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Based on medical record reviews, staff interviews, and policy/procedure/standards review, the facility failed to meet the emergency needs of obstetrical patients in accordance with acceptable standards of practice. The cumulative effect of this systemic practice resulted in a risk to the health and safety of all obstetrical patients who presented to the ED (Emergency Department).

Based on medical record reviews, staff interviews, and policy review, the facility failed to ensure policies, procedures and/or standards governing assessment/care of obstetrical patients in the emergency department were established by and were a continuing responsibility of the medical staff. This affected six of six obstetrical patients reviewed who presented to the ED and were transferred out with the potential to affect all future patients. (Patient #1, #2, #3, #4, #5 and #8 ) There were 28 transfers of OB patients between 10/01/17 and 09/22/18.

Findings include:

1. Review of the medical record for Patient #1 revealed the patient presented to the Emergency Department on 10/04/17 at 5:41 PM with complaints of abdominal pain and pregnancy. The hospital does not provide inpatient obstetric/labor and delivery services.

At 5:43 PM Patient #1 was triaged and assigned an acuity level of 3 (three) with level 1 (one) high acuity and five (5) the lowest. Physical examination by the ED physician at 5:52 PM revealed abdomen gravid "consistent with 33 weeks" and "cervical os closed." There was no evidence in the record fetal heart tones (FHT) were obtained.

At 6:03 PM a Genitalia and GYN Pregnancy Assessment were documented by the RN. The RN noted fetal movement was present.
At 6:19 PM the RN documented patient "contractions 5 minutes apart."
At 6:23 PM the RN documented patient reported she was "having a contraction."
At 6:31 PM the RN (registered nurse) recorded patient's pulse was 102.

Medical Decision Making/ED Course note revealed Patient #1 had contractions "proximally 5 minutes apart for the last several hours. Patient has had prenatal care and has not had any complications with this pregnancy."

The ED physician then documented he spoke with a labor and delivery physician at another hospital. They agreed a pelvic exam would be performed. Patient #1's os was noted to be closed. At that time the decision was made to transfer Patient #1 to a hospital with labor and delivery services.

At 6:05 PM the provider signed A Consent to Transfer Patient to Another Acute Care Facility form. Reason for transfer was documented as "Community Physician Preference." The benefit of transfer was "eval for premature labor," and the risk of transfer was listed as minimal. Patient #1's condition at the time of transfer was "stable."

At 6:35 PM the physician documented Patient #1's water broke, and "contractions are still 5 minutes apart." Transport was now present to take Patient #1 to the other hospital. The physician noted the other hospital was "only 10-15 minutes away, and we will allow them to take patient to facility with labor and delivery." There was no evidence in the record fetal heart tones (FHT) were obtained.

The ED Provider Note incorrectly documented the patient was 33 years old (actual age 21 years). The patient was noted to be "33 weeks pregnant by ultrasound," but there was no documented evidence an ultrasound was performed on 10/04/17.

Staff B, the RN assigned to Patient #1, was interviewed on 09/25/18 at 10:26 AM. Staff B was provided a copy of Patient #1's medical record for review and asked specifically about assessing fetal movement and FHT (fetal heart tones). Staff B was asked how she assessed fetal movement and stated she wouldn't have. Staff B stated fetal movement would be assessed using the portable ultrasound machine, and she is not trained to use it. Staff B stated she knew where it was located and how to turn it on/off. Staff B explained that the resident would have used the ultrasound machine to assess the fetal movement. Staff B was asked if this was documented in patient's medical record and confirmed it was not.

Staff B was then asked how to assess FHT. Staff B stated using a Doppler machine. Staff B was asked if FHT's were assessed on this particular patient and stated yes. Staff B was asked what the result was and confirmed there was no documented number or range.


2. Patient #2 presented to the ED on 06/29/18 at 2:33 AM with complaints of cramping and pregnancy per the medical record. At 2:36 AM Patient #2 was triaged and assigned an acuity level of 2 (two). FHT (fetal heart tones) at 2:41 AM were 140. Genourinary comments: approximately 2 cm dilated, very posterior. Per physician history of present illness at 3:21 AM, Patient #2 was 39 weeks and 6 days gestation. At 3:25 AM the decision was made to transfer Patient #2 to a facility with labor and delivery services. At 4:42 AM Patient #2 was transferred. There was no further documented evidence the fetus/unborn child was assessed for stability prior to the transfer.


3. Patient #3 presented to ED on 08/18/18 at 11:29 AM with complaints of pregnancy, abdominal pain, low back pain and buttock pain per the medical record. At 11:30 AM Patient #3 was triaged and assigned an acuity level of 3 (three).
Per physician history of present illness Patient #3 was 24.4 weeks gestation and a high risk pregnancy. Physical examination at 11:43 AM revealed Patient #3 was "station -3, 0 effacement, and close cervix." At 11:52 AM the decision was made to transfer Patient #3 to a facility with labor and delivery services. At 11:53 AM FHT (fetal heart tone) were 148, and at 12:48 PM Patient #3 was transferred. There was no further documented evidence the fetus/unborn child was assessed for stability prior to the transfer.

4. Patient #4 presented to the ED on 8/15/18 at 9:54 AM with complaints of abdominal pain and pregnancy per the medical record. She was triaged at 10:04 AM and assigned an acuity level of 3 (three). Physical examination revealed the cervix was closed, FHT were 142. Gestational age consistent with 21 weeks. At 11:00 AM the decision was made to transfer Patient #4 to a facility with labor and delivery services. At 5:27 PM Patient #4 was transferred. There was no further documented evidence the fetus/unborn child was assessed for stability prior to the transfer.

5. Patient #5 presented to the ED on 08/19/18 at 2:38 PM with complaints of bleeding with pregnancy per the medical record. She was triaged at 2:41 PM and assigned an acuity level of 3 (three). Physical examination revealed abdomen "consistent with dates" and FHT of 152. Ultrasound was performed and revealed a single live intrauterine gestation with estimated age of 20 weeks and 3 days. At 6:00 PM the decision was made to transfer Patient #5 to a facility with labor and delivery services, and at 6:35 PM Patient #5 was transferred. There was no further documented evidence the fetus/unborn child was assessed for stability prior to the transfer.

6. Patient #8 presented to the ED on 07/31/18 at 9:41 PM with complaints of heavy bleeding and pregnancy per the medical record. Physical examination revealed blood in the vaginal vault but no acute bleeding. The edge of the cervix was not able to be visualized but the amniotic sac was. Ultrasound was performed at 11:18 PM and revealed a single live intrauterine gestation of 19 weeks and 3 days. FHR (fetal heart rate) was 160 beats per minute.
At 12:51 AM the decision was made to transfer Patient #8 to a facility with labor and delivery services, and at 1:56 AM Patient #8 was transferred. There was no further documented evidence the fetus/unborn child was assessed for stability prior to the transfer.

7. On 09/24/18 at 1:25 PM Staff C and Staff E were asked for the facility's policies on ED patient assessment and pregnant ED patient assessment. None was provided during survey.

8. Staff A, Medical Director of Emergency Department, was interviewed on 09/24/18 between 4:02 PM and 4:55 PM. Staff A has been the Medical Director since January of 2018. Staff C, Staff D and Staff E were also present for the interview.

During the interview Staff A was provided a copy of Patient #1's medical record for review. Staff A was asked how FHT (fetal heart tones) are assessed in pregnant patients. Staff A stated "younger" doctors are using ultrasound equipment, and the "older" doctors are being trained to use ultrasound. Staff A stated FHT should be documented in the medical decision making note or physical examination by the physician. Staff A stated there is also a handheld Doppler device that can be used to detect FHT.

Staff A was asked if a number would be documented if staff assessed FHT. Staff A stated a number or range, usually in the 140's, should be documented. Staff A stated he likes to have a number or documenting "present" is probably fine.

Staff A was asked if there was a Standard of Practice or procedure for assessing FHT and stated no. Staff A stated there were no
"Care Paths" for obstetrics.

Staff A was asked if there was anything in place to guide staff to conduct a fetal assessment and stated no, he didn't think so. Staff A explained that physicians do an assessment and examination and document the findings. Staff A explained that fetal movement was not usually palpated until 20 weeks. Staff A stated after 20 weeks, you can feel and palpate for movement. Staff A stated you could document this. Staff A stated you could also use ultrasound to detect fetal movement and document this.

Staff A was asked if the patient is asked if they feel fetal movement. Staff A stated that was the subjective part of the physician's note, ask the patient if they feel movement and how often. Staff A stated it should be documented in the physical exam.

Staff A was then asked specifically for Patient #1 and Patient #2 how the facility determined the fetus/unborn child was stable for transfer. Staff A stated you would not be able to. Staff A stated the facility doesn't have the capability to do so. Staff A stated FHT and fetal movement would factor into the determination, but they couldn't determine whether or not the fetus/unborn child was in distress.

Staff A was asked if he saw documented evidence FHT's were assessed on Patient #1 and confirmed they were not. Staff A stated there was no documented evidence in the attending or resident's note that FHT was assessed. Staff A stated the expectation was physicians document FHT. Staff D interjected and stated nursing was responsible assessing fetal movement but not FHT.

Staff A was asked about the reference in Patient #1's medical record to "33 weeks pregnant by ultrasound." Staff A confirmed there was no documented evidence an ultrasound was performed, but stated it could have been determined by looking in the electronic record.

9. On 09/25/18 at 8:30 AM Staff D provided a policy titled Triage Policy (reviewed 04/21/16) and stated there were no policies for assessment. Staff D was asked what standards of practice are used for documentation and assessment in the ED and stated the Joint Commission, American College of Emergency Physicians and the Emergency Nursing Association.

On 09/26/18 at 8:40AM a policy was presented titled "Care of the Obstretic Patient and Transfers to Other Facilities SOP. The policy target group was listed as Cleveland Clinic Health System Emergency Departments without Labor and Delivery units date last approved 04/21/2015. On 09/26/18 at 8:40AM per the Director of Quality this policy was not officially approved yet but used as best practice at this location. The policy listed South Pointe hospital and 8 other hospitals.

The purpose was listed to provide guidelines to the ED staff on the care and management of obstetric patients for whom delivery was imminent while in the ED and stated patients who present where delivery is imminent will be delivered in the ED. The policy also listed Instructions for patients that were Pregnant in Labor. At #1. Initial exam to be done immediately by the ED attending physician/LIP (licensed independent provider). 2. If patient has attending OB that physician is to be notified. 3. If in labor, and delivery is not imminent, the patient will be transferred to another facility that has OB services. Notify tranfer center and refer to EMTALA Transfer Policy and complete Consent to Transfer.

10. On 9/24/18 from 4:02 PM to 4:55 PM an interview was conducted with Staff A in the presence of Staff C, Staff D and Staff E regarding ongoing/continuing monitoring of the medical care provided in the emergency service department. Staff A confirmed one of the duties assigned to this employee was for the employee to review at least 10 medical records of each physician who works in the Emergency Department (ED) in 2018. Staff A stated the review is conducted to ensure completeness of documentation in accordance with standards of practice. When asked if these audits have been completed for 2018, Staff A responded they were completed in 2017 but have not been started for 2018 due to Staff A having questions about the process. Staff A stated after completion, the audit information is submitted to the emergency academy as part of the quality assurance process.

On 09/26/18 at 3:12 PM interviews were conducted simultaneously with Staff C, Staff D and Staff E. Staff E confirmed until Patient #1's medical record was reviewed during survey and discussed with the facility, the staff were not aware of the lack of Fetal Heart tones in Patient #1's October 2017 emergency medical record.

At this same interview, Staff D provided evidence of medical record audits for the emergency department for 2017 but did not have any for 2018. Staff E was unable to provide information the medical records for emergency room patients have been reviewed as part of quality assurance in 2018. None of the records reviewed during survey were reviewed as part of the hospital's QA process.

This deficiency substantiates Substantial Allegation OH00099770.













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