HospitalInspections.org

The Condition of Patient Rights has not been met.

Based on clinical record review, hospital policy review, and staff interviews for 1 of 3 sampled patients reviewed for restraint use (Patient #1), the hospital failed to provide care in a safe setting when the hospital failed to ensure that Deep Vein Thrombosis (DVT) prophylaxis in place while the patient was restrained for 8 continuous days and as a result, the patient experienced a Pulmonary Embolism (PE) and expired, and failed to ensure that restraints were discontinued when the patient no longer exhibited the behaviors that necessitated the restraint, failed to ensure that a new restraint order was written every 4 hours, failed to discontinue the use of restraints at the earliest possible time, failed to ensure that the patient was evaluated face-to-face by a provider within one hour of the initiation of each restraint order, and failed to ensure the patient's immediate situation, reaction to the intervention, medical and behavioral condition, and the need to continue or terminate the restraint were assessed with each restraint order.

Please see A144, A171, A174, A178 and A179

Based on clinical record review, hospital policy review, and staff interviews for 1 of 3 sampled patients reviewed for restraint use (Patient #1), the hospital failed to provide care in a safe setting when the hospital failed to ensure that Deep Vein Thrombosis (DVT) prophylaxis in place while the patient was restrained for 8 continuous days and as a result, the patient experienced a Pulmonary Embolism (PE) and expired, and failed to ensure that restraints were discontinued when the patient no longer exhibited the behaviors that necessitated the restraint. The findings include:


a. Patient #1 was admitted to the Emergency Department (ED) on 8/7/22 from the behavioral health unit for elevated laboratory blood values and rhabdomyolysis and was subsequently admitted to a medical unit.

Review of the history and physical dated 8/7/22 at 12:18 PM noted that while on the behavioral health unit, the patient's Creatinine Kinase and Liver Function Tests were elevated, and the patient was brought to the ED for IV hydration. The note identified the patient was manic, easily distracted and had pressured speech.

Review of the Patient #1's History & Physical (H&P) identified that the Deep Vein Thrombosis (DVT) prevention section was not completed as prompted.

MD Progress notes dated 8/7/22 at 5:40 PM noted the patient would be admitted for treatment of rhabdomyolysis.

Interview on 1/18/23 at 11:15 AM with MD #1 identidfied that he assessed Patient #1 on 8/15/22. MD #1 stated that he realized that the Venous Thromboembolism (VTE) scoring had not been done on admission and that the guidelines direct that it be done on admission then every 5 days to assess for a DVT and to ensure that preventative measures are in place.

Review of the clinical record identified that DVT prophylaxis interventions were not initiated until 8/13/22.

Interview with MD #2 on 3/1/23 at 11:35 AM stated that when he assessed Patient #1 on 8/7/22, the patient was not restrained and was able to ambulate. While completing the admission H&P, the prompt for VTE prophalaxis scoring did not come up on the computer.
MD #2 identified that patients are assessed on admission for the risk of developing a DVT and depending on the patients score, interventions would be implemented.

b. Review of Patient #1's clinical record on 1/19/23 at 9:30 AM with the Clinical Info Specialist identified that between 8/8/22 at 2:30 PM and 8/9/22 at 5:26 PM (26 hours and 56 minutes) the patient was continuously restrained in 4-point bilateral locked restraints. Although the shift nursing narrative notes identified the patient was agitated, demanding, and restless, the flow sheets dated 8/8/22 from 2:00 PM through 8/9/22 at 1:00 PM (23 hours) lacked documentation that the patient was assessed every two hours for behaviors, circulation, sensation and movement, respiratory status, and range of motion to both upper and lower extremities, per hospital policy. Additionally, during this time frame the 4-point locked restraints were not reordered every 4 hours per hospital policy (order required renewal five times but was only reordered 3 times).

c. Review of the clinical record review with the Clinical Info Specialist on 1/19/23 at 9:30 AM identified that between 8/9/22 at 12:02 PM and 8/13/22 at 10:51 AM, the patient was continuously restrained with bilateral locked wrist restraints (a total of 94 hours and 49 minutes). Although the shift nursing narrative notes identified the patient was agitated, demanding, verbally abusive, pulling on IV lines, anxious and restless, the flow sheets dated 8/9/22 through 8/13/22 at 10:51 AM lacked documentation that the patient was assessed every two hours for behaviors, circulation, sensation and movement, respiratory status, and range of motion to both upper and lower extremities per hospital policy. Additionally, during this time frame the bilateral locked wrist restraints were not reordered every 4 hours per hospital policy (orders required renewal 21 times but were only reordered 9 times) and staff failed to discontinue the use of restraints when the patient no longer exhibited the behaviors that necessitated the restraints.

d. Physician progress notes dated 8/7/22, 8/10/22, 8/11/22, and 8/12/22 noted that Patient #1 was still requiring restraints. The clinical record failed to indicate that a physician evaluated the patient in accordance with the guideline for Venous Thromboembolism (VTE) scoring which directed this be completed on admission then every 5 days (assessment due 8/12/22) to assess for a DVT and to ensure that preventative measures are in place.

Interview with MD #3 on 3/1/23 at 12:00 PM stated he assessed Patient #1 on 8/10, 8/11, and 8/12/22. MD #3 reviewed the clinical record and identified that DVT prophylaxis was not documented, but recalls the patient's score was a one, and based on the protocol the patient would be at low risk for DVT but would require mechanical prophylaxis to be put into place. MD #3 stated that although he was aware that the patient was in restraints, he did not put any mechanical prophylaxis in place for prevention of DVT's.

Review of flowsheets from 8/8/22 through 8/13/22 noted Sequential Compression Devices (SCD) (DVT prevention treatment) were not ordered. In addition, documentation identified the patient only ambulated on 8/8/22.

Physician progress notes dated 8/13/22 at 10:51 AM noted that Patient #1 still needed to be in locked restraints, and SCD's were ordered for VTE prevention.

Physician orders dated 8/13/22 at 10:56 AM directed to apply SCDs to the patient.

Flowsheets dated from 8/13/22 through 8/15/22 identified the SCDs were not used due to patient refusal, and the provider was aware. The flowsheets identified that during that timeframe fluids were promoted for venous thromboembolism prevention.

Interview with MD #4 on 3/1/23 at 12:20 PM stated he assessed Patient #1 on 8/13/22 and 8/14/22 and did not recall being made aware that Patient #1 refused the SCDs. MD #4 stated that had he been aware of the refusal, he would have documented it and ordered a chemical prophylaxis like Heparin or Lovenox.

Physician orders dated 8/13/22 at 8:37 AM directed to apply tied bilateral padded hand mitts for interference with medical treatment. The order was discontinued at 10:51AM.

Physician orders dated 8/13/22 at 10:51AM through 8/13/22 at 8:16 PM (9 hours and 25 minutes) noted the patient was continuously restrained with bilateral locked wrist restraints due to a danger to others.

Between 8/13/22 at 10:51 AM and 8/13/22 at 8:16 PM documentation failed to identify that the restraints were reordered every 4 hours per hospital policy and staff failed to discontinue the use of restraints when the patient no longer exhibited the behaviors that necessitated the restraints. Flow sheets indicated that during that timeframe range of motion and hygiene were provided, and elimination was offered. The flow sheets lacked documentation that Patient #1 was ambulated.

Physician orders dated 8/13/22 at 8:16 PM through 8/15/22 at 12:49 PM (43 hours and 33 minutes) noted the patient was continuously restrained with a right locked wrist restraint for danger to self and others. In this time frame documentation failed to identify that the restraints were reordered every four hours per hospital policy (order required renewal 11 times but only reordered 8 times) and staff failed to discontinue the use of restraints when the patient no longer exhibited the behaviors that necessitated the restraints.

The right wrist locked restraint was discontinued on 8/15/22 at 2:49 PM.

e. In addition, while Patient #1 was restrained from 8/8/22 to 8/15/22 (120 hours and 19 minutes), licensed providers failed to conduct face-to-face evaluations 30 times. In this timeframe, licensed providers failed to consider alternative DVT prophylaxis when the patient could not tolerate compression devices.

Review of the policy for restraints identified in part, that a face-to-face evaluation of the patient by the provider must be completed within one hour of the initiation of the restraint to evaluate and document the patient's immediate situation, reaction to the intervention, medical and behavioral condition as well as the need to continue or terminate the restraint.


f. Psychiatry progress notes dated 8/15/22 at 11:56 AM noted that Patient #1 was seen and evaluated at the bedside, and identified that he/she felt anxious, was unable to sleep, that the wrist restraint increased his/her anxiety, stated that he/she would maintain safe if the restraint was removed, and reported worsened shortness of breath with anxiety, and was requesting oxygen be administered.

Physician progress note dated 8/15/22 at 5:06 PM noted that Patient #1 required oxygen at 2 liters since this morning, suspect acute hypoxic respiratory failure secondary to anxiety/agitation, as well as aspiration given frequent use of antipsychotics, and that a chest X-ray was ordered. The note identified the patient received scheduled Clonazepam 0.5mg at 10:00 AM, the last dose of IV Haldol was administered at 2:23 PM for agitation, and restraints were removed at that time per recommendation from psychiatry. The note further identified at about 3:30 PM Patient #1 was observed to be in respiratory distress followed by respiratory arrest. CPR was initiated, and despite live saving treatments the patient was pronounced expired at 4:14 PM.

Nurse's notes dated 8/15/22 at 7:43 PM noted that Patient #1 was on 2 Liters of oxygen, Haldol was administered for anxiety with good effect, and restraints were discontinued at 2:49 PM (1 hour and 25 minutes before the patient expired).

Interview with MD #1 on 1/18/23 at 11:15 AM stated that he examined Patient #1 on the morning on 8/15/22 and that the patient was on 2 liters of oxygen for difficulty breathing during the night. MD #1 stated that he assessed the patient and noted crackles in the lungs, oxygen saturation was down but the patient did not appear to be short of breath, and an x-ray was ordered to rule out aspiration. MD #1 stated that he saw the patient again in the afternoon with psychiatry and it was decided to discontinue the use of the restraints. MD #1 stated that approximately 1 hour after the patient's restraints were removed the patient experienced respiratory distress, CPR was started, but the patient expired.


Review of the autopsy report and interview with the Medical Examiner on 1/25/23 at 9:25 AM noted the cause of Patient #1's death was pulmonary thromboembolism due to deep vein thrombosis complicated by medical restraint for acute bipolar disorder. The Medical Examiner stated that the length of time the patient was in restraints caused the embolism. The Medical Examiner stated that DTV prophylactic measures were usually implemented for patients who are inactive or bedridden due to the use of restraints as was this patient.

Review of the hospital policy for Venous thromboembolism (VTE) noted the goal is to have consistent, risk stratified approach for prophylaxis of VTE in medicine patients with subsequent decrease of preventable VTE events. The policy identified nursing responsibilities included assist and encourage early and frequent ambulation, at least three times a day, document and inform the prescriber if the patient is unable or unwilling to be out of bed at least three times a day, document and inform prescriber if patient refuses chemical and/or mechanical VTE prophylaxis and administer chemical and apply mechanical prophylaxis per hospital guideline as ordered.

Review of the policy for restraints identified that restraints or seclusion may only be imposed to insure the immediate physical safety of the patient, staff or others and must be discontinued at the earliest possible time. The policy identified that a face-to-face evaluation of the patient by the provider must be completed within one hour of the initiation of the restraint to evaluate and document the patient's immediate situation, reaction to the intervention, medical and behavioral condition as well as the need to continue or terminate the restraint. Additionally, the policy identified the RN must assess the patient's behaviors, circulation, sensation, movement, respiratory status, range of motion, hygiene, food and fluids, elimination and need for less restrictive interaction and/or discontinuation of restraints every two hours while restrained.

Interview with the Director of Patient Safety and Quality and the Assistant Director of Hospitalists on 1/18/23 at 10:30 AM stated that after the death of Patient #1 on 8/15/22, they reviewed the hospital's policy on restraints and began reeducating staff on the use of restraints, placed a trigger warning in the clinical record to ensure all components are met, and began auditing clinical records for the use of restraints. Additionally, the Director stated that they are developing a Behavioral Time Out Huddle for patients to decrease the use of restraints.

Based on clinical record review, hospital policy and staff interview for 1 of 3 sampled patients reviewed for restraints (Patient #1), the hospital failed to ensure that a new restraint order was written every 4 hours for a patient who was continuously restrained for 8 days. The findings include:

Patient #1 was admitted to the Emergency Department (ED) on 8/7/22 from the behavioral health unit for elevated laboratory blood values and rhabdomyolysis and then admitted to a medical unit.

Review of the history and physical dated 8/7/22 at 12:18 PM noted that while on the behavioral health unit Patient #1's Creatinine Kinase and Liver Function Tests were elevated and the patient was brought back to the ED for IV hydration. The note identified the patient was manic, easily distracted and had pressured speech.

Review of Patient #1's clinical record on 1/19/23 at 9:30 AM with the Clinical Information Specialist identified that between 8/8/22 at 2:30 PM and 8/9/22 at 5:26 PM (26 hours and 56 minutes) the patient was continuously restrained in 4-point bilateral locking restraints.

Between 8/9/22 at 12:02 PM and 8/13/22 at 10:51 AM Patient #1 was continuously restrained with bilateral locking wrist restraints (94 hours and 49 minutes). In this time frame documentation failed to identify that a physician order was written every four hours per hospital policy.

Physician orders dated 8/13/22 at 8:37AM directed to apply tied bilateral padded hand mitts for interference with medical treatment. The order was discontinued at 10:51AM.

Physician orders dated 8/13/22 at 8:16 PM through 8/15/22 at 12:49 PM (43 hours and 33 minutes) noted the patient was continuously restrained with a right locking wrist restraint due to a danger to self and others. In this time frame documentation failed to identify the physician order was written every four hours per hospital policy.

The right wrist locking restraint was discontinued on 8/15/22 at 2:49 PM.

Patient #1's clinical record was reviewed with the Clinical Information Specialist and identified that the patient was restrained for 165 hours and 30 minutes over 8 days from 8/8/22 through 8/15/22. During this time frame, the restraint orders should have been ordered 41 times but were only ordered 23 times.

The hospital policy for the use of restraints identified that violent restraint orders are time limited and expire in 4 hours.

Based on clinical record review, hospital policy review, and staff interview for 1 of 3 sampled patients reviewed for restraints, the hospital failed to discontinue the use of restraints at the earliest possible time for a patient who was continuously restrained for 8 days. The findings include:


Patient #1 was admitted to the Emergency Department (ED) on 8/7/22 from a behavioral health unit for elevated laboratory blood values and rhabdomyolysis and admitted to a medical unit.

Review of the history and physical dated 8/7/22 at 12:18 PM noted that while on the behavioral health unit the patient's Creatinine Kinase and Liver Function Tests were elevated and the patient was brought to the ED for IV hydration. The note identified the patient was manic, easily distracted and had pressured speech.

Review of Patient #1's clinical record on 1/19/23 at 9:30 AM with the Clinical Information Specialist identified that between 8/8/22 at 2:30 PM and 8/9/22 at 5:26 PM (26 hours and 56 minutes) the patient was continuously restrained in 4-point bilateral locking restraints.

Between 8/9/22 at 12:02 PM and 8/13/22 at 10:51 AM Patient#1 was continuously restrained with bilateral locking wrist restraints (94 hours and 49 minutes).

Physician orders dated 8/13/22 at 8:37AM directed to apply tied bilateral padded hand mitts for interference with medical treatment. The order was discontinued at 10:51 AM.

Between 8/13/22 at 8:16 PM and 8/15/22 at 12:49 PM (43 hours and 33 minutes) Patient#1 was continuously restrained with a right locking wrist restraint due to a danger to self and others.

Review of the clinical record with the Clinical Information Specialist on 1/19/23 at 11:00 AM identified that although nursing narrative notes from 8/8/22 to 8/15/22 at 2:31 PM noted the patient was agitated/restless, the continuous observation flow sheets from 8/8/22 at 2:15 PM to 8/15/22 at 2:31 PM noted the patient was calm, cooperative, resting with eyes closed and sleeping. The Specialist stated that restraints should have been discontinued when the patient's behaviors subsided.

Review of the hospital policy for the use of restraints noted the discontinuation criteria included one or more of the following: improved mental status, the behavior that led to the restraint is improved, capacity to adhere to agreement regarding expected behavior/safety, time limit of order has expired and management by less restrictive interventions.

Based on clinical record review, hospital policy and staff interview for 1 of 3 sampled patients reviewed for restraints (Patient #1), the hospital failed to ensure that the patient who was restrained for 8 continuous days was evaluated face-to-face by a provider within one hour of the initiation of each restraint order in accordance with hospital policy. The findings include:

Patient #1 was admitted to the hospital from a psychiatric unit on 8/7/22 for IV hydration due to increased laboratory values. The H&P dated 8/7/22 at 2:14 PM noted the patient was manic with pressured speech, had rhabdomyolysis, would order aggressive IV fluids, and monitor the patient's laboratory values. The note further identified would order psychiatric medications per initial evaluation, obtain a psychiatric consult, and that the patient would be on constant observation unless discontinued by psychiatry.

a. Physician orders dated 8/8/22 at 2:30 PM directed to apply bilateral wrist and ankle locked restraints due to a danger to others. Review of the clinical record with the Clinical Information Specialist on 1/12/23 at 12:45 PM noted although bilateral locked wrist and ankle restraints were applied to the patient at 2:30 PM, there was no face-to-face evaluation completed by a physician or trained RN within one hour of the initiation of the restraints. The Specialist stated that RNs are not trained to conduct the face-to-face evaluation.


b. Physician orders dated 8/8/22 at 8:34 PM, 8/9/22 at 12:02 PM, and 8/9/22 at 12:02 PM directed to apply bilateral locked wrist and ankle restraints due to a danger to others. Review of the clinical record with the Clinical Information Specialist on 1/12/23 at 12:48 PM noted that there were no face-to-face evaluations completed by a physician within one hour of the initiation of the restraints.


c. Physician orders dated 8/10/22 at 7:36 AM directed to apply bilateral locked wrist restraints due to a danger to others. Review of the clinical record with the Clinical Information Specialist on 1/12/23 at 12:58 PM noted that there was no face-to-face evaluation completed by a physician within one hour after the initiation of the restraints. Further review noted that Patient #1 was seen by the MD on 8/10/22 at 10:18AM (2 hours and 42 minutes later).


d. Further review of the clinical record with the Clinical Information Specialist on 1/12/23 at 1:05 PM identified 14 additional times where physician orders directed to apply locked restraints due to a danger to others and there were no face-to-face evaluations completed by a physician within one hour of the initiation of the restraints. The dates of the missing face-to-face evaluations were 8/10/22 at 5:58 PM, 8/11/22 at 6:04 PM, 8/12/22 at 7:02 AM, 8/12/22 at 5:36 PM, 8/12/22 at 9:26 PM, 8/13/22 at 3:49 AM, 8/13/22 at 4:33 PM, 8/13/22 at 8:16 PM, 8/14/22 at 1:05 AM, 8/14/22 at 4:40 AM, 8/14/22 at 9:03 AM, 8/14/22 at 5:08 PM, 8/14/22 at 9:24 PM, and 8/15/22 at 12:10 AM.

Interview with MD #1 on 1/18/23 at 11:15 AM stated that he examined Patient #1 on the morning on 8/15/22 and that the patient was on 2 liters of oxygen for difficulty breathing during the night. MD #1 stated that he assessed the patient and noted crackles in the lungs, oxygen saturation was down but the patient did not appear to be short of breath, and an x-ray was ordered to rule out aspiration. MD #1 stated that he saw the patient again in the afternoon with psychiatry and it was decided to discontinue the use of the restraints. MD #1 stated that approximately 1 hour after the patient's restraints were removed the patient experienced respiratory distress, CPR was started, but the patient expired.

Review of the autopsy report and interview with the Medical Examiner on 1/25/23 at 9:25 AM noted the cause of Patient #1's death was pulmonary thromboembolism due to deep vein thrombosis complicated by medical restraint for acute bipolar disorder. The Medical Examiner stated that the length of time the patient was in restraints caused the embolism. The Medical Examiner stated that DTV prophylactic measures were usually implemented for patients who are inactive or bedridden due to the use of restraints as was this patient.

Review of the hospital policy for restraints identified when restraints for violent/self-destructive are applied to a patient, a face-to-face evaluation must be completed by the provider or trained RN within one hour after initiation to evaluate and document the patient's immediate situation, reaction to the intervention, medical and behavior condition as well as the need to continue or terminate the restraint. The policy further identified the provider must re-evaluate the patient in person at least every 8 hours.

Based on clinical record review, hospital policy and staff interview for 1 of 3 sampled patients reviewed for restraints (Patient #1), the hospital failed to ensure the patient was evaluated within one hour of the initiation of the application of locked restraints to include the patient's immediate situation, reaction to the intervention, the patient's medical and behavioral condition, and the need to continue or terminate the restraint. The findings include:

Patient #1 was admitted to the hospital from a psychiatric unit on 8/7/22 for IV hydration due to increased laboratory values. The H&P dated 8/7/22 at 2:14 PM noted the patient was manic with pressured speech, had rhabdomyolysis, would order aggressive IV fluids, and monitor the patient's laboratory values. The note further identified would order psychiatric medications per initial evaluation, obtain a psychiatric consult, and that the patient would be on constant observation unless discontinued by psychiatry.

a. Review of Patient #1's clinical record with the Clinical Information Specialist on 1/12/23 at 12:45 PM identified 21 times where Physician orders directed to apply 2 or 4-point locked restraints and there were no physician face-to-face assessments. For each of the 21 times the restraints were ordered, there was no physician's assessment of the patient's immediate situation, the patient's reaction to the restraint intervention, the patient's medical and behavioral condition, or the need to continue or terminate the restraint. The dates of the physician orders included 8/8/22 at 2:30 PM, 8/8/22 at 8:34 PM, 8/9/22 at 12:02 PM, 8/9/22 at 12:02 PM, 8/10/22 at 7:36 AM, 8/10/22 at 5:58 PM, 8/11/22 at 6:04 PM, 8/12/22 at 7:02AM, 8/12/22 at 5:36 PM, 8/12/22 at 9:26 PM, 8/13/22 at 3:49 AM, 8/13/22 at 4:33 PM, 8/13/22 at 8:16 PM, 8/14/22 at 1:05 AM, 8/14/22 at 4:40 AM, 8/14/22 at 9:03 AM, 8/14/22 at 5:08 PM, 8/14/22 at 9:24 PM, and 8/15/22 at 12:10 AM.


Interview with MD #1 on 1/18/23 at 11:15 AM stated that he examined Patient #1 on the morning on 8/15/22 and that the patient was on 2 liters of oxygen for difficulty breathing during the night. MD #1 stated that he assessed the patient and noted crackles in the lungs, oxygen saturation was down but the patient did not appear to be short of breath, and an x-ray was ordered to rule out aspiration. MD #1 stated that he saw the patient again in the afternoon with psychiatry and it was decided to discontinue the use of the restraints. MD #1 stated that approximately 1 hour after the patient's restraints were removed the patient experienced respiratory distress, CPR was started, but the patient expired.

Review of the autopsy report and interview with the Medical Examiner on 1/25/23 at 9:25 AM noted the cause of Patient #1's death was pulmonary thromboembolism due to deep vein thrombosis complicated by medical restraint for acute bipolar disorder. The Medical Examiner stated that the length of time the patient was in restraints caused the embolism. The Medical Examiner stated that DTV prophylactic measures were usually implemented for patients who are inactive or bedridden due to the use of restraints as was this patient.

Review of the hospital policy for restraints identified when restraints for violent/self-destructive are applied to a patient, a face-to-face evaluation must be completed by the provider or trained RN within one hour after initiation to evaluate and document the patient's immediate situation, reaction to the intervention, medical and behavior condition as well as the need to continue or terminate the restraint. The policy further identified the provider must re-evaluate the patient in person at least every 8 hours.