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Based on records reviewed and interviews, for one of ten sampled patients (Patient #7), the Hospital failed to ensure staff implemented the Hospital's Restraint/Seclusion Policy, which indicated chemical restraint was not practiced at the Hospital, when on 2/3/22, Patient #7 was administered one intramuscular dose of Haloperidol Lactate (Haldol, an antipsychotic), five milligram (mg), and Lorazepam (Ativan, a benzodiazepine), one mg, in conjunction with a four-point mechanical restraint due to his/her behaviors and safety concerns in the Emergency Department.

Refer to TAG: A-0160.

Based on interviews and record reviews, the Hospital failed to provide care in a safe setting for one of ten sampled patients (Patient #1) when Patient #1, who was assessed as being high risk of falls and required a continuous one-to-one patient observer, was left alone in the hallway on a stretcher while waiting for imaging and had an unwitnessed fall that required a computerized tomography (CT) scan, which revealed an increased size of Patient #1 ' s subdural hematoma from two to three millimeters (mm) (from a prior CT scan completed on 12/31/22) to six mm.

Refer to TAG: A-0144.

Based on records reviewed and interviews, for one of ten sampled patients (Patient #7), the Hospital failed to ensure that staff implemented the Hospital's Complaint/Grievance Policy when, on 2/4/22, the Hospital received a written complaint alleging that on 2/3/22, Patient #7 was resting calmly on a stretcher in the Emergency Department when staff physically and chemically restrained him/her, which resulted in Patient #7 sustaining a face injury.

Findings include:

Review of the Department of Public Health's (DPH) Health Care Facility Reporting System (HCFRS), dated 12/27/22, indicated that a grievance was filed with the Hospital regarding concerns with Patient #7 ' s Hospital stay during February 2023; however, it was alleged that the Hospital did not provide a written notice of the grievance ' s outcome.

Review of the Hospital's Response to Patient and Facility Feedback and Complaints Policy, undated, indicated that once a grievance case was completed, the Hospital would issue a closing letter to the complainant.

Review of the Hospital ' s internal complaint report and investigation, dated 2/7/22, indicated the Hospital received a written complaint alleging that on 2/3/22, Patient #7 was resting calmly on a stretcher in the Emergency Department when staff physically (four-point mechanical) and chemically (one intramuscular dose of Haloperidol Lactate (Haldol, an antipsychotic), five milligram (mg), and Lorazepam (Ativan, a benzodiazepine), one mg) restrained him/her and drew blood, which resulted in Patient #7 sustaining a face injury.

There was no documentation to support the Hospital having implemented their Complaint Policy following the allegations reported to the Hospital regarding the care concerns for Patient #7 from 2/3/22.

During an interview with the Executive Director of Risk Management on 8/29/23 at 9:00 A.M., and throughout the survey, she acknowledged that Patient #7 submitted a written complaint to the Hospital regarding care concerns from 2/3/22; however, the Hospital was unable to provide documentation to support Patient #7 having been issued a written closing letter in response to the complaint.

Based on interviews and record reviews, the Hospital failed to provide care in a safe setting for one of ten sampled patients (Patient #1) when Patient #1, who was assessed as being high risk of falls and required a continuous one-to-one patient observer, was left alone in the hallway on a stretcher while waiting for imaging and had an unwitnessed fall that required a computerized tomography (CT) scan, which revealed an increased size of Patient #1 ' s subdural hematoma from two to three millimeters (mm) (from a prior CT scan completed on 12/31/22) to six mm.

Findings include:

Review of the Hospital ' s SSH Guideline: One-to-one Observer Guidelines Policy, undated, indicated the patient observer must be in direct line -of sight and no farther away than the patient's doorway. The Policy indicates the one-to-one observer would maintain a safe environment, was responsible for the patient's overall safety needs, and was to immediately alert a nurse of any patient changes.

Review of the medical records indicated Patient #1, who was Vietnamese- and English- speaking and confused, presented to the Hospital ' s Emergency Department and was admitted in December 2022, and after an unwitnessed fall at home (a nursing home), resulting in a two to three mm subdural hematoma, mildly displaced fractures of the left orbit, and a mildly displaced left maxillary sinus wall fracture.

Review of the Nurse Progress Note, dated 1/2/23 at 3:37 A.M., indicated Patient #1 had a language barrier, dementia, restlessness, and poor safety awareness, and he/she was attempting to exit his/her bed. The Note indicated Patient #1 had a bed alarm and a one-to-one observer implemented for safety. The Note indicated Patient #1 was administered Haldol, one milligram, with fair effect.

Review of the Neurosurgery Progress Note, dated 1/2/23 at 12:11 P.M., indicated Patient #1 had an unwitnessed fall on the way to a CT scan, which showed interval (subdural hematoma) increase from two mm to six mm.

Review of the Department of Public Health's Health Care Facility Reporting System, dated 1/11/23, indicated the Hospital reported that on 1/2/23, Patient #1, who was assessed as being high risk of falls and required a constant one-to-one patient observer, was left alone in the hallway on a stretcher while waiting for imaging and had an unwitnessed fall. The report indicated that once staff found Patient #1 on the floor, a rapid response was called and performed a CT scan which revealed an increased size of Patient #1 ' s subdural hematoma from two to three millimeters (mm) (from a prior CT scan completed on 12/31/22) to six mm. The Report indicated that Patient #7 ' s fall was likely preventable.

Review of the Hospital ' s Root Cause Analysis (RCA), dated 1/11/23, indicated Patient #1 ' s one-to-one Observer did not follow the Hospital ' s Observer Policy when the assigned Observer failed to accompany Patient #1 and the patient transporter off the unit. The RCA indicated the one-to-one Observer was unaware of the requirement to stay with Patient #1 during a transport off the unit, unless otherwise approved by a nurse. The RCA identified that this type of event could happen in all inpatient care areas.

Further review of the Hospital's internal investigation indicated there was no documentation to support the Hospital implemented and monitored corrective actions identified in the RCA.

During an interview on 8/28/23 at 8:30 A.M. and throughout the survey, the Executive Director of Risk Management acknowledged a root cause analysis was completed 1/11/23 to discuss Patient #1's adverse event on 1/2/23; however, the Hospital was unable to provide documentation to support corrective actions had been developed or implemented in response to the Patient #1 ' s preventable event on 1/2/23.

Based on records reviewed and interviews, for one of ten sampled patients (Patient #7), the Hospital failed to ensure staff implemented the Hospital's Restraint/Seclusion Policy, which indicated chemical restraint was not practiced at the Hospital, when on 2/3/22, Patient #7 was administered one intramuscular dose of Haloperidol Lactate (Haldol, an antipsychotic), five milligram (mg), and Lorazepam (Ativan, a benzodiazepine), one mg, in conjunction with a four-point mechanical restraint due to his/her behaviors and safety concerns in the Emergency Department.

Findings include:

Review of the Department of Public Health's (DPH) Health Care Facility Reporting System (HCFRS), dated 12/27/22, indicated the Hospital received a written complaint alleging that on 2/3/22, Patient #7 ' s patient rights were violated when he/she was resting calmly on a stretcher in the Emergency Department (ED) when staff physically and chemically restrained him/her and drew blood, which resulted in Patient #7 sustaining a face injury.

Review of the Hosptial ' s Restraint/Seclusion Policy, undated, indicated that chemical restraint was not practiced at the Hospital. The Policy defined a chemical restraint as the use of a medication used to restrict the patient ' s freedom of movement that was not a standard treatment for the patient ' s new or continuing medical or behavioral condition. The Policy indicated it was the Hospital ' s practice to only use medications that are a standard treatment for the patient ' s ongoing and emerging condition.

Federal Regulations define a chemical restraint as a drug or medication that was used to manage the patient's behavior or restrict the patient's freedom of movement and that was not a standard treatment or dosage for the patient's condition.

According to the American College of Emergency Physicians, to ensure patient safety, protocols should be developed to address observation and treatment during the period of restraint and periodic assessment as to the need and means of continuing or discontinuing restraint. The use of restraints should be carefully documented, including the reasons for and means of restraint, and the periodic assessment of the restrained patient. Chemical restraint via antipsychotic and benzodiazepine medication may be used to facilitate medical workup and patient safety.

Review of Patient #7 ' s medical record indicated that he/she presented to the Hospital ' s ED in February 2022 with concerns of a head injury and hallucinations after falling on ice and hitting his/her head.

Further Review of Patient #7 ' s medical record indicated an ED Physician ordered one dose of the following medications which were scanned as given as an intramuscular (IM) injection at 10:38 P.M. by Nurse #1: Haloperidol Lactate (Haldol, an antipsychotic), five milligrams (mg) and Lorazepam (Ativan, a benzodiazepine), one mg; additionally, an ED Phyician ordered a four-point mechanical restraint which was applied by security staff at 10:45 P.M.

Review of Nurse #1 ' s Progress Note, dated 2/3/22, indicated Patient #7 was refusing bloodwork and was ready for discharge when he/she told staff, "But I am going to kill myself." The Note indicated security was called as Patient #7 was noncompliant with the plan of care and/or bloodwork, he/she was swearing, threatening to sue staff, and threatening to leave the Hospital. The Note indicated Patient #1 was restrained by security, had a one-to-one observer and was given bedside medications per physician's order.

Review of the Physician ' s Progress Note, dated 2/3/22, indicated Patient #7 was transiently aggressive and a harm to him/herself and staff, but improved after anxiolysis.

During an interview with Nurse #1 on 8/30/23 at 3:15 P.M., she acknowledged caring for Patient #7 on 2/3/22, when Patient #7 became angry and wanted to leave the Hospital. Nurse #1 said she spoke with Patient #7 ' s physician and requested assistance from security due to safety concerns. Nurse #1 said that she may scan an IM medication prior to entering a patient ' s room to administer the mediation if there are safety concerns due to violence that require a therapeutic hold/restraint to administer an IM medication. Nurse #1 said she was unable to recall if she administered Patient #7 ' s IM antipsychotic and benzodiazepine before or after the physical restraint was applied on 2/3/22.

During an interview with the Executive Director of Risk Management and the Chief Quality and Safety Officer on 8/28/23 at 10:10 A.M., they acknowledged that the Hospital ' s Restraint/Seclusion Policy indicated that chemical restraint was not practiced at the Hospital

During an interview with the Chair of Emergency Medicine on 8/28/23 at 11:06 A.M., he acknowledged the Hospital ' s Restraint/Seclusion Policy indicated that chemical restraint was not practiced at the Hospital. The Chair of Emergency Medicine said a chemical restraint would be a medication/medication combination that would physically immobilize a patient to restrict movements. The Chair of Emergency Medicine said that if a patient was administered an antipsychotic and benzodiazepine, IM, without the patient ' s consent, and while in a physical restraint/physical hold, the Hospital would not consider that a chemical restraint if said patient ' s unsafe behaviors are part of their underlying psychiatric condition.

Although the Hospital does not have a chemical restraint Policy, staff interviews and record reviews indicated Patient #7 was administered one IM dose of Haloperidol Lactate (Haldol, an antipsychotic), five milligrams (mg) and Lorazepam (Ativan, a benzodiazepine), one mg, in conjunction with a four-point mechanical restraint due to his/her behaviors and safety concerns in the ED.

The Condition of Participation: Quality Assessment and Performance Improvement Program (QAPI) was out of compliance.

Findings included:

Based on records reviewed and interviews, for two of ten sampled patients (Patient #1 and Patient #7), the Hospital failed to ensure the Quality Assurance and Performance Improvement (QAPI), the objective of which was to implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program to implement preventative actions in response to preventable adverse patient events and to develop and/or implement a Hospital Restraint Policy, in accordance with Federal Regulations.

Refer to TAG: A-0283.

Based on records reviewed and interviews, for two of ten sampled patients (Patient #1 and Patient #7), the Hospital failed to ensure the Quality Assurance and Performance Improvement (QAPI), the objective of which was to implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program to implement preventative actions in response to preventable adverse patient events and to develop and/or implement a Hospital Restraint Policy, in accordance with Federal Regulations.

Findings include:

1. Review of the Hospital ' s SSH Guideline: 1:1 Observer Guidelines Policy, undated, indicated the patient observer must be in direct line –of sight and no farther away than the patient's doorway. The Policy indicates the one-to-one observer would maintain a safe environment, was responsible for the patient's overall safety needs, and was to immediately alert a nurse of any patient changes.

Review of the Department of Public Health's Health Care Facility Reporting System, dated 1/11/23, indicated the Hospital reported that on 1/2/23, Patient #1, who was assessed as being high risk of falls and required a constant one-to-one patient observer, was left alone in the hallway on a stretcher while waiting for imaging and had an unwitnessed fall. The report indicated that once staff found Patient #1 on the floor, a rapid response was called and performed a CT scan which revealed an increased size of Patient #1 ' s subdural hematoma from two to three millimeters (mm) (from a prior CT scan completed on 12/31/22) to six mm. The Report indicated that Patient #7 ' s fall was likely preventable.

Review of the Hospital ' s Root Cause Analysis (RCA), dated 1/11/23, indicated Patient #1 ' s one-to-one Observer did not follow the Hospital ' s Observer Policy when the assigned Observer failed to accompany Patient #1 and the patient transporter off the unit. The RCA indicated the one-to-one Observer was unaware of the requirement to stay with Patient #1 during a transport off the unit, unless otherwise approved by a nurse. The RCA identified that this type of event could happen in all inpatient care areas.

Further review of the Hospital's internal investigation indicated there was no documentation to support the Hospital implemented and monitored any systemwide corrective actions to prevent future potential of similar adverse incidents.

During an interview on 8/28/23 at 8:30 A.M. and throughout the survey, the Executive Director of Risk Management acknowledged a root cause analysis was completed 1/11/23 to discuss Patient #1's adverse event on 1/2/23; however, the Hospital was unable to provide documentation to support systemwide corrective actions had been developed or implemented in response to the Patient #1 ' s preventable event on 1/2/23.

2. Review of the Hospital ' s Restraint/Seclusion Policy, undated, indicated that chemical restraint was not practiced at the Hospital. The Policy defined a chemical restraint as the use of a medication used to restrict the patient ' s freedom of movement that was not a standard treatment for the patient ' s new or continuing medical or behavioral condition. The Policy indicated it was the Hospital ' s Policy to only use medications that are a standard treatment for the patient ' s ongoing and emerging condition.

Review of Patient #7 ' s medical record indicated that he/she presented to the Hospital ' s ED in February 2022 with concerns of a head injury and hallucinations after falling on ice and hitting his/her head.

Further Review of Patient #7 ' s medical record indicated an ED Physician ordered one dose of the following medications which were scanned as given as an intramuscular (IM) injection at 10:38 P.M. by Nurse #1: Haloperidol Lactate (Haldol, an antipsychotic), five milligrams (mg) and Lorazepam (Ativan, a benzodiazepine), one mg; additionally, an ED Phyician ordered a four-point mechanical restraint which was applied by security staff at 10:45 P.M.

Review of Nurse #1 ' s Progress Note, dated 2/3/22, indicated Patient #7 was refusing bloodwork and was ready for discharge when he/she told staff, "But I am going to kill myself." The Note indicated security was called as Patient #7 was noncompliant with the plan of care and/or bloodwork, he/she was swearing, threatening to sue staff, and threatening to leave the Hospital. The Note indicated Patient #1 was restrained by security, had a one-to-one observer and was given bedside medications per physician's order.

Review of the Physician ' s Progress Note, dated 2/3/22, indicated Patient #7 was transiently aggressive and a harm to him/herself and staff, but improved after anxiolysis.

During an interview with Nurse #1 on 8/30/23 at 3:15 P.M., she acknowledged caring for Patient #7 on 2/3/22, when Patient #7 became angry and wanted to leave the Hospital. Nurse #1 said she spoke with Patient #7 ' s physician and requested assistance from security due to safety concerns. Nurse #1 said that she may scan an IM medication prior to entering a patient ' s room to administer the mediation if there are safety concerns due to violence that require a therapeutic hold/restraint to administer an IM medication. Nurse #1 said she was unable to recall if she administered Patient #7 ' s IM antipsychotic and benzodiazepine before or after the physical restraint was applied on 2/3/22.

During an interview with the Executive Director of Risk Management and the Chief Quality and Safety Officer on 8/28/23 at 10:10 A.M., they acknowledged that the Hospital ' s Restraint/Seclusion Policy indicated that chemical restraint was not practiced at the Hospital

During an interview with the Chair of Emergency Medicine on 8/28/23 at 11:06 A.M., he acknowledged the Hospital ' s Restraint/Seclusion Policy indicated that chemical restraint was not practiced at the Hospital. The Chair of Emergency Medicine said a chemical restraint would be a medication/medication combination that would physically immobilize a patient to restrict movements. The Chair of Emergency Medicine said that if a patient was administered an antipsychotic and benzodiazepine, IM, without the patient ' s consent, and while in a physical restraint/physical hold, the Hospital would not consider that a chemical restraint if said patient ' s unsafe behaviors are part of their underlying psychiatric condition.

Although the Hospital does not have a chemical restraint policy, staff interviews and record reviews indicated Patient #7 was administered one IM dose of Haloperidol Lactate (Haldol, an antipsychotic), five milligrams (mg) and Lorazepam (Ativan, a benzodiazepine), one mg, in conjunction with a four-point mechanical restraint due to his/her behaviors and safety concerns in the ED.