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Based on record review and policy review, the hospital failed to provide within its capability and capacity, an appropriate medical screening examination (MSE) for two patients (#12 and #14) of 20 Emergency Department (ED) and Obstetric (OB, the branch of medical science concerned with childbirth and caring for and treating women in or in connection with childbirth) records reviewed from 01/01/22 to 01/30/22 and 03/01/23 to 05/15/23. These failed practices had the potential to cause harm to all patients who presented to the ED and OB seeking care for an emergency medical condition (EMC). The hospital's average ED monthly census over the past six months was 1,013. The hospital's average OB monthly triage (process of determining the priority of a patient's treatment based on the severity of their condition) visits over the past six months was 100.

Findings included:

Review of the hospital's policy titled, Emergency Medical Treatment and Active Labor Act (EMTALA) Policy," dated 07/2021, showed a MSE is the process required to reach, with reasonable clinical confidence, the point at which it can be determined whether or not an EMC exists, or with respect to a pregnant woman having contractions (the periodic tightening and relaxing of the uterine muscle), whether the woman is in labor. The MSE can be performed by a Qualified Medical Professional (QMP), which could include a trained OB nurse.

Review of hospital's policy titled, "Obstetrical Medical Screening on Labor and Delivery," dated 12/2021, showed an exam and assessment should be completed in the electronic medical record (EMR) or paper documentation. The exam included an assessment of the status of membranes (a fluid-filled bag [amniotic sac] that surrounds and protects the fetus) as intact or suspected ruptured with a ROM plus test (rapid test for the detection of amniotic fluid in vaginal secretions of pregnant women with signs and symptoms of rupture of membranes) when possible. The status of ruptured membranes exam also included the time membranes ruptured, color, odor and amount of any fluid present. That assessment includes a sterile vaginal exam to determine cervical dilation (opening of the cervix [the lower, narrow end of the uterus that forms a canal between the uterus and vagina]), cervical effacement (shortening of the cervix), fetal station (depth of the leading part of the baby into the mother's pelvis [large boney structure near the base of the spine]), cervical position (location of the cervix relative to baby's leading part and the mother's pelvis), cervical consistency (feel of the cervix ranging from firm to soft), fetal presentation (body part of the baby is leading into the pelvis) and fetal position (placement of the baby's leading part relative to the pelvis). Assessment also includes the maternal response to uterine contractions.

Review of the hospital's policy titled, "Pain Management," dated 12/14/21, showed all patients will be assessed on admission for pain utilizing a numeric rating scale of zero to 10 and regular reassessments will be performed, as indicated, based on the patient's condition at regular intervals, at least every four hours and after every pain management intervention, including medication administration.

Review of Patient #14's medical record dated 01/22/22, showed she was a 23-year-old pregnant female at 38 weeks gestation (a measure of the age of a pregnancy which is taken from the beginning of the woman's last menstrual period and the date of delivery, full-term is defined as 39 weeks through 40 weeks and 6 days) who presented at 3:25 AM and reported that her water broke at 2:00 AM the same day. Staff K, RN, performed an initial assessment which included vital signs (body temperature, blood pressure, heart rate, and breathing rate), collection of a ROM plus test, monitoring of fetal heart rate (FHR, the number of times the heart beats within a certain time period, normally between 110 to 160 beats per minute) and contractions, and the patient's description of "constant right upper abdominal pain that increased and decreased". There was not a numeric rating of the patient's perceived pain level documented. Staff K performed a vaginal examination of the patient at 3:42 AM and at 4:59 AM and documented that she was six centimeters (cm, unit of measure) dilated. The ROM plus resulted as negative for amniotic fluid. Patient #14's contractions throughout her triage were documented as no contractions, then irritability (uncoordinated uterine contractions that do not result in cervical change) and then mild contractions for the last hour and one-half before discharge. Staff E, OB Physician, was notified at 7:30 AM of Patient #14's contraction status, laboratory results and FHR. An order for discharge was received, the patient was discharged at 7:43 AM with instructions to return to the hospital if she developed a fever, experienced cramping, continuous pain, painful contractions or fluid leaking which saturated a pad. Patient #14's vital signs and vaginal examination were not repeated within an hour prior to discharge. Her numeric pain level was never documented as assessed. There was no documentation of an assessment of cervical effacement, cervical position, cervical consistency, or fetal station, position or presentation for the triage visit.

Patient #14 reported to Hospital B, a Critical Access Hospital (CAH, a small facility that gives limited outpatient and inpatient hospital services to people in rural areas) later that same day and was determined to be in active labor. She was given an intravenous (IV, in the vein) antibiotic, and delivered her baby on 01/23/22 at 02:17 AM. The baby was transported via helicopter to Hospital C for neonatal evaluation, admitted and treated with IV antibiotics for two weeks.

Review of Patient #12's OB triage record, dated 03/08/23 at 7:45 PM, showed she was a 27-year-old female at 38 weeks and four days gestation who presented with contractions. Patient #12's history included six vaginal births. Her vaginal examination showed she was at four cm of dilation, 80% effacement, and minus one fetal station and ballotable (baby is not engaged in the mother's pelvis, will float away when pressure applied to leading part) with her cervix in the middle position and soft. Her pain level was seven. Between 8:15 PM and 10:45 PM, she contracted every two to six minutes. A repeat vaginal examination performed at 9:20 PM, showed four cm of cervical dilation. There was no documentation of cervical effacement, cervical position, cervical consistency, fetal station, fetal position, or fetal presentation. There were no additional assessments for pain and Patient #14 was discharged to home at 10:55 PM on 03/08/23. On 03/09/23 at 12:40 AM, Patient #14 returned to the OB triage via ambulance after a precipitous vaginal delivery (when a baby is born within three hours of regular contractions starting) at home on 03/08/23 at 11:31 PM, 36 minutes after discharge.








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Based on interview, record review and policy review, the hospital failed to provide within its capability and capacity, an appropriate medical screening examination (MSE) for two patients (#12 and #14) of 20 Emergency Department (ED) and Obstetric (OB, the branch of medical science concerned with childbirth and caring for and treating women in or in connection with childbirth) records reviewed from 01/01/22 to 01/30/22 and 03/01/23 to 05/15/23. These failed practices had the potential to cause harm to all patients who presented to the ED and OB seeking care for an emergency medical condition (EMC). The hospital's average ED monthly census over the past six months was 1,013. The hospital's average OB monthly triage (process of determining the priority of a patient's treatment based on the severity of their condition) visits over the past six months was 100.

Findings included:

Review of the hospital's policy titled, Emergency Medical Treatment and Active Labor Act (EMTALA) Policy," dated 07/2021, showed a MSE is the process required to reach, with reasonable clinical confidence, the point at which it can be determined whether or not an EMC exists, or with respect to a pregnant woman having contractions (the periodic tightening and relaxing of the uterine muscle), whether the woman is in labor. The MSE can be performed by a Qualified Medical Professional (QMP), which could include a trained OB nurse.

Review of hospital's policy titled, "Obstetrical Medical Screening on Labor and Delivery," dated 12/2021, showed an exam and assessment should be completed in the electronic medical record (EMR) or paper documentation. The exam included an assessment of the status of membranes (a fluid-filled bag [amniotic sac] that surrounds and protects the fetus) as intact or suspected ruptured with a ROM plus test (rapid test for the detection of amniotic fluid in vaginal secretions of pregnant women with signs and symptoms of rupture of membranes) when possible. The status of ruptured membranes exam also included the time membranes ruptured, color, odor and amount of any fluid present. The assessment included a sterile vaginal exam to determine cervical dilation (opening of the cervix [the lower, narrow end of the uterus that forms a canal between the uterus and vagina]), cervical effacement (shortening of the cervix), fetal station (depth of the leading part of the baby into the mother's pelvis [large boney structure near the base of the spine]), cervical position (location of the cervix relative to baby's leading part and the mother's pelvis), cervical consistency (feel of the cervix ranging from firm to soft), fetal presentation (body part of the baby leading into the pelvis) and fetal position (placement of the baby's leading part relative to the pelvis). Assessment also included the maternal response to uterine contractions.

Review of the hospital's policy titled, "Pain Management," dated 12/14/21, showed all patients will be assessed on admission for pain utilizing a numeric rating scale of zero to 10 and regular reassessments will be performed, as indicated, based on the patient's condition at regular intervals, at least every four hours and after every pain management intervention, including medication administration.

1. Review of Patient #14's medical record from 01/22/22 showed she was a 23-year-old pregnant female at 38 weeks gestation (a measure of the age of a pregnancy which is taken from the beginning of the woman's last menstrual period and the date of delivery, full-term is defined as 39 weeks through 40 weeks and 6 days) who presented to Northeast Regional Medical Center (NRMC) at 3:25 AM and reported that her water broke at 2:00 AM. Patient 14's history included two vaginal births. Staff K, Registered Nurse (RN), performed an initial assessment which included vital signs (body temperature, blood pressure, heart rate, and breathing rate), collection of a ROM plus test, monitoring of fetal heart rate (FHR, the number of times the heart beats within a certain time period, normally between 110 to 160 per minute) and contractions (the periodic tightening and relaxing of the uterine muscle), and documented the patient's report of "constant right upper abdominal pain that increased and decreased". Staff K performed vaginal examinations at 3:42 AM and 4:59 AM and documented that she was six centimeters (cm, unit of measure) dilated. Staff E, OB physician, was notified at 7:30 AM of Patient #14's contraction status, laboratory results and FHR. An order for discharge was received, the patient was discharged at 7:43 AM. FHR were documented as between 130 and 145 per minute. Her contractions were documented first as no contractions present, then irritability (uncoordinated uterine contractions that do not result in cervical change) and then as mild contractions for two hours before discharge. Patient #14's vital signs were not reassessed within an hour of her discharge. A vaginal examination was not repeated within two and one-half hours prior to discharge and there was no documentation of cervical effacement, cervical position, cervical consistency, or fetal station, position or presentation during her entire triage visit. Her numeric pain level was never assessed.

Review of Patient #14's medical record from Hospital B, a Critical Access Hospital (CAH, a small facility that gives limited outpatient and inpatient hospital services to people in rural areas), showed she presented on 01/22/22 at 11:51 PM. She reported that her water had broken at 2:00 AM and that she began feeling contractions after she reported to the ED at Hospital B. Vaginal examination at 12:22 AM showed "quite a bit of fluid," the patient's cervix was dilated eight cm, 80% effaced, and the baby's head was present in an occiput anterior (baby's is facing towards the mother's backside) position. FHR was documented between 197 and 206 within the hour before his delivery. Patient #14's was given an intravenous (IV, in the vein) antibiotic. Patient #14's vaginal examination showed progression to ten cm, 100% cervical effacement and the baby was delivered on 01/23/22 at 02:17 AM. A specialty transport team from Hospital D was present during the delivery and for newborn stabilization. The newborn's temperature was initially recorded as 101F, he was hypoglycemic (low blood sugar) and had weak respirations. The mother and baby were transferred to Hospital C (an acute care hospital).

Review of Patient #14's baby's Critical Care Transport (CCT) record on 01/23/22 showed the team was contacted by the ED physician at Hospital B at 00:40 AM for a newborn anticipated to deliver at a CAH without labor and delivery or neonatal services. At 2:18 AM (immediately after delivery) the baby's appearance was documented as pink with blue extremities and weak respirations, but no resuscitative measures were required. The baby's initial temperature was recorded as elevated at 100.9F and his blood glucose (sugar that circulates in the blood and when too high or too low can be detrimental to a person's health) was 65. At 4:40 AM a critical low (unmeasurable, less than 30) blood glucose was reported and the baby was given oral glucose and electrolytes. At 4:55 AM another critical low blood glucose was recorded, an IV was started and the baby was given Dextrose 10% (D10W, solution of dextrose [sugar] in water for injection for intravenous injection to replace fluid and nutrients) through the IV. At 05:15 AM vital signs were within normal ranges including a temperature of 97.0F and a blood glucose reading of 78. Patient #14 and her baby were transferred to Hospital C.

Review of Patient #14's baby's medical record from Hospital C showed that he was born on the date of admission 01/23/22 at Hospital B and transferred due to Patient #14's rupture of membranes for greater than 24 hours before delivery, respiratory distress and low blood glucose. The baby's complete blood count (CBC, a blood test performed to determine overall health including inflammation or infection) and C-reactive protein (CRP, a protein made by the liver) collected on admission to Hospital C were indicative of possible inflammation and infection. He required oxygen support, close monitoring of his blood glucose levels and was started on a regular schedule of IV antibiotics with concerns of sepsis (life threatening condition when the body's response to infection injures its own tissues and organs). Admitting diagnoses were large for gestational age newborn, need for observation, evaluation of newborn for sepsis, and respiratory distress of newborn. He remained hospitalized on IV antibiotics for 14 days. The baby was discharged home from Hospital C on 02/06/22.

During an interview on 05/17/23 at 8:30 AM, Staff E, Physician, Perinatal (relating to the time immediately before and after birth) Chairman, stated that if a patient whose ROM plus was negative and nursing staff or the patient reported continual leaking fluid, he would order that the test be repeated and he might come to the hospital to examine the patient himself. He did not recall what was reported to him regarding Patient #14's cervical condition regarding effacement, station and cervical position on 01/22/22, except that it was essentially the same as an examination completed two or three days prior. He would have expected another vaginal examination completed prior to her discharge.

During an interview on 05/17/23 at 9:30 AM, Staff F, RN, stated that a nurse would document leakage of fluid, blood on the examination glove and patient reports of discomfort during vaginal examination.

During an interview on 05/17/23 at 09:55 AM, Staff G, RN, Women's Services Director, stated that documentation of Patient #14's initial vaginal examination was incomplete because it did not include any observation assessed except for dilation of the cervix.

During a telephone interview on 05/18/23 at 11:00 AM, Staff I, OB Physician, stated that a ROM plus test could result a false negative. If the nurse was suspicious that a false negative had occurred, the physician would come to the hospital, perform a cervical examination on the patient and check for "ferning" (Dried amniotic fluid produces a microscopically visible crystallization in a "fern" pattern. Dried normal vaginal fluid does not produce a "fern" pattern) of vaginal fluid on a microscope slide.

During a telephone interview on 05/19/23 at 2:00 PM, Staff K, RN, stated that when a patient complained of their water breaking, the nurse would place a fetal monitor to assess the baby's status and see if contractions were occurring, would obtain a ROM plus test to see if amniotic fluid was present in the vagina and would do a vaginal examination to check the condition of the patient's cervix. She obtained the ROM plus and performed a vaginal examination when Patient #14 presented to the hospital on 01/22/22. She remembered that the cervix was very posterior (tilting towards the back). She omitted documentation of the condition of Patient #14's cervix other than dilation and did not document her pain assessment. If Patient #14 had reported any pain with contractions, she may have performed another vaginal examination after the exam at 4:59 AM. She did not believe that the ROM plus was a false negative result.

During a telephone interview on 05/23/23 at 5:30 PM, Staff M, Neonatal Nurse Practitioner, stated that Patient #14's baby was brought to Hospital C by Hospital D's CCT team. Patient #14's membranes were reported as ruptured for more than 24 hours and the baby was reported to have had an elevated temperature at delivery. The baby's CBC and CRP on admission were indicative of an infection. The baby was felt to possibly have been septic because of the advanced length of time that Patient #14's membranes were ruptured.

During a telephone interview on 05/24/23 at 9:00 AM, Staff N, ED Physician, stated that he cared for Patient #14 when she presented to the ED at Hospital B with complaints of labor. When she first presented, they were uncertain as to the mother's gestational age, or if she had received prenatal care, so he requested that the CCT team from Hospital D be present during the delivery. When he examined her, it was evident her membranes had ruptured, but he could not be certain how long they had been ruptured. He was not certain why he ordered IV azithromycin (a medication used to treat certain bacterial infections). He felt that the baby was doing well after delivery and was not concerned with sepsis.

During a telephone interview on 05/24/23 at 10:00 AM, Staff O, Registered Respiratory Therapist (RRT), stated that she was on the CCT team that responded to Hospital B during the delivery of Patient #14's baby. The gestational age of the baby was initially not known, so the team set up a special warmer for premature infants. The team felt the "chemical warmer" was the reason the baby's initial temperature registered elevated and all of the repeat temperature assessments were normal. There were no concerns with the baby immediately after delivery. She was uncertain as to why Hospital C would have been concerned about sepsis unless it was based on the baby's initial temperature.

2. Review of Patient #12's OB triage record, dated 03/08/23 at 7:45 PM, showed she was a 27-year-old pregnant female at 38 weeks and four days gestational age who presented with contractions. Patient #12's history included six vaginal births. Her first vaginal examination at 8:15 PM, showed she was at four centimeters of dilation, 80% effacement, and minus one fetal station and ballotable (baby is not engaged in the mother's pelvis, will float away when pressure applied to leading part) with her cervix in the middle position and soft. Her pain level was seven. Between 8:15 PM and 10:45 PM, she contracted every two to six minutes for 40 to 80 seconds in length with mild intensity. A repeat vaginal examination performed at 9:20 PM, showed four centimeters of cervical dilation. There was no documentation of cervical effacement, cervical position, cervical consistency, fetal station or fetal presentation. She had a repeat cervical examination at 10:40 PM, which showed four centimeters of dilation and a ballotable fetal station. There were no additional assessments for pain and Patient #14 was discharged to home at 10:55 PM on 03/08/23. On 03/09/23 at 12:40 AM, Patient #12 returned to the OB triage via ambulance after a precipitous vaginal delivery (when a baby is born within three hours of regular contractions starting) at home on 03/08/23 at 11:31 PM, 36 minutes after discharge.

Review of Patient #12's OB triage record, dated 03/08/23 at 10:37 AM, showed she presented with a complaint of decreased fetal movement. Pain was zero at 10:49 AM and at 11:00 AM. Documentation showed no contractions. Patient #12 was discharged to home on 03/08/23 at 11:33 AM.

Review of Patient #12's fetal monitoring strip, dated 03/08/2023 from 10:41 AM to 11:08 AM, showed FHR of 140 beats per minute and no contractions.

Review of Patient #12's fetal monitoring strip, dated 3/08/2023 from 7:58 PM to 10:46 PM, showed the fetal heart rate of 150 to 155 beats per minute. Contraction assessment showed irregular contractions between 7:58 PM to 8:54 PM and beginning at 8:55 PM, Patient #12 contracted every two to three and a half minutes.

During an interview on 05/17/2023 at 8:30 AM, Staff E, Physician, Perinatal Chairman, stated that it was unusual for an examination to be at a minus one station and ballotable.

During an interview on 05/17/2023 at 09:55 AM, Staff G, RN, Women's Services Director, stated that she would have expected an additional cervical examination to be performed on Patient #12, prior to discharge home. She "might be surprised" that Patient #12's fetal station was documented as minus one and ballotable, typically a fetal station was not ballotable at a minus one station.

During a telephone interview on 05/17/2023 at 6:30 PM, Staff H, RN, stated that Patient #12 seemed to be in pain, which was consistent with her initial pain assessment of seven out of ten, but did not feel it necessary to perform any additional pain assessments prior to discharge. She did not feel that an additional pain assessment was indicated after the Vistaril (a medication used to treat anxiety, vomiting, itching, and allergies) administration. She also stated, that she found it "unusual" that Patient #12 did not make any cervical change during her stay. She stated that Patient #12 seemed "upset and frustrated" at being discharged home, asking "How am I supposed to know when I am in labor?"

During a telephone interview on 05/18/23 at 11:20 AM, Staff J, RN, stated that during Patient #12's OB triage visit on 03/08/23 at 10:37 AM, she did recall asking Patient #12 if she was feeling any contractions, and Patient #12 had no complaints of contractions or pain.

During an interview on 05/17/2023 at 8:30 AM, Staff E, Physician, Perinatal Chairman, stated that active labor was contractions that bring about cervical change on vaginal examination. He stated that if a patient had a change in cervical effacement, that patient would be kept for a longer observation and cervical reexamination.

During an interview on 05/17/2023 at 9:30 AM, Staff F, RN, stated that active labor was determined by cervical change and complaints of painful contractions or strong contractions observed during fetal monitoring. A vaginal examination would include assessment and documentation of cervical dilation, cervical effacement, cervical position, fetal station, cervical consistency and fetal presentation; if able to determine. Repeat vaginal examinations were performed to assess for cervical change. She stated that a pain assessment was included in the vital signs assessment, and was performed upon patient arrival to OB triage. Pain would be reassessed with any interventions such as medication and treatment, and at a minimum of one additional time prior to discharge home.

During an interview on 05/17/2023 at 09:55 AM, Staff G, RN, Women's Services Director, stated that active labor was determined by any change in cervical dilation, cervical effacement, cervical position, and/or cervical consistency. Nurses documented cervical dilation, cervical effacement, cervical position, fetal station and fetal presentation during the initial vaginal examination and any pertinent change was documented on re-examination. She stated a pain assessment was included with the initial vital signs assessment and again with any change in patient status or intervention in care.

During an interview on 05/17/2023 at 11:00 AM, Staff A, RN, Chief Nursing Officer, stated that a pain assessment was expected upon arrival and the frequency of reassessment was dependent upon the situation, but at a minimum of every four hours. Additional pain reassessments would be performed following pain medication administration depending upon the expected onset of pain relief in relation to medication administration route.

During a telephone interview on 05/17/2023 at 6:30 PM, Staff H, RN, stated that an initial cervical exam would be completed as part of the MSE and the cervical dilation, cervical effacement, cervical position, cervical consistency and fetal presentation would be documented. She stated that when she performed a repeat cervical examination, she only documented cervical dilation, and she did not document cervical effacement, cervical position, cervical consistency or fetal presentation.

During a telephone interview on 05/18/23 at 11:00 AM, Staff I, OB Physician, stated that sometimes the cervical examinations performed by the nurses were "cut short, not the most thorough way of doing it." She also stated that it was important to assess the patient's body language in regards to pain and to report changes in observations, such as appeared to experience more or less pain than previous observation. She also stated that she would keep a patient for longer observation when the patient demonstrated pain.

During a telephone interview on 05/22/23 at 8:00 AM, Staff L, RN, stated that she may not perform a physical assessment of her own on a patient after receiving report from another nurse. It was not always necessary to repeat vital signs on a patient before they were discharged home. She did not remember caring for Patient #14.



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