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3000 CORAL HILLS DR

CORAL SPRINGS, FL 33065

COMPLIANCE WITH 489.24

Tag No.: A2400

Based on a review of medical records, ambulance/fire rescue report, Obstetrical Physician on-call schedules, and interviews, it was determined that the facility failed to ensure that Patient #1 (of 10 sampled patients with pregnancy related conditions) 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 obstetrical physician routinely available to the emergency department) to provide further medical evaluation and treatment as required to stabilize the determined emergency medical conditions for Patient #1. This resulted in Patient #1 experiencing a precipitous out-of-hospital delivery of a non-viable 15-week fetus in a public restroom within hours after being discharged from the Hospital A. Hospital A's failure to provide an appropriate medical screening examination, within the capability of the hospital's emergency department, and to stabilize Patient #1's emergency medical conditions, within the capabilities of the staff and facilities available at the hospital, placed the patient at immediate risk for deterioration of her health and wellbeing as a result of untreated emergency medical conditions.

Refer to A2406 and A2407.

MEDICAL SCREENING EXAM

Tag No.: A2406

Based on a review of hospital records, ambulance/fire rescue report, Obstetrical Physician on-call schedules, and interviews, it was determined that the hospital failed to ensure that Patient #1 (of 10 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 obstetrical physician routinely available to the emergency department) to determine whether an emergency medical condition existed.

On December 14, 2022, Patient #1, presented at the hospital at 15 weeks pregnant "gushing amniotic fluid" and experiencing pelvic cramping and bleeding. The facility failed to provide a sufficient physical examination (such as, but not limited to, an examination for abdominal tenderness, a sterile speculum examination, an evaluation of cervical dilation, and/or examination of the leaking fluid), diagnostic testing (such as, but not limited to, pH testing, microscopic examination, and/or biochemical testing of the leaking fluid), and monitoring/re-evaluation (including to determine whether her pelvic cramping was a manifestation of pre-term labor). The hospital's on-call obstetrical physician was available and on-call when Patient #1 presented to the hospital's emergency department (ED) but did not participate in the evaluation or management of Patient #1. The failure to include these measures as part of the MSE meant that the facility did not screen the patient for known risks associated with her presenting signs and symptoms, including those which would independently constitute an EMC, such as, but not limited to, a developing infection, early labor, or bleeding. The MSE provided to Patient #1 was both inadequate and inappropriate on its face and disparate from the MSE provided to a similarly situated patient identified upon record review.

Hours after being discharged from the hospital, Patient #1 experienced a precipitous out-of-hospital delivery of a non-viable 15-week fetus in a public restroom. Patient #1 was transported by emergency medical services to another hospital (Hospital B). At Hospital B, Patient #1 was diagnosed with "incomplete miscarriage," requiring an operation. A suction dilatation and curettage (a procedure to remove the remaining placenta and contents of the uterus), insertion of intrauterine balloon (to help stop severe bleeding), and uterine artery embolization (to cut off blood flow to a persistently bleeding blood vessel supplying the uterus) were performed. She was described as "requiring ICU (intensive care unit)," and she was "mechanically ventilated." Hospital B documented that it suspected that Patient #1 also had placenta accreta syndrome (a serious pregnancy condition that occurs when the placenta grows too deeply into the uterine wall), contributing to the heavy bleeding Patient #1 experienced.

Hospital A's failure to provide an appropriate medical screening examination, within the capability of the hospital's emergency department placed the patient at immediate risk for deterioration of her health and wellbeing as a result of untreated emergency medical conditions.


Findings include:

1. A review of Patient #1's Hospital record, labeled "Facesheet," stated that at 22:33 on December 14, 2022, Patient #1 presented to the hospital seeking examination and treatment for "Water Gushing 15 Weeks Pregnant." A hospital record, labeled "ED Forms," documented that Patient #1 stated "she is 15 weeks pregnant, was walking and noticed she is draining clear li[q]uid from her vagina."

2. A hospital record, labeled "Nursing Notes," dated December 15, 2022, at 01:00 stated that Patient #1 is "15 weeks pregnant c/o [complains of] ruptured amniotic fluid start[e]d today." A review of Patient #1's hospital record, labeled "Emergency Dept," signed by Physician A (an ED Physician) on December 15, 2022, at 01:55 states, "Pregnancy Problem < 20 weeks." The record further stated that "the [patient] says she is gushing amniotic fluid. She has had multiple miscarriages in the past and she had mild pelvic cramping and mild bleeding."

3. According to the hospital record labeled "Emergency Dept" dated December 14, 2022, at 22:43, Patient #1's physical examination included "Gastrointestinal: Non distended," but there was no documentation that Patient #1 was examined for abdominal tenderness, vaginal bleeding, cervical dilation (opening), presentation of fetal parts, leakage or pooling of amniotic fluid. Nor was there documentation that Physician A tested Patient #1's leaking fluid using available laboratory methods.

4. A hospital record, dated December 15, 2022, and labeled "Ultrasound," revealed that Physician A ordered an ultrasound (an imaging test that uses sound waves to create a picture of the fetus in the mother's uterus) for Patient #1. The hospital "Ultrasound" record showed the fetus' heart rate was "131 bpm [beats per minute]" and that the there was a "Single Live Intrauterine Gestation With Gestational Age Of 15 Weeks." The hospital "Ultrasound" record further showed that Patient #1's "AFI [Amniotic Fluid Index, a measure of the amount of amniotic fluid, where normal is 5cm to 25cm] was 0 cm (centimeters)" with "Free fluid near the cervix."

The hospital documentation stated, "No Significant Amniotic Fluid Seen On The Provided Images." The hospital determined that Patient #1 had anhydramnios, the absence of amniotic fluid surrounding the fetus. Anhydramnios itself can cause abnormal or incomplete fetal lung development, growth restriction, and infection, among other complications.

5. On December 15, 2022, at 01:51, Hospital records indicate that Physician A called Patient #1's "ob [obstetrician] doctor" who "recommends giving her a shot of Rocephin [sic] (an antibiotic) and putting her on po (by mouth) antibiotics and will see her in her office in the afternoon." According to hospital records, Patient #1's obstetrician did not evaluate her at the hospital's ED on December 14-15, 2022.

6. The facility's "Physician On-call Obstetrical schedule" for "December 2022" revealed that on the night of December 14, 2022, there was another on-call obstetrical physician available when Patient #1 presented to hospital's ED. According to hospital records, the on-call obstetrical physician also did not participate in the evaluation or management of Patient #1 as part of her medical screening examination.

7. Hospital records documented that Patient #1's "Diagnosis" was "Abortion." According to the hospital's "Outpatient Coding Summary," Patient #1's "admission diagnosis" was "pelvic and perineal pain" and her "principal diagnosis" was "complete or unspecified spontaneous abortion without complication." On December 15, 2022, at 01:55, Physician A documented that Patient #1 was being discharged and that "Condition Improved. Disposition Home." Patient #1's hospital record did not contain a certification that Patient #1 was in false labor, as described by 42 CFR 489.24(b) "Labor."

When the hospital was discharging Patient #1, she was given "Patient Visit Summary Materials" that included "Understanding Miscarriage: Trying Again" and "Understanding Miscarriage: Emotions."
8. A telephone interview was conducted on May 17, 2023, with Patient #1 at 9:12 AM. Patient #1 said she had 17 miscarriages in 2 years. She said her "water broke when [she] was walking outside of a restaurant" on December 14, 2022. She recalled that her primary OB doctor had told her if she had any issues to go to the L&D (Labor and Delivery) department at Broward Health Coral Springs, so her husband took her directly to the L&D department of the facility. When she told them she was 16 weeks along, they said she "would have to go to the main ED." The L&D staff escorted her to the ED and checked her in. She stated she "had to wait in the ED waiting room with amniotic fluid leaking out of [her] for an hour." She said that when Physician A came into the room, he told her she had "premature rupture of membranes." She said her husband asked the doctor if she and the baby would be ok, and the doctor responded that she would likely deliver the fetus in 12-24 hours. She told the doctor she did not understand what that meant and asked the doctor if she was going to be admitted to the hospital. He told her she would not be admitted but that she should follow up with her Primary OB doctor the following day or "come back to the ED if [she] went into active labor."

During the same interview, Patient #1 stated that after discharge from the hospital she was at a place of business and used the public bathroom. She stated that "something told me to push," and then she heard the fetus hit the water. She called her husband who came into the bathroom and saw she was bleeding, and he called 911. She said that when EMS (Emergency Medical Services) arrived, they told her that she was losing a lot of blood.

9. According to a review of the EMS report, EMS was called on December 15, 2022 at 12:33 PM for a complaint of "Pregnancy/Childbirth" and arrived on scene at 12:40 PM and "found [Patient #1] sitting on toilet" reporting that "she felt cramps" and "when she sat down on the toilet, she felt something come out of her vagina. When she looked her fetus was in the toilet." A "trauma dressing was applied to control bleeding," and the patient was taken to Hospital B. Patient #1 arrived at Hospital B at 13:01 PM.

10. According to Hospital B's medical records dated December 15, 2022, at 1:15 PM, Patient #1 had "significant vaginal bleeding described as large-volume dark blood with several clots." On December 15, 2022, at 2:38 PM, an ultrasound showed a large amount of material within the uterus, including part of the placenta and retained products of pregnancy. At Hospital B, Patient #1 was taken to the operating room where a suction dilatation and curettage under ultrasound guidance (a procedure to remove the remaining placenta and contents of the uterus), insertion of intrauterine balloon (to help stop severe bleeding), and uterine artery embolization (to cut off blood flow to a persistently bleeding blood vessel supplying the uterus) were performed. Hospital B suspected that Patient #1 also had placenta accreta syndrome (a serious pregnancy condition that occurs when the placenta grows too deeply into the uterine wall). She was described as "admitted to ICU (intensive care unit)," and she was "mechanically ventilated." Patient #1 was discharged from Hospital B on December 21, 2022, after being treated at Hospital B for 6 days.

11. On May 15, 2023, surveyors interviewed Registered Nurse (RN) D, Hospital A's ED Charge Nurse who was on duty when Patient #1 presented at Hospital A's ED. She explained that the nurses in the ED can call the on-call OB for an evaluation.
12. An interview was conducted with Physician H on May 15, 2023, at 10:58 AM. He said if the patient is less than 20 weeks along with a chief complaint that is pregnancy related, the main ED staff conducts a full physical evaluation along with a (chaperoned and consented) pelvic exam. He said if the patient is less than 20 weeks along, they can be admitted to the Labor and Delivery (L&D) department.
13. On May 15, 2023, at 11:20 AM, an interview was conducted with RN E, Hospital A's OB Nurse Manager and RN F, Hospital A's Director of Women and Children's Services. She said when the patient is brought to the L&D department, they are placed into a triage exam room where they are immediately attached to a monitor, and the nurse obtains vital signs and the patient's chief complaint. She said ultrasounds can be done in this area as well and that there is an ultrasound technician available in-house 24/7. She explained that there are OB Hospitalists available in-house 24/7, and that a patient's Primary OB doctors can also be consulted when necessary. She said depending on the urgency of the situation, the OB Hospitalist and the Primary OB can be consulted.
14. A telephone interview was conducted on May 16, 2023, at 3:53 PM with Physician I, Hospital A's Medical Director of OB. Physician I stated that she started this position on May 1, 2023. She stated that the hospital's protocol is to offer induction of labor for any previable preterm premature rupture of membranes (PPROM); they have the necessary forms to fill out. She said, "It's the standard of care, has been a while, regardless of heartbeat, due to the risk to the mother."

15. Review of a sample medical records revealed that Patient #22 went to the ED at Hospital A on August 11, 2022, at 17 weeks of pregnancy seeking examination and treatment for abdominal pain and "leakage of fluids." She underwent an ultrasound which showed that "fetal heart rate: 149" and "amniotic fluid index: 0 cm." The hospital's on-call obstetrician was consulted, and she was placed in observation status on the Labor and Delivery floor. Patient #22's "assessment" was documented as "consistent with ruptured membranes" and "non-viable pregnancy." An OB/GYN physician documented, "no stigmata of infection at this point. I had extensive conversation with patient and husband regarding physiology and expected outcomes and management strategies for pregnancy with extreme premature rupture membranes. Our discussion included that the likelihood of reaching viability for this baby was very very very low and that risk to mother for having ruptured membranes for extended period of time can affect future fertility." The documented "Plan" included "Admit to L&D ...Will inform administration as well to confirm all rules/regulations/compliance." Patient #22 underwent induction of labor and dilation and curettage at Hospital A and was discharged on August 12, 2022.

STABILIZING TREATMENT

Tag No.: A2407

Based on a review of hospital records, ambulance/fire rescue report, Obstetrical Physician on-call schedules, and interviews, it was determined that the hospital failed to ensure that Patient #1 (of 10 sampled patients) who presented at the hospital's emergency department) received further medical examination and treatment as required to stabilize Patient #1's emergency medical conditions within the capabilities of the staff and facilities available at the hospital.

On December 14, 2022, Patient #1, presented at the hospital at 15 weeks pregnant "gushing amniotic fluid" and experiencing pelvic cramping and bleeding. The hospital determined that Patient #1 had one or more emergency medical conditions and failed to provide necessary stabilizing examination and treatment. The hospital determined that Patient #1 had "0" amniotic fluid (also known as anhydramnios, the absence of amniotic fluid surrounding the fetus) and previable (before the fetus is mature enough to survive on its own outside the uterus) preterm premature rupture of membranes (also known as PPROM). 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 to future fertility, among other complications, each of which represents a serious jeopardy to health.

Despite Patient #1 having emergency medical conditions (anhydramnios with previable PPROM), the hospital discharged Patient #1 without stabilizing her emergency medical conditions. There was no documentation that the hospital offered Patient #1 further in-hospital care, consultation with the hospital's on-call obstetrical physician, or any stabilizing treatment. Instead, the hospital discharge instructions included documentation that Patient #1 was given materials on "Understanding Miscarriage: Trying Again" (although miscarriage had not yet occurred), provided a prescription for an antibiotic, and she was told to follow up with her Obstetrician (OB).

Hours after being discharged from the hospital, Patient #1 experienced a precipitous out-of-hospital delivery of a non-viable 15-week fetus in a public restroom. Patient #1 was transported by emergency medical services to another hospital (Hospital B). At Hospital B, Patient #1 was diagnosed with "incomplete miscarriage," requiring an operation. A suction dilatation and curettage (a procedure to remove the remaining placenta and contents of the uterus), insertion of intrauterine balloon (to help stop severe bleeding), and uterine artery embolization (to cut off blood flow to a persistently bleeding blood vessel supplying the uterus) were performed. She was described as "requiring ICU (intensive care unit)," and she was "mechanically ventilated." Hospital B documented that it suspected that Patient #1 also had placenta accreta syndrome (a serious pregnancy condition that occurs when the placenta grows too deeply into the uterine wall), contributing to the heavy bleeding Patient #1 experienced.

Hospital A's failure to stabilize Patient #1's emergency medical conditions, within the capabilities of the staff and facilities available at the hospital, placed the patient at immediate risk for deterioration of her health and wellbeing as a result of untreated emergency medical conditions.


Findings include:

1. A review of Patient #1's Hospital record, labeled "Facesheet," stated that at 22:33 on December 14, 2022, Patient #1 presented to Hospital A's emergency department seeking examination and treatment for "Water Gushing 15 Weeks Pregnant." A hospital record, labeled "ED Forms," documented that Patient #1 stated "she is 15 weeks pregnant, was walking and noticed she is draining clear li[q]uid from her vagina."

A hospital record, labeled "Nursing Notes," dated December 15, 2022, at 01:00 states that Patient #1 is "15 weeks pregnant c/o [complains of] ruptured amniotic fluid start[e]d today." A review of Patient #1's hospital record, labeled "Emergency Dept," signed by Physician A (an ED Physician) on December 15, 2022, at 01:55 states, "Pregnancy Problem < 20 weeks." The record further states that "the [patient] says she is gushing amniotic fluid. She has had multiple miscarriages in the past and she had mild pelvic cramping and mild bleeding."

On December 14-15, 2022, the hospital had the capabilities of an on-call obstetrical physician available to the ED, a Labor & Delivery (L&D) department with OB hospitalists in house at all times, and the other capabilities required to provide necessary stabilizing treatment for emergency medical conditions. The facility's "Physician On-call Obstetrical schedule" for "December 2022" revealed that on the night of December 14, 2022, there was an on-call obstetrical physician available when Patient #1 presented to Hospital A's ED. Although Hospital A determined that Patient #1 had one or more emergency medical conditions, the on-call obstetrical physician did not participate in the evaluation or management of Patient #1. Additionally, during staff interviews, hospital staff stated that if the patient is fewer than 20 weeks along, a patient can be admitted to Labor & Delivery for care by the OB hospitalist, if it is appropriate for that patient.

2. Hospital records documented that Patient #1's "Diagnosis" was "Abortion." According to the hospital's "Outpatient Coding Summary," Patient #1's "admission diagnosis" was "pelvic and perineal pain" and her "principal diagnosis" was "complete or unspecified spontaneous abortion without complication." However, a hospital record, dated December 15, 2022, and labeled "Ultrasound," revealed that Physician A ordered an ultrasound which showed the fetus was alive, the fetal heart rate was "131 bpm (beats per minute)" and that the there was a "Single Live Intrauterine Gestation With Gestational Age Of 15 Weeks."

The hospital "Ultrasound" record further showed that Patient #1's "AFI [Amniotic Fluid Index, a measure of the amount of amniotic fluid, where normal is 5cm to 25cm] was 0 cm (centimeters)" with "Free fluid near the cervix." The hospital documentation stated, "No Significant Amniotic Fluid Seen On The Provided Images." The hospital determined that Patient #1 had anhydramnios, the absence of amniotic fluid surrounding the fetus. Anhydramnios itself can cause abnormal or incomplete fetal lung development, growth restriction, and infection, among other complications, and in the setting of a patient who reports sudden "gushing amniotic fluid," it is the result of rupture of the amniotic membranes. Preterm premature rupture of membranes (PPROM) is a pregnancy complication in which the amniotic membrane surrounding the fetus ruptures before week 37 of pregnancy and carries the risk of infection, sepsis, severe bleeding, premature labor, and risk to future fertility, among other complications.

The medical record did not contain documentation that the hospital provided the necessary treatments to stabilize Patient #1's emergency medical conditions prior to discharge.

4. A telephone interview was conducted at 9:12 AM on May 17, 2023, with Patient #1. She said she had 17 miscarriages in 2 years. She said her "water broke when [she] was walking outside of a restaurant" on December 14, 2023. She said that when Physician A came into the room, he told her she had "premature rupture of membranes." She said her husband asked the doctor if she and the baby would be ok and the doctor responded that she would likely deliver the fetus in 12-24 hours. She stated she also asked the physician if "premature rupture of membranes" could be fixed, but was told it cannot be fixed and that, once the fluid is lost, the baby cannot be saved because she was at only 16 weeks along. Patient #1 stated that she asked the physician if she was going to be admitted to the hospital. He told her she would not be admitted but that she should follow up with her Primary OB doctor the following day or "come back to the ED if [she] went into active labor."

6. Hours after being discharged from the ED, Patient #1 experienced a precipitous out-of-hospital delivery of a non-viable 15-week fetus in a public restroom. According to a review of the EMS report, EMS was called at 12:33 PM on December 15, 2022, for a complaint of "Pregnancy/Childbirth" and arrived on scene at 12:40 PM and "found [ Patient #1] sitting on toilet" reporting that "she felt cramps" and "when she sat down on the toilet, she felt something come out of her vagina. When she looked her fetus was in the toilet." A "trauma dressing was applied to control bleeding," and the patient was taken to Hospital B. Patient #1 arrived at Hospital B at 13:01.

According to Hospital B's medical records dated December 15, 2022, at 1:15 PM, Patient #1's "symptoms began this morning with . . .significant vaginal bleeding described as large-volume dark blood with several clots." On December 15, 2022, at 2:38 PM, an ultrasound showed a large amount of material within the uterus, including part of the placenta and retained products of pregnancy. At Hospital B, Patient #1 was taken to the operating room where a suction dilatation and curettage under ultrasound guidance (a procedure to remove the remaining placenta and contents of the uterus), insertion of intrauterine balloon (to help stop severe bleeding), and uterine artery embolization (to cut off blood flow to a persistently bleeding blood vessel supplying the uterus) were performed. Hospital B suspected that Patient #1 also had placenta accreta syndrome (a serious pregnancy condition that occurs when the placenta grows too deeply into the uterine wall). She was described as "requiring ICU (intensive care unit)," and she was "mechanically ventilated." Patient #1 was discharged from Hospital B on December 21, 2022, after being treated at Hospital B for 6 days.