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SOUTHCOAST HOSPITALS GROUP 363 HIGHLAND AVENUE FALL RIVER, MA 02720 April 13, 2021
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on records reviewed and interviews the Hospital failed for three patients (Patients #1, #2 & #3) to ensure that the Quality Assessment and Performance Improvement (QAPI) Program activities thoroughly analyzed, implemented preventative actions and mechanisms (monitor/audit) compliance and effectiveness for sustained improvement across Hospital Campuses (Campuses L, C & T) as clinically relevant.

Findings included:

The Quality Management Plan, dated 1/24/2018, indicated that the Hospital's Quality Management System included the process (activity) of auditing (monitoring) for effectiveness of corrective and Preventive Action Plans.

The Hospital Policy titled, Sentinel Event Review and Reporting, dated 11/12/2019, indicated the Quality Steering Committee was responsible for for oversight of the sentinel event process and that departmental directors and medical staff leaders were responsible for assuring improvement actions in their areas of responsibility were carried out.

1.) Regarding Patient #1:

The Hospital Report, dated 11/19/2020, indicated a Registered Nurse administered a pregnant woman Lidocaine (a medication used to numb the perineal area for surgical repair after delivery) instead of normal saline (a sterile salt and water solution used to dilute medications for intravenous administration) in error at Hospital Campus C.

During an interview, at 11:00 A.M. on 4/7/2021, Risk Manager #1 said that the Hospital investigated, and the Pharmacy Department conducted monitoring (audits) activities for dispensed and not used returns of Lidocaine to the Pharmacy.

During an interview, at 2:00 P.M. on 4/7/2021, Pharmacist #1 said that the Pharmacy did not monitor Hospital Campus L (also has a Maternity Service) for Lidocaine dispensed and not used returns of Lidocaine to the Pharmacy.

2.) Regarding Patient #2:

The Hospital Report, dated 1/14/2021, indicated approximately ten months after Patient #2 had an uncomplicated Cesarean section, Patient #2 notified the obstetric office, on 12/15/20, that she was pregnant and that she had consented for a Bilateral Tubal Ligation (a surgical procedure for female sterilization) to be done during Cesarean section ten months earlier at Hospital Campus L. The Hospital Report indicated that the Obstetrician Operative Note did not indicate that the Bilateral Tubal Ligation was performed

The Informed Consent for Medical, Surgical, and or Diagnostic Procedures, dated 12/25/20, indicated a signature to represent Patient #2 authorized Obstetrician #1 to perform a Cesarean section with Bilateral Tubal Ligation.

During interview, at 10:30 A.M. on 4/8/2021, the Chief of Obstetrics, and, at 11:45 A.M. on 4/8/2021, Risk Managers #2 & #3 said the root cause of Patient #2's adverse patient event was a failure of Hospital Staff to follow the Hospital's Universal Protocol (Time-Out policy) and scheduling (booking) procedures for Surgical procedures.

Obstetric & Gynecology Department Meeting Minutes for Hospital Campus C, dated 2/26/2021, indicated communication to the obstetric medical staff regarding the Corrective Action Plan following Patient #2's adverse patient event; however, the Obstetric & Gynecology Department Meeting Minutes for Hospital Campus L, dated 2/4/2021, indicated no communication to the obstetric medical staff regarding the Corrective Action Plan following Patient #2's adverse patient event.

The Hospital did not provide documentation to indicate Quality Assessment and Performance Improvement activities analyzed all maternity surgical booking procedures, implemented corrective actions and monitored both Hospital Campuses (L & C) that provided Maternity Services as one Hospital and as one distinct entity, following Patient #2's adverse patient event.

3.) Regarding Patient #3:

The Hospital Report, dated 1/19/2021, indicated an adolescent psychiatric patient was not discharged from the Emergency Department directly to the care of Patient #3's guardian.

During interviews, at 2:00 P.M. on 4/8/2021, Risk Managers #2 & #3, and, at 7:30 A.M. on 4/13/2021, the Associate Chief Nursing Officer, said the Hospital (Campuses L, C & T) did not conduct (QAPI activity of) monitoring (that is, to ensure that adolescent patients were properly discharged directly to the care of a parent or guardian).

The Hospital did not provide documentation to indicate Quality Assessment and Performance Improvement activities analyzed, implemented corrective actions and monitored Hospital Campuses (L, C & T) that provided Maternity Services and Emergency Services as one Hospital and as one distinct entity, following Patients #1's, #2's & #3's adverse patient events.