HospitalInspections.org

Based on medical records reviews, policy and procedure review, on-call physician schedules, and interviews, it was determined the facility failed to utilize the staff and facilities available, to include the Maternal Fetal Medicine (MFM) on-call physician, to provide further medical evaluation and treatment as required to stabilize the emergency medical conditions for one (Patient #1) of 10 sampled patients who presented to the Obstetrical Emergency Department (OBED) with pregnancy complaints.

Cross Refer to A2407.

Based on review of medical records, policies and procedures, on-call physician schedules, and interviews, it was determined the facility failed to provide, within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the identified emergency medical conditions for one (Patient #1) of 10 sampled patients who presented to the Obstetrical Emergency Department (OBED) with pregnancy complaints. The facility determined that Patient #1 had emergency medical conditions. Patient #1 and her unborn fetus presented to the hospital's OBED on 12/21/22 at 19 weeks 4 days of gestation complaining of lower abdominal cramping that had become more severe and more frequent day-by-day for more than five days. Patient #1 reported to Physician H that she had a rupture of her membrane since 12/15/22. During the pelvic examination on 12/21/22 at 0327, Patient #1's cervix was observed to be 4 cm (centimeters) dilated 60% effaced and -2 station (fetus head in the birth canal). Ultrasound confirmed absence of amniotic fluid, and the medical screening examination confirmed prolonged previable preterm premature rupture of membranes. The facility determined that Patient #1 had at least 2 emergency medical conditions: (1) previable preterm premature rupture of membranes; and (2) contractions during pregnancy with cervical dilation and anhydramnios (absence of amniotic fluid), such that discharge posed a threat to the health and safety of Patient #1 and her fetus.

Findings Include:

1. The facility's "Memorial Healthcare System Standard of Practice-Transfer/Access to Emergency Care", dated March 1992, reviewed: October 2021, revised: October 2021 was reviewed. The Standard of Practice specified in part, "42 USC 1395 dd (sometimes referred to Emergency Medical Treatment and Labor ACT or 'EMTALA') and regulations promulgated there under 42 CFR section 489 ... create certain obligations on the part of hospitals with emergency departments and on the part of physicians providing emergency services and care ...IV. The term 'emergency medical condition' means: A. A medical condition manifesting itself by acute symptoms of sufficient severity (which may include severe pain) such that the absence of immediate medical attention could reasonably be expected to result in any of the following: 1. Serious jeopardy to patient health, including a pregnant woman or fetus; 2. Serious impairment to bodily function; or 3. Serious dysfunction of any bodily organ or part ... B. with respect to a pregnant woman; ...3. That there is evidence of labor, which means the process of childbirth beginning with the latent or early phase of labor or there is an onset and persistence or uterine contractions or there is rupture of membranes and continuing through delivery of the placenta ... V. The term 'emergency services and care' means: ... C. If an emergency medical condition does exist, the care, treatment, or surgery by a physician necessary to stabilize the emergency medical condition, within service capability of the facility. 'Stabilize or stabilized' means that no material deterioration of the patient's condition is likely, within reasonable medical probability, to result from or occur during the transfer."

2. Hospital Visit #1: A review of the hospital's Face Sheet, section titled "Encounter" revealed that Patient #1 was admitted to the facility's OBED (Obstetrical Emergency Department) on 12/21/2022 as "Patient Class: Observation." The Admitting Physician was Physician A. Further review revealed, "Nature Admit: EMERGENCY," Admit Source: Emergency." The patient was "Admitted: 12/21/2022 0101", Observation: 12/21/2022 0320" and "Discharged: 12/21/2022 2100." Patient #1 was admitted to observation status, but not as an inpatient, to the Labor and Delivery Unit on 12/21/2022.

Physician B (Service: Obstetrics and Gynecology) documented in part, "(H&P) [History and Physical]" on 12/21/2022 0327:

"Chief Complaint: Lower abdominal Cramping".

"Subjective: [Patient #1] is a 32 y.o. [year old] G3P0020 [third pregnancy, prior two pregnancies were pregnancy losses] at 19w4d [19 weeks, 4 days] presenting to the OB ED complaining of lower abdominal cramping over the last 5 days. This is an IVF [in vitro fertilization, a procedure to help a woman get pregnant] pregnancy complicated by PPPROM [previable preterm premature rupture of the membranes, a pregnancy complication in which the amniotic membrane surrounding the fetus breaks (ruptures) before week 37 of pregnancy and before the fetus is viable or mature enough to survive on its own outside the uterus] on 12/15 - she has been seen at multiple hospital systems as well as her own OB since then and was repeatedly told that due to the gestational age, nothing could be done and she was sent home. She says that day by day her lower abdominal cramping is becoming more severe and more frequent, and she is worried that she will end up delivering at home. She also endorses light pink vaginal discharge and constant leaking of fluid but denies all other symptoms including fever, chills, nausea, vomiting, vaginal bleeding or urinary symptoms".

"Her last US [ultrasound] at [Hospital A] on 12/17/22 revealed a pregnancy at 19w0d with AFI [Amniotic Fluid Index, a measure of the amount of amniotic fluid, where normal is 5 cm to 25 cm] 1.5 cm, Cervical length of 1.7 cm [normal approximately 3.5 to 4.8 cm at this stage of pregnancy], and closed cervix".

Physical Exam (examination) documented by Physician B revealed in part, "Abdomen: Gravid [pregnant abdomen], soft, non-tender, non-distended ... Pelvic: 4/60/-2 [indicating 4 centimeters dilated (referring to size of the opening of the cervix), cervical effacement (referring to degree of thinning of the cervix in preparation for delivery), and station the fetus head in the birth canal], fetal parts palpated on VE [vaginal examination]. No pooling on speculum exam. Moderate pink/brown discharge noted."

FHT (fetal heart - fetal heart rate beats per minutes) were in the 160s.

The patient's vital signs documented on the physical exam note: BP (blood pressure) 127/79, Pulse 86, Temperature 37.1°C (Celsius) (oral), Respirations 19.

Physician B ordered on 0143 laboratory tests for Patient #1, including: urinalysis and testing of vaginal secretions for ROM (Rupture of Membranes) as part of the medical screening examination.

Physician B also ordered on 12/21/2022 at 0144 an (obstetrical ultrasound US). The reason for the US examination was identified as "19 weeks rupture of membranes." The US result interpretation was documented by Physician I, a Radiologist on 12/21/2022 0314. Review of the US dated 12/21/2022 0244, revealed, among other findings, a fetal heart rate of 150 bpm (beats per minute), Anhydramnios (complete or near-complete lack of amniotic fluid), and AFI of 0.0 cm (where normal range is 5cm to 25cm), and under "maternal anatomy" that the cervix was "Open with presenting fetal part." The "clinical summary" noted: "Single live intrauterine gestation at 19w4d Cervix appears open with fetal head within." The clinical summary also noted Anhydramnios.

Review of "Laboratory Evaluation: Recent Results (from the past 24 hour(s))" and collection time 12/21/2022 0150 revealed some abnormal results for "Urinalysis with reflex microscopic" (test that measures chemical constituents of urine with microscopic examination to detect the presence of cells, bacteria, yeast, and other formed elements). The urine abnormal results included an "Appearance" value of "Cloudy (A) [Abnormal]" where the reference range was "Clear"; Blood ur (Urine) with a value of 3+ (A) where the reference range was "Negative"; and "Leukocyte esterase ur" (a test to look for white blood cells and other signs of infection) with a value of 3+ (A) where the reference range was "Negative". The medical record did not contain documentation that the abnormal urinalysis results were addressed or discussed with Patient #1.

A review of lab results collected on 12/21/2022 0150 revealed "ROM plus" (Amnisure ROM is a rapid test for the detection of amniotic fluid in vaginal secretions of pregnant women with signs and symptoms of rupture of membranes) result for "Rupture of fetal membranes" was "Positive".

Review of "All orders and Results" dated 12/21/2022 at 0320 by Physician A revealed, in part, orders consistent with planned vaginal and/or surgical delivery, including orders for:

"Compression Sleeves [used after surgery to prevent blood clots from developing in the legs] apply" with the frequency given as: "Continuous 12/21/22 at 0319- Until Specified". The order for compression sleeves was discontinued on 12/21/2022 at 2328 due to "Patient Discharge".

There was no documentation in the medical records that compression sleeves were applied to Patient #1's lower extremities as ordered by Physician A on 12/21/2022.

"Surgical Prep [washing the surgical site with antiseptic soap]" with frequency of "once" 12/21/22 at 0319 and under order comments: "Abdominal clipping and prep". The order was discontinued on 12/21/2022 2328 due to "Patient Discharge".

"Bedrest" frequency of "Continuous 12/21/22 0319- Until Specified" and an order comment that stated, in part, "Complete bedrest for the initial 2 hours after Cervidil [topical medication used in a pregnant woman to relax the muscles of the cervix in preparation for inducing labor at the end of a pregnancy] insertion". The order for bedrest was discontinued on 12/21/2022 due to "Patient Discharge."

CeFAZolin (also known as Ancef - it is an antibiotic medication used to treat bacterial infections) to be administered "[o]nly if patient converts to cesarean section" and given "within 60 minutes prior to incision." It was indicated for use as "Surgical Prophylaxis" and the order status was "Cancel Held."

Azithromycin (also known as Zithromax-medication used to treat certain bacterial infections) to be administered "[o]nly if patient converts to cesarean section" and given "within 60 minutes prior to incision[.]" It was indicated for use as "Surgical Prophylaxis" and the order status was "Cancel Held."

Physician A consulted "Anesthesiology" on 12/21/2022 0320 with a comment that, "Patient may have Epidural Anesthesia [anesthetic used to block pain from labor contractions during childbirth] unless contraindicated." This order was discontinued on 12/21/2022 at 2328 due to "Patient Discharged".

Review of the "Anesthesia Record" (timing of this evaluation not indicated) revealed that CRNA (Certified Registered Nurse Anesthetist - a nurse who has specialized training in anesthesia) J documented "labor onset date/time as: 12/15/2022 at 0700"; The CRNA documented: "Preterm Labor? Yes"; "Antenatal Steroids [medication used to reduce neonatal mortality and respiratory distress system]? None"; "Antibiotics Received During Labor? No"; "Rupture Date/Time: 12/15/2022 0700"; and "Maternal Complications: preterm premature rupture of membranes".

The scanned consent titled "CONSENT TO DELIVERY AND CARE" was signed by Patient #1 on 12/21/2022 at 0430 and witnessed by RN E. The form documented in part, "I CONSENT TO VAGINAL DELIVERY. IF VAGINAL DELIVERY WILL INCREASE RISKS TO ME AND/OR MY BABY AS DETERMINED BY MY DOCTOR, I CONSENT TO A CESAREAN SECTION."

Physician B documented the following PRN (as needed) medications were ordered: "carboprost (HEMABATE) injection [medication used to induce abortion]"; "CHG [Chlorhexidine used in antimicrobial skin for surgical scrub]"; "methylergonovine [medication used to prevent and control bleeding from the uterus that can happen after childbirth] injection"; "misoprostol (CYTOTEC) [medication effective in cervical ripening for first trimester surgical abortion]"; and oxytocin (to stimulate uterine contractions in labor and childbirth).

Physician B's H&P (History and Physical) note dated 12/21/2022 0327 stated that the plan included, among other things: (1) "Admit to L&D [Labor and delivery] for 23 hours observation"; and (2) "Discussed with patient that at current gestational age her fetus is considered pre-viable and therefore there is not much that can be done. Discussed our plan to observe her for 23 hours to see if she delivers on her own makes cervical change. If not, she will be discharged home for expectant management. Discussed that chances of the pregnancy making it to viability [the point at which a human fetus can survive outside the uterus] are slim".

Physician A documented on 12/21/2022 at 0325 that Patient #1's Problem List as of 12/22/2022 included: "Bilateral lower abdominal cramping"; "19 weeks gestation of pregnancy"; and "Premature rupture of membranes in second trimester".

The Discharge Summary documentation dated 12/21/2022 2009 was reviewed and revealed an Admission Date and Discharge date of 12/21/2022. Physician C documented that the discharge diagnosis was: "Previable premature rupture of membranes, threatened preterm labor".

Physician C documented on 12/21/22: "Patient instructions: Follow up with primary OB/MFM [Maternal Fetal Medicine - a sub-specialty of obstetrics that focuses on high-risk pregnancies] team[.] Discharge Medications List: You have not been prescribed any medications. Activity: Pelvic rest, nothing in the vagina until delivery." The patient was instructed to follow up with Physician F for "Prenatal care" on 12/28/2022.

Review of "Nursing All-Notes" dated 12/21/2022 at 2047, where RN B documented, "Patient IV removed, patient given discharge instructions. Patient gathered all personal belongings. No further questions from patient." At 2121, RN documented, "Pt transported via wheelchair for discharge."

The facility failed to utilize the staff and facilities available including the Maternal Fetal Medicine (MFM) on-call physician, and failed to provide stabilizing treatment to assure, within reasonable medical probability, that no material deterioration of Patient #1 and her unborn fetus' conditions were likely when Patient #1 presented to the hospital's OB ED on 12/21/2022 with prolonged previable preterm rupture of membranes and contractions. On 12/21/2022, the hospital had the capabilities of an on-call MFM physician who was available, OB operating rooms, and neonatal intensive care unit to provide stabilizing treatment as required, as recognized in the facility's policy and procedure. Patient #1 consented to delivery, and had orders placed consistent with an intent to deliver her fetus. However, she was subsequently discharged prior to delivery and without being provided medical treatment during her 12/21/2022 visit.

Review of subsequent medical records from Patient #1's second presentation to the hospital's OBED on 12/26/22 revealed in part, "She was found to be completed [sic] dilated with Fetal parts a 1+ station this morning, with positive FHT at 99 bpm.... Patient delivered a nonviable fetus at 0907."

3. An interview was conducted with the Director of Nursing for labor and delivery at 1508 05/03/23. She explained that any patients who come into the hospital at less than 20 weeks gestation are seen by a gynecologist and an Emergency Department doctor. She said the Maternal Fetal Medicine (MFM) doctor is on site 8 hours per day and on call 24/7. The surveyor asked what happens if a patient presents at 19 weeks with cramping and complaint that their water broke. She stated the gynecologist would evaluate the patient in the main ED and the patient would be given options (discharge home, be admitted to L&D, or be admitted to antepartum). She clarified that antepartum is used for patients who are high risk or experiencing complications.

4. A telephone interview was conducted with Physician A, OB physician on 05/04/23 at 1558. She recalled that she saw Patient #1 with Physician B (an OB/GYN 3rd year resident). She said the patient had a prior diagnosis of premature rupture of membranes from 12/15/22 and was undergoing "expectant management". She said the patient came in with complaints of cramping and dilation. The patient was kept for observation for the possibility of continued dilation and delivery of the fetus. She stated the patient had two ultrasounds (one on 12/17/22 and one on 12/21/22), and the cervix went from closed to 4 cm. When asked if there was any hope of the patient carrying the fetus to viability, she stated "there is always hope, always a chance, but because cervix was dilated the chance of going to viability is very low." She said the patient wanted the expected management care because this was a highly desired pregnancy based on IVF and previous pregnancy losses. Physician A said the patient stated she wanted a chance to carry the baby to viability. Physician A stated, per the new abortion law, as long as the baby has a heartbeat, the patient is not a candidate for induction. Physician A stated the biggest risk to the patient when the water has broken, and the cervix is dilated is infection because the cervix normally acts as a barrier between the "outside world" and "inside world". If a patient is sent home, they are counseled to check temperature daily for fever, check for changes in vaginal discharge, watch for signs of infection, abdominal pain. In the note it was documented that not much could be done- she explains this is because the baby was previable. There are no active interventions that could be done for the fetus pre-viability, can't make it viable. Before the change in law, the options were termination of pregnancy, could be medically or surgically, vs expectant management. Now if there is a heartbeat they can terminate only if the patient is actively at risk of harm. Physician A stated that, because of the new laws, if a patient's water breaks after 15 weeks, the staff cannot intervene unless there is danger to the patient's health. If the patient is beyond 15 weeks, two doctors have to decide if the baby has a lethal fetal anomaly or if the patient's life is in imminent danger. She stated there is a risk of infection or bleeding when the patient miscarries. In a worse case, it could lead to hemorrhage, death, or bacteremia.

5. An interview was conducted with Physician C (OB/GYN 3rd year resident physician) and Physician L (Associate Director for OB/GYN Residency Program) together on 5/04/23 at 1620. The physicians reviewed Patient #1's chart during the interview. Physician C recalled that she discharged the patient from her first admission, and she said the patient was aware of the prognosis and understood that the prognosis for her fetus was not good. Physician C said the patient understood the plan was expectant management and does not remember the patient wanting to do anything different, but they wouldn't have had any alternatives to offer the patient. Not many treatment options were available. The ultrasound that was done showed no amniotic fluid. Physician L said he was not at the hospital on that day but if he had been, he would have advised Patient #1 that with no fluid at 19 weeks, the chance of survival to make it to 24 weeks was beyond poor, that this was a critical stage for lung development, and you need some fluid to help lung development but had zero. Physician L said they could not offer anything else other than termination. He explained that the risk of continuing the pregnancy is that the baby's chance of survival was very low, but the risk of infection to mom was high. Physician L stated the best thing for the patient if she wanted to continue the pregnancy would be to return to the hospital when she was 23 weeks along for steroid treatment to help the baby's prognosis. However, if she had wanted to terminate the pregnancy, that option would be difficult as the 15-week law was already in effect. Physician L stated, there is a hospital policy where two doctors have to certify the patient's life is at risk and then the doctors have to sign the forms prior to termination. Physician L said it is the national standard of care to offer termination in this type of case.

6. A telephone interview was conducted with Patient #1 on 05/04/23 at 1657. She said the hospital told her she was at risk for infection, and they could not help her but that all she could do was go home and watch for signs of infection. Patient #1 said she asked to terminate the pregnancy, but the hospital could not do that because of the new law. She said the hospital admitted her for 23 hours for observation but then they told her they couldn't do anything else until the baby came. She said once her water broke, she knew she was going to lose the baby and that the safest thing for her would have been to terminate so she didn't get an infection. The staff at the hospital told her a termination was not an option. When asked if the staff asked her if she wanted to carry the fetus until possible viability at 22 weeks, she said yes but she feels they were only asking to make her feel better. She said she was already 4 cm dilated and the fetus was already in the birth canal, so she knew since there was no amniotic fluid that there was no hope for the fetus.

7. A review of the facility's Maternal Fetal Medicine on-call schedule dated December 2022 was reviewed. Review revealed Maternal Fetal Medicine Physician J was on-call and available on 12/21/2022 to provide further evaluation and treatment to stabilize Patient #1 and her unborn fetus. The on-call Maternal Fetal Medicine Physician J could have discussed with Patient #1 her options and the likelihood of fetal survival with expectant management verses the risks of maternal sepsis (if sepsis develops either before or after pregnancy, it's called maternal sepsis and can be a life-threatening condition).