Harborview Medical Center

“DELIVERY OF DRUGS CFR(s): 482.25(b) §482.25(b) Standard: Delivery of Services In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. This Standard is not met as evidenced by: 42597 . Based on interview and document review, the hospital failed to develop effective policies and procedures to detect and report drug diversion for all staff with access to controlled substances (Item #1) and failed to identify the diversion of controlled substances in such a manner as to minimize the time frame between the actual loss or diversion to the time of detection (Item #2). Failure to adopt and implement effective processes to detect diversion of controlled substances as soon as possible places patients at risk of exposure to bloodborne pathogens, inadequate sedation or pain control, and/or harm due to substandard care delivered by an impaired practitioner and places staff at risk of harm or death due to unintended overdose. Reference: American Society of Health System Pharmacists (ASHP) Guidelines on Preventing Diversion of Controlled Substances Findings included: Item 1 Effective Policies for Diversion Detection 1. Review of the policy titled, “Drug Diversion Investigation and Response (UW Medicine),” revised 12/22, showed: a. Drug diversion is defined as intentionally and without proper authorization, using or taking possession of a prescription medication or anesthetic gas from UW Medicine supplies, UW Medicine patients, UW Medicine property, or using UW Medicine prescription, ordering, or dispensing systems. b. Examples of drug diversion include, but are not limited to, medication theft, using or taking possession of a medication without a valid order or prescription, using or taking possession of medication waste. Review of the hospital policy titled, “Controlled Substances: Auditing and Surveillance,” last reviewed 05/23, showed that: a. Controlled substance audits will be conducted on a regular basis to verify compliance with applicable policies and regulations and identify potential diversion. b. Pharmacy staff will conduct audits of controlled substance (CS) transactions and documentation. The audit will cover a number of areas including the ordering, inventory management, reconciliation of discrepancies, and document retention. 2. On 08/26/25 at 10:30 AM, Investigator #1 reviewed hospital documents and interviewed the Director of Pharmacy (Staff #6) and the Inpatient Pharmacy Operations Manager (Staff #11). During the interview, Staff #6 stated that the pharmacy conducts a weekly review of Pyxis transactions including post discharge transactions, emergency department and anesthesia unreconciled CS transactions (mismatch between what was withdrawn as compared to administration or disposition records), overrides, hand entered patients, discrepancy resolution audits, open discrepancies and returns through anesthesia stations transactions. Individual usage compared to peers is not included in the process. Staff #6 stated that the pharmacy is trialing a retrospective two week review process for inpatient nursing units at a rate of one unit per week, to analyze individual user data for number of override removals, CS canceled transactions, waste of CS greater than 120 minutes, undocumented waste greater than 24 hours, delay in administration greater 60 minutes, CS dispenses after patient discharge, hand entered patients, whole dose wastes, returns greater than 120 minutes, unreconciled transactions, and the average percent of unreconcilable transactions. Results of the review are to be shared with the unit manager during the week post audit, or as soon as possible for follow-up. 3. On 08/27/25 at 11:05 AM, Staff #6 provided the Investigator with a document titled, “Harborview Inpatient Nursing Unit Controlled Substance Audits,” no policy number, updated 08/25. The Investigator noted that the document did not include the post anesthesia care unit (PACU). At 1:30 PM, Staff #6 provided the Investigator with a document titled, “Harborview PACU Controlled Substance Audits,” no policy number, updated 08/25. Staff #6 confirmed that the documents had been written after the start of the investigation and that the trial process did not include monitoring of all staff with access to controlled substances in procedural units, such as the cardiac catheterization lab, interventional radiology, endoscopy or the operating room. During the interview, Staff #6 also confirmed that the hospital’s current CS audit process did not include regular monitoring of anesthesia providers. Item #2 Timely Identification of Diversion Findings included: 1. Review of the hospital policy titled, “Drug Diversion Investigation and Response (UW Medicine),” last reviewed 12/22, showed the following: a. Examples of drug diversion include medication theft and using or taking possession of medication waste. All suspected incidents of drug diversion will be thoroughly investigated. b. Suspicion of drug diversion may arise from a variety of circumstances including notification of suspected drug diversion by a coworker or an external source. c. Upon notification of suspected drug diversion, the supervisor will perform an initial safety assessment and promptly call their immediate supervisor or Administration on Call, the Director of Pharmacy (DOP), and the Drug Diversion Prevention (DDP) Specialist. d. Upon notification of suspected diversion, the DDP Specialist or DOP will initiate a preliminary investigation to review records as necessary, and if reasonable suspicion still exists, the DDP Specialist or DOP will convene a Drug Diversion Assessment Response Team (DDART). e. The DDART is responsible for overseeing the investigatory process and reviewing the evidence to determine the next steps which may include further investigation, additional surveillance, or an investigatory interview with the staff involved. Review of the hospital policy titled, “Controlled Substances: Auditing and Surveillance,” last reviewed 05/23, showed that controlled substance audits will be conducted on a regular basis to verify compliance with applicable policies and regulations and identify potential diversion. Staff #1 2. A review of hospital documents showed that in October 2023, pharmacy reports showed that an anesthesia resident (Staff #1) had transactions suspicious for controlled substance (CS) diversion. Staff #1 had a high amount of CS full dose wastes, a few unreconciled dispenses, instances of manual entry of patients into the Pyxis system and a pattern of removing CS from the Pyxis well before scheduled case start times. A preliminary hospital investigation on 10/26/23 confirmed that Staff #1’s actions were suspicious for diversion. On11/08/23, the DDART conducted an investigatory meeting with Staff #1. Hospital documents showed that Staff #1 agreed the reports could be interpreted as suspicious but denied diverting CS and attributed the anomalies to a lack of training about the hospital’s processes for controlled substance handling and stewardship. Documents showed Staff #1 received coaching and education on CS handling and stewardship, and the pharmacy would conduct additional surveillance. There was no evidence of drug testing for reasonable suspicion, that Staff #1 was placed on administrative leave or that their Pyxis access was temporarily revoked between 10/26/23 and 11/08/25, or that Staff #1’s anomalies were compared to peer anomalies to determine the standard deviation from normal. Hospital documents showed that additional surveillance for Staff #1 consisted of a retrospective report for the time period of 11/1/23-03/01/24 which showed 4 instances of whole dose waste. Staff #1’s practice was considered improved. The investigator found no further evidence of CS surveillance, and Staff #1 continued working as an anesthesia resident. On 01/13/25, an outside facility notified hospital leadership that during their residency rotation, Staff #1 was confirmed to have diverted fentanyl and hydromorphone. On 02/04/25, 22 days after notification, the hospital began a new investigation into Staff #1’s CS activity. On 02/10/28, 28 days after their initial notification, the DDART team was activated to investigate Staff #1’s unusual CS transactions including multiple instances of whole dose waste and hand entering patients. During the DDART investigation, Staff #1 admitted they were diverting CS. Staff #2 3. A review of hospital documents showed that Staff #2 was contracted as a travel nurse in a procedural unit. Staff #2’s contract ended on 05/25/25. In June 2025, hospital documents showed Staff #2 was a significant outlier for canceled transactions of diphenhydramine, ketorolac, and ondansetron (commonly diverted non-controlled substances). Pharmacy review of medication room video showed Staff #2 canceling transactions in the Pyxis but removing and pocketing vials of the canceled medications. The hospital found no documentation showing that Staff #2 returned or administered the medications removed during the canceled transactions. Additional review showed that while working in a procedural area where hydromorphone was rarely used, Staff #2 removed hydromorphone for a patient without an active order and then documented a full dose waste. 4. On 08/27/25 10:00 AM and 11:40 AM, and on 09/08/25 between 9:30 AM and 11:30 AM, the investigator conducted document review and interview with the Director of Pharmacy (Staff #6). Review and interview showed that the pharmacy’s current process includes a retrospective two week review of inpatient nursing units at a rate of one unit per week with results of the review shared with the unit manager during the week post audit or as soon as possible for follow-up. Staff #6 confirmed that at the current review rate, each inpatient unit audit would occur approximately once every 3 months. Staff #6 confirmed that the current process did not include procedural areas and would not include staff who had not worked in a unit during the 2 week retrospective review period. Staff #6 confirmed the hospital did not have a process to ensure the timely review of CS audits for travel or agency staff or for staff who frequently float between different departments. Staff #6 confirmed that the hospital did not have a current process to promptly identify CS diversion by anesthesia providers and residents. .”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 38532 . Based on interview, record review, and review of hospital policies and procedures, the hospital failed to protect and promote patient rights. Failure to protect and promote each patient’s rights risks physical and psychological harm. Findings included: 1. The hospital failed to meet complaint response times. Cross Reference A0123 2. The hospital failed to follow informed consent procedures according to accepted standards of practice. Cross Reference A0131 3. The hospital failed to ensure providers ordered the level and type/technique of restraint based on assessment and the patient’s condition. Cross Reference: A0168 4. The hospital failed to ensure providers placed orders for restraint or seclusion. Cross Reference: A0168 5. The hospital failed to ensure staff obtained a provider orders when restraints were reapplied. Cross Reference: A0169 6. The hospital failed to ensure staff followed approved policies and procedures for restraint monitoring. Cross Reference: A0175 7. The hospital failed to ensure that patients placed in restraints or seclusion received a face-to-face assessment within one hour by a physician or licensed independent practitioner Cross Reference: A0178 Due to the scope and severity of deficiencies under 42 CFR 482.13, the Condition of Participation for Patient Rights was NOT MET. .”

“PATIENT RIGHTS: NOTICE OF GRIEVANCE DECISION CFR(s): 482.13(a)(2)(iii) At a minimum: In its resolution of the grievance, the hospital must provide the patient with written notice of its decision that contains the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion. This Standard is not met as evidenced by: 38532 . . Based on interview, document review, and review of policies and procedures, the hospital failed to complete and send written communication (extension letter) to the complainant when the investigation was not going to be completed within stated timeframes for 3 of 3 grievances reviewed (Patient #701, #702, and #703). Failure to meet complaint response times is a violation of the patient’s right to a timely response to concerns. Findings included: 1. Document review of the hospital’s policy and procedure titled, “Patient Grievance Policy, no number, last reviewed 04/25, showed the following: a. Complaints that cannot be resolved at the point of service, are considered grievances. b. Any written complaint about patient care, access to care the patient relations office will send out an acknowledgement letter and the patient rights and responsibilities notice, within 7 days. c. The Patient Relations Office (PRO) will send out a resolution letter within 30 business days. d. If the grievance requires additional time for the resolution, the PRO will advise the patient or their representative of the timeline for the extension, up to an additional 30 days. 2. On 05/15/25 between 9:37 AM and 11:00 AM, Surveyor #7 and the Director of Patient Relations (Staff #701) reviewed 3 grievances investigated by the hospital. The review showed the following: a. The grievance for patient #701 was received by the hospital on 01/15/25. Surveyor #7 found no evidence of a closure letter. b. The grievance for Patient #702 was received by the hospital on 01/16/25. Surveyor #7 found no evidence of a closure letter. c. The grievance for Patient #703 was received by the hospital on 01/17/25. Surveyor #7 found no evidence of a closure letter. 3. At the time of the review, Staff #701 verified that the 3 grievances reviewed had no closure letters sent to the patients. .”

“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: 38532 . Based on document review and interview, the hospital failed to ensure that staff followed its policy and procedure for surgical consent in 1 of 1 patients (Patient #301). Failure to follow informed consent procedures according to accepted standards of practice places patients at risk for unauthorized procedures or care, poor patient outcomes, and violates their right to be involved in care decisions. Findings include: 1. Document review of hospital policy and procedure titled, “UW Medicine Informed Consent Manual,” no policy number, last revised 06/22, showed the following: a. Consent is limited to the procedure or treatment discussed with the patient and noted on the form. b. Additional or modified consent is required for additional procedures. Document review of the hospital procedure titled “Preoperative Preparation of Inpatient Adults” (no number, last reviewed 09/21) showed that when telephone consent is obtained, the person giving consent must be identified on the form along with the signature of the staff member witnessing the call. 2. On 05/14/25 between 1:30 PM and 3:45 PM, Surveyor #3, Clinical Nurse Specialist (CNS Staff #309), CNS (Staff #310), and Nurse Manager (Staff #301) completed a medical record review. The review showed the following: a. On 05/11/25 at 6:07 PM, the provider documented that consent for exploratory laparotomy, possible resection, possible ostomy, and possible temporary closure was obtained from Patient #301’s authorized representative. The telephone monitored consent box was checked, and the witness signature box was blank. b. On 05/11/25 at 7:19 PM, Patient #301 underwent an exploratory laparotomy, colonoscopy, and temporary abdominal closure. During the review, Staff #310 stated that a witness should have signed the consent form when the procedure was discussed with the patient’s representative, and the additional procedures should have been listed. .”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) The use of restraint or seclusion must be in accordance with the order of a physician or other licensed independent practitioner who is responsible for the care of the patient as specified under §482.12(c) and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 38532 . Item #1 Type/Technique of Restraint Based on record review, interview, and review of hospital policy and procedures, the hospital failed to develop and implement policy and procedures to ensure providers wrote orders for restraints which were specific to the type and number of restraints required 5 of 5 patient records reviewed (Patients #504, #511, #512, #707 and #1007 ). Failure to order the correct level and type of restraint based on assessment and the patient’s condition places patients, staff, and others at risk for serious physical or psychological harm due to inappropriate use of restraint or restraint type and is a violation of patients’ rights. Reference: CFR 482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of 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. Findings included: 1. Document review of the hospital’s policy titled, “Restraint Management (APOP 5.33A), policy number 5.33A, reviewed 03/24, showed the following: a. A Physician or Licensed Independent Practitioner order is required for all uses of restraint. b. The type and level of restraint necessary is determined by the clinician directing the application of the restraint with the goal of maintaining patient and staff safety while using the least restrictive means of restraint. Document review of the hospital document titled, “Restraint Violent/Self-Destructive Reevaluation Protocol,” dated 03/23, showed the following: a. Reduce, increase, or continue based on indications/criteria listed below. Discontinue restraint when indications for restraint are no longer present. b. In the column titled, “Less Restrictive Measure Not Effective:” 5-point restraint i. Patient has harmed/attempted to harm self or others ii. Patient is unable to be safe out of restraint. 4-point restraint i. Patient can demonstrate a pattern of safe behavior with restraint ii. Patient is unable to be safe out of all restraint. 3-point restraint i. Patient can demonstrate a pattern of safe behavior with restraint. ii. Patient is unable to be safe out of all restraint. 2-point restraint i. Patient can demonstrate a pattern of safe behavior with restraint reduction. ii. Patient is unable to be safe out of restraint. 1-point restraint i. Harborview Medical Center: No 1-point restraint, minimum of 2 unless medically contraindicated) 0-point restraint i. Patient can demonstrate a pattern of behavior that shows they are no longer an imminent risk to self or others with restraint reduction. 2. On 05/14/25 at 10:05 AM, Surveyor #5, the Associate Chief Nursing Officer for Emergency Department Services and Staff Development (Staff #501), reviewed the medical record for Patient #504, who was receiving care in the Emergency Department for the treatment of Paranoid Delusions. The review showed the following: a. On 05/13/25 at 4:40 PM, a provider ordered Violent Restraints. The patient was placed in a left wrist and right ankle locking restraint. Surveyor #5 found no evidence that the provider ordered the specific type or level (amount) of restraint. At the time of the review, Staff #501 stated that the hospital policy was that “type” of restraint meant violent or non-violent, and that it was the staff’s discretion on the kind and how many to apply. 3. On 05/14/25 AT 10:43 AM, Surveyor #7 and an Assistant Nurse Manager (Staff #708) reviewed the medical record for Patient #707, who was in a Broda chair, with the table/tray locking in the back of the patient chair, in 3-point locking restraints and bilateral mitts. The review showed the following: a. An order for “Restraints Non-Violent or Non-self-destructive” was placed on 05/12/25 at 5:54 PM; no amount or type of restraint was noted on the order. b. Flow sheet documentation on 05/11/25 shows the patient is in 3-point restraints that include left hand mitt, left wrist soft restraint, and left wrist locked restraint. c. Flow sheet documentation showed the patient is “up in chair” on 05/12/25 from 8:00 AM until 4:00 PM, and on 05/14/25 from 8:46 AM until the time of observation at 10:43 AM. Surveyor #7 found no order for the Broda chair restraint. d. Flow sheet documentation on 05/14/25 from 12:00 AM until 10:00 AM showed the patient in bilateral mitts, bilateral locking wrist restraints, and a locking right ankle restraint. Surveyor #7 found no additional order for restraints after the “Restraints Non-Violent or Non-self-destructive”order on 05/12/25 at 5:54 PM. 5. At the time of the review, Staff #708 verified there was no order for the Broda chair restraint, and that the order placed on 05/12/24 at 5:54 PM did not contain the type/amount of restraint that the patient was to be placed in. 6. On 05/15/25 at 11:00 AM, Surveyor #5, the Associate Chief Nursing Officer for Emergency Department Services and Staff Development (Staff #501) and the Psychiatric Emergency Services (PES) Manger (Staff #506) reviewed the medical record for Patient #511 who was admitted to the Emergency Department on 05/12/25 at 7:43 AM for the treatment of Suicidal Ideation with a Plan. The patient arrived via private vehicle. The review showed the following: a. On 05/13/25 at 5:45 AM, a nursing note showed the patient was standing in the room looking blankly around. On approach, he stated that he was confused and was unable to state his name, where he was, or the date and year. At 6:00 AM, the patient was placed in 2-point locking violent restraints and was moved from the Psychiatric Emergency room to the main Emergency Department for assessment of Stroke symptoms. b. On 05/13/25 at 6:30 AM, the provider ordered violent restraint. Surveyor #5 found no evidence that the provider ordered the specific type or level (amount) of restraint. 7. At the time of the review, Staff #501 verified the finding and provided the Surveyor with a copy of the hospital protocol that guides staff in increasing and decreasing the number or amount of violent restraints. 8. On 05/15/25 at 12:00 PM, Surveyor #5 and the Associate Chief Nursing Officer for Emergency Department Services and Staff Development (Staff #501) and the 5E Nurse Manager (Staff #507), reviewed the medical record for Patient #512, who was admitted to the Emergency Department on 05/12/25 for attempted suicide by overdose. The patient was transferred to an inpatient unit, and on 05/13/24 at 10:42 PM, the patient attempted to elope. The patient was then placed in a 4-point restraint. a. On 05/12/24 at 10:42 PM, a provider ordered violent restraints. Surveyor #5 found no evidence that the provider ordered the specific type or level (amount) of restraint. 9. Staff #501 stated that the hospital’s policy was to order violent or non-violent. 10. On 05/15/25 at 2:00 PM, Surveyor #10, a clinical director (Staff #1005), an ICU nurse manager (Staff #1013), and a nurse educator (Staff #1001) reviewed the medical record of Patient #1007, who was admitted to the Trauma Surgical ICU on 03/10/25 at 5:30 AM. The review showed the following: a. On 03/10/25 at 9:51 PM, a physician ordered Restraints Non-Violent or Non-Self Destructive, for the reason of cognitive impairment- disrupts necessary invasive devices. The order did not specify what type of restraint to apply. b. On 03/11/25 at 10:15 PM, the patient was placed in 4-point locked restraints to the bilateral wrists and bilateral ankles. A physician order for Restraints Non-Violent or Non-Self Destructive, for the reason of cognitive impairment-disrupts necessary invasive devices, was placed on 03/11/25 at 9:51 PM. The order did not specify what type of restraint to apply. 11. At the time of the review, Surveyor #10 asked Staff #1005 about who determined what type of restraint to use, since Patient #1007 had soft, locking, wrist and ankle restraints applied without orders indicating which to use. Staff #1005 said the provider order shows what type of restraint - non-violent or violent. Staff assess the patient’s condition and determine the least restrictive tool to use, which can mean removing or adding tools within a restraint episode. Item #2 Order for Restraint Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure that there were providers’ orders for restraint for 2 of 3 patients reviewed. (Patient #704 and #705) Failure to place orders for restraint or seclusion staff and risks psychological harm, loss of dignity, and violation of patient rights. Reference: CFR 482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of 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. Findings included: 1. Document review of the hospital policy titled, “Restraint Management”, APOP #5.33A, last revised 03/24, showed the following: a. “As soon as possible” is defined as within 60 minutes. b. A physician or LPI order is required for all uses of restraints. c. Restraint is defined as any manual hold, physical hold, or mechanical device that reduces the ability of the patient to move their arms, legs, body, or head and cannot be easily removed by the patient. 2. Flowsheet review titled “restraint type (NV) Every 2 hours” showed “Chair with Table” as an option for non-violent restraints. 3. On 05/13/25 at 10:30 AM, Surveyor #7 and the Nurse Manager of the 3WH Unit (Staff #702) observed Patient #704 in the hallway in a Broda chair, a wheelchair that can recline and has a tray table. Patient #704 had a tray on the chair that was clipped at the back of the chair, out of the patient’s reach. Surveyor #7 interviewed Patient #704, who advised that they could not get the tray off the chair. 4. On 05/13/25 at 10:37 AM, Surveyor #7 and Staff #702 reviewed the medical record for Patient #704, who was restrained in a Broda chair in the hall. Surveyor #7 found no order for restraint, nor any documentation at all related to Patient #704 being placed in the Broda chair. 5. At the time of the review, Staff #702 verified that the tray table was clipped behind the back of the Broda chair, that the patient could not reach the clip to remove the tray table, and that there was no order for restraint in the chart. 6. Surveyor #7 interviewed Staff #702 and an Assistant Chief Nursing Officer (Staff #703), who advised that the Broda chair was not considered a restraint. 7. On 05/13/25 at 11:09 AM, Surveyor #7 observed a Registered Nurse (Staff #704) passing medications to Patient #705. Surveyor #7 observed Patient #705 was in a Broda chair with the tray table clipped at the back of the chair. 8. At the time of the observation, Staff #704 verified the patient was in a Broda chair with the tray table clipped at the back of the chair out of the patient’s reach. 9. On 05/15/25 at 3:30 PM, Surveyor #7 and an Assistant Chief nursing officer (Staff #705) reviewed the medical record for Patient #705, who was in a Broda chair with the tray table clipped behind the back of the chair. Surveyor #7 found no order for restraint in the patient’s chart or documentation indicating the patient was in the Broda chair. 10. At the time of the review, Staff #705 verified there was no order for restraint in the patient’s chart. .”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(6) Orders for the use of restraint or seclusion must never be written as a standing order or on an as needed basis (PRN). This Standard is not met as evidenced by: 38532 . Based on interview, record review, and review of hospital policies and procedures, the hospital failed to ensure that hospital staff members did not reapply physical restraints on an “as needed” basis without first obtaining a providers order for 2 of 2 patients with restraints removed and reapplied reviewed (Patient #504, #707, and #1007). Failure to obtain a provider order when restraints are reapplied puts patients at risk for not having appropriate physician re-evaluations based on their changing conditions, and is a violation of patients’ rights. Reference: CFR 482.13(e)(6) - Orders for the use of restraint or seclusion must never be written as a standing order or on an as-needed basis (PRN). Findings included: 1. Document review of the hospital’s policy titled, “Restraint Management (APOP 5.33A), policy number 5.33A, reviewed 03/24, showed the following: a. There will be no standing or as-needed (PRN) orders for restraint use. If a patient was recently released from restraint or seclusion and then exhibits behaviors that can only be handled through the reapplication of restraint or seclusion, a new order would be required. b. A “trial, release” constitutes PRN use of restraint or seclusion and, therefore, is not permitted. Document review of the hospital document titled, “Restraint Violent/Self-Destructive Reevaluation Protocol,” dated 03/23, showed the following: a. Reduce, increase, or continue based on indications/criteria listed below. Discontinue restraint when indications for restraint are no longer present. b. In the column titled, “Less Restrictive Measure Not Effective:” 5-point restraint i. Patient has harmed/attempted to harm self or others ii. Patient is unable to be safe out of restraint. 4-point restraint i. Patient can demonstrate a pattern of safe behavior with restraint ii. Patient is unable to be safe out of all restraint. 3-point restraint i. Patient can demonstrate a pattern of safe behavior with restraint. ii. Patient is unable to be safe out of all restraint. 2-point restraint i. Patient can demonstrate a pattern of safe behavior with restraint reduction. ii. Patient is unable to be safe out of restraint. 1-point restraint i. Harborview Medical Center: No 1-point restraint, minimum of 2 unless medically contraindicated) 0-point restraint i. Patient can demonstrate a pattern of behavior that shows they are no longer an imminent risk to self or others with restraint reduction. 2. On 05/14/25 at 10:05 AM, Surveyor #5, the Associate Chief Nursing Officer for Emergency Department Services and Staff Development (Staff #501), and the Assistant Administrator for Behavioral Health and Primary Care (Staff #505) reviewed the medical record for Patient #504, who was receiving care in the Emergency Department for the treatment of Paranoid Delusions. The review showed conflicting documentation in the restraint flow sheets. Surveyor #5 was unable to determine based on the timing of the documentation if the patient was removed from restraint and restraints reapplied, or if it was a continuous episode from the main Emergency Department to the Psychiatric Emergency Department (a unit within the Emergency Department). At the time of the review, Staff #505 stated that it was hospital policy that staff can increase or decrease the number or amount of restraints without a provider order. They can go from 2-point to 3-point, to 4-point without a new order as the hospital considers the restraint an episode. If staff decrease the restraint from 3-points to 2-points, they can increase the restraint (for example, go from 2-point to 4-point) without a provider order, as it is still the same episode of restraint. If restraints are removed completely, then staff would need to obtain a new order. Staff #505 stated that the hospital had a protocol to guide staff for reducing or increasing physical restraints. 3. On 05/14/25 AT 10:43 AM, Surveyor #7 and an Assistant Nurse Manager (Staff #708) reviewed the medical record for Patient #707, who was in a Broda chair, with the table/tray locking in the back of the patient chair, in 3-point locking restraints and bilateral mitts. The review showed the following: b. Flow sheet documentation on 05/11/25 showed the patient is in 3-point restraints that include left hand mitt, left wrist soft restraint, and left wrist locked restraint. c. On 05/14/25 from 12:00 AM until 10:00 AM (a period of 10 hours), staff placed the patient in additional retraint. Flow sheet documentation showed on the patient was in left and right mitts, left and right locking wrist restraints, and a locking right ankle restraint. 5. At the time of the review, Staff #708 verified that a provider order was not obtained when staff placed the patient in additional restraint. 6. On 05/15/25 at 2:00 PM, Surveyor #10, a clinical director (Staff #1005), an ICU nurse manager (Staff #1013), and a nurse educator (Staff #1001) reviewed the medical record of Patient #1007, who was admitted to the Trauma Surgical ICU on 03/10/25 at 5:30 AM. The review showed the following: a. On 03/12/25 at 12:00 AM, locked restraints to bilateral ankles were discontinued, and reapplied at 1:00 AM. 7. Surveyor #10 found no evidence that a provider ordered the reapplication of the restraint. 8. At the time of the review, Staff #1013 confirmed that orders to remove and replace the ankle restraints were not in the medical record. Surveyor #10 asked Staff #1005 about who determined what type of restraint to use, since Patient #1007 had soft, locking, wrist and ankle restraints applied without orders indicating which to use. Staff #1005 said the provider order shows what type of restraint - non-violent or violent. Staff assess the patient’s condition and determine the least restrictive tool to use, which can mean removing or adding tools within a restraint episode. .”

“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 independent 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: 38532 . Based on record review, interview, and review of hospital policies and procedures, the hospital failed to ensure that hospital staff members monitored a patient while in restraints as directed by the hospital’s restraint policy for 1 of 2 patients not located in a psychiatric or emergency area reviewed (Patient #1007). Failure to follow approved policies and procedures for restraint monitoring risks physical and psychological harm, loss of dignity, and violation of patient rights. Reference: §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 who have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. Findings included: 1. Document review of the hospital’s policy titled, “Restraint Management (APOP 5.33A), policy number 5.33A, reviewed 03/24, showed the following: a. Observation and monitoring of patients on the psychiatric units and in the Emergency Department will occur at least every 15 minutes. Observation and monitoring in other clinical areas of patients in restraints will occur at least every 2 hours. 2. On 05/15/25 at 2:00 PM, Surveyor #10, a clinical director (Staff #1005), an ICU nurse manager (Staff #1013), and a nurse educator (Staff #1001) reviewed the medical record of Patient #1007, who was admitted to the Trauma Surgical ICU on 03/10/25 at 5:30 AM. The review showed the following: a. The “Restraints (NV)” flowsheet group “Restraint Type (NV) Every 2 Hours” showed that 2-point soft restraints to bilateral wrists started at 03/10/25 at 7:00 AM. There was no documentation in the flowsheet group “Restraint Monitoring Every 2 hours”, which has fields for assessment of circulation, mobility, fluids, food, elimination, environment check, restraint evaluation, and behaviors observed. b. The next entry in the flowsheet showed that soft restraints to bilateral wrists started at 03/10/25 at 8:00 PM, and the behavior observed was “calm”. c. Surveyor #10 found no documentation of patient monitoring or reassessment of restraints for a period of 13 hours. 3. At the time of the review, Staff #1013 verified the missing monitoring and assessment on 03/10/25. .”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(12) When restraint or seclusion is used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others, the patient must be seen face-to-face within 1-hour after the initiation of the intervention -- o By a-- - Physician or other licensed independent practitioner; or - Registered nurse or physician assistant who has been trained in accordance with the requirements specified in paragraph (f) of this section. This Standard is not met as evidenced by: 38532 . Based on interview, record review, and review of the policies and procedures, the hospital failed to ensure that patients placed in restraints or seclusion received a face-to-face assessment within one hour by a physician or licensed independent practitioner as directed by hospital policy for 1 of 3 patients in violent restraint reviewed (Patient #512). Failure to perform the required face-to-face evaluation to determine whether the patient actually meets the specific criteria for restraint or seclusion places patients at risk of harm, injury, or other decline in status. Reference: CFR 482.13(e)(12) - When restraint or seclusion is used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others, the patient must be seen face-to-face within 1 hour after the initiation of the intervention -- (i) By a - (A) Physician or other licensed practitioner; or (B) Registered nurse who has been trained in accordance with the requirements specified in paragraph (f) of this section. Findings included: 1. Document review of the hospital’s policy titled, “Restraint Management (APOP 5.33A), policy number 5.33A, reviewed 03/24, showed that a face-to-face evaluation of the patient must be completed by the Licensed Independent Practitioner or qualified psychiatric Registered Nurse within 1 hour of the initiation of the restraint. 2. On 05/15/25 at 12:00 PM, Surveyor #5 and the Associate Chief Nursing Officer for Emergency Department Services and Staff Development (Staff #501) and the 5E Nurse Manager (Staff #507), reviewed the medical record for Patient #512, who was admitted to the Emergency Department on 05/12/25 for attempted suicide by overdose. The patient was transferred to an inpatient unit and on 05/13/24 at 10:42 PM, attempted to elope. The patient was then placed in a 4-point restraint. a. On 05/12/24 at 10:42 PM, a provider ordered violent restraints. b. The face-to-face evaluation was completed on 05/13/25 at 11:16 AM (a period of 12 hours and 34 minutes). 3. At the time of the review, Staff #507 verified that the face-to-face evaluation was not documented within 1 hour of the patient being placed in restraint. .”