St Clare Hospital

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(1)(i)(B) [A restraint is-] (B) A drug or medication when it is used as a restriction to manage the patient’s behavior or restrict the patient’s freedom of movement and is not a standard treatment or dosage for the patient’s condition. This Standard is not met as evidenced by: 45663 . Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure that patients do not receive chemical restraints, as directed by hospital policy in 3 of 4 patients (Patient #901, #902, and #903) Failure to ensure that staff follow approved policies and procedures for restraint use risks severe physical and psychological harm, loss of dignity, and is a violation of patient rights. Findings included: 1. Document review of the hospital’s policy and procedure titled, “Restraint and Seclusion Policy, 964.00,” PolicyStat ID #12719679, last approved 12/22, showed the following: a. A restraint is any physical or chemical method, mechanical device, or equipment that immobilizes or reduces a patient’s ability to move or access any body part. b. The hospital uses the least restrictive form of restraint or seclusion to protect the physical safety of the patient, staff, or others. c. The hospital does not use restraints or seclusion as a means of coercion, discipline, convenience, or staff retaliation. d. Chemical restraint is not a standard use of medication to treat a patient’s medical or behavioral condition. Virginia Mason Franciscan Health (VMFH) does not use chemical restraint. 2. On 06/18/24 between 10:00 AM and 12:00 PM, Investigator #9 and Chief Nursing Officer (Staff #901) reviewed the medical records of patients who had been restrained. The review showed the following: a. On 06/15/24 at 8:34 PM, Patient #901 was brought into the Emergency Department for a mental health evaluation. At 8:36 PM, orders were placed by a provider for violent restraints and Droperidol (an antipsychotic medication) 2.5 milligrams intramuscularly, Midazolam (a sedative hypnotic medication) 2 milligrams intramuscularly (IM), and Diphenhydramine (an antihistamine and sedative) 50 mg intramuscularly. The investigator found no documentation of the application of physical restraint. At 9:00 PM, the patient’s behavior was documented as cooperative and anxious. At 9:09 PM, the patient’s behavior was documented as resting/asleep. At 9:15 PM, the patient’s behavior is documented as resting/asleep. At 9:15 PM, the patient received Droperidol 2.5 milligrams IM and Diphenhydramine 50 milligrams IM. At 9:16 PM, the patient received Midazolam 2 milligrams IM. At 9:43 PM, the provider documentation showed that the patient was taken out of violent restraint and was sleepy but arousable. b. On 06/13/24 at 7:05 PM, Patient #902 was brought into the Emergency Department for evaluation for possible drug intoxication. At 7:07 PM, the patient was placed in violent 4 point locking restraint with a chest strap. At 7:21 PM, orders were placed for Droperidol 5 milligrams injection, Midazolam 2 milligrams intramuscularly, and Diphenhydramine 50 mg intramuscularly. At 7:31 PM, the patient received Diphenhydramine 50 mg intramuscularly and Midazolam 2 milligrams intravenously. At 7:37 PM, the patient received Droperidol 5 milligrams intravenously. c. On 06/11/24 at 8:32 PM, Patient #903 was brought into the Emergency Department by a friend for evaluation for inability to care for himself. At 9:45 PM, the patient became agitated and yelling at staff and was placed in violent locking 4 point restraint. The patient’s psychological status is documented as agitated/restless, tearful, delusional, and confused. At 9:57 PM, Droperidol 2.5 milligrams intramuscularly and Lorazepam (an antianxiety medication) 2 milligrams was administered. Provider documentation on 06/12/24 at 12:50 PM, showed that the patient is too sedated to perform mental health evaluation at this time. 3. At the time of the review, Staff #901 verified the documentation of restraint as above. Investigator #9 interviewed Staff #901 regarding what the hospital considered to be a chemical restraint. Staff #901 stated that the hospital does not use chemical restraints. .”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(4)(ii) [The use of restraint or seclusion must be--] (ii) implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by hospital policy in accordance with State law. This Standard is not met as evidenced by: 45663 . Based on record review, interview, and review of the hospital policy and procedure, the hospital failed to ensure that patients placed in nonviolent restraints received a complete face-to-face assessment by a provider as directed by hospital policy for 3 of 6 patients in nonviolent restraints reviewed (Patients 905, #906, and #907). Failure to perform the required face-to-face evaluation to determine whether the patient meets the specific criteria for restraint or seclusion places patients at risk of harm, injury, or other decline in status. Findings included: 1. Document review of the hospital’s policy titled, “Restraint and Seclusion Policy, 964.00,” PolicyStat ID 1271679, last approved 12/22, showed the following: a. The organization has authorized the Physician to delegate the ordering and patient evaluation for restraint use to his/or attending Certified Provider Assistants (PA) or Advanced Registered Nurse Practitioner (ARNP). Providers must have a working knowledge of the hospital restraint and seclusion policy. b. For nonviolent restraint a new order may be issued each day after a face to face by the Provider. 2. On 05/15/24 at 9:30 AM, Investigator #9 and Nurse Educator (Staff #901) reviewed the medical record of Patient #905 who was admitted on 04/19/24 for treatment of schizoaffective disorder, bipolar type and dementia and was placed in nonviolent restraint. The review showed the following: a. An order was placed for nonviolent restraint on 05/03/24 at 3:47 PM. A progress note was completed by a provider at 3:52 PM and showed the only mention of restraint documented as “try to wean off restraint as per protocol”. b. An order was placed for nonviolent restraint on 05/04/24 at 5:47 PM. A progress note was completed by a provider at 4:38 PM and showed the only mention of restraint documented as “try to wean off restraints per protocol”. c. An order was placed for nonviolent restraint on 05/05/24 at 4:04 PM. A progress note was completed by a provider at 4:08 PM and showed the only mention of restraint documented as “try to wean off restraints per protocol”. d. Similar findings for orders and progress notes were found on 05/06/24, 05/07/24, 05/08/24, 05/09/24, 05/10/24, 05/11/24, and 05/12/24. The patient was discharged on 05/13/24. 3. At the time of the review, Staff #901 verified the documentation of restraint in the progress notes. 4. On 05/15/24 at 10:15 AM, Investigator #9 and Nurse Educator (Staff #901) reviewed the medical record of Patient #906 who was admitted on 04/30/24 for treatment of cholecystitis (inflammation of the gall bladder commonly caused by gall stones) and was placed in nonviolent restraint on 05/05/24 at 7:12 AM. The review showed the following: a. An order for nonviolent restraint was placed on 05/05/24 at 7:12 AM. A progress note was completed by a provider on 05/05/24 at 11:04 AM. The investigator found no mention of restraint or face to face in the note. The note showed that the patient was oriented to time, place, and person. b. An order for nonviolent restraint was placed on 05/06/24 at 8:46 AM. A progress note was completed by a provider on 05/06/24 at 2:26 PM. The investigator found no mention of restraint or face to face in the note. The note showed that the patient was oriented to time, place, and person. 5. At the time of the review, Staff #901 verified there was no documentation regarding restraint in the provider note. The nursing documentation showed a “no” in the face to face row of the flowsheet on 05/05/24 at 7:12 AM and “yes” in the face to face row of the flowsheet on 05/06/24. 6. On 05/15/24 at 12:15 PM, Investigator #9 and Nurse Educator (Staff #901) reviewed the medical record of Patient #907 who was admitted on 05/10/24 for treatment of respiratory failure and placed in nonviolent restraint on 05/10/24 at 10:00 AM. The review showed the following: a. An order for nonviolent restraint was placed by a provider on 05/10/24 at 11:00 AM. A history and physical was completed and filed by a provider on 05/10/24 at 11:39 AM. The investigator found no mention of restraint or face to face in the note. b. An order for nonviolent restraint was placed on 05/11/24 at 10:53 AM. A progress note was completed by a provider on 05/11/24 at 11:03 AM. The investigator found no mention of restraint or face to face in the note. 7. At the time of the review, Staff #901 verified there was no documentation regarding restraint in the provider notes. .”

“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: 45663 . Based on record review, interview, and review of the hospital policy and procedure, the hospital failed to ensure that patients placed in violent restraints received a complete face-to-face assessment by a provider as directed by hospital policy for 4 of 6 patients in violent restraints reviewed (Patients #901, #902, #903, and #904). Failure to perform the required face-to-face evaluation to determine whether the patient meets the specific criteria for restraint or seclusion places patients at risk of harm, injury, or other decline in status. Findings included: 1. Document review of the hospital’s policy titled, “Restraint and Seclusion Policy, 964.00,” PolicyStat ID 1271679, last approved 12/22, showed the following: a. The organization has authorized the Physician to delegate the ordering and patient evaluation for restraint use to his/or attending Certified Provider Assistants (PA) or Advanced Registered Nurse Practitioner (ARNP). Providers must have a working knowledge of the hospital restraint and seclusion policy. b. For violent restraint use, a one hour face to face evaluation by the provider to include: patient’s immediate situation, patient’s reaction to the intervention, patient’s medical and behavioral condition, and the need to continue or terminate the restraint or seclusion is required. 2. On 05/16/24 between 2:00 PM and 3:00 PM, Investigator #9 and Emergency Department Manager (Staff #902), Chief Nursing Officer (Staff #903), Chief Medical Officer (Staff #904), Chief Operating Officer (Staff #905) and Regulatory Manager (Staff #906) reviewed the medical records of patient’s placed in violent restraint. The review showed the following: a. Patient #901 presented to the Emergency Department for Psychotic Disorder and hallucinations. The patient was placed in violent restraint on 05/13/24 at 10:13 PM. The Investigator found no evidence a provider documented a complete face-to-face assessment. b. Patient #902 presented to the Emergency Department for Psychosis and substance use. The patient was placed in violent restraint on 05/09/24 at 5:54 AM. The Investigator found no evidence a provider documented a complete face-to-face assessment. c. Patient #903 presented to the Emergency Department for agitated and aggressive behavior after a drug overdose. The patient was placed in violent restraint on 05/04/24 at 12:51 AM. The Investigator found no evidence a provider documented a complete face-to-face assessment. d. Patient #904 presented to the Emergency Department for altered mental status and drug overdose. The patient was placed in violent restraint at 6:53 PM. The Investigator found no evidence a provider documented a complete face-to-face assessment. 3. At the time of the review, Staff #902 verified that they did not see all 4 elements of the face to face in the provider documentation. 4. Investigator #9 interviewed an Emergency Department physician (Staff #908) regarding process for completing face to face documentation in the Emergency Department. Staff #908 stated that they understood the only documentation required for the face to face was the order. .”

“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 ensure the Hospital operated under one unified Nursing Service under the direction of one Registered Nurse who was responsible for the quality of care provided to hospital patients by hospital and non-hospital nursing staff. Failure to ensure that Nursing Services are provided under the direction of one hospital-wide nursing service under the direction of one Registered Nurse accountable for the quality of nursing care provided to its patient’s places patients at risk for inconsistent or inadequate care, adverse outcomes, and death. Findings included: 1. The hospital failed to ensure the hospital operated with one hospital-wide Nursing Service, and failed to ensure that a single nursing service was under the direction of one Registered Nurse responsible for the operation of the services and the quality of the patient care provided by nursing services. Cross Reference: A0386 2. Based on interview and document review, the hospital failed to ensure the Director of Nursing Operations or designated qualified hospital registered nurse conducted clinical evaluation activities of all shared services nursing personnel who provided patient care. Cross Reference: A0398 .”

“ORGANIZATION OF NURSING SERVICES CFR(s): 482.23(a) The hospital must have a well-organized service with a plan of administrative authority and delineation of responsibilities for patient care. The director of the nursing service must be a licensed registered nurse. He or she is responsible for the operation of the service, including determining the types and numbers of nursing personnel and staff necessary to provide nursing care for all areas of the hospital. This Standard is not met as evidenced by: 45663 . Based on interview and document review, the hospital failed to ensure that St Clare Hospital operated with one hospital-wide Nursing Service and failed to ensure that a single nursing service was under the direction of one Registered Nurse responsible for the operation of the service and the quality of patient care provided by nursing services. Failure to ensure that Nursing Services are provided under the direction of one Nursing Service under the direction of one Registered Nurse places patients at risk for suboptimal care, adverse outcomes, and death. Findings included: 1. Document review of the hospital’s organizational chart titled, “St. Clare Hospital,” dated 2023, showed the following: a. The Med Tele Units, Progressive Care Unit, Intensive Care Unit, Ortho/Surgical, Outpatient Oncology, and Emergency Services reported directly to the Director of Nursing Operations. b. Perioperative Services including Surgery Services and Sterile Processing, Recovery Services, and Interventional Radiology Nursing Services report directly to the Chief Operating Officer. c. The Organization chart stated that positions with a solid line indicated a direct report. The position of Perioperative Services Director showed a solid line to the Chief Operating Officer. Document review of the Job Description for the job title, “Director Perioperative Services,” states that the position reports to, “Depends on assigned facility.” Under the section titled, “Job Summary,” the document stated, “working closely with the Medical Director and other hospital department managers to integrate/coordinate/evaluate all phases of patient care, and “providing input to the hospital President for development, implementation, monitoring, and other operational issues.” Investigator #9 found no evidence Perioperative Services or the Perioperative Services Director, Surgery Services and Sterile Processing, Recovery Services, or Interventional Radiology Nursing Services was under the direction of the Director of Nursing Operations. 2. On 03/21/24 at 4:05 PM, Investigator #9 and the Director of Nursing Operations (Staff #911) discussed the hospital’s organizational chart and oversight of nursing services. Staff #911 verified that all Perioperative Services reported to the Chief Operating Officer. Staff #911 verified that they were the nurse who had oversight for the rest of the nursing services within the hospital. Staff #911 stated that that the Director of Nursing Operations and the Chief Operating Officer collaborate, meet monthly, and provide dual oversight. Staff #911 was unable to provide any documentation of this collaboration as there were no meeting minutes. .”

“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 . Based on interview and document review, the hospital failed to ensure the Director of Nursing Operations or designated qualified hospital registered nurse conducted clinical evaluation activities of all shared services nursing personnel who provided patient care. Failure to evaluate the nursing care provided by non-hospital personnel by a qualified hospital registered nurse risks patients receiving inconsistent or inadequate care. Findings include: 1. Document review of the hospital’s organizational chart titled, “St. Clare Hospital,” dated 2023, showed that Wound Care Services and Gastroenterology Services are not listed on the organizational chart, and both provide nursing services to patients receiving care at St Clare Hospital through a shared service agreement. Document review of the hospital agreement titled, “Reciprocal Shared Services and Employee Lease Agreement by and Among Franciscan Health System and its Affiliated Entities, Hospitals, and other Operations”, and “Statement of Work” (SOW), no policy number, no date, showed the following: a. The “Lessor” will provide technical or professional personnel (“leased employee”) to another (the “Lessee”) to perform services on behalf of the other. b. The Lessee shall exercise exclusive oversight, direction, and clinical supervision of the leased employee. c. The Lessee shall evaluate the leased employee’s job performance on a regular basis and provide such an evaluation to the Lessor. 2. On 03/21/24 at 4:05 PM, Investigator #9 and the Director of Nursing Operations (Staff #911) discussed the hospital’s organizational chart, oversight of nursing services, and evaluation of shared services. Staff #911 verified that they do not evaluate the performance of the nursing staff within the Wound Care team or Gastroenterology team that provide nursing services at the hospital. Staff #911 stated there is a manager for each of those teams and the evaluation is completed by them. .”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 47458 . 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 appropriate non-violent restraint orders places patients at risk for harm due to inappropriate application of restraint or restraint type. Cross Reference: A 0159 2. Failure to obtain a physician’s written restraint order places patients at risk for harm due to inappropriate application of restraint or restraint type. Cross Reference: A 0168 3. Failure to ensure staff limit the use of restraints to the least restrictive intervention risks serious physical and psychological harm, loss of dignity, and violation of patient rights. Cross Reference: A 0174 4. Failure to follow approved policies and procedures for restraint or seclusion use risks physical and psychological harm, loss of dignity, and violation of patient rights. Cross Reference: A 0175 5. Failure to ensure medical staff receive restraint and seclusion training risks patient injury or decline in status from improper application, assessment, or removal. Cross Reference: A 0176 Due to the cumulative effect of these findings, the Condition of Participation at 42 CFR 482.13 Patient Rights was NOT MET. .”

“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: 45663 . Based on record review, interview, and review of hospital policy and procedures, hospital staff failed to appropriately order the application of non-violent restraints for 1 of 3 non-violent restraint patients reviewed (Patient #205). Failure to obtain appropriate non-violent restraint orders places patients at risk for harm due to inappropriate application of restraint or restraint type. Findings include: 1. Document review of the hospital’s policy and procedure titled, “Restraint and Seclusion Policy, 964.00,” PolicyStat ID #12719679, last approved 12/22, showed the following: a. Virginia Mason Fransciscan Health does not use side rails as a restraint. 2. Document review of the hospital’s policy and procedure titled, “Fall Prevention and Management,” PolicyStat ID 12592642, last approved 04/23, showed the following: a. All patients will be assessed at the time of admission, every shift, upon transfer to another level of care, and after a fall. b. Interventions for high fall risk include maintaining a safe environment, considering moving the patient closer to the nurse’s station, use of a bed alarm, applying a fall mat with the non-beveled edge next to the bed, and use of a virtual companion or sitter. c. Use of a posey vest or side rails is not included in the Morse Falls Assessment and Interventions Tool. 3. On 03/20/24 between 1:55 PM and 3:15 PM, Investigator #2 and the Intensive Care Unit Nurse Manager (Staff #201), and the Medical/Telemetry and Orthopedic Unit Based Educator (Staff #207) reviewed the medical record of Patient #205 who was an 88-year-old male admitted to the Orthopedic Unit on 10/10/23 with a diagnosis of generalized weakness secondary to hyponatremia and recurrent falls. The review showed the following: a. On 10/10/23 at 10:58 PM, Patient #205 had a provider order for non-violent restraints to include four side rails. b. On 10/11/23 at 6:28 PM, Patient #205 had a provider order for non-violent restraints to include four side rails. c. On 10/10/23 at 10:58 PM, Patient #205 had a provider order for non-violent restraints to include four side rails. 4. At the time of the review, Staff #201 verified the non-violent restraint order and interventions ordered. .”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§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. This Standard is not met as evidenced by: 47458 . Item 1 - Timely order for restraint Based on record review, interview, and review of hospital policy and procedures, hospital staff failed to obtain a physician’s order for the application of nonviolent behavioral restraints in a timely manner for 1 of 3 non-violent restraint patients reviewed (Patient #908). Failure to obtain a physician’s written restraint order places patients at risk for harm due to inappropriate application of restraint or restraint type. Findings included: 1. Document review of the hospital’s policy and procedure titled, “Restraint and Seclusion Policy, 964.00,” PolicyStat ID 6436707, last approved 06/19, showed that if a provider is not available at the time of the assessment indicating the need for restraint and least restrictive measures have failed, a Registered Nurse may initiate a restraint to protect the patient, staff, or others from harm. An order is obtained from the provider as soon as possible after initiation. 2. On 03/20/24 and 03/21/24, Investigator #9 and Nurse Educator (Staff #908) reviewed the medical record of Patient #908 who was a 69 year old admitted on 11/22/20 for altered mental status. The review showed that Patient #908 was placed in a posey vest on 11/25/20 at 5:30 AM for attempting to get out of bed. The patient had right and left wrist restraints applied on 11/25/20 at 9:30 AM for pulling out the intravenous line. The wrist restraint order was entered at 6:39 PM (a period of approximately 9 hours) after the application of the restraint. 3. At the time of the review, Staff #908 verified the timing of the provider order for restraint. Item 2 - Violent restraint orders Based on record review, interview, and review of hospital policy and procedures, hospital staff failed to obtain a physician’s order for the application of a chest strap restraint for 1 of 3 violent restraint patients reviewed (Patient #907). Failure to obtain a physician’s written restraint order places patients at risk for harm due to inappropriate application of restraint or restraint type. Findings included: 1. Document review of the hospital’s policy and procedure titled, “Restraint and Seclusion Policy, 964.00,” PolicyStat ID 12719679, last approved 12/22, showed the following: a. Restraint and Seclusion require an order from a Physician or Licensed Provider. b. The order must include the type, reason, and duration. c. The type of restraint must include the device and location/laterality. 2. On 03/22/24 between 9:10 AM and 10:00 AM, Investigator #9 and the Nurse Manager of the Emergency Department (Staff #901) reviewed the medical record of Patient #907 who was a 39-year-old brought into the Emergency Department on 03/19/24 evaluated for altered mental status. The review showed that on 03/19/24 at 6:30 PM, a chest strap restraint was applied in addition to the 4-point locking restraints. Investigator #9 found no evidence of an order for the chest strap restraint. 3. At the time of the review, Staff #901 verified the documentation and stated that there isn’t usually an order for the chest strap restraint as it is included in the policy. .”

“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: 47458 . Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure that staff limited the use of restraints to the least restrictive intervention that would be effective to protect the patient, staff member, or others from harm for 1 of 3 patients with non-violent restraint orders reviewed (Patient #205). Failure to ensure that staff limit the use of restraints to the least restrictive intervention risks serious physical and psychological harm, loss of dignity, and violation of patient rights. Findings included: 1. Document review of the hospital’s policy and procedure titled, “Restraint and Seclusion Policy, 964.00,” PolicyStat ID #12719679, last approved 12/22, showed the following: a. Restraints are any physical or chemical method, or mechanical device or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body. b. The hospital uses restraint and seclusion only when less restrictive interventions are ineffective. c. Non-violent restraints are used when behaviors interrupt medical healing such as protecting dressings, lines, tubes, or catheters or for safety when the patient is unable to comprehend or comply with instructions. d. Alternate strategies for interference with medical treatment include assessing for pain and discomfort related to the treatment, reviewing the need for treatment/interventions, changing continuous intravenous (IV) medication to intermittent or use other routes as soon as possible, placing the IV in the least restrictive/intrusive sites, covering IV with tubing/gauze/stockinette/wristbands. e. A virtual companion is a staff member who is trained to provide remote observation of a patient to promote safety. A virtual companion may be used as a least restrictive alternative to non-violent restraint. f. Virginia Mason Franciscan Health does not use side rails as a restraint. 2. Document review of the hospital’s policy and procedure titled, “Fall Prevention and Management,” PolicyStat ID 12592642, last approved 04/23, showed the following: a. All patients will be assessed at the time of admission, every shift, upon transfer to another level of care, and after a fall. b. Interventions for high fall risk include maintaining a safe environment, consider moving the patient closer to the nurses station, use of a bed alarm, applying a fall mat with the non beveled edge next to the bed, and use of a virtual companion or sitter. c. Use of a posey vest or side rails is not included in the Morse Falls Assessment and Interventions Tool. 3. On 03/20/24 between 1:55 PM and 3:15 PM, Investigator #2 and the Intensive Care Unit Nurse Manager (Staff #201), and the Medical/Telemetry and Orthopedic Unit Based Educator (Staff #207) reviewed the medical record of Patient #205 who was an 88-year-old male admitted to the Orthopedic Unit on 10/10/23 with a diagnosis of generalized weakness secondary to hyponatremia and recurrent falls. The review showed the following: a. On 10/10/23 at 10:58 PM, Patient #205 was assigned a virtual companion, bed alarm was used, they were placed in vest restraint, left and right wrist soft restraint with 4 side rails up at the same time for being unable to follow instructions and agitation. The patient remained with all methods of restraint until their death on 10/13/23 at 7:15 AM (a period of 56 hours). b. On 10/11/23 from 2:00 AM through 6:00 AM (a period of approximately 4 hours), restraint flow sheet documentation showed the patient was asleep. c. On 10/12/23 from 6:00 AM through 10:00 AM (a period of approximately 4 hours), restraint flow sheet documentation showed the patient was asleep. d. On 10/13/23 from 10:00 PM through 4:00 AM, AM (a period of approximately 6 hours), restraint flow sheet documentation showed the patient was asleep. 4. At the time of the review, Investigator #2 found no evidence that the least restrictive intervention was attempted before additional interventions were implemented. 5. On 03/21/24 at 8:30 AM, Investigator #2 interviewed two Registered Nurses (Staff #208 and #209) from the Orthopedic Unit regarding non-violent restraints. During the interview, both RNs indicated that they follow the Provider’s order of what restraint type is included on the non-violent restraint order. The routine process is to start with the side rails and vest or side rails and soft limb restraints and add vest or soft limb restraints as necessary. 6. On 03/21/24 at 8:30 AM, Investigator #9 interviewed Nurse Educator (Staff #908) about the education provided to staff regarding restraint use. Staff #908 stated that if a patient is pulling on lines or tubes, soft mitts would come first followed by soft wrist restraints. If a patient would be unsafe getting out of bed, 4 side rails would be used first and if the patient is impulsive and not redirectable and at risk for a fall, a vest restraint would be implemented. .”

“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: 47458 . Based on interview, document review, and review of the hospital policy and procedure, the hospital failed to ensure that staff members accurately documented assessments for 1 of 3 patients in violent restraints reviewed (Patient #908). Failure to follow approved policies and procedures for restraint or seclusion use risks physical and psychological harm, loss of dignity, and violation of patient rights. Reference: CFR 42.482.13 (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.” Findings included: 1. Document review of the hospital’s policy and procedure titled, “Restraint and Seclusion Policy, 964.00,” PolicyStat ID 12719679, last approved 12/22, showed the following: a. Each episode of restraint/seclusion is documented in the patient’s medical record in accordance with regulatory requirements and hospital-approved standards. b. Staff members who monitor patients in restraint will receive training in appropriate documentation. 2. On 03/22/24 between 9:10 AM and 10:00 AM, Investigator #9 and the Nurse Manager of the Emergency Department (Staff #901) reviewed the medical record of Patient #907 who was a 39-year-old brought into the Emergency Department on 03/19/24 evaluated for altered mental status. The review showed the following: a. On 03/19/24 at 5:15 PM, the patient was placed in locking 4-point restraint. Documentation showed the restraint was discontinued at 9:08 PM. b. After discontinuation of the restraint, documentation (approximately 13 entries into the medical record) from 03/19/24 at 9:15 PM until 03/20/24 at 12:17 AM, showed that the patient was in restraint. 3. At the time of the review, Staff #901 verified the inconsistencies in documentation. .”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(11) Physician and other licensed independent practitioner training requirements must be specified in hospital policy. At a minimum, physicians and other licensed practitioners authorized to order restraint or seclusion by hospital policy in accordance with State law must have a working knowledge of hospital policy regarding the use of restraint or seclusion. This Standard is not met as evidenced by: 47458 . Based on document review and interview, the hospital failed to implement minimum standards for medical staff who are authorized to order restraints. Record review showed 3 of 3 medical providers authorized to order restraint or seclusion had no documentation to demonstrate initial or periodic training as required (Staff #614, Staff #615, and Staff #616). Failure to ensure medical staff receive restraint and seclusion training risks patient injury or decline in status from improper application, assessment, or removal. Findings included: 1. Document review of the hospital’s “Virginia Mason Franciscan Health, Franciscan Medical Staff Rules and Regulations,” effective 02/27/24, showed that physicians and other practitioners authorized to order restraint or seclusion must have a working knowledge of hospital policy regarding the use of restraint and seclusion. Document review of the hospital’s policy, “Virginia Mason Franciscan Health Restraint and Seclusion Policy, 964.00, PolicyStat ID 12719679,” approved 12/22, showed that providers must have a working knowledge of the hospital restraint and seclusion policy. Addendum D: medical staff shall receive training in subjects as it relates to their duties performed under the Restraint and Seclusion Policy. Training shall take place during new employee orientations, and on a periodic basis as indicated by the results of quality monitoring activities and recommendations from Education Services. 2. On 03/21/24 from 10:10 AM to 10:30 AM, Investigator #6 reviewed medical staff personnel files with the Division Director of Peer Review (Staff #610), the Division Manager for Medical Staff Services (Staff #611), the Medical Staff Coordinator (Staff #612), and the Northwest Region Chief Medical Officer (CMO) (Staff #613). The review showed 3 of 3 medical staff records (Staff #614, Staff #615, and Staff #616) did not include documentation of restraint and seclusion training. 3. At the time of the review, Investigator #6 interviewed Staff #610, Staff #611, and Staff #612 about medical provider restraint training. Staff #612 stated that providers received restraint training at New Employee Orientation, but she was not certain of the frequency of subsequent training. .”