HospitalInspections.org

The Patient Rights Condition of Participation was out of compliance.

Findings included:

The Hospital failed to ensure for two patients (Patients #3 and #7) in a sample of ten patients reviewed to establish an effective process for resolution of patient grievances.

Refer to TAG: A-0118.

Based on records reviewed and interviews the Hospital failed to ensure for two patients (Patients #3 and #7) in a sample of ten patients reviewed to establish an effective process for resolution of patient grievances.

Findings included:

The Hospital policy titled Patient, Family Complaint and Grievance Mechanism, dated 7/2020, indicated a grievance was a formal or informal, written, or verbal complaint made to the Hospital by a patient or patient's representative regarding patient care, related to the Hospital compliance with the Center for Medicare and Medicaid Services (CMS) Hospital Conditions of Participation. The policy indicated complaints were documented in the Patient Complaint & Grievance system; the Service Director conducted the investigation, and written response of the resolution was sent to the Complainant.

1.) Regarding Patient #7:

The Hospital failed to ensure that the informal complaint verbalized by Patient #7's Mother to the Hospital and Medical Staff was recorded in the Hospital's electronic Patient Complaint & Grievance system for tracking and resolution of patient complaints.

The Emergency Department (ED) Record, dated 9/22/2020, indicated Patient #7 presented to the Emergency Department (by ambulance) for increased respiratory distress. In the ED Patient #7 experienced decreased blood oxygenation and bradycardia (slow heartbeat) requiring cardio-pulmonary resuscitation and a surgeon replaced Patient #7's tracheostomy tube with an endotracheal (in the windpipe) tube through the tracheostomy (A tracheostomy is an opening surgically created through the neck into the trachea (windpipe) to breathe through a tracheostomy tube). The tracheostomy tube had complete occlusion by a known granuloma (tracheal scar tissue).

Patient #7's medical record, dated 9/22/2020 indicated Patient #7 was well oxygenated following stabilization of Patient #7's airway with the endotracheal tube placed in the ED.

The Discharge Summary, dated 10/29/2020, indicated the Patient #7 was moved to the Pediatric Intensive Care Unit and transferred to the Operating Room where Patient #7's tracheostomy tube was replaced.

During an interview, on 12/15/2020, Complainant #1 said that Patient #7's Mother asked why they did not change Patient #7's tracheostomy tube in the ED; the Mother told them Patient #7 could not breath and the ED Staff did not listen to Patient #7's Mother.

During an interview, at 1:30 P.M. on 1/6/2021, the Performance Improvement Director said Risk Management conducted the Hospital investigation and Risk Manager #1 remembered that Patient #7's Mother was upset that Patient #7's tracheostomy tube was not changed in the ED; however Patient #7's trachea was scared [hypertrophic (thickened, wide, often raised scar that developed where skin was injured)] resulting in a potential unsafe procedure if conducted in the Emergency Department; Physicians determined the Operating Room was the safest setting to change Patient #7's tracheostomy tube; The Hospital investigation determined Patient #7's clinical care was appropriate.

During an interview, at 10:00 A.M. on 1/7/2021, Risk Manager #1 said Patient #7's Mother was very upset that ED Providers were not listening to her when she told them that Patient #7's tracheostomy tube was obstructed.

During an interview, at 4:30 P.M. on 1/7/2021, the Pediatric Intensive Care Unit Physician said Patient #7's Mother was upset that Patient #7's tracheostomy tube was not changed in the ED.

The document titled Timeline, undated, indicated on 9/22/2020 Patient #7's Mother was very upset that ED Providers were not listening to her when she told them that Patient #7's tracheostomy tube was obstructed and that Patient #7's Mother was hiring a lawyer.

The Hospital provided no documentation to indicate that Patient #7's Mother's complaint regarding changing Patient #7's tracheostomy tube in the ED was recorded in the Hospital's electronic Patient Complaint & Grievance system for tracking and resolution of the complaint.


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2.) Regarding Patient #3:

A Patient Complaint filed with the Massachusetts Department of Public Health, dated 7/29/2020, indicated Patient #3's Family Members witnessed Patient #3 tied to the bed in a waist restraint on 7/21/2020 from approximately 4:20 P.M. until 6:00 P.M. The Patient Complaint indicated that:

- Registered Nurse #1 said Patient #3 kept trying to get out of bed and they did not have the staffing to address Patient #3's behavior.

- When Patient #3's second Family Member arrived, the Family Member insisted the restraint be removed and the Family Member walked Patient #3 in the hallway.

- Family Members said Registered Nurse #1 did not know Patient #3 was ambulatory. The Patient Complaint indicated Patient #3's Attending Physician said there was no order for restraints.

- Patient #3's Family Member called the Hospital's Patient Relations Office, on 7/21/2020, and left a telephone message with his/her name, telephone number and a verbal grievance regarding Patient #3's restraint but there was no follow up.

- Patient #3's Family Member said his/she called again on 7/22/2020 and was told by the Patient Relations Department that they had 24 hours to respond to his/her complaint.

- The Patient Relations Representative then called back Patient #3's Family Member on 7/28/2020, seven days after the initial grievance, and said the Nurse Manager would look into the grievance and the Family Member would be notified of the findings.

- There was no further communication to Patient #3's Family Member during the approximately six months since the complaint was made.

Admission History and Physical Record, dated 7/18/2020, indicated Patient #3 was admitted with alcohol intoxication with withdrawal symptoms, was admitted to an inpatient unit for acute withdrawal.

Patient #3's Nursing Progress Note, dated 7/21/2020 at 1:00 A.M., indicated Patient #3 was alert and oriented, had tremors and a stutter at baseline, was sometimes impulsive and became more restless during the night. The Clinical Institute Withdrawal Assessment (a protocol for alcohol withdrawal) was followed for tremors and restlessness. The Nursing Progress Note indicated Patient #3 was medicated with Ativan (anti-anxiety medication) with effect for his/her restlessness.

Review of Patient #3's Nurse Progress Notes, indicated that on 7/21/2020, from 7:00 A.M. to 7:00 P.M., there was no progress note documented by Registered Nurse #1.

The Inpatient Unit Schedule indicated Registered Nurse #1 was scheduled to work on the Inpatient Unit on 7/21/2020 from 7:00 A.M. until 7:00 P.M.

The Hospital provided no documentation of the Inpatient Unit Schedule for Patient Assignments, to determine if Registered Nurse #1 was assigned to care for Patient #3 on 7/21/2020 or was assigned as the Charge Nurse.

During an interview on 1/5/2021 at 5:15 P.M., Registered Nurse #1 said she did work on Patient #3's Inpatient Unit on 7/21/2020 from 7:00 A.M. to 7:00 P.M. Registered Nurse #1 said she did not recall if Patient #3 was in her patient assignment or if he/she was in a waist restraint, or that Patient #3's Family Members complained regarding him/her being in an unnecessary restraint.

Review of the Patient Grievance Log for July 2020 to September 2020 indicated there was not a documented grievance for Patient #3's complaint.

During an interview on 1/6/2021 at 9:47 A.M. with the Director of Patient Relations, indicated there was no documented grievance from Patient #3's Family Member and he did not recall any conversation or complaint from Patient #3's Family Member.

Review of the telephone message notebook, documented by the Patient Relations Coordinator, was a written telephone message, dated 7/27/2020 at 10:47 A.M., indicated Patient #3's Family Member had called last week and was told that the Patient Relations Department would get back to him/her and no one had called her back.

The Hospital provided no documentation to indicate there was a follow-up to Patient #3's Family Members' complaint, nor a Hospital analysis of neither the investigation nor the resolution. Patient #3's restraint complaint on an inpatient unit was not recorded in the Hospital's electronic Patient Complaint & Grievance system for tracking and resolution of the complaint.

The Quality Assessment and Performance Improvement Program Condition of Participation was out of compliance.

Findings included:

1.) The Hospital Quality Assessment and Performance Improvement (QAPI) activities failed for four patients (Patients #1, #3, #6, & #7) in a sample of ten patients reviewed improved patient care through identification and analysis of events (adverse patient events).

Refer to TAG: A-0273.

2.) The Hospital Quality Assessment and Performance Improvement (QAPI) activities failed for six patients (Patients #1, #3, #5, #6, #7, & #10) in a sample of ten patients reviewed to ensure the Hospital-wide quality assessment and performance improvement efforts addressed priorities for improved quality of care and patient safety and that improvement actions were evaluated.

Refer to TAG: A-0309.

Based on records reviewed and interviews, Hospital Quality Assessment and Performance Improvement (QAPI) activities failed to ensure for four patients (Patients #1, #3, #6, & #7) in a sample of ten patients reviewed improved patient care through identification and analysis of events (adverse patient events).

Findings included:

The Quality Management and Patient Safety Plan, dated 2021, indicated the Patient Safety Committee improved patient care through identification and analysis of events.

The Hospital policy titled Adverse Event, dated 2/2020, indicated an adverse patient event was an unexpected or unfavorable medical occurrence. The policy indicated the Office of Patient Safety, Performance Improvement Services and the Clinical Risk Management Department were responsible for investigation and analysis of adverse patient events.

1.) Regarding Patient #1:

Hospital QAPI activities failed to ensure analysis of Patient #1's pain management considering Patient #1's risk factors of opioid use disorder, obesity and snoring during sleep prior to Patient #1's adverse patient event.

Hospital report, dated 7/27/2020, indicated Patient #1 died three days after a Cesarean section delivery. The report indicated Patient #1 had a history that included opioid use disorder and that Patient #1 was found breathing but unresponsive (adverse patient event). The Hospital report indicated Patient #1 had issues with pain control in the postoperative course.

Medical Record Review indicated Patient #1 weighed 102.2 kilograms (225.5 pounds) and 65 inches (5 foot 4 inches) tall with a Body Mass Index (BMI) of 38.7 indicated Patient #1 was considered obese.

During an interview, at 12:30 A.M. on 1/5/2021, the Obstetric Nurse Manager said Patient #1 was snoring prior to the event. The Obstetric Nurse Manager said that the Hospital investigation did not investigate Patient #1's snoring (risk factor for sleep apnea and sedation side effect of pain medication).

During an interview, at 9:14 A.M. on 1/6/2021, the Obstetric Chairperson said the Hospital investigation did not analyze Patient #1's pain management. The Obstetric Chairperson said that the Hospital investigation did not consult with Pharmacy Services to analyze the medications and medication doses administered to Patient #1.

During an interview, at 11:00 A.M. on 1/14/2021, the Pharmacy Senior Director said that Pharmacy Services had an Opioid Stewardship Program (a pain management consultative service offered by Pharmacy Services to work with Providers to identify patients at risk for adverse events as well as potentially risky opioid ordering practices) that started approximately one and one/half years ago and the Pharmacy Services hired a Pharmacist specific for the Opioid Stewardship Program.

2.) Regarding Patient #7:

Hospital QAPI activities failed to ensure Patient #7's, medically complicated pediatric patient specialized care needs were available to Emergence Department (ED) Providers upon Patient #7's presentation to the ED.

The ED Record, dated 9/22/2020, indicated Patient #7 presented to the ED (by ambulance) for increased respiratory distress. In the ED Patient #7 experienced decreased oxygenation and bradycardia (slow heartbeat) requiring cardio-pulmonary resuscitation and a surgeon replaced the tracheostomy tube with another tube called an endotracheal (in the windpipe) tube through the tracheostomy [a tracheostomy is an opening surgically created through the neck into the trachea (windpipe) to breathing through a tracheostomy tube].

The Discharge Summary, dated 10/29/2020, indicated Patient #7 had a history of scar tissue (hypertrophic; thickened, wide, often raised scar that developed where skin was injured) including the area near the end of the tracheostomy and this was an ongoing issue.

During an interview, at 4:30 P.M. on 1/7/2021, the Pediatric Intensive Care Unit Physician said the Pediatric Intensive Care Unit Physicians communicated with the ED Physicians regarding medically complicated pediatric patient specialized care needs in a document in the patient's electronic medical record referred to as, Medically Complicated Pediatric Patient Discharge Note. The Pediatric Intensive Care Unit Physician said that Patient #7 did not have a Medically Complicated Pediatric Patient Discharge Note in Patient #7's electronic medical record.

During an interview, at 11:00 A.M. on 1/8/2021, Emergency Department Physician #1 said that the electronic medical record alert (for the Medically Complicated Pediatric Patient Discharge Note) was not implemented in the electronic medical record.

The Hospital provided no documentation to indicate communication between the Pediatric Medical Staff and the Emergency Department Medical Staff regarding Patient #7's medically complicated pediatric patient specialized care needs.



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3.) Regarding Patient #3:

Hospital QAPI activity failed to address a potential violation of patient rights on an Inpatient Unit via the grievance process when it was reported to Patient Relations that Patient #3 was physically restrained with a waist restraint tied to the bed and without a physician's order.

A Patient Complaint filed with the Massachusetts Department of Public Health, dated 7/29/2020, indicated Patient #3's Family Members witnessed Patient #3 tied to the bed in a waist restraint on 7/21/2020 from approximately 4:20 P.M. until 6:00 P.M. The Patient Complaint indicated that:

- Registered Nurse #1 said Patient #3 kept trying to get out of bed and they did not have the staffing to address Patient #3's behavior.

- When Patient #3's second Family Member arrived, the Family Member insisted the restraint be removed and the Family Member walked Patient #3 in the hallway.

- Family Members said Registered Nurse #1 did not know Patient #3 was ambulatory. The Patient Complaint indicated Patient #3's Attending Physician said there was no order for restraints.

- Patient #3's Family Member called the Hospital's Patient Relations Office, on 7/21/2020, and left a telephone message with his/her name, telephone number and a verbal grievance regarding Patient #3's restraint but there was no follow up.

- Patient #3's Family Member said his/she called again on 7/22/2020 and was told by the Patient Relations Department that they had 24 hours to respond to his/her complaint.

- The Patient Relations Representative then called back Patient #3's Family Member on 7/28/2020, seven days after the initial grievance, and said the Nurse Manager would look into the grievance and the Family Member would be notified of the findings.

- There was no further communication to Patient #3's Family Member during the approximately six months since the complaint was made.

The Hospital provided no documentation of the Inpatient Unit Schedule for Patient Assignments, to determine if Registered Nurse #1 was assigned to care for Patient #3 on 7/21/2020 or was assigned as the Charge Nurse.

Admission History and Physical Record, dated 7/18/2020, indicated Patient #3 was admitted with alcohol intoxication with withdrawal symptoms, was admitted to an inpatient unit for acute withdrawal.

During an interview on 1/5/2021 at 5:15 P.M., Registered Nurse #1 said she did work on Patient #3's Inpatient Unit on 7/21/2020 from 7:00 A.M. to 7:00 P.M. Registered Nurse #1 said she did not recall if Patient #3 was in her patient assignment or if Patient #3 was in a waist restraint, or that Patient #3's Family Members complained regarding Patient #3 being in an unnecessary restraint.

Review of the Patient Grievance Log for July 2020 to September 2020 indicated there was not a documented grievance for Patient #3's complaint.

During an interview on 1/6/2021 at 9:47 A.M. with the Director of Patient Relations, indicated there was no documented grievance from Patient #3's Family Member and he did not recall any conversation or complaint from Patient #3's Family Member.

Review of the telephone message notebook, documented by the Patient Relations Coordinator, was a written telephone message, dated 7/27/2020 at 10:47 A.M., that indicated Patient #3's Family Member had called last week and was told that the Patient Relations Department would get back to her and no one had called her back.

The Hospital provided no documentation to indicate there was a follow up to Patient #3's Family Members' complaint, nor a Hospital analysis of neither the investigation nor the resolution. Patient #3's restraint complaint on an inpatient unit was not recorded in the Hospital's electronic Patient Complaint & Grievance system for tracking, resolution or analysis of the complaint.

4.) Regarding Patient #6:

The Hospital failed to ensure for Patient #6, in Outpatient Services, that Registered Nurse #1 recognized and reported the signs and symptoms of a stroke (a medical emergency when there is an insufficient blood supply to the brain) and failed to respond emergently to facilitate the Emergency Medical Services.

The Physician's Emergency Medicine Note, dated 9/11/2020 and timed at 1:05 P.M., indicated Patient #6 had a mental status change, was brought in by his family after Patient #6 was found unresponsive. Diagnoses included dementia and a previous stroke, was unstable and was admitted to the Intensive Care Unit.

The Discharge Summary, dated 9/16/2020, indicated Patient #6's imaging study showed an acute cerebral vascular accident (a stroke). Patient #6 was made comfort care and Patient #6 died on 9/16/2020.

The Hospital provided no documentation to indicate their internal investigation identified who was responsible for the initial clinical assessment of Patient #6's stroke symptoms (complaint of left sided throbbing and numbness as possible symptoms) and for requesting a healthcare provider to call Patient #3, as Patient #3 had requested.

The Hospital failed to ensure implementation of a standard of practice for identification of cerebral vascular accident symptoms (stroke) and with the timeliness of interventions.

During an interview at 9:10 A.M. on 1/8/2021, the Vice President of Neurology said the acronym FAST from the American Stroke Association is beneficial with detection for the warning signs of a stroke. The letters stand for; F - facial drooping, A- arm weakness, S - speech difficulties and T- time to call emergency services. The Vice President of Neurology said the Hospital should send patients with stroke symptoms to a Healthcare Provider (the ED) to be readily addressed (evaluated and treated as necessary).

During an interview on 1/7/2021 at 3:40 P.M., Registered Nurse #1 said Patient # 6 notified the Contact Center via telephone on 9/10/2020 at 9:00 A.M., and spoke to the Medical Assistant, who forwarded Patient #6's complaint and need for a medication refill to Patient #6's prescription Refill Nurse (Registered Nurse #1). Registered Nursed #1 sent a high priority electronic message on 9/10/2020 at 9:28 A.M. to the Physician #1 and to the Outpatient Triage Nurse. This message included the narcotic refill history request (seven lines of repetitive information with dates, in small print) and then in larger print on line ten, stating that Patient #6 complained of left sided throbbing and numbness and to please contact Patient #6 to triage these signs and symptoms. Registered Nurse #1 said she did not call the Physician.

During an interview on 1/8/2021 at 8:48 A.M., Physician #1 said at the Outpatient Clinic all the physicians were on leave and covering their own patients off site. Physician #1 said she partially read this message on 9/10/2020 at 12:03 P.M., she was on vacation and checked her messages, and did not read line ten related to Patient #6's symptoms of left sided throbbing and numbness. Patient #6's medications were refilled.

During an interview on 1/7/2021 at 1:10 P.M., Registered Nurse #5 said that the Triage Nurse and the Primary Care Physician only partially read the message and did not see that Patient #6 had the signs and symptoms consistent with a stroke, or that he/she wanted to be called back by a Healthcare Provider, which did not occur. Neither the Primary Care Physician nor the Triage Nurse were aware that Patient #6 had symptoms of a stroke on 9/10/2020, until after he/she was admitted to the Hospital Emergency Department on 9/11/2020 at 1:00 P.M. (greater than 28 hours later) after being found down and unresponsive with a diagnosis of an acute stroke.

The Hospital failed to effectively communicate an emergent message directly and effectively to the Physician and the Triage Nurse and to follow up appropriately.

Review of the Hospital's Quality Committee Minutes, dated 12/14/2020, indicated a root cause analysis (RCA, Hospital investigation) was performed.

The Hospital investigation, dated 9/25/2020, failed to identify the following contributing factors:

- Registered Nurse #1 did not recognize the signs and symptoms of a possible vascular accident (stroke).

-Registered Nurse #1 did not call Patient #6 to elicit a more specific history of the location of the left sided throbbing and numbness nor the onset and duration in a patient with a previous stroke and significant cardiovascular history.

- Registered Nurse #1 did not effectively communicate with the Physician and the Triage Nurse.

-The Primary Care Physician and the Triage Nurse did not completely read the email.

- No licensed staff called nor spoke with Patient #6 on 9/10/2020 after his/his symptoms, were potentially consistent with a stroke. There was no follow up communication with the Primary Care Physician and the Triage Nurse to ensure they received and were aware of the contents of the electronic message. There was no documented verification that Patient #6 was called by a healthcare provider as Patient #6 requested for the evaluation of left sided numbness and throbbing.

- There were no emergency and failure mode responses to be planned or tested (corrective actions implemented and monitored for effectiveness) because the Hospital failed to identify the initial (root) cause of the event.

- Educational needs: During an interview on 1/7/2021 at 3:40 P.M., Registered Nurse #1 did not know the window of opportunity for thrombolytics (a clot buster medication to reverse a thrombotic (clot) event), in the event of a patient having symptoms of a stroke.

- There was no in-service training provided to Registered Nurse #1 regarding signs and symptoms of a stroke over four months after this event, to reduce the risk of similar events in the future.

- During an interview on 1/7/2021 at 3:10 P.M., Medical Assistant #1 said the incoming patient calls to the Control Center are not clearly separate requests, because calls were frequently not solely to the clinical line (for clinical concerns) or the refill line (for medication refills) but often a combination of the two topics. When patients have long wait times on the clinical line, often patients call the medication refill line. In addition, other patients similar to Patient #6's circumstance may have dementia and therefore have difficulty navigating these calls to the correct line in the Control Center.

The Hospital investigation documented that the following were not contributing factors, when they were contributing factors:

- There were no human factors relevant to the outcome.

- Staff performance during the event meets expectations.

- There were no emergency and failure mode responses to be planned tested.

- In-service training or orientation did not need to be revised to reduce the risk of such events in the future.

The Hospital failed to ensure immediate preventable and effective actions were immediately implemented to recognize and identify corrective actions for stroke patients during the past four months.

Based on records reviewed and interviews the Hospital failed to ensure for six patients (Patients #1, #3, #5, #6, #7, & #10) in a sample of ten patients reviewed, the Hospital-wide quality assessment and performance improvement efforts (including Medical Staffs) addressed priorities for improved quality of care and patient safety and that improvement actions were evaluated.

Findings included:

1.) The Hospital failed to ensure for two patients (Patients #3 and #7) Hospital-wide quality assessment and performance improvement efforts regarding Patient Rights were addressed and established a process of resolution of patient grievances.

Regarding Patient #3:

The Hospital failed to ensure that there was an effective and timely process for patient and family complaints.

The Hospital failed to investigate the usage of a physical restraint to ensure that physical restraints were not used without a physician's order, that patient's ambulatory function was maintained, and that the restraints were not used out of convenience due to inadequate staffing.

The Hospital provided no documentation to indicate there was a follow-up to Patient #3's Family Members complaint, nor a hospital analysis of the investigation nor resolution. Patient #3's restraint complaint on an inpatient unit and was not recorded in the Hospital's electronic Patient Complaint & Grievance system for tracking and resolution of the complaint.

Regarding Patient #7:

The Hospital provided no documentation to indicate Patient #7's Mother's complaint regarding changing Patient #7's tracheostomy tube in the ED was recorded in the Hospital's electronic Patient Complaint & Grievance system for tracking and resolution of complaints.

2.) The Hospital failed for four patients (Patients #1, #3, #6, & #7) to ensure Hospital-wide quality assessment and performance improvement efforts Regarding Quality Assessment and Performance Improvement (QAPI) activities were addressed.

Regarding Patient #1:

The Hospital failed to ensure that Patient #1's adverse patient event (death) was thoroughly analyzed.

During an interview, at 9:14 A.M. on 1/6/2021, the Obstetric Chairperson said the Hospital investigation did not analyze Patient #1's pain management. The Obstetric Chairperson said that the Hospital investigation did not consult with Pharmacy Services to analyze the medications and medication doses administered to Patient #1.

Regarding Patient #6:

The Hospital failed to recognize the signs and symptoms of a stroke and have adequate Primary Care Physician coverage for the patients in the Outpatient Clinic.

The Hospital failed to evaluate the call volume at the Call Center for the clinical symptom telephone line to assess if there were an adequate number of Registered Nurses available for patients' clinical complaints.

The Hospital failed recognize, identify and implement immediate corrective actions regarding a travesty in communication resulting in Patient #6's delay in treatment and subsequent stroke preceding his/her death.

The Hospital failed to provide documentation that Patient #6's adverse patient event (stroke) was thoroughly investigated, and corrective actions were implemented in Out-Patient Services to prevent similar events. The scope of the Hospital investigation did not include the competency of licensed staff for assessing stroke symptoms, the adequacy of medical staffing schedules and evaluation of the Call Center's clinical symptom line, to determine if the patient call volume, wait times and staffing meet the patient needs to address telephone call backs for timely and accurate assessments.

Regarding Patient #7:

The Hospital failed to ensure that Patient #7's medically complicated pediatric patient specialized care needs were available to Emergence Department (ED) Providers upon Patient #7's presentation to the Emergency Department. The Hospital provided no documentation to indicate communication between the Pediatric Medical Staff and the Emergency Department Medical Staff regarding Patient #7's medically complicated pediatric patient specialized care needs.

3.) The Hospital failed to ensure for two patients (Patients #5 and #10) Hospital-wide quality assessment, performance improvement (including Medical Staff) efforts addressed care provided by Crisis Clinicians of the Behavioral Health Network Contracted Service as determined eligible (by the Medical Staff) for privileges granted by the Governing Body to provide care (psychiatric evaluations) for psychiatric patients in the Emergency Department (ED).

The Hospital provided no documentation to indicate the Medical Staff evaluated through its credentialing and privileging system competency review that the Crisis Clinicians as non-physician practitioners and were eligible for privileges; to provide Psychiatric Evaluations consistent with State law, including Scope of Practice laws and as specified in the Medical Staff Bylaws, Rules, and Regulations; to take advantage of the expertise and skills of practitioners (the Crisis Clinicians) to furnish care (psychiatric evaluations) to Hospital patients, when making recommendations and decisions.

Refer to TAG: A-0338, Medical Staff

The Medical Staff Condition of Participation was out of compliance.

Findings included:

The Hospital Medial Staff failed to ensure for two patients (Patient #5 & #10) in a sample of ten patients reviewed, that non-physician practitioners (Crisis Clinicians) were determined eligible (by the Medical Staff) for privileges granted by the Governing Body to provide care (psychiatric evaluations) for psychiatric patients in the Emergency Department (ED).

Refer to TAG: A-0339.

Based on records reviewed and interviews the Hospital Medial Staff failed to ensure for two patients (Patient #5 & #10) in a sample of 10 patients, that non-physician practitioners (Crisis Clinicians) were determined eligible (by the Medical Staff) for privileges granted by the Governing Body to provide psychiatric evaluations to psychiatric patients in the Emergency Department (ED).

Findings included:

Regarding Patient #10:

The Emergency Medicine Note, dated 1/4/2021, indicated Patient #10 presented with depression, suicide risk, hallucination, and psychosis. The Emergency Medicine Note indicated that a Physician medically cleared Patient #10 for further psychiatric evaluation and the Physician referred Patient #10 to BHN Crisis.

The document titled ESP-BHN Details (ESP, Emergency Service Program), dated 1/5/2021, indicated a psychiatric evaluation conducted by Crisis Clinician #1. The psychiatric evaluation indicated that it was Crisis Clinician #1's clinical opinion that Patient #10 would benefit from an inpatient admission for safety and containment, medication evaluation, mood stabilization, coping skills and further diagnostic clarification. The psychiatric evaluation indicated a signature to represent Crisis Clinician #1 completed the psychiatric evaluation.

The Medical Staff Bylaws, dated 11/13/2018, indicated Associate Professional Staff were organized and governed in accordance with the Associate Professional Staff Rules and Regulations.

The Associate Professional Staff Rules and Regulations, dated 5/13/2019, indicated Associate Professional Staff (non-physician practitioners) were health care professionals other than members of the Medical Staff who were qualified to practice within an established category of the Associate Professional Staff. The Associate Professional Staff Rules and Regulations indicated Associate Professional Staff had recognized but limited scope of practice within medicine, were licensed or certified to provide services independently. The Associate Professional Staff Rules and Regulations indicated Associate Professional Staff requested application for membership within an established category of the Associate Professional Staff, for evaluation by the Credentials Committee and recommendation of the Medical Staff Executive Committee, for appointment granted by the Board of Trustees (Governing Body) for clinical privileges to the Associate Professional Staff. The Associate Professional Staff Rules and Regulations indicated no indication Crisis Clinicians were within an established category of the Associate Professional Staff (as non-physician practitioners).

The document titled Services Agreement, dated 4/1/2014 indicated a contracted service between the Hospital and the Behavioral Health Network for behavioral health services. The Services Agreement indicated that the BHN (Behavioral Health Network) provided face-to-face assessment (evaluation) of the patient's level of functioning and risk of patients for whom a consultation was requested. The assessment included: past and present behavioral health concerns (including substance abuse, precipitating events to the current problems, behavioral status evaluation, current medical and psychiatric services, including current psychiatric medications, level of risk determination, clinical impressions and recommendations, and outcome plan.

During an interview, at 4:00 P.M. on 1/5/2021, the Behavioral Health Clinical Coordinator for the ED said an ED Physicians medically cleared (determined that a patient's behavior was not due to a medical condition) for Crisis Clinicians (non-physician practitioners) from the Behavioral Health Network. The Behavioral Health Clinical Coordinator said the Behavioral Health Network was a Service Contracted (Service Contract) to provide psychiatric risk evaluation, identify disposition (patient required inpatient hospitalization or outpatient care and treatment) and collaborated with the ED Physician for the patient's final disposition.

During the interview, at 4:00 P.M. on 1/5/2021, the Performance Improvement Director said that the Crisis Clinicians were not credentialed through the Medical Staff (that was the Crisis Clinicians were not determined eligible for privileges granted by the Governing Body to provide psychiatric evaluations for psychiatric patients in the ED).

During an interview, at 10:00 A.M. on 1/6/2021, the Chair Emergency Medicine said the primary responsibility of the Crisis Clinicians was to make recommendations (to the ED Physician) regarding the psychiatric patient's disposition (that is, for inpatient hospitalization or outpatient care).

During an interview, at 1:45 P.M. on 1/6/2021, with the Chief Regulatory Officer and the Performance Improvement Director, the Chief Regulatory Officer said the Crisis Clinicians were consultants to the ED Physicians. The Chief Regulatory Officer said the Crisis Clinicians did not fit into a category (as defined in the Hospital Medical Staff Bylaws). The Chief Regulatory Officer said credentialing was delegated to the Behavioral Health Network (the Contracted Service) and that the Hospital did not maintain personnel files.

During an interview, at 4:00 P.M. on 1/6/2021, with the Senior Vice President, Chief Legal Counsel, and the Chief Medical Officer. The Senior Vice President, Chief Legal Counsel said that the Hospital relied on the Behavioral Health Network contracted service to credential the Crisis Clinicians. The Senior Vice President, Chief Legal Council said that the Hospital made the decision that the Crisis Clinicians would not go through the Medical Staff because the Crisis Clinicians were not practicing independently.

During an interview, at 1:30 P.M. on 1/7/2021, the Behavioral Health Network Crisis Team Administrator said the Behavioral Health Network Job Description was described the role of Crisis Clinicians.

Crisis Clinician #1's Personnel File indicated Crisis Clinician #1 was a Social Worker. The Personnel File included the document titled Behavioral Health Network Job Description, dated 11/2016, indicated job performance for Youth-Adult Crisis Clinicians included
Performance of a comprehensive evaluation, including mental status and level of risk, and based on evaluation, determined, and implemented an appropriate treatment-referral.

Regarding Patient #5:

The Emergency Note, dated 9/10/2020, indicated Patient #5 was sectioned 12 (an involuntary psychiatric evaluation) for suicide ideation with a recent suicide attempt by drinking Benadryl (a medication for sleep). Patient #5 had worsening symptoms of of depression, anxiety and auditory hallucinations and diagnosed with a major depressive disorder with psychotic features. The Emergency Medicine Note indicated that a Physician medically cleared Patient #5 for further psychiatric evaluation to BHN Crisis.

Crisis Clinician #2's Personnel File indicated Crisis Clinician #2 was an Early Intervention Specialist with a master's degree in Arts. The Personnel File included a Certificate for completion of the concentration in Cognitive-Behavioral Therapy, dated 2006, and a Certificate for completion of the concentration in Child and Family Therapy.

The Hospital provided no documentation to indicate the Medical Staff evaluated through its credentialing and privileging system competency review that Crisis Clinicians as non-physician practitioners and were eligible for privileges; to provide Psychiatric Evaluations consistent with State law, including Scope of Practice laws and as specified in the Medical Staff Bylaws, Rules, and Regulations; to take advantage of the expertise and skills of practitioners (the Crisis Clinicians) to furnish care (psychiatric evaluations) to Hospital patients, when making recommendations and decisions.

The Emergency Services Condition of Participation was out of compliance.

Findings included:

The Hospital failed to ensue for two patients (Patient #5 and Patient #10) in a sample of ten patients that the Emergency Department Medical Staff was responsible for the assessment of care provided to Emergency Department Patients and based on the ongoing monitoring conducted by the Medical Staff, Emergency Department Medical Staff and Quality Assessment and Performance Improvement activities.

Refer to TAG: A-1104

Based on records reviewed and interviews the Hospital failed to ensue for two patients (Patient #5 and Patient #10) in a sample of ten patients that the Emergency Department Medical Staff was responsible for the assessment of care provided to Emergency Department Patients and based on the ongoing monitoring conducted by the Medical Staff, Emergency Department Medical Staff and Quality Assessment and Performance Improvement activities.

Findings included:

Regarding Patient #10:

The Emergency Medicine Note, dated 1/4/2021, indicated Patient #10 presented with depression, suicide risk, hallucination, and psychosis. The Emergency Medicine Note indicated that a Physician medically cleared Patient #10 for further psychiatric evaluation and the Physician referred Patient #10 to BHN Crisis.

The document titled ESP-BHN Details (ESP, Emergency Service Program), dated 1/5/2021, indicated a psychiatric evaluation conducted by Crisis Clinician #1. The psychiatric evaluation indicated that it was Crisis Clinician #1's clinical opinion that Patient #10 would benefit from an inpatient admission.

During an interview, at 10:00 A.M. on 1/6/2021, the Chair Emergency Medicine said the primary responsibility of the Crisis Clinicians was to make recommendations (to the ED Physician) regarding the psychiatric patient's disposition (that is, for inpatient hospitalization or outpatient care).

The Hospital provided no documentation to indicate the Medical Staff evaluated through its credentialing and privileging system competency review that the Crisis Clinicians as non-physician practitioners and were eligible for privileges; to provide Psychiatric Evaluations consistent with State law, including Scope of Practice laws and as specified in the Medical Staff Bylaws, Rules, and Regulations; to take advantage of the expertise and skills of practitioners (the Crisis Clinicians) to furnish care (psychiatric evaluations) to Hospital patients, when making recommendations and decisions


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Regarding Patient #5:

The Emergency Note, dated 9/10/2020, indicated Patient #5 was sectioned 12 (an involuntary psychiatric evaluation) for suicide ideation with a recent suicide attempt by drinking Benadryl (a medication for sleep). Patient #5 had worsening symptoms of of depression, anxiety and auditory hallucinations and diagnosed with a major depressive disorder with psychotic features. The Emergency Medicine Note indicated that a Physician medically cleared Patient #5 for further psychiatric evaluation to BHN Crisis.

Crisis Clinician #2's Personnel File indicated Crisis Clinician #2 was an Early Intervention Specialist with a master's degree in Arts. The Personnel File included a Certificate for completion of the concentration in Cognitive-Behavioral Therapy, dated 2006, and a Certificate for completion of the concentration in Child and Family Therapy.
The document titled ESP - BHN, dated 9/10/2020.

The document titled ESP- BHN Details, dated 9/10/2020, indicated a psychiatric evaluation was conducted by Clinician #2. The psychiatric evaluation indicated that it was Crisis #2's opinion that Patient #5 would benefit from and inpatient psychiatric admission.

The Hospital provided no documentation to indicate the Medical Staff evaluated through its credentialing and privileging system competency review that the Crisis Clinicians as non-physician practitioners and were eligible for privileges; to provide Psychiatric Evaluations consistent with State law, including Scope of Practice laws and as specified in the Medical Staff Bylaws, Rules, and Regulations; to take advantage of the expertise and skills of practitioners (the Crisis Clinicians) to furnish care (psychiatric evaluations) to Hospital patients, when making recommendations and decisions.