HospitalInspections.org

There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body .

Based on observation, interview, record review, the facility failed to have an effective governing body legally responsible for the conduct of the hospital when:

1. The Governing Body (GB) did not ensure that the hospital had an active and effective quality assurance and performance improvement (QAPI) program that collected and analyzed data for improvement in patient care. (Cross-reference A 263, A 283)

2. The GB did not ensure that safe care was provided for a 36-year old woman who came to the hospital in alcohol withdrawal with critically low potassium, magnesium, and phosphorous levels. The patient was treated with supplemental potassium, magnesium, and phosphorous in the Emergency Department, but medication did not continue after the patient was admitted, and her blood was not tested timely to monitor if her blood levels were improving, her heart monitor was removed without an order or physician assessment, and the order for CIWA protocol was not followed. The patient had a cardiac arrest the next morning and was transferred to Intensive Care where she died. (Cross-reference A 398)


Because of the serious actual harm to Patient 3 when nurses did not follow hospital policies and procedures and not to follow up on critical labs Immediate Jeopardy (IJ) situation was called for situation on 4/19/24 at 6:00 p.m., under Code of Federal A 0398 §482.42 in the presence of the President and Market Leader, the Chief Nursing Officer, The Chief Medical Officer, and the Director of Quality were provided the IJ template which documented the immediate actions necessary to address the IJ situation. The hospital submitted an acceptable plan of removal to address the IJ situation. Plan of removal was accepted on 4/22/24 at 3:30 p.m. Survey team's observations and interviews validated the hospital implemented appropriate corrective actions and the IJ was removed on 4/22/24 at 5:00 p.m. in the presence of the Director Quality and the Manager of Quality and Accreditation. Following the IJ removal, the facility remained in substantial non-compliance.



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 for staff and patients.

Based on observation, interview, and record review, the hospital failed to protect and promote each patient's rights when:

1.One of five sampled patients (Patient (Pt) 1) was admitted to the hospital for active labor and fetal heart monitoring was not reviewed during hand off from OB ED to L&D and Physician was not made aware of Category 2 tracing in OB ED. These failures resulted in Pt 1's baby not being monitored appropriately and contributed to the baby's death. (Refer to A0144, Pt 1)

2.One of three sampled patients (Pt 3) was admitted to the hospital and placed on CIWA protocol (Clinical Institute Withdrawal Assessment for Alcohol protocol - a specialized questionnaire designed to evaluate the intensity of alcohol withdrawal symptoms, aiding in guiding effective treatment strategies) and it was not followed nor was Pt 3 monitored appropriately. These failures resulted in Pt 3 not being assessed and possibly contributed to her death. (Refer to A0144, Pt 3)

The cumulative effect of these systemic problems resulted in the hospital's inability to provide care in a safe and effective manner in accordance with the statutory-mandated Condition of Participation for Patient Rights.

Based on observation, interview, and record review the hospital failed to provide care in a safe setting for two of 34 patients sampled (Pt 1 and Pt 3) when:

1.Pt 1 was admitted to the hospital for active labor and fetal heart monitoring was not reviewed during hand off from OB ED (Obstetrics Emergency Department) to L&D (Labor and Delivery) and Physician was not made aware of Category 2 tracing in OB ED. These failures resulted in Pt 1's baby not being monitored appropriately and contributed to the baby's death.

2.Pt 3 was admitted to the hospital and placed on CIWA protocol (Clinical Institute Withdrawal Assessment for Alcohol protocol - a specialized questionnaire designed to evaluate the intensity of alcohol withdrawal symptoms, aiding in guiding effective treatment strategies), and it was not followed nor was he monitored appropriately. These failures resulted in Pt 3 not being monitored appropriately and possibly contributed to his death.

Findings:

1.During an interview on 3/28/24 at 3:42 p.m. with Patient (Pt) 1, Pt 1 stated she did not have any complications during her pregnancy. Pt 1 stated her last appointment with her obstetrician was on 3/12/24, which was her due date. Pt 1 stated she was dilated to 3 centimeters (meaning her cervix was dilated; cm- indicates a unit of measurement where 10 cm is fully dilated and ready to give birth). Pt 1 stated she had a non-stress test (NST) scheduled for 3/15/24 but ended up going into labor on 3/14/24. Pt 1 stated she went to the hospital when the contractions got stronger and arrived at approximately 4:30 p.m. Pt 1 stated she went to the fourth floor OB triage (same as OB ED) where she was registered and had her vital signs taken. Pt 1 stated the nurse tried to get the baby's heartbeat but was not able to. Pt 1 stated she was taken to the OB triage room to a bed where they hooked her up to the fetal monitor and she could hear the baby's heartbeat. Pt 1 stated the nurse told her the heart rate was 133 (beats per minute [bpm]). Pt 1 stated she stayed in the triage bed while she waited for a bed in labor and delivery. Pt 1 stated the fetal monitor was disconnected before she was transported to the sixth floor labor and delivery unit. Pt 1 stated when she got to the labor room, she requested an epidural but was told the anesthesiologist was with another patient, so Pt 1 went to the restroom and then walked back to bed. Pt 1 stated the nurse had her sit on the edge of the bed to wait for the anesthesiologist and the nurse did not put the fetal monitor on. Pt 1 stated the nurse could not put the monitor on her because her back was arched, so the nurse was in front of her holding the monitor on her abdomen. Pt 1 said she signed the consent, the anesthesiologist put in the epidural and then they laid her back down on the bed and put the fetal monitor on her but could not find the heartbeat. Pt 1 said they brought in a doppler and still could not find it. Pt 1 stated the doctor (MD 2) came in and used an ultrasound machine and said there was no heartbeat and no movement. Pt 1 stated a lady put her hands on Pt 1's stomach and "shook it to get him [the baby] moving," and another nurse asked about going to the operating room for a c-section. Pt 1 stated the doctor (MD 2) "decided no c-section, let's let it come naturally." Pt 1 stated her baby had a heartbeat when she was in triage and questioned why they couldn't have resuscitated him. Pt 1 stated "they wrote the time of death at 6 p.m. and I asked if they were 100% positive. They said yes, he was gone, and they were going to confirm with another ultrasound. I'm thinking why wait so many hours after to do an ultrasound, why not do a c-section?"

During a review of Pt 1's face sheet, dated 4/19/23, Pt 1's face sheet indicated Pt 1 was a 36-year-old female who was admitted on 3/14/24 for the following diagnosis of Normal labor.
During a concurrent interview and record review on 4/9/24 at 3:20 p.m. with Obstetric Emergency Department (OB ED) Registered Nurse (RN 5), Pt 1's medical record was reviewed. The record indicated Pt 1 was 40 weeks and two days pregnant with her fourth baby. Review of the "Labor and Delivery [L&D] Timeline" indicated Pt 1 came to the OB ED on 3/14/24 at 4:38 p.m. with a chief complaint of contractions which started at 3 a.m. that morning. Pt 1 was moved from the waiting room to a bed in the OB ED at 4:45 p.m. The L&D Timeline indicated at 5 p.m., an external fetal monitor was in place and the fetal heart rate (FHR) was 140 beats per minute (bpm). There was no assessment of the unborn baby's FHR variability, presence, or absence of accelerations and/or decelerations, or characteristics of uterine contractions. Pt 1's pain level was 7/10 (meaning on a scale of 1 to 10, pain level was 7, or moderate to severe pain). At 5:02 p.m., a cervical exam indicated Pt 1 was dilated to 6 cm, intact membranes, 70% effaced (effacement- thinning and shortening of the cervix), and the presenting part was at a minus 2 station (The location of the baby's presenting part [head] is in relationship to the ischial spines of the pelvis). At 5:05 p.m., admission orders were entered into the electronic health record (EHR) by RN 4 as "Telephone orders with readback [when the physician gives orders over the phone to the RN, and the RN reads those orders back to the physician to confirm accuracy]." The orders included intravenous (IV) fluid, lab tests, medications for pain and an order for an epidural. At 6:54 p.m., RN 4 documented a provider notification note for 5:09 p.m. which indicated "Provider in [Operating Room] OR, RN to enter orders." RN 5 stated there is no documentation in the record indicating RN 4 spoke with the obstetrician (MD 2) or attempted to contact MD 2. RN 5 stated if an RN needed to communicate with a physician who was in the OR, a call could be made into the OR to directly speak with the physician, or to a nurse in the OR. RN 4's note indicated Pt 1 was having contractions every 1-5 minutes lasting 60-90 seconds, the FHR was 140 bpm, with absent accelerations and minimal variability. RN 4's note also indicated Pt 1 requested an epidural and that this request was communicated by RN 4 to the Practice Coordinator (PC 2) in L&D. At 5:42 p.m., RN 4's note indicated the FHR was 145 bpm, minimal variability, absent accelerations, and variable decelerations. Fetal monitoring was discontinued at 5:42 p.m. There was no indication that RN 4 attempted to notify MD 2 of the minimal FHR variability or absent accelerations for the 42 minutes of fetal monitoring, or the variable deceleration.

During a concurrent interview and record review on 4/9/24 at 3:55 p.m. with OB ED RN (RN 5), Pt 1's medical record was reviewed. Review of the L&D timeline indicated Pt 1 was transferred from the OB ED on the fourth floor to labor and delivery on the sixth floor at 6:04 p.m., with report given by RN 4 to L&D RN (RN 2). RN 5 stated there is nothing else documented from 5:42 p.m. until 6:09 p.m. when vital signs were obtained, and no documentation of fetal status after 5:42 p.m. The record indicated a consent form for anesthesia was signed by Pt 1 at 6:10 p.m. and review of the anesthesiologist (MD 4) notes indicated at 6:23 p.m. an epidural catheter was placed and at 6:25 p.m. the epidural medication was started. The fetal monitor strips beginning at 6:04 p.m. did not reflect a baseline fetal heart rate. RN 5 stated there was no documentation of an assessment of the FHR after 5:42 p.m., and no assessment by the obstetrician (MD 2) prior to placement of the epidural. Review of RN 10's notes indicated at 6:25 p.m. RN 10 repositioned Pt 1 following epidural placement and attempted unsuccessfully to obtain a FHR. The OB ED on-call physician (MD 2) was notified and was at Pt 1's bedside at 6:36 p.m. MD 2 performed a bedside ultrasound and confirmed there was no FHR. Review of MD 2's OB history and Physical dated 3/14/24 at 6:59 p.m. indicated, "...I was called to the bedside in my role as the OB ED Laborist to assess an urgent issue, the inability to find fetal heart tones. This was the first time I was notified that the patient was admitted for active labor..." A review of MD 2's OB Vaginal Delivery Note dated 3/15/24 at 12:01 a.m., indicated Pt 1 had delivered a stillborn male infant at 11:33 p.m. on 3/14/24 with a "There was a large 6 inch clot noted in the cord at the fetal insertion...Intact placenta delivered on 3/14/24 at 11 :36 p.m. Membranes were meconium stained..."

During a review of the fetal monitor strip dated 3/14/24 beginning at 5 p.m. and ending at 5:42 p.m., the monitor strip indicated a baseline fetal heart rate of 140-145 bpm, minimal FHR variability, and no FHR accelerations. At 5:36 p.m., the monitor strip indicated a variable deceleration. There were also several instances where the heart rate did not record, at 5:05 p.m. for less than one minute, at 5:09 p.m. for approximately two minutes, at 5:23 p.m. for less than one minute and at 5:29 p.m. for approximately two minutes. The monitor strip stops at 5:42 p.m. and 50 seconds and does not resume until 6:04 p.m. A review of the fetal monitor strip dated 3/14/24 beginning at 6:04 p.m. and ending at approximately 6:16 p.m., indicated between 6:04 p.m. and 6:08 p.m. a baseline FHR could not be determined, and from 6:08 p.m. until 6:16 p.m. there is sporadic recording of a heart rate of 100-110 bpm and there are no corresponding nurses notes to provide an explanation for what is reflected on the monitor strip, and no indication in the record that the maternal pulse was assessed at the same time as the fetal heart rate in order to ensure the fetal heart beat was correctly identified.

During a concurrent interview and record review on 4/11/24, at 3 p.m., with Registered Nurse (RN) 4, Pt 1's electronic health records (EHR) for her admission on 3/14/24 was reviewed. RN 4 stated she was the primary OB ED nurse for Pt 1 on 3/14/24; Pt 1 arrived in the OB ED and presented in active labor, dilated to 6 cm, and having painful contractions. RN 4 stated she never contacted the in-house OB ED physician who was covering for Pt 1's obstetrician. RN 4 stated she knew the in- house physician was in the OR (operating room) in a c-section and did not want to disturb her, so she put in the "telephone orders with readback" knowing that this was not true. RN 4 stated she did not get admitting orders to include the epidural orders from the doctor and did not read them back to anyone and she knew this was wrong. RN 4 stated she knew she could call into the OR and either speak with the doctor or the nurse and relay that this patient was here, and she needed orders, but she just did not do that. RN 4 stated she moved Pt 1 up to Labor and Delivery (L&D) and recalls giving report, but it did not include the reviewing the fetal heart rate monitor strip which reflected a category 2 tracing (category 1 is normal baby heart rate 110-160, moving; category 2 minimal movement of baby's heart rate still 110-160 but concerning- needs to be addressed). RN 4 stated, "it was inappropriate" of her to have not reviewed the FHR strip with the nurse receiving Pt 1.

During an interview on 4/11/24 at 4:25 p.m. with RN 10, RN 10 stated she was the L&D nurse who received Pt 1 from OB ED on 3/14/24. RN 10 stated PC 2 told her Pt 1 was going to have an epidural. RN 10 stated she met RN 4 and Pt 1 at the elevator and received report from RN 4. RN 10 stated she was provided a brief report about Pt 1 and was told Pt 1 wanted an epidural. RN 10 stated she did not receive report regarding the status of the baby including the FHR tracing. RN 10 stated she would have expected to be informed if there were any concerns about the baby. RN 10 stated she assumed RN 4 notified the physician and obtained orders from the physician. RN 10 stated the anesthesiologist was getting set up when Pt 1 arrived in L&D. Pt 1 went to the bathroom and came back and sat on the side of the bed for the epidural procedure. RN 10 stated she was positioned at bedside down in front of Pt 1 and held the ultrasound from the fetal monitor up against Pt 1's abdomen in an attempt to obtain the fetal heart rate while the epidural was being placed. RN 10 stated she did not look at the fetal monitor during the epidural while she held the ultrasound on pt 1's abdomen and thought at the time she was hearing the fetal heartbeat. RN 10 stated after the epidural was in, she repositioned Pt 1 lying down and then attempted to obtain the FHR but did not detect a heartbeat. RN 10 stated she did Leopold's maneuvers (abdominal palpation used to determine fetal presentation) but did not feel any fetal movement. RN 10 stated she called for assistance and MD 2 was called to the bedside. RN 10 stated MD 2 performed an ultrasound and did not detect a heartbeat.

During an interview on 4/16/24 at 1:40 p.m. with PC 2, PC 2 stated she was the PC on the day shift in L&D on 3/14/24. PC 2 stated she was notified that Pt 1 was in the OB ED, was in active labor and needed a bed. PC 2 stated she was also contacted by RN 4 to notify her that Pt 1 had requested an epidural, so PC 2 could let the anesthesiologist in L&D know for planning purposes. PC 2 stated that was the extent of the information she was given about Pt 1 and did not know the fetal monitor strip in OB ED indicated a Category II tracing. PC 2 stated she was called after RN 10 could not find a FHR after the epidural was placed. PC 2 stated she did not find out until after the dayshift ended at 7:30 p.m. that RN 4 did not call MD 2 to notify her of Pt 1's arrival, contractions, cervical exam, and results of fetal monitoring, and did not obtain telephone orders from MD 2 for admission and an epidural. PC 2 stated if she was asked for help contacting a physician who was in the OR, she would have done that. PC 2 stated she expected the RN in OB ED to provide report to the L&D RN regarding the well-being of the patient and the baby including a review of the fetal monitor strip, and to have notified the physician and obtained orders for admission and labor prior to transferring the patient to L&D. PC 2 stated fetal well-being should be determined prior to a labor epidural being placed.

During an interview on 4/16/24, at 3:20 p.m., with the Interim OB Director (OBD), the OBD stated she expects that a RN to RN report at transfer includes a review of the fetal monitor strips. OBD stated a nurse should never indicate an order was obtained from a physician by telephone unless it was. OBED stated of course MD2 should have been notified of Pt 1, including the results of the fetal monitoring while Pt 1 was in the OB ED. The OBD stated fetal well-being should be established prior to the patient receiving an epidural.
During an interview on 4/16/24 at 10:35 a.m. with the Chief Medical Officer (CMO), the CMO stated in a hospital with in-house obstetrician coverage twenty-four hours a day and the capability for fetal monitoring twenty-four hours a day, an intrapartum fetal death should not occur.

During a review of the State of California Certificate of Fetal Death issued on 4/8/24, the certificate indicated, "...THIS FETUS- DATE OF EVENT [Fetal Death]: 3/14/2024 HOUR: 1800 [6 p.m.] ..." The Certificate of Fetal Death was signed by MD 2 on 4/2/24.

During a review of the [Name of Hospital] website accessed 4/12/24 at 6:46 p.m., the website indicated, "As part of our vision to elevate the level of care and service we provide to expectant moms, [Name of hospital] is proud to provide the Central Valley area's only OB Emergency Department (OBED) that is staffed 24/7, 365 days a year, with Board Certified OB/GYN hospitalists. If you are greater than 20 weeks and have an urgent or emergent pregnancy-related need, take comfort in knowing that you will be seen by one of our OB/GYN hospitalists or your personal OB/GYN - regardless of time, complications, or circumstances."

During a review of the P&P titled, "Care of the Obstetrical Emergency Department [OB ED] Patient," dated 6/20, the P&P indicated, "...Patients that are 20 weeks gestation or greater that present to the OB ED with obstetrical complaints other than scheduled Inductions/Cesarean sections, may be assessed and observed for no more than four (4) hours in the OB ED...A qualified Obstetrical triage nurse will briefly and accurately evaluate all patients based upon urgency of complaints or time of arrival if equal urgency, including but not limited to chief complaint and clinical status, using the Maternal Fetal Triage Index (MFTI a 5-level system to facilitate the care of pregnant women seeking care in an obstetrical triage unit [priority 1 being the highest acuity and priority 5 being the lowest acuity])...After triage assessment, patients who do not require immediate care shall be assigned to an exam room as soon as possible...Continuous fetal monitoring will be initiated as applicable for pregnancy gestations 24 weeks or greater, and a Non-Stress Test [NST] conducted to evaluate fetal heart rate, variability, presence of periodic and/or episodic patterns, fetal movement and presence of contractions...A complete nursing assessment shall include, but is not limited to maternal physical status, fetal status, labor status, psychosocial needs and patient interview...The primary Physician/On-call Physician/Hospitalist shall be notified after the initial assessment is complete..."

During a review of the P&P titled, Scope of Services for the Obstetrical Emergency Department," dated 4/20, the P&P indicated, "...The OB ED is open for service to Obstetrical patients, physicians and staff twenty-four (24) hours a day, seven (7) days a week. Then OB ED delivers care to pregnant patients of all ages, 20 weeks gestation or greater, who are experiencing uncomplicated emergency and/or remedial problems associated with pregnancy...The [Name of Hospital] OB ED shall fulfill the following responsibilities: a. Assessment, evaluation, management, and treatment, that is appropriate and timely to patients with obstetric conditions. b. Definitive care for those patients not requiring greater in-depth expertise or follow-up care. c. Provision of care that begins in the prehospital setting (provided by EMS), continues in the OB ED, and concludes with responsibility for the patient transferred to the Labor and Delivery [L&D] Unit, another unit, to another physician, or the patient is discharged...The Obstetrical Unit of ED will be covered by Board Certified OB/GYNs to include private physicians and OB Hospitalist program. The Hospitalist group will remain in hospital 24/7 to provide emergency coverage and provide medical care to the uninsured, no established prenatal care patients...Patients are triaged upon arrival, they are seen on the basis of acuity, otherwise they are treated on a first-come, first-served basis...All patients entering the OB ED shall be assessed by an RN...Patients will be classified according to the Maternal Fetal Triage Index..."

During a review of the policy and procedure (P&P) titled, Epidural Anesthesia For Labor Patients, Patient Controlled," dated 12/21, the P&P indicated,"...PURPOSE: To provide guidelines to nursing staff in assisting the anesthesiologist with epidurals for Labor and Delivery, considering care for mother and unborn fetus. POLICY: Continuous epidural anesthesia is administered by a qualified provider as described by the American Society of Anesthesiologists...Candidates for epidural anesthesia will be agreed upon by the anesthesiologist and the obstetrician. PROCEDURE: Pre-Procedure by RN: Apply Fetal Monitor and assess the FHR. Notify the obstetrician and obtain an order of patient request for epidural anesthesia. Notify anesthesiologist assigned to labor and delivery...Assess the fetal heart rate as continuous as possible during the procedure...Monitor fetal heart rate and contractions continuously during epidural infusion..."

During a review of the policy and procedure (P&P) titled, "Fetal Heart Rate And Uterine Surveillance," dated 8/23, the P&P indicated, "... Procedure for External EFM Ultrasound Application- Validate the fetal heart rate by auscultation before placing the transducer. Assess and confirm FHR baseline rate, baseline variability, and FHR pattern characteristics [presence or absence of accelerations and/or decelerations], and interventions as appropriate using the NICHD definitions. Differentiate fetal heart tracing with maternal heart rate upon admission and as clinically indicated. This can be done by checking the mother's pulse, or briefly with the pulse oximeter.... Include in RN and OB Provider shift handoff communications: Admission FHR and uterine pattern, Current FHR and uterine pattern, and Significant events and interventions in labor ...All patients presenting to Labor and Delivery units at viability should undergo an initial period of electronic fetal monitoring for a minimum of 20 minutes or until fetal well-being is assured after the MFTI (maternal fetal triage index) is assigned. Monitoring for longer periods may be continued depending on the clinical circumstances... Documentation regarding assessment of FHR pattern and uterine activity: Use the full description of the FHR tracing per NICHD definitions to include FHR baseline rate, baseline variability, and FHR pattern characteristics (presence or absence of accelerations and/or type of decelerations), and interventions as appropriate. Document the actions taken to maintain a continuous FHR tracing and/or uterine activity tracing ... Manage the FHR patterns based upon the interpretation of the tracing ... Management algorithm for intrapartum fetal heart rate [FHR] tracing. Category II-evaluation and surveillance. Absent FHR accelerations and Absent/Minimal FHR variability- Initiate intrauterine resuscitation as appropriate for Category II patterns and document interventions...Documentation regarding Indeterminate (Category II) / Abnormal (Category III) FHR Patterns includes duration of the indeterminate/abnormal FHR pattern, clinical context (e.g. tachysystole, maternal hypotension, maternal temperature, bleeding, medications, etc.), specific intrauterine resuscitation measures implemented and the maternal- fetal response, and notification of the OB Provider and the content of the conversation. Examples of Category II FHR tracings include any of the following: ...Minimal baseline variability [Minimal variability- Amplitude range is greater than undetectable and less than or equal to 5 bpm] ..."

During a review of the policy and procedure (P&P) titled, "Orders Management," dated 1/2020, the P&P indicated, "...Telephone /Verbal Orders are accepted in limited situations: A. Communication of orders by this method is limited to urgent situations where immediate written or electronic communication is not feasible. B. The appropriate communication type (Telephone or Verbal) is selected. C. The entire order is entered and then read back and confirmed to the ordering Licensed Independent Practitioner [LIP]..."
During a review of the professional reference titled, "American College of Obstetricians and Gynecologists Committee Opinion Number 667, Hospital-based Triage of Obstetric Patients," dated 7/2016 (reaffirmed 2020), the reference indicated, "...An individual or individuals determined qualified as designated by hospital policy must perform an appropriate medical screening examination to determine whether the patient has an emergency medical condition. This determination should take into account the health of the woman and the fetus..."

During a review of the professional reference titled, "American Society of Anesthesiologists Statement on Neuraxial Analgesia or Anesthesia in Obstetrics," dated 10/13/21, the reference indicated, "...Neuraxial analgesia or anesthesia should not be administered until: 1) the patient has been examined by a qualified individual; and 2) a physician with obstetrical privileges to perform operative vaginal or cesarean delivery, who has knowledge of the maternal and fetal status and the progress of labor and who agrees with the initiation of labor analgesia, is readily available to supervise the labor and manage any obstetric complications that may arise. Under circumstances defined by department protocol, qualified personnel may perform the initial pelvic examination. The physician responsible for the patient's obstetrical care should be informed of her status so that a decision can be made regarding present risk and further management. Neuraxial analgesia for labor and/or vaginal delivery requires that the parturient' s vital signs and the fetal heart rate be monitored and documented by a qualified individual..."

During a review of the professional reference titled, "Practice Guidelines for Obstetric Anesthesia An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology," dated 2/2016, the reference indicated, "... Conduct a focused history and physical examination before providing anesthesia care. This should include, but is not limited to, a maternal health and anesthetic history, a relevant obstetric history, a baseline blood pressure measurement, and an airway, heart, and lung examination, consistent with the ASA "Practice Advisory for Preanesthetic Evaluation." A communication system should be in place to encourage early and ongoing contact between obstetric providers, anesthesiologists, and other members of the multidisciplinary team. Fetal heart rate patterns should be monitored by a qualified individual before and after administration of neuraxial analgesia for labor..."

During a review of the professional reference titled, " AHRQ Publication No. 17-0003-18-EF, AHRQ Safety Program for Perinatal Care- Monitoring for Perinatal Safety: Electronic Fetal Monitoring [EFM]," dated 5/17, the reference indicated, "...Key Safety Elements that support the safe use of EFM:...Teamwork Training-Components of Teamwork Training... Situational awareness during use of EFM refers to all staff caring for the patient knowing what the patient's plan is through briefings and team management, being aware of what is going on and what is likely to happen next, and what resources are available if needed. In the context of EFM, situational awareness is particularly relevant for Category II tracings, where continued surveillance is often required before a definitive course of action can be determined, and staff need to know what resources are available to them should the patient's status suddenly change...Use of transition communication techniques to ensure a shared mental model of plan of care and perceived risks between shifts or between units..."

During a review of the professional reference titled, " National Library of Medicine StatPearls: Fetal Monitoring," dated 1/24, the reference indicated, "...During the first two stages of labor, fetal circulation is subject to compression as the fetus changes position and as uterine contractions occur, and this has the potential to lead to hypoxia and/or acidosis, which may induce fetal distress predisposing to poor outcomes. In monitoring the fetal status, clinicians should pay attention to the baseline fetal heart rate (FHR), variability, accelerations, and decelerations. Category II patterns may involve tachycardia, bradycardia, reduced or marked variability, and/or occasional variable or late decelerations. These patterns may indicate a wide range of fetal and maternal disorders and prompt further investigation into the underlying cause and may necessitate maternal or fetal resuscitation. Category II patterns may resolve spontaneously to become category I, at which point no intervention is necessarily warranted. However, closer observation is needed as the pattern may deteriorate to category III ..."

2. During a concurrent interview and record review on 4/19/24 at 10:00 a.m. with Manager (Mgr) 4, the Electronic Medical Record (EMR) for Patient (Pt) 3 was reviewed. The facility document titled, "ED (Emergency Department) Provider Notes" dated 4/13/2024 at 5:03 a.m. by MD 12 indicated, "History of present illness: 36-year-old female with history of arthritis, anxiety, and depression BIBA (brought in by ambulance) with a complaint of AMS (altered mental status - not thinking or acting as usual.) ... history of heavy alcohol abuse but no known medical problems EMS (Emergency Medical Service) ... noticed numerous empty vodka and beer containers with patient appearing altered. Upon arrival I was able to appreciate patient with [symptoms of] withdrawing from alcohol ...initiate CIWA protocol (CIWA, Clinical Institute Withdrawal Assessment for Alcohol is an assessment tool used by doctors and nurses designed to evaluate the intensity of alcohol withdrawal symptoms and gives guidance on medication management based on the CIWA score.) During a review of MD 12's orders dated 4/13/24 at 5:46 a.m., an order for a CIWA protocol was initiated with an expiration date of 4/16/24.

During a concurrent interview and record review on 4/19/24 at 11:00 a.m. with the Director of Emergency Department (Dir 2), Dir 2 reviewed the laboratory (lab) blood test orders and stated the first blood draw on 4/13/24 at 6:03 a.m. for electrolytes (necessary minerals in blood and other body fluids that carry an electric charge) Pt 3's potassium (K+ - one of the electrolytes) and results were called to MD 12 on 4/13/24 at 6:51 a.m. Pt. 3's K+ level was reported as a dangerously low level of 2.0 (normal range is 3.5-6.2.) On 4/13/24 at 7:07 a.m., MD 12 ordered intravenous (IV) K+ to infuse at 10 mEq (milliequivalents - a unit of measure) in 100 mL fluid per hour over the next 8 hours. MD 12 also ordered 40 mEq of K+ to be given PO (by mouth) at the same time. At 3:04 p.m., Pt 3's blood was redrawn and her K+ was 2.2, a very slight increase. At 3:57 p.m., MD 8 ordered, "Potassium chloride 40 mEq PO x 2 doses" and the first dose was given at 3:58 p.m. The EMR indicated, Pt 3 was then transferred from the ED to 2 West, an acute medical unit and was placed on a telemetry monitor (wires attached to the chest to monitor heart rate and rhythm.) Pt 3 arrived on 2 West at 5:51 p.m. and received her second dose of potassium chloride 40 mEq PO at 6:05 p.m., completing the order from the ED. Dir 2 was unable to find an order to recheck Pt 3's K+ level until 4:03 a.m. the next morning on 4/14/24, and there was no order for additional K+ medication.

During a concurrent interview and record review on 4/19/24 at 10:32 a.m. with the Manager of 2 West (Mgr 2) and Mgr 4, Mgr 2 reviewed the EMR for Pt 3 and stated no K+ was given after 6:05 p.m. on 4/13/24 and no repeat lab draw was done until 4:13 am on 4/14/24. The CIWA order set (preapproved physician orders for patient's experiencing alcohol withdrawal) was reviewed. The document titled, "Initiate CIWA-Ar assessment (Order 1021465339)" indicated, "Comments: Initiate CIWA-AR Assessment 1. If score is LESS than 10 (mild to no withdrawal symptoms); reassess every 2 hours x 2, then every 4 hours ..." Mgr 2 stated the nursing documentation indicated. Pt 3 had a CIWA score of 6 at 5:39 p.m., and a score of 8 at 7:12 p.m. There is no documentation indicating the nurses continued to assess Pt 3 and no further CIWA scores are in the chart. Mgr 2 stated with the score increasing from 6 at 5:39 p.m. to 8 at 7:12 p.m., the patient should have been reassessed two hours later at about 9:12 p.m. to ensure that the score wasn't continuing to increase. Mgr 2 stated there was no assessment at 9:12 p.m., and no further assessments throughout night. The nurses note dated 4/14/24 at 12:20 a.m. by RN 2 was reviewed. The nurses note indicated, " ...End of shift summary: maintained on CIWA monitoring, refused remote telemetry monitoring MD aware, continue with plan of care, hourly rounding ..." Mgr 2 stated the night shift did not end until 07:30 a.m. on 4/14/24. The text message from Registered Nurse (RN) 2 sent to MD 9 on 4/13/24 at 10:07 p.m. was reviewed. The text message indicated, patient is "refusing to keep her remote telemetry monitor on, we had been replacing it back several times, but she keeps on removing it claiming that the leads make her itchy. She had been asking if she can go home tonight but we told her that it will be against medical advice. She said she'll think about it and does not want the monitor on." MD 9 responded with "okay that's fine." RN 2 checked Pt 3's vital signs at midnight, and Pt 3's heart rate was 107 beats per minute, a fast heart rate. Pt 3's heart rate at 2:30 a.m. was 114 beats per minute. Pt

Based on interview and administrative record review, the hospital failed to implement and maintain an on-going, comprehensive, data-driven Quality Assurance and Performance Improvement (QAPI) program to improve both quality and safety when the hospital did not maintain a QAPI program which evaluated and monitored the safety of all of its services and the quality of patient care, with data collection and analysis, monitoring of implementation, and tracking performance to ensure that improvements are sustained.

Review of recent past surveys for this facility indicated:

1.) During a survey dated 8/4/23, the facility was found to be in substantial non-compliance with 263 QAPI due to the facility failing to use data collected to identify opportunities for improvement.

2.) During a survey dated 10/16/23, the facility was found to be in substantial non-compliance with 263 QAPI due to the facility failing to analyze causes and implement preventive measures following an adverse event.

3.) During a revisit survey dated 1/25/24 (combined revisit for 1 and 2 above), the facility was found to be in substantial non-compliance with 263 QAPI when the facility failed to take actions aimed at performance improvement when corrective actions listed on a Plan of Correction (POC) for surveys 1 and 2 and were not implemented.

4.) The POC for the revisits has not yet been accepted.


During this current survey, the facility was found to be in substantial non-compliance with 263 QAPI due to the facility failing to have an active and effective QAPI program. Previous Plans of Correction and survey findings have not prompted effective quality improvement projects to make a difference in overall compliance.

During an interview on 4/25/2024 @ 3:00 p.m. with the Board of Directors, the CEO of the West Region (CEO) stated, "when I started about a year ago, we assessed the organization and saw there were gaps in quality as they had not filled key positions, and those who were in the positions did not have the expertise for the challenges we faced." The CEO stated they have been "regulatory crisis" for the last year. The CEO stated, "we are not where we want to be."

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality patient care in a safe environment.

Based on interview and record review, the hospital failed to develop a program to analyze indicators to improve health outcomes when there was no process in place to review and analyze quality indicators across the hospital. Data was collected in some individual departments, but the information was not reported up to the Quality Department for review and analysis.

This failure resulted in the hospital not identifying and acting on critical incidents that could affect all inpatients' health and well-being.

Findings:

During a concurrent interview and record review on 4/18/24 at 8:45 a.m. interview with the Director of Quality (DQ) the Quality Assurance and Performance Improvement (QAPI) Plan was reviewed. The DQ stated, "I'm going to be honest with you. We have a plan that has been developed, but it hasn't been approved or implemented yet." The DQ stated they have not been meeting as a group to review and analyze quality indicators or department projects. The DQ stated the Emergency Department has a robust project they have been working on, but they are the only department that has been reporting consistently. The DQ stated she just started to work at this facility last month, and the documentation prior to her arrival was not organized in a way that she would consider a QAPI program. She stated the hospital Quality Committee has not met for a long time and she could not produce minutes for any meetings.

During a concurrent interview on 4/26/24 at 10:00 a.m. with the hospital leadership team, the CMO stated he was present in August 2023 when the California Department of Public Health (CDPH) identified similar concerns with the hospital's Quality Assurance and Performance Improvement (QAPI) Program.

Based on interview and record review, the hospital failed to have an organized nursing service when:

1. One of three sampled patients (Pt 3) was not assessed for alcohol withdrawal symptoms and a low serum potassium (an electrolyte in the body that is important for the function of nerves and muscles -- normal value 3.6 to 5.2 mmol/L (millimoles per liter)) lab value and was not addressed with follow up and more analysis of the clinical condition of the patient as per hospital policy.

2. Three of five patients sampled (Patient (Pt) 1, Pt 23, and Pt 24) had epidurals (an injection in your back to stop you feeling pain in part of your body) placed and the hospital policy was not followed. Pt 1's baby fetal heart tones (FHT) were not being monitored appropriately. (refer to A398)

3. Two of 10 sampled patients (Pt 26 and Pt 27) had orders for telemetry monitoring (continuous tracking of your heartbeat) and monitoring was not done appropriately per the hospital policy. (refer to A398)

4. One of one certified registered nurse anesthetist (CRNA 1) was observed placing an epidural in Pt 4 and not performing proper hand hygiene when CRNA 1 was seen removing dirty gloves and then placed on sterile gloves without performing hand hygiene in-between. (refer to A398)

5. One of three patients sampled (Pt 2) had a low serum glucose (sugar in the blood - normal value 70 to 100 mg/dL (milligrams per deciliter)) lab value and was not addressed with follow up and more analysis of the clinical condition of the patient. (refer to A398)

6. One of 10 patients sampled patients (Pt 7) were not assessed or re-assessed for pain before or after the administration of pain medication per hospital policy and procedure. (refer to A398)

7. One of 4 sampled patients (Pt 10) did not have vital signs documented every four hours as required by the clinical condition of the patient and per hospital policy and procedure. (refer to A398)

8. One of 10 sampled patients (Pt 25) had two consents for procedures/surgeries that were not signed and or witnessed appropriately per the hospital policy. (refer to A398)

9. The hospital failed to develop and keep current care plans for three of 10 patients in accordance with the policy "Patient Care Policy and Procedure - Documentation". The primary care needs related to safety for Pts 6, 15 and 19 were not assessed and developed and not documented in the patients' care plans. (refer to A396)

Because of the serious actual harm to Patient 3 when nurses did not following hospital policies and procedures and did not to follow up on critical labs an Immediate Jeopardy (IJ) situation was called on 4/19/24 at 6:00 p.m., under Code of Federal A 0398 §482.42 in the presence of the President and Market Leader, the Chief Nursing Officer, The Chief Medical Officer, and the Director of Quality were provided the IJ template which documented the immediate actions necessary to address the IJ situation. The hospital submitted an acceptable plan of removal to address the IJ situation. Plan of removal was accepted on 4/22/24 at 3:30 p.m. Survey team's observations and interviews validated the hospital implemented appropriate corrective actions and the IJ was removed on 4/22/24 at 5:00 p.m. in the presence of the Director Quality and the Manager of Quality and Accreditation. Following the IJ removal, the facility remained in substantial non-compliance.

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality health care by the nursing staff.

Based on interview and record review, the hospital failed to develop and keep current care plans for three of 10 patients in accordance with the policy "Patient Care Policy and Procedure - Documentation". The primary care needs related to safety for Pts 6, 15 and 19 were not assessed and developed and not documented in the patients' care plans.

This failure had the potential to result in Patient 6, 15, and 19's care needs going unmet.

Findings:

1. During a concurrent interview and record review of Pt 6's electronic health record (EHR- digital collection of medical information) on 4/18/24, at 12:40 p.m., Pt 6's "History and Physical (H&P -- the formal document that physicians produce through the interview with the patient, the physical exam, and the summary of the testing either obtained or pending)", dated 4/16/2024 at 8:05 a.m. and "Education [Nursing Care Plan]", dated 4/16/2024, were reviewed with the Director of Medical/Surgical (Dr1) and Practice Coordinator, 2 West (PC1). Pt 6's H&P indicated Pt 6 was brought to the hospital "with a past medical history significant for generalized anxiety disorder [mental health condition that causes fear, a constant feeling of being overwhelmed and excessive worry about everyday thing], ADHD [Attention Deficit Hyperactivity Disorder -- differences in brain development and brain activity that affect attention, the ability to sit still, and self-control] and intolerance to multiple psychotropic medications [drug that affects how the brain works and causes changes in mood, awareness, thoughts, feelings, or behavior]; who was brought into us by ambulance secondary to hydroxyzine [drug that prevents the effects of a histamine (a bodily substance released during an allergic reaction)] overdose with suicidal ideation. The patient consumes approximately 14 tabs of unknown dosage ... She was initially put on 5150 [temporary, involuntary psychiatric commitment of individuals who present a danger to themselves or others due to signs of mental illness] secondary to suicidal ideation ... At this time patient will be kept for observation for suicidal ideation. ... Suicidal ideation ... One-to-one sitter [health care worker assigned to provide one to one nursing or observation care to an individual patient for a period of time] ...". Pt 6's "Education [Nursing Care Plan]" indicated, " ... Acute Pain, ... Cognitive: Tissue Perfusion, Cerebral [education related to a stroke] ... First Dose Education ..." as the focused care problems for nursing interventions. Dir1 stated, the care plan does not address the major reason for the admission. Dir1 stated, there should be a focus in the nursing care plan that addresses the patient's safety related to the suicide ideations. Dir1 stated nurses are expected to develop a care plan that matches and guides the care of the patient.

2. During a concurrent interview and record review on 4/18/24, at 9:15 a.m., with Manager of Intensive Care (Mgr 4), Pt 15's Cardiology Consult (a note from a physician who specializes in heart conditions) and Pt 15's Plan of Care were reviewed with the Mgr 4. The Cardiac Consult, dated 3/31/2024 at 3:02 p.m., indicated Pt 15 was a 77-year-old woman who came into the Emergency Department (ED) on 3/30/24 at 5:47 with pneumonia (an infection of one or both of the lungs caused by bacteria) and was admitted to the hospital. The cardiologist was consulted 3/31/24 at 3:02 p.m. The Cardiology Consult note indicated, " ...Known history of afib (atrial fibrillation - the upper chambers of the heartbeat irregularly which can lead to heart failure and stoke)) and diastolic heart failure (the heart can not properly fill with blood during the resting period between each beat. The document titled Care Plan was reviewed. The Care Plan did not include any plans related to Pt 15's heart disease. Mgr 10 stated, "there should be a care plan that addresses cardiac output (amount of blood pumped by the heart minute) because she had a significant cardiac history."

3. During a concurrent interview and record review on 4/18/24 at 1:50 p.m, with Mgr 7, Pt 19's H&P dated 3/21/24 at 5:32 p.m., indicated Pt 19 was a 78-year-old man who came to the ED 3/21/2024 at 5:32 p.m. with a chief complaint of urinary retention (patient unable to urinate when bladder is full.) Pt 19 had a history of BPH (benign prostatic hyperplasia - the prostate gland enlarges and can block the urine stream,) CKD stage IV (severe kidney disease,) hypotension (low blood pressure) and type 2 diabetes (common condition that causes the level of sugar (glucose) in the blood to become too high).The document titled Care Plan was reviewed. The Care Plan did not include any plans related to Pt 19's urinary retention, kidney disease, or diabetes. Mgr 7 stated this care plan is incomplete. It should include interventions for urinary retention and for diabetes, because the main reason he came to the hospital was for urinary retention.

During an interview on 4/26/24, at 10:10 a.m., with the Chief Nursing Officer (CNO) and the Quality Director (QD) and the Chief Medical Officer (CMO), care plans for Pt's 6. 15, and 19 were reviewed. The CNO stated, the nursing care plan should address the main complaint for admission. The CNO stated, the nursing care plan should address the main care needs of the patient. The CNO stated, the nurses are expected to follow the policy to documenting and updating the care plan.

During a review of the facility policy and procedure (P&P) ""Patient Care Policy and Procedure - Documentation", dated 10/2022, the P&P indicated, " ... lnterprofessional Plan of Care (IPOC) is initiated and updated within the first 4 hours of patient's arrival to the unit and reviewed once a shift. A Problem Specific IPOC and a Transitional Care IPOC are initiated on all inpatients. ..."

The "Lippincott Manual of Nursing Practice 10th Edition," dated 2014, page 16-17 indicated, " Standards of practice General Principles... 1. The practice of professional nursing has standards of practice setting minimum levels of acceptable performance for which its practitioners are accountable ...b. These standards provide patients with a means of measuring the quality of care they receive ...5. A deviation from the protocol should be documented in the patient's chart with clear, concise statements of the nurse's decisions, actions, and reasons for the care provided, including any apparent deviation ... Legal claims most commonly made against professional nurses include the following departures from appropriate care: failure to assess the patient properly or in a timely fashion, follow physician orders, follow appropriate nursing measures, communicate information about the patient, adhere to facility policy or procedure, document appropriate information in the medical record ... Failure to formulate or follow the nursing care plan ..."

45977


Based on observation, interview, and record review the hospital failed to follow the following policies and procedures when:

1. Three of five patients sampled (Patient (Pt) 1, Pt 23, and Pt 24) had epidurals (an injection in your back to stop you feeling pain in part of your body) placed and the hospital policy was not followed. These failures resulted in Pt 1's baby fetal heart tones (FHT) not being monitored appropriately and possibly a contributing factor in the Pt 1's baby's death and placed both Pt 23 and Pt 24 at risk of a possible adverse reaction to having their epidurals removed without proper monitoring.

2. One of 3 sampled patients (Pt 3) was not assessed for alcohol withdrawal symptoms and a low serum potassium (an electrolyte in the body that is important for the function of nerves and muscles -- normal value 3.6 to 5.2 mmol/L (millimoles per liter)) laboratory (lab) value and was not addressed with follow up and more analysis of the clinical condition of the patient. These failures resulted in Pt 3's not being monitored appropriately and possibly a contributing factor in the Pt 3's death.

3. Two of 10 sampled patients (Pt 26 and Pt 27) had orders for telemetry monitoring and monitoring was not done appropriately per the hospital policy. These failures place Pt 26 and Pt 27 at risk of not having their heart rhythm monitored and thus placing them at risk of having irregular rhythms affecting their health.

4. One of one certified registered nurse anesthetist (CRNA 1) was observed placing an epidural in Pt 4 and not performing proper hand hygiene when CRNA 1 was seen removing dirty gloves and then placed on sterile gloves without performing hand hygiene in-between. This failure placed Pt 4 at risk of infection in Pt 4 epidural site.

5. One of 3 patients sampled (Pt 2) had a low serum glucose (sugar in the blood - normal value 70 to 100 mg/dL (milligrams per deciliter)) lab value and was not addressed with follow up and more analysis of the clinical condition of the patient. This failure had the potential to miss a change of condition for Pt 2.

6. One of 10 patients sampled patients (Pt 7) were not assessed or re-assessed for pain before or after the administration of pain medication. This failure had the potential to leave patients with uncontrolled pain and/or oversedation.

7. One of 4 sampled patients (Pt 10) did not have vital signs documented every four hours as required by the clinical condition of the patient. This failure had the potential to miss a change of condition for Pt 10.

8. One of 10 sampled patients (Pt 25) had two consents for procedures/surgeries that were not signed and or witnessed appropriately per the hospital policy. These failures placed Pt 25 at risk of having procedures performed without his consent.

Because of the serious actual harm to Patient 3 when nurses did not follow hospital policies and procedures and not to follow up on critical labs Immediate Jeopardy (IJ) situation was called on 4/19/24 at 6 p.m., under Code of Federal A 0398 §482.42 in the presence of the President and Market Leader, the Chief Nursing Officer, The Chief Medical Officer, and the Director of Quality were provided the IJ template which documented the immediate actions necessary to address the IJ situation. The hospital submitted an acceptable plan of removal to address the IJ situation. Plan of removal was accepted on 4/22/24 at 3:30 p.m. Survey team's onsite observations and interviews validated the hospital implemented appropriate corrective actions and the IJ was removed onsite on 4/22/24 at 5:00 p.m. in the presence of the Director Quality and the Manager of Quality and Accreditation. Following the IJ removal, the facility remained in substantial non-compliance.

Findings:

1. During a review of Pt 1's face sheet, dated 4/19/23, Pt 1's face sheet indicated Pt 1 was a 36-year-old female who was admitted on 3/14/24 for the following diagnosis of Normal labor.

During a review of Pt 1's "OB H&P (Obstetrics [the branch of medicine and surgery concerned with childbirth and the care of women giving birth] History & Physical)" dated 3/14/24 at 6:59 p.m., the H&P indicated, " ... 36 y.o. (year old) G4P3003 (gravida- number of pregnancies; para - number of live births) @ (at) 40w2d (40 weeks 2 days) admitted due to active labor (your cervix will dilate from six centimeters (cm) to ten cm). Pt was brought quickly to the labor room and an epidural (an anesthetic delivered through a catheter (small tube) into a potential space outside the spinal cord called the epidural space) was placed. Once the patient was calm, the nurses were able to place her baby on the monitor. No fetal heart tones were found. Leopold's (maneuvers used to palpate/determine the position and presentation of the baby) were performed and no fetal movement noted. A call was made to the OBED (Obstetrics Emergency Department) doctor and a beside Sono (sonogram- visual image produced from an ultrasound) was performed, and no cardiac activity was noted. This was the first time I [Laborist - MD2] was notified the patient was on the floor ... I was called to the bedside in my role as an OBED Laborist to assess an OB urgent issue, the inability to find fetal heart tones. This was the first time I was notified that the patient was admitted for active labor. Upon my arrival, the room was full of nursing staff, approximately 10 nursing staff members and the anesthesiologist, [name - MD7] ..."

During a concurrent interview and record review on 4/11/24, at 3 p.m., with Registered Nurse (RN) 4, Pt 1's electronic health records (EHR) for her admission on 3/14/24 was reviewed. RN 4 stated she was the primary OB ED nurse for Pt 1 on 3/14/24 Pt 1 arrived in the OBED and presented in active labor, dilated to 6 cm (active stage of labor), and having painful contractions. RN 4 stated she never contacted the in-house OB ED physician who was covering for Pt 1's obstetrician. RN 4 stated she knew the in- house physician was in the operating room (OR) in a c-section (the surgical delivery of a baby through a cut (incision) made in the birth parent's abdomen and uterus) and did not want to disturb her, so she put in the "telephone orders with readback" knowing that this was not true. RN 4 stated she did not get admitting orders to include the epidural orders from the doctor and did not read them back to anyone and she knew this was wrong. RN 4 stated she knew she could call into the ORand either speak with the doctor or the nurse and relay that this patient was here, and she needed orders, but she just did not do that. RN 4 stated she moved Pt 1 up to Labor and Delivery (L&D) and recalls giving report, but it did not include the reviewing the fetal heart rate monitor strip which reflected a category 2 tracing (category 1 is normal baby heart rate 110-160 beats per minute, moving; category 2 minimal movement of baby's heart rate still 110-160 but concerning- needs to be addressed). RN 4 stated, "it was inappropriate" of her to have not reviewed the fetal heart rate (FHR) strip with the nurse receiving Pt 1.

During a record review of Pt 1's Labor & Delivery Timeline dated 3/14/24 4:38 p.m. to 3/15/24 3:19 a.m., the timeline indicated on 3/14/24 at 5:09 p.m. "Event Labor Provider Notificaton Provider Name/Title: Provider in OR RN to enter orders User [name of RN 4] . onsite.."

During an interview on 4/16/24, at 3:20 p.m., with the Interim OB Director (OBD), the OBD stated she expects that a RN would give report to the RN taking over the care of the patient. The OBD stated report would include a review of the fetal monitor strips. OBD stated a nurse should never indicate an order was obtained from a physician by telephone unless it was. OBED stated of course MD2 should have been notified of Pt 1, including the results of the fetal monitoring while Pt 1 was in the OB ED. The OBD stated fetal well-being should be established prior to the patient receiving an epidural.

During a review of the hospitals policy titled, "Epidural Anesthesia for Labor Patients, Patient Controlled" date last reviewed 12/2021, the policy indicated, "PURPOSE: To provide guidelines to nursing staff in assisting the anesthesiologist with epidurals for Labor and Delivery, considering care for mother and unborn fetus. OUTCOME: The RN assists the anesthesiologist in the provision of epidurals for the OB patient ... PROCEDURE: 1. Pre-Procedure by RN: A. Apply Fetal Monitor [measures the heart rate and rhythm of your baby]and assess the FHR. B. Notify the obstetrician and obtain an order of patient request for epidural anesthesia [medical intervention that prevents patients from feeling pain]. C. Notify anesthesiologist assigned to labor and delivery ... 6. Contraindications to labor epidural: ... E. Fetal heart rate pattern requiring immediate birth ..."

During a review of Pt 23's face sheet, dated 4/23/24, Pt 23's face sheet indicated Pt 23 was a 28-year-old female, admitted on 4/15/24 for a diagnosis of Normal labor.

During a concurrent interview and record review on 4/23/24, at 9:30 a.m., with RN 5, Pt 23's electronic health records (EHR) for her admission starting 4/15/24 was reviewed. RN 5 stated Pt 23 had an order for an Epidural. Pt 23's flowsheets for lines, tubes and drains indicated two epidurals were placed, the first on 8/16/24 at 8:53 a.m. and removed the same time at 8:53 a.m., the second was placed on 8/16/24 at 8:58 a.m. and removed at 10:04 a.m. RN 5 stated Pt 23's epidural removals are missing the documentation of the site and no mention of the tip of the catheter is intact after removal. RN 5 stated the expectation is this information would be documented after removal of the epidural.

During a review of Pt 24's face sheet, dated 4/23/24, Pt 24's face sheet indicated Pt 24 was a 28-year-old female, admitted on 1/15/24 for a diagnosis of Normal labor.

During a concurrent interview and record review on 4/23/24, at 10:14 a.m., with Interim Nurse Manager (RNM) 1, Pt 24's EHR for her admission starting 1/15/24 was reviewed. RNM 1 confirmed Pt 24 had an order for an epidural to be placed and per Pt 24's flowsheets for lines, tubes, and drains indicated an epidural was placed on 1/16/24 at 12:04 a.m. and was removed at 10 a.m. the same day and no documentation of the site and no mention of the tip of the catheter being intact after removal. RNM 1 stated the expectation after an epidural is removed is that the site is assessed and documented every shift and the risk to the patient if this is not done is possible site infection and possible leak of spinal fluid causing headaches.

During a review of the hospitals policy titled, "Epidural Anesthesia for Labor Patients, Patient Controlled" date last reviewed 12/2021, the policy indicated, "PURPOSE: To provide guidelines to nursing staff in assisting the anesthesiologist with epidurals for Labor and Delivery, considering care for mother and unborn fetus. OUTCOME: The RN assists the anesthesiologist in the provision of epidurals for the OB patient ... PROCEDURE: ... 5. Discontinuing the epidural catheter: A. An RN may discontinue the epidural catheter per order. 1. The RN needs to have demonstrated competency on removal of epidural catheter. 2. Refer to Lippincott Procedures for epidural catheter removal ... 4. Notify anesthesiologist a. If any signs of infection are present. b. The catheter tip is either frayed or not intact. c. Leaking of excess fluid from the epidural site saturating the bandage. d. Patient exhibits prolonged recovery or decreased mobility or sensation in her extremities. 5. Document a. Assess the insertion site for tenderness, drainage, redness, or irritation. b. Date and time of removal of catheter and if tip intact ..."

2. During a concurrent interview and record review on 4/19/24 at 10:00 a.m. with Manager (Mgr) 4, the Electronic Medical Record (EMR) for Patient (Pt) 3 was reviewed. The facility document titled, "ED (Emergency Department) Provider Notes" dated 4/13/2024 at 5:03 a.m. by MD 12 indicated, "History of present illness: 36-year-old female with history of arthritis, anxiety, and depression BIBA (brought in by ambulance) with a complaint of AMS (altered mental status - not thinking or acting as usual.) ... history of heavy alcohol abuse but no known medical problems EMS (Emergency Medical Service) ... noticed numerous empty vodka and beer containers with patient appearing altered. Upon arrival I was able to appreciate patient with [symptoms of] withdrawing from alcohol ...initiate CIWA protocol (CIWA, Clinical Institute Withdrawal Assessment for Alcohol is an assessment tool used by doctors and nurses designed to evaluate the intensity of alcohol withdrawal symptoms and gives guidance on medication management based on the CIWA score.) During a review of MD 12's orders dated 4/13/24 at 5:46 a.m., an order for a CIWA protocol was initiated with an expiration date of 4/16/24.

During a concurrent interview and record review on 4/19/24 at 11:00 a.m. with the Director of Emergency Department (Dir 2), Dir 2 reviewed the laboratory (lab) blood test orders and stated the first blood draw on 4/13/24 at 6:03 a.m. for electrolytes (necessary minerals in blood and other body fluids that carry an electric charge) Pt 3's potassium (K+ - one of the electrolytes) and results were called to MD 12 on 4/13/24 at 6:51 a.m. Pt. 3's K+ level was reported as a dangerously low level of 2.0 (normal range is 3.5-6.2.) On 4/13/24 at 7:07 a.m., MD 12 ordered intravenous (IV) K+ to infuse at 10 mEq (milliequivalents - a unit of measure) in 100 mL fluid per hour over the next 8 hours. MD 12 also ordered 40 mEq of K+ to be given PO (by mouth) at the same time. At 3:04 p.m., Pt 3's blood was redrawn and her K+ was 2.2, a very slight increase. At 3:57 p.m., MD 8 ordered, "Potassium chloride 40 mEq PO x 2 doses" and the first dose was given at 3:58 p.m. The EMR indicated, Pt 3 was then transferred from the ED to 2 West, an acute medical unit and was placed on a telemetry monitor (wires attached to the chest to monitor heart rate and rhythm.) Pt 3 arrived on 2 West at 5:51 p.m. and received her second dose of potassium chloride 40 mEq PO at 6:05 p.m., completing the order from the ED. Dir 2 was unable to find an order to recheck Pt 3's K+ level until 4:03 a.m. the next morning on 4/14/24, and there was no order for additional K+ medication.

On 4/19/24 at 10:32 a.m. during a concurrent interview and record review with the Manager of 2 West (Mgr 2) and Mgr 4, Mgr 2 reviewed the EMR for Pt 3 and stated no K+ was given after 6:05 p.m. on 4/13/24 and no repeat lab draw was done until 4:13 a.m. on 4/14/24. The CIWA order set (preapproved physician orders for patient's experiencing alcohol withdrawal) was reviewed. The document titled, "Initiate CIWA-Ar assessment (Order 1021465339)" indicated, "Comments: Initiate CIWA-AR Assessment 1. If score is LESS than 10 (mild to no withdrawal symptoms); reassess every 2 hours x 2, then every 4 hours ..." Mgr 2 stated the nursing documentation indicated. Pt 3 had a CIWA score of 6 at 5:39 p.m., and a score of 8 at 7:12 p.m. There is no documentation indicating the nurses continued to assess Pt 3 and no further CIWA scores are in the chart. Mgr 2 stated with the score increasing from 6 at 5:39 p.m. to 8 at 7:12 p.m., the patient should have been reassessed two hours later at about 9:12 p.m. to ensure that the score was not continuing to increase. Mgr 2 stated there was no assessment at 9:12 p.m., and no further assessments throughout night. The nurses note dated 4/14/24 at 12:20 a.m. by RN 2 was reviewed. The nurses note indicated, " ...End of shift summary: maintained on CIWA monitoring, refused remote telemetry monitoring MD aware, continue with plan of care, hourly rounding ..." Mgr 2 stated the night shift did not end until 07:30 a.m. on 4/14/24. The text message from Registered Nurse (RN) 2 sent to MD 9 on 4/13/24 at 10:07 p.m. was reviewed. The text message indicated, patient is "refusing to keep her remote telemetry monitor on, we had been replacing it back several times, but she keeps on removing it claiming that the leads make her itchy. She had been asking if she can go home tonight but we told her that it will be against medical advice. She said she'll think about it and does not want the monitor on." MD 9 responded with "okay that's fine." RN 2 checked Pt 3's vital signs at midnight, and Pt 3's heart rate was 107 beats per minute, a fast heart rate. Pt 3's heart rate at 2:30 a.m. was 114 beats per minute. Pt 3's MD was not contacted to inform regarding the high heart rate. Mgr 2 stated the CIWA assessments should have continued through the night, and pulling at the monitor and ahigh heart rate are signs of agitation for Pt 3. Mgr 2 stated that if the CIWA protocol had been followed, the nurse may have had other interventions that might have changed the outcome for Pt 3. Mgr 2 stated the patient may have needed lorazepam, it would depend on the CIWA score, but the nurse did not re-evaluate to see if it was greater than 10 at any time after 7:12 p.m. Mgr 4 stated at the time RN 2 reported that Pt 3 did not want her heart monitor on at 10:46 p.m., she should have been assessed per the protocol, because "maybe the patient's CIWA score was already increasing at that point. That would have been the time for another assessment. The patient was being uncooperative, which could be a sign of agitation." Mgr 2 stated the patient's vital signs were done at midnight by RN 2, but RN 2 did not notify the doctor about the increased heart rate, agitation and being disconnected from the heart monitor. Mgr 2 stated the heart monitor order was never discontinued. The nurse note from RN 2 dated 4/14/24 at 12:20 a.m. indicated, " ...End of shift summary: maintained on CIWA monitoring, refused remote telemetry monitoring MD aware, continue with plan of care, hourly rounding ..." Mgr 2 stated the night shift ended at 07:30 a.m., not at 12:20 a.m., and she did not know why RN 2 wrote an end of shift summary halfway through the shift.

During a concurrent interview and record review on 4/24/24 at 8:05 a.m. with RN 2, RN 2 stated she had worked at this facility for about 5 years. RN 2 remembered Pt 3. RN 2 stated she received report from RN 1 and made rounds on her patients. She recalled doing the CIWA assessment on this patient, and her score was an 8 so she did not need to give medication. RN 2 stated the CIWA protocol is used when patients are alcoholics. RN 2 stated lorazepam is administered if the scoring indicated it is needed. RN 2 stated she knew she needed to do one more CIWA assessment for this patient, but she got busy with other patients, and she did not get around to doing the third CIWA assessment. RN 2 stated she had a total of four patients, and it was not a heavy assignment. RN 2 stated the patient was placed on telemetry monitoring because of her electrolytes, she needed her heart to be monitored because her potassium was low, but she would not keep the monitor on. "I called the doctor, and she said it was okay." RN 2 stated "Low potassium can cause arrythmias (irregular heart rate or rhythm) that's why we have to replace it. There was not an ongoing potassium order." RN 2 stated Pt 3's blood was drawn on 4/14/24 at 4 a.m. and her K+ level was 2.1, and also her sodium phosphate was low. "I notified the on-call doctor when I got the results." RN 2 stated the patient was agitated, frequently trying to get out of bed. "We would help her back to bed, she was standing up at the bedside, she was very agitated, pulling at her monitor. She just didn't listen. She said she couldn't sleep. I had to change her because she had a huge bowel movement. She seemed not to care that she was laying in it. She said she wanted to go home. I asked why she wanted to go when she was still so sick. She said she had a lot of laundry to do." In hindsight, RN 3 says she thinks those actions sound like alcohol withdrawal. "I should have checked in with the doctor." RN 3 stated the last time she saw Pt 3 before she coded was when she restarted her intravenous line (IV) at about 7:15 a.m. RN 3 stated during the IV start, Pt 3 did not respond verbally, "she just moaned and fell back to sleep. I thought she was just really tired."

During an interview on 4/24/24 at 8:30 a.m. with RN 1, RN 1stated she remembered Patient 3. She received report from the ED nurse, including Pt 3's low K+ level and medications given in the ED. She stated she gave the last dose of K+ to Pt 3. RN 1 stated Pt 3 was on telemetry monitoring because of electrolyte imbalance, including low K+. RN 1 stated, "That (low K+) can mean there's something going on with their heart, with their muscles, any number of things." RN 1 stated she returned the next morning and was again assigned to care for Pt 3. When she went to see the patient with RN 2, Pt 3 was sleeping, and RN 2 stated she needed to restart her IV so she could receive IV K+. RN 1 stated right after she received report, she saw MD 9 come out of the room stating Pt 3 was coding. RN stated MD 9 and several nurses responded immediately, then the Code Blue team (designated staff who respond to all life-threatening events) arrived quickly. Pt 3 was taken to intensive care unit (ICU).

During a concurrent interview and record review on 4/23/24 at 10:45 a.m. with MD 8, MD 8 stated she remembered Pt 3 and saw her twice in ED and recalled Pt 3 was admitted with Alcohol Withdrawal Disorder and severe electrolyte derangement (not within normal range.) MD 8 stated she started to "aggressively treat her electrolytes." MD 8 stated Pt 3 was having pain from the IV K+, so she changed the order to PO K+. MD 8 stated, "that was the end of what I heard about her in the ED. MD 8 stated "it's unclear how much of the IV potassium we were able to get into her, because the IV line was hurting her, so we stopped the infusion and changed to the oral form. MD 8 stated she signed out and left the facility at around 6:00 or 7:00 p.m., but she responded to a message from the Pt 3's nurse around 7:30 p.m. that night saying Pt 3 had headache and neck stiffness. "We did a head CT (computerized tomography, a scan to see if there are any brain injuries) and I knew that was negative." MD 8 stated she instructed the nurse to do warm compresses to Pt 3's neck. MD 8 stated all of her notes were in the medical record for Pt 3, so the oncoming doctors could read what she had written and what medications had been given and the lab results. MD 8 stated she returned the next morning and reviewed Pt 3's chart and saw that she was no longer on the heart monitor and that her K+ was still very low, and her platelets (blood cells that help blood clot) were also very low. MD 8 stated she went to see the patient in her room and could not wake her up, and she had foam around her mouth. MD 8 called a code blue and started emergency treatment. Pt 3 was then transferred to intensive care.

During a concurrent interview and record review on 4/23/24 at 11:00 a.m. with MD 9, MD 9 stated took over care for Pt 3 at around 7:00 p.m. on 4/13/24. She stated she had access to Pt 3's EMR and could see her medications and lab results. MD 9 stated she got a message on 4/13/24 at around 8:12 p.m. from Pt 3's nurse (RN 2) indicating patient was asking for sleeping pills, so she ordered melatonin (a hormone that aids in sleep.) MD 9 stated she got another message from RN 2 around 10 p.m. indicating Pt 3 kept removing her [heart monitor] leads. "I said that's fine." MD 9 stated RN 2 did not indicate that Pt 3 was showing signs of increased agitation. MD 9 stated at about 5 a.m. she received a message that Pt 3's K+ and phosphorus results were critically low, with both electrolytes measuring 2.1. MD 9 stated she ordered IV K+ and phosphorous (another essential electrolyte) because Pt 3 did not improve with the PO medication the day before. MD 9 stated she did not go to the bedside to observe the patient at any time during the night. MD 9 stated, "I wasn't thinking about agitation at that point or that she needed another CIWA assessment."

During a concurrent interview and record review on 4/19/24 at 11:20 a.m. with the Director of 2 West Medical (Dir 1), Dir 1 stated, "The second dose of oral K+ 40 mEq was given right after she [Pt 3] got to 2 West at 6:05 p.m. (that was an ED order). There was no K+ ordered for her [Pt 3] inpatient stay until 4/14/24 when her morning lab results labs came back at 5:25 a.m., and RN 2 sent a message to MD 9. Dir 1 stated the K+ was drawn as part of a CMP (comprehensive metabolic panel - a group of blood tests that include electrolytes) at 4:12 a.m., resulted (completed in the lab) at 4:42 a.m. showing a K+ level of 2.1 The Clinical Laboratory Specialist called RN 2 on 4/19/24 at 5:25 a.m. with the results. RN 2 then sent a message to MD 9 at 5:31 a.m., and MD 9 ordered IV K+ for Pt 3. Dir 1 stated there is no indication that MD 9 came to the bedside to see the patient.

During a concurrent interview and record review on 4/24/24 at 12:30 p.m. with MD 10, MD 10 stated, "I saw her (Pt 3) in the ED, and she was alert. We asked them (the ED nurses) to give the PO order then repeat. I think she had received a lot of K+ IV before that. I would expect her to come up to 3.5 (back into normal range for K+). Maybe that's why they didn't recheck the levels until the next morning." MD 10 stated admission orders are to be carried out on the floor, even if they are written in the ED. The order for K+ was written in the ED by MD 8. MD 10 stated once we see the patient any changes in the clinical status should get updates from the RN. She received quite a lot of K+ in the ED. When the 2.2 result came back and they ordered 40 mEq of K+ x 2 (two doses) at 3:57 p.m. then again at 6:05 p.m. Normally after that amount of K+ has been given there would be an order for repeat the lab draw to check her levels 2 or 3 hours after the last dose. MD 10 stated. "she wasn't a high cardiac risk," then stated, "a potassium level of 2.2 is at high-risk patient of cardiac event, that's why we replaced the potassium so aggressively." MD 10 stated, "Any patient with a change in mental status should be seen by a provider, but I don't think that was communicated." MD 10 stated the information about the patient's clinical condition was available to MD 9 if she had gone into the chart to read the notes. MD 10 stated. "[MD 9] is a first-year intern. If the nurse and the MD had talked by phone, maybe they would have communicated better, and the MD would have understood that the patient was agitated."

During an interview on 4/25/24 10:00 a.m. with the CMO, CNO, and DQ. Pt 3 was discussed. The CMO stated, "if the patient refusing the monitor, an MD should have gone to see the patient to have a dialogue." The CMO stated if the patient was still refusing, talk about the reasons why the monitor is needed for their safety. A patient with very low K+ is at risk and needs to be monitored closely. The CMO stated, "When you [any MD] order labs, you are responsible to follow up on those labs. The MD responsible for the patient (Pt 3) should have been aware of how much K+ she had received and should have followed up with repeat lab draws to make sure the levels are coming up, and if not, they would most likely order more K+ to be given. The doctors all have access to that information in the patient's EMR.

The CNO stated the nurse should have talked to the doctor about Pt 3's agitation, because the doctor may have ordered lorazepam and may have ordered repeat K+ lab tests. The CNO stated "the nurses should have been doing the CIWA protocol as ordered. I expect nurses to follow orders and protocols." The CNO stated nurses should look at their patients' lab results during handoff and discuss issues. If they were concerned that Pt. 3's K+ was low with no order to continue giving the medication, they should have called the doctor.

During a concurrent interview and record review with RN 1 the "Nursing Note" dated 4/14/2024 at 10:56 a.m. was reviewed. The "Nursing Note" indicated, "code blue was called overhead for this patient around 7:45 AM. Patient was found with foam on her mouth and gurgling sounds not responsive according to MD 8 who went in to see the patient. No pulse was felt on the patient and code blue was activated. Patient received CPR, meds, was intubated and transferred to ICU. MD 8 called to update patient's mother who is patient's decision maker as well, according to patient's interview yesterday."

During a review of Pt 3's "Progress Notes" dated 4/14/24 at 8:17 a.m. by MD 8 indicated, "Brief Note: I received sign out this morning that patient had taken off her telemetry leads and was not allowing them to be put back on with her pulse oximetry. I went to evaluate patient around 7:50 a.m. when I found patient unresponsive to auditory or painful stimuli. Patient had gurgling breath sounds and pulse was barely detectable. Subsequently called code blue and nursing staff immediately started CPR. Patient required multiple rounds of Epi (epinephrine - a powerful drug used during cardiac arrest) and CPR (cardiopulmonary resuscitation) with subsequent ROSC (Return of Spontaneous Circulation - heart started beating on its own again.) Called family and updated patient's mother of current events and patient's transfer to ICU. Signed out patient to doctor [name]."

The hospital policy titled, " ...Patient Care Policy and Procedure Critical Test and Critical Results and Values," the document indicated, " ... Purpose: to establish guidelines for the licensed caregiver on the management and notification of critical value test results ... Definition: critical value - a result displaying variance from normal as to represent a pathophysiologic state (illness) that is life threatening unless some action is taken within a very short time." POLICY: ...9. Critical value results will be documented in the electronic health record by the licensed staff member and will include the critical value result, critical value result read back, name of physician notified, time physician notified, and actions taken .... "Performance Improvement: 1. Performance improvement data to evaluate the timeliness of reporting of critical results of tests and diagnostic procedures are collected and reported to the data analysis committee, the quality council, and the quality evaluation committee of the board. Two. Appropriate actions are taken to improve, and ongoing monitoring will evaluate the effectiveness of actions taken. Appendix A: Laboratory Critical Values ...Potassium - <2.8 or > 6.2 mEq/L

The hospital policy titled "Alcohol Withdrawal: Care of the Patient," dated July 2022, indicated, "... Purpose: to provide guidelines for the care of a patient in alcohol withdrawal. Outcome: screening and ongoing assessment are used to manage symptoms of alcohol withdrawal ...Procedure: 2. B. RN assesses patient using clinical institute withdrawal assessment alcohol revised (CIWA-Ar) tool and provides medical intervention per CIWA-Ar criteria ... CIWA-Ar Measuring Severity of Withdrawal ... Score 7-11 Assess q (every) 1 hour ... [administer] 2 mg. [Brand name]IV (intravenously - in a vein) or PO [by mouth]. A research article from The Oxford Academic retrieved from https://doi.org/10.1093/alcalc/agad016 from March 2023 indicated, " ...The estimated death rate from severe AWS (alcohol withdrawal syndrome) varies from 5% in treated cases to ... as high as 37% in untreated cases (Rahman and Paul, 2022), including deaths from Delirium Tremens (DTs), seizure, stroke, heart disease and other causes. From these figures, we estimate about 270,000 US deaths annually. One study notes a 37% death rate among DT cases within 8 years of the initial occurrence (Perala et al., 2010)."

A professional article from Experimental and Clinical Cardiology titled, "Hypokalemia (low potassium) and Sudden Cardiac Death" dated 3/2020 indicated, " ...Worldwide, approximately three million people suffer sudden cardiac death annually. These deaths often emerge from a complex interplay of substrates and triggers. Disturbed potassium homeostasis (all systems are balanced) among heart cells is an example of such a trigger. Thus, hypokalemia and, also, more transient reductions in plasma potassium concentration are of importance ..."

3. During a review of Pt 26's face sheet, dated 4/23/24, indicated Pt 26 was 83-year-old male who was admitted on 4/15/24 for a diagnosis of syncope (temporary loss of consciousness caused by a fall in blood pressure) and collapse.

During a review of Pt 26's "Telemetry Monitoring

Based on interview and record review the medical staff failed to refer infant remains to the pathologist (a physician who exams tissues and determine abnormal tissue, injury and/or cause of death) for examination of fetal and/or infant remains in accordance with hospital policy and procedure

This failure prevented determination of injury, infection and/ or the cause of infant death of 5 of 5 infants, In1, IN2, In3, In4 and In5 by a qualified pathologist.

Findings:

During an interview and concurrent record review on 4/24/2024 at 11:30 a.m. with (Obstetrician (Medical Doctor and surgeon- MD2) who provides medical care to pregnant mothers and unborn infants), accompanied by Chief Medical Officer and Obstetrician (CMO), and Director of Medical Staff Affairs (DMS), the Patient 1's (Pt1) medical record provided by the hospital and hospital policies were reviewed and discussed MD2 stated she "understands hospital policies ...been at the hospital for twenty years". MD2 acknowledged she was the medical provider for Pt1 during her stay in the emergency obstetric department (OBED) and the labor and delivery (L&D) unit. MD2 stated that she did not evaluate Pt1 in the OBED, and the Pt1's "first time" evaluation was 39 minutes after arrival to L&D. MD2 indicated she did not review the fetal heart tones or laboratory values of Pt1.

During an interview and concurrent record review on 4/24/2024 at 11:30 a.m., MD2 explained abnormal and changes of FHT could indicate fetal distress and compromise and require emergency intervention to ensure the life and safety of the fetus and mother. MD2 explained abnormal and changes of FHT could indicate fetal distress and compromise, for example, low to no oxygen delivery or blood flow. MD2 indicated if a fetus expels meconium (fetal stool), it is abnormal and a sign of fetal distress.

During an interview and concurrent record review on 4/24/2024 at 11:30 a.m., Review of the patient's chart, indicated Pt1 had a "high" white count (WBC, a sign of an infection) of 13.7 (normal 5.5-11) on 3/14/2024 at 5:28 p.m. and 18.2 on 3/15/2024 at 2:16 a.m. Review of Pt1's delivery notes at 11:33 p.m., indicated MD2 recorded the delivery of the fetus. The record indicated there was a "tight nuchal cord noted around the baby's neck that could not be reduced ...large 6-inch clot noted in [umbilical] cord at the fetal insertion ...[placenta] membranes meconium stained ... cord and placenta discarded ... infant and patient in delivery room in good and stable condition". MD2 stated on delivery of the infant and placenta, the infant had a "tight nuchal cord" around the neck and the placenta had an "abnormal large clot". MD2 stated the placenta, blood clot and meconium were "abnormal". MD2 stated infant death "could have been from a nuchal cord, but not sure". MD2 stated she "discarded the placenta and cord" of Pt1's fetal (Infant, In1) remains.

During an interview and concurrent record review on 4/24/2024 at 11:30 a.m., MD2 stated she spoke with the farther 'only one time" when she informed the mother and father and "explained infant died". MD2 stated she "did not know the father's primary language" or speak with the mother regarding autopsy (examination of body remains by a pathologist) of the fetal remains of In1. "[Hospital] Authority for Release of Body" indicated that the "body [infant] released to funeral home" on 3/20/2024. The form titled "Certificate of Vital Records, Certificate of Fetal Death State of California", dated 4/8/2024 indicated the space for the coroners' signature and dates were blank. The chart indicated the In1 remains (fetus, placenta and umbilical cord) were not referred to the corners (pathologist, known as a medical examiner) for an autopsy by the MD2 in accordance with hospital policy. There is no documented evidence that the MD discussed with the parents the policy requiring referral to the coroner, autopsy and pathology examination of fetal remains.

MD2 indicated she "understood the policies" and requirements regarding fetal demise autopsy and pathology when fetal demise occurs.

During an interview with concurrent record review on 4/25/2024 at 9:00 a.m., with Medical Doctor, Emergency Department Director (MD3) accompanied by CMO and DMS, the hospital policies were reviewed and discussed, but MD 3 could not read the records due to technology. MD3 stated the coroner is notified of all deaths that occur in the ED and the "autopsy is decided by the coroner".

During an interview and concurrent record review on 4/24/2024 at 4:45 p.m. with Medical Doctor, Obstetrician and Department Director (MD1), accompanied by CMO) and MRA, the Patient 1's medical record provided by the hospital and hospital policies were discussed and reviewed. MD1 stated he was the director of the Ob-Gyn department. MD1 acknowledged according to OB gyn policies the OB-GYN department include pediatrics, NICU, and neonatology. The hospital provided a list titled "Expired Death Patient Log", and documentation of four neonatal deaths (In2, In3, In4 and In5) that occurred at the hospital for the prior 6 months. MD1 stated he was not aware of four of the six deaths in that occurred in the past 6 months. MD1 stated he was aware of a neonatal death due to sepsis, because he "cared for the infant" and Pt1's infant, In1, but neither of these two were on the log. MD1 indicated that except for two patients he was aware of, he did not know the events surrounding the deaths or why autopsies were not completed. MD1 acknowledged the Ob-Gyn department did not track the events causes of fetal and infant deaths. There was no documented evidence by the physician why the infants or fetuses did not have autopsies. MD1 indicated he was not aware of the hospital policy titled "[Hospital] Patient Care Policy & Procedure, Postmortem Policies, Index No. A-35". MD1 stated "maybe the policy and laws are wrong" MD1 stated all the placentas and cords of fetal or newborn demise should go to pathology. MD1 stated Pt1's placenta and cord should not have been "discarded" by MD2

During record review of hospital policy titled "Bylaws of the Medical staff for [Hospital]", effective 1/27/20212, amendment effective 7/27/20218 stated, "Medical Staff ' or "Staff ' means those physicians, dentists, and podiatrists who are Members of the Medical Staff ... BASIC RESPONSIBILITIES OF MEDICAL STAFF MEMBERSHIP providing patients with the quality of care meeting the professional standards of the Medical Staff ... abiding by these Bylaws, the Medical Staff Rules and Regulations, the departmental Rules and Regulations, and the Policies and Procedures of the Medical Staff ... complying with all Federal and State statutes ... Section 6. Deceased Patients ... When a patient expires, the attending physician or any physician Member of the Medical Staff, or a nursing supervisor or competent designee if no physician is readily available will pronounce the patient dead and record this by a written note in the patient's chart ... Medical Staff Members are encouraged to seek permission and document that effort for autopsy examination on all patients ... Special effort should be made to secure permission for autopsy in many of the following circumstances: 1. When death is not an anticipated outcome; 2. When the cause of death is not known; 3. In situations where autopsy may help allay concerns of the family; 4. When death occurs following a surgical procedure or invasive diagnostic procedure done during the same hospitalization; 5. When death occurs in patients who are participants in formal clinical trials; and 6. All obstetrical and neonatal deaths.

During record review of hospital policy titled "[Hospital] Patient Care Policy & Procedure, Postmortem Policies, Index No. A-35", effective 2/1987, last reviewed 1/2021, stated if "yes to any of the below, you must report the death to the coroner ...All children, including neonates [new born] ... Fetal deaths greater than twenty weeks or greater than four-hundred grams [measure of weight] ... Deaths resulting from known or suspected reportable contagious disease and constituting a public hazard ... Any unnatural cause of death ... Regulatory references ... Title 22 California Code of Regulations ... Government code 27491 [It shall be the duty of the coroner to inquire into and determine the circumstances, manner, and cause of all violent, sudden, or unusual deaths. The coroner shall have discretion to determine the extent of inquiry to be made into any death occurring under natural circumstances] ... Title 17 2500 [Reporting to the local health authority, diseases, and conditions] ... Title 22 [Regulations that apply to Acute care hospitals]".

During record review of hospital policy titled "[Hospital] Patient Care Policy & Procedure, Specimens/Tissue: Care and Handling, Index No. J-1", effective 1/1986, last reviewed 4/2023, stated "Properly labeled and prepared specimens are delivered to the Laboratory for pathological, microbiological, or chemical examination/analysis ....All specimens removed from a patient will be properly labeled ...Examination by a pathologist .... Product of Conception (POC)/Fetal Newborn Death ... Placenta, requiring genetic studies or cultures ..."

California Code of Regulations, Title 22, 70243. Clinical Laboratory Service General Requirements stated "Tissue specimens shall be examined by a physician who is certified or eligible for certification in anatomical and/or clinical pathology by the American Board of Pathology or possesses qualifications which are equivalent to those required for certification ... A record of his findings shall become a part of the patient's medical record".

Based on interview and record review, the hospital failed to ensure Obstetricians (OB physician and surgeon who provides medical care to pregnant mothers and unborn infants) provided standard medical care and followed hospital policies and procedures for the deliverance of safe medical care to pregnant mothers.

The failure of 2 of 2 OB surgeons ((Medical Doctor, OB Department Director (MD1) and Medical Doctor, OB (MD2)), to provide timely appropriate medical care and take responsibility for the emergent care of 1 of 1 pregnant mother, (Pt1), jeopardized the safety and well-being of Pt1 and her fetus, and contributed Pt1's harm and fetal [unborn baby] demise .

Findings:

Record review of Pt1's medical care from 3/14/2024 4:38 p.m. to 3/15/2024 10:35 a.m. indicate the following:

The chart indicate Pt1 spent 85 minutes in the obstetric emergency department (OBED) plus 33 minutes in L&D before being evaluated by a physician for a medical emergency.

On 3/14/2024 at 4:38 p.m., the chart indicated Pt1 arrived at the OBED in "Labor [signs indicating ready to give birth]" and was placed in a room.

At 4:45 p.m., the chart indicated a RN (nurse) placed orders for medications, intravenous (I.V.- given via a vein) fluids and monitors, and provided a diagnosis and started to carry out her orders for Pt1. There was no documented evidence, an OBED nurse spoke with a physician. There was no documented evidence a medical screening examination (MSE) for Pt1 and her fetus' by a physician occurred for an emergency medical condition (EMC).

At 5:00 p.m., the nurses documented, Pt1 was placed on a fetal heart monitor for (FHT- measures character, pattern and rate of a fetus' heartbeat. A normal heartbeat fluctuates between110 to 160 that increase and decrease with sleep, activity and contractions and signals fetal well-being). FHT were measured at 140 beats per minute without the normal heart rate fluctuations (a signal of fetal harm and distress). There was no documented evidence a MSE examination or stabilization an EMC was provided by a physician.

At 5:05 p.m., chart indicated verbal orders were "authorized" by MD1 and indicated that the OB physician was to be notified for meconium (fetal stool), fetal heart rate abnormalities per policy. There was no documented evidence MD1 spoke with a nurse or examined the Pt1.

At 5:09 p.m., chart indicated MD2 ordered I.V. fluids with instructions: "May increase to 500mL bolus [large volume of I.V. fluid given rapidly] for abnormal fetal heart rate patterns". There was no documented evidence MD2 spoke with a nurse or examined the Pt1.

At 5:20 p.m., the nurses documented FHT were measured at 140 bpm without the normal heart rate fluctuations that would signal fetal well-being. Treatment initiated by nurses were I.V. fluid bolus and "therapeutic touch".

At 5:28 p.m., the nurses documented Pt1's complaints of pain "7/10 [zero to ten pain scale, 0 equals no pain, 10 equals severe]". Nursing intervention "therapeutic touch". There was no documented evidence an OBED nurse spoke with a physician or a physician evaluation.

At 5:28 p.m., the chart indicated Pt1 had a "high" white count (WBC, high counts are a sign of an infection) of 13.7 (normal 5.5-11).

At 5:36 p.m., the nurses documented FHT monitoring strip indicated fetal heart rate 145 bpm with new variable deceleration (abnormal decrease in FHT and a signal of fetal harm and distress) without the normal heart rate fluctuations that would signal fetal well-being. There was no documented evidence an OBED nurse spoke with a physician or a physician evaluated Pt1.

At 5:41 p.m., the chart indicated MD2 signed Pt1's orders and diagnosis placed by the nurses and MD1. There was no documented evidence, MD1 spoke to the nurses or a physician examined the Pt1.

At 5:42 p.m., the nurses documented FHT 145 bpm without the normal heart rate fluctuations that would signal fetal well-being, and thereafter FHT recording stops. There was no documented evidence an OBED nurse spoke with a physician, or a physician examined the Pt1.

At 5:56 p.m., the nurses documented Pt1's complaints of "cramping", "worsening" and pain "7/10". Nursing intervention "therapeutic touch". There was no documented evidence an OBED nurse spoke with a physician or a physician examined the Pt1.

At 6:02 p.m. the nurses documented fetal heart rate 145 bpm with continued variable deceleration without the normal heart rate fluctuations that would signal fetal well-being. There was no documented evidence of FHT monitoring strips from 5:42 p.m. onward. There was no documented evidence an OBED nurse spoke with an OB physician. There was no documented evidence an OB physician provided a MSE or stabilization for an EMC prior to Pt1 leaving the OBED.

At 6:04 p.m., the chart indicated Pt1 was admitted to Labor and Delivery (L&D) floor and transferred from the OBED. There was no documented evidence Pt1 received a medical exam or medical stabilization by an OB physician on arrival to L&D.

At 6:05 p.m., there was no documented evidence of FHT. The chart indicated that a labor epidural (when a women is ready to deliver an infant a doctor can place a catheter in the back that infuses medication to decrease labor pain) was requested by nursing staff. There was no documented evidence MD2 communicated with spoke with Medical Doctor, Anesthesiologist (MD4, provide specialized care before, during and after surgery, procedures and very ill and emergency patients) and requested the procedure or discussed the status of Pt1 and her fetus. The labor epidural was initiated by MD4.

From 6:05 p.m. to 6:38 p.m., the chart indicated the L&D nurses were unable to detect FHT. There was no documented evidence an OBED nurse spoke with an OB physician, or Pt1 received a medical exam or medical stabilization by an OB physician.

At 6:23 p.m., MD4 completed the epidural. There was no documented evidence, MD4 interrupted the epidural to determine the status of Pt1 and the fetus. There was no documented evidence MD4 spoke with an OB physician to discuss the status of Pt1 and the fetus.

At 6:25 p.m., the nursing exam note indicated, unable to locate FHT, and "no fetal movement". There was no documented evidence an OB physician was at Pt1's bedside.

At 6:39 p.m., the chart indicated MD2 was called to the bedside. The chart indicated this was the first evaulation of Pt1 by an OB physician. MD2 documented "no fetal heart tones per" and diagnosed "IUFD [intrauterine fetal demise, death of infant before birth]".

At 11:26 p.m., the nurse's note indicated, "meconium" before the delivery of the infant.

At 11:33 p.m., MD2 recorded the delivery of the fetus. The record indicated there was a "tight nuchal cord [the umbilical cord connects mother and baby in the womb and supplies blood, oxygen and nutrients to the fetus that gets tangled causing a decrease or absent blood flow] ...noted around the baby's neck that could not be reduced ...large 6 inch clot noted in [umbilical] cord at the fetal insertion ...[placenta] membranes meconium stained ... cord and placenta [organ in the womb that hold fluid and the fetus] discarded ... infant and patient in delivery room in good and stable condition". There was no documented evidence MD2 sent fetal remains for examination by a pathologist (a physician who exams tissues and determines abnormal tissue, injury and/or cause of death).

On 3/15/2024 at 2:16 a.m., review of the patient's chart, indicated Pt1 had a "high" white count of 18.2, increased from 13.7 (normal 5.5-11) a few hours earlier.

On 3/15/2024 at 10:35 a.m. the chart indicated MD1 evaluated Pt1 for the first time.

During an interview and concurrent record review on 4/24/2024 at 11:30 with MD2, accompanied by Chief Medical Officer and Obstetrician (CMO), and Director of Medical Staff Affairs (DMS), Patient 1's (Pt1) medical record provided by the hospital and hospital policies were reviewed and discussed. MD2 stated that on 3/14/2024 on call she was on call to see patients in the OBED, and was "available" to attend to OB emergencies. MD2 acknowledged she was responsible physician for the OB emergency services, MSE and stabilization of OB patients, and not the nurses. MD2 stated she "understands hospital policies ...been at the hospital for twenty years" and EMTALA (Emergency Medical Treatment and Labor Act). MD2 indicated she understood responsibilities of emergency care of pregnant patients.

MD2 indicated that the emergency department for obstetrics (OBED) was a unit that evaluated emergency pregnant patients, determined their acuity, diagnosed medical issues, made a plan of care, managed and stabilized them. MD2 stated the patient will be "seen by the nurses [RNs]". MD2 stated "nurses are "qualified" to complete medical screening exams (MSE) and provide stabilizing medical treatment and if the "RN needs direction, it is given over the phone". MD2 stated if she "can't see the patient ... over the phone ...give directions" to the nurse. MD2 stated the physician "doesn't need to see the patient", and this has been the "standard" for years at the hospital.

MD2 stated, without a physician evaluation of a pregnant patient, nurses are allowed to place "verbal orders" for medications, monitors, intravenous fluids, treatments and provide an admitting diagnosis for a patient in the computer without a physician evaluation or communication. MD2 stated that she "signs 100's of orders" from the nurses that "pop-up" in her computer "inbox" and one of her "chores" is to e-sign (electronically sign) and approve orders from nurses. MD2 indicated she does not evaluate patients that she signs verbal orders for, nor determine who the orders are for or why they were ordered by the nurse. MD2 stated she "doesn't call the nurses when verbal orders are placed by the nurse ... I sign the orders" for nurses.

Pt1's timeline of events was reviewed with MD2. MD2 stated discussing Pt1's care was a "loaded question". MD2 stated that on 3/14/2024 on call she was on call to see patients in the OBED. MD2 acknowledged she was responsible physician for the OB emergency services, MSE and stabilization of OB patients, and not the nurses. MD2 stated she was "available" to see Pt1 when she arrived at the emergency department for obstetrics (OBED) at 4:39 p.m. but did not provide a MSE or stabilization for Pt1 and her fetus' EMC or speak with the OB nurses.

At 5:09 p.m., the chart indicated MD2 ordered intravenous fluids, MD2 acknowledged that she did not speak to the nurses or evaluate Pt1. MD2 acknowledged at 5:41 p.m., she signed and agreed with the OBED diagnosis and orders that the nurse had placed in the computer as "verbal orders". MD2 acknowledges she did not call the nurse about the PT1's status and emergency medical condition, nor ask the nurses about the orders placed or admitting diagnosis. MD2 acknowledged she did not evaluate Pt1 or call the and speak to the nurses and ask about Pt1's EMC, medical status or distress when she placed orders and signed the nurses' orders.

MD2 stated ongoing fetal (unborn baby) heart tones (FHT, character, pattern and rate of a fetus' heart) are "important to monitor" and reflect the "well-being of the infant". MD2 explained abnormal and changes of FHT could indicate fetal distress and compromise and require emergency intervention to ensure the life and safety of the fetus and mother. MD2 indicated if a fetus expels meconium (fetal stool), it is abnormal and a sign of fetal distress.
MD2 explained abnormal and changes of FHT could indicate fetal distress and compromise, for example, low to no oxygen delivery or blood flow. MD2 indicated OB RNs are "qualified" to interrupt, diagnose and act upon abnormal FHT, but are not physicians. Thus, not qualified to diagnosis, prescribe, order interventions, medications and therapeutics or perform emergency procedures and/or surgeries.

The chart indicated for 62 minutes, the fetal heart rate was 140 -145 bpm, with minimal variability and decelerations and after that, for another 25 minutes, FHT could not be located. The FHT record strips from 5:00 p.m. to 5:42 p.m. were reviewed with MD2. MD2 stated that she "never saw" the FHT monitor strips (recordings of fetal heart tones) during Pt1's hospital admission. MD2 stated the Pt1's FHT tracing strips were "not normal" because there was "variable deceleration", "no reaction" of the baby to contractions or other signals of fetal well-being. MD2 acknowledged the tracings that did not improve and "could signal an emergency" for the fetus and mother. MD2 indicated she did not receive a call from the nurse regarding the abnormal FHTs. MD2 stated OB RNs are "qualified" to interrupt, diagnose and act upon abnormal FHT.

Review of the patient's chart, indicated Pt1 had a "high" white count (WBC, a sign of an infection) of 13.7 (normal 5.5-11) on 3/14/2024 at 5:28 p.m. and 18.2 on 3/15/2024 at 2:16 a.m. There was no documented evidence MD2 reviewed the labs, provided an interruption of the labs or initiated care to Pt1.

MD2 acknowledged Pt1 spent 85 minutes in the OBED plus 33 minutes in L&D before being evaluated by a physician for a medical emergency. MD2 indicated that she did not provide medical oversight or direction to the OBED and L&D nurses who provided the ongoing evalautions and orders for Pt1's EMC for the first 118 minutes Pt1 was in the facility.
MD2 stated she was called because the nurses "could not find FHTs" and evaluated the Pt1 for the "first time" at 6:39 p.m.

Pt1's delivery note was reviewed with MD2. MD2 stated the delivery of the infant and placenta was at 11:33 p.m. The infant had a "tight nuchal cord" around the neck and the placenta had an "abnormal large clot". MD2 stated the placenta, umbilical cord, blood clot and meconium were "abnormal". MD2 stated infant death "could have been from a nuchal cord, but not sure". MD2 stated she "discarded the placenta and cord". MD2 indicated she "understood the policies" and requirements regarding fetal demise autopsy and pathology when fetal demise occurs.

MD2 stated she spoke with the farther 'only one time" when she informed the mother and father and "explained infant died". MD stated "she "did not know the father's primary language". There is no documented evidence that the MD discussed with the parents the policy requiring referral to the coroner, autopsy and pathology examination of fetal remains

During a interview and concurrent record review on 4/24/2024 at 4:45 p.m. with MD1, accompanied by CMO and MRA, Patient 1's medical record provided by the hospital and hospital policies were discussed and reviewed. MD1 stated he was the Director of the OB department. MD1 stated indicated he understood EMTALA requirements and OB policies. MD1 stated the "concerns" on the OB floors are related to "problems caused by [hospital] management". MD1 indicated that management "hired nurses" to work on OB floor and have "zero management oversite" of the care they provided. The nurses "didn't know how to put on monitors and didn't know what was going on" with pregnant mothers and fetal status".

MD1 indicated that he was not in agreement with hospital policies regarding the response time requirements to provide patients with an evaluation and time requirements to address maternal and/or fetal comprise and distress. MD1 stated the OBED physician will evaluate patients who arrive at the emergency department, but the evaluation time "expectation is a tricky question ...and depends".

MD1 explained the "normal process" in the OBED. MD1 stated OB RNs are "QMP [non-physician qualified medical provide; thus, not qualified to diagnosis, prescribe, order interventions, medications and therapeutics or perform emergency procedures and surgeries. ]" and complete a medical screening exam (MSE), stabilizations and ongoing evalautions for OB and L&D patients. the nurses will "triage [determine level of acuity]" and determine if there is an "emergency". MD1 stated the "standard for years" at the hospital has allowed the nurses to use their "judgment" to diagnosis, order medications and treatments, and admit to patients in order to "expedite" medical care that may otherwise be "delayed". After the nurse has provided a MSE, without physician evaluation or communication, the nurses will place orders, as "verbal orders", for medications, monitors, intravenous fluids, treatments, diagnosis and admit patients The orders written by the nurses are sent to the physicians "in box" electronically and the physician will sign them up to 2 days later. MD1 stated he receives "100's of orders [written by nurses] and do not check who they are from ... it is difficult to verify who and what the orders are for ...just sign-off" without review. At some time, the nurses will "talk with the physician" about the patient's status. It's "standard procedure" at the hospital.

MD1 stated continuous FHT monitors "make sure the baby is okay ...ensure fetal well-being ...needs to be maintained throughout [hospital] stay". MD1 stated he does not agree with the time recommended to intervene for abnormal FHT tracings that last greater than 20 minutes. The hospital policy titled Patient Care Policy and Procedure for: Women's and Infants Services, Fetal Heart Rate and Uterine Surveillance, Index No. 21" was reviewed with MD1.It indicated management of possible FHR patterns: Category I (CAT1): Routine management. Normal FHR baseline between 110 and 160 bpm (heart beat per minute) with variability (an increase or decrease of 6 to 25 bpm of FHR with sleep, activity and mother's contractions MD1 stated CAT1 "reassures" fetal well-being. Category II (CAT2): Absent FHR acceleration (normal increase is 6 - 25 bpm from bassline with a maximum HR of 160 bpm) and/or absent or minimal FHR variability (amplitude (height) range undetectable and less or equal to 5 bpm variability. Tachycardia (fast heart rate greater than 160). " If FHR do not improve consider delivery". MD1 acknowledged that the CAT 2 tracing could change to CAT 3 emergency tracings. Category III (CAT3): FHR tracings include: Persistent absent baseline FHR variability. Bradycardia (slow FHR, below 110). Sinusoidal pattern (visually apparent, smooth, sine wave-like undulating pattern in FHR baseline) for > 20 minutes. If FHR tracing "do not improve, consider prompt delivery". MD1 stated he was not in agreement with the time limitations.

The chart indicated for 62 minutes, the fetal heart rate was 140 -145 bpm, with minimal variability and decelerations and after for another 25 minutes FHT could not be located. The FHT record strips from 5:00 p.m. to 5:42 p.m. were reviewed with MD1. MD1 stated the first variable deceleration was at 5:36 p.m., and FHT monitoring records were not available after 5:48 p.m. According to nursing documentation, variable decelerations were still present at 6:02 p.m. After 6:05 p.m., MD1 indicated after arrival on the L&D floor, the couple of minutes of FHT tracing strips were not informative and may have been the "mother's heart rate". MD1 stated after 5:48 p.m., "something happened" to the baby" and fetal well-being "could not be determined". MD1 acknowledged that FHT tracing were abnormal, may have changed to CAT3 and required emergency intervention. MD1 stated he does not agree with policy that a physician should evaluate and intervene if abnormal FHT tracings last greater than 20 minutes. MD1 indicated OB nurses are qualified to interrupt, diagnose and respond to abnormal FHT. MD1 stated if the nursing staff were "not worried" about FHT than "nothing is done".

MD1 acknowledged MD2 was on call for the OBED and L&D emergencies on 3/14/2024 and was responsible for Pt1's care from 3/14/204 at 4:38 p.m. until the next morning. MD1 indicated that he was the primary OB provider for Pt1 on 3/14/2024 from 4:46 p.m. to 3/15/2024 3:10 p.m., because he had been her physician throughout pregnancy. The records indicated MD1 "authorized" nurse to place orders under his name for Pt1 on 3/14/2024 as early as 5:05 p.m. On 3/14/2024, MD1 stated he did not evaluate Pt1 or discuss her status with the nurses. MD1 stated he only evaluated Pt1 on 3/15/2024.
MD1 indicated that OB emergency medical services and ongoing evaluations and stabilization of Pt1 and her fetus was provided nurses, and not physicians from 3:38 p.m. to 6:39 p.m.

MD1 stated all the placentas and cords of fetal or newborn demise should go to pathology. MD1 stated Pt1's placenta and cord should not have been "discarded" by MD2.

MD1 stated "during root cause analysis (RCA- a process to uncover causes of problems) and interview with the nurses", they reported "heard FHT", but there were no FHT strips. MD1 indicated hearing noise does not determine fetal well-being, "it could have been the mother's" heartbeat. MD1 stated Pt1 was removed from the monitors at 5:48 p.m. and it appeared "the fetus was alive ... but not properly monitored in the OBED after 5:48 p.m. and not on L&D". The chart indicate Pt1 spent 85 minutes in the OBED plus another 33 minutes in L&D before being evaluated by the OBED on call physician, MD2, for a medical emergency. MD1 acknowledged MD2 did not provide Pt1 care in the OBED, did not evaluate Pt 1's EMC, provide a MSE or stabilizing medical care to Pt1 and her fetus. MD1 stated it took "longer than expected" for Pt1 to be evaluated by MD2. MD1 stated, even if Pt1 and her fetus had a timely MSE, evaluation and stabilization it "would not have made a difference in the outcome ...fetal demise would have occurred". It was "unfortunate". MD1 stated the "physicians and nurses do a great job ...experienced ... the hospital is not unsafe".

During a interview and concurrent record review on 4/25/2024 at 9:00 a.m. with Medical Doctor, Emergency Department Director (MD3) accompanied CMO and DMS, hospital policies were reviewed and discussed, but MD 3 could not see the records due to technology. MD3 stated he was the medical director for the hospital emergency department (ED). MD3 stated indicated that he understood EMTALA requirements and hospital policies. MD3 stated there should "always" be a physician in the ED, and there is "never" a case when there is not. MD3 indicated patients who arrive at the ED are screened for an EMC, provided a MSE and stabilizing medical treatment. MD3 stated the patient is the responsibility of the physician and medical care is provided "as soon as you can". MD3 stated an EMC, MSE and stabilization of patient is "not done the over the phone" by a physician and "nobody [patient] leaves the department without a face-to-face evaluation". MD3 stated a pregnant woman in labor who arrive in the OBED or ED, EMTALA requirements still apply. MD3 indicated OB patients can be seen in the main ED and are provided a MSE and stabilization. If the complaint labor or pregnancy related, after triage, the patient is "escorted" by ED staff to the OBED. On the other hand, a pregnant women go directly to the OBED for an EMC, receive an MSE and stabilizing treatment by an OB physician and it's "not done by phone".

During record review of hospital policy titled "Bylaws of the Medical staff for [Hospital]", effective 1/27/20212, amendment effective 7/27/20218 indicated that Basic responsibilities of the medical staff included "providing patients with the quality of care meeting the professional standards of the Medical Staff ... abiding by these Bylaws, the Medical Staff Rules and Regulations, the departmental Rules and Regulations, and the Policies and Procedures of the Medical Staff ... complying with all Federal and State statutes ... A Member of the Medical Staff shall be responsible for the medical care and treatment of the patients for whom he or she is the admitting or primary physician ... Each Medical Staff Member must assure timely, adequate, professional care for his patients in the Hospital ...Therapeutic orders, including electronic written and verbal, may be given by authorized Members of the Medical Staff and allied health staff who are specifically authorized to give orders ... Emergency Services The Medical Staff shall adopt a method of providing medical coverage in the Department of Emergency Medicine ... Physician Members of the Department of Emergency Medicine shall be under the direction of the director, who shall be responsible for the professional activities of Members of the department and the quality of patient care rendered by such Members ... will be bound by the provisions of Paragraph 1317 of the Health & Safety Code, State of California [CA EMTALA Care Law] ... Medical Records ...completing accurate and complete medical records including electronic records ... The updated examination of the patient, including any changes in the patient's condition, must be completed and documented by a physician ...Pertinent progress notes shall be recorded at the time of observation sufficient to permit continuity of care and transferability".

During record review of the hospital policy titled, Department of OB-GYN [obstetrics (OB)- care of pregnanat women & Gynecology (GYN) women's reproductive system] /Perinatology, [care of pregnant mothers-woman's heath/care of fetus, unborn baby], Rules and Regulations", effective 5/2012, last reviewed 8/2023, stated that "EMTALA requirements related to obstetric care should be as follows: 1. A medical screening examination (MSE) must be performed by an appropriately privileged physician to determine whether the patient has an emergency medical condition, 2. If an emergency medical condition exists, patient must be stabilized and transferred to the labor unit or appropriate acute care hospital department ...labor and delivery nurse is qualified by virtue of his/her training to perform the medical screening exam to determine the presence of labor".

During record review of hospital policy titled, "[Hospital] Policy and Procedure for Women and Infants Services, Scope of Services for the Obstetrical Emergency Department, Index No. G-5", effective June 2014, last reviewed 4/2020, stated that "assessment, evaluation, management and treatment, that is appropriate and timely, to patients with obstetric conditions without delay ... Patients in labor will be transferred to the Labor and Delivery unit after an appropriate medical screening examination and stabilization in accordance with EMTALA regulations".

During record review of hospital policy titled "[Hospital] OB Emergency Services Standardized Procedure, Standardized Procedure: OB Medical Screening Examination index No. G-3", effective June 2014, last reviewed 1/2022, stated that " Supervision: The OB ED physician or patient's primary OB physician will provide supervision... A pregnant individual having contractions is considered to have an emergency medical condition ... 'Emergency medical condition' means a medical condition manifesting itself by acute symptoms of sufficient severity such that the absence of immediate medical attention could reasonably be expected to result in placing the health of the pregnant woman and/or her unborn child in serious jeopardy ... Diagnosis: Physician is to give a diagnosis on all patients receiving a MSE in OBED".

During record review of Patient Care Policy and Procedure for: Women's and Infants Services, Fetal Heart Rate and Uterine Surveillance, Index No. 21", effective 3/2020, last reviewed 8/2023, stated that "All patients presenting to Labor and Delivery units should undergo an initial period of electronic fetal monitoring ... continuous monitoring will be required to assure appropriate assessment of fetal well-being .... [FHT] validation by a supervising physician ... Examples of High Risk Conditions/Indications for requiring continuous electronic fetal monitoring [measures well-being and fetal heart rate] during labor, [include] Epidural/intrathecal Anesthesia [medication introduced directing into the spine or via a catheter in order to reduce pain and/or movement] ... Meconium [abnormal fetal expelling poop passed into amniotic fluid, a signal of fetal distress] ... Fetal arrhythmia [abnormal FHT] ... Abnormal/Indeterminate fetal assessment testing". The tables in the policy indicated management of possible FHR patterns: Category I: Routine management. Normal FHR baseline between 110 and 160 bpm with variability (10 to 25 bpm increase or decrease of FHR with sleep, activity and mother's contractions). Also considered "reassure" fetal well-being ... Category II: Absent FHR acceleration (normal increase is 10 - 25 bpm from bassline and maximum HR of less than 160 bpm) and/or absent/minimal FHR variability (Amplitude range undetectable and ? (less or equal to) 5 bpm (heart beat per minute] variability. Tachycardia (fast heart rate) Baseline rate greater than160 bpm. If FHR do not improve consider delivery ... Category III FHR tracings include: Persistent absent baseline FHR variability. Bradycardia (slow FHR, below 110). Sinusoidal pattern (visually apparent, smooth, sine wave-like undulating pattern in FHR baseline) for > 20 minutes. If FHR tracing do not improve, consider prompt delivery".

During review of California Code of Regulations, Title 22, 70243. Clinical Laboratory Service General Requirements stated "Tissue specimens shall be examined by a physician who is certified or eligible for certification in anatomical and/or clinical pathology by the American Board of Pathology or possesses qualifications which are equivalent to those required for certification ... A record of his findings shall become a part of the patient's medical record".

During record review of hospital policy titled "[Hospital] Patient Care Policy & Procedure, Specimens/Tissue: Care and Handling, Index No. J-1", effective 1/1986, last reviewed 4/2023, stated "Properly labeled and prepared specimens are delivered to the Laboratory for pathological, microbiological, or chemical examination/analysis ....All specimens removed from a patient will be properly labeled ...Examination by a pathologist .... Product of Conception (POC)/Fetal Newborn Death ... Placenta, requiring genetic studies or cultures".

During record review of hospital policy titled "[Hospital] Patient Care Policy & Procedure, Postmortem Policies, Index No. A-35", effective 2/1987, last reviewed 1/2021, stated if "yes to any of the below, you must report the death to the coroner ...All children, including neonates [new born] ... Fetal deaths greater than twenty weeks or greater than four-hundred grams [measure of weight] ... Deaths resulting from known or suspected reportable contagious disease and constituting a public hazard ... Any unnatural cause of death ... Regulatory references ... Title 22 California Code of Regulations ... Government code 27491 [It shall be the duty of the coroner to inquire into and determine the circumstances, manner, and cause of all violent, sudden, or unusual deaths. The coroner shall have discretion to determine the extent of inquiry to be made into any death occurring under natural circumstances] ... Title 17 2500 [Reporting to the local health authority, diseases and conditions] ... Title 22 [Regulations that apply to Acute care hospitals]".

Based on observation, interview and record review, the hospital failed to provide anesthesia services in a well-organized manner when:

1. The hospital failed to follow Medical Staff Bylaws, Rules and Regulations and California state law and ensure anesthesia services were appropriate to a Certified Registered Nurse Anesthetist's (CRNAs- a nurse trained to provide anesthesia (specialized care before for surgery, pain management, critical care and emergencies) as "independent practitioners" and the same as anesthesiologist (physician specialist who provides anesthesia medical care for surgery, pain management, critical care and emergencies who has full prescriptive, diagnostic and therapeutic authority). (Refer A1001)

2. Anesthesiologist (physician who provides specialized care before, during and after surgery, procedures to decrease pain) did not complete the pre-anesthesia procedure for Pt 1's and her fetus prior to initiating a labor epidural (a type of regional anesthesia where a doctor places a catheter tube in the patient's back and infuses medication to decrease labor pain). (Refer to A 1003)

3. Anesthesiologists (physician who provides specialized care before, during and after surgery, procedures to decrease pain) failed to provide ongoing evaluations of a labor epidural with continuous medication infusions and delegated anesthesia tasks to nurses who were not qualified to administer anesthesia. (Refer to A1004)

4. Anesthesiologist (physician who provides specialized care before, during and after surgery, procedures to decrease pain), failed to provide a post-operative procedure evaluation who received regional anesthesia and delegated anesthesia tasks to nurses who were not qualified to administer anesthesia. (Refer to A1005)

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 follow Medical Staff Bylaws, Rules and Regulations and California state law and ensure anesthesia services (specialized care before for surgery, pain management, critical care and emergencies), were appropriate to a Certified Registered Nurse Anesthetist's (CRNAs- a nurse trained to provide anesthesia (specialized care before for surgery, pain management, critical care and emergencies) scope of the practice and were appointed to the Medical Staff by the Governing Body (GB- a committee that leads a health care organization's compliance and quality oversight efforts), as "independent practitioners" and the same as anesthesiologist (physician specialist who provides anesthesia medical care for surgery, pain management, critical care and emergencies who has full prescriptive, diagnostic and therapeutic authority).

The failure to have physician's orders, discretion and oversight of the anesthesia services including for on-call, high risk invasive procedures and emergency services, provided by 3 of 3 CRNAs had the potential of endangering any patients who received "independent" anesthesia care from a non-physician (not qualified to diagnosis, prescribe, order interventions, medications and therapeutics or perform emergency procedures and surgeries).

Findings:

During an interview and concurrent record review on 4/25/2024 at 2:09 p.m., with the Medical staff team which included Chief Medical Officer and Obstetrician (CMO), Director of Medical Staff Affairs (DMS), Director of Medical Staff Affairs (DMS), Registered Nurse, Quality, Scribe (RNQ1), and Manager of Regulatory and Accreditation (MRA), hospital polices and the files of three CRNAs, (CRNA1, CRNA2, and CRNA3) were requested to be available for review by CDPH. To start the record review, CRNA polices, and forms were discussed. The hospital policy titled, "Allied Health Professional [AHP] Policy/Procedure Manual", indicated "Allied Health Professional or AHP means an individual, other than a licensed physician which included CRNAs ... CRNAs are privileged to perform tasks and functions which fall within the usual and customary scope of nursing practices ... under the supervision or the direction of a Medical Staff member possessing privileges to provide such care in the Hospital ...Therapeutic orders, including electronic written and verbal, may be given by authorized Members of the Medical Staff and allied health staff who are specifically authorized to give orders". DSM indicated the "CRNA Privilege Form describes the CRNAs' scope practice at the facility and if privileges are approved, CRNAs have "authority to practice independently"," and can provide to any patient medical care at the facility like an anesthesiologist. The CMO and DSM stated CRNAs are "independent practitioners" and based on "the laws" CRNAs can diagnosis, plus prescribe and order any medication, therapeutics, and treatment for patients without physician orders, oversight or discretion. The CMO and DSM indicated CRNAs have the same scope of practice and independence as an anesthesiologist.

During an interview and concurrent record review on 4/25/2024 at 2:09 p.m., A list of CRNAs with anesthesia privileges at the hospital was provided by the DSM. The list indicated Twenty-eight of the 33 CRNAs did not have a "sponsoring physician" recorded. The "Anesthesia Call List Calendar" for dates of September 1, 2023 to April 24, 2024, provided by the hospital, listed CRNAs on call every day to provided medical services to patients for emergencies, surgeries, anesthesia obstetrics (OB- care for pregnant mothers and unborn infant), an airway management (provided medical care to patients who difficulty with breathing) and/or critical care procedures (undefined by facility or privilege form), and there was not a physician named who provided for medical direction, oversight and/or orders. DSM stated the hospital does not require CRNAs to have a "supervising or sponsoring physician".

During an interview and concurrent record review on 4/25/2024 at 2:09 p.m., DSM pointed to the hospital policy titled, "CA association of Nurse Anesthetists (CANA) CRNA scope of Practice Guidelines" and stated "CRNAs are not required to have DEA number [Drug Enforcement Administration license that allows providers to order, procure and prescribe medications]". DSM stated CRNAs are allowed to order medications under California "AB 15 [Assembly Bill AB No.15, COVID 19 relief: tenancy: Tenant Stabilization Act of 2021]". DSM stated "according to California law CRNAs provide independent medical care" without a medical license. DSM stated several times the laws and policy gave CRNAs the authority to practice independently, and prescribe and order medications, therapeutics, and treatments. The CMO agreed with DSM but stated that he will check with "legal counsel to make sure doing things right".

During an interview on 4/24/2024 at 2:30 a.m. with Medical Doctor, Anesthesiologist (MD4), accompanied by CMO and DMS, hospital policies were reviewed and discussed. MD4 stated he has been practicing anesthesia since 1990. MD4 stated at the facility, CRNAs provide anesthesia services and are "independent practitioners" and provide medical care to patients without the involvement of a physician. MD4 indicated he does not supervise or provide physician oversight or medical direction for CRNAs, nor write orders for CRNAs to provide medical services.

During an interview on 4/25/2024 at 1:00 p.m. with Anesthesiologist (MD5), accompanied by CMO, DMS and Registered Nurse, Quality, Scribe (RNQ2) hospital policies were reviewed and discussed. MD5 state he has been practicing anesthesia for 16 years. MD5 stated at the facility, CRNAs provide anesthesia services and "practice independently", like "any other physician". CRNAs provide on-call anesthesia coverage to patients, including obstetrics (OB) and emergencies without the involvement of a physician. MD5 indicated he does provide physician oversight or medical direction to CRNAs, nor write orders for CRNAs to provide medical services, treatments, therapeutics, or medications.

During an interview with concurrent record review on 4/24/2024 at 3:30 p.m., with Anesthesiologist, (MD6) provide accompanied by Chief Medical Officer, CMO and DMS, the provider agreements were reviewed and discussed. MD6 stated he is the managing director of the anesthesia agreement with the facility and prior director of the department. MD6 stated he has been an anesthesiologist for over 26 years. MD6 stated the CRNA at the facility work under the current anesthesia agreements with companies that he manages. MD6 stated the structure is a "partnership". MD6 stated CRNAs are "restricted" from being considered independent contractors, unlike physicians because of California AB 5 (Assembly Bill No. 5, Worker status: employees and independent contractors). MD6 stated at the facility CRNA provided the "full gamut of anesthesia services". MD6 indicated CRNAs are on call at the hospitals to provide "independent" medical services for emergencies, surgeries, anesthesia obstetrics, an airway management and/or critical care procedures, and there was not an anesthesiologist who provided for medical direction, oversight and/or orders for the CRNA. Even though the contract indicated non-physician personnel and the anesthesia group "shall supervise the activities of such personnel while in the clinical/technical performance of Anesthesia Services and in the presence of an Anesthesiologist". The hospital has designated that CRNAs are non-physician, Advance Health Provider (AHP), but MD6 stated at the hospital, CRNAs are "independent practitioners", like physicians and provide the same services. MD6 stated CRNA do not have DEA licenses (DEA- Drug Enforcement Administration allows a physician to prescribe drugs prescribe, order, and procure drugs), but doesn't understand how CRNAs can order and prescribe medications. MD6 indicated anesthesiologists in the group do not write orders for treatments, medications, or therapeutics for CRNAs, provide oversight or direction, nor under their discretion.

During record review of hospital document title, "Copy of AHP Roster", the documented indicated the following: listed 33 CRNAs who were on medical staff and approved to provide anesthesia services. CRNAs were listed as "AHP" and "Expertise ... Anesthesiology". Twenty-eight of 33 CRNAs did not have a sponsoring physician recorded. The documents stated, "Sponsor name [of physician], CRNA does not require supervising physician". Thirty-three of the CRNAs did not have a listed physician of record for oversight, direction, or orders.

During record review of hospital document title, "Anesthesia Call List Calendar" for dates of September 1, 2023 to April 24, 2024, listed CRNAs on call every day in order to provided medical services to patients for emergencies, anesthesia obstetrics (OB- care for pregnant mothers and unborn infant), an airway management (provided medical care to patients who difficulty with breathing) and/or critical care procedures (undefined by facility or privileges), without a named physician for medical direction, oversight and/or orders.

During record review of hospital titled "Allied Health Professional [AHP] Policy/Procedure Manual", revised May 2023, stated "Allied Health Professional or AHP means an individual, other than a licensed physician, dentist, or podiatrist, who exercises independent judgment within the areas of his or her professional competence ... who is qualified to render direct or indirect medical, dental, or podiatric care under the supervision or the discretion of a Medical Staff member possessing privileges to provide such care in the hospital ... Advanced Practice Professionals (APP) are: Certified Registered Nurse Anesthetist (a nurse trained to provide anesthesia care under the orders and discretion of a physician), Nurse Practitioner (a nurse trained to provided medical care under standardized procedures, that is, specific directions from a physician), Physician Assistant (a nurse or other person trained to provided medical care under a practice agreement, that is, specific directions from a physician) ... CRNAs are privileged to perform tasks and functions which fall within the usual and customary scope of nursing practices".

During record review of hospital form titled, "CRNA Privilege Form CRNA Scope. Privilege form" for anesthesia practice at the hospital, indicated that CRNAs are "Allied Health Professional or AHP... other than a licensed physician ...Request and interpret results of any indicative diagnostic laboratory test ... Assess and implement appropriate treatment for any problems ... Select pre-medication ...make decisions to withhold certain medications ... implement corrective actions ... Core privileges include Regional Anesthesia [subspecialty of anesthesiology, which may take an additional year of training. They are procedures that can take away all feeling from a specific part of the body using special drugs]. Venous Catheters [high risk procedures that are associated with increased injury and death]".

During record review of California (CA) Business and Professions Code (BPC) 2826, stipulated that a "Nurse anesthetist' means a person who is a registered nurse licensed by the board who has met standards for certification from the board".

During record review of CA BPC, 2725(b)(2) stipulated that "Direct and indirect patient care services, including, but not limited to, the administration of medications and therapeutic agents, necessary to implement a treatment, disease prevention, or rehabilitative regimen ordered by and within the scope of licensure of a physician".

During review of CA BPC 2827 stipulated, the "utilization of a nurse anesthetist to provide anesthesia services in an acute care facility shall be approved by the acute care facility administration and the appropriate committee, and at the discretion of the physician, dentist or podiatrist".

During review of CA BPC 2833.5, stipulated that "the practice of nurse anesthetist does not confer authority to practice medicine or surgery".

During record review of hospital policy titled "Bylaws of the Medical staff for [Hospital]", effective 1/27/20212, amendment effective 7/27/20218 stated that "Medical Staff ' or 'Staff ' means those physicians, dentists, and podiatrists who are Members of the Medical Staff ... Allied Health Professional or AHP means an individual, other than a licensed physician, dentist, or podiatrist, who exercises independent judgment within the areas of his or her professional competence and the applicable State Practice Act, who is qualified to render direct or indirect medical, dental, or podiatric care under the supervision or the direction of a Medical Staff member possessing privileges to provide such care in the Hospital ...AHPs are not eligible for Medical Staff membership ...Therapeutic orders, including electronic written and verbal, may be given by authorized Members of the Medical Staff and allied health staff who are specifically authorized to give orders".

During record review of hospital document title, "Copy of AHP Roster", the documented indicated the following: listed 33 CRNAs who were on medical staff and approved to provide anesthesia services. CRNAs were listed as "AHP" and "Expertise ... Anesthesiology". Twenty-eight of 33 CRNAs did not have a sponsoring physician recorded. The documents stated, "Sponsor name [of physician], CRNA does not require supervising physician". Thirty-three of the CRNAs did not have a listed physician of record for oversight, direction, or orders.

During record review of hospital document title, "Anesthesia Call List Calendar" for dates of September 1, 2023 to April 24, 2024, listed CRNAs on call every day to provided medical services to patients for emergencies, anesthesia obstetrics (OB, care for pregnant mothers and unborn infant), an airway management (provided medical care to patients who difficulty with breathing) and/or critical care procedures (undefined by facility or privileges), without a named physician for medical direction, oversight and/or orders.

During record review of hospital titled "Allied Health Professional [AHP] Policy/Procedure Manual", revised May 2023, stated "Allied Health Professional or AHP means an individual, other than a licensed physician, dentist, or podiatrist, who exercises independent judgment within the areas of his or her professional competence ... who is qualified to render direct or indirect medical, dental, or podiatric care under the supervision or the direction of a Medical Staff member possessing privileges to provide such care in the hospital ... Advanced Practice Professionals (APP) are: Certified Registered Nurse Anesthetist (a nurse trained to provide anesthesia care under the orders and discretion of a physician), Nurse Practitioner (a nurse trained to provided medical care under standardized procedures, that is, specific directions from a physician), Physician Assistant (a nurse or other person trained to provided medical care under a practice agreement, that is, specific directions from a physician) ... CRNAs are privileged to perform tasks and functions which fall within the usual and customary scope of nursing practices".

During record review of hospital document titled "Professional Services Agreement Amendment Two and Restatement Department of Anesthesia, an agreement between [Hospital] and Anesthesia Group", indicated the "Group employs or otherwise contracts with physicians and certified Registered Nurse Anesthetists ...Hospital wishes to assure proper and consistent clinical supervision and administration of the Department, appropriate control and standardization of clinical procedures performed in the Department, necessary clinical education and training .... OB Anesthesia Coverage. Group agrees to provide in-house Anesthesia Services for Obstetrics (OB) cases twenty-four hours a day, seven days a week ... Non-physician Personnel ... Group shall supervise the activities of such personnel while in the clinical/technical performance of Anesthesia Services and in the presence of an Anesthesiologist, and Hospital shall be solely responsible for such personnel in all other aspects of their employment". Group agreed anesthesia services would be provided by CRNAs and/or anesthesiologists who practice independently.

Based on interview and record review, in accordance with hospital policy, a pre-anesthesia procedure evaluation for one of one pregnant patient, (Pt1), was not completed by the medical doctor, anesthesiologist (MD4- physician who provides specialized care before, during and after surgery, procedures to decrease pain, and emergency care).

The failure to determine Pt1's medical condition and status of the fetus, before initiating a labor epidural (a type of regional anesthesia where a doctor places a catheter tube in the patient's back and infuses medication to decrease labor pain) missed problems and protentional complications that may have contributed to patient harm and fetal demise.

Findings:

Record review of Pt1's medical care on 3/14/2024 from 4:38 p.m. to 6:05 p.m. indicate the following:

On 3/14/2024 at 4:38 p.m., the chart indicated Pt1 arrived at the OBED in "Labor [signs indicating ready to give birth]" and was placed in a room.

At 4:45 p.m., the chart indicated a RN (nurse) placed orders for medications, intravenous (I.V.- given via a vein) fluids and monitors, and provided a diagnosis and started to carry out her orders for Pt1. There was no documented evidence, an OBED nurse spoke with a physician. There was no documented evidence a medical screening examination (MSE) by a physician occurred for an emergency medical condition (EMC).

At 5:00 p.m., the nurses documented, Pt1 was placed on a fetal heart monitor for (FHT- measures character, pattern and rate of a fetus' heartbeat. A normal heartbeat fluctuates between110 to 160 that increase and decrease with sleep, activity and contractions and signals fetal well-being). FHT were measured at 140 beats per minute without the normal heart rate fluctuations (a signal of fetal harm and distress). There was no documented evidence a MSE examination or stabilization an EMC was provided by a physician.

At 5:05 p.m., chart indicated verbal orders were "authorized" by MD1 and indicated that the OB physician was to be notified for meconium (fetal stool), fetal heart rate abnormalities per policy. There was no documented evidence MD1 spoke with a nurse or examined the Pt1.

At 5:09 p.m., chart indicated MD2 ordered I.V. fluids with instructions: "May increase to 500mL bolus [large volume of I.V. fluid given rapidly] for abnormal fetal heart rate patterns". There was no documented evidence MD2 spoke with a nurse or examined the Pt1.

At 5:20 p.m., the nurses documented FHT were measured at 140 bpm without the normal heart rate fluctuations that would signal fetal well-being. Treatment initiated by nurses were I.V. fluid bolus and "therapeutic touch".

At 5:28 p.m., the nurses documented Pt1's complaints of pain "7/10 [zero to ten pain scale, 0 equals no pain, 10 equals severe]". Nursing intervention "therapeutic touch". There was no documented evidence an OBED nurse spoke with a physician or a physician evaluation.

At 5:28 p.m., the chart indicated Pt1 had a "high" white count (WBC, high counts are a sign of an infection) of 13.7 (normal 5.5-11).

At 5:36 p.m., the nurses documented FHT monitoring strip indicated fetal heart rate 145 bpm with new variable deceleration (abnormal decrease in FHT and a signal of fetal harm and distress) without the normal heart rate fluctuations that would signal fetal well-being. There was no documented evidence an OBED nurse spoke with a physician or a physician evaluated Pt1.

At 5:41 p.m., the chart indicated MD2 signed Pt1's orders and diagnosis placed by the nurses and MD1. There was no documented evidence, MD1 spoke to the nurses or a physician examined the Pt1.

At 5:42 p.m., the nurses documented FHT 145 bpm without the normal heart rate fluctuations that would signal fetal well-being, and thereafter FHT recording stops. There was no documented evidence an OBED nurse spoke with a physician, or a physician examined the Pt1.

At 5:56 p.m., the nurses documented Pt1's complaints of "cramping", "worsening" and pain "7/10". Nursing intervention "therapeutic touch". There was no documented evidence an OBED nurse spoke with a physician or a physician examined the Pt1.

At 6:02 p.m. the nurses documented fetal heart rate 145 bpm with continued variable deceleration without the normal heart rate fluctuations that would signal fetal well-being. There was no documented evidence of FHT monitoring strips from 5:42 p.m. onward. There was no documented evidence an OBED nurse spoke with an OB physician. There was no documented evidence an OB physician provided a MSE or stabilization for an EMC prior to Pt1 leaving the OBED.

At 6:04 p.m., the chart indicated Pt1 was admitted to Labor and Delivery (L&D) floor and transferred from the OBED. There was no documented evidence Pt1 received a medical exam or medical stabilization by an OB physician on arrival to L&D.

At 6:05 p.m., Prior to the procedure, there was no documented evidence MD4 reviewed Pt1's care events or spoke with an OB physician regarding the status of Pt1 and her fetus. In accordance with hospital policy, MD4's pre-procedure OB evaluation documented "no relevant active problems". There was no documented evidence of patient overall condition, back exam, abdomen exam, fetal age, weight, height, ability to cooperate or laboratory values. There was no documentation of Pt1's pre-procedure heart rate, blood pressure, respiratory rate, blood oxygen levels or recording of fetal heart rate and patterns.

From 6:05 p.m. to 6:38 p.m., the chart indicated the L&D nurses were unable to detect FHT. There was no documented evidence an OBED nurse spoke with an OB physician, or Pt1 received a medical exam or medical stabilization by an OB physician.

During a interview and concurrent record review on 4/24/2024 at 3:30 p.m. with Medical Doctor, Anesthesiologist, (MD6), accompanied by CMO and DMS, Patient 1's medical record provided by the hospital and hospital policies were reviewed and discussed. MD6 stated he has been an anesthesiologist for over 26 years. MD6 stated he is the managing director of the anesthesia agreement with the facility and prior Director of the anesthesia department. MD6 stated the care of the mother and fetus are "hot topics" at the facility. MD6 indicated he is aware of hospital polices, not necessary to review them and stated that "if a policy states a process, need to follow it".

MD6 indicated OB anesthesia services are for the pregnant patient. MD6 stated when a pregnant mom presents for an epidural, there are "two issues, two lives". MD6 stated "any anesthesia procedures ...anything we [anesthesiologist] do, any procedure, medication ... can affect the fetus and compromise both ... everything is connected [mother and fetus] ...why monitors for fetus and mom" are needed. MD6 stated if there is a problem with fetal heart rate and monitoring, the OB physician is called and an epidural may not be appropriate. MD6 stated the OB nurses are the "first line to assess warning signs" of the mother and fetus. MD6 stated the "RNs job is to monitor FHT" during the epidural and communicate the findings, and if the anesthesiologists believe the fetus or mother are "not doing well", OB is called to assess the mother and fetus.

During a interview and concurrent record review on 4/24/2024 at 2:30 am with Medical Doctor, Anesthesiologist (MD4) accompanied by CMO and DMS, Patient 1's (Pt1) medical record provided by the hospital and hospital policies were reviewed and discussed. MD4 stated he has been practicing anesthesia, including OB anesthesia since 1990. MD4 stated the anesthesiologist at the facility are available to provide OB anesthesia and emergency services to patients 24 hours a day, 7 days a week (24/7). MD4 stated if a labor epidural is needed for a patient, the nurse or OB physician will contact the anesthesiologist.

MD4 stated the anesthesia care provided to a pregnant woman is a "philosophical issue". MD4 indicated even if the mother and fetus are one, the fetus is not a patient and "not my concern". MD4 acknowledged the fetus is dependent on the mother and labor epidurals can affect the mother's well-being, and in turn, affect the fetus' well-being. MD4 stated the "customary practice" is to monitor FHT rate and pattern, and mother's vitals during anesthesia procedures. MD4 acknowledged the hospital policy for OB anesthesiologists required FHT monitoring during anesthesia procedures, but he stated it was "meant for nurses". MD4 stated the fetus is not a patient and the job of anesthesia is "only the mother", and the well-being of the unborn baby is the "OB's and the nurses' job".

Pt1's chart and timeline were reviewed with MD4. MD4 acknowledged he provided OB anesthesia services for Pt1 on 3/14/2024 when she arrived on L&D and until 7:10pm. MD4 stated on a nurse "really needed" an "urgent" epidural for Pt1. MD stated Pt1 was "howling" and "screaming", and "not cooperative". MD4 acknowledged he did not confirm if an OB physician had evaluated the pregnant mother, OB had determined fetal well-being, OB physician was immediately available, nor reviewed the nurses notes and FHT. MD4 stated it was the "nurse's job, not anesthesia". MD4 stated "even if there was a concern with FHT and [baby] status, not my job ...fetal well-being is not my job description ... My job is to place the epidural". MD4 acknowledged before the epidural placement, there was no documented evidence of maternal vital signs, overall condition of mom, FHT or fetal well-being by the anesthesiologist. MD4's pre-procedure OB evaluation was reviewed. MD4 documented, "no relevant active problems". There was no documented evidence of patient overall condition, back exam, abdomen exam, fetal age, weight, height, ability to cooperate or laboratory values. There was no documentation of Pt1's pre-procedure heart rate, blood pressure, respiratory rate, blood oxygen levels or recording of fetal heart rate and patterns. MD4 stated the anesthesia pre-procedure template note for labor epidurals is "pre-populated" and to complete the chart, "check boxes" in the "electronic" chart. MD4 stated "does not record or look at the FHT", but "checked the box" as if he did because it was part of the anesthesia ongoing assessment during a labor epidural.

During a interview and concurrent record review on 4/25/2024 at 1:00 p.m. with Medical Doctor, Anesthesiologist (MD5), accompanied by CMO, DMS and RNQ2, Patient 1's medical record provided by the hospital and hospital policies were reviewed and discussed. MD5 state he has been practicing anesthesia for 16 years. MD5 stated he "follows [hospital] policies". MD5 indicated OB anesthesia provides labor epidurals, pain management and emergency care to pregnant mothers. MD5 stated OB anesthesia's "primary care is for the mother, and fetus as well". MD5 stated an anesthesiologist's training includes "basic FHT" monitoring and interpretation, but the "professional interpretation" is the OB physician's responsibility. MD5 stated he can "recognize fetal distress and compromise" on FHT monitor tracings and understands the "basic" changes of fetal heart rates on FHT monitors. MD5 stated when procedures are done on the mother by anesthesia, the anesthesiologist "worry about changes in FHTs". MD5 stated a "decrease in heart rate or increase in heart rate" can reflect "fetal distress and compromise". MD5 indicated that if he has any concerns about the fetus, he will ask the nurses to call the OB physician and call the "team for help", because his "primary concern is for the mother".

MD5 stated before starting a labor epidural, he reviews the patient's history, pregnancy status, obtains consent. The nurses apply monitors for blood pressure, oxygen saturation (measures blood oxygen levels) and FHT. MD5 stated before the procedure MD5 stated that he "looks" at the FHT monitor, checks for "FHT changes" and monitors mother's vitals, especially for "low blood pressure", but does not document them.

During record review of hospital titled policy, "Department of Anesthesia Rules and Regulations", approved 11/10/2020 and signed by MEC, Board and Chair of anesthesia department, stated that anesthesiologists "provide medical management of patients ... during surgical, obstetrical, and other medical procedures ... Care will include preoperative, intra-operative, and postoperative evaluation and treatment of these patients ... Anesthesiologists are expected to be familiar with these documents and the standards outlined and follow them in the practice of anesthesiology at [Hospital] ASA (American Society of Anesthesiology) GUIDELINES FOR PATIENT CARE IN ANESTHESIOLOGY, ASA BASIC STANDARDS FOR PREANESTHESIA CARE, ASA STANDARDS FOR BASIC ANESTHETIC MONITORING, ASA STANDARDS FOR POSTANESTHESIA CARE "

During record review of hospital policy titled. "[Hospital] Anesthesiology Clinical Privileges", approved 7/31/2020, stated the "Core Privileges. Administration of anesthesia, including general, regional, and local [anesthesia ... and the management of emotional stress during surgical, obstetrical and certain other medical procedures; including preoperative, intraoperative and postoperative evaluation and treatment ... Assess, stabilize, and determine disposition of patients with emergent conditions consistent with medical staff policy regarding emergency and consultative call services.

During record review of hospital policy titled "[Hospital] Obstetrical Anesthesia, Index No. O-2", effective 3/2005, last reviewed 11/2023, stated that anesthesiologist are "committed to providing safe and effective anesthesia ... Regional anesthesia may be performed after the appropriate written consent is obtained from the patient and the attending OB is notified and approval is given ... appropriate lab work must be in the chart ... Fetal heart rate (FHR) must be documented by appropriate personnel before and after the procedure ... Monitoring as stated by the American Society of Anesthesiology must be available and utilized ... the attending OB must be in house prior to the placement of a regional block ... Postoperative care ...the anesthesia provider is responsible".

During record review of hospital titled policy, "[Hospital] Anesthesiology Department Policy and Procedure, Regional Anesthesia, Index No. R-1", effective 12/2004, last reviewed 11/2023, stated that "Procedure Safety Considerations [include] ... using ASA monitors ...weight and physical condition of the patient ... ...contradictions to performing regional anesthetic include ... inability of the patient to cooperate ..."

During record review of hospital policy titled ,"[Hospital] Anesthesiology Department Policy and Procedure, Basic Standards for Pre-anesthesia Care, Index No. B-2", effective 10/1998, last reviewed 11/2023, stated that anesthesiologist adhere "to the practice standards promulgated by the American Society of Anesthesiologist ... Enhanced patient safety in the perioperative period ... An anesthesia provider shall be responsible for determining the medical status of the patient ...developing a plan of anesthesia care ...Interviewing and examining the patient ... assess those aspects of the physical condition that might affect decisions regarding perioperative risk and management ... obtaining and/or reviewing tests".

During record review, according to Practice Guidelines for Obstetric Anesthesia, the ASA recommends that physicians should be approved through the institutional credentialing process to initiate and direct the maintenance of obstetric anesthesia and to manage procedure related complications. Guidelines includes, but not limited to the following: consultation with the obstetrician who has knowledge of the maternal and fetal status and the progress of labor and who agrees with the initiation of labor analgesia. Conducting a relevant obstetrical history and physical examination (maternal health and condition, including airway, heart, lung and back). Obtain laboratory tests. Monitoring vital signs (heart rate, respiratory rate, oxygen blood levels and blood pressure) prior to, during and after administration of labor regional anesthesia, i.e. labor epidural. Perianesthetic recording of fetal heart rate and patterns before, during and after administration of regional anesthesia. Fetal heart rate patterns may change after the administration of neuraxial anesthetics and placing patients at increased risk (e.g., non-reassuring fetal heart rate pattern) Therefore, the patient should remain under continuous direct observation by a provider for at least 20 minutes. https://pubs.asahq.org/anesthesiology/article/124/2/270/12693/Practice-Guidelines-for-Obstetric-Anesthesia (Accessed 4/24/2024) and https://www.asahq.org/standards-and-practice-parameters/statement-on-neuraxial-anesthesia-in-obstetrics (Accessed 4/24/2024)

During record review of Patient Care Policy and Procedure for: Women's and Infants Services, Fetal Heart Rate and Uterine Surveillance, Index No. 21", effective 3/2020, last reviewed 8/2023, stated that "All patients presenting to Labor and Delivery units should undergo an initial period of electronic fetal monitoring ... continuous monitoring will be required to assure appropriate assessment of fetal well-being .... [FHT] validation by a supervising physician ... Examples of High Risk Conditions/Indications for requiring continuous electronic fetal monitoring [measures well-being and fetal heart rate] during labor, [include] Epidural/intrathecal Anesthesia [medication introduced directing into the spine or via a catheter in order to reduce pain and/or movement] ... Meconium [abnormal fetal expelling poop passed into amniotic fluid, a signal of fetal distress] ... Fetal arrhythmia [abnormal FHT] ... Abnormal/Indeterminate fetal assessment testing".

Based on interview and record review, in accordance with hospital policy, the 2 of 2 anesthesiologists (physician who provides specialized care before, during and after surgery, procedures to decrease pain, and emergency care), MD 4 and MD 5, failed to provide ongoing evalautions of a labor epidural with continuous medication infusions for one of one patient, (Pt1) and delegated anesthesia tasks to nurses who were not qualified to administer anesthesia.

The failure of the anesthesiologist to monitor Pt1's medical condition and status of the fetus, during the placement of the labor epidural and continuous infusion of epidural medications, missed protentional complications or problems that may have contributed to patient harm and fetal injury.

Findings:

Record review of Pt1's medical care on 3/14/2024 from 5:28 p.m. to 11:33 p.m. indicate the following:

At 5:28 p.m., the chart indicated Pt1 had a "high" white count (WBC, high counts are a sign of an infection) of 13.7 (normal 5.5-11).

From 6:05 p.m. to 6:38 p.m., the chart indicated the L&D nurses were unable to detect FHT. There was no documented evidence, an OBED nurse spoke with an OB physician.

At 6:05 p.m., there was no documented evidence of FHT. The chart indicated that a labor epidural (when a women is ready to deliver an infant a doctor can place a catheter in the back that infuses medication to decrease labor pain) was requested by nursing staff. There was no documented evidence MD2 communicated with spoke with MD4 and requested the procedure or discussed the status of Pt1 and her fetus. The labor epidural was initiated by MD4. During the placement of the labor epidural and initiating medication, there was no documented evidence that MD4 charted and monitored Pt1's patient overall condition, heart rate, blood pressure, respiratory rate, blood oxygen levels or recording of fetal heart rate and patterns. The chart indicated the nurse were unable to locate FHT. There was no documented evidence, MD4 interrupted the epidural to determine the status of Pt1 and the fetus.

At 6:23 p.m., MD4 completed the epidural.

At 6:25 p.m., the nursing exam note indicated, unable to locate FHT, and "no fetal movement". There was no documented evidence an anesthesiologist or OB physician were at Pt1's bedside. There was no documented evidence MD4 evaluated Pt1 for a possible emergency when there was concern of fetal compromise and injury.

At 6:39 p.m., the chart indicated MD2 was called to the bedside. The chart indicated this was the first evaulation of Pt1 by an OB physician. MD2 documented "no fetal heart tones per" and diagnosed "IUFD [intrauterine fetal demise, death of infant before birth]".

At 7:10 p.m., MD4 turned Pt1's anesthesia care over to MD5. There is no documented evidence MD4 evaluated Pt1's status, vitals or condition before signing Pt1 over to MD5. There was no documented evidence MD5 evaluated Pt1's status, vitals or condition when he assumed care of Pt1's labor epidural and infusion of medications. There was no documented evidence MD4 or MD5 spoke with an OB physician to discuss the status of Pt1 and the fetus.

At 11:26 p.m., the nurse's note indicated, "meconium" before the delivery of the infant. There was no documented evidence MD5 Pt1's Pt1's status, vitals or overall condition during the labor epidural infusion of medications.

At 11:33 p.m., MD2 recorded the delivery of the fetus. The record indicated there was a "tight nuchal cord [the umbilical cord connects mother and baby in the womb and supplies blood, oxygen and nutrients to the fetus that gets tangled causing a decrease or absent blood flow] ...noted around the baby's neck that could not be reduced ...large 6 inch clot noted in [umbilical] cord at the fetal insertion ...[placenta] membranes meconium stained ... cord and placenta [organ in the womb that hold fluid and the fetus] discarded ... infant and patient in delivery room in good and stable condition". There was no documented evidence MD2 sent fetal remains for examination by a pathologist (a physician who exams tissues and determines abnormal tissue, injury and/or cause of death).

During a interview and concurrent record review on 4/24/2024 at 3:30 p.m. with Medical Doctor, Anesthesiologist, (MD6), accompanied by CMO and DMS, Patient 1's medical record provided by the hospital and hospital policies were reviewed and discussed. MD6 stated he has been an anesthesiologist for over 26 years. MD6 stated he is the managing director of the anesthesia agreement with the facility and prior Director of the department. MD6 stated the care of the mother and fetus are "hot topics" at the facility. MD6 indicated he is aware of hospital polices, not necessary to review them and stated that "if a policy states a process, need to follow it".

MD6 indicated OB anesthesia services are for the pregnant patient. MD6 stated when a pregnant mom presents for an epidural, there are "two issues, two lives". MD6 stated "any anesthesia procedures ...anything we [anesthesiologist] do, any procedure, medication ... can affect the fetus and compromise both ... everything is connected [mother and fetus] ...why monitors for fetus and mom" are needed. MD6 stated if there is a problem with fetal heart rate and monitoring, the OB physician is called and an epidural may not be appropriate. MD6 stated the OB nurses are the "first line to assess warning signs" of the mother and fetus. MD6 stated if the anesthesiologists believe the fetus or mother are "not doing well", OB is called to assess the mother and fetus.

During a interview and concurrent record review on 4/24/2024 at 2:30 am with Medical Doctor, Anesthesiologist (MD4), accompanied by CMO and DMS, Patient 1's (Pt1) medical record provided by the hospital and hospital policies were reviewed and discussed. MD4 stated he has been practicing anesthesia, including OB anesthesia since 1990. MD4 stated the anesthesiologist at the facility available to provide OB anesthesia and emergency services to patients 24 hours a day, 7 days a week (24/7). MD4 stated the anesthesia care provided to a pregnant women is a "philosophical issue". MD4 indicated even if the mother and fetus are one, the fetus is not a patient and "not my concern". MD4 acknowledged the fetus is dependent on the mother and labor epidurals can affect the mother's well-being, and in turn, affect the fetus' well-being. MD4 stated the "customary practice" is to monitor FHT rate and pattern, and mother's vitals during anesthesia procedures. MD4 indicated the hospital policies for OB anesthesia and anesthesiologists required FHT monitoring during labor epidurals and patient monitoring were "meant for nurses". MD4 stated the fetus is not a patient and the job of anesthesia is "only the mother", and the well-being of the unborn baby is the "OB's and the nurses' job".

MD4 acknowledged he did not confirm maternal status of fetal well-being during the epidural placement. MD4 stated the nurse was trying to obtain FHT. MD4 acknowledged he completed the epidural and did not ask the nurse about fetal well-being. MD4 stated "even if there was a concern with FHT and status, not my job ...fetal well-being is not my job description ... My job is to place the epidural".

At 6:23 p.m., MD4 stated the anesthesia procedure template note for labor epidurals is "pre-populated", with the procedure details and to complete the chart, "check boxes" in the "electronic" chart. MD4 stated "does not record or look at the FHT", but "checked the box" as if he did because it was part of the anesthesia ongoing assessment during the procedure. MD4 indicated he did not communicate with the OB physician regarding Pt1's status and completion of the epidural. During and after the placement of the labor epidural and initiating medication, there was no documented evidence MD4 charted and monitored Pt1's patient overall condition, heart rate, blood pressure, respiratory rate, blood oxygen levels or recording of fetal heart rate and patterns. MD4 stated monitoring Pt1 was the "nurse's job, not anesthesia".

MD4 stated he usually stays for 20 minutes after the epidural placement, but left. He stated a "few minutes after leaving a nurse ran into the my room" and informed him that the Pt1 needed a "emergency c-section [surgery to remove the fetus from the womb]". MD4 acknowledged he did not document the communication with the nurse, going to the Pt 1's bedside, or evaluating Pt1. MD4 indicated he did not evaluate the Pt1 after the labor epidural placement or during the medication infusion. MD4 indicated he transferred Pt1's care to MD5 on 3/14/2024 at 7:10 p.m.

During a interview and concurrent record review on 4/25/2024 at 1:00 p.m. with Medical Doctor, Anesthesiologist (MD5), accompanied by CMO, DMS and RNQ2, Patient 1's medical record provided by the hospital and hospital policies were reviewed and discussed. MD5 state he has been practicing anesthesia for 16 years. MD5 stated he "follows [hospital] policies". MD5 indicated OB anesthesia provides labor epidurals, pain management and emergency care to pregnant mothers. MD5 stated OB anesthesia's "primary care is for the mother, and fetus as well". MD5 stated an anesthesiologist's training includes "basic FHT" monitoring and interpretation, but the "professional interpretation" is the OB physician's responsibility. MD5 stated he can "recognize fetal distress and compromise" on FHT monitor tracings and understands the "basic" changes of fetal heart rates on FHT monitors. MD5 stated when labor epidurals with medications are done for the mother, the anesthesiologist "worry about changes in FHTs". MD5 stated a "decrease in heart rate or increase in heart rate" can reflect "fetal distress and compromise". MD5 provided an example of low blood pressure in the mother can cause abnormal "changes in FHTs". MD5 stated the FHT monitors are watched by the nurses in the room and at the nurses' station. He explained the nurses' station monitors all the FHT in one central location on L&D. MD5 indicated the OB nurses notify physicians when FHTs are a concern, the procedure is stopped if necessary. MD5 indicated, if he has any concerns about the fetus, he will ask the nurses to call the OB physician and call the "team for help", because his "primary concern is for the mother". MD5 stated during the placement of the labor epidural and continuous infusion of epidural medications, MD5 stated that he "looks" at the FHT monitor, checks for "FHT changes" and monitors mother's vitals, especially for "low blood pressure". MD5 stated after the epidural placement, he stays for "10 minutes or until the mother is comfortable" before leaving the bedside. Thereafter, the "mother is assessed at least every 12 hours and as needed".

MD5 stated he signed the chart indicating he was the provided OB anesthesia services for Pt1 during the evening of 3/14/2024. MD5 acknowledged, at 7:10pm he "assumed" the anesthesia care and labor epidural from MD4. MD5 stated anesthesia service ended when the epidural was removed at 11:33 pm. MD5 stated the "nurse is present to oversee" the labor epidurals and "nurses take care of the epidural" and discontinue them. There was no documented evidence in the Pt1's record that MD5 provided any anesthesia care or assessments during the labor epidural infusion. MD5 stated he "did not check on her [Pt 1]" or provide any medical care during the epidural and infusion of medication during the epidural. Nonetheless, MD5 acknowledged he signed the anesthesia record certifying he provided OB anesthesia care to Pt1 from 7:10pm to 11:33 p.m.

During record review of hospital titled policy, "Department of Anesthesia Rules and Regulations", approved 11/10/2020 and signed by MEC, Board and Chair of anesthesia department, stated that anesthesiologists "provide medical management of patients ... during surgical, obstetrical, and other medical procedures ... Care will include preoperative, intra-operative, and postoperative evaluation and treatment of these patients ... Anesthesiologists are expected to be familiar with these documents and the standards outlined and follow them in the practice of anesthesiology at [Hospital] ASA (American Society of Anesthesiology) GUIDELINES FOR PATIENT CARE IN ANESTHESIOLOGY, ASA BASIC STANDARDS FOR PREANESTHESIA CARE, ASA STANDARDS FOR BASIC ANESTHETIC MONITORING, ASA STANDARDS FOR POSTANESTHESIA CARE "


During record review of hospital policy titled. "[Hospital] Anesthesiology Clinical Privileges", approved 7/31/2020, stated the "Core Privileges. Administration of anesthesia, including general, regional, and local [anesthesia ... and the management of emotional stress during surgical, obstetrical and certain other medical procedures; including preoperative, intraoperative and postoperative evaluation and treatment ... Assess, stabilize, and determine disposition of patients with emergent conditions consistent with medical staff policy regarding emergency and consultative call services.

During record review of hospital policy titled "[Hospital] Obstetrical Anesthesia, Index No. O-2", effective 3/2005, last reviewed 11/2023, stated that anesthesiologist are "committed to providing safe and effective anesthesia ... Regional anesthesia may be performed after the appropriate written consent is obtained from the patient and the attending OB is notified and approval is given ... appropriate lab work must be in the chart ... Fetal heart rate (FHR) must be documented by appropriate personnel before and after the procedure ... Monitoring as stated by the American Society of Anesthesiology must be available and utilized ... the attending OB must be in house prior to the placement of a regional block ... Postoperative care ...the anesthesia provider is responsible".

During record review of hospital titled policy, "[Hospital] Anesthesiology Department Policy and Procedure, Regional Anesthesia, Index No. R-1", effective 12/2004, last reviewed 11/2023, stated that "Procedure Safety Considerations [include] ... using ASA monitors ...weight and physical condition of the patient ... ...contradictions to performing regional anesthetic include ... inability of the patient to cooperate ..."

During record review of hospital titled policy ,"[Hospital] Anesthesiology Department Policy and Procedure, Basic Anesthetic Monitoring, Index No. B-1", effective 10/1998, last reviewed 11/2023, indicated that "these standards apply to all anesthesia care ... This set of standards addresses only the issue of basic anesthetic monitoring, which is one component of anesthesia care ... Qualified anesthesia personnel shall be present in the room throughout the conduct of all general anesthetics, regional anesthetics and monitored anesthesia care ... Because of the rapid changes in patient status during anesthesia, qualified anesthesia personnel shall be continuously present to monitor the patient and provide anesthesia care ... Every patient receiving anesthesia shall have the electrocardiogram continuously displayed from the beginning of anesthesia until preparing to leave the anesthetizing location ... During regional anesthesia, the adequacy of ventilation shall be evaluated by continual observation of qualitative clinical signs .... Every patient receiving anesthesia shall have blood pressure and heart rate determined and evaluated at least every five minutes".

During record review, according to Practice Guidelines for Obstetric Anesthesia, the ASA recommends that physicians should be approved through the institutional credentialing process to initiate and direct the maintenance of obstetric anesthesia and to manage procedure related complications. Guidelines includes, but not limited to the following: consultation with the obstetrician who has knowledge of the maternal and fetal status and the progress of labor and who agrees with the initiation of labor analgesia. Conducting a relevant obstetrical history and physical examination (maternal health and condition, including airway, heart, lung and back). Obtain laboratory tests. Monitoring vital signs (heart rate, respiratory rate, oxygen blood levels and blood pressure) prior to, during and after administration of labor regional anesthesia, i.e. labor epidural. Perianesthetic recording of fetal heart rate and patterns before, during and after administration of regional anesthesia. Fetal heart rate patterns may change after the administration of neuraxial anesthetics and placing patients at increased risk (e.g., non-reassuring fetal heart rate pattern) Therefore, the patient should remain under continuous direct observation by a provider for at least 20 minutes. https://pubs.asahq.org/anesthesiology/article/124/2/270/12693/Practice-Guidelines-for-Obstetric-Anesthesia (Accessed 4/24/2024) and https://www.asahq.org/standards-and-practice-parameters/statement-on-neuraxial-anesthesia-in-obstetrics (Accessed 4/24/2024)

During record review of Patient Care Policy and Procedure for: Women's and Infants Services, Fetal Heart Rate and Uterine Surveillance, Index No. 21", effective 3/2020, last reviewed 8/2023, stated that "All patients presenting to Labor and Delivery units should undergo an initial period of electronic fetal monitoring ... continuous monitoring will be required to assure appropriate assessment of fetal well-being .... [FHT] validation by a supervising physician ... Examples of High Risk Conditions/Indications for requiring continuous electronic fetal monitoring [measures well-being and fetal heart rate] during labor, [include] Epidural/intrathecal Anesthesia [medication introduced directing into the spine or via a catheter in order to reduce pain and/or movement] ... Meconium [abnormal fetal expelling poop passed into amniotic fluid, a signal of fetal distress] ... Fetal arrhythmia [abnormal FHT] ... Abnormal/Indeterminate fetal assessment testing".

Based on interview and record review, in accordance with hospital policy, for one of one patient, (Pt1) the anesthesiologist (physician who provides specialized care before, during and after surgery, procedures to decrease pain, and emergency care), MD 5, failed to provide a post-operative procedure evaluation who received regional anesthesia and delegated anesthesia tasks to nurses who were not qualified to administer anesthesia.

The failure to evaluate Pt1's post labor epidural evaluation of Pt1's medical condition and status of the fetus had the protentional to miss complications and determine if anesthesia procedure contributed to patient harm, fetal compromise or elevated white count (sign of infection).

Findings:

Record review of Pt1's medical care of indicate the following:

On 3/14/2024 at 11:33 p.m., the OB physician recorded the delivery of nonviable infant . The chart indicated discontinuation of epidural medication and epidural catheter removal and the post-procedure anesthesia evaluation was completed by the nurses. There was no documented evidence MD5 evaluated Pt1 after delivery of the infant, discontinuation of the labor epidural medications or removal of the catheter tube.

On 3/15/2024 at 2:16 a.m., review of the patient's chart, indicated Pt1 had a "high" white count of 18.2, increased from 13.7 (normal 5.5-11) a few hours earlier. There was no documented evidence MD5 evaluated Pt1 for possible infection and risks after a labor epidural.

During a interview and concurrent record review on 4/24/2024 at 3:30 p.m. with Medical Doctor, Anesthesiologist, (MD6), accompanied by CMO and DMS, Patient 1's medical record provided by the hospital and hospital policies were reviewed and discussed. MD6 stated he has been an anesthesiologist for over 26 years. MD6 stated he is the managing director of the anesthesia agreement with the facility and prior Director of the department. MD6 stated the care of the mother and fetus are "hot topics" at the facility. MD6 indicated he is aware of hospital polices, not necessary to review them and stated "if a policy states a process, need to follow it".

During a interview and concurrent record review on 4/25/2024 at 1:00 p.m. with Medical Doctor, Anesthesiologist (MD5), accompanied by CMO, DNS and RNQ2, Patient 1's medical record provided by the hospital and hospital policies were reviewed and discussed. MD5 state he has been practicing anesthesia for 16 years. MD5 stated he "follows [hospital] policies". MD5 indicated OB anesthesia provides labor epidurals, pain management and emergency care to pregnant mothers. MD5 stated OB anesthesia's "primary care is for the mother, and fetus as well". MD5 stated when procedures are done on the mother by anesthesia, the anesthesiologist "worry about changes in FHTs". MD5 stated a "decrease in heart rate or increase in heart rate" can reflect "fetal distress and compromise". MD5 provided an example of low blood pressure in the mother. MD5 indicated, if he has any concerns about the fetus, he will ask the nurses to call the OB physician and call the "team for help", because his "primary concern is for the mother".

MD5 stated he signed the chart indicating he was the provided OB anesthesia services for the night of 3/14/2024 for Pt1. MD5 acknowledged, at 7:10pm he "assumed" the anesthesia care and labor epidural from MD4. MD5 stated anesthesia care ended when the epidural catheter was removed at 11:33 pm. MD5 stated the "nurse is present to oversee" the labor epidurals and "nurses take care of the epidural" and discontinue them. MD5 stated the nurse will document in the anesthesia record the anesthesia "stop time" when they have stopped the medication, removed the epidural catheter and completed the note. The nurse will forward the note for a physician signature. MD5 stated he "checks the dashboard [notes that need to signed in the computer]" to sign the note from the nurses. The MD5 stated he will sign the note after the nurse have completed the post-procedure entries and evaluation.

MD5 acknowledged he signed the post "Procedure Summary" at 12:04, certifying he provided OB anesthesia care to Pt1 from 7:10pm to 11:33 p.m. There was no documented evidence in the Pt1's record that MD5 provided any anesthesia care or assessments after removal of the epidural catheter or provided a post-procedure examination on 3/15/2024. MD5 stated he "did not check on her [Pt1] during the epidural", after the removal of the epidural by the nurses or provide a post-procedure exam.

During record review of hospital titled policy, "Department of Anesthesia Rules and Regulations", approved 11/10/2020 and signed by MEC, Board and Chair of anesthesia department, stated that anesthesiologists "provide medical management of patients ... during surgical, obstetrical, and other medical procedures ... Care will include preoperative, intra-operative, and postoperative evaluation and treatment of these patients ... Anesthesiologists are expected to be familiar with these documents and the standards outlined and follow them in the practice of anesthesiology at [Hospital] ASA (American Society of Anesthesiology) GUIDELINES FOR PATIENT CARE IN ANESTHESIOLOGY, ASA BASIC STANDARDS FOR PREANESTHESIA CARE, ASA STANDARDS FOR BASIC ANESTHETIC MONITORING, ASA STANDARDS FOSR POSTANESTHESIA CARE "

During record review of hospital policy titled. "[Hospital] Anesthesiology Clinical Privileges", approved 7/31/2020, stated the "Core Privileges. Administration of anesthesia, including general, regional, and local [anesthesia ... and the management of emotional stress during surgical, obstetrical and certain other medical procedures; including preoperative, intraoperative and postoperative evaluation and treatment ... Assess, stabilize, and determine disposition of patients with emergent conditions consistent with medical staff policy regarding emergency and consultative call services.

During record review of hospital policy titled "[Hospital] Obstetrical Anesthesia, Index No. O-2", effective 3/2005, last reviewed 11/2023, stated that anesthesiologist are "committed to providing safe and effective anesthesia ... Monitoring as stated by the American Society of Anesthesiology must be available and utilized ... Postoperative care ...the anesthesia provider is responsible".

During record review of hospital policy titled ,"[Hospital] Anesthesiology Department Policy and Procedure, Basic Standards for Pre-anesthesia Care, Index No. B-2", effective 10/1998, last reviewed 11/2023, stated that anesthesiologist adhere "to the practice standards promulgated by the American Society of Anesthesiologist ... Enhanced patient safety in the perioperative period ... An anesthesia provider shall be responsible for determining the medical status of the patient ...developing a plan of anesthesia care ...Interviewing and examining the patient ... assess those aspects of the physical condition that might affect decisions regarding perioperative risk and management ... obtaining and/or reviewing tests".

During record review, according to Practice Guidelines for Obstetric Anesthesia, the ASA recommends that physicians should be approved through the institutional credentialing process to initiate and direct the maintenance of obstetric anesthesia and to manage procedure related complications. Guidelines includes, but not limited to the following: consultation with the obstetrician who has knowledge of the maternal and fetal status and the progress of labor and who agrees with the initiation of labor analgesia. Conducting a relevant obstetrical history and physical examination (maternal health and condition, including airway, heart, lung and back). Obtain laboratory tests. Monitoring vital signs (heart rate, respiratory rate, oxygen blood levels and blood pressure) prior to, during and after administration of labor regional anesthesia, i.e. labor epidural. Perianesthetic recording of fetal heart rate and patterns before, during and after administration of regional anesthesia. Fetal heart rate patterns may change after the administration of neuraxial anesthetics and placing patients at increased risk (e.g., non-reassuring fetal heart rate pattern) Therefore, the patient should remain under continuous direct observation by a provider for at least 20 minutes. https://pubs.asahq.org/anesthesiology/article/124/2/270/12693/Practice-Guidelines-for-Obstetric-Anesthesia (Accessed 4/24/2024) and https://www.asahq.org/standards-and-practice-parameters/statement-on-neuraxial-anesthesia-in-obstetrics (Accessed 4/24/2024)

Based on observation, interview and record review, and in accordance with hospital policies, the emergency department (ED) failed to ensure timely and appropriate obstetric (OB- care to pregnant mothers and unborn infants) emergency screening exam (MSE) for an emergency medical condition (EMC) was provided by a licensed physician, but instead delegated emergent medical care to nurses (RN) who were not qualified physicians.

This failure allowed non-physician RNs to diagnosis and provide medical screening exams, medical stabilization, orders and other emergent medical services without OB physician oversight and placed patient safety and medical care in jeopardy for one of one patient and her fetus (Pt1).

Findings:

Record review of Pt1's OB emergency department (OBED) medical care on 3/14/2024 from 4:38 p.m. to 5:42 p.m. indicate the following:

On 3/14/2024 at 4:38 p.m., the chart indicated Pt1 arrived at the OBED in "Labor [signs indicating ready to give birth]" and was placed in a room.

At 4:45 p.m., the chart indicated a RN (nurse) placed orders for medications, intravenous (I.V.- given via a vein) fluids and monitors, and provided a diagnosis and started to carry out her orders for Pt1. There was no documented evidence, an OBED nurse spoke with a physician. There was no documented evidence a medical screening examination (MSE) by a physician occurred for an emergency medical condition (EMC).

At 5:00 p.m., the nurses documented, Pt1 was placed on a fetal heart monitor for (FHT- measures character, pattern and rate of a fetus' heartbeat. A normal heartbeat fluctuates between110 to 160 that increase and decrease with sleep, activity and contractions and signals fetal well-being). FHT were measured at 140 beats per minute without the normal heart rate fluctuations (a signal of fetal harm and distress). There was no documented evidence a MSE examination or stabilization an EMC was provided by a physician.

At 5:05 p.m., chart indicated verbal orders were "authorized" by MD1 and indicated that the OB physician was to be notified for meconium (fetal stool), fetal heart rate abnormalities per policy. There was no documented evidence MD1 spoke with a nurse or examined the Pt1.

At 5:09 p.m., chart indicated MD2 ordered I.V. fluids with instructions: "May increase to 500mL bolus [large volume of I.V. fluid given rapidly] for abnormal fetal heart rate patterns". There was no documented evidence MD2 spoke with a nurse or examined the Pt1.

At 5:20 p.m., the nurses documented FHT were measured at 140 bpm without the normal heart rate fluctuations that would signal fetal well-being. Treatment initiated by nurses were I.V. fluid bolus and "therapeutic touch".

At 5:28 p.m., the nurses documented Pt1's complaints of pain "7/10 [zero to ten pain scale, 0 equals no pain, 10 equals severe]". Nursing intervention "therapeutic touch". There was no documented evidence an OBED nurse spoke with a physician or a physician evaluation.

At 5:28 p.m., the chart indicated Pt1 had a "high" white count (WBC, high counts are a sign of an infection) of 13.7 (normal 5.5-11).

At 5:36 p.m., the nurses documented FHT monitoring strip indicated fetal heart rate 145 bpm with new variable deceleration (abnormal decrease in FHT and a signal of fetal harm and distress) without the normal heart rate fluctuations that would signal fetal well-being. There was no documented evidence an OBED nurse spoke with a physician or a physician evaluated Pt1.

At 5:41 p.m., the chart indicated MD2 signed Pt1's orders and diagnosis placed by the nurses and MD1. There was no documented evidence, MD1 spoke to the nurses or a physician examined the Pt1.

At 5:42 p.m., the nurses documented FHT 145 bpm without the normal heart rate fluctuations that would signal fetal well-being, and thereafter FHT recording stops. There was no documented evidence an OBED nurse spoke with a physician, or a physician examined the Pt1.

During a interview and concurrent record review on 4/25/2024 at 9:00 a.m. with Medical Doctor, Emergency Department Director (MD3) accompanied by Chief Medical Officer and Obstetrician (CMO), and Director of Medical Staff Affairs (DMS), hospital policies were reviewed and discussed, but MD 3 could not see the records due to technology. MD3 stated he was the medical director for the hospital emergency department (ED). MD3 stated there should "always" be a physician in the ED, and there is "never" a case when there is not. MD3 stated indicated that he understood EMTALA (Emergency Medical Treatment and Labor Act) requirements and hospital policies. MD3 indicated patients who arrive at the ED are screened for an EMC, provided a MSE and stabilizing medical treatment. MD3 stated the patient is the responsibility of the physician and medical care is provided "as soon as you can". MD3 stated an EMC, MSE and stabilization of patient is "not done the over the phone" by a physician and "nobody [patient] leaves the department without a face-to-face evaluation". MD3 stated a pregnant woman in labor who arrive in the OBED or ED, EMTALA requirements still apply. MD3 indicated OB patients can be seen in the main ED and are provided a MSE and stabilization. If the complaint labor or pregnancy related, after triage, the patient is "escorted" by ED staff to the OBED. On the other hand, a pregnant women go directly to the OBED for an EMC, receive an MSE and stabilizing treatment by an OB physician and it's "not done by phone".

During an interview and concurrent record review on 4/24/2024 at 11:30 a.m. with Medical Doctor (MD), Obstetrician (physician who provides medical care to pregnant mothers and unborn infants), accompanied by Chief Medical Officer and Obstetrician (CMO), and Director of Medical Staff Affairs (DMS), Patient 1's (Pt1) medical record provided by the hospital and hospital policies were reviewed and discussed. The Medical Doctor, Obstetrician (MD2), stated she "understands hospital policies ...been at the hospital for twenty years" and EMTALA. MD2 stated a patient with an EMC needs to be seen by the physician "within 30 minutes" of arrival. MD2 acknowledged she was responsible physician for the OB emergency services, MSE and stabilization of OB patients, and not the nurses. MD2 indicated that the OBED was a unit that evaluated emergency pregnant patients, determined their acuity, diagnosed medical issues, made a plan of care, managed and stabilized them. MD2 stated a woman in labor (ready to deliver a baby) is considered a "medical emergency condition [EMC]", and the patient requires a medical screening exam (MSE) and stabilization of an EMC.

MD2 explained the process for evaluating EMC and providing a MSE. MD2 stated "nurses are "qualified" to complete MSE and provide stabilizing medical treatment. MD2 stated the patient will be "seen by the nurses", and if the "RN needs direction, it is given over the phone". MD2 stated if she "can't see the patient ...over the phone ...give directions" to the nurse. MD2 stated the physician "doesn't need to see the patient", and this has been the "standard" for years at the hospital.

MD2 stated that nurses are allowed to place "verbal orders" for medications, monitors, intravenous fluids, treatments and provide an admitting diagnosis for a patient in the computer without a physician evaluation or communication. MD2 stated that she "signs 100's of orders" from the nurses that "pop-up" in her computer "inbox" and one of her "chores" is to e-sign (electronically sign) and approve orders from nurses. MD2 indicated she does not evaluate patients that she signs verbal orders for, nor determine who the orders are for or why they were ordered by the nurse. MD2 stated she "doesn't call the nurses when verbal orders are placed by the nurse ... I sign the orders" for nurses.

MD2 stated fetal (unborn baby) heart tones (FHT, character, pattern and rate of a fetus' heart) are "important to monitor" and reflect the "well-being of the infant". MD2 explained abnormal and changes FHT could indicate fetal distress and compromise, for example, low to no oxygen delivery or blood flow. MD2 stated a "nuchal cord [the umbilical cord connects mother and baby in the womb and supplies blood, oxygen and nutrients to the fetus] can get tangled and there is a decrease or absent blood flow". It can become "tight enough" to limit or stop blood and oxygen delivery to the unborn infant and can be "tight enough to be fatal". MD2 indicated if a fetus expels "meconium (fetal stool)", it is abnormal and a sign of fetal distress.

MD2 stated discussing Pt1's care was a "loaded question". MD2 acknowledged Pt1 was admitted to the OBED in "labor" and had an EMC. MD2 stated she was "available" to see Pt1 when she arrived at the emergency department for obstetrics (OBED) at 4:39 p.m., but the nurses provided the MSE. The chart indicted MD2 signed verbal orders for the nurses at 5:41 p.m. MD2 acknowledged she, during Pt1's stay in the OBED did not communicate with the nurse about the Pt1's status and EMC, nor ask the nurses about the orders placed or admitting diagnosis. MD2 stated she "doesn't call the nurses when verbal orders are placed by the nurse".

The FHT record strips from 5:00 p.m. to 5:42 p.m. were reviewed with MD2. MD2 stated that she "never saw" the FHT monitor strips (recordings of fetal heart tones) during Pt1's OBED admission. MD2 indicated OB RNs were "qualified" to interrupt, diagnose and act upon abnormal FHT. MD2 stated FHT record strips at 5:00 p.m. to 5:42 p.m. were "not normal" because there was "no reaction" of the baby to contractions or other signals of fetal well-being. MD2 acknowledged she did not evaluate Pt1's status, fetal well-being or FHT. MD2 acknowledged the tracings that did not improve and "could signal an emergency" for the fetus and/or mother.

MD2 acknowledged that she did not provide a MSE for Pt1 and her fetus' emergency needs. MD2 indicated the nurses provided the MSE for an EMC and interruption of FHT.

During a interview and concurrent record review on 4/24/2024 at 4:45 p.m. with Medical Doctor, Obstetrician and Department Director (MD1), accompanied by the CMO and MRA, hospital policies were discussed and reviewed. MD1 stated he was the Director of the OB department. MD1 stated indicated he understood EMTALA requirements and OB policies. MD1 indicated that he was not in agreement with hospital policies regarding the response time requirements to provide patients with an evaluation and time requirements to address maternal and/or fetal comprise and distress. MD1 stated the OBED physician will evaluate patients who arrive at the emergency department, but the evaluation time "expectation is a tricky question ...and depends". MD1 stated the "physicians and nurses do a great job ...experienced ... the hospital is not unsafe". MD1 stated the "concerns" on the OB floors are related to "problems caused by [hospital] management". MD1 indicated that management "hired nurses" to work on OB floor who have "zero management oversite" of the care they provided, and some nurses "do not know how to put on monitors and didn't know what was going on" with pregnant mothers and fetal status.

MD1 explained the "normal process" in the OBED. MD1 stated OB RNs are "QMP [non-physician qualified medical providers; thus, not qualified to diagnosis, prescribe, order interventions, medications and therapeutics or perform emergency procedures and surgeries]". The RN completes MSE for EMCs. MD1 stated the "standard for years" at the hospital has allowed the nurses to use their "judgment" to diagnosis, order medications and treatments, and admit to patients in order to "expedite" medical care that may otherwise be "delayed". MD1 stated continuous FHT monitors "make sure the baby is okay ...ensure fetal well-being ...needs to be maintained throughout [hospital] stay". MD1 indicated OB nurses are qualified to interrupt, diagnose and respond to abnormal FHT.

After the nurse has provided a MSE, without physician evaluation or communication, the nurses will place orders, as "verbal orders", for medications, monitors, intravenous fluids, treatments, diagnosis and admit patients. The orders written by the nurses are sent to the physicians "in box" electronically and the physician will sign them up to 2 days later. MD1 stated he receives "100's of orders [written by nurses] and do not check who they are from ... it is difficult to verify who and what the orders are for ...just sign-off" without review. At some time, the nurses will "talk with the physician" about the patient's status.

MD1 indicated that he was Pt1's primary OB provider throughout her pregnancy and was listed inpatient provider on 3/14/2024 from 4:46 p.m. to 3/15/2024 3:10 p.m. MD1 acknowledged Pt1 was in labor when she arrived in the OBED at 4:38 p.m. and had a EMC. MD1 acknowledged at 5:00 p.m. Pt1's FHT were abnormal. The records indicated MD1 "authorized" nurse to place orders under his name for Pt1 on 3/14/2024 as early as 5:05 p.m. MD1 stated he did not evaluate Pt1 or discuss her status with the nurses. MD1 stated he only evaluated Pt1 on 3/15/2024.

MD1 acknowledged, on 3/14/2024 MD2 was on call for labor and delivery emergencies and the OB emergencies in the OBED. MD1 acknowledged MD2 did not provide Pt1 care in the OBED, did not provide a MSE for Pt 1's EMC, and it "longer than expected" for Pt1 to be evaluated by MD2.

During record review of the hospital policy titled, Department of OB-GYN [obstetrics (OB)- care of pregnanat women & Gynecology (GYN) women's reproductive system] /Perinatology, [care of pregnant mothers-woman's heath/care of fetus, unborn baby], Rules and Regulations", effective 5/2012, last reviewed 8/2023, stated that "OB-GYN is organized as a major department of the Medical Staff, encompassing obstetrics, gynecology, perinatology, pediatrics [care of children] and neonatology [care of newborns] ... High risk Ob-Gyn cases will be managed by an individual who has completed a fully approved residency training program in Obstetrics & Gynecology ... The OBED will work to collaborate with the Emergency Department ... EMTALA requirements related to obstetric care should be as follows: 1. A medical screening examination (MSE) must be performed by an appropriately privileged physician to determine whether the patient has an emergency medical condition ...An appropriately trained labor and delivery nurse is qualified by virtue of his/her training to perform the medical screening exam to determine the presence of labor".

During record review of hospital policy titled "[Hospital] Emergency Medical Treatment and Labor Act (EMTALA) Compliance, Index No. A-11" approved July 2023, stated an "Emergency Medical Condition ("EMC"): A medical condition manifesting itself by acute symptoms of sufficient severity ...such that the absence of immediate medical attention could reasonably be expected to result in ...placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy ... A pregnant woman who is having contractions is considered to have an EMC".

During record review of hospital policy titled "[Hospital] Policy and Procedure for Women and Infants Services, Scope of Services for the Obstetrical Emergency Department, Index No. G-5", effective June 2014, last reviewed 4/2020, stated that "assessment, evaluation, management and treatment, that is appropriate and timely, to patients with obstetric conditions without delay".
During record review of hospital policy titled "[Hospital] OB Emergency Services Standardized Procedure, Standardized Procedure: OB Medical Screening Examination index No. G-3", effective June 2014, last reviewed 1/2022, stated that " Supervision: The OB ED physician or patient's primary OB physician will provide supervision... A pregnant individual having contractions is considered to have an emergency medical condition ... 'Emergency medical condition' means a medical condition manifesting itself by acute symptoms of sufficient severity such that the absence of immediate medical attention could reasonably be expected to result in placing the health of the pregnant woman and/or her unborn child in serious jeopardy ... Diagnosis: Physician is to give a diagnosis on all patients receiving a MSE in OBED".

During record review of hospital policy titled "Bylaws of the Medical staff for [Hospital]", effective 1/27/20212, amendment effective 7/27/20218 indicated the "BASIC RESPONSIBILITIES OF MEDICAL STAFF MEMBERSHIP providing patients with the quality of care meeting the professional standards of the Medical Staff ... abiding by these Bylaws, the Medical Staff Rules and Regulations, the departmental Rules and Regulations, and the Policies and Procedures of the Medical Staff ... complying with all Federal and State statutes ... preparing and completing accurate and complete medical records including electronic records ... updated examination of the patient, including any changes in the patient's condition, must be completed and documented by a physician ...Therapeutic orders, including electronic written and verbal, may be given by authorized Members of the Medical Staff and allied health staff who are specifically authorized to give orders ... No patient shall be admitted to the Hospital until a provisional diagnosis or valid reason for admission has been stated by the admitting physician ... Each Medical Staff Member must assure timely, adequate, professional care for his patients in the Hospital".

During record review of Patient Care Policy and Procedure for: Women's and Infants Services, Fetal Heart Rate and Uterine Surveillance, Index No. 21", effective 3/2020, last reviewed 8/2023, stated that "All patients presenting to Labor and Delivery units should undergo an initial period of electronic fetal monitoring ... continuous monitoring will be required to assure appropriate assessment of fetal well-being .... [FHT] validation by a supervising physician ... Examples of High Risk Conditions/Indications for requiring continuous electronic fetal monitoring [measures well-being and fetal heart rate] during labor, [include] Epidural/intrathecal Anesthesia [medication introduced directing into the spine or via a catheter in order to reduce pain and/or movement] ... Meconium [abnormal fetal expelling poop passed into amniotic fluid, a signal of fetal distress] ... Fetal arrhythmia [abnormal FHT] ... Abnormal/Indeterminate fetal assessment testing". The tables in the policy indicated management of possible FHR patterns: Category I: Routine management. Normal FHR baseline between 110 and 160 bpm with variability (10 to 25 bpm increase or decrease of FHR with sleep, activity and mother's contractions). Also considered "reassure" fetal well-being. Category II: Absent FHR acceleration (normal increase is 10 - 25 bpm from bassline and maximum HR of less than 160 bpm) and/or absent/minimal FHR variability (Amplitude range undetectable and ? (less or equal to) 5 bpm (heart beat per minute] variability. Tachycardia (fast heart rate) Baseline rate greater than160 bpm. If FHR do not improve consider delivery. Category III FHR tracings include: Persistent absent baseline FHR variability. Bradycardia (slow FHR, below 110). Sinusoidal pattern (visually apparent, smooth, sine wave-like undulating pattern in FHR baseline) for > 20 minutes. If FHR tracing do not improve, consider prompt delivery.

The policies and procedures governing medical care provided in the emergency service or department are established by and are a continuing responsibility of the medical staff they provide stabilizations and ongoing evalautions for OB and L&D patients.

Based on observation, interview and record review, and in accordance with hospital policies, the emergency department (ED) failed to ensure ongoing assessments and stabilization of emergent obstetric (OB- pregnant woman and unborn baby) patients was provided by a licensed physician, but instead OBED medical care were provided by unsupervised nurses (RNs).

This failure allowed RNs to determine the ongoing emergency medical needs and stabilization of one of one patient and her unborn fetus (Pt1) without physician direction, oversight and orders which placed patient safety and medical care in jeopardy of one of one patient (Pt1).

Findings:

Record review of Pt1's OB emergency department (OBED) medical care on 3/14/2024 from 5:20 p.m. to 6:39 p.m. indicate the following:

The chart indicate Pt1 spent 86 minute (4:38 p.m. to 6:04 p.m.) in the OBED plus 33 minutes in L&D before being evaluated by a physician for a medical emergency.

At 5:20 p.m., the nurses documented FHT were measured at 140 bpm without the normal heart rate fluctuations that would signal fetal well-being. Treatment initiated by nurses were I.V. fluid bolus and "therapeutic touch".

At 5:28 p.m., the nurses documented Pt1's complaints of pain "7/10 [zero to ten pain scale, 0 equals no pain, 10 equals severe]". Nursing intervention "therapeutic touch". There was no documented evidence an OBED nurse spoke with a physician or a physician evaluation.

At 5:28 p.m., the chart indicated Pt1 had a "high" white count (WBC, high counts are a sign of an infection) of 13.7 (normal 5.5-11).

At 5:36 p.m., the nurses documented FHT monitoring strip indicated fetal heart rate 145 bpm with new variable deceleration (abnormal decrease in FHT and a signal of fetal harm and distress) without the normal heart rate fluctuations that would signal fetal well-being. There was no documented evidence an OBED nurse spoke with a physician or a physician evaluated Pt1.

At 5:41 p.m., the chart indicated MD2 signed Pt1's orders and diagnosis placed by the nurses and MD1. There was no documented evidence, MD1 spoke to the nurses or a physician examined the Pt1.

At 5:42 p.m., the nurses documented FHT 145 bpm without the normal heart rate fluctuations that would signal fetal well-being, and thereafter FHT recording stops. There was no documented evidence an OBED nurse spoke with a physician, or a physician examined the Pt1.

At 5:56 p.m., the nurses documented Pt1's complaints of "cramping", "worsening" and pain "7/10". Nursing intervention "therapeutic touch". There was no documented evidence an OBED nurse spoke with a physician or a physician examined the Pt1.

At 6:02 p.m. the nurses documented fetal heart rate 145 bpm with continued variable deceleration without the normal heart rate fluctuations that would signal fetal well-being. There was no documented evidence of FHT monitoring strips from 5:42 p.m. onward. There was no documented evidence an OBED nurse spoke with an OB physician. There was no documented evidence an OB physician provided a MSE or stabilization for an EMC prior to Pt1 leaving the OBED.

At 6:04 p.m., the chart indicated Pt1 was admitted to Labor and Delivery (L&D) floor and transferred from the OBED. There was no documented evidence Pt1 received a medical exam or medical stabilization by an OB physician on arrival to L&D.

At 6:39 p.m., the chart indicated MD2 was called to the bedside. The chart indicated this was the first evaulation of Pt1 by an OB physician. MD2 documented "no fetal heart tones per" and diagnosed "IUFD [intrauterine fetal demise, death of infant before birth]".

During an interview and concurrent record review on 4/24/2024 at 11:30 am with Medical Doctor (MD), Obstetrician (physician who provides medical care to pregnant mothers and unborn infants), accompanied by Chief Medical Officer and Obstetrician (CMO), and Director of Medical Staff Affairs (DMS), Patient 1's (Pt1) medical record provided by the hospital and hospital policies were reviewed and discussed. The Medical Doctor, Obstetrician (MD2), stated she "understands hospital policies ...been at the hospital for twenty years". MD2 indicated she understood responsibilities of EMTALA and OB patient care requirements. MD2 indicated that OBED was a unit that evaluated emergency pregnant patients, determined their acuity, diagnosed medical issues, made a plan of care, provided stabilizations and ongoing assessments. MD2 stated a woman in labor is considered a "medical emergency condition", and after a MSE requires stabilization and ongoing assessments.

Pt1's timeline of events was reviewed with MD2. MD2 stated discussing Pt1's care was a "loaded question". MD2 stated that on 3/14/2024 on call she was on call for the OBED and L&D emergencies and was responsible for evaluation, stabilizations and ongoing assessments of OB patients, and not the nurses. MD2 stated that Pt1 was in labor on arrival to the OBED and had a EMC that required stabilization and ongoing assessments. MD2 stated that nurses are "qualified" to provide stabilizing medical treatment for an EMC and if the "RN needs direction, it is given over the phone". MD2 stated the physician "doesn't need to see the patient", and this has been the "standard" for years at the hospital. MD2 stated, without a physician's ongoing evaluation of an OBED patient, nurses are allowed to place orders as "verbal orders" for medications, monitors, intravenous fluids, and treatments for a patient in the computer. MD2 stated that she "signs 100's of orders" from the nurses that "pop-up" in the computer "inbox" and one of her "chores" is to e-sign (electronically approve) and approve orders from nurses. MD2 indicated she does not evaluate patient she signs verbal orders for or determine who the orders are for or why they were ordered by the nurse. MD2 acknowledged at 5:41 p.m., she signed Pt1's nursing orders. MD2 acknowledged she did not call the nurse about the PT1's status and emergency medical condition. MD2 stated she "doesn't call the nurses when verbal orders are placed by the nurse ...I sign the orders" for nurses.

Review of the patient's chart, indicated Pt1 had a "high" white count (WBC, a sign of an infection) of 13.7 (normal 5.5-11) on 3/14/2024 at 5:28 p.m. and 18.2 on 3/15/2024 at 2:16 a.m. There was no documented evidence MD2 reviewed the labs, provided an interruption of the labs or initiated care to Pt1.

MD2 stated ongoing fetal (unborn baby) heart tones (FHT, character, pattern and rate of a fetus' heart) are "important to monitor" and reflect the "well-being of the infant". MD2 explained abnormal and changes of FHT could indicate fetal distress and compromise and require emergency intervention to ensure the life and safety of the fetus and mother. MD2 indicated if a fetus expels meconium (fetal stool), it is abnormal and a sign of fetal distress. MD2 explained abnormal and changes of FHT could indicate fetal distress and compromise, for example, low to no oxygen delivery or blood flow. MD2 indicated OB RNs are "qualified" to interrupt, diagnose and act upon abnormal FHT, but are not physicians. Thus, not qualified to diagnosis, prescribe, order interventions, medications and therapeutics or perform emergency procedures and surgeries.

MD2 stated OB RNs are "qualified" to interrupt and diagnose FHTs. The chart indicated while Pt1 was in the OBED, for 85 minutes, the fetal heart rate was 140 -145 bpm, with minimal variability and decelerations. The FHT record strips from 5:00 p.m.to 5:42 p.m. were reviewed with MD2. According to nursing documentation, variable decelerations were still present at 6:02 p.m. MD2 stated that she "never saw" the FHT monitor strips (recordings of fetal heart tones) during Pt1's hospital admission. MD2 stated the Pt1's FHT tracing strips were "not normal" because there was "variable deceleration", "no reaction" of the baby to contractions or other signals of fetal well-being. MD2 acknowledged the tracings that did not improve and "could signal an emergency" for the fetus and/or mother.

MD2 acknowledged that on 3/14/2024 she was on call to provide medical services and "responsible" physician for the OB emergency services and ongoing evaluations and stabilization of OB patients, and not the nurses. MD2 acknowledged that she did not provide stabilizing medical care and ongoing assessments for Pt1's or determine emergency needs of the fetus during their 85 minute stay in the OBED. MD2 indicated the nurses provided the ongoing evalautions and orders for Pt1's EMC and interrupt and respond to abnormal FHT.

During a interview and concurrent record review on 4/24/2024 at 4:45 p.m. with Medical Doctor, Obstetrician and Department Director (MD1), accompanied by CMO) and MRA, Patient 1's medical record provided by the hospital and hospital policies were discussed and reviewed. MD1 stated he was the Director of the OB department. MD1 stated that he understood EMTALA requirements and OB policies. MD1 stated the "physicians and nurses do a great job ...experienced ... the hospital is not unsafe". MD1 stated the "concerns" on the OB floors are related to "problems caused by [hospital] management". MD1 indicated that management "hired nurses" to work on OB floor and have "zero management oversite" of the care they provided, and some nurses "didn't know how to put on monitors and didn't know what was going on" with pregnant mothers and fetal status.

MD1 explained the "normal process" in the OBED. MD1 stated OB RNs are "QMP [non-physician qualified medical provide; thus, not qualified to diagnosis, prescribe, order interventions, medications and therapeutics or perform emergency procedures and surgeries]" and after the RN completes the medical screening exam (MSE), they provide stabilizations and ongoing evalautions for OB and L&D patients. MD1 stated the "standard for years" at the hospital has allowed the nurses to use their "judgment" to diagnosis, order medications and treatments, and admit to patients in order to "expedite" medical care that may otherwise be "delayed". After the nurse has provided a MSE, without physician evaluation or communication, the nurses will place orders, as "verbal orders", for medications, monitors, intravenous fluids, treatments, diagnosis and admit patients. The orders written by the nurses are sent to the physicians "in box" electronically and the physician will sign them up to 2 days later. MD1 stated he receives "100's of orders [written by nurses] and do not check who they are from ... it is difficult to verify who and what the orders are for ...just sign-off" without review. At some time, the nurses will "talk with the physician" about the patient's status. It's "standard procedure" at the hospital.

MD1 stated continuous FHT monitors "make sure the baby is okay ...ensure fetal well-being ...needs to be maintained throughout [hospital] stay". MD1 stated he does not agree with the time recommended to intervene for abnormal FHT tracings that last greater than 20 minutes. The hospital policy titled Patient Care Policy and Procedure for: Women's and Infants Services, Fetal Heart Rate and Uterine Surveillance, Index No. 21" was reviewed with MD1.It indicated management of possible FHR patterns: Category I (CAT1): Routine management. Normal FHR baseline between 110 and 160 bpm (heart beat per minute) with variability (an increase or decrease of 6 to 25 bpm of FHR with sleep, activity and mother's contractions MD1 stated CAT1 "reassures" fetal well-being. Category II (CAT2): Absent FHR acceleration (normal increase is 6 - 25 bpm from bassline with a maximum HR of 160 bpm) and/or absent or minimal FHR variability (amplitude (height) range undetectable and less or equal to 5 bpm variability. Tachycardia (fast heart rate greater than 160). " If FHR do not improve consider delivery". MD1 acknowledged that the CAT 2 tracing could change to CAT 3 emergency tracings. Category III (CAT3): FHR tracings include: Persistent absent baseline FHR variability. Bradycardia (slow FHR, below 110). Sinusoidal pattern (visually apparent, smooth, sine wave-like undulating pattern in FHR baseline) for > 20 minutes. If FHR tracing "do not improve, consider prompt delivery". MD1 stated he was not in agreement with the time limitations.

The chart indicated for 62 minutes, the fetal heart rate was 140 -145 bpm, with minimal variability and decelerations and after for another 25 minutes FHT could not be located. MD1 stated continuous FHT monitors "make sure the baby is okay ...ensure fetal well-being ...needs to be maintained throughout [hospital] stay". MD1 indicated OB nurses are qualified to interrupt, diagnose and respond abnormal FHT. The FHT record strips from 5:00 p.m. to 5:42 p.m. were reviewed with MD1 MD1 stated the first variable deceleration was at 5:36 p.m., and FHT monitoring records were not available after 5:48 p.m. According to nursing documentation, variable deceleration were still present at 6:02 p.m. MD1 stated after 5:48 p.m., "something happened" to the baby" and fetal well-being "could not be determined". MD1 acknowledged that FHT tracing were abnormal and could have required emergency intervention. MD1 stated he does not agree with policy that a physician should evaluate and intervene if abnormal FHT tracings last greater than 20 minutes. MD1 indicated OB nurses are qualified to interrupt, diagnose and respond to abnormal FHT. MD1 stated if the nursing staff were "not worried" about FHT than "nothing is done

MD1 indicated was the primary OB provider for Pt1 on 3/14/2024 from 4:46 p.m. to 3/15/2024 3:10 p.m., because he had been her physician throughout pregnancy.
The records indicated MD1 "authorized" nurse to place orders under his name for Pt1 on 3/14/2024 as early as 5:05 p.m. MD1 stated he did not evaluate Pt1 or discuss her status with the nurses. MD1 stated he only evaluated Pt1 on 3/15/2024.

MD1 indicated that OB emergency medical services and ongoing evaluations and stabilization of Pt1 and her fetus was provided nurses, and not physicians.

MD1 stated "during root cause analysis (RCA, a process to uncover causes of problems) and interview with the nurses", they reported "heard FHT", but there were no FHT strips. MD1 indicated hearing noise does not determine fetal well-being. MD1 stated the Pt1 was removed from the monitors at 5:48 p.m. and it appeared "the fetus was alive when left the OBED but not properly monitored in the OBED after 5:48 p.m. and not on L&D". MD1 acknowledged MD2 did not provide Pt1 care in the OBED, did not evaluate Pt 1's EMC, provide MSE or stabilization. MD1 stated it took "longer than expected" for Pt1 to be evaluated by MD2. MD1 stated, even if Pt1 had a timely MSE evaluated by EDOB physician, MD2 evaluated the well-being of the fetus, and Pt1 had continuous FHT, it "would not have made a difference in the outcome ...fetal demise would have occurred". It was "unfortunate". MD1 stated the hospital provides "safe care".

During a interview and concurrent record review on 4/25/2024 at 9:00 a.m. with Medical Doctor, Emergency Department Director (MD3) accompanied by CMO and DMS hospital policies were reviewed and discussed, but MD 3 could not see the records due to technology. MD3 stated he was the medical director for the hospital emergency department (ED). MD3 stated there should "always" be a physician in the ED, and there is "never" a case when there is not. MD3 stated indicated that he understood EMTALA requirements and hospital policies. MD3 indicated patients who arrive at the ED are screened for an EMC, provided a MSE and stabilizing medical treatment. MD3 stated the patient is the responsibility of the physician and medical care is provided "as soon as you can". MD3 stated an EMC, MSE and stabilization of patient is "not done the over the phone" by a physician and "nobody [patient] leaves the department without a face-to-face evaluation". MD3 stated a pregnant woman in labor who arrive in the OBED or ED, EMTALA requirements still apply. MD3 indicated OB patients can be seen in the main ED and are provided a MSE and stabilization. If the complaint labor or pregnancy related, after triage, the patient is "escorted" by ED staff to the OBED. On the other hand, a pregnant women go directly to the OBED for an EMC, receive an MSE and stabilizing treatment by an OB physician and it's "not done by phone".

During record review of the hospital policy titled, Department of OB-GYN [obstetrics (OB)- care of pregnant women & Gynecology (GYN) women's reproductive system] /Perinatology, [care of pregnant mothers-woman's heath/care of fetus, unborn baby], Rules and Regulations", effective 5/2012, last reviewed 8/2023, stated that "High risk Ob-Gyn cases will be managed by an individual who has completed a fully approved residency training program in Obstetrics & Gynecology ... Obstetrical Emergency Department (OBED) located in a designated location on the obstetrical unit to be assessed for medical conditions ... The OBED will work to collaborate with the Emergency Department ... EMTALA requirements related to obstetric care should be as follows ... If an emergency medical condition exists, patient must be stabilized and transferred to the labor unit or appropriate acute care hospital department".

During record review of hospital policy titled "[Hospital] Emergency Medical Treatment and Labor Act (EMTALA) Compliance, Index No. A-11" approved July 2023, stated an "Emergency Medical Condition ("EMC"): A medical condition manifesting itself by acute symptoms of sufficient severity ...such that the absence of immediate medical attention could reasonably be expected to result in ...placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy ... A pregnant woman who is having contractions is considered to have an EMC ...To Stabilize or Stabilized: No material deterioration of the EMC is likely".

During record review of hospital policy titled "[Hospital] Policy and Procedure for Women and Infants Services, Scope of Services for the Obstetrical Emergency Department, Index No. G-5", effective June 2014, last reviewed 4/2020, stated that "assessment, evaluation, management and treatment, that is appropriate and timely, to patients with obstetric conditions without delay ...Therapies, procedures and interventions that are conducted in the OBED include, but are not limited to: Recognition, interpretation and recording of patient vital signs and symptoms, particularly those that require immediate notification of a physician [and] Physician Oversight ... Patients in labor will be transferred to the Labor and Delivery unit after an appropriate medical screening examination and stabilization in accordance with EMTALA regulations".

During record review of hospital policy titled "[Hospital] OB Emergency Services Standardized Procedure, Standardized Procedure: OB Medical Screening Examination index No. G-3", effective June 2014, last reviewed 1/2022, stated that " Supervision: The OB ED physician or patient's primary OB physician will provide supervision... A pregnant individual having contractions is considered to have an emergency medical condition ... 'Emergency medical condition' means a medical condition manifesting itself by acute symptoms of sufficient severity such that the absence of immediate medical attention could reasonably be expected to result in placing the health of the pregnant woman and/or her unborn child in serious jeopardy ... Diagnosis: Physician is to give a diagnosis on all patients receiving a MSE in OBED.

During record review of hospital policy titled "Bylaws of the Medical staff for [Hospital]", effective 1/27/20212, amendment effective 7/27/20218 indicated the "BASIC RESPONSIBILITIES OF MEDICAL STAFF MEMBERSHIP providing patients with the quality of care meeting the professional
standards of the Medical Staff ... abiding by these Bylaws, the Medical Staff Rules and Regulations,
the departmental Rules and Regulations, and the Policies and Procedures of the Medical Staff ... complying with all Federal and State statutes ... preparing and completing accurate and complete medical records including electronic records ... updated examination of the patient, including any changes in the patient's condition, must be completed and documented by a physician ...Therapeutic orders, including
electronic written and verbal, may be given by authorized Members of the Medical Staff and allied health staff who are specifically authorized to give orders ... No patient shall be admitted to the Hospital until a provisional diagnosis or valid reason for admission has been stated by the admitting physician ... Each Medical Staff Member must assure timely, adequate, professional care for his patients in the Hospital".

During record review of Patient Care Policy and Procedure for: Women's and Infants Services, Fetal Heart Rate and Uterine Surveillance, Index No. 21", effective 3/2020, last reviewed 8/2023, stated that "All patients presenting to Labor and Delivery units should undergo an initial period of electronic fetal monitoring ... continuous monitoring will be required to assure appropriate assessment of fetal well-being .... [FHT] validation by a supervising physician ... Examples of High Risk Conditions/Indications for requiring continuous electronic fetal monitoring [measures well-being and fetal heart rate] during labor, [include] Epidural/intrathecal Anesthesia [medication introduced directing into the spine or via a catheter in order to reduce pain and/or movement] ... Meconium [abnormal fetal expelling poop passed into amniotic fluid, a signal of fetal distress] ... Fetal arrhythmia [abnormal FHT] ... Abnormal/Indeterminate fetal assessment testing". The tables in the policy indicated management of possible FHR patterns: Category I: Routine management. Normal FHR baseline between 110 and 160 bpm with variability (10 to 25 bpm increase or decrease of FHR with sleep, activity and mother's contractions). Also considered "reassure" fetal well-being. Category II: Absent FHR acceleration (normal increase is 10 - 25 bpm from bassline and maximum HR of less than 160 bpm) and/or absent/minimal FHR variability (Amplitude range undetectable and ? (less or equal to) 5 bpm (heart beat per minute] variability. Tachycardia (fast heart rate) Baseline rate greater than160 bpm. If FHR do not improve consider delivery. Category III FHR tracings include: Persistent absent baseline FHR variability. Bradycardia (slow FHR, below 110). Sinusoidal pattern (visually apparent, smooth, sine wave-like undulating pattern in FHR baseline) for > 20 minutes. If FHR tracing do not improve, consider prompt delivery.

The emergency services must be supervised by a qualified member of the medical staff ... A qualified member of the medical staff must supervise the provision of emergency services. Since §482.55(a)(1) requires that emergency services must be organized under the direction of a qualified member of the medical staff, the requirement for supervision at§482.55(b)(1) must be distinguished from the prior requirement. In this context, "supervision" implies a more immediate form of oversight by a qualified member of the medical staff during all times the hospital makes emergency services available ... verify that a qualified member of the medical staff is designated to supervise emergency services.

Based on observation, interview and record review, in accordance with hospital policies, the emergency department (ED) failed to ensure the presence of a qualified physician obstetrician (OB- care of pregnant mother and fetus) to supervise nurses whom provided emergent medical care to one of one pregnant patient (Pt1).

This failure allowed unsupervised RNs to provide emergency medical care to patients and placed the safety and care in jeopardy for all patients entering the OB emergency department (OBED) and Labor and Delivery (L&D) with emergent medical conditions.

Findings:

Record review of Pt1's OBED medical care from 3/14/2024 3:38 p.m. to 6:39 p.m. indicate the following:

The chart indicate Pt1 spent 86 minutes in the OBED and after being transferred spent another 33 minutes in Labor and Delivery (L&D) without an evaluation by a physician for a medical emergency.

On 3/14/2024 at 4:38 p.m., the chart indicated Pt1 arrived at the OBED in "Labor [signs indicating ready to give birth]" and was placed in a room.

At 4:45 p.m., the chart indicated a RN (nurse) placed orders for medications, intravenous (I.V.- given via a vein) fluids and monitors, and provided a diagnosis and started to carry out her orders for Pt1. There was no documented evidence, an OBED nurse spoke with a physician. There was no documented evidence a medical screening examination (MSE) by a physician occurred for an emergency medical condition (EMC).

At 5:00 p.m., the nurses documented, Pt1 was placed on a fetal heart monitor for (FHT- measures character, pattern and rate of a fetus' heartbeat. A normal heartbeat fluctuates between110 to 160 that increase and decrease with sleep, activity and contractions and signals fetal well-being). FHT were measured at 140 beats per minute without the normal heart rate fluctuations (a signal of fetal harm and distress). There was no documented evidence a MSE examination or stabilization an EMC was provided by a physician.

At 5:05 p.m., chart indicated verbal orders were "authorized" by MD1 and indicated that the OB physician was to be notified for meconium (fetal stool), fetal heart rate abnormalities per policy. There was no documented evidence MD1 spoke with a nurse or examined the Pt1.

At 5:09 p.m., chart indicated MD2 ordered I.V. fluids with instructions: "May increase to 500mL bolus [large volume of I.V. fluid given rapidly] for abnormal fetal heart rate patterns". There was no documented evidence MD2 spoke with a nurse or examined the Pt1.

At 5:20 p.m., the nurses documented FHT were measured at 140 bpm without the normal heart rate fluctuations that would signal fetal well-being. Treatment initiated by nurses were I.V. fluid bolus and "therapeutic touch".

At 5:28 p.m., the nurses documented Pt1's complaints of pain "7/10 [zero to ten pain scale, 0 equals no pain, 10 equals severe]". Nursing intervention "therapeutic touch". There was no documented evidence an OBED nurse spoke with a physician or a physician evaluation.

At 5:28 p.m., the chart indicated Pt1 had a "high" white count (WBC, high counts are a sign of an infection) of 13.7 (normal 5.5-11).

At 5:36 p.m., the nurses documented FHT monitoring strip indicated fetal heart rate 145 bpm with new variable deceleration (abnormal decrease in FHT and a signal of fetal harm and distress) without the normal heart rate fluctuations that would signal fetal well-being. There was no documented evidence an OBED nurse spoke with a physician or a physician evaluated Pt1.

At 5:41 p.m., the chart indicated MD2 signed Pt1's orders and diagnosis placed by the nurses and MD1. There was no documented evidence, MD1 spoke to the nurses or a physician examined the Pt1.

At 5:42 p.m., the nurses documented FHT 145 bpm without the normal heart rate fluctuations that would signal fetal well-being, and thereafter FHT recording stops. There was no documented evidence an OBED nurse spoke with a physician, or a physician examined the Pt1.

At 5:56 p.m., the nurses documented Pt1's complaints of "cramping", "worsening" and pain "7/10". Nursing intervention "therapeutic touch". There was no documented evidence an OBED nurse spoke with a physician or a physician examined the Pt1.

At 6:02 p.m. the nurses documented fetal heart rate 145 bpm with continued variable deceleration without the normal heart rate fluctuations that would signal fetal well-being. There was no documented evidence of FHT monitoring strips from 5:42 p.m. onward. There was no documented evidence an OBED nurse spoke with an OB physician. There was no documented evidence an OB physician provided a MSE or stabilization for an EMC prior to Pt1 leaving the OBED.

At 6:04 p.m., the chart indicated Pt1 was admitted to Labor and Delivery (L&D) floor and transferred from the OBED. There was no documented evidence Pt1 received a medical exam or medical stabilization by an OB physician on arrival to L&D.

At 6:39 p.m., the chart indicated MD2 was called to the bedside. The chart indicated this was the first evaluation of Pt1 by an OB physician. MD2 documented "no fetal heart tones per" and diagnosed "IUFD [intrauterine fetal demise, death of infant before birth]".

During a interview and concurrent record review on 4/25/2024 at 9:00 a.m. with Medical Doctor, Emergency Department Director (MD3) accompanied by Chief Medical Officer and Obstetrician (CMO), and Director of Medical Staff Affairs (DMS), hospital policies were reviewed and discussed, but MD 3 could not see the records due to technology. MD3 stated he was the medical director for the hospital emergency department (ED). MD3 stated there should "always" be a physician in the ED, and there is "never" a case when there is not. MD3 stated the patient is the responsibility of the physician and medical care is provided "as soon as you can". MD3 stated an EMC, MSE and stabilization of patient is "not done the over the phone" by a physician and "nobody [patient] leaves the department without a face-to-face evaluation". MD3 stated a pregnant woman in labor who arrive in the OBED or ED, EMTALA requirements still apply. MD3 indicated OB patients can be seen in the main ED and are provided a MSE and stabilization. If the complaint labor or pregnancy related, after triage, the patient is "escorted" by ED staff to the OBED. On the other hand, a pregnant women go directly to the OBED for an EMC, receive an MSE and stabilizing treatment by an OB physician and it's "not done by phone".

During an interview and concurrent record review on 4/24/2024 at 11:30 am with Medical Doctor (MD), Obstetrician (physician who provides medical care to pregnant mothers and unborn infants), accompanied by CMO and DMS, Patient 1's (Pt1) medical record provided by the hospital and hospital policies were reviewed and discussed. The Medical Doctor, Obstetrician (MD2), stated she "understands hospital policies ...been at the hospital for twenty years". MD2 indicated she understood responsibilities of EMTALA (Emergency Medical Treatment Act and Active Labor Act). MD2 indicated that the emergency department for obstetrics (OBED) was a unit that evaluated emergency pregnant patients, determined their acuity, diagnosed medical issues, made a plan of care, managed and stabilized them. MD2 stated a woman in labor (ready to deliver a baby) is considered a "medical emergency condition [EMC]", and the patient requires a medical screening exam (MSE, evaluation of a emergency medical condition). MD2 indicated RNs were non-physicians; thus, not qualified to diagnosis, prescribe, order interventions, medications and therapeutics or perform surgeries.

MD2 stated the patient will be "seen by the nurses [RNs]". MD2 stated "nurses are "qualified" to complete MSE for an EMC, and provide stabilizing medical treatment and ongoing assessments. MD2 stated if the "RN needs direction, it is given over the phone". MD2 stated the physician "doesn't need to see the patient", and this has been the "standard" for years at the hospital.

MD2 stated, without a physician evaluation of a pregnant patient, nurses are allowed to place orders as "verbal orders" for medications, monitors, intravenous fluids, treatments, admission and provide an admitting diagnosis for a patient in the computer. MD2 stated that she "signs 100's of orders" from the nurses that "pop-up" in her computer "inbox" and one of her "chores" is to e-sign (electronically sign) and approve orders from nurses. MD2 indicated she does not evaluate patients that she signs verbal orders for, nor determine who the orders are for or why they were ordered by the nurse.

At 5:09 p.m., the chart indicated MD2 ordered intravenous fluids, MD2 acknowledged that she did not speak to the nurses or evaluate Pt1. The chart indicated MD2 ordered intravenous fluid. MD2 acknowledged at 5:41 p.m., she signed and agreed with the admitting diagnosis and orders, the nurse had placed in the computer as "verbal orders". MD2 acknowledges she did not call the nurse about the PT1's status and emergency medical condition, nor ask the nurses about the orders placed or admitting diagnosis. MD2 stated she "doesn't call the nurses when verbal orders are placed by the nurse ... I sign the orders" for nurses.

MD2 stated ongoing fetal (unborn baby) heart tones (FHT, character, pattern and rate of a fetus' heart) are "important to monitor" and reflect the "well-being of the infant". MD2 explained abnormal and changes of FHT could indicate fetal distress and compromise and require emergency intervention to ensure the life and safety of the fetus and mother. MD2 explained abnormal and changes of FHT could indicate fetal distress and compromise, for example, low to no oxygen delivery or blood flow. MD2 indicated if a fetus expels meconium (fetal stool), it is abnormal and a sign of fetal distress. MD2 acknowledged abnormal FHT tracings that do not improve and "could signal an emergency" for the fetus and/or mother. MD2 indicated OB RNs are "qualified" to interrupt, diagnose and act upon abnormal FHT, but are not physicians. Thus, not qualified to diagnosis, order interventions, or perform emergency procedures and surgeries for pregnant patients.

The chart indicate Pt1 spent 85 minutes in the obstetric emergency department (OBED) plus 33 minutes in L&D before being evaluated by a physician for a medical emergency.
MD2 acknowledged that on 3/14/2024 she was on call to provide medical services and "responsible" physician for the OB emergency services, MSE, stabilization and ongoing assessments of OB patients, and not the nurses. MD2 stated she was "available" to see Pt1 when she arrived at the emergency department for obstetrics (OBED) at 4:39 p.m. MD2 acknowledged the nurses admitted, provided a diagnosis and wrote orders for Pt1's. MD2 indicated that the first time she spoke to the nurse about Pt1 was about 30 minutes after she was admitted to L&D. MD2 acknowledged she did not provide medical care or medical oversight to the OBED and L&D nurses for the first 119 minutes Pt1 was in the facility.

During a interview and concurrent record review on 4/24/2024 at 4:45 p.m. with Medical Doctor, Obstetrician and Department Director (MD1), accompanied CMO and MRA, Patient 1's medical record provided by the hospital and hospital policies were discussed and reviewed. MD1 stated he was the Director of the OB department. MD1 stated indicated he understood EMTALA requirements and OB policies. MD1 stated the "concerns" on the OB floors are related to "problems caused by [hospital] management". MD1 indicated that management "hired nurses" to work on OB floor and the have "zero management oversite" of the care they provided. The nurses "didn't know how to put on monitors and didn't know what was going on" with pregnant mothers and fetal status.

MD1 explained the "normal process" in the OBED. MD1 stated OB RNs are "QMP [non-physician qualified medical provide; thus, not qualified to diagnosis, prescribe, order interventions, medications and therapeutics or perform emergency procedures and surgeries]" and complete a medical screening exam (MSE), stabilizations and ongoing evaluations for OB and L&D patients. The nurses will "triage [determine level of acuity]" and determine if there is an "emergency". MD1 stated the "standard for years" at the hospital has allowed the nurses to use their "judgment" to diagnosis, order medications and treatments, and admit to patients in order to "expedite" medical care that may otherwise be "delayed". After the nurse has provided an MSE, without physician evaluation or communication, the nurses will place orders, as "verbal orders", for medications, monitors, intravenous fluids, treatments, diagnosis and admit patients. The orders written by the nurses are sent to the physicians "in box" electronically and the physician will sign them up to 2 days later. MD1 stated he receives "100's of orders [written by nurses] and do not check who they are from ... it is difficult to verify who and what the orders are for ...just sign-off" without review. At some time, the nurses will "talk with the physician" about the patient's status.

MD1 stated continuous FHT monitors "make sure the baby is okay ...ensure fetal well-being ...needs to be maintained throughout [hospital] stay". MD1 stated he does not agree with the time recommended to intervene for abnormal FHT tracings that last greater than 20 minutes. The hospital policy titled Patient Care Policy and Procedure for: Women's and Infants Services, Fetal Heart Rate and Uterine Surveillance, Index No. 21" was reviewed with MD1.It indicated management of possible FHR patterns: Category I (CAT1): Routine management. Normal FHR baseline between 110 and 160 bpm (heart beat per minute) with variability (an increase or decrease of 6 to 25 bpm of FHR with sleep, activity and mother's contractions MD1 stated CAT1 "reassures" fetal well-being. Category II (CAT2): Absent FHR acceleration (normal increase is 6 - 25 bpm from bassline with a maximum HR of 160 bpm) and/or absent or minimal FHR variability (amplitude (height) range undetectable and less or equal to 5 bpm variability. Tachycardia (fast heart rate greater than 160). " If FHR do not improve consider delivery". MD1 acknowledged that the CAT 2 tracing could change to CAT 3 emergency tracings. Category III (CAT3): FHR tracings include: Persistent absent baseline FHR variability. Bradycardia (slow FHR, below 110). Sinusoidal pattern (visually apparent, smooth, sine wave-like undulating pattern in FHR baseline) for > 20 minutes. If FHR tracing "do not improve, consider prompt delivery".

The chart indicated for 62 minutes, the fetal heart rate was 140 -145 bpm, with minimal variability and decelerations and after for another 25 minutes FHT could not be located. The FHT record strips from 5:00 p.m. to 5:42 p.m. were reviewed with MD1. MD1 stated the first variable deceleration was at 5:36 p.m., and FHT monitoring records were not available after 5:48 p.m. According to nursing documentation, variable decelerations were still present at 6:02 p.m. After 6:05 p.m., MD1 indicated Pt1 was on the L&D floor and the couple of minutes of FHT tracing strips were not informative and may have been the "mother's heart rate". MD1 stated after 5:48 p.m., "something happened" to the baby" and fetal well-being "could not be determined". MD1 acknowledged that at 5:00 p.m., FHT tracing were abnormal, may have changed to CAT3 and required emergency intervention. MD1 stated he does not agree with policy that a physician should evaluate and intervene if abnormal FHT tracings last greater than 20 minutes. MD1 indicated OB nurses are qualified to interrupt, diagnose and respond to abnormal FHT. MD1 stated if the nursing staff were "not worried" about FHT than "nothing is done".

The records indicated MD1 "authorized" nurse to place orders under his name for Pt1 on 3/14/2024 as early as 5:05 p.m. On 3/14/2024, MD1 stated he did not evaluate Pt1 or discuss Pt1's status with the nurses. MD1 stated he only evaluated Pt1 on 3/15/2024. MD1 indicated from 3:38 p.m. to 6:39 p.m. OB emergency medical services, MSE, and ongoing evaluations and stabilization of Pt1 and her fetus was provided by nurses, and not physicians.

MD1 stated "during root cause analysis (RCA- a process to uncover causes of problems) and interview with the nurses", they reported "heard FHT", but there were no FHT strips. MD1 indicated hearing noise does not determine fetal well-being, "it could have been the mother's" heartbeat. MD1 stated Pt1 was removed from the monitors at 5:48 p.m. and it appeared "the fetus was alive ... but not properly monitored in the OBED after 5:48 p.m. and not on L&D". The chart indicate Pt1 spent 85 minutes in the OBED plus another 33 minutes in L&D before being evaluated by the OBED on call physician, MD2, for a medical emergency. MD1 stated it took "longer than expected" for Pt1and the fetus to be evaluated by MD2. MD1 stated, even if Pt1 and her fetus had a timely MSE, evaluation and stabilization, it "would not have made a difference in the outcome ...fetal demise would have occurred". It was "unfortunate". MD1 stated the "physicians and nurses do a great job ...experienced ... the hospital is not unsafe".

During record review of the hospital policy titled Department of OB-GYN [obstetrics (OB)- care of pregnant women & Gynecology (GYN) women's reproductive system] /Perinatology, [care of pregnant mothers-woman's heath/care of fetus, unborn baby], Rules and Regulations", effective 5/2012, last reviewed 8/2023, stated that " High risk Ob-Gyn cases will be managed by an individual who has completed a fully approved residency training program in Obstetrics & Gynecology ...Obstetrical Emergency Department (OBED) located in a designated location on the obstetrical unit to be assessed for medical conditions ... The OBED will work to collaborate with the Emergency Department ... EMTALA requirements related to obstetric care should be as follows ... A medical screening examination (MSE) must be performed by an appropriately privileged physician to determine whether the patient has an emergency medical condition, 2. If an emergency medical condition exists, patient must be stabilized and transferred to the labor unit or appropriate acute care hospital department".

During record review of hospital policy titled "[Hospital] Emergency Medical Treatment and Labor Act (EMTALA) Compliance, Index No. A-11" approved July 2023, stated an "Emergency Medical Condition ("EMC"): A medical condition manifesting itself by acute symptoms of sufficient severity ...such that the absence of immediate medical attention could reasonably be expected to result in ...placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy ... serious impairment to bodily functions ... A pregnant woman who is having contractions is considered to have an EMC ... Medical Screening Examination ("MSE"): An examination conducted by a physician or Qualified Medical Personnel ...as documented in the Hospital's Bylaws, Rules and Regulations or Board Resolution ...To Stabilize or Stabilized: No material deterioration of the EMC is likely".

During record review of hospital policy titled "[Hospital] Policy and Procedure for Women and Infants Services, Scope of Services for the Obstetrical Emergency Department, Index No. G-5", effective June 2014, last reviewed 4/2020, stated that "assessment, evaluation, management and treatment, that is appropriate and timely, to patients with obstetric conditions without delay ...Therapies, procedures and interventions that are conducted in the OBED include, but are not limited to: Recognition, interpretation and recording of patient vital signs and symptoms, particularly those that require immediate notification of a physician [and] Physician Oversight ... Patients in labor will be transferred to the Labor and Delivery unit after an appropriate medical screening examination and stabilization in accordance with EMTALA (Emergency Medical Treatment and Labor Act] regulations".

During record review of hospital policy titled "[Hospital] OB Emergency Services Standardized Procedure, Standardized Procedure: OB Medical Screening Examination index No. G-3", effective June 2014, last reviewed 1/2022, stated that " Supervision: The OB ED physician or patient's primary OB physician will provide supervision... A pregnant individual having contractions is considered to have an emergency medical condition ... 'Emergency medical condition' means a medical condition manifesting itself by acute symptoms of sufficient severity such that the absence of immediate medical attention could reasonably be expected to result in placing the health of the pregnant woman and/or her unborn child in serious jeopardy ... Diagnosis: Physician is to give a diagnosis on all patients receiving a MSE in OBED.

During record review of hospital policy titled "[Hospital] Emergency Medical Treatment and Labor Act (EMTALA) Compliance, Index No. A-11" approved July 2023, stated an "Emergency Medical Condition ("EMC"): A medical condition manifesting itself by acute symptoms of sufficient severity ...such that the absence of immediate medical attention could reasonably be expected to result in ...placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy ... serious impairment to bodily functions ... A pregnant woman who is having contractions is considered to have an EMC ... Medical Screening Examination ("MSE"): An examination conducted by a physician or Qualified Medical Personnel ...as documented in the Hospital's Bylaws, Rules and Regulations or Board Resolution ...To Stabilize or Stabilized: No material deterioration of the EMC is likely".

During record review of hospital policy titled "[Hospital] Policy and Procedure for Women and Infants Services, Scope of Services for the Obstetrical Emergency Department, Index No. G-5", effective June 2014, last reviewed 4/2020, stated that "assessment, evaluation, management and treatment, that is appropriate and timely, to patients with obstetric conditions without delay ...Therapies, procedures and interventions that are conducted in the OBED include, but are not limited to: Recognition, interpretation and recording of patient vital signs and symptoms, particularly those that require immediate notification of a physician [and] Physician Oversight ... Patients in labor will be transferred to the Labor and Delivery unit after an appropriate medical screening examination and stabilization in accordance with EMTALA (Emergency Medical Treatment and Labor Act] regulations".