HospitalInspections.org

A0115

This CONDITION is not met as evidenced by:

Based on medical record review, document review, policy review, and interview, the facility failed to protect and promote the rights of all patients related to the use of restraints as evidence by: security officers used handcuffs to restrain Patient #2 and spit hoods for hospital patients (A0154); security officers utilized an unapproved facility restraint technique on Patient #2 that resulted in a fracture (broken bone) of Patient #2 's left arm, that required surgical repair (A0167); security officers manually restrained Patient #2 without the direction and/or oversight of the clinical staff that resulted in a left arm fracture (A0168); and staff did not provide ongoing restraint assessment and monitoring for restrained patients (A0175).

On 07/24/23 at 07:23 PM, an Immediate Jeopardy (IJ) situation was identified for the CoP of Patient Rights. The facility implemented immediate interventions that included editing existing policies to reflect handcuffs/spit hoods will no longer be used for hospitalized patients, educating clinical/security staff on restraint polices, and auditing of documentation to ensure compliance with immediate interventions. At 11:27 PM, the IJ was removed based on onsite surveyor verification of the immediate actions implemented by the facility through observations, policy review, document review, and interviews.

Cross Reference:

482.13(e)-Patient Rights. All patients have the right to be free from physical or mental abuse, and corporal punishment. All patients have the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time.

482.13(e)(4)(ii)-Patient Rights. The use of restraint or seclusion must be.... implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by hospital policy in accordance with State law.

482.13(e)(5)-Patient Rights. The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law.

482.13(e)(10)-Patient Rights. The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy.

Based on document review, medical record review, policy review, and interview, the facility does not ensure that all patients have the right to be free from physical or mental abuse, corporal punishment, and restraint imposed as a means of coercion, discipline, convenience, or retaliation by staff.
1. Security Officers utilized locking, metal handcuffs to subdue and restraint Patient #2. Handcuffs are considered a law enforcement restraint device and not considered a safe, appropriate healthcare restraint intervention for use by hospital staff, including security officers. The use of handcuffs in the healthcare setting could result in a negative outcome to patients.
2. Facility staff used spit hoods for emergency department and medical/surgical patients. There is no clinical policy and/or training curriculum for the use of spit hoods/socks; there is lack of documentation for the discontinuation of spit hoods/socks; and there is lack of monitoring documentation. The use of spit hoods/socks without training and monitoring could result in an adverse patient outcome.

Findings for #1:

Review on 07/21/23 of Safety and Security Reports revealed on 05/13/2023 at 09:39 PM and on 06/21/23 at 04:41 PM, Patient #2 was handcuffed by security officers for aggessive behavior.

Medical record review on 07/21/23 revealed that on 05/13/23 at 11:00 PM, the registered nurse note revealed Patient #2 attempted to exit the isolation room. Staff attempted to redirect Patient #2. Patient #2 became physically aggressive, swinging and biting staff. Security was notified. Patient #2 was escorted back to their room and placed in four-point restraints. (the note does not indicate Patient #2 was placed in handcuffs). On 06/21/23 at 06:00 PM, the registered nurse note revealed that Patient #2 was yelling "mama." Security arrived onsite. Patient #2 became agitated when sitting in a wheelchair. Patient #2's behavior further escalated, and they were placed in handcuffs by security officers.

Interview on 07/20/23 at 03:58 PM with Staff (CC), Security Officer, revealed on one occasion, they placed Patient #2 in handcuffs in order to prevent Patient #2 from further harming the patient care technician and security officers.

Interview on 07/24/23 at 11:30 AM with Staff (JJ), Security Officer, revealed handcuffs are used on the medical floors but not used on the inpatient psychiatric unit. Handcuffs are used when patients are exhibiting violent behaviors to self, to staff, and when waiting for restraints to be brought to the unit.

Interview on 07/24/23 at 01:24 PM with Staff (OO), Security Officer, revealed handcuffs are used when the holds are not working and/or when patients are a threat to themselves or others. On a medical floor, handcuffs would be applied for the patient's own safety when restraints are not easily accessible and used until restraints are available.

Findings for #2:

Review of the policy "Security Officers: Subject Resistance," effective January 2023, indicates the use of a personal protective equipment spit guard/mask/hood is not considered a restraint, but as personal protection equipment used for infection prevention. PPE spit guards/masks/hoods are not approved for restraint use and should only be used on patients while they are under the care/observation of a physician, advanced practice professional, or a registered nurse because the mask cannot be removed by the patient who is otherwise restrained. The mask creates a risk of aspiration should the subject vomit. (This is the only policy related to the use of a spit guard/mask/hood. No staff training on the application and/or monitoring requirements for the use of a spit guard/mask/hoods was found).

Review on 07/22/23 of the following medical records and security reports revealed lack of documentation of when spit hoods were initiated and/or discontinued for the following patients:
-Patient #32: At 01/31/23 at 10:37 AM, a provider note revealed "a spit hood is on and lower extremity restraints are in place." At 05:17 PM, Patient #32 was discharged. There is no documentation of when the spit hood was discontinued.
-Patient #34: On 03/23/23 at 08:15 PM, a nursing note revealed a spit hood was initiated. There is no documented time when the spit hood was removed.
-Patient #35: On 05/13/23 at 01:39 AM, Patient #35 was placed in a spit hood. There is no documented time when the spit hood was removed.
-Patient #36: On 03/27/23 at 11:44 PM, a security report revealed a spit hood was placed over Patient #36 head. On 03/28/23 at 02:19 AM, Patient #36's temperature was unable to be assessed due to a spit hood. There is no patient monitoring documentation from 02:19 AM to 04:00 AM, when the spit hood was utilized. There is no documented time when the spit hood was removed.
-Patient #38: On 07/9/23 at 05:15 PM, a security report revealed Patient #38 was placed in five-point restraints and a spit hood to prevent Patient #38 from spitting on staff. There is no documented time when the spit hood was removed.
- Patient #51: On 06/10/23 at 03:57 PM, a nursing note revealed a spit hood was placed for safety. There is no documented time when the spit hood was removed.
- Patient #54: On 06/04/23 at 12:28 PM, a nursing note revealed a spit hood was placed. There is no documented time when the spit hood was removed.

Interview on 07/25/23 at 11:30 AM, with Staff (PP), Chief Nursing Officer, revealed clinical staff are not trained or in-serviced on the use of spit hoods. Interview at 04:00 PM with Staff (E), Senior Director of Compliance, revealed there is no policy for the use of spit hoods for nursing staff.

Based on document review, policy review, medical record review, and interview, security officers utilized a manual restraint on Patient #2 that resulted in the fracture (broken bone) of the left humerus (arm bone) that required surgical repair.

Findings include:

Review of the training "Preventing and Managing Crisis Situations (PMCS)," version 9.01 training (no date-required for security officers) and policy "Restraints for Behavior Management-Four and Five Point Restraint/Seclusion/Room Restriction," last reviewed May 2022 revealed the training for secuirty officers and other staff for inpatient behavioral health units. (This training does not included a manual restraint intervention of holding a patient's arms behind their back).

Review of policy " Restraints for Behavior Management-Four and Five Point Restraint/Seclusion/Room Restriction, " last reviewed May 2022, is the restraint policy that applies to all hospital inpatient units for all staff. Policy "Restraints for Medical Necessity," last reviewed March 2022, is the policy that applies to all staff hospital areas and staff for the use of medical restraints. (These two policies do not include a manual restraint intervention of holding a patients arm behind their back).

Review on 07/21/23 of Safety & Security Reports for Patient #2's revealed on 07/08/23 at 05:34 PM, security officers were dispatched to Patient #2's room and grabbed Patient #2 by the right and left arm/wrists. Patient #2 continued to thrash and was able to get up on both of his knees on the bed. Security officers were losing their grip on Patient #2's arms and placed Patient #2's hands behind his back. Patient #2 continued to thrash around, moving their body around awkwardly in attempt to get free. The security officer heard a smack noise and thought Patient #2 hit their head on the bed railing due to thrashing. After hearing the snapping noise, Patient #2 stopped fighting back, and security loosened their grips on Patient #2's arms.

Review on 07/25/23 of Patient #2's medical record revealed on 07/08/23 at 05:25 PM, a nursing note by Staff (L), RN indicated Patient #2 was banging their head into bedrest, hitting the side rails, and thrashing around in bed. Security officers were called. Multiple security officers held Patient #2 down. A 'pop' was heard. At 08:12 PM, the physician assistant (PA) note indicates that Patient #2 had a decreased range of motion of left shoulder due to what seems to be pain and moaned with range of motion of the left elbow. An x-ray showed a left humeral fracture (left broken arm). At 11:15 PM, an orthopedic surgical consult was obtained and confirmed the left humeral fracture. On 07/19/23 at 04:27 PM, the orthopedics post-operative/procedure note indicated there were no complications during the open reduction and internal fixation surgical procedure for left distal humerus fracture.

Interview on 07/20/23 at 03:58 PM with Staff (CC), Security Officer, revealed that along with Staff (BB), Security Officer, they were the first to respond to Patient #2's room on 07/08/23. They entered the room and utilized verbal de-escalation techniques using simple statements because of Patient #2 was nonverbal. Patient #2 started to move off the bed and the security officers feared for their safety. Staff (BB), took the left arm, Staff (CC) took the right and attempted to hold both arms down at Patient #2's sides. Patient #2 was sitting on the bed with legs crisscrossed. Patient #2 became more aggressive and thrashing around, and attempted to pull their hands/arms free. Patient #2 attempted to bite and dug their nails into both security officers arms, while lifting their self up off the bed. Both secuirty officers placed Patient #2's arms slightly behind their back at hip level, and leaned Patient #2 forward. Patient #2 started to thrash/body lunge from side to side. A "pop" noise was heard and Patient #2 stopped thrashing aggressively. Two more security officers were called and entered the room. One security office placed their hand lightly on Patient #2's feet and the other placed their hand lightly on Patient #2's chest. At this time, the RN entered the room and injected Patient #2 with a medication. Patient #2 calmed down, and the security team departed the room.

Interview on 07/21/23 at 11:11 AM with Staff (DD), Patient Care Technician (PCT), revealed two security officers came to the floor and immediately went into Patient #2's room. The security officer's grabbed Patient #2's arms and placed both arms behind their back. Patient #2 was leaned forward. Patient #2's face looked like it was in the bed. Patient #2 fought back while being held by the security officers. A loud "pop" was heard. Security officers continued to hold Patient #2 for approximately forty five more seconds. At this time, Staff (L), RN, entered the room and administered medication. The security officers let go of Patient #2, who began to cry and was not moving their left arm. Staff (L), RN, called the doctor.

Interviews on 07/24/23 at 07:23 PM, with Staff (A), Regulatory Compliance, and Staff (C), President confirmed these findings.

Based on policy review, document review, and interview, the use of restraint must be in accordance with the order of a physician or licensed practitioner who is responsible for the care of the patient. Specifically, security officers manually restrained Patient #2 without direction and/or oversight of the registered nurse, who is responsible for the emergency application of restraints. Failure to follow clinical direction has the potential inadequate/incorrect interventions and/or for an adverse patient outcome.

Findings include:

Review of the policy "Restraints for Behavior Management-Four and Five Point Restraint/Seclusion/Room Restriction," last reviewed May 2022 revealed the application and removal of restraints will take place under the supervision of the RN. The Security department staff may be called when restraints are needed to assist with providing a safe environment. Security staff is under the direction of the RN caring for the patient.

Review on 07/21/23 of the Safety & Security Report for Patient #2 dated 07/08/23 at 05:34 PM revealed security officers (Staff CC and Staff BB), were dispatched to Patient #2's room. On the security officer's arrival, Staff (DD), Patient Care Technician, was standing outside of Patient #2's room at a distance. Staff (L), Registered Nurse was farther back, looking flushed, doing nothing except looking back and forth between security and Patient #2. There were three to four staff members (nursing staff) on the unit standing in the hallway that looked panicked. Staff (DD), Patient Care Technician stated, "staff are concerned he's going to get violent with us, and we're not sure what to do." Staff (CC), Security Officer, looked back at the group of staff (nursing staff) and asked, "what's the plan?" Nursing staff did not answer or acknowledge if they had a plan at all. The security officers looked into the room and observed Patient #2 bellowing, shrieking aggressively, and biting self.. The security officers went into the room and grabbed Patient #2's right and left arm and wrists. No direction was given to the security officers by the medical (nursing) staff. Patient #2 continued to thrash and was able to get up on both of his knees on the bed. The security officers were losing their grip on Patient #2's arms and placed Patient #2's hands behind his back while using verbal de-escalation techniques. Patient #2 continued to thrash around and move their body around awkwardly in attempt to get free. At this point, medical (nursing) staff still had not entered the room and had not informed the security officers of the plan going forward to stabilize Patient #2. Staff (CC), Security Officer, looked out of the doorway and called out to staff asking, "what's the plan?" Patient #2 continued to thrash around. The security officers heard a smack noise and thought Patient #2 hit their head on the bed rail. After the snapping noise, Patient #2 stopped fighting back, and security officers loosened their grips on Patient #2's arms. Unit staff did not wish to use restraints. Staff (L), RN, gave Patient #2 an intramuscular (IM) medication.

Interview on 07/20/23 at 03:58 PM with Staff (CC), Security Officer, confirmed the information in the 07/08/23 Safety & Security Report for Patient #2. Staff (CC) stated when security officers respond to situations on the floors, they are always meet by the registered nurse who will inform them of what's going on and what the plan is prior to security engaging with a patient. When they arrived on the floor on 07/08/23, floor staff did not meet or approached them to let them know what was going on and/or what the plan was.

Interviews on 07/24/23 at 07:23 PM, with Staff (A), Regulatory Compliance, and Staff (C), President, confirmed these findings.

Based on policy review, medical record review, document review, and interview, facility staff do not provide ongoing restraint assessment and monitoring, as evident for two of forty patients (Patient #43 and 49). Failure to provide ongoing monitoring to patients while restrained has the potential for an adverse patient event.

Findings Include:

Review of policy "Restraints for Behavior Management-Four and Five Point Restraint/Seclusion/Room Restriction", last reviewed May 2022 indicates that the use of restrictive interventions must be ordered by a physcian for inpatient behavioral health areas or by a physician, physician assistant, or nurse practitioner in other areas of care. Nursing staff will monitor the patient's medical condition and document in nursing flowsheets every 15 minutes while the patient is in restraint or seclusion.

Review of the medical record for Patient #43 revealed dated 06/17/23 at 08:29 AM, the physician ordered five-point restraint and 1:1 observation for physical aggression/verbal threats for two hours. There is no documentation of the initiation of five-point restraints, patient monitoring every fifteen minutes, and for the discontinuation of the restraints.

Review on 07/25/23 of the Safety & Security Report for Patient #49 dated 06/17/23 at 04:39 PM revealed Patient #49 arrived at ED with the police. Patient #49 was restrained to the stretcher upon entry to the hospital. Staff (IIII), RN, ordered Patient #49 to be placed in four-point restraints. Review of the medical record dated 06/17/23 revealed no provider order for four-point restraints. There is no documentation for the initiation of the four-point restraints, patient monitoring every fifteen minutes, and for the discontinuation of the restraints.

Interview on 08/09/23 at 11:00 AM with Staff (R), RN Clinical Nurse Specialist, verified these findings.

Based on policy review, interview, medical record review, and document review, the facility does not ensure quality assurance data is collected for behavioral restraints and used to identify opportunities for improvement. Failure to identify trends and/or high risk interventions has to potential for poor patient outcomes and adverse patient events.

Findings include:

Review of policy "Quality Assurance, Patient Safety, & Performance Improvement Plan," (no date) indicates each hospital's quality committee serves as a multidisciplinary governing body responsible and accountable for ensuring the hospital implements and maintains an effective quality management system. The Quality Assurance, Patient Safety, & Performance Improvement Plan activities includes, but not limited to: The review of care provided by medical and nursing staff, review of medical records, medical care evaluation studies, complaints, incidents, and other pertinent data sources; The maintenance and continuous collection of information, negative healthcare outcomes, injuries, and patient incidents; Rochester Regional Health measures and monitors quality outcomes and assists with the implementation of appropriate changes using: Established quality objectives for relevant documented key processes using risk based thinking with priority for high risk, problem prone areas, processes, and functions including consideration of incidence, prevalence, and severity. The use data to identify and quantify areas of improvement opportunities and areas for maintain or improving the standard of care; Corrective/preventative action plans are initiated when non-conformities are identified in an effort to control and manage non-conformity product; and internal audits provide objective evidence for management review and provide accountability for process owners to ensure the organizations requirements are effectively implemented and maintained. Following completion of the internal audit, the level of conformance is determined by the assigned lead auditor in conjunction with the team. An executive summary of the findings and results is shared with the identified process owners.

Interview on 08/09/23 at 09:20 AM with Staff (A), Regulatory Compliance, and Staff (E), Senior Director of Compliance, revealed restraints are reported out semi-annually during the overall Quality Assurance committee and sentinel events are reported out monthly at the Quality Assurance committee. Indicators are based on DNV (Accreditation Organization) standards and involve nursing documentation. Security reports are reviewed by security leadership and are not reviewed as part of the hospital wide quality review of restraints.

Interview on 08/09/23 at 11:24 AM with Staff (G), Clinical Nurse Specialist, revealed nurse managers on all floors complete an audit tool or a "Redcap" survey weekly, excluding the behavioral health unit. The audit includes the following behavioral restraint information: the behavioral restraint order matches the device; the behavioral restraint order is renewed every two hours; and the behavioral restraint documentation is compliant. Five medical records are selected randomly on each unit, but not according to intervention. A patient medical record selected for the weekly audit may have not required the use of restraints.

Review on 07/25/23 of patient medical records and security reports revealed the following:
-Patient #2 required behavioral restraints on 02/15/23, 05/13/23, 06/21/23, 06/28/23, 06/29/23, 07/07/23, 07/08/23 and 07/10/23. On 05/13/23 and 06/21/23 included the use of handcuffs. On 07/08/23, Patient #2 sustained a fractured arm during a restraint intervention.
-Patient #3 required behavioral restraints on 04/13/23.
-Patient #38 required behavioral restraints on 07/09/23.
-Patient #43 required behavioral restraints on 06/07/23 twice.
-Patient #46 required behavioral restraints on 06/07/23.
-Patient #49 required behavioral restraints on 06/07/23.
-Spit hoods (high risk intervention per facility policy) were utilized for Patient #25 on 07/21/23, Patient #28 on 01/26/23, Patient #31 on 01/23/23, Patient #32 on 01/31/23, Patient #33 on 02/19/23, Patient # 34 on 03/23/23, Patient #35 on 05/13/23, Patient #36 on 03/27/23, Patient # 37 on 06/04/23, Patient #38 on 07/09/23, Patient #51 on 06/10/23, and Patient #54 on 06/04/23.

Review of the Rochester General Hospital Nursing-Restraint Documentation Data report (audit) and the weekly summarized Nursing-Restraint Documentation Data report from 01/02/23 to 07/17/23 revealed no behavioral restraint data was documented from 02/13/23 to 04/24/23 and from 05/08/23 to 07/17/23, (0% is listed for 05/29/23).

Review of the Rochester General Hospital Quality Committee Meeting minutes dated 06/07/23 revealed aggregate data regarding the use of restraint shall be collected and analyzed for the identification of patterns and trends. Intensive analysis will be conducted in the event a patient is injured through the use of restraint, or a staff member is injured through the application of restraint. Data (%) was listed for the following indicators related to restraints (timeframe of data collection is not documented):
-Behavioral restraint order matches device: 0 %
-Behavioral restraint order renewed every 2 hours: 0 %
-Behavioral restraint documentation compliant: 0 %

Review of the Quality Committee meeting minutes from 12/07/22 to 06/07/23 and the Nursing-Restraint Documentation Data report/audits from 01/02/23 to 07/17/23 revealed restraint activity (see medical record review) was not captured by the internal nursing unit audits.