Good Samaritan Hospital

Based on observation, interview, and record review, the hospital failed to ensure compliance with all Conditions of Participation. This resulted in two condition-level deficiencies (Nursing Services, and Quality Assessment and Performance Improvement Program). The governing body failed to fully address serious, systemic, and recurring issues, placing 13 of 37 sampled patients at risk for adverse events.

Findings:

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

2. 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 inform the governing body about two contracted services during the annual contract review. This deficient practice resulted in the governing body being unable to evaluate whether the contracted services were provided in a safe and effective manner to patients.

Findings:

During a review of the hospital's List of Contracts (2020), undated, revealed 375 contracts but did not include the medical gas contract or the elevator contract.

During a review of the Quality Improvement Committee meeting minutes for 11/5/20, indicated 375 contracted services were discussed.

During a review of the Board of Trustees meeting minutes for 11/18/2020, revealed the annual review of physician and services contracts was presented to the governing body, with the number of contracted services documented as 375.

During a review of the medical gas contract, effective 1/15/19, indicated the hospital was on the list of existing medical gas purchasers. During a review of the elevator contract, effective 11/1/2016 and expiring 10/31/21, indicated the hospital was on the list of purchasing facilities.

During an interview on 6/9/21 at 2:14 p.m. with the Vice President of Operations (VPOP), the VPOP stated the hospital's typical procedure is to evaluate contracts annually. The VPOP stated all contracts on the List of Contracts (2020) undergo annual evaluations by the hospital.

During a concurrent interview and document review on 6/9/21 at 9:33 a.m. with the VPOP, the VPOP confirmed the medical gas contract was not on the List of Contracts (2020) because it was a contract maintained by corporate. The VPOP stated the medical gas contract was not included in contract evaluation presentations to the Quality Improvement Committee or the Board of Trustees. When asked how the governing body would know if the medical gas vendor was performing to a satisfactory level, the VPOP stated we would let them know if there were issues. The VPOP stated the hospital's corporate-maintained contracts are not downloaded onto the List of Contracts (2020). When asked how the hospital knows which corporate-maintained contracts are relevant to the hospital, the VPOP stated the corporate office tells them. The VPOP stated corporate performs the medical gas contract evaluation and asks for feedback from the hospital. When asked if the hospital receives the medical gas contract evaluation from corporate, the VPOP stated no, the hospital just receives information if there are any vendor issues with other corporate-owned facilities. When asked if the hospital's governing body receives any information about the medical gas contract evaluation from corporate, the VPOP stated only if there are issues.

During a concurrent interview and document review on 6/9/21 at 12:09 p.m. with the VPOP, the VPOP confirmed the List of Contracts (2020) was the list of all hospital contracts with evaluations. When asked if the hospital has a way to access the corporate evaluation of the medical gas vendor, the VPOP stated no.

During a concurrent interview and document review on 6/9/21 at 1:35 p.m. with the VPOP, the VPOP confirmed the elevator contract was not on the List of Contracts (2020) because it was a contract maintained by corporate. The VPOP stated the elevator contract has not undergone formal annual contract evaluations at the hospital level, and the elevator contract has only been discussed with the governing body if an issue affecting patient care came up. When asked if there was a way to find out what other corporate-maintained contracts are clinically relevant to the hospital, the VPOP stated it would be very time-consuming and he did not have that information right now.

During a review of the hospital's Bylaws Governing the Board of Trustees, reviewed 11/19, Article 6.6.2 revealed ... The Board shall ensure that contracted services are performed safely and effectively through implementation of the performance improvement program ....

Based on interview and record review, the hospital failed to maintain a complete and accurate list of contracted services. This deficient practice had the potential for the hospital to be unaware of which contracted services were in effect.

Findings:

During a review of the hospital's List of Contracts (2020), undated, revealed 375 contracts but did not include the medical gas contract or elevator contract.

During a review of the Quality Improvement Committee meeting minutes for 11/5/20, indicated there were 375 contracted services.

During a review of the Board of Trustees meeting minutes for 11/18/2020, revealed the annual review of physician and services contracts was presented to the governing body, with the number of contracted services documented as 375.

During an interview on 6/8/21 at 2:10 p.m. with the Regulatory and Accreditation Manager (RAM), the RAM confirmed the hospital has a medical gas vendor.

During a review of the medical gas contract, effective 1/15/19, indicated the hospital was on the list of existing medical gas purchasers. During a review of the elevator contract, effective 11/1/2016 and expiring 10/31/21, indicated the hospital was on the list of purchasing facilities.

During a concurrent interview and document review on 6/9/21 at 9:33 a.m. with the Vice President of Operations (VPOP), the VPOP confirmed the medical gas contract was not on the List of Contracts (2020) because it was a contract maintained by corporate. The VPOP stated the hospital's corporate-maintained contracts are not downloaded onto the List of Contracts (2020). When asked how the hospital knows which corporate-maintained contracts are relevant to the hospital, the VPOP stated the corporate office tells them.

During a concurrent interview and document review on 6/9/21 at 1:35 p.m. with the VPOP, the VPOP confirmed the elevator contract was not on the List of Contracts (2020) because it was a contract maintained by corporate. When asked if there was a way to find out what other corporate-maintained contracts are clinically relevant to the hospital, the VPOP stated it would be very time-consuming and he did not have that information right now.

During an interview on 6/9/21 at 12:09 p.m. with the VPOP, when asked if the List of Contracts (2020) was a complete list of contracted services, the VPOP stated no.

During a review of the hospital's Bylaws Governing the Board of Trustees, reviewed 11/19, Article 6.6.3 revealed ... The Board shall require that the hospital maintain a list of all contracted services ....

Based on interview and record review, the hospital failed to implement its policy when emergency technician B's (ET B) competency was not validated prior to her working in the hospital. This failure had the potential for an unqualified staff to provide care to patients.

Review of ET B's Sitter Competency and Tech Competency Validation documents, dated 6/9/2021, indicated ET B signed these forms on 6/9/2021.

During an interview with the nurse interim director in emergency department (NIDED) on 6/10/2021 at 10:45 a.m., the NIDED stated ET B transferred from an affiliate hospital and was hired on 1/28/2021. The NIDED stated ET B's competency validation records were unavailable upon hire to this hospital. The NIDED stated there was no evidence that ET B's competency was validated before she started work at this hospital.

During an interview on 6/11/2021 at 9:50 a.m., the Human Resources Vice President (HRVP) stated units leaders should validate employees' competencies before they start working on the units.

Review of the hospital's policy, Employee Records Policy, dated 1/1/2015, indicated the purpose was to established standards by which information was managed in employee records in order to achieve accuracy, privacy and compliance (e.g. legal, regulatory, or accreditation compliance).

Review of the hospital's policy, Competency Assessment Policy, dated 8/10/2020, indicated the purpose was to define mechanisms used to assess and maintain competency of colleagues, as required for the position and by regulatory agencies. It stated pre-employment assessment included validation of training required by the job description. The initial competency assessment included, at a minimum, the validation of core competencies specific to the role and responsibility of each position.

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

1. Failure to assess corrective action plan for effectiveness or sustainability after one adverse patient event (refer to A-0286).

2. Failure to assess corrective action plan for sustainability after one adverse patient event (refer to A-0286).

3. Failure to extend learning from two adverse patient events to other areas of the hospital at risk for similar events (refer to A-0286).

4. Failure to recognize the potential for or track actual negative patient care outcomes that occurred during staffing shortages, failure to revise action plan for staffing shortages despite repeated occurrences, and failure to relay staffing shortage occurrences and negative patient care outcomes to the governing body (refer to A-0286).

5. Failure to evaluate two contracted services at the hospital level and to relay this information to the governing body (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. The corrective action plan after one adverse patient event did not assess for effectiveness or sustainability.

2. The corrective action plan after one adverse patient event did not assess for sustainability.

3. The learning from two adverse patient events was not rolled out to other areas of the hospital at risk for similar events.

4. The hospital did not recognize the potential for or track actual negative patient care outcomes that occurred during staffing shortages, did not revise its action plan for staffing shortages despite repeated occurrences, and did not relay staffing shortage occurrences and negative patient care outcomes to the governing body.

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

Findings:

1. During an interview on 6/8/21 at 8:27 a.m. with the Regulatory and Accreditation Manager (RAM), the RAM stated the hospital's root cause analyses (method used to analyze adverse events, which focuses on identifying underlying problems that increase likelihood of errors) are called serious event analyses (SEA).

During an interview on 6/10/21 at 10:14 a.m. with the Director of Patient Safety and Risk Management (DPSRM), the DPSRM reviewed the SEA for an October 2020 adverse patient event in the Emergency Department (ED). The DPSRM stated a suicidal patient under a 5150 hold (a hold placed when a patient is a danger to self, others, or gravely disabled) harmed herself with a clothing item while alone in the bathroom. The DPSRM stated staff had opened the bathroom door to check on the patient every ten seconds. The DPSRM stated one root cause was staff feeling uncomfortable with taking the patient's belongings and clothing and putting the patient in a paper gown. The DPSRM stated the ED leadership educated staff about the department's 5150 policy through staff huddles. When asked if there was any other education provided, the DPSRM stated no. When asked if there was any auditing of ED staff interactions with 5150 patients after the provided education, either via direct observation or chart review, the DPSRM stated no.

During a concurrent interview and document review on 6/10/21 at 3:57 p.m. with the DPSRM, the DPSRM provided the hospital's policy and procedure, Patient Awaiting Psychiatric Evaluation in the Emergency Department, approved 01/22/2020. The DPSRM stated the previous ED director, who was the director at the time of the adverse patient event, modified the policy and then educated the ED staff in huddles. When asked if there were huddle minutes, the DPSRM stated no. When asked if there was documentation of which staff attended the huddles, the DPSRM stated no and that should have happened. When asked if there was a quiz or method of validation after the huddles, the DPSRM stated he was not aware of any. When asked, without validation, how the hospital would know if its staff education was effective, the DPSRM stated he understood the need for tracking.

During an interview on 6/14/21 at 11:19 a.m. with Registered Nurse F (RN F), RN F stated there are no sign-in sheets during staff huddles.

During a concurrent interview and document review on 6/11/21 at 4:00 p.m. with the DPSRM, the DPSRM showed the Emergency Department SEA summary. The summary revealed the action plan for each of the three root causes was to modify the department's policy to guide staff on what to do when patients refuse to surrender personal items. The summary revealed the action plan's measure of success (MOS) was the completion of updates to the policy, and the MOS monitoring period was the distribution of the updated policy to ED staff.

During a concurrent interview and document review on 6/10/21 at 4:31 p.m. with the DPSRM, the DPSRM showed the Emergency Department SEA summary. The DPSRM stated the distribution of the updated policy to ED staff referred to the education that took place during the staff huddle.

During an interview on 6/11/21 at 3:43 p.m. with the DPSRM and Registered Nurse C (RN C), RN C recalled the previous ED director providing education in a staff huddle after the ED patient adverse event. RN C stated the previous ED director told staff that all patients need their belongings removed and that patients need to wear paper scrubs. However, RN C stated it still was not clear what and how many personal items 5150 patients can keep with them. RN C also stated sometimes 5150 patients are allowed to lock the door while using the bathroom. RN C stated the ED staff needs more training about behavioral health patients. RN C stated some patients keep their mobile phone chargers with them, which can be used to harm themselves. When asked if there was any discussion about formal re-education of ED staff regarding 5150 patients after the patient adverse event, the DPSRM stated no, not that he was aware of.

During a concurrent interview and document review on 6/14/21 at 9:32 a.m. with the DPSRM, the DPSRM showed the Emergency Department SEA summary. The DPSRM stated that all three root causes related to issues with staff knowledge, and that was why the previous ED director modified the department's 5150 policy and conducted staff huddles associated with the updated policy. When asked how the hospital was going to monitor the effectiveness and sustainability of the SEA action plan, the DPSRM stated we saw it as education provided or not and that he did not really have a good answer. The DPSRM stated there was no formal re-education of staff about 5150 patients, and that the hospital's online training program would have been a good platform for that. The DPSRM stated theoretically, beyond the huddles, they could have looked at monitoring. The DPSRM stated no sustainability process was built into the ED SEA action plan.

During a review of the hospital's policy and procedure, Serious Safety Event Identification, Notification and Management, approved 1/27/2021, indicated the hospital ... will utilize this policy following identification of a patient serious safety event ... to ... Implement established actions ... Monitor implementation, effectiveness and sustainability of actions ... Act when monitoring indicates actions are not effective and/or sustained ....

2. During an interview on 6/8/21 at 8:27 a.m. with the Regulatory and Accreditation Manager (RAM), the RAM stated the hospital's root cause analyses (method used to analyze adverse events, which focuses on identifying underlying problems that increase likelihood of errors) are called serious event analyses (SEA).

During an interview on 6/10/21 at 10:14 a.m. with the Director of Patient Safety and Risk Management (DPSRM), the DPSRM reviewed the SEA for an October 2020 adverse patient event in the inpatient psychiatry unit. The DPSRM stated a patient under a 5150 hold (a hold placed when a patient is a danger to self, others, or gravely disabled) was inappropriately discharged and harmed himself with an object in his possession while waiting for transportation. The DPSRM stated, after the adverse event, the inpatient psychiatry unit staff underwent education about the department's 5150 policy and a Skills Day.

During a concurrent interview and document review on 6/11/21 at 10:37 a.m. with the Director of Behavioral Health (DBH), the DBH reviewed the inpatient psychiatry adverse patient event. The DBH stated the patient was inappropriately discharged . The DBH stated, after the adverse event, the department completed training for staff on how to discharge patients.

During a concurrent interview and document review on 6/10/21 at 3:57 p.m. with the DPSRM, the DPSRM provided a document containing an emailed agenda and tests from the Skills Day. The email, dated 12/1/2020, instructed staff to log into the online Skills Day on 12/1/2020. The agenda included a review of the 5150 policy, a workflow for discharges, and a post-test.

During a concurrent interview and document review on 6/14/21 at 9:32 a.m. with the DPSRM, the DPSRM showed the inpatient psychiatry SEA summary. The summary revealed two root causes. When asked if there was concern about staff knowledge of 5150 patients, the DPSRM stated yes, that this type of adverse event could happen again so the hospital wanted to make sure staff did not deviate from normalized processes. When asked if there was any auditing of staff, either via direct observation or chart review, after the Skills Day, the DPSRM stated no. The DPSRM stated the Skills Day was the completion of the SEA action plan, after which there were no other monitoring plans included in the SEA.

During a concurrent interview and document review on 6/11/21 at 2:33 p.m. with the DPSRM and the DBH, the DBH stated he has been performing chart review of ten randomly selected patient charts every month since November 2020. When asked if there is data from the chart review, the DBH stated he reviews the data monthly and sends it to corporate but has not formally compiled it. The DBH stated he also directly observed a subset of physician discharges in December 2020 and January 2021. When asked if there is data for the physician discharges, the DBH stated no. The DBH stated he started the chart review and direct observations outside of the SEA action plan, and that he had not sent his chart review data to the hospital's Quality Department or the Quality Improvement Committee. The DPSRM confirmed the chart review and direct observation of physician discharges were not on the inpatient psychiatry SEA summary.

During an interview on 6/14/21 at 10:34 a.m. with the DBH, the DBH stated the chart review tool he used did not contain questions specifically related to staff interactions with 5150 patients. When asked if, as part of the SEA process itself, there was any auditing of staff after the Skills Day, the DBH stated no.

During a review of the hospital's policy and procedure, Serious Safety Event Identification, Notification and Management, approved 1/27/2021, indicated the hospital ... will utilize this policy following identification of a patient serious safety event ... to ... Implement established actions ... Monitor implementation, effectiveness and sustainability of actions ... Act when monitoring indicates actions are not effective and/or sustained ....

3. During an interview on 6/8/21 at 8:27 a.m. with the Regulatory and Accreditation Manager (RAM), the RAM stated the hospital's root cause analyses (method used to analyze adverse events, which focuses on identifying underlying problems that increase likelihood of errors) are called serious event analyses (SEA).

During an interview on 6/10/21 at 10:14 a.m. with the Director of Patient Safety and Risk Management (DPSRM), the DPSRM reviewed the SEA for an October 2020 adverse patient event in the Emergency Department (ED). The DPSRM stated a suicidal patient under a 5150 hold (a hold placed when a patient is a danger to self, others, or gravely disabled) harmed herself with a clothing item while alone in the bathroom. The DPSRM stated staff had opened the bathroom door to check on the patient every ten seconds. The DPSRM stated one root cause was staff feeling uncomfortable with taking the patient's belongings and clothing and putting the patient in a paper gown.

During a concurrent interview and document review on 6/14/21 at 9:32 a.m. with the DPSRM, the DPSRM showed the Emergency Department SEA summary. The DPSRM stated that all three root causes related to issues with staff knowledge.

During an interview on 6/11/21 at 3:43 p.m. with the DPSRM and Registered Nurse C, RN C recalled the previous ED director providing education in a staff huddle after the ED patient adverse event. RN C stated the ED director told staff that all patients need their belongings removed and that patients need to wear paper scrubs. However, RN C stated it still was not clear what and how many personal items 5150 patients can keep with them. RN C also stated sometimes 5150 patients are allowed to lock the door while using the bathroom. RN C stated the ED staff needs more training about behavioral health patients. RN C stated some patients keep their mobile phone chargers with them, which can be used to harm themselves.

During a concurrent interview and document review on 6/11/21 at 4:00 p.m. with the DPSRM, the DPSRM showed the Emergency Department SEA summary. There was no discussion about rolling out the action plan to other areas of the hospital at risk for similar events.

During an interview on 6/10/21 at 10:14 a.m. with the DPSRM, the DPSRM reviewed the SEA for an October 2020 adverse patient event in the inpatient psychiatry unit. The DPSRM stated a patient under a 5150 hold was inappropriately discharged and harmed himself with an object in his possession while waiting for transportation.

During a concurrent interview and document review on 6/14/21 at 9:32 a.m. with the DPSRM, the DPSRM showed the inpatient psychiatry SEA summary. The summary revealed two root causes. When asked if there was concern about staff knowledge of 5150 patients, the DPSRM stated yes, that this type of adverse event could happen again so the hospital wanted to make sure staff did not deviate from normalized processes.

During a concurrent interview and document review on 6/14/21 at 9:32 a.m. with the DPSRM, the DPSRM showed the inpatient psychiatry SEA summary. There was no discussion about rolling out the action plan to other areas of the hospital at risk for similar events.

During an interview on 6/10/21 at 3:57 p.m. with the DPSRM, when asked if the learning from the Emergency Department and the inpatient psychiatry adverse patient events was extended to staff in other departments, the DPSRM stated no, the education was mainly focused on these two departments.

During an interview on 6/10/21 at 10:14 a.m. with the DPSRM, when asked if 5150 patients are admitted to areas of the hospital besides the inpatient psychiatry unit, the DPSRM stated yes.

During an interview on 6/11/21 at 12:06 p.m. with the Manager of the Neurosurgical Intensive Care Unit (MNSICU), the MNSICU confirmed that patients under a 5150 hold can be admitted to inpatient rooms located in units other than the inpatient psychiatry unit.

During an interview on 6/11/21 at 3:43 p.m. with the DPSRM, when asked if there was any discussion about other departments and their staff being at risk for similar adverse events with 5150 patients, and whether the learning should be expanded to those departments, the DPSRM stated no. When asked if the ED and inpatient psychiatry patient adverse events both relate to staff interactions with 5150 patients, the DPSRM stated yes.

During a review of the hospital's policy and procedure, Serious Safety Event Identification, Notification and Management, approved 1/27/2021, indicated for patient serious safety events that ... Feedback to the organization as a whole is also essential to create a culture of safety and shared learning ....

4. During an interview on 6/11/21 at 11:20 a.m. with the Director of the Intensive Care Unit (DICU), the DICU stated intensive care unit patients are classified by acuity levels from level one to level four. The DICU stated there is a ratio of one nurse to two patients for level one through level three patients, and a ratio of one nurse to one patient for level four patients.

During a concurrent interview and record review on 6/9/21 at 8:33 a.m. with the Manager of the Neurosurgical Intensive Care Unit (MNSICU), the Neurosurgical Intensive Care Unit (NSICU) nursing staff assignment sheets were reviewed. The assignment sheets revealed one nurse was assigned three patients on 4/12/21 between 11:00 a.m. and 3:00 p.m.; two nurses were each assigned three patients on 5/4/21 between 3:00 p.m. and 7:00 p.m.; three nurses were each assigned three patients on 5/5/21 between 7:00 a.m. and 11:00 a.m.; two nurses were each assigned three patients on 5/5/21 between 11:00 a.m. and 7:00 p.m.; one nurse was assigned three patients on 5/9/21 between 3:00 p.m. and 7:00 p.m.; two nurses were each assigned three patients on 5/9/21 between 7:00 p.m. and 11:00 p.m.; and three nurses were each assigned three patients on 5/10/21 between 7:00 a.m. and 11:00 a.m. The MNSICU acknowledged the nurse-to-patient ratios were one nurse to three patients in the NSICU on 4/12/21, 5/4/21, 5/5/21, 5/9/21, and 5/10/21.

During a concurrent interview and record review on 6/9/21 at 11:55 a.m. with the DICU, the Cardiovascular Intensive Care Unit (CVICU) nursing staff assignment sheets were reviewed. The assignment sheets revealed three nurses were each assigned three patients on 5/5/21 between 7:00 a.m. and 11:30 a.m., and one nurse was assigned three patients on 5/7/21 between 7:00 a.m. and 11:30 a.m. The DICU acknowledged the nurse-to-patient ratios were one nurse to three patients in the CVICU on 5/5/21 and 5/7/21.

During an interview on 6/14/21 at 2:29 p.m. with the Chief Nursing Officer (CNO), the CNO stated the hospital utilizes employed nurses, registry nurses, and traveler nurses for staffing. The CNO stated the hospital has a registry nurse group that provides registry nurses and traveler nurses. The CNO stated the house supervisors meet with the nurse leaders of each unit every four hours to discuss staffing. The CNO stated the house supervisors may request staffing from the registry nurse group at any time. The CNO stated if the nurse leader cannot find staffing for an upcoming shift, the issue is escalated to the unit manager, then the unit director, then to her as CNO.

When asked if she was aware there were nurses caring for more patients than allowed by state nurse-to-patient ratios on 4/12/21 in the NSICU, the CNO stated yes. When asked what actions were taken when the nurses were out-of-ratio, the CNO stated the hospital called employed nurses and its registry nurse group to obtain more nurses, evaluated if any patients could be downgraded from the intensive care units (ICU), and evaluated if the hospital could close the ICU to incoming transfers or surgeries.

When asked if she was aware there were nurses caring for more patients than allowed by state nurse-to-patient ratios on 5/4/21 in the NSICU, the CNO stated yes. When asked what actions were taken when the nurses were out-of-ratio, the CNO stated the hospital looked at ways to obtain more traveler nurses and more rapidly.

When asked what actions were taken when the nurses were out-of-ratio in the CVICU on 5/5/21, the CNO stated the hospital pulled nurses from other patient care units. The CNO stated that after each out-of-ratio occurrence, her actions were the same calling in employed nurses, requesting registry and traveler nurses, downgrading patients, and evaluating surgery schedules. When asked what other actions were taken, the CNO stated the hospital has hired new staff and partnered with nursing schools to get nurses in. The CNO stated the hospital did not pivot quickly enough and thus was out-of-ratio on the previously mentioned days.

When asked what actions the hospital took to prevent out-of-ratio occurrences from repeating, the CNO stated the hospital has a safety huddle every day, during which all managers, directors, and the executive team discuss staffing. When asked if there are meeting minutes for the executive team meetings, the CNO stated not since the previous Chief Executive Officer departed.

When asked if the hospital has any protocols or guidelines for out-of-ratio occurrences, the CNO stated only its strategies to pivot. When asked if out-of-ratio occurrences or staffing issues were discussed beyond the executive team, the CNO stated she has given verbal reports to the Medical Executive Committee (MEC) and the Board of Trustees about staffing and what the hospital is doing to obtain more nurses. The CNO stated she did not recall bringing up specific out-of-ratio occurrences to either the MEC or the Board of Trustees.

During an interview on 6/14/21 at 4:47 p.m. with the CNO and the Regulatory and Accreditation Manager (RAM), the CNO stated there was no documentation of any discussions or actions the executive team took to address the out-of-ratio occurrences. When asked if there was any evidence of actions taken at a systems level, the CNO stated there was no documentation. The CNO stated the executive team looked at the surgery schedule to see which surgeries could be cancelled, but she did not hear which cases were cancelled. The CNO stated the hospital did not have any guidelines outlining what to do when nurses are out-of-ratio. When asked if the hospital modified its strategies or action plan when out-of-ratio events occurred, the CNO stated she is evaluating strategies to see what did and did not work, and has requested more traveler nurses.

During a concurrent interview and record review on 6/9/21 at 8:33 a.m. with the MNSICU, NSICU patient records were reviewed. One registered nurse (RN), assigned to three patients on 5/5/21, missed patient assessments for Patient 9, Patient 11, and Patient 12. One RN, assigned to three patients on 5/5/21, missed patient assessments for Patient 19. One RN, assigned to three patients on 5/9/21, missed patient assessments for Patient 9 and Patient 20. One RN, assigned to three patients on 5/9/21, missed patient assessments for Patient 10, Patient 17, and Patient 18. One RN, assigned to three patients on 5/10/21, missed patient assessments for Patient 9, Patient 19, and Patient 20. One RN, assigned to three patients on 5/10/21, missed patient assessments for Patient 14, Patient 21, and Patient 22.

During a concurrent interview and record review on 6/10/21 at 1:00 p.m. with the MNSICU, NSICU patient records were reviewed. One RN, assigned to three patients on 5/5/21, did not titrate Patient 8's nicardipine (a medication that lowers blood pressure) infusion as ordered by the physician, or notify a provider when the infusion was at zero milligrams/hour as ordered by the physician. One RN, assigned to three patients on 5/4/21 and on 5/5/21, did not document Patient 12's heart rate and blood pressure according to the physician order while Patient 12 was on an amiodarone (a medication used to treat abnormal heart rhythms) infusion. One RN, assigned to three patients on 5/5/21, did not document Patient 19's pain level according to the physician order while Patient 19 was on a fentanyl (a pain medication) infusion. One RN, assigned to three patients on 5/9/21, administered acetaminophen (a medication used to treat pain or fever) to Patient 20 for pain when the physician order, dated 5/8/21, indicated acetaminophen was to be administered as needed for temperature greater than 99 degrees Fahrenheit.

During a review of QIC meeting minutes for 11/5/2020, indicated concern was expressed that issues with staffing were impacting safe quality of care.

During a review of QIC meeting minutes for 5/6/2021, revealed concern that there were not enough nurses to take care of patients in the intensive care units and other units. Issues with two specific patients were brought up. A concern was also expressed that the transfer center should not accept additional patients because the hospital, due to significant staffing issues, did not have the capacity to care for them.

During a review of the Board of Trustees meeting minutes for 1/27/2021, 3/24/2021, 4/28/2021, and 5/26/2021, indicated nurse recruitment and retention strategies were discussed. There was no discussion about specific out-of-ratio occurrences or negative patient outcomes related to short-staffing.

During a concurrent interview and document review on 6/14/21 at 4:47 p.m. with the CNO and the RAM, the CNO stated she was not aware of multiple patient assessments being missed and medications not being administered according to physician orders while nurses were out-of-ratio. When asked if anyone assesses for potential patient care issues when there are out-of-ratio occurrences, the CNO stated her expectation is the nursing unit leaders would tell her if there were any concerns. The CNO stated there is no system in place to evaluate the nursing care provided during out-of-ratio shifts.

When asked if the missed patient assessments or medication administration outcomes, or the potential for negative patient care outcomes, were brought up to the QIC, the MEC, or the Board of Trustees, the CNO stated she was not aware of these outcomes so she did not bring them up at these committee meetings. The CNO stated these negative patient care outcomes should have been brought up.

The CNO stated when staffing issues were brought up at QIC meetings, she discussed open nurse positions and strategies to get more nurses. The CNO confirmed she was present at the 5/6/2021 QIC meeting. When asked if there was any further discussion about the staffing-related patient care concerns, the CNO stated there was no further discussion during or after the 5/6/2021 QIC meeting.

During a concurrent interview and document review on 6/14/21 at 5:43 p.m. with the CNO, the CNO stated she did not follow-up regarding the staffing-related patient care concerns brought up at the 5/6/2021 QIC meeting. When asked if she brought up these patient care concerns to the MEC or the Board of Trustees, the CNO stated no, she only talked about open nurse positions and strategies to mitigate the hospital's staffing shortage. When asked if the potential for negative patient care outcomes and actual negative patient care outcomes related to staffing shortages were issues the MEC and the Board of Trustees should know about, the CNO stated yes.

During a review of the hospital's Organizational Performance Improvement Plan 2021, approved 02/24/2021, revealed Quality Improvement Committee members ... Oversee and coordinate evaluation of all patient care and patient safety related activities hospital wide ... Reviewing data including ongoing indicators/trends ... Ensuring data is ... analyzed on an ongoing basis by trending of data ... Ensuring information from data is used to make changes that improve performance and patient safety and reduce risk of sentinel events ....

During a review of the hospital's Bylaws Governing the Board of Trustees, reviewed 11/19, Article 6.7 revealed ... The Board is ultimately responsible for the quality of patient care and services provided by the Hospital ... At least annually, a report to the Board shall be present [sic] regarding the occurrence of medical/healthcare errors and actions taken to improve patient safety, both in response to actual occurrences and proactively ... The Board shall oversee the activities to improve organization performance and patient safety to ensure that actions are taken appropriate to findings and that the outcomes of such actions are documented ....

Based on interview and record review, the hospital failed to inform the governing body about two contracted services during the annual contract review. This deficient practice resulted in the governing body being unable to evaluate whether the contracted services were provided in a safe and effective manner to patients.

Findings:

During a review of the hospital's List of Contracts (2020), undated, revealed 375 contracts but did not include the medical gas contract or the elevator contract.

During a review of the Quality Improvement Committee meeting minutes for 11/5/20, indicated 375 contracted services were discussed.

During a review of the Board of Trustees meeting minutes for 11/18/2020, revealed the annual review of physician and services contracts was presented to the governing body, with the number of contracted services documented as 375.

During a review of the medical gas contract, effective 1/15/19, indicated the hospital was on the list of existing medical gas purchasers. During a review of the elevator contract, effective 11/1/2016 and expiring 10/31/21, indicated the hospital was on the list of purchasing facilities.

During an interview on 6/9/21 at 2:14 p.m. with the Vice President of Operations (VPOP), the VPOP stated the hospital's typical procedure is to evaluate contracts annually. The VPOP stated all contracts on the List of Contracts (2020) undergo annual evaluations by the hospital.

During a concurrent interview and document review on 6/9/21 at 9:33 a.m. with the VPOP, the VPOP confirmed the medical gas contract was not on the List of Contracts (2020) because it was a contract maintained by corporate. The VPOP stated the medical gas contract was not included in contract evaluation presentations to the Quality Improvement Committee or the Board of Trustees. When asked how the governing body would know if the medical gas vendor was performing to a satisfactory level, the VPOP stated we would let them know if there were issues. The VPOP stated the hospital's corporate-maintained contracts are not downloaded onto the List of Contracts (2020). When asked how the hospital knows which corporate-maintained contracts are relevant to the hospital, the VPOP stated the corporate office tells them. The VPOP stated corporate performs the medical gas contract evaluation and asks for feedback from the hospital. When asked if the hospital receives the medical gas contract evaluation from corporate, the VPOP stated no, the hospital just receives information if there are any vendor issues with other corporate-owned facilities. When asked if the hospital's governing body receives any information about the medical gas contract evaluation from corporate, the VPOP stated only if there are issues.

During a concurrent interview and document review on 6/9/21 at 12:09 p.m. with the VPOP, the VPOP confirmed the List of Contracts (2020) was the list of all hospital contracts with evaluations. When asked if the hospital has a way to access the corporate evaluation of the medical gas vendor, the VPOP stated no.

During a concurrent interview and document review on 6/9/21 at 1:35 p.m. with the VPOP, the VPOP confirmed the elevator contract was not on the List of Contracts (2020) because it was a contract maintained by corporate. The VPOP stated the elevator contract has not undergone formal annual contract evaluations at the hospital level, and the elevator contract has only been discussed with the governing body if an issue affecting patient care came up. When asked if there was a way to find out what other corporate-maintained contracts are clinically relevant to the hospital, the VPOP stated it would be very time-consuming and he did not have that information right now.

During a review of the hospital's Bylaws Governing the Board of Trustees, reviewed 11/19, Article 6.6.2 revealed ... The Board shall ensure that contracted services are performed safely and effectively through implementation of the performance improvement program ....

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 at 1:2 or fewer at all times in the intensive care units (refer to A-0392).

2. Failure to provide charge nurses every shift in each unit (refer to A-0392).

3. Failure to provide unexpired supplies (refer to A-0392 and A-0398).

4. Failure to keep a refrigerator within the acceptable temperatures (refer to A-0392).

5. Failure to designate outpatient nursing staff for outpatient services (refer to A-0392).

6. Failure to validate nursing staff's competency prior to providing care (refer to A-0397).

7. Failure to provide a sitter (refer to A-0392).

9. Failure to assess patients and document the assessment (refer to A-0398).

10. Failure to inspect emergency crash carts (refer to A-0398).

11. Failure to administer medications as ordered (refer to A-0405).

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 adequate nursing staff when:

1. Nurse-to-patient ratios exceeded 1:2 (ratio of one nurse to two patients) for five occurrences in the Neurosurgical Intensive Care Unit (NSICU) and two occurrences in the Cardiovascular Intensive Care Unit (CVICU).

2. Charge nurses were lacking for two out of 30 days in the CVICU, four out of 30 days in the NSICU, two out of 30 days in the Emergency Department, and once in the Labor and Delivery (L&D) unit.

3. Medications were not administered as ordered for four patients (Patients 8, 12, 19, and 20) when the nurse-to-patient ratios exceeded 1:2 (ratio of one nurse to two patients) in the NSICU.

4. In the Pediatric Unit (PED) and Pediatric Intensive Care Unit (PICU), patients were placed in the PICU regardless of their acuity, outpatients (patients who receive medical treatment without being admitted into a hospital) were placed in the PICU, and inpatient nurses provided outpatient services. One charge nurse was assigned to both units and, occasionally, charge nurses were unavailable.

5. In the Neonatal Intensive Care Unit (NICU), suction canisters were not changed because a unit technician was unavailable. The temperatures of a breast milk refrigerator were recorded out of acceptable ranges but no further actions were taken.

6. In the Telemetry unit, a sitter was unavailable when a patient required a sitter.

7. In the Labor and Delivery (L&D) unit, two nurses were unassigned to a patient.

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

Findings:

1. Review of nursing staff assignment sheets, with the Manager of Neurosurgical Intensive Care Unit (MNSICU), on 6/9/21 at 8:33 a.m., indicated there were nurse-to-patient ratios of one nurse to three patients on the NSICU:

a. On 4/12/21, from 11 a.m. to 3 p.m., one bedside nurse had three assigned patients.

b. On 5/4/21, from 3 p.m. to 7 p.m., two bedside nurses had three assigned patients each.

c. On 5/5/21, from 7 a.m. to 11 a.m., three bedside nurses had three assigned patients each; and, from 11 a.m. to 7 p.m., two bedside nurses had three assigned patients each.

d. On 5/9/21, from 3 p.m. to 7 p.m., one bedside nurse had three assigned patients; and, from 7 p.m. to 11 p.m., two nurses had three assigned patients each.

e. On 5/10/21, from 7 a.m. to 11 a.m., three bedside nurses had three assigned patients each.

During concurrent interview, the MNSICU acknowledged there were nurse-to-patient ratios of one nurse to three patients on the NSICU for those 5 days.

Review of nursing staff assignment sheets with the ICU Director (DICU), on 6/9/2021 at 11:55 a.m., indicated the following periods when there were nurse-to-patient ratios of one nurse to three patients in the CVICU:

a. On 5/5/2021, from 7 a.m. to 11:30 a.m., three bedside nurses had three assigned patients each.

b. On 5/7/2021, from 7 a.m. to 11:30 a.m., one bedside nurse had three assigned patients.

During concurrent interview with the ICU Director, she acknowledged the two time periods in May 2021 when there were nurse-to-patient ratios of one nurse to three patients on the CVICU.

During an interview with the ICU Director, on 6/11/2021 at 11:20 a.m., she stated ICU patients were classified by acuity levels from 1 to 4. She stated Level 1 to level 3 patients could have nurse-to-patient ratios of 1:2, and Level 4 patients would have a nurse-to-patient ratio of 1:1.

Review of the Administrative Services Policy Manual, dated 2/24/2016, regarding the hospital's ICUs indicated, Patients are assigned a nurse patient ratio of 1:1 or 1:2 depending on patient acuity, the California Nurse Staffing Ratio Regulation...

Review of the 2013 California Code of Regulations, Title 22, º (a)(1) indicated, The licensed nurse-to-patient ratio in a critical care unit shall be 1:2 or fewer at all times. Critical care unit means a nursing unit of a general acute care hospital which provides one of the following services: an intensive care service...

Review of nursing staff assignment sheets with the NSICU Manager (MNSICU), on 6/11/2021 at 3:40 p.m., indicated the following time periods were without charge nurses present in the NSICU: 5/3/2021 from 3 p.m. to 7 p.m., 5/4/2021 from 3 p.m. to 11 p.m., 5/8/2021 from 3 p.m. to 7 p.m., and 5/9/2021 from 3 p.m. to 11 p.m.

During concurrent interview with the NSICU Manager, she acknowledged the four time periods in May 2021 that the NSICU lacked charge nurses and that there should have been charge nurses present.

Review of nursing staff assignment sheets with the ICU Director, on 6/14/2021 at 9:37 a.m., indicated the following were time periods without charge nurses present in the CVICU: 5/4/2021 from 11 p.m. to 7 a.m. and 5/30/2021 from 7 a.m. to 11 a.m.

During concurrent interview with the ICU Director, she acknowledged the two time periods in May 2021 that lacked charge nurses on the CVICU and that there should have been charge nurses present.

a. Review of the emergency department staffing sheets, with the nurse manager emergency department (NMED), on 6/8/2021 at 2:30 p.m., indicated the following time periods were without charge nurses present: 5/26/2021 3 a.m. to 7 a.m. and 5/27/2021 from 3 a.m. to 7 a.m.

During a concurrent interview with the NMED, she acknowledged the two time periods in May 2021 that lacked charge nurses in the ED.

b. Review of L&D's nursing staff assignment, for the evening shift, dated 6/12/2021, indicated there was no charge nurse assigned.

During an interview, on 6/14/2021, at 11:30 a.m., RN L stated on 6/12/2021, four nurses were scheduled for the evening shift and there was no charge nurse in the unit. All efforts failed to find a charge nurse for the evening shift and the LD manger refused to come in to work as the charge nurse. RN M stated from 3:00 p.m. until 7:00 p.m. no nurse was available to function as a charge nurse in the L&D unit.

Review of the Administrative Services Policy Manual, dated 2/24/2016, indicated, Charge Nurses are scheduled each shift to coordinate the care of the patient population, monitor and coordinate unit operations, assess staffing needs for current census/acuity as well as the needs of the oncoming shift.

3. During a record review and concurrent interview with Manager of Neurosurgical Intensive Care Unit (MNSICU) on 6/10/21 at 1 p.m., the following were identified:

a. Review of Daily Staffing Sheet NSICU, dated 5/5/21, from 7 a.m. to 7 p.m., indicated three patients, including Patient 8, were assigned to one registered nurse (RN).

Review of Patient 8's Consultation Note, dated 4/30/21, indicated the patient presented with left-sided weakness and altered mental status ..., ...on CT of the head, the patient was noted to have an acute hemorrhage [bleeding an escape of blood from a ruptured blood vessel]..., and CT angiogram [a computed tomography technique used to visualize arterial and venous vessels] of the head and neck showed ...aneurysm [an excessive localized enlargement of an artery caused by a weakening of the artery wall]... It indicated the plan was Treatment of hypertensive emergency to systolic blood pressure [SBP, the force of the blood against artery walls when the heart beats] less than 140 mmHg [millimeters of mercury, a measurement of pressure].

Review of Patient 8's physician's order, dated 4/30/21, indicated Nicardipine (antihypertensive drug) to initiate at 5 milligrams per hour (mg/hr), titrate (dose changes based on patient response) up and down by 2.5 mg/hr every 5 minutes, maintain SBP less than 140 mmHg or Diastolic blood pressure (DBP, the pressure of the blood against artery walls while the heart is resting) less than 90 mmHg. The maximum rate was 15 mg/hr and the maintain goal was for 20 minutes, then titrate down to lowest rate that maintained the goal. If the drip was at zero rate, notify a provider immediately if the drip needed to be titrated up.

Review of Patient 8's electronic medication administration record (eMAR), dated 5/5/21, indicated, at 10 a.m., Nicardipine was administered at 5 mg/hr and at 1:30 p.m., it was down to zero, instead of 2.5 mg/hr. There was no evidence a provider was notified.

Review of Patient 8's blood pressure records and eMAR, dated 5/5/21, indicated the patient's blood pressure was 143/66 mmHg at 7:30 a.m., 155/80 mmHg at 8 a.m., 146/65 mmHg at 9 a.m., 152/64 mmHg at 9:16 a.m., 146/65 mmHg at 9:30 a.m., 148/67 mmHg at 9:45 a.m., and 156/65 at 10:15 a.m. There was no evidence Patient 8's Nicardipine was increased as ordered to maintain the patient's SBP less than 140 mmHg.

During a concurrent interview, MNSICU stated Patient 8's Nicardipine was not administered and titrated as ordered. She stated the dose should be down by 2.5 mg/hr, the nurse should have notified a provider when the medication was discontinued, and Nicardipine should be increased when the patient SBP was checked more than 140 mmHg.

b. Review of Daily Staffing Sheet NSICU, dated 5/4/21, from 3 p.m. to 7 p.m. and 5/5/21 from 7 a.m. to 7 p.m., indicated three patients, including Patient 12, were assigned to one RN.

Review of Patient 12's physician order, dated 5/3/21, indicated Amiodarone IV to infuse at 1 mg/min for 6 hours and 0.5 mg for 18 hours. It indicated the medication was started on 5/3/21 at 5:08 p.m. and stopped on 5/4/21 at 5:29 p.m. The order included to document the patient's heart rate (HR) and blood pressure (BP) per standard vital sign routine.

Review of Patient 12's Blood Pressure, dated 5/4/21 indicated the BP was 169/72 mmHg at 5 a.m. and 128/61 mmHg at 7 p.m. There was no other BPs or HRs documented between 5 a.m. and 7 p.m. while the patient was on Amiodarone.

Review of Patient 12's other Amiodarone order, dated 5/5/21, indicated to infuse Amiodarone at 1mg/min.

Review of Patient 12's eMAR indicated it was started on 5/5/21 at 3 p.m. and discontinued on 5/6/21 at 8:05 a.m.

Review of Patient 12's Blood Pressure, dated 5/5/21, indicated the patient's BP was checked at 6 a.m. and the following documented BP was at 8:17 p.m. There were no documented BP and HR on 5/5/21, from 3 p.m. to 8 p.m.

During a concurrent interview, MNSICU stated Patient 12's BP and HR should be monitored at least every 2 hours and there was no evidence the patient's BP and HR were monitored on 5/4/21, from 5 a.m. to 7 p.m. and on 5/5/21, from 3 p.m. to 8 p.m., while the patient was on Amiodarone.

c. Review of Daily Staffing Sheet NSICU, dated 5/5/21 from 7 a.m. to 7 p.m., indicated three patients, including Patient 19, were assigned to one RN.

Review of Patient 19's physician's order, dated 5/5/21, indicated Fentanyl IV 10 micrograms/hours (mcg/hr) to maintain pain scale (a pain scale measures pain on a scale of 0-10. 0 means no pain and 10 means the worst possible pain) less than 3. It indicated to titrate up and down by 10 mcg/hr every 60 minutes then, titrate to down to lowest rate that maintained the goal.

Review of Patient 19's IV Drip Status indicated the patient's Fentanyl IV was initiated on 5/5/21 at 2:26 p.m., and discontinued on 5/10/21 at 9:50 p.m.

Review of Patient 19's IV Drip Status and Pain assessment indicated on 5/5/21, there were no rate changes at 3 p.m. and 5 p.m. but there was no documented evidence the patient's pain was assessed to determine whether the pain scale met the goal and/or the titration was required.

During a concurrent interview, MNSICU stated Patient 19's pain was not assessed every hour while the patient was on Fentanyl.

d. Review of Daily Staffing Sheet NSICU, dated 5/9/21 from 3 p.m. to 7 p.m., indicated three patients, including Patient 20, were assigned to one RN.

Review of Patient 20's physician order, dated 5/8/21, indicated Acetaminophen 650 mg by oral as needed when the temperature was greater than 99¦F.

Review of Patient 20's eMAR, dated on 5/9/21 at 3:25 p.m., indicated Acetaminophen was administered for 5 of 10 pain on the head and neck and there was no documented evidence that the patient's pain was reassessed after the medication was administered.

During a concurrent interview, MNSICU stated Patient 20's Acetaminophen was ordered for fever and the medication was administered for pain, an inappropriate indication and the nurse should have called the physician to get a new order for pain. She stated after administering a pain medication, the nurse should have reassessed the patient's pain to determine whether the intervention was effective. She stated medications should be administered as ordered.

During a telephone interview on 6/13/21 at 11 a.m., registered nurse I (RN I) stated when she was assigned to three patients, she did not have enough time to document the necessary assessment for the IV titration.

During a telephone interview on 6/13/21 at 1 p.m., registered nurse J (RN J) stated when she was assigned to three patients, she could not titrate the medication as ordered. She stated she titrated the patient's IV medication when she was able to assess the patient. She further stated she could miss documenting of the titration she performed because she did not have time to document during her shift.

4. During an interview on 6/11/21 at 10:35 p.m., the manager of pediatric department (MPD) stated the hospital has 4 licensed pediatric intensive care (PICU) beds, in Rooms 179, 180, 181, and 182, and 17 licensed pediatric (PED) beds. She stated one charge nurse is assigned to two units, PICU and PED units.

During a record review and concurrent interview, on 6/14/21 at 11:06 a.m., with registered nurse L (RN L) and the manager of children services (MCS), the following were identified:

Review of PICU ASSIGNMENT SHEET, dated 2/24/21, indicated at 2:30 p.m. two patients' acuity status, in Rooms 179 and 181, were changed from PICU to PED patients and they were remained in the same PICU beds, with the same nurse assigned. At the same time, an outpatient (a patient who receives medical treatment without being admitted to a hospital) was placed in Room 182, which was licensed for PICU bed, for infusion. A break nurse (break relief nurses are not assigned a patient load at the beginning of the shift, rather, they cover for nurses when the nurses are on their 15-minute morning break and hour-long lunch break) was assigned to the outpatient service.

Review of PICU ASSIGNMENT SHEET, dated 2/25/21, from 3:30 p.m. to 8:40 p.m., a charge nurse was assigned to an outpatient's infusion service, in Room 181, which was licensed for PICU, while there was a PICU patient in another room.

Review of PICU ASSIGNMENT SHEET, dated 4/6/21, indicated staffing for PICU and PED units were scheduled under one charge nurse assigned and two PED patients were placed in PICU, in Rooms 180 and 181. It indicated an outpatient was placed in Room 190, which was licensed for a PED bed, and an inpatient nurse provided outpatient infusion service, from 11:20 a.m. to 3:30 p.m.

Review of PICU ASSIGNMENT SHEET, dated 4/7/21, indicated a charge nurse, who was assigned for both PICU and PED units, was assigned to an outpatient baby for a car seat challenge (a way used to identify babies that might be at higher risk for problems, such as trouble breathing while in a semi-reclined position) from 11 a.m. to 1:20 p.m. It indicated the charge nurse was also assigned to a new pediatric patient at 11:20 a.m. and she sent the patient to an operating room at 1:20 p.m. It indicated two RNs were sent to the neonate intensive care unit (NICU) on that shift to help them, while the PICU charge nurse provided care for outpatient service and to a pediatric patient.

During a concurrent interview, MCS confirmed that the assignment of the car seat challenge was outpatient service and the care seat challenge required bed side monitoring.

During a concurrent interview, RN L stated she was unsure the exact date but, at the end of February 2021, two units, PICU and PED units, were combined for staffing, due to the low census. One charge nurse from the PICU was assigned for both units, and PED patients were placed in PICU.

Review of the 2013 California Code of Regulations, Title 22, º . Intensive Care Service definition indicated an intensive care service is a nursing unit in which there are specially trained nursing and supportive personnel and diagnostic, monitoring and therapeutic equipment necessary to provide specialized medical and nursing care to critically ill patients.

Review of the 2013 California Code of Regulations, Title 22, º . Pediatric Service definition indicated Pediatric service means the observation, diagnosis and treatment (including preventive treatment) of children and their illnesses, injuries, diseases and disorders by appropriate staff, space, equipment and supplies.

Review of the 2013 California Code of Regulations Title 22, º . Pediatric Service General Requirements indicated a pediatric nursing unit shall be provided if the hospital has eight or more licensed pediatric beds.

Review of the 2013 California Code of Regulations Title 22, º . Outpatient Service Staff indicated the outpatient service shall have a person designated to direct and coordinate the service.

Review of the 2013 California Code of Regulations Title 22, º . Outpatient Service Space indicated the number of examination and treatment rooms shall be adequate in relation to the volume and nature of work performed.

5. a. During an initial tour in the neonatal intensive care unit (NICU), with the manager of children services (MCS), on 6/7/21 at 10 a.m., in Room 1, including Beds 1-10, suction canisters (a temporary storage container that is used to collect body fluids or secretions from the patient from suctioning until it is disposed; suction canisters are usually attached to the wall of the patient's room or in close proximity to the patient's bed) were observed marked with Exp. [expired] 6/6/21.

During a concurrent interview, MCS stated a unit technician changes the suction canisters daily. On the previous day, no unit technician was working, and the suction canisters were not changed.

b. During review of the NICU Breast milk Refrigerator log, dated 6/6/21, for a breast milk refrigerator in Room 1, indicated the temperatures were recorded at 39.7¦F at 7:30 a.m. and 39.6¦F at 7:45 p.m.

Review of Sensor Alarm Report, dated 6/6/21 at 7:45 a.m., indicated the acceptable temperature ranged from 35¦F to 39¦F. It indicated the reason for the increased temperature was the opened door and the temperature was back within the range at 8:45 a.m.

During a review of the NICU Breast milk Refrigerator log, dated 6/6/21, indicated the temperatures were recorded in red: 39.2¦F at 2:45 p.m., 39.4¦F at 3 p.m., 39.1¦F at 3:15 p.m., 40.2¦F at 3:30 p.m., 39.9¦F at 3:45 p.m., 39,2¦F at 4 p.m., 39.3¦F at 4:15 p.m., 39.2¦F at 4:30 p.m., 39.1¦F at 4:45 p.m., 39.3¦F at 5 p.m., 39.3¦F at 5:15 p.m., 39.3¦F at 5:30 p.m., and 39.3¦F at 5:45 p.m.

During an interview on 6/11/21 at 2 p.m., MCS stated a unit clerk was in charge to monitor the temperature of the breast milk refrigerator. On 6/6/21, the unit clerk did not check, and there was no evidence any actions were taken for the unacceptable temperatures, from 2:45 p.m. to 5:45 p.m. MCS stated she receives automatic alert e-mails regarding the unacceptable temperatures but she could not check the e-mails because it occurred on Sunday.

6. Review of Patient 3's History and Physical (the initial clinical evaluation and examination of the patient), dated 5/10/21, indicated the patient had a history of alcoholism (an addiction to the consumption of alcoholic liquor or the mental illness and compulsive behavior resulting from alcohol dependency), tachycardia (an abnormally rapid heart rate), and hypertension (a disease where blood flows through the arteries at higher than normal pressure). On 5/7/21, the patient visited the hospital's emergency department due to acute alcohol withdrawal (symptoms that may occur when a person who has been drinking too much alcohol on a regular basis suddenly stops drinking alcohol) and hypertensive urgency (an acute, severe elevation in blood pressure without signs or symptoms of end-organ damage).

Review of Patient 3's physician order, dated 5/9/21 at 1:40 a.m., indicated the patient required a sitter.

During an interview with the Director of Cardiovascular Unit (DCVU) on 6/10/21 at 1:10 p.m., she confirmed Patient 3 had a physician's order for a sitter. Upon reviewing the nursing staff assignment sheets and nurses' notes, the DCVU stated there was no documentation indicating a sitter was provided from the time it was ordered. A staff monitoring form, Sitter/Suicide Precaution Observation Sheet, was also not completed. She acknowledged a sitter should have been provided as soon as possible after obtaining the order for patient safety, due to episodes of confusion and agitation.

During a telephone interview with registered nurse G (RN G) on 6/11/21 at 1:10 p.m., she stated she was assigned to take care of Patient 3, on 5/9/21 from 7 a.m. to 3 p.m. RN G confirmed there was no sitter assigned to Patient 3 during her shift.

Review of the hospital's policy, Close Observation/Sitter Approval and Assessment for Continuation, dated 3/27/19, indicated the goal is to provide an added level of surveillance for patients deemed appropriate for consistent bedside monitoring. A sitter works under the supervision of the registered nurse to provide a physical presence to a patient or patients who display at risk behaviors.

7. Review of Patient 24's Antepartum Progress Notes, dated 5/18/21, indicated the patient was a 34-weeks pregnant woman with the diagnoses of placenta (a structure implanted into the wall of the uterus [the hollow, pear-shaped organ in a woman's pelvis where an unborn baby develops and grows] that supply the baby with oxygen and nutrients) previa (a serious condition that the placenta partially or totally covers the mother's cervix [the outlet for the uterus]) and vaginal bleeding.

Review of L&D's nursing staff assignment sheet, dated 5/15/2021, with the director of woman's services (DWS), on 6/11/2021, at 10:30 a.m., indicated [Room A] Antepartum closed, but pt [patient] in room. [name of a nurse] agreed to stay over.

During an interview, on 6/8/2021, at 10:02 a.m., RN L stated Patient 24 had issues with noises and visitors in the L&D unit and the L&D manager decided to place the patient in Room A, in the antepartum unit, that was closed. She stated the patient was placed in Room A alone with a nurse in the closed unit and the patient was a high-risk pregnancy patient.

During a concurrent interview, DWS acknowledged one nurse was assigned to Patient 24 in the closed antepartum unit. DWS stated there should have been two nurses assigned in the antepartum unit, even though there was only one patient, one back-up nurse, in case of an emergency situation.

During an interview on 6/14/2021, at 2:15 p.m., the manager of L&D (MLD) stated she was aware Patient 24 was moved to the closed antepartum unit and one nurse was assigned. She stated there should have been two nurses assigned when a patient is admitted to the unit.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure a licensed nursing staff had proper training prior to providing care to a patient with an external ventricular drain (EVD, a temporary method that uses gravity to drain cerebrospinal fluid [CSF,clear colorless bodily fluid found in the brain and spine] out of compartments in the brain, called ventricles, via a thin tube that exits out of the head into a bag). This failure had the potential to negatively affect the patients' health and safety.

Findings:

Review of Patient 25's Emergency Provider Report, dated 5/31/2021, indicated the patient visited the emergency department (ED) with a chief complaint of altered mental status (a change in cognition or level of consciousness) and clinical impressions of acute (sudden onset) thalamic (thalamus, one of the two oval-shaped parts of the brain that control feeling and all the senses except for the sense of smell) bleed with a mass and [DIAGNOSES REDACTED] (a condition in which fluid accumulates in the brain).

Review of Patient 25's Operative Report, dated 5/31/2021, indicated the placement of external ventricular drain (EVD) catheter through twist burr-hole technique was performed.

Review of Patient 25's Emergency Notes, dated 5/31/2021, indicated neurologist [a doctor who diagnosis and treat problems with the brain and nervous system] at bedside, ICU [Intensive Care Unit] nurse RN at bedside, EVD done on patient.

During a telephone interview on 6/9/2021 at 11:10 a.m., registered nurse A (RN A) stated on 5/31/2021, she was assigned to Patient 25, and a neurologist and an ICU nurse were with Patient 25 for the EVD procedure. RN A stated after the procedure, the ICU nurse gave her instructions to monitor Patient 25 and left the ED. RN A stated she did not have training to take care of a patient with an EVD and was uncomfortable.

During an interview and concurrent record review with the nurse manager in ED (NMED), on 6/10/2021 at 10:20 a.m., NMED stated RN A and the rest of the licensed nurses in the ED, did not have competency to take care of a patient who had an EVD. NMED stated for Patient 25, the ICU nurse should have stayed with the patient to monitor.

Based on interview and record review, the hospital failed to ensure nursing staff followed the hospital's policies when:

1. In the neurosurgical intensive care unit (NSICU), registered nurses missed on-going assessments for 11 patients (Patients 9, 10, 11, 12, 14, 17, 18, 19, 20, 21, and 22), while one nurse was assigned to three patients. This failure had the potential of nursing staff not detecting patients' health complications or needs, and providing necessary treatment in the timely manner. Also, this failure can cause inaccurate and insufficient patients' information in their records.

2. In the post operative care unit (PACU), a Broselow Pediatric cart (a pediatric resuscitation cart) had expired items. This failure had the potential of nursing staff using the expired items when they provide care to patients.

3. In the PACU and the antepartum unit (a unit designed to care for high-risk patients before deliver), nursing staff did not check the crash carts daily. This failure had the potential of not providing necessary supplies and equipment when an emergency occurs.

Findings:

1. During record review and concurrent interview with the Manager of Neurosurgical Intensive Care Unit (MNSICU), on 6/9/21 at 8:33 a.m., the following were identified:

a. Review of Daily Staffing Sheet NSICU, dated 5/5/21 from 7 a.m. to 7 p.m., indicated three patients (Patients 9, 11 and 12) were assigned to one registered nurse (RN).

Review of Patient 9's Shift Assessment, dated 5/5/21, indicated the RN missed the patient's assessment at 10 a.m., 12 p.m., 2 p.m. 4 p.m., and 6 p.m.

Review of Patient 11's Shift Assessment, dated 5/5/21, indicated the RN missed the patient's assessment at 8 a.m., 10 a.m. and 12 p.m.

Review of patient 12's Shift Assessment, dated 5/5/21, indicated the RN missed the patient's assessment at 10 a.m., 12 p.m. and 4 p.m.

b. Review of Daily Staffing Sheet NSICU, dated 5/5/21, from 7 a.m. to 7 p.m., indicated three patients (Patients 10, 13, and 19) were assigned to one RN.

Review of Patient 19's Shift assessment, dated 5/5/21, indicated the RN missed the patient's assessment at 2 p.m., 4 p.m. and 6 p.m.

c. Review of Daily Staffing Sheet NSICU, dated 5/9/21, from 7 p.m. to 11 p.m., indicated three patients (Patients 9, 19, and 20) were assigned to one RN.

Review of Patient 9's Shift assessment, dated 5/9/21, indicated the RN missed the patient's assessment at 10 p.m.

Review of Patient 20's Shift assessment, dated 5/9/21, indicated the RN missed the patient's assessment at 10 p.m.

d. Review of Daily Staffing Sheet NSICU, dated 5/9/21, from 7 p.m. to 11 p.m., indicated three patients (Patients 10, 17, and 18) were assigned to one RN.

Review of Patient 10's Shift assessment, dated 5/9/21, indicated the RN missed the patient's assessment at 10 p.m.

Review of Patient 17's Shift assessment, dated 5/9/21, indicated the RN missed the patient's assessment at 10 p.m.

Review of Patient 18's Shift assessment, dated 5/9/21, indicated the RN missed the patient's assessment at 10 p.m.

e. Review of Daily Staffing Sheet NSICU, dated 5/10/21, from 7 a.m. to 11 a.m., indicated three patients (Patients 9, 19, and 20) were assigned to one RN.

Review of Patient 9's Shift assessment, dated 5/10/21, indicated the RN missed the patient's assessment at 10 a.m.

Review of Patient 19's Shift assessment, dated 5/10/21, indicated the RN missed the patient's assessment at 10 a.m.

Review of Patient 20's Shift assessment, dated 5/10/21, indicated the RN missed the patient's assessment at 10 a.m.

f. Review of Daily Staffing Sheet NSICU, dated 5/10/21, from 7 a.m. to 11 a.m., indicated three patients (Patients 14, 21, and 22) were assigned to one RN.

Review of Patient 14's Shift assessment, dated 5/10/21, indicated the RN missed the patient's assessment at 10 a.m.

Review of Patient 21's Shift assessment, dated 5/10/21, indicated the RN missed the patient's assessment at 10 a.m.

Review of Patient 22's Shift assessment, dated 5/10/21, indicated the RN missed the patient's assessment at 10 a.m.

During a concurrent interview, MNSICU stated in the ICU, nurses perform the patient's full assessment at 8 a.m. then they should reassess patients every 2 hours and document their assessment.

During a telephone interview on 6/13/21 at 11:00 a.m., registered nurse I (RN I) stated she was assigned to three patients and she did not have time to perform assessment for three patients. She stated she had to quickly check other patients whether they were okay while she was busy with one patient. She stated she started documenting her assessment after her shift ended, because she did not have time to document her assessment during her shift.

During a telephone interview on 6/13/21 at 1 p.m., registered nurse J (RN J) stated she was assigned to three patients and she missed either performing assessment or documenting her assessment. She stated she felt she did not have enough time to assess patients and she had to start documenting her assessment after she gave her shift report to the following shift nurse. She stated she did not have time to document patient's assessment during her shift.

Review of the hospital's Intensive Care Units Standards of Care, dated 12/12/89 and revised 2/2019, indicated the RN will perform and document patient full assessment every shift with a selected focus system assessment every 2 hours.

2. a. On 6/7/2021 at 2:40 p.m., with the director of surgery (DOS), in the PACU, the Broselow Pediatric Cart was inspected and two expired items, Green IV (intravenous) Delivery Module with the expiration date of 4/30/2021 and Green Intraosseus Module with the expiration date of 5/31/2021, were observed.

During a concurrent interview, DOS confirmed the expired items.

Review of Daily Crash Cart Checklist, dated January 2021, indicated the checklist remained blank on 1/11/2021, 1/13/2021, 1/19/2021, 1/20/2021, 1/24/2021, and 1/29/2021.

Review of Daily Crash Cart Checklist, dated May 2021, indicated the checklist remained blank on 5/1/2021, 5/2/2021, 5/9/2021, and 5/16/2021.

During an interview on 6/9/2021 at 8:20 a.m., DOS stated it was the responsibility of the registered nurses to check the pediatric crash cart daily and document. She confirmed that on those 10 days, there was no documented evidence nursing staff checked the crash cart daily as required.

b. Review of the antepartum unit's Daily Crash Cart Checklist, dated April 2021, indicated the checklist remained blank on 4/1/2021 and 4/27/2021.

Review of the antepartum unit's Daily Crash Cart Checklist, dated May 2021, indicated the checklist remained blank on 5/5/2021, 5/6/2021, 5/11/2021, 5/12/2021, 5/15/2021, 5/23/2021, and 5/28/2021.

During an interview with the director of women's services (DWS), on 6/11/2021 at 2:30 p.m., she confirmed there was no documented evidence nursing staff checked the crash cart on those days.

Review of the hospital's policy,Resuscitation of an Adult/Pediatric Patient (Code Blue), dated 5/27/2020, indicated, Emergency Cart Management: Inspection and Stocking (Crash Carts and Broselow carts)...The Charge Nurse or designate is responsible to insure the routine emergency cart inspections are completed per policy. Once in 24 hours (daily inspection), designated personnel will inspect the emergency cart for intactness of the lock, inspect the presence of necessary supplies and equipment on open areas of cart. Signing, initialing or documenting...on the emergency cart checking record implies that all emergency supplies are present, that the emergency cart is sealed by a lock, and that equipment checks have been performed.

Based on interview and record review, the hospital failed to ensure nursing staff administered medications as ordered for four patients (Patients 8, 12, 19, and 20), who received care in the intensive care unit (a unit where seriously ill patients receive specialized care), when:

1. Patient 8's Nicardipine (antihypertensive drug) was not administered and titrated as ordered.

2. There was no evidence Patient 12's blood pressure (BP) and heart rate (HR) were monitored constantly while the patient was on intravenous (IV) Amiodarone (a medication to treat irregular heartbeat).

3. Patient 19's Fentanyl (a very strong narcotic pain medication) IV drip was not titrated as ordered and relevant pain assessment, to titrate the medication, was missing.

4. Patient 20's Tylenol (a pain medication) was administered with an inappropriate indication and there was no evidence the patient's pain was r-assessed.

These failures had the potential to cause harm to the patients receiving inaccurate medications.

Findings:

During a record review and concurrent interview, with the Manager of Neurosurgical Intensive Care Unit (MNSICU), on 6/10/21 at 1 p.m., the following were identified:

1. Review of Patient 8's Consultation Note, dated 4/30/21, indicated the patient presented with left-sided weakness and altered mental status..., on CT of the head, the patient was noted to have an acute hemorrhage [bleeding an escape of blood from a ruptured blood vessel]..., and CT angiogram [a computed tomography technique used to visualize arterial and venous vessels] of the head and neck showed...aneurysm [an excessive localized enlargement of an artery caused by a weakening of the artery wall]... It indicated the plan was Treatment of hypertensive emergency to systolic blood pressure [SBP, the force of the blood against artery walls when the heart beats] less than 140 mmHg [millimeters of mercury, a measurement of pressure].

Review of Patient 8's physician's order, dated 4/30/21, indicated Nicardipine (antihypertensive drug) to initiate at 5 milligrams per hour (mg/hr), titrate (dose changes based on patient response) up and down by 2.5 mg/hr every 5 minutes, maintain SBP less than 140 mmHg or diastolic blood pressure (DBP, the pressure of the blood against artery walls while the heart is resting) less than 90 mmHg. The maximum rate was 15 mg/hr and the maintain goal was for 20 minutes, then titrate down to lowest rate that maintained the goal. If the drip was at zero rate, notify a provider immediately if the drip needed to be titrated up.

Review of Patient 8's electronic medication administration record (eMAR), dated 5/5/21, indicated at 10 a.m., Nicardipine was administered at 5 mg/hr and at 1:30 p.m., the rate was down to zero, instead of 2.5 mg/hr. There was no evidence a provider was notified.

Review of Patient 8's blood pressure records and eMAR, dated 5/5/21, indicated, the patient's blood pressure was 143/66 mmHg at 7:30 a.m., 155/80 mmHg at 8 a.m., 146/65 mmHg at 9 a.m., 152/64 mmHg at 9:16 a.m., 146/65 mmHg at 9:30 a.m., 148/67 mmHg at 9:45 a.m., and 156/65 at 10:15 a.m. There was no evidence Patient 8's Nicardipine was increased as ordered to maintain the patient's SBP less than 140 mmHg.

During a concurrent interview, MNSICU stated Patient 8's Nicardipine was not administered and titrated as ordered. She stated the dose should be down by 2.5 mg/hr, the nurse should have notified a provider when the medication was discontinued, and Nicardipine should be increased when the patient SBP was checked more than 140 mmHg.

2. Review of Patient 12's physician order, dated 5/3/21, indicated Amiodarone IV to infuse at 1 mg/min for 6 hours and 0.5 mg for 18 hours. The IV drip was started on 5/3/21 at 5:08 p.m. and stopped at 5/4/21 at 5:29 p.m. The order included to document the patient's HR and BP per standard vital sign routine.

Review of Patient 12's Blood Pressure, dated 5/4/21 indicated, the BP was 169/72 mmHg at 5 a.m. and 128/61 mmHg at 7 p.m. There was no other BPs or HRs documented, on 5/4/21 from 5 a.m. to 7 p.m., while the patient was on Amodarone.

Review of Patient 12's another Amiodarone order, dated 5/5/21, indicated to infuse Amiodarone at 1mg/min.

Review of Patient 12's eMAR indicated, the IV drip was started on 5/5/21 at 3 p.m. and discontinued on 5/6/21 at 8:05 a.m.

Review of Patient 12's Blood Pressure, dated 5/5/21, indicated the patient's BP was checked at 6 a.m. and the following documented BP was at 8:17 p.m. There were no documented BP and HR on 5/5/21 from 3 p.m. to 8 p.m.

During a concurrent interview, MNSICU stated Patient 12's BP and HR should be monitored at least every 2 hours and there was no evidence the patient's BP and HR were monitored on 5/4/21 from 5 a.m. to 7 p.m. and on 5/5/21 from 3 p.m. to 8 p.m., while the patient was on Amiodarone.

3. Review of Patient 19's physician's order, dated 5/5/21, indicated Fentanyl IV 10 micrograms/hours (mcg/hr) to maintain pain scale (a pain scale measures pain on a scale of 0-10. 0 means no pain and 10 means the worst possible pain) less than 3. It indicated to titrate up and down by 10 mcg/hr every 60 minutes then, titrate to down to lowest rate that maintained the goal.

Review of Patient 19's IV Drip Status indicated the patient's Fentanyl IV was initiated on 5/5/21 at 2:26 p.m. and discontinued on 5/10/21 at 9:50 p.m.

Review of Patient 19's IV Drip Status and Pain assessment indicated, on 5/5/21, there were no rate changes at 3 p.m., 5 p.m. 9:20 p.m. 9:30 p.m. but there was no documented evidence the patient's pain was assessed to determine whether the pain scale met the goal and/or the titration was required. It also indicated the patient's pain was not assessed from 5/5/21 at 10 p.m. to 5/6/21 at 8 a.m. while the patient was on Fentanyl.

During a concurrent interview, MNSICU stated Patient 19's pain was not assessed every hour while the patient was on Fentanyl.

4. Review of Patient 20's physician order, dated 5/8/21, indicated Acetaminophen 650 mg by oral as needed when the temperature was greater than 99¦F.

Review of Patient 20's eMAR, dated on 5/9/21 at 3:25 p.m., indicated Acetaminophen was administered for 5 of 10 pain on the head and neck and there was no documented evidence that the patient's pain was reassessed after the medication was administered.

During a concurrent interview, MNSICU stated Patient 20's Acetaminophen was ordered for fever, the medication was administered for pain, an inappropriate indication, and the nurse should have called the physician to get a new order for pain. She stated after administering a pain medication, the nurse should have reassessed the patient's pain to determine whether the intervention was effective. She stated medications should be administered as ordered.

Review of the hospital's policy, Administration of Medication by Nursing, dated 1/97 and revised 6/20, indicated to document intravenous fluids on the eMAR and rate changes for titrated infusions will also be documented in eMAR as appropriate with completion of any required queries. A patient's response to a medication is assessed and documented in the medical record.

Based on interview and record review, the hospital failed to comply with the requirements of 42 CFR 489.24 by failing to develop specific policies and procedure regarding unavailability of on-call physicians (refer to tag A2404), and planning for an appropriate hospital-to-hospital transfer (refer to tag A2409).

Based on interview and record review, the hospital failed to develop specific policies and procedures for emergency department on-call physician coverage for one of 30 sampled patients (1). Findings:

Patient 1 was admitted to Emergency Department A (ED A) on Sunday 6/16/13 at 1:08 p.m. with headache and neck pain following a lumbar puncture (LP, a diagnostic procedure where a needle is inserted into a fluid-filled space around the spinal cord of the lower back) done on 6/14/13 at another hospital (Hospital B).

Patient 1's record was reviewed on 12/2/13. The ED physician (EDP) documented Patient 1 required treatment by an Interventional Radiologist (IR, a specialist physician) who was unavailable at the hospital for the weekend. The EDP documented he recommended Patient 1 and a family member drive to another hospital for treatment. The record further indicated Patient 1's family member was advised that the procedure needed for her condition is unavailable at this time. He (Patient 1's family member) was offered to have his wife wait in the ER and we would attempt transfer back to (Hospital B) for further care of her condition, but this process would take several more hours. The EDP documented Patient 1 and a family member elected to drive to the other hospital in a private vehicle. Prior to discharge from ED A, the record indicated Patient 1 received medications for pain, nausea, and anxiety and was discharged to the care of family on 6/16/13 at 2:11 p.m. Patient 1 reported at the time of discharge, she had a pain level of 8 on a 1-10 scale with 10 being the worst pain.

During an interview on 12/3/13 at 1:30 p.m. The EDP stated, Hospital B instructed Patient 1 to go to her nearest emergency department (emergency department A) for a blood patch (a procedure to correct leaking spinal fluid associated with a lumbar puncture) to relieve her headache. The EDP stated it was his practice to utilize an IR specialist to perform blood patches. The EDP stated at the time of Patient 1's visit he was under the impression there was no IR coverage. When asked regarding essential and non-essential on-call physician coverage, the EDP stated he was unaware there were two different categories for on-call physicians.

During an interview on 12/3/13 at 11 a.m., the ED medical director (EDMD) stated there was an interruption of IR coverage for nights and weekends from the end of May, 2013 to mid June, 2013. Although not sure, the EDMD stated he believed there was IR coverage during Patient 1's visit. The EDMD stated he informed the emergency department medical staff of restored IR coverage via an email, but was not sure if the EDP was aware of this. The EDMD further stated the emergency department had many on-call physicians, specialists, and sub-specialists. The EDMD categorized on-call physicians as either being essential (able to provide stabilizing treatment for individuals with emergency medical conditions) and non-essential (courtesy on-call).

During interviews with the chief executive officer (CEO) on 12/3/13 at 10:15 a.m., and 12/4/13 at 9 a.m., he explained the difference between contracted (essential) on-call coverage versus non-contracted (non-essential) on-call coverage. Contracted on-call coverage was always available to provide stabilization treatment to an individual with an emergent medical condition. Non-contracted on-call service was a courtesy service available to an ED patient if needed. The CEO stated IR coverage required for Patient 1's medical condition was a non-contracted service.

During an interview and record review on 12/3/13 at 9:30 a.m., the medical staff services consultant (MSSC) stated she was responsible for scheduling on call physician coverage for the ED. The MSSC provided a copy of the 6/2013 medical staff calendar coverage (form A) which indicated an IR would be available on-call for each day of the month, including the weekend of 6/15-6/16/13. The MSSC stated although form A indicated there would be IR ED coverage she had no way of validating if the ED had IR coverage for the said days.

Record review on 12/4/13 at 10:30 a.m. of the emergency department on-call schedule (form B) for 6/16/13 contained no information regarding IR on-call availability.

Record review on 12/4/13 at 10:20 a.m. of the Medical Staff General Rules and Regulation dated March 2013, indicated: Each department/division of the Medical Staff,other than the Emergency Department, shall establish the criteria and maintain, by the procedure of its choice, a list of panel consultants that best meets the needs of the community and furnish the Emergency Department on at least a monthly basis a schedule of on-call panelists for consultation assumption of care, and/or referral of unassigned patients. The schedule must include the specific name of physician on-call (not the physician's group or practice name) and shall be available to the Emergency Department on on-call participants prior to it's implementation. The document further indicated it is understood that occasionally a physician who practices within an under-represented specialty may be unavailable to respond to Emergency Department calls from this facility due to involvement in another case. In those instances it is the responsibility of that physician to ensure that (Hospital in question) emergency department is aware of his/her lack of availability so that the Hospital does not accept cases involving that specialty.

Record review on 12/4/13 at 10:45 a.m. of the hospital policy and procedure dated 2/10 regarding Provision of On-Call Coverage indicated The hospital must maintain a list of physicians on its medical staff who are on call for duty after the initial examination to provide further evaluation and/or treatment necessary to stabilize an individual receiving treatment for an emergency medical condition. Further review of the policy and procedure had no explanation regarding contracted versus non-contracted on-call services.

Based on interview and record review, the hospital failed to provide evidence the risk and benefits of a transfer were explained to a patient, and failed to provide evidence all reasonable steps were taken to obtain a written refusal by a patient for one of 30 sampled patients (1). Findings:

Patient 1 was admitted to Emergency Department A (ED A) on Sunday 6/16/13 at 1:08 p.m. with headache and neck pain following a lumbar puncture (LP, a diagnostic procedure where a needle is inserted into a fluid-filled space around the spinal cord of the lower back) done on 6/14/13 at another hospital (Hospital B).

Patient 1's record was reviewed on 12/2/13. The ED physician (EDP) documented Patient 1 required treatment by an Interventional Radiologist (IR, a specialist physician) who was unavailable at the hospital for the weekend. The EDP documented he recommended Patient 1 and a family member drive to another hospital for treatment. The record further indicated Patient 1's family member was advised that the procedure needed for her (Patient 1) condition is unavailable at this time. He (Patient 1's family member) was offered to have his wife wait in the ER and we would attempt transfer back to (Hospital B) for further care of her condition, but this process would take several more hours. The EDP documented Patient 1 and a family member elected to drive to the other hospital in a private vehicle.

However, further review of the above note also indicated the following; Patient 1 was stable for discharge, but was instructed to return to the (Hospital B) clinic, Physician, or emergency department where they may arrange for your procedure today. Follow-up instruction included for Patient 1 to follow-up with your doctor (Hospital B) clinic, emergency room today even if well. Prior to discharge, Patient 1 received medications for pain, nausea, and anxiety and was discharged to the care of family on 6/16/13 at 2:11 p.m. Patient 1 reported at the time of discharge she had a pain level of 8 on a 1-10 scale with 10 being the worst pain.

During an interview on 11/15/13 at 10 a.m. Patient 1 stated she felt ill on 6/16/13 to the point where she could not walk. She stated after arriving at the ED, the physician told her the hospital could not provide the treatment she needed and advised her to go to a different hospital for treatment. Patient 1 stated the physician could arrange for an ambulance to transfer her to Hospital B, but it would take approximately six hours. Patient 1 stated she felt anxious at the prospect of making a trip to the other hospital, and her family member was frightened and angry at the prospect of driving her in a car when she was feeling so ill. Patient 1 stated she ended up going to the other hospital by private vehicle, where she was treated successfully without the use of an IR. Patient 1 stated she felt what happened prolonged the time it took her to get relief for her symptoms and was a bad experience for her and her family.

During an interview on 12/3/13 at 1:30 p.m. The EDP stated Hospital B instructed Patient 1 to go to her nearest emergency department (emergency department A) for a blood patch (a procedure to correct leaking spinal fluid associated with a lumbar puncture) to relieve her headache. The EDP stated he was unable to order treatment (blood patch) for Patient 1 due to the unavailability of IR coverage, and therefore suggested Patient 1 return to Hospital B.

During an interview on 12/3/13 at 11 a.m., the ED medical director (EDMD) stated there was an interruption of IR coverage for nights and weekends from the end of May, 2013 to mid June, 2013. Although not sure, the EDMD stated he believed there was IR coverage during Patient 1's visit. The EDMD stated he informed the emergency department medical staff of restored IR coverage via an email, but was not sure if the EDP was aware of this.

Review of the hospital's EMTALA-California Transfer Policy dated 2/13 indicated if an individual refuses to consent to the hospital's offer to transfer all reasonable steps would be taken to secure a written refusal... the medical record would contain the patient was informed of the risks and benefits and the reason for the individual's refusal to consent to the transfer.

Review of Patient 1's medical record on 12/4/13 at 2 p.m., had no indication Patient 1 was informed of the risks and benefits of the transfer, and the record lacked evidence the hospital took all reasonable steps to obtain a written refusal from the patient.