HospitalInspections.org

Based on document review, staff and patient interviews, the hospital failed to ensure the Emergency Department (ED) staff followed hospital policy, resulting in 1 of 20 sampled patients (Patient #9) not receiving an appropriate medical screening exam (MSE) or stabilizing treatment on April 8, 2024, and not being transferred appropriately after presenting to the ED requesting medical care on April 9, 2024.

Failure to provide an appropriate MSE, stabilizing treatment, and an appropriate transfer to patients with an emergency medical condition has the potential to result in deterioration of the patient's health or bodily functions (including, but not limited to, risk of dehydration, organ failure, infection, sepsis, severe bleeding, premature labor, risk of future infertility, poor fetal outcomes, and death).

(Cross refer A2406, A2407, and A2409.)

Based on medical record review, policy review, staff and patient interviews, the hospital failed to provide 1 of 20 patients (Patient #9) selected for review an appropriate medical screening examination (MSE) that made use of the hospital's capabilities (including the ancillary services routinely available to the emergency department) to determine whether an emergency medical condition (EMC) existed. The facility did not screen Patient #9 in accordance with its own policies, including for risks known to hospital physicians and staff associated with her presenting signs and symptoms, including those which would independently constitute an EMC, such as, but not limited to, developing intrauterine infection, preterm labor, or preterm premature rupture of membranes (PPROM). The MSE provided to Patient #9 was both inappropriate on its face and disparate from the MSE provided to two similarly situated patients identified upon record review.

Failure to provide an appropriate MSE placed patients at risk for an undiagnosed emergency medical condition (EMC), which has the potential to result in deterioration of the patient's health or bodily functions (including, but not limited to, risk of dehydration, organ failure, infection, sepsis, severe bleeding, premature labor, risk of future infertility, poor fetal outcomes, and death).

Findings include:

1. Review of Trinity Muscatine's ("TM's") Scope of Services revealed they offer emergency services, surgical services, and medical/surgical care. Ultrasound was available Monday through Friday 8am-4pm. Review of the on-call schedule for the past 6 months (November 2023 to May 2024) revealed the hospital does not have OB/GYN specialists on-call.

2. Review of the hospital's "Transfer and Emegency Examination-EMTALA Policy Number: 50000.278 (100)" revealed "individuals who present to the emergency department shall receive a medical screening examination within the capabilities of the Trinity Medical Center hospital (including ancillary services routinely available to the TMC hospital or TM's Emergency Department) to determine whether or not an emergency medical condition exists. The medical screening examination will occur in the Emergency Department, however: ... 2. Muscatine - pregnant women reporting contractions or having complications with pregnancy will be transferred to the maternity center at a TMC hospital (Trinity - Bettendorf or Trinity - Moline), or the patient's hospital of choice for examination as appropriate." The policy further required that individuals "shall be examined according to Emergency Department protocol and procedures" as part of an appropriate medical screening examination.

3. Information about the hospital's available ultrasound capabilities was inconsistent. Review of the hospital's "Ultrasound Emergency & After Hours On-Call Policy #: 22200.127 (729)" with scope including "Campus: ...Muscatine" revealed that emergency ultrasound capabilities include "OB>14wks-Evaluation of a pregnant patient greater than 14 weeks with pain or vaginal bleeding, or when abruption, hematoma, placenta previa or fetal demise is suspected." Capabilities also include, among other, "Suspected gall bladder disease if septic and unstable or there is other sign of medical instability and the patient is a candidate for emergency surgery." However, Executive Director, Staff L later provided an email to surveyors on June 4, 2024, describing, "The US [ultrasound] policy actually doesn't apply for the Muscatine campus as we do not have an on call ultrasound team available."

4. Review of Patient #9's medical record, dated April 8, 2024, revealed the following:

a. On 4/8/24 at 3:36 PM, ED RN J documented that Patient #9 presented to the hospital ED complaining of abdominal pain and vomiting and was 18 weeks pregnant. RN J documented that Patient #9 denied vaginal discharge or bleeding upon arrival and documented Patient #9's pain score was "9" (using a scale of 0 to 10, with 10 reported as the most severe pain) in the "lower" abdomen.

b. In the "ED Provider Note" filed on 4/8/24 at 6:27 PM, Physician D (ED Physician) documented "The patient states that she has had abdominal pain and vomiting for the past 2 days. She states that her abdominal pain is in both the lower abdomen and the right upper quadrant and epigastric regions. She states the pain under her rib cage is worsened today to the point that it was hard to walk, so she came in for further evaluation." Physician D documented Patient #9's "Physical Exam" to include "She is in acute distress." and "There is abdominal tenderness in the right upper quadrant, epigastric area and suprapubic area" and that the patient's abdomen was "Gravid" (visibly pregnant).

c. At 3:45 PM, RN J documented Patient #9's heart rate was elevated, 115 beats per minute (60-100 beats per minute is the normal adult resting heart rate range). The medical record did not include documentation of any further ongoing monitoring of patient # 9's heart rate or other vital signs, or evaluation of the fetal heart rate.

d. The medical record "ED Care Timeline" showed at 4:16 PM Staff F, a Registered Diagnostic Medical Sonographer, performed ultrasound imaging of Patient #9's abdomen ("ultrasound abdomen limited") with "reason for exam: pain." Review of the radiology report showed the ultrasound findings were limited to the right upper quadrant of the patient's abdomen which included the pancreas, inferior vena cava (large vein that brings oxygen-poor blood from lower body to the heart), aorta (large artery), liver, gallbladder, and right kidney. The interpretation by Physician Q (radiologist) at 4:52 PM was, "Impression: No findings to explain patient's symptoms."

e. At 6:27 PM under "Medical Decision Making," Physician D documented, "Vital signs were assessed and patient was noted to be tachycardic with a heart rate of 115. On physical exam, the patient had epigastric, right upper quadrant, and suprapubic tenderness ...Labs were remarkable for elevated white blood cell [WBC] count of 17.6 [commonly associated with infection or inflammation, normal range at this hospital reported as 4.00 to 11.0]. Right upper quadrant ultrasound was done and demonstrated no evidence of cholecystitis [gallbladder infection]. UA [urinalysis] demonstrated no sign of UTI [urinary tract infection] ...I instructed her to follow-up with her OB." Physician D documented Patient #9's "Final diagnoses: Abdominal pain during pregnancy in second trimester; Nausea and vomiting, unspecified vomiting type ...Plan Disposition: Discharge."

f. At 6:33 PM, RN J documented Patient #9 described her pain level as "5 (Moderate Pain)" and discharged Patient #9 from the ED at 6:34 PM. The patient's vital signs noted on the Discharge Instructions "After Visit Summary" recorded the patient's heart rate as 115 beats per minute.

5. During an interview on 5/30/24 at 11:30 AM, ED RN J was asked whether routine screening practice would include evaluation of fetal heart tones in the setting of abdominal pain at 18 weeks pregnancy. She replied, "Yes, it is not required before 20 weeks. It is part of my nursing judgment. But the doctor can put in an order for it. If I have other critical patients, it's possible that I didn't do it on my own."

6. During an interview on 5/30/2024 at 12:00 PM ED RN K was asked when it was routine screening practice to evaluate fetal heart tones. She replied, "If the patient is over 12 weeks pregnant."

7. During an interview on 5/29/24 at 7:05 PM, ED RN C was asked how often it was expected to check vital signs on "an OB patient [who] came in for abdominal pain, nausea, vomiting." She relied "I would every 30 minutes." When asked, "Would you check vitals before discharging a patient," she replied, "Yes."

8. During an interview on 5/29/24 at 7:30 PM, Physician D recalled an 18 week pregnant patient presented with abdominal pain and vomiting for two days and reported evaluating Patient #9 on 4/8/24. When asked about assessing fetal heart tones as part of routine screening of patients in the second trimester of pregnancy, Physician D stated "Typically the nurses will attempt to do that." Physician D described the process for assessing an obstetrical patient as "stable" to include "normal vital signs, hemoglobin; we do a cervical exam to check in labor. I would use a speculum to see if there is blood loss." When asked, "Would you expect the nurse to evaluate pain and check vitals before discharge," Physician D said, "Yes, I usually talk to them and reassess ..." When asked, "Is elevated WBC expected in pregnancy," Physician D replied, "I don't think so; I was worried about infection."

9. During a follow up interview on 6/3/24 at 5:00 PM, Physician D indicated an OB patient would need to be transferred if "we don't have the services needed." Physician D indicated if the pregnancy was less than 20 weeks gestation, "then we focus on the mom; there is nothing to do to save the baby at that point." When asked about obstetrical ultrasound availability, Physician D said, "We only have ultrasound available during the day time. I put in the order, and they will come do it." Physician D was asked to describe the hospital's "routine general process to evaluate for PPROM" (preterm premature rupture of membranes) and replied, "If the patient complains of abdominal pain or leakage of fluid, I would do a speculum exam ...If I really think they need one, I'll transfer, unless it is life-threatening to the mom. ... The OB's would rather us just transfer if there is a chance for PPROM because you risk introducing bacteria into the uterus." Physician D indicated that the hospital's usual process to screen for PPROM involved evaluation of the cervix, often Amnisure testing (biochemical testing for amniotic fluid), and communication with OB/GYN physicians at a different facility to consider transfer.

10. During an interview on 5/30/24 at 8:00 AM, Staff F, Registered Diagnostic Medical Sonographer (RDMS), confirmed she performed an ultrasound on Patient # 9 on 4/8/24 and that the ultrasound was limited to "Liver, bladder, pancreas, common bile duct and right kidney, and the proximal aorta and inferior vena cava." Staff F said, "We cannot look at baby [during the ultrasound] unless we are told to look at baby." Staff F confirmed that she performs "a lot" of obstetrical ultrasounds and can perform exams ordered by the ED.

11. During an interview on 5/29/24 at 4:15 PM, Patient #9 confirmed that her visit to the hospital ED on 4/8/24 did not appear to include evaluation of her fetus or uterus. Patient #9 said, "They had the ultrasound tech look at my gallbladder, but they didn't look at the baby. They didn't say why they didn't look at the baby. It was the end of the day, and the ultrasound tech was getting ready to leave." Patient # 9 recalled, "I'm not a complainer, but I was in so much pain ...They brought in discharge papers for me to sign and all of them rushed out. My partner caught the last one and asked if there was anything else I could have for pain and the nurse said no because you are pregnant. Maybe try Tylenol. They never asked me to rate my pain."

12. Review of medical records for two similarly situated patients (Patients #5 and 6) revealed, in part:

a. Patient #5 presented to the hospital emergency department on January 20, 2024, at 11:50 AM, 23 weeks pregnant with abdominal pain in "the periumbilical region" (in the area of the belly button). She had a normal heart rate, and her appearance included that, "She is not in acute distress." She underwent physical examination of her cervix, and fetal heart tones were measured. Patient #5 was transferred to another facility for "obstetrical evaluation to rule out preterm labor."

b. Patient #6 presented to the hospital emergency department on May 25, 2024, at 8:31 PM, 20 weeks pregnant with upper and lower abdominal pain and vomiting. Her heart rate was 105; her pain score was "8," white blood cell count elevated at 13.74, and her physical exam described her as "in acute distress." She underwent physical examination of her cervix, and fetal heart tones were measured. Patient #6 was transferred to another facility for "further obstetrical care."

13. The medical record lacked evidence the hospital provided Patient #9 an appropriate medical screening examination that made use of the hospital's capabilities (including the ancillary services routinely available to the emergency department) to determine whether an emergency medical condition (EMC) existed. Despite the hospital's ultrasound policy describing availability of ultrasound for "evaluation of a pregnant patient greater than 14 weeks with pain" and interviews with hospital physicians that described a routine practice of obstetrical ultrasound being available as part of the MSE for this indication, the medical record did not contain evidence that such screening was offered or performed as part of Patient #9's MSE. Despite hospital policy that patients "shall be examined according to Emergency Department protocol and procedures" and interviews with hospital physicians that described the hospital's routine procedures as making use of available diagnostic testing to screen for rupture of membranes in second trimester pregnant patients with abdominal pain (such as, but not limited to, sterile speculum examination, evaluation of cervical dilation, pH testing, microscopic examination, Amnisure testing [biochemical testing for amniotic fluid], evaluation of fetal heart tones, and/or ultrasonography) and monitoring/re-evaluation (including to determine whether her abdominal pain was a manifestation of preterm labor), the medical record did not contain evidence that such screening was offered or performed as part of Patient #9's MSE. Despite interviews that described re-evaluation of vital signs as routinely required prior to discharge, the medical record also did not contain evidence that Patient #9's tachycardia was re-evaluated during her visit on April 8, 2024. The failure to include these measures as part of the MSE meant that the facility did not screen Patient #9 in accordance with its own policies, including for risks known to hospital physicians and staff associated with her presenting signs and symptoms, including those which would independently constitute an EMC, such as, but not limited to, developing intrauterine infection, preterm labor, or preterm premature rupture of membranes (PPROM). The MSE provided to Patient #9 was both inappropriate on its face and disparate from the MSE provided to two similarly situated patients identified upon record review.

(Cross refer A2400, A2407, and A2409.)

Based on medical record review, policy review, and staff and patient interviews, the hospital failed to provide 1 of 20 patients (Patient #9) selected for review necessary stabilizing treatment for the emergency medical condition(s) (EMC) it identified prior to discharging her.

Failure to provide appropriate stabilizing treatment, placed patients at risk for deterioration of their health or bodily functions (including, but not limited to, risk of dehydration, organ failure, infection, sepsis, severe bleeding, premature labor, risk of future infertility, poor fetal outcomes, and death).

Findings include:

1. Review of Trinity Muscatine's ("TM's") Scope of Services revealed they offer emergency services, surgical services, and medical/surgical care. Ultrasound was available Monday through Friday 8am-4pm. Review of the on-call schedule for the past 6 months (November 2023 to May 2024) revealed the hospital does not have OB/GYN specialists on-call.

2.Review of the hospital's "Transfer and Emegency Examination-EMTALA Policy Number: 50000.278 (100)" revealed "individuals who present to the emergency department shall receive a medical screening examination within the capabilities of the Trinity Medical Center hospital (including ancillary services routinely available to the TMC hospital or TM's Emergency Department) to determine whether or not an emergency medical condition exists. The medical screening examination will occur in the Emergency Department, however: ... 2. Muscatine - pregnant women reporting contractions or having complications with pregnancy will be transferred to the maternity center at a TMC hospital (Trinity - Bettendorf or Trinity - Moline), or the patient's hospital of choice for examination as appropriate." The policy further required that individuals "shall be examined according to Emergency Department protocol and procedures" as part of an appropriate medical screening examination.

The policy also required that, "Further steps when emergency medical condition is found: If the individual has an emergency medical condition, further medical examination and treatment within the capabilities of the staff and facilities must be provided as required to stabilize the emergency medical condition, unless the individual or authorized representative refuses further examination and treatment or requests transfer. The hospital personnel providing the medical screening examination will inform the individual ...of the hospital's responsibility to offer and, unless treatment is refused, to provide further examination and treatment as required to stabilize the emergency medical condition."

The policy also described, "F. Discharge: Prior to discharging an individual seeking emergency medical services (except an individual with an unstabilized emergency medical condition being transferred to another medical facility), the examining health care practitioner shall document in the individual's medical record that (i) the individual is not in an emergency medical condition, or (ii) the individual's emergency medical condition is stabilized," and "I. Determination that emergency medical condition does not exist: If the Emergency Department Physician (or Qualified Medical Personnel) determines that the individual is not in an emergency medical condition: 1. Documentation: The Emergency Department Physician (or Qualified Medical Personnel ) shall document the determination that the individual did not come to the hospital in an emergency medical condition in the individual's Transfer Record and/or medical record. 2. Continuity of care/discharge planning: The Emergency Department personnel shall follow appropriate continuity of care or discharge planning protocol for follow-up care for the individual."

3. Review of a hospital document entitled "Standard work: OB Alert," last review date 4/5/2024 included a process diagram beginning with "Patient presents to ED with labor complaints," followed by "Physician completes medical screening exam <5 minutes upon arrival," followed by trifuration into three options: "Precipitous labor," "Urgent Transfer," and "Discharge." The box pertaining to discharge said, "Discharge (Strongly consider OB consult)[;] Have AMA [against medical advice] form signed," and a connected subsequent box said, "Be sure follow-up is established with OB provider."

4. Review of Patient #9's medical record, dated April 8, 2024, revealed the following:

a. On 4/8/24 at 3:36 PM, ED RN J documented that Patient #9 presented to the hospital ED complaining of abdominal pain and vomiting and was 18 weeks pregnant. RN J documented that Patient #9 denied vaginal discharge or bleeding upon arrival and documented Patient #9's pain score was "9" (using a scale of 0 to 10, with 10 reported as the most severe pain) in the "lower" abdomen.

b. In the "ED Provider Note" filed on 4/8/24 at 6:27 PM, Physician D (ED Physician) documented "The patient states that she has had abdominal pain and vomiting for the past 2 days. She states that her abdominal pain is in both the lower abdomen and the right upper quadrant and epigastric regions. She states the pain under her rib cage is worsened today to the point that it was hard to walk, so she came in for further evaluation." Physician D documented Patient #9's "Physical Exam" to include "She is in acute distress." and "There is abdominal tenderness in the right upper quadrant, epigastric area and suprapubic area" and that the patient's abdomen was "Gravid" (visibly pregnant).

c. At 3:45 PM, RN J documented Patient #9's heart rate was elevated, 115 beats per minute (60-100 beats per minute is the normal adult resting heart rate range). The medical record did not include documentation of any further ongoing monitoring of patient # 9's heart rate or other vital signs, or evaluation of the fetal heart rate.

d. The medical record "ED Care Timeline" showed at 4:16 PM Staff F, a Registered Diagnostic Medical Sonographer, performed ultrasound imaging of Patient #9's abdomen ("ultrasound abdomen limited") with "reason for exam: pain." Review of the radiology report showed the ultrasound findings were limited to the right upper quadrant of the patient's abdomen which included the pancreas, inferior vena cava (large vein that brings oxygen-poor blood from lower body to the heart), aorta (large artery), liver, gallbladder, and right kidney. The interpretation by Physician Q (radiologist) at 4:52 PM was, "Impression: No findings to explain patient's symptoms."

e. At 6:27 PM under "Medical Decision Making," Physician D documented, "Vital signs were assessed and patient was noted to be tachycardic with a heart rate of 115. On physical exam, the patient had epigastric, right upper quadrant, and suprapubic tenderness ...Labs were remarkable for elevated white blood cell [WBC] count of 17.6 [commonly associated with infection or inflammation, normal range at this hospital reported as 4.00 to 11.0]. Right upper quadrant ultrasound was done and demonstrated no evidence of cholecystitis [gallbladder infection]. UA [urinalysis] demonstrated no sign of UTI [urinary tract infection] ...I instructed her to follow-up with her OB." Physician D documented Patient #9's "Final diagnoses: Abdominal pain during pregnancy in second trimester; Nausea and vomiting, unspecified vomiting type ...Plan Disposition: Discharge."

f. At 6:33 PM, RN J documented Patient #9 described her pain level as "5 (Moderate Pain)" and discharged Patient #9 from the ED at 6:34 PM. The patient's vital signs noted on the Discharge Instructions "After Visit Summary" recorded the patient's heart rate as 115 beats per minute.

5. Patient #9 ' s medical record did not contain documentation by the examining health care practitioner that she did not have an emergency medical condition or that her emergency medical condition was stabilized. The record also did not contain evidence that Patient #9 refused further examination and/or treatment or that hospital staff informed her of the hospital ' s stabilization obligation, as described by hospital policy. The medical record also did not contain a "Transfer Record" or other form of documentation described in the hospital ' s discharge planning protocol for patients presenting to the ED with labor complaints.

6. During an interview 5/30/24 at 11:30 AM, ED RN J explained that hospital staff have received training that the hospital ' s routine practice is to "urgently transfer" out patients with pregnancy-related EMCs only upon reaching viability, including that "we talk about it and have PowerPoints on it" but that "If less than 20 weeks, it is the doctor ' s discretion." ED RN J also verified that if a patient "needed an OB ultrasound at night," "we would transfer."

7. During an interview on 5/29/24 at 7:05 PM, ED RN C was asked how often it was expected to check vital signs on "an OB patient [who] came in for abdominal pain, nausea, vomiting." She relied "I would every 30 minutes." When asked, "Would you check vitals before discharging a patient," she replied, "Yes."

8. During an interview on 5/29/24 at 7:30 PM, Physician D recalled an 18 week pregnant patient presented with abdominal pain and vomiting for two days and reported evaluating Patient #9 on 4/8/24. Physician D described the process for assessing an obstetrical patient as "stable" to include "normal vital signs, hemoglobin; we do a cervical exam to check in labor. I would use a speculum to see if there is blood loss." When asked, "Is elevated WBC expected in pregnancy," Physician D replied, "I don ' t think so; I was worried about infection."

9. During a follow up interview on 6/3/24 at 5:00 PM, Physician D indicated an OB patient would need to be transferred if "we don ' t have the services needed." Physician D indicated if the pregnancy was less than 20 weeks gestation, "then we focus on the mom; there is nothing to do to save the baby at that point." Physician D was asked to describe the hospital ' s "routine general process to evaluate for PPROM" (preterm premature rupture of membranes) and replied, "If the patient complains of abdominal pain or leakage of fluid, I would do a speculum exam ...If I really think they need one, I ' ll transfer, unless it is life-threatening to the mom. ... The OBs would rather us just transfer if there is a chance for PPROM because you risk introducing bacteria into the uterus." Physician D indicated that the hospital ' s usual process to screen for PPROM involved evaluation of the cervix, often Amnisure testing (biochemical testing for amniotic fluid), and communication with OB/GYN physicians at a different facility to consider transfer. Physician D used the term "life threatening" to characterize some of complications of second trimester pregnancy including that, "Any kind of bleeding is life-threatening for mom."

10. During an interview on 5/29/24 at 4:15 PM, Patient #9 stated that hospital staff did not explain the risks of leaving the hospital or offer to transfer her to another facility during her first visit and that her condition upon being discharged from the ED "was not great; my pain wasn ' t relieved. I was trusting that the doctor told me I was ok. Patient #9 recalled, "I ' m not a complainer, but I was in so much pain ...They brought in discharge papers for me to sign and all of them rushed out. My partner caught the last one and asked if there was anything else I could have for pain and the nurse said no because you are pregnant. Maybe try Tylenol. They never asked me to rate my pain."

11. Despite the inappropriate MSE during her visit on April 8, 2024, the hospital determined that Patient #9 had one or more emergency medical conditions and failed to provide necessary stabilizing treatment during her visit on April 8, 2024, prior to discharging her. The medical record and interviews reflected that the hospital had knowledge of Patient #9 ' s severe upper and lower abdominal pain, abnormal vital signs, abnormal laboratory values, and absence of ultrasound "findings to explain patient's symptoms" at the time of discharge, and interviews support that staff and physicians understood the risks of such a medical condition to include serious jeopardy to health, serious impairment to bodily functions, and/or serious dysfunction of any bodily organ or part. The medical record did not reflect that the hospital provided such medical treatment of Patient #9 ' s condition necessary to assure, within reasonable medical probability, that no material deterioration of the condition was likely to result from her discharge (including treatment of pain, evaluation of the specific source of the patient ' s pain, vomiting, and acute distress sufficient to exclude intrauterine infection, preterm labor, or preterm premature rupture of membranes, or monitoring/re-evaluation of the patient ' s rapid heart rate and abnormal white blood cell count). Additionally, despite hospital policy that "prior to discharging an individual seeking emergency medical services, ...the examining health care practitioner shall document in the individual ' s medical record that ...the individual is not in an emergency medical condition," no such documentation appeared in Patient #9 ' s medical record.

(Cross refer A2400, A2406, and A2409.)

Based on medical record review, policy review, and staff and patient interviews, the hospital failed to arrange an appropriate transfer to a hospital with the appropriate capabilities and capacity for 1 of 20 emergency patients (Patient #9, during her second visit to the hospital) selected for review.

Failure to provide an appropriate transfer to a hospital with OB/GYN capabilities and capacity placed Patient #9 at risk for deterioration of her emergency medical condition (EMC), including deterioration of the patient ' s health or bodily functions (including, but not limited to, risk of dehydration, organ failure, infection, sepsis, severe bleeding, premature labor, risk of future infertility, poor fetal outcomes, and death).

Findings include:

1. Review of Trinity Muscatine's ("TM's") Scope of Services revealed they offer emergency services, surgical services, and medical/surgical care. Ultrasound was available Monday through Friday 8am-4pm. Review of the on-call schedule for the past 6 months (November 2023 to May 2024) revealed the hospital does not have OB/GYN specialists on-call.

2. Review of the hospital's "Transfer and Emegency Examination-EMTALA Policy Number: 50000.278 (100)" revealed "individuals who present to the emergency department shall receive a medical screening examination within the capabilities of the Trinity Medical Center hospital (including ancillary services routinely available to the TMC hospital or TM's Emergency Department) to determine whether or not an emergency medical condition exists. The medical screening examination will occur in the Emergency Department, however: ... 2. Muscatine - pregnant women reporting contractions or having complications with pregnancy will be transferred to the maternity center at a TMC hospital (Trinity - Bettendorf or Trinity - Moline), or the patient's hospital of choice for examination as appropriate." The policy further required that individuals "shall be examined according to Emergency Department protocol and procedures" as part of an appropriate medical screening examination.

The policy also required that, "Further steps when emergency medical condition is found: If the individual has an emergency medical condition, further medical examination and treatment within the capabilities of the staff and facilities must be provided as required to stabilize the emergency medical condition, unless the individual or authorized representative refuses further examination and treatment or requests transfer. The hospital personnel providing the medical screening examination will inform the individual ...of the hospital's responsibility to offer and, unless treatment is refused, to provide further examination and treatment as required to stabilize the emergency medical condition."

The policy also described, "F. Discharge: Prior to discharging an individual seeking emergency medical services (except an individual with an unstabilized emergency medical condition being transferred to another medical facility), the examining health care practitioner shall document in the individual's medical record that (i) the individual is not in an emergency medical condition, or (ii) the individual's emergency medical condition is stabilized," and "I. Determination that emergency medical condition does not exist: If the Emergency Department Physician (or Qualified Medical Personnel) determines that the individual is not in an emergency medical condition: 1. Documentation: The Emergency Department Physician (or Qualified Medical Personnel ) shall document the determination that the individual did not come to the hospital in an emergency medical condition in the individual's Transfer Record and/or medical record. 2. Continuity of care/discharge planning: The Emergency Department personnel shall follow appropriate continuity of care or discharge planning protocol for follow-up care for the individual."

3. Review of a hospital document entitled "Standard work: OB Alert," last review date 4/5/2024 included a process diagram beginning with "Patient presents to ED with labor complaints," followed by "Physician completes medical screening exam <5 minutes upon arrival," followed by trifuration into three options: "Precipitous labor," "Urgent Transfer," and "Discharge." The box pertaining to discharge said, "Discharge (Strongly consider OB consult)[;] Have AMA [against medical advice] form signed," and a connected subsequent box said, "Be sure follow-up is established with OB provider."

4. Review of Patient #9 ' s medical record, dated April 9, 2024, revealed the following:

a. Patient # 9 presented to the hospital ED on 4/9/24 at 2:12 AM, approximately 7 ½ hours after her prior discharge, complaining of "Pregnant 18 wks [weeks], spotting [light vaginal bleeding], vomiting."

b. The "ED Provider Note" documented by ED Physician B described "She is currently 18 weeks pregnant[;] she just moved here from a town 3 hours away and has no local OB/GYN yet" and described that Patient #9 was experiencing "generalized abdominal pain and some spotting." Physician B documented Patient #9 ' s "Physical Exam" to include "There is abdominal tenderness" and "I did do an external exam and tested for rupture of membranes with AmniSure test [which] is currently pending[;] internal exam was deferred at this time." Under "Medical Decision Making," Physician B documented, "Patient came in with concerns for rupture of membranes and vaginal bleeding. Her AmniSure was negative. However, pelvic exam was done with [RN C] at the bedside and there was fairly large amount of yellowish almost mucousy fluid in the vagina unable to tell if was coming from the cervix or not. This was discussed with OB/GYN who felt she should be evaluated. However, patient will go home and rest for little while and go up to the OB triage area in Bettendorf later in the morning when ultrasound is available and she will be evaluated at that time." Her "Plan" was documented as "Disposition: Discharge."

5. Patient #9 ' s medical record did not contain documentation by the examining health care practitioner that she did not have an emergency medical condition or that her emergency medical condition was stabilized. The record also did not contain evidence that Patient #9 refused further examination, treatment, and/or transfer or that hospital staff informed her of the hospital ' s stabilization obligation, as described by hospital policy. The medical record also did not contain a "Transfer Record" or other form of documentation described in the hospital ' s discharge planning protocol for patients presenting to the ED with labor complaints. There was not documentation that Patient #9 signed an "against medical advice" form referred to in the hospital ' s standard work document. The medical record also did not contain a physician certification that, based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual or, in the case of a woman in labor, to the woman or the unborn child, from being transferred.

6. During an interview 5/30/24 at 11:30 AM, ED RN J explained that hospital staff have received training that the hospital ' s routine practice is to "urgently transfer" out patients with pregnancy-related EMCs only upon reaching viability, including that "we talk about it and have PowerPoints on it" but that "If less than 20 weeks, it is the doctor ' s discretion."

7. During an interview on 5/29/24 at 6:14 PM, Physician B stated that he recalled Patient #9. "I remember her very well. She came in 18 weeks pregnant and was seen earlier that shift or that day. She was in pain, but after she was evaluated, felt stable and was discharged. She still had some abdominal discomfort but had concern for some bleeding or a gush of fluid. She thought her membranes had ruptured but wasn ' t sure. I did a pelvic exam and actually performed an US on her too, but apparently I didn ' t document the US. She did have amniotic fluid and fetal heart tones of the baby. I contacted the OB in [city of Hospital B] and told her my findings and what my concerns were, and we both agreed that she should go up to get checked because we didn ' t have ultrasound capabilities there. They could fully evaluate her and get the expert involved to see if she truly did rupture or not rupture. I talked with the patient about going there in the middle of the night versus in the morning. I told her that there was nothing we could do if she ruptured, and that was it. She would miscarry. There ' s nothing we could do to save the baby at all. Period."

Physician B described that the decision to transfer a patient with an obstetrical emergency medical condition or potential emergency medical condition "depends how far along they are, what we believe is going on, and if they ' re stable or unstable. We ' d look at vitals and if they ' re bleeding. We do sometimes send patients home that are miscarrying. We may talk to OB and try to transfer them, but they may say yes or no." Physician B described the transfer considerations in preterm premature rupture of membranes (PPROM) by saying, "Essentially, we evaluate this with an AmniSure. If it was positive, we would talk to OB and work on the transfer. If it ' s negative, we do a pelvic exam to check for fluid and call OB to inform them ... I probably wouldn ' t do a pelvic if it was positive and I plan on transferring. We don ' t want to introduce infection. If it ' s negative, I would do a pelvic exam to visualize." Physician B clarified that his understanding of the sensitivity and specificity of molecular testing, such as AmniSure, for PPROM was that the test "is not great. There are false negatives and false positives."

When asked "Do you recall specifically asking [Patient #9] if she wanted to be transferred there," Physician B replied, "I didn ' t ask her. I just presented the options. We could do either or. We talked about it, and I told her there ' s nothing we could do. She could go up there and just sit idle for hours waiting or she can wait at home. She seemed like she understood that there was nothing we could do either way so my impression was that she preferred to wait at home and maybe get some sleep." Physician B continued, "I was concerned her baby was dying. I don ' t remember my exact verbiage. I was trying to tell her I was strongly concerned about the baby. I can neither confirm or deny that a miscarriage was happening. We can get you up there or you can go home and rest but I ' m not super optimistic that everything is okay ...I was very concerned that she was miscarrying the fetus."

8. During an interview on 5/29/24 at 4:15 PM, Patient #9 described her decision to return to the ED after being discharged on April 8, 2024: "When I got home, I tried to lay down and rest, and I was still uncomfortable. I was thinking they told me nothing was wrong. I woke up at 1:30 AM with worse pain, still vomiting. I was spotting, and fluid was leaking. I couldn ' t walk, so my partner pushed me in the wheelchair. The night crew was more thorough and more concerned. They said my urine was drastically different than earlier in the day. They did a test to check the amniotic fluid, and it was negative. I asked why some fluid was leaking, and they said sometimes when you are pregnant the pressure pushes on your bladder, and urine can leak out. He wasn ' t offering to transfer me. He did call [city of Hospital B], and they said OB wouldn ' t be available until the morning so I would just be laying there until 9 am so they asked for me to come around 9 am. The doctor said I could go home and be comfortable until we could drive to [name of hospital B] in the morning." Patient #9 described that hospital staff did not explain the risks of leaving the hospital, and "I didn ' t know I could have asked to be transferred." She recalled, "was especially in lots of pain the second time I left."

9. Review of medical records for two similarly situated patients (Patients #5 and 6) revealed, in part:

a. Patient #5 presented to the hospital emergency department on January 20, 2024 at 11:50 AM, 23 weeks pregnant with abdominal pain in "the periumbilical region" (in the area of the belly button). She had a normal heart rate, and her appearance included that, "She is not in acute distress." She underwent physical examination of her cervix, and fetal heart tones were measured. Patient #5 was transferred to another facility for "obstetrical evaluation to rule out preterm labor."

b. Patient #6 presented to the hospital emergency department on May 25, 2024 at 8:31 PM, 20 weeks pregnant with upper and lower abdominal pain and vomiting. Her heart rate was 105; her pain score was "8," white blood cell count elevated at 13.74, and her physical exam described her as "in acute distress." She underwent physical examination of her cervix, and fetal heart tones were measured. Patient #6 was transferred to another facility for "further obstetrical care."

10. While Patient #9 ' s medical record reflected that the hospital intended to move Patient #9 (including by discharge) to Hospital B at the direction of any person employed by (or affiliated or associated, directly or indirectly, with) the hospital, the medical record did not contain evidence that the hospital transferred her in accordance with hospital policy and the requirements of an appropriate transfer.

11. Medical records from Hospital B reflected that Patient #9 presented there on April 9, 2024 at 9:41 AM in "active labor" with previable PPROM and fetal heart tones still present upon arrival and later delivered a demised female fetus.