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7050 GALL BLVD

ZEPHYRHILLS, FL 33541

MEDICAL STAFF - ACCOUNTABILITY

Tag No.: A0049

Based on Medical record, facility's policies, and staff interviews it was determined the facility failed to ensure the medical staff notified the patient that an adverse incident that was identified regarding her care in labor and delivery that resulted in the delivery of a stillborn birth in one (Patient #1) of four sampled patients.


Findings included:

Review of the Policy and Procedure titled, "Fetal Monitoring", Policy # ZH16739, effective date 08/31/2021 ...Page 6 ...Provider should be notified of any change in fetal status or intrauterine resuscitation required that does not result in reassuring (Fetal Heart Rate) FHR. (Reassuring FHR patterns include each of the following: (1) a baseline fetal heart rate of 110 to 160 beats per minute, (2) moderate variability, (3) gestational age-appropriate FHR accelerations, and (4) absence of FHR decelerations. When all 4 of these criteria are present, the provider can be reassured that no fetal acidemia is present.) ...

Review of the facility Policy and Procedure titled, "Risk Management Policy Plan", Policy # ZH17331, Review date 07/29/2021 Page 2 ... A disclosure system for unanticipated outcomes to support the right of the patient to know when they are the subject of an adverse event ...Reporting specific "Adverse Events", over which health care personnel could exercise control ... The attending physician, or another physician involved in the treatment, surgery or procedure, is responsible for ensuring disclosure takes place.

Review of the medical record for patient #1 revealed that on 11/21/2021 at 5:38 PM, the patient was admitted to the facility for labor induction (the stimulation of the uterine contractions during pregnancy before labor begins on its own to achieve a vaginal birth).

On 11/23/2021 at 3:30 AM the Fetal Heart Rate (FHR) begin to show deceleration (decrease of 15 or more beats per minute below the baseline in FHR during labor). The nurse begins intrauterine resuscitation efforts by turning patient #1 and discontinue the oxytocin (Pitocin) infusion. The nurse also applied oxygen at 10 liters through a non-rebreather mask, increased the intravenous fluids and notified the provider.

On 11/23/2021 at 4:24 AM Patient #1's medical record revealed the nursing note for fetal monitor annotation (a note of explanation or comment added) documentation that the nurse notified the provider through a text message.

On 11/23/2021 at 5:12 AM the nursing note for FHR deceleration intervention (action taken to improve a situation) revealed the nurse notified the provider. (Time corrected from 4:00 AM to 5:12 AM by nurse).
On 11/23/2021 at 6:00 AM the nursing note for FHR deceleration intervention showed the nurse notified the provider. Flagged for significance by the nurse.

On 11/23/2021 at 6:31 AM the nursing note for Fetal Monitor Annotation revealed pushing with provider at bedside.

On 11/23/2021 at 6:38 AM the nursing note for Patient #1 revealed the provider restarted the Pitocin (Oxytocin).

On 11/23/2021 at 6:55 AM The nursing note for patient #1 showed the provider at bedside.

On 11/23/2021 at 7:15 AM the nursing note showed the FHR Variable deceleration tachycardia after the variable and the oxytocin was discontinued.

On 11/23/2021 at 7:30 AM the nursing note revealed the FHR had variable and late deceleration. FHR description recurrent of variables and late (20-minute segment).
(Late decelerations in fetal heart rate are caused by decreased blood flow to the placenta and can signify impending fetal acidemia.)

On 11/23/2021 at 8:11 AM nursing note revealed female singleton neonate outcome: death.

Review of Patient #1 medical records revealed the nurse documented the provider was notified four times. The first notification was at 3:30 AM when there was an FHR deceleration, then at 4:24 AM, then 5:12 AM and again at 6:00 AM. The nursing notes showed the doctor at bedside at 6:31 AM.

On 02/14/2022 at 10:00 AM an interview conducted with the Chief Medical Officer (CMO) who disclosed that the provider (MD J) did not consider a Cesarean Section for the Fetal Heart deceleration and tachycardia (for Patient #1).

Further review of Patient #1 medical record revealed no documentation that Patient #1 was notified that fetal heart decelerations and changes in fetal heart rate variability were not timely recognized and communicated to the provider.

On 02/15/2022 at 1:07 PM an interview conducted with the Director of Risk Management revealed that the Risk manager does not inform the patient of the adverse event and the doctor taking care of the patient at the time does, but they are available to assist if the provider asks them to.

On 02/15/2022 at 3:11 PM an interview was attempted with MD J with Chief Medical Officer and attorney on phone. When asked if the patient was made aware of the adverse event the attorney informed for MD J to not answer.

QUALITY IMPROVEMENT ACTIVITIES

Tag No.: A0283

Based on review of medical records, facility's policies and staff interviews it was determined the facility failed to have a complete analysis of an adverse event and the development of an effective correction plan in 1 of 2 sampled events.

Findings included:

Review of the Hospital analysis of the Adverse event for Patient #1 revealed the fetal heart rate decelerations and changes in fetal heart rate variability were not timely recognized and communicated to the provider.

Review of the facility document Agency RN Competency Based Orientation The Women's Health Center Definition: Competency is the applications of skills and knowledge to meet predetermined standards Verification of Competency: Competency is meet when all critical elements are demonstrated/ directly observed by designed expert during the delivery of patient care.

Review of the facility job description for Women's Center Registered Nurse, revised 6/2020, indicates " ...LICENSURE, CERTIFICATION OR REGISTRATION REQUIRED ...Current Fetal Monitoring certification or AWHONN (Association Of Women's Health, Obstetric And Neonatal Nurses) fetal Monitoring completed within the past 2 years ..."

Review of Personnel file for Staff B (Agency staff) revealed the certification in intermediate fetal monitoring course expired on 04/18/2020. Further review of Staff B personnel file reveals no competency found.

Review of personnel file for Staff M (Agency staff) revealed all competencies were signed off on 11/19/2021 with no demonstration or direct observation to verify staff M was qualified to work labor and delivery.

On 02/14/2022 at 10:37 AM an interview with the Assistant Vice President of Nursing disclosed that the facility was aware of staff B expired certificate for intermediate fetal monitoring prior to working scheduled shifts. The Assistant Vice President of Nursing stated, "With the critical staffing we felt that she has done the course in the past and should be good to work."

No evidence that a QAPI plan was developed.

Review of the facility's documentation for fetal monitoring strips and maternal drill education revealed the hospital has not included the contracted agency Registered Nurses.

No evidence found that the facility has measures in place to track education and competencies of agency staff or that they are held to the standards set forth in their policies for their staff.

STAFFING AND DELIVERY OF CARE

Tag No.: A0392

Based on the facility staff schedule and interview it was determined that the facility failed to have a qualified Registered Nurse (RN) immediately available for care of the patient in 1 of 1 day sampled.

Findings included:

Review of the facility schedule for 02/13/2022, 7 PM-7 AM, the facility had three RNs working the night shift. The Charge RN had two patients, one RN had triage and one RN had a patient.

On 02/16/2021 at 8:19 AM an interview conducted with staff H, revealed that she does not have time to check on other patients because she is the charge nurse, triaging patients and also had a patient that was laboring. Staff H stated, "Night shift is a common occurrence to have one staff charge RN with two agency RN with no competencies being done and the charge nurse having patients".

SUPERVISION OF CONTRACT STAFF

Tag No.: A0398

Based on the hospital's policies, staffing sheet and interviews it was determined that the facility failed to provide adequate supervision and evaluation of competencies for agency nursing personnel in labor and delivery for 2 ( Staff B and M) of 2 agency personnel.

Findings included:

Review of the Policy and Procedure titled, "Competency" Policy # 17212, effective date 04/13/2021 ...Competence is demonstrated prior to a procedure or task in a high risk, problem prone, and patient care situation. Evidence is documented at the department level.

Review of the Policy and Procedure title, "Scope of Service- Women's Health" policy # ZH16778, effective date 08/02/2021 ...Page 2 ...v. The women's Health Center is under the direction of the Manager of the women's health center and has 24-hour accountability for the unit and administers, directs, and coordinates activities of patient care within the Women's Health Center. She is responsible for the direction and evaluation of patient care delivery ensuring care is delivered ... The Registered nurse is responsible for the observation, assessment, planning, intervention, and evaluation of care for all patients. The RN reports to the manager and is accountable for the staff working under her ... Staffing plan ...minimum staffing level is 1 RN charge nurse and 2 RNs

Review of Personnel file for Staff B revealed certification in intermediate fetal monitoring course expired on 04/18/2020. Further review of Staff B personnel file showed no evidence that competency was done.

On 02/14/2022 at 10:37 AM an interview with the Assistant Vice President of Nursing disclosed that the facility was aware of staff B's expired certificate for intermediate fetal monitoring prior to working scheduled shifts. The Assistant Vice President of Nursing stated, "With the critical staffing we felt that she has done the course in the past and should be good to work."
Review of personnel file for Staff M revealed all competencies were signed off on 11/19/2021 with no demonstration or direct observation to verify staff M was qualified to work labor and delivery.

Review of the facility schedule for 02/13/2022 7 PM-7 AM the facility had three RN working the night shift. The Charge RN had two patients, one RN had triage and one RN had a patient.

On 02/16/2021 at 8:19 AM an interview conducted with staff H, revealed that she does not have time to check on other patients because she is the charge nurse, having to triage patients and also had a patient that was laboring. Staff H stated, "Night shift is a common occurrence to have one staff RN with two agency RN with no competency being done and the charge nurse having patients".


On 02/15/2022 at 10:05 AM an interview was conducted with Staff L revealed that Staff M worked with her one night (11/19/2021) and the Policy and Procedures were discussed but no direct observation of patient care observed.