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Based on observations, staff interviews, medical record and document reviews, the hospital failed to comply with 42 CFR 489.24, the EMTALA requirements as evidenced by:

1. The hospital failed to provide an appropriate medical screening examination within the capability of the hospital's emergency department (ED), including ancillary services routinely available to the emergency department, conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations, to determine whether or not an emergency medical condition (EMC) exists, for 4 of 24 sampled patients (Patients 1, 5, 7 and 9). (Refer to A2406)

2. The hospital failed to provide stabilizing treatment to a pregnant patient within the capabilities of the staff and facilities available at the hospital, before transferring the patient(s) to higher level of care, for 1 of 24 patients. (Refer to A2407)

3. The hospital failed to appropriately transfer a patient to another hospital, when the hospital failed to provide stabilizing treatments within the hospital's capabilities prior to transfer, to 4 of 24 sampled patients (Patients 1, 5, 7 and 9). The transfer was not effected with qualified personnel when ground ambulance was used staffed with one paramedic to care for two potential patients who may have required medical interventions simultaneously. (Refer to A2409)

4. Policies and Procedures (P&Ps) to set clear guidance and expectations in accordance with acceptable standards of practice were lacking for the assessment, management, and criteria necessary for the safe transfer of a pregnant patient in order to minimize risks and optimize the health and safety of the mother and/or her unborn child. P&Ps did not outline procedures or the full array of resources available to the hospital to expedite these tasks, in order to effect a successful outcome for mother and baby.

Findings:

4. Formal guidance to ED personnel to assess and monitor pregnant patients with EMC's was lacking.

During a tour of the ED with Registered Nurse (RN) 5 and RN 6 on 7/22/14 at 5:15 p.m., equipment to assess and treat pregnant patients in the ED was inspected. A device to amplify a baby's heart sounds if applied to the abdomen of a pregnant woman (Doppler) and a device to illuminate a woman's vagina were stored in a lower cabinet of a locked medication room near the clerical desks. Instruments to insert into a woman's vagina were stored in a central supply room. An infant warmer with life-saving equipment to support breathing and blood circulation was stored in a corner exam room. Life-saving medications for infants and children were stored in a rainbow-colored cart stationed in a corner opposite to where the infant warmer was located. A gurney equipped with foot supports (stirrups) for pelvic exams was stationed in a hall adjacent to the central supply room. RN 6 indicated that ED staff routinely supported examinations of women for rape using some of this equipment. All ED nurses were trained in rescue skills for infants, including newborns. A blood bank was available in the hospital laboratory for immediate access to blood for transfusions. A technician to perform pelvic ultrasound testing on pregnant patients was available 24 hours/day and radiologists to view the ultrasound images was also available 24 hours/day. When transport of critical patients was needed, ED staff could summon a Critical Care Transport team or helicopter that would be equipped with trained staff and equipment for both a mother in labor and a newborn needing medical interventions.

RN's 5 and 6 also stated that the hospital closed its obstetric services 3 years ago. One of the obstetricians who then provided care to women in labor was still available on a variable schedule (on-call) for gynecologic emergencies. RN's 5 and 6 indicated that the on-call physician was very approachable even if not on call to provide advice and guidance on the management of a pregnant patient with a medical emergency, such as active labor or imminent delivery. RN's 5 and 6 also indicated that the ED maintained a daily call schedule for pediatricians who had previously covered the care of newborns while the hospital had an obstetric service (experienced in stabilization of babies at birth).

In interviews with RN 2 (who worked in the ED) on 7/23/14 at 9 a.m., with Administrative Staff (AS) 2 (who managed the ED services) on 7/23/14 at 9:30 a.m., and with RN 4 (an obstetric nurse at Hospital 2 with an obstetric service) on 7/23/14 at 9:55 a.m., all indicated that once a baby's head had descended to the opening of the vagina or was visibly "crowning," delivery was imminent and the proper action was to set up for the rest of the delivery, not transfer the mother away from a hospital setting. Management of a patient with advanced labor or about to deliver included hydration, positioning, optimizing oxygenation, assessment of fetal heart rate, presence or amount of vaginal bleeding, breathing and pain control, comfort, and preparing to revive the infant if needed.

In a collaborative review of training materials for Emergency Department Registered Nurses on 7/24/14 at 11:10 a.m., AS 2 presented a training manual for obstetric emergencies. The training manual was reviewed annually by ED nurses (but not by ED physicians). The training manual noted that the evaluation of a pregnant patient included a pelvic examination and measurement of fundal height (how much the belly protruded). The training manual outlined the criteria for imminent delivery of a baby: uterine contractions less than 2 minutes apart, feeling of rectal fullness, urge to push, head presenting in vagina, and vaginal fluid leakage. The training manual contained guidance/procedures for preparing for delivery, monitoring fetal well-being (heart rate) using a stethoscope or sound machine (Doppler), and supporting the mother during labor. The equipment and skills to provide this care was all available to ED staff. The knowledge base of the nurses responsible for pregnant patients presenting to the ED in labor, or about to deliver a baby, was significantly deeper than that of the ED physicians interviewed. AS 2 confirmed that the expectations and standards of care for assessments and support of pregnant patients who may have pregnancy-related emergency medical conditions, such as active labor or imminent delivery of a baby, were partly outlined in the training manual. However, the content was not formalized in hospital policies or approved by the governing body.

Review of the ED P&Ps presented by the hospital as guidance for ED care related to pregnancy, labor and delivery, did not correspond to the content of the ED RN training. One P&P referenced a nursing text book, which contained 4 pages related to management of an unborn baby. Other polices were focused on the steps to arrange transfer of a pregnant patient to another hospital. No policy was presented to outline criteria or expectations for supportive care during the active stages of labor and imminent delivery. No policy clearly outlined the resources available to ED staff to assess, monitor and stabilize a pregnant patient in active labor or imminent delivery, or set criteria for a safe transfer of a pregnant patient with potential for these conditions.

Thus, formal procedures for physicians and nurses (providers of care to pregnant patients who present to the ED with potential EMC's) were not developed, implemented or approved by the governance leadership to ensure that the needs of women in labor and/or their unborn child were met.

Based on staff interviews, clinical record review, P&P (policy and procedure) and document reviews, the hospital failed to provide an appropriate medical screening examination within the capability of the hospital's emergency department (ED), including ancillary services routinely available to the emergency department, conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations, to determine whether or not an emergency medical condition exists, for 4 of 24 sampled patients (Patient 1, 5, 7, and 9), as evidenced by:

A. The ED staff functioning as Qualified Medical Personnel (QMP) failed to perform timely and complete physical assessments and use applicable resources available at the hospital, such as laboratory studies, ultrasound equipment and services, and ongoing nursing assessments and monitoring, to ensure that appropriate medical screening examinations (MSE) were provided timely to determine whether or not an emergency medical condition (EMC) existed (e.g. active labor and/or imminent delivery of a baby), for 4 of 24 sampled patients (Patient 1, 5, 7 and 9).

B. Medical Screening Examinations (MSE's) were conducted by individuals lacking current demonstrated competence in the assessment, management and delivery of pregnant patients who presented to the ED during various stages of labor, including imminent delivery of an infant, for 8 of 8 ED physicians reviewed (Medical Doctor-MD 1, MD 2, MD 3, MD 6, MD 7, MD 8, MD 9 and MD 14).

C. Determination of who was qualified to perform medical screening examinations was not documented in the medical staff bylaws, rules or regulations.

These failures put patients at risk for omissions or delays to provide medical interventions to minimize serious harm from emergency medical conditions that pose a threat to health and life, including the health of a mother or her unborn child.

Findings:

A. MSE's were incomplete or delayed.

A-1. A 7/22/14 review of Patient 1's ED record with Administrative Staff (AS) 1, who served as the hospital quality and risk manager, showed that Patient 1 was a 15 year old female who presented to the ED on 6/7/14 at 3:43 a.m. with a chief complaint reported to the registration clerk of "constipated, vaginal bleeding, cramps". The record showed that Patient 1 had no primary care physician.

Review of ED nursing triage (the process of determining the priority of patients' treatments based on the severity of their condition) and nursing progress notes indicated that Registered Nurse (RN) 1 triaged the patient at 3:52 a.m. for a chief complaint of "abdominal pain and constipation." The initial vital signs showed an elevated blood pressure (BP) of 156/107 and heart rate (HR) of 107 beats per minute (tachycardia, fast rate, normal HR is 60-100). Pain level was noted 8/10 (severe, zero no pain and 10 worst pain ever felt). RN 1 indicated that Patient 1 reported her last normal menstrual period was in March 2014. The patient also reported positive pregnancy test, but was not sure how many weeks pregnant she was. After triage Patient 1 was moved to the waiting room at 3:56 a.m.

Review of the ED policies showed no specific policy detailing emergency OB (obstetric) patient care in the ED.

Review of a policy titled "Emergency Nursing Procedures" (rev 8/2012) indicated, "The Emergency Department will utilize the Emergency Nursing Procedures textbook by Jean A Proehle for all Emergency Nursing Procedures not covered in (Hospital 1's name) policy." The textbook contained "Procedure 108 Assessing Fetal Heart Tones (FHT)" with instructions to assess fetal (unborn baby's) status when the pregnant patient was ill, injured, or in labor. FHT are also known as fetal heart rate (FHR). The equipment needed for assessing FHR included stethoscope and/or Doppler ultrasonic flowmeter (a hand-held ultrasonic device for detecting fetal heart tones, available in the hospital's ED). Consultation with an obstetrical nurse or physician was recommended early in the assessment of the pregnant patient to validate FHTs. The procedural steps included instructions for measuring FHTs and gave normal FHT ranges between 120 and 160 beats per minute. FHT less than 110 beats per minute (bradycardia) or greater than 160 beats per minute (tachycardia) may indicate fetal distress and should be reported immediately. It was further indicated to "Check the FHT each time the mother's vital signs are checked. If mother is in labor, FHTs should be checked at least every 15 minutes in early labor and every 5 minutes during the second stage of labor."

The Merck Manual for Health Care Professionals defined stages of labor in "Management of Normal Labor" (retrieved on line at: ) as follows:

"Labor begins with irregular uterine contractions of varying intensity; they apparently soften (ripen) the cervix, which begins to efface and dilate. As labor progresses, contractions increase in duration, intensity, and frequency...

There are 3 stages of labor.

The 1st stage-from onset of labor to full dilation of the cervix (about 10 cm)-has 2 phases, latent and active. During the active phase, the cervix becomes fully dilated, and the presenting part descends well into the midpelvis... Pelvic examinations are done every 2 to 3 h (hours) to evaluate labor progress...

The 2nd stage is the time from full cervical dilation to delivery of the fetus... In the 2nd stage, women should be attended constantly, and fetal heart sounds should be checked continuously or after every contraction. Contractions may be monitored by palpation or electronically.

The 3rd stage of labor begins after delivery of the infant and ends with delivery of the placenta."

RN 1 documented that Patient 1 was roomed at 4:15 a.m., noting the patient appeared "in pain" and "abdomen soft." (No pain scale or description of pain such as character, intensity, frequency, duration were documented).

Review of hospital-wide "Care of Patients" policy #101 titled "Pain Management" (rev 6/2014) indicated that all patients will be assessed for pain using a method appropriate for the patient. The pain will be assessed and documented using a 0-10 numeric scale (0= no pain, 10=worst possible pain) for patients who are able to self-report pain. In addition, location, quality, onset and duration of pain will be assessed and recorded. The policy indicated that pain should be assessed on admission and ongoing.

Review of nursing notes at 4:13 a.m. by RN 1 indicated that Patient 1 was not able to provide a urine specimen. At 4:25 a.m. a "soap suds enema was given to the patient with poor result." Review of 6/7/14 ED physician orders showed orders by MD 1 for an enema at 4:20 a.m.

At 5:18 a.m. RN 1 documented an attempt to insert a (urinary) catheter, and noted "pt (patient) feels the need to defecate (to bear down and push in order to relieve rectal pressure) and cannot lie still, during attempt pt noted to have large, hard translucent, membranous mass appear in vaginal vault. (MD 1's name) called to bedside to witness and examine pt."

Review of the 6/7/14 ED physician progress notes by MD 1 indicated "time seen: 4:20 (a.m.)." MD 1 documented that Patient 1 arrived by car with a friend, chief complaint of abdominal pain, started yesterday, gradual onset, pain described as "cramping and diffuse. No radiation. Modifying factors-not relieved by anything." Under "review of systems" MD 1 noted, "The patient has had abdominal pain and constipation. She has had abnormal bleeding (mild vaginal bleeding)..."

Under "physical exam" (untimed entry) MD 1 documented that Patient 1 appeared alert and "in moderate distress." The patient was noted "Hypertensive (elevated blood pressure). Tachycardic (high heart rate)." The physical assessment section documented that abdomen was: "Soft. Distention."

Under "Course of care" (untimed entry) MD 1 documented that Patient 1 reported she was early in pregnancy (5-6) weeks and quantitative blood pregnancy test "suggesting early pregnancy".

Review of 6/7/14 ED physician orders showed an order timed at 5:40 a.m. for an ultrasound test of the patient's abdomen and pelvis to be done at 6:30 a.m.

In an interview on 7/23/14 at 8 a.m., the emergency physician who cared for Patient 1 on 6/7/14, MD 1, clarified that "time seen" at 4:20 a.m. only marked the time when MD 1 became aware of Patient 1 from communications with RN 1 reporting Patient 1's constipation. MD 1 stated he ordered enemas but did not actually examine the patient until after the ultrasound test (done at 6:43 a.m.), which confirmed a viable fetus (live baby) already descending through the birth canal.

MD 1 explained that he did not see (meet) Patient 1 until RN 1 called him into the patient's room (at 5:18 a.m.) to inspect membranes (as described by RN 1 above) appearing in the patient's vaginal canal. MD 1 stated that at that time he only performed a visual inspection and saw what appeared to be "a bag of water" (tissue with fluids that surrounds a developing baby inside the mother's womb). MD 1 stated that he assumed Patient 1 was having a miscarriage and ordered an ultrasound test, without examining the patient. MD 1 stated that he ordered the ultrasound test at 5:40 a.m. to be done at 6:30 a.m., the time the ultrasound technician was scheduled to arrive. MD 1 stated he did not feel that urgent ultrasound was warranted, although the hospital had an ultrasound technician available to call in 24 hours per day. MD 1 confirmed he did not perform an abdominal exam for fundal height (to show size of the fetus and dates of development), did not perform examination of the vagina and pelvis to determine condition of the opening of the mother's womb (cervix) and did not obtain fetal heart tones (FHT, the sound of the baby's heart beating) to assess wellbeing of the fetus.

Nursing notes by RN 1 indicated that Patient 1 did not go for ultrasound test until 6:43 a.m., noting: "Patient transferred to sonogram by stretcher." No indication of whether trained staff accompanied Patient 1 to where the ultrasound test was performed was documented.

Prior to ultrasound at 6:40 a.m. RN 1 documented that Patient 1 was reporting a current pain level of 8/10 (no location), noting the pain alternated between pain levels 5 to 10/10, describing the pain as "pressure pain".

At 6:42 a.m. RN 1 noted vital signs of Patient 1, BP 133/81, HR 86, RR (respirations) 18, T (temperature) 98 and oxygen saturation 96% on room air. No evaluation of fetal condition, such as auscultation of the abdomen for fetal heart tone (FHT), was documented. During Patient 1's ED stay thus far there was no indication that FHT evaluation was attempted by either MD 1 or RN 1.

The nursing notes by RN 1 demonstrated opportunities for RN 1 to identify that Patient 1 was in an active phase of labor in the first hour of the patient's arrival to the ED. The ED records showed no documented evidence that RN 1 assessed fetal status or attempted to obtain FHTs initially and on an ongoing basis. The ED staff failed to monitor and evaluate pain quality, intensity and duration on an ongoing basis to identify the pain was consistent with labor contractions (varying intensity pain).

On 6/7/14 at 6:45 a.m. MD 1 documented in the progress notes receiving a phone report from an ultrasound technician notifying the MD that Patient 1 was 33 weeks pregnant, the (infant's) head was in cervical canal and fetal heart tones (FHT) rate of 141. MD 1 noted that MD 4, an OB physician on call at Hospital 2, was contacted and accepted Patient 1 for transfer.

At 7:02 a.m. RN 2 documented in nursing notes the presence of "large hematoma" on the right vulva (entrance to vagina) and the following entries:
7:04 a.m.- "ED physician at the patient's bedside (name of MD 1)"
7:05 a.m.- "RN assist with external vag(inal) exam-large hematoma (localized collection of blood outside the blood vessels), RT (right) vauva (sic for vulva- the external genital organs of the female) with bleeding peri pad placed."

MD 1 also documented in an untimed progress note: "R (right) labial/vulvar hematoma (?). Head in birth canal, mild progression. Follow-up report to (Name of Hospital 2)."

Review of Patient 1's physician progress notes showed no documented evidence that MD 1 performed a pelvic/vaginal exam on Patient 1 before or after the ultrasound to evaluate the pregnancy status, to determine whether the cervix was dilated, and to evaluate the stage of labor, active or not. There was no documented evidence that MD 1 or nursing staff evaluated the well-being of the fetus; or that nursing staff provided ongoing monitoring of Patient 1, including monitoring of contractions and quality and duration of pain. There was no evidence of guidance provided by MD 1 for evaluation and continuous monitoring of the condition of the patient and the fetus, to determine if there was an emergency medical condition that required stabilizing treatments.

In fact, the ultrasound report documented only one FHT reading rate of 99 while Patient 1 was in ultrasound, indicative of possible fetal distress. The low FHT was not addressed as a potential emergency medical condition by MD 1 in ED progress notes. The FHT of 141 (reported to MD 1 by phone from the ultrasound technician) was not recorded in the final report. Variable FHT with rates that fall below 100 for prolonged periods signify lack of oxygen or blood supply to the baby and warrant medical interventions.




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A-2. Review of the medical records for Patient 1 with AS 1 and AS 2 on 7/24/14 at 3:15 p.m. indicated that prior to the 6/7/14 ED visit, on 5/25/14 Patient 1 presented to the emergency department (ED) with a chief complaint of "Fall 8-10 feet (from window - screen came out)," documented by a Triage Nurse at 7:46 p.m. MD 2 noted an initial contact time with Patient 1 at 7:47 p.m. MD 2 documented, "injury to the foot and ankle, happened just prior to arrival. Fell. (sitting on window sill and fell). Patient is experiencing moderate pain. No other injury."

The Triage Nurse assessment notes documented a heart rate of 123 beats per minute (normal 60-100) and pain score of 8 out of 10, 10 being the worst pain ever experienced. Although the nurse noted aspects of Patient 1's breathing and heart sounds, with her abdomen "soft and nontender" [Patient 1 was very thin and about 33 weeks pregnant at the time and would be expected to have a significantly protruding belly], MD 2 recorded that her heart rate was fast (without further detail) and no comment related to lung function, abdominal condition, or mid and lower spine condition.

An x-ray of Patient 1's left ankle was performed at 7:58 p.m. It showed shattering of both of the bones of the lower leg, with displacement of the ends of the bones, and prominent swelling of the surrounding tissue. This was a serious injury that would require surgical repair with hardware to stabilize the broken fragments in order to restore weight-bearing function.

In an interview on 7/23/14 at 11:30 a.m., MD 2 stated that he did not examine other parts of Patient 1's body for injuries because she did not report problems anywhere except the ankle. MD 2 indicated that the ankle injuries were "interesting" and often associated with other injuries of the knee, hip and lower spine. MD 2 viewed his role as the ED provider to quickly treat what the patient reported as a problem and move them along. MD 2 did not treat adolescents differently, despite the developmental risks for adolescents to be unreliable reporters, to engage in high-risk lifestyles, particularly when lacking adult supervision. Patient 1 was not accompanied to the hospital by a parent. Parental consent was obtained by telephone from her father. [It was later learned that Patient 1 came from a disorganized home with limited social support.] MD 2 did not consider the mechanism of Patient 1's fall to be unusual, or possibly inflicted (pushed out the window).

Although the hospital had a protocol for the Triage Nurse to initiate orders for x-rays of an injured body part, such as in Patient 1's presentation, and the protocol directed that a screening test for pregnancy be obtained prior to the x-ray, MD 1 indicated that he bypassed the pregnancy screen in order to save time. MD 1 did not conduct any inquiry or examination to determine pregnancy, and did not consider the radiation risks from the ankle x-rays to warrant screening because the exam site was not of the pelvis or abdomen. MD 2 acknowledged that the radiation safety provisions for x-rays of a pregnant person would include shielding of the pelvis. But Patient 1 was not given the opportunity to decline the x-rays or weigh the risks/benefits if she had known she was pregnant.

MD 2 documented that he spoke with an orthopedic surgeon who was able to review the x-ray of Patient 1's ankle, but who was not asked to come to the hospital to examine her. Surgery was recommended by the orthopedist, and an ED nurse applied a splint to Patient 1's leg. Patient 1 was released to her home with crutches and instructions to make an appointment with the orthopedist.

Patient 1 did visit the orthopedist on 5/30/14 where a focused and limited examination of the ankle and x-rays was performed. The surgical repair was scheduled for 6/5/14. A pre-operative screening call dated 5/30/14 from a surgery service nurse noted that Patient 1's mother was worried that she was pregnant. She was advised to have pregnancy testing done. She did not. Patient 1 appeared for the surgery on 6/5/14 where a pregnancy screening test was performed. It was positive. A blood test to confirm pregnancy was positive. Patient 1 was told she was in early pregnancy, 5-6 weeks, erroneously based on the blood test. No medical provider examined Patient 1 to determine her stage of pregnancy. No preparations for a 3 hour surgery on a patient of advanced pregnancy [Patient 1 was actually 35 weeks pregnant according to the physical assessment of the baby at the receiving hospital.] were implemented. No precautions to prevent or monitor for blood clots, or to account for the stress of tissue injury from such a surgery, or for shifts in blood volume related to pregnancy were implemented. Patient 1 developed abdominal pain within 1 day of the surgery and presented back to the ED less than 2 days after the surgery in active and advanced labor, which went unrecognized by the ED qualified medical practitioner (QMP) for several hours. Patient 1 delivered her baby in an ambulance while being transferred from the ED to another hospital on 6/7/14.

A-3. Review of the medical record on 7/23/14 at 3:07 p.m. with AS 2 indicated that Patient 7 presented to the ED on 3/18/14 at 9 a.m. with possible contractions and vaginal fluid leakage for 1 day. Patient 7 did not speak English and reported being 37 weeks pregnant (infant fully developed and ready to deliver). A nurse documented at 9:15 a.m., "appears in pain." A physician examined Patient 7's "gravid uterus" (belly was enlarged from a uterus that housed a baby) and noted the baby's heart rate was 156 at 9:06 a.m. No vaginal examination to determine the status of the opening to the uterus (cervix) or emergence of the baby was documented. No characteristics of uterine contractions (duration, intensity, frequency) were documented. No orders to support a patient in potential labor or imminent delivery were documented. An ED physician noted (note had not time recorded) that an obstetric physician from Hospital 2 accepted transfer of Patient 7. At 9:14 a.m. a ED nurse noted giving report to a nurse at a receiving hospital (Hospital 2). At 9:17 a.m. a ED nurse gave report to an ambulance technician. At 9:22 a.m. Patient 7 departed for Hospital 2 in an ambulance.

A-4. Patient 9 presented to the ED on 3/2/14 at 2:48 p.m. stating she was 24 weeks pregnant and had not felt her baby move for 3 days. Patient 9 reported to an ED nurse that she had "some abdominal pain" at a level of 4 out of 10, 10 being the worst pain ever felt, but her pain level was 3/10 on admission. A physician assistant documented a medical screening examination, noting a "gravid uterus palpable to midpoint between [pelvic bone] and [belly button]. Size of uterus not consistent with dates. Normal fetal heart tones [FHR was 160 beats per minute-normal rate 100-140]. The physician assistant noted "no contractions, pelvic pain, vaginal bleeding or discharge or complaint of leakage of fluid." No details of Patient 9's "abdominal pain" were noted by the nurse (duration, intensity, frequency). At 3:11 p.m., a nurse noted "Abdomen nontender. No contractions noted. Vaginal bleeding. Vaginal discharge."

At 3:15 p.m. an ED nurse gave report to a labor and delivery nurse from Hospital 2, who was accepting the transfer of Patient 9.
At 3:33 p.m. an obstetric physician at Hospital 2 accepted transfer of Patient 9.
At 3:42 p.m. a nursing reassessment noted a pain level of 4/10 (without details). No FHT, uterine contraction characteristics, or further comments about vaginal bleeding were documented prior to transfer. Determination of the stage of labor was not documented.

A-5. Patient 5 presented to the ED on 5/12/14 at 7:09 p.m. for being kicked in the stomach multiple times prior to arrival, at 26 weeks of pregnancy, with a pain level of 7/10 (severe). Although MD 14's examination noted tenderness in the left side of Patient 5's belly, MD 14 did not note the size of the uterus (fundal height), vaginal or pelvic features of the cervix or baby, uterine contractions, FHT, or determination of possible labor.

Between 9:15 p.m. and 9:47 p.m. an ultrasound test was performed and viewed by a radiologist at 10:29 p.m., who noted that the baby's heart rate was 132 and the cervix was closed. A nurse noted "calm and resting quietly" at 9:47 p.m. At 10:06 p.m. a nurse noted "Pt states, 'I have belly pain every 2 minutes lasting 2 minutes.'"At 10:10 p.m. MD 14 recorded that the ultrasound "shows no problems but the patient now complains of intermittent abdominal pains which occur every few minutes." At 10:19 p.m. an obstetric physician at Hospital 2 accepted transfer of Patient 5. No reassessments of the duration, intensity, frequency of uterine contractions, of the cervix, of baby's heart rate, or determination of the stage of labor were documented prior to transfer.

In an interview and review of records for Patients 5 and 9 on 7/24/14 2:15 p.m., the ED Manager (AS 2) stated that a nursing assessment for labor (according to ED RN training and expectations) would include direct palpation of the abdomen to determine if the pattern of pain corresponded with muscle tension, consistent with uterine contractions. A nurse was expected to document whether pain was intermittent, increasing/decreasing in intensity, whether firmness of the abdomen was felt when a patient reported pain at its maximum intensity. She agreed that the assessment of the pain for a pregnant patient should include location, quality, onset and duration of the pain. AS 2 agreed that she could not identify all of these elements in the pain assessments conducted for Patient 5 on 5/12/14 at 7:19 p.m., 9:47 p.m., 10:06 p.m., and 10:33 p.m. AS 2 stated that the ED staff documented no reassessment of Patient 5's cervix or the baby's condition after the ultrasound was completed at 9:47 p.m., nor while the patient reported frequent uterine contractions. AS 2 confirmed that no determinations were documented of the presence or absence of the active phase of labor or possible imminent delivery.

AS 2 agreed that the hospital-wide pain management policy was not applicable to address the needs of Patient 5's potential emergency medical condition (i.e. pregnant woman in labor) and confirmed no other policy provided such guidance for these needs.

B. Medical Screening Examinations (MSE's) were conducted by individuals lacking current demonstrated competence in the assessment, management and delivery of pregnant patients who present to the ED during various stages of labor, including imminent delivery of the infant.

Review of the Medical Staff Roster and corresponding medical staff files indicated there were 8 medical staff members who were authorized (granted clinical privileges by the hospital leadership) to perform emergency care for pregnant patients that included vaginal delivery of a newborn (MD 1, MD 2, MD 3, MD 6, MD 7, MD 8, MD 9 and MD 14). However, the files contained no documented evidence of recent experience, specialized education and training, or competence for such care for MD 1, MD 2, MD 3, MD 6, MD 7, MD 8, MD 9 and MD 14.

In an interview on 7/23/14 at 8:30 a.m., MD 1 stated that he was "grandfathered" in to a certification Board for Emergency Medicine in 1991. MD 1 indicated that he maintained the certification, but that the Board testing had limited coverage for obstetric and gynecologic topics with no hands-on assessment of skills to perform care, such as assessment of labor or determination of imminent delivery. MD 1 stated that his competency for these tasks was based on his training more than 35 years ago. MD 1 last delivered a baby about 32 years ago. Up until 3 years ago, the hospital had an active obstetric service which took on most of the care for pregnant patients in the latter stages of pregnancy, the care of patients in labor, the infant delivery care, and the care of the newborn after birth. After the obstetric service closed, the ED physicians did not attend mandatory trainings with hands-on skill development for the tasks formerly conducted by the obstetric unit, nor for assessing whether a pregnant patient had an emergency medical condition (i.e., was potentially in labor which may require medical monitoring or interventions). Instead, the ED physicians routinely transferred patients that were suspected to be in labor or who might need obstetric services to an affiliate hospital that had the full capability to care for obstetric patients.

MD 1 also stated that following a recent concern of a pregnant patient who delivered a baby in an ambulance during such a transfer (Patient 1), MD 1 attended a 20 minute training offered by a paramedic. MD 1 stated that the training did provide the opportunity to practice a vaginal delivery of an infant, and focused on techniques to deliver babies. MD 1 stated that the training did not define how to determine whether a delivery was imminent and should be completed at the facility, rather than attempting to transfer a woman in labor to another hospital. MD 1 indicated that he was not comfortable delivering babies or treating newborns. MD 1 stated that if the position of a baby's head was at the perineum (already passed through the cervix and vaginal canal), it may still be safe to transfer the mother if she and/or the baby were high-risk for complications, since the hospital did not have the support of an obstetric service. MD 1 acknowledged that the hospital did have capacity and capability to support a delivering mother with hydration fluids, blood transfusions, surgical repair of injuries, oxygen, breathing support and medications to both mother and newborn if they were compromised from complications of birth.

In an interview on 7/23/14 at 11:30 a.m., MD 2 indicated that he had no recent experience delivering babies. His medical training in internal medicine was more than 30 years ago. MD 2 stated that labor and delivery of a baby was a natural process that did not routinely require medical interventions, and it was best to just step aside and stay out of the way if birth was imminent. MD 2 did not have skills to use bedside ultrasound to assess the abdomen and uterus for the presence of a live baby or signs of labor. MD 2 stated that the hospital did not have the capability to monitor the progress of patients in labor through the birth of an infant. Therefore, pregnant patients were routinely transferred to a hospital that did have that capability.

In interviews with RN (registered nurse) 2 (who worked in the ED) on 7/23/14 at 9 a.m., with Administrative Staff (AS) 2 (who managed the ED services) on 7/23/14 at 9:30 a.m., and with RN 4 (an obstetric nurse at a hospital with an obstetric service) on 7/23/14 at 9:55 a.m., all indicated that once the baby's head had descended to the opening of the vagina or was visibly "crowning," delivery was imminent and the proper action was to set up for the rest of the delivery, not transfer the mother away from a hospital setting. Management of a patient with advanced labor or about to deliver included hydration, positioning, optimizing oxygenation, assessment of fetal heart rate, presence or amount of vaginal bleeding, breathing and pain control, comfort, and preparing to revive the infant if needed.

In a collaborative review on 7/24/14 at 11:10 a.m., AS 2 presented a training manual for obstetric emergencies. The training manual was reviewed annually by ED nurses (but not by ED physicians). The training manual noted that the evaluation of a pregnant patient included a pelvic examination and measurement of fundal height (how much the belly protruded). The training manual outlined the criteria for imminent delivery of a baby: uterine contractions less than 2 minutes apart, feeling of rectal fullness, urge to push, head presenting in vagina, and vaginal fluid leakage. The training manual contained guidance/procedures for preparing for delivery, monitoring fetal well-being (heart rate) using a stethoscope or sound machine (Doppler), and supporting the mother during labor. The equipment and skills to provide this care was all available to ED staff. The knowledge base of the nurses responsible for pregnant patients presenting to the ED in labor, or about to deliver a baby, was significantly deeper than that of the ED physicians interviewed.

In a telephone interview on 7/22/14 at 4:15 p.m., MD 4 (the obstetric physician who accepted Patient 1's transfer request on 6/7/14 without knowledge of how far her labor had progressed) explained that it was important to support the mother during the late stages of labor, to control the descent of the baby to minimize injury to the mother's birth canal, and to minimize stress on the infant. MD 4 stated that if the baby's head was crowning and descended to the end of the birth canal, the baby should have been delivered and the mother should not have been transferred.

In an interview on 7/23/14 at 2:45 p.m., the ED Medical Director (MD 3) indicated that it was challenging to evaluate competence for a skill like vaginal delivery of babies that was performed very infrequently by ED physicians. MD 3 acknowledged that the ED physicians had very little experience or training for the skills needed, as they had relied on the obstetric service through most of their careers (until 3 years ago when the obstetric service closed). After the obstetric service closed, no formal education, training, or practice for the initial assessment and management of ED patients who may potentially be in labor and require obstetric care was instituted for the ED physician staff.

MD 3 indicated that following Patient 1's delivery of a baby in an ambulance during transfer from the hospital to another hospital, the 20-minute paramedic training on vaginal delivery was offered to all 8 ED physicians. (5 of the 8 appeared on the attendance names list.) Informal training for ultrasound of the pregnant patient by the hospital's ultrasound technician staff was now mandatory, but only about half of the physicians had completed that requirement. Formal ultrasound certification was not sought as a requirement for competency in managing the care of these patients. Periodic rotation of ED physicians through the obstetric unit of other hospitals had not been conducted. Efforts to recruit the hospital's gynecologic specialist (who had provided obstetric services up until 3 years ago and still served on-call for gynecologic emergencies approximately 2-4 days/week) to provide education, training, or temporary assistance to ED physicians faced with the initial management of such patients had not occurred. Collaboration with the affiliate hospital's obstetric providers, whether formal or informal, to outline situations that warranted early consultation between ED physicians and obstetric providers (aside from the late phone contact to request a transfer) which could provide guidance on the early assessment and management of the conditions had not occurred.

Review of the Emergency Services Agreement between the hospital and the E

Based on staff interview, medical record and document review, the hospital failed to provide stabilizing treatment to a pregnant patient within the capabilities of the staff and facilities available at the hospital, before transferring the patient(s) to higher level of care, for 1 of 24 patients (Patient 1).

Findings:

The medical record review indicated, Patient 1 was pregnant and presented to the Emergency Department (ED) on 6/7/14 with abdominal pain and vaginal bleeding. Once the patient was diagnosed with active labor and imminent delivery, the patient was transferred to another hospital without prior stabilizing treatment (such as management of contractions and monitoring of fetal wellbeing and delivery of child and placenta, for imminent delivery).

The ED physician, MD 1, documented in progress notes on 6/7/14 at 6:45 a.m. receiving a phone report from an ultrasound technician notifying the MD that Patient 1 was 33 weeks pregnant, the (infant's) head had descended through the cervical canal, and fetal heart tones (FHT, the sounds of a baby's heart beating) rate was 141. (Normal heart rate of an unborn baby-fetus is 120-160.)

Review of the ultrasound imaging report (performed on 6/7/14 at 6:43 a.m.) for Patient 1 indicated the test was ordered by MD 1 for "pregnancy/pelvic pain" exam, with no comparison report available noted. The report indicated Patient 1 was 32 weeks pregnant, plus or minus 2 weeks, based on this ultrasound, with single fetus, fetal head located within the cervical canal. The ultrasound report documented only one FHT reading rate of 99 while Patient 1 was in ultrasound, indicative of possible fetal distress. The low FHT was not addressed by MD 1 in ED progress notes. The FHT of 141 (reported to MD 1 by phone from the ultrasound technician) was not recorded in the report. Variable FHT with rates that fall below 100 for prolonged periods signify lack of oxygen or blood supply to the baby and warrant medical interventions, such as oxygen, fluids, positioning, and facilitation of delivery of the baby.

Review of nursing notes by Registered Nurse (RN) 2 indicated Patient 1 returned from sonogram (ultrasound) at 7:02 a.m., MD 1 was at the patient's bedside at 7:04 a.m., and at 7:05 a.m. the RN assisted with external vaginal exam, noting "large hematoma (localized collection of blood outside the blood vessels), RT (right) vauva (vulva- the external genital organs of the female) with bleeding peri pad placed."

Review of 6/7/14 of "Patient Transfer/ Discharge Summary" form for Patient 1 documented diagnosis of "Pregnant/Imminent Delivery" and indicated that Patient 1 was being transferred to Hospital 2, reason OB services not available, signed by MD 1 on 6/7/14 at 7:05 a.m.

In a late entry (at 10:31 a.m.) for 7:05 a.m. RN 2 documented that Patient 1 "Appears in pain and anxious. Abdominal distention. Fetal heart tones present (per sono reported to MD 1: FHT-141). Pre-delivery exam; mild bleeding and no discharge noted upon external exam. Vaginal bleeding present, consisting of bright red blood (pad placed)..." RN 2 documented vital signs at 7:05 a.m. of BP 125/75, HR 110, RR 18, T 98.7; oxygen saturation 99% on room air, and pain 4/10 but no evaluation of the FHT was recorded.

Review of physician orders showed no orders for IV fluids (for hydration) or any new interventions for Patient 1.

At 7:20 a.m. RN 2 documented in the nursing notes that report was given via phone call to Hospital 2's Labor and Delivery nurse, RN 4.

In a telephone interview on 7/23/14 at 9:55 a.m. RN 4 stated that after RN 2 reported to her crowning (baby's scalp visible in the vaginal opening), she told RN 2 that Patient 1 should not be transferred, "its EMTALA."

In a telephone interview on 7/22/14 at 4:15 p.m. Hospital 2's physician, an expert in OB (Obstetric) care, MD 4, also stated that if delivery was imminent and crowning was present, the patient should not have been transferred.

In an interview on 7/23/14 at 9 a.m. RN 2 stated, ED RNs were expected and trained to evaluate pain associated with contractions, the contraction quality and duration, and basic FHTs using a stethoscope or a hand-held Doppler (a device to hear a baby's heart sounds through the mother's abdomen), available in the ED. RN 2 stated that on 6/7/14 she came to the ED on the morning shift at 6:45 a.m. While receiving report from night nursing staff, RN 2 overheard MD 1 receiving a phone call from an ultrasound technician reporting to MD 1 that Patient 1 was pregnant with a live fetus. RN 1 asked MD 1 about FHR. MD 1 called ultrasound back and obtained FHR with readings within normal range (did not recall the numbers). RN 2 along with the charge nurse, RN 3, took over Patient 1's care. RN 3 was calling for transport out (to transfer the patient). RN 2 stated , Hospital 1 usually transferred out patients over 20 weeks pregnant to Hospital 2, because this hospital did not provide OB (obstetric) services. Upon Patient 1 returning from ultrasound, RN 2 stated, she followed MD 1 into the room. MD 1 performed visual inspection of Patient 1's peritoneal area and noted a large hematoma on right labial area. Without further examination or giving any new orders, MD 1 left the room. RN 2 stated she called and gave a report to Hospital 2's Labor and Delivery nurse, RN 4, where Patient 1 was going to be transferred. RN 3, who took over Patient 1's care, told RN 2 that visual exam showed the baby's head in vaginal vault. Upon reporting this to RN 4, RN 4 told her that if the baby's head was visible, the patient should not be transferred, because delivery was imminent. MD 1 was informed and insisted on transfer. RN 2 stated that RN 3 completed the hand-off of Patient 1's care to the ambulance crew (one driver and one paramedic).

The EMT (Emergency Medical Technician) record review showed call (from Hospital 1) was received at 7:04 a.m.; at the scene at 7:10 a.m.; at patient's bedside at 7:21 a.m.; time transporting 7:38 a.m.; and transport arrival (Hospital 2) at 7:58 a.m.

The ED record review showed, on 6/7/14 at 7:15 a.m. (and in late entries for 7:15 a.m. at 11:08 a.m. and 11:14 a.m.) RN 3 documented in nursing progress notes the following entries for Patient 1, indicative that the patient was in active stage of labor and imminent delivery:

- appeared in pain, anxious and complaining of abdominal cramping
- abdominal tenderness and pain to the entire abdomen
- fundus palpated at approximately 7 centimeters above umbilicus with obvious distention
- swelling and hematoma noted to right vulvus
- patient crying and stating she is having contractions

RN 3 continued notes for 7:22 a.m., in late entry at 11:20 a.m., documenting mother's vital signs of BP 132/78, HR 109, RR 22, oxygen saturation 99% on oxygen NC 2 liters, but no FHT . RN 3 further noted that "patient crying and states she wants to push" and MD notified. RN 3 documented that "crowning noted in vaginal vault" by RN and MD, discussed with physician, and no new orders received. Patient 1 was noted reporting pain 10/10 prior to transport to Hospital 2. There was no documentation that attempts were made to alleviate pain and deliver the baby.

In a telephone interview on 7/28/14 at 3 p.m. RN 3 stated that she was the charge nurse in the ED coming on day shift on 6/7/14, arrived at the ED and received report starting about 6:45 a.m. RN 3 overheard phone call from ultrasound to MD 1 reporting Patient 1 was 33 weeks pregnant, not 4-6 weeks pregnant as per the nursing report. RN 2 was assigned to take over Patient 1's care. RN 3 spoke with MD 1 asking about the patient status and for direction on how to proceed with Patient 1's care. MD 1 had to call ultrasound department to inquire about the fetus's condition. Per ultrasound technician, FHT were within 135-145 beats per minute. At that time Patient 1 was still in the ultrasound department but the assumption was that the patient was in some stage of labor. As the patient was still in the ultrasound, MD 1 ordered to arrange transfer to Hospital 2 with L&D/OB services, by ambulance-"lights and siren" (equivalent to 911-call per RN 3), understood as staffed with a driver and one paramedic. The ambulance estimated time of arrival was given to her as 10 minutes (RN 3 called the ambulance at about 7:02 a.m.). RN 3 stated that after Patient 1 returned from the ultrasound RN 3 went into Patient 1's room to evaluate the patient. MD 1 was not in the room at that time. Patient 1 was moaning in pain allover abdomen, anxious, in denial that she was pregnant "a lot". RN 3 placed her hands on the patient's abdomen and felt contractions up to about 7 cm above umbilicus. RN 3 stated that she evaluated FHTs at that time but did not document, the FHT were about 130 to 140 beats per minute between contractions (used stethoscope).

RN 3 stated, after her evaluation, she left the room to find MD 1, who then came to Patient 1's bedside. RN 3 described assisting MD 1 as follows: as the patient was lying on her left side, with left leg elevated on a pillow between knees, MD 1 gloved up and touched the vulva and performed visual inspection, showing crowning, meaning the head of the baby was emerging and the infant's head (with scalp suture line) visible to staff. RN 3 asked MD 1 if the patient should be moved to room 1 (trauma room with OB delivery equipment) and prepared for imminent delivery, but MD 1 directed to proceed with transfer. MD 1 told the patient that the baby was coming "soon" and she was to be transfer to another hospital because this hospital did not have the services needed. RN 3 stated MD 1 was aware and it was obvious that the patient was crowning.

On 6/7/14 at 7:29 a.m. RN 2 documented Patient 1's departure time was 7:28 a.m.

Review of ED progress notes showed prior to Patient 1's departure, MD 1 documented top of the baby's scalp was visible. MD 1 further documented: "Disposition: Transferred to (name of Hospital 2). Condition (labor, pending delivery)." There was no documented evidence of MD 1 or any other QMP (Qualified Medical Practitioner) ordering or providing any stabilizing treatments for Patient 1 prior to departure.

In an interview on 7/23/14 at 8 a.m., the Emergency Physician, MD 1 stated, he did not see Patient 1 until RN 1 called him into the patient's room (at 5:18 a.m.) to inspect membranes appearing in the patient's vaginal canal and only performed a visual inspection before sending the patient for ultrasound. MD 1 confirmed that after patient returned from ultrasound and prior to transfer, MD 1 diagnosed Patient 1 as being in active labor and imminent delivery (the patient had signs and symptoms consistent with imminent delivery, such as frequent contractions, baby's head presenting in the vaginal opening and urgency to push) and ordered to proceed with transfer.

Based on staff interview medical record and document review the hospital failed to appropriately transfer patients (who had not been stabilized) to another hospital for 4 of 24 sampled patients (Patients 1, 5, 7 and 9).

The hospital failed to provide stabilizing treatments within the hospital's capacity (resources that were available to emergency department personnel) to minimize the risks to a women in labor or her unborn child prior to transfer to 4 of 24 sampled patients (Patients 1, 5, 7 and 9).

The transfers were not effected with qualified personnel when ground ambulance transportation was staffed with one paramedic to care for two potential patients who may have required medical interventions simultaneously, for 4 of 24 sampled patients (Patients 1, 5, 7 and 9).

These failures put patients at risk for medical complications or delays to provide critical medical interventions during transfer from one hospital to another.

Findings:

1. Patient 1, who was pregnant and presented to the Emergency Department (ED) on 6/7/14 with abdominal pain and vaginal bleeding, did not receive adequate medical screening exam by the ED physician to diagnose pregnancy and active phase of labor. Once the patient was diagnosed with active labor and imminent delivery, the patient was transferred to another hospital without prior stabilizing treatment [timely hydration, management of contractions, monitoring of fetal wellbeing and delivery of child and placenta]. Patient 1 delivered a child within 7 minutes of transfer while in the ambulance, with only one ambulance staff (a paramedic) facilitation of delivery, caring for the mother and the newborn initially required implementing life saving measures for the infant.

At 7:20 a.m. RN 2 documented in the nursing notes that report was given via phone call to Hospital 2's Labor and Delivery nurse, RN 4.

In a telephone interview on 7/23/14 at 9:55 a.m. RN 4 stated that after RN 2 reported to her crowning (baby's head starts to emerge during each contraction, occurs during the second stage of labor) was present, she told RN 2 that Patient 1 should not be transferred "its EMTALA."

Similarly, in a telephone interview on 7/22/14 at 4:15 p.m. Hospital 2's physician, an expert in OB (Obstetric) care, MD 4 stated that if crowning was present, delivery was imminent and the patient should not have been transferred.

The ED nursing record documentation by RN 3 for care on 6/7/14 at 7:15 a.m. indicated Patient 1 was having signs and symptoms of imminent delivery, including frequent contractions an urge to push and crowning.

Review of policy titled "Emergency Nursing Procedures" (rev 8/2012) indicated, "The Emergency Department will utilize the Emergency Nursing Procedures textbook by Jean A Proehle for all Emergency Nursing Procedures not covered in (Hospital 1's name) policy." The textbook contained "Procedure 109 Emergency Childbirth", which indicated "To deliver an infant when birth is imminent, as evidenced by the following:
1. The woman is having contractions and is pushing.
2. The woman has the urge to defecate or bear down.
3. The women tells you ' the baby is coming'
4. The perineum is bulging (crowning), and the infant's head is seen at the vaginal opening, even between contractions. Birth is imminent if you see the infant's head at any time in women who has had previous vaginal deliveries."

In a telephone interview on 7/28/14 at 3 p.m. RN 3 stated that she was the charge nurse in the ED coming on day shift on 6/7/14, arrived at the ED and received report starting about 6:45 a.m. RN 3 stated that she was in the patient room when MD 1 evaluated the patient at about 7:15 a.m. RN 3 stated that as the patient was lying on her left side, with left leg elevated on a pillow between knees, MD 1 gloved up and touched the vulva and performed visual inspection, showing crowning, meaning the head of the baby was emerging and the infant's head (with suture line) visible to staff. RN 3 asked MD 1 if the patient should be moved to room 1 (trauma room with OB delivery equipment) and prepare for imminent delivery, but MD 1 directed to proceed with transfer to Hospital 2. MD 1 told the patient that the baby was coming "soon" and she was to be transfer to another hospital because this hospital did not have the services needed. RN 3 stated MD 1 was aware and it was obvious that the patient was crowning. The paramedic arrived and was at the bedside at that time.

The ED record review showed MD 1's untimed progress notes on 6/7/14 documenting that AMR (ambulance) arrived to transfer Patient 1 to Hospital 2's family birth center, noting "top of fetal scalp visible" and "will proceed with transfer." MD 1 documented "Disposition: Transferred to (name of Hospital 2). Condition (labor, pending delivery)."

Review of 6/7/14 of "Patient Transfer/ Discharge Summary" form for Patient 1 documented diagnosis of "Pregnant/Imminent Delivery" and indicated that Patient 1 was being transferred to Hospital 2, reason OB services not available, signed by MD 1 on 6/7/14 at 7:05 a.m.

On 6/7/14 at 7:29 a.m. RN 2 documented that report was given to the ambulance staff (one paramedic and a driver) and Patient 1's departure time was 7:28 a.m.

The EMT record review showed call (from Hospital 1) received at 7:04 a.m.; at the scene at 7:10 a.m.; at patient's bedside at 7:21 a.m.; time transporting 7:38 a.m.; and transport arrival (Hospital 2) at 7:58 a.m. (20 minutes from Hospital 1 to Hospital 2- 19.3 miles distance).

The EMT narrative report documented that ambulance was called for child birth; arrived to find 15 y/o c/o abdominal pain and "OB related complications". Patient has not been under the care of OB. The patient had abdominal pain "with contraction like discomfort, 2-3 min apart lasting for approximately 30-40 sec in duration. Pt indicated that the urge to push was present. Upon visual inspection a large hematoma was noted to the vaginal region and crowning was present. {Hospital 1's name} ED MD requested a code 3 (lights and sirens) transfer to {Hospital 2's name} L&D." En route to {Hospital 2's name} the patient started pushing and upon visualization head was noted, neonate (baby) with no MVMT (movement) present, neonate cyanotic (blue discoloration signifying lack of oxygen) through the entire body, improved after aggressive suction. It was noted that placenta was not delivered in the ambulance. The childbirth was documented at 7:45 a.m.

In a telephone interview on 7/23/14 at 3:30 p.m. the paramedic, EMS 1, confirmed that on 6/7/14, within 5-10 minutes of leaving Hospital 1, EMS 1 delivered the baby of Patient 1 in the ambulance. EMS 1 confirmed he was alone providing care to mother and the newborn en route to Hospital 2, as other staff was driving. EMS 1 confirmed that the baby was born limp/blue, not breathing, not moving, not crying- consistent of APGAR score =2 out of 10, signifying severe distress and threat to life. EMS 1 stated the baby needed rescue measures including suctioning, warming and oxygen blow over the face.

The 6/12/14 Neonate Discharge Summary from Hospital 2 documented the newborn baby of Patient 1 required 5 days in the hospital of intensive care for prematurity, breathing and feeding difficulties.

The 6/7/14 Hospital 2 Labor and Delivery record showed Patient 1 underwent repair and evacuation of acute labial hematoma and post-partum laceration repair under general anesthesia.

In an interview on 7/23/14 at 8 a.m., the Emergency Physician, MD 1, stated, he felt it was
for the patient's and the neonate's benefit to transfer regardless of the stage of labor, because he did not feel equipped to handle neonate and high risk delivery that he anticipated for Patient 1. MD 1 stated that he last delivered a baby about 32 years ago. MD 1 stated that he was aware that ambulance transporting Patient 1 to Hospital 2 (approximately. 16 miles away) was staffed with a driver and one paramedic to assist with this high risk delivery. MD 1 acknowledged that ED had resources available that included a surgeon on call to manage potential complications of the mother (for example bleeding) and a pediatrician on call to manage the neonate care (for example respiratory rescue). MD 1 also stated that if the same situation occurred again, he would make the same decision, because the hospital did not have OB and neonatal services and he had no current competencies in managing labor and delivery care.

In an interview on 7/23/14 at 9 a.m. the Manager of Emergency Services (AS 2) stated that the transfer process was physician driven and the type of transport was requested-ordered by MD 1. AS 2 stated that the hospital had specialized resources available if needed for transport or to provide specialized assistance if needed onsite. The hospital had a contract with air transport, available to the ED upon request, approximate time of arrival-within 8 minutes. The transport team had 2 RNs trained in critical care, able to provide OB care including delivery on ground and specialized transport capability for mother /neonate if needed after delivery. MD 1 did not request specialized transport for Patient 1.



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Review of a hospital Memorandum of Understanding (MOU) for Air Ambulance Services, effective 6/14/12, indicated that a company that provided air transport services was a resource available to assist with the needs of obstetric patients. The company offered its transport coordination center to coordinate and execute all aspects of a patient transport once an attending physician from the sending institution determined a patient transfer was needed. The coordination service was "designed to provide an effective means for referring facilities and physicians to safely and efficiently coordinate the movement of a patient to tertiary (high level care with subspecialty support like obstetric and neonatal) care." The company offered the services of a RN/RN crew to participate in ground transport of a critically ill patient if the air base ambulance was not available. The company's RN/RN crew had access to physician guidance through its Medical Director and protocols. The RN/RN crew also took direction (orders) from either a sending facility's physician, or a receiving facility's physician. If a transfer was needed, but the receiving bed and/or physician had not yet been identified, the company agreed to activate its aircraft and RN/RN Crew to render care at the sending facility.

Exhibit A of the MOU specifically provided instructions to utilize the coordination center services "to coordinate high risk maternal patient transfers" from the Hospital's emergency department to an affiliate hospital's perinatal department, (that was located 18.7 drive miles away and 24 minutes of drive time away, according to google.com/maps). If infant delivery was determined to be imminent, the company medical crew would assist with further transport arrangements (to include care and support of the infant). The company's protocols included care and transport of high risk obstetric patients, emergency childbirth, pre-term labor, obstetric vaginal bleeding, and obstetric maternal transport.

In an interview on 7/23/14 at 9:30 a.m., the Manager of Emergency Services (AS 2) indicated that the air ambulance company provided efficient and rapid response services for trauma patients, with mobilizing their crew locally to arrive within 5-10 minutes and transport by helicopter to the affiliate hospital within another 5-10 minutes. However, the company's services were not routinely utilized for obstetric emergencies.

In an interview on 7/24/14 at 9:50 a.m., the Chief Nurse Executive (CNE) reviewed the air ambulance contract and agreed that the language suggested that it could provide two obstetric-trained nurses who could manage via protocols, or assist in care of labor and delivery care for both the mother and the infant, either on site of the sending facility, or en route during a transfer, by air or ground.

2. Review of the medical record on 7/23/14 at 3:07 p.m. with AS 2 indicated that Patient 7 presented to the ED on 3/18/14 at 9 a.m. with possible contractions and vaginal fluid leakage for 1 day. Patient 7 did not speak English and reported being 37 weeks pregnant (infant fully developed and ready to deliver). A nurse documented at 9:15 a.m., "appears in pain." A physician examined Patient 7's "gravid uterus" (belly was enlarged from a uterus that housed a baby) and noted the baby's heart rate was 156 at 9:06 a.m. No vaginal examination to determine the status of the opening to the uterus (cervix) or emergence of the baby was documented. No characteristics of uterine contractions (duration, intensity, frequency) were documented. No orders to support a patient in potential labor or imminent delivery were documented. An ED physician noted (note had not time recorded) that an obstetric physician from Hospital 2 accepted transfer of Patient 7. At 9:14 a.m. a ED nurse noted giving report to a nurse at a receiving hospital (Hospital 2). At 9:17 a.m. a ED nurse gave report to an ambulance technician. At 9:22 Patient 7 departed for Hospital 2 in an ambulance. No reassessments of Patient 7's uterine contractions, pain, baby's heart rate, vaginal bleeding, or cervix condition were documented prior to transfer. No determination of the stage of labor was documented (to ensure delivery was not imminent).

A transportation order for Basic Life Support ground ambulance (minimum staff to include a driver and one attendant) to monitor vital signs was documented. No arrangements were documented for trained staff to provide medical interventions to a woman potentially in active labor who may deliver a baby en route. No arrangements were documented for trained staff to provide medical interventions to a distressed baby at the same time as a mother with complications en route.

On 7/24/14 at 9:30 a.m. AS 1 confirmed that a Transfer Form (as required by hospital policy) to document Patient 7's informed consent to be transferred to another hospital, as well as to formally document a physician certification of the risks, benefits and alternatives to transfer, as well as the verification that the receiving hospital had capacity and capability to receive Patient 7, was not found in the medical record.

Review of Policy GPCP 557 titled "Interfacility Transfer of [hospital name] Patient," effective 11/20/12, noted that the transferring physician was responsible to "Contact receiving facility physician to confirm acceptance and complete the Physician section of the Patient Transfer/Discharge Summary form." The team nurse was responsible to initiate the Patient Transfer/Discharge Summary form for patient transferring to another acute care facility, was responsible to complete the Nurse section of the form, and have the patient sign the consent portion.

Further medical record reviews indicated the following:

3. Patient 9 presented to the ED on 3/2/14 at 2:48 p.m. stating she was 24 weeks pregnant and had not felt her baby move for 3 days. Patient 9 reported to an ED nurse that she had "some abdominal pain" at a level of 4 out of 10, 10 being the worst pain ever felt, but her pain level was 3/10 on admission. A physician assistant documented a medical screening examination, noting a "gravid uterus palpable to midpoint between [pelvic bone] and [belly button]. Size of uterus not consistent with dates. Normal fetal heart tones [baby's heart rate was 160 beats per minute, upper limit of normal]. The physician assistant noted "no contractions, pelvic pain, vaginal bleeding or discharge or complaint of leakage of fluid." No details of Patient 9's "abdominal pain" were noted by the nurse (duration, intensity, frequency). At 3:11 p.m., a nurse noted "Abdomen nontender. No contractions noted. Vaginal bleeding. Vaginal discharge."

At 3:15 p.m. an ED nurse gave report to a labor and delivery nurse from Hospital 2, who was accepting the transfer of Patient 9.
At 3:33 p.m. an obstetric physician accepted transfer of Patient 9.
At 3:42 p.m. a nursing reassessment noted a pain level of 4/10 (without details). No FHT, uterine contraction characteristics, or further comments about vagina bleeding were documented prior to transfer. Determination of the stage of labor was not documented.

At 3:48 p.m. Patient 9 departed by ground ambulance transportation, without additional trained personnel on board to provide medical interventions to mother and baby simultaneously, had Patient 9 been in active labor with imminent delivery or any other conditions not been stabilized prior to transfer.

4. Patient 5 presented to the ED on 5/12/14 at 7:09 p.m. for being kicked in the stomach multiple times prior to arrival, at 26 weeks of pregnancy, with a pain level of 7/10 (severe). Although MD 14's examination noted tenderness in the left side of Patient 5's belly, MD 14 did not note the size of the uterus (fundal height), vaginal or pelvic features of the cervix or baby, uterine contractions, FHT, or determination of possible labor.

Between 9:15 p.m. and 9:47 p.m. an ultrasound test was performed and viewed by a radiologist at 10:29 p.m., who noted that the baby's heart rate was 132 and the cervix was closed. A nurse noted "calm and resting quietly" at 9:47 p.m. At 10:06 p.m. a nurse noted "Pt states, 'I have belly pain every 2 minutes lasting 2 minutes.'"At 10:10 p.m. MD 14 recorded that the ultrasound "shows no problems but the patient now complains of intermittent abdominal pains which occur every few minutes." At 10:19 p.m. an obstetric physician at Hospital 2 accepted transfer of Patient 5. No reassessments of the duration, intensity, frequency of uterine contractions, of the cervix, of baby's heart rate, or determination of the stage of labor were documented prior to transfer.

At 10:33 p.m. Patient 5 departed (with pain level 7/10) by ground ambulance with no request for additional trained personnel to accompany her, should progression of labor occur with delivery of a baby en route where both mother and baby may require medical interventions.