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An Immediate Jeopardy (IJ) was identified beginning on 9/8/21 and was determined to be ongoing at the time of the survey exit. The hospital failed to maintain an effective, ongoing, hospital wide, data driven quality assessment and performance improvement program.

Based on medical record reviews and staff interviews, the hospital failed to implement an effective Quality Assurance and Performance Improvement (QAPI) plan, including a complete analysis of an adverse event, development of an effective plan of correction, and measures in place to track performance and success for Patient #4 who presented to Baptist Medical Center Jacksonville's Labor and Delivery (L&D) triage area with a prior history of depressed fetal heart monitoring wave forms and decreased fetal movement. The facility failed to ensure quality indicator data related to discharge of patients who present to L&D triage for fetal heart monitoring, and discharged without physician review of history and fetal heart monitoring was comprehensive to ensure the effectiveness and safety of services, and that quality patient care was monitored for improved patient safety (see A0286).

On 6/17/22 at 6:36 PM the Hospital President, was informed of the IJ situation which began on 9/8/21. The cumulative deficits placed the patients at risk for not having their needs met resulting in the Condition of Participation being out of compliance.
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Based on review of medical records and staff interviews, it was determined the hospital failed to implement thorough preventive actions and mechanisms following an adverse patient event. The hospital did not require on-call obstetric physicians (OB/MD) to access and review the medical history or fetal heart monitoring of patients being seen in the hospital's outpatient Labor and Delivery (L&D) triage area when a physician was not familiar with the patient's history. It was determined the OB/MD failed to review the medical record or fetal heart monitor for 1 of 4 patients reviewed for L&D triage. (Patient #4) The hospital's failure to fully analyze the incident contributed to Patient #4's fetal demise, resulting in a cesarean section to remove the deceased fetus, and put other L&D patients at a likelihood of serious harm or death. This resulted in Immediate Jeopardy at the Condition of Participation for QAPI.

The findings include:

1. Review of the medical record for Patient #4 revealed the patient arrived at the Outpatient Labor and Delivery (L&D) triage on 9/8/21 at 10:31 PM due to complaint of decreased to absent fetal movement since 9/7/21. This was not an emergency services area; this was strictly an outpatient L&D service.

Patient #4 was assessed by the L&D triage nurse, Employee D, RN and placed on a fetal heart monitor. Initial wave forms indicated decreased variability (may represent a stressful intrapartum event such as fetal asphyxia and acidosis, and subsequent distress in the fetus).

Employee D called the on-call Obstetrician (OB) Medical Doctor (MD), Employee E, and on 9/8/21 at 10:54 PM received orders for intravenous (IV) fluids of lactated ringers (LR) to infuse 1 liter of fluids over 20-30 minutes.

At 11:28PM, Employee D documented the following: patient had a variable (decreased heart rate); repositioned at 11:30 PM; 4 variables within 20 minutes; repositioned again at 11:47 PM.

After interventions were completed by Employee D, RN called the OB/MD, Employee E, with an update.
On 9/9/21 at 00:06 AM, Employee E, OB/MD was informed of persistent decreased variability, positive fetal movement, positive acceleration, and no decelerations. Patient #4 was scheduled for a follow up appointment later that day (9/9/21). Employee E, OB/MD, gave orders to discharge the patient home with instructions to attempt to get an earlier appointment to be placed back on the monitor and perform a Biophysical Profile (BPP, an ultrasound that measures the health of the fetus by checking the heart rate, muscle tone, movement, breathing, and the amount of amniotic fluid around the fetus). Patient #4 was discharged from L&D triage on 9/9/21 at 00:26 AM.

Continued record review revealed Patient #4 called her obstetrics office to move her afternoon appointment to an earlier time, but was unsuccessful. Patient #4 arrived at her afternoon appointment. BPP was done and revealed fetal demise. Patient #4 was given instructions to be admitted to the hospital L&D unit to undergo a cesarean section to remove the no longer viable fetus. On 9/9/21 at 11:42 PM a fetus without heartbeat was delivered via cesarean section.

2. On 6/15/22 at 11:30 AM an interview was conducted with Employee I, Registered Nurse (RN), Vice President of Nursing (VPN), and Employee J, RN, Director of Nursing (DON). They stated when the fetal heart monitor wave forms were reviewed it should have prompted Employee D, RN to request the physician to review the tracings prior to the patient being discharged. They stated their review of Patient #4 revealed the patient should not have been discharged based on the persistent depressed fetal heat monitor wave forms. The OB/MDs have remote access to the medical records and the fetal heat monitoring.

3. Review of the Code 15 corrective action plan dated 9/24/21 revealed:
"Nurse re-education on communication and chain of command processes (Completed 9/10/21). Staff re-education of communication and chain of command processes (to be completed 10/4/21)." Review of the staff re-education revealed an email with an attached PowerPoint material. As of 10/4/21 the department had received 35 of 49 "read receipts".

On 6/15/22 at 2:00 PM an interview was conducted with Employee G, RN, Nurse Manager (NM) for L&D.
When asked if she conducted any audits on patients who were placed on fetal heart monitors and were discharged home, she stated no.

4. On 6/16/22 at 3:55 PM an interview was conducted with Employee E, OB/MD. When asked if he recalled a fetal demise that occurred in September of 2021, he stated he was on call that night and received a call about 11:30 PM from Employee D, RN stating Patient #4 had come in for decreased fetal movement, a tracing that was flat, and not a lot of reactivity. He gave orders to hydrate and monitor a little longer. Employee D, RN called back saying the baby had moved and had a little reactivity. He gave the order to discharge and to follow up in the morning (9/9/21) with OB.

Employee E, OB/MD stated he was aware Patient #4 called the office in the morning and was told she could not move her appointment up, but to keep the appointment that was scheduled in the afternoon. Patient #4 came in, saw one of his partners, who was Patient #4's OB, and was asked to come in to confirm findings of fetal demise. The scan showed there was not much fluid and no heartbeat. He stated the patient was naturally very upset. Patient #4 was told to come back, in a couple hours, to be admitted for an "elective cesarean section" for intrauterine fetal demise.

He later reviewed the fetal heart monitor wave forms, and "they were not very good." He stated during the call from the nurse, he did not get the impression that it was as bad as it was. He did not know Patient #4 and did not receive any history that the patient had been in before, no level of concern from parents, and no push back.

He believed he would have admitted Patient #4 had he seen the wave forms, with a possible emergency cesarean section to deliver a live baby. He has always depended on the staff and was aware there was a "chain of command thing" if there were questions regarding orders to discharge. He did not know Patient #4 and did not ask for the patient's history.

5. On 6/17/22 at 10:13 AM a telephone interview was conducted with Employee D, RN, staff nurse in L&D working the night of the incident. Employee D, RN, stated Patient #4 came to L&D triage with complaint of no fetal movement since the prior day (9/7/21). When the patient was put on the fetal heart monitor there was a heartbeat and no contractions.

Employee D reported to Employee E, OB/MD the "basic" information, age of gestation, other symptoms and what the first 10-15 minutes of fetal heart monitoring looked like. The initial fetal monitoring showed a "flattened" wave form. When she tried to look at prior encounters for the patient, she received an alert stating she was violating HIPAA and was unable to access Patient #4's prior history. Employee D stated she called Employee E, OB/MD and relayed the status of the patient. She received orders to give the patient an IV bolus of fluids (20-30 minutes) and to call back with an update. She called the physician back and told him the wave form was still depressed, but there had been some fetal movement and no decelerations. The physician gave orders to discharge patient to home with follow-up in OB later that day. She questioned the OB/MD about the discharge by saying, "You want to discharge?" When the physician stated, yes, she assumed he knew the patient and did not see a need to escalate to her supervisor.

6. On 6/17/22 at 11:15 AM an interview was conducted with the Quality Team which included, Employee L, RN, Risk Manger (RM) for L&D; Employee M, VP Risk Management and Patient Safety (RM & PS); Employee N, Director of Safety and Clinical Quality (DSCQ); and Employee O, RN, Clinical Quality Improvement (CQI). During the Quality Team interview, Employee L stated she asked if Employee E, OB/MD looked at the fetal heart monitoring, he said no, and stated he was reassured by what he was told by Employee D "to be safe, he recommended patient to come in the next morning to complete a BPP. Employee L stated she asked the physician what he would have done if he had seen the fetal heart monitor and he stated he would have admitted the patient.

During the interview Employee O stated they ensured the OB/MDs had access to the fetal heart monitoring system. Employee M stated that the obstetricians relied on the nursing staff to look at the fetal heart monitoring and there is no requirement for physicians to look at the fetal heart monitoring wave forms prior to discharge. The Quality Team was asked if there were any corrective action items involving the physician, and the group indicated they were not aware of any items except to ensure all the OB/MDs had remote access to the fetal heart monitoring system and medical records.

The Quality Team stated the following action items were developed due to the incident on 9/9/21 (these were not reflected on the Code 15 documentation):
a) Fetal marking buttons to be used as a tool to identify fetal movement. Fetal Buttons can be used as a tool, new monitors did not have the fetal buttons. (Were not available at that time). Employee L stated it was reported Patient #4 felt fetal movement. Continued to state to manage patients with decreased movement in the future, they wanted to have buttons in place to monitor movement, ensure not a contraction but actually fetal movement. (Audits from November 2021 through March 2022 reviewed)

b) HIPAA alert was changed so the L&D nurses could access prior encounters. Employee L stated
the HIPAA alert was strongly worded in the OB's electronic medical record system. Nursing staff did not understand it was okay to bypass the alert when accessing prior encounters. The alert was changed and implemented quickly, and used as reinforcement to view previous fetal heart monitor tracings and prior history.

c) Fetal Strip rounds, to review fetal heart monitoring as a team to interact and talk about the fetal strip activity. Understand when to escalate the concerns. Implemented, but has only occurred twice since the implementation in December, 2021.

d) Peer review discussed. Employee O stated peer review is conducted internally. Outcome of the review had not been communicated to the Quality Team. There was understanding Employee E, OB/MD, after reviewing the strip, felt the strip was not very reactive, but the nurse indicated the strip was more reactive than it truly was, which led to reassurance of fetal well-being, and this was a very experienced nurse. Employee O stated the OB/MDs have the choice whether or not to review the fetal heat monitors. There was a gap from the physician side when the choice was made to not review prior to discharge, but felt the true root cause was the nurse not escalating her concerns when she received the discharge order.
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An Immediate Jeopardy (IJ) was identified beginning on 9/8/21 and was determined to be ongoing at the time of survey exit. Failure to ensure on-call obstetric physicians (OB/MDs) have access to and review medical records, and fetal heart monitoring wave forms for patients being seen in Baptist Medical Center's outpatient Labor and Delivery (L&D) triage area prior to being discharged from the outpatient setting was identified.

Based on medical record reviews and staff interviews, the hospital failed to ensure outpatient services met the needs of the patients. The OB/MDs did not review the medical records and fetal heart monitor wave forms for patients they are not familiar with or know their history, and are seen in the hospital's outpatient L&D triage area. This resulted in an intrauterine fetal demise and the need for Patient #4 to undergo a cesarean section for the removal of the deceased fetus (see A1077) due to the physician not accessing Patient #4's medical record and fetal heart monitoring.

On 6/17/22 at 6:36 PM, the Hospital President was informed of the IJ situation which began on 9/8/21. The cumulative deficits place the patients at risk for not having their needs met resulting in the Condition of Participation being out of compliance.
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Based on review of medical records and staff interviews, it was determined the hospital failed to ensure outpatient services were appropriately organized and integrated with inpatient services. The on-call obstetric physician (OB/MD) did not access and review the medical history or fetal heart monitor of a patient being seen in the hospital's outpatient Labor and Delivery (L&D) triage area when the physician was not familiar with the patient's history. It was determined the OB/MD failed to review the patient's medical record or fetal heart monitor for 1 of 4 patients reviewed for L&D triage. (Patient #4) The hospital's failure contributed to Patient #4 needing a cesarean section to remove the deceased fetus and put other L&D patients at a likelihood of serious harm or death. This resulted in Immediate Jeopardy at the Condition of Participation for Outpatient Services.

The findings include:

1. Review of the medical record for Patient #4 revealed the patient arrived at the Outpatient Labor and Delivery (L&D) triage on 9/8/21 at 10:31 PM due to complaint of decreased to absent fetal movement since 9/7/21. This was not an emergency services area; this is strictly an outpatient L&D service.

Patient #4 was assessed by the L&D triage nurse, Employee D, and placed on a fetal heart monitor. Initial wave forms indicated decreased variability (may represent a stressful intrapartum event such as fetal asphyxia and acidosis and subsequent distress in the fetus).

Employee D called the on-call Obstetrician (OB) Medical Doctor (MD), Employee E, and on 9/8/21 at 10:54 PM received orders for intravenous (IV) fluids of lactated ringers (LR) to infuse 1 liter of fluids over 20-30 minutes.

At 11:28PM Employee D, documented the following: patient had a variable (decreased heart rate); repositioned at 11:30 PM; 4 variables within 20 minutes; repositioned again at 11:47 PM.

After interventions were completed, Employee D, RN called the OB/MD, Employee E with an update.
On 9/9/21 at 00:06 AM Employee E, OB/MD was informed of persistent decreased variability, positive fetal movement, positive acceleration, and no decelerations. Patient #4 was scheduled for a follow up appointment later that day (9/9/21). Employee E, OB/MD gave orders to discharge the patient home with instructions to attempt to get an earlier appointment to be placed back on the monitor and perform a Biophysical Profile (BPP, an ultrasound that measures the health of the fetus by checking the heart rate, muscle tone, movement, breathing, and the amount of amniotic fluid around the fetus). Patient #4 was discharged from L&D triage on 9/9/21 at 00:26 AM.

Continued record review revealed Patient #4 called her obstetrics office to move her afternoon appointment to an earlier time, but was unsuccessful. Patient #4 arrived at her afternoon appointment. BPP was done and revealed fetal demise. Patient #4 was given instructions to be admitted to the hospital L&D unit to undergo a cesarean section to remove the no longer viable fetus. On 9/9/21 at 11:42 PM a fetus without heartbeat was delivered via cesarean section.

2. On 6/15/22 at 11:30 AM an interview was conducted with Employee I, Registered Nurse (RN), Vice President of Nursing (VPN), and Employee J, RN, Director of Nursing (DON). They stated when the fetal heart monitor wave forms were reviewed it should have prompted Employee D, RN to request the physician to review the tracings prior to the patient being discharged. They stated their review of Patient #4 revealed patient should not have been discharged based on the persistent depressed fetal heat monitor wave forms. The OB/MDs have remote access to the medical records and the fetal heart monitoring.

3. On 6/16/22 at 3:55 PM an interview was conducted with Employee E, OB/MD. When asked if he recalled the fetal demise that occurred in September of 2021, he stated he was on call that night and received a call about 11:30 PM from Employee D, RN stating Patient #4 had come in for decreased fetal movement, a tracing that was flat, and not a lot of reactivity. He gave orders to hydrate and monitor a little longer. Employee D, RN called back saying the baby had moved and had a little reactivity. He gave the order to discharge and to follow up in the morning (9/9/21) with OB.

He was aware Patient #4 called the office in the morning and was told she could not move her appointment up, but to keep the appointment that was scheduled in the afternoon. Patient #4 came in, saw one of his partners, who was Patient #4's OB, and was called in to confirm the findings of fetal demise. The scan showed there was not much fluid and no heartbeat. He stated the patient was naturally very upset. Patient #4 was told to come back, in a couple hours, to be admitted for an "elective cesarean section" for intrauterine fetal demise.

Employee E, OB/MD stated he reviewed the fetal heart monitor wave forms after the fact, and that they were not very good. During the call from the nurse he did not get the impression that it was as bad as it was. He did not know Patient #4 and did not receive any history that the patient had been in before, no level of concern from parents, no push back.

He believed he would have admitted Patient #4 had he seen the wave forms, with possible emergency cesarean section to deliver a live baby. He has always depended on the staff and was aware there was a "chain of command thing" if there were questions regarding orders to discharge. He did not know Patient #4 and did not ask for the patient's history.

4. On 6/17/22 at 10:13 AM a telephone interview was conducted with Employee D, RN, staff nurse in L&D working the night of the incident. Employee D, RN, stated Patient #4 came to L&D triage with complaint of no fetal movement since the prior day (9/7/21). When the patient was put on the fetal heart monitor, there was a heartbeat and no contractions.

Employee D reported to Employee E, OB/MD the "basic" information, age of gestation, other symptoms and what the first 10-15 minutes of fetal heart monitoring looked like. The initial fetal monitoring showed a "flattened" wave form. When she tried to look at prior encounters for the patient, she received an alert stating she was violating HIPAA and was unable to access Patient #4's prior history. Employee D stated she called Employee E, OB/MD and relayed the status of the patient. She received orders to give the patient an IV bolus of fluids (20-30 minutes) and call back with update. She called the physician back and told him the wave form was still depressed, but there had been some fetal movement and no decelerations. The physician gave orders to discharge to home with follow-up in OB later that day. She questioned the OB/MD about the discharge by saying, "You want to discharge?" When physician stated, yes, she assumed he knew the patient and did not see a need to escalate to her supervisor.

5. On 6/17/22 at 11:15 AM an interview was conducted with the Quality Team which included, Employee L, RN, Risk Manger (RM) for L&D; Employee M, VP Risk Management and Patient Safety (RM & PS); Employee N, Director of Safety and Clinical Quality (DSCQ); and Employee O, RN, Clinical Quality Improvement (CQI).

During the group interview, Employee L stated she asked if Employee E, OB/MD looked at the fetal heart monitoring, he said no, and stated he was reassured by what he was told by Employee D "to be safe, he recommended patient to come in the next morning to complete a BPP. Employee L stated she asked the physician what he would have done if he had seen the fetal heart monitor and he stated he would have admitted the patient.

During the group interview Employee O stated they ensured that OB/MDs had access to the fetal heart monitoring system. Employee M stated that the obstetricians relied on the nursing staff to look at the fetal heart monitoring and there is no requirement for physicians to look at the fetal heart monitoring wave forms prior to discharge.
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