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Based on records reviewed and interviews the Hospital failed to ensure the Condition of Participation for Radiologic Services was met.

Findings included:

1.) Based on records reviewed and interviews the Hospital failed to ensure Radiologic Services provided Radiologic Services in accordance with approved standards for safety (i.e., patient care quality).

Refer to TAG: A-0535.

Based on records reviewed and interviews the Hospital failed for seven patients (Patients #6, #7, #8, #9, #10 & Unsampled Patients #1 & #2) to ensure Radiologic Services provided Radiologic Services in accordance with approved standards for safety (i.e., patient care quality).

Findings included:

A.) Regarding Patient #6's Adverse Patient Event

The Hospital Report, dated 01/28/2022, indicated an outside Provider ordered Patient #6 for a DEXA scan (Dual-Energy X-ray Absorptiometry, bone strength and density x-ray to diagnose osteoporosis). Clerical staff scanned into Patient #6's chart another patient's order for "an image guided right shoulder intra-articular injection". Patient #6 was consented to and underwent a fluorographic guided right shoulder arthrogram (that is: image guided right shoulder intra-articular injection intended for the other patient) with mixed anesthetic (pain medication) and steroid (a medication) injection. Patient #6 did not sustain any serious injury from the incorrect procedure.

B.) Regarding Quality Assessment and Performance Improvement activities:

The Medical Staff By-Laws titled The Staff of Beth Israel Deaconess Hospital Milton, Massachusetts, dated 12/6/2021, indicated a list of Departments that included the Radiology Department. The Medical Staff By-Laws indicated functions of Department Chiefs (a physician) to include the integration of the (Radiology) Department into the primary functions of the Hospital (Quality Assessment and Performance Improvement Program, QAPI) and participate in every phase of administration of the (Radiology) Department with Hospital administration in matters affecting patient care, including personnel, coordinate and integrate interdepartmental and intradepartmental services and communication (i.e., with the Hospital QAPI Program).

The Agreement titled Integrated Radiology Services, dated 1/1/2017, indicated a contracted service for Radiologic Services between the Hospital and Beth Israel Medical Center. The Contract indicated the Chief (a physician) of Radiology at the Hospital held responsibilities to quality performance at the Hospital.

The Quality Assessment Performance Improvement Plan (QAPI) FY 2022, dated 10/27/2021, indicated the Medical Staff Quality Improvement Committee was responsible for review of Radiology Departmental quality reports. The QAPI Plan indicated the Quality Patient Experience Care Assessment Committee (QPECAC, a Governing Body level committee) was responsible for the programs, policies, and procedures that support quality and safety. The QAPI Plan indicated the QPECAC reviewed for trends and performance improvement activities of individual departments.

The Hospital policy titled Adverse Event Reporting, dated at 10/2021, indicated a process for analyzing patient events. The Adverse Event Reporting policy indicated the Director, Healthcare Quality & Patient Safety (or his/her designee) in collaboration with appropriate Department Leaders would monitor the event process from initial reporting and follow-up resolution. The Adverse Event Reporting policy indicated the Healthcare Quality Department would work with managers, supervisors to ensure quality issues were addressed and that required corrective actions were identified and carried out.

The Hospital Report, dated 02/27/2022 regarding Patient #6, indicated a Hospital investigation that discovered the Providers (Radiologist) assumed the order was correct.

Meeting Minutes, Medical Staff quality Improvement Committee, dated 3/4/2022, indicated Patient #6's wrong procedure event as informational with a corrective action that included Information Technology and Radiology Services investigating options for transitioning from faxed orders to electronic ordering.

The Meeting Minutes of the Quality & Patient Experience Care Assessment Committee (QPECAC), dated 3/23/2022, indicated the Hospital had multiple processes for ordering Radiology Services. The Meeting Minutes indicated the Director of Radiology and Director of Information Systems responsible to investigate opportunities for providers currently faxing, to transition to electronic entry, with a timeline of 3/31/2022 for completion. The Meeting Minutes indicated the status as in process, and no evidence of completion.

The E-mail, dated 3/31/2022 from the Quality Department to Radiology Services, indicated a request for Radiology Services to provide five providers who were ordering imaging by fax. The E-mail contained an attachment of appropriately 1200 ordering providers.

The Memorandum, dated 9/6/2022, indicated evaluation of ordering providers (for Radiologic Services) was in ongoing discussion with the Chief Medical Information Officer to improve the receipt and efficiency of orders but an electronic interface was not feasible.

During the interview at 10:00 A.M. on 9/7/2022, the Radiology Director said orders for Radiology services come to the Hospital via fax in forms as handwritten, on prescriptions, in forms developed by the specific Primary Care Provider from different computer systems, some were self-designed forms and they all look different. The Radiology Director said Radiology Services with the Chief Medical Information Officer regarding faxed orders for Radiology Services was an ongoing discussion for several years.

During the interview at 10:00 A.M. on 9/7/2022, the Radiology Chief said that he performed the procedure and did not look at the orders. The Radiology Chief said that the four (Radiologists) in the group discussed looking at orders however no decision was reached.

The Hospital web-site, https://www.bidmilton.org/assets/Uploads/Radiology/Radiology-Requisition-rev.pdf, dated Copyright © 2022 and reviewed on 9/20/2022 indicated instructions for Medical Professionals to refer a patient for a Radiology examination to complete the Radiology Request Form and fax to 617-313-1555. The Radiology Requisition (Radiology Request Form) indicated a standardized form to request Radiology Services.

The Radiology Department provided no documentation to indicate:

-safety and QAPI activities regarding corrective action(s) or complete follow-up resolution about Radiologists (physicians) verifying the Radiologic order in accordance with the Hospital Adverse Event Reporting Policy, Hospital QAPI Plan or Medical Staff By-Laws,

-Radiology Services follow-up to requests from the Quality Department for the request for Radiology Services to provide five providers who were ordering imaging by fax.

-analysis for the implementation of the Radiology Requisition as indicated in the Hospital website as a standardized faxed order sheet for Radiology Services as a feasible immediate corrective action prior to computerized, electronic implementation.

C.) Regarding QAPI and wrong procedures, Patient #7 & #8:

The Hospital Report, dated 8/2/2022 through 9/1/2022, indicated Patient #7 did not need a head Computerized Tomography (CT) Scan and had radiation exposure that was unrequired (unnecessary). The Report indicated Patient #7 was cared for in Room # (de-identified however the same # as Patient #8's Hallway #).

The Hospital Report, dated 8/2/2022 through 9/1/2022, indicated Patient #8 fell, hit his/her head, was on anticoagulation medication and was ordered for a head Computerized Tomography (CT) Scan on 8/28/2022. The head CT revealed that Patient #8 did not have a head bleed however the CT showed Patient #8 had a craniotomy (brain surgery) and Patient #8 never had brain surgery. The Report indicated Patient #8 was cared for in Hallway # (de-identified however the same # has Patient #7's Room #). The Report indicated the case remained open.

The Hospital provided no immediate corrective action regarding analysis of Radiology Services procedures with Emergency Department Services or evaluation of Hallway # and Room # assignments.

D.) Regarding Patient #7's incomplete medical record:

The Hospital (By-Laws) Rules of the (Medical) Staff, dated 12/6/2021, indicated it was the Attending Practitioner's responsibility for a complete medical record. The Rules of the Staff indicated a physician progress note was required for any event and must be written.

The Hospital policy titled Adverse Event Reporting, dated at 10/2021, indicated an account of the event must be documented in the Patient's medical record as well as actions taken as a result of the event.

Patient #7's medical record indicated no documentation regarding an incorrect Radiologic procedure in accordance with the Hospital policy titled Rules of the Staff.

E.) Radiology & Ultrasound Services regarding Patients #9 & #10:

The Report, dated 1/1/2022 through 9/1/2022, indicated two patients (Patient #9 & #10) where ultrasound services were unavailable (ordered after hours and unavailable).

The ED Physician Report, dated 7/2/2022, indicated a Physician's concern for Patient #9 having an ectopic pregnancy, no trans-abdominal ultrasound was available, and Patient #9 was transferred.

The ED Physician Report, dated 6/15/2022, indicated a Physician's concerns for Patient #10
having an ovarian cyst versus (ovarian) torsion (the ovary or fallopian tubes twist on the tissues that support them causing severe pelvic pain; surgery is the only way to treat ovarian torsion) and a transvaginal ultrasound was not available at this time and planned to transfer the Patient #10.

During the interview, at 4:00 P.M. on 9/8/2022, the Radiology Chief said he did not know who was tracking patient needs for ultrasounds after hours.

E.) Regarding Unsampled Patients #1 & #2.

The Report, dated 6/14/2022, indicated two patients (Unsampled Patients #1 & #2); Radiology Services performed an ultrasound on Patient #1 and the ultrasound was ordered for Unsampled Patient #2.

The Hospital did not demonstrate Radiology Services were thoroughly integrated with the Emergency Department and the Hospital's Healthcare Quality & Patient Safety Department to implement effective quality and safety activities (that is: Radiology Services did not demonstrate closed-loop quality management, connecting quality process or performance from one area to another including incorporating feed-back processes).

Based on records reviewed and interviews the Hospital failed to ensure the Condition of Participation for Emergency Services was met.

Findings included:

The Hospital failed to ensure Emergency Services provided psychiatric patients with an appropriate Medical Screening Examination, to determine if a Psychiatric Emergency Medical Condition existed; conducted by a Qualified Medical Personnel (QMP) who the Hospital determined qualified by Hospital by-laws or rules and regulations; and within the scope of practice of the Crisis Clinician.

Refer to TAG: A-1112.

Based on records reviewed and interviews the Hospital failed for three patients (Patients #2, #3, & #5) of ten patients sampled, to ensure Emergency Services provided psychiatric patients with an appropriate medical screening examination, to determine if a psychiatric emergency condition existed; conducted by Qualified Medical Personnel (QMP) who the Hospital determined qualified by Hospital By-Laws, Medical Staff Policy; and within the scope of practice of the individual Crisis Clinician.

Findings included:

The Medical Staff By-Laws titled The Staff of Beth Israel Deaconess Hospital Milton, Massachusetts, dated at 12/6/2021, indicated a list of Departments that included the Emergency Department. The Medical Staff By-Laws indicated functions of Department Chiefs (a physician) to include:

-Promoting compliance with the Emergency Medical Treatment and Active Labor Act by promoting policies and procedures which outlines physician responsibility for an appropriate (psychiatric) medical screening examination and

-Recommending to the Credentials Committee the criteria for requesting clinical privileges that were relevant to the care provided in the medical staff Department (Emergency Department, ED).

Medical Staff By-Laws indicated Allied Health Professionals were Psychologists, Licensed Independent Clinical Social Workers, Licensed Mental Health Clinicians, Physician Assistants, and Expanded Role Nurses were granted clinical privileges in accordance with the Hospital's Credentialing Policy. Medical Staff By-Laws indicated the Credentials Committee oversaw the granting of clinical privileges.

The Hospital policy titled Credentialing Policy for the Medical Staff and Allied Health Staff, dated at 11/2021, indicated it was the policy of the Medical Staff, Administration and the Board of Trustees to credential staff physicians and other licensed practitioners in accordance with current standards established by Board (Governing Body), Medical Executive Committee as well as in accordance with the regulations issued by the Centers for Medicare and Medicaid Services in its Conditions of Participation. The Credentialing Policy indicated the purpose of evaluation was to determine qualifications specific to privileges granted. The Credentialing Policy indicated Allied Health Professionals consisted of Psychologists, Licensed Independent Clinical Social Workers, Nurse Practitioners, Physician Assistants, Certified Registered Nurse Anesthetists and other appropriately trained and licensed health care practitioners as designated by the Board of Trustees (Governing Body), and the Medical Executive Committee, who were granted privileges to provide services for patients. The Credentialing Policy indicated failure to follow the policy could result in providers being incompletely, incorrectly or non-credentialed prior to providing care, this in turn could result in patient harm.

The Hospital policy titled Emergency Department Patient Arrival and Transfer Process, dated at 12/2021, indicated the medical screening examination shall be performed by a Physician and or Physician Assistant and or Nurse Practitioner in order to determine whether or not an emergency medical condition existed.

The Contract titled Professional Services Agreement, dated at 10/1/2017, indicated an agreement between the Hospital and South Shore Mental Health Center, Inc. The Professional Services Agreement indicated Behavioral Health Professionals, including Emergency Service Program (ESP) Crisis Clinicians performed behavioral health evaluations to determine appropriate level of care (i.e., disposition to an inpatient behavioral health unit and or crisis stabilization unit or other appropriate alternative treatment programs or sites of care). The Professional Services Agreement indicated the initial intake assessment and recommended plan of care would be completed at the time of the first visit.

During the interview and medical record review, at 10:15 A.M. on 9/8/2022, the Director of Healthcare Quality said Aspire was the Emergency Service Program (ESP) Behavioral Health Contracted Service that provided the psychiatric evaluations and recommendations to the Emergency Department Physician regarding psychiatric patients.

During the interview, at 1:00 P.M. on 9/8/2022, the Director of Healthcare Quality said the Hospital credentialed three Aspire Licensed Independent Social Workers however there were others from Aspire that Aspire credentialed. The Director of Healthcare Quality said Crisis Clinician #1 was the Hospital's primary Crisis Clinician and the Hospital did not have a credentialing nor (personnel) file (maintained in the Hospital to validate qualification to provide Emergency Department patients with a psychiatric evaluation). The Director of Healthcare Quality said the Director of Case Management, a Social Worker, oversaw the Aspire Contract. The Director of Healthcare Quality said South Shore Mental Health had changed to Aspire and the Hospital did not have a Contract with Aspire.

During the interview, at 2:30 P.M. on 9/8/2022, the Nurse Director of the Emergency Department said Aspire provided the psychiatric evaluations screening examinations.

Regarding Patients #2, #3, & #5.

Patient #2:

The History & Physical, dated at 5:38 P.M. on 8/6/2020, indicated the ED Physician's clinical impression was Patient #2 had chronic schizophrenia, disorganized behavior and behavioral problem(s). The H&P indicated Patient #2 was well known to Aspire.

The Social Work (SW) Progress Notes, dated 8/8/2022 & 8/10/2022 indicated Crisis Clinician #1 authenticated (signed) the SW Progress notes. The Signatures did not indicate Crisis Clinician #1's qualification(s).

The ED Physician Report, dated at 7:00 on 8/10/2022, indicated Patient #2 was medically cleared (a physician determination made with reasonable medical certainty, that a patient's behaviors, signs or symptoms were related to a psychiatric condition and not a medical or surgical condition), evaluated by the Aspire team and found to meet criteria for inpatient psychiatric care.

The Behavioral Health Care Plan, dated at (untimed) on 8/11/2022, indicated Crisis Clinician #1 developed and authenticated (signed) the Behavioral Health Care Plans as an Aspire Clinician. The Signatures did not indicate Crisis Clinician #1's degree or licensure [as qualification(s)].

Patient #3.

The Emergency Department Physician Report, dated at 9:28 A.M. on 6/11/2022, indicated Patient #3 reported chronic depression, suicidal thoughts and a moderate plan to overdose on illicit substances; the psychological examination included that Patient #3's mood and affect were normal with normal memory and judgement; medical decision making included consultation with Aspire the Crisis Team following medical clearance.

The PCS (undefined) Discharge Summary, documented by Registered Nurses, indicated Patient #3's Suicide Risk Levels, dated at 7:24 A.M. on 6/11/2022 as high, and at 8:00 A.M., 12:00 P.M., 4:00 P.M., 8:00 P.M., & 12:00 A.M. on 6/11/2022 as moderate.

The Columbia Suicide Severity Rating Scale (C-SR), dated at 3:30 A.M. on 6/12/2022 indicated Patient #3's score of 20 and conducted by Crisis Clinician #2, a Licensed Mental Health Councilor (LMHC).

The Basic Clinical Scoring Guide for the C-SR, dated 2016, https://dphhs.mt.gov/assets/suicideprevention/basicscoringguideforclinicians.pdf, indicated a patient with a score of:

-Moderate (6-10) 11 times the risk of suicide,

-Mod. Severe (11-15) 13 times the risk of suicide,

-Severe (16-20) 19 times the risk of suicide, and

-Very Severe (21-25) 34 times the risk of suicide.

The Behavioral Health Care Plan, dated at 3:30 A.M. on 6/12/2022, indicated Patient #3 with a Suicide Risk Level as moderate. The Behavioral Health Care Plan indicated Crisis Clinician #3's illegible signature with the qualifications of a Licensed Mental Health Councilor (LMHC).

The Crisis Emergency Follow-Up Plan, dated at 3:30 A.M. on 6/12/2022, indicated Patient #3 with suicidal ideation and multiple plans and intent (to implement suicide), documented by Crisis Clinician #3 an LMHC with an illegible signature.

The PCS Discharge Summary, document by Registered Nurses, indicated Patient #3's Suicide Risk Levels, dated at 4:00 A.M., 8:00 A.M., 11:20 A.M., 12:00 P.M., & 4 :00 P.M. on 6/12/2022 as moderate,

The Behavioral Health Care Plan, dated at (untimed) A.M. on 6/12/2022, indicated Patient #3 with a Suicide Risk Level as Low. The Behavioral Health Care Plan indicated Crisis Clinician #1's signature without degree or licensure [qualification(s)].

The Crisis Emergency Follow-Up Plan, dated at (untimed) on 6/12/2022, indicated Patient #3 denied suicidal ideation and was able to plan for safety in the community. The Behavioral Health Care Plan indicated Crisis Clinician #4's illegible signature without degree or licensure.

The Emergency Department Physician Report, dated at 8:19 P.M. on 6/12/2022, indicated Patient #3 was cleared by behavioral health (Aspire) and discharged.

Patient #5.

The Physician Emergency Department Report, dated at 9:38 P.M. on 6/30/2022, indicated Patient #5 presented to the Hospital with anxiety, requesting evaluation by psychiatric services and was signed out (medically cleared) pending psychiatric evaluation.

The Physician Emergency Department Report, dated at 10:49 P.M. on 6/30/2022, indicated Patient #5's disposition as discharged.

The Physician Emergency Department (ED) Report, dated at 7:21 A.M. on 7/1/2022, indicated Patient #5 was seen (by Aspire) in the morning, cleared and discharged to home.

The Behavioral Health Care Plan, dated at 10:30 A.M. on 7/1/2022, indicated Crisis Clinician #5 evaluated Patient #5 with a suicide risk level as low with a plan for inpatient level-of- care. The Behavioral Health Care Plan indicated the (Aspire) Clinician must speak with a Registered Nurse (RN) face to face to confirm the patient's suicide risk level and plan following their evaluation. The Behavioral Health Care Plan did not indicate an RN signature in the space provided for an RN Signature.

The Crisis Emergency Follow-Up Plan, dated at (untimed) on 7/1/2022, indicated Crisis Clinician #5 recommended Patient #5 for inpatient level-of-care.

The Crisis Emergency Follow-Up Plan, dated at 9:15 A.M. on 7/1/2022, indicated Crisis Clinician #5 recommended Patient #5 for discharge

The ESP Adult PIF (undefined) Assessment (psychiatric examination from Aspire), dated at 5:37 P.M. on 7/1/2022, indicated ESP #5 conducted a Mental Status Examination, Risk Assessment, the Patient appeared to be at psychiatric baseline, eye contact and speech were appropriate, the patient's mood was neutral with congruent affect, thought process disorganized with some evidence of paranoia. The ESP Adult PIF Assessment indicated the Crisis Clinician #5 advised Patient #5 to follow-up with Patient #5's pervious outpatient providers and reach out to Crisis (Aspire) if necessary. The ESP Adult PIF Assessment indicated Crisis Clinician #5 identified needs and goals for treatment for Patient #5, that included medication management and coping skills. The ESP Adult PIF Assessment indicated Crisis Clinician #5 recommended partial hospitalization, urgent outpatient (care) and urgent psychopharmacology (medication).

The Hospital provided no documentation to indicate:

1.) The Hospital reviewed, others appropriately trained (Aspire Crisis Clinicians), as designated by the Board of Trustees (Governing Body) and the Medical Executive Committee, to grant privileges to provide services for patients in accordance with the Hospital policy titled Credentialing Policy for the Medical Staff and Allied Health Staff.

2.) Behavioral Health Professionals, and ESP Crisis Clinicians (with the Aspire contracted service) were granted clinical privileges to perform the initial intake assessment (psychiatric medical screening examination) nor to determine appropriate level of care (determine whether or not an emergency psychiatric condition existed) in accordance with Hospital By-Laws, or

3.) A Contract with Aspire.