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Based on observation, interview and record review, the hospital failed to develop and implement effective hospital policies and procedures to ensure a safe environment that prevented hospital acquired pressure injuries (HAPI) in 1 of 4 patient records reviewed (Patient #1) (item #1), and the hospital failed to develop and implement Emergency Department (ED) policies and procedures that ensure all patients seeking emergency medical treatment are monitored, treated, reassessed, and discharged, and that staff complete documentation in the medical record according to accepted standards of practice (item #2).

Failure to develop and implement effective hospital policies and procedures for prevention of hospital acquired pressure injuries, and failure to develop and implement policies and procedures to direct patient care according to accepted standards of practice places patients at risk for harm or death due to inconsistent, delayed, and inadequate care.

Item #1 Hospital Acquired Pressure Injury Prevention (HAPI)

Findings included:

1. Document review of the hospital's patient handout titled, "Patient Rights and Responsibilities," no date, showed that all patients have the right to receive care in a safe setting, free from abuse or harassment.

Document review of the hospital's policy titled, "Scope of Service - Emergency Department," reviewed 01/24/22, showed that the emergency department (ED) is a Level 3 Trauma Center and Emergency Medical Service Department. The patient population includes newborn, pediatric, adolescent, adult and geriatric patients. All patients seeking care shall receive a medical screening exam, and all necessary definitive treatment will be provided within the capability of the hospital. ED patients are then evaluated for response to treatment and are admitted, transferred, or discharged with follow-up instructions as appropriate. The department uses the Emergency Nurses Association (ENA), Trauma Nurse Core Course (TNCC), and American College of Emergency Physicians (ACEP) standards to formulate and review policies, procedures, and standards of practice. Policies and procedures are reviewed and approved by the medical staff and leadership of the hospital.

Document review of the hospital's policy titled, "Wound Care Protocol," reviewed 08/26/22, showed that wounds will be assessed and managed by nursing in accordance with evidence-based practice and infection prevention policies. All wounds will be measured and photographed on identification, every day and on the day of discharge. All wounds should be offloaded whenever possible, even if their initial cause is not pressure related. Wound care consultation requires a provider order and is recommended for deep wounds, exudate not managed with Wound Care Protocol interventions, and any concern for complication, infection, or necrosis. The Wound Care Protocol includes interventions for Shallow Dry, Shallow Wet, Deep Dry, and Deep Wet wounds.

2. On 05/03/23 at 9:30 AM, investigators interviewed the Director of Nursing Services (Staff #2) and the ED Nurse Manager (Staff #3). The interview showed that when patients are boarding in the ED for over 24 hours and there is no plan for discharge, staff will move the patient from a gurney to a hospital bed.

3. Review of patient medical records showed the following:

Patient #1 was an 80-year-old seen in the ED on 01/03/23 for progressive weakness. Pertinent medical history included congestive heart failure, myocardial infarction (heart attack), coronary stenting, pacemaker implant, urinary retention with indwelling catheter, chronic back pain, total knee replacement, and spinal surgery. The patient reported that he had been non-ambulatory for years due to a back injury in 2003. Patient #1 discharged from an inpatient rehab facility on 12/23/22. One week prior to discharging, the patient's insurance benefits expired, and his physical therapy services ended.

The patient did not meet criteria for hospital admission, but he did not have the appropriate caregivers or resources available to return home. He remained in the ED while the social worker helped with discharge planning arrangements. Document review showed that on 01/07/23, the patient remained on a gurney in the ED. On 01/09/23 at 10:44 PM, ED nursing note documentation showed that the patient had a 15 cm Stage II sacral pressure injury. The review showed that on 01/10/23, Patient #1 transferred from the ED to the inpatient medical-surgical floor as an ED overflow patient. Upon arrival to the Medical-Surgical unit nursing staff documented photos of the patient's sacral pressure wound and another wound on the Patient's penis. Nursing note documentation showed no evidence that ED staff moved the patient to an inpatient hospital bed, performed regular skin assessments, or implemented measures to prevent pressure ulcers in an immobile patient.

4. On 05/04/23 at 1:58 PM, the Manager of Applications and Informatics (Staff #4) confirmed the investigator's findings regarding the missing documentation.

5. On 05/24/23 at 12:00 PM, an interview with the Executive Director of Quality and Compliance (Staff #1) and the Executive Director of Nursing (Staff #2) showed that the hospital did not have policies and procedures for preventing pressure ulcers in extended length of stay patients in the ED.

Item #2 Policies and Procedures to Direct Patient Care

Findings included:

1. Document review of the hospital's policy titled, "Scope of Service - Emergency Department," reviewed 01/24/22, showed that the emergency department (ED) is a Level 3 Trauma Center and Emergency Medical Service Department. The patient population includes newborn, pediatric, adolescent, adult and geriatric patients. All patients seeking care shall receive a medical screening exam, and all necessary definitive treatment will be provided within the capability of the hospital. ED patients are then evaluated for response to treatment and are admitted, transferred, or discharged with follow-up instructions as appropriate. The department uses the Emergency Nurses Association (ENA), Trauma Nurse Core Course (TNCC), and American College of Emergency Physicians (ACEP) standards to formulate and review policies, procedures, and standards of practice. Policies and procedures are reviewed and approved by the medical staff and leadership of the hospital.

2. On 05/03/23, 05/04/23, and 05/09/23, investigators requested copies of the hospital's ED policies related to patient assessment/reassessments, skin assessments and wound care, patient discharge and patient hand-off, and documentation requirements, but no policies were provided.

3. On 05/24/23 at 12:00 PM, an interview with the Executive Director of Quality and Compliance (Staff #1) and the Executive Director of Nursing (Staff #2) showed that the hospital did not have the policies and procedures requested by investigators.

4. On 05/24/23 at 12:20 PM, a telephone interview with the Director of Emergency Medicine (Staff #5) showed that the hospital did not have policies and procedures directing providers on rounding and documentation requirements in the ED.
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Based on interview, document review, and review of the hospital's quality program, the hospital failed to develop, implement, and maintain a hospital-wide, data-driven quality assessment and performance improvement program that included systematic data collection, analysis, and implementation of process improvement with oversight of the hospital's Governing Body.

Failure to systematically collect and analyze hospital-wide performance data limited the hospital's ability to identify problems and formulate action plans. This reduced the likelihood of sustained improvements in clinical care and patient outcomes.

Findings included:

1. Failure to identify, investigate, and report adverse events according to hospital policy and State requirements.

Cross Reference: C 1311

2. Failure to periodically evaluate and monitor the effectiveness of hospital quality committees.

Cross Reference: C 1315

3. Failure to identify problems, implement corrective actions, and monitor to ensure ongoing compliance with barcode scanning of patient medications prior to administration in the emergency department (ED).

Cross Reference: C 1319

4. Failure to systematically identify, collect or analyze information regarding unanticipated patient outcomes.

Cross Reference: C 1325
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Based on interview and document review, the facility failed to identify and investigate unanticipated events and report adverse events to the Department of Health according to hospital policy and State requirements for 3 of 3 patient records reviewed (Patients #1, #3, and #4).

Failure to identify, investigate, and report adverse events limits the hospital's ability to implement interventions to prevent reoccurrence, and places patients at risk of serious injury, including death.

Findings included:

1. Document review of the hospital's policy titled, "Event Reporting System," last reviewed 08/16/22, showed the following:

a. An event is an unexpected occurrence not consistent with the desired operation of the hospital.

b. An adverse event is a medical error that could have and should have been avoided. Adverse events that must be documented in the Event Reporting System include Stage III, Stage IV, and unstageable pressure ulcers and the discharge of a patient who is unable to make their own decisions (without an authorized caregiver).

c. Leadership is required to report an adverse event to the Department of Health within 48 hours of event confirmation. Then, the hospital must complete and submit a root cause analysis (RCA) and a corrective action plan within a prescribed timeframe.

Patient #1

2. Medical record review showed that on 01/03/23 at 12:49 PM an 80-year-old patient (Patient #1) arrived with complaints of weakness. Patient #1 had recently been discharged from a skilled nursing facility and was waiting for home health to start physical therapy in the home. The home health agency nurse reported concerns to the social worker that the patient needed more support at home because of frequent falls. Patient #1 was never admitted as an inpatient or observation status patient, but he remained hospitalized 12 days while the hospital social worker worked to coordinate a discharge plan for the patient. On 01/09/23, document review showed that the patient had developed a 15 cm Stage II pressure ulcer. On 01/13/23, Wound Clinic documentation showed that the patient had a 11.5 x 8 x 0.1 cm unstageable sacral pressure injury, a 1.9 x 1.1 x 0.1 cm Stage II device related pressure injury on his penis, and a 0.4 x 0.4 x 0.1 Stage II left ankle wound.

3. On 05/04/23 at 12:35 PM, investigators reviewed hospital Event Report documents and interviewed the Executive Director of Quality and Compliance (Staff #1), the Executive Director of Nursing (Staff #2), and the ED Nurse Manager (Staff #3). Staff #2 stated that it is the hospital's expectation that nursing staff enter an Event Report when patients develop hospital acquired pressure injuries (HAPIs). The document review showed no evidence that an Event Report was filed related to Patient #1's injuries. Staff #1 confirmed the missing Event Report and stated that the hospital has not report any Stage III, IV, or unstageable HAPIs to the Department of Health in the past 12 months.

Patient #3

4. Medical record review showed that Patient #3 was seen in the ED on 11/28/22 for shortness of breath and hypoxia. The patient had Stage I pressure injuries on her sacrum and on her right lower leg documented present on admission. Documentation showed that on 12/04/22, the sacral wound had worsened to a Stage III pressure injury with multiple types of bacteria present. Nursing note documentation dated 12/06/22 showed that the wound nurse reviewed photos of the patient's wounds remotely and classified the sacral pressure injury as a deep tissue injury. Provider note documentation dated 12/07/22 and 12/09/22, described the patient's sacral ulcer as superficial except for an irregular eschar on the right buttocks. The provider classified the pressure ulcer as "Stage II, possibly III," rather than an unstageable pressure injury (known but not stageable due to coverage of wound bed by slough and/or eschar).

5. On 05/04/23 at 12:35 PM, investigators reviewed hospital Event Report documents and interviewed the Executive Director of Quality and Compliance (Staff #1), the Executive Director of Nursing (Staff #2), and the ED Nurse Manager (Staff #3). Staff #2 stated that it is the hospital's expectation that nursing staff enter an Event Report when patients develop hospital acquired pressure injuries (HAPIs). The document review showed no evidence that the hospital received any Event Reports related to HAPIs in the past 12 months. Staff #1 confirmed the investigators' findings. Staff #1 confirmed that the hospital did not reported any Stage III, Stage IV, or unstageable HAPIs to the state in 2022 or 2023.

Patient #4

6. Medical record review showed that on 06/03/22 at 2:11 PM, Patient #1 arrived by ambulance after a ground-level fall. The pre-hospital report completed by the triage RN showed that Patient #4 had a history of dementia and lived at a memory care facility, and the patient's dementia diagnosis was clearly documented in the patient's medical record. The patient was examined, treated, and an order to discharge was entered. Patient #1 went to the ED nurse's station asking to be discharged. The discharging RN reviewed the discharge instructions with Patient #4. Patient #4 said they would arrange for a taxi from the lobby. The patient was given discharge instructions and discharged to the waiting room alone at 3:51 PM.

7. On 05/04/23 at 9:00 AM, the investigators interviewed the ED Nurse Manager about Patient #4, who eloped from the hospital lobby on 06/03/22 and was missing for 3 hours before she was found and returned to the memory care facility at 7:00 PM. Staff #3 stated that the charge nurse called her on 06/03/22 after 4:50 PM and notified her of the missing patient. Staff #3 stated that she followed up with staff the next day. Staff #3 stated that staff should have filed an Event Report, but she was not sure if this happened.

8. On 05/04/23 at 12:35 PM, investigators reviewed hospital Event Report documents and interviewed the Executive Director of Quality and Compliance (Staff #1), the Executive Director of Nursing (Staff #2), and the ED Nurse Manager (Staff #3). The document review showed that staff failed to file an Event Report after Patient #4 eloped from the facility. Staff #1, #2, and #3 confirmed that no report was filed, and the hospital did not complete a root cause analysis into the incident. Staff #1 confirmed that the incident was not reported to the Department of Health.
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Based on interview, document review and review of the hospital's Quality Management System Manual, the hospital failed to conduct periodic evaluations of the Code Blue and Evaluation of Patient Care Services hospital committees in 2022 and 2023.

Failure to have quality committees that are periodically evaluated limits the hospital's ability to identify and develop action plans to improve patient care services.

Findings include:

1. Review of the hospital document, "Quality Management System Manual," no policy number, reviewed 03/04/23, showed the following:

a. The intent of the Quality Management System is to identify the systematic approach to improve and sustain performance through the prioritization, design, implementation, monitoring, and analysis of performance improvement initiatives.

b. The Patient Care Safety Quality Meeting (PCSQ) is responsible for review of quality data, quality review team (which is the Quality Management System data), patient safety risks, internal audit results, patient experience data, and performance improvement projects. The objective of the team's work are to ensure that valid and complete data and action plans are provided to the organization's Quality Committees.

c. The Quality Department reports identified patterns and trends, which may require performance improvement and patient safety and outcomes initiatives, to the affected departments and Quality Improvement Committee (QIC).

d. Quality objectives can be determined through several means:

i. Review of past and current performance in processes that fall under the domains of Quality, Service, Safety, Accountability, and Collaboration

ii. Requirement of Quality Measures (QM.7)

iii. Required reporting to CMS (Centers for Medicare &Medicaid Services)

iv. As a result of internal audits

v. As a result of a survey finding

vi. As an identified performance improvement need

vii. As a result of identified trend in patient survey results

viii. A preventative or corrective action that needs to be taken to increase patient safety

Document review of the Quality Review Team (QRT) Annual Reporting Calendar showed:

a. 2022 and 2023: Evaluation of Patient Care and Services are to report to the PCSQ meeting monthly.

b. 2022 and 2023: Critical Process: Code Blue report to the PCSQ meeting monthly.

2. Document review of the PCSQ meeting minutes for Evaluation of Patient Care and Services and Critical Process: Code Blue did not have a report to the committee for all of 2022 and 2023.

3. Document review of the Quality Review Team meeting minutes for Evaluation of Patient Care and Services and Critical Process: Code Blue did not have a report to the committee for all of 2022 and 2023.

4. On 05/24/23 at 10:40 AM, the investigators interviewed the ED Manager (Staff #1) about the frequency of the Evaluation of Patient Care and Services and Critical Process: Code Blue. Staff #1 confirmed the investigators' findings that the Code Blue Committee did not meet for 6-8 months in 2022 and met once in 2023. Staff #1 stated that there have been no mock drills during 2022 or 2023 due to staffing constraints.

5. The Executive Director of Nursing (Staff #2) and the Executive Director of Regulatory/Compliance Officer (Staff #3) verified there have been no report-outs from the two committees during the time frame and confirmed the investigators' findings that there has not been timely follow-up on the action items identified in committee meeting minutes.
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Based on interview and review of hospital documents, the hospital failed to identify problems, implement corrective actions, and monitor to ensure ongoing compliance with barcode scanning of patient medications prior to administration in the emergency department (ED).

Failure to develop and implement corrective action plans for identified problems and monitor for sustained improvement limits the hospital's ability to provide high-quality clinical care and improve patient outcomes.

Findings included:

1. Review of the hospital document, "Quality Management System Manual," no policy number, reviewed 03/04/23, showed the following:

a. The intent of the Quality Management System is to identify the systematic approach to improve and sustain performance through the prioritization, design, implementation, monitoring, and analysis of performance improvement initiatives.

b. Department leaders are responsible for ongoing performance improvement and patient safety activities in their departments, and for acting on recommendations generated by quality assurance analysis and corrective action plans, performance improvement, and patient safety activities.

2. Review of the hospital's department quality dashboard data showed that for the past 6 months, ED nursing staff has averaged 50% compliance with the hospital's policy of barcode scanning patient medications prior to administration.

3. On 05/24/23 at 10:40 AM, the investigators interviewed the ED Nurse Manager (Staff #1), the Executive Director of Nursing, (Staff #2) and the Executive Director of Quality/Compliance Officer (Staff #3) about scanning patient medications prior to administration. Staff #1 stated that overall staff compliance is low for scanning medications prior to administration, the department goal is 90%, and confirmed that the department is currently at 50% for the last 6 months. Staff #1 and Staff #2 stated that the hospital's department quality dashboard does not contain any updated action items showing how the ED plans to reach the department goal of 90% compliance.
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Based on interview, medical record review and review of hospital documents, the hospital failed to systematically identify, collect or analyze information regarding unanticipated patient outcomes for 5 of 5 records reviewed (Patients #1, #2, #3, #4, and #5).

Failure to systematically identify, collect, and analyze information regarding serious patient care events limits the hospital's ability to develop and implement action plans to improve healthcare outcomes.

Findings included:

1. Review of the hospital document, "Event Reporting System", no policy number, reviewed 08/16/22, showed the following:

a. Event reporting is part of WhidbeyHealth's Patient Safety Evaluation System/Patient Care Safety Quality Committee and is intended to identify trends which allow the hospital to actively prevent, correct and improve processes. The event reporting process ensures full and complete reporting of events related to Quality of Care, Patient Safety, Staff Safety, and Compliance.

b. An "event" is an unexpected occurrence not consistent with the desired operation of the health care system and includes events that reached, or could have reached a patient, staff, or visitor and compromised service and/or safety, events related to staff, provider, patient, or visitor behavior that compromised, or could have compromised, service and or/safety.

c. Event reporting is required for events defined in this policy. When an unanticipated event occurs, staff shall assess the situation and take action to prevent further injury, report the event to their department manager and hospital supervisor, and contact the administrator on call. The administrator will contact the Director of Quality.

d. Upon receipt of the event report, the manager/supervisor/medical director will review the event report and follow up with appropriate staff if necessary. The manager/supervisor/medical director will initiate an investigation and implement immediate corrective actions to prevent reoccurrence for incidents with a harm score of E or higher. Pharmacy staff will review Medication Error and Adverse Drug Reaction Reports, collaborate with nursing leadership for investigations, and conduct investigations according to designated timelines. Assigned tasks for events with a harm score of E or above must be completed within 7 business days. The Quality Department is responsible for reviewing all event report tasks and assisting with investigations and event follow-up as needed.

e. Event reporting is required for events listed in the definition section of this policy. The person who directly observes or has knowledge of the event must create an event in the Event Reporting System or relay the information to the designee to be entered on their own behalf.

2. Medical record review showed that on 01/03/23 at 12:49 PM an 80-year-old patient (Patient #1) arrived with complaints of weakness. Patient #1 had recently been discharged from a skilled nursing facility and was waiting for home health to start physical therapy in the home. The home health agency nurse reported concerns to the social worker that the patient needed more support in the home because of frequent falls. Patient #1 was never admitted as an inpatient or observation status patient, but he remained hospitalized 12 days while the hospital social worker worked to coordinate a discharge plan for the patient. On 01/09/23, document review showed that the patient had developed a 15 cm Stage II pressure ulcer. On 01/13/23, Wound Clinic documentation showed that the patient had a 11.5 x 8 x 0.1 cm unstageable sacral pressure injury, a 1.9 x 1.1 x 0.1 cm Stage II device related pressure injury on his penis, and a 0.4 x 0.4 x 0.1 Stage II left ankle wound.

3. On 05/04/23 at 12:35 PM, investigators reviewed hospital Event Report documents and interviewed the Executive Director of Quality and Compliance (Staff #1), the Executive Director of Nursing (Staff #2), and the ED Nurse Manager (Staff #3). Staff #2 stated that it is the hospital's expectation that nursing staff enter an Event Report when patients develop hospital acquired pressure injuries (HAPIs). The document review showed no evidence that an Event Report was filed related to Patient #1's injuries.

Patient #2

4. Medical record review showed that Patient #2 was admitted to the hospital on 01/21/23 with a Stage II pressure injury present on admission. On 01/25/23, nursing note documentation showed that the patient had developed a new HAPI just beneath the pre-existing one.

5. On 05/04/23 at 12:35 PM, investigators reviewed hospital Event Report documents and interviewed the Executive Director of Quality and Compliance (Staff #1), the Executive Director of Nursing (Staff #2), and the ED Nurse Manager (Staff #3). Staff #2 stated that it is the hospital's expectation that nursing staff enter an Event Report when patients develop hospital acquired pressure injuries (HAPIs). The document review showed no evidence that an Event Report was filed following the discovery of Patient #2's new HAPI.

Patient #3

6. Medical record review showed that Patient #3 was seen in the ED on 11/28/22 for shortness of breath and hypoxia. The patient had Stage I pressure injuries on her sacrum and on her right lower leg documented present on admission. Documentation showed that on 12/04/22, the sacral wound had worsened to a Stage III pressure injury with multiple types of bacteria present. Nursing note documentation dated 12/06/22 showed that the wound nurse reviewed photos of the patient's wounds remotely and classified the sacral pressure injury as a deep tissue injury. Provider note documentation dated 12/07/22 and 12/09/22, described the patient's sacral ulcer as superficial except for an irregular eschar on the right buttocks. The provider classified the pressure ulcer as "Stage II, possibly III," rather than an unstageable pressure injury (known but not stageable due to coverage of wound bed by slough and/or eschar).

7. On 05/04/23 at 12:35 PM, investigators reviewed hospital Event Report documents and interviewed the Executive Director of Quality and Compliance (Staff #1), the Executive Director of Nursing (Staff #2), and the ED Nurse Manager (Staff #3). Staff #2 stated that it is the hospital's expectation that nursing staff enter an Event Report when patients develop hospital acquired pressure injuries (HAPIs). The document review showed no evidence that the hospital received any Event Reports related to HAPIs in the past 12 months. Staff #1 confirmed the investigators' findings.

Patient #4

8. Medical record review showed that on 06/03/22 at 2:11 PM, Patient #1 arrived by ambulance after a ground-level fall. The pre-hospital report completed by the triage RN showed that Patient #4 had a history of dementia and lived at a memory care facility, and the patient's dementia diagnosis was clearly documented in the patient's medical record. The patient was examined, treated, and an order to discharge was entered. Patient #4 went to the ED nurse's station asking to be discharged. The discharging RN reviewed the discharge instructions with Patient #4. Patient #4 said they would arrange for a taxi from the lobby. The patient was given discharge instructions and discharged to the waiting room alone at 3:51 PM.

9. On 05/04/23 at 9:00 AM, the investigators interviewed the ED Nurse Manager about Patient #4, who eloped from the hospital lobby on 06/03/22 and was missing for 3 hours before she was found and returned to the memory care facility at 7:00 PM. Staff #3 stated that the charge nurse called her on 06/03/22 after 4:50 PM and notified her of the missing patient. Staff #3 stated that she followed up with staff the next day.

10. On 05/04/23 at 12:35 PM, investigators reviewed hospital Event Report documents and interviewed the Executive Director of Quality and Compliance (Staff #1), the Executive Director of Nursing (Staff #2), and the ED Nurse Manager (Staff #3). The document review showed that staff failed to file an Event Report after Patient #4 eloped from the facility. Staff #1, #2, and #3 confirmed that staff did not follow the hospital's process and should have entered an Event Report.

Patient #5

11. Review of hospital documents showed that on 07/07/22, the hospital received a grievance from the mother of Patient #5 stating that staff had physically, verbally, and mentally abused the child. The grievance alleged that staff chemically restrained Patient #5 when it was not necessary, and Patient #5 received an incorrect dosage of ketamine (a medication used for chemical restraint) that required intervention.

12. Medical record review showed that on 07/02/22, Patient #5 was found in the bathroom banging her head against the wall. A nurse (Staff #7) carried the patient from the bathroom to the patient's room and placed the patient on the bed. The patient was placed in a physical hold, and ketamine 300 mg was injected intramuscularly (IM). (Previous ketamine administration doses were 191mg IM on 06/02/22, and 240mg IM on 06/03/23, 06/06/22, and 06/30/22.) Document review showed that 20 minutes after the ketamine injection, Patient #5's oxygen saturation level decreased to the 70s (normal 92-100). Provider documentation showed that he performed a jaw thrust and that supplemental oxygen was required before the patient's oxygen saturation level returned to normal. Document review showed that two hours later, Patient #5's mother requested that the provider examine the patient. The patient was found to have cheek pain and neck scratches.

13. On 05/04/23 at 12:35 PM, investigators reviewed hospital Event Report documents and interviewed the Executive Director of Quality and Compliance (Staff #1), the Executive Director of Nursing (Staff #2), and the ED Nurse Manager (Staff #3) about Event Reports and patient grievances. Staff #1 confirmed that no Event Reports were filed regarding the allegations in the grievance. Staff #1, Staff #2, and Staff #3 confirmed that the hospital did not investigate the allegations of abuse, inappropriate use of chemical restraints, or possible medication error.
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