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Tag No.: C2400
Based on interview, and record review, the facility failed to ensure that emergency medical services were provided in accordance with CFR 489.24, the regulations for the Emergency Medical Treatment and Active Labor Act (EMTALA) when:
1. There was no medical screening evaluation provided for one of 21 sampled patients (Patient 0) (refer to C 2406), and,
2. The medical record was incomplete in regards to a transfer for one of 21 sampled patients (Patient 18) (refer to C 2409).
Tag No.: C2406
Based on observation, interview, and record review, Hospital A failed to provide a medical screening examination (MSE), necessary stabilizing treatment, and ambulance transfer for one of 21 sampled patients (Patient 0) experiencing an Emergency Medical Condition (EMC). Patient 0 was Spanish-speaking, 39 weeks 5 days pregnant (full term), and presented to the Emergency Department (ED) experiencing contractions followed by the rupture of membranes (her water broke). Despite Family Member (FM) 0 requesting ambulance transfer to Hospital B (60 miles away), nursing staff informed them that delivery did not appear imminent (about to happen), and that they could drive to Hospital B, and they could call an ambulance on the way if they felt it was necessary.
This failure placed Patient 0 and her unborn child at risk for life-threatening medical complications, which could lead to negative and severe clinical outcomes.
Findings:
The Emergency Medical Treatment and Labor Act (EMTALA - known as the "Patient Anti-Dumping Law") is a federal law that ensures hospitals participating in Medicare programs provide MSEs, and stabilize patients with an EMC. EMTALA guidelines indicate that a pregnant woman experiencing labor is considered to have an EMC, unless a physician has certified in writing that the individual is in "false," labor.
A review, of the facility's policy titled, "Triage of Emergency Department (ED) Patients," dated 2/27/25, indicated that all patients presenting to the ED will be triaged (assessed to determine urgency of need for treatment). The policy directs the Registered Nurses (RNs) to assess every patient in a timely manner, and indicated that any identified special needs would be assisted by addressing language, hearing, learning, or spiritual needs a medical translation service will be used if needed.
A review, of the facility's policy titled, "Interpretation Services," dated 8/28/19, indicated that the facility provided communication aids to current and prospective patients with limited English proficiency to ensure they had an opportunity to apply for, receive, participate in, or benefit from the services offered by the facility. The policy indicated language interpretation was available 24-hours a day, seven days a week, and could be provided from any touch tone (push-button) phone.
A review, of the facility's policy titled, "EMTALA - Medical Screening Examination and Stabilization," dated 7/1/24, indicated that an EMTALA obligation was triggered when (1) an individual came to an ED and requested an exam or treatment for a medical condition or, (2) a prudent layperson observer (non-medical person with good judgment) would conclude from the individual's appearance or behavior that the individual needed an exam or treatment of an EMC. The policy indicated that if a prudent layperson observer believed the individual was experiencing an emergency medical condition (EMC), then an appropriate MSE would be performed. The policy indicated the exam must be completed by an individual qualified to perform such an exam to determine whether an EMC existed or, for a pregnant woman having contractions, if the woman was in labor and if the treatment requested was explicitly for an EMC. The policy indicated, that if an EMC is determined to exist, the individual will be provided necessary stabilizing treatment.
A review, of the facility's policy titled, "EMTALA Transfer Policy," dated 10/29/24, indicated that a woman in labor who requested a transfer to another facility may not be discharged against medical advice to go to the other facility. The policy indicated the risks associated with leaving must be thoroughly explained to the patient and documented. If the patient insisted on leaving to go to another facility, the facility should take all reasonable steps to obtain the patient's request in writing and take all reasonable steps to have the patient transported using qualified personnel and transportation equipment. The policy indicated, that transporting a woman in labor by privately-owned vehicle is not an appropriate form of transportation. The policy indicated that a woman who is in labor is considered stabilized only after she has been delivered of the child and the placenta.
A review, of a facility's policy titled, "Childbirth and Maternal Care in the Emergency Department," dated 6/26/24, indicated that a pregnant patients who presented to the ED where delivery was imminent would be cared for by qualified staff. After delivery and stabilization of mother and infant, an attempt would be made to transfer mother and infant to another facility for admission and continuing care. The policy indicated the procedure for "Pregnancy in Labor" was as follows: 1. Initial examination would be conducted immediately by the ED attending provider. 2. After MSE and consultation with the Obstetrician (OB, a physician who specializes in delivering infants) or private provider, the patient may be transferred to another facility that provided OB services if the transfer was determined safe. 3. If delivery was imminent, delivery will occur in the Emergency Department (ED).
During a concurrent observational tour of the ED, and interview, with the ED Manager (EDM) on 6/3/25 at 11:35 am, it was observed that the ED had one triage room, and six patient rooms or "bays." EDM stated, that Room 6 was typically used for "fast track issues," (non-life-threatening), and for Obstetrical/Gynecological (OB/GYN - OB related to care of pregnancy, deliver and after birth, GYN related to care of female reproductive system) issues. Observations of Room 6 indicated, a bed with stirrups for OB/GYN exams and a pediatric (for infants/children) "crash cart" (a mobile storage unit containing medications and equipment for emergency life support). EDM stated there was a larger delivery bed with stirrups for patients in labor and a Panda warmer (provides heat to warm the baby while the pediatric team does an assessment after delivery) in an alcove outside the room that were brought in if delivery was imminent, and those items were observed.
During an interview, with Registered Nurse (RN) A on 6/3/25 at 3:21 pm, RN A stated she had worked as a nurse at the facility since 2000. RN A stated she got a call from Admitting Clerk (AC) A on 5/3/25; AC A informed her a pregnant woman was, "here to ask questions," but was not "signed in." RN A stated, "If the patient had been signed in, I would have triaged her and brought her back, but she wasn't." RN A stated she went to the lobby and found four individuals: Patient 0 (pregnant, having contractions); Family Member (FM) 0 (older female, spoke English and provided translation for the family); FM 1 (older male, driver); and FM 2 (younger male, Patient 0's partner).
RN A stated FM 0 asked if they could "check the patient," to see if she should go to Hospital B to deliver the baby. RN A stated she informed them that Patient 0 would "have to stay there and deliver," if Patient 0 signed in, the nurse checked her, and Patient 0 had been more than 4 centimeters (cm - a unit of measure) dilated (scale of 1-10 cm, 10 cm indicating the cervix is completely dilated and ready for delivery). RN A informed them the facility was capable of delivering a baby but that they did not have an OB part of the hospital, Patient 0 would not get an epidural because there wasn't a Certified Registered Nurse Anesthetist (CRNA - advanced practice nurse who administers an epidural - medication into the spine - for pain relief during labor) on staff, but that pain medication was available. RN A informed them they did not have a surgical department and, "If there are complications, we do not do Cesarean sections (C-sections)." RN A stated, "At that time, I was just informing them of their options" and stated, "I told them what we did have." RN A stated she excused herself to call Family Nurse Practitioner (FNP) A, the midlevel provider (provides a level of care less than a doctor but can function with significant independence) on duty that morning, who was in the "sleep house," (on facility property). RN A stated her call woke him. RN A stated she asked how experienced he was delivering babies, and he told her, "I'm not." RN A stated the family talked in Spanish and then stated they were going to Hospital B. RN A stated Patient 0 stood up to leave and looked "uncomfortable," but FM 0 was "insistent," they were leaving. RN A stated she asked who was driving, and if they had a suitable car to get there; FM 1 stated he could drive. RN A stated she did not use translation services "because [Patient 0] wasn't signed in as a patient." RN A stated, "They just stopped for a question and wanted me to give them information." RN A stated she wished she had called Hospital B ahead of time to say they had been here. RN A stated, "I feel that's the only thing I did wrong." When asked if RN A told the family they could call an ambulance on the way, RN A stated, "Yes, if they felt the need. I did have that conversation." RN A also stated there were areas of no cell phone service between hospitals, and she informed them that.
During an interview, with Director of Quality (DOQ), and EDM, on 6/3/25 at 3:35 pm, EDM stated, that RN A had worked as an OB Nurse at the facility when they had OB services, and that she "had delivered, I believe, 40 babies before." DOQ stated, that they last had OB in 2016. DOQ stated, that video existed of the interaction between RN A, and the family but noted the audio was difficult to hear. DOQ stated, that the Director of Safety & Security (DSS) created a translation. DOQ noted that the events of 5/3/25 occurred with AC A's window open and "AC A is bilingual." DOQ stated, "I interviewed [AC A] after the fact and noted some pretty extreme translation gaps by [FM 0] of what she heard [RN A] say."
During a phone interview, with Patient 0 using interpretation services on 6/4/25 at 9 am, Patient 0 acknowledged her original birth plan had been to deliver her baby at Hospital B. Patient 0 stated, "I don't remember," when asked if she understood any of the conversation at Hospital A on 5/3/25, or if she relied on translation from FM 0. Patient 0 acknowledged, that her water broke inside Hospital A, and that staff were aware. Patient 0 said, "Yes, there was a lady who knew... I think it was a nurse." When asked if an ambulance had been called during the drive from Hospital A to Hospital B, Patient 0 stated, "Yes." When asked how far away from Hospital B they were when they called the ambulance, Patient 0 stated, "I really couldn't tell exactly because I was in really bad shape."
During concurrent interview, with Medical Staff Coordinator (MSC), and employee file review, on 6/5/25 at 10:56 am, MSC stated FNP A's employee records indicated medical privileges to include obstetrical and gynecological precipitous (happens very quickly) delivery.
During an interview, with RN B on 6/5/25 at 4:24 pm, RN B stated when a pregnant woman presents to the ED in labor, nursing staff typically ask questions about prenatal care received, how far along she is, and if her water has broken. RN B stated the patient is typically placed in Room 6, the smaller bed is moved out, and a "TOCO monitor" (tocodynamometer - a device placed on the patient's abdomen that measures uterine contractions) is placed. RN B stated the larger delivery bed, Panda warmer, and supplies are placed in the room, and the Medical Doctor (MD), Respiratory Therapist (RT), and Nurse Administrator On Call (NAOC) are called. RN B stated the NAOC typically comes to the facility to assist and places calls to get more staff because the ED only staffs two nurses; RN B stated at least one more nurse would be needed. When asked if she would use the translation service for a pregnant Spanish-speaking patient who presented in active labor, RN B stated, "Yes, I always use it." RN B stated there are three tablets available, and the facility provides the translation line on the tablets. RN B stated she would grab a tablet and the provider, then call the translation line, so the patient only had to give the history once and all team members and patient were clear on the plan.
During an interview, with EDM on 6/5/25 at 4:38 pm, EDM stated, that she had spoken with RN A and reviewed the video tape. EDM stated, "In my opinion, after hearing RN A's account, there's a fine line between giving information and medical advice." EDM stated, "I would have said, 'We need to get you checked in so I can do a full assessment.' EDM acknowledged, "You can see [in the video] she's actively in labor." EDM stated the language line definitely would have been beneficial, but she wasn't a patient. EDM stated, when we pull in more and more and more resources for someone who isn't admitted, it gets sticky. Where do we draw the line? EDM stated Patient 0 said she wanted an epidural, and the facility could not provide that; EDM stated she believed that is why they left.
During concurrent observation, of the 5/3/25 ED lobby video (Video 1) and ED entrance (Video 2) and interview, with DSS on 6/5/25 at 10:50 am, DSS stated, as a layperson with no medical background, Patient 0 appeared "scared," and "in pain," on the videos and that pain "seemed to be increasing," towards the end of the visit.
A. On review of Video 1:
(1) Patient 0 appeared to have constant abdominal pain, held her hands to her belly, repeatedly changed positions, and did pursed-lip breathing throughout the encounter. (2) RN A can be heard saying to family: "We don't have any epidural, we don't have any anesthesia. If the water breaks, there's concern for (inaudible). You don't look like you're going to have a baby in an hour. Do you want me to call [provider] and see if he can deliver the baby?" (3) As Patient 0 stood to leave, observed her to look down at the front of her pants. FM 0 stated, "Oh, her water broke." RN A stated, "Oh, it did?" and bent to look at Patient 0's pants. FM 0 stated, "Right now." RN A stated, "Ok, ok. Well, I still think it will be quite a while, but (inaudible)." (4) RN A can be heard speaking with AC A after family left:
"Even though your water breaks, (inaudible) can go on for multiple hours. It's not perfect, is it? It's an hour to get there; you can still drive 80." (5) DSS reviewed my transcription of the video while watching Video 1 and acknowledged hearing all quotes as written above.
B. DSS stated Video 2 did not have audio as there were no speakers outside. On review of Video 2, observed the ED lobby entrance. Observed FM 1 left the facility and returned in a small 4-door car to the driveway outside the ED lobby entrance where he parked but left the car running. Patient 0 and FM 2 left the facility shortly afterward, Patient 0 with hand on FM 2's shoulder, FM 2 supporting her back with his arm. Patient 0 stopped walking, turned to FM 2, appeared to have a painful contraction, did pursed-lip breathing, bent at the waist, and placed her head on his shoulder. FM 0 left the facility, saw Patient 0, and pointed back to the lobby. A short (inaudible) conversation was had, and they walked to the car. FM 2 placed his coat on the seat before Patient 0 got in the car.
During a phone interview, with AC A on 6/6/25 at 10:13 am, AC A stated she was bilingual in English and Spanish and remembered the events of 5/3/25. AC A stated she and FM 0 knew each other outside of the facility and that FM 0 was also bilingual. AC A stated FM 0 asked in Spanish if a nurse could give advice to see if Patient 0 would "make it" to [Hospital B] to have her baby. AC A stated Patient 0 said her contractions started the day before, and Patient 0 had "at least two" contractions during the encounter. AC A stated RN A told them if Patient 0 checked in, "You can't leave afterwards" adding, "If they want to leave, they could sign an against medical advice (AMA - form acknowledging risks of leaving without medical treatment)." AC A stated RN A explained the facility "didn't have any equipment for a baby," and if Patient 0 did need a C-section, "we didn't have the team." RN A also stated they had a nurse practitioner and "she could ask if he could deliver." AC A stated FM 0 "was not directly translating right." AC A stated FM 0 told Patient 0 in Spanish, "If you stay here, they don't have anything for you, and you're going to die." AC A stated RN A told Patient 0 it was her decision to leave or stay, and FM 0 was "pushing her to leave." AC A stated the patient seemed hesitant and "wasn't really answering" FM 0. AC A stated she felt FM 0 knew enough English but that "she was panicking, so I think that's why she wasn't translating right." When asked, AC A acknowledged she did not intervene and tell RN A what FM 0 was translating to Patient 0. AC A stated FM 0 asked, "If we call an ambulance, will they take her?" AC A stated RN A told them no, they (ambulance) would "reroute her here." AC A stated the family got the car ready, and Patient 0's water broke at that time. AC A stated RN A told them, "You can still make it to the hospital" and to "be careful of the deer." AC A stated she believed RN A understood Patient 0's water broke prior to leaving; RN A said, "Maybe you peed. If it broke, you can still make it." AC A stated she and RN A talked after the family left about what transpired, noting, "We were hoping she made it out of there." AC A indicated she did not have medical/nursing experience, but as a layperson, Patient 0 "looked scared to me, like she didn't know what to do." AC A stated the family said they were going to call an ambulance on their way over and Patient 0 "didn't say anything."
A review of Patient 0's medical records from Hospital B was performed:
1. "ED Physician Notes," dated 5/3/25 at 5:39 am, indicated Hospital B received a "field call (over the radio) for patient in active labor," contractions lasting 20 to 30 seconds approximately 3 to 4 minutes apart. The note indicated Patient 0 was a 19 year old who arrived by ambulance and was subsequently seen by MD A (ED physician). The note indicated that Patient 0 was "briefly" seen in the ED and a Labor and Delivery (L&D) nurse and the OB on-call were contacted. The note indicated it did not appear Patient 0 would have "emergent precipitous (happening right now) delivery," and MD A deemed her stable for transfer to the L&D floor "for optimal delivery team/setting." The note indicated Patient 0 was transferred to L&D at 5:38 am.
2. "ED Physician Notes," dated 5/3/25 at 5:58 am, indicated Patient 0 was being "prepped for delivery and OB arrival" when MD A was notified Patient 0 was "ready to deliver." The note indicated MD A arrived at L&D, Patient 0 "began crowning (baby's head was showing) with eventual delivery after one push." The note indicated the baby was delivered without complication.
3. "History and Physical," dated 5/3/25 at 8:56 am, indicated Patient 0 was accompanied by FM 0 and FM 2. Social History indicated Patient 0 was born in California, grew up in Mexico, and had been living back in the area for approximately the last year.
4. "Physician Note," dated 5/4/25 at 9:25 am, indicated Patient 0 was "doing well" on day after vaginal delivery without complications. The note indicated Patient 0 had an "episode of hypotension (low blood pressure) and borderline loss of consciousness approximately an hour after the delivery." Discharge of Patient 0 was anticipated for the next day (5/5/25) but she needed to stay 48 hours "since Group-B Streptococcus (GBS - common bacteria carried in the lower genital tract of pregnant women that can be passed to baby, leading to serious infection) status is unknown."
5. "Discharge Summary," dated 5/5/25 at 8:43 am, indicated Patient 0 initially went to Hospital A where she was told that "she could not deliver there," and that she needed to "immediately go to a hospital that can deliver her baby." The note indicated Patient 0's water broke at Hospital A "less than 2 hours," before delivery, and Patient 0 was "complete and starting to crown," upon arrival to L&D at Hospital B. Patient 0's urine culture at Hospital B was positive for Escherichia coli (E. coli - bacterial urinary tract infection that can increase the risk of early delivery, low birth weight, and stillbirth), "treated with antibiotics during pregnancy."
Hospital A failed to document the encounter with Patient 0 who presented with an EMC (active labor), nor did staff certify in writing that Patient 0 did not have an EMC per EMTALA guidelines. Translation services were not provided per facility's policy for a Spanish-speaking prospective patient, and it is unclear if Patient 0 and family could make an informed decision about the risks associated with leaving the facility. RN A, and FNP A, failed to provide an MSE and necessary stabilizing treatment to Patient 0. Neither an OB physician, or FNP A's supervising physician, were consulted. The facility failed to provide ambulance transfer per facility policy and upon request by family members.
Tag No.: C2409
Based on interview, and record review, the facility failed to ensure that the transfer process was completely documented in the medical record for one of 21 sampled patients (Patient 18), as evidenced by the inability to produce an informed consent form for a transfer to another facility.
This failure had the potential for Patient 18 to be uninformed as to risks and consequences associated with their transfer which could lead to negative clinical outcomes.
Findings:
A review, of the facility's policy titled, "Transfer of Patients via Ambulance," effective 5/30/19, indicated that the process of transferring a patient included obtaining the patient's signature on appropriate EMTALA (Emergency Medical Treatment and Active Labor Act) consent forms.
A review, of Patient 18's medical record indicated that he had diagnoses that included pneumothorax (a collapsed lung), and a right hip injury. An Emergency Department (ED) Provider Note, dated 5/8/25 at 2:32 am, by Family Nurse Practitioner (FNP) A, indicated that Patient 18 required a higher level of care and would be transferred out from the facility.
A review, of Patient 18's EMTALA Note, by FNP A dated 5/8/25 at 2:46 am, indicated that consent for transfer had been obtained.
A review, of Patient 18's Provider's Orders, by FNP A dated 5/8/25 at 5:32 am, directed that Patient 18 was to be transferred to another facility.
During an interview, on 6/5/25 at 1:38 pm, the ED Manager (EDM) stated, that she was unable find written consent for the transfer in Patient 18's medical record, and explained that consent forms are filled out on an electrical tablet, including patient signatures, and if the form was missing, it was because it had not been completed. The EDM affirmed, that consent is necessary, and stated that without it, the facility did not have proof that permission was given for transfer, or that the risks and benefits of the transfer had been explained fully to the patient.