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Based on a review of medical records, hospital policies, Medical Staff Rules and Regulations, OB/GYN Physician on-call schedules, and interviews, it was determined that Hospital #1 failed to ensure that Patient #1 (one of 17 sampled patients with pregnancy related conditions who presented at the hospital's emergency department) received an appropriate medical screening examination (MSE) that made use of the hospital's capabilities (including but not limited to the ancillary services of the on-call OB/GYN physician routinely available to the emergency department) to determine whether an emergency medical condition (EMC) existed. The hospital's failure to provide an appropriate medical screening examination, within the capability of the hospital's emergency department, placed the patient at risk for deterioration of her health and wellbeing as a result of an untreated emergency medical condition(s).

The findings included:

On December 4, 2022, Patient #1 presented to the hospital emergency department 19-weeks pregnant with a complaint of "watery" vaginal discharge and lower abdominal pain. Ultrasound showed a live intrauterine pregnancy. Despite hospital policy requiring that for pregnant patients seeking emergency care, "the medical records should show evidence that the screening examination includes, at a minimum, on-going evaluation of fetal heart tones, regularity and duration of uterine contractions, fetal position and station, cervical dilation, and status of membranes (i.e. ruptured, leaking and intact), to document whether or not the woman is in labor," only fetal heart tones were assessed and documented. There was no documentation to support that Patient #1 was evaluated for contractions, fetal position and station (location within the pelvis), cervical dilation, status of membranes, or preterm labor. Hospital policy further required that "the evaluation of rupture of membranes should be made using Amnisure test when patients report signs, symptoms, or complaints suggestive of rupture of membranes," but no such testing was performed or offered, despite Patient #1's reported symptoms and complaints of "watery" discharge and lower abdominal pain. The hospital's Medical Staff Rules and Regulations require that on-call physicians "help stabilize and/or evaluate" emergency department patients upon request, and the hospital's on-call schedule revealed that there was an on-call OB/GYN physician available when Patient #1 presented. However, the on-call OB/GYN physician did not participate in the evaluation or management of Patient #1 as part of her medical screening examination. The hospital's failure to provide an appropriate medical screening examination, within the capability of the hospital's emergency department and in accordance with hospital policies, placed the patient at risk for deterioration of her health and wellbeing as a result of an untreated emergency medical condition(s).

Cross Refer to 2406.

Based on a review of medical records, hospital policies, Medical Staff Rules and Regulations, OB/GYN Physician on-call schedules, and interviews, it was determined that Hospital #1 failed to ensure that Patient #1 (one of 17 sampled patients with pregnancy related conditions who presented at the hospital's emergency department) received an appropriate medical screening examination (MSE) that made use of the hospital's capabilities (including but not limited to the ancillary services of the on-call OB/GYN physician routinely available to the emergency department) to determine whether an emergency medical condition (EMC) existed. Specifically, the hospital failed to follow its own policies that described required elements of an appropriate MSE for pregnant patients and failed to make use of its on-call OB/GYN physician, who was available when Patient #1 presented. Consequently, Patient #1 was not provided an MSE appropriate to assess for preterm premature rupture of membranes (also known as PPROM) and/or preterm labor by making use of available diagnostic testing (such as, but not limited to, pH testing, microscopic examination, Amnisure testing [biochemical testing of the leaking fluid], and/or consultative ultrasonography to assess for oligohydramnios). PPROM is a pregnancy complication in which the amniotic membrane surrounding the fetus ruptures before week thirty-seven of pregnancy. PPROM carries the risk of infection, sepsis, severe bleeding, premature labor, and risk of future infertility, among other complications. Oligohydramnios is an amniotic fluid disorder resulting in decreased amniotic fluid volume for gestational age. Low amniotic fluid volumes can be the result of numerous maternal, fetal, or placental complications and can lead to poor fetal outcomes, including death.

The findings included:

1. Review of Hospital #1's Medical Staff Rules and Regulations, approved July 2019, revealed, "... Emergency Services [:] a. Emergency Screening, Stabilization, and Transfer: Medical screening as defined by EMTALA will be provided to all patients presenting for emergency care in accordance with present federal, state, and local law and facility policy and procedure. A physician or designated qualified medical personnel with the appropriate approval by the Board of Trustees will provide this medical screen ...o. Emergency Department On-Call Requirements: It is the responsibility of the medical staff to support the patient care mission of the Hospital by providing treatment for patients presenting to the facility seeking emergency medical care, regardless of the patient's ability to pay for such services ...Every member of the medical staff in the 'Active' category ...shall be expected to participate in the Hospital's on-call system and respond promptly ...when called to render clinical services within their specialization. This includes coming to the Hospital upon the request of the Emergency Department physician to help stabilize and/or evaluate the patient for needed care and/or for transfer to another facility where appropriate care may be given."

2. Review of Hospital #1's "TN [Tennessee] EMTALA, Medical Screening Examination and Stabilization" policy, last revised June 2020, revealed, "1. When an MSE is Required[:] A hospital must provide an appropriate MSE within the capability of the hospital's emergency department, including ancillary services routinely available to the DED, to determine whether or not an EMC exists: (i) to any individual, including a pregnant woman having contractions, who requests such an examination; (ii) an individual who has such a request made on his or her behalf; or (iii) an individual whom a prudent layperson observer would conclude from the individual's appearance or behavior needs an MSE. An MSE shall be provided to determine whether or not the individual is experiencing an EMC or a pregnant woman is in labor . . . 3. Extent of the MSE [:] a. Determine if an EMC exists. The hospital must perform an MSE to determine if an EMC exists ... b. Definition of MSE. An MSE is the process required to reach, with reasonable clinical confidence, the point at which it can be determined whether the individual has an EMC or not. It is not an isolated event. The MSE must be appropriate to the individual's presenting signs and symptoms and the capability and capacity of the hospital... e. Extent of MSE varies by presenting symptoms [:] i. Depending on the individual's presenting symptoms, an appropriate MSE can involve a wide spectrum of actions, ranging from a simple process involving only a brief history and physical examination to a complex process that also involves performing ancillary studies and procedures. ii. Pregnant Women: The medical records should show evidence that the screening examination includes, at a minimum, on-going evaluation of fetal heart tones, regularity and duration of uterine contractions, fetal position and station, cervical dilation, and status of membranes (i.e. ruptured, leaking and intact), to document whether or not the woman is in labor."

3. Review of Hospital #1's "Amnisure" policy, last approved September 2021, revealed, "A. Purpose [:] To obtain a timely and accurate diagnosis of ruptured fetal membranes. B. Policy 1. The evaluation of rupture of membranes should be made using Amnisure test when patients report signs, symptoms, or complaints suggestive of rupture of membranes. 2. Amnisure test must be ordered by a physician..." The Amnisure policy does not limit testing to patients of any specific gestational age.

4. Medical record review revealed that on December 4, 2022, at 1944 hours, Patient #1 presented to Hospital #1 with a 19-week pregnancy seeking examination and treatment for vaginal discharge and lower abdominal pain. Although some details of the hospital's records are internally inconsistent, the majority of records clearly indicate that Patient #1's chief complaint was yellow, watery vaginal discharge over a period of one week. A hospital record labeled "Rapid Initial Assessment" and created by Triage Registered Nurse documented that Patient #1 presented to the emergency department (ED) with a stated complaint of " ...pregnant with watery continuous vaginal d/c [discharge] x [times] 1 wk [week] with thick yellow d/c [discharge] intermittently. Also now having lower ABD [abdominal] pain intermittently ..." Documentation by ED Physician #1 also corroborated Patient #1's complaint was "vaginal discharge that is yellow, watery over the past week." A subsequent "Assessment" by Registered Nurse #1 documented that Patient #1's vaginal discharge was "pink-tinged" and "light" in amount and began "12-24 hours ago." (This latter documentation appeared to contradict the description of Patient #1's complaint in multiple other locations in the medical record.) The fetal heart rate was recorded as 143.

5. A hospital record labeled "Emergency Provider Report", dated December 4, 2022, at 2002 hours completed by ED Physician #1, documented "20 Year old female ...presenting with vaginal discharge that is yellow, watery over the past week ...Denies any current vaginal bleeding." Patient #1's physical examination included: "Genitourinary: Vaginal discharge ...Abdomen/GI: Atraumatic, Soft, Non-tender ...Genitourinary: Vaginal Bleeding/Discharge: Discharge thick, Discharge yellow." The medical record did not contain evidence that the screening examination included evaluation for contractions, fetal position and station (location within the pelvis), cervical dilation, status of membranes, or preterm labor. There also was no documentation that ED Physician #1 assessed for preterm premature rupture of membranes (also known as PPROM) by making use of available diagnostic testing (such as, but not limited to, pH testing, microscopic examination, and/or consultative ultrasonography to assess for oligohydramnios), all of which were routinely available to the emergency department. There was no documentation that ED Physician #1 ordered or performed Amnisure testing (biochemical testing of the leaking fluid), as recommended by hospital policy "to obtain a timely and accurate diagnosis of ruptured fetal membranes," despite Patient #1's reported symptoms and complaints of "watery" discharge and lower abdominal pain, which are commonly associated with PPROM.

6. The hospital's "Gynecology" on-call schedule for December 2022 revealed that on December 4, 2022, there was an on-call OB/GYN physician available when Patient #1 presented to the hospital's ED. According to hospital records, the on-call OB/GYN physician did not participate in the evaluation or management of Patient #1 as part of her medical screening examination.

7. ED Physician #1's "MDM" (medical decision-making) documented in Patient #1's medical record reads, in its entirety, "This is a 20-year-old female presenting with vaginal discharge in wanting a pregnancy check. She is approximately 19 weeks pregnant. Reports yellowish creamy discharge. Denies any STD [sexually transmitted disease] exposure and low suspicion for such. I did a pelvic exam, which shows no cervical motion tenderness or adnexal tenderness, however there is creamy yellow discharge. Wet prep is negative. UA [urinalysis] is positive. I do have concerns for chlamydia and expressed that [to] her privately. We will treat her for gonorrhea, chlamydia, discharge her on oral antibiotics and advised her to check the portal to see if this is positive. Otherwise, may require antibiotic change if this is only UTI [urinary tract infection]. I also performed a bedside transabdominal ultrasound, which shows a live intrauterine pregnancy with a heart rate of 166 and movement of all the extremities."

8. Hospital records documented that Patient #1's sole diagnosis at discharge on December 4, 2022, was "UTI [urinary tract infection]." Hospital instructions provided to Patient #1 were documented as the following: "Your urine appears to be infected." Patient #1 was given a prescription for antibiotics and referred to make an appointment with her OB/GYN.

9. In a telephone interview on December 12, 2023, at 1300 hours, ED Physician #1 reported that if an ED patient presented with OB complaints, they would typically consult with OB/GYN. When asked what was typically done for patients that are less than 20 weeks gestation, ED Physician #1 stated those patients are seen in the ED, and their screening might include a vaginal exam, vaginal swab, urinalysis, STD testing, and sometimes ultrasounds depending on the patient's complaint. ED Physician #1 stated, "Most orders, I send them for a formal ultrasound. If in the early stage, I usually send them for a transvaginal; I don't do those." ED Physician #1 was asked if he performed ultrasounds in the ED, and he stated, "I just do abdominal ultrasound to look for heartbeat and movement. We're not able to document the images...In general, my ultrasounds are limited, an alive fetus is all I can determine...I do them to show them [patient] the baby is moving and has a heart rate; it decreases their stress level when they see an obvious heartbeat." He did not describe evaluation for oligohydramnios as part of his limited bedside ultrasound examination. ED Physician #1 was asked when he would consult the OB/GYN physician on-call. He stated, "It depends on how far along they are and if there were any concerns."

10. In a telephone interview on December 12, 2023, at 1500 hours, Registered Nurse (RN) #1 verified she was the primary nurse for Patient #1 on the December 4, 2022 visit but was unable to recall the patient. The RN was asked what type of services were provided to pregnant patients in the ED. The RN stated vaginal exams are completed on some pregnant patients that present with complaints of vaginal spotting or bleeding with the RN standing by while the physician performs the exam. When asked which patients usually had ultrasounds ordered, RN #1 stated, "We do them on pregnant patients if they say they are hurting." The RN verified the ultrasounds are usually done by ultrasound technicians. RN #1 was asked if she had seen any of the ED Providers perform the ultrasounds in the ED. The RN stated, "I've never seen a physician do an ultrasound in the ED." The RN was asked when OB/GYN physicians were usually consulted. RN #1 stated, "The physicians contact OB/GYN; we tell them what we see, then the provider notifies OB. Nurses don't make the decisions to notify OB."

11. In a telephone interview on December 14, 2023, at 1022 hours, the ED Medical Director (EDMD) verified he had access to Patient #1's medical record. The EDMD was asked if the ED providers ever perform ultrasounds at the bedside. The EDMD stated, "If we [ED providers] pick up an ultrasound probe, we have enough concern and we are already calling the techs [ultrasound technicians]. We don't have the means of keeping our results." The EDMD was asked if ED providers had credentials and training to perform and interpret ultrasounds. The EDMD verified ED Physician #1 was credentialed to perform bedside ultrasounds and also verified the facility had ultrasound technicians available 24 hours a day, 7 days a week.

12. Medical records from Hospital #2 were reviewed for context about Patient #1's subsequent clinical course and revealed Patient #1 was hospitalized on December 15-17, 2022. The Discharge Summary revealed an admitting and discharge diagnosis of Previable Preterm Premature Rupture of Membranes (pPPROM). The summary further specified a "Hospital Course" as follows: "Pt [Patient] presented for routine OB visit and US [ultrasound], reported leaking fluid for a week. She was found to have pooling positive and an AFI [amniotic fluid index] of 3. She was sent to [Hospital #2] for monitoring for possible septic abortion or hemorrhage due to placenta previa."

13. Medical record review from Hospital #3 revealed Patient #1 was subsequently hospitalized from December 20, 2022 through January 17, 2023. According to medical records dated December 20, 2022, Patient #1 presented with the following stated complaint: "[M]y water broke about 2 or 3 [weeks] ago and I need a second [opinion]." Hospital #3 record labeled "History and Physical" dated December 20, 2022, documented, "Two weeks ago, she experienced leaking of clear fluid ...reports she was diagnosed with UTI and told it looked like she had chlamydia ...When she went for her anatomy scan last week, she was found to have very low fluid and admitted to [Hospital #2] for IV fluids for 2 days ...She followed up with an MFM [maternal fetal medicine specialist physician] at that practice today and was told she had no [amniotic] fluid on US [ultrasound] ....This is a desired pregnancy and she wants every effort made to prolong pregnancy." In an addendum to this record, a physician noted, "[Patient #1] here for suspected previable ROM [rupture of membranes] 2-3 weeks ago... It was discussed with patient high likelihood of poor fetal outcomes and pt seems to understand this... Exam notable for vaginal discharge with an odor and a mild leukocytosis. Will monitor closely for infection, and she is certainly at risk." Patient #1 was admitted to Hospital #3 for PPROM. On January 15, 2023, at 0108 hours, Patient #1 underwent surgical cesarean section (C-Section) to deliver a premature male infant at 24 4/7 weeks estimated gestational age. The male infant died approximately one hour after delivery. Discharge records indicate Patient #1 experienced "Pregnancy complicated by prolonged PPROM since 18 weeks, fetal demise 2/2 hypoplastic [underdeveloped] lungs, gHTN [gestational hypertension]."