematic process to report, monitor, evaluate, and improve the quality of patient care services through systematic data collection, analysis, and implementation and monitoring of quality activities as evidenced by a failure to ensure that the hospital implemented policies and procedures for reporting concerns related to the safety, care, and treatment of patients.

Failure to implement a systematic process for the identification, analysis, implementation, and monitoring of quality activities and reporting of incidents and adverse events puts patients at risk of serious injury or death and limited the hospital's ability to improve patient care outcomes.

Findings included:

1. Document review of the hospital's policy titled, "Incident Reports," policy number QUR301, revised 11/27/17, showed:

a. An electronic Quality Memo (QM) is to be completed to report all occurrences of actual or potential injury to patient and non-patients.

b. Sentinel or serious adverse events as well as near misses will undergo a root cause analysis to identify issues that may have contributed to the process failure.

c. Medical Staff occurrences, including adverse outcomes or Quality Care concerns will be referred to the QUR Committee. Contact problems, documentation issues or other concerns will be referred to the Department Chair for investigation, discussion and forwarded to QUR as appropriate.

d. Summary reports including trending of all organizational occurrences will be sent to Board Quality, Safety & Compliance at least twice a year.

2. On 01/22/21 at 2:00 PM, Investigators declared an Immediate Jeopardy/Serious Safety Event related to the hospital's failure to have a systematic process to report, monitor, evaluate, and improve the quality of patient care services including:

a. Failure to report medication errors, infections, and provider practice concerns in the Cardiac Cath Lab.

b. Failure to report medication errors, infections, and provider practice concerns observed when attending medical emergencies in the Cardiac Cath Lab.

b. Failure to report a pressure ulcer on a patient boarded in the emergency department.

c. Failure to ensure staff reported telemetry and cardiac monitoring equipment malfunctions and events via the hospitals incident reporting system.

3. On 01/21/21 at 3:15 PM, Investigator #4 interviewed the Director of Risk, Quality, and Compliance (Staff #404). Staff #404 stated that he was not notified of the investigation by CardioSolutions regarding Patient #402. He stated that hospital staff did not enter Quantros incident reports related to the provider practice concerns, the hospital acquired infection, or the return to surgery for Patient #402, and therefore, the hospital was unaware of the events and investigation and peer review processes were not initiated.

4. On 01/21/21 at 3:15 PM, Investigator #4, #5, and #9 interviewed the Director of Risk, Quality, and Compliance (Staff #404). Staff #404 stated that he was not notified of the investigation by CardioSolutions regarding Patient #402. He stated that hospital staff did not enter Quantros incident reports related to the provider practice concerns, the hospital acquired infection, or the return to surgery for Patient #402, and therefore, the hospital was unaware of the events and investigation and peer review processes were not initiated.

5. At this same time, Staff #404 stated that hospital staff had not entered Quantros incident reports related to the provider practice concerns, or the medication error for Patient #904, and therefore, the hospital was unaware of the events, did not initiate an investigation, and did not perform an RCA to identify system failures.

6. On 01/25/21 at 10:00 AM, during interview with the Director of Quality and Risk (Staff #508) related to the hospital's alarm failures and patients deaths related to the potentially malfunctioning telemetry monitoring system, Staff #508 stated that Spacelabs was investigating aspects of the system failures to determine if the failures were related to hardware and software problems, hospital server problems, equipment failures, and/or staff errors. Staff #508 stated that because staff had not been entering incident reports through the hospital's electronic incident reporting system (QANTROS) until they received education as part of the previous declarations of Immediate Jeopardies/Serious Safety Events called on 01/22/21, the hospital was unaware of the scale of the clinical monitoring system malfunction. The hospital had not completed an RCA related to events to identify system failures.

7. On 01/28/21 at 11:02 AM. Investigator #5, the Quality and Risk Director, (Staff #508), the Chief Executive Officer (Staff #509), and the hospital's Board of Directors, reviewed the Governing Body minutes and discussed the Governing Body's role and responsibilities for the hospital. At this time, Staff #509 stated that staff had not reported the incidents via the hospital's incident reporting system and therefore the hospital was unaware of the incidents in the Cardiac Cath Lab and the extent of the Monitoring System malfunction.

8. At this same time, Staff #508 verified that the hospital had not implemented its clinical contract review process and had not conducted a review for the contracted service running the hospital's Cardiac Cath Lab and were unaware of the events identified during the investigation.

Cross Reference: A0273

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Based on interview and document review, the hospital failed to ensure that the medical staff operated in compliance with rules and by-laws approved by the governing body.

Failure of the medical staff to operate in compliance with the hospital's rules and by-laws puts patients at risk of substandard care and adverse outcomes.

Findings included:

1. Document review of the hospital's "Medical Staff Bylaws of Grays Harbor Community Hospital", adopted 12/14/2017, showed that the hospital utilized ongoing professional practice evaluations (OPPE) as a method of determining clinical privileges renewal.

a. On 01/20/21 at 3:05 PM, Investigator #4 reviewed medical staff files with the Director of Medical Staff Services (Staff #403). Of the medical staff files reviewed, 2 of 2 (Staff #401 and Staff #402) were missing OPPEs, but their privileges were still renewed. Staff #403 confirmed that OPPE was not done for medical staff at that time.

b. On 01/21/21 at 3:15 PM, Investigator #4 interviewed the Director of Quality, Risk and Compliance (Staff #404). Staff #404 confirmed that OPPEs were not performed. It was shared that the hospital hired more staff to restart the OPPE process that had been dormant for several years. A sample was given of Staff #401's purposed OPPE data for the last year. The data presented failed to capture a death (Patient #401) and an infection (Patient #402) that Investigator #4 had previously confirmed through chart review.

2. Document review of the hospital's "Medical Staff Bylaws of Grays Harbor Community Hospital", adopted 12/14/2017, showed that the hospital utilized focused professional practice evaluations (FPPE) as a method of medical staff peer review and oversight.

a. On 01/21/21 at 3:05 PM, Investigator #4 requested the separate peer review files of two members of the medical staff (Staff #401, Staff #402). In an interview with the Director of Medical Staff Services (Staff #403), Staff #403 reported that no separate peer review files existed for Staff #401 and Staff #402 because she had not received any peer review documents for Staff #401 or Staff #402.

b. On 01/21/21 at 3:15 PM, Investigator #4 interviewed the Director of Quality, Risk and Compliance (Staff #404). Staff #404 confirmed that the FPPEs format for peer review had not been implemented for any medical staff at this time.

c. On 01/19/21 at 2:05 PM, Investigator #4 interviewed the Chief Medical Officer (Staff #405) regarding the medical staff peer review process and oversight. Staff #405 stated that their current process for peer review comes from concerns reported through Quantros (an internal quality reporting system), reviewed by Quality staff, and then sent to peer review. Investigator #4 reviewed Patient #401's medical record and death report with Staff #405. Staff #405 confirmed that Patient #401's case had not been reported to peer review nor had it been seen in a Quantros report.

3. On 01/19/21 starting at 2:05 PM, Investigator #4 continued the interview with the Chief Medical Officer (Staff #405). Staff #405 confirmed that the registered nurses (RNs) in the Quality Department screen all Quantros concerns and send pertinent medical staff-related concerns over for peer review. Staff #405 also reported that Quantros complaints that are not sent for peer review will still be reviewed by the Chief Medical Officer and brought to peer review if requested by peer review committee members.

a. On 01/29/21 at 4:00 PM, Investigator #4 interviewed the Clinical Data Abstractor (Staff #408) regarding Patient #401's case not being reported to the Quality Department and then forwarded to the Peer Review Committee. Staff #408 reported that the concerns regarding Patient #401's care were brought to the Quality Department via email. An email correspondence from 10/27/20 to 11/13/20 showed a request from the Director of Emergency Services (Staff #406) for a peer review of Patient #401's care in the Cardiac Cath Lab. Staff #406 reported in her email to the Quality Improvement Specialist Registered Nurse (RN) (Staff #407) that several Emergency Department (ED) staff members attended Patient #401's Code Blue in the Cardiac Cath Lab on 10/23/20 and had verbalized concerns regarding Patient #401's medical care.

b. On 01/21/21 at 3:15 PM, Investigator #4 interviewed the Director of Quality, Risk, and Compliance (Staff #404). Staff #404 confirmed that no Quantros entry was received regarding Patient #401 and that Staff #404 was never made aware of Patient #401's case.

c. On 01/19/21 at 12:10 PM, Investigator #4 interviewed the CardioSolutions Field Operations and Quality Manager (Staff #409). Staff #409 confirmed that 2 written complaints were received on 10/23/20 regarding Patient #401's care. Staff #409 stated that he forwarded the complaints to their contracted agency's Regional Chief Medical Officer and Chief Medical Officer for review.

d. Document review of a contract titled "CardioSolutions Master Services Agreement", #11190344v9/71356.15, showed that CardioSolutions was to notify the hospital of any investigations initiated by CardioSolutions.

e. On 01/19/21 at 2:05 PM, Investigator #4 interviewed the Chief Medical Officer (Staff #405). Staff #5 confirmed that she was not aware of the concerns reported to CardioSolutions or the concerns reported by staff regarding Patient #401's medical care.

f. On 01/15/21 at 1:20 PM, Investigator #4 interviewed the Director of Risk, Quality, and Compliance (Staff #404). Staff #404 stated that he was not notified of the investigation by CardioSolutions regarding Patient #401. Therefore, the hospital investigation and peer review processes were not initiated.
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Based on interview, document review, and review of hospital policies and procedures, the hospital failed to ensure that nursing staff members provided nursing care in accordance with the patient's health care needs.

Failure to follow hospital policy and procedure and recognized standards of care for nursing oversight for patient assessments, reassessment, evaluation, and treatment puts patients at risk for delayed treatment, inappropriate treatment, poor health care outcomes, and patient harm.

Findings included:

1. Failure to Implement Immediate Jeopardy Removal Plan/ Immediate Risk to Patient Safety Removal Plan: Monitoring of the Clinical Alarm System in the Emergency Department.

2. Failure to ensure the hospital had sufficient qualified nursing personnel to assess and monitor patients at risk of Suicide.

3. Failure to ensure the hospital had sufficient qualified nursing personnel to assess and monitor patients at risk of Elopement.

Cross Reference A0392

4. Failure to develop and implement Emergency Department (ED) policies and procedures that define Standards of Care/Standards of practice to direct ED staff when and how to assess, reassess, and care for patients held for an extended length of time in the ED.

Cross Reference A0395

Due to the scope and severity of these deficiencies, the Condition of Participation at 42 CFR 482.23, Nursing Services was NOT MET

This is a repeat Citation from 11/09/20
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Item #1: Monitoring of the Clinical Alarm System in the Emergency Department

Based on document review and interview, the hospital leadership failed to ensure the hospital had sufficient qualified staff to provide hemodynamic/telemetry monitoring for patients in the Emergency Department.

Failure to provide an adequate number of trained nursing personnel risks patient safety and delays in care and treatment.

Findings included:

1. Document review of the hospital document titled, "Grays Harbor Community Hospital Immediate Jeopardy: Care in a Safe Environment Removal Plan," approved 01/28/20 at 9:00 AM, showed the following:

a. The hospital stated Implementation Date of the removal plan was 01/28/21 at 12:00 PM.

b. Beginning no later than 01/27/21, a staff member shall be assigned and present for continuous monitoring of the Emergency Department (ED) patient monitoring system.

c. The staff member shall be trained in the use of the patient monitoring system.

d. The staff member will have no other assigned duties.

e. The corrective action shall remain in place, until troubleshooting of the monitoring system and any identified repairs have been completed.

2. On 03/03/21 at 6:05 AM- 7:30 AM, Investigator #5 interviewed hospital staff in the hospital's Emergency Department (ED). During this time, an ED Staff Member (Staff #513) stated that there was not enough staff to provide continuous monitoring of the hemodynamic/telemetry monitor system in the ED. Staff #513 stated that the hospital provided staff to monitor the monitors less than half of the time. Staff #518 stated that the hospital, including the house supervisors, were aware that there was not enough staff to monitor the monitors. She stated that ED staff were told to take it out of their staffing, but that would mean that there were no nurses to care for patients seeking care in the emergency department including providing care to boarding patients, patients in restraints, and patients with behavioral health care and safety needs. Staff #513 stated that she had reported the staff shortage and additionally had completed "Assignment Despite Objections" forms related to not having staff to monitor the monitoring system and not having staff to provide 1 to 1 care for behavioral health and patients in 4 point restraints.

3. On 03/03/21 at 6:05 AM- 7:30 AM, Investigator #5 interviewed hospital staff in the hospital's Emergency Department (ED). During this time, an ED Staff Member (Staff #514) stated that there were a lot of night shifts when there was no staff to monitor the telemetry system.

4. On 03/03/21 at 6:05 AM- 7:30 AM, Investigator #5 interviewed hospital staff in the hospital's Emergency Department (ED). During this time, an ED Staff Member (Staff #515) stated that for the most part the hospital provided staff on the day shift to monitor the monitors, but night shift had shifts with no coverage. Staff #515 stated that there were shifts when a nurse was sent down to the ED from upstairs, but the ED was understaffed and that nurse would take patients if they were trained in the ED and the charge nurse would watch the monitors. The charge nurse would also triage new patients and would often also care for the patient boarding in the ED.

5. On 03/03/21 at 6:05 AM- 7:30 AM, Investigator #5 interviewed hospital staff in the hospital's Emergency Department (ED). During this time, an ED Staff Member (Staff #516) stated that staffing the ED is "horrible," and there were many nights when there was no staff to monitor the monitors. She stated that it was not uncommon to be short staffed by 2 nurses. After midnight, the charge nurse had to care for boarding patients who were often behavioral health patients, triage all the new patients seeking care, and try to monitor the telemetry monitors.

6. On 03/03/21 at 6:05 AM- 7:30 AM, Investigator #5 interviewed hospital staff in the hospital's Emergency Department (ED). During this time, an ED Staff Member (Staff #512) stated that in the last month, only 2 shifts that she had worked had staff provided by the hospital to monitor the telemetry monitoring system. She stated that often the charge nurse tried to monitor the telemetry monitors, but that the charge nurse was often responsible for caring of the boarding patients and responsible to triage new patients as well as deal with any and all issues that came up during the shift. Staff #512 stated that she had reported the staff shortages to leadership, completed incident reports, and she had completed "Assignment Despite Objections" forms related to not having staff to monitor the monitoring system.

7. On 03/03/21 at 8:00 AM, Investigator #5 and the Emergency Room Director (Staff #517) reviewed the ED shift and staffing report sheets from 02/01/21 to 02/24/21. The review showed there were no staff assigned or available to provide continuous monitoring of the hemodynamic/cardiac telemetry system for 23 of 24 days reviewed. The review showed the following dates and times with no staff available/assigned to provide system monitoring:

a. 02/01/21 from 3:00 PM until 7:00 AM (a period of 16 hours).

b. 02/02/21 from 5:00 AM until 7:00 AM (a period of 2 hours).

c. 02/03/21 from 11:00 PM until 7:00 AM (a period of 8 hours).

d. 02/04/21 from 7:00 AM until 8:00 AM and 4:30 PM until 7:00 AM (a period of 15.5 hours).

e. 02/05/21 from 11:00 PM until 7:00 AM (a period of 8 hours).

f. 02/06/21 from 5:00 PM until 7:00 AM (a period of 14 hours).

g. 02/17/21 from 12:00 AM until 7:00 AM (a period of 7 hours).

h. 02/08/21 from 6:30 AM until 10:00 AM (a period of 3.5 hours).

i. 02/09/21 from 7:00 AM until 7:00 AM (a period of 24 hours).

j. 02/10/21 from 3:00 AM until 7:00 AM (a period of 4 hours).

k. 02/11/21 none (a period of 24 hours).

l. 02/12/21 none (a period of 24 hours).

m. 02/13/21 none (a period of 24 hours).

n. 02/14/21 7:15 PM until 7:00 AM (a period of 11.75 hours).

o. 02/15/21 from 11:00 PM until 7:00 AM (a period of 8 hours).

p. 02/17/21 from 7:15 PM until 7:00 AM (a period of 11.75 hours).

q. 02/18/21 from 8:00 PM until 7:00 AM (a period of 11 hours).

r. 02/19/21 from 7:15 PM until 7:00 AM (a period of 11.75 hours).

s. 02/20/21 from 8:00 PM until 7:00 AM (a period of 11 hours).

t. 02/21/21 from 7:15 PM until 7:00 AM (a period of 11.75 hours).

u. 02/22/21 from 7:15 PM until 7:00 AM (a period of 11.75 hours).

v. 02/23/21 7:00 PM until 7:00 AM (a period of 12 hours).

w. 02/24/21 none (a period of 24 hours).

8. At the time of the review, Staff #518 verified the documentation on the staffing sheets and stated that staff were instructed to pull from staffing provided each shift. However, when short staffed, this would have meant there were not enough staff available to care for patients presenting and boarded in the hospital's emergency room. Investigator #5 asked Staff #518 if she was aware of the staff concerns and if she had received the Assignment Despite Objection forms that discussed the failure to provide staff to monitor the hemodynamic/telemetry monitoring system in the Emergency Department. Staff #518 stated that both she and the CNO received the reports and that she had many discussions with the CNO regarding the lack of staffing during this time period.

9. On 03/03/21 at 10:35 AM, Investigator #5 interviewed the Chief Executive Officer (Staff #510) and the Director of Quality and Risk (Staff #508) related to the hospital's failure to implement its Immediate Jeopardy/Serious Safety Event Removal Plan in the Emergency Department. Staff #510 stated that the hospital leadership was not aware that there were not staff to provide continuous monitoring in the Emergency Department per the hospital's removal plan.

Investigator #5 requested an interview with the Chief Nursing Officer (CNO). Staff #510 stated that the CNO (Staff #518) had previously been out on medical leave and was not available for interview.

10. Staff #508 stated that the hospital had purchased additional monitoring equipment and on 02/25/21, moved the Emergency Department monitoring to the Medical /Telemetry Department. He stated that it had not been conveyed to him that the hospital was not able to provide staff to monitor the monitors in the Emergency Department.

Item #2 Patient Assessment and Monitoring of Patients with Suicidal Ideation

Based on document review and interview, the hospital leadership failed to ensure the hospital had sufficient qualified nursing personnel to assess and monitor patients on suicide risk precautions.

Failure to provide an adequate number of trained nursing personnel risks patient safety and delays in care and treatment.

Findings included:

1. Document review of the hospital's policy titled "Care of the Suicidal Patient," policy number PS031, revised 06/27/18 showed the following:

a. When a patient arrives to the ED or is identified during their ED stay with suicidal ideations Staff will compete the Columbia Suicide Severity Rating Scale (CSSRS) to determine level of risk.

b. If a patient answers "Yes" to questions 3, 4, 5, 6a and/or 6b, staff are to order a Behavioral Health Consult.

c. If a patient answers "Yes" to questions 4, 5, and/or 6b, staff are to implement Patient Safety Precautions.

d. Staff are to notify the provider of any answers of "Yes."

e. Interventions to consider included: Every 15-minute visual checks, 1:1 monitoring, providing a protective environment, removing the persons personal belongings, and keeping curtains open.

f. Staff are to complete and document a CSSRS Checklist once that remains part of the permanent record.

g. Staff are to complete, and document interventions used from the Suicide Precaution Checklist.

h. Staff are to complete and document a reassessment once per shift whether or not the patient has current thoughts of suicide. Staff are to document the patient's responses in the medical record.

i. Nurses are to document in the nursing notes a detailed subjective and objective data regarding the patient condition which either supports the continuation or discontinuation of current safety intervention.

j. Nurses are to document in the nursing notes all activities of daily living (ADL) including documentation of every 15-minute checks, when appropriate.

k. Staff will document that the discharge brochure was given.

Patient #504

2. On 03/03/21 at 11:00 AM, Investigator #5 and a Registered Nurse (Staff #519) reviewed the medical record for Patient #504 who was admitted to the hospital's Emergency Department (ED) on 03/02/21 for a chief complaint of Suicide Attempt and evaluation of chest pressure, tremulous (shaking) hands and concerns that anxiety was not being managed. The reviewed showed the following:

a. On 03/02/21 at 12:22 PM, a Registered Nurse (RN) completed the patient's Columbia Suicide Severity Rating Scale (CSSRS). The evaluation showed that the patient answered "yes" to every question and wished he was dead, had thoughts of killing himself, had been planning how to kill himself, had intention to act on these thoughts, and intended to carry out the plan. The evaluation scoring showed that staff were to put "Patient Safety Precautions" in place, order a Behavioral Health Consult and notify the provider.

b. The Emergency Department Provider report completed on 03/02/21 at 12:29 PM showed that the patient denied suicidal ideation, but reported that he has thoughts about guns more often lately and that the patient's significant other discussed recent concerns for the guns in the house and that per the patient the guns and ammunition had been locked away. The patient was seeking voluntary placement in a Behavioral Health Facility. The patient agreed to voluntarily stay overnight pending a psychological evaluation from the hospital's social worker the following day.

c. The patient had been seen in the hospital's Emergency Department on 02/24/21 (6 days prior) for increased anxiety and the patient was discharged from the ED with a plan to follow up with mobile crisis.

Investigator #5 found no evidence in the medical record that staff completed a "Suicide Precaution Checklist."

Investigator #5 found no evidence in the medical record that staff document interventions used from the Suicide Precaution Checklist.

Investigator #5 found no evidence in the medical record that staff performed or documented safety checks every 15 minutes.

Investigator #5 found no evidence in the medical record that the patient received 1:1 observation.

Investigator #5 found no evidence in the medical record that staff completed a reassessment once per shift or documented whether or not the patient had current thoughts of suicide.

3. At the time of the review, Staff #519 verified the missing documentation.

Patient #505

4. On 03/03/21 at 11:30 AM, Investigator #5 and a Registered Nurse (Staff #519) reviewed the medical record for Patient #505 who was brought into the ED on 03/02/21 by law enforcement for evaluation of Suicidal Ideation. The record review showed the following:

a. The Emergency Department Provider Report completed on 03/02/21 at 12:30 PM, showed that the patient had consumed 2 fifths of alcohol in the last 24 hours and reported that he wanted to end his life today, but did not have a definitive plan other than to "steal an airplane and fly it over the ocean until it runs out of gas." The provider reported that the patient had felt this way in the past, but never to the extent he currently felt. The plan was to await sobriety for medical clearance and then get a social worker evaluation for suicidal ideation.

b. A nursing note completed on 03/02/21 at 12:45 PM, shows that the patient drank 2 fifths of alcohol and wants to kill himself. The patient has a history of alcohol abuse and a history of mental health hospitalizations.

c. On 03/02/21 at 2:54 PM, a Registered Nurse completed a suicide screen. The screen showed that the patient answered "yes" to questions 1, 2, 3, 4, and 5 and therefore, staff needed to order a Behavioral Health Consult and implement Patient Safety Precautions.

d. On 03/02/21 at 11:12 AM, a nursing note showed the patient was discharged.

e. On 03/03/21 at 11:54 AM, an Agency Affiliated Counselor-Registered (Staff #520) stated, "67-year-old man brought in by law enforcement for Suicidal Ideation evaluation. Patient states he does not remember telling an Emergency Room Doctor that he was suicidal as he was alcohol intoxicated. Patient denies suicidal ideation/homicidal ideation and wishes to discharge back to Westport."

Investigator #5 found no evidence in the medical record that staff completed a "Suicide Precaution Checklist."

Investigator #5 found no evidence in the medical record that staff documented interventions used from the Suicide Precaution Checklist.

Investigator #5 found no evidence in the medical record that staff performed, or documented safety checks every 15 minutes.

Investigator #5 found no evidence in the medical record that the patient received 1:1 observation.

Investigator #5 found no evidence in the medical record that staff completed a reassessment once per shift or documented whether or not the patient had current thoughts of suicide.

Investigator #5 found no evidence a Social Worker evaluated the patient or performed a Psychological evaluation.

5. At the time of the review, Staff #519 verified the missing documentation.

6. On 03/03/21 at 6:55 AM, during interview with Investigator #5, the Registered Nurse (Staff #512) caring for Patient #504 and #505 stated that the patients were suicide risks and should have received at minimum safety checks every 15 minutes, however she was responsible to care for 4 boarding patients with behavioral health diagnoses (3 of which were suicidal patients), she was responsible to triage new patients, and for performing all charge nurse functions in the ED during her shift and she did not have time to complete the every 15 minute safety checks. She stated there were no other staff available to complete every 15-minute safety checks for any of her patients. She stated that the hospital does not provide 1:1 monitoring for suicidal patients and that the ED staff are supposed to take sitters for behavioral health patients and patients in 4-point restraints out of their regular staffing. She stated that the Emergency Department Staff, "do the best we can," but that the patients are not monitored how they are supposed to be.

7. On 03/03/21 at 4:49 PM, during interview with Investigator #5, the Emergency Room Director (Staff #517) verified that staff are unable to provide 15 minute safety checks or 1:1 observation for patients at risk of suicide related to lack of qualified staff in the Emergency Department. She stated that it is difficult to get sitters or increased staff for these types of patients. She stated she had discussed the staffing concerns with the Chief Nursing Officer (Staff #518) who is her Chain of Command.

Item #3 Monitoring of Patients at Risk for Elopement

Based on document review and interview, the hospital leadership failed to ensure the hospital had sufficient personnel to monitor patients at risk for elopement.

Failure to provide an adequate number of trained personnel risks patient safety.

Findings included:

1. On 03/03/21, Investigator #5 reviewed the hospital's Quantros Incident Report log for elopements from the Emergency Department from 01/28/21 through 03/02/21 (a period of 33 days). The report did not include patients who left against medical advice or left without being seen. The report showed 28 elopements in 33 days.

At 5:00 PM, the Director of Quality (Staff #508) stated that the hospital did not have a policy or procedure that addressed patient elopement, staff assessment for patient elopement risk, or staff monitoring for patients at risk of elopement.

Patient #506

2. On 03/03/21 at 3:04 PM, Investigator #5 and a Registered Nurse (Staff #519) reviewed the medical record for Patient #506 who was admitted on 02/15/21 for the treatment of alcohol detoxification. The record review showed the following:

a. The Emergency Department Provider Report completed on 02/15/21 at 7:50 PM, showed that the patient stated he wanted to go to a detox center as he was going to work in Alaska and first needed to detox. The plan was to keep the patient overnight, medicate with Ativan (a benzodiazepine used to prevent seizures from alcohol cessation) every 1 to 2 hours, and have a social service consult in the morning.

b. The patient was receiving Ativan for signs and symptoms of alcohol withdrawal. Staff administered the last dose on 02/16/21 at 2:29 PM.

c. The departure note completed on 02/16/21 at 7:03 PM, stated that the patient "Eloped from the Emergency Department," and that staff did not notice.

3. At the time of the review, Staff #519 verified the observations and stated that she did not know what the ED policy was.

Patient #507

4. On 03/03/21 at 3:45 PM, Investigator #5 and a Registered Nurse (Staff #519) reviewed the medical record for Patient #507, who was brought to the Emergency Department by the police on 02/25/21 for a psychiatric evaluation. The record review showed the following:

a. On 02/17/21 at 4:11 PM, the patient was brought to the hospital's Emergency Department by ambulance. The record showed that the patient was detained on an involuntary hold by the Designated Crisis Responders (DCR) (a mental health professional who based on evaluation determines if a person needs to be involuntarily detained for mental health or substance abuse that results in the person being a danger to self, danger to others, danger to other's property, or serious harm due to being Gravely Disabled) for the reason of Gravely Disabled. Between 6:00 PM and 7:06 PM the patient eloped from the Emergency Department without staff notice.

Investigator #5 found no evidence of increased observation or monitoring for patient safety related to the involuntary behavioral health hold for patient safety concerns.

b. On 02/24/21 at 7:44 PM, the patient was again brought to the Emergency Department by law enforcement. She was detained by the DCR for Gravely Disabled. The patient eloped from the Emergency Department without staff notice between 8:45 PM and 10:25 PM.
Investigator #5 found no evidence of increased observation or monitoring for patient safety related to the involuntary behavioral health hold for patient safety concerns. Investigator #5 found no evidence of elopement risk assessment or additional interventions implemented related to the elopement on 02/17/21.

c. On 02/25/21 at 7:36 AM, the patient again arrived to the Emergency Department escorted by law enforcement. The patient was detained by the DCR. The record showed the following:

i. At 8:41 AM, the patient attempted to get out of her restraints and the "staff put her back in restraints."

ii. At 9:31 AM, a nursing assistant from the Critical Care Unit will come down to observe the patient for elopement risk.

5. At the time of the review, Staff #519 verified the findings including the patient was an involuntary hold for all 3 Emergency Room visits, the patient eloped twice, and the patient restraint removal attempt that required staff to put the patient back in restraints. Staff #519 stated that the hospital did not have a policy related to elopement prevention or elopement risk assessments.

6. On 03/03/21 at 4:30 PM, Investigator #5 interviewed the Emergency Department Director (Staff #517) related to elopements and repeat elopements from the Emergency Room and the Emergency Department process to ensure patient safety and a safe environment for patients at risk. Staff #517 stated that the hospital did not have a policy or process to evaluate patients at high risk for elopement. She stated that all mental health patients are an elopement risk, but that staffing to monitor patients is limited and the patients sometimes "sneak" out. Investigator #5 asked if Staff #518 was aware of staff reports that there was not enough staff to monitor the Telemetry monitors, provide 1:1 observation for patients in restraint, or to provide adequate supervision of patients who are at risk of elopement. Staff #518 stated that the hospital was aware and that in addition, there had also been 15 to 20 staff assaults by patients in the previous 30 days.

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43948

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Item #1 - Assessments and Plan of Care for Patients Boarding in the Emergency Department.

Based on observation, interview, and record review, the hospital failed to implement Emergency Department (ED) policies and procedures that define Standards of Care/Standards of Practice to direct ED staff when and how to assess, reassess, and care for patients held for an extended length of time in the ED for 3 of 3 patients reviewed (Patients #901, #403, and #404).

Failure to develop and implement policies to direct patient assessment and care puts patients at risk for inconsistent, inadequate, delayed, and unsafe care.

Findings included:

1. Document review of the hospital policy titled, "Nursing Admission Assessments and Reassessments," policy number PS-006, revised 09/07/18, showed that a nursing admission assessment was to be completed no later than 24 hours after the patient's inpatient, or bedded outpatient, admission to the hospital. Nursing shift assessments are to be completed at the beginning of each shift.

Request for document review of the hospital's Emergency Department Boarding Policy found that the hospital did not have an approved and implemented policy that addressed the care, treatment, and services provided to patients boarding in the Emergency Department (ED).

Patient #901

2. On 01/25/21, Investigator #9 and the Director of Emergency Services (#901) reviewed the medical record for Patient #901, a boarded patient in the hospital's ED (Boarding is the practice of holding patients in the Emergency Department or another temporary location while awaiting transfer to another facility, admissions placement or discharge). Patient #901 was an 80-year-old male who was transferred by ambulance to the hospital's Emergency Department (ED) on 12/10/20 after a fall at home. The patient had a history of diabetes mellitus, hypertension (high blood pressure), morbid obesity, atrial fibrillation (irregular, often rapid heartbeat), and a history of falls. He was recently seen in the ED, less than one week prior under similar circumstances. Initial vital signs taken during triage: weight 185 kg/407 pounds, blood pressure 182/124, pain 7 out of 10, glucose 328 mEq/L. At the patient's request, Social Services was consulted for placement in a rehabilitation or skilled nursing facility due to the patient's inability to care for himself and lack of adequate help at home. The patient remained in the ED until 12/31/20 (a 22-day period) when he was discharged back to his home. Document review of the patient's 22-day admission in the ED showed the following:

a. Patient #901 did not receive an initial nursing admissions assessment as directed by hospital policy.

b. Patient #901 was admitted on 12/10/20 and the first nursing shift re-assessment was documented on 12/15/20, 5 days after the patient's admission to the Emergency Department.

c. Patient #901 did not receive nursing shift re-assessments for 14 out of 42 shifts, including 12/10/20 nightshift, 12/11/20 dayshift, 12/11/20 nightshift, 12/12/20 dayshift, 12/12/20 nightshift, 12/13/20 dayshift, 12/13/20 nightshift, 12/14/20 dayshift, 12/14/20 nightshift, 12/16/20 nightshift, 12/17/20 nightshift, 12/19/20 nightshift, 12/26/20 dayshift, 12/28/20 dayshift.

d. 39 of 42 provider notes did not address any type of patient assessment or care and only contained documentation of the transfer of patient care from one provider to another.

3. On 01/27/21 at 12:45 PM, Investigators #4, #5, and #9 interviewed the Chief Nursing Officer (Staff #902) and the Director of Emergency Services (Staff #901) regarding care of patients boarding in the ED and nursing assessments. Staff #901 stated that the patients in the Emergency Department should be receiving nursing re-assessments every shift. Staff #901 verified that there is currently no policy defining the assessment and documentation requirements for patients boarding in the ED.

4. On 01/28/21 at 9:52 AM, during an interview with Investigator #9, Emergency Department Nursing Staff (#903) stated that the Emergency Department recording system does not have a trigger to initiate the nursing shift assessment. She stated that staff sometime "forget," but once the initial nursing shift assessment is entered, it will create a prompt for re-assessments every 12 hours.

Patient #403

5. On 01/26/21 at 2:00 PM, Investigator #4 and the Clinical Data Abstractor (Staff #408) reviewed the medical record for Patient #403, a patient boarded in the hospital's Emergency Department (ED), from 01/22/21 to 01/26/21. Review of the patient's medical record showed the following:

a. On 01/21/21, Patient #403 was seen in the hospital's ED for shortness of breath related to end-stage liver disease, ascites (fluid in abdomen), and hepatic encephalopathy (neurological symptoms related to liver disease).

b. Patient #403 did not meet criteria to be admitted to the hospital but did require placement in a skilled nursing facility.

c. Patient #403 did not receive an initial nursing assessment.

d. On 01/26/21 at 2:15 PM, Investigator #4 confirmed with Staff #408, that Patient #403 did not receive nursing shift re-assessments for 4 out of 8 shifts, including 01/22/21 dayshift, 01/22/21 nightshift, 01/23/21 dayshift, 01/25/21 nightshift.

Patient #404

6. On 01/26/21 at 2:00 PM, Investigator #4 and the Clinical Data Abstractor (Staff #408) reviewed the medical record for Patient #404, a patient boarded in the Emergency Department (ED), from 01/18/21 to the day of medical record review, 01/26/21. Review of the patient's medical record showed the following:

a. On 01/18/21, Patient #404 was seen in the hospital's ED for a psychological evaluation. Patient #404 had a history of strokes, dementia, schizophrenia (mental disorder), hepatitis C (viral liver disease), anoxic brain injury (brain damage from lack of oxygen) and was wheelchair dependent.

b. Patient #404 did not meet criteria to be admitted to the hospital but did require placement in a skilled nursing facility.

c. Patient #404 did not receive an initial nursing assessment.

d. Patient #404 was admitted on 01/18/21 and the first nursing shift re-assessment was documented on 01/22/21, 4 days after the patient's admission to the Emergency Department.

e. On 01/26/21 at 2:15 PM, Investigator #4 confirmed with Staff #408, that Patient #404 did not receive nursing shift re-assessments for 9 out of 16 shifts, including 01/19/21 dayshift, 01/19/21 nightshift, 01/20/21 dayshift, 01/20/21 nightshift, 01/21/21 dayshift, 01/21/21 nightshift, 01/22/21 dayshift, 01/23/21 nightshift, 01/25/21 dayshift.

7. On 01/27/21 at 12:37 PM, Investigators #4, #5, and #9 interviewed the Chief Nursing Officer (Staff #902) regarding care of patients boarding in the ED. During the interview, Staff #902 stated the following:

a. Staff #902 verified that there is currently no policy guiding care, treatment and services for patients boarding in the ED.

b. Staff #902 reported that they were putting the draft policy in a "different format and adding numbers" before seeking final approval and implementation.

c. Staff #902 stated that she had "dropped the ball" on ensuring that the Emergency Department's Boarding Policy was adopted and implemented prior to 01/08/21, as directed by the hospital's most recent federal and state corrective action plans.

d. Chief Nursing Officer (Staff #902) reported that she was unaware of the protocol for the Emergency Department providers regarding the daily assessment, care, and documentation requirements for patient's boarded in the ED. She was unsure if the providers were seeing the ED patients daily or if they were gathering their information from the nurses during shift report. Staff #902 stated she was unsure of the assessment and documentation requirements for the ED Providers.

e. Staff #902 agreed to provide the Investigators with the Contract for the Emergency Room providers, which outlines their responsibilities. After several requests, this document was not provided by the facility prior to exit.

Item #2 - Wound Care and Management for Patients Boarding in the Emergency Department

Based on interviews, and record review, the hospital failed to develop and implement Emergency Department (ED) policies and procedures that define Standards of Care/Standards of Practice to guide staff in the care of patients boarded in the ED for extended periods of time for 2 of 3 patients reviewed (Patients #901 and #403).

Failure to develop and implement policies to direct patient screening, assessment, treatment and management for wound care puts patients at risk for inconsistent, inadequate, delayed, and unsafe care.

Findings included:

1. Document review of the hospital policy titled "Wound Management," policy number PS-081, revised 01/24/19, showed the following:

a. The policy provides nursing staff guidelines on the treatment of pressure ulcers and wound care management.

b. A pressure injury occurs as a result of intense and/or prolonged pressure or pressure in combination with shear.

c. The policy defines a Stage I pressure injury as a non-blanchable erythema (a reddened area that does not change color when pressed on) of intact skin. If a stage I pressure ulcer develops, the policy states that the provider and wound care team should be notified, and treatment should be initiated.

d. The policy defines a Stage II pressure injury as partial-thickness skin loss with exposed dermis. If a Stage II pressure injury develops, the policy states that the provider and the wound care team should be notified.

e. The policy states that a Stage II or greater pressure injury is a reportable condition and requires an entry into Quantros (hospital's electronic incident reporting system).

f. Treatment for pressure injuries includes the following:

i. Provider order and recommendation of wound care team.

ii. Frequency of dressing changes per Provider order.

iii. Obtain Wound Kit.

iv. Complete E-Z Graph Worksheet.

v. Utilize Therapeutic Support Surface Decision Tool - noting that all patients with a BRADEN score (a nursing skin assessment and score) below 16 indicates level of concern and prompts interventions.

vi. BRADEN score of 16 or below requires a minimum intervention of a standard mattress (typical hospital bed).

g. Documentation for the interventions and treatment of pressure injuries includes the following:

i. Documentation of notification of Provider and wound care team.

ii. E-Z Graph Wound Assessment Worksheet. Done initially, then weekly thereafter.

iii. Develop Skin Integrity Care Plan with minimum of 2 interventions.

iv. Skin/Fall/Safety Rounding completed a minimum of every 2 hours.

v. Patient/Family education document teaching and level of understanding.

Patient #901

2. On 01/21/21, Investigator #9 reviewed the medical record for Patient #901. The record review showed the following:

a. Staff assessed the patient's BRADEN scores ranging from 15-7 throughout his 22-day admission. A BRADEN score of 16 (or below) requires interventions as directed by hospital policy.

b. On 12/11/20 at 9:30PM, the Integumentary Assessment noted a small red sore near the coccyx documented as a Stage I pressure sore.

Investigator #9 found no evidence that a provider ordered wound care or skin interventions, or that staff implemented or documented interventions, except for moving the patient from a gurney to a hospital bed.

c. On 12/19/20 at 10:13 AM, staff documented, a change in condition from a Stage I to a Stage II pressure ulcer and staff applied calamine cream.

Investigator #9 found no evidence that staff implemented or documented any further interventions except for the one-time application of calamine cream.

d. Patient did not have a Skin Integrity Care Plan, as directed by hospital policy.

e. Patient did not receive a referral to the Wound Care Team, as directed by hospital policy.

f. No document of notification to the providers requesting orders for interventions.

g. No orders were found for the treatment or prevention of pressure injuries.

h. No documentation of wound care provided to patient.

i. There was no documentation found for patient education related to skin integrity and wound care management.

j. There was no incident report initiated in Quantros for the Stage II pressure injury, as directed by hospital policy.

k. 42 out of 42 notes were missing any reference to the patient's skin integrity, Stage I or Stage II pressure injuries, interventions, referrals to Wound Care Team, or focused plan of care.

l. No documented orders for interventions to treat or prevent Stage I or II pressure injuries throughout the patient's admission to the ED.

3. On 01/27/21 at 12:37 PM, Investigators #1, #5, and #9 interviewed the Chief Nursing Officer (Staff #902) and the Director of Emergency Services (Staff #901) regarding wound care services for patients boarded in the ED. Staff #902 and Staff #901 stated that the wound care team had disbanded over two years ago when the hospital went through a financial review and reorganization. Staff #902 verified that the Wound Management policy had not been updated to reflect the elimination of the wound care team years ago. Staff #902 and Staff #901 reported that based on the current electronic health record system for Emergency Department Recording, Emergency Department nursing staff are unable to initiate a plan of care, order interventions, or assess and document interventions for boarded patients with skin integrity concerns and/or pressure injuries as required in the Wound Management Policy.

4. On 01/28/21 at 03:15 PM, during an interview with Investigator #9, the Director of Quality, Risk and Compliance (Staff #904), reported that on 12/29/20 (10 days after the Stage II wound was first documented), the Emergency Department Director (Staff #901), the Director of Infection Control (Staff #905), and Staff #904 completed an EZ Graph Assessment and took pictures of the Stage II pressure injury and placed the documents into Patient #901's medical record. Staff #904 provided copies of the EZ Graph Wound Assessment worksheet dated 12/29/20, documenting the wound as a Stage II pressure injury. The assessment was missing the assessor's signature. Staff #904 stated that he believed that "someone else" would complete the incident report. Staff #904 verified that no incident report was created for the Stage II pressure injury in Quantros.

Patient #403

5. On 01/21/21, Investigator #4 reviewed the medical record for Patient #403. The record review showed the following:

a. On 01/22/21 a BRADEN score of 12 was documented. A BRADEN score of 16 (or below) requires interventions as directed by hospital policy. The patient was not moved from an ED gurney (narrow bed with thin mattress for ED triage and treatment) to a standard mattress (hospital bed), as directed by hospital policy, until 01/25/21.

b. Review of the nursing focused skin assessment documentation on 01/22/21 at 11:59 PM, showed that Patient #3 had a Stage 1 pressure ulcer on the sacrum. There was no documentation indicating that nursing staff notified the assigned provider of the pressure ulcer, as directed by hospital policy.

c. The patient's medical record did not have a documented referral to the wound care team, as directed by hospital policy.

d. The patient's medical record did not have any documented interventions for prevention and treatment of skin breakdown, as directed by hospital policy.

6. On 01/27/21 at 12:37 PM, Investigators #4, #5, and #9 interviewed the Chief Nursing Officer (Staff #410) and Director of Emergency Services (Staff #406) regarding boarding of ED patients. Staff #410 and Staff #406 reported that the wound care team was dissolved a few years ago and the skin interventions and care plans are now completed by the nurse assigned to the patient. Staff #410 verified that there was no current policy to guide staff in the care and treatment of patients needing wound care management. Staff #410 and Staff #406 also confirmed that the current ED recording system is not set up to allow nursing or interdisciplinary care plans. The system also does not allow for treatment from other hospital-based services such as nutrition services, physical therapy, or occupational therapy. Staff #410 and #406 confirmed that an ED boarding policy had not been implemented.

Item #3 - Nutritional Assessment and Screening for Patients Boarding in the Emergency Department

Based on interviews and record review, the hospital failed to develop and implement Emergency Department (ED) policies and procedures that define Standards of Care/Standards of Practice to ensure the nutritional needs for patient's boarded in the ED for extended periods of time are met for 2 of 3 patients reviewed (Patient #901 and #404).

Failure to develop and implement policies to direct patient screening, assessment, treatment and management for nutritional care puts patients at risk for inconsistent, inadequate, delayed, and unsafe care.

Findings included:

1. Document review of the hospital's policy for nutrition services titled, "Nutritional Assessment Parameters and Screening," policy number NUT-202, revised 11/15/17, showed the following:

a. Emergency room patients, including boarder patients, can only receive one nutritional consultation. All other nutritional services, including nutritional assessments and Registered Dietitian services are not available to patients in the ED.

All other nutritional services detailed in the policy are available only to patient's admitted to the hospital.

Patient #901

2. On 01/21/21, Investigator #9 and the Director of Emergency Services (Staff #901), reviewed the medical record for Patient #901 who was a boarder patient in the hospital's ED from 12/10-31/20. The review showed the following:

a. Diabetic Point of Care Testing results showed that from 12/10/20 to 12/30/20 the patient's fasting blood glucose results were out-of-normal range as defined by the hospital's protocols including:

i. Treatment notes showed that 20 of the fasting glucose results were flagged as "critical values," as defined by hospital protocols. However, only 8 of the 20 critical glucose values documented in the medical record showed that the provider was notified of the critical results and only 10 of the 20 critical glucose results were reported as critical values to the nursing staff. Investigator #9 found no evidence that staff implemented any interventions or changes in the patient's care based on the critical results.

ii. Investigator #9 found no evidence in review of 28 of 28 nursing notes and shift re-assessments that staff addressed the patient's blood glucose results or diabetes management.

iii. Investigator #9 found no evidence in review of 41 of 42 provider notes that the ED provider addressed the patient's nutritional status, diabetic glucose test results, interventions, or plan of care.

b. Patient #901 had a diagnosis of a decubitus ulcer (Stage I and Stage II pressure injury) and uncontrolled diabetes. Both diagnoses are parameters used to identify patients with increased nutritional risk and assist in guiding nutrition care planning for patients admitted to the hospital, as directed by hospital policy. There is no policy to direct the screening, assessment, treatment and management of nutritional care for patients boarded in the ED. The review showed the following:

i. Hospital staff documented the patient's nutritional assessment as "within normal limits" (WNL).

ii. Staff did not submit a request for a special diabetic diet.

iii. The patient did not receive a consultation from Nutritional Services, as directed by hospital policy.

iv. The Investigator found no evidence of documentation from Nutrition Services or a Clinical Dietitian, as directed by hospital policy.

v. Patient #901 who was boarded in the ED from 12/10-31/20, did not receive any nutritional care services.

3. On 01/27/21 at 12:45 PM, during an interview with Investigators #4, #5, and #9, the Director of Emergency Services (Staff #901) verified that during the patient's 22-day admission, there was no documentation of an order for a special diabetic diet or request for Nutritional Consultation with the Clinical Dietitian. She stated that ED providers do not usually put in orders for diets. Patients in the ED typically receive safety trays and finger foods. Staff #901 verified that the hospital had not implemented any policies to guide care for patients boarded in the ED.

4. On 01/28/21 at 9:52 AM during interview with Investigator #9, the ED Nurse (Staff #903), reported that there is not a way to order daily blood glucose monitoring checks, such as the standard "before meals and at bedtime (ACHS)" through the Emergency Department Charting system.

Patient #403

5. On 01/26/21 at 2:00 PM, Investigator #4 reviewed the medical record for Patient #403. The record showed the following:

a. Investigator #4 found no evidence that the patient received a nutritional consult.

b. No diet order was entered for the patient from 01/18/21 to 01/26/21.

c. The patient received food without accommodation for his medical diagnoses.

6. On 01/27/21 at 12:45 PM, during an interview with Investigators #4, #5, and #9, the Chief Nursing Officer (Staff #902) stated that there is currently no policy or protocol in place for boarding patients in the ED to receive more than a nutritional screening and optional consultation. Staff #902 stated that once the upcoming policy changes are implemented, the ED patients will be able to "utilize the same hospital-wide criteria."

7. On 01/28/21 at 10:50 AM, during interview with Investigators #4 and #9, the ED Charge Nurse (Staff #411) reported that the current ED ordering system did not allow for a diet order to be entered. Staff #411 showed Investigators #4 and #9 her computer screen and demonstrated entering a diet, for which the system failed to input.

This is a repeat citation from 11/09/20
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