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Based on interview and record review, the hospital failed to comply with the regulatory requirements for EMTALA for one of 23 patients (Patient 1) when the hospital failed to provide Patient 1 (baby of mother, Patient 1a) stabilizing measures after identifying an emergency medical condition (EMC) following birth in accordance with the capacity and capability of the hospital. Obstetrician (a physician or surgeon qualified to practice in childbirth) for Patient 1a identified meconium stained (fluid has a green or brown tint baby's first bowel movement) fluid during the C-section (Cesarean a surgical operation for delivering a child by cutting through the wall of the mother's abdomen) on 1/16/23 and Patient 1 was born after a difficult and prolonged procedure at 2:07 a.m. on 1/16/23. Patient 1 did not breathe for the first five minutes of life and an EMC was identified. Apgar's (Apgar is a test given to newborns soon after birth, checks heart rate, muscle tone, skin color, reflex irritability, and respiratory effort. Usually done twice once at 1 minute and again at 5 minutes. Score between 7-10 is normal; a score between 4-6 needs proper reevaluation and monitoring for the next 5 minutes; 1-3 means baby may need immediate medical attention, such as suctioning of the airways or oxygen to help them breathe better) for Patient 1 were 1 at one minute, 6 at five minutes and 7 at ten minutes. The hospital's Neonatal Resuscitative Program was not followed, and Patient 1 was not immediately intubated (a medical procedure in which a tube is placed into the windpipe (trachea) through the mouth or nose). The pediatrician (a doctor who specializes in children's health from birth all the way through early adulthood) was not at the delivery until one hour after birth. The neonatologist (medical professional who specializes in caring for newborn babies, particularly those who are ill or born prematurely) on-call was available and not called to attend the delivery and arrived three hours after birth. The neonatologist intubated Patient 1 about three hours after birth.

These failures resulted in the hospital not appropriately acting on an EMC, delay in the stabilizing measures of immediately notifying the pediatrician and neonatologist and delay in providing respiratory support to Patient 1 and contributed to the death of Patient 1 which occurred on 1/16/23 at 7:40 a.m. (Refer to A 2407)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and responsible manner.

Based on interview and record review, the hospital failed to provide Patient 1 (baby of mother, Patient 1a) stabilizing measures after identifying an emergency medical condition (EMC) following birth in accordance with the capacity and capability of the hospital. Obstetrician (a physician or surgeon qualified to practice in childbirth) for Patient 1a identified meconium stained (fluid has a green or brown tint baby's first bowel movement) fluid during the C-section (Cesarean a surgical operation for delivering a child by cutting through the wall of the mother's abdomen) on 1/16/23 and Patient 1 was born after a difficult and prolonged procedure at 2:07 a.m. on 1/16/23. Patient 1 did not breathe for the first five minutes of life and an EMC was identified. Apgar's ( a test given to newborns soon after birth, checks heart rate, muscle tone, skin color, reflex irritability, and respiratory effort. Usually done twice once at 1 minute and again at 5 minutes. Score between 7-10 is normal; a score between 4-6 needs proper reevaluation and monitoring for the next 5 minutes; 1-3 means baby may need immediate medical attention, such as suctioning of the airways or oxygen to help them breathe better.) for Patient 1 were 1 at one minute, 6 at five minutes and 7 at ten minutes. The hospital's Neonatal Resuscitative Program was not followed, and Patient 1 was not immediately intubated (a medical procedure in which a tube is placed into the windpipe (trachea) through the mouth or nose). The pediatrician (a doctor who specializes in children's health from birth all the way through early adulthood) was not at the delivery until one hour after birth. The neonatologist (medical professional who specializes in caring for newborn babies, particularly those who are ill or born prematurely) on-call was available and not called to attend the delivery and arrived three hours after birth. The neonatologist intubated Patient 1 about three hours after birth. These failures resulted in the hospital not appropriately acting on an EMC, delay in the stabilizing measures of immediately notifying the pediatrician and neonatologist and delay in providing respiratory support to Patient 1 and contributed to the death of Patient 1 which occurred on 1/16/23 at 7:40 a.m.

Findings:

A review of Patient 1a's document titled, "Labor Events," dated 9/6/23, indicated, Patient 1a had " ... spontaneous rupture of membranes on 1/15/23 at 12:48 p.m. Labor was allowed to proceed with plans for an attempted vaginal birth. Labor Event Times Dilation complete: 1/15/23 at 7:38 p.m., started pushing at the same time. Cesarean [a surgical operation for delivering a child by cutting through the wall of the mother's abdomen] decision: 1/16/23 at 12:12 a.m. Labor Length 2nd stage: 6 hours and 29 minutes ... Newborn Delivery Information Delivery: 1/16/23 at 2:07 a.m. Delivery Type C-Section ... Cesarean priority: non-scheduled Primary Cesarean Indication: Arrest of Descent [baby stopped moving down in the birth canal] ... Labor & Delivery Complications: Cephalopelvic Disproportion [occurs when there is mismatch between the size of the fetal head and size of the maternal pelvis, resulting in "failure to progress" in labor for mechanical reasons] ... Presentation at birth: Vertex [headfirst position facing the spine] Position at birth: OA [occiput anterior - head down baby's body facing towards mothers back] Newborn Measurements Birth weight: 3620 g [gram- unit of measure] Birth length: 50.8 cm [centimeters- unit of measure] Birth head circumference: 33.7 cm Newborn Assessment Living Status: Living Live birth disposition: NICU Apgar Scores - 1 Minute score 1; 5 Minutes score 6; 10 Minutes score 7; 15 Minutes score 8 [Apgar is a test given to newborns soon after birth, checks heart rate, muscle tone, skin color, reflex irritability, and respiratory effort. Usually done twice once at 1 minute and again at 5 minutes. Score between 7-10 is normal; a score between 4-6 needs proper reevaluation and monitoring for the next 5 minutes; 1-3 means baby may need immediate medical attention, such as suctioning of the airways or oxygen to help them breathe better.] ..."

A review of Patient 1a's note titled, "Cesarean Delivery Procedure Note," dated 1/16/23 at 1:36 a.m., written by the Obstetrician (OB), indicated, "Pre-Operative diagnosis/ Indication for surgery: 40w1d [40 weeks 1 day] pregnancy, Cesarean delivery for arrest of descent ... Procedure Details: ... A low transverse uterine incision [surgical cut across the abdomen] was made. Meconium [dark green substance forming the first feces of a newborn infant] stained Amniotic Fluid [fluid that surrounds the fetus] noted. Delivered Viable [capable of life] female infant [Patient 1]... Fetal head deeply wedged [force into a narrow space] into pelvic cavity [a funnel-shaped space surrounded by pelvic bones] and vagina [elastic tube that connects the uterus [the organ in the lower body of a woman where babies are conceived] and cervix [the narrow passage forming the lower end of the uterus] to the vulva [female external genitalia]. Assistance with Nurse pushing fetal head via vagina ... Complications: Fetal Head severely wedged into pelvic cavity and vagina ..."

During an interview on 9/8/23, at 9:15 a.m., with the Obstetrician (OB), the OB stated Patient 1a was her patient and delivered Patient 1, the baby. The OB stated that she could not recall if Meconium was present during the birth of Patient 1 and referred to her "Cesarean Procedure Note" which indicated, "Meconium stained Amniotic Fluid noted". The OB stated the fetal head was severely wedged into the pelvic cavity and she needed assistance from the nurses to help push Patient 1 out of the pelvic cavity. The OB stated that after the decision was made to do a c-section, it was the nursing staff's responsibility to notify the Intermediate Care Nursery (ICN) that there is going to be a c-section. The ICN team then makes the decision if the on-call doctor should be called in and that doctor decides if the neonatologist will be called in. The OB stated, "even for an uncomplicated c-section an ICN team and RT [Respiratory Therapist] are in the room, that is the standard." The OB stated, "I depend on them to do their part [referring to all the team members in the room]." The OB stated the ICN and RT are supposed to able to ask the Anesthesiologist (ANS) for assistance with the baby if needed, "I don't remember if the Anesthesiologist was asked for help." The OB stated she could not recall if there was a pediatrician in the room at the time of birth for Patient 1.

During a review of Patient 1a's Anesthesia Report (AR), dated 1/15/23, the AR indicated, Patient 1a in operating room on 1/16/23 at 1:02 a.m., Incision/Procedure start 1/16/23 at 1:36 a.m., Closing Started 1/16/23 at 2:25 a.m.

During a record review for Patient 1's Electronic Health Record (EHR) titled, "Care Team Note (CTN)," dated 1/16/23 at 8:35 a.m., the CTN indicated,

"0207 [2:07 a.m.] - Attending primary C/S [c-section] of female infant. Infant to pre-warmed radiant warmer [equipment used to heat baby's body and prevent low body temperature of infant], infant flaccid [limp and without muscle tone], pale and floppy. Infant dried and stimulated [gentle and brief rubbing of a newborn's back, trunk or extremities using pre-warmed soft absorbent towels and flicking the soles of the feet], initial Heart Rate [HR] 80 [normal 120-140 beats per minute], stimulation continued no respiratory effort [breathing effort] from infant.

0208 [2:08 a.m.] - PPV [Positive Pressure Ventilation- the process of either using a mask or, more commonly, a ventilator to deliver breaths and to decrease the work of breathing in a critically ill patient] began for low heart rate and lack of respiratory effort, tactile stimulation continued... pulse oximeter [device that reads the oxygen level in the infant] placed on infant, but not reading.
0209 [2:09 a.m.]- Infant suctioned by RT, HR 90

0210 [2:10 a.m.] - HR 120 No respiratory effort, tactile stimulation continued

0211 [2:11 a.m.] - HR 140 No respiratory effort, tactile stimulation continued

0213 [2:13 a.m.] - HR 160, few spontaneous [breaths] attempted by infant, Sa O2 73 % (oxygen saturation of arterial blood] [percentage]

0220 [2:20 a.m.]- CPAP [continuous positive airway pressure- is a machine that uses mild air pressure to keep breathing airways open] began for GFR [Glomerular filtration rate- shows how well the kidneys are working] and desaturations [the condition of a low blood oxygen concentration], infant passed large amt of meconium

0224 [2:24 a.m.] - Infant suctioned for thick bloody secretions

0238 [2:38 a.m.] - transported to NICU [neonatal intensive care unit] via transport isolette [a clear plastic enclosed crib that maintains a warm environment for a new baby and isolates him or her from germs], CPAP continued during transportation

0240 [2:40 a.m.]- Arrived in NICU, infant placed in bed 3, vitals as noted

0245 [2:45 a.m.]- MRSA [Methicillin-resistant Staphylococcus aureus- infection is caused by a type of staph bacteria that's become resistant to many of the antibiotics used] Nasal swab obtained

0250 [2:50 a.m.] - Infant placed on bubble CPAP [a noninvasive respiratory support modality used to manage newborns with respiratory distress] by RT 5cm [centimeters- unit of measure], 8L [Liter- unit of measure], 60 % [of oxygen].

0300 [3:00 a.m.] - Infant Blood glucose [measure of sugar concentrated in the blood] 177

0310 [3:10 a.m.] - [name of Pediatrician (PD)] arrived on unit, Infant weighted 3620 gms [grams- unit of measure] [7 pounds 15.7 ounces], cap gas [meaning capillary blood gas used to measure how much oxygen and carbon dioxide are in the blood] ordered and drawn

0330 [3:30 a.m.]- Blood Culture [a test that looks for infections in the blood] drawn from Right Hand

0355 [3:55 a.m.]- Chest X-ray [a radiologic image of a part of the body] obtained, [name of PD] at Bedside

0400 [4:00 a.m.] - Radiant warmer heat turned down to 35 degrees C [Celsius- unit of measuring temperature] for passive cooling [involves withholding any external heat sources and monitoring the newborn's temperature frequently]

0415 [4:15 a.m.] - IV [intravenous catheter- used to administer fluids placed in left AC [antecubital - situated in the anterior or inner part of the elbow] after 4 attempts

0430 [4:30 a.m.] - D10W [IV fluids] @ [at] 12 mls [milliliter - unit of measure] an hour started as ordered, [name of PD] went to talk with family also to give and obtain informed consent for Umbilical Line Placement [catheter that is inserted into one of the two arteries or the vein of the umbilical cord].

0440 [4:40 a.m.] - Time Out for Umbilical Line Placement. UVC [umbilical venous catheter] at 8 cm, UAC [umbilical arterial catheter] at 18 cm [UVCs deliver fluids, nutrition, and medications, while UACs are used to monitor your baby's blood pressure and obtain blood samples to monitor your baby's condition.]

0517 [5:17 a.m.] - Abdominal X-ray for line placement confirmation, UVC inserted further to = 11cm, UAC @ 20 cm

0524 [5:24 a.m.] - Infant blood sugar 80

0532 [5:32 a.m.] Infant bradycardic [low heart rate] and having desaturations [low oxygen levels], ET intubation [Endotracheal intubation is a medical procedure in which a tube is placed into the windpipe (trachea) through the mouth or nose] attempted by RT x 2 & [name of PD] x 1 both attempts were unsuccessful

0533- [5:33 a.m.] - name of Neonatologist [NN] arrived on unit, infant successfully intubated, chest compressions began for HR of 0, radiant warmer heat turned off for cooling."

During a review of Patient 1's Chest X-Ray, dated 1/16/23, at 3:44 a.m., the Chest X-ray indicated, "Comparison: None Clinical Indication: Distress/Tachypnea [abnormally rapid breathing] ... Findings: Lines and tubes: None. Lungs: Extensive bilateral [both sides] confluent [bend into one another] airspace opacities [meaning not clear and translucent] raising the possibility of neonatal pneumonia [lung infection], meconium aspiration [occurs when a newborn breathes a mixture of meconium and amniotic fluid into the lungs around the time of delivery] or extensive pulmonary edema [too much fluid in the lungs making it difficult to breathe] in the case of tachypnea of newborn ..."

During a review of Patient 1's EHR Flowsheets titled Vital Sign [VS], dated 9/6/23, the VS indicated start time:

1/16/23

2:08 a.m. pulse 80

2:09 a.m. pulse 90 note no respiratory effort

2:10 a.m. pulse 120 note no respiratory effort

2:11 a.m. pulse 140 note no respiratory effort

2:13 a.m. pulse 160 note spontaneous respirations started SpO2 73%

2:18 a.m. pulse 140 RR [respiratory rate] 30 SpO2 81%

2:20 a.m. pulse 140 RR 40 SpO2 83%

2:30 a.m. pulse 144 RR 50 SpO2 96%

2:40 a.m. pulse 147 RR 47 SpO2 98%

3 a.m. pulse 141 RR 59 SpO2 88%

3:15 a.m. pulse 140 RR 42 SpO2 90%

4 a.m. pulse 115 RR 30 SpO2 80%

5 a.m. pulse 102 RR 20 SpO2 62%

5:30 a.m. pulse 86 RR23 SpO2 86%

5:32 a.m. pulse 48 RR 48 SpO2 67%

5:33 a.m. pulse 0 RR 43 SpO2 76% compressions began

5:34 a.m. pulse 50 RR 56 SpO2 73%

5:41 a.m. pulse 107 RR 33 SpO2 55%

5:42 a.m. pulse 111 RR 45 SpO2 68%

5:45 a.m. pulse 112 RR 40 SpO2 76 %

6 a.m. pulse 106 RR 45 SpO2 85%

6:04 a.m. pulse 98 RR 53 SpO2 98%

6:35 a.m. pulse 165 RR 37 SpO2 81 % BP 46/12

6:14 a.m. placed on mechanical ventilator (machine used to help baby breathe]

6:36 a.m. pulse 140 RR 37 SpO2 100%-0652

During a review of Patient 1's Labs dated 1/16/23, the labs indicated:

3:01 a.m. Blood Sugar 177

3:50 a.m. Blood Gas taken from left heel pH 6.815 [pH- refers to how acidic the blood is normal is 7.35-7.45], resulted at 3:55 a.m.

4:25 a.m. CBC [complete blood count] with differential drawn

5:24 a.m. Blood Sugar 80

6:18 a.m. ABG [Arterial Blood Gas] pO2 40.7 low, SpO2 85 % on ventilator

6:47 a.m. Blood Sugar 199

During an interview on 9/7/23, at 8:30 a.m., with Respiratory Therapist (RT) 1, RT 1 stated she was the primary RT present during the birth of Patient 1. RT 1 stated she has been an RT for 13 years. RT 1 stated the hospital follows NRP (Neonatal Resuscitation Program) guidelines. RT 1 stated this was the longest c-section she has ever been to, she stated she called for a backup RT in case something happened to Patient 1 and the second RT arrived before Patient 1 was born. RT 1 stated the Registered Nurses First Assist (RNFA), Charge RN, RN 1 and the OB were having trouble getting the baby out, it took three nurses attempting to push from the vagina to push the baby out. RT 1 stated Patient 1 was born and was floppy when brought to the warmer. RT 1 stated the NICU Registered Nurse (RN) immediately got a heart rate of 80 when Patient 1 was brought back to the warmer. RT 1 suctioned with a bulb syringe and then placed Patient 1 on Positive Pressure Ventilation (PPV). RT 1 stated Patient 1's heart rate went up to 90 and was continuing to go up. RT 1 stated she mentioned intubating Patient 1 but her recommendation was ignored by the NICU nurses. Patient 1 was suctioned, and a lot of bloody secretions were removed and eventually they heard a weak cry. RT 1 stated Patient 1 was placed on CPAP and labs were being drawn by a separate RT. Patient 1 was making small gasps; Patient 1 was retracting too much to get the CPAP off. RT 1 stated once we got the baby in the NICU the Pediatrician (PD) was not there, she drew a capillary blood gas and when she came back the PD was there. RT 1 stated we lost the blood sample for the capillary blood gas so we asked if we could draw another one, it was done, and results were relayed to the PD of pH 6.8 (normal pH is 7.35-7.45). RT 1 stated she asked if they could intubate Patient 1 and the PD told her "no". RT 1 stated her, and another RT stepped out to chart but could still see Patient 1 through the window and Patient 1 was struggling to breath and became apneic (when a person's breathing temporarily and involuntarily stops for any reason). RT 1 stated at that time she started to manually ventilate Patient 1 while the PD was placing two umbilical lines. RT 1 stated she was doing manual ventilation on Patient 1 for some 40 minutes. RT 1 stated another ABG (arterial blood gas) was drawn during this time and the PD did not give the order to intubate until after it had resulted. RT 1 stated she attempted to intubate Patient 1 twice and the PD attempted once, then the Neonatologist arrived and intubated Patient 1 successfully. RT 1 stated she felt Patient 1 should have been intubated sooner, right after the pH of 6.8 and should have secured an airway before the PD attempted to put in the lines. RT 1 stated after Patient 1 was intubated she began to crash, heart rate 0 and compressions were started along with medication per NRP guidelines. RT 1 stated they were able to revive Patient 1, but her lab work came back, and the gas was not detectable. RT 1 stated she was not aware that a Neonatologist was on call and available to come help with Patient 1. RT 1 stated there was a miscommunication between staff and the Pediatrician on call, the doctor was told he might be needed but a second call went out once Patient 1 reached the NICU, telling him he was needed.

During an interview on 9/7/23, at 7 p.m., with RT 2, RT 2 stated she was called in by RT 1 for back up for Patient 1's c-section on 1/16/23. RT 2 stated when she entered the operating room staff were still attempting to get Patient 1 out. RT 2 said Patient 1 was not breathing at all so RT 1 started doing PPV and resuscitation, Patient 1 had some cries but not consistent. RT 2 stated they continued to do tactile stimulation, suction, and provide PPV on Patient 1 for the next 10-15 minutes and then took Patient 1 to the NICU. RT 2 stated she felt Patient 1 was progressing so there was no need to intubate in the beginning. RT 2 stated she remembers Patient 1 having blood-tinged sputum but does not recall meconium. RT 2 stated when she attempted to draw cord blood gas the cord was so cold, and it kept clotting (becoming thick and stuck together). RT 2 stated when they got a cord gas the first sample was destroyed by the machine and when we got the second gas it was about an hour later. RT 2 stated when the blood gas came back results were given to the PD, and we suggested to intubate Patient 1 because her oxygen levels were not coming up and the PD ignored our suggestion. RT 2 stated we placed Patient 1 on bubble and stepped out to chart. RT 2 stated we were called back into room shortly after Patient 1's oxygen sats were in the 80's and we took her off bubble and began bagging her for quite a while, and a chest x-ray was done. RT 2 stated around 5 a.m. the Neonatologist came in and intubated the patient and he told the nursing staff he should have been called a long time ago. RT 2 stated she was aware of the on-call lists for the doctors, but they are usually called by the nurse.

During an interview on 9/6/23, at 7 p.m., with RT 3, RT 3 stated she has been a respiratory therapist for over 20 years and was working on 1/15/23-1/16/23 when Patient 1 was born. RT 3 stated when she entered the OR Patient 1 had been born for approximately 8 minutes, RT 1 was seen bagging Patient 1 and Patient 1 was not crying. RT 3 stated she stepped in and began stimulating the baby and got the baby to cry. RT 3 stated Patient 1 had an Apgar score of 1 for the first minute, 6 at five minutes and 7 at 10 minutes. RT 3 stated "It would have been the RT that would have intubated the baby, I would have intubated within the minute. If a meconium baby comes out and doesn't cry you intubate immediately in order to be able to suction the meconium out."

RT 2 stated we use the NRP guidelines and since the baby was stuck in the birth canal so long Patient 1 absolutely might have respiratory issues. RT 2 stated when Patient 1's blood gas came back with a pH of 6.8, at this time she said staff should have intubated Patient 1. RT 3 stated, "I think that delivery could have gone a lot differently."

During an interview on 9/8/23, at 8:56 a.m., with the Respiratory Care Manager (RCM), the RCM stated the RT at the time of the incident was not expecting a hypoxic baby. The RCM stated, "You've talked with the RT, so I won't try to say what happened, because I wasn't there." The RCM stated at the time of the event, we were going through a leadership transition and as a result of the incident, we got a designated RT Educator and Quality Coordinator. The RCM stated we (the facility) started our action plan immediately after the incident, which included interdisciplinary training. The RCM stated, "they welcomed it [staff welcomed the training), especially those who experienced the death of this infant, and their peers knew that it could have been them." The RCM stated we [referring to all staff) are not working in silos anymore.

During a concurrent interview and record review of Patient 1's EHR on 9/6/23, at 2:53 p.m., with the Neonatologist (NN), the Progress Note dated 1/16/23 1:53 p.m. was reviewed. Patient 1's Progress Note was written by NN and indicated, "I was called by [name of PD] at 0517 [5:17 a.m.]. I was informed by him that there was a term infant who was born at 0207 [2:07 a.m.] and in critical condition. He had informed me that the transport team from [name of facility] had been notified to transport the patient for cooling due to severe metabolic acidosis [too much acid accumulates in the body) and severe encephalopathy [disease, damage, or malfunction of the brain]. I arrived at 0527 [5:27 a.m.] and [Patient 1] was noted to be on CPAP at 100% FiO2 [the fraction of inspired oxygen defined as the percentage or concentration of oxygen that a person inhale]. Three attempts had previously been made to intubate the patient however patient had yet to be intubated. I intubated the patient on first attempt by me with a 3.5 ETT [Endotracheal tube- tube inserted into patient airway to help them breathe]. Placement was confirmed by CXR [chest x-ray]. Initial chest x-ray showed tube in the right main stem [part of the lung] for which the tube was then adjusted to be in the appropriate position. Patient after intubation noted to have HR <60 for which chest compressions were started and two rounds of epinephrine [medication used to help increase the heart rate] given ... Patient's heart rate recovered and in meantime patient was then given 2 NS [normal saline- fluids] bolus at 10 mL/kg [milliliter/kilogram units of measure] per dose and given sodium bicarbonate [used to neutralize acid in the blood] at 2 mEq/kg [Milliequivalents/kilogram units of measure]. Patient had repeat blood gas which showed undetectable pH. At this time patient had a very poor prognosis with no improvement in pH status. Parents notified of the poor prognosis. Transport team arrived and patient then afterwards had another code again this time requiring high dose epinephrine where patient was given two rounds of 1 mL of 1:10,000. Patient's heart rate recovered however in discussion with the attending at [name of transport hospital], it was determined that patient had a very poor prognosis. I went to explain to the parents regarding the poor prognosis of the patient and explained that at this point further medical care would be medically futile and would not change the outcome of the patient. Mother and father acknowledged the information given and opted for comfort care [patient plan that focuses on symptom control, pain relief and quality of life]. Transport team was dispatched back to [name of city] and patient was prepped for comfort care. Patient was brought to postpartum room with parents while still intubated. Patient had ET tube removed once in mother's arms. Patient then later reassessed. Time of death 0740 [7:40 a.m.]." The NN stated he was on call the night of 1/15/23 and when he is on call, he is housed in a hotel approximately 10 minutes away from the hospital. The NN stated the facility should have called him earlier, he would have expected a call within five minutes after the baby was born or sooner if they thought the baby would be in any respiratory distress.
The NN stated per NRP guidelines the baby should have been intubated sooner. The NN stated if the RT was having to give blow by and the baby's sats were still dropping for 40 minutes then per NRP if you have a need for prolonged ventilation then you have a need for a more secure airway.

During an interview on 9/8/23, at 8:56 a.m., with the Manager of NICU (MNICU), the MNICU stated she was not the Manager at the time of this incident. MNICU stated she was hired in May of 2023 and has been added onto the monthly Root Cause Analysis (RCA) meetings being done because of this incident. The MNICU stated, "NRP is the standard" that should be followed. The MNICU stated NRP is based on 30 second intervals and the interventions done during those intervals, after baby is born you dry, stimulate, and give PPV (positive pressure ventilation), 30 second reevaluate, reposition mask give oral suction. The MNICU stated, "During the first couple of minutes the baby [Patient 1] would have needed a separate airway." The MNICU stated NRP has the RT and the NICU nurse work as a team and either could have made the decision to intubate the baby. The MNICU stated, "NICU nurses do not have enough experience to intubate, they would have expected the RT to intubate. I know I was hired because of this incident and my background at a level 3 [meaning level 3 Neonatal Intensive Care Unit]."

During an interview on 9/8/23, at 10:03 a.m., with the Anesthesiologist (ANS), the ANS stated he was the anesthesiologist for Patient 1a's c-section. The ANS stated he was called for this patient and was told baby's descent was not going as planned so a c-section was required. The ANS stated the OB, and the nurses were in constant communication with each other but for whatever reason the baby's head was stuck. The ANS stated, "it could have been caused by the length of time mom spent pushing." The ANS stated, "I don't have a medical duty to the baby, I have a duty to the mom's care. After the baby comes out and mom is stable. Providing medical care to those in need when appropriate. We will help, it is part of our duty to help." The ANS stated he does not think the NICU nurse, or the RT asked for help with Patient 1, "I don't try to butt into their business," if they had asked for help, I would have helped, "I can't assume someone needs my help."

During a concurrent interview and document review on 9/8/23, at 11:30 a.m., with the Director of Quality and Patient Safety (DQPS), the CentralLogic (hospital computerized system for staffing) On Call calendars for January 2023 were reviewed. The DQPS confirmed the January 2023: [name of hospital] - ICN First Call calendar indicated on 1/15/23 Pediatrics: [name of Pediatrician (PD)] 07:00 - 06:59. The DQPS confirmed the January 2023: [name of hospital] - ICN Back-up Call indicated on 1/15/23 and 1/16/23 [name of neonatologist (NN)] 07:00 - 06:59.

During an interview on 9/7/23, at 10:34 a.m., with Patient 1a, stated she was awake during the delivery of Patient 1. Patient 1a stated, "The baby's head was stuck." Patient 1a stated she had tried to delivery naturally for 24 hours, but her doctor told her there was no way this was going to happen, so she agreed to a c-section. Patient 1a stated, "Everything was normal" while she was laboring. Patient 1a stated the reason Patient 1 did not make it is because she had meconium and she asphyxiated (died by being deprived of air), she stated they (staff) tried to clear her lungs, they took Patient 1 to the NICU and Patient 1 took a turn for the worst. Patient 1a stated Patient 1 did not make it through, it was a fluke, but she does remember hearing her cry. Patient 1a stated staff were wonderful at the hospital, did everything by the book, explained everything to me, and "they were straight with me." Patient 1a stated her husband was present during the C-section. Patient 1a stated the hospital offered grievance counseling, and she has family and church for support.

During an interview on 9/7/23, at 12:45 p.m., with the Chief Medical Officer (CMO), the CMO stated that he was informed of the incident on 1/15/23, and he came into the facility to meet with the Department Manager about the case. The CMO stated on 1/19/23 the facility had a first group meeting to determine who needed to be in the discussion. On 1/25/23 the facility had a first large group meeting that included the PD, NN, RN from both L&D and NICU, RTs, the OB, and some other staff involved. The CMO stated the facility put together a timeline of what happened, and everyone participated to determine what were the deviations (the action of departing from an established course or accepted standard) from the acceptable standards. The CMO stated the Chief Nursing Executive was also involved, questions were asked, and responses were evaluated to determine if the incident was a systemic issue. The CMO stated we met again on 2/8/23 after reviewing all the information and decided what were the core deviations and started working on our statements so we could work on improvements. The CMO stated hospital staff now meet monthly to discuss this case and the changes that we have made and continue to make, along with monitoring that the changes are being done. The CMO stated as part of the plan for improvement we brought in some very experienced interim leaders and had some staff leave. The CMO stated the main issues we identified was the hospital did not have a policy on managing the second stage of labor. The CMO stated a new policy was created and has gone through MEC for approval in May of 2023. The CMO stated this new protocol outlines when the nurse should be contacting the physicians and the OBs are required to check on their laboring patients every 90 minutes. The CMO stated we identified that there had been deviations in the NRP process during this incident and have provided retraining of NRP to all L&D, delivery staff and RT's. The CMO stated one of our goals was to make sure we function as a team, and anyone can call out deviations. The CMO stated we started an OB hospitalist program on 1/1/23 but on the day of the incident we did not have an OB hospitalist on call. The CMS stated the hospital is building this program up and a second set of hands would have been optimal for this incident. The CMO stated RTs were the only ones trained to draw the blood gases and now we have trained the nurses as well so if they are busy resuscitating the baby the nurse could draw the gas. The CMO stated the hospital staff did not get blood gases on time for this event. The CMO stated we now are using the Neonatal Nurse Practioners (NNP) and plan to have one in house twenty-four hours a day/ seven days a week (24/7) and the Neonatal Association of California is supporting them through telemedicine (the remote diagnosis and treatment of patients by means of telecommunications technology) that is also available 24/7.

During an interview on 9/7/23, at 3:30 p.m., with the Director of the OB Hospitalist Program (DHP), the DHP stated she is in charge of coordinating elements of the plan for improvement, including education and the simulation (SIMS) program for the physicians, NNPs, nurses and RTs. The DHP stated the goal is to improving patient safety and physician availability and to have a Laborist (a doctor certified in OB/GYN (obstetrics/gynecology), who is dedicated to delivering babies or responding to obstetrical and gynecological emergencies at a hospital) present in the hospital 24/7. The DHP stated she has been working on building up the SIMS (simulation-based training) program, L&D nurses are required to attend two SIMS a year they consist of a three-hour course and didactic followed by simulation. The DHP stated the MDs are now required to attend two SIMS a year to renew their credentials they must have completed four SIMS for the two years. The DHP stated some of the SIMS courses include Preeclampsia (condition in pregnancy characterized by high blood pressure), shoulder dystocia (failure to deliver the fetal shoulders using solely gentle downward traction), precipitous delivery (when a baby is born within three hours of regular contractions starting), prolapsed cord (happens when the umbilical cord exits the cervix before the head of the baby), OB life support, and baby resuscitation. The DHP stated Patient 1 was one of the reasons for the revamping of the new training, "It shocked everybody". The DHP stated it has been great improvement havi