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

Findings included:

1.) The Hospital failed for three patients (Patients #1, #2 & #4) in a sample of eleven patients to ensure the Quality Assessment and Performance Improvement (QAPI) Program monitored the effectiveness and safety of services and quality of care following Patients #1, #2 & #4's adverse patient events.

Refer to TAG: A-0273.

2.) The Hospital failed for one patient (Patient #3) in a sample of eleven patients to ensure the QAPI Program developed, implemented and monitored a corrective action plan to reduce the severity or seriousness in communication of critical radiology findings following Patient #3's adverse patient event.

Refer to TAG: A-0283.

3.) The Hospital failed for one patient (Patient #2) to ensure QAPI Program activities were thorough following Patient #2's adverse patient event.

Refer to TAG: A-0286.

4.) The Governing Body (Hospital Executives) failed for six patients (Patients #1, #2, #3, #4, #6 & #11) in a sample of eleven patient to ensure responsibility for operations of the Hospital (an effective) and ongoing QAPI Program for quality improvement and patient safety.

Refer to TAG: A-0309.

Based on records reviewed and interviews the Hospital failed for three patients (Patients #1, #2 & #4) in a sample of eleven patients to ensure the Quality Assessment and Performance Improvement (QAPI) Program monitored the effectiveness and safety of services and quality of care following Patients #1, #2 & #4's adverse patient events.

Findings included:

Regarding Patient #1:

The Hospital Report, dated 4/12/2021, indicated Patient #1 was administered epinephrine (a medication) intravenously (into a vein) instead of intramuscular (into a muscle) for an anaphylactic (life-threatening) reaction in error, while cared for in the Emergency Department resulting in tachycardia (fast heart beat) and hypoxia (low blood oxygen level) and Patient #1 was transferred to a higher-level of care hospital.

During an interview, at 1:00 P.M. on 10/5/2021 with a Hospital QAPI Team, Emergency Department Associate Chief Nurse said staff received and email for educational information specific to anaphylaxis (life-threatening reactions). The Emergency Department Associate Chief Nurse said the Hospital did not require an attestation (documentation of proof that the Hospital educated the staff).

The Hospital provided no documentation to indicate completed education and monitoring, that improvements were sustained following Patients #1's adverse patient event.

Regarding Patient #2:

The Hospital report, dated 5/26/2021, indicated Patient #2 had an anaphylactic reaction with lip and tongue swelling; Patient #2 was administered epinephrine intravenously, in error, while being cared for on a medical-surgical unit, requiring Intensive Care Unit management for the anaphylaxis.

During an interview, at 1:00 P.M. on 10/5/2021 with a Hospital QAPI Team, Quality Staff Member #1 said the correct dose of epinephrine was not available on the medical-surgical unit; was not available in the Pyxis Machine (automated medication dispensing system) and was not available in the emergency code cart. Quality Staff Member #1 said the Hospital made available (implemented) the correct dose of epinephrine on the medical-surgical unit and all Pyxis Machines and emergency code carts in the Hospital. Quality Staff Member #1 said staff were educated at staff meetings, huddles (team meeting) and staff were involved in getting the word out (educating staff that the Pyxis Machine and emergency code cart contained the correct does of epinephrine).

The Hospital provided no documentation to indicate improvements were sustained (monitoring for effectiveness of staff education) following Patients #2's adverse patient event (the second adverse patient event involving epinephrine within one month).

Regarding Patient #4:

Hospital Federal Regulation, Condition of Participation for Surgical Services A-0945, indicated Surgical Technicians were recognized to practice as Surgical First Assistants at surgery providing the Governing Body granted such privileges based on qualifications in accordance with Federal and State laws and regulations. The Massachusetts Board of Registration in Nursing Advisory Ruling on Nursing Practice, Registered Nurses as First Assistants at Surgery, Advisory Ruling Number: 9901, indicated the Commonwealth of Massachusetts recognized Registered Nurses with documented competency in perioperative nursing practice, to practice as First Assistants at surgery, however the Commonwealth of Massachusetts does not recognize Surgical Technicians to practice as First Assistants at surgery.

The Job Description titled Surgical Technologist, undated, (appropriately) indicated no role description indicative of Surgical First Assistant duties; the Surgical Technologist Job Description (appropriately) indicate no duties approving performing closing the skin incision

The Hospital report, dated 5/5/2021, indicated a Surgical Technician was observed closing the skin incision at the end of Patient #4's surgery for a right total knee replacement.

During an interview, on 10/5/2021, Quality Staff Member #3 said the Hospital discussed at the Board Safety (the topic of surgical technicians closing Patient #4's skin incision) and that the Hospital had no meeting minutes of the Board Safety Meeting. Quality Staff Member #3 said the Hospital was not monitoring the orthopedic surgeons.

The Hospital provided no documentation to indicate monitoring of two orthopedic surgeons known to foster surgical technicians in the learning and practice of a Surgical First Assistant.

Based on records reviewed and interview the Hospital failed for one patient (Patient #3) in a sample of eleven patients to ensure the Quality Assessment and Improvement (QAPI) Program developed, implemented and monitored a corrective action plan to reduce the severity or seriousness in communication of critical radiology findings following Patient #3's adverse patient event.

Findings included:

Medical Staff By-Laws, dated 10/15/2019, indicated the Patient Care Assessment Program made recommendations to the Medical Executive Committee on improvements to Hospital systems and procedures based on root cause analyses (Hospital investigations) of sentinel events (an unexpected adverse patient event that resulted in death, permanent harm, or severe temporary harm).

The Hospital report, dated 7/19/2021, indicated a delayed medical follow-up of one-year regarding Patient #3's liver and adrenal (kidney) mass resulting in advanced size of the liver mass (a critical radiology finding). The Hospital report indicated system failures were under review, and mitigation would be put into place based upon root cause analysis (Hospital investigation).

During an interview, at 1:00 P.M. on 10/5/2021 with a Hospital Team, Quality Staff Member #3 said the Hospital was working on it and it was the goal to standardize critical radiology findings. Quality Staff Member #3 said the Hospital had not implemented yet (corrective actions) and was to start (implementing corrective actions) in November.

The Hospital provided no documentation to indicate mitigation or a corrective action plan to reduce the severity or seriousness in communication of critical radiology findings.

Based on records reviewed and interview the Hospital failed for one patient (Patients #2) to ensure Quality Assessment and Performance Improvement (QAPI) activities were thorough following the Patient #2's adverse patient event.

Findings included:

The Hospital report, dated 5/26/2021, indicated Patient #2 had an anaphylactic reaction with lip and tongue swelling; Patient #2 was administered epinephrine intravenously (in a vein instead of into a muscle), in error.

During an interview, at 1:00 P.M. on 10/5/2021 with a Hospital QAPI Team, Quality Staff Member #1 said the correct dose of epinephrine was not available on the medical-surgical unit; was not available in the Pyxis Machine (automated medication dispensing system) and was not available in the emergency code cart.

Quality Staff Member #1 said the Hospital did not know why the correct dose of epinephrine was not standardized in all Pyxis Machines and emergency code carts prior to the event (consistent with standardization of medication error prevention actions). Quality Staff Member #1 said it was possibly a space issue (standardization allows individual health care workers to learn how medications were organized in one area and to use that knowledge to find medications when working in different areas, this is important for those who regularly work in several areas, for example, on one or more patient care units, www.ismp).

The Hospital provided no documentation of a thorough investigation regarding the emergency code carts not standardized for epinephrine dose in-order to implement opportunities for improvement, following Patients #2's adverse patient event.

Based on records reviewed and interviews Governing Body (Hospital Executives) failed for six patients (Patients #1, #2, #3, #4, #6 & #11) in a sample of eleven patients to ensure responsibility for operations of the Hospital (an effective) and ongoing program for quality improvement and patient safety.

Findings included:

The document titled Cambridge Health Alliance Patient Safety and Quality Assurance Performance Plan, dated Fiscal Year 2022, indicated that the Board of Trustees (Governing Body) served as the institutions Governing Body accountable for the quality and safety of patient care.

1.) The Hospital failed for three patients (Patients #1, #2 & #4) in a sample of eleven patients to ensure the Quality Assessment and Performance Improvement (QAPI) Program monitored the effectiveness and safety of services and quality of care following Patients #1, #2 & #4's adverse patient event.

The Hospital failed for one patient (Patient #3) in a sample of eleven patients to ensure the QAPI Program developed, implemented and monitored a corrective action plan to reduce the severity or seriousness in communication of critical radiology findings following Patient #'3 adverse patient event.

The Hospital failed for one patient (Patient #2) to ensure QAPI Program activities were thorough following the Patient #2's adverse patient event.

2.) Hospital Executives failed for seven patients (Patients #1, #2, #3, #4, #6 & #11) in a sample of eleven patient to ensure responsibility for operations of the Hospital (an effective) and ongoing QAPI Program for quality improvement and patient safety.

3.) The Hospital failed to ensure for one patient (Patient #1) in a sample of eleven patients that the Director of Nursing Service (Chief Nursing Officer) provided for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the Nursing Service.

Refer to TAG: A-0398.

4.) The Hospital failed for two patients (Patients #6 & #11) in a sample of eleven patients to ensure that Emergency Services Personnel (Crisis Team Mermers) were qualified in psychiatric evaluation needs of patients cared for in the Emergency Department consistent as non-physician practitioners.

Refer to TAG: A-1100.

Based on records reviewed and interview the Hospital failed to ensure for one patient (Patient #1) in a sample of eleven patients the Director of Nursing Services (Chief Nursing Officer) provided for Registered Nurse #1's annual evaluation; as Registered Nurse #1 was involved with Patient #1's medication error.

Findings included:

1.) Nursing Services failed to ensure documentation of a current performance evaluation for Registered Nurse #1.

The Hospital Policy & Procedure titled Performance Review, dated 1/2020, indicated that each employee would participate in a performance review and an annual review would be conducted with the employee.

The Personnel File of Registered Nurse #1 indicated no documentation of a current performance evaluation and Registered Nurse #1 was working in the Emergency Department for three years.

During an interview, at 1:00 P.M. on 10/6/2021, Quality Staff #3 said that the Hospital did not have a current, for 2021, performance evaluation for Registered Nurse #1.

The Condition of Participation: Emergency Services was out of compliance.

Findings included:

The Hospital failed for two patients (Patients #6 & #11) in a sample of eleven patients to ensure that Emergency Services Personnel (Crisis Team Members) were qualified in psychiatric evaluation needs of patients cared for in the Emergency Department consistent as non-physician practitioners.

Refer to TAG: A-1112.

Based on records reviewed and interviews the Hospital failed for two patients (Patients #6 & #11) in a sample of eleven patients to ensure that Emergency Services Personnel (Crisis Team Members) were qualified in psychiatric evaluation needs of patients cared for in the Emergency Department consistent as non-physician practitioners.

Findings:

Regarding Eliot Crisis Team Members providing psychiatric evaluations:

The document titled ESP (Emergency Service Program) Services Agreement, dated 10/12/2016, indicated a contracted service between the Hospital and Eliot Community Human Services. The ESP Services Agreement indicated Eliot and the Hospital ensured care for patients who came to the Everett Hospital Campus Emergency Department in mental health or substance use crisis were properly coordinated after the Everett Hospital stabilized the patient. The ESP Services Agreement indicated once the Everett Hospital Campus Emergency Department Physician determined the appropriate disposition of the patient covered by this contract, the Physician referred to an Eliot Crisis Team Member. The Eliot Crisis Team Member would evaluate and screen the patient to determine whether the patient meets the Massachusetts Behavioral Health Partnership Contract (the Eliot Services was a contracted service of the Massachusetts Behavioral Health Partnership Contract.

During an interview, at 11:45 A.M. on 10/6/2021, the Chief Nursing Officer said that Eliot [the Emergency Service Program (ESP, a contracted psychiatric emergency service)] did psychiatric evaluations at the Everett Hospital Campus of Cambridge Health Alliance.

During an interview, at 12:20 P.M. on 10/6/2021, the Chief Medical Officer said Eliot (Eliot Crisis Team Members) were not credentialed; (in accordance with the Hospital's Medical Staff Bylaws). The Chief Medical Officer said that Eliot staff (Crisis Team Members) were credentialed by a different organization (undefined).

During an interview, at 10/30 A.M. on 10/7/2021, the Emergency Department Associate Chief Nursing Officer said the Emergency Department Provider conducted the medical screening examination and cleared (a Provider determined psychiatric symptoms were not due to medical or surgical conditions) a psychiatric patient to receive a psychiatric examination by the Psychiatric Emergency Service (ESP, Emergency Service Program). The Emergency Department Associate Chief Nursing Officer said the Everett Campus used the Eliot (ESP).

During Medical Record Review, on 10/7/2021, the Medical Records Navigator said the ESP Crisis Team Members took this information (the psychiatric evaluation) and shared the information with the Emergency Department Provider. The Medical Records Navigator said the Eliot Crisis Team Members do not go through the Medical Staff Office (that is the Eliot Crisis Team Members were not granted privileges by the Hospital Governing Body to provide Hospital patients psychiatric evaluations following recommendations of the Hospital Medical Staff in accordance with Hospital Federal Regulations as non-physician providers).

During an interview, at 10:00 A.M. on 10/8/2021, the Chief of Emergency Services said the Hospital had two Emergency Departments; Cambridge Hospital Campus utilized the B.E.S.T. ESP and the Everett Hospital Campus utilized the Eliot ESP. The Chief of Emergency Services said the Eliot Crisis Team Members were from Contracted Services and they collected information and screened for MassHealth (insurance) payment. The Chief of Emergency Services said the Emergency Department Providers were responsible for the psychiatric evaluation, completed a comprehensive history and physical examination to determine risk or not of danger and arrange to admit or discharge the patient.

During an interview, at 10:30 A.M. on 01/8/2021, Nurse Manager #1 said that either a Medical Doctor or a Physician Associate (Assistant) provided patients in psychiatric crisis with a medical screening, developed a plan and medically cleared the patient for Eliot screening. Nurse Manager #1 said the Eliot Crisis Team Member talked with the patient and had a conversation with the patient's Provider regarding risk assessment. Nurse Manager #1 said both the Eliot Crisis Team Member and the Emergency Department Provider identified the patient's needs and goals and the form (that documented Patient #11's needs and goals) was signed by the Eliot Crisis Team Member as a Licensed Mental Health Councilor.

During an interview, at 11:00 A.M. on 10/8/2021, Mental Health Counselor #1 said he was from the Eliot ESP and he saw patients after the patient was medically cleared by an Emergency Department Provider for psychiatric evaluation. Mental Health Counselor #1 said he provided the psychosocial evaluation that included an evaluation of safety concerns, suicidal ideation (thoughts), homicidal ideation and psychotic behavior. Mental Health Counselor #1 said he made recommendations for service programs, identified goals and needs, consulted with the Eliot Supervisor, and then the Emergency Department Provider to develop the most appropriate disposition of the patient, as a team.

Regarding Patient #6:

The Emergency Department (ED) Medical Decision-Making Note, dated at 2:14 P.M. on 4/1/2021, indicated Patient #6 presented to the Emergency Department with disorganized thought and suicidal statements witnessed by the police. The ED Medical Decision-Making Note indicated the Provider was unable to perform a significant examination due to Patient #6's threatening behavior. The ED Medical Decision-Making Note indicated Patient #6 was medically cleared and awaiting psychiatric evaluation.

ED Provider Note, dated at 7:53 P.M. on 4/2/2021, indicated Behavioral Health (ESP Crisis Team Member) saw Patient #6 and (ESP Crisis Team Member) would start a bed search. ED Provider Notes indicated no documentation that ensured: based on a credentialed practitioner's history and examination Patient #6 had an emergency psychiatric condition, which required insurance clearance for inpatient psychiatric hospitalization by ESP Crisis Team Members for inpatient level of care (consistent with the Chief of Emergency Department Service's interview).

ESP Eliot Crisis Team Member Note, dated 4/2/2021, indicated a Mental Status Examination and Risk Assessment; Patient #6 had suicidal ideation with a past history of suicidal ideation with a plan, impulsivity, lacking insight, and guarded. The ESP Eliot Crisis Team Member Note indicated following the Crisis Team Member's documentation of Clinical Formulation, Narrative, Medical Necessity for Further Treatment included that after consulting with Eliot Triage Supervisor and Everett ED Provider Patient #6 met criteria for inpatient admission. ESP Eliot Crisis Team Member Note indicated psychopharmacology (psychiatric medication therapy) as an Identified Need and Goal of Treatment. ESP Eliot Crisis Team Member Note, indicated a Licensed Clinical Social Worker performed Patient #6's psychiatric crisis evaluation with the documented initials of MA (undefined as possibly Massachusetts or Master of Arts degree).

Regarding Patient #11:

The ED Provider Note, dated at 5:11 P.M. on 10/6/2021, indicated a psychiatric examination that included Patient #11 was appropriate for age, time of day, and situation. The ED Provider Note ED Course and Medical Decision-Making indicated Patient #11 had assaulted a nursing assistant, had no acute medical issues and was cleared for psychiatric evaluation. The ED Provider Note Disposition indicated that disposition was pending the behavioral health evaluation.

ESP Eliot Crisis Team Member Note, dated 5:11 P.M. on 10/6/2021, indicated a Mental Status Examination and Risk Assessment of Patient #11. The ESP Eliot Crisis Team Member Note indicated the Crisis Team Member's documentation of Clinical Formulation, Narrative, Medical Necessity for Further Treatment included Patient #11 was referred to In-Patient Level of Care due to combative, assaultive behaviors, concerns for psychosis, and disposition was supported by supervisor and ED Physician. ESP Eliot Crisis Team Member Note indicated Mood Stabilization and psychopharmacology (psychiatric medication therapy) as Identified Needs and Goals of Treatment. ESP Eliot Crisis Team Member Note, indicated Inpatient Psychiatric (Care) as a Resolution, Disposition, Treatment Recommendation. ESP Eliot Crisis Team Member Note, indicated a Licensed Mental Health Counselor performed Patient #11's psychiatric crisis evaluation without the initials to identify a master's degree.

The Hospital provided to documentation to clearly indicate who provided psychiatric patients with a psychiatric examination. The Hospital provided no documentation to clearly indicate Emergency Department Providers consistently conducted the psychiatric evaluation or that Crisis Team Members were appropriately reviewed by the Medical Staff for qualifications to provide psychiatric evaluations; the Hospital provided no documentation to indicate the Medical Staff made recommendations to the Governing Body to grant Crisis Team Members, Hospital privileges to provide psychiatric evaluations to Hospital patients as non-physician providers.

Regarding monitoring the ESP Contracted Services:

During an interview, at 11:30 A.M. on 10/8/2021, the Chief Quality Officer said the Eliot Crisis Team Members were non credentialed (that is the Eliot Crisis Team Member were not granted privileges by the Hospital Governing Body to provide Hospital patients psychiatric evaluations following recommendations of the Hospital Medical Staff in accordance with Hospital Federal Regulations as non-physician providers). The Chief Quality Officer said the quality review of the (ESP) Contract was an Emergency Department Contract, done by credentialed (Emergency Department) not improvement (QAPI activities).

Meeting Minutes, dated 3/11/2021 & 6/10/2021, indicated Hospital and Eliot Quarterly Meetings. The Meeting Minutes indicated Eliot ESP Data Review that included volume, response time and disposition. The Meeting Minutes indicated an Eliot presentation of data that included: the volume had increased steadily compared to past months, feels like more due to the acuity and boarding issues, staffing issues, response time was close to three hours, looking to add an additional person on higher volume days and times. The Meeting Minutes indicated no indication of a Hospital quality review of the data presented.

The Hospital provided no documentation to indicate the ESP Contracted Services were integrated into the Hospital's QAPI program to evaluate the psychiatric services provided under contract, identify quality and performance problems, implement appropriate corrective or improvement activities, and to ensure the monitoring and sustainability of those corrective or improvement activities.