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SHENANDOAH, IA 51601

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Tag No.: C2400

Based on document review and staff interviews, the Critical Access Hospital's (CAH) administrative staff failed to ensure 2 of 12 patients who presented to the Emergency Department (ED) between 5/1/2017 to 1/8/2018 seeking care for an obstetrical complaint (Patient #1 and Patient # 2) received an appropriate medical screening exam within its capabilities and capacity. The CAH's administrative staff identified an average of 34 ED patients per month who presented and requested emergency medical care.

Failure to conduct an adequate medical screening exam within the CAH's capabilities and capacity resulted in Patient #1 returning to the CAH by ambulance approximately 13 hours after discharge in respiratory arrest, and Patient # 2 returning by ambulance 2 ½ hours after discharge in active labor.

Please refer to C-2406 for additional information

Findings included:

1. Review of the policy "COBRA-EMTALA" effective June 1, 2017 revealed in part, that "A pregnant woman who comes to the DED (Dedicated Emergency Department) ... ....seeking medical treatment related to pregnancy shall be immediately transported ..... to the Labor and Delivery Department which shall function as a DED for purposes of providing the Medical Screening Examination ...." "The medical screening exam is an ongoing process." "Monitoring must continue until the individual is stabilized or appropriately admitted or transferred."

2. Review of the "OB-Medical Screening Exam for Labor Status by Qualified Medical Personnel" effective May 5, 2017 revealed in part, "Purpose: To provide assessment and treatment for the obstetric patient at 20 weeks of gestation or greater who presents to the hospital as an unscheduled patient or to provide OB assessment support to the Emergency Department for any OB patient in conjunction with a medical provider."

3. Review of the medical record revealed Patient #1 presented to the CAH on 9/30/2017 at 7:30 PM seeking obstetrical care (due date 10/2/17). and was discharged undelivered on 10/1/17 at 11:33AM. During her stay, Patient # 1 experienced critically high blood pressures, lower leg edema and a headache, all signs of preeclampsia (if left untreated it can lead to serious, even fatal complications for mother and/or baby). The medical record did not contain evidence that patient # 1's blood pressure and edema were addressed. After being sent home the patient returned by ambulance the next night following a probable preeclamptic seizure. Cardio-pulmonary resuscitation (CPR) was initiated at home for unresponsive respiratory arrest when paramedics arrived. Patient # 1 had an emergency C-section, her and her baby were transferred to higher level hospitals. Patient #1 never regained consciousness and died on 1/12/2018 at the receiving hospital.

4. Review of Patient #2's medical record revealed this was a 7th pregnancy and she has 5 living children. Patient #2 was 25 weeks pregnant. (A pregnancy at full term is 38 - 40 weeks.) Patient #2 presented to the Shenandoah Emergency Department on 11/26/2017 at 6:43 PM with complaints of cramping and spotting of blood. Contraction intensity was mild, contractions are every 3-4 minutes apart lasting 50 to 80 seconds on 11/26/2017 at 7:30 PM. No vaginal exam was performed. Patient #2 was discharged at 10:26 PM. Patient #2 returned 2 hours and 26 minutes later by ambulance from another CAH and spontaneously delivered a very premature baby within a few minutes of arrival.

Please refer to C-2406 for additional information concerning the hospital's failure to provide patient # 2 with a medical screening examination.

MEDICAL SCREENING EXAM

Tag No.: C2406

Based on document review and staff interviews, the Critical Access Hospital's (CAH) administrative staff failed to ensure 2 of 12 patients who presented to the Emergency Department (ED) between 5/1 /2017 to 1/8/2018 with an obstetrical complaint (Patient's #1 and #2) received an appropriate medical screening exam. The CAH's administrative staff identified an average of 34 ED patients per month who presented and requested emergency medical care.

Failure to conduct an adequate medical screening exam including ongoing monitoring, resulted in Patient #1 returning to the CAH by ambulance approximately 13 hours after discharge in respiratory arrest, and Patient #2 returning by EMS 2 ½ hours later in active labor.

Findings included:
1. Review of the policy "COBRA-EMTALA" effective June 1, 2017 revealed in part, that "A pregnant woman who comes to the DED (Dedicated Emergency Department) ... ....seeking medical treatment related to pregnancy shall be immediately transported ..... to the Labor and Delivery Department which shall function as a DED for purposes of providing the Medical Screening Examination ...." "The medical screening exam is an ongoing process." "Monitoring must continue until the individual is stabilized or appropriately admitted or transferred."

2. Review of the "OB-Medical Screening Exam for Labor Status by Qualified Medical Personnel" effective May 5, 2017 revealed in part, "Purpose: To provide assessment and treatment for the obstetric patient at 20 weeks of gestation or greater who present to the hospital as an unscheduled patient or to provide OB assessment support to the Emergency Department for any OB patient in conjunction with a medical provider." "Procedures: E. If the patient is to be observed and discharged, the nurse will ... ... calculate the discharge assessment score after the observation time has lapsed. The nurse will notify the physician of the discharge assessment score before the patient's dismissal from the unit." The scoring tool includes an assessment of four clinical indicators that are evaluated with a vaginal exam. No vaginal examination was completed and the Obstetrical Medical Screening Tool was not found in the Patient #2's medical record.

3. Review of the medical record revealed Patient #1, 39 weeks pregnant presented to the hospital's Obstetrical (OB) Department for induction of labor on 9/30/2017 at 7:30 PM. The OB nurse triaged patient # 1 and documented the patient was a high risk teen pregnancy and had "edema" (swelling) in both ankles. Further documentation showed patient # 1's blood pressure was continuously monitored from 7:39 p.m. on 9/30/17 through 11:02 a.m. on 10/1/17. At 7:45 p.m. patient # 1's blood pressure was recorded at 168/101 (normal range is between 120-140 / 80-90). During the approximately 16 hours of monitoring, patient # 1's blood pressure was consistently higher than the normal range.

At 8:08 a.m. on 10/1/17, the OB nurse documented that Cytotec 25 mcg, the medication used for cervical ripening (the process of preparing the cervix for labor) had been held due to the patient's "frequent contractions even though they were mild in quality." At 8:14 a.m. patient # 1's blood pressure was 151/107. At 8:44 a.m. the OB nurse documented patient # 1 complained of a headache rated "6" on a scale of 1-10 (10 most severe), "states not having any pain with contractions now but that the headache is becoming unbearable and that [she] has migraines routinely and this is becoming one." The OB nurse gave the patient Tylenol. Further documentation showed that at 9:45 a.m. patient # 1's obstetrician performed an examination and determined that the patient's cervix remained unfavorable for induction of labor. At 9:45 a.m. the patient's blood pressure was 147/104, and at 10:14 a.m. 161/123. At 10:58 a.m. the OB nurse documented patient # 1 wanted to go home.

At 11:33 a.m. on 10/1/17 the OB nurse documented patient # 1 was instructed to resume normal activities, and to call her doctor if she had any fever, pain, leakage of amniotic fluids, vaginal bleeding, decrease in baby's movement, or regular strong uterine contractions/labor begins. Patient # 1's medical record failed to include evidence the CAH staff treated Patient # 1's high blood pressure or performed an examination sufficient to determine she did not have pre-eclampsia (a potentially serious pregnancy complication characterized by high blood pressure in excess of 140/90 along with one or more other symptoms including new-onset headaches or visual disturbances ...).

Review of a second medical record showed patient # 1 returned to the CAH by ambulance on 10/2/17 at 2:00 a.m., approximately 13 hours after discharge in cardio-pulmonary arrest.

4. Review of Policy # 1220, version 7, effective May 5,2017 titled, "OB- Medical Screening Exam for Labor Status by Qualified Medical Personnel reveals, in part, "Purpose: To provide assessment and treatment for the obstetric patient at 20 weeks of gestation or greater who present to the hospital as an unscheduled patient or to provide OB assessment support to the Emergency Department for any OB patient in conjunction with a medical provider." "Procedures: E. If the patient is to be observed and discharged, the nurse will ... ... calculate the discharge assessment score after the observation time has lapsed. The nurse will notify the physician of the discharge assessment score before the patient's dismissal from the unit." The scoring tool includes an assessment of four clinical indicators that are evaluated with a vaginal exam. The Obstetrical Medical Screening Tool was not found in the Patient #1's medical record.

5. Review of "Obstetric Medical Screening Tool" revealed in part, "Part A: If conditions, in Part A, are present, notify the patient's physician and receive orders for further management and do not complete Part B....Blood Pressure (BP) less than 80/40 or greater than 160/100...Part D: NOTIFICATION/DISPOSITION Part A= If any are present, patient is admitted and physician is contacted for orders".

6. During an interview on 1/10/2018 at 12:40 pm, Registered Nurse (RN) E identified she entered the admission assessment on the night of 9/30/17. RN E said a blood pressure reading between 140/90 to 160/110 would be considered a severe value and there had been training informing nurses any blood pressure over 140/90 is to be reported to the Obstetrician.

During an interview on 11/7/17 at 2:55 PM, RN D revealed she cared for Patient #1 on 10/1/17 from 7:00 AM until discharge and informed Obstetrician A of the high elevations in the patient's blood pressure. RN D reported elevated blood pressures are a concern because it could be a sign of preeclampsia; RN D also revealed Patient #1 was not being treated for an elevated blood pressure.

During an interview on 11/7/2017 at 3:44 PM Obstetrician A revealed Patient #1 had a history of high blood pressure and he was aware of Patient #1's high blood pressures during her stay. Obstetrician A said he was not concerned with the blood pressures as he stated it is common with women in labor.

During an interview on 1/10/2018 at 11:20 AM, Obstetrician A acknowledge patient # 1's medical record did not contain orders for inpatient admission as he forgot to put them into the system. He identified nothing should have happened and the nurses should have called him. Obstetrician A denied having knowledge of any high blood pressures, saying the nurses should have informed him of the blood pressure values as he is unable to obtain that information on the computer system he has access to. Obstetrician A reported had he known the blood pressures were high he would have approached treatment differently. Obstetrician A was aware of Patient #1's headaches as Patient #1 had a history of migraines.

7. Review of a medical record revealed Patient #2 presented to the Shenandoah OB unit on 11/26/2017 at 6:43 PM with complaints of cramping and spotting of blood during her third trimester of pregnancy. At 7:43 p.m. the OB nurse documented contact with the on-call OB physician and that patient # 2 complained of "cramping, spotting, mucus discharge." Further documentation showed the OB physician ordered a urine test which revealed the patient had a urinary tract infection (UTI), Additional orders included an intravenous (IV) antibiotic (2 grams of Ancef) for treatment of the UTI, intravenous fluids for hydration and instructions for the OB nurse to call back with an update on patient # 2's status after his orders were completed.

The OB nurse E placed patient # 2 on the fetal monitor for continuous monitoring. At 7:30 PM on 11/26/17 documentation showed that patient # 2's contractions were mild, 3-4 minutes apart and lasted 50 to 80 seconds. Documentation showed that a vaginal examination to determine if the contractions were of sufficient quality to make changes in the cervix was not performed. At 9:46 PM on 11/26/2017 OB nurse E spoke with OB physician B on the telephone and received orders for discharge. OB nurse E documented at 9:51 PM 11/26/2017 that the patient was still experiencing some minor cramping, and some uterine irritability was being picked up by the fetal monitor and that the monitoring was discontinued. OB nurse E discharged Patient #2 at 10:26 PM with instructions to return if her contractions were less than 5 minutes apart, or if she experienced any of the following: inability to breath through contractions, vaginal bleeding, leaking of fluid, decreased fetal movement, headache that is severe and persistent, visual disturbances, sudden shortness of breath, pressure or rectal pain, or urinary frequency.

The medical record did not contain evidence that the obstetrical qualified medical professional (QMP) examined patient # 2, who was at higher risk for prenancy complications such as early labor having already delivered five infants (grand multiparity), or her fetus to determine whether or not an emergency medical condition existed.

Review of Hospital B's medical record showed that patient # 2 presented to their emergency department with severe cramping and in active labor at 11:41 p.m. on 11/26/17, approximately 80 minutes after discharge from Shenandoah Medical Center.

An interview with the RN E at 12:40 PM on 1/10/2017 revealed that she did not perform a vaginal exam and indicated that nurses at this CAH do not do vaginal exams until the patient reaches 37-38 weeks gestation. The doctor on call would come in and do the vaginal exam if needed. The RN E indicated they generally monitor a patient for at least 20 to 30 minutes after providing a treatment such as medication to see if it is effective. If they are not seeing anything at the 30 minute mark the nurse will call the doctor and ask for further direction. OB nurse E revealed in this particular case the patient had a significant UTI and had complained of some vaginal bleeding. OB nurse E stated that patient # 2 felt better after the IV fluids and antibiotic and wanted to go home.

An interview with Dr. B at 10:14 AM on 1/10/2017 revealed that he did not come in to see Patient #2. He received a phone call that the patient had come in, was 25 weeks with complaints of cramping and spotting. A urinalysis indicated a urinary tract infection and he treated her for this. He reported initially that she was having minimal contractions when she left but they were not painful and attributed them to the bladder infection. A short time later he reported the contractions went away with antibiotic and she was not uncomfortable. If contractions would have persisted he would have been more concerned and would have come in.