Virginia Mason Medical Center

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 42597 . Based on document review, medical record review, and interview, the hospital failed to promote and protect patient rights. Failure to promote and protect each patient’s rights risks physical and psychological harm, and loss of patient dignity. Findings included: 1. Failure to promptly and thoroughly investigate and resolve allegations of controlled substance diversion and failure to incorporate evidence based references into policy. Cross Reference Tag # A0144 Due to the scope and severity of deficiencies under 42 CFR §482.13, the Condition of Participation: Patient Rights was NOT MET. .”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 42597 . Based on document review, medical record review, and interview, the hospital failed to ensure that staff nurses, nurse managers, and the chief nursing officer complied with hospital policies and procedures related to accountability of controlled substances in accordance with state and federal laws and regulations. Failure to ensure compliance with policies and procedures for controlled substance places patients at risk for harm, poor pain control and potential staff diversion of controlled substances. Findings included: 1. Failure to promptly investigate and resolve narcotic variances in a timely manner and failure to accurately maintain proactive diversion surveillance. Cross Reference Tag # A0398 Due to the scope and severity of deficiencies under 42 CFR §482.23, the Condition of Participation: Nursing Services was NOT MET. .”

“Condition of Participation: Pharmaceutical Se CFR(s): 482.25 §482.25 Condition of Participation: Pharmaceutical Services. The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service. This Condition is not met as evidenced by: 42599 . Based on document review, medical record review, and interview, the hospital failed to ensure compliance with use and accountability of controlled substances in accordance with state and federal laws and regulations. Failure to ensure accurate records for controlled substance accountability places patients at risk for harm, poor pain control and potential diversion by staff. Findings included: 1. Failure to ensure a proactive diversion program for all staff members with access to controlled substances. Cross-reference: Tag A0494 Due to the scope and severity of deficiencies under 42 CFR §482.25, the Condition of Participation: Pharmaceutical Services was NOT MET. .”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 42597 . Based on document review, interview, and review of hospital policies and procedures, the hospital failed to provide care in a safe environment by ensuring that allegations of controlled substance diversion were promptly and thoroughly investigated (Item #1) and to incorporate referenced recommendations in the Prevention of Retained Surgical Items policy (Item #2). Failure to promptly and thoroughly investigate allegations of controlled substance diversion and to incorporate best practice recommendations into policies may lead to patient harm and death. Item #1 Proactive Diversion Surveillance 1. Review of the hospital document titled, “Bluesight Nursing Review Process,” v.5, dated 05/20 and active at the time of the diversion events, showed that once a month, unit leadership will check the IRIS Dashboard Rankings for their assigned areas and review details on the top 3 providers by deviation from the norm, to see if there is any suspicious activity. During the monthly review, the unit leader will: a. Select each behavior metric to review information contributing to the IRIS score. b. Complete and submit the review and attach the downloaded investigation data from the monthly review. Add department leadership and pharmacy as collaborators and submit. 2. Review of internal hospital documents showed that Staff #1, a registered nurse (RN), was employed by the hospital in the post-anesthesia care unit (PACU) from 11/27/23 until 07/29/24, when Staff #1 fled the hospital after discovering that their automated drug dispensing cabinet (ADC) access had been suddenly revoked. 3. On 02/05/25 between 11:00 AM and 2:00 PM, Investigator #1 reviewed internal hospital documents during separate interviews with the Director of Pharmacy (Staff #2) and the Director of Perioperative Services (Staff #7). The interviews and document review showed: a. Between 11/27/23 and 07/29/24, Staff #1 diverted 62 vials of fentanyl (a narcotic pain medication) and 21 cartridges of hydromorphone (a narcotic pain medication), in addition to smaller quantities of other controlled substances. b. On 07/16/24, The PACU Manager (Staff #9) stated that “a few” PACU RNs reported saftey concerns about Staff #1’s handling of controlled substances, but Staff #9 attributed the concerns to differences in perception. c. Staff #9 checked Staff #1’s ADC discrepancies and found nothing wrong. Staff #9 did not follow the required Bluesight Nursing Review process for suspected diversion. d. Staff #9 did not follow up on staff concerns by directly observing Staff #1, filing a patient safety alert, contacting the pharmacy, or escalating to the operating room (OR) or other surgical service leadership. e. On review, Staff #7 found over 500 PACU controlled substance variances. Item #2 Post Operative Instrument Counts Based on document review, interview, and review of hospital policies and procedures, the hospital failed to adopt the practices referenced in its Retained Surgical Item Prevention policy. Failure to ensure the use of referenced best practices places patients at risk for substandard care. Reference: Association of Perioperative Registered Nurses (AORN) Guidelines for Prevention of Retained Surgical Items (RSI) 1. Account for instruments in all procedures for which the likelihood exists that an instrument could be retained. 2. Count instruments for all procedures involving an open body cavity (i.e., thorax, abdomen). 3. The World Health Organization recommends that health care organizations determine which instruments will be counted and which procedures will have instrument counts, to include procedures involving open cavities. Findings included: 1. Review of the hospital policy titled, “Retained Surgical Item Prevention,” PolicyStat ID 15886689, effective 06/25/24, showed: a. The policy information was adopted based on references found in the “Guideline for prevention or retained surgical items.” In: Guidelines for Perioperative Practice. Denver, CO: AORN b. In contrast to the AORN guidelines, the policy stated, “to preclude possible retention of a surgical instrument, intraoperative imaging, in lieu of instrument counts, will be performed before the patient is transferred from the operating room (OR).” No reference was provided. 2. On 02/06/25 at 11:20 AM, Investigator #1 observed a post-operative patient in the OR immediately following an open cardiac procedure. Investigator #1 interviewed the circulating registered nurse (RN)(Staff #8) about prevention of unintended retained surgical items (URI) in patients. Staff #8 stated that two people counted all soft goods such as sponges or packing, and sutures/needles. Staff #8 stated that they did not count surgical instruments because every patient received an x-ray after cavity closure to be sure that no operative instruments were inadvertently left inside. 3. On 02/06/25 at 12:00 PM, Investigator #1 interviewed the Director of Perioperative Services (Staff #7). Staff #7 confirmed that it was not the hospital’s practice to perform post operative instrument counts. .”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 42597 . Based on document review, interview, and review of hospital policies and procedures, the hospital failed to ensure that staff nurses (RNs), nurse managers, and the chief nursing officer (CNO) followed proactive diversion detection policies and procedures as required by hospital policy. Failure to follow proactive diversion detection policies and procedures places patients at risk for inadequate pain control, exposure to blood borne pathogens, and poor outcomes. Findings included: 1. Review of the policy titled, “Controlled Substance Management Acute Care,” PolicyStat ID 16814780, effective 11/12/24, showed: a. The policy purpose was to establish a standardized process for the effective monitoring, analysis, and reporting of drug diversion activities to ensure safe medication practices and regulatory compliance. b. The nurse manager or designee will receive a monthly report of all discrepancies and resolutions. c. Any discrepancies in the controlled substance count will be investigated within 24 hours and an action plan regarding reconciliation will be completed within 72 hours. Reports should be resolved within 2 weeks. d. The CNO or designee will follow up with each nurse manager to ensure appropriate and timely resolution of all discrepancies. Review of the document titled, “ControlCheck Diversion Analytic Program Sop,” PolicyStat ID 17033051, effective 11/12/24, showed: a. Open variances (discrepancies related to the amount of controlled substance administered versus the amount dispensed) are reviewed within 72 hours at minimum. Unresolved variances should be entered into the hospital safety event review platform. b. Nurse managers and directors must review the Individual Risk Identification Score (IRIS) monthly surveillance reports to identify staff with behavior abnormalities associated with diversion. Abnormalities must be investigated within 2 weeks. Review of the hospital policy titled, “Event Reporting and Management Procedure, Clinical A-023P,” PolicyStat ID 14655701, effective 10/23, showed that employees must immediately notify their department leader/designee of any event that appears to fall within the definition of a serious safety event and file a patient safety alert. 2. On 02/05/25 between 11:00 AM and 2:00 PM, Investigator #1 reviewed internal hospital documents in separate sessions with the Pharmacy Director (Staff #2) and the Perioperative Services Director (Staff #7). The documents showed: a. While employed at the facility between 11/27/23 and 07/29/24, Staff #1 diverted 62 vials of fentanyl (a narcotic pain medication), 21 cartridges of hydromorphone (a narcotic pain medication), and smaller quantities of other narcotics and controlled substances. b. In June 2023, two RNs verbally reported concerns to their unit manager about Staff #1’s behavior, which included frequent unexplained absences from the unit, frequent and overlong trips to the restroom, and dozing while at their workstation. In July 2023, another RN reported the same concerns through email to to the unit manager. The unit manager did not follow the policy and procedure for suspected diversion. None of employees filed a patient safety alert. c. Staff #1 continued to divert narcotics until 07/29/24, when Staff #2 revoked Staff #1’s access to all automated drug dispensing cabinets. Staff #1 fled the hospital before they could be interviewed. d. The hospital’s investigation identified 498 patients who may have been exposed to blood borne pathogens as a result of Staff #1’s diversion. 3. On 02/05/25 between 1:30 PM and 3:00 PM, Investigator #1 individually interviewed 2 Post Anesthesia Care Unit (PACU) RNs (Staff #10, Staff #11) and 3 Emergency Department RNs (Staff #12, Staff #13, Staff #14). None of the RNs interviewed stated that they would file a patient safety alert if they suspected a coworker of diversion. 4. On 02/05/25 at 3:30 PM, Investigator #1 interviewed the Director of Emergency Services (Staff #4). Staff #4 stated that they were unfamiliar with monitoring the IRIS surveillance report and did not know how to run the surveillance report using ControlCheck Software. Staff #4 did not recall receiving any recent training about diversion surveillance or how to run surveillance reports using Control Check software. 5. On 02/05/25 at 12:29 PM, Investigator #2 interviewed the critical care unit (CCU) manager (Staff #20) and the CCU supervisor (Staff #21) about the hospital’s proactive diversion process. Staff #20 and Staff #21 stated that they review pharmacy variance reports daily. Staff #20 stated that if a variance occurs, she will send a screenshot of the variance to the nurse involved, and the nurse is expected to respond by then end of their next scheduled shift. Staff #20 and Staff #21 stated that they had not received training on how to run the Individual Risk Identification Score (IRIS) report and were not aware of any hospital requirements to do so. 6. On 02/05/25 at 3:00 PM, Investigator #2 interviewed the Procedural Services Manager (Staff #23) about the hospital’s proactive narcotic diversion training process. Staff #23 stated that he knew how to run individual staff usage reports, but he had received no formal or recent education on the hospital’s proactive diversion processes. Staff #23 was unaware of any policy or procedures requiring monthly surveillance report reviews. 7. On 02/10/25 at 11:07 AM, Investigator #1 interviewed the Regional Manager of Clinical Education (Staff #5), and reviewed diversion education documents produced and assigned to staff as follow-up to Staff #1’s diversion event. Staff #5 stated that the diversion prevention education module was assigned to all bedside care registered nurses on 01/11/25, with an expectation of 100% completion within 30 days. At the time of interview, Staff #5 stated that 55% of bedside RNs had completed the education. Staff #5 confirmed that RN managers and directors had not been assigned the diversion education but was not sure why. 8. Investigator #1 reviewed the Medication Safety Committee (MSC) meeting minutes, dated 12/23/24. The minutes showed: a. 91 staff members with Red IRIS user scores (IRIS score ranges from green (no anomaly) to red (most anomalous) when compared to peers waiting for investigation). b. The group considered historical variances and decided to notify nursing and anesthesia leaders to document all variances greater than 30 days old as “closed, unable to reconcile, due to staff members likely to be unable to recall the circumstances that created the variance.” 9. On 02/12/25 at 4:52 PM, Investigator #1 reviewed an email response from the Director of Pharmacy (Staff #2). The email showed that 4,142 historical event summaries (variances) occurring between 01/01/24 and 06/30/24 were archived without an investigation completed because the Medication Safety Committee didn’t think that people would be able to remember specific circumstances surrounding each variance. Currently there is no ability to account for the medications in question, and no further analysis has been performed. 10. On 02/12/25 at 11:30 AM, Investigator #1 reviewed internal documents with Staff #2. Staff #2 stated that Control Check software was used for controlled substance surveillance monitoring. The software produced an “IRIS” report that flagged individual utilization as green (least anomalous), yellow, or red (most anomalous). The report was not as accurate as it could have been because Staff #2 did not yet have the list of nurses by unit necessary to compare usage among like groups. As of 02/10/25, the report showed 4 registered nurses who had flagged red. For the time period between 07/01/24 and 02/12/25, 83 event summaries remained unresolved. .”

“PHARMACY DRUG RECORDS CFR(s): 482.25(a)(3) Current and accurate records must be kept of the receipt and distribution of all scheduled drugs. This Standard is not met as evidenced by: 42597 . Based on observation, document review, interview, and review of hospital policies and procedures, the hospital failed to fully implement, monitor, and evaluate a proactive diversion monitoring program that included all clinical areas and services. Failure to maintain a comprehensive proactive diversion program and ensure accurate records for controlled substance tracking places patients at risk for inadequate pain control and harm and provides opportunities for staff diversion of controlled substances. Findings included: 1. Review of the policy titled, “Controlled Substance Management Acute Care,” PolicyStat ID 16814780, effective 11/12/24, showed: a. VMFH will sustain compliance to the Drug Enforcement Agency through processes and policies that require immediate detection, investigation and reporting, maintaining accountability and proper dispensing of all narcotics and controlled substances. b. The policy establishes a standardized process for the effective monitoring, analysis, and reporting of drug diversion activities to ensure safe medication practices and regulatory compliance. Review of the policy titled, “ControlCheck Diversion Analytic Program Sop,” PolicyStat ID 17033051, effective 11/12/24, showed that the policy applied to inpatient nursing units and procedural areas where controlled substance medications are distributed and/or wasted through the automated dispensing cabinets (ADC). The policy failed to specify that it applied to credentialed providers responsible for the administration of controlled substances to patients. Review of the policy titled, “Pharmacy Automated Drug Dispensing Devices,” PolicyStat ID 16116801, effective 07/24, showed: a. Automated Drug Dispensing Devices (ADDD) policies and procedures cover diversion prevention and monitoring in procedural areas. b. Quality assurance activities include auditing of anesthesia records for one day each week. 2. On 02/05/25 at 11:30 AM, Investigator #1 reviewed a variance report and while interviewing the Pharmacy Director (Staff #2). Staff #2 stated that the anesthesiology diversion prevention process differed from the nursing process. The anesthesia department head was responsible for reviewing and ensuring reconciliation for all variances created by anesthesia providers. Staff #2 stated that the facility did not audit anesthesia records for one day each week as required by hospital policy. At the time of review, Staff #2 confirmed that for the time period between 11/01/24 and 01/31/25, the variance report for anesthesia providers contained 16 unresolved variances, with 8 unresolved for greater than 72 hours. 3. On 02/05/25 at 3:40 PM, Investigator #1 interviewed the Chief of Anesthesiology (Staff #3). Staff #3 stated that they did not receive or run diversion surveillance reports for anesthesia providers. .”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 42597 . Based on document review, medical record review, and interview, the governing body failed to provide effective oversight of the medical staff. Failure to provide effective oversight of the medical staff places patients at risk for poor outcomes and death. Findings included: 1. Failure to ensure provider accountability. Cross-reference: Tag A0049 2. Failure to ensure that medical staff members were appointed based on, at minimum, verified documentation of individual character, competence, training, experience, and judgement. Cross-reference: Tag A0050 Due to the scope and severity of deficiencies under 42 CFR §482.12, the Condition of Participation Governing Body WAS NOT met. .”

“MEDICAL STAFF CFR(s): 482.22 The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. This Condition is not met as evidenced by: 42597 . Based on document review, medical record review, and interview, the hospital failed to ensure that the medical staff operated by the Medical Staff Bylaws, Rules and Regulations, and Credentialing Program. Failure to operate under the Medical Staff Bylaws, Rules and Regulations, and Credentialing Program places patients at risk for poor outcomes. Findings included: 1. Failure to ensure comprehensive provider evaluations. Cross-reference A0340 2. Failure to ensure that medical staff members were privileged and credentialed based on verified documentation of individual character, competence, training, experience, and judgement. Cross-reference A0341 Due to the scope and severity of deficiencies under 42 CFR §482.22, the Condition of Participation: Medical Staff was NOT MET. .”

“MEDICAL STAFF - ACCOUNTABILITY CFR(s): 482.12(a)(5) [The governing body must] ensure that the medical staff is accountable to the governing body for the quality of care provided to patients. This Standard is not met as evidenced by: 42597 . Based on document review and interview, the Board of Directors failed to ensure that the medical staff was accountable to the governing body. Failure to ensure accountability places patients at risk of receiving care from medical staff members who may be poorly qualified or who exhibit unprofessional behaviors. Findings included: 1. Review of the hospital document titled, “Bylaws of the Medical Staff of Virginia Mason Medical Center,” dated 12/30/22, showed that duties of the Medical Executive Committee (MEC) included: a. To account to the board of directors for the medical care rendered to patients in the hospital. b. To take all reasonable steps to ensure professionally ethical conduct and competent clinical performance on the part of all members of the medical staff. c. That request for investigation of provider care could be made to the Medical Executive Committee (MEC) when a practitioner allegedly has engaged in conduct that is or is reasonably likely to be detrimental to the quality of healthcare, patient safety, or to the professional standards of the hospital medical staff. 2. The investigator reviewed documentation related to a physician (Staff #1). On 02/27/23, Staff #10 was placed on a performance improvement plan for incidences of intentional substandard infection prevention practice on 12/22/22, 01/13/23, and 01/16/23. Staff #10 was documented as noncompliant with the plan on records dated 07/07/23, 07/23/23, and 08/02/23. No documented referral to the MEC was found, and the investigator found no documentation to show that the governing body was notified of was notified of Staff #10’s substandard performance and performance improvement plan. Staff #10 resigned on 11/16/23. 3. The investigator reviewed documentation related to the care of Patient #2 by Staff #11 and Staff #12. On 08/29/24, Patient #2 underwent an interventional cardiac procedure. Patient #2 died the next day with cardiogenic shock and multisystem organ failure. The Patient Safety Department staff referred the cases to Medical Staff with request for review. The reviews of the standard of care given by Staff #11 and Staff #12 were iniated on 09/04/24 and 09/19/24. Reviews were completed by a single reviewer on 01/02/25 and 01/14/25. The reviewer(s) concluded that Staff #11 and Staff #12 did not meet the expected standard of care during Patient #2’s interventional cardiac procedure. 4. Document review of case logs and credentialing files for Staff #11 and Staff #12 showed: a. Privileges for trans-septal puncture (piercing of the wall between the two sides of the heart) and left atrial appendage closure (LAAC) (intentional blockage of an area of the heart prone to blood clots) procedures were initially granted to Staff #11 and Staff #12 based on cases performed at an outside facility. b. Primary source verification or quality information related to patient outcomes were not obtained. c. Provider #11 and Provider #12 did not completed focused professional practice evaluation (FPPE) as required by the Medical Staff Bylaws, Medical Staff Rules and Regulations, and Credentialing Program. 5. On 12/17/24 at 2:30 PM, the investigator interviewed the Chief of Staff (Staff #8) regarding Patient #1 and Patient #2. Staff #8 confirmed that the hospital did not require providers to complete FPPE, and the medical staff did not have a structured peer review process. If a concern regarding the standard of care was raised, the Department Chief would ask one or two reviewers to independently perform a clinical care review and then share any findings with the Department Chief. Staff #8 stated that there was not a standardized process for reporting events up through the Credentialing Committee, the MEC, or the Board of Directors. At the time of interview, the events related to Patient #1 and Patient #2 had not been reported to the Credentialing Committee, the MEC, or the Board of Directors. .”

“MEDICAL STAFF - SELECTION CRITERIA CFR(s): 482.12(a)(6) [The governing body must] ensure that criteria for selection are individual character, competence, training, experience, and judgement. This Standard is not met as evidenced by: 42597 . Based on interview and document review, the governing body failed to ensure that medical staff members were appointed based on, at minimum, verified documentation of individual character, competence, training, experience, and judgement for 10/10 medical staff records reviewed (Staff #10, #11, #12, #13, #14, #15, #16, #17, #18, #19). Failure to ensure that evaluation of providers requesting initial or renewed privileges includes verified documentation of individual character, competence, training, experience, and judgement places patients at risk for substandard care and poor outcomes. Findings included: 1. Review of the hospital document titled, “Bylaws of the Medical Staff of Virginia Mason Medical Center,” dated 12/30/22, showed that the Board of Directors shall be responsible for initial appointments and reappointments to the Medical Staff, the granting of initial, renewed, or revised clinical privileges, and the restriction, modification, or revocation of such appointments or privileges. Review of the hospital document titled, “Virginia Mason Medical Center Medical Staff Rules and Regulations,” approved 06/21, showed that the medical staff core clinical competencies are subject to review and include patient care and procedural skills, medical knowledge, practice based learning and improvement, interpersonal and communication skills, professionalism, and system based practices. Review of the hospital document titled, “Credentialing Program of the Medical Staff of Virginia Mason Medical Center,” approved 01/24, showed: a. Medical Staff Services verifies receipt of provider application materials and primary source verified documents. b. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, or secure electronic communication. 2. On 12/19/24 at 2:30 PM and on 12/23/24 at 9:00 AM, the investigator and 2 medical staff coordinators (Staff #3 and Staff #4) reviewed 10 provider credentialing files. The files showed: a. No evidence of primary source verification of documents for any files reviewed. b. No evidence of ongoing evaluation of core clinical competencies, patient care and procedural skills, medical knowledge, practice based learning and improvement, interpersonal and communication skills, professionalism, or system based practices for any files reviewed. c. Letters of appointment or reappointment issued by the Board of Directors and signed by the Medical Staff Services Division Manager for all files reviewed, despite missing documentation of primary source verification and ongoing evaluations. 3. At the time of review, Staff #3 and Staff #4 stated that they were not aware of a requirement for primary source verification for credentialing and that primary source verification was not part of their assigned duties. Staff #3 and Staff #4 organized the credentialing files for the credentialing committee and did not have access to assessment of medical staff core clinical competencies, patient care and procedural skills, medical knowledge, practice based learning and improvement, interpersonal and communication skills, professionalism, or system based practices. Staff #3 and Staff #4 stated that those items would be the responsibility of the Department Chief. 4. On 01/16/25 at 11:30 AM, the investigator conducted a group interview with the Chief of Staff (Staff #8), the Chair of the Credentialing Committee (Staff #13), and the Medical Staff Services Division Manager (Staff #14), who confirmed that primary source verification was not part of the credentialing process. Staff #8 and Staff #13 also confirmed that physician evaluation for credentialing or recredentialing was not consistent with the process defined in the Medical Staff Bylaws, the Medical Staff Rules and Regulations, and the Credentialing Program process, and that hospital leaders had not realized that the inconsistent process resulted in the routine presentation of incomplete credentialing files presented to the Board of Directors for approval. .”

“MEDICAL STAFF PERIODIC APPRAISALS CFR(s): 482.22(a)(1) The medical staff must periodically conduct appraisals of its members. This Standard is not met as evidenced by: 42597 . Based on document review and inteview, the hospital failed to assess providers based on current work practice, special training, quality of specific work, patient outcomes, and adherence to medical staff rules for 10 of 10 credentialing files reviewed (Staff #10, #11, #12, #13, #14, #15, #16, #17, #18, #19). Failure to assess providers based on current work practice, special training, quality of specific work, patient outcomes, and adherence to medical staff rules risks appointment and reappointment of unqualified practitioners and may result in poor patient outcomes. 1. Review of the hospital document titled, “Bylaws of the Medical Staff of Virginia Mason Medical Center,” approved 12/23, showed: a. All initially requested privileges shall be subject to a period of focused professional practice evaluation (FPPE). b. The medical staff will also engage in ongoing professional practice evaluation (OPPE) to identify professional practice trends that affect quality of care and patient safety. Review of the hospital document titled, “Virginia Mason Medical Center Medical Staff Rules and Regulations,” approved 06/21, showed: a. Core clinical competencies are subject to review and include patient care and procedural skills, medical knowlege, practice based learning and improvement, interpersonal and comminication skills, professionalism, and system based practices. b. All initially requested privileges shall be subject to a period of focused professional practice evaluation (FPPE). Review of the hospital document titled, “Credentialing Program of the Medical Staff of Virginia Mason Medical Center,” dated 01/24, showed that all physicians must complete FPPE within 6 months of appointment to the medical staff and/or when concerns arise regarding professional performance, competence, or behavior that may affect the provision of safe, quality patient care. Review of the hospital document titled, “Virginia Mason Medical Center Policy: Focused Professional Practice Evaluation,” approved 11/17, showed that: a. To demonstrate current competence, all new practitioners and existing practitioners who are requesting new or additional privileges will undergo a Focused Professional Practice Evaluation (FPPE) of at least 3 cases. FPPE must be completed within six months of privileges being initially granted. In the event that the practitioner has not completed the process, the practitioner shall voluntarily relinquish the relevant privileges. b. FPPE documentation is maintained in the individual practitioner’s quality file. c. FPPE is monitored by Medical Staff Services on behalf of the Credentials Committee. Noncompliance with FPPE and any significant findings will be reported to the Credentials Committee. d. On 12/16/24 and 12/23/24, the investigator requested a copy of the hospital’s OPPE policy. The hospital did not provide an OPPE policy as requested. 2. On 12/19/24 at 2:30 PM and on 12/23/24 at 9:00 AM, the investigator and 2 medical staff coordinators (Staff #3 and Staff #4) reviewed 10 practitioner credentialing files. Review showed: a. No documentation of completed FPPE. b. No documentation of review of core clinical competencies including patient care and procedural skills, medical knowledge, practice based learning and improvement, interpersonal and communication skills, professionalism, or system based practices. c. The single hospital performance indicator for emergency, orthopedics, and cardiology providers was the rate and quantity of opioid prescription. At the time of review, Staff #3 and Staff #4 confirmed that they had no information regarding provider FPPE. 3. On 12/23/24 at 12:00 PM, the investigator conducted a group interview with the Chief Clinical Officer (Staff #7), the Chief of Staff (Staff #8), and the Chief of Medicine (Staff #9). Staff # and Staff #8 confirmed that the hospital did not have an established and enforced FPPE process, and that the OPPE process had opportunities for improvement. .”

“MEDICAL STAFF CREDENTIALING CFR(s): 482.22(a)(2) The medical staff must examine the credentials of all eligible candidates for medical staff membership and make recommendations to the governing body on the appointment of the candidates in accordance with State law, including scope-of-practice laws, and the medical staff bylaws, rules, and regulations. A candidate who has been recommended by the medical staff and who has been appointed by the governing body is subject to all medical staff bylaws, rules, and regulations, in addition to the requirements contained in this section. This Standard is not met as evidenced by: 42597 . Based on document review and interview, the hospital failed to follow the credentialing process defined in the Medical Staff Bylaws and the Credentialing Program of the Medical Staff for 10 of 10 files reviewed (Staff #10, #11, #12, #13, #14, #15, #16, #17, #18, #19). Failure to follow the credentialing process risks appointment and reappointment of poorly qualified physicians which may result in poor patient outcomes. 1. Review of the hospital document titled, “Credentialing Program of the Medical Staff of Virginia Mason Medical Center,” dated 01/24 showed: a. Medical Staff Services verifies receipt of provider application materials and primary source verified documents. b. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, or secure electronic communication. c. All physicians must complete FPPE within 6 months of appointment to the medical staff and/or when concerns arise regarding professional performance, competence, or behavior that may affect the provision of safe, quality patient care. d. Each currently privileged and credentialed provider will undergo yearly ongoing professonal practice evaluation (OPPE) in compliance with the Joint Commission accreditation requirements. Review of the hospital document titled, “Virginia Mason Medical Center Policy: Focused Professional Practice Evaluation,” approved 11/17, showed that: a. To demonstrate current competence, all new practitioners and existing practitioners who are requesting new or additional privileges will undergo a Focused Professional Practice Evaluation (FPPE) of at least 3 cases. b. FPPE must be completed within six months of privileges being initially granted. In the event that the practitioner has not completed the process, the practitioner shall voluntarily relinquish the relevant privileges. c. FPPE documentation is maintained in the individual practitioner’s quality file. d. FPPE is monitored by Medical Staff Services on behalf of the Credentials Committee. Noncompliance with FPPE and any significant findings will be reported to the Credentials Committee. Review of the hospital document titled, “Virginia Mason Medical Center Medical Staff Rules and Regulations,” approved 06/21, showed that the medical staff will engage in ongoing professional practice evaluation (OPPE). Core clinical competencies are subject to review and include patient care and procedural skills, medical knowledge, practice based learning and improvement, interpersonal and communication skills, professionalism, and system based practices. 2. On 12/19/24 at 2:30 PM and on 12/23/24 at 9:00 AM, the investigator and 2 medical staff coordinators (Staff #3 and Staff #4) reviewed 10 practitioner credentialing files. The review showed: a. No files contained documentation of completed FPPE. b. No files contained evidence that the providers had relinquished priviledges based on noncompliance with FPPE requirements. c. OPPE consisted of a single quality metric based on opioid prescription. d. No files contained documentation of primary source verification. e. At the time of review, Staff #3 and Staff #4 stated that they were not aware of an active FPPE process and that primary source verification was not part of their assigned duties. 3. On 01/16/25 at 11:30 AM, the investigator conducted a group interview with the Chief of Staff (Staff #8), the Chair of the Credentialling Committee (Staff #13) and the Medical Staff Services Division Manager (Staff #14). The staff members confirmed that there was not an active FPPE process, providers who had not completed FPPE had not been asked to relinquish privileges, and that primary source verification was not a part of the privileging/credentialing process. . .”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 43760 . Based on observation, interview, and document review, the Hospital failed to meet the requirements for the Condition of Participation for Patient Rights. Failure to establish and implement policies and procedures for restraint or seclusion risks physical and psychological harm, loss of dignity, and violation of patient rights which can lead to negative patient outcomes. Findings included: 1. Failure to obtain patient consent for treatment risks patients reciving care that may not be to the patients’ desires. Cross Reference: A 0131 2. Failure to ensure orders contained the type and amount of restraint to be applied to patients increases the risk of incorrect seclusion, or restraint application, leaves the order(s) open for interpretation by staff and risks psychological harm, loss of dignity, and violation of patient rights. Cross Reference: A 0159 3. Failure to document imminent physical harm to the patient , staff or others for violent restraint use risks serious physical and psychological harm, loss of dignity, and violation of patient rights. Cross Reference: A 0154 4. Failure to utilize least restrictive measures before use of restraint or seclusion risks psychological harm, loss of dignity, and violation of patient rights. Cross Reference: A 0165 5. Failure to ensure that providers followed timelines for renewal of violent restraint or seclusion orders places patients at risk for harm due to inappropriate application of restraint or restraint type. Cross Reference: A 0171 6. Failure to ensure providers saw and assessed patients that had continuous application of violent restraint or seclusion for periods greater than or equal to 24 hours risks physical and psychological harm, loss of dignity, and violation of patient rights. Cross Reference: A 0172 7. Failure to discontinue restraints at the earliest opportunity risks physical and psychological harm, loss of dignity, and violation of patient rights. Cross Reference: A 0174 8. Failure to monitor patients in restraint at designated intervals as required by hospital policy risks physical and psychological harm, loss of dignity, and violation of patient rights. Cross Reference: A 0175 9. Failure to ensure a licensed practitioner or trained registered nurse conducted a face-to-face evaluation of the patient that included all required elements within 1 hour of restraint initiation risks physical and psychological harm, loss of dignity, and violation of patient rights. Cross Reference: A 0179 Due to the cumulative effect of these findings, the Condition of Participation at 42 CFR 482.13 was NOT MET. .”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 45663 . Based on observation, interview, and document review, the Hospital failed to meet the requirement for the Condition of Participation for Nursing Services. Failure to ensure that patient needs are met by ongoing assessments of patients needs and providing nursing care to meet those needs risks patients not receiving care appropriate to their needs. Findings included: 1. Failure to ensure staff completed and documented appropriate screenings and assessments risks patient harm due to delayed recognition of condition and inadequate or substandard treatment. Cross Reference: A 0395 2. Failure to develop and implement an individualized plan of care can result in the inappropriate, inconsistent, or delayed treatment of a patient’s needs and may lead to patient harm and lack of appropriate treatment for a medical condition. Cross Reference: A 0396 3. Failure to develop and implement policies and procedures to define Standards of Care risks inappropriate and/or ineffective patient care and poor outcomes. Cross Reference: A 0398 4. Failure to follow the hospital’s medication administration processes places patients at risk for serious medication errors and patient harm. Cross Reference: A 0405 5. Failure to follow the hospital’s verbal order medication policy places patients at risk for serious medication errors and patient harm. Cross Reference: A 0407 Due to the cumulative effect of these findings, the Condition of Participation at 42 CFR 482.23 was NOT MET. .”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 45663 . Based on interview, record review, and document review of hospital policy and procedures, the hospital failed to ensure that hospital staff properly obtained consent to treat for 3 of 9 Emergency Department patients reviewed (Patient #902, #905, and #917). Failure to properly obtain consent for treatment risks patients receiving care that may not be to the patients’ desires. Findings included: 1. On 09/20/24 between 9:20 AM and 12:00 PM, and on 09/24/24 between 10:30 AM and 1:30 PM, Investigator #9 and Emergency Department Director (Staff #904) and Registered Nurse (Staff #905) reviewed the medical records of patients receiving care in the hospital’s Emergency Department. The review showed the following: a. Patient #902 was a 6 year old evaluated for an allergic reaction with hives all over their body. The Investigator found no evidence of a consent to treat for this visit. b. Patient #905 was a 5 year old evaluated for a fever. The Investigator found no evidence of a consent to treat for this visit. c. Patient #917 was a 31 year old evaluated for a peritonsillar abscess. The Investigator found no evidence of a consent to treat for this visit. 2. At the time of the reviews, Staff #904 and #905 verified the missing consents in the medical record. Staff #905 stated that patients seen in the Emergency Department should sign a consent to treat unless unable to due to their medical condition. .”

“USE OF RESTRAINT OR SECLUSION CFR(s): 482.13(e) Patient Rights: Restraint or Seclusion. All patients have the right to be free from physical or mental abuse, and corporal punishment. All patients have the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time. This Standard is not met as evidenced by: 43760 . Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure that staff evaluated and documented physical need and safety of restrained patients as required by policy for 3 of 5 records reviewed (Patients #704, #709, and #711). Failure to ensure that staff follow approved policies and procedures for restraint use risks serious physical and psychological harm, loss of dignity, and violation of patient rights. 1. Document review of the hospital policy titled, “Restraint and Seclusion Policy, 964.00” PolicyStat #15941773, last approved 07/08/24, showed the following: a. The hospital uses the least restrictive form of restraint or seclusion that protects the physical safety of the patient, staff, and others. b. When a patient arrives at the hospital in restraints, the patient must be reassessed for the need for restraints. 2. On 09/19/24 at 2:49 PM, Investigator #7 and the High Acuity Unit Director (Staff #701) reviewed the medical record for Patient #704 who was placed in restraints. The review showed the following: a. Patient #704 arrived at the ED at 11:53 AM. b. Patient was documented as placed in violent restraints at 12:15 PM. c. The circumstances for violent restraints was documented as “Patient arrived in restraint.” 3. Investigator #7 found no other documentation of behaviors or actions of the patient that would warrant violent restraints. 4. At the time of the observation, Staff #701 verified there was no documentation of less restrictive measures or behaviors that jeopardized the immediate physical safety of the patient staff or others. 5. On 09/20/24 at 10:09 AM, Investigator #7 and Staff #701 reviewed the medical record for Patient #709 who was placed in restraints. The review showed the following: a. Patient #709 arrived via ambulance on 07/13/24 at 10:34 AM in restraints. b. Restraint documentation showed violent restraints were initiated at 10:44 AM, 10 minutes after arrival. c. The Circumstances for Violent Restraints was documented as “Arrived in ED in restraints.” 6. Investigator #7 found no clinical justification, harm to self or others, or least restrictive measures documented when Patient #709 was placed in restraints. 7. At the time of the review, Staff #701 verified there was no documentation of less restrictive measures or behaviors that jeopardized the immediate physical safety of the patient staff or others. 8. On 09/24/24 at 12:18 PM, Investigator #7 and Staff #701 reviewed the medical record for Patient #711. The review showed the following: a. Patient #711 arrived via ambulance on 09/02/24 at 10:57 AM in restraints. b. Patient was documented in locking restraints at 11:20 AM. c. The Circumstances for Violent Restraints was documented as “Arrived in ED in restraints.” 9. Investigator #7 found no clinical justification, harm to self or others, or least restrictive measures documented when Patient #711 was placed in restraints. 10. At the time of the review, Staff #701 verified there was no documentation of less restrictive measures or behaviors that jeopardized the immediate physical safety of the patient staff or others. .”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(1)(i)(A) Definitions. (i) A restraint is- (A) Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely; or This Standard is not met as evidenced by: 43760 . Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure that providers’ orders for seclusion, or restraint, are patient specific and contain all components including, but not limited to, the type of restraint and the amount of restraints (5-point, 4-point, etc.) to be used for 5 of 5 charts reviewed (Patients #704, #709, #710, #711, and #712). Failure to place complete orders increases the risk of incorrect seclusion or restraint application, leaves the order(s) open for interpretation by staff, and risks psychological harm, loss of dignity, and violation of patient rights. Findings included: 1. Document review of the hospital policy titled, “Restraint and Seclusion Policy, 964.00” PolicyStat #15941773, last approved 07/08/24, showed the following: a. Restraint and Seclusion require an order from a Physician or Licensed Provider. b. The order must include: i. The category (violent or non-violent). ii. The type of device(s) to be used. iii. The reason. iv. The duration. 2. On 09/19/24 at 2:49 PM, Investigator #7 and the High Acuity Unit Director (Staff #701) reviewed the medical record for Patient #704 who was placed in restraints. The review showed the following: a. Patient #704 arrived at the ED on 08/03/24 at 11:53 AM. b. Patient was documented as in violent restraints, beginning on 08/03/24 at 12:15 PM until 1:00 PM and on 08/03/24 at 9:30 PM until 08/04/24 at 6:58 PM. c. Orders for 4 hour violent restraints were placed as follows: i. Restraint initiation by RN: violent/self-destructive on 08/03/24 at 12:57 PM. ii. Restraint initiation by RN: violent/self-destructive on 08/03/24 at 9:25 PM. iii. Renew restraint: violent/self-destructive on 08/04/24 at 1:51 AM, with restraint type indicating “Key Lock Cuff.” iv. Renew restraint: violent/self-destructive on 08/04/24 at 5:23 AM, with restraint type indicating “Key Lock Cuff.” v. Renew restraint: violent/self-destructive on 08/04/24 at 10:05 AM, with restraint type indicating “Key Lock Cuff.” vi. Renew restraint: violent/self-destructive on 08/04/24 at 1:29 PM, with restraint type indicating “Key Lock Cuff.” d. A provider note signed on 08/05/24 at 12:44 AM, indicating the patient was placed in 4-point restraints. 3. Investigator #7 found no indication for the amount of restraint per the order i.e. 4-point or 5-point restraint, and no restraint type for the 12:57 PM and 9:25 PM orders. 4. At the time of the review, Staff #701 verified the late orders and that the orders did not specify the amount of restraint. 5. On 09/20/24 at 10:09 AM, Investigator #7 and Staff #701 reviewed the medical record for Patient #709 who was placed in restraints. The review showed the following: a. Patient #709 arrived at the ED on 07/13/24 at 10:34 AM. b. Patient was documented as in violent restraints beginning on 10:44 AM. c. Orders for 4-hour violent restraints were as follows: i. Initiate Restraint: Violent/Self-destructive with type noted as “Key Lock Cuff” on 07/13/24 at 10:44 AM. ii. Renew restraint: violent/self-destructive on 07/13/24 at 2:44 PM, with restraint type indicating “Key Lock Cuff.” 6. The remaining 11 Renew Restraint orders were ordered the same way with no amount of restraint indicated. i.e. 4 point or 5 point. 7. At the time of the review, Staff #701 verified the orders did not specify the amount of restraint. 8.On 09/24/24 at 10:47 AM, Investigator #7 and Staff #701 reviewed the medical record for Patient #710. The review showed the following: a. On 07/15/24 at 3:20 AM, Patient #710 was placed in locking restraints. b. An order to renew “Key Lock Cuff and waist” restraints was placed on 07/15/24 at 4:01 AM. 9. At the time of the review, Staff #701 verified the order did not specify the amount of restraint. 10. On 09/24/24 at 12:18 PM, Investigator #7 and Staff #701 reviewed the medical record for Patient #711. The review showed the following: a. On 09/02/24 at 11:20 AM, Patient #711 was placed in locking restraints. b. An order to Initiate Restraint: Violent/Self-destructive with type noted as “Key Lock Cuff” on 09/02/24 at 11:20 AM. c. An order to renew “Key Lock Cuff and waist” restraints was placed on 09/02/24 at 4:16 PM. 11. At the time of the review, Staff #701 verified the orders did not specify the amount of restraint. 12. On 09/24/24 at 1:45 PM, Investigator #7 and Staff #701 reviewed the medical record for Patient #712 who was placed in violent restraints on 07/14/24 at 3:42 PM. The review showed the following: a. An order to Initiate Restraint: Violent/Self-destructive with type noted as “Key Lock Cuff” on 07/14/24 at 3:42 PM. b. An order to renew “Key Lock Cuff and waist” restraints was placed on 07/14/24 at 7:12 PM. 13. At the time of the review, Staff #701 verified the orders did not specify the amount of restraint. .”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(3) The type or technique of restraint or seclusion used must be the least restrictive intervention that will be effective to protect the patient or others from harm. This Standard is not met as evidenced by: 43760 . Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure there were less restrictive measures attempted prior to placing patients in restraint or seclusion, for 3 of 5 charts reviewed (Patient #704, #709, and #711). Failure to follow approved policies and procedures, risks psychological harm, loss of dignity, and violation of patient rights. Findings included: 1. Document review of the hospital policy titled, “Restraint and Seclusion Policy, 964.00” PolicyStat #15941773, last approved 07/08/24, showed the following: a. The hospital uses the least restrictive form of restraint or seclusion that protects the physical safety of the patient, staff and others. b. When a patient arrives at the hospital in restraints, the patient must be reassessed for the need for restraints. 2. On 09/19/24 at 2:49 PM, Investigator #7 and the High Acuity Unit Director (Staff #701) reviewed the medical record for Patient #704 who was placed in restraints. The review showed the following: a. Patient #704 arrived at the ED at 11:53 AM. b. Patient was documented as placed in violent restraints at 12:15 AM. c. The circumstances for violent restraints was documented as “Patient arrived in restraint.” 3. Investigator #7 found no other documentation of behaviors or actions of the patient that would warrant violent restraints. 4. At the time of the review, Staff #701 verified there was no documentation of less restrictive measures or of behaviors that jeopardized the immediate physical safety of the patient staff or others. 5. On 09/20/24 at 10:09 AM, Investigator #7 and Staff #701 reviewed the medical record for Patient #709 who was placed in restraints. The review showed the following: a. Patient #709 arrived via ambulance on 07/13/24 at 10:34 AM in restraints. b. Restraint initiation showed violent restraints were initiated at 10:44 AM, 10 minutes after arrival. c. The Circumstances for Violent Restraints was documented as “Arrived in ED in restraints.” 6. Investigator #7 found no clinical justification, harm to self or others, or least restrictive measures documented when Patient #709 was placed in restraints. 7. At the time of the review, Staff #701 verified there was no documentation of less restrictive measures or behaviors that jeopardized the immediate physical safety of the patient staff or others. 8. On 09/24/24 at 12:18 PM, Investigator #7 and Staff #701 reviewed the medical record for Patient #711. The review showed the following: a. Patient #711 arrived via ambulance on 09/02/24 at 10:57 AM in restraints. b. Patient was documented in locking restraints at 11:20 AM. c. The Circumstances for Violent Restraints was documented as “Arrived in ED in restraints.” 9. Investigator #7 found no clinical justification, harm to self or others, or least restrictive measures documented when Patient #711 was placed in restraints. 10. At the time of the review, Staff #701 verified there was no documentation of less restrictive measures or behaviors that jeopardized the immediate physical safety of the patient staff or others. .”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(8) Unless superseded by State law that is more restrictive-- (i) Each order for restraint or seclusion used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others may only be renewed in accordance with the following limits for up to a total of 24 hours: (A) 4 hours for adults 18 years of age or older; (B) 2 hours for children and adolescents 9 to 17 years of age; or (C) 1-hour for children under 9 years of age; This Standard is not met as evidenced by: 43760 . Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure that there were providers orders for seclusion or restraint for 4 of 5 patients reviewed. (Patient #704, #709, #710, and #711) Failure to place orders for restraint or seclusion every 4 hours risks psychological harm, loss of dignity, and violation of patient rights. Findings included: 1. Document review of the hospital policy titled, “Restraint and Seclusion Policy, 964.00” PolicyStat #15941773, last approved 07/08/24, showed the following: a. Violent restraint and seclusion require an order from a physician or Licensed Practitioner (LP) be placed immediately after restraints have been initiated and the scene is safe. b. If the provider is not available at the time of the assessment indicating the need for restraint or seclusion and less restrictive measures have failed, an RN without an order, may initiate restraint to protect the patient, staff and others from harm. In this case, an order is immediately obtained from the provider as soon as the scene is safe. c. Each order for restraint or seclusion used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, staff or others may only be renewed in accordance with the following limits for up to 24 hours: i. 4 hours for adults 18 years of age or older. ii. 2 hours for children and adolescents 9-17 years of age. iii. 1 hour for children under 9 years of age. 2. On 09/19/24 at 2:49 PM, Investigator #7 and the High Acuity Unit Director (Staff #701) reviewed the medical record of Patient #704 who was placed in restraints. The review showed the following: a. Patient #704 arrived at the ED on 08/03/24 at 11:53 AM. b. Patient was documented as in violent restraints beginning on 08/03/24 at 12:15 PM until 1:00 PM and on 08/03/24 at 9:30 PM until 08/04/24 at 6:58 PM. c. Orders for 4-hour violent restraints were placed every 4 hours except for as follows: i. On 08/03/24 at 9:25 PM then 4 hours and 26 minutes later on 08/04/24/at 1:51 AM. ii. On 08/04/24 at 5:23 AM then 4 hours and 42 minutes later at 10:05 AM. 3. Investigator #7 found no further orders for the remainder of the time Patient #704 was restrained. 4. At the time of the review, Staff #701 verified the late orders. Staff #701 further verified Patient #704 was documented in restraints until 6:58 PM on 08/04/24 and should have had one more order for restraint. 5. On 09/20/24 at 10:09 AM, Investigator #7 and Staff #701 reviewed the medical record for Patient #709 who was placed in restraints. The review showed the following: a. Patient #709 arrived at the ED on 07/13/24 at 10:34 AM. b. Patient was documented as in violent restraints beginning on 10:44 AM. c. Orders for 4-hour violent restraints were placed every 4 hours except for as follows: i. On 07/14/24 at 2:51 PM then 5 hours and 57 minutes later at 8:48 PM. ii. On 07/15/24 at 6:51 AM then 4 hours and 40 minutes later at 11:31 AM. 6. At the time of the review, Staff #701 verified the late orders. 7.On 09/24/24 at 10:47 AM, Investigator #7 and Staff #701 reviewed the medical record for Patient #710. The review showed the following: a. On 07/15/24 at 3:20 AM Patient #710 was placed in locking restraints. b. An order for “Key Lock Cuff and waist” restraints was placed at 4:01 AM. c. Patient #710 was documented as restraints discontinued on 07/15/24 at 12:12 PM. 8. Investigator #7 found no further orders for the appoximately 8 hours Patient #710 was restrained. 9. At the time of the review, Staff #701 verified the missing order. 10. On 09/24/24 at 12:18 PM, Investigator #7 and Staff #701 reviewed the medical record for Patient #711. The review showed the following: a. Patient #711 arrived via ambulance on 09/02/24 at 10:57 AM in restraints. b. An order for locking restraints at 11:20 AM. c. 4 hours and 55 minutes later the next order for continued locking restraints was documented at 4:15 PM. 11. At the time of the review, Staff #701 verified the restraint order was late. .”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(8) [Unless superseded by State law that is more restrictive,] (ii) After 24 hours, before writing a new order for the use of restraint or seclusion for the management of violent or self-destructive behavior, a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law must see and assess the patient. This Standard is not met as evidenced by: 43760 . Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure that staff performed a face-to-face assessment every 24 hours a patient was in restraints as directed by hospital policy for 3 of 5 patients placed in physical restraints reviewed (Patients #709, #710, and #711). Failure to reevaluate patients in restraints every 24 hours to assess the need to continue or discontinue risks restraining a patient for longer than is needed, inappropriate and/or ineffective patient care, and poor patient outcomes. Finding included: 1. Document review of the hospital policy titled, “Restraint and Seclusion Policy, 964.00” PolicyStat #15941773, last approved 07/08/24, showed the following: a. All new restraint or seclusion orders require a Physician or Licensed Practitioner (LP) to evaluate the patient face-to-face within 1-hour after the initiation of the intervention. b. The face-to-face assessment must include: i. The patients’ immediate situation. ii. Patients’ reaction to the intervention. iii. Patients’ medical and behavioral condition. iv. The need to continue or terminate the restraint or seclusion. c. Patients in continuous restraints or seclusion require a face-to-face assessment to be completed with each new order and at least every 24 hours. 2. On 09/20/24 at 10:09 AM, Investigator #7 and Staff #701 reviewed the medical record for Patient #709 who was placed in restraints. The review showed the following: a. Patient #709 arrived at the ED on 07/13/24 at 10:34 AM. b. Patient was documented as in violent restraints beginning on 07/13/24 at 10:44 AM and remained in violent restraints until 07/15/24 at 2:58 PM (a period of approximately 52 hours). 3. Investigator #7 found no documentation of a face-to-face assessment for the entirety of the restraint episode. 4. At the time of the review, Staff #701 verified there should have been documentation of a provider face-to-face every 24 hours. 5. On 09/24/24 at 12:16 PM, Investigator #7 and Staff #701 reviewed the medical record for Patient #710 who was placed in restraints. The review showed the following: a. On 07/16/24 at 7:06 PM, Patient #710 was placed in locking restraints. The patient was not released from restraints until 07/20/24 at 2:46 AM (a period of over 79 hours). b. On 07/18/24 at 4:29 PM, a face-to-face assessment was documented by the provider. c. On 07/18/24 at 4:32 PM, a face-to-face assessment dated 07/17/24 was documented by the provider. d. On 07/18/24 at 4:33 PM, a face-to-face assessment dated 07/16/24 was documented by the provider. 6. Investigator #7 found no documentation of face-to-face reassessment for 07/19/24. 7. At the time of the review, Staff #701 verified the documentation dates and missing face-to-face assessments. 8. On 09/24/24 at 12:18 PM, Investigator #7 and Staff #701 reviewed the medical record for Patient #711. The review showed the following: a. Patient #711 arrived via ambulance on 09/02/24 at 10:57 AM in restraints and was documented as being placed in locking restraints at 11:20 AM. b. At 3:29 PM on 09/02/24, the patient was transferred to the 7th floor where they remained in restraints until 09/04/24 at 7:07 AM. 9. Investigator #7 found no documentation of a face-to-face assessment dated 09/03/24 or 09/04/24. 10. At the time of the review, Staff #701 verified there was no documentation of the required 24-hour face to face assessments. .”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(9) Restraint or seclusion must be discontinued at the earliest possible time, regardless of the length of time identified in the order. This Standard is not met as evidenced by: 43760 . Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure patients were free from restraint at the earliest time possible for 2 of 5 patients reviewed (Patient #704 and #709). Failure to follow approved policies and procedures for restraint use risks physical and psychological harm, loss of dignity, and violation of patient rights. Findings included: 1. Document review of the hospital policy titled, “Restraint and Seclusion Policy, 964.00” PolicyStat #15941773, last approved 07/08/24, showed staff must assess and monitor the patients condition on an ongoing basis to ensure that the patient is released from restraint at the earliest possible time. Every attempt is made to initiate the removal of the patient from restraints. 2. On 09/19/24 at 2:49 PM, Investigator #7 and the High Acuity Unit Director (Staff #701) reviewed the medical record for Patient #704 who was placed in restraints. The review showed the following: a. Patient #704 arrived at the ED on 07/13/24 at 11:53 AM. b. Patient was documented as in violent restraints beginning on 08/03/24 at 12:15 AM until 1:00 PM and on 08/03/24 at 9:30 PM until 08/04/24 at 6:58 PM. c. Patient #704’s every 15 minute documentation showed the following: i. On 08/03/24 at 1:00 PM, documentation showed “calm” until 9:35 PM when documention showed “Agitated.” ii. Agitated or calm on 08/03/24 at 9:35 PM until 11:15 PM. iii. On 08/03/24 at 11:15 PM until 08/05/24 at 1:02 PM, documentation showed patient was either calm or sleeping. 3. At the time of the review, Staff #701 verified documentation showed the patient had not been released at the earliest possible time. 4. On 09/20/24 at 10:09 AM, Investigator #7 and Staff #701 reviewed the medical record for Patient #709 who was placed in restraints. The review showed the following: a. Patient #709 arrived at the ED on 07/13/24 at 10:34 AM. b. Patient was documented as in violent restraints, beginning on 07/13/24 at 10:44 AM until 07/15/24 at 2:58 PM. c. One episode on 07/14/24 at 2:30 AM where Patient #709 had documented combative behaviors and was restrained from 3-point back to 4-point restraints. 15 minutes later the patient is documented as cooperative with no further combative episodes. 5. Investigator #7 noted every 15-minute rounding, for the majority of the restraint episode, documented the patient as calm, sleeping relaxed, restless and occasionally agitated. Investigator #7 was unable to find any clinical justification documentation to keep Patient #709 in restraints for the entire time she was restrained. 6. At the time of the review, Staff #701 verified the documentation was calm, sleeping relaxed, restless, and occasionally agitated, and with the exception of the combative episode on 07/14/24 at 2:30 AM, there was no documented behaviors that would warrant continued violent restraint use. .”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(10) The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. This Standard is not met as evidenced by: 43760 . Based on document review and interview, the hospital failed to ensure that patients placed in restraints were monitored for safety per hospital policy for 2 of 5 patients reviewed (Patients #709 and #710). Failure to monitor patients in restraints places patients at risk for physical and psychological harm, other decline in status, loss of dignity and violation of patient rights. Findings included: 1. Document review of the hospital policy titled, “Restraint and Seclusion Policy, 964.00” PolicyStat #15941773, last approved 07/08/24, showed the following for patients in violent restraints: a. An RN or delegate must monitor every 15 minutes and document the physiologic condition and patient behaviors. b. An RN must assess and document at least every 2 hours: i. Respiratory and circulation. ii. Skin integrity. iii. Signs of injury. iv. Mental/cognitive status. v. Emotional wellbeing. vi. Behavior that may indicate continued need for restraint or readiness for discontinuation of restraint. 2. On 09/20/24 at 10:09 AM, Investigator #7 and Staff #701 reviewed the restraint observation record for Patient #709 who was placed in restraints. The review showed the following late rounding documentations: a. Every 15 minute rounding: 07/13/24 at 10:44 AM placed in restraints then 35 minutes later at 11:19 AM. 11:19 AM then 56 minutes later at 12:15 PM. 12:23 PM then 112 minutes later at 2:15 PM. 3:00 PM then 21 minutes later at 3:21 PM. 3:21 PM then 39 minutes later at 4:00 PM. 4:00 PM then 44 minutes later at 4 :44 PM. 5:00 PM then 104 minutes later at 6:44 PM. 6:44 PM then 16 minutes later at 7:00 PM. 11:45 PM then 30 minutes later at 12:15 AM. 07/14/24 5:45 AM then 17 minutes later at 6:02 AM. 6:02 AM then 16 minutes later at 6:18 AM. 2:08 PM then 67 minutes later at 3:15 PM. 7:15 PM then 65 minutes later at 8:20 PM. 8:22 PM then 59 minutes later at 9:21 PM. 9:21 PM then 69 minutes later at 10:30 PM. 07/15/24 7:00 AM then no further every 15 minute documentation for the 7 hours and 46 minutes the patient remained in restraints. b. Nursing every 2 hour rounding: 07/13/24 10:44 AM then 4 hours and 14 minutes later at 2:59 PM. 4:00 PM then 2 hours and 25 minutes later at 6:25 PM. 3. At the time of the review Staff #701 verified the every 15-minute restraint rounding and the RN every 2 hour assessments were late. 4. On 09/24/24 at 10:47 AM, Investigator #7 and Staff #701 reviewed the medical record for Patient #710 who was placed in locking restraints on 07/15/24 at 3:20 AM. The review showed the following late rounding documentations: a. Every 15 minute rounding 07/15/24 at 4:45 AM then 35 minutes later at 5:20 AM. 6:23 AM then 50 minutes later at 7:13 AM. 8:19 AM then 45 minutes later at 9:04 AM. 9:04 AM then 54 minutes later at 10:00 AM. 10:00 AM then 60 minutes later at 11:00 AM. 11:00 AM then 60 minutes later at 12:00 AM. b. Nursing every 2 hours rounding: On 07/15/24 at 8:31 AM then 3 hours and 29 minutes later at 12:00 PM. 5. At the time of the review Staff #701 verified the late 15 minute rounding and the late RN every 2 hours rounding. .”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(12) [the patient must be seen face-to-face within 1 hour after the initiation of the intervention -- ] §482.13(e)(12)(ii)To evaluate - 1. The patient’s immediate situation; 2. The patient’s reaction to the intervention; 3. The patient’s medical and behavioral condition; and 4. The need to continue or terminate the restraint or seclusion. This Standard is not met as evidenced by: 43760 . Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure that staff performed a face-to-face assessment within 1 hour after restraint application as directed by hospital policy for 4 of 5 patients placed in physical restraints reviewed (Patients #704, #709, #711, and #712). Failure to assess patients in restraints within the first hour to assess the need to continue or discontinue risks restraining a patient for longer than is needed, inappropriate and/or ineffective patient care and poor patient outcomes. Finding included: 1. Document review of the hospital policy titled, “Restraint and Seclusion Policy, 964.00” PolicyStat #15941773, last approved 07/08/24, showed the following: a. All new restraint or seclusion orders require a Physician or Licensed Practitioner (LP) to evaluate the patient face-to-face within 1-hour after the initiation of the intervention. b. The face-to-face assessment must include: i. The patients’ immediate situation. ii. Patients’ reaction to the intervention. iii. Patients’ medical and behavioral condition. iv. The need to continue or terminate the restraint or seclusion. 2. On 09/19/24 at 2:49 PM, Investigator #7 and the High Acuity Unit Director (Staff #701) reviewed the medical record for Patient #704 who was placed in restraints. The review showed the following: a. Patient #704 arrived at the ED at 11:53 AM. b. Patient was documented as in violent restraints beginning on 08/03/24 at 12:15 AM until 1:00 PM and on 08/03/24 at 9:30 PM until 08/04/24 at 6:58 PM. 3. Investigator #7 found no documentation of a face-to-face assessment within 1 hour of initiation of the restraint episodes. 4. At the time of the review, Staff #701 verified that there was no face-to-face documentation. 5. On 09/20/24 at 10:09 AM, Investigator #7 and Staff #701 reviewed the medical record for Patient #709 who was placed in restraints. The review showed the following: a. Patient #709 arrived at the ED on 07/13/24 at 10:34 AM. b. Patient was documented as in violent restraints beginning on 10:44 AM. 6. Investigator #7 found no documentation of a face-to-face assessment within 1 hour of initiation of the restraint episodes. 7. At the time of the review, Staff #701 verified there that there was no face-to-face documentation. 8. On 09/24/24 at 12:18 PM, Investigator #7 and Staff #701 reviewed the medical record for Patient #711. The review showed the following: a. Patient #711 arrived via ambulance on 09/02/24 at 10:57 AM in restraints and was documented as being placed in locking restraints at 11:20 AM. b. On 09/02/24 at 3:29 PM, the patient was transferred to the 7th floor where they remained in restraints until 09/04/24 at 7:07 AM. 9. Investigator #7 found no documentation of a face-to-face assessment within 1-hour of initiation of restraints. 10. At the time of the review, Staff #701 verified there was no face-to-face documentation. 11. On 09/24/24 at 1:45 PM Investigator #7 and Staff #701 reviewed the medical record for Patient #712 who was placed in violent restraints on 07/14/24 at 3:42 PM. Investigator #7 found no documentation of a face-to-face evaluation within 1-hour of restraint initiation. 12. At the time of the review, Staff #701 verified there was no face-to-face documentation within 1-hour of restraint initiation. .”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 45663 . Item #1 Pain assessment Based on interview, record review, and review of hospital policy and procedure, the hospital failed to ensure staff members completed and documented pain assessments and reassessments for each pain management intervention for 3 out of 6 patients receiving pain medication reviewed (Patients #906, #909, and #917). Failure to assess and reassess a patient’s pain risks inconsistent, inadequate, or delayed relief of pain and risks patient harm related to delayed recognition of adverse effects of pain medication. Findings included: 1. Document review of the hospital’s policy and procedure titled, “Pain Management: Inpatient, Emergency Department, Inpatient Surgical/Procedural Areas, and Outpatient Surgical Centers,” PolicyStat ID 13662137, last approved 12/22, showed the following: a. Patient assessment, goals, reassessment, and plan of care will be documented in the medical record. b. Reassessment should be completed in a timely manner after each pain management intervention. 2. On 09/19/24 between 10:00 AM and 11:15 AM, Investigator #9 and Registered Nurse (Staff #909) reviewed the medical record of a patient who was admitted after a surgical procedure. The review showed the following: a. The patient received Oxycodone (an opioid narcotic pain medication) 5 milligrams orally at 5:55 AM for a pain score of 7 out of 10. The Investigator found no evidence of a pain reassessment after the medication intervention. b. The patient received Oxycodone 5 milligrams orally at 7:51 AM for a pain score of 7 out of 10. The Investigator found no evidence of a pain reassessment after the medication intervention. 3. At the time of the review, Staff #909 verified the missing pain assessment documentation. 4. On 09/24/24 between 10:30 AM and 1:30 PM, Investigator #9 and Registered Nurse (Staff #905) reviewed the medical record of a patient who was evaluated for a peritonsillar abscess (infection of the tonsils). The review showed the patient received Toradol (a medication used to treat pain) 10 milligrams intravenously for a pain score of 7 out of 10. The Investigator found no evidence of a pain reassessment after the medication intervention. 5. At the time of the review, Staff #905 verified that there was no documentation of a pain reassessment following the medication intervention. 6. On 09/24/24 between 1:30 PM and 2:30 PM, Investigator #9 and Registered Nurse (Staff #920) reviewed the medical record of a patient receiving care in the post anesthesia unit. The review showed the patient received Oxycodone 5 milligrams orally for a pain score of 5 out of 10. The Investigator found no evidence of a pain reassessment after the medication intervention. 7. At the time of the review, Staff #920 verified that there was no documentation of a pain reassessment following the medication intervention. Item #2 Initial suicide screening Based on interview, record review, and review of policy and procedure, the hospital failed to ensure that patients receiving care received a suicide risk assessment as directed by hospital policy and procedure for 11 of 12 medical records reviewed (Patient #906, #908, #909, #910, #1001, #1002, #1003, #1004, #1005, #1006, and #1007). Failure to perform a suicide risk assessment, risks that patients would not receive medical treatment appropriate to their care needs. Findings included: 1. Document review of the hospital’s policy and procedure titled, “Core Nursing Standards of Practice,” PolicyStat #13687643, last approved 01/23, showed the following: a. The Registered Nurse (RN) should screen patients for falls, skin risk, sepsis, mobility, and suicide. b. A suicide screening should be completed upon admission and as needed. Document review of the hospital’s policy and procedure titled, “Admission, Assessment, and Reassessment of the Perinatal Patient,” PolicyStat ID 13681201, last approved 02/23, showed a suicide risk assessment is to be completed on admission. 2. On 09/17/24 at 10:45 AM, Investigator #10 and the Director of Acute Care Services (Staff #1008), Quality Program Manager (Staff #1009), and a Staff Nurse (Staff #1003) reviewed the medical record of Patient #1001. The Investigator found no evidence of a suicide screening on admission. 3. At the time of the review, Staff #1003 stated that if the abuse screen questions in the admission form were “positive”, the system would trigger to perform a suicide screen. Otherwise, a suicide screen was not required. 4. On 09/18/24 at 10:00 AM, Investigator #10 and the Director of Medical Units (Staff #1001), a Quality Program Manager (Staff #1009), and a Charge Nurse (Staff #1010) reviewed the medical record of Patient #1002, who had been admitted for chest pain. Investigator #10 found no evidence of a suicide screening on admission. 5. At the time of the review, Staff #1001 stated that admission suicide screens are only required for patients with a behavioral health primary diagnosis. 6. Medical record reviews of five additional patients admitted for medical treatment showed no evidence of suicide screening done on admission (Patients #1003, #1004, #1005, #1006, and #1007). At the time of the reviews, Staff #1001 verified the finding. 7. On 09/18/24 between 1:00 PM and 4:30 PM, Investigator #9 and Registered Nurse (Staff # 910) and Registered Nurse (Staff #911) reviewed the medical records of patients admitted to the obstetrical unit. The review showed the following: a. Patient #908 was admitted for labor. The Investigator found no evidence of a suicide screening on admission. b. Patient #909 was admitted for labor. The Investigator found no evidence of a suicide screening on admission. c. Patient #910 was admitted for labor. The Investigator found no evidence of a suicide screening on admission. 8. At the time of the reviews, Staff #910 and Staff #911 stated that the suicide screen is not done on admission anymore. 9. On 09/19/24 at 9:00 AM, Investigator #9 and Registered Nurse (Staff #908) reviewed the medical record of Patient #906 admitted for hip replacement surgery. The Investigator found no evidence of a suicide screening on admission. 10. At the time of the review, Staff #908 stated that a suicide screening is not done on all patients. Director of Acute Care Services (Staff #907) stated that suicide screening is not done unless a patient is admitted for a behavioral health diagnosis. Item #3 Initial pain assessment-pediatric patients Based on interview, document review, and review of hospital policies and procedures, the hospital failed to ensure staff completed and documented initial pain assessments for 2 of 5 pediatric patients receiving care in the Emergency Department reviewed (Patients #901 and #902). Failure to perform an initial assessment of pain creates risk that patients would not receive medical treatment appropriate to their care needs. Findings included: 1. Document review of the hospital’s policy and procedure titled, “Pain Management: Inpatient, Emergency Department, Inpatient Surgical/Procedural Care Areas and Outpatient Surgical Centers,” PolicyStat ID 13662137, last approved 12/22, showed patients are screened for pain during emergency department visits and at time of admission. 2. On 09/20/24 between 9:20 AM and 12:00 PM, Investigator #9 and Emergency Department Director (Staff #904) reviewed the medical records of pediatric patients evaluated in the hospital’s Emergency Department. The review showed the following: a. Patient #901 was evaluated for a head laceration that required local anesthesia for staples. The Investigator found no evidence of a pain assessment during the visit. b. Patient #902 was evaluated for an allergic reaction with hives all over their body. The Investigator found no evidence of a pain assessment during the visit. 3. At the time of the review, Staff #904 verified the missing pain assessment documentation. Item #4 Initial triage physical assessment-pediatric patients Based on interview and document review, the hospital failed to ensure staff completed and documented a focused physical assessment pertinent to the chief complaint for 3 of 5 Emergency Department pediatric patients reviewed (Patient #901, #902, and #903). Failure to perform an initial focused physical assessment creates risk that patients would not receive medical treatment appropriate to their care needs. Findings included: 1. On 09/20/24 between 9:20 AM and 12:00 PM, Investigator #9 and Emergency Department Director (Staff #904) reviewed the medical records of pediatric patients evaluated in the hospital’s Emergency Department. The review showed the following: a. Patient #901 was evaluated for a head laceration that required stapling to close. The Investigator found no evidence of a focused physical assessment of the skin/wound. b. Patient #902 was evaluated for an allergic reaction with hives all over their body. The Investigator found no evidence of a focused physical assessment of the skin, breath sounds, or cardiovascular system. c. Patient #903 was evaluated for ear pain. The Investigator found no evidence of a focused physical assessment of the ear. 2. At the time of the review, Staff #904 verified that focused physical assessments were not documented. Item #5 Initial falls risk assessment Based on interview and document review, the hospital failed to ensure that hospital staff members completed and documented an appropriate initial falls risk assessment for 4 of 9 emergency department patients reviewed (Patient #901, #902, #903, and #918). Failure to perform an appropriate falls risk assessment of the patient risks patient safety and not receiving care appropriate to their care needs. Findings included: 1. On 09/20/24 between 9:20 AM and 12:00 PM and on 09/24/24 between 10:30 AM and 1:30 PM, Investigator #9 and Emergency Department Director (Staff #904) reviewed the medical records of patients evaluated in the hospital’s Emergency Department. The review showed the following: a. Patient #901 was a 9 year old evaluated for a head laceration after a fall. The falls risk assessment used was the Memorial ED for patients 16 years and older. b. Patient #902 was a 6 year old evaluated for an allergic reaction with hives all over their body. The Investigator found no evidence of a falls risk assessment documented as there was not a Triage 2 note which contains that field of information. c. Patient #903 was an 8 year old evaluated for ear pain. The falls risk assessment used was the Memorial (an evidence based risk assessment tool) ED for patients 16 years and older and the fields were blank. d. Patient #918 was a 60 year old evaluated for dizziness. The Investigator found no evidence of a falls risk assessment. 2. At the time of the review, Staff #904 acknowledged the missing falls assessments. Item #6 Initial neonatal pain assessment Based on interview, record review, and review of hospital policies and procedures, the hospital failed to ensure staff completed and documented neonatal pain assessments for 1 of 3 neonatal records reviewed (Patient #911). Failure to assess and reassess a patient’s pain risks inconsistent, inadequate, or delayed relief of pain and risks patient harm related to delayed recognition and treatment of pain. Findings included: 1. Document review of the hospital’s policy and procedure titled, “Newborn Admission, Assessment, and Reassessment,” PolicyStat ID 14555625, last approved 10/23, showed the following: a. Assess newborn vital signs, heart rate, respiratory rate, temperature, and pain at 15-30 minutes, 60 minutes, and 90 minutes of age. b. Ongoing assessments per early sepsis score and clinical assessment and routine (every 8 hours). 2. On 09/18/24 between 2:20 PM and 3:00 PM, Investigator #9 and Registered Nurse (Staff #911) reviewed the medical record of a patient admitted to the obstetrical unit. The patient delivered a newborn on 09/15/24 at 3:44 AM. The initial pain assessment documented on the newborn was on 09/15/24 at 2:54 PM (a period of approximately 11 hours after birth). 3. At the time of the review, Staff #911 verified the missing pain assessment documentation. Item #7 Initial focused assessment Based on interview, document review, and review of the hospital’s policy and procedure the hospital failed to ensure staff completed focused assessments for 2 of 3 medical records reviewed (Patients #704 and #705). Failure to perform focused assessments, risks deterioration of the patient’s condition, poor outcomes, and death. Findings include: 1. Investigator #7 requested a copy of the Emergency Department (ED) Standards of care and was informed the hospital does not currently have an approved Nursing Standard of Care for the ED. The last guidance used was titled, “Inpatient Nursing documentation Guidelines”, no number, last approved on 07/20 with the next review date set for 07/31/23. Staff further advised there was a draft ED standard of care, but it also had not been approved yet. Review of the Inpatient Nursing documentation Guidelines showed the following: a. In the ED, patients are to receive a triage assessment. b. A “Physical assessment (focused)” is done once per shift. 2. On 09/19/24 at 2:49 PM, Investigator #7 and the High Acuity Unit Director (Staff #701) reviewed the medical record for Patient #704 who was seen in the ED for Suicidal Ideation and 5 lacerations to Bilateral Wrists. The review showed the following: a. A skin assessment dated 08/03/24 at 11:24 PM showed skin Within Normal Limits (WNL). b. A provider note dated 08/03/24 at 12:20 PM detailing the 5 laceration repairs with sutures to the bilateral wrists. 3. Investigator #7 found no additional documentation related to the 5 lacerations on the bilateral wrists. No assessment related to Psych. 4. At the time of the review Staff #701 verified there was no focused assessment documented related to the primary reason for the visit and that the skin assessment only showed “WNL”. 5. On 09/20/24 at 8:36 AM, Investigator #7 and Staff #701 reviewed the medical record for Patient #705 who was seen in the ED after being involved in a Motor Vehicle Accident (MVA). 6. Investigator #7 found no evidence of a focused assessment or of any nursing interaction after the initial triage. 7. At the time of the review Staff #701 verified there was no focused assessment and no additional nursing assessments or interventions after the triage. Item #8 Magnesium Sulfate assessment Based on interview, record review, and review of hospital policies and procedures, the hospital failed to ensure staff completed specialized assessments for obstetrical patients receiving magnesium sulfate therapy for seizure prevention for 1 of 1 patient reviewed (Patient #908). Failure to perform assessments risks harm related to delayed recognition of condition warranting immediate care. Findings included: 1. Document review of the hospital’s policy and procedure titled, “Nursing Assessment Guidelines for Patients with Preeclampsia- addendum,” PolicyStat ID 11317724, last revised 03/22, showed the following: a. For patients on Magnesium Sulfate for preeclampsia, deep tendon reflexes and level of consciousness will be assessed every hour, lungs will be auscultated every 2 hours. b. After the Magnesium Sulfate is discontinued, lungs will be auscultated every 2 hours for the first 24 hours and deep tendon reflexes, and level of consciousness will be assessed every 4 hours. 2. On 09/18/24 between 1:30 PM and 2:20 PM, Investigator #9 and Registered Nurse (Staff #910) reviewed the medical record of a patient admitted for induction of labor with a diagnosis of preeclampsia and receiving Magnesium Sulfate (a medication administered to prevent a seizure). The review showed that Magnesium Sulfate was initiated on 09/16/24 at 4:25 PM and discontinued on 09/17/24 at 5:59 AM. The Investigator found no documentation of assessment of breath sounds from 09/16/24 at 8:00 PM through 09/17/24 at 7:31 AM (a period of approximately 11.5 hours). 3. At the time of the review, Staff #910 verified the missing breath sound assessments. Item #9 Aldrete assessment Based on interview, record review, and review of the hospital policy and procedures, the hospital failed to ensure specialized assessments were completed prior to transfer according to hospital policy for 1 of 1 cesarean section patients reviewed (Patient #908). Failure to perform specialized assessments creates risk that patients would not receive medical treatment appropriate to their care needs and lead to unanticipated outcomes. Findings included: 1. Document review of the hospital’s policy and procedure titled, “Obstetric Recovery Period and Postpartum Care,” PolicyStat ID 16115513, last approved 07/24, showed the following: a. For post cesarean recovery, the anesthesia provider will remain with the patient until an adequate airway is maintained, and the recovery nurse assumes care of the patient. b. The Aldrete Sedation Assessment score will be utilized to assist with patient assessment on admission and readiness for discharge from Phase 1 or discharge to the next level of care. c. An Aldrete score of eight or greater prior to discharge. d. If the score is less than eight, the anesthesia care provider and/or physician must be notified prior to discharge. 2. On 09/18/24 between 1:30 PM and 2:20 PM, Investigator #9 and Registered Nurse (Staff #910) reviewed the medical record of a patient admitted for induction of labor who delivered by cesarean section. The Investigator found no evidence of documentation of an Aldrete sedation assessment in the postoperative period. 3. At the time of the review, Staff #910 verified that there was no documentation of the Aldrete score and that it was not usual practice in the department. .”

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 45663 . Based on interview, document review, and review of policies and procedures, the hospital failed to develop and implement an individualized plan of care for 6 of 9 patient care plans reviewed (Patients #906, #907, #1003, #1005, #1006, and #1007). Failure to develop and implement an individualized plan of care can result in the inappropriate, inconsistent, or delayed treatment of a patient’s needs and may lead to patient harm and lack of appropriate treatment for a medical condition. Findings included: 1. Document review of the hospital’s policy and procedure titled, “Core Standards of Nursing Practice,” Policy Stat ID 13687643, last approved 01/23, showed the following: a. The Registered Nurse identifies expected outcomes for a plan individualized to the patient. b. The Registered Nurse engages the patient in partnership to identify expected outcomes. c. The Registered Nurse develops a plan that prescribes strategies to attain expected, measurable outcomes. d. The Registered Nurse partners with the patient to implement the plan. e. The Registered Nurse documents implementation, modifications and evaluations of goals including changes or omissions of the identified plan. f. The Plan of Care is reviewed and updated at a minimum of every shift. 2. On 09/19/24 at 9:00 AM, Investigator #9 and Registered Nurse (Staff #908) reviewed the medical record of a current inpatient. The review showed the following: a. The patient was admitted on 09/17/24 at approximately 4:25 PM. The Collaborative Care Plan note documented at 6:52 PM, was blank in the areas for Goals/Progress, Interventions/Outcomes, and Evaluation. b. The Collaborative Care Plan note documented on 09/18/24 at 6:09 AM, was blank in the areas for Goals/Progress, Interventions/Outcomes, and Evaluation. c. The Collaborative Care Plan note documented on 09/18/24 at 7:29 PM, was blank in the areas for Goals/Progress, Interventions/Outcomes, and Evaluation. d. The Collaborative Care Plan note documented on 09/19/24 at 5:37 AM, was blank in the areas for Goals/Progress, Interventions/Outcomes, and Evaluation. 3. At the time of the review, Staff #908 verified that the Goals/Progress, Interventions/Outcomes and Evaluation areas were blank. 4. On 09/19/24 at 11:00 AM, Investigator #9 and Registered Nurse (Staff #909) reviewed the medical record of a current inpatient. The review showed the following: a. The patient was admitted on 09/17/24 and admitted to the current unit at 10:30 PM. The Collaborative Care Plan note documented on 09/18/24 at 2:21 AM, was blank in the areas for Goals/Progress, Interventions/Outcomes, and Evaluation. b. The Collaborative Care Plan note documented on 09/18/24 at 7:39 PM, was blank in the areas for Goals/Progress, Interventions/Outcomes, and Evaluation. c. The Collaborative Care Plan note documented on 09/19/24 at 2:25 AM, was blank in the areas for Goals/Progress, Interventions/Outcomes, and Evaluation. 5. At the time of the review, Staff #909 verified that the Goals/Progress, Interventions/Outcomes and Evaluation areas were blank. 6. On 09/20/24 between 8:45 AM and 11:00 AM, Investigator #10, the Director of Medical Units (Staff #1001), and two clinical informaticists (Staff #1004 and #1005) reviewed the medical record of Patient #1003, who was hospitalized from 07/27/24 to 08/06/24. Investigator #10 found that care plan documentation was missing for multiple shifts. 7. At the time of the observation, Staff #1001 verified that documentation of care plan Goals/Progress, Interventions/Outcomes, and Evaluation is expected every shift and was missing for Patient #1003. 8. On 09/24/24 between 11:00 AM and 4:00 PM, Investigator #10, Staff #1001, the Critical Care Supervisor (Staff #1006), and a clinical informaticist (Staff #1007) reviewed the medical records of critical care unit (CCU) and progressive care unit (PCU) patients. The reviewed showed the following: a. Patient #1005 was hospitalized from 08/13/24 to 08/22/24. Investigator #10 found that care plan documentation was missing for multiple shifts. b. Patient #1006 was hospitalized from 08/14/24 to 08/20/24. Investigator #10 found that care plan documentation was missing for multiple shifts. c. Patient #1007 was hospitalized from 08/06/24 to 08/09/24. Investigator #10 found that care plan documentation was missing for multiple shifts. 9. At the time of the observations, Staff #1006 verified that documentation of care plan Goals/Progress, Interventions/Outcomes, and Evaluation is expected every shift in CCU and PCU, and that this required documentation was missing for Patients #1005, #1006, and #1007. .”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 45663 . Item #1 Perioperative Standards of Care Based on record review and interview, the hospital failed to develop and implement policies and procedures to define Standards of Care for Perioperative Services. Failure to develop and implement policies and procedures risks inappropriate and/or ineffective patient care and poor patient outcomes. Findings included: 1. On 09/17/24, Investigator #9 and Interim Operating Room Director (Staff #902) inspected the perioperative area. The Investigator requested a policy for Standards of Care for the Perioperative area to include the preoperative, intraoperative, and post anesthesia units. 2. On 09/19/24 at 4:00 PM after additional requests for the Standards of Care policies for the Perioperative area, Staff #902 verified that at present there was not a Standard of Care policy, and that the hospital was in the process of creating one. 3. On 09/25/24 at 10:00 AM, Investigator #9 interviewed Outpatient Surgery Center Director (Staff #906) regarding Standards of Care used at the Surgery Center. Staff #906 stated that they follow the same Standards of Care for the hospital operative area. The Investigator asked Staff #906 to provide those standards. 4. On 09/25/24 at 12:00 PM, Acute Care Director (Staff #907) stated that they were unable to locate any current outpatient surgery Standard of Care polices. Item #2 Emergency Department Standard of Care Based on record review and interview, the hospital failed to develop and implement policies and procedures to define standards of care for Emergency Services. Failure to develop and implement policies and procedures risks inappropriate and/or ineffective patient care and poor patient outcomes. Findings included: 1. On 09/17/24 Investigator #7 requested a copy of the Emergency Department (ED) Standards of Care. 2. On 09/20/24 at 9:00 AM, The High Acuity Unit Director (Staff #701) informed Investigator #7 that the hospital does not currently have an approved Nursing Standard of Care for the ED. Item #3 Pediatric Triage Standards of Care Based on record review and interview, the hospital failed to develop and implement policies and procedures to define standards of care for pediatric triage patients. Failure to develop and implement policies and procedures risks inappropriate and/or ineffective patient care and poor patient outcomes. Findings included: 1. On 09/20/24 during medical record review with Emergency Department Director (Staff #904), Investigator #9 requested copies of the hospital’s triage policy for pediatric patients. 2. On 09/24/24 at 11:15 AM, Staff #904 stated that they did not have a pediatric triage policy. .”

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 45663 . Based on document review and interview, the hospital failed to ensure that staff obtained complete provider orders prior to providing care including ventilator settings and management of sedation for patients requiring respiratory support for 1 of 2 patients reviewed (Patient #1006). Failure to ensure complete orders places patients at risk for receiving care and services which were not what the provider had intended or not receiving care which the provider had intended with the potential for harm as a consequence. Findings included: 1. On 09/24/24 at 11:00 AM, Investigator #10, the Director of Medical Units (Staff #1001), the Critical Care Supervisor (Staff #1006), and a clinical informaticist (Staff #1007), and a respiratory therapist (Staff #1011) reviewed the medical record of Patient #1006. The review showed the following: a. Patient #1006 was admitted on 08/14/24 for a planned coronary artery bypass graft (CABG, or open-heart surgery). At the completion of surgery, the patient remained on a ventilator and sedating medications and went to the intensive care unit for recovery. b. An order for “RT Ventilator Weaning and Discontinue” was entered by a provider on 08/14/24 at 6:14 AM. An order comment stated, “RN to page Respiratory Therapist if order is STAT”, but the area for ventilator settings were blank. c. An order for Propofol 10mcg/kg/min (a sedating medication) showed that the dose would be titrated based on goals (objective clinical measures to guide changing rate). The Goal showed “refer to order details.” The order details area was blank. d. An order for Dexmedetomidine 0.4mcg/kg/ml (a sedating medication) showed that the dose would be titrated based on goals (objective clinical measures to guide changing rate). The Goal showed “refer to order details.” The order details area was blank. e. The medication administration record showed that the rate of propofol was decreased from 50mcg/kg/min at 2:00 PM on 8/14/24 to 30mcg/kg/min at 2:15 PM, and to 0mcg/kg/min at 2:45 PM. 2. At the time of the review, Staff #1006 verified that ventilator setting orders were missing and that medications were administered and titrated without orders for a goal and parameters. Staff #1006 added that ventilator settings and sedation monitoring parameters were a standard part of post-operative CABG orders, so it was unclear how those were not included the record. .”

“VERBAL ORDERS FOR DRUGS CFR(s): 482.23(c)(3)(i) If verbal orders are used, they are to be used infrequently. This Standard is not met as evidenced by: 45663 . Item #1 Verbal medication orders in the cardiac catheterization laboratory Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure staff followed its policy for verbal orders for 3 of 3 cardiac catheterization patient records reviewed (Patients #912, #913, and #914). Failure to follow the hospital’s medication administration processes places patients at risk for serious medication errors and patient harm. Findings included: 1. Document review of the hospital’s policy and procedure titled, “Medication Management Verbal or Telephone Orders,” Policy Stat ID 13662117, last approved 06/22, showed the following: a. It is the policy of Virginia Mason Medical Center to minimize verbal and telephone orders. b. If a verbal order is necessary, it must immediately be reduced to writing, dated, identified by the names of the individuals who originated and received it, and signed by the receiver. Document review of the hospital’s document titled, “Medical Staff Rules and Regulations,” dated 06/21, showed the following: a. All orders for medications must be entered directly into the clinical information system via computerized provider order entry (CPOE) or written onto an approved pre-printed order sheet. b. Orders must be entered or signed by an individual authorized to prescribe. c. Verbal orders will be acted upon but require a co-signature within 48 hours. d. Authentication for verbal orders must be completed by the prescribing physician or ARNP who is responsible for the care of the patient. 2. On 09/20/24 at 9:00 AM, Investigator #9 and Procedural Director (Staff #912) and Cardiac Catheterization Manager (Staff #913) reviewed the medical record of Patient #912 who had undergone a cardiac catheterization procedure. Investigator #9 interviewed Staff #912 regarding the process for medication administration and documentation in the catheterization lab. Staff #912 stated that the hospital uses a system that does not interface with the hospital’s electronic medical record to document events during the procedure. This record is printed and scanned into the patient’s electronic medical record. The record of events is completed by a person monitoring the procedure outside of the cardiac catheterization laboratory in the control room. The review showed the following: a. The patient received a total of 100 micrograms of Fentanyl (an opioid narcotic medication) in 4 separate doses and 2 milligrams of Versed (a medication used for relaxation and to provide an amnesic effect) in 4 separate doses during the procedure. b. The Investigator requested to see the medication orders entered by the nurse and signed/authenticated by the provider giving the verbal orders. c. Staff #912 stated the orders for medications are verbal orders by the physician to the nurse administering medication in the room and the scanned note is the documentation of the procedure. The provider writes the medications administered in their procedure note. The Investigator found no evidence of any written and signed orders for the medications administered by the Registered Nurse as verbal orders during the procedure. 3. On 09/24/24 at 2:35 PM, Investigator #9 and Procedural Director (Staff #912) reviewed the medical record of Patient #913 who had undergone a cardiac catheterization procedure. The review showed the following: a. The patient received a total of 300 micrograms of Fentanyl in 10 separate doses and 6 milligrams of Versed in 10 separate doses. The Investigator requested to see the medication orders entered by the nurse and signed/authenticated by the provider giving the verbal orders. b. The Investigator found no evidence of any written and signed orders for the medications administered by the Registered Nurse as verbal orders during the procedure. 4. On 09/24/24 at 3:00 PM, Investigator #9 and Procedural Director (Staff #912) reviewed the medical record of Patient #914 who had undergone a cardiac catheterization procedure. The review showed the following: a. The patient received a total of 25 micrograms of Fentanyl in 1 dose and Versed 1 milligram in 1 dose. The Investigator requested to see the medication orders entered by the nurse and signed/authenticated by the provider giving the verbal orders. b. The Investigator found no evidence of any written and signed orders for the medications administered by the Registered Nurse as verbal orders during the procedure. 5. On 09/25/24 at 11:30 AM, Investigator #9 interviewed Interim Pharmacy Director (Staff #914) and Director of Pharmaceutical Services (Staff #915) regarding the orders for medications administered by Registered Nurses for moderate sedation in the procedural areas. Staff #915 reviewed the medications ordered for the patients above and verified that there were no orders entered for the Fentanyl and Versed administered by the Registered Nurse. Item #2 Nurse Administered Propofol Continuous Infusion System Orders Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure staff followed its policies for medication administration for 2 of 2 Gastrointestinal (GI) procedure patient records reviewed (Patients #915 and #916). Failure to follow the hospital’s medication administration processes places patients at risk for serious medication errors and patient harm. Findings included: 1. Document review of the hospital’s policy and procedure titled, “Medication Management: Administration of Medication,” PolicyStat ID 13654903, last approved 08/22, showed that a provider order is required before a medication is administered to a patient. Document review of the hospital’s policy and procedure titled, “Nurse Administered Propofol Continuous Infusion System,” PolicyStat ID 13663006, last reviewed 06/22, showed that all changes to the Propofol (a sedative-hypnotic medication) will be with the provider’s verbal order. Document review of the hospital’s document titled, “Medical Staff Rules and Regulations,” dated 06/21, showed the following: a. All orders for medications must be entered directly into the clinical information system via computerized provider order entry (CPOE) or written onto an approved pre-printed order sheet. b. Orders must be entered or signed by an individual authorized to prescribe. c. Verbal orders will be acted upon but require a co-signature within 48 hours. d. Authentication for verbal orders must be completed by the prescribing physician or ARNP who is responsible for the care of the patient. 2. On 09/25/24 between 8:40 AM and 11:20 AM, Investigator #9 and Director of the Outpatient Surgery Center (Staff #916), Nurse Manager (Staff #917) and Registered Nurse (Staff #918) reviewed medical records of patients having procedures at the outpatient surgery center. Investigator #9 interviewed Staff #916 regarding the process for medication administration and documentation for GI procedures. Staff #918 stated that the hospital uses a system named Provation for documentation of the procedure and medications are ordered within the Provation system as part of the provider note. The facility uses a Nurse Administered Propofol Continuous Infusion System as long as there is an anesthesia provider present in the facility. The review showed the following: a. Patient #915 underwent a flexible sigmoidoscopy (a procedure to look at the lower part of the intestine). Review of the document “Nurse Note” showed a total dose of Propofol 130 milligrams administered to the patient during the procedure. The note showed “Medications given per closed loop verified MD order: YES.” There were an additional 4 rate changes to the Propofol infusion and 5 “PRN Propofol dose given IV” documented. Review of the document “MD note” showed a medical history, surgical history, a prepopulated order set that is not individualized to the patient, and a history and physical. After the history and physical section, the document was esigned by the provider. The Investigator requested to see where the verbal medication orders given during the procedure were signed by the provider. b. Staff #918 stated that the provider note in Provation system was the medication orders. c. Patient #916 underwent a colonoscopy. Review of document “Nurse Note” showed a total dose of Propofol 450 milligrams administered to the patient during the procedure. The note showed “Medications given per closed loop verified MD order: YES.” There were an additional 8 rate changes to the Propofol infusion and 9 “PRN Propofol dose given IV” documented. Review of the document “MD note” showed a medical history, surgical history, a prepopulated order set that is not individualized to the patient, and a history and physical. After the history and physical section, the document was esigned by the provider approximately 70 hours after the procedure. The Investigator requested to see where the verbal medication orders given during the procedure were signed by the provider. d. Staff #918 stated that the provider note in Provation system was the medication orders. .”