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81 HIGHLAND AVENUE

SALEM, MA 01970

PATIENT RIGHTS

Tag No.: A0115

The Patients' Rights Condition of Participation was out of compliance:

Findings included:

The Hospital failed for one patient (Patient #8) in a sample of 10 patients, to ensure the Emergency Department implemented the use of seclusion in accordance with the Hospital's policy titled Management of the Patient in Restraint/Seclusion in the non-psychiatric setting.

Refer to TAG: 0167.

The Hospital failed to ensure training requirements to Physicians and other Licensed Practitioners consistent with the Hospital policy titled Management of the Patient in Restraint/Seclusion in the non-psychiatric setting.

Refer to TAG: 0176.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0167

Based on records reviewed and interview the Hospital failed for one patient (Patient #8) in a sample of 10 patients, to ensure the Emergency Department implemented the use of seclusion in accordance with the Hospital's policy titled Management of the Patient in Restraint/Seclusion in the non-psychiatric setting.

Findings included:

The Hospital policy titled Patient Rights and Responsibilities, dated 12/2019, indicated the Hospital only used a restraint (seclusion) if needed to protect the patient and or others from harm and only if less restrictive interventions were determined ineffective.

The Hospital policy titled Management of the Patient in Restraint/Seclusion in the non-psychiatric setting, dated 9/24/19, indicated:

-restraint and seclusion were prescriptive measures and may only be used if a Physician and or a Registered Nurse (RN) assessed and documented their [the Patient's] need.

-monitoring and assessment of patient safety and physical needs occurred every two hour or more frequently, as individually assessed to meet the patient's needs; monitoring was accomplished by observation, intervention with the patient, or related direct examination of the patient by qualified staff (undefined); monitoring determined vital signs and pain, psychological status, and changes in condition.

The Doctors' Order, dated 10/8/2020, indicated a Provider Order for Patient #8's seclusion; Patient #8 was moved to a seclusion padded room for the goal of maintained safety due to demonstrated imminent risk of self-harm; for a duration of four hours.

The Sitter, Safety Observer Sheets, dated 10/7/2020 through 10/8/2020 and 10/8/2020 through 10/9/2020, indicated incomplete document regarding Patient #8's care.

The Sitter, Safety Observer Sheets, dated 10/7/2020 through 10/8/2020 indicated: Page 1 indicated no name of the observer; Page 2 indicated no time, no date or time the Registered Nurse signed the Sitter, Safety Observer Sheet; Pages 2, 3 & 5 indicated no indication of the observation as a Sitter (constant observation) or Safety Observer (15-minute checks); Pages 2, 4 & 6 indicated no documentation of the number of times the patient attempted to get out of bed; Pages 4 & 6 indicated no documentation of Patient #8's behavior, ability to use call bell, or communicate needs; Page 5 did not indicate Patient #8's name; Page 6 indicated no documentation of the Registered Nurse's name or signature; Page 7 & 8 indicated an incomplete Sitter, Safety Observer Care Plan.

During an interview with the Executive Director for the Emergency Department and the Director for the Emergency Department, at 4:14 P.M. on 12/1/2020, the Director for the Emergency Department said Patient #8's medical record did not include the required nursing documentation.

Review of Patient #8's medical record indicated no documentation of Nursing Notes to indicate monitoring and assessment of patient safety; vital signs or pain, psychological status, or changes in condition consistent with the Hospital policy titled Management of the Patient in Restraint/Seclusion in the non-psychiatric setting.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0176

Based on records reviewed and interview the Hospital failed to ensure training requirements to Physicians and other Licensed Practitioners consistent with the Hospital policy titled Management of the Patient in Restraint/Seclusion in the non-psychiatric setting.

Findings include:

The Hospital policy titled Management of the Patient in Restraint/Seclusion in the non-psychiatric setting, dated 9/24/19, indicated Hospital Physicians and Licensed Independent Practitioners would complete training during orientation, before participating in restraint, seclusion, and at re-credentialing. The policy Management of the Patient in Restraint/Seclusion in the non-psychiatric setting indicated training and competency would be documented in credential files.

During an interview, at 10:20 A.M. on 11/24/2020, Patient Safety and Quality Staff #1 said that she co-chaired the Restraint Committee with a Physician. Patient Safety and Quality Staff #1 said she requested to the Medical Staff that restraint training be assigned to all Providers. Patient Safety and Quality Staff #1 said the Medical Staff responded that this was not part of the re-credentialing process. Patient Safety and Quality Staff #1 said that this gap was identified in approximately 10/2019.

Review of a Physician Credential File indicated no documentation of training requirements of the Hospital policy regarding the use of patient restraint and or seclusion consistent with the Hospital policy titled Management of the Patient in Restraint/Seclusion in the non-psychiatric setting.

QAPI

Tag No.: A0263

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

Findings included:

1.) The Hospital failed for one patient (Patient #8) in a sample of ten patients to ensure the Hospital's QAPI program analyzed data collected regarding the effectiveness and safety of the Emergency Department's use of patient seclusion and quality of care.

Refer to TAG: A-0273.

The Hospital failed for four patients (Patients #1, #3, #4 & #5) in a sample of ten patients to ensure through processes for QAPI activities that implemented preventive actions and learning activities after Adverse Patient Events. The Hospital failed to: implement preventative actions with Psychiatric Staff after Patient #3's Adverse Patient Event; implement learning activities with Security Officer Staff following Patient #1's Adverse Patient Event, implement learning activities with the Hospitalist Staff after Patient #5's Adverse Patient Event and complete learning activities with Obstetric Providers after Patient #4's Adverse Patient Event.

Refer to TAG: A-0286.

The Hospital failed to ensure that its medical staff and administrative officials (Hospital Leadership) were responsible and accountable for a thorough and ongoing QAPI program that analyzed patient seclusion events, identified opportunities for improvement or implemented learning actions.

Refer to TAG: 0309.

DATA COLLECTION & ANALYSIS

Tag No.: A0273

Based on records reviewed and interview the Hospital failed for one patient (Patient #8) in a sample of ten patients to ensure the Hospital's Quality Assessment and Performance Improvement (QAPI) program analyzed data collected regarding the effectiveness and safety of the Emergency Department's use of patient seclusion and quality of care.

Findings included:

The Hospital policy titled Patient Rights and Responsibilities, dated 12/2019, indicated the Hospital only used a restraint (seclusion) if needed to protect the patient and or others from harm and only if less restrictive interventions were determined ineffective.

The document titled Medical Staff Bylaws and Rules & Regulations, dated 9/19/2017, indicated the Patient care Assessment Committee was a medical peer review committee responsible for programs, policies and procedures of the Hospital and Medical Staff designed to foster optimal patient care through the Patient Care Assessment Program.

The document titled Patient Care Assessment Plan (QAPI Plan), dated 1/2/2020, indicated there was ongoing critical review of patient care to identify problems before they occur and implement preventative measures.

The document titled Restraint and Seclusion Report, dated 7/1/2020-11/20/2020, indicated Patient #8 required Seclusion.

The Hospital policy titled Management of the Patient in Restraint/Seclusion in the non-psychiatric setting, dated 9/24/19, seclusion was the involuntary confinement of a patient alone in a room or area from which the patient was physically prevented from leaving. The policy indicated seclusion may only be used for the management of violent or self-destructive behavior that jeopardized the immediate physical safety of the patient, a staff member, or others.

The Doctors' Order, dated 10/8/2020, indicated a Provider Order for Patient #8's seclusion; Patient #8 was moved to a seclusion padded room for the goal of maintained safety due to demonstrated imminent risk of self-harm; for a duration of four hours.

During an interview, at 3:20 P.M. on 12/1/2020, Patient Safety and Quality Staff #1 said that the Restraint and Seclusion Committee did not review all patient events of restraint and seclusion, only if there was a trend or things did not go right.

The Hospital provided no documentation to indicate the Hospital's QAPI Program activities analyzed patient seclusion event data collected regarding the effectiveness and safety of the Emergency Department's use of patient seclusion and quality of care.

PATIENT SAFETY

Tag No.: A0286

Based on records reviewed and interviews the Hospital failed for four patients (Patients #1, #3, #4 & #5) in a sample of ten patients to ensure through processes for Quality Assessment and Performance Improvement (QAPI) Program activities that implemented preventive actions and learning activities after Adverse Patient Events. The Hospital failed to implement: preventative actions with Psychiatric Staff after Patient #3's Adverse Patient Event; implement learning activities with Security Officer Staff following Patient #1's Adverse Patient Event, implement learning activities with the Hospitalist Staff after Patient #5's Adverse Patient Event and complete learning activities with Obstetric Providers after Patient #4's Adverse Patient Event.

Findings included:

The document titled Patient Care Assessment Plan (QAPI Plan), dated 1/2/2020,
indicated serious incidents (Adverse Patient Events) were investigated thoroughly and appropriate follow-up was completed in a timely fashion. The Patient Care Assessment Plan indicated the Quality and Patient Safety Department was responsible for follow-up (of Adverse Patient Events).

The Hospital policy titled Safety Reporting, dated 12/2018, indicated the person accountable for the area of service where the event occurred was responsible for implementation of corrective actions, resolution of the event and that a responsibility of the Quality and Patient Safety Department was to communicate with responsible Hospital Leadership to ensure timely investigation, follow-up, and closure of reports (Adverse Patient Events). The Hospital policy titled Safety Reporting, dated 12/2018, indicated a purpose of the policy was to reveal learning experiences for the Hospital.

The Hospital policy titled Safety Reporting indicated policy and procedures for managing the Safety Reporting system (computerized reporting system). The Safety Reporting policy did not indicate a policy for clear guidelines or responsibilities of the processes to investigate, identify corrective actions, opportunities for improvement, nor monitoring regarding Adverse Patient Events.

Regarding Patient #1:

The Hospital failed to implement learning activities with Security Officer Staff following Patient #1's Adverse Patient Event.

The Emergency Department Record, dated 6/28/2020, indicated Patient #1 presented with altered mental status.

During observation, on 11/20/2020, of a surveillance video recording of Patient #1's presentation to the Hospital Emergency Department, the Surveyor observed one Emergency Medical Service (EMS) staff assault Patient #1, Security Officer #1 hold-down Patient #1's arm and a Hospital Staff Member leaving the Emergency Department.

The Hospital Security policy titled Required Conduct, dated 6/29/2009, indicated Security Officers were required to immediately inform their Sergeant or Staff Member in Charge of any matter of importance.

During an interview, at 1:20 P.M. on 11/20/2020, the Security Director said that there was no formal process for Security Staff to verbally communicate patient events to a Supervisor. The Security Director said that the event regarding Patient #1 was a Human Resources case (responsibility to investigate the performance of Security Officer #1).

During an interview, at 9:45 A.M. on 11/24/2020, he Human Resources Representative #1 said that Security Officers were directed to input events into the Hospital electronic reporting system and that they (staff and Hospital Leaders) would talk in the morning. The Human Resources Representative #1 said it was hard to say (she did not know) about processes for staff re-education (learning) regarding reporting to a Sergeant or Staff Member in Charge any matter of importance because of boundaries within the Quality, Patient Safety and Human Resources departments. The Human Resources Representative #1 said it was a Registered Nurse seen in the surveillance video leaving the Emergency Department. The Human Resources Representative #1 said the Registered Nurse did not report to the Hospital until the following day that she saw the EMS staff member assault Patient #1.

During an interview, on at 1:45 P.M. on 11/24/2020, the Security Operations Manager said there was no formal training with the Security Staff regarding reporting to a Supervisor or Staff Member in Charge matters of importance.

During an interview, at 3:30 P.M. on 11/24/2020, Patient Safety and Quality Staff #1 said that the Hospital did not conduct a Collaborative Case Review (Hospital investigation) because the event regarding Patient #1 was a Human Resources issue, not a clinical issue and that there was no indication for immediate corrective actions.

The Hospital provided no documentation to indicate that Quality, Patient Safety and Human Resources departments collaborated to re-educate Security, Emergency Department and Hospital Staff to report to a Supervisor or Staff Member in Charge matters of importance.

Regarding Patient #3:

A.) The Hospital failed to implement preventative actions with Psychiatric Staff after Patient #3's Adverse Patient Event.

The Hospital Report, dated 11/2/12020, indicated Patient #3 harmed himself/herself while shaving with a razor.

The Hospital Report, dated 11/10/2020, indicated the Hospital investigation identified risk reduction strategies (preventative corrective actions) included identification of the bathroom that patients would benefit from performing Activities of Daily Living (ADLs, shaving) including re-education (regarding ADLs).

During an interview, at 2:45 P.M. on 11/24/2020, the Psychiatric Nurse Manager said that Patient #3's event occurred in a hallway bathroom possibly due to hallway distractions and that all patient rooms had private bathrooms. The Psychiatric Nurse Manager said she had not yet had a meeting to discuss immediate corrective actions or opportunities for improvement (more than one month after Patient #3 cut himself/herself with a razor).

The Hospital provided no documentation of corrective actions or improvement opportunities.

Regarding Patient #4:

The Hospital failed to complete learning activities with Obstetric Providers after Patient #4's Adverse Patient Event.

The Newborn Nursery Discharge Summary, dated 5/16/19, indicated the baby was delivered by a Vaginal Birth After Caesarean-section (VBAC) and was deceased.

The Hospital Investigation, dated 5/2019, indicated a plan included Grand Rounds (learning opportunity) on the Management of the Category II Tracing (Electronic Fetal Monitoring interpretation) and that the Grand Rounds would be available by video conferencing for future learning.

The document titled Department of Obstetrics & Gynecology Attendance, dated 6/6/19, indicated the topic of the Grand Rounds was Surviving and thriving when everything is Category II. The Attendance Sheet indicated seven of twenty-four Obstetric Providers did not participate in the Grand Rounds learning opportunity.

The Hospital provided no documentation to indicate a plan for completion of this learning opportunity, greater than one year after Patient #4's Adverse Patient Event.

B.) The Hospital failed to implement risk reduction strategies (corrective actions or learning opportunities) consistent with the Hospital investigation.

The Hospital Investigation (Root Cause Analysis), dated 6/27/29, indicated risk reduction strategies included development of guidelines for OB Huddle STAT (in real time obstetric emergency patient care review).

The document titled Birthplace Daily Safety Huddle Ground Rules, undated included instructions to arrive on time, start on time, be prepared, be respectful with no eating or drinking or side-bar conversations or phone use with only one person speaking to follow the script for labor patients.

The document titled Labor Patients Safety Rounds Script, undated, indicated that the Charge Nurse would present the patient, patient room, gravida & para, gestational age, reason for admission, significant laboratory results, last cervical (uterus) examination, Electronic Fetal Monitoring (EFM) category (interpretation) with a plan for a Category II (neither normal nor abnormal fetal heart rate pattern) EFM.

The E-mail, dated 7/17/19, indicated that the first OB Huddle STAT and that there was confusion about what exactly a "Stat Huddle" meant.

The documents titled Birthplace Daily Safety Huddle Ground Rules nor the Labor Patients Safety Rounds Script indicated no guideline for determining an OB Huddle STAT. The Hospital provided no documentation to indicate monitoring of the OB Huddle STAT to analyze its effectiveness.

Regarding Patient #5:

The Hospital failed to implement learning activities with the Hospitalist Staff after Patient #5's Adverse Patient Event.

The Hospital Report, dated 10/19/20, indicated that Patient #5 had chronic obstructive pulmonary disease and required supplemental oxygen. The Hospital Report indicated, on 10/19/2020, Patient #5's oxygen level declined to 80% (low).

The E-mail, dated 11/19/2020, indicated communication to the Hospitalist Chair that a Physician turned-off Patient #5's oxygen, in error. The E-mail indicated a request that a general reminder be sent to the Hospitalist Team to be careful when manipulating oxygen equipment.

The Hospital provided no documentation to indicate an improvement of the strength of the request, as a corrective action, or that the E-mail, dated 11/19/2020, request was implemented, by the time of the Survey.

QAPI EXECUTIVE RESPONSIBILITIES

Tag No.: A0309

Based on records reviewed and interviews the Hospital failed for six patients (Patients #1, #3, #4, #5 #6 & #8) in a sample of ten patients to ensure that its Medical Staff and administrative officials (Hospital Leadership) were responsible and accountable for an ongoing Quality Assessment and Performance Improvement (QAPI) Program that analyzed patient seclusion events, identified opportunities for improvement or implemented learning actions with completeness, consistent with the Hospitals' Patient Care Assessment Plan.

Findings included:

The document titled Patient Care Assessment Plan (QAPI Plan), dated 1/2/2020,
indicated the Governing Body responsibility was leadership of the Hospital by overseeing the credentialing programs, and oversight through its review and reports from the Medical Executive Committee.

Regarding QAPI Program Hospital Investigations of Adverse Patient Events:

The Hospital did not provide for Surveyor review an organized Quality Assessment Performance Improvement (QAPI) Program regarding Patients #3, #4, #5. The QAPI Program Service Area Specific Leaders responsibilities did not reflect a progression with appropriate documentation of QAPI activities regarding adverse patient events; that included investigation(s), corrective action(s) identification, improvement and learning opportunities, implementation of those corrective actions and improvement opportunities with appropriate documentation and corrective action monitoring for effectiveness.

Regarding Credentialing:

The Hospital provided no documentation to indicate the Licensed Mental Health Counselor that provided Patient #1 with a Psychiatric Triage Evaluation, the Licensed Independent Clinical Social Worker that provided Patient #6 with a Psychiatric Triage Evaluation or the (MA) that provided Patient #8 with a Psychiatric Triage Evaluation were determined eligible for appointment by competency review and evaluation under the Hospital's Medical Staff privileging system, were recommended by the Medical Staff to the Hospital Governing Body who granted privileges to provide care to patients, in accordance with Medical Staff Bylaws, Rules and Regulations, consistent with State scope-of-practice laws.

During an interview, at 2:00 P.M. on 11/25/2020, the Executive Director of Behavioral Health, said that the Triage Staff in the Emergency Department that conducted the Psychiatric Triage Evaluations were a group of non-physician providers and that the Triage Staff was not credentialed (privileged) through the Medical Staff.

MEDICAL STAFF

Tag No.: A0338

The Medical Staff Condition of Participation was out of compliance.

Findings included:

The Hospital failed for three patients (Patients #1, #6 & #8 in a sample of ten patients to ensure non-physician practitioners [Licensed Mental Health Councilors (LMHC), Licensed Independent Clinical Social Workers (LICSW) and Undefined (MA)] were determined eligible for appointment by competency review and evaluation under the Hospital's Medical Staff privileging system, were recommended by the Medical Staff to the Hospital Governing Body, who granted privileges to provide care to patients, in accordance with Medical Staff Bylaws, Rules and Regulations, consistent with State scope-of-practice laws.

Refer to TAG: 0339.

ELIGIBILITY & PROCESS FOR APPT TO MED STAFF

Tag No.: A0339

Based on records reviewed and interview the Hospital failed for three patients (Patients #1, #6 & #8) in a sample of ten patients to ensure non-physician practitioners [Licensed Mental Health Councilor (LMHC), Licensed Independent Clinical Social Worker (LICSW), & Undefined (MA)]were determined eligible for appointment by competency review and evaluation under the Hospital's Medical Staff privileging system, were recommended by the Medical Staff to the Hospital Governing Body who granted privileges to provide care to patients, in accordance with Medical Staff Bylaws, Rules and Regulations, consistent with State scope-of-practice laws.

Findings included:

The document titled Medical Staff Bylaws and Rules & Regulations, dated 9/19/2017, indicated Allied Health Professionals included licensed physician assistants, nurses practicing in the expanded role and individuals with a doctorate in psychology from and accredited college or university and individuals with a Doctor of Education appropriately trained and licensed as a psychologist or neuropsychologist. Allied Health Professionals may engage in direct patient care and would be credentialed and privileged consistent with the Medical Staff Bylaws.

The document titled Patient Care Assessment Plan (QAPI Plan), dated 1/2/2020,
indicated the Governing Body responsibility was leadership of the Hospital by overseeing the credentialing programs, and oversight through its review and reports from the Medical Executive Committee.

During an interview, at 2:00 P.M. on 11/25/2020, with the Executive Director of Behavioral Health and the Director of Behavioral Health, the Director of Behavioral Health said that the Triage Staff in the Emergency Department that conducted the Psychiatric Triage Evaluations were a group of non-physician providers and employed by the Hospital. The Director of Behavioral Health said that the Triage Staff determined the psychiatric patient's level of care needed (outpatient psychiatric treatment or inpatient psychiatric hospitalization) and made this recommendation to the Emergency Department Physician. The Director of Behavioral Health said that the Triage Staff was not credentialed (privileged) through the Medical Staff.

The Psychiatric Triage Evaluation, dated 2/28/2020, indicated a signature to represent a person (credentials undefined) provided Patient #1 with a psychiatric evaluation. The Psychiatric Triage Evaluation indicated a signature to represent a Licensed Mental Health Councilor (LMHC) co-signed Patient #1's Psychiatric Triage Evaluation.

The Psychiatric Triage Evaluation, dated 7/27/2020, indicated a signature to represent a Licensed Independent Clinical Social Worker (LICSW) provided Patient #6 with a psychiatric evaluation.

The Psychiatric Triage Evaluation, dated 10/7/2020, indicated a signature to represent an MA (undefined) provided Patient #8 with a psychiatric evaluation.

The document titled Medical Staff Bylaws and Rules & Regulations, indicated no documentation to indicate that the Medical Staff recommended to the Governing Body that LMHCs, LICSWs, or MAs be privileged to provide psychiatric evaluations for Hospital patients.