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Based on interview, documentation reviewed in the medical records for 3 of 3 patients (Patients 2, 4 and 17), incident documentation reviewed for 11 of 11 patients (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 17), grievance documentation reviewed for 7 of 7 patients selected from the grievance log (Patients 11, 12, 13, 14, 15, 16 and 18), review of a list of physician and LIP staff, review of staff training/education records, review of staff education materials, review of QAPI documents, review of policies and procedures, and review of other documentation, it was determined that the governing body failed to ensure the provision of safe and appropriate care to patients in the hospital that complied with the Conditions of Participation.

This Condition-level deficiency represents a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

1. Refer to the findings cited under Tag A115, CFR 482.13 - CoP Patient's Rights.

2. Refer to the findings cited under Tag A263, CFR 482.21 - CoP Quality Assessment and Performance Improvement.

Based on interview, documentation reviewed in the medical records for 3 of 3 patients (Patients 2, 4 and 17), incident documentation reviewed for 11 of 11 patients (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 17), grievance documentation reviewed for 7 of 7 patients selected from the grievance log (Patients 11, 12, 13, 14, 15, 16 and 18), review of a list of physician and LIP staff, review of staff training/education records, review of staff education materials, review of policies and procedures, and review of other documentation, it was determined that the hospital failed to develop and enforce policies and procedures to ensure patients' rights were recognized, protected and promoted in the following areas:
* The hospital failed to conduct thorough, complete, clear and timely investigations and follow up actions of potential abuse or neglect, and potential or actual harm, to ensure those did not recur. Patient incidents included:
- Patient 1 who had a clogged NG feeding tube and missed his/her tube feedings for an unknown period of time; and RN staff who accessed and managed the feeding tube had not been trained or determined competent by the hospital to conduct those tasks.
- Patient 4 who was administered an IV solution through a temporary dialysis catheter that was accessed by RN staff who were not trained, determined competent, or permitted by the hospital to conduct those tasks.
- Patient 6 who became unresponsive and experienced an acute change of condition and loss of consciousness.
- Patients 9 who experienced repeated falls.
- Patient 17 who was physically restrained to the bed by his/her upper extremity and was subsequently found on the floor next to the bed with the restraint still attached, and RN staff failed to appropriately assess the patient for injuries. In another incident, Patient 17 became unresponsive and required resuscitation and ventilator support after RN staff administered the patient repeated doses of Valium and failed to evaluate the patient's response to the drug.
- Patients 2, 3, 5, 7, 8, 10, and 17 regarding patient falls, physical restraints, agitated behaviors, pneumonia management, dressing changes, "rough" staff, and trach "self- decannulation."
* Responses to and investigations of patient complaints/grievances, including those related to potential abuse or neglect.
* Physician and LIP staff restraint policies and training.
* Staff training and competencies in the use of restraints during orientation and annually.

This Condition-level deficiency represents a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

1. Refer to the findings cited at Tag A123, CFR 482.13(a)(2)(iii) - Patient Rights: Standard: Notice of Grievance Decision. Those findings reflect the hospital's failure to provide written notice of follow-up investigation and resolution that contained the required elements.

2. Refer to the findings cited at Tag A145, CFR 482.13(c)(3) - Standard: Patient Rights: Free from Abuse/Harassment. Those findings reflect the hospital's failure to ensure investigations and follow up actions to potential abuse and neglect events with actual or potential harm, were conducted and were timely, clear, and complete to prevent recurrence.

3. Refer to the findings cited at Tag A176, CFR 482.13(e)(11) - Standard: Patient Rights: Restraint or Seclusion. Those findings reflect the hospital's failure to ensure physician and other LIP training requirements were specified in hospital policy; and physician and LIP staff authorized to order restraints were not trained to ensure they had, at minimum, a working knowledge of the hospital's P&Ps regarding the use of restraints.

4. Refer to the findings cited at Tag A196, CFR 482.13(f)(1) - Standard: Patient Rights: Restraint or Seclusion. Those findings reflect the hospital's failure to ensure staff were trained and demonstrated competency in the application of restraints during orientation and annually in accordance with hospital P&Ps.

5. Refer to the findings cited at Tag A202, CFR 482.13(f)(2)(iv) - Standard: Patient Rights: Restraint or Seclusion. Those findings reflect the hospital's failure to ensure staff were trained and demonstrated competency in the application and use of all types of restraints available and approved for use in the hospital.

6. Refer to the findings cited at Tag A206, CFR 482.13(f)(2)(vii) - Standard: Patient Rights: Restraint or Seclusion. Those findings reflect the hospital's failure to ensure staff were trained and demonstrated knowledge in the use of immediate interventions and first aid to be provided to a restrained patient who is in distress or injured.

Based on interview, documentation reviewed in the medical records for 3 of 3 patients (Patients 2, 4 and 17), incident documentation reviewed for 11 of 11 patients (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 17), grievance documentation reviewed for 7 of 7 patients selected from the grievance log (Patients 11, 12, 13, 14, 15, 16 and 18), review of a list of physician and LIP staff, review of staff training/education records, review of staff education materials, review of QAPI documents, review of policies and procedures, and review of other documentation, it was determined the hospital failed to develop, implement, and maintain an effective QAPI program to ensure the provision of safe and appropriate care to patients in the hospital that complied with the Conditions of Participation in the following areas:
* Staff failed to conduct thorough, complete, clear and timely investigations and follow up actions of potential abuse or neglect, and potential or actual harm, to ensure those did not recur. Patient incidents included:
- Patient 1 who had a clogged NG feeding tube and missed his/her tube feedings for an unknown period of time; and RN staff who accessed and managed the feeding tube had not been trained or determined competent by the hospital to conduct those tasks.
- Patient 4 who was administered an IV solution through a temporary dialysis catheter that was accessed by RN staff who were not trained, determined competent, or permitted by the hospital to conduct those tasks.
- Patient 6 who became unresponsive and experienced an acute change of condition and loss of consciousness.
- Patients 9 who experienced repeated falls.
- Patient 17 who was physically restrained to the bed by his/her upper extremity and was subsequently found on the floor next to the bed with the restraint still attached, and RN staff failed to appropriately assess the patient for injuries. In another incident, Patient 17 became unresponsive and required resuscitation and ventilator support after RN staff administered the patient repeated doses of Valium and failed to evaluate the patient's response to the drug.
- Patients 2, 3, 5, 7, 8, 10, and 17 regarding patient falls, physical restraints, agitated behaviors, pneumonia management, dressing changes, "rough" staff, and trach "self- decannulation."
* Responses to and investigations of patient complaints/grievances, including those related to potential abuse or neglect.
* Physician and LIP staff restraint policies and training.
* Staff training and competencies in the use of restraints during orientation and annually.
* RN supervision and evaluation of patients in a manner that ensured safe care.
* QAPI activities and recommendations for process improvement.

This Condition-level deficiency represents a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

1. Refer to the findings cited under Tag A115, CFR 482.13 - CoP Patient's Rights.

2. Refer to the findings cited at Tag A273, CFR 482.21(a),(b)(1),(b)(2)(i),(b)(3) - Standard: Data Collection & Analysis. Those findings reflect the hospital's failure to enter complaints/grievances into the hospital's grievance tracking log; and analyze, summarize, and review patient complaints/grievances; and make recommendations for process improvement in accordance with hospital P&Ps.

3. Refer to the findings cited under Tag A395, CFR 482.23(b)(3) - Standard: RN Supervision of Nursing Care. Those findings reflect the hospital's failure to ensure the RN supervised and evaluated patients in a manner that ensured the provision of safe and appropriate care in accordance with hospital P&Ps.

Based on interview, review of grievance documentation for 7 of 7 patients selected from the grievance log (Patients 11, 12, 13, 14, 15, 16 and 18), review of the medical record and incident documentation for Patient 17, review of policies and procedures, and review of other documentation, it was determined that the hospital failed to fully implement policies and procedures that ensured patients' rights were recognized, protected and promoted as follows:
* Responses to and investigations of patient complaints/grievances were not conducted, or were not timely or complete including those related to potential abuse or neglect.
* A written grievance notice that contained the required elements including the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion was not provided to each patient/patient representative who filed a complaint/grievance with the hospital.

Findings included:

1. The P&P titled "Complaint and Grievance Process," dated last reviewed "2/19" was reviewed. It reflected:
* "Vibra Hospital encourages patients, families/legal guardians and visitors to freely express their grievances, complaints, concerns ... through established channels ... Concerns, complaints or grievances may be in written or verbal form."
* "Vibra Hospital attempts to resolve all grievances internally as soon as possible. Most grievances should be resolved within seven days. A written response is sent to the complainant upon resolution of the grievance. For complex grievances that require deeper investigation or resolution of systemic problems, a longer timeframe may be necessary as determined by hospital administration, usually no longer than 30 days. In this instance, the complainant is notified that administration is still working on the resolution and will follow-up with a written response within a stated number of days."
* "Written notice of grievance resolution and decisions made is provided to complainants and contains the following ... Name of Vibra Hospital's contact person ... Steps taken on behalf of the patient to investigate the grievance ... Results of the grievance process ... Date of completion."
* "Procedure: Staff member receiving complaint: Entering into the Hospital's incident reporting system ... The Patient Complaint is entered into the Incident reporting system for all complaints received ... All information/sections in the hospital's incident reporting system will be completed when entering in a complaint ... Enter all staff involved with the complaint ... Describe the complaint or issue ... Describe the desired resolution ... Describe the actions taken to resolve the issue/complaint ... Indicate if the issue was resolved or remains unresolved ... If resolved, indicate if the complainant is satisfied with resolution. If not satisfied, include a brief description of the unresolved issue. The DQM will then proceed with the Grievance procedure process."
* "Completing Grievance Investigation and Resolution form ... Interview complainant, staff involved, and review pertinent documentation and enter findings on form ... Collaborate with hospital management and physician(s) if indicated to investigate grievance ... Ensure documentation of the grievance in the Grievance Log."

2. Grievance documentation for Patient 11 was reviewed and reflected:
* The "Discovered Date:" was 03/17/2020.
* The grievance was categorized as "Dissatisfaction - Patient/Customer Complaint."
* The documentation reflected "Pt reporting that nsg/CNA attempting to use axillary thermometer orally and have not been sanitizing it."
There was no documentation that reflected the hospital conducted an investigation of the grievance or provided a written notice to the patient/patient's representative in response to the complaint that included the name of the hospital's contact person, steps taken on behalf of the patient to investigate the grievance, results of the grievance process, and date of completion in accordance with hospital P&Ps.

3. Grievance documentation for Patient 12 was reviewed and reflected:
* The "Discovered Date:" was 04/04/2020 at 1245.
* The grievance was categorized as "Dissatisfaction - Patient/Customer Complaint."
* The documentation reflected "[nurse] is loud ... I've asked [him/her] to lower [his/her] voice but [he/she] continues to scream and talk over me when [he/she] takes care of me. [He/she] makes assumptions on a few words (when my cap is removed from my trach) and then cuts me off ... [he/she] was at the nursing station outside my room yelling ... It's far too loud out there and I can't sleep. I've asked to speak to the House Supervisor at night but I never can reach anyone ... the RT, lied about me not wanting cough assist last night-[he/she] never came to my room and refused to see me."
There was no documentation that reflected the hospital conducted an investigation of the complaint or provided a written notice to the patient/patient's representative in response to the complaint that contained the required elements in accordance with hospital P&Ps.

4. Grievance documentation for Patient 13 was reviewed and reflected:
* The "Discovered Date:" was 04/21/2020 at 2200.
* The grievance was categorized as "Dissatisfaction - Patient/Customer Complaint."
* The documentation reflected " ... crying in pain ... called family indicating that [he/she] was being mistreated by having necessary pain medications removed by the [doctors] because of [his/her] ethnicity ... "
There was no documentation that reflected the hospital provided a written notice to the patient/patient's representative in response to the complaint that contained the required elements in accordance with hospital P&Ps.

5. Grievance documentation for Patient 14 was reviewed and reflected:
* The "Discovered Date:" was 08/28/2020.
* The grievance was categorized as "Dissatisfaction - Patient/Customer Complaint."
* The documentation reflected the patient's family member submitted a complaint regarding missing clothing items.
There was no documentation that reflected the hospital provided a written notice to the patient/patient's representative in response to the complaint that contained the required elements in accordance with hospital P&Ps.

6. Grievance documentation for Patient 15 was reviewed and reflected:
* The "Discovered Date:" was 09/12/2020 at 1200.
* The grievance was categorized as "Dissatisfaction - Patient/Customer Complaint."
* The documentation reflected the patient's family member submitted a grievance regarding "nursing care."
There was no documentation that reflected the hospital conducted an investigation of the complaint or provided a written notice to the patient/patient's representative in response to the complaint that contained the required elements in accordance with hospital P&Ps.

7. Grievance documentation for Patient 16 was reviewed and reflected:
* The "Discovered Date:" was 09/25/2020 at 2000.
* The grievance was categorized as "Dissatisfaction - Patient/Customer Complaint."
* The documentation reflected "[Family member] called to speak with nursing ... Pt reported feeling disgusted, increase in depression ... pt reported that [he/she] had not had a bath in 5 days ... "
There was no documentation that reflected the hospital conducted an investigation of the complaint or provided a written notice to the patient/patient's representative in response to the complaint that contained the required elements in accordance with hospital P&Ps.

8. a. The medical record for Patient 17 was reviewed. A "Case Management - Weekly Progress Summary" note dated 11/30/2020 at 1019 reflected " ... [During] check in with [family member] [he/she] was very upset about [patient's] care. [He/she] stated that during [his/her] recent visit [he/she] waited 45min (sic) for personal care. Patient was left in bm for that period of time. Informed DON of this issue. Patient advocate is also talking with management regarding this issue."

8. b. Review of the hospital's grievance log for 03/01/2020 through 04/19/2021 reflected the complaint involving Patient 17 in finding 8. a. was not on the grievance log; and there was no documentation that the hospital provided a written notice to the patient/patient's representative in response to the complaint that included the required elements in accordance with hospital P&Ps.

8. c. In an email from the DQR dated 05/20/2021 at 1116, the DQR confirmed no written notice was submitted to the patient/patient's representative in response to the complaint involving Patient 17 in finding 8. a. The email reflected "There was not a written notice sent to the complaint (sic)."

9. a. Refer to Tag A145. Finding 15 reflects another complaint/grievance was submitted to the hospital regarding Patient 17 on 12/22/2020 at 1930. That complaint/grievance, submitted by a family member, reflected " ... facility caused the patient's pneumonia ... [patient's] abdominal dressing was dirty and needed to be changed ... the [family] stated 'that [he/she] has never seen anything that filthy' ... [his/her] nurse was rough."

9. b. Review of the hospital's grievance log for 03/01/2020 through 04/19/2021 reflected the complaint involving Patient 17 in finding 9. a. was not on the grievance log; and there was no documentation that the hospital provided a written notice to the patient/patient's representative in response to the complaint that contained the required elements in accordance with hospital P&Ps.

9. c. In an email from the DQR dated 05/20/2021 at 1116, the DQR confirmed no written notice was submitted to the patient/patient's representative in response to the complaint involving Patient 17 submitted on 12/22/2020 at 1930. The email reflected "No there was not a written notice sent to the complaint (sic)."

10. Grievance documentation for Patient 18 was reviewed and reflected:
* The "Discovered Date:" was 03/15/2021 at 2145.
* The grievance was categorized as "Dissatisfaction Patient/Customer Complaint."
* The documentation reflected the patient's family member " ... expressed concerns that [patient] is not getting adequate care ... [patient] has frequent leaking of liquid stool from [his/her] rectal tube and [family member] stated that PT skin is breaking down; stated that [he/she] feels PT is getting sicker here. [Family member] also feels that we are not properly staffed to give proper care to the patients [here] at the facility and [he/she] is ready to get [patient] out of here ... "
There was no documentation that reflected the hospital provided a written notice to the patient/patient's representative in response to the complaint that contained the required elements in accordance with hospital P&Ps.

11. During an interview with the DQR on 04/19/2021 at 1520, the DQR confirmed the lack of investigations and written notices provided to patients/patient's representatives involving Patients 11, 12, 13, 14 , 15, 16 and 18.

Based on interview, documentation reviewed in the medical records for 3 of 3 patients (Patients 2, 4 and 17), incident documentation reviewed for 11 of 11 patients (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 17), review of policies and procedures, and review of other documentation, it was determined that the hospital failed to develop and enforce policies and procedures to ensure patients' rights were recognized, protected and promoted and all components of an effective abuse and neglect prevention program were evident, including thorough, complete, clear and timely investigations and follow up actions of potential abuse or neglect as defined by CMS, and potential or actual harm, to ensure those incidents did not recur. Patient incidents included:
* Patient 1 who had a clogged NG feeding tube and missed his/her tube feedings for an unknown period of time; and RN staff who accessed and managed the feeding tube had not been trained or determined competent by the hospital to conduct those tasks.
* Patient 4 who was administered an IV solution through a temporary dialysis catheter that was accessed by RN staff who were not trained, determined competent, or permitted by the hospital to conduct those tasks.
* Patient 6 who became unresponsive and experienced an acute change of condition and loss of consciousness.
* Patients 9 who experienced repeated falls.
* Patient 17 who was physically restrained to the bed by his/her upper extremity and was subsequently found on the floor next to the bed with the restraint still attached, and RN staff failed to appropriately assess the patient for injuries.
* In another incident, Patient 17 became unresponsive and required resuscitation and ventilator support after RN staff administered the patient repeated doses of Valium and failed to evaluate the patient's response to the drug.
* Patients 2, 3, 5, 7, 8, 10, and 17 regarding patient falls, physical restraints, agitated behaviors, pneumonia management, dressing changes, "rough" staff, and trach "self- decannulation."

The CMS Interpretive Guideline for this requirement at CFR 482.13(c)(3) reflects "Abuse is defined as the willful infliction of injury, unreasonable confinement, intimidation, or punishment, with resulting physical harm, pain, or mental anguish. This includes staff neglect or indifference to infliction of injury or intimidation of one patient by another. Neglect, for the purpose of this requirement, is considered a form of abuse and is defined as the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness."

Further, the CMS Interpretive Guideline reflects that components necessary for effective abuse protection include, but are not limited to:
o Prevent.
o Identify. The hospital creates and maintains a proactive approach to identify events and occurrences that may constitute or contribute to abuse and neglect.
o Protect. The hospital must protect patients from abuse during investigation of any allegations of abuse or neglect or harassment.
o Investigate. The hospital ensures, in a timely and thorough manner, objective investigation of all allegations of abuse, neglect or mistreatment.
o Report/Respond. The hospital must assure that any incidents of abuse, neglect or harassment are reported and analyzed, and the appropriate corrective, remedial or disciplinary action occurs, in accordance with applicable local, State, or Federal law.

Findings include:

1. a. The P&P titled "Incident Reporting," dated last revised "9/20" was reviewed and reflected:
* "All incidents are to be reported. It is the responsibility of each employee to immediately report any incident, complaint or condition that causes an injury or poses a threat of injury to a patient, employee or visitor to his or her immediate supervisor. An incident report must be submitted before the end of the shift."
* "All events, incidents & complaints are to be entered into the Hospital incident reporting system, except those that relate to an employee occurrence/injury, those (sic) need to to be completed on the employee incident/injury form."
* "Employee Responsibility ... Notify the Physician/Supervisor/CCO/CNO, Department Head or AOC (Administrator on Call) ... If applicable, take corrective action immediately, to prevent recurrence & to resolve any complaint there may be ... In case of patient incident, appropriately document event and immediate follow-up actions in the medical record ... Initiate the appropriate Incident Report prior to the end of the shift, and ensure that this report is accurate, clear and objective. Each report at a minimum, must have all asteric (sic) areas completed ... Employees who have difficulty reporting electronic form/or down time report should request assistance from their immediate supervisor ... The Supervisor/or designated department head should investigate the incident immediately, enter all information, follow up and the resolution to the incident."
* "Nursing Supervisor/CCO/Department Head Responsibility ... Review medical record for appropriate and timely documentation. Report all findings into the incident reporting system ... Investigate the to (sic) determine related facts and record the investigation in the electronic Incident Reporting system ... Implement immediate corrective action to prevent a recurrence of the event (e.g. fall mats, scanning of armband, etc.) ... The Department Head will thoroughly investigate the incident immediately upon receipt of the incident and document the findings in the incident reporting system. Every effort will be made to ensure a timely turn around. Incidents should be investigated and closed within two (2) weeks ... If the Department head is unable to immediately provide the necessary follow up, investigation, or needs additional time, the department head will notify the Director of Quality Risk Management."
* "Director of Quality Management Responsibility ... Ensure completion of the appropriate electronic Incident Report including all pertinent data has been entered ... Determine if appropriate individuals were notified (i.e., Physician, Safety Officer, Chief Executive Officer (CEO), Chief Clinical Officer (CCO), Director of Quality Management (DQM) assigned by the DQM or designee in the electronic incident reporting system ... Review the Incident Reports, analyzing data for evidence of negative patterns or trends ... Collaborate with department heads and Safety Officer to improve standards, develop corrective actions in collaboration with the Department Heads. Monitor the corrective actions, review the documentation provided by the department heads to support the actions plan and prevent recurrence of problems ... Summarize reported events to the appropriate committees up to and including QAPI ... Summarize analysis and associated corrective action plans and report to the appropriate committees up to and including QAPI ... "
* "Governing Body Responsibility ... Review all patterns/trends, findings and recommendations of the Patient Safety, QAPI and the Medical Executive Committee and provide resources or alternative strategies to ensure corrective actions are taken to prevent recurrences."
* "An incident is an actual or risk thereof, adverse event that impacts a patient, employee or visitor. The event may affect the individual physically or psychologically. An incident includes a process variation for which a recurrence would carry a significant chance of a serious adverse outcome, this includes complaints."

1. b. The Nursing P&P titled "Assessment and Reassessment," dated last revised "12/16" reflected:
* "Data is collected to identify problems and assess the needs of the patient ... the data is analyzed to establish the plan of care ... Decisions are made regarding patient care or treatment based on analysis of the data ... "
* "Patients at the Hospital receive care based upon a documented assessment of patient care needs and problem identification."
* "The patient's assessment/reassessment process includes consideration of biophysical, psychological, cultural, spiritual, environmental, self-care ... "
* "A nursing re-assessment will be conducted and documented in the following circumstances ... with any changes in condition/diagnosis ... in response to care or treatment ... The reassessment process is on-going throughout the patient's course of hospitalization, is based on the identified needs of the patient ... "

1. c. The Nursing P&P titled "Change in Condition," dated last revised "12/16" reflected:
* "The following could describe a significant change in patient condition ... Any single finding does describe a significant change in condition and requires Assessment, Documentation and Notification ... Change in mental status: level of consciousness (LOC), neurological status. Examples: Decrease LOC: New onset confusion, delirium ... If post fall closely monitor ... "
* "Upon recognition of change in condition a Rapid Response Team will be called ... A complete head to toe assessment by the Registered Nurse along with consultation as appropriate among the clinical team ... Data to be obtained includes, but is not limited to ... A complete set of vital signs including accurate temp ... A rhythm strip ... Pulse ox reading ... Finger stick glucose ... A complete pain assessment ... "
* "Documentation ... The complete assessment should appear in the Electronic Medical Record (EMR) or Nursing flow sheet ... "

1. d. The P&P titled "Restraint Use," dated last revised "12/16" reflected:
* "Indications: Restraints are only used when less restrictive interventions have been determined to be ineffective in protecting the patient, staff or others from harm."
* "Comprehensive assessment of the patient will include physical assessment to identify medical problems that may be causing the behavior changes. For example, hypoxia, hypoglycemia, electrolyte imbalance, drug interactions and side effects may cause confusion, agitation and combative behavior. Addressing these medical issues can often eliminate the need for restraint use ... The assessment must determine that the risks associated with the use of the restraint are outweighed by the risk of not using it. Alternative interventions do not always need to be tried, but should be considered prior to use of a restraint."
* "The type of restraint used will be the least restrictive intervention that will be effective in protecting the patient, staff or others from harm."
* "Patient assessment is ongoing throughout the episode of restraint. Attention to the patient's physical needs and assessment of continued need for restraint is documented per policy specific to the patient population and the behavior for which the restraint use was initiated ... On-going assessment includes: Minimally every 2 hours or more frequently if condition warrants ... "

2. The "LTACH Education Plan 2019 Vibra Hospitals," "LTACH Education Plan 2020 Vibra Hospitals," and "LTACH Education Plan 2021 Vibra Hospitals" each reflected the following:
* "It is the responsibility of Department Director/Managers to inform Education (email, personal conversation, Request for Education form) when a new equipment, process, policy, etc. which may require staff education. In collaboration with the dept managers, Education will assist in the completion and documentation of the education."
* "The initial Clinical Orientation Core Competency program will include core competencies, which will prepare the clinician to work with patients in the clinical setting at a safe and therapeutic level. They will include, but are not limited to "... Maintenance care and flushing of I.V. devices (RN, LPN/LVN) ... Drug administration (RN, LPN/LVN, RT) ... Restraints utilization ... Enteral nutrition management ... Documentation... "
* "Performance expectations will include completion of the competencies listed according to the proficient goal. When an area is not met as proficient, additional education will be provided and the staff member will be re-evaluated within one-month (30) days until proficiency is achieved ... "

3. a. Regarding Patient 1: Review of an incident document reflected that on 05/24/2020 at 2000 "Pt missed tube feeding this shift due to NG tube being clogged. Jevity 1.5 at 70mL/hr was supposed to run from 8pm to 5am ..."
* The "Recommendations" section was blank.
* The "Operational Factors" section was followed by 23 preprinted choices. None of the choices were selected.
* The "Patient Factors" section was followed by 6 preprinted choices. None of the choices were selected.
* The "Plan" section reflected "What actions should be taken to avoid similar events?" followed by 11 preprinted choices, of which "No other action needed at this time" was selected.
* The "General Comments/Other Findings Identified During Investigation:" section was followed by "Noted."
There was no further investigation or follow up actions.

The documentation lacked a thorough investigation and follow up actions as required by hospital P&Ps. For example:
* There was no investigation that reflected the cause of the clogged feeding tube.
* The documentation was unclear regarding the duration of the clogged feeding tube and missed tube feeding.
* There was no documentation of interventions provided to address the clogged feeding tube.
* There was no investigation into whether the NG tube was appropriately managed and flushed prior to the incident in accordance with physician orders and hospital P&Ps.
* There was no investigation that reflected whether nursing staff who managed and/or accessed the NG tube were appropriately trained and competent to conduct those tasks.
* There was no investigation that reflected if abuse and neglect were ruled out.
* It was unclear how it was determined no action was needed to address the incident.
There was no further investigation or follow up actions.

3. b. In an email from the DQR on 05/12/2021 at 1456, the DQR stated that nine nurses managed or accessed Patient 1's NG tube between 05/17/2020 and 05/24/2020, and "We were unable to find [NG tube] training on two nurses [Employees 16 and 17]."

3. c. During an interview with the COO on 05/21/2021 at 1430, the COO stated he/she reviewed Patient 1's medical record. The COO stated the record was "very ambiguous" and he/she could not tell how long the patient's feeding tube was clogged or how long the patient had gone without his/her tube feeding.

Due to the failure to conduct a complete, thorough and timely investigation and follow up actions; and nurse staff training in accordance with the hospital's P&Ps, there was no assurance similar incidents involving other patients would not occur.

4. Regarding Patient 2: Review of an incident document reflected that on 05/27/2020 at 0800 "Pt attempting to get out of bed, kicking the bed and side rails. This nurse asked patient if [he/she] would like to get out of bed to chair pt (sic) agreed. Nursing staff and CNA staff in room, removed pt from restraints to transfer pt from bed to wheelchair. Pt stood up and swung at this nurse, then attempted to push CNA [name]. Pt pushed this nurse to the corner with [his/her] body, called rapid response ... Pt able to redirect enough to get pt in chair and on the restraints again. Once pt was in chair began kicking at staff, code grey called and Security entered room. Pt. attempting to stand with wrists attached to wheelchair, then attempting to take off restraints. Security able to calm patient down enough to transfer back to bed. Pt in bed sleeping after incident."
* The "Recommendations" section was blank.

There was no further investigation or follow up actions. For example:
* There was no investigation that reflected whether the patient experienced injuries as a result of the incident.
* There was no investigation that reflected whether the patient was assessed to determine the cause or potential causes of his/her behaviors.
* There was no investigation that reflected whether staff involved in the incident responded appropriately to the patient's escalating behaviors.
* There was no investigation that reflected whether staff who were involved in the incident were appropriately trained and competent to manage patients who were physically restrained.
* There was no investigation that reflected whether appropriate hospital P&Ps were followed including but not limited to those related to physical restraints, management of patient behaviors, and nursing assessments.

5. a. Another incident document regarding Patient 2 was reviewed and reflected on 05/27/2020 at 0830 "Walked into pt. room after physical therapy reported pt. was trying to get out of bed. Pt agitated with legs in bed rails and head/upper body off bed. This nurse asked patient if patient would like to get out of bed and into wheel chair. Pt agreed, [CNA] called to room to assist. pt in B/L soft wrist restraints, removed for transfer. Pt stood up and attempting to push this nurse and CNA. pt. cornered this nurse into the walk (sic), called rapid response. Pt calmed down once staff showed up and sat in WC. Once in WC this nurse attempted to put restraints on pt. (sic) kicked this nurse, code grey called. [Name] entered room, pt. stabilized for a moment before attempting to stand up and walk with restraints to the wheel chair. Reoriented and asked if pt. would like to go back to bed, pt. agreed, sleeping once back in bed ... "
* The "Recommendations" section reflected "Staff to be trained better on de-escalation techniques."

There was no further investigation or follow up actions. For example:
* There was no investigation that reflected whether the patient experienced injuries as a result of the incident.
* There was no investigation that reflected whether the patient was assessed to determine the cause or potential causes of his/her behaviors.
* There was no investigation that reflected whether staff involved in the incident responded appropriately to the patient's escalating behaviors.
* There was no investigation that reflected why staff attempted to reapply the restraints after the "Pt calmed down ... and sat in WC." There was no investigation that reflected appropriate hospital P&Ps were followed related to all aspects of physical restraint use, including that restraints be used only when less restrictive interventions have been determined ineffective in protecting patients, staff or others from harm.
* There was no documentation of follow up to the recommendation "Staff to be trained better on de-escalation techniques."
There was no further investigation or follow up actions.

5. b. The medical record for Patient 2 was reviewed and reflected he/she was admitted to the hospital on 05/16/2020 at 0054. LPN notes dated 05/27/2020 at 1200 reflected "Walked into pt. room after physical therapy reported pt. was trying to get out of bed. Pt agitated with legs in bed rails and head/ upper body off bed. VS stable, lungs corse (sic), TM on. This nurse asked patient if patient would like to get out of bed and into wheel chair. Pt agreed, [CNA] called to room to assist. Pt in B/L soft wrist restraints, removed for transfer. Pt stood up and attempting to push this nurse and CNA. [Patient] cornered this nurse into the walk (sic), called rapid response. Pt calmed down once staff showed up and [patient] sat in WC. Once in WC this nurse attempted to put restraints on pt. kicked this nurse, code grey called. [Name] entered room, pt. stabilized for a moment before attempting to stand up and walk with restraints to the wheel chair. Reoriented and asked if pt. would like to go back to bed, pt. agreed, sleeping once back in bed ... This nurse switched pt with another nurse ... report given."

5. c. During an interview with the COO on 05/21/2021 at 1440, the COO reviewed the incident document dated 05/27/2020 at 0830 and the patient's medical record. The COO stated it would have been an opportune time to reassess the necessity of the bilateral wrist restraints when the "Pt calmed down once staff showed up and [patient] sat in WC." However, he/she stated there was no documentation that reflected the nurse reassessed the patient's continued need for the restraints in accordance with hospital P&Ps. The COO confirmed the documentation reflected the nurse instead attempted to reapply the restraints and the patient "kicked the nurse and a code grey was called."

Due to the failure to conduct a complete, thorough and timely investigation and follow up actions in accordance with the hospital's P&Ps, there was no assurance similar incidents involving other patients would not occur.

6. Regarding Patient 3: Review of an incident document reflected that on 08/24/2020 at 2018 "CNA found pt on left side head (sic) out the door, pt stated [he/she] was looking for condom catheter so [he/she] could go to the restroom. Fell on left hip. ice pack applied, VSS."
* The "Recommendations" section reflected "appropriate staffing, frequent rounding."

The documentation lacked a thorough investigation as required by hospital P&Ps. For example:
* There was no investigation that reflected when the patient was last checked prior to the incident.
* There was no investigation related to when the patient was last assisted with bowel/bladder needs or when his/her condom catheter was last checked.
* The documentation reflected "appropriate staffing, frequent rounding" were recommended, but did not include whether "staffing" or "rounding" were appropriate at the time of the incident, and if not, whether those contributed to the incident.
* The documentation reflected the patient fell on his/her left hip and ice was applied, but there was no investigation that reflected if the nurse assessed the patient's hip, and if the patient had any signs or symptoms of injury.
* There was no investigation that reflected if the patient had a fall prevention care plan prior to the fall, and if so, whether it was followed.
* There was no investigation that reflected whether appropriate hospital P&Ps were followed including but not limited to those related to fall prevention, care planning, and nursing assessments, and patient supervision and monitoring.
* There was no investigation that reflected if abuse and neglect were ruled out.
There was no further investigation or follow up actions.

Due to the failure to conduct a complete, thorough and timely investigation and follow up actions in accordance with the hospital's P&Ps, there was no assurance similar incidents involving other patients would not occur.

7. a. Regarding Patient 4: Review of an incident document reflected that "On 8/24-25 [patient] was NPO ... [He/she] was hypoglycemic overnight 8/24 into 8/25 and apparently the night nurse used the HD port to give a continuous D5 drip and the drip was continued by the daytime nurse on 8/25 ... Since then, [his/her] WBC has been slowing trending up, I started on empiric antibiotics on 8/29 and the blood cultures from 8/29 are now growing gram positive cocci ... We will be checking cultures from the HD port directly to see if the port is infected, if it is, it needs to come out ... I think there needs to really (sic) good education as to proper line usage. A HD port/line should never be accessed by anyone but a dialysis nurse. There were multiple nurses involved who should have questioned it, but did not. What can we do to prevent this from happening again?"
* The "Recommendations" section was blank.

There was no investigation or follow up actions in accordance with hospital P&Ps. For example:
* The documentation reflected "We will be checking cultures from the HD port directly to see if the port is infected." However, there was no investigation that reflected the results of the cultures.
* The documentation reflected "A HD port/line should never be accessed by anyone but a dialysis nurse." However, there was no investigation that reflected if the nurses involved in the incident were "dialysis nurses" or had appropriate training and competencies to access and administer drugs through the "HD port/line."
* There was no investigation related to the "multiple nurses involved who should have questioned it, but did not."
* The documentation reflected "I think there needs to really (sic) good education as to proper line usage" and "What can we do to prevent this from happening again?" However, there was no investigation or follow up actions to those.
* There was no investigation that reflected if hospital P&Ps were followed as appropriate, including but not limited to HD port/line access, management, and nursing training/competencies.
* There was no investigation that reflected if the patient experienced harm as a result of the incident.
* There was no investigation that reflected if abuse and neglect were ruled out.

7. b. The medical record for Patient 4 was reviewed and reflected the patient was admitted on 08/20/2020 with diagnoses that included acute kidney failure, HTN, DM, and hypoxic respiratory failure.
* Physician notes on 08/25/2020 at 1344 reflected "D5-1/2NS .... was started on 75cc/hr overnight ... "
* Physician notes dated 08/31/2020 at 1337 reflected "8/25 HD [TDC] was inadvertently accessed by floor nursing for D5 drip. Will get blood [culture] ... "

7. c. During an interview with the COO on 05/06/2021 at 0930, the COO provided the following information regarding the incident involving Patient 4 on 08/24/2020 and 08/25/2020:
* The patient had a TDC for the purpose of HD treatments.
* Two RNs, Employees 14 and 15, accessed and administered an IV solution through the patient's TDC.
* The COO stated Employees 14 and 15 did not have training or competencies to access and administer IV solutions through the patient's TDC. The COO stated "That is an advanced skill that needs special competencies."
* The COO stated that the risk of accessing the TDC without appropriate training "predisposes the patient to a central line infection."

7. d. During an interview with the DQR on 04/20/2021 at 1600, he/she stated a RCA should have been completed regarding the incident involving Patient 4, and he/she confirmed no RCA was done.

7. e. During an interview with the COO and DQR on 05/06/2021 at 0940, the COO stated Employees 14 and 15 were not trained to access TDCs "because that's not normally allowed."

Due to the failure to conduct a complete, thorough and timely investigation; follow up actions; and staff training in accordance with the hospital's P&Ps, there was no assurance similar incidents involving other patients would not occur.

8. Regarding Patient 5: Review of an incident document reflected that on 08/28/2020 at 2100 "pt was off pulse ox monitor, this RN immediately went to assess pt and found pt laying on the floor to the L side of the bed. RRT immediately called. Pt was checked on approximately 30mins (sic) prior to fall. Pt denied hitting [his/her] head. Denied headache ... Complained of back pain ... "
* The "Recommendations" section was blank.

The documentation lacked a thorough investigation and follow up actions as required by hospital P&Ps. For example:
* The documentation reflected the patient was checked 30 minutes prior to the fall, but there was no investigation related to the patient's condition when he/she was last checked.
* The documentation reflected the patient denied hitting his/her head and denied headache, but there was no investigation that reflected whether the patient was a reliable historian, or whether a neurological assessment was completed secondary to the incident.
* The documentation reflected the patient was "off pulse ox monitor," but did not indicate what the patient's SpO2 was when he/she was found, when it was last checked, and if the patient had orders for oxygen administration at the time of the incident.
* The documentation reflected the patient complained of back pain, but there was no investigation that reflected whether the nurse assessed the patient's back for injuries.
* The documentation reflected RRT was called and "Vital signs obtained and within normal limits per pt's baseline," but did not include if the patient experienced harm or injuries as a result of the incident.
* There was no investigation that reflected if the patient had a fall prevention care plan prior to the fall, and if so, whether it was followed.
There was no further investigation or follow up actions.

9. Regarding Patient 6: Review of an incident document reflected that on 08/31/2020 at 1125 "Patient Unresponsive To Deep Sternal Rub. Acute Change in LOC."
* "Incident Area: Patient Room."
* The "Recommendations" section reflected "ABG, EKG, Labs and Stat Head CT Ordered."
There was no investigation of the incident.
* There was no investigation that reflected when the patient was last checked and his/her condition at that time.
* There was no investigation that reflected where in the patient's room he/she was and what position he/she was in at the time of the incident (e.g. on the bed, on the floor, prone, supine, etc.).
* There was no investigation that reflected the patient's vital signs at the time of the incident.
* There was no investigation that reflected recent drugs administered or other potential drug or treatment related factors.
* There was no investigation that reflected how staff responded to the patient's acute change and unresponsive condition, including any treatment provided.
* There was no investigation that reflected the patient's outcome as a result of the incident.
* There was no investigation that reflected whether hospital P&Ps were followed as applicable including but not limited to those related to change of condition, LOC, and nursing assessment and monitoring.
* There was no investigation that reflected if abuse or neglect were ruled out.
There was no further investigation or follow up actions.

Due to the failure to conduct a complete, thorough and timely investigation and follow up actions in accordance with the hospital's P&Ps, there was no assurance similar incidents involving other patients would not occur.

10. Regarding Patient 7: Review of an incident document reflected that on 12/15/2020 at 2230 "Found Patient Laying On The Floor, No Any (sic) Injury Noted But Had Previous Scar On Right Knee And Scant Amount Of Blood Noted. Denied Pain Or Discomfort. Transfer Patient On Bed With The Help Of Hoyer."
* The "Recommendations" section was blank.
* The "Operational Factors" section was followed by 23 preprinted choices of which no choices were selected.
* The "Patient Factors" section was followed by 6 preprinted choices of which "Behavioral factors" was selected.
* The "Plan" section reflected "What actions should be taken to avoid similar events?" followed by 11 preprinted choices of which "Environment modified" was selected.
* The "General Comments/Other Findings Identified During Investigation:" section was followed by "Fall without injury. Bed alarm placed. No further action at this time."

The documentation lacked a thorough investigation as required by hospital P&Ps. For example:
* Although the documentation reflected the patient was found laying on the floor and broadly reflected "Fall without injury," there was no investigation regarding whether the patient hit his/her head, if a neurological or other assessments were considered and completed after the fall, and if so, whether assessments were conducted timely and in accordance with hospital P&Ps.
* The documentation reflected both "Fall without injury" and "Scant Amount Of Blood Noted." It was unclear how the patient had no injury if there was blood noted.
* There was no investigation related to how high the bed was at the time of the fall or if side rails were raised.
* The documentation reflected the patient had behavioral factors, but there was no further investigation about those factors with respect to the patient's risk for falling.
* There was no investigation that reflected if the patient had a fall prevention care plan prior to the fall, and if so, whether it was followed.
* There was no investigation that reflected whether hospital P&Ps were followed as applicable including but not limited to those related to fall prevention, and nursing assessment and monitoring.
* There was no investigation that reflected if abuse and neglect were ruled out.
There was no further investigation or follow up actions.

11. Regarding Patient 8: Review of an incident document reflected that on 12/25/2020 at 2336 "Bedside RN found patient self-decannulated during routine safety check and restraint check ... RN immediately noticed blood on the chux, patient speaking, still restrained at both wrists but had slid down in bed and was able to reach [his/her] tr

Based on interview, review of a list of physician and LIP staff authorized to order restraints, review of medical staff orientation materials, review of restraint policies and procedures, and other documentation it was determined that the hospital failed to fully develop and implement policies and procedures as follows:
* Hospital policies did not clearly specify restraint training and competency requirements for physician and LIP staff who were authorized by the hospital to order restraints; and
* Physician and LIP staff authorized to order restraints did not receive restraint training.

Findings included:

1. The P&P titled "Restraint Use" dated last revised "12/16" was reviewed and reflected:
* "Licensed Independent Practitioner (LIP)s who order restraints shall be trained in the requirements of this policy and shall demonstrate a working knowledge of this policy through ongoing compliance."
* The P&P did not include how frequently LIPs were required to be trained. For example, initially, annually, or other frequency of ongoing training.
* The P&P reflected staff "shall demonstrate a working knowledge of this policy through ongoing compliance," but did not include how and when ongoing compliance would be evaluated and determined to ensure working knowledge of the policy.

2. During an interview on 04/19/2021 at 1310, the DQR stated that all physicians, PAs, and NPs were authorized to order restraints at the hospital.

3. A list of 116 physician and other LIP "providers" with hire dates between 03/18/2007 and 11/02/2020 was provided. The list was referred to as "all providers who can order and manage restraints" at the hospital.

4. A medical staff orientation power point dated "Jan 2020" titled "LIP Orientation" was reviewed and lacked documentation that reflected physician and other LIPs were trained on orientation in the requirements of the hospital's restraint P&Ps. For example,
* Power point page 19 reflected "Policies and Procedures ... Standardized policies and procedures are kept in a policy management system called 'Compliance 360.'" Power point page 20 reflected "Key Policies and Procedures" followed by "Restraints." However, there were no other references to restraints, and no evidence that physicians and other LIPs were, at minimum, trained and had a working knowledge of the hospital's restraint P&Ps.

5. During an interview with the DQR on 04/28/2021 at 1300, the DQR stated there was no restraint training provided to physician or other LIP staff.

6. In an email from the DQR dated 05/11/2021 at 1411 regarding physician and LIP restraint training, the DQR wrote "I am told by corporate that 'none of Vibra's privilege forms mention restraints.'" No further information was provided related to the lack of physician and LIP restraint training.

Based on interview, review of restraint training/education records for 9 of 9 hospital staff who participate in patient restraint (Employees 2, 4, 5, 6, 7, 8, 9, 10 and 11), review of restraint education materials, and review of policies and procedures, and other documentation it was determined that the hospital failed to ensure staff were trained and able to demonstrate competency in the application of restraints, monitoring, assessment, and providing care of patients in restraint in accordance with hospital policies and procedures and as part of orientation:
* Staff were not trained in the use of restraints during orientation; and
* Staff were not trained annually in the use of restraints in accordance with hospital policy.

Findings include:

1. Refer to the deficiency cited at Tag A202, CFR 482.13(f)(2)(iv) Patient Rights: Restraint or Seclusion. That deficiency reflects the hospital's failure to ensure staff were trained in the use of restraints during orientation and annually in accordance with hospital P&Ps.

Based on interview, review of restraint training/education records for 9 of 9 hospital staff who participate in patient restraint (Employees 2, 4, 5, 6, 7, 8, 9, 10 and 11), review of restraint education materials, review of policies and procedures, and review of other documentation, it was determined the hospital failed to fully develop and implement policies and procedures as follows:
* Staff were not trained and did not demonstrate competency in the safe application and use of all types of restraints available and approved for use in the hospital.

Findings include:

1. The P&P titled "Restraint Use," dated last revised "12/16" was reviewed and reflected:
* "Clinical personnel will be trained on ordering, application or monitoring of restrained patients. Training will take place during orientation and annually ... "
* "Staff who assess patients for restraint or who apply restraint will receive training in the following ... The safe application and use of all types of restraint used by the staff member, including training in how to recognize and respond to signs of physical and psychological distress (for example, positional asphyxia)."
* "Only staff who have been properly trained may apply or monitor a patient in restraints."
* "Use only Vibra approved restraints."
* The P&P referenced "Limb Restraints," "Mitt Restraints," "Freedom Restraints," "Wheelchair Lap Belt," "Vest restraint," "Geri chair" and other restraints.

2. An undated, untitled handwritten document was provided by the DQR on 04/19/2021 at 1610 in response to a request for a list of the specific types of restraints approved for use by the hospital. The document was reviewed and reflected the following:
* "Soft Wrist Restraint (single or bilateral)"
* "Mitts (single/bilateral)"
* "Seizure pads for TBI who hit their head on the side rail"
* "Posey bed - TBI/no airway (Trach vent)"
* "Arm Splint - on elbow to stop bending"

3. During an interview with the RNE on 04/19/2021 at 1615, he/she stated all of the restraint types in finding 2 were available for use in the hospital.

4. The restraints identified on the list of restraints approved by the hospital and available for use was inconsistent with the hospital's restraint P&P. For example:
* The list of restraints approved by the hospital and available for use included:
- "Soft Wrist Restraint (single or bilateral)"
- "Mitts (single/bilateral)"
- "Seizure pads for TBI who hit their head on the side rail"
- "Posey bed - TBI/no airway (Trach vent)"
- "Arm Splint - on elbow to stop bending"
Although the hospital's P&P titled "Restraint Use," dated last revised "12/16" referred to "Vest restraint," "Geri chair" and other restraints, those were not reflected on the list of restraints approved by the hospital.

Although the hospital's P&P referenced vest restraints, during an interview with the DQR on 05/24/2021 at 1440, he/she stated no vest restraints were permitted. The DQR stated "There shouldn't be any of those anywhere."

5. Staff restraint training materials were reviewed and did not include staff training and competencies for the restraint types specified on the list of restraints approved by the hospital and available for use and the hospital's restraint P&Ps in findings 1 and 2. For example:
* The annual "Skill Fair 2021" education documents provided for RN, LPN and CNA/Clinical Assistant staff did not include training and demonstrated competency content related to the following restraint types:
- "Soft Wrist Restraint (single or bilateral)"
- "Mitts (single/bilateral)"
- "Seizure pads for TBI who hit their head on the side rail"
- "Posey bed - TBI/no airway (Trach vent)"
- "Arm Splint - on elbow to stop bending"
- "Vest restraint"
- "Geri chair"
Instead the annual education documents broadly referred to "Restraints" and "Restraint Quick Release Knot."

* The undated annual education checklist titled "Competency/Demonstration Restraints" provided for RN, LPN, CNA, CA, and RT staff reflected a list of 18 individual "Components," of which none reflected training and demonstrated competency related to the following restraint types:
- "Seizure pads for TBI who hit their head on the side rail"
- "Posey bed - TBI/no airway (Trach vent)"
- "Vest restraint"
- "Geri chair"

Similar findings were identified related to lack of restraint training and demonstrated competencies during review of the following orientation documents:
* The undated orientation education materials document titled "Core Competency/Demonstration Registered Nurse" provided for RN staff.
* The orientation education materials document titled "Core Competency/Demonstration LPN/LVN" dated "Revised April 2020" provided for LPN staff.
* The undated orientation education materials document titled "Core Competency/Demonstration Clinical Assistant" provided for CA staff.

During an interview with the DQR on 05/24/2021 at 1440, he/she confirmed finding 5.

6. A manufacturer instructions manual provided for "Posey bed" restraint titled "Posey Bed Professional User's Manual" dated "2013," was reviewed and reflected:
* "The Posey Bed 8070 is a hospital bed, canopy, and mattress system ... Because the bed is a restraint, its use must be prescribed by a licensed physician. Anyone interacting with the bed must complete the Posey Bed 8070 In-Service Training Program which includes proficiency in the use of this manual."
* "Improper use of the Posey Bed may lead to serious injury or death. Patient monitoring should be established by hospital protocol and the patient's care plan. As with any less restrictive restraint system, it is important to be familiar with the indications for use, the contraindications for use and in particular, risks associated with entrapment, suffocation, choking, and falls."
* The manual included 33 additional pages of instructions including but not limited to contraindications, patient reassessments, description, warnings, precautions, basic bed operation, new patient selection and monitoring, emergency patient access and exit, regular daily patient care, cleaning, washing and trouble shooting.
Although the manufacturer's instructions included extensive precautions, instructions, and specific in-service training information, there was no documentation that was considered or included in the hospital's restraint P&Ps or training/competency education materials.

7. Review of staff education and competency records reflected they were incomplete and lacked documentation of orientation restraint education and competencies specific to the hospital's approved and available restraint types. For example:

7. a. Employee 8, CNA with hire date 03/24/2020 reflected:
* The orientation "Competency/Demonstration Restraints" checklist dated 04/02/2020, signed by the "Lead CNA" reflected "Applies selected restraint correctly ... Extremity restraint ... Mitten restraint ... Elbow restraint" with a check mark next to it but did not include the "Method" (Verbal, Demo, or MR/PI Review) of competency assessment.
* The certification of competency, recommendation, and "Manager/Director" signature and date sections at the bottom of the checklist were blank.
* The checklist lacked information specific to all of the hospital's authorized and available restraint types. For example, the education did not include "Seizure pads for TBI who hit their head on the side rail" and "Posey bed - TBI/no airway (Trach vent)."

7. b. Similar findings were identified related to lack of orientation restraint education and competencies specific to the hospital's approved and available restraint types for the following staff:
* Employee 2, RN with hire date 03/02/2020;
* Employee 4, RN with hire date 11/16/2020;
* Employee 5, CNA with hire date 03/05/2017;
* Employee 6, RN with hire date 03/19/2018;
* Employee 7, RN with hire date 08/05/2019;
* Employee 10, agency RN with hire date 10/26/2016 ; and
* Employee 11, RN with hire date 08/24/2020.

7. c. During an interview and review of the staff restraint education/competency records with the DQR on 05/24/2021 at 1440, he/she confirmed the lack of orientation restraint education and competencies specific to the hospital's approved and available restraint types.

8. Review of staff restraint education and competency records reflected they lacked documentation of annual restraint education and competencies specific to the hospital's approved and available restraint types in accordance with hospital P&Ps. For example:

8. a. Employee 6, RN with hire date 03/19/2018 reflected:
* The annual "Competency/Demonstration Restraints" checklist dated 10/18/2019, signed by the "Manager/Director" reflected "Applies selected restraint correctly ... Extremity restraint ... Mitten restraint ... Elbow restraint" with a check mark next to it but did not include information specific to all of the hospital's authorized and available restraint types. For example, the education did not include "Seizure pads for TBI who hit their head on the side rail" and "Posey bed - TBI/no airway (Trach vent)."
* No documentation of annual restraint education and competencies for 2020.

8. b. Employee 10, agency RN with hire date 10/26/2016 reflected:
* A one-page "Express Healthcare Professionals LLC" document that reflected "Date of Exam: Sep 27, 2020" and "Restraints 100% (5 of 5)." There was no further information provided. There was no documentation that reflected restraint education and demonstrated competencies specific to the hospital's approved and available restraint types.

8. c. Similar findings were identified during review of annual restraint education and competencies documentation for the following staff:
* The annual "Competency/Demonstration Restraints" checklist dated 03/16/2021 for Employee 5, CNA with hire date 03/05/2017, lacked documentation of restraint education and demonstrated competencies specific to the hospital's approved and available restraint types.
* The annual "Competency/Demonstration Restraints" checklist dated 03/17/2021 for Employee 7, RN with hire date 08/05/2019, lacked documentation of restraint education and demonstrated competencies specific to the hospital's approved and available restraint types.
* The annual "Competency/Demonstration Restraints" checklist dated 03/16/2021 for Employee 9, RN with hire date 01/06/2010, lacked documentation of restraint education and demonstrated competencies specific to the hospital's approved and available restraint types.

8. d. During an interview and review of the staff restraint education/competency records with the DQR on 05/24/2021 at 1440, he/she confirmed the lack of annual restraint education and competencies specific to the hospital's approved and available restraint types.

Due to the unclear and inconsistent information related to the types of restraint devices approved by the hospital; and the restraint types referenced within P&Ps, training materials, and manufacturer's instructions, there was no assurance staff were appropriately trained and demonstrated competency in the specific types of restraints used in the hospital on orientation and annually in accordance with hospital P&Ps.

Based on interview, review of restraint training/education records for 9 of 9 hospital staff who participate in patient restraint (Employees 2, 4, 5, 6, 7, 8, 9, 10 and 11), review of restraint education materials, and review of policies and procedures, it was determined that the hospital failed to fully develop and implement policies and procedures that ensured staff were trained and demonstrated knowledge in the use of immediate interventions and first aid to be provided to a restrained patient who is in distress or injured.

Findings include:

1. The P&P titled Restraint Use," dated last revised "12/16" was reviewed and reflected:
* "Clinical personnel will be trained on ordering, application or monitoring of restrained patients. Training will take place during orientation and annually ... "
* "Staff who assess patients for restraint or who apply restraint will receive training in the following ... The use of first aid techniques ... "

2. Restraint education materials provided were reviewed and lacked documentation of training and demonstrated competency related to first aid techniques for patients who were restrained. For example:
* The annual "Skill Fair 2021" education documents provided for RN, LPN and CNA/Clinical Assistant staff did not include training and demonstrated competency content related to first aid techniques for patients who were restrained.
* The undated orientation and annual education document titled "Competency/Demonstration Restraints" provided for RN, LPN, CNA, and RT staff reflected a list of 18 individual "Components," of which none reflected training and demonstrated competency related to first aid techniques for patients who were restrained.
* The undated orientation education document titled "Core Competency/Demonstration Registered Nurse" provided for RN staff included a "Restraints" section, of which there was no information regarding training and demonstrated competency related to first aid techniques for patients who were restrained.
* The orientation education document titled "Core Competency/Demonstration LPN/LVN" dated "Revised April 2020" provided for LPN staff included a "Restraints" section, of which there was no information regarding training and demonstrated competency related to first aid techniques for patients who were restrained.
* The undated orientation education document titled "Core Competency/Demonstration Care Assistant" provided for "Care Assistant" staff included a "Restraints" section, of which there was no information regarding training and demonstrated competency related to first aid techniques for patients who were restrained.

3. Review of staff training/education documents for the following staff reflected no evidence of training and competency related to first aid techniques for patients who were restrained, including appropriate first aid required if a restrained patient was in distress or injured:
Employee 2, RN with hire date 03/02/2020
Employee 4, RN with hire date 11/16/2020
Employee 5, CNA with hire date 03/05/2017
Employee 6, RN with hire date 03/19/2018
Employee 7, RN with hire date 08/05/2019
Employee 8, CNA with hire date 03/24/2020
Employee 9, CNA with hire date 01/06/2010
Employee 10, agency RN with hire date 10/26/2016
Employee 11, RN with hire date 08/24/2020

4. During an interview with the RNE on 04/28/2020 at 1300, he/she confirmed Employees 2 and 4-11 had no orientation or annual training or competencies related to first aid techniques for patients who were restrained. The RNE stated the hospital had no restraint related first aid training for any staff.

Based on interview, review of grievance documentation for 7 of 7 patients selected from the grievance log (Patients 11, 12, 13, 14, 15, 16 and 18), review of medical record and incident documentation for Patient 17, review of QAPI documents, review of policies and procedures, and review of other documentation, it was determined the hospital failed to implement policies and procedures to ensure an effective QAPI program as follows:
* Patient complaints/grievance were not entered into the hospital's grievance tracking log; and
* Patient complaint/grievance data was not analyzed, summarized, reviewed, and recommendations made for process improvement in accordance with hospital policies and procedures.

Findings include:

1. The P&P titled "Complaint and Grievance Process," dated last reviewed "2/19" was reviewed. It reflected:
* "The DQM will assist [with] all [complaints] & will track, and report outcomes to the CEO & through the appropriate committees."
* "Complaints are tracked for the purpose of trending, improving the processes, and ensuring customer satisfaction with follow-through."
* "The Governing Board delegates the grievance process to the Hospital's Quality Assurance Performance Improvement Committee. (QAPI) ... Specific responsibilities are designated to the following roles ... DQM: Auditing, aggregating and analyzing data to present to the Hospital's QAPI Committee for review and recommendation."
* "Quality Department ... Upon receipt of Patient Complaint ... The DQM or designee will ensure that all of the necessary information had been entered in by all parties assigned for follow up. Once this has been completed ... she/he will close out the incident/complaint ... Ensure documentation of the grievance in the Grievance Log ... The Complaint and Grievance Log summarized and presented to the hospital's QAPI Committee, Medical Executive Committee and the Governing Board on a regular basis for review and recommendations."

2. Refer to the findings at Tag A123 that reflects:
* Complaints/grievances were submitted to the hospital involving Patients 11, 12, 13, 14, 15, 16, 17 and 18.
* Complaints/grievances involving Patient 17 were not entered into the hospital's grievance log in accordance with hospital P&Ps.

3. QAPI documents dated 2020 and 2021 were provided and reviewed. The documents contained no information specific to patient complaints and grievances, including no documentation that reflected complaint/grievance data was analyzed, summarized, reviewed, and recommendations made for process improvement in accordance with hospital P&Ps.

4. During an interview with the DQM on 05/21/2021 at 1320, the DQM was asked to provide a summary and presentation of the complaint/grievance log to the hospital's QAPI Committee, Medical Executive Committee and the Governing Board for review and recommendations in accordance with hospital P&Ps. The DQM stated "That is something we have not done." The DQM stated not all complaint/grievances were being reported and entered into the hospital's reporting system. He/she stated "We need to tighten that up."

5. During an interview with the DQR on 5/24/2021 at 1440, the DQR confirmed he/she had no documentation of auditing, aggregating, and analyzing complaint/grievance data for review and recommendations in accordance with the hospital's P&P.

Based on interview, documentation reviewed in the medical records for 2 of 2 patients for provision of nursing services (Patients 4 and 17), incident documentation reviewed for 3 of 11 patients (Patient 1, 4 and 17), review of policies and procedures, and review of other documentation, it was determined that the hospital failed to ensure the RN supervised and evaluated patients in a manner that ensured the provision of safe and appropriate care in accordance with hospital policies and procedures including:
* Patient 1 had a clogged NG feeding tube and missed his/her tube feedings for an unknown period of time; and RN staff who accessed and managed the feeding tube had not been trained or determined competent by the hospital to conduct those tasks.
* Patient 4 was administered an IV solution through a temporary dialysis catheter that was accessed by RN staff who were not trained, determined competent, or permitted by the hospital to conduct those tasks.
* Patient 17 was physically restrained to the bed by his/her upper extremity and was subsequently found on the floor next to the bed with the restraint still attached, and RN staff failed to appropriately assess the patient for injuries.
* Patient 17 became unresponsive and required resuscitation and ventilator support after RN staff administered the patient repeated doses of Valium and failed to evaluate the patient's response to the drug.

Findings include:

1. Refer to the findings identified under Tag A145 CFR 482.13(c)(3) - Standard: Patient Rights: Abuse/Harassment. Those findings reflect the hospital's failure to ensure the RN appropriately supervised and evaluated Patients 1, 4, and 17; and were appropriately trained and determined competent by the hospital to care for Patients 1 and 4.