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760 BROADWAY

BROOKLYN, NY 11206

QAPI

Tag No.: A0263

Based on document review and interview, the facility's Quality Assessment and Performance Improvement Program did not ensure all incidents were fully investigated and reviewed or identified gaps in patient care and implement appropriate corrective actions to improve patient care and prevent adverse outcomes (Patient #1, Patient #27).

Findings:

Review of the facility incidents and occurrences reports identified that the facility's quality assessment review of patient incidents,
a) failed to identify and implement appropriate corrective actions for a patient's death from obstetric complications, b) failed to Identify gaps in patient care and implement appropriate corrective actions for a patient found pulseless on the floor while on a cardiac monitor. in the Emergency Department. (Patient #1, Patient #27)

See Tag A-0283

MEDICAL STAFF

Tag No.: A0338

Based on medical record review, document review and interview, and one (1) of 24 medical records reviewed, the facility failed to, a) develop and implement detailed protocols that identify high-risk obstetric pregnancies and,
b) respond timely to a patient's emergent obstetric condition. (Patient #1)

Findings:

The facility failed to create and implement a protocol to define the high-risk obstetric patient and ensure that the medical staff identify and timely respond to the needs of a patient experiencing severe abdominal pain and fetal bradycardia.
(Patient #1)

See TAG A0347

NURSING SERVICES

Tag No.: A0385

Based on medical record review, document review, and interview, in one (1) of 24 medical records reviewed, the facility failed to ensure all nurses providing obstetrical (OB) care were trained to activate an "OB STAT" Team when they identify sudden change in the physiologic status of the obstetrical patient (Patient #1).


Findings:

Patient #1 developed increased abdominal pain and decreased fetal heart rate. The nurse notified the physician and there was a 15-minute delay in response to repeated calls to the attending physician.


See Tag A-0395

MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY

Tag No.: A0347

Based on medical record review, document review and interview, in one (1) of 24 medical records reviewed the facility failed to a) develop and implement detailed protocols to ensure appropriate classification and treatment of high-risk obstetric pregnancy, and b) respond timely to a patient's emergent obstetric condition (Patient #1).

Findings:

Review of the medical record of Patient #1 revealed: this patient at 36 weeks and 3 days gestational age with an estimated date of delivery of 10/09/2024, presented to the Labor and Delivery (L&D) Triage on 09/14/2024 at 6:10 PM, with a chief complaint of vomiting since her discharge from Labor and Delivery (L&D) ED triage on 09/11/2024. The patient had a history of cesarean delivery in 2019 in setting of preterm labor at 32 weeks 1day, complicated by neonatal death one (1) hour after birth, preterm labor current pregnancy. The patient received Trial of Labor After Cesarean (TOLAC) counseling and consented on 08/14/2024.

At 6:50 PM: RN Triage note documented the patient received a nursing assessment, Fetal Heart Rate was 150 beats per minute (BPM), the patient reported lower abdominal pain, back and pelvic pain scale 7-8 of 10 (normal range 0 -10). The patient was awaiting evaluation and disposition.

At 7:07 PM: Certified Nurse Midwife (CNM) documented history and physical (signed at 11:20 PM) stated the patient complained of lower abdominal pain from hunger and lower back pain, and denied loss of fluid, or vaginal bleeding. The patient reported fetal movement. The patient was assigned a triage acuity level 3 (urgent). The patient's family endorsed concerns for the patient's continued vomiting and poor obstetric history.

Between 8:33 PM and 11:00 PM, the medical record documented assessment by Certified Nurse Midwife (CNM) and RN for vomiting, fetal heart rate monitoring and administration of IV fluids, a medication for heartburn and upset stomach and Tylenol for pain.

At 11:31 PM: Triage RN note documented the patient was transferred to the Mother Baby Unit (Antepartum) for observation and treatment.

During a tour of the L&D Unit on 10/02/2024 at 11:49 AM, surveyor observed the Mother Baby Unit was a distance from the L&D Unit. Registered Nurses interviewed during the tour indicated they were not trained to manage antepartum emergencies and continuous fetal monitoring was not required.

Per documentation by the Antepartum Unit RNs, on 09/15/2024 at 4:05 AM and 5:08 AM; the patient complained of lower abdominal pressure and pain 8 of 10 and 3 of 10 respectively (normal range 0 -10), feeling contractions, and physician was informed of the patient complaints. At 7:10 AM the patient reported intensifying anterior abdominal and back pain, the physician was again notified at 7:20 AM. At 7:35 AM, the physician was at the patient's bedside and ordered the patient be transferred to the L&D Triage for further assessment. EFM showed fetal heart rate decreasing to 100-115.

At 7:40 AM: The patient was transferred to L&D Triage room 110.

At 8:11 AM: Triage RN note signed at 8:23 AM, documented receiving the patient at 7:38 AM for complaint of pain and pressure, fetal decelerations (heart rate decreasing) 95-100 bpm, fetal resuscitation measures began, and the patient was transferred to Labor and Birthing Room12.

Per Labor and Delivery Attending Physician "Significant Event Note" signed on 09/16/24 at 7:49 AM documented, incision at 8:22 AM. Baby's time of birth 8:25 AM, upon delivery, complete placenta abruption was noted.
At 8:50 AM patient suddenly became bradycardic, 9:05 AM patient became pulseless, ACLS protocol initiated.
The Code Team performed 2 hours of resuscitative measures without success. The patient was pronounced deceased at 11:05AM.

There was no documented evidence of a provider assessment or consultation for another source of the patient's pain.

There was approximately a 15-minute delay from the time the attending physician was notified of the change in the patient's condition to the time the physician evaluated the patient.

There was an additional 45-minute delay in the attendings decision to move the patient to the operating room.

During interview on 10/8/24 at 9:56 AM, Staff R, ED Triage RN who was involved in the patient's care stated, the patient tolerated the oral challenge of water, and juice. However, the Staff V, Certified Nurse Midwife still wanted to admit the patient for observation. Staff W, Attending Physician covering L&D and Triage did not want to admit the patient and did not examine the patient. The Staff V, CNM, escalated and spoke to Staff O, another Attending Physician covering Mother Baby Unit who accepted the patient. Staff O came over from Mother Baby Unit, went in to speak with the patient but did not examine the patient.

During interview on 10/08/2024 at 10:46 AM, Staff S, RN from the Antepartum Mother Baby Unit stated, at 4:05 AM, the patient complained of lower abdominal pressure scale eight 8 of 10, they placed the patient on the monitor. FHR was 145-150 BPM, no uterine contractions were noted. They informed Staff O, Ob/Gyn attending physician of the patient's pain at 4:10 AM. No pain meds were ordered.

During interview on 10/08/2024 at 11:03 AM, Staff T, RN on the Antepartum Unit stated they received report from the covering RN of the patient's complaint of pain earlier and they informed Staff O, Ob/Gyn attending. Staff O, Ob/Gyn attending did not go to assess the patient. At 7:09 AM, the patient's call bell was going off. "I went to the room. The kind of pain the patient was in I've never seen that before...They called for help and their charge nurse and colleagues came. They called Staff O, Ob/Gyn attending. I called both phones. Both went to voicemail. The attending called back. I told them what happened, they said give me five (5) minutes, I'm in the shower. I went back to the room...No physician really did anything. Then we started to hear this slowdown in heartrate. It went down to 110 and 100. Staff O, Ob/Gyn attending not there yet, they made a second phone call to Staff O It was about 7:20, 7:30 AM, Staff O came about two (2) minutes after..."

During interview on 10/09/2024 at 1:36 PM, Staff C, Chief of OB/GYN stated there was no policy specific to the identification and treatment of high-risk pregnancies, the facility adopted the ACOG guidelines. The surveyor was provided with copied pages from an article in The American College of Obstetricians and Gynecologists Vol. 134, NO.2, August 2019, which described various levels of care for pregnant patients. Staff C also stated that an intrapartum patient with one (1) previous c-section would not be considered a high-risk patient.
Staff C also stated: " ...There was a delay. I would've liked patient to get to the OR sooner. There seem to be a 16-minute gap between leaving the triage and getting to the labor floor. Nobody knew patient was coming but it is a bit long to me. I don't know why the delay happened ..."

Per review of the ACOG guidelines presented by the facility, the guidelines did not provide guidance for identifying a high-risk OB patient.


During interview on 10/10/2024 at 10:58 AM Staff A, Chief Medical Officer stated the ability to manage the patient safely is based on their comorbidities, and risk is a clinical decision guided by Maternal Fetal Medicine as well as service leadership and Regional Perinatal Centers colleagues. "We try not to be overly picky about that."

During interview on 10/11/2024 at 11:00 AM, Staff B-1, Attending Physician stated, during morning sign out on 09/15/2024 at 8:05 AM, they looked at the screen and saw a deceleration. "It was clear there was a deceleration. I asked who the patient was, I was given a quick debrief and went to the room. The patient was by themself. I arrived in the room. The patient was in acute distress screaming, jumping all over the bed, in great distress. It was as if someone was cutting them open. I saw baby's heart rate was down. The patient was in severe pain ...I took the patient emergently to the OR ..."

An Immediate Jeopardy (IJ) situation was identified on 10/16/2024 at 5:29 PM, due to the facility's failure to,
a) develop and implement protocols to ensure appropriate identification and treatment of high-risk maternal patients and, b) failure to respond timely to a patient's emergent obstetric condition.

The facility provided an IJ Removal Plan to survey staff on 10/21/2024 at 2:50 PM.

The plan included a newly created policy titled: Identification and Management of High-Risk Patients in the Prenatal/Antepartum/Intrapartum Setting, and to provide education to pertinent staff on the newly created policy. The chief of OB/GYN would be responsible to ensure all pertinent staff get trained with a goal of 100% completion of training by 10/31/2024.

The IJ Removal Plan was accepted on 10/22/2024 at 12:33 PM.

The IJ was removed on 10/23/2024 at 5:50 PM, based on onsite verification of the facility's implementation of the IJ Removal Plan.
Surveyors verified the policy was created, and training of pertinent staff had begun.

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on medical record review, document review, and interview, in one (1) of 24 medical records reviewed, the facility failed to ensure all nurses providing obstetrical (OB) care were trained to activate an "OB STAT Team" when they identify sudden change in the physiologic status of the obstetrical patient (Patient #1).

Findings:

The facility Policy and Procedure titled, "OB STAT Team," Effective 11/20/2023, states on Page 3:

"PURPOSE:
1. The American College of Obstetricians and Gynecologists, the Institute for Healthcare Improvement and the American Medical Association has endorsed the rapid response system approach which has applicability to inpatient obstetric care, where there is not one patient, but two, and where the status of both mother and baby can change dramatically from one moment to the next. Unique to the obstetric setting is the fact that the status of one patient (either the mother or the baby) can profoundly affect the outcome of the other.

2. Approximately 1 to 2 percent of pregnancies are complicated by an obstetrical emergency, and in extreme obstetrical emergencies, minutes are crucial to perinatal outcome. Therefore, the timing of the delivery and the ability to quickly assemble all necessary personnel and equipment is critical.

3. The purpose of the OB STAT Team is to provide rapid, organized, efficient response to obstetrical emergencies and improve maternal and neonatal outcomes.

Policy 1: Any clinical staff member that identifies an obstetrical patient is experiencing a sudden change in physiologic status or feels uncomfortable with a patient condition/situation and desires additional help, can activate the OB STAT Team."


Review of the Medical Record (MR) for Patient #1 revealed: patient presented to the Labor and Delivery (L&D) Triage on 09/14/2024 at 6:10 PM, with a chief complaint of vomiting. The patient was pregnant at 36 weeks and 3 days gestational age with an estimated delivery date of 10/09/2024. The patient also endorsed lower abdominal pain from hunger and lower back pain, The patient was assigned a triage acuity of Level 3 (urgent).

On 9/15/24 at 7:24 AM, Staff T, Registered Nurse (RN) documented, "0710 AM Patient called to report intensifying anterior abdominal and back pain. Pain rated 10/10 pain... Staff O, nightshift Mother Baby Attending Physician, made aware of patient's complaints.
0735 AM Staff O, nightshift Mother Baby Attending Physician at patient's bedside. As per MD's order, patient can be transferred to Triage for further assessment. EFM [External Fetal Monitor] showed fetal heart rate decreasing to 100-115 [normal 110-160].
0740 AM: Patient transferred to Triage room 110."

On 9/15/24 at 8:15 AM, note from Staff B-1, the dayshift L&D Attending indicated: "I arrived at the hospital and assumed day shift at 8:05 AM ...I immediately looked at the screen with all fetal tracings and noted that the EFM was abnormal with decelerations (decrease in the fetal heart rate below the fetal baseline heart rate 110 to 160 beats per minute), and fetal bradycardia (slow heart rate). I asked for rapid debrief about the patient, and then ran out of "sign out" to go assess patient at the bedside ... patient was in active distress, complaining of acute abdominal pain, writhing in pain, jumping up in the bed and fetal heart rate was 89 bpm. I saw that there had been several minutes of intermittent bradycardia prior to my arrival ...I recommended STAT cesarean section."

Staff B-1, day shift L&D Attending documented the following timeline in their operative report including:
8:22 AM: Incision
8:24 AM: Uterine incision
8:25 AM: Baby's time of birth, upon delivery, complete placenta abruption was noted.
(Signs and symptoms of placental abruption includes abdominal pain, back pain, uterine tenderness and contractions. Vaginal bleeding may or may not occur).

Per interview with Staff T, RN on 10/8/2024 at 11:03 AM, they stated, "At 7:10 AM I went into the patient's room... I've never seen anyone in pain like that before ...with the way she was screaming, it was like a continuous contraction with no rest phase ...I called the other nurses to help, and when they came in, I made the phone call to Staff O, Mother Baby Attending Physician. I called his personal phone and pager. He called back and said he would be there in five (5) minutes. I went back in the room and tried to help the patient change positions, and then we heard the sound of the fetal heart rate dropping into the low 100s on the monitor ...the charge nurse called Staff O, Mother Baby Attending Physician again around 7:20 AM and told them to come right away ...I wish there was a way to call for an antepartum emergency outside of a code green or code blue."

Per interview with the Staff C, OBGYN Chief on 10/9/24 at 4:11 PM, they stated, "I think the OB STAT would be helpful to do more education with the mom/baby nurses."

Per interview with the Staff A, Chief Medical Officer on 10/10/24 at 10:57 AM, they stated, "If a nurse wasn't getting assistance from a physician, they could have called an OB STAT to expedite the process."

Per follow-up interview with the Staff T, RN on 10/11/24 at 12:38 PM, when asked if they were trained on the OB STAT policy, they stated, "I never had the opportunity to be trained on OB STAT before this happened."

An immediate jeopardy situation was identified on 10/16/24 at 5:27 PM due to the facility's failure to ensure nursing staff caring for obstetrical patients were educated on the OB STAT policy.

The facility provided an IJ Removal Plan to survey staff on 10/21/2024 at 2:50 PM.

The IJ Removal Plan included educating nursing staff on the OB STAT policy before the start of their shift on the Mother-Baby Unit, L&D Unit, Pediatrics, and Neonatal Intensive Care Unit (NICU).

The IJ Removal Plan was accepted on 10/22/2024 at 12:33 PM.

The IJ was removed on 10/23/2024 at 5:50 PM, 2024 based on onsite verification, including interviews and document review, that the facility had implemented their Plan.