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Based on observation, record review, policy review and staff interview, the hospital failed to ensure a qualified medical person performed a medical screening examination to determine whether or not an emergency medical condition existed and failed to ensure qualified medical personnel was approved by the hospital's governing board as qualified to administer a medical screening examination (A2406). The hospital failed to ensure individuals transferred to another hospital had appropriate transfers including a physician signed certification with a summary of the risks and benefits of the transfer (A2409).

Based on medical record review, policy review, medical staff document review, and staff interview, the hospital failed to ensure a qualified medical person performed a medical screening examination to determine whether or not an emergency medical condition existed for one of 26 medical records reviewed (Patient #23) and failed to ensure qualified medical personnel was approved by the hospital's governing board as qualified to administer a medical screening examination. The sample size was 26. There were 38,042 emergency department visits from 01/01/2020 through 07/14/2020.

Findings include:

The Born Alive Infant Protection Act (Pub 107-207) of 2002 states an infant born alive at any age or any stage of development is an individual. EMTALA (42 US Code 1395 dd) states if an infant is born alive, the infant is an individual and the screening requirement of EMTALA applies. An appropriate medical screening exam must be provided to any individual who comes to an emergency department. An emergency department includes labor and delivery units/departments.

Staff F and Staff G were interviewed on 07/16/2020 at 3:31 PM and asked if they were aware of the Born Alive Infant Protection Act and it's implication to EMTALA. Staff G responded he/she had no knowledge of the law. Although Staff F stated he/she was aware of the existence of the Born Alive Infant Protection Act, he/she was uncertain of it's details.

The medical record of Patient #19 revealed the patient, a Gravida 6 Para 3 at an unknown gestation, presented to Obstetric Triage on 01/22/20 at 8:25 AM with complaints of a large gush of clear fluid that started at 4:30 AM that day and continued for several hours before the patient presented to Obstetric Triage. According to an obstetric physician's History and Physical (H&P), although the patient had no prenatal care, the fetus was dated at 24.2 weeks gestation by a special studies ultrasound using biometry. A cervical exam revealed the patient's cervix was visually closed. The H&P also noted there was currently no evidence of labor. The fetal heart tracing was noted to be a Category I, or normal, fetal heart tracing with no apparent signs of fetal distress. The fetal heart rate was noted to be 155 beats per minute. A Nitrazine Test was positive indicating preterm premature rupture of membranes (PPROM) had occurred. The H&P noted the patient reported that this pregnancy was unplanned and not desired.

An obstetrics physician noted the patient was counseled extensively on the recommended management of pregnancy with early membrane rupture and the patient reported she did not want to continue the pregnancy, did not want resuscitation of the fetus, and elected for comfort measures only. A facility neonatologist, ethicist, and maternal fetal medicine (MFM) physician were also consulted to speak to the patient.

The note from the ethics consult revealed the patient reported wanting to terminate the pregnancy when she became aware of the pregnancy three to four months ago; however, the patient reported not having the financial resources to pursue the termination. The ethicist documented that the patient had the "autonomous right to make an informed refusal of treatment" and to make decisions believed to be in the best interest of the fetus. It was further noted that the patient was informed of the risks, benefits, and alternative treatment and the patient elected to pursue this treatment limitation.

The neonatologist's consult note revealed he/she discussed with the patient the survival rate for a 24 week fetus was approximately 60%. A note also revealed the neonatologist explained the hospital policy regarding the management of periviable infants. It was explained that the decision for resuscitation or comfort care is at the discretion of the mother until 24 6/7 weeks gestation but at 25 weeks and 0 days, facility policy would require the infant to be resuscitated. The patient requested comfort measures only and the decision was made to induce the patient's labor. The patient was transferred to the labor and delivery unit for an induction of labor with Pitocin.

The Medication Administration Record (MAR) revealed the Pitocin infusion was initiated at 2 milliunits per minute at 10:11 PM on 01/22/2020 and was increased regularly over the next two days. The Delivery Summary noted the patient delivered an infant male on 01/25/2020 at 2:19 AM weighing 630 grams (1.389 pounds). The apgars, which were assigned by a labor and delivery staff nurse, were 6 at one minute of life, 3 at five minutes of life, and 3 at 10 minutes of life. The infant was 24.5 weeks gestation at the time of delivery. The infant was placed skin to skin on mom. At the time of birth, the infant was noted by a labor and delivery registered nurse to have a heart rate greater than 100 beats per minute. The infant's heart rate had decreased to 63 beats per minute by 2:29 AM, although the activity of the newborn was described as "spontaneous." The nurse further noted he/she was unable to elicit developmental reflexes, the newborn had ten fingers and ten toes, and the scapula was positioned symmetrically.

The medical record lacked documentation of a medical screening exam to determine the need for stabilizing treatment or transfer. At 3:02 AM, the staff nurse noted the newborn's heart rate was 44 beats per minute and described the infant as non-responsive. At 3:05 AM, the nurse noted the infant was "gasping." The infant was pronounced deceased at 3:51 AM. The medical record lacked documentation a physician was present at the birth of the infant to perform a medical screening exam.

Staff F was interviewed on 07/16/2020 at 1:07 PM and asked to provide documentation a medical screening exam was performed for the newborn. Staff F stated he/she had reviewed the medical record and could find no documentation of a medical screening exam. He/She also stated staff pediatricians are responsible for performing the medical screening exam as staff nurses are not qualified to perform this exam.


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Review of the policy titled, "CP - 79 - EMTALA Medical Screening Examination and Stabilization" revised September 2016 revealed a medical screening exam (MSE) would be provided when an individual comes to the emergency department or any other area of the hospital campus seeking emergency care or requests an examination or treatment for an emergency medical condition (EMC). The purpose of an MSE was to determine if an EMC existed. The MSE would be provided by physicians or Qualified Medical Personnel (QMP) who were appropriately approved and privileged through the medical staff bylaws or rules and regulations. The governing body must approve rules and regulations or by-laws that designate the qualifications and scope of practice for QMP. Qualified licensed independent practitioners (LIP) may be considered QMP for purposes of providing the MSE if they have been credentialed and approved by the facility as qualified to perform the MSE.

Review of the medical staff bylaws and medical staff rules and regulations revealed no specific language regarding MSE, EMC, or QMP.

Review of the "UH Hospitals Emergency Medicine Privilege Form" revised 10/19 revealed core privileges included, "Assess, evaluate, diagnose, and initially treat patients of all ages who present in the Emergency Department with any symptom, illness, injury or condition. Provide immediate recognition, evaluation, care, stabilization and disposition in response to acute illness and injury." The form lacked specification regarding MSE or QMP.

Review of the "UH Hospitals Certified Nurse Practitioner/Nurse Specialist/Physician Assistant Privilege Form" revised 7/19 revealed core privileges included, "Order, perform, and interpret diagnostic studies, administer intravenous fluids, assess patients and develop and implement treatment plans for patients, administration of medication to the extent permitted by law, initiate and change orders on patient charts, initiate consults/referrals, monitor the effectiveness of therapeutic interventions, obtain medical history and perform physical examination." The form lacked specification regarding MSE or QMP.

On 07/16/2020 at 9:00 AM, Staff B, C, and D were interviewed. The staff stated that the bylaws and medical staff rules and regulations define the medical staff, but do not specifically discuss the MSE or QMP. The privilege forms for the physician and LIP credentials detail the responsibility for assessment, treatment, and responsibility for emergency care, but do not contain the exact wording for MSE or QMP. The only providers who can perform a MSE would be physicians or LIP, registered nurses would not be able to conduct a MSE.

This substantiates Substantial Allegation OH00109890.

Based on policy review, medical record review and staff interview, the hospital failed to ensure individuals transferred to another hospital had appropriate transfers including a physician signed certification with a summary of the risks and benefits of the transfer for one of five medical records of transferred patients reviewed (Patient #15). The sample size was 26. There were 38,042 emergency department visits from 01/01/2020 through 07/14/2020.

Findings include:

Review of the policy titled, "CP-77-EMTALA Transfer" revised September 2016 revealed an appropriate transfer included a physician certification of risk and benefits. "The certification contains a complete picture of the benefits to be expected from appropriate care at the recipient facility and the risks associated with the transfer, including those associated with the time away from an acute care setting that is necessary to execute the transfer."

Review of the medical record for Patient #15 revealed an arrival date of 05/22/2020 at 5:12 PM to the emergency department. The medical record contained documentation the patient had decompensated psychosis and an "Application for Emergency Admission" (involuntary admission) was dated 05/23/2020 at 7:33 AM. The medical record contained documentation the patient was transferred to a psychiatric facility on 05/23/2020 at 2:24 PM. The medical record lacked documentation of a transfer document that listed the risks and benefits of the transfer signed by the physician.

On 07/16/2020 at 2:35 PM, Staff E verified the "Transfer Note," which contained the physician certification for transfer including the summary of risks and benefits of transfer, was not completed for Patient #15. Staff E stated that as psychiatric patients were unable to consent to transfer, the only form required for transfer was the "Application for Emergency Admission". Staff E verified the "Application for Emergency Admission" did not contain the risks associated with the actual transportation between facilities such as a car accident.