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1. Based on a review of hospital's medical records, policies and procedures, on-call schedules, and interviews, the hospital failed to provide an appropriate medical screening examination (MSE) that made full use of its capabilities, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition (EMC) existed for 1 of 10 patients (Patient #1 on two different visits) who presented to the Obstetrical Emergency Department (OBED) seeking emergency medical care for obstetrical complaints. The hospital's failure to provide an appropriate medical screening examination placed the patient and the fetus at immediate risk for deterioration of their health and wellbeing as a result of an unidentified and/or untreated emergency medical condition. Cross Refer to A2406.

2. Based on reviews of the hospital's medical records, policies and procedures, and interviews, the hospital failed to ensure that Patient #1 and her fetus received further evaluation and treatment as required, within the capabilities of staff and facilities available at the hospital, to stabilize the emergency medical condition for 1 (Patient #1 on two different visits) of 10 Obstetrical Emergency Department (OBED) patient medical records reviewed. The hospital's failure to provide further evaluation and treatment to stabilize the emergency medical condition placed the patient and the fetus at immediate risk for deterioration of their health and wellbeing as a result of one or more untreated emergency medical condition(s). Cross Refer to A2407.

Based on the review of the hospital's Central Log Policy, the hospital failed to maintain an accurate central log, with the required information, on each individual who presented to the emergency department seeking assistance for 6 of 23 patients (Patients #3, #5, # 6, #9, #10 and #17) reviewed for emergency services in the Emergency Department (ED).

The findings included:

1. The hospital's policy, titled, "Florida EMTALA - Central Log Policy," effective 01/01/99, replace date 10/29/20, and with a review date of 01/30/23, documented in part, "Policy: The hospital will maintain a Central Log containing information on each individual who requests emergency services or care or whose appearance or behavior would cause a prudent layperson observer to believe the individual needed examination or treatment, whether he or she left before a medical screening examination ("MSE") could be performed, whether he or she refused treatment, whether he or she was refused treatment, or whether he or she was transferred, admitted and treated, stabilized and transferred or discharged. The Central Log includes the patient logs from the traditional ED and, either by direct or indirect reference, patient logs from any other areas of the hospital that may be considered DEDs (dedicated emergency departments) or where an individual may present for emergency services or receive a medical screening examination, such as Labor and Delivery...Procedure...The Central Log, including all additional logs incorporated in the Central Log by reference, shall be maintained in the same manner and with the same central core of information. The logs must contain at a minimum, the name of the individual and whether the individual: refused treatment, was refused treatment, was transferred, was admitted and treated, was stabilized and transferred, was discharged, or expired."

2. Review of the printed "Electronic Central Log" for 12/22/2022 revealed Patient #3 arrived in the ED at 1144. The central log did not document a disposition (whether he refused treatment, was refused treatment, was transferred, was admitted and treated, was stabilized and transferred, was discharged, or expired) for the patient.

3. Review of the handwritten "Outpatient Register," provided as the "Labor and Delivery Emergency Department Central Log," revealed Patient #5 arrived in the ED on 11/01/2022 at 1458. The central log did not document a disposition or discharge time for the patient.

4. Review of the printed "Electronic Central Log" for 04/28/2023 revealed Patient #6 arrived in the ED at 1320. The central log did not document a disposition or discharge time for the patient.

5. Review of the printed "Electronic Central Log" for 04/20/2023 revealed Patient #9 arrived in the ED at 1838. The central log did not document a disposition or discharge time for the patient.

6. Review of the printed "Electronic Central Log" for 04/20/2023 revealed Patient #10 arrived in the ED at 1859. The central log did not document a disposition or discharge time for the patient.

7. Review of the handwritten log provided as the "Labor and Delivery Emergency Department Central Log," for Patient #17 revealed the patient arrived in the ED on 02/02/2023 at 1109. The central log did not document a disposition or discharge time for the patient.

Based on a review of hospital's medical records, policies and procedures, on-call schedules, and interviews, the hospital failed to ensure that Patient #1 received an appropriate medical screening examination (MSE) that made full use of the hospital's capabilities, including ancillary services of the on-call Maternal Fetal Medicine (MFM) Specialist, to determine whether or not an emergency medical condition (EMC) existed for 1 of 10 patients (Patient #1 on two different visits) who presented to the Obstetrical Emergency Department (OBED) seeking emergency medical care for obstetrical complaints. The hospital also failed to conduct an appropriate screening to identify the presence or absence of infection that could represent an EMC during both visits and failed to conduct appropriate screening to determine whether the symptom of severe abdominal pain on 12/18/2022 was a manifestation of an EMC. The MFM was available and on-call when Patient #1 presented to the hospital's OBED on 12/17/2022, 18-19 weeks pregnant as a result of in vitro fertilization, complaining of "a 'big gush' of fluid," feeling some contractions, and her water had broken. Patient #1 was subsequently discharged and presented to the OBED again on 12/18/2022 with complaints of severe abdominal pain described as a 9 on a 10-point scale (hospital's pain scale of 0 -10, with 10 being most severe) and a heart rate of 113 (normal range 60-100). The hospital's failure to provide an appropriate medical screening examination placed the patient and the fetus at immediate risk for deterioration of their health and wellbeing as a result of an unidentified and/or untreated emergency medical condition.

Findings include:

1. Hospital Visit #1: A review of the "Emergency Provider Report" note, dated 12/17/22, revealed that Patient #1 was initially seen in the hospital's main Emergency Department (ED) by Physician A. The History of Present Illness (HPI) form included documentation that the patient was a 32-year-old with a history of prior spontaneous miscarriages who was 18-19 weeks pregnant and presented to the ED on 12/17/22 at 0017. The Chief Complaint was listed as PROM [premature rupture of membrane (breaking open) of membranes (Amniotic sac) before labor begins].

The documentation on the Emergency Provider Report revealed "Pt sts [states] she had PROM 2 days ago in Jamaica and was going to have treatment there but decided to fly back to the US. She sts [states] it was a 'big gush' of fluid, and now she is having some spotting." According to the hospital's medical record on 12/17/22, the patient's past medical history includes "18 WKS (weeks) PREG/ABD (pregnant/Abdomen) PAIN/BLEEDING."

On the Coding Summary, dated 12/17/22 at 0000, the hospital documented the "REASON FOR VISIT" and "PRINCIPAL" diagnosis were "042.90 PREM ROM (premature rupture of membranes; PPROM is before preterm or before 37 weeks),7THO BETW RUPT & ONST LABR [unspecified as to the length of time between rupture and onset of labor], UNSP WEEKS OF GEST (unspecified weeks of gestation)."

On 12/17/22 at 0059, Physician A, Emergency Medicine Physician, ordered the laboratory tests for Patient #1 to include a basic metabolic panel (BMP measures glucose (sugar), electrolytes, and kidney function), complete blood count (CBC measures red and white blood cells and platelets), blood type, serum beta-hCG (a blood pregnancy hormone level), and an obstetrical ultrasound. At 0227, the "INDICATION" for the ultrasound was "PROM at 18 weeks; 18 WKS PREG/ ABD PAIN/ BLEEDING." The Ultrasound Impression, documented by Physician K (Radiologist), noted: "1. Single live intrauterine pregnancy with an estimated gestational age of 19 weeks 0 days. 2. Severe oligohydramnios [low level of amniotic fluid surrounding the baby] with AFI measuring 1.5 cm [a method of measuring amniotic fluid, normal 5-25 cm]. 3. Shortened cervix measuring 1.7 cm [normal >4 cm]. 4. Hypoechoic [referring to a darker appearance than surrounding tissue on the ultrasound] area in the inferior aspect of the placenta [an organ that develops in the uterus during pregnancy -provides oxygen and nourishment to a growing fetus] measuring 2.3 x 1.4 x 1.2 cm. Possible placental lake [Enlarged spaces in the placenta filled with blood]. Cannot exclude retroplacental hemorrhage [bleeding in the connection between the fetus and the uterus]. Recommend follow-up."

A review of the "Re-evaluation and MDM (Medical Decision Making) note" documented by Physician A, included "Primary Impression: Premature rupture of membranes ... Pt [patient] explained all results. Pt. presented to OB on call, [sic] I was instructed to send the patient upstairs. She is agreeable with this," and the record reflected that the patient was moved to the Antepartum/Obstetric ED (Ante/OBED). A notation in the medical record reads, "Patient discharged from ER to go to L&D (Labor and Delivery)", with an arrival timestamp of 12/17/22 at 0437 documented in the labor and delivery records and a "Physically Leaves" timestamp documented in the ED record of 12/17/22 at 0321. The patient was in the OBED as an outpatient on 12/17/22 and evaluated by Physician B (OB/GYN physician). Patient #1 was not admitted as an inpatient to the Labor and Delivery Unit on 12/17/22.

The Antepartum/Obstetric ED (Ante/OBED) Admission Note, dated 12/17/22, showed at 0437, fetal monitor strips were ordered. Further review revealed, "Pt. states water broke on 12/14/22 ... Patient states she is having some vaginal bleeding."

The "Provider Notification" Note, dated 12/17/22 at 0458, included documentation by Nurse A, specified in part, "Called to notify MD Pt. arrival in triage c/o [Complaint of] water broke 12/14/22 @7:30A. Read off U/S report from ER ...Start IV (intravenous) Fluids, MFM consult, and she will come to see the pt. soon."

There was no further documentation in the medical record that the MFM Specialist on-call came to the ED or Ante/OBED for further evaluation and treatment of Patient #1 on 12/17/22 to determine whether or not an EMC existed. The "Discharge Report" dated 12/17/22 at 0502 was reviewed. The review revealed that Physician B was consulted for "PPROM 19 weeks."

A scanned document image titled "Operative and Procedural Consent" with the handwritten procedure of "vaginal delivery or primary cesarian section" has Patient #1's legible name on the signature line. A signature followed by "RN" (registered nurse) A was the "witness to signature" line with the timestamps of 12/17/22 0530.

A second scanned consent document titled "Consent to Administer Cervical Ripening Agents and/or Oxytocin Agents for Induction of Labor and/or Augmentation of Labor" also has Patient #1's legible name on the signature line and a signature followed by "RN" A on the "witness to signature" line with timestamps of 12/17/22 0530.

A third scanned document titled "Consent for Operative Vaginal Delivery" also has Patient #1's legible name on the signature line and a signature followed by "RN" A on the "witness to signature" line with timestamps of 12/17/22 0530.

A fourth scanned document titled "Informed Consent for Anesthesia Services" has Patient #1's legible name on the signature line, initials matching Patient #1's next to lines that say "Spinal/Epidural Anesthesia" and "MAC (Monitored Anesthesia Care)" and "Regional Block/IV Regional" and a signature was followed by "RN" A on the "witness to signature" line with timestamps of 12/17/22 0530.

A scanned document titled "Anesthesia Questionnaire" contains handwritten information about Patient #1's medical history and has Patient #1's legible name written on the signature line with a timestamp of 12/17/22 0530.

There was no documentation in the medical record that the patient ultimately underwent vaginal delivery or primary cesarian section, cervical ripening, induction of labor, augmentation of labor, operative vaginal delivery, or any anesthesia services. There was no documentation to indicate why there may have been an abrupt change in the patient's care plan after consents were signed by Patient #1 and witnessed by RN A for these procedures.

Further review revealed that on 12/17/22 at 0625, Physician B documented in part, "OB ED history HPI [History of Present Illness]-Pt#1 is a very nice 32 y/o [year old] G [number of pregnancies] 3 P [number of live births] 0020 [had two pregnancies, neither of which survived to a gestational age of 24 weeks] with an EDD [Expected date of delivery] 5/13/23 presenting at 19w0d with 'gush of fluid' on 12/15 at 07:30, clear. Had intermittent spotting and cramping, but none now. The patient was in Jamaica at the time and flew back for evaluation. Denies pregnancy complications. H/o [history of] SAB [spontaneous abortion, also known as "miscarriage"]. Patient of [Physician D] ...Physical Exam: abdomen gravid pregnant]), soft, no abdominal tenderness, no guarding, Uterine Activity Toco, frequency (description): none, Pelvic lesions: none, Sterile speculum exam: visually closed, no pooling, no bleeding, FHR [Fetal Heart Rate] evaluation:145 bpm (beats per minute), Membranes: Membranes: status: undetermined. Results: ROM test: [AmniSure tests - a test used by a clinician to look for a protein present in amniotic fluid in the vaginal discharge of a pregnant patient to help assess for rupture of membranes], ROM negative ... "Diagnosis and Assessment & Plan" Problem List: "Preterm Premature Rupture of Membranes (PPROM) with unknown onset of labor ..." Physician B documented in part, "[Patient #1] is a very nice 32 yo G3POO2O with an EDD 5/13/23 presenting at 19w0d with suspected PPROM on 12/15/22. Reviewed Options with pt, IOL [induction of labor, when a pregnancy care provider starts labor, instead of letting labor start on its own]; vs [versus] D&E [dilatation and evacuation, a procedure to surgically remove the contents of the uterus] vs expectant management [waiting for the miscarriage to happen]. Possible oligohydramnios [Too little amniotic fluid surrounding the fetus; the fetus needs amniotic fluid to grow] could be of other etiology besides PPROM. Patient would like to speak with [her] primary OB [Physician D, also an MFM Specialist] prior before making a final decision." Physician B documented, "Clinically stable and able to manage expectantly. Case d/w [discussed with] [Physician C, an OB MD] and he agrees with d/c [discharge] and f/u [follow-up] on Monday with [Physician D]."

A review of the "Provider Notification" note revealed that on 12/17/22 at 0644, Nurse C "notified Physician B report test results; provider consults." The results showed a white blood cell count (blood cells that fight infection) of 12.0 elevated (the hospital's normal range is 4.0 to 10.5 for white blood cells) and beta-hCG 9502 (within limits for this stage of pregnancy). The note included the ultrasound interpretation results.

The "ANTEPARTUM/OBED DISCHARGE PRETERM INSTRUCTIONS" dated 2/17/22 at 0647, revealed that Physician B was the discharging provider. Patient #1's "Discharge Method: ambulatory ...Condition: Stable and discharged to home ...Discharge Vitals, Pain, Contractions T(temp) 98.7/37.1; P (pulse) 74; Resp (respirations)18; B/P: 136/83; Pain: No Pain Frequency of Contractions: None."

The hospital's policy, titled "Florida EMTALA Medical Screening Examination and Stabilization Policy", effective 01/01/1999, last reviewed on 1/30/2023, revealed the following: An EMTALA Obligation is triggered when: An individual or a representative acting on the individual's behalf ...requests emergency services and care ...Such obligation is further extended to those individuals presenting elsewhere on hospital property, requesting examination or treatment for an emergency medical condition (EMC). Further, if a prudent layperson observer would believe that the individual is experiencing an EMC, then an appropriate medical screening examination (MSE) within the capabilities of the hospital's Dedicated Emergency Department (DED) (including ancillary services routinely available, and the availability of the on-call physician) shall be performed."

2. Hospital Visit #2: A review of the ante/OBED admission form revealed that Patient #1 presented to the hospital again on 12/18/2022 at 2118 for an OBED evaluation. The admitting Registered Nurse (G) documented the reason for this visit as "Abdominal Pain" and that the patient was complaining of having abdominal pain "since Thursday ...getting worse and more frequent since 1500 today." Further documentation revealed that fetal movement was present. The OBED evaluation note, dated 12/18/2022 at 2219 by OBED Physician H, documented Patient #1's Chief Complaint as "Uterine Contractions (with cramping), vaginal spotting dark brown discharge." The HPI was reviewed for Patient #1 and specified in part, "presenting for evaluation of lower abdominal cramping in setting of suspected PPROM. The patient was seen in OBED yesterday for LOF [leaking of fluid] after she experienced a 'big gush' of fluid in Jamacia on 12/15/2022 at 0730." The patient also reported to OBED Physician H that "she did not have a swab to confirm the diagnosis of PPROM, but she did have an US [ultrasound] in Jamacia on 12/16/2022] that showed she had oligohydramnios. OB US completed here on 12/17/2022] showed an AFI of 1.5 cm and a cervical length of 1.7 cm; AmniSure was negative at that time. Patient was counseled on expectant management and advised to follow up with her OB provider tomorrow, Monday [12/19/2022]. She returns to the ED today because she reports feeling stronger contractions since 3PM this afternoon. Patient also reports vaginal discharge, brownish in color, but has not had continuous leakage of fluids."

The patient's vital signs at 2214 were recorded as follows: pulse 113 elevated (normal 60-100), blood pressure 125/74, temperature 36.9 C (normal), and the patient was experiencing severe abdominal pain described on a scale of 9 (on a pain scale of 0-10 with 10 most severe). A repeat ultrasound was done on 12/19/2022 at 0055 and documented "oligohydramnios with a maximum vertical pocket of 1.2 cm" (Low level of amniotic fluid surrounding the fetus). The results of the urinalysis indicated rare bacteria and >100 white blood cells (infection-fighting cells), and a urine culture was ordered. Physician H documented "will need further evaluation for other possible etiologies of oligohydramnios, which can be performed, as previously planned, in the outpatient setting by the patient's OB and MFM providers." Additional documentation, by Physician H, stated that Patient #1 "was not in PTL [Preterm Labor-regular uterine contractions caused by cervical changes before 37 completed weeks of pregnancy], hemodynamically stable, afebrile [no fever]." Medical record review revealed that Patient #1 was discharged home on 12/19/2022 at 0151 and encouraged to follow up with Physician D.

3. On 05/02/2023 at 1412, an interview was conducted with Physician J/Hospital Chief Medical Officer (CMO) and Physician F, Chair of Labor and Delivery. Physician F confirmed she is the Chair of the Obstetrics Department. Physician F stated that the doctor-patient relationship is very important in OB because the patient's condition can change quickly, and decisions need to be made quickly. "It is my job to discuss all options and give all options within evidence-based medicine, and the patients decide how they want to make a decision based on the information given." Physician F stated that when PPROM happens before a fetus is 20 weeks along (i.e., is previable), it is impossible to save the pregnancy because the fetus' lungs would not be developed enough to live outside the mother. If there is PPROM, there is a "high likelihood of the mother becoming septic" (a life-threatening medical emergency when an infection triggers a chain reaction throughout your body). If the mother develops an infection, the pregnancy will "need to be terminated for the mother's health, and it is a high likelihood that an infection will develop. If no infection develops and the mother remains in stable condition and does not want to terminate the pregnancy, she would have to be monitored closely." Physician F also stated, "It is all about counseling and discussing the different options" with patients. She said their hospital's protocol for previable PPROM would be to "consult Neonatal and Maternal Fetal Medicine to discuss options for the patient and fetus. It is a risk vs benefit decision, taking the patient's health and safety into higher consideration than that of the fetus, even if there is a heartbeat."

4. On 05/03/2023 at 1033, a telephone interview was conducted with Physician A, ED Physician. She stated she remembered this patient and called upstairs with the low amniotic fluid; that she always calls upstairs [Labor and Delivery Department] when a pregnant patient comes in because it is "out of her wheelhouse," and the OB doctor "makes the decisions." She further stated the decision was discussed with the patient, and she agreed to go upstairs [Labor and Delivery Department].

5. A telephone interview was conducted on 05/03/2023 at 0856 with Physician H, who stated that Patient #1 had complained of potential PPROM three days prior, which might be why the Amnisure test was negative. Physician H stated that when the diagnoses are inconclusive, one would have to investigate further, including "lab tests and rule out infection before discharging the patient for expectant management." "If there was more severe abdominal pain, that could be a reason to keep the patient to observe and order labs. There are different things to take into account. It would be a discussion with the patient. If there are signs of infection or if the patient is already in labor, that decides for you. There may be an infectious state if there is an elevated white blood cell count, fever, vaginal discharge, or changes in vital signs." She stated, "It is not a one provider decision. Typically start with Maternal Fetal Medicine providers." "Discuss with the patient that the baby was pre-viable; the risk of abnormalities due to low fluid, want [sic] to continue or not, risks of continuing with low fluid. [They] might have the option of terminating the pregnancy, but with the Amnisure negative, they only know that the fluid was low, which could be other etiologies. The differential could be infection, such as rubella or varicella. Some are very affected and some not, would have a risk discussion about the potential risk of carrying to term."

The facility's MFM on call schedule for 12/17/22 and 12/18/22 was reviewed and revealed that Physician E was listed as being on-call for Maternal Fetal Medicine.

The findings showed the hospital failed to provide an appropriate medical screening examination within the capability of the hospital's ED, to include ancillary services of the on-call Maternal Fetal Medicine specialist, for a patient who presented with a history of prior spontaneous miscarriages, was 18-19 weeks pregnant by in vitro fertilization, had an elevated white blood cell count, had ultrasound results identifying severe oligohydramnios, and on one visit had severe pain and brown vaginal discharge. As a result, the hospital failed to determine whether those signs and symptoms were the result of an emergency medical condition that existed for Patient #1 on 12/17/2022 and 12/18/2022, which posed a threat to the health and safety of the patient and the fetus.

Based on reviews of the hospital's medical records, policies and procedures, and interviews, the hospital failed to ensure that Patient #1 and her fetus received further evaluation and treatment as required, within the capabilities of staff and facilities available at the hospital, to stabilize the emergency medical condition for 1 (Patient #1 on two different visits) of 10 Obstetrical Emergency Department (OBED) patient medical records reviewed. The hospital identified that Patient #1 had previable preterm premature rupture of membranes [pPPROM] when the amniotic sac that surrounds the fetus breaks before the fetus could survive outside the womb ["the water broke early"]), severe oligohydramnios [low level of amniotic fluid surrounding the baby], and complaints of severe abdominal pain. The hospital's failure to provide stabilizing treatment for pPPROM and associated medical condition(s) placed the patient and the fetus at immediate risk for deterioration of their health and wellbeing.

Findings include:

1. The hospital's policy, titled, "Florida EMTALA Medical Screening Examination and Stabilization Policy", effective 01/01/1999, last reviewed on 1/30/2023 revealed the following: An EMTALA Obligation is triggered when: An individual, or a representative acting on the individual's behalf ...requests emergency services and care ... The MSE must be completed by an individual (i) qualified to perform such an examination to determine whether an EMC exists, or (ii) with respect to a pregnant woman having contractions, whether the treatment requested is explicitly for an EMC is determined to exist, the individual will be provided necessary treatment to relieve or eliminate the EMC, within the capability and capacity of the hospital ...7. Stabilizing Treatment with the Hospital's Capability ...An individual has been provided sufficient stabilizing treatment when the physician treating the individual in the DED (Dedicated Emergency Department) has determined, within reasonable clinical confidence, that no material deterioration of the condition is likely, within reasonable medical probability, to result or occur during transfer ...or with respect to an emergency medical condition of woman in labor that the women has delivered the child and placenta.

2. The "Provider Notification" Note, dated 12/17/22 at 0458 by Nurse A, specified in part, "Called to notify MD Pt. arrival in triage c/o [Complaint of] water broke 12/14/22 @7:30A. Read off U/S report from ER ...Start IV (intravenous) Fluids, MFM consult, and she will come to see the pt. soon." The Maternal Fetal Medicine (MFM) Specialist was available and on-call when Patient #1 presented to the hospital's OBED on 12/17/2022 and 12/18/2022. There was no documentation in the medical record that the on-call MFM Specialist went to the ED or Ante/OBED to provide further evaluation and treatment for Patient #1 on 12/17/22 or 12/18/2022.

3. Hospital Visit #1: Cross Refer to A2406. The hospital's Coding Summary, dated 12/17/22 at 0000, documented Patient #1's "REASON FOR VISIT" and "PRINCIPAL" diagnosis were "042.90 PREM ROM [premature rupture of membranes; PPROM is before preterm or before 37 weeks],7THO BETW RUPT & ONST LABR [unspecified as to the length of time between rupture and onset of labor], UNSP WEEKS OF GEST [unspecified weeks of gestation]." A review of the "Re-evaluation and MDM (Medical Decision Making) note" documented by Physician A included, "Primary Impression: Premature rupture of membranes. Review of the results of the abnormal laboratory results, dated 12/17/22 at 0145 AM, revealed White Blood Cells (WBC) = 12.0 High (normal range 4.0 - 10.5), absolute neutrophils = 9.66 High (normal range 1.56 - 6.13), segmented neutrophils = 80.7 High (normal range 34.0 - 71.1). High values for each typically mean the body is under stress due to infection or inflammation. The Ultrasound Impression, documented by Physician K (Radiologist), noted: "1. Single live intrauterine pregnancy with an estimated gestational age of 19 weeks 0 days. 2. Severe oligohydramnios [low level of amniotic fluid surrounding the baby] with AFI measuring 1.5 cm [a method of measuring amniotic fluid, normal 5-25 cm]. 3. Shortened cervix measuring 1.7 cm [normal >4 cm]. 4. Hypoechoic [referring to a darker appearance than surrounding tissue on the ultrasound] area in the inferior aspect of the placenta [an organ that develops in the uterus during pregnancy -provides oxygen and nourishment to a growing fetus] measuring 2.3 x 1.4 x 1.2 cm. Possible placental lake [Enlarged spaces in the placenta filled with blood]. Cannot exclude retroplacental hemorrhage [bleeding in the connection between the fetus and the uterus]. Recommend follow-up." There was no documentation in the medical record indicating the hospital medical staff addressed the abnormal laboratory results on 12/17/22 nor the severe oligohydramnios.

A review of the medical record revealed the hospital staff had Patient #1 sign several consent forms on 12/17/2022. A scanned document image entitled "Operative and Procedural Consent" with the handwritten procedure of "vaginal delivery or primary cesarian section" has Patient #1's legible name appear on the signature line. A signature followed by "RN" (registered nurse) A was the "witness to signature" line with the timestamps of 12/17/22 0530. There was no documentation in the medical record that the patient ultimately underwent vaginal delivery or primary cesarian section, cervical ripening, induction of labor, augmentation of labor, operative vaginal delivery, or any anesthesia services. There was no documentation to indicate why there may have been an abrupt change in the patient's care plan after consents were signed by Patient #1 and witnessed by RN A for these procedures.

A telephone interview was conducted with Patient #1 on 5/4/23 at 1655. The patient was asked if the hospital staff asked if she wanted to carry the fetus until possible viability at 22 weeks, and she said "Yes." Additionally, during a telephone interview with Physician D (Patient #1's primary OB and an MFM Specialist) on 5/3/21 at 1251, Physician D stated that she was out of town and was not consulted on 12/17/2022.

The discharge instructions titled "ANTEPARTUM/OBED DISCHARGE PRETERM INSTRUCTIONS" dated 12/17/2022, at 06:47 AM by Physician B, revealed in part, "Discharged to home Condition Stable ... Discharge Vitals, Pain and Contractions ...Pain: No Pain ...frequency of Contractions: None ... Normal activity as tolerated ...Comments: 1. Follow up with primary provider on Monday ... Follow-Up on 12/19/22 Follow-up at [Physician D]." On this form, a handwritten note stated, "Time out @ (at) 0745." A review of the Antepartum/OBED Discharge instructions Preterm Instructions dated 12/17/22 specified in part, "Notify your healthcare provider if you have rupture of membranes (bag of water breaks): Your bag of water breaking may be a gush of fluid from your vagina or constant leaking of fluid that does not stop, even after emptying your bladder Your water can break before you start having contractions. Remember to note the time it happened and the color of the fluid (clear, pinkish, greenish, etc.)."

4. Hospital Visit #2: Cross Refer to A2406. The ante/OBED admission form revealed that Patient #1 presented to the hospital again on 12/18/22 at 2115 for an OBED evaluation. The admitting Registered Nurse (G) documented the reason for this visit as "Abdominal Pain" and that the patient was complaining of having abdominal pain "since Thursday ...getting worse and more frequent since 1500 today." Further documentation revealed that fetal movement was present. The HPI [History of Present Illness] for Patient #1 specified in part, "presenting for evaluation of lower abdominal cramping and contractions in the setting of suspected PPROM. The patient was seen in OBED yesterday for evaluation LOF [leaking of fluid] after she experienced a 'big gush' of fluid in Jamacia on 12/15/2022 at 0730." The patient also reported to OBED Physician H that "she did not have a vaginal swab to confirm the diagnosis of PPROM, but she did have an US [ultrasound] in Jamacia on 12/16/2022] that showed oligohydramnios." The HPI further noted, "OB US completed here on 12/17/2022] showed an AFI of 1.5 cm and a cervical length of 1.7 cm; AmniSure was negative at that time. Patient was counseled on expectant management and advised to follow up with her OB provider tomorrow, Monday [12/19/2022]. She returns to the ED today because she reports feeling stronger contractions since 3PM this afternoon. Patient also reports vaginal discharge, brownish in color, but has not had continuous leakage of fluids."

A repeat ultrasound report, on 12/19/22 at 0055, documented "oligohydramnios with a maximum vertical pocket of 1.2 cm" [Low level of amniotic fluid surrounding the fetus]. The results of the urinalysis indicated rare bacteria and >100 white blood cells (infection-fighting cells), and a urine culture was ordered. The "Coding Summary" sheet, dated 12/18/22 at 2015, specified in part, "Diagnoses: Reason for visit 026.879 Cervical shortening, unspecified trimester (ICD10) ...Principal DX 009.812 Supervision of Preg RSLT From Assist Reproductv Tech, Second Trimester, Other DX 041.02X0 Oligohydramnios, Second Trimester, Not applicable or unsp 279.82 Long Term (current) use of Aspirin Z3A.19 19 weeks gestation of pregnancy."

A Review of the Discharge Report dated 12/18/22 revealed that at 2108 a consult for the "OB Hospitalist" (Physician H). There was no documentation in the medical record indicating that Physician E, MFM Specialist, was consulted despite being on-call and available on 12/18/22 to provide further evaluation and treatment as stated in the hospital's policy and procedure. There was no documentation in the record to indicate that Patient #1 was provided further evaluation and treatment on 12/18/22. The hospital had capabilities of staff and equipment (anesthesia, L&D Operating room, Neonatal ICU (Intensive Care Unit, etc.), and the availability to include MFM specialist on-call and available to provide further evaluation and treatment interventions to stabilize pPPROM on 12/17/22 and 12/18/22.

Medical record review revealed that Patient #1 was discharged to home on 12/19/2022 at 0151 and was encouraged to follow-up with Physician D. The discharge instructions specified in part, "Maternal Observation Discharge Addendum ...Your physician placed you in the hospital as an outpatient and ordered observation services but did not formally admit you as an inpatient. The reason for this notice is that Florida law requires that hospitals notify patients of their outpatient observation status upon discharge." The hospital's failure to provide further evaluation and treatment, within the capabilities of staff and facilities available at the hospital, to stabilize the emergency medical condition placed the patient and the fetus at immediate risk for deterioration of their health and wellbeing as a result of one or more untreated emergency medical condition(s).

5. On 05/02/2023 at 1412, an interview was conducted with Physician J/Hospital Chief Medical Officer (CMO) and Physician F, OB Chair of Labor and Delivery. Physician F confirmed she is the Chair of the Obstetrics Department. Physician F stated that the doctor-patient relationship is very important in OB because the patient's condition can change quickly, and decisions need to be made quickly. "It is my job to discuss all options and give all options within evidence-based medicine, and the patients decide how they want to make a decision based on the information given." Physician F stated that when PPROM happens before a fetus is 20 weeks along (i.e., is previable), it is impossible to save the pregnancy because the fetus' lungs would not be developed enough to live outside the mother. If there is PPROM, there is a "high likelihood of the mother becoming septic" (a life-threatening medical emergency when an infection triggers a chain reaction throughout your body). If the mother develops an infection, the pregnancy will "need to be terminated for the mother's health, and it is a high likelihood that an infection will develop. If no infection develops and the mother remains in stable condition and does not want to terminate the pregnancy, she would have to be monitored closely." Physician F also stated, "It is all about counseling and discussing the different options" with patients. She said their hospital's protocol for previable PPROM would be to "consult Neonatal and Maternal Fetal Medicine to discuss options for the patient and fetus. It is a risk vs benefit decision, taking the patient's health and safety into higher consideration than that of the fetus, even if there is a heartbeat."

6. A telephone interview was conducted on 05/03/2023 at 0856 with Physician H, who stated that Patient #1 had complained of potential PPROM three days prior, which might be why the Amnisure test was negative. Physician H stated that when the diagnoses are inconclusive, one would have to investigate further, including "lab tests and rule out infection before discharging the patient for expectant management." "If there was more severe abdominal pain, that could be a reason to keep the patient to observe and order labs. There are different things to take into account. It would be a discussion with the patient. If there are signs of infection or if the patient is already in labor, that decides for you. There may be an infectious state if there is an elevated white blood cell count, fever, vaginal discharge, or changes in vital signs." She stated, "It is not a one provider decision. Typically start with Maternal Fetal Medicine providers." "Discuss with the patient that the baby was pre-viable; the risk of abnormalities due to low fluid, want [sic] to continue or not, risks of continuing with low fluid. [They] might have the option of terminating the pregnancy, but with the Amnisure negative, they only know that the fluid was low, which could be other etiologies. The differential could be infection, such as rubella or varicella. Some are very affected and some not, would have a risk discussion about the potential risk of carrying to term."