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Based on records review and interviews, the hospital failed to provide an appropriate medical screening examination utilizing its available resources on a 34-year old who was 6-weeks pregnant presented with complaint of severe left-sided cramping and vomiting. The hospital failed to provide an OB-Gyn consultation, which was an expected component of the medical screening examination for the presentation to the Emergency Department (ED) of a pregnant woman with ectopic pregnancy.

This failed practice resulted in Patient #1being transferred to another facility for a surgery which was available at the hospital and in accordance with their policies, and had the potential for other ED patients to be transferred unnecessarily which could result in delay of stabilizing treatment.


Findings:


A review of the medical record for Patient #1 documented, the patient arrived at the ED by private vehicle on 08/21/18, at 1:07 am, with the chief complaint of severe left-sided cramping with vomiting, she was 6 weeks pregnant. The ED physician completed the preliminary examination at 3:39 am. The patient's BHCG level (Beta-Human Chorionic Gonadotropin, Quantitative, serum-used for monitoring patients for retained products of conception) was 4600. The vaginal ultrasound showed "fetal pole shows color Doppler signals within it" (Heartbeat), no intrauterine sac, and a small to moderate fluid in pelvis. Vital signs were stable. Other laboratory tests essentially were within defined limits (WDL). The patient was transferred by ambulance to another facility (non-Catholic) at 4:30 am.


The medical record showed no OB-GYN physician was consulted. Staff B's Certification for transfer (which was unsigned by Dr and patient) did not document the specific risks & benefits that were discussed. On 09/07/18, the hospital provided a Certification at 4:07 am which documented, "Risk: Time delay, Deterioration, Loss of IV" and "Benefit: Necessities available at receiving facility, Staff of receiving facility are capable of providing the level of care needed" that was not signed by the physician or the patient. On 09/10/18, the hospital provided the Certification signed by the ED physician, and Staff D stated, it was found in the medical record. The physician documented he/she had a "long discussion with Patient #1 regarding findings", Patient #1 required "emergent treatment," was a "very complicated case," had fetal heartbeat present, and consistent with Catholic initiatives of the hospital could not be "treated" at the hospital.


A review of the medical records from receiving facility for Patient #1 showed surgery was performed at 08/21/18 at 12:24 pm. The operative report documented the physician attempted salpingostomy, but due to difficulty separating ectopic pregnancy from fallopian tube and inadequate hemostasis of tubal serosa, proceeded with left salpingectomy.


A review of 17 of 20 ED medical records from 06/01/18 to 09/05/18 showed pregnant patients presenting with chief complaints of vaginal bleeding and/or abdominal pain received examination by the ED physician. The medical records of 17 of 20 patients had BHCG levels drawn (and other labs), and vaginal ultrasound examinations. There were 10 of 17 pregnant patients diagnosed with ectopic pregnancies. In nine (Patients #2, 3 [second visit for Patient #2], 4 through 11) of 10 patients, an OB-Gyn consultaion were done but the patient involved in the complaint did not receive an OB-Gyn consult.


A review of policy titled, "Emtala-Triage and Medical Screening-The Emergency Department Process of Care Triage Assessment and Reassessment of Patients" (date 06/13) documented, the medical screening examination must be provided appropriate to the individual's presenting signs and symptoms as well as the capability and capacity of the hospital.


A review of policy draft titled, "Management of Ectopic Pregnancy (Methotrexate) (dated 08/18)" updated the 12/01/17 Memo from Staff K and had the addition of "A consultation with the patient's OB-Gyn provider or an on-call OB-Gyn provider for unassigned patients is expected before a treatment or disposition decision is made."


A review of "Medical-Dental Staff Rules and Regulations (date 06/26/18) documented OB consultation was strongly encouraged for gestational age <18 weeks.


A review of the document titled, "2018 OB/Gyn Unassigned Call Schedule" from 05/19 through 09/18 showed an OB-Gyn provider was available 24/7.


On 09/05/18 at 4:16 pm, Staff A, ED physician, stated he/she always got an OB-Gyn physician consult for a patient presenting with suspected ectopic pregnancy.


On 09/10/18 at 11:37 am, Staff K and Staff C, physician leadership, stated an OB-Gyn consult should have been done for Patient #1, and Staff K stated no OB-Gyn provider was involved in the decision-making for Patient #1.

Based on records review and interviews, the hospital failed to provide the necessary stabilizing treatment within its capabilities to a 34-year old pregnant woman who presented with complaints of severe left-sided cramping and vomiting. Patient #1 was diagnosed by the ED physician as having ectopic pregnancy that required medical treatment and/or surgical intervention, both treatment mdalities are within the hospital's capabilities to provide but the ED physician decided to transfer the patient to another hospital instead.


This failed practice resulted in Patient #1's transfer to another facility for treatment/surgical intervention and had the potential for other ED patients to be transferred unnecessarily.


Findings:


A review of 17 (Patients # 1 through12, 14 through18) of 20 ED medical records from 06/01/18 to 09/05/18 showed pregnant patients presenting with chief complaints of vaginal bleeding and/or abdominal pain received examination by the ED physician. The medical records showed the following:

* 17 (Patients #1 through17) of 20 patients had BHCG levels drawn (and other labs), and vaginal ultrasound examinations.

* 10 (Patients #1, 2, 3 [second visit for Patient #2], 4 through 11) of 17 pregnant patients were diagnosed with ectopic pregnancies.

* Nine (Patients #2, 3 [second visit for Patient #2], 4 through 11) of 10 medical record for ectopic pregnancy patients documented by the OB-Gyn physician the findings and specific treatment options available to the patient based on their condition.

*One (Patients #2, 3 [second visit for Patient #2]) of 10 ectopic pregnant patients received the medication, Methotrexate (MTX). The condition of the patient receiving MTX worsened and had surgery, which made the total of eight (Patient #1, 2, 3 [second visit for Patient #2], 6 through 11 of 10 patients had surgery as treatment for ectopic pregnancy.

* One (Patients # 1) of 10 ectopic pregnant patients was transferred to another facility for surgery as treatment for ectopic pregnancy.


Patient #1:

A review of the medical record for Patient #1 documented, the patient arrived at the ED by private vehicle on 08/21/18, at 1:07 am, with the chief complaint of severe left-sided cramping with vomiting; she was 6 weeks pregnant. Patient #1 was triaged at 1:12 am, assigned an emergency severity index of three. The ED physician completed the examination at 3:39 am. The patient's BHCG level (Beta-Human Chorionic Gonadotropin, Quantitative, Serum-used for monitoring patients for retained products of conception) was 4600. The vaginal ultrasound showed "fetal pole shows color Doppler signals within it" (Heartbeat), no intrauterine sac, and a small to moderate fluid in pelvis. Vital signs were stable. Other laboratory tests were essentially witin defined limits (WDL). The patient was transferred by ambulance to another facility (non-Catholic) at 4:30 am.


The medical record showed no OB-Gyn physician was consulted. Staff B's Certification for transfer (which was unsigned by Dr and patient) did not document the specific risks & benefits that were discussed. On 09/07/18, the hospital provided a Certification at 4:07 am which documented, "Risk: Time delay, Deterioration, Loss of IV" and "Benefit: Necessities available at receiving facility, Staff of receiving facility are capable of providing the level of care needed" that was not signed by the physician or the patient. On 09/10/18, the hospital provided the Certification signed by the ED physician, and Staff D stated it was found in the medical record. The physician documented he/she had a "long discussion with Patient #1 regarding findings", Patient #1 required "emergent treatment", was a "very complicated case", had fetal heartbeat present, and consistent with Catholic initiatives of the hospital could not be "treated" at the hospital.


A review of the Memo titled, "New Policy for the Management of Ectopic Pregnancy and Methotrexate (dated 12/01/17) from Staff K to the obstetricians, emergency medicine physicians, and advanced practice practitioners documented the following:

1. If it is determined that the embryo was living (based on vaginal ultrasound criterion), full or partial salpingectomy and expectant management were acceptable ethical options. "Use of methotrexate or salpingostomy is not." [Patient #1 met this criterion].

2. "If embryonic demise is established, any clinically appropriate intervention may be used (methotrexate, salpingostomy, salpingectomy).

This policy failed to address the treatment option for patient, such as Patient #1, whose vaginal ultrasound showed a fetus with a heartbeat.


A review of policy draft titled, "Management of Ectopic Pregnancy (Methotrexate)" (dated 08/18) documented a form titled, "Ectopic Pregnancy with Living Fetus Patient Advice Statement and Consent" documented the treatment options for the ectopic patient. On 09/10/18 at 11:37 am, Staff C stated, she had not seen the consent, and Staff K said, it was developed in the prior five months. The consent listed the following treatment options:

"1. Removal of the tube (salpingectomy) or partial removal (partial salpingectomy) of tube with surgery performed at Saint Francis Hospital.

2. Transfer to another facility outside of the Saint Francis health System to consider:

a. Surgically opening the fallopian tube to remove the fetus (salpinostomy)

b. Medical (nonsurgical) treatment (Methotrexate)."


On 09/05/18 at 2:20 pm, Staff K stated, the only ectopic pregnancy patient that should be transferred to another hospital would by patient request or the clinical scenario of not ruptured ectopic pregnancy, with embryo/fetus with a heartbeat as evidence by vaginal ultrasound, who wanted MTX treatment or salpingostomy. Staff K stated, the Patient #1 should have had surgery at their hospital due to the evidence of rupture and free fluid by vaginal ultrasound; thereby, dictating the surgical procedure of salpingectomy, which could be done at their facility.


Patient #7;

A review of the medical record of Patient #7 documented a potential lack of adherence to the ectopic pregnancy related policies by the physicians providing care to the patient with ectopic pregnancy at their Catholic hospital.


On 07/19/18, Patient #7 with a history of an ectopic pregnancy, BHCG level of 14,090, and a 07/19 vaginal ultrasound showed ectopic pregnancy on left with fetal cardiac activity and no significant free fluid. The medical record documented the Risk and Benefits discussion by OB-Gyn physician which included "discussed with patient will attempt salpingostomy, but if pregnant in tube a salpingectomy may be required. Salpingostomy would increase risk of further ectopic.


On 09/10/18 at 11:37 am, Staff K and Staff C stated, the documented plan for Patient #7 did not follow the hospital policy and Staff K needed to provide more physician training.


On 09/06/18 at 10:30 am, Staff D and Staff K stated, the Ethical Directives from the Pope were not specific in addressing ectopic pregnancy treatment, and in 2016, the Catholic Bishop gave specific treatment directives. They stated at that time, Staff L (on Ethic Committee) determined the hospital was not in compliance with the Bishop's directives. Staff K stated discussion [began 11/17] and policies were developed from [11/17 to 08/18] to change hospital processes to be in accordance with Catholic directives and standards of practice.