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Based on document review, policy review, medical record review, and interview, the facility failed to comply with New York State Title 10, Adverse Event Reporting 405.8 (a)-(b) (1) requirements for reporting deaths that occurred while patients were in restraints according to the New York State Department of Health for six of eight patients (Patient #1, #2, #3, #4, #5 and #8). Lack of compliance with Federal, State, and local law requirements has the potential for adverse patient outcomes.

Findings include:

Review of the New York State public health document "§ 2805-l. Adverse Event Reporting,'" dated 06/04/18 revealed that the following adverse events shall be reported to the department: (a) patients' deaths or impairments of bodily functions in circumstances other than those related to the natural course of illness, disease, or proper treatment in accordance with generally accepted medical standards. The hospital shall investigate events within thirty days of obtaining knowledge of any information which reasonably appears to show that such an event has occurred the hospital shall provide to the department a copy of the investigation report within twenty-four hours of completion.

Review of the policy "Reporting Adverse Events, Near Miss, and Unsafe Conditions-Patients and Visitors," dated 03/10/22 indicated that an event is an adverse occurrence related to the care and services provided to patients and their visitors. Serious events, including those with an adverse effect on patient outcome, must be reported immediately to area leadership and to the office of counsel to the medical center and/or quality assurance office. Any serious event that is or might be a critical/sentinel event or a New York State Department of Health 30-day report (New York State Patient Occurrence Reporting and Tracking System or NYPORTS) requires a root cause analysis and must be reviewed and evaluated by senior management. Review of events are a required element of strong memorial hospital quality plan for performance improvement. Some events require individual case review.

Review of the policy "2023 Strong Memorial Hospital Quality Assurance Performance Improvement Program," revealed that the hospital incident reporting program indicates in the case of serious accident, injury, or serious adverse outcomes unrelated to natural course of illness or underlying conditions, the office of counsel to the medical center and the quality assurance office is to be notified immediately by telephone or email. The quality assurance office assures review of all significant events by receiving a copy of referrals of significant and routine incidents and reviewing case reviews submitted by quality assurance liaisons. Potential serious events are reviewed by the medical executive committee and quality improvement to determine if they meet NYPORTS criteria. The serious event notification process indicated that the office of counsel to the medical center, senior hospital management and quality assurance are notified of the event within 24 hours. A senior hospital management team member is designated and determines the appropriate process for review of the event and notification of appropriate department leadership based on the available information. A preliminary review of the circumstances of the event may be undertaken within 48 hours of notification of the event.

Review of the document "New York State Department of Health Reporting Guide: New York patient occurrence reporting and tracking system, known as NYPORTS," dated 07/19/19 revealed a patient death or serious injury associated with the use of physical restraints or bedrails while being cared for in a healthcare setting is reportable. A level one event report with a root cause analysis is required.

Review of the document "New York Patient Occurrence Reporting and Tracking System, known as NYPORTS Serious Events, " last revised October 2019 revealed a level one (1) event as a patient death and/or serious injury while being cared for in a health care setting under Code 915 (RES)- restraints, physical restraints, or bedrails. Report events immediately to the department leader and the quality assurance office.

Review on 09/06/23 of the medical record for Patient #1 revealed, Patient #1 was in restraints at the time of death on 05/09/22 at 10:52 PM. (Patient #1's death while in restraints met the criteria as reportable to NYPORTS requiring a root cause analysis). Interview with Staff (D), Assistant Quality Officer, indicated that a NYPORTS report and/or a root cause analysis was not completed.

Review on 09/07/23 of the facility quality assurance meetings from January 2022 to September 2023 revealed no evidence Patient #1 ' s death in restraints, that occurred on 05/09/22, was reviewed and/or reported to NYPORTS.

Review on 09/08/23 of the email communication between the onsite surveyors and the NYPORTS staff revealed Patient #1's death while in restraints must be reported and a root cause analysis performed according to code 915- (RES) for a patient death or serious injury associated with the use of physical restraints or bedrails while being cared for in a healthcare setting.

Medical record review on 09/06/23 revealed that the following patients expired while in restraints, met the NYPORTS criteria for reporting, and required a root cause analysis: Patient #2 on 06/18/23 at 09:40 AM, Patient #3 on 04/23/23 at 10:14 AM, Patient #4 on 02/19/23 at 06:35 AM, Patient #5 on 01/02/23 at 02:02 PM, and Patient #8 on 02/20/22 at 09:34 PM. (All cases meet the NYPORTS criteria for reporting a death while in restraint). Interview with Staff (E), Assistant Quality Officer, indicated that a NYPORTS report and/or a root cause analysis was not completed.

Interview on 09/08/23 at 01:19 PM with Staff (E), Associate Quality Officer, verified the findings.

A115
This CONDITION is not met as evidenced by:

Based on policy review, medical record review, document review, video review, and interview, it was determined that the facility failed to ensure that care is provided in a safe setting related to the implementation of restraint interventions. The provider does not perform a face-to-face assessment for the implementation of non- violent restraints (A0167). The facility does not ensure there is a physician order for the use of restraints (A0168). Staff failed to perform ongoing restraint assessment and monitoring (A0175). This failure resulted in an Immediate Jeopardy, posing a serious risk of harm to the patients.

On 09/07/23 at 06:45 PM, an Immediate Jeopardy situation was identified for the CoP of Patient Rights. At 10:55 PM, the facility provided a corrective action plan to onsite survey staff with the following corrective actions: Education was provided to all staff immediately and prior to their next shift requiring face to face assessments to be completed within 60 minutes of restraint initiation; orders for restraints will be obtained for all patient within 60 minutes of the initiation of restraints; nursing staff will conduct observation/monitoring checks every 30 minutes and assessment of restraints every two hours; and nursing staff will release restraints at regular intervals and document intervention in the medical record. On 09/08/23 at 02:15 PM, the Immediate Jeopardy was removed based on observations, document review, and interviews with staff which verified that the corrective action plan was fully implemented.

Cross Reference:

482.13(e)(4)(ii)- Patient Rights- Restraints must be implemented in accordance with safe and appropriate techniques as determined by hospital policy in accordance with State law.
482.13 (e)(5)- Patient Rights- The use of restraints 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 by hospital policy in accordance with State law.
482.13 (e)(10)- Patient Rights- The condition of the patient who is restrained must be monitored by a physician, other licensed practitioner or trained staff that have completed training criteria.
482.13 (f)(1)- Patient Rights- Staff must be trained and able to demonstrate competency in the application of restraints, monitoring, assessment, and providing care for a patient in restraints.
482.13 (f)(2)(vii)- Patient Rights- The hospital must require appropriate staff to have education, training, and demonstrate knowledge in the use of first aid techniques and certification in the use of cardiopulmonary resuscitation, including periodic recertification.
482.13 (g)(1) & (3)(i)- Restraint and Seclusion Death Report- Hospitals must report deaths associated with the use of restraints to CMS.

Based on policy review, medical record review, and interview, the facility does not ensure all patients are informed of their rights for six out of seventeen patients (Patients # 2, #3, #4, #5, #8, and #10). Failure to inform patients of their rights has the potential for patients making uninformed decisions.

Findings Include:

Review of the policy "Patient's Rights and Responsibilities," last revised 06/10/20 indicates that emergency department (ED) patients are provided a copy of the Patients' Rights and Responsibilities as part of the registration process. As part of the nursing assessment during the inpatient admission process, patients are provided a copy of the Admission Guide that includes the Patients' Rights and Responsibilities, which is documented in the medical record.

Review on 09/07/23 of the medical record for Patients #2, #3, #4, #5, #8, and #10 revealed no evidence that a copy of the Patients' Rights and Responsibilities was received and/or provided during registration or during the inpatient admission process.

Interview on 09/11/23 at 12:45 PM with Staff (C), Assistant Quality Officer, verified these findings.

Based on policy review, medical record review, and interview, the facility failed to implement restraints in accordance with safe and appropriate restraint techniques as determined by hospital policy. Specifically, the provider did not perform a face-to-face assessment for two of five patients (Patients #1 and 3) in non-violent medical restraints. Lack of evaluation has the potential for inadequate treatment and places patients at risk for an adverse event.

Findings Include:

Review of policy "Restraints for Non-Violent, Non-Destructive Behaviors," dated October 2021, indicates the physician shall perform a face-to-face assessment of the patient's physical and psychological status within one hour of the initiation of non-violent restraints.

Review on 09/06/23 of the medical record for Patient # 1 revealed physician orders and nursing documentation confirmation for the application of medical posey vest and wrist restraints from 05/05/22 at 11:01 PM to 05/09/22 at 11:30 AM. There is no documentation of a physician face-to-face restraint assessment during this time.

Review on 09/06/23 of the medical record for Patient #3 revealed physician orders and nursing documentation confirmation for the application of medical bilateral wrist restraints from 04/22/23 at 09:29 AM to 04/23/23 at 07:38 AM There is no documentation of a physician face-to-face restraint assessment during this time.

Interview on 09/08/23 at 01:19 PM with Staff (E), Associate Quality Officer, verified these findings.

Based on policy review, medical record review, and interview, the facility does not ensure there is a physician order for the use of restraints for two of seven patients (Patient #1 and #2).

Findings Include:

Review of policy "Restraints for Non-Violent, Non-Destructive Behaviors," dated 11/10/21 indicates that a provider is required to write an order for the use of non-violent restraints.

Review on 09/07/23 of the medical record for Patient #1 revealed that on 05/05/22 at 11:01 PM, a physician order was received for a posey vest and right wrist medical restraint. Nursing documentation indicates that a posey vest and bilateral wrist restraints were applied. No physician order was found for the left wrist restraint. Nursing documentation indicates Patient #1 remained in posey vest from 05/06/22 at 03:00 PM until 05/09/22 at 11:30 AM when the posey vest was removed. No physician orders were found for the use of the posey vest during this time. The posey vest was reapplied by nursing staff on 05/09/22 at 07:30 PM and remained in place until Patient #1 was found unresponsive at 10:45 PM. No physician orders were found for the reapplication of the posey vest during this time.

Review on 09/07/23 of the medical record for Patient #2 revealed that on 06/18/23 at 12:00 AM, a physician order was received for the use of all four side rails as a restraint. At 08:02 AM, nursing staff document that a posey vest medical restraint was applied and the four side rails were not implemented. No physician order was found for the use of a posey vest.

Interview on 09/08/23 at 01:19 PM with Staff (E), Associate Quality Officer, verified these findings.

Based on policy review, medical record review, and interview, facility staff failed to perform ongoing restraint assessment and monitoring for two of seven patients (Patients #1 and #5) in restraints. Failure to provide ongoing monitoring to patients while restrained has as the likelihood to cause serious injury, serious harm, serious impairment or death.

Findings Include:

Review of policy "Restraints for Non-Violent, Non-Self-Destructive Behaviors," dated 08/10/21 indicates that the purpose of monitoring an individual in restraint or seclusion is to ensure their safety. The physical and psychological well-being of the patient who is restrained will be observed every 30 minutes or more frequently as clinically indicated. Monitoring includes, but is not limited to, respiratory and circulatory status, nutrition/hydration needs, skin integrity and vital signs. Nursing assessments of a patient's response to interventions are conducted at least every two hours or more often as indicated by clinical need. Monitoring is provided by a staff member who is trained and competent in the monitoring of a patient in restraint. Range of motion is performed at regular intervals on each limb restrained during an episode of restraint.

Review on 09/06/23 of the medical record for Patient #1 revealed nursing documentation indicates a posey vest (medical restraint) was applied from 05/06/22 at 03:00 PM until 05/09/22 at 11:30 AM when the vest was removed. There is no documentation of thirty-minute checks, and every two-hour RN assessment. Nursing staff reapplied the posey vest on 05/09/22 at 07:30 PM until 10:30 PM. The last observation of Patient #1 by nursing staff is at 09:00 PM with the RN Assessment. There is no documentation of thirty-minute checks from 09:30 PM to 10:30 PM, when Patient #1 was found unresponsive. Patient #1 was pronounced dead on 05/09/22 at 10:52 PM.

Review on 9/06/23 of the medical record for Patient #5 revealed that on 01/01/23 at 08:47 AM, the physician wrote an order for bilateral wrist restraints. From 09:00 AM to 05:45 PM, there is no documentation of thirty-minute checks, and every two-hour RN assessment. On 01/01/23 at 06:17 PM, the physician wrote an order for bilateral wrist restraints. From 07:00 PM to 10:00 PM there is no documentation of thirty-minute checks, and every two-hour RN assessment. On 01/02/23 at 02:02 PM Patient #5 expired while in restraints.

Interview on 09/08/23 at 01:19 PM with Staff (E), Associate Quality Officer, verified these findings.

Based on policy review, document review, and interview, the facility does not ensure all staff having direct patient care responsibilities, to demonstrate competence in the application of restraints and the monitoring, assessment, and providing care for a patient in restraints for two of twelve staff members (Staff # S and TT) per facility policy. Lack of training has the potential for an adverse patient outcome.

Findings Include:

Review of the policy "Restraints for Non-Violent, Non Self-Destructive Behaviors," dated 08/10/21, indicates all staff who apply restraints (providers, nursing staff and Department of Public Safety) receives education, training and demonstrate knowledge on the following: Strategies to identify staff and patient behaviors, events, and environmental factors that may trigger circumstances that require the use of restraint, use of nonphysical intervention skills, safe application and use of all types of restraint used in the hospital and the use of first aid techniques and certification in the use of cardiopulmonary resuscitation, including required periodic recertification. Staff training occurs at the time of orientation, prior to participating in the use of restraint or seclusion, and annually thereafter. This training and demonstrated competence are documented in staff records.

Review on 09/12/23 of the registered nurse job description "Novice Nurse Level 1 and Level 2 Registered Nurse (RN) Minimum Qualifications and Position Expectations," (no date) indicates that the RN is accountable to maintain compliance with all annual competency updates and requirements.

Review on 09/11/23 of the personnel file for Staff (S), Physician Assistant, revealed a hire dated of 11/01/20. There is no evidence Staff (S) received any restraint training since hire date.

Review on 09/11/23 of the personnel file for Staff (TT), Registered Nurse, revealed a hire date of 03/16/00. No evidence was found of annual restraint training in 2021 or 2022.

Interview on 09/11/23 at 12:45 PM with Staff (E), Associate Quality Officer, verified these findings.

Based on document review, policy review, personnel file review, and interview, the facility does not require all staff who apply restraints to have certification in cardiopulmonary resuscitation (CPR) for four of twelve staff members (Staff O, U, V, and W). Lack of training has the potential for a delay in a patient receiving life-saving interventions in an emergency and an adverse patient outcome.

Findings Include:

Review on 09/07/23 of Division of Hospitals and Diagnostic & Treatment Centers Dear Administrator Letter (DAL) 17-13: Security Guards and Restraints, dated 11/02/17 indicated hospitals must ensure that all staff who are authorized to apply restraints or care for patients in restraints, including security personnel, are trained in cardiopulmonary resuscitation, first aid, and the appropriate use of restraints (including physical holds), and that they are trained and understand when it is appropriate to apply a restraint and what restraint is appropriate to use as outlined in the hospital policies and procedures.

Review of the "Novice Nurse Level 1 and Level 2 Registered Nurse (RN) Minimum Qualifications and Position Expectations," (no date) indicates that the RN is accountable to maintain a current CPR certification and compliance with all annual competency updates and requirements are required.

Review of the job descriptions for a "Public Safety Peace Officer" and "Public Safety Officer," (no dates) revealed the facility does not require training in (CPR), first aid, and/or the application/use of restraints for these positions.

Review of the policy "Restraints and Seclusion for Violent/Self-Destructive Behaviors Policy" last revised 11/10/21, indicates all staff who apply restraints (Providers, Nursing Staff and Department of Public Safety) receives education, training, and demonstrate knowledge on strategies to identify staff and patient behaviors; events and environmental factors that may trigger circumstances that require the use of restraint or seclusion; use of non-physical intervention skills; safe application and use of all types of restraint or seclusion; and the use of first aid techniques and certification in CPR, including required periodic recertification. Staff training occurs at the time of orientation, prior to participating in the use of restraint or seclusion, and annually thereafter. This training and demonstrated competence are documented in staff records.

Review on 09/11/23 of the personnel file for Staff (O), Registered Nurse, revealed a hire date of 06/07/21. BLS training expired in May 2023. No evidence of current BLS training was found.

Review on 09/11/23 of the personnel File for Staff (S), Physician Assistant, revealed a hire dated of 11/01/20. There is no evidence Staff (S) received any restraint training since hire date.

Review on 09/11/23 of personnel file for Staff (U), Department of Public Safety, Peace Officer revealed a hired date of 02/14/22. No CPR certification and/or training was found prior to 09/09/23.

Review on 09/11/23 of personnel file for Staff (V), Department of Public Safety Officer revealed a hire date of 04/06/92. No CPR certification and/or training was found prior to 09/08/23.

Review on 09/11/23 of personnel file for Staff (W), Department of Public Safety, Peace Officer revealed a hire date of 06/22/15. No CPR certification and/or training was found prior to 09/08/23.

Review on 09/11/23 of the personnel File for Staff (TT), Registered Nurse, revealed Staff (TT), Registered Nurse with a hire date of 3/16/00. No evidence was found of annual restraint training in 2021 or 2022.

Interview on 09/11/23 at 12:45 PM with Staff (E), Associate Quality Officer, verified these findings.

Based on document review, medical record review, and interview, the facility does not follow policies for reporting patient deaths that occurred while in restraints to the Centers for Medicare & Medicaid Services (CMS) for five of eight patients (Patient #3, #4, #5, #6 and #8). Lack of reporting has the potential for delaying or not identifying trends that could lead to adverse patient outcomes.

Findings Include:

Review of the Centers for Medicare and Medicaid Services (CMS) document "QSO-20-04-Hospital-CAH DPU," revised 01/17/20 revealed that in accordance with the requirements at 42 CFR 482.13(g), "Death Reporting Requirements," all patient deaths associated with restraint and/or seclusion (except two point soft wrist restraints that must be recorded in an internal hospital log or other system) are required to be reported to the CMS regional locations using the form CMS10455 "Report of a Hospital Death Associated with the Use of Restraint or Seclusion," by all types of hospitals.

Medical record review on 09/06/23 revealed the following patient's expired while in restraints: Patient #3 on 04/23/23 at 10:14 AM; Patient #4 on 02/19/23 at 06:35 AM; Patient #5 on 01/02/23 at 02:02 PM; Patient #6 on 03/01/22 at 8:12 PM; and Patient #8 on 02/20/22 at 09:34 PM. No evidence was found to indicate the facility submitted a report to CMS for the patient deaths while in restraints.

Interview on 09/08/23 at 01:19 PM with Staff (E), Associate Quality Officer, verified these findings.

Based on policy review, medical record review, and interview, nursing staff did not turn and position one of three patients (Patient #34) per policy to prevent skin breakdown. Failure to turn and re-position patients can cause patient injury.

Findings Include:

Review of policy "Skin Care: Pressure Injuries Assessment, Prevention and Treatment Procedure" last revised 12/10/21 indicates staff are to use proper positioning, transferring, and turning techniques including positioning devices such as foam wedges to offload pressure and maintain position change. When a patient develops a pressure injury, continue to follow the nursing plan of care. Assess the injury by anatomical location, stage of injury, measurement, condition of surrounding skin, odor, and pain. Contact the Wound/Ostomy Nurse Team for a consult on staging and treatment recommendations. Reassessment of the pressure injury is completed by staff with each scheduled dressing change and document in the medical record.

Review on 09/18/23 of the medical record for Patient #34 revealed an admission date of 05/14/23 for cardiac arrest. On 05/14/23 at 02:30 PM, the RN Shift assessment indicated that Patient #34 was sedated, had completely limited sensory perception, was immobile, and was bedfast. Skin integrity was within defined limits (no breakdown or discoloration). On 5/20/23 from 08:00 AM to 12:00 PM, there is no documentation of turning and re-positioning. On 05/21/23 at 07:00 PM, the Wound/Skin evaluation and treatment order note indicated there is a pressure injury wound located on the buttocks that was not present upon admission. The wound is described as a deep tissue pressure injury (DTPI- a wound that is persistent, non-blanchable, deep red, maroon, or purple in discoloration).

Interview on 09/11/23 at 01:30 PM with Staff (C), Assistant Quality Officer, verified the lack of turning and repositioning documentation, indicating it should be completed every two hours.

Based on policy review, medical record review, and interview, nursing staff did not notify the provider when vital signs were outside ordered parameters for one of one patient (Patient #1). Failure to notify the provider has the potential for a delay in treatment and/or an adverse patient event.

Findings Include:

Review of policy "Communication Regarding Patient Care" last revised on 03/10/21 indicates, when the nurse cannot implement the provider's order because of concerns for patient's safety, they will notify the charge nurse/unit leadership of the circumstances. The nurse/unit leadership notifies the practitioner who wrote the order. The charge nurse discusses the nurse's concern with the physician in charge of the patients care. If the practitioner is a resident physician and does not respond in a timely manner, the charge nurse refers the concern to the next level provider of the appropriate service. If the problem is not resolved, the attending physician is notified. If the attending physician does not respond in a timely manner, the charge nurse determines if a referral to the program medical director if necessary.

Review on 09/11/23 of the medical record for Patient #1 revealed the following a physician order dated 04/01/22 at 03:53 AM to notify the provider of the following vital sign parameters: a pulse less than 60 or greater than 120, respiratory rate less than 12 or greater than 25, temperature less than 36.0 Celsius (96.8 Fahrenheit) or greater than 38.5 Celsius (101.3 Fahrenheit), systolic blood pressure (the first number, measures the pressure in your arteries when your heart beats) less than 90 or greater than 140, diastolic blood pressure (the second number, measures the pressure in your arteries when your heart rests between beats) greater than 90, pulse oximetry (the oxygen saturation in the blood) less than 90%, and a blood glucose less than 60 or greater than 350.
On 05/08/22 at 11:58 AM, vital signs revealed a pulse of 56. At 04:50 PM the systolic blood pressure was 157. At 11:27 PM the systolic blood pressure was 147. There is no documentation that nursing staff notified the provider for vital signs outside of the ordered parameters.
On 05/09/22 at 02:21 PM, vital signs revealed a respiratory rate of 32. At 03:51 PM the respiratory rate was 26. At 04:09 PM, a text page was sent to Staff (XX), Nurse Practitioner (NP), regarding a fluctuating respiratory rate of 32 to 26. There is no documentation that the NP responded to the text sent at 04:09 PM. At 06:50 PM, the systolic blood pressure was 85 and the pulse oximetry was 88%. There is no documentation to indicate nursing staff notified the provider of the systolic blood pressure and pulse oximetry that were outside of the ordered parameters.

Interview on 09/06/23 at 01:45 PM with Staff (C), Assistant Quality Officer, verified these findings. Vitals Signs are completed per provider order. There is no specific vital sign policy.