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Based on observation, interview, and record review, the hospital failed to ensure compliance with all Conditions of Participation. This resulted in three condition-level deficiencies (Patient Rights, Nursing Services, and Quality Assessment and Performance Improvement Program). The governing body failed to fully address serious, systemic, and recurring issues, placing 26 of 50 sampled patients at risk for adverse events.

Findings:

1. Failure to protect and promote each patient's rights (refer to A-0115).

2. Failure to ensure that nursing services were provided to meet the needs of patients (refer to A-0385).

3. Failure to carry out an effective, system-wide quality assessment and performance improvement program (refer to A-0263).

The governing body failed to implement an effective system that provided for oversight of staffing and maintenance of a safe environment for all patients.

These cumulative failures resulted in the hospital's inability to ensure patient safety and quality of care.

Based on interview and record review, the hospital failed to evaluate one contracted service annually. This deficient practice had the potential for the governing body to be unaware of whether the contracted service was provided in a safe and effective manner to patients.

Findings:

During a review of the hospital's remote patient monitoring contract indicated it was signed June 21, 2020. The remote patient monitoring contract indicated it was a corporate contract and included the hospital as a participant.

During a review of the hospital's list of clinically relevant contracts, undated, revealed there was no remote patient monitoring contract included.

During a concurrent interview and record review on 11/15/22 at 9:03 a.m. with the Director of Quality and Risk Management (DQRM), the Quality and Peer Review Program Manager (QPPM), and the Contracts Specialist (CS), the hospital's list of clinically relevant contracts, undated, was reviewed. The CS stated the list was the hospital's entire list of clinically relevant non-physician contracts. The CS confirmed the remote patient monitoring contract was not on the list. The CS stated she was not aware of this contract previously. The QPPM stated he has a spreadsheet of the hospital's contracts and sends out established metrics to each contract's business leader to review annually. The business leader then sends his or her review to the DQRM, who sends it to the Quality Improvement and Patient Safety Committee, Medical Executive Committee, and the Board of Directors. The QPPM stated he has not completed a contract evaluation for the remote patient monitoring contract. The QPPM and DQRM stated a contract evaluation should have been done. The DQRM stated, if the Board of Directors did not see a contract evaluation, it would not be aware if the hospital was satisfied with the contract or not.

During a concurrent interview and record review on 11/16/22 at 8:46 a.m. with the Director of Quality and Risk Management (DQRM), the DQRM provided the hospital's policy and procedure titled Non-Physician Contract Procedure, undated. The DQRM stated the policy is still in draft form, but that it is what the hospital is following currently. The policy indicated "... PROCEDURE - Clinical Contracts Annual Quality Review ... The contract owner is responsible for management of the contract, scope and nature of the contract, performance metrics, and completion of annual contract evaluations ..." The policy noted "... The designated hospital leader ... will conduct, at a minimum, an annual evaluation of the services provided using the Contract Evaluation Summary ... The hospital leader will forward the completed Contract Evaluation Summary for approval to the Quality Improvement and Patient Safety Committee (QIC), and Medical Executive Committee for approval and recommendation for renewal ... A summary of approved contracts with specific performance metrics will be presented annually to the Board of Directors for review, input and approval ...".

Based on interview and record review, the facility failed to maintain a complete and accurate list of contracted services. This deficient practice resulted in the facility being unaware of which contracted services were in effect.

Findings:

During a review of the hospital's linen contract indicated it is effective from February 6, 2022 to February 5, 2027. The linen contract indicated it was a corporate contract and included the hospital as a participant.

During a review of the hospital's remote patient monitoring contract indicated it was signed June 21, 2020. The remote patient monitoring contract indicated it was a corporate contract and included the hospital as a participant.

During a review of the hospital's list of clinically relevant contracts, undated, revealed there was no linen contract or remote patient monitoring contract included.

During a concurrent interview and record review on 11/15/22 at 9:03 a.m. with the Director of Quality and Risk Management (DQRM), the Quality and Peer Review Program Manager (QPPM), and the Contracts Specialist (CS), the hospital's list of clinically relevant contracts, undated, was reviewed. The CS stated the list was the hospital's entire list of clinically relevant non-physician contracts. The CS confirmed the linen contract and remote patient monitoring contract were not on the list. The CS stated she was not aware of these contracts previously, and had to reach out to corporate for them. When asked if the hospital's contract list was complete, the DQRM stated the hospital needed to do a deep dive to see how it missed the linen and remote patient monitoring contracts. The CS stated her involvement was at this hospital's level only. When asked if there are any other corporate-maintained contracts relevant to the hospital that they are unaware of, the CS stated they will look into this. The DQRM stated the hospital needs to make sure its contracts list matches the corporate contracts list.

During a concurrent interview and record review on 11/16/22 at 8:46 a.m. with the Director of Quality and Risk Management (DQRM), the DQRM provided the hospital's policy and procedure titled Non-Physician Contract Procedure, undated. The DQRM stated the policy is still in draft form, but it is what the hospital is following currently. The policy indicated "... PROCEDURE - Clinical Contracts Annual Quality Review ... The hospital shall maintain a database listing all patient care service contracts ... ".

Based on observation, interview, and record review, the hospital failed to comply with the Condition of Participation for Patient's Rights as evidenced by:

1. Failure to train nursing staff for safe use of restraints (refer to A-0194)

2. Failure to inform patients or their representatives of the patients' transfers in the emergency department (refer to A-0131)

3. Failure to inform patients or their representatives of video monitoring (refer to A-0131)

4. Failure to use restraints for appropriate indications (refer to A-0154)

5. Failure to implement less restrictive measures prior to use of restraints (refer to A-0154)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on observation, interview, and record review, the facility failed to ensure the patient's rights when:

1. Patients or their representatives were not informed of remote video monitoring for 3 of 3 patients (Patients 31, 49 and 50); and,

2. The patient acknowledgement on the transfer form was not complete when the patients were transferred to other facilities, indicating patients or their representatives were informed of the reason, benefits and risks of transfer and they agreed with the transfer for 8 patients (Patients 4, 7, 8, 12, 14, 16, 24, and 28)

These failures have the potential the patients or their representatives not being able to exercise their rights to be informed and refuse the treatment or services.

Findings:

1. During an initial tour of the hospital, on 11/9/22 at 10:50 a.m., in Patient 49's room, a portable stand with a camera was placed in the patient's room.

During a concurrent interview, the unit manager (UM) stated the camera was to monitor the patient remotely, called "Telesitter" or "Avasys", and the hospital brought the remote video monitoring in 2019. She stated Avasys was mostly used for patients who were at high risk of falls and the patient should be able to follow simple directions. She stated upon admission of the patient, the care team decided the use of Avasys and explained to the patients about the use. She stated if a patient refused to use of the camera, a sitter (safety attendant) would be provided. She stated, for the patients who were confused to make their own medical decisions and did not have family members to decide the use of the camera, she stated the care team could still continue to initiate and use Avasys monitoring on patients.

Review of the service company's material, "TELESITTER: PATIENT MONITORING TECHNOLOGY", dated 2018, indicated Telesitter has a video camera and two-way audio which, allows a trained staff member to see and speak to the patient. When the patient is trying to get up, the staff member will ask the patient to stay in bed until a healthcare provider arrives in the room to provide help. It indicated staff member will monitor the patient from a central room by watching a video feed. They can see the patient all of the time except when Telesitter is set to privacy mode. The privacy cover is used when the doctor or nurse is providing care and when the patient is dressing, bathing or using the toilet.

Review of Patient 31's History and Physical, dated 10/23/22, indicated the patient was admitted with chief complaints of chronic agitation and schizoaffective disorder (a combination of symptoms of schizophrenia [a disorder that affects a person's ability to think, feel, and behave clearly] and mood disorder).

Review of Patient 31's Telemental Health Consult Note, dated 10/27/22, indicated the patient was "still agitation and not making any sense ...pt's [patient's] son would like a repeat psych consult ...in bilateral wrist restraint ...pt is not answering any orientation questions and not responding at all to questions."

During a record review and concurrent interview, on 11/17/22 at 9:30 a.m., the unit manager (UM) reviewed Patient 31's clinical record and stated the patient was on Avasys monitoring. She stated the patient was unable to communicate and there was no documented evidence her family members were informed of Avasys use.

Review of Patient 49's History and Physical, dated 10/22/22, indicated the patient was a 74-year-old male with diagnoses including dementia (a group of thinking and social symptoms that interferes with daily functioning) and schizoaffective disorder. It stated he was brought to the emergency department after being found on the floor, he had a difficulty in ambulating with multiple recent falls, and was admitted to the hospital for small subdural hematoma (bleeding in the brain) due to the fall.

Review of Patient 49's Patient Video Monitor Initiation Form, dated 10/29/22, indicated the patient was on Avasys monitoring.

During an interview and record review, on 11/17/22 at 9:30 a.m., the UM reviewed Patient 49's clinical record and stated the patient had a safety attendant and on 10/29/22, Avasys monitoring was initiated replacing the safety attendant, but there was no documented evidence the patient or family members were educated, informed, discussed, and/or agreed regarding Avasys use.

Review of Patient 50's History and Physical, dated 11/10/22, indicated the patient was a 76-year-old male with diagnoses including Alzheimer's dementia and brought in after falling down a spiral staircase at home. It stated, " ...did not call his wife .... but the morning hospitalist may talk to her to discuss CODE STATUS ...also clarify home medications ..."

Review of Patient 50's Facesheet indicated the patient's wife was listed to be notified.

Review of Patient 50's Patient Video Monitor Initiation Form, dated 11/14/22, indicated the patient's Avasys monitoring was initiated.

During a record review and concurrent interview, on 11/17/22 at 9:30 a.m., the UM reviewed Patient 50's clinical record and stated Avasys monitoring was initiated on 11/14/22 and there was no documented evidence the patient or family members were informed, discussed, and agreed regarding Avasys use. The UM sated the patient or his family member should be informed prior to a new implementation and the use of Avasys monitoring should be discussed as a part of the patient's plans of care.

Review of the hospital's policy, "Video Monitoring of Patients", dated 6/17/20, indicated initiation of continuous visual monitoring can be utilized to ensure patient safety as an additional tool in the plan of care for patients at high risk for falls, confusion, impaired mobility, etc. It indicated to document in the patient's Electronic Health Record (EHR) under "Patient Education", details to include notification of patient and /or patient representative that video monitoring has been implemented to enhance patient safety. The policy did not indicate for use of video monitoring for the patients who are unable to make their own decision and do not have representatives to make a decide for themselves.

Review of the hospital policy, "Patient Rights and Responsibilities," dated 11/10/21, indicated the patients have the right to information regarding their care, health status, diagnosis, course of treatment, and the right to effective communication regarding their plan of care, and they are to be provided with information regarding risks involved.

2. Review of the hospital's "Transfer Summary" indicated three sections are to be completed by staff prior to transfer. The "patient" section indicated the patient had the right to a medical screening examination and evaluation before and after transfer, the right to be informed of the risks and benefits associated with transfer, and that the patient was informed of the reason for the transfer. The form further indicated that the risk of accident during the transfer is a possibility. The patient and the staff witness were to sign, date, and indicated the time as an acknowledgement the information regarding was provided to the patient or legal representative or parent of the patient.

Review of Patient 4's ED notes, 9/27/22, indicated the patient was a 17-year-old female brought in by ambulance for suicidal ideations after taking multiple medications with the intent to kill herself. It indicated the patient was placed on a 5150 hold and was medically cleared for transfer to a higher level of care, due to psychiatric services not available at the hospital.

During a concurrent interview and record review on 11/7/22 at 12:10 p.m. with the Emergency Department Manager (EDM), Patient 4's Transfer Summary, dated 9/27/22 was reviewed. The Transfer summary indicated "Patient acknowledgement for medical and non-medical transfers" section of the transfer summary was not completed, evidenced by a line through the section and "5150" written in place of the signature/date. The check box stating "Unable/unwilling to sign" was not checked. The EDM stated, if the patient or parent refuses to sign the "Patient Acknowledgement for Medical and Non-Medical Transfers" then the box is checked unwilling to sign (on the transfer summary) indicating the patient/parent was provided the information about the transfer.

During an interview on 11/7/22 at 2:30 p.m. with Registered Nurse 9 (RN), RN 9 stated she was under the assumption patients did not have to sign (the acknowledgement section) of the transfer form and stated, "I usually just cross it off".

Review of Patient 7's ED Physician notes, dated 8/31/22, indicated the patient was suicidal and was placed on a 5150 hold.

During interview and concurrent record review with the emergency department manager (EDM), on 11/4/22 at 10:40 a.m., the EDM confirmed Patient 7 was transferred to another facility for a higher level of care on 9/1/22 at 10:55 a.m. The EDM confirmed the patient section of the "transfer summary" form had a line through it with "5150" written. The EDM confirmed this section of the form, labeled "Patient," informs the patient of their rights upon transfer and the risks and benefits of the transfer.

During concurrent interview and record review with the Director of the Emergency Department (DED), on 11/7/22 at 2:05 p.m., she confirmed a line was marked through the patient acknowledgement section and "5150" was written. The DED confirmed the form should have been fully completed and should indicate if the patient was willing to sign or not sign the form.

Review of Patient 12's ED Physician Notes, dated 5/30/22, indicated the patient presented to the ED after she attempted to jump out of a car into roadway, a 5150 hold was placed, and after treatment in the hospital, she was transferred to another hospital for suicidal ideation.

Review of Patient 12's Transfer Summary, dated 5/30/22, indicated, a section "PATIENT ACKNOWLEDGEMENT FOR MEDICAL AND NON-MEDICAL TRANSFER" was crossed out with "5150" written. There was no documented evidence their family were informed and agreed with the patient's transfer.

During an interview on 11/4/22 at 8:47 a.m., the ED manager (EDM) reviewed Patients 7 and 12's clinical record and stated for patients under a 5150 hold, the section asking for patient's acknowledgement on Transfer Summary, was crossed out and staff wrote down "5150". She stated the section should be completed with the signatures of patients or family members, indicating they agreed or refused the transfer after they were fully informed about the transfer.

Review of Patient 8's ED notes, dated 8/29/22, indicated Patient 8 had a history of schizophrenia (severe persistent mental illness that impairs thinking, feeling and behavior) and was on a 5150 hold for "harm to others."

During interview with the Emergency Department Manager (EDM), on 11/4/22 at 10:40 a.m., she stated she believed Patient 8 was transferred to another facility for care. She confirmed there was no transfer form in Patient 8's medical record. She indicated staff did not always fill out the transfer form.

Review of Patient 14's ED Physician Notes, dated 5/26/22, indicated the patient was brought into the ED, accompanied by law enforcement, for suicidal ideation and placed on a 5150 hold.

Review of Patient 14's ED Discharge Note, dated 5/26/22, indicated the patient was transferred to a mental health facility. There was no transfer form completed, indicating the patient was informed of risks and benefits of the transfer, whether the patient was informed and agreed with the transfer.

During an interview on 11/4/22 at 9 a.m., the ED manager (EDM) reviewed Patient 14's clinical records and confirmed there was no Transfer Summary complete including the patient's acknowledgement for the transfer.

Review of Patient 16's ED physician Notes, dated 5/19/22, indicated the patient brought in by ambulance, with law enforcement, after she cut her left wrist for suicidal ideation. The patient was placed under a 5150 hold, received laceration repair in the ED, and was transferred to CSP (Crisis Stabilization Program), accompanied by law enforcement. There was no Transfer Summary completed in the record.

During an interview on 11/4/22 at 9:44 a.m., EDM confirmed that Patient 16's Transfer Summary was missing.

Review of Patient 28's ED Physician Notes, dated 8/4/22, indicated the patient, a 16-year-old male, presented "for medical clearance prior to transfer to CSP after being placed on a 5150 hold for danger to self and others." It stated the patient made numerous homicidal statements towards his father.

Review of Patient 28's medical records indicated there was no Transfer Summary.

During a record review and concurrent interview on 11/7/22 at 2 p.m., the EDM stated when law enforcement takes the patient to CSP, the ED staff do not complete the transfer summary.

During a review of Patient 24's medical record, indicated the patient was seen in the hospital's emergency department by Emergency Department Physician M on October 29, 2022. Emergency Department Physician M placed Patient 24 on a 5150 hold and ordered a safety attendant. In his ED Physician Notes, dated October 29, 2022 at 5:00 p.m., Emergency Department Physician M noted Patient 24 was suicidal and "... medically cleared for evaluation at CSP ...". Emergency Department Physician M transferred Patient 24 to CSP, noting Patient 24's condition was stable. In his ED Physician Notes Addendum, dated October 30, 2022 at 8:29 a.m. Emergency Department Physician G indicated he assumed care for Patient 24 and "... [Patient 24] has been accepted for transfer to CSP for further care and evaluation ...". In her ED Discharge Note - Text, dated October 30, 2022 at 11:03 a.m., Registered Nurse 16 indicated Patient 24 was discharged. Patient 24's Transfer Summary form, signed by Emergency Department Physician G on 10/30/22 at 9:15 a.m., had sections filled out for clinical impression, reason for transfer, medical screening examination documentation, receiving physician, mode of transfer, patient status at time of transfer, name of employee at receiving hospital who accepted transfer, date and time of acceptance, and vital signs at time of transfer. In the section about patient acknowledgement for medical and non-medical transfers, the form noted "... I understand that ... I have a right to be informed of the reasons for my transfer. I acknowledge that I have received a medical screening examination and evaluation by a physician, or other appropriate personnel, and that I have been informed of the reasons for my transfer. All transfers have risks of traffic delays, accidents during transport, inclement [unpleasant] weather, rough terrain or turbulence, and the limitations of equipment and personnel present in the vehicle ...". There was no patient signature. There was "5150" written above the line for signature of patient/parent/legal representative.

During a concurrent interview and record review on 11/7/22 at 3:06 p.m. with the Director of the Emergency Department and Critical Care (DED), Patient 24's medical record was reviewed. When asked if there was any discussion with Patient 24 about the risks and benefits of transfer to Santa Cruz County Crisis Stabilization Program (CSP), the DED stated she did not see any specific note about the ED physician having a discussion with Patient 24 about the risks and benefits of transfer. The DED stated the ED physician should have a discussion about the risks and benefits of transfer with the patient. The DED stated, in the section about patient acknowledgement for medical and non-medical transfers, a patient signature should be obtained if the patient is appropriate or has capability to sign.

During an interview on 11/7/22 at 3:33 p.m. with Registered Nurse 9 (RN 9), RN 9 confirmed she was an Emergency Department (ED) nurse. RN 9 stated she was told 5150 patients are not supposed to sign the Transfer Summary form. RN 9 stated she was told the hospital does not need patient permission so the hospital does not need to have 5150 patients sign the Transfer Summary form.

Review of the hospital's policy, "Dignity Health Emergency Medical Care/Emergency Medical Treatment and Labor Act (EMTALA) Corporate Policy", dated 8/17/22, indicated " ...the hospital sends to the receiving facility all medical records ...including ...(ii) the individual's informed written consent to transfer ..."

Review of the hospital's policy, "Patient Rights and Responsibilities," dated 11/10/21, indicated the patients have the right to information regarding their care, health status, diagnosis, course of treatment, and the right to effective communication regarding their plan of care, and they are to be provided with information regarding risks involved.


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Based on interview and record review the facility failed to ensure the patient's right to be free from restraints when:

1. The indication for use of restraint for Patient 17 was climbing out of bed/chair risking safety and flight risk and less restrictive alternatives to restraint use were not fully implemented prior to restraint use; and,

2. For Patient 40, less restrictive measures were not attempted or determined to be ineffective prior to restraint use and restraint monitoring was not done every two hours.

These failures have the potential to result in the use of restraint for staff convenience and can impact the health and safety of the patient.

Findings:

1. Review of Patient 17's Emergency Department (ED) triage assessment notes, dated 10/21/22, indicated the patient presented to the ED not answering questions appropriately and identifying as a lemur. The patient was placed on a 5150 hold (involuntary psychiatric hold for a mental health crisis for up to 72 hours) and was admitted to the hospital.

Review of Patient 17's physician orders, from 10/22/22 to 10/25/22., indicated a 24 hour daily order, for non violent three point restraints (bilateral wrists and one ankle), were ordered with the indication being climbing out of bed/chair and flight risk.

Review of Patient 17's care plan, dated 10/23/22, indicated the least restrictive measures be used prior to restraint use. The care plan further indicated the expectation was for alternatives to be attempted prior to restraint including administering medication prior to restraint use.

Review of Patient 17's Physician orders, dated 10/23/22 at 6:46 p.m., indicated haloperidol (antispychotic medication to improve thinking, mood, and behavior) 0.5 milligrams (mg) was ordered for intramuscular injection as needed every six hours for agitation.

Review of Patient 17's Physician orders, dated 10/24/22 at 4:59 a.m., indicated lorazepam (medication for anxiety and agitation) 2 mg was ordered for intramuscular injection as needed for agitation.

Review of Patient 17's Physician orders, dated 10/24/22 at 10:50 a.m., indicated olanzapine (medication taken for the treatment of mental disorder) 5 mg by mouth was ordered as needed daily for agitation.

During interview with Registered Nurse 6 (RN 6), on 11/17/22 at 2:18 p.m., RN 6 confirmed she cared for Patient 17 for two eight hour shifts. She stated she did not recall if she tried to do a slow release on the three point restraints. She confirmed Patient 17 was in restraints throughout her shifts and stated she was "worried of her falling." She stated Patient 17's risk of falling was the primary concern and reason for continued restraints. RN 6 stated elopement was a secondary concern.

During interview with the Medical Surgical Educator Nurse (MSE), on 11/18/22 at 9:51 a.m., the MSE confirmed restraints use are not acceptable for the prevention of falling. She indicated a safety attendant at bedside should be utilized. She stated the staff could distract the patient, reorient the patient, assist with decreasing stimuli, assist with providing relaxing imagery on the the television, or provide music that is relaxing. The MSE further indicated Patient 17's physician orders included the medications Ativan, haloperidol and olanzapine which were to be given as needed for anxiety or agitation. The MSE confirmed the care plan indicated an intervention of administering medication to Patient 17 prior to restraint use and the medication Ativan was administered to Patient 17 on 10/22/22 at 4:59 a.m. and again on 10/23/22 at 6:44 p.m.. The medication Haldol was administered to Patient 17 on 10/24/22 at 4:28 a.m. The MSE confirmed Patient 17 had an additional antipsychotic medication, Zyprexa, which could have been given prior to restraint use, but was not documented as administered. The MSE confirmed Patient 17 was in three restraints for roughly 84 hours during her stay at the hospital from 10/21/22 to 10/25/22.

During interview and concurrent record review with the MSE, on 11/18/22 at 9:51 a.m., the MSE confirmed hospital policy for the prevention of falls does not include three point restraint use as an intervention for the prevention of falls.

Review of hospital policy "Fall Prevention and Management," dated 7/26/22, does not include three point restraints as an intervention for patients with a low, moderate, or high fall risk.

Review of hospital policy "Use of Restraint," dated 8/3/22, indicated non violent restraints can be used for the patient who is pulling at lines, the patient who is interfering with the staff's ability to provide required medical care, and /or the patient's actions are endangering themselves.



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2. Review of Patient 40's medical record indicated the patient was admitted to the hospital for suspected stroke on 9/10/22.

Review of Patient 40's physician orders, indicated the patient had the following orders:

Restraints-nonviolent/nondestructive, soft limb, hand right, right ankle for pulling at lines, tubes, or dressings, dated 9/11/22.

Restraints-nonviolent/nondestructive, enclosure bed, for climbing out of bed/chair risking safety, dated from 9/12/22 to 10/25/22 and from 11/13/22 to 11/18/22.

Neurontin 100 mg, PO, cap (capsule), every eight hours (q8h), priority: Routine, dated 9/15/22.

Atarax (hydroxyzine) 25 milligrams (mg, unit of measurement), PO (by mouth), QID (four times a day), priority: Routine, PRN (as needed) Anxiety/Agitation, dated 10/8/22.
Haldol 5 mg, IM (intramuscular), INJ (injection), every four hours, priority: Routine, PRN Agitation, dated 10/11/22.

Seroquel 25 mg, PO, Tab (tablet), every bedtime, dated 10/19/22.

Olanzapine 5 mg, IM, INJ, susp, q8h, priority: Routine, PRN Agitation, dated 11/8/22.

Trazodone 50 mg, PT, tab, TID (three times a day), priority: Routine, PRN Agitation, dated 11/8/22.

During an interview on 11/14/22 at 9:24 a.m., Nurse Manager (NM) stated enclosure beds were treated as a restraint.

During concurrent interview and record review of Patient 40's medical record with the Medical Surgical Educator (MSE), on 11/17/22 at 11:08 a.m., there was documentation on the restraints flowsheet on 9/12/22 that indicated Patient 40 was "Calm with periods of agitation or combativeness," "Combative and/or abusive, Restlessness," and "Agitated, Combative, Restless." There was no documentation that indicated a safety attendant was attempted prior to the use of restraints for Patient 40. The MSE stated there was no documentation that indicated the hospital attempted to use a safety attendant for Patient 40 on 9/10/22 or 9/11/22. The MSE stated she would absolutely like to see a safety attendant attempted before using restraints. Patient 40's restraints flowsheet also indicated there was missing restraint documentation on 9/20/22, 9/23/22, 9/30/22, 10/10/22, 10/11/22, 10/21/22, and 10/24/22. The MSE confirmed there was missing documentation and stated restraint assessments should be completed every two hours.

During concurrent interview and record review with the Unit Manager (UM) on 11/18/22 9:52 a.m., Patient 40's medical record was reviewed. Patient 40's Physical Therapy Daily Progress Note, dated 11/3/22 indicated, "She is on Seroquel 25 mg, gabapentin 100 mg TID, hydroxyzine prn to assist with agitation. These have allowed her to move from the veil bed [enclosed bed] to a standard hospital bed." The UM confirmed Patient 40's medication order dates. She stated the doctor should have attempted medication for behaviors prior to the use of restraints for Patient 40.

Review of Patient 40's flowsheet, dated 10/11/22 indicated the patient was very agitated and was throwing her body around in the enclosed bed.

Review of Patient 40's Nursing Progress Note, dated 11/13/22, indicated, "Patient escalated with aggression throughout my shift. Patient bit, pinched, kicked, hit me and other staff that could help today. Security was called more then [sic] once during my shift. Patient was given all PRN [as needed] medication available for agitation/anxiety and still continued to escalate ...Patient pealed [sic] off table tops of her bedside table, tore off the foam of another brace that was brought to her by PT, and broke parts of a wheelchair that she had been sitting in ..."

Review of Patient 40's medical record indicated there was no documented evidence the manufacturer required checklist, New Patient Selection and Monitoring checklist to identify whether the Posey enclosure bed was appropriate for the patient, was complete. There was no documented evidence Patient 40 was assessed whether the patient had any condition that may cause violent or self-destructive behaviors, or aggression, which the manufacturer indicated the Posey bed was not intended for.

During an interview on 11/18/22 at 12:11 p.m., the CNO stated there was no documentation that checklists were completed prior to the use of the enclosure bed restraints for Patient 40.

Review of undated Posey Bed 8070 User Manual indicated the following:

Contraindications (When the Bed Should Not be Used): "Given the nature of some patients' diagnoses, activity level or uncontrolled movements, the Posey Bed is not suitable for every patient ...The Posey Bed is not intended for use with...Patients diagnosed with any condition that may cause violent or self-destructive behaviors.
- These could result in self-injury and/or damage to the Posey Bed.
- Violent moving of the body from side to side could cause the Posey Bed to tip over or move to a position where the patient is injured by contact with an object in the room ..."

For violent or aggressive patients: "NEVER leave a patient in the Posey Bed if there is a risk of self-injury, injury to others or of the bed tipping over, or if the patient tries to damage the bed. It also indicated, "Failure to comply with ...all instructions, warnings and cautions in the manual and on all labels on the Posey Bed, could result in patient death or serious injury."

New Patient Selection and Monitoring: The checklist is provided "as a guide to make sure that the bed is appropriate for a new patient and that his or her first hours in the bed are safe and secure." It also indicated a warning, "Before allowing a patient to use the bed, confirm ...the attending caregiver has been properly trained in the use of the bed." The New Patient and Selection and Monitoring checklist included the following questions: Has the patient been diagnosed with any condition that may cause violent or self-destructive behaviors? Has the patient been diagnosed with claustrophobic tendencies? Has the patient been diagnosed as at-risk and cannot reposition himself or herself when the head of the bed is raised, and, therefore, requires a flat bed or gap fillers?

Review of the hospital's policy, "Use of Restraint," dated 8/3/22, indicated, "Restraint may only be used if needed to improve the patient's well-being AND less restrictive interventions have been determined to be ineffective in protecting the patient or others from harm." The policy also indicated other monitoring shall be completed as specified every 2 hours using the electronic Restraint monitoring form or flow sheet or downtime paper form to include: Visual/Safety Observation Completed, Skin, Circulation Motion Sensation (CMS), Level of Consciousness (LOC), Toilet offered, Fluid/Nourishment Offered, Restraint, Response, Additional Information.

Based on observation, interview, and record review, the hospital failed to ensure that nursing staff completed the required training on the use of the Posey enclosure bed (a tent-like enclosure entirely covering a hospital bed. Someone on the outside of the bed must unzip one of the tent flaps before a patient can get out of the bed) restraint (any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move freely), per manufacturer's instructions. Patient 40 was placed in a Posey enclosure bed restraint while Patient 40's assigned nurse did not complete the training, prior to participating in the application of the restraint. In addition, the hospital failed to ensure three of three patients (Patients 38, 39, and 40) had the manufacturer's required checklists completed prior to the first-time use of the enclosure bed, as the nurses were not trained to complete and review the checklists to safely implement the enclosure bed restraint. These failures had the potential to result in serious injury, including entrapment, suffocation, choking, and falls, or death, related to the restraint use, to Patients 38, 39, and 40 and other patients who may use the Posey enclosure beds.

On November 18, 2022 at 4:58 p.m., an immediate jeopardy (IJ, a situation that has threatened or is likely to threaten the health and safety of a patient) was called under A-0194, §482.13(f) Standard: Restraint or seclusion: Staff training requirements, in the presence of the Chief Executive Officer (CEO), Chief Operating Officer, Chief Medical Officer, Chief Nursing Officer, Director of Quality and Risk Management, and Patient Safety and Risk Manager.

On November 18, 2022, at 5:43 p.m., the removal plan was accepted. The plan was to remove all Posey enclosure beds from the hospital. The CEO stated enclosure beds would not be reintroduced as a treatment option until staff are appropriately trained on the use of Posey enclosure beds and the hospital has a policy regarding enclosure beds.

On November 21, 2022, at 11:01 a.m., the immediate jeopardy was removed after the removal plan was verified to be implemented on-site, through observations, interviews, and record review, in the presence of the Chief Executive Officer, Chief Medical Officer, Chief Nursing Officer, Director of Quality and Risk Management, Patient Safety and Risk Manager, and the Director of Adult Services.

Findings:

Review of Patient 38's medical record indicated the patient was admitted to the hospital on 8/2/22 for acute cerebrovascular accident (CVA/stroke, a condition resulting from a lack of oxygen in the brain potentially causing a loss of sensory and motor function).

Review of Patient 38's physician orders, dated 8/2/22 and 8/3/22, indicated orders for restraints-nonviolent/nondestructive, enclosure bed for pulling at lines, tubes or dressings and for climbing out of bed/chair risking safety.

Review of Patient 38's medical record indicated there was no documented evidence the checklists that the manufacturer required were complete, including Check for Proper Bed Assembly, Guidelines for Proper Bed Location, Guidelines for Staff Training, and New Patient Selection and Monitoring checklists for Patient 38, before the use of the enclosure bed restraint.

During concurrent interview and record review of Patient 38's flowsheet with Registered Nurse 13 (RN 13) on 11/16/22 at 1:55 p.m., there was documentation on 8/3/22 at 12 a.m. that indicated Patient 38 was impulsive and unsteady. RN 13 stated they would use the enclosed bed for patients who were attempting to get out of bed and had physical limitations and who are unable to understand safety precautions.

Review of Patient 39's History and Physical, dated 8/17/22 indicated the patient was admitted to the hospital on 8/17/22 to be monitored for bradycardia (slow heart rate). It also indicated the patient reported she had episodes of lightheadedness accompanied with a sense of the room spinning, then she becomes weak and falls.

Review of Patient 39's physician orders, dated 8/18/22, indicated restraints-nonviolent/nondestructive, enclosure bed, for climbing out of bed/chair risking safety.

During concurrent interview and record review of Patient 39's flowsheet with RN 13 on 11/16/22 at 3 p.m., there was documentation on 8/18/22 that Patient 39 was agitated and disoriented.

Review of Patient 39's medical record indicated there was no documented evidence the checklists that the manufacturer required were complete, including Check for Proper Bed Assembly, Guidelines for Proper Bed Location, Guidelines for Staff Training, and New Patient Selection and Monitoring checklists for Patient 39, before the use of the enclosure bed restraint.

Review of Patient 40's record indicated the patient was admitted to the hospital for suspected stroke on 9/10/22.

Review of Patient 40's physician orders, dated 9/12/22, indicated the patient had an order for restraints-nonviolent/nondestructive, enclosure bed, for climbing out of bed/chair risking safety. Patient 40 had orders for enclosure bed restraints from 9/12/22 to 10/25/22 and from 11/13/22 to 11/18/22.

Review of Patient 40's Nursing Progress Note, dated 11/13/22, indicated, "Patient escalated with aggression throughout my shift. Patient bit, pinched, kicked, hit me and other staff that could help today. Security was called more then [sic] once during my shift. Patient was given all PRN [as needed] medication available for agitation/anxiety and still continued to escalate ...Patient pealed [sic] off table tops of her bedside table, tore off the foam of another brace that was brought to her by PT, and broke parts of a wheelchair that she had been sitting in ..."

During concurrent interview and record review of Patient 40's flowsheet with the Medical Surgical Educator, on 11/17/22 at 11:08 a.m., there was documentation on 9/12/22 that indicated Patient 40 was "Calm with periods of agitation or combativeness," "Combative and/or abusive, Restlessness," and "Agitated, Combative, Restless."

During an interview on 11/17/22 at 2:09 p.m., Registered Nurse 6 (RN 6) stated Patient 40 is easily agitated. RN 6 stated when Patient 40 was agitated on her shift, Patient 40 was kicking RN 6 and pulling RN 6's clothes.

Review of Patient 40's medical record indicated there was no documented evidence the checklists that the manufacturer required were complete, including the New Patient Selection and Monitoring checklist to identify whether the Posey enclosure bed was appropriate for the patient. There was no documented evidence Patient 40 was assessed whether the patient had any condition that may cause violent or self-destructive behaviors, or aggression, which the manufacturer indicated the Posey bed was not intended for.

Review of Enclosure Bed Patient List, provided by the hospital on 11/15/22, indicated 13 patients used the Posey enclosure beds, from 5/15/22 to 11/5/22.

During an interview on 11/14/22 at 9:24 a.m., Nurse Manager (NM) stated enclosure beds were treated as a restraint.

During an interview on 11/15/22 at 8:48 a.m., the Chief Nursing Officer (CNO) stated the hospital did not have a policy on the use of enclosure beds and he was not able to locate any verbiage regarding enclosure beds in the hospital's restraint policy.

During an interview on 11/18/22 at 11:45 a.m., the CNO stated enclosure beds were a type of non-violent restraint.

During an interview on 11/18/22 at 12:11 p.m., the CNO stated there was no documentation that checklists were completed prior to the use of the enclosure bed restraints for Patients 38, 39, and 40.

During a telephone interview on 11/18/22 at 12:16 p.m., the CNO stated there was no specific in-service training on the Posey enclosure bed.

During an observation and concurrent interview on 11/18/22 at 1:47 p.m., in Unit A, Patient 40 was in her room inside an enclosure bed. Registered Nurse 7 (RN 7) stated she had not taken care of a patient who used a Posey enclosure bed prior to Patient 40's care. RN 7 stated when she started her shift on 11/18/22, the charge nurse, Registered Nurse 8, gave her instructions on how to use the zippers, how to lock the brakes, and how the bed moves. RN 7 stated she could not recall if she received and completed a training for use of the Posey enclosure bed. During a concurrent interview, Registered Nurse 8 (RN 8) stated she received training on the enclosure bed when she first started working at the hospital 18 years ago.

During an interview on 11/18/22 at 1:50 p.m., in Unit B, the Medical Surgical Educator (MSE) stated the hospital provided an annual training regarding general restraint use but, the training did not include the use of Posey enclosure bed specifically. She stated, in 2016, when the hospital brought the Posey enclosure beds in, she sent out an email to nursing staff regarding the Posey enclosure bed, with the link to the manufacturer's information. She stated the training did not include access to the checklists that the manufacturer required and the checklists had not been used. She stated the hospital did not provide the Posey enclosure bed specific training since then. During a concurrent interview with Registered Nurse 12 (RN 12), in Unit B, she stated the Posey enclosure beds were used in her unit. She stated she did not receive a training on the use of the Posey enclosure bed and there was no specific training on the Posey bed at the last annual restraint training. She stated she did not have a concern for the Posey enclosure bed itself.

Review of undated Posey Bed 8070 User Manual indicated the following:

"This User's Manual is intended as a guide for those using the Posey Bed 8070 in the care of patients, and who have successfully completed training. Proper training in the use of the Posey Bed 8070 is important and is provided by your authorized Posey Bed dealer or Posey Products."

Required Training: "Anyone interacting with the bed must complete the Posey Bed 8070 In-Service Training Program which includes the ability to use this manual."

Risks: "Improper use of the Posey Bed 8070 may lead to serious injury or death. Patient monitoring should be determined by hospital protocol, a doctor, and the patient care plan ...it is important to understand when the Posey Bed 8070 is needed, when it should not be used, and the dangers related to entrapment, suffocation, choking, and falls."

Contraindications (When the Bed Should Not be Used): "Given the nature of some patients' diagnoses, activity level or uncontrolled movements, the Posey Bed is not suitable for every patient ...The Posey Bed is not intended for use with ...Patients who weigh less than 46 pounds or are shorter than 46 inches ...Patients who weigh 300 pounds or more ...Patients diagnosed with any condition that may cause violent or self-destructive behaviors.
- These could result in self-injury and/or damage to the Posey Bed.
- Violent moving of the body from side to side could cause the Posey Bed to tip over or move to a position where the patient is injured by contact with an object in the room ..."

Warnings and Precautions: " ...Raising the head of the Posey Bed creates "gaps" or "pockets" between the head of the bed and the canopy. These areas pose an extreme risk of serious injury or death from entrapment for certain at-risk patients ...To help reduce the risk of suffocation, adhere to the following: NEVER put a mattress inside the patient area. ALWAYS keep the mattress in the mattress compartment and completely zipped ...NEVER use the Posey Bed if there is damage to the canopy, access panels or zippers. A failure to heed this warning may result in patient escape or unassisted bed exit, which may lead to serious injury or death from a fall."

For violent or aggressive patients: "NEVER leave a patient in the Posey Bed if there is a risk of self-injury, injury to others or of the bed tipping over, or if the patient tries to damage the bed. It also indicated, "Failure to comply with ...all instructions, warnings and cautions in the manual and on all labels on the Posey Bed, could result in patient death or serious injury."

Before First-Time Use: A series of checklists was provided "to make sure the bed has been properly assembled, is in an appropriate location and that anyone who interacts with a patient in the bed has successfully completed training prior to first use. Use the following checklists before using the bed with a patient: Check for Proper Bed Assembly; Guidelines for Proper Bed Location; and Guidelines for Staff Training."

The Checking for Proper Bed Assembly checklist included the following questions: Is the canopy metal frame unbent and unbroken? Does the bed feel secure and free from any loose or moving parts? Is the metal canopy frame completely covered by foam padding with no visible foam?

The Guidelines for Proper Bed Location checklist included the following questions: Can the patient be easily accessed and can the bed be moved to the center of the room to allow access from all four sides in an emergency situation? Is the bed positioned so that the patient is not exposed to injury from contact to walls, furniture or other equipment? Is the bed free of clutter or foreign objects?

New Patient Selection and Monitoring: The checklist is provided "as a guide to make sure that the bed is appropriate for a new patient and that his or her first hours in the bed are safe and secure." It also indicated a warning, "Before allowing a patient to use the bed, confirm ...the attending caregiver has been properly trained in the use of the bed." The New Patient and Selection and Monitoring checklist included the following questions: Has the patient been diagnosed with any condition that may cause violent or self-destructive behaviors? Has the patient been diagnosed with claustrophobic tendencies? Has the patient been diagnosed as at-risk and cannot reposition himself or herself when the head of the bed is raised, and, therefore, requires a flat bed or gap fillers?

Review of the hospital's policy, "Use of Restraint", dated 8/3/22, indicated all staff having direct patient contact must have clinical orientation, education and training in the proper and safe use of restraints. Ongoing education and training will occur if opportunities for improvements are identified or when there are changes in policy and procedures. All competency and training will be documented. Staff competency and training will include demonstration of the following prior to the application/care of patients in restraints: The application of restraints, monitoring of restraints, how to apply restraints, and providing care to patients in restraints.

Based on interview and record review, the hospital failed to carry out its Quality Assessment and Performance Improvement (QAPI) program when the following occurred:

1. Failure to track the number of patients on a 5150 hold [involuntary psychiatric hold for patient deemed to be a danger to self, to others, or gravely disabled] who eloped from the hospital (refer to A-0286).

2. Failure to provide training for nursing staff on the enclosure bed restraint (refer to A-0286).

3. Failure to assess the corrective action plan for effectiveness or sustainability for one root cause analysis (refer to A-0286).

4. Failure to evaluate one contracted service annually (refer to A-0308).

These cumulative failures resulted in the hospital's inability to ensure provision of quality care in a safe environment, as required by the Quality Assessment and Performance Improvement Program Condition of Participation.

Based on interview and record review, the hospital failed to fully implement its Quality Assessment and Performance Improvement program when:

1. Elopements [leaving the hospital without permission] of patients on 5150 holds [involuntary psychiatric hold for patient deemed to be a danger to self, to others, or gravely disabled] were not being tracked;

2. There was no staff training on the use of the Posey enclosure bed despite current use of the bed as a restraint; and,

3. The corrective action plan after one adverse patient event did not assess for effectiveness or sustainability.

These deficient practices had the potential to jeopardize the health and safety of patients.

Findings:

1. During a review of the hospital's Entity Reported Incident to the state survey agency, received 10/04/2022, indicated Patient 1 was seen and discharged from the hospital's emergency department on 9/23/2022. The report noted Patient 1 returned to the hospital's emergency department on 9/24/2022 and was placed on a 5150 hold by the emergency department physician, who felt Patient 1 was gravely disabled. The report noted Patient 1 eloped from the emergency department that evening, and that the sheriff was called but unable to locate Patient 1. The report indicated a nurse manager asked the sheriff's office on 9/26/2022 if Patient 1 was found. The report noted the sheriff's office notified the nurse manager on 9/28/2022 that Patient 1 had been hit by a car on the freeway on 9/26/2022 and transported to another hospital.

During a review of the hospital's policy and procedure titled Elopement and Wandering Assessment and Prevention, approved 2/17/22, indicated the policy applied to "... all inpatients and outpatients who are at high risk for wandering and elopement ... patients are considered high risk for elopement or wandering if they ... are legally committed ... are considered dangerous to self or others ... have a history of wandering or being missing ... lack cognitive ability or capacity to make relevant decisions ... have physical or mental impairments that increase their risk of harm to self or others. (May be on 5150 Holds) ...". The policy defined elopement as "... a patient who is incapable of adequately protecting himself, and who departs the health care facility unsupervised and undetected. A patient may be aware that he/she is not permitted to leave, but does so with intent ...". The policy noted "... For patients identified as high risk for elopement or wandering, the nurse shall initiate the following interventions ... Evaluate placement of a sitter to monitor patient ...".

During a review of the hospital's policy and procedure titled Safety Attendant: For Patients at Risk for Harm to Self or Others, effective July 18, 2018, indicated "... Criteria for assessing patient behaviors to determine the need for a safety attendant includes, but are not limited to behaviors associated with ... Suicidal or non-suicidal psychiatric patients including involuntary psychiatric hold ("5150" in California ...) ... Risk of elopement ...".

During a review of the hospital's policy and procedure titled Code Green Missing/Eloped Patient, approved 2/3/22, defined a high-risk patient for elopement as "... A patient who fits the following criteria or who leaves the patient care unit without permission who is ... On a legal hold (danger to themselves or others) ... Gravely disabled - unable to provide food, shelter or clothing ...".

During a review of Patient 1's medical record, indicated Patient 1 was seen in the hospital's Emergency Department on 9/23/22 by Emergency Department Physician D (EDP D). Patient 1 was an allegedly 20-year-old female brought in by ambulance on 9/23/22 at 7:08 a.m. for evaluation of multiple abrasions after asking bystanders to call 911. In her nursing notes, Registered Nurse 2 (RN 2) noted Patient 1 was out of bed trying to leave the emergency department (ED) at 9/23/22 at 7:40 a.m., and RN 2 tried to reason with her but Patient 1 was uncooperative. RN 2 noted Patient 1 was outside the ED at 9/23/22 at 7:50 a.m. with the Emergency Department Manager providing wound care, and that law enforcement was on its way. RN 2 noted on 9/23/22 at 8:00 a.m. that Patient 1 was speaking with law enforcement outside the ED. RN 2 noted on 9/23/22 at 8:41 a.m. that hospital security reported Patient 1 was escorted to a bus stop after speaking with law enforcement. In her ED Physician Notes, dated 9/23/22, EDP D stated Patient 1 was refusing to answer any questions regarding her injuries, refusing labs and pain medication, and refusing a full physical examination. EDP D stated Patient 1 only wanted her wounds cleaned. EDP D stated Patient 1 confirmed having a safe place to go but was unable to provide information on how she would get there. EDP D noted, moments after leaving Patient 1's room, Patient 1 said she wanted to go. EDP D stated Patient 1's thought process was linear and clear, that Patient 1 did not exhibit signs of grave disability or suicidality, and that Patient 1 did not meet criteria to hold her in the ED against her will. Patient 1 was discharged from the ED.

During a continued review of Patient 1's medical record, indicated Patient 1 was seen in the hospital's Emergency Department on 9/24/22 by Emergency Department Physician B (EDP B). Patient 1 was a 21-year-old female brought in by ambulance on 9/24/22 at 1:08 p.m. for evaluation of injuries to knees, lower legs, and feet after asking a bystander to call 911. In the ambulance report, dated 09/24/2022, ambulance staff noted Patient 1 did not have any shoes on, was very dirty from head to toe, and her shirt was wet. In his ED Physician Notes, EDP B indicated Patient 1 tried to sign out from the ambulance staff but because she did not have shoes, a phone, or a plan, the ambulance staff did not think that was wise. EDP B noted Patient 1 requested her wounds be cleaned and then she wanted to leave the ED. EDP B noted Patient 1 could not provide a plan to find shelter, food, or clothing and thus he placed Patient 1 on a 5150 hold on 9/24/22 at 2:20 p.m. for grave disability because she was unable to care for herself. EDP B ordered labwork and intravenous fluids [fluids given through a vein]. EDP B transitioned care to Emergency Department Physician N to follow up with repeat labs after the intravenous fluids. In his nursing note, dated September 24, 2022 at 7:21 p.m., Registered Nurse 3 noted Patient 1 had eloped, that security was notified and would search for Patient 1. In a Security Report, dated 09/24/2022 at 8:09 p.m., a security officer reported fire alarms going off in the ED lobby on 9/24/22 at 7:09 p.m. The security report indicated fire alarms were cleared then went off again, then were cleared again. The security officer reported Registered Nurse 9 (RN 9) asked her if Patient 1 had walked out of the ED, and that RN 9 was looking for Patient 1. The security report noted Patient 1 was in an ED bed without a safety attendant, and described clothing Patient 1 was wearing at the time of the elopement. The security officer told RN 9 that she did not see Patient 1 and checked her surroundings. The security officer notified another security officer, who checked a back hallway. The security report indicated ED Technician H (EDT H) said a kitchen employee observed a patient in a hospital gown running down the street. The report noted Registered Nurse 3 called the Santa Cruz County Sheriff's Office to report the patient elopement. Patient 1 was not found.

During a continued review of Patient 1's medical record, indicated Patient 1 was hit by a truck on the freeway on 9/26/22. In an ambulance report, dated 9/26/22, ambulance staff was dispatched for a 21-year-old female patient who stumbled onto the freeway and was struck by a truck traveling about 50 to 55 miles per hour. Patient 1 was taken by air ambulance to another hospital.

During an interview on 11/2/22 at 10:09 a.m. with Registered Nurse 1 (RN 1), RN 1 confirmed he was the Emergency Department (ED) charge nurse on 9/24/22 when Patient 1 was seen in the ED. RN 1 stated the hospital was not able to provide a safety attendant for Patient 1. RN 1 stated every 5150 patient should have a safety attendant. RN 1 stated the ED often is not provided safety attendants for patients when requested.

During an interview on 11/2/22 at 11:07 a.m. with Emergency Department Physician B (EDP B), EDP B stated it was inferred that 5150 patients need a safety attendant.

During an interview on 11/2/22 at 3:19 p.m. with Emergency Department Physician D (EDP D), EDP D stated 5150 patients automatically need a safety attendant.

During an interview on 11/2/22 at 2:31 p.m. with Registered Nurse 3 (RN 3), RN 3 stated the ED has between one to six patients on a 5150 hold per shift.

During an interview on 11/2/22 at 1:05 p.m. with Registered Nurse 2 (RN 2), RN 2 stated there are a lot of 5150 patients in the ED. RN 2 stated staffing of safety attendants is an issue. RN 2 stated she has had 5150 patients for which she could not get a safety attendant. RN 2 stated, when she is unable to get a safety attendant, it is scary and affects her work. RN 2 stated she does the best she can, that she wants to make sure staff and the patient are safe.

During an interview on 11/3/22 at 9:58 a.m. with the Emergency Department Manager (EDM), the EDM stated a lot of times the hospital does not have safety attendants available to send to the ED. The EDM stated she sends a report to hospital senior leadership when the ED staff reports there was no safety attendant available for a patient. When asked if hospital senior leadership responds to her, the EDM said not directly.

During an interview on 11/3/22 at 12:31 p.m. with the House Supervisor C (HS C), the HS C stated safety attendants are either patient care technicians or certified nursing assistants. The HS C stated, if the hospital does not have enough staff, it sometimes has to pair several 5150 patients to one safety attendant. The HS C stated they have had discussions with their supervisors about critically low staffing. The HS C stated the house supervisors file a nursing supervisor report every morning with Risk Management, the Chief Nursing Officer, and everyone in management. The HS C stated, in the nursing supervisor report, they document how many 5150 patients are in each hospital department and if the hospital did not have enough safety attendants for the 5150 patients.

During an interview on 11/16/22 at 10:03 a.m. with the Director of the Emergency Department and Critical Care (DED), Emergency Department Manager (EDM), and Emergency Department Physician N (EDP N), the DED stated the emergency department does not track elopements of 5150 patients from the ED.

During an interview on 11/17/22 at 2:32 p.m. with the Director of Quality and Risk Management (DQRM) and the Patient Safety and Risk Manager (PSRM), the PSRM stated the emergency department does not track elopements of high-risk patients, which include patients who are on 5150 holds.

During an interview on 11/21/22 at 1:00 p.m. with the Director of Quality and Risk Management (DQRM) and the Patient Safety and Risk Manager (PSRM), the PSRM stated the hospital does not have data about true patient elopements from the hospital. The PSRM stated high-risk patient elopements are only on their radar because staff know they should report elopements in the hospital's event reporting system. When asked how many 5150 patient elopements or attempted elopements there were in 2022, the PSRM stated six. The PSRM stated there was a 5150 patient without a safety attendant who eloped from the hospital in January 2022. The PSRM stated this patient was later found and brought to the ED. The PSRM stated because of staffing shortages, the floor managers were not able to review the event with the Quality Department. The PSRM stated she did not complete a root cause analysis of this patient elopement at that time, but now she would. The PSRM stated there was a 5150 patient without a safety attendant who eloped from the ED in February 2022. The PSRM stated this patient was later found and brought to the ED.

During a review of the hospital's policy and procedure titled Patient Safety Plan, approved 3/23/2022, indicated "... Undesirable patterns or trends in performance and sentinel events will be intensively analyzed to determine where best to focus changes for improvement. Intensive analysis will be initiated when ... Levels of performance, patterns, or trends vary significantly and undesirably from those expected ...".

2. On November 18, 2022 at 4:58 p.m., an immediate jeopardy (IJ, a situation that has threatened or is likely to threaten the health and safety of a patient) was called under A-0194, §482.13(f) Standard: Restraint or seclusion: Staff training requirements, in the presence of the Chief Executive Officer (CEO), Chief Operating Officer, Chief Medical Officer, Chief Nursing Officer, Director of Quality and Risk Management, and Patient Safety and Risk Manager, when Patient 40 was placed in a Posey enclosure bed restraint while there was no documented evidence Patient 40's assigned nurse and hospital nurses completed the required in-service training on the use of the Posey enclosure bed per manufacturer's instructions. (Refer to A-0194).

During a review of the Posey Bed 8070 User Manual, undated, indicated "... This User's Manual is intended as a guide for those using the Posey Bed 8070 in the care of patients, and who have successfully completed training. Proper training in the use of the Posey Bed 8070 is important and is provided by your authorized Posey Bed dealer or Posey Products, LLC sales representative ... you should also review ... The Assembly Instructions ... The In-Service Training Manual ...". The manual noted " ... Because the bed is a restraint ... Anyone interacting with the bed must complete the Posey Bed 8070 In-Service Training Program which includes the ability to use this manual ... Improper use of the Posey Bed 8070 may lead to serious injury or death ... it is important to understand when the Posey Bed 8070 is needed, when it should not be used, and the dangers related to entrapment, suffocation, choking, and falls ...".

During a review of Patient 40's medical record, indicated Patient 40 was admitted to the hospital on 9/10/22 for suspected stroke [condition where there is loss of blood flow to part of the brain]. Patient 40's physician orders indicated an order for enclosure bed restraints from 9/12/22 to 10/25/22, and from 11/13/22 to 11/18/22.

During a review of Patient 38's medical record, indicated Patient 38 was admitted to the hospital on 8/2/22 for acute cerebrovascular accident [stroke]. Patient 38's physician orders indicated an order for enclosure bed restraints on 8/2/22 and 8/3/22.

During a review of Patient 39's medical record, indicated Patient 39 was admitted to the hospital on 8/17/22 for bradycardia [slow heart rate]. Patient 39's physician orders indicated an order for enclosure bed restraints on 8/18/22.

During an interview on 11/18/22 at 11:45 a.m. with the Chief Nursing Officer (CNO), the CNO stated enclosure beds were a type of non-violent restraint.

During an interview on 11/18/22 at 12:16 p.m. with the CNO, the CNO stated there was no specific in-service training on the Posey enclosure bed.

During an interview on 11/18/22 at 1:50 p.m. with the Medical Surgical Educator (MSE), the MSE stated the hospital provides annual training regarding general restraint use but the training does not specifically include the use of the Posey enclosure bed. The MSE stated there was one training in 2016 when the hospital purchased the Posey enclosure beds, but there has been no specific training on Posey enclosure beds since then.

During an interview on 11/21/22 at 1:00 p.m. with the Director of Quality and Risk Management (DQRM) and the Patient Safety and Risk Manager (PSRM), the DQRM stated she was not aware staff was not trained in the use of the Posey enclosure bed.

During a review of the hospital's policy and procedure titled Patient Safety Plan, approved 3/23/2022, indicated "... Undesirable patterns or trends in performance and sentinel events will be intensively analyzed to determine where best to focus changes for improvement. Intensive analysis will be initiated when ... Levels of performance, patterns, or trends vary significantly and undesirably from those expected ...".

3. During a concurrent interview and record review on 11/16/22 at 1:00 p.m. with the Patient Safety and Risk Manager (PSRM), the root cause analysis for a patient event was reviewed. The PSRM stated, in February 2022, a patient undergoing a massive transfusion protocol [MTP, rapid administration of large amounts of blood products for hemorrhagic shock, which is when severe bleeding leads to inadequate oxygen delivery to the body] received a blood transfusion intended for a different patient. The PSRM stated one of the underlying issues was the inability to use Blood Bridge, a program within the hospital's electronic health record (EHR) that ensures the blood product matches the intended patient, for massive transfusion protocols. The PSRM stated, with Blood Bridge, hospital staff scan the intended patient and the blood product to ensure everything matches. The PSRM confirmed that Blood Bridge is a tool that helps prevent blood transfusion errors. The PSRM said Blood Bridge requires a lot of information so staff do not have time to input all of this information in a MTP situation. The PSRM stated, as part of the corrective action plan, the hospital looked into whether there was a different Blood Bridge platform they could use. The PSRM said, however, they are not actively moving forward with using Blood Bridge in MTP situations. The PSRM stated Blood Bridge is part of the EHR, so changes have to be made at the corporate level, which involves a proposal and going through committees. The PSRM stated this is only if corporate is open to receiving changes, and currently there is a moratorium [temporary suspension] on making changes. The PSRM said there are times when Blood Bridge is down or not functioning. The PSRM stated another underlying issue was nursing staff did not perform a two-nurse check to compare the blood product to the blood transfusion order and the patient's identity before starting the blood transfusion. The PSRM stated the corrective action plan after this patient event was to educate staff about the blood administration policy and performing the two-nurse check, which involved staff reading a policy and procedure. The PSRM stated the two-nurse check was "blood administration 101".

During an interview on 11/16/22 at 2:46 p.m. with the PSRM, the PSRM stated the blood administration policy was assigned to all nurses to read and attest to. When asked if there was a post-education test, the PSRM stated she did not believe there was a test. When asked if there were audits of blood transfusions as a result of this patient event, the PSRM stated it was not part of the hospital's action plan because it is an ongoing audit done by the Blood Utilization Committee.

During a concurrent interview and record review on 11/18/22 at 11:30 a.m. with the PSRM, the hospital's blood transfusion audits for 2022 were reviewed. The PSRM stated a program manager was randomly auditing blood transfusions, and probably started doing so in 2020 or 2021. For the blood transfusion audits, the PSRM confirmed there were four sampled blood transfusions in January 2022 and four sampled blood transfusions in February 2022 where the two licensed signatures on record were missing. The PSRM stated the two licensed signatures on record usually meant two nurses but could also include physicians. The PSRM stated there was no data on the two licensed signatures on record after February 2022. The PSRM stated the program manager left in April 2022 and that she was not aware blood transfusion audits were not being done until September 2022. The PSRM stated there is a hospital staff member now trying to find the data to restart the audits. The PSRM confirmed the hospital does not have any current data to indicate how well it is doing with the two-nurse check of blood transfusions. The PSRM confirmed that Blood Bridge is a safety net for administering the correct blood product to the correct patient, and that it is not available for MTP situations. When asked if she was aware that previous blood transfusions were missing two-nurse checks, the PSRM stated it was mentioned to her but not specific numbers. When asked if it was concerning the hospital had issues with two-nurse checks of blood transfusions prior to this patient event and that Blood Bridge is not available as a safety net for MTP situations, the PSRM stated the hospital relies on nurses to do what they are supposed to do. When asked what preventative measures the hospital is implementing to decrease the risk of this type of patient event from occurring again, the PSRM stated she did not know and that the hospital could add more to the action plan.

During a review of the hospital's policy and procedure titled Patient Safety Event Reporting and Management, effective February 27, 2019, indicated "... An Event Review/RCA [root cause analysis] team ... will meet to ... Identify system and process-based solutions ... Construct an action plan addressing the root causes and reasonable strategies to reduce the risk of similar events occurring in the future that addresses the following: action to be taken ... strategies for evaluating the effectiveness of the actions and strategies for sustaining the change ...".

Based on interview and record review, the hospital failed to evaluate one contracted service annually. This deficient practice had the potential for the governing body to be unaware of whether the contracted service was provided in a safe and effective manner to patients.

Findings:

During a review of the hospital's remote patient monitoring contract indicated it was signed June 21, 2020. The remote patient monitoring contract indicated it was a corporate contract and included the hospital as a participant.

During a review of the hospital's list of clinically relevant contracts, undated, revealed there was no remote patient monitoring contract included.

During a concurrent interview and record review on 11/15/22 at 9:03 a.m. with the Director of Quality and Risk Management (DQRM), the Quality and Peer Review Program Manager (QPPM), and the Contracts Specialist (CS), the hospital's list of clinically relevant contracts, undated, was reviewed. The CS stated the list was the hospital's entire list of clinically relevant non-physician contracts. The CS confirmed the remote patient monitoring contract was not on the list. The CS stated she was not aware of this contract previously. The QPPM stated he has a spreadsheet of the hospital's contracts and sends out established metrics to each contract's business leader to review annually. The business leader then sends his or her review to the DQRM, who sends it to the Quality Improvement and Patient Safety Committee, Medical Executive Committee, and the Board of Directors. The QPPM stated he has not completed a contract evaluation for the remote patient monitoring contract. The QPPM and DQRM stated a contract evaluation should have been done. The DQRM stated, if the Board of Directors did not see a contract evaluation, it would not be aware if the hospital was satisfied with the contract or not.

During a concurrent interview and record review on 11/16/22 at 8:46 a.m. with the Director of Quality and Risk Management (DQRM), the DQRM provided the hospital's policy and procedure titled Non-Physician Contract Procedure, undated. The DQRM stated the policy is still in draft form, but that it is what the hospital is following currently. The policy indicated "... PROCEDURE - Clinical Contracts Annual Quality Review ... The contract owner is responsible for management of the contract, scope and nature of the contract, performance metrics, and completion of annual contract evaluations ..." The policy noted "... The designated hospital leader ... will conduct, at a minimum, an annual evaluation of the services provided using the Contract Evaluation Summary ... The hospital leader will forward the completed Contract Evaluation Summary for approval to the Quality Improvement and Patient Safety Committee (QIC), and Medical Executive Committee for approval and recommendation for renewal ... A summary of approved contracts with specific performance metrics will be presented annually to the Board of Directors for review, input and approval ...".

Based on interview and record review, the hospital failed to monitor clinical privileges [a list of specific services and procedures a healthcare provider is deemed qualified to provide or perform] for three of ten sampled providers (Allied Health Provider J, Allied Health Provider K, and Physician L) when:

1. Two providers (Allied Health Provider J and Physician L) were granted privileges on reappointment without documentation they completed the required number of procedures and one provider (Allied Health Provider K) was granted privileges without a method for evaluating continued competence to perform those procedures.

2. One provider (Allied Health Provider J) was granted privileges for a procedure no longer performed by that provider type at the hospital.

These deficient practices had the potential for providers to be performing procedures without demonstrating continued competency and for placing patients at risk.

Findings:

1. During a review of the hospital's Medical Staff Bylaws, approved June 16, 2021, indicated in Article V, Section 5.2 "... Requests for clinical privileges shall be evaluated on the basis of the member's education, training, experience, current demonstrated professional competence and judgment, clinical performance ...". In Section 8.1, the Medical Staff Bylaws defined an Allied Health Practitioner (AHP) as "... a health care professional, other than a physician, who holds a license or other legal credential, as required by California law, to provide certain professional services ...". The Medical Staff Bylaws defined service authorization as "... permission granted to an Allied Health Staff member to provide specified patient care services within his or her qualifications and scope of practice ...". In Section 8.2, the Medical Staff Bylaws indicated that Allied Health Practitioner is eligible for a service authorization if he or she "... Agrees to comply with all medical staff and Department and Service bylaws, rules and regulations, and protocols to the extent applicable to the AHP ...". In Section 8.4, the Medical Staff Bylaws indicated "... AHP applications for initial granting and renewal of service authorizations ... shall be processed in a parallel manner to that provided in Articles IV and V for medical staff members ...".

a. During a concurrent interview and record review on 11/14/22 at 1:22 p.m. with the Medical Staff Director (MSDIR) and Medical Staff Coordinator (MSC), the credential file of Allied Health Provider J (AHP J) was reviewed. AHP J was reappointed as an allied health provider on 7/31/22. A review of AHP J's requested and granted clinical privileges from September 2022 included Episiotomy & Perineal Laceration Repair [procedure to repair tears or cuts to the vagina when a pregnant patient delivers a baby], Furnishing Medications, and Cesarean Section First Assist [assisting the physician during surgical delivery of baby]. For Episiotomy & Perineal Laceration Repair, ongoing competency evaluation required five procedures every two years. For Furnishing Medications, ongoing competency evaluation required five prescriptions every two years. For Cesarean Section First Assist, ongoing competency evaluation required two first assists every two years. On AHP J's log titled Diagnosis Index Summary Report from 6/01/2020 to 6/01/2022, there was no documentation of Episiotomy & Perineal Laceration Repair, Furnishing Medications, or Cesarean Section First Assist. For AHP J, the MSDIR stated the hospital only had reappointment case logs by diagnosis code, not by procedure code.

During an interview on 11/15/22 at 2:50 p.m. with the MSDIR, the MSDIR stated there was no way to validate that AHP J met the reappointment competency requirements for Episiotomy & Perineal Laceration Repair, Furnishing Medications, or Cesarean Section First Assist.


b. During a concurrent interview and record review on 11/15/22 at 10:22 a.m. with the Medical Staff Director (MSDIR) and Medical Staff Coordinator (MSC), the credentialing file of Physician L (MD L) was reviewed. MD L was reappointed to the medical staff on 11/30/21. A review of MD L's requested and granted clinical privileges from November 2021 included posterior colporrhaphy [procedure performed to correct an abnormal bulging of the rectum, or last part of the large intestine, into the vagina] and sacral nerve stimulator placement [procedure to stimulate the sacral nerve with electrical current to help with bowel or bladder problems]. MD L's Delineation of Privileges form indicated reappointment criteria for posterior colporrhaphy was performing three cases in the past 24 months, and for sacral nerve stimulator placement was performing one case in the past 24 months. On MD L's log titled Diagnosis Index Summary Report from 10/01/2019 to 9/30/2021, there was no documentation of posterior colporrhaphy or sacral nerve stimulator placement. The MSC stated a procedure activity log was not part of MD L's reappointment packet.

During a concurrent interview and record review on 11/14/22 at 1:22 p.m. with the MSDIR and MSC, the credential file of Physician L (MD L) was reviewed. For MD L, the MSDIR stated the hospital only had reappointment case logs by diagnosis code, not by procedure code.

During an interview on 11/15/22 at 2:50 p.m. with the MSDIR, the MSDIR stated she was unable to find posterior colporrhaphy or sacral nerve stimulator placement cases in MD L's file.


c. During a concurrent interview and record review on 11/14/22 at 10:23 a.m. with the Medical Staff Director (MSDIR) and Medical Staff Coordinator (MSC), the credential file of Allied Health Provider K (AHP K) was reviewed. AHP K was reappointed as an allied health provider on 10/31/22. A review of AHP K's requested and granted clinical privileges from October 2022 included central line placement [a thin flexible tube inserted into a large vein], arterial line placement [a thin flexible tube inserted into an artery], chest tube insertion [a plastic tube placed through the chest wall between ribs to drain air or fluid from the chest], and thoracentesis [needle inserted between the lung and chest wall to remove fluid for diagnostic or therapeutic purposes]. The MSC stated there were no minimum number of cases required for central line placement, arterial line placement, chest tube insertion, or thoracentesis. The MSC stated the reappointment case log for AHP K was by diagnosis code, and there was no procedure activity log for AHP K. On AHP K's log titled Diagnosis Index Summary Report from 9/01/2020 to 9/01/2022, there was no documentation of central line placement, arterial line placement, chest tube insertion, or thoracentesis.

During a review of the California Board of Registered Nursing policy and procedure titled Nursing Practitioners: Laws and Regulations, approved 9-11-2013, described standardized procedure guidelines promoted by the Medical Board of California and the California Board of Registered Nursing. The guidelines noted "... Each standardized procedure shall ... Specify any experience, training, and/or education requirements for performance of standardized procedure functions ... Establish a method for initial and continuing evaluation of the competence of those registered nurses authorized to perform standardized procedure functions ...".

During a concurrent interview and record review on 11/15/22 at 2:50 p.m. with the MSDIR, the California Board of Registered Nursing policy and procedure titled Nursing Practitioners: Laws and Regulations, approved 9-11-2013, was reviewed. The MSDIR stated she was unable to find criteria for initial appointment or reappointment for AHP K with regards to procedures. When asked how the hospital knows AHP K is capable of performing procedures or has continuing competency without a procedure activitiy log, the MSDIR stated the hospital should have reappointment criteria and that it sounded like the privilege form needed to be revamped. The MSDIR stated allied health providers are supposed to follow all medical staff bylaws. The MSDIR confirmed the hospital follows the California Board of Registered Nursing policy and procedure titled Nursing Practitioners: Laws and Regulations.


2. During a concurrent interview and record review on 11/14/22 at 1:22 p.m. with the MSDIR and MSC, the credentialing file of Allied Health Provider J (AHP J) was reviewed. AHP J was reappointed as an allied health provider on 7/31/22. A review of AHP J's requested and granted clinical privileges from September 2022 included Microscopy Procedure Fern Testing [test to see if pregnant patient has ruptured the sac surrounding the unborn baby]. For Microscopy Procedure Fern Testing, annual competency testing was required.

During an interview on 11/15/22 at 2:50 p.m. with the MSDIR, the MSDIR stated AHP J's provider category no longer performs Microscopy Procedure Fern Testing at the hospital. The MSDIR stated they stopped about two years ago, so the hospital will remove it from the privilege form.

Based on interview and record review, the hospital failed to enforce its medical staff bylaws when one provider (Allied Health Provider J) did not have documentation of annual tuberculosis testing [highly contagious disease spread through tiny droplets released during coughing or sneezing].

This deficient practice had the potential to result in the provider being unaware of her tuberculosis status and risking the health of others.

Findings:

During an interview on 11/15/22 at 2:50 p.m. with the Medical Staff Director (MSDIR), the MSDIR stated Allied Health Provider J did not have a Quantiferon test [blood test that helps to diagnose tuberculosis infection] result for 2021 or 2022.

During a review of the hospital's policy and procedure titled Medical Staff Health Status Documents, approved 8/15/22, indicated "... Annually all appointed practitioners (excluding Affiliate and Telemedicine providers) are required to submit the current QuantiFeron (QFT) results and a completed Health Screening questionnaire ...".

During a review of the hospital's Medical Staff Bylaws, approved June 16, 2021, indicated in Section 2.5 "... the ongoing responsibilities of each member of the medical staff include ... abiding by the medical staff bylaws, medical staff rules and regulations, and policies ...". In Section 8.1, the Medical Staff Bylaws defined an Allied Health Practitioner (AHP) as "... a health care professional, other than a physician, who holds a license or other legal credential, as required by California law, to provide certain professional services ...". The Medical Staff Bylaws defined service authorization as "... permission granted to an Allied Health Staff member to provide specified patient care services within his or her qualifications and scope of practice ...". In Section 8.2, the Medical Staff Bylaws indicated that Allied Health Practitioner is eligible for a service authorization if he or she "... Agrees to comply with all medical staff and Department and Service bylaws, rules and regulations, and protocols to the extent applicable to the AHP ...".

Based on observation, interview, and record review, the hospital failed to comply with the Condition of Participation for Nursing Services as evidenced by:

1. Failure to provide nursing staff to meet Nurse-to-Patient ratios (refer to A-0392).

2. Failure to provide safety attendants to monitor pateints (refer to A-0392).

3. Failure to obtain physician orders for safety attendants (refer to A-0398)

4. Failure to assess patients' elopement risks (refer to A-0398)

5. Failure to perform patients' imminent risk assessment (refer to A-0398)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview and record review, the hospital failed to provide sufficient nursing staff when:

1. One safety attendant was assigned to monitor two patients simultaneously, who required one-to-one observation for six patients (Patients 18, 33, 37, 42, 45 and 46) and a safety attendant was not provided for two patients (Patients 18 and 42); and,

2. The licensed nurse-to-patient ratio in Mother Child Health Unit (MCU) did not follow the State's minimum nurse to patient ratios.

These failures had the potential to negatively impact the quality of patient care.

Findings:

1. Review of Patient 18's History and Physical (a report containing a patient's medical history and the results of the patient's physical examination), dated 9/14/22, indicated the patient presented to the emergency department (ED) two days prior to the admission, after a suicide attempt with a laceration on her left wrist. It stated the patient was back to the ED with dehiscence of the wound and new cellulitis (skin infection) and admitted.

Review of Patient 18's physician order, dated 9/17/22, indicated "one to one observation (sitter)" for self-endangerment.

Review of Patient 18's Safety Attendant Observation Form indicated there was no documented evidence a safety attendant was provided on 9/16/22 and 9/17/22 for Patient 18's suicidal ideation.

Review of Patient 42's History and Physical, dated 8/27/22, indicated the patient was brought to the ED with confusion. It stated the patient threatened and attempted to hit her family member and threatened to burn the complex of her apartment down. The patient was placed on a 5150 hold (involuntary psychiatric hold for a mental health crisis for up to 72 hours) and admitted.

Review of Safety Attendant Observation Forms of Patients 18 and 42, from 9/19/22 to 10/9/22, indicated the signatures of safety attendants on the forms, were the same. It also indicated there was no documented evidence a safety attendant was assigned to the patients on 9/20/22 from 12 p.m. to 11:59 p.m. and 9/24/22 from 8 a.m. to 11:59 p.m.

During an interview on 11/16/22 at 1:52 p.m., the unit manager (UM) stated a safety attendant was required for suicidal psychiatric patients including involuntary psychiatric hold. She stated, for Patient 18, she should have had a safety attendant upon admission for suicidal ideation. For Patients 18 and 42, she stated they should have had one safety attendant each, but one safety attendant was assigned to monitor two patients at the same time, from 9/19/22 to 10/9/22. She confirmed there was no documented evidence a safety attendant was assigned to Patients 18 and 42, on 9/20/22 from 12 p.m. to 11:59 p.m. and 9/24/22 from 8 a.m. to 11:59 p.m.

Review of Patient 45's History and Physical, dated 9/17/22, indicated the patient was a 15- year-old female, presented to the ED for increased suicidal thoughts, was placed on a 5150 hold and admitted.

Review of Patient 46's History and Physical, dated 9/18/22, indicated the patient was a 15-year-old female with history of cutting her wrist and depression, presented to the ED for increased suicidal thoughts and self-harm. The patient was placed on a 5150 hold and admitted.

Review of Safety Attendant Observation Forms of Patients 45 and 46, from 9/17/22 to 9/19/22, indicated the signatures of safety attendants on the forms, were the same.

During an interview on 11/16/22 at 1:52 p.m. p.m., the unit manager (UM) stated Patient 45 and 46 required a safety attendant each because they were on a 5150 hold for suicidal ideation. She confirmed safety attendants were assigned to two patients, Patient 45 and 46 at the same time, from 9/17/22 to 9/19/22.

Review of Patient 33's History and Physical, dated 7/12/22, indicated the patient was brought to the ED when he was found lethargic. It stated he was screaming and yelling when anyone tried to touch or speak to him. He was a 71-year-old homeless and admitted with diagnoses, including positive COVID -19, acute and chronic leg wound and infection. It indicated the patient was noncompliant to treatment plans and combative.

Review of Patient 33's clinical record indicated there was no Imminent Risk Screening Tool utilized to determine the type of safety attendant and level of observation needed upon admission.

Review of Patient 37's History and Physical, dated 9/23/22, indicated the patient was brought to the ED for suicidal ideation. It stated per the 5150 hold report, the patient expressed desire to kill herself, cut her wrist with a razor approximately 1 week before she was admitted, and had history of prior suicidal attempts.

Review of Safety Attendant Observation Forms of Patients 33 and 37, from 9/25/22 to 9/30/22, indicated safety attendants observed Patients 33 and 37 at the same time.

During an interview on 11/16/22 at 1:52 p.m., the UM reviewed Safety Attendant Observation Forms of Patients 33 and 37, from 9/15/22 to 9/28/22, and confirmed one safety attendant was assigned to two patients at the same time. She stated Patient 37 should be placed on one-to-one observation and for Patient 33, she was unsure the type of safety attendant and level of observation needed because there was no Imminent Risk Screening Tool utilized to determine.

Review of the hospital's policy, "Safety Attendant: For Patients at Risk for Harm to Self or Others", dated 7/18/18, indicated one-to-one observation means one competent observer to one patient within line of sight, in close proximity with no physical barriers in the same room/area to assure the safety and well-being of an individual patient or others. One-to-one observation is utilized only when a patient is screened to be at imminent risk of harm to self or others, placing other in the immediate vicinity at imminent risk of harm. This requires continuous visual observation of one designated patient. The guidelines indicated a safety attendant is a resource used to meet the needs of patients requiring close observation. The imminent Risk Screening Tool a long with reasonable discretion will be used to determine the type of safety attendant and level of observation necessary to protect patients and others from potential harm. Criteria for assessing patient behaviors to de determine the need for safety attendant includes suicidal or non-suicidal psychiatric patients including involuntary psychiatric hold and violent/harmful behavior. It stated patients assessed as an imminent risk of harm to self or others, due to a suicide attempt with a continuous active suicide plan with ideations and intent to succeed will be placed on one-to-one observation. The RN assigned to the patient completes the imminent Risk Screening tool and Safety attendant utilize the Safety Attendant Observation Form or Safety Precautions checklist.

Review of the hospital's policy, "Identifying and Assessing Patients at Risk of Suicide/Self-harm", dated 12/12/2019, indicated to identify and assess patients for risk of suicide/harm to self-using the Columbia Suicide assessment tools and patients screened/assessed and found to be at high risk will be monitored under direct one-to-one (1:1) observation. The safety attendant is assigned to observe only one patient at all times. This allows the safety attendant to immediately intervene should the patient attempt harm.

Review of the hospital's policy, "72 Hour Holds 5150", dated 8/17/22, indicated the procedure when a person is admitted. It indicated patients who are assessed to be a risk for danger to self and/or danger to others, require a physician order for a sitter.



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2. During a tour of the Mother Child Health Unit (MCU) on 11/9/22 at 10:30, five pediatric beds were observed, Rooms 1102, 1104, 1106, 1107, and 1108. A white staffing board in the nurse's station indicated one Registered Nurse (RN) was assigned to one couplet (mother and newborn baby) in Room 1102, a pediatric patient who was just discharged in Room 1104, a pediatric patient in Room 1107, a pediatric patient in Room 1108, and a expected admission from the emergency department in Room 1106.

During a concurrent interview, the Maternal Child Health Manager (MCHM) stated nursing staff were assigned to four rooms either singles (one pediatric patient) or couplets (mother and baby) or combination of both.

During a concurrent observation and interview on 11/10/22 at 10:30 a.m., the charge nurse (CN) stated, she tried to assign one nurse to only pediatric patients, but would assign the pediatric patients and the couplets at the same time, if needed.

During a review of the Maternal Child Health staffing sheets from 10/30/22 to 11/9/22, the staffing sheets indicated:

On 10/30/22 Day shift, one Registered Nurse (RN) had one pediatric (P) patient and three mother/baby (MB) couplets in rooms 1108 (P), 1110 (MB), 1112 (MB), 1118 (MB). The nurse-to-patient ratio was 1:7.

On 11/1/22 Day shift, one RN had patients in rooms 1109(P), 1114 (MB), 1121 (MB). The nurse-to-patient ratio was 1:5.

On 11/3/22 Night shift, one RN had one patients in rooms 1106 (Gyn, Gynecology patient), 1109 (P), 1114 (MB), 1119 (MB). The nurse-to-patient ratio was 1 nurse: 6 patients.

On 11/4/22 Night shift, one RN had patients in rooms 1104 (Gyn), 1109 (P), 1110 (MB), 1114 (MB). The nurse-to-patient ratio was 1 nurse: 6 patients.

On 11/5/22 Day shift, one RN had patients in rooms 1106 (P), 1110 (MB), 1112 (MB), 1121 (MB). The nurse-to-patient ratio was 1 nurse:7 patients.

On 11/6/22 Day shift, one RN had patients in rooms 1109 (P), 1110 (MB), 1119 (MB), 1121 (MB). The nurse-to-patient ratio was 1 nurse:7 patients.

On 11/7/22 Day shift, one RN had patients in rooms 1103 (MB), 1106 (P), 1119 (MB), 1120 (MB). The nurse-to-patient ratio was 1 nurse:7 patients.

On 11/8/22 Day shift, one RN had patients in rooms 1106 (P), 1108 (P), 1118 (MB), 1119 (MB). The nurse-to-patient ratio was 1 nurse:6 patients

During an interview on 11/15/22 at 10:27 a.m. with the Maternal Child Health Manager (MCHM), the MCHM stated pediatrics and post-partum patients have combined nursing staffing. She stated she was unaware each nursing unit should have their own nursing staffing to meet the nurse-to-patient ratio.

During a review of the facility's policy titled "Nurse Staffing Plan" dated 2/21/21, indicated postpartum ratios are 1 nurse to 4 or fewer at all times of Mother-Baby couplets, Pediatric ratios are 1 nurse to 4 or fewer at all times. "The staffing plan shall include the following: a. Adherence to minimum nurse to patient ratios." "Staffing assignments are made by the charge nurse at the beginning of each shift taking into consideration: ...e. Title 22 requirements for nurse-patient ratios."

Review of the 2013 California Code of Regulations Title 22, §70217. Nursing Service Staff indicated, " ... (4) The licensed nurse-to-patient ratio in a postpartum area of the perinatal service shall be 1:4 mother-baby couplets or fewer at all times. In the event of multiple births, the total number of mothers plus infants assigned to a single licensed nurse shall never exceed eight. For postpartum areas in which the licensed nurse's assignment consists of mothers only, the licensed nurse-to-patient ratio shall be 1:6 or fewer at all times.

(5) The licensed nurse-to-patient ratio in a combined Labor/Delivery/Postpartum area of the perinatal service shall be 1:3 or fewer at all times the licensed nurse is caring for a patient combination of one woman in active labor and a postpartum mother and infant The licensed nurse-to-patient ratio for nurses caring for women in active labor only, antepartum patients who are not in active labor only, postpartum women only, or mother-baby couplets only, shall be the same ratios as stated in subsections (3) and (4) above for those categories of patients.

(6) The licensed nurse-to-patient ratio in a pediatric service unit shall be 1:4 or fewer at all times."

Based on interview and record review, the hospital failed to ensure nursing staff implemented its policy when:

1. The elopement risk assessment was not performed for seven patients (Patients 1, 2, 4, 8, 10, 11, and 22);

2. Imminent Risk Screening tool was not utilized for 14 patients (Patients 1, 2, 4, 7, 8, 10, 11, 18, 22, 33, 37, 42, 45, and 46);

3. Physician orders were not obtained for safety attendants for three patients (Patients 37, 45, and 46); and

4. The suicide risk assessment tool and a discharge safety plan was not completed for one patient (Patient 18).

The failures had potential to miss the opportunities, to assess patients' elopement risks and timely implement plans of care to prevent actual elopement and to assess the patient's suicide risk and produce a discharge plan to prevent a suicide attempt after discharge. Imminent Risk Screening and accurate physician orders can determine the type of safety attendant and level of observation needed for their safety of the patients at risk.


Findings:

1. Review of Patient 1's ED notes, dated 9/24/22, indicated Patient 1 was placed on a 5150 hold (an emergency 72 hour hold due to being a danger to self, danger to others, or gravely disabled) in the ED because of grave disability (unable to provide a plan for providing self with shelter, food, or clothing).

During concurrent interview and record review with the EDM, on 11/7/22 at 11:27 a.m., she confirmed no elopement assessment was documented for Patient 1. The EDM confirmed an elopement assessment should be completed for each patient and should be part of the patient's medical record.

Review off Patient 2's record indicated the patient was a 35-year-old who presented to the emergency department on a 5150 hold placed prior to arrival for being a danger to herself as determined by law enforcement. Patient 2 was admitted 9/29/22 at 7:00 p.m. and discharged 9/30/22 at 10:43 a.m. with law enforcement. Patient 2 was medically cleared for transfer to a higher level of care due to psychiatric services not available at the facility.

During concurrent interview and record review on 11/4/22 at 9:30 a.m. with the Director of Quality & Risk Management (DQRM), Patient 2's medical record was reviewed. DQRM confirmed there was no evidence of an elopement assessment completed.

Review of Patient 4's record indicated the patient was a 17-year-old female brought in by ambulance for suicidal ideations after taking multiple medications with the intent to kill herself. Patient 4 was on a 5150 hold and was medically cleared for transfer to a higher level of care due to psychiatric services not available at the facility.

During concurrent interview and record review on 11/4/22 at 9:50 a.m., with the Director of Quality & Risk Management (DQRM), Patient 4's medical record was reviewed. DQRM confirmed there was no evidence of an elopement assessment completed.

Review of Patient 8's ED notes, dated 8/29/22, indicated Patient 8 had a history of schizophrenia (severe persistent mental illness that impairs thinking, feeling and behavior) and was on a 5150 for "harm to others."

During concurrent interview and record review with the EDM, on 11/7/22 at 11:27 a.m., she confirmed no elopement assessment was documented for Patient 8. The EDM confirmed an elopement assessment should be completed for each patient and should be part of the patient's medical record.

Record review of Patient 10's ED triage note, dated 8/23/22, indicated Patient 10 was placed on a 5150 hold for suicidal ideation.

During concurrent interview and record review with the EDM, on 11/7/22 at 11:27 a.m., she confirmed no elopement assessment was documented for Patient 10. The EDM confirmed an elopement assessment should be completed for each patient and should be part of the patient's medical record.

Record review of Patient 11's ED triage note, dated 8/27/22, indicated Patient 11 was placed on a 5150 hold for concern of danger to others.

During concurrent interview and record review with the EDM, on 11/7/22 at 11:27 a.m., she confirmed no elopement assessment was documented for Patient 11. The EDM confirmed an elopement assessment should be completed for each patient and should be part of the patient's medical record.

Review of Patient 22's ED Physician Notes, dated 6/10/22 indicated he presented to the ED after attempting to shoot himself with a gun. Patient 22 was placed on a 5150 hold and was cleared to be transferred to a higher level of care due to psychiatric services not available at the facility.

During an interview on 11/7/22 at 10:47 a.m., the Director of ED & Critical Care (DED) reviewed Patient 22's medical record and confirmed no elopement assessment was documented for Patient 22. The DED confirmed an elopement assessment should be completed for each patient and should be part of the patient's medical record.

Review of the hospital policy, "Elopement and Wandering Assessment and Prevention,' dated 2/17/22, indicated the facility should complete an elopement and wandering assessment throughout the patient's hospitalization so any patient at risk of elopement or wandering would be identified. The policy further indicated any patient on a legal hold for danger to themselves, danger to others, and/or grave disability are considered high risk for elopement and interventions to prevent elopement or wandering should be implemented.

2. Review of Patient 1's ED notes, dated 9/24/22, indicated Patient 1 was placed on a 5150 hold in the ED because of grave disability (unable to provide a plan for providing self with shelter, food, or clothing).

During interview with the EDM, on 11/7/22 at 11:27 a.m., she confirmed no imminent risk assessment was documented for Patient 1.

Review of Patient 2's record indicated the patient was a 35-year-old who presented to the emergency department on a 5150 hold placed prior to arrival for being a danger to herself as determined by law enforcement. Patient 2 was admitted 9/29/22 at 7:00 p.m. and discharged 9/30/22 at 10:43 a.m. with law enforcement. Patient 2 was medically cleared for transfer to a higher level of care due to psychiatric services not available at the facility.

During concurrent interview and record review on 11/7/22 at 12:10 p.m. with Emergency Department Manager (EDM), Patient 2's medical record was reviewed. The EDM confirmed there was no evidence of an imminent risk screening tool completed.

Review of Patient 4's medical record indicated the patient was a 17-year-old female brought in by ambulance for suicidal ideations after taking multiple medications with the intent to kill herself. Patient was on a 5150 hold (involuntary psychiatric hold for a mental health crisis for up to 72 hours). Patient 4 was medically cleared for transfer to a higher level of care due to psychiatric services not available at the facility.

During concurrent interview and record review on 11/7/22 at 12:15 with the EDM, Patient 4's medical record was reviewed. The EDM confirmed there was no evidence of an imminent risk screening tool completed.

Review of Patient 7's ED Physician notes, dated 8/31/22, indicated the patient was suicidal and was placed on a 5150 hold.

During concurrent interview and record review with the EDM, on 11/7/22 at 11:27 a.m., she confirmed no imminent risk assessment was documented for Patient 7.

Review of Patient 8's ED notes, dated 8/29/22, indicated Patient 8 had a history of schizophrenia (severe persistent mental illness that impairs thinking, feeling and behavior) and was on a 5150 hold for "harm to others."

During concurrent interview and record review with the EDM, on 11/7/22 at 11:27 a.m., she confirmed no imminent risk assessment was documented for Patient 8.

Review of Patient 10's ED triage note, dated 8/23/22, indicated Patient 10 was placed on a 5150 hold for suicidal ideation.

During concurrent interview and record review with the EDM, on 11/7/22 at 11:27 a.m., she confirmed no she confirmed no imminent risk assessment was documented for Patient 10.

Review of Patient 11's ED triage note, dated 8/27/22, indicated Patient 11 was placed on a 5150 hold for concern of danger to others.

During concurrent interview and record review with the EDM, on 11/7/22 at 11:27 a.m., she confirmed no imminent risk assessment was documented for Patient 11.

During interview with the EDM, on 11/3/22 at 9:54 a.m., confirmed policy states the imminent risk form is to be completed as an assessment and indicated the imminent risk form is not consistently utilized in the ED and stated staff was confused over who was to complete the assessment. The EDM stated the assessment is used to determine if a patient attendant is needed. The EDM further stated the imminent risk tool is not part of the patient's electronic medical record.

Review of Patient 22's ED Physician Notes, dated 6/10/22 indicated he presented to the ED after attempting to shoot himself with a gun. Patient 22 was placed on a 5150 hold and was cleared to be transferred to a higher level of care due to psychiatric services not available at the facility. There was no documented evidence the Imminent Risk Assessment Tool was utilized to determine the patient required a safety attendant.

During an interview on 11/7/22 at 10:47 a.m., the Director of ED & Critical Care (DED) reviewed Patient 22's medical record and confirmed the Imminent Risk Assessment Tool was not utilized.

Review of Patient 18's History and Physical (a report containing a patient's medical history and the results of the patient's physical examination), dated 9/14/22, indicated the patient visited the emergency department (ED) two days prior to the admission, after a suicide attempt with a laceration on her left wrist. It stated the patient was back with dehiscence of the wound and new cellulitis (skin infection) and admitted.

Review of Patient 33's History and Physical, dated 7/12/22, indicated the patient was brought to the ED when he was found lethargic. It stated he was screaming and yelling when anyone tried to touch or speak to him. He was a 71-year-old homeless and admitted with diagnoses, including positive COVID -19, acute and chronic leg wound and infection. It indicated the patient was noncompliant to treatment plans and combative.

Review of Patient 37's History and Physical, dated 9/23/22, indicated the patient was brought to the ED for suicidal ideation. It stated per the 5150 hold report, the patient expressed desire to kill herself and cut her wrist with a razor approximately 1 week before she was admitted and had history of prior suicidal attempts.

Review of Patient 42's History and Physical, dated 8/27/22, indicated the patient was brought to the ED with confusion. It stated the patient threatened and attempted to hit her family member and threatened to burn the complex of her apartment down. The patient was placed on a 5150 hold and admitted.

Review of Patient 45's History and Physical, dated 9/17/22, indicated the patient was a 15- year-old female, presented to the ED for increased suicidal thoughts, was placed on a 5150 hold (involuntary psychiatric hold for a mental health crisis for up to 72 hours) and admitted.

Review of Patient 46's History and Physical, dated 9/18/22, indicated the patient was a 15-year-old female with history of cutting her wrist and depression, presented to the ED for increased suicidal thoughts and self-harm. The patient was placed on a 5150 hold and admitted.

Review of clinical record of Patients 18, 33, 37, 42, 45, and 46 indicated there was no Imminent Risk Screening Tool utilized to determine the type of safety attendant and level of observation needed upon admission.

During an interview on 11/16/22 at 1:52 p.m., the unit manager (UM) confirmed Imminent Risk Screening Tool was not utilized for Patients 18, 33, 37, 42, 45, and 46.

Review of the hospital's policy, "Safety Attendant: For Patients at Risk for Harm to Self or Others", dated 7/18/18, indicated the imminent Risk Screening Tool a long with reasonable discretion will be used to determine the type of safety attendant and level of observation necessary to protect patients and others from potential harm.

3. Review of Patient 37's History and Physical, dated 9/23/22, indicated the patient was brought to the ED for suicidal ideation. It stated per the 5150 hold report, the patient expressed desire to kill herself and cut her wrist with a razor approximately 1 week before she was admitted and had history of prior suicidal attempts.

Review Patient 37's Safety Attendant Observation Forms from 9/25/22 to 9/30/22, indicated the patient had safety attendants.

Review of Patient 37's clinical record indicated there was no physician order for a safety attendant.

Review of Patient 45's History and Physical, dated 9/17/22, indicated the patient was a 15- year-old female, presented to the ED for increased suicidal thoughts, was placed on a 5150 hold (involuntary psychiatric hold for a mental health crisis for up to 72 hours) and admitted.

Review of Patient 46's History and Physical, dated 9/18/22, indicated the patient was a 15-year-old female with history of cutting her wrist and depression, presented to the ED for increased suicidal thoughts and self-harm. The patient was placed on a 5150 hold and admitted.

Review of Safety Attendant Observation Forms of Patients 45 and 46, from 9/17/22 to 9/19/22, indicated the patients had safety attendants.

Review of the hospital's policy, "72 Hour Holds 5150", dated 8/17/22, indicated the procedure when a person is admitted. It indicated patients who are assessed to be a risk for danger to self and/or danger to others, require a physician order for a sitter.

Review of Patient 46's clinical record indicated, there was no Imminent Risk Screening Tool utilized and there was no physician order for a safety attendant.

During an interview on 11/16/22 at 1:52 p.m., the unit manager (UM) confirmed there was no physician order for a safety attendant for Patients 37, 45, and 46.

Review of the hospital's policy, "72 Hour Holds 5150", dated 8/17/22, indicated the procedures when a person is admitted. It indicated patients who are assessed to be a risk for danger to self and/or danger to others, require a physician order for a sitter.








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4. Review of Patient 18's Discharge Summary, dated 9/12/22 indicated the patient was admitted to the hospital on 8/30/22 after a suicide attempt with laceration to her left wrist. Patient 18 required surgery to repair the damaged nerves and tendons. Patient 18 was hospitalized from 8/30/22 to 9/12/22.

Review of Patient 18's History and Physical, dated 9/14/22 indicated the patient returned to the hospital on 9/14/22 after a "visiting nurse noticed that her wrist wound had completely dehisced [wound separated or split open] and had surrounding erythema [redness]." It indicated the patient denied doing anything to the wound when she was sent home on 9/12/22.

During interview and concurrent record review with the Medical Surgical Educator (MSE) on 11/15/22 at 9:55 a.m., Patient 18's records were reviewed. On 9/6/22, Patient 18's Columbia Suicide Severity Rating Scale (C-SSRS) was high, meaning high risk for suicide/harm to self. The MSE stated nurses should have continued to complete the C-SSRS frequent screener every shift.

During interview and concurrent record review with the MSE on 11/17/22 at 10:40 a.m., Patient 18's records were reviewed. There was no discharge safety discharge plan for Patient 18. The MSE confirmed there was no C-SSRS frequent screener assessment completed when Patient 18 was discharged on 9/12/22. The MSE stated the last C-SSRS frequent screener assessment was completed on 9/9/22. The MSE also confirmed there was no documentation of a discharge safety plan for Patient 18.

Review of the hospital's policy, "Identifying and Assessing Patients at Risk of Suicide/Self-harm," dated 12/12/2019 indicated, "Patients identified as being at risk (MODERATE or HIGH) of suicide are reassessed at minimum of each shift...using the Columbia Suicide Severity Rating Scale - FREQUENT SCREENER tool..." The policy also indicated, "Discharge Planning - For patients previously identified as a suicide risk: 1. Evaluation of risk is performed prior to patient's discharge using C-SSRS FREQUENT SCREENER Tool...2. A Discharge Safety Plan is developed for patients with suicide ideation who are not being transferred to an inpatient behavioral health unit..." The Discharge Safety Plan indicated the following information should be completed: Warning Signs or When Should This Plan be Used, Actions You Can do to Not Follow Through on Thoughts and Urges, Social Setting(s) That Can Take Your Mind Off Your Problems, and List the family members, friends or clergy that can help you during a crisis (Name and Phone Number).