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Based on review of facility policy, medical record review, and interviews the facilty failed to provide an appropriate ongoing medical screening examination and failed to provide stabilizing treatment for 1 patient (#21) who presented to the Emergency Department (ED) with vaginal bleeding, cramping, and an ectopic pregnancy of 30 medical records reviewed.

The findings included:

Patient #21 presented to the ED on 2/9/2022 with vaginal bleeding and cramping. She had been evaluated by her Obstetrics and Gynecology (OB/GYN) physician and was sent to the ED for treatment and a transvaginal ultrasound to rule out an ectopic pregnancy. She had a positive urine pregnancy test in the office. She was evalauated by the Provider in Triage (PIT) provider where a Medical Screening Examination (MSE) was started. Diagnostic testing was ordered and initiated including a Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), urine HCG (pregnancy test), Beta HCG (blood pregnancy test), urinalysis (UA) and a transvaginal ultrasound. A transvaginal ultrasound was completed at 2:21 PM with appropriate measurements and findings documented. The ultrasound showed no evidence of an ectopic pregnancy. Her HCG was positive. The ED physician discussed the findings with the on-call OB/GYN physician and the OB/GYN physician advised the patient could follow-up in the office within 48 hours for repeat pregnancy test and an ultrasound. There was no evaluation by the OB/GYN physician and the patient was not admitted. On 2/11/2022 the patient was evaluated by her OB/GYN and an ultrasound in the office showed a left heterogenous mass superior to the left ovary with blood flow measuring 3.7 x 3.2 x 2.8 cm which was not present on the ultrasound on 2/9/2022. She was admitted to the facility and then taken to the Operating Room on 2/11/2022 for a Laparoscopic left Salpingectomy (surgical removal of a fallopian tube) and removal of an adnexal mass (lump of tissue near the uterus, usually in the ovary or fallopian tube). She was discharged home on 2/11/2022.

Refer to A-2406.

Based on review of facility policy, medical record review, and interviews, the facility failed to ensure an appropriate and ongoing medical screening examination for 1 patient (#21) who presented with vaginal bleeding, cramping, and an ectopic pregnancy of 30 medical records reviewed.

The findings included:

Review of facility policy, Emergency Medical Treatment and Labor Act (EMTALA) guidelines, last reviewed 1/2021, showed "...Medical Screening Examination [MSE] is defined as the process required to reach, with reasonable clinical confidence, the point which it can be determined whether the individual had an emergency medical condition [EMC] or not. An MSE is an ongoing process that begins with triage...MSE may include...[Xl] notification and use of on call physicians to diagnose and/or stabilize the patient's condition..."

Medical record review of a Nursing Triage dated 2/9/2022 at 12:13 PM showed the patient stated she was sent by her Obstetrician/Gynecologist (OB/GYN) physician with a positive pregnancy test and possible ectopic pregnancy. The patient stated she had bright red blood and extreme cramping in LLQ (left lower quadrant). She described her pain at a 10/10. She was triaged with an Emergency Severity Index (ESI) score of a 3 indicating emergent but non-emergent needs.

Medical record review of a Provider in Triage (PIT) provider note dated 2/9/2022 at 1:05 PM showed the patient presented with left lower quadrant pain and vaginal bleeding. She had been seen by her Primary Care Provider today (2/9/2022) and her urine pregnancy test came back positive. She was sent to the Emergency Department (ED) due to concerns for possible ectopic pregnancy.

Medical record review of a Radiology Diagnostic Test, Transvaginal Ultrasound, dated 2/9/2022 at 2:21 PM showed "...no intrauterine gestational sac [pregnancy]. No fetal pole or yolk sac [first stages of an embryo's development in pregnancy] is identified...there is no adnexal mass [a lump in tissue near the uterus]. Small amount of free fluid is seen in the pelvic cul-de-sac. Impression: no intrauterine pregnancy. There is most likely missed spontaneous abortion. Very early pregnancy cannot be excluded but thought to be less likely. Mid free fluid in the cul-de-sac..."

Medical record review showed the following laboratory diagnostic testing was ordered and completed for the patient:
2/9/2022 at 4:55 PM: Beta HCG: 4049 (normal 0.0-5.0)
2/9/2022 at 5:10 PM: Urinalysis: 3+ blood and a urine culture
2/9/2022 at 5:11 PM: CBC: her White Blood Count was 12.4 (normal 4-11); otherwise no further acute findings
2/9/2022 at 5:16 PM: Urine Pregnancy Test: Positive

Medical record review of an ED Physicians Record dated 2/9/2022 at 6:13 PM showed the patient had been evaluated by her OB/GYN physician the same day and was sent to the ED related to a possible ectopic pregnancy. She had stated she had bight red bleeding with extreme cramping which started yesterday (2/8/2022) approximately 1 week after her normal menses stopped. She had previous history of endometriosis (disease characterized by the presence of tissue in the the lining of the uterus) and normally had heavy periods. She had a positive pregnancy test in the OB/GYN office. Her pain was cramping in nature with no fever, nausea, or vomiting. She reported she was G2P2. Her diagnoses included Endometriosis, Pelvic Pain in female, Threatened Miscarriage.

Medical record review of an ED Physicians Progress Note dated 2/9/2022 at 6:18 PM showed "...case discussed with OB [Obstetrician] on-call. Patient was given Tylenol for pain...[6:39 PM] Spoke with [OB/Gyn]. Reviewed patient's presentation including physical exam findings, and labs and ultrasound findings. At this point there is no obvious ectopic pregnancy seen. She feels like patient will need 48 hour follow-up which will include beta HCG and repeat ultrasound. She can see her in the office...patient is stable and ready for discharge..." She was given prescriptions for Hydrocodone (pain medication) 10/325 mg (milligrams) 1 tablet every 6 hours PRN (as needed) for pain and Zofran (medication used for nausea) 4 mg, 1 tablet orally every 8 hours PRN.

Medical record review of the discharge instructions dated 2/9/2022 at 7:49 PM showed the patient was given instructions related to a Threatened Miscarriage and Pelvic Pain.

Medical record review showed the patient was admitted to the facility on 2/11/2022 for a Laparoscopic left Salpingectomy (surgical removal of one or both fallopian tubes) and removal of an adnexal mass.

Medical record review of an Admission History and Physical dated 2/11/2022 at 5:08 PM showed the patient presented to the office with complaints of increasing pain. She was evaluated in the ED on Wednesday (2/9/2022) where her HCG was approximately 4000 with no IUP (intrauterine pregnancy) visualized but also no adnexal mass. She had presented on 2/11/2022 with worsening pain. In the office an ultrasound showed left heterogenous mass superior to the left ovary with blood flow measuring 3.7 x 3.2 x 2.8 cm (centimeters). Moderate free fluid. She also reported nausea and vomiting. Her physical examination showed the patient had severe pain with a bimanual exam, left adnexal pain with rebound and guarding. The Assessment/Plan included suspected ectopic pregnancy on the left side with significant pelvic pain.

Medical record review of an Intraoperative Report dated 2/11/2022 at 6:59 PM showed a successful Laparoscopic Partial left Salpingectomy was performed.

During a telephone interview on 4/28/2022 at 1:10 PM, Ultrasound Technician #2, stated she did not see an intrauterine pregnancy and the patient's beta HCG was 4000 which is very low suggestive of a very early pregnancy.

During an interview on 4/28/2022 at 1:35 PM, Radiologist #1 stated he had reviewed the transvaginal ultrasound on 2/9/2022. The ultrasound showed a left simple cyst, no intrauterine gestational sac, and no adnexal mass. He stated "...I did not see any suggestive signs of an ectopic pregnancy at that time. Her HCG levels were elevated but on the lower side of high. There was no mass suggestive of an ectopic pregnancy. She did have some fluid in pelvic cul-de-sac but this would be normal for a female who had just had a period. There were no definitive signs of an ectopic pregnancy..."

During a telephone interview on 4/28/2022 at 3:05 PM, OB/GYN Physician #1, stated she was called by the ED physician on 2/9/2022 related to the patient and the diagnostic findings. The patient had a positive urine HCG in the office with complaints of vaginal bleeding and pain. She had been sent to the ED for a transvaginal ultrasound to rule out an ectopic pregnancy. The ultrasound showed small fluid and a simple cyst but did not show an ectopic pregnancy. She stated the diagnostic findings were discussed and it was agreed the patient should follow-up in the office in 48 hours (2/11/2022) for repeat HCG and an ultrasound. The patient returned to the office on 2/11/2022 with continued bleeding and pain. The ultrasound in the office showed a heterogenous mass which was not present during the ultrasound on 2/9/2022. She confirmed the patient was taken to surgery on 2/11/2022 by one of her practice partners for an ectopic pregnancy.

During an interview on 4/28/2022 at 3:55 PM, ED Physician #1 stated the patient presented with vaginal bleeding and cramping on 2/9/2022. She had been evaluated by her OB/GYN in the office where she had a positive pregnancy test. Diagnostic testing was ordered and completed for the patient. The radiologist read the ultrasound which showed some fluid and no viable fetus. The patient was hemodynamically stable, and her pain had eased with Tylenol. He had spoken with the on-call OB/GYN and the diagnostic findings were discussed. He confirmed the patient was sent home with follow-up in the office in 48 hours for repeat labs and an ultrasound; and the patient was not admitted.