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BROCKTON, MA 02301

PATIENT SAFETY

Tag No.: A0286

Based on records reviewed and interviews the Hospital Quality Assessment & Performance Improvement (QAPI) Program failed for one patient (Patient #2) of ten sampled patients to conduct a thorough Hospital investigation and implement corrective actions and opportunities for learning after Patient #2's still birth (infant born dead).

Findings included:

The History and Physical, dated 4/28/19, indicated the Hospital admitted Patient #2 to the Hospital for deceased fetal movement and a scheduled induction of labor the following day. The History and Physical indicated Patient #2's fetus had a non-reactive (possible concern for the fetal heart rate pattern) Non-Stress Test (NST), and the Biophysical Profile (BPP, test for fetal well-being) was 8/8 (perfect score).

The Discharge Summary indicated the fetus had a sudden decrease in heart rate, an emergent Cesarean was performed for a stillborn noted to have two knots in the umbilical cord.

The Surveyor interviewed Risk Manager #1 at 1:00 P.M. on 5/22/19. Risk Manager #1 said the Hospital reviewed Patient #2's medical, obstetric care on 5/15/19. Risk Manager #1 said Maternal Fetal Medicine (experts in high-risk obstetric medical care) Physicians were available seven days a week, twenty-four hours a day and the Maternal Fetal Medicine Physicians had access to computers to review tests of fetal well-being (BPP). Risk Manager #1 said that Hospital QAPI activities had not yet identified corrective actions. Risk Manager #1 said that Hospital QAPI activities had not yet identified opportunities for improvement.

The Surveyor interviewed Registered Nurse #1 at 9:00 A.M. on 5/23/19. Registered Nurse #1 said she was concerned about Patient #2's fetal heart rate pattern and she was surprised that the test for fetal well-being was 8/8 because the fetal heart rate pattern was not reactive. Registered Nurse #1 said that the Charge Nurse had the same concerns about the fetal heart rate pattern. Registered Nurse #1 said it was unusual to report to the Nursing Supervisor because the Nursing Supervisors do not have obstetric experience and could not do anything for us. Registered Nurse #1 said no one was on-call and that the Nurse Manager was out of the country. Registered Nurse #1 said that she spoke with the Acting Nurse Manager who was on that night but did not speak with the Acting Nurse Manager during her shift. Registered Nurse #1 said the Director of Maternal Child Health implemented corrective actions that included fetal heart rate pattern review and review of the Hospital Chain of Command Policy (following Patient #2's stillbirth).

Hospital QAPI Program activities provided no clear indication that the implementation of the Director of Maternal Child Health's corrective actions that included fetal heart rate pattern reviews and review of the Hospital Chain of Command Policy were integrated into the Hospital QAPI corrective actions after Patient #2's stillbirth.

The Surveyor interviewed the Chief of Obstetrics at 11:00 A.M. on 5/23/19. The Chief of Obstetrics said all non-reassuring fetal heart rate (non-reactive, fetal heart rate patterns that show that the fetus may be experiencing distress) recordings and Biophysical Profiles would be reviewed by Maternal Fetal Medicine Physicians. The Chief of Obstetrics said that he informed providers that deliver babies of this practice change after Patient #2's stillbirth. The Chief of Obstetrics said he planned to inform two providers before their next scheduled shift.

Hospital QAPI Program activities provided no information or documentation to indicate the Hospital QAPI Program was aware of the Chief of Obstetrics expectation that all non-reassuring fetal heart rate patterns and Biophysical Profiles would be reviewed by Maternal Fetal Medicine Physicians. Hospital QAPI Program activities provided no information or documentation to indicate monitoring of the Chief of Obstetrics change in practice that all non-reassuring fetal heart rate patterns and Biophysical Profiles would be reviewed by Maternal Fetal Medicine Physicians.

The Surveyor interviewed Obstetrician #1 at 9:00 A.M. on 5/24/19. Obstetrician #1 said he was not aware that Maternal Fetal Medicine was available. Obstetrician #1 said he was aware that Maternal Fetal Medicine provided consultation.

The Surveyor interviewed Registered Nurse #2 at 9:30 A.M. on 5/24/29. Registered Nurse #2 said she did not know if the Maternal Medicine Service was to review all pregnant patients Non-Stress Test that present to the outpatient maternal service for Non-Stress Tests. Registered Nurse #2 said that the Nursing Supervisors do not always round (administrative call or visit to collect patient care concerns generally from a charge nurse) on the Maternity Unit. Registered Nurse #2 said that she did not know if the Radiology Technicians that performed Maternal Ultrasounds performed Non-Stress Tests or Biophysical Profiles correctly. Registered Nurse said Radiology Technicians move the mother side-to-side, therefore moving the baby. Registered Nurse #2 said she did not know if this fetal movement, from the gravity of maternal movement, could be misinterpreted as actual fetal movement that indicated fetal well-being.

The Surveyor interviewed the Director of Maternal Child Health at 10:00 A.M. on 5/24/19. The Director of Maternal Child Health said she identified corrective action plans after Patient #2's stillbirth. The Director of Maternal Child Health said when there was a concern for the fetus's well-being (the mother was taken off the electronic fetal monitoring machine and sent to the Radiology Department for the fetal well-being test and the fetus was not monitored during the transport). The Director of Maternal Child Health said that corrective actions included:

-Reviewing the practice of taking a patient off the Electronic Fetal Monitoring (EFM) machine to use the bathroom when there was a concern for fetal well-being,

-Reviewing the practice of taking a patient off the EFM machine to send the patient off the Maternity Unit for fetal well-being testing (NST, BPP), when there was a concern for fetal well-being,

-Reviewing the Hospital policy on on-call Ultrasound Technologist response time for conducting fetal well-being testing when there was a concern for fetal well-being.

QAPI EXECUTIVE RESPONSIBILITIES

Tag No.: A0309

Based on records reviewed and interviews Hospital Executives failed for one patient (Patient #2) of ten sampled patients to maintain an ongoing Quality Assessment and Performance Improvement (QAPI) Program.

Findings included:

The History and Physical, dated 4/28/19, indicated the Hospital admitted Patient #2 to the Hospital for deceased fetal movement and fetus had a non-reactive (possible concern for the fetal heart rate pattern) Non-Stress Test (NST), and the Biophysical Profile (BPP, test for fetal well-being) was 8/8 (perfect score). The Discharge Summary indicated the fetus had a sudden decrease in heart rate, an emergent Cesarean was performed for a stillborn noted to have two knots in the umbilical cord.

The Surveyor interviewed Risk Manager #1 at 1:00 P.M. on 5/22/19. Risk Manager #1 said that Hospital QAPI activities had not yet identified corrective actions. Risk Manager #1 said that Hospital QAPI activities had not yet identified opportunities for improvement.

The Surveyor interviewed the Chief of Obstetrics at 11:00 A.M. on 5/23/19. The Chief of Obstetrics said all non-reassuring fetal heart rate (non-reactive, fetal heart rate patterns that show that the fetus may be experiencing distress) recordings and Biophysical Profiles would be reviewed by Maternal Fetal Medicine Physicians.

The Surveyor interviewed the Director of Maternal Child Health at 10:00 A.M. on 5/24/19. The Director of Maternal Child Health said she identified corrective action plans after the Patient #2's stillbirth.

Hospital QAPI Program activities provided no clear indication or documentation that the Hospital thoroughly investigated, identified corrective actions, implemented corrective actions identified by the Chief of Obstetrics and Director of Maternal Child Health's and that the Hospital monitored corrective actions after Patient #2's stillbirth.

2.) Event Report #1, dated 2/28/19, indicated occurrence regarding surgical coverage for a potential Cesarean section.

The Surveyor interviewed the Director of Quality and Risk Manager #1 at 2:00 P.M. on 5/22/19. The Director of Quality said that Risk Manager was responsible for the Event Reporting System (a computer that records patient events and documents processes to resolution or closure). The Quality Director said that the information in the Event Reporting System was unclear regarding the resolution of Event Report #1. Risk Manager #1 said that getting the information to her takes a while. The Risk Manager said that she did not know of the Obstetric Department corrective action regarding the physicians from Maternal Fetal Medicine analyzing fetal well-being tests (BPP). The Director of Quality and the Risk Manager said they did not know of a plan for monitoring that the physicians from Maternal Fetal Medicine were analyzing fetal well-being tests.