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Tag No.: C2400
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Based on interview and record review, the hospital failed to meet the regulatory requirements under the Emergency Medical Treatment and Labor Act (EMTALA) as evidenced by:
1. Three of 21 patients (Patient #3, Patient #17 and Patient #18) whose records were reviewed were not provided with an appropriate medical screening examination (MSE) to determine whether an emergency medical condition existed. Additionally, the patients did not receive the same MSE the hospital performed on other patients who came to the Emergency Department with similar signs and symptoms. (Cross refer to tag C2406).
2. Patient #18 was not provided with the necessary stabilizing treatment within the capabilities of the hospital (Cross refer to tag C2407).
3. The hospital failed to ensure an appropriate transfer when Patient #18, who was in labor, was transferred to a hospital about an hour away without fetal monitoring and with erroneous certification that her emergency medical condition was "stabilized" and not "in labor" (Cross refer to tag C2409).
Tag No.: C2406
.
Based on medical record review, ED log review, transfer log review, policy review, and staff interviews, it was determined the hospital failed to provide an appropriate medical screening exam to 3 of 21 patients (Patients #3, #17, #18) who presented to the ED and whose medical records were reviewed. The MSEs provided to Patient #3 and Patient #17 were both inappropriate on their face and disparate from the MSE provided to three similarly situated patients identified upon record review (Patients #13, 19, and 21). This failed practice had the potential to put patients at risk of deterioration due to an unidentified EMC.
Findings include:
Review of a hospital policy titled "Medical Screening Exam", dated 9/20/23, showed, "An MSE is the process required to reach, with reasonable clinical confidence, the point at which it can be determined whether a medical emergency does or does not exist. The hospital must apply a screening process that is reasonably calculated to determine whether an emergency medical condition exists in a non-discriminatory manner."
Review of a hospital policy titled "Emergency Medical Treatment and Labor Act (EMTALA) Policy," dated 10/20/2022, showed, in part: "If an individual comes to the Emergency Department the hospital will provide... an appropriate medical screening examination within the capability of the Hospital ' s
Dedicated Emergency Department, including ancillary services routinely available, to determine whether or not an emergency medical condition exists" and "The Hospital shall provide a medical screening examination to any individual who comes to the Emergency Department." The policy required that "the medical screening examination is the examination of the patient by the Qualified Medical Person required to determine within reasonable clinical confidence whether an emergency medical condition does or does not exist" and that the "medical screening examination is required to reach, with reasonable clinical confidence, the point at which it can be determined whether the individual has an emergency medical condition or not."
Review of a hospital policy titled "Emergency Department - Labor (Obstetrical) Patient," dated 2/03//2021, showed the policy ' s stated "purpose" was to "establish guidelines for a laboring (obstetrical) patient that [sic] presents to the emergency department" and required that "If delivery does not appear to be imminent," assessment is to include, among other things, "fetal heart tones via Doppler, ...Vaginal bleeding, ...Membrane status ...Intact, leaking, or ruptured, ...If ruptured: time, color, odor, [and] Contractions ...Frequency, duration, strength." The policy required that "if delivery appears to be imminent or if unable to transfer patient:
1. Contact all staff listed on the attached Call List - Obstetric Patient in Labor.
2. Contact Life Flight and request dispatch of the neonatal team, [and] prepare for delivery." The policy then lists specific equipment and supplies to use, describes how to perform the delivery, and directs hospital staff to "Prepare mother and infant for transport to another facility" after delivery.
Review of the "Emergency Department - Scope of Services" policy, dated 9/29/22, revealed that "Emergency Medicine Privileges" routinely include "delivery of newborn, emergency" and "resuscitation, all age."
Review of a hospital policy titled "Standing Order - Vaginal Bleeding," dated 12/13/21, described the "scope/responsibility" of the policy to include "trained hospital nursing staff and ED providers" and the policy purpose "to provide expedited care to any patient presenting to the emergency department (ED) of ...
with vaginal bleeding." Among other items, the policy described the "procedure" for screening to include "Establish intravenous (IV) access to obtain blood for labs via purple, green, red, blue, and yellow tubes and order type and cross; ...Evaluate and quantify bleeding; ...Order qualitative/quantitative pregnancy test (Human Chorionic Gonadotropin [HCG]/âHCG); Set up for pelvic exam including the following: 1. Lighted speculum. 2. Lubricant. 3. Culture swabs. 4. Vaginal packing; ...Check for ultrasound availability and order if necessary."
Review of Patient #3 ' s medical record showed Patient #3 presented to the hospital ED on 3/17/24 at 12:47 PM with a chief complaint of vaginal bleeding. Documentation by Physician A described that she was a 32-year-old female who reported "that she is approximately 6 weeks pregnant when she had heavy vaginal bleeding yesterday" and "had abdominal cramping yesterday but that has mostly resolved. She was on the phone with her midwife today who encouraged her to come to the [emergency] department."
The medical record did not contain documentation that Patient #3 had previously undergone an ultrasound examination during this pregnancy to confirm that the location of her pregnancy was intrauterine (inside the uterus), as opposed to potentially ectopic. Ectopic pregnancy occurs when a pregnancy implants outside the uterus and can be associated with life-threatening hemorrhage, loss of future fertility, infection, coagulopathy (dysfunction of the body ' s blood clotting organs and system), and damage or dysfunction to the uterus, fallopian tubes, ovaries, and/or other abdominal and pelvic organs.
The medical record also did not contain documentation that Patient #3 was evaluated for other causes of bleeding, such as traumatic injury, nor offered any laboratory testing (including quantitative human chorionic gonadotropin testing [measurement of pregnancy hormone levels]), pelvic examination, or consideration of ultrasound as part of her MSE, as required by hospital policy. The medical record did not contain evidence that Patient #3 refused any portion of her examination or treatment.
Review of Patient #17 ' s medical record showed that Patient #17 presented to the hospital ED on 9/29/23 at 4:44 PM with a chief complaint of vaginal bleeding while in custody of law enforcement. Documentation by Physician A described that she was a 22-year-old female who was 10 weeks, 5 days pregnant, and "She woke up from her nap and she had vaginal bleeding. She reports her underwear was covered in blood ...She has not had an ultrasound yet with this pregnancy." Physician A documented the "physical exam" to include "Abdomen Mild tenderness to palpation in pelvic area," but there was otherwise no documentation to suggest evaluation or quantification of bleeding or further pelvic examination. The medical record also did not contain documentation that Patient #17 was evaluated for other causes of bleeding, such as traumatic injury.
The "Medical Decision Making" documented for Patient #17 by Physician A stated, "22-year-old female presents to the emergency department in law enforcement custody with complaint of vaginal bleeding. Patient is approximately 10 weeks pregnant. She had not had an ultrasound to demonstrate IUP [intrauterine pregnancy] yet. She does complain of pelvic pain. Concern for ectopic pregnancy persist."
Laboratory testing for quantitative human chorionic gonadotropin testing (measurement of pregnancy hormone levels) was collected 9/29/2023 at 5:50 PM, but the result was not available or reviewed prior to discharge. Physician A documented that the hospital did not have ultrasound capabilities at the time of Patient #17 ' s visit and that she would be transferred to another facility with those capabilities. However, the medical record did not contain evidence that Patient #17 was offered other screening within the hospital ' s capabilities prior to being transferred, including the procedure described by the hospital ' s "Standing Order - Vaginal Bleeding" policy. Documentation by RN #1 reflected that Patient #17 was transferred to another facility by law enforcement 9/29/2023 at 6:15 PM.
Review of comparator medical records from similarly situated patients included the following:
Review of Patient #13 ' s medical record showed she presented to the hospital ED on 1/15/2024 at 8:25 AM approximately seven weeks pregnant with a complaint of vaginal spotting and pelvic cramping. There was documentation that Patient #13 had previously undergone ultrasound evaluation to confirm intrauterine pregnancy. Patient #13 ' s medical record contained evidence of pelvic examination, laboratory testing, blood bank evaluation, repeat point of care ultrasound, evaluation and quantification of bleeding, and other screening required by hospital policy as part of her MSE.
Review of Patient #19 ' s medical record showed she presented to the hospital ED on 11/14/2023 at 6:04 PM approximately 20 weeks pregnant with a complaint of vaginal bleeding. She was evaluated by Physician A, who quantified her bleeding on pelvic examination as "moderate." Physician Assistant #1 ordered an ultrasound. Patient #19 ' s medical record also contained evidence of laboratory testing, blood bank evaluation, and other screening required by hospital policy as part of her MSE, and she was subsequently transferred to another facility.
Review of Patient #21 ' s medical record showed she presented to the hospital ED on 11/22/2023 at 2:51 PM with a complaint of lower abdominal and pelvic cramping and described taking multiple home pregnancy tests, which were positive. Patient #21 ' s medical record contained evidence of laboratory testing, including quantitative human chorionic gonadotropin testing (measurement of pregnancy hormone levels), ultrasound, and evaluation and quantification of bleeding as part of her MSE. Ultrasound was concerning for ectopic pregnancy, and Patient #21 was transferred to another facility for further treatment.
Review of Patient #18 ' s medical record showed that she presented to the hospital ED on 9/24/2023 at 3:30 AM with a chief complaint of "water broke 2 [hours] ago." Under "History of Present Illness," Physician B documented that Patient #18 was a "33-year-old G5 [number of times she has been pregnant], P2 [number of times she had given birth] at 36 weeks 2 days EGA [estimated gestational age] presenting via POV [privately operated vehicle] in labor. Patient felt a large gush of fluid and thinks her water broke approximately 2 hours prior to presentation. Some very minimal pink spotting, no frank vaginal bleeding. Active fetal movement. Reports contractions are just under 10 minutes apart. Patient presented [to] the emergency department as her last 2 children came very quickly when she went into labor, and she was worried she would not make it to [name of Hospital B, 52 miles away]," where she had planned to deliver her child.
The "Physical Exam" documented by Physician B described Patient #18's "cervix was dilated to 3 cm [centimeters], 50% effaced, [a measurement of thinning of the cervix prior to birth], -2 [station, location of the fetal head within the pelvis], soft." "Medical Decision Making" documented by Physician B stated Patient #18 was "presenting in labor ...decision was made to transport patient via EMS to [Hospital B] for obstetric services." Patient #18's medical record did not contain evidence that her MSE included evaluation of fetal heart tones via Doppler, membrane status (intact, leaking, or ruptured and if ruptured, time, color, and odor), or frequency, duration, or strength of contractions, as required by hospital policy prior to transfer.
During an interview on 7/25/24 at 12:30 PM, RN #1 confirmed the ED had two available dopplers for evaluation of fetal heart tones at the time of Patient #18 ' s presentation. When asked about normal procedure for assessment of fetal heart tones for an ED patient in labor, she reported that nurses often take the fetal heart tones but that a doctor can also assess fetal heart tones.
Cross-refer to tags C-2407 and C-2409.
Tag No.: C2407
.
Based on hospital policy review, staff interviews, and review of patient medical records and documents, it was determined the hospital failed to stabilize 1 of 21 patients (Patient #18) who presented to the ED seeking emergency care and whose records were reviewed. The hospital determined that Patient #18 was "in labor" but failed to provide stabilizing treatment outlined in its policies for imminent delivery, including assurance that Patient #18 delivered her fetus and placenta prior to discharge or transfer. This failed practice placed the patient at risk of precipitous out-of-hospital delivery and placed the health of the patient and her fetus in serious jeopardy, including complications of delivery such as shoulder dystocia, respiratory distress of the infant, and maternal hemorrhage, among others.
Findings include:
Review of a hospital policy titled "EMTALA Policy", dated 12/04/2020, which defines "Labor" as "the process of childbirth, beginning with the latent or early phase of labor and continuing through the delivery of the placenta. A woman experiencing contractions is in true labor unless a provider, certified nurse-midwife or other qualified medical person acting within his or her scope of practice as defined in hospital medical staff bylaws and state law, certifies that, after a reasonable time of observation, the woman is in false labor." The policy further requires that the hospital "1. Provide to an individual who is determined to have an emergency medical condition such further medical examination and treatment as is required to stabilize the emergency medical condition; or 2. Arrange for transfer of the individual to another medical facility."
Review of a hospital policy titled "Emergency Department - Labor (Obstetrical) Patient," dated 2/3/21, showed the policy ' s stated "purpose" was to "establish guidelines for a laboring (obstetrical) patient that [sic] presents to imminent, staff shall prepare for a precipitous delivery in the ED. When mother and newborn are stable, they will be transferred to the nearest appropriate facility for postpartum care. Emergency Medical Treatment and Labor Act (EMTALA) guidelines shall be followed for all patient transfers." The policy required that "if delivery appears to be imminent or if unable to transfer patient:
1. Contact all staff listed on the attached Call List - Obstetric Patient in Labor.
2. Contact Life Flight and request dispatch of the neonatal team, [and] prepare for delivery." The policy then lists specific equipment and supplies to use, describes how to perform the delivery, and directs hospital staff to "Prepare mother and infant for transport to another facility" after delivery. The policy further requires that, "if delivery does not appear to be imminent," various screening be performed (cross refer to tag C-2406) and "the provider will ...seek consultation from an OB provider regarding transfer to another facility or discharge to home."
Review of the "Emergency Department - Scope of Services" policy, dated 2/03/21, revealed that "Emergency Medicine Privileges" routinely include "delivery of newborn, emergency" and "resuscitation, all ages."
Review of Patient #18 ' s medical record showed that she presented to the hospital ED on 9/24/2023 at 3:30 AM with a chief complaint of "water broke 2 [hours] ago." Under "History of Present Illness," Physician B documented that Patient #18 was a "33-year-old G5 [number of times she has been pregnant], P2 [number of times she had given birth] at 36 weeks 2 days EGA [estimated gestational age] presenting via POV [privately operated vehicle] in labor. Patient felt a large gush of fluid and thinks her water broke approximately 2 hours prior to presentation. Some very minimal pink spotting, no frank vaginal bleeding. Active fetal movement. Reports contractions are just under 10 minutes apart. Patient presented [to] the emergency department as her last 2 children came very quickly when she went into labor, and she was worried she would not make it to [ Hospital B, 52 miles away]," where she had planned to deliver her child."
"Medical Decision Making" documented by Physician B stated Patient #18 was "presenting in labor" and reflected that the hospital had knowledge of Patient #18 ' s prior two precipitous deliveries and Patient #18 ' s concern that there was inadequate time to effect a safe transfer to another hospital before delivery. Patient #18's medical record contained an ED note from PA #1 which stated, "Patient presented the[sic] Emergency Department as her last 2 children came very quickly when she went into labor, and she was worried she would not make it to [Hospital B]." The medical record did not contain evidence that Patient #18 delivered her fetus and placenta prior to discharge or transfer, nor that the hospital determined her delivery was "not imminent," as required by hospital policy.
Review of collateral records also supported that the hospital had knowledge that Patient #18 was a pregnant woman having contractions such that there was inadequate time to effect a safe transfer to another hospital before delivery and/or that transfer may pose a threat to the health or safety of Patient #18 or her fetus. Physician B documented having spoken to Physician C, an OB/GYN physician at Hospital B, about Patient #18 ' s presentation to arrange transfer to Hospital B. Review of transfer center records from Hospital B describe the call from Physician B as "looking to initiate transfer for this [patient] that [sic] is in active labor..." Subsequent transfer-related communication documentation attributed to Physician B further said, "Connected w/ [Physician C]; case and presentation reviewed, this is a 33F who is G5P3 who came into Benewah in active labor. She is currently 36 weeks and 2 days. Contractions 9 minutes apart, 3.5 cm dilated, water has broke."
Review of the emergency medical services (EMS) records for Patient #18 revealed that EMS personnel were called to the hospital to assist in transferring Patient #18 to Hospital B and "were informed by the MD on staff [Physician B] to make it to [Hospital B] as quickly as possible as she was progressing fairly rapidly. Patient stated that her water had broken approx. 2 hours prior and that she delivers quickly as her 2 previous deliveries had arrived approximately 2 hours after her water had broken as well" and that "patient has a history of hemorrhage following deliveries." Staff documented that Patient #18 was transferred to Hospital B on 9/24/2023 at or about 4:00 AM via emergency medical services (EMS). Ambulance Transport Order marked "EMT transport only (routine emergency measures: follow BLS guidelines) Vital signs q [every]15 min." Confirmed ambulance transfer was volunteer EMTs willing to transfer patient to [Hospital B], 52 miles away on a 2-lane winding rural mountain road.
Physician B was interviewed on 7/25/24 at 10:15 AM. Physician B confirmed he thought Patient #18 was stable for transfer. Physician B reported Patient #18's vitals were stable, and it seemed like "normal labor." When asked if he assessed the stability of the fetus through fetal heart tones or other method, Physician B reported he believed that he had.
Surveyors were unable to find a record of fetal heart tones or other monitoring of unborn child in Patient #18's medical record.
Review of hospital credentialing file for Physician B revealed that Physician B was credentialed to perform "delivery of newborn, emergency" and "resuscitation, all ages" as well as "attendance at delivery to assume care of normal newborns."
Cross-refer to tags C-2406 and C-2409.
Tag No.: C2409
.
Based on hospital policy, staff interviews, and review of patient records and documents, the hospital failed to provide an appropriate transfer because it failed to minimize risk of the transfer, failed to assure the transfer was effected through qualified personnel and transportation equipment, and misrepresented patient condition for 1 of 21 patients (Patient #18) who presented to the ED for emergency care and whose record was reviewed. This failed practice placed the patient at risk of precipitous out-of-hospital delivery and placed the health of the patient and her fetus in serious jeopardy.
Findings include:
Review of a hospital policy titled "EMTALA Policy", dated 12/04/2020, defines "Labor" as "the process of childbirth, beginning with the latent or early phase of labor and continuing through the delivery of the placenta. A woman experiencing contractions is in true labor unless a provider, certified nurse-midwife or other qualified medical person acting within his or her scope of practice as defined in hospital medical staff bylaws and state law, certifies that, after a reasonable time of observation, the woman is in false labor." The policy further requires that the hospital "1. Provide to an individual who is determined to have an emergency medical condition such further medical examination and treatment as is required to stabilize the emergency medical condition; or 2. Arrange for transfer of the individual to another medical facility."
"When the Hospital transfers an individual with an unstabilized emergency medical condition to another facility, the transfer shall be carried out in accordance with the following procedure: a. The Hospital shall, within its capability, provide medical treatment that minimizes the risks to the individual's health and, in the case of a woman who is having contractions, the health of the unborn child." The policy also stated "The transfer must be performed through appropriately trained professionals and transportation equipment, including the use of necessary and medically appropriate life support measures during the transfer. The provider is responsible for determining the appropriate mode of transport, equipment, and transporting professionals to be used for the transfer."
Review of a hospital policy titled "Emergency Department - Labor (Obstetrical) Patient," dated 02/03/21, showed the policy ' s stated "purpose" was to "establish guidelines for a laboring (obstetrical) patient that [sic] presents to the emergency department" and required that "If the ED provider determines that delivery is imminent, staff shall prepare for a precipitous delivery in the ED. When mother and newborn are stable, they will be transferred to the nearest appropriate facility for postpartum care. Emergency Medical Treatment and Labor Act (EMTALA) guidelines shall be followed for all patient transfers." The policy required that "if delivery appears to be imminent or if unable to transfer patient:
1. Contact all staff listed on the attached Call List - Obstetric Patient in Labor.
2. Contact Life Flight and request dispatch of the neonatal team, [and] Prepare for delivery." The policy then lists specific equipment and supplies to use, describes how to perform the delivery, and directs hospital staff to "Prepare mother and infant for transport to another facility" after delivery.
Review of Patient #18 ' s medical record showed that she presented to the hospital ED on 9/24/2023 at 3:30 AM with a chief complaint of "water broke 2 [hours] ago." Under "History of Present Illness," Physician B documented that Patient #18 was a "33-year-old G5 [number of times she has been pregnant], P2 [number of times a she had given birth] at 36 weeks 2 days EGA [estimated gestational age] presenting via POV [privately operated vehicle] in labor. Patient felt a large gush of fluid and thinks her water broke approximately 2 hours prior to presentation. Some very minimal pink spotting, no frank vaginal bleeding. Active fetal movement. Reports contractions are just under 10 minutes apart. Patient presented [to] the emergency department as her last 2 children came very quickly when she went into labor, and she was worried she would not make it to [Hospital B]" where she had planned to deliver her child.
"Medical Decision Making" documented by Physician B stated Patient #18 was "presenting in labor" and reflected that the hospital had knowledge of Patient #18 ' s prior two precipitous deliveries and Patient #18 ' s concern that there was inadequate time to effect a safe transfer to another hospital before delivery. The medical record also did not contain evidence that Patient #18 delivered her fetus and placenta prior to discharge or transfer, nor that the hospital determined her delivery was "not imminent," as required by hospital policy.
Review of collateral records also supported that the hospital had knowledge that Patient #18 was a pregnant woman having contractions such that there was inadequate time to effect a safe transfer to another hospital before delivery and/or that transfer may pose a threat to the health or safety of the Patient #18 or her fetus. Physician B documented having spoken to Physician C, an OB/GYN physician at Hospital B, about Patient #18 ' s presentation to arrange transfer to Hospital B. Review of transfer center records from Hospital B describe the call from Physician B as "looking to initiate transfer for this [patient] that [sic] is in active labor at Benewah." Subsequent transfer-related communication documentation attributed to Physician B further said, "Connected w/ [Physician C]; case and presentation reviewed, this is a 33F who is G5P3 who came into Benewah in active labor. She is currently 36 weeks and 2 days. Contractions 9 minutes apart, 3.5 cm dilated, water ha broke."
Review of the emergency medical services (EMS) records for Patient #18 revealed that EMS personnel were called to the hospital to assist in transferring Patient #18 to Hospital B and "were informed by the MD on staff [Physician B] to make it to [Hospital B] as quickly as possible as she was progressing fairly rapidly. Patient stated that her water had broken approx. 2 hours prior and that she delivers quickly as her 2 previous deliveries had arrived approximately 2 hours after her water had broken as well" and that "patient has a history of hemorrhage following deliveries."
Patient #18's record included a scanned image of an "Ambulance Transport Order" marked "EMT transport only (routine emergency measures: follow BLS guidelines) Vital signs q[every]15 min." "IV fluids," "Medications," and "Other Orders" were left blank, and there were no further orders for personnel or transportation equipment or other necessary and medically appropriate life support measures during the transfer. Patient #18's record included a scanned image of a "Provider's Certification Statement" marked "Reason for Transport: Labor." A handwritten checkmark appears next to "Needed treatment is available at Benewah Community Hospital but patient requested transfer to another facility." A checkmark next to "Needed treatment is not available at Benewah Community Hospital" appears to have been crossed out and initialed.
On a scanned image of an "Emergency department patient treatment or transfer consent/request/refusal" form, a handwritten checkmark appears next to "Consent to transfer (To be completed if the patient consents to a transfer recommended by a physician) I have been examined by a physician ...They have explained my condition to me and have recommended that I be transferred to ___," followed by a blank line that does not contain an entry. No checkmark appears next to "Request for transfer ...I request a transfer or discharge for the following reasons ..." The form has a signature on the line for "patient or authorized representative" that corresponds to Patient #18 ' s name.
Patient #18 ' s medical record also contains a scanned image of a "Provider's Assessment and Certification" form marked "The patient has been stabilized such that within reasonable medical probability, no material deterioration of the patient's condition or the condition of the unborn child(ren) is likely from transfer," and no checkmark appears next to "The patient is in labor."
The medical record otherwise does not contain evidence of a discussion with Patient #18 regarding risks of transfer, nor does there appear to be a request made by Patient #18 in writing, indicating the reasons for the request as well as indicating that she is aware of the risks and benefits of the transfer. The medical record also does not contain a physician certification that the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the risks to Patient #18 or her fetus.
Review of Patient #18's medical record indicated Patient #18 was transferred to Hospital B on 9/24/2023 at or about 4:00 AM via emergency medical services (EMS).
Review of an emergency medical services (EMS) record reflected that Patient #18 continued having contractions every two to eight minutes during the transfer and described that Patient #18 "felt [a] need to push" enroute. The report "narrative" includes documentation of contractions at 4:04, 4:11, 4:19, 4:25, 4:28, 4:32, 4:35, 4:39, 4:43, 4:50, 4:53, 4:56 ("Contraction - Felt need to push"), and 4:58. Arrival at Hospital B is documented as 5:00 and "at arrival to [Hospital B], we were rushed back to OB and immediately got patient [transferred] to the OB bed. Gave report to nurse and patient [stated] that she needed to push. [Hospital B] staff immediately started the process for delivery and [EMS] exited the room."
Review of records from Hospital B revealed that Patient #18 arrived 9/24/2023 at 5:05 AM "in active labor" and delivered a viable neonate at 05:12 AM.
Cross-refer to tags C-2406 and C-2407.