Holy Cross Hospital

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 33162 Based on review of hospital records, Gynecological Physician on-call schedules, and interviews, it was determined that the hospital failed to ensure that Patient #2 and Patient #15 (two of twelve sampled patients with pregnancy related conditions who presented at the hospital’s emergency department) received an appropriate medical screening examination (MSE) that made use of the hospital’s capabilities (including but not limited to the ancillary services of the on-call gynecological physician routinely available to the emergency department) prior to transferring the patients to other hospitals for labor and delivery services. In addition, the hospital failed to provide an appropriate transfer to another medical facility for Patient #2 and Patient #15 (two of sixteen sampled patients who were transferred from Hospital A to another hospital) including but not limited to providing medical treatment within its capacity to minimize the risks to the individuals health and health of their unborn fetuses, confirm the receiving facility had available space and qualified personnel for the treatment of the patients, the receiving facility agreed to accept the transfer of the individuals prior to discharging the patients from Hospital A’s Emergency Department, and send to the receiving hospital all medical records related to the EMC that were available at the time of transfer. Cross Refer to findings at A2406 and A2409.”

“POSTING OF SIGNS CFR(s): 489.20(q) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to post conspicuously in any emergency department or in a place or places likely to be noticed by all individuals entering the emergency department, as well as those individuals waiting for examination and treatment in areas other than traditional emergency departments (that is, entrance, admitting area, waiting room, treatment area) a sign (in a form specified by the Secretary) specifying the rights of individuals under section 1867 of the Act with respect to examination and treatment for emergency medical conditions and women in labor; and to post conspicuously (in a form specified by the Secretary) information indicating whether or not the hospital or rural primary care hospital (e.g., critical access hospital) participates in the Medicaid program under a State plan approved under Title XIX. This Standard is not met as evidenced by: 33162 Based on observation and staff interview, the hospital failed to ensure Emergency Medical Treatment and Labor Act (EMTALA) signage was posted conspicuously and visible to all patients who entered the Emergency Department (ED) for evaluation via the ambulance entrance. The findings included: A tour of the Emergency Department (ED) was conducted on 04/11/24 beginning at 1:26 PM. There was no signage regarding patients’ rights pertaining to examination and treatment for emergency medical conditions, women in labor, and whether the hospital participated in the Medicaid program observed in the areas where patients enter the ED by ambulance. During an interview on 04/11/24 at 2:23 PM, the Director of the Emergency Department confirmed the only signage related to EMTALA rights, patient rights and Medicaid participation was located inside the walk-in ED entrance and next to the registration desk in the adjoining waiting room. The Director of the Emergency Department confirmed this signage was not at the ambulance entrance.”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 33162 Based on review of hospital records, Gynecological Physician on-call schedules, and interviews, it was determined that the hospital failed to ensure that Patient #2 and Patient #15 (two of twelve sampled patients with pregnancy related conditions who presented at the hospital’s emergency department) received an appropriate medical screening examination (MSE) that made use of the hospital’s capabilities (including but not limited to the ancillary services of the on-call gynecological physician routinely available to the emergency department) to determine whether an emergency medical condition (EMC) existed prior to transferring the patients to a hospital for labor and delivery services.. The findings included: 1. Review of the hospital’s Policy and Procedure, titled, EMTALA - Transfer Policy [Emergency Medical Treatment and Active Labor Act], reviewed 04/02/24, documented, in part, “General Requirements. If an individual (or the individual’s designated representative) “comes to the Emergency Department” of the Hospital requesting (or a prudent layperson would assume the individual would be requesting) either medical care or emergency medical care and an emergency medical condition is identified, the Hospital must provide either: A. Further medical examination and treatment, including hospitalization, if necessary, as required to stabilize the medical condition within the capabilities of the staff and facilities available at the Hospital;” 2. Review of Patient #2’s medical record revealed the patient presented to the ED (Emergency Department) on 03/18/24 at 10:39 AM with complaints of “ ...contractions and 39-week pregnancy. The patient states she she [sic] started contracting last night ...she has not had any evidence of water breaking ...” Patient #2 had a medical screening examination initiated by Physician B at 10:48 AM and she was triaged with an acuity Level 2 (indicating Emergency: could become life-threatening). The physical exam documented Patient #2’s abdomen was soft with no tenderness. There was no documentation a pelvic exam was completed to determine cervical dilation, assessment of fetal station, or an ultrasound. A pain assessment, documented at 11:16 AM, revealed Patient #2’s abdominal pain was rated 7 (severe - on a zero to 10 scale) with “contractions every 7 minutes.” 3. Physician B’s medical decision-making note documented “Patient is a 30-year-old female who comes into the ER (Emergency Room) today complaining of contractions. The patient states she is roughly 39 weeks pregnant. She denies having any rush of fluid consistent with her water breaking. She has had no vaginal bleeding. I spoke directly with (name of Hospital A Gynecologist physician) who states he is not her physician and checked with the office to verify this. He therefore recommends her to be transferred to (Hospital B). Since the patient is in early labor she will be transferred via 911 to (Hospital B). Spoke with (Hospital B Physician) as a courtesy call.” 4. The facility’s “Emergency Department ‘On-Call’ Roster” for “March 2024” revealed that on the day of March 18, 2024, there was an on-call Gynecologist physician available when Patient #2 presented to the hospital’s ED. According to hospital records, the on-call gynecological physician did not participate in the evaluation or management of Patient #2 as part of her medical screening examination. 5. The hospital medical record documented Patient #2 was discharged on 03/18/24 at 10:55 AM via Emergency Medical Services (EMS) for transfer to Hospital B (16 minutes after her initial presentation). A hospital document labeled “After Visit Summary” documented Patient #2’s diagnosis was “39 weeks gestation of pregnancy” and reason for visit was “contractions.” 6. An interview was conducted on 04/12/24 at 9:02 AM with Emergency Department Physician, Physician B, who was assigned to Patient #2 on 03/18/24 who stated Patient #2 was 39 weeks pregnant and reported feeling contractions, that they verified a fetal heart rate by bedside ultrasound and transferred her to Hospital B under the “assumed transfer agreement policy, which is similar to the trauma policy.” Physician B stated if a patient required Obstetrical care, they cannot do it here (at Hospital A) since there are no Obstetrical services here, so they transfer them to (Hospital B), unless their obstetrician goes to a different hospital where they may transfer them, and they give (Hospital B) a call to let them know the patient is coming and to give them information. Physician B stated he would not say Patient #2 was in “full labor, because her contractions were not every 2 or 3 minutes” and there was nothing eminent or unsafe about the transfer since she was not in the delivery phase, although he did expect she would deliver in the next 24 hours. Physician B stated he typically does not do a GU (genitourinary) exam for women in labor and did not do one for this patient because he did not want to cause trauma or issues with the laborist. Physician B stated the Emergency Department physicians are trained how to do deliveries, but if it is not imminent, they send them to a hospital that has Obstetrical services, and they can be best managed. 7. Review of Patient #15’s hospital medical record revealed the patient presented to the Emergency Department on 11/26/23 at 1:01 PM with complaints of “34 weeks preg [pregnant], leaking fluid.” Patient #15’s acuity was documented at Level 2 (indicating Emergency: could become life-threatening). The hospital record “ED Provider Note” documented “ ...43 y.o. [year old] female ...with feeling that her water broke and pelvic bleeding. Patient states both of her prior pregnancies were early. One was at 36 weeks and 1 [one] was at 27 weeks.” The medical record documented “Abdominal: Abdomen is gravid and nontender + [positive] Fetal movement.” Under the section titled “Genitourinary: GU-normal external female genitalia Patient has fluid by the labia. No crowning. Speculum deferred given concern for preterm ROM [Rupture of Membranes].” The medical decision making note documented “ ...34 weeks pregnant presenting with concern for preterm rupture of membranes. She was not crowning on examination. Fetus is palpable in the uterus. There appears to be fluid in the vaginal area consistent with her description ...” There was no documentation the ED Physician examined Patient #15 to assess cervical dilation or to determine if her membranes had ruptured. Further review of the record revealed no evidence of a pelvic or speculum exam to determine labor status and eminence of delivery, or of an ultrasound to determine fetal well-being before she was transferred to Hospital B who offered Obstetrical Services. 8. The facility’s “Emergency Department ‘On-Call’ Roster” for “November 2023” revealed that on the day of November 26, 2023, there was an on-call Gynecologist physician available when Patient #15 presented to the hospital’s ED. According to hospital records, the on-call gynecological physician did not participate in the evaluation or management of Patient #15 as part of her medical screening examination. 9. The hospital medical record documented 11/26/23 at 1:20 PM Patient #15’s “ED Disposition set to Transfer to Another Facility” (19 minutes after presentation). On 11/26/23 at 1:54 PM, Patient #15 departed from Hospital A’s ED (53 minutes after her initial presentation). 10. An interview was conducted on 04/10/24 at 12:49 PM with the Chief of Emergency Medicine and President of Medical Staff/ER physicians, Physician D, who stated they have Gynecolological services (GYN) who can see patients and they can describe how the patient presents, such as if the cervix is dilated, effaced, the fetal heart tones (FHT). The GYN specialist can get this by performing a bedside ultrasound, but they do not have equipment to do monitoring here. He stated that the GYN specialists have no OB (Obstetrical) privileges at this hospital since they do not have a Labor and Delivery department. Cross Refer to 2409.”

“APPROPRIATE TRANSFER CFR(s): 489.24(e)(1)-(2) (1) General If an individual at a hospital has an emergency medical condition that has not been stabilized (as defined in paragraph (b) of this section), the hospital may not transfer the individual unless - (i) The transfer is an appropriate transfer (within the meaning of paragraph (e)(2) of this section); and (ii)(A) The individual (or a legally responsible person acting on the individual’s behalf) requests the transfer, after being informed of the hospital’s obligations under this section and of the risk of transfer. The request must be in writing and indicate the reasons for the request as well as indicate that he or she is aware of the risks and benefits of the transfer. (B) A physician (within the meaning of section 1861(r)(1) of the Act) has signed a certification that, based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual or, in the case of a woman in labor, to the woman or the unborn child, from being transferred. The certification must contain a summary of the risks and benefits upon which it is based; or (C) If a physician is not physically present in the emergency department at the time an individual is transferred, a qualified medical person (as determined by the hospital in its bylaws or rules and regulations) has signed a certification described in paragraph (e)(1)(ii)(B) of this section after a physician (as defined in section 1861(r)(1) of the Act) in consultation with the qualified medical person, agrees with the certification and subsequently countersigns the certification. The certification must contain a summary of the risks and benefits upon which it is based. (2) A transfer to another medical facility will be appropriate only in those cases in which - (i) The transferring hospital provides medical treatment within its capacity that minimizes the risks to the individual’s health and, in the case of a woman in labor, the health of the unborn child; (ii) The receiving facility (A) Has available space and qualified personnel for the treatment of the individual; and (B) Has agreed to accept transfer of the individual and to provide appropriate medical treatment. (iii) The transferring hospital sends to the receiving facility all medical records (or copies thereof) related to the emergency condition which the individual has presented that are available at the time of the transfer, including available history, records related to the individual’s emergency medical condition, observations of signs or symptoms, preliminary diagnosis, results of diagnostic studies or telephone reports of the studies, treatment provided, results of any tests and the informed written consent or certification (or copy thereof) required under paragraph (e)(1)(ii) of this section, and the name and address of any on-call physician (described in paragraph (g) of this section) who has refused or failed to appear within a reasonable time to provide necessary stabilizing treatment. Other records (e.g., test results not yet available or historical records not readily available from the hospital’s files) must be sent as soon as practicable after transfer; and (iv) The transfer is effected through qualified personnel and transportation equipment, as required, including the use of necessary and medically appropriate life support measures during the transfer. This Standard is not met as evidenced by: 33162 Based on review of hospital records, Gynecological Physician on-call schedules, and interviews, it was determined that the hospital failed to provide an appropriate transfer to another medical facility for Patient #2 and Patient #15 (two of sixteen sampled patients who were transferred from Hospital A to another hospital) including but not limited to providing medical treatment within its capacity to minimize the risks to the individuals health and health of their unborn fetuses, confirm the receiving facility had available space and qualified personnel for the treatment of the patients, the receiving facility agreed to accept the transfer of the individuals prior to discharging the patients from Hospital A’s Emergency Department, and send to the receiving hospital all medical records related to the EMC that were available at the time of transfer. The findings included: 1. The hospital’s Policy and Procedure, titled, EMTALA - Transfer Policy (Emergency Medical Treatment and Active Labor Act), reviewed 04/02/24, documented in part, “For purposes of transferring, a woman in labor is considered stabilized only when she has delivered the child and the placenta...A transfer of an individual not medically stable to another medical facility will not be appropriate unless: a. A physician has signed a certification that based on the information available at the time of the transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual or, in the case of a woman in labor, to the unborn child, from being transferred. This certification must contain a summary of the risks and benefits upon which it is based... i. An express written certification is required. Physician certification cannot be implied from the finding in the individual’s medical record and the fact that the individual was transferred. The certification must state the reason(s) for the transfer. This rationale may be documented on the certification form or elsewhere in the medical record. ii. The certification form must contain a complete picture of the benefits to be expected from appropriate care at the receiving facility as well as the summary of the material risks associated with the transfer, including the time away from an acute care setting necessary to affect the transfer...Requirements for All Transfers. For any transfer to occur, whether or not the individual is stabilized, the following circumstances must be met: a. The transferring hospital must call the receiving hospital to verify that the receiving hospital has available space and qualified personnel for the treatment of the individual and must have agreed to accept the transfer and provide appropriate treatment....The transferring hospital must document its communication with the receiving hospital including the date and time of the transfer request and the name of the person accepting the transfer. b. The transferring hospital must send copies of all available medical records pertaining to the individual’s emergency conditions to the hospital where the individual is being transferred ...” 2. The hospital’s “Transfer Agreement and Protocol” with Hospital B, effective 10/04/22, documented, in part, “Whereas, the parties wish to ensure the delivery of necessary medical care, and the continuity of care and treatment appropriate to the needs of OB (Obstetric) patients (hereafter “Patients”) in their respective institutions...” (first parentheses added) and “No Patient shall be transferred from [name of sending hospital - Hospital A]) to [name of receiving hospital - Hospital B], unless the appropriate representative at [Hospital A] has contacted his or her counterpart at [Hospital B] and obtained the approval of said representative for transfer in accordance with the admission policies, procedures, and practices of [Hospital B] and the Patient’s primary treating physician has medically cleared the Patient for transfer.” The protocol continued with “No Patient shall be transferred from [Hospital A] to [Hospital B] unless [Hospital A] shall first have obtained the written consent of the Patient or the Patient’s legal guardian or representative, and shall have forwarded to [Hospital B] a copy of such consent...A physician must certify that the expected medical benefits to the patient from the provision of services at [Hospital B] outweigh the increased risks to the patient’s medical condition from affecting the transfer.” 3. Review of the Emergency Department “On-call” physician roster, from November 2023 through April 2024, revealed no Obstetrician specialist was listed on the on-call list. However, Hospital A did have on-call gynecological physicians available during this same timeframe. 4. Review of Patient #2’s record revealed the patient presented to the ED on 03/18/24 at 10:39 AM, was seen by Physician B at 10:48 AM, and was triaged with an acuity Level 2 (Emergent: Life Threatening) for a Chief Complaint of “contractions” and reported she was 39 weeks pregnant. Patient #2’s ED Provider Note documented this was her second pregnancy, she started having contractions “last night”, but denied any rush of fluid consistent with her water breaking. On physical exam her abdomen was soft with no tenderness. The medical record documented “since the patient is in early labor she will be transferred via 911 to (Hospital B). Spoke with (physician name at Hospital B) as a courtesy call.” Review of Patient #2’s “Transfer Summary” form dated 03/18/24 at 10:39 AM documented under section “Present Medical Status” she was “39 weeks pregnant, contractions.” The “Physician Certification” had a blank line with no explanation documented of the rationale or risks and expected benefits for transfer. There was no documentation in the sections “Receiving Facility” or “Sending Facility” of an accepting physician, available bed and services at the receiving facility, type of transport needed, report called to the receiving facility, or of any medical records sent with Patient #2. 5. An interview was conducted on 04/12/24 at 9:02 AM with the Emergency Physician, Physician B, who provided care to Patient #2. Physician B stated if a patient requires OB (Obstetrical) care, they cannot do it here since there is no OB care at Hospital A, they transfer them to Hospital B, and give them (Hospital B) a call to let them know the patient is coming and give information. Physician B acknowledged his notes generally do not specify whether there is an EMC (Emergency Medical Condition), that he would not say Patient #2 was in full labor since her contractions were not every 2 or 3 minutes. Physician B stated typically, he does not do a genitourinary examination because he does not want to cause trauma or issues with the laborist and they [Hospital B] have never asked for a cervical exam in the past. Physician B stated for a patient in active labor, if delivery is imminent, the ED physicians [at Hospital A] can do the delivery, but if it is not an imminent delivery, they send them [patients] where they can be best managed by an OB (Obstetrician), and that the risks and benefits are on a case-by-case basis. Physician B agreed it could be a risk to have the baby in transport without a physician present and stated there are implied benefits of being where complications can be managed for care of the fetus and mother. Physician B stated that GYNs may come look at patients, but they will only do gynecology and have made it very clear they are not going to get involved in the delivery. Physician B did not report any need to verify an accepting physician and capacity/agreement to treat before sending the patient. 6. An interview was conducted on 04/12/24 at 9:02 AM with the Chief of Emergency Medicine and President of Medical Staff/ER physicians, Physician D. The Chief of Emergency Medicine and President of Medical Staff/ER physicians stated this hospital (Hospital A) does not have Obstetric services and has a transfer agreement with Hospital B for Obstetrics. Physician D stated they (Hospital A) cannot do fetal monitoring here since they do not have the equipment, so Patient #2 was transferred to Hospital B to avoid delivering in Hospital A. Physician D stated Patient #2 was sent before having an accepting physician because paramedics had just dropped off another patient and were willing transport but in a hurry to take her. Physician D stated there is a trauma transfer protocol that “does supersede EMTALA” and Physician D explained for the conditions in that protocol, it is an automatic transfer via “911” and they do not need to get an accepting physician first, they can just call ahead as a courtesy. Physician D stated the Emergency Department has been operating under the assumption that there is a similar agreement for Obstetric transfers, so they send them and make a courtesy call to Hospital B to let them know what is coming. Physician D stated a patient with any contractions for gestation greater than 20 weeks is transferred, and that abdominal pain at greater than 20 weeks gestation “always” supports the benefits of transfer over the risks involved. Physician D stated that Hospital A is supposed to call and ensure bed availability, the ability to provide care, and an accepting physician. Physician D stated for Patient #2, who was at 38 weeks gestation, they did not do a bimanual exam but did an ultrasound and verified viability and fetal heart rate. Physician D stated they can do regular uncomplicated deliveries at Hospital A, but if there are problems, they are not prepared for it and would want them [patients] where they can get a c-section, which would be better for the patient if it happened on the way to Hospital B, than in Hospital A and still must transfer them. 7. Review of Patient #15’s record revealed the patient presented to the ED on 11/26/23 at 1:01 PM with “Chief Complaint” of “Pregnancy Problem 34 weeks preg [pregnant], leaking fluid.” The patient was triaged with an acuity Level 2 at 1:08 PM. Review of Patient #15’s medical record documented “ ...43 y.o. [year old] female ...with feeling that her water broke and pelvic bleeding. Patient states both of her prior pregnancies were early. One was at 36 weeks and 1 [one] was at 27 weeks.” The medical record documented “ ...Unfortunately do not have obstetrics at our facility and patient will require transfer to [Hospital B]. EMS [Emergency Medical Services] was available and patient was transported via EMS to [Hospital B] labor and delivery. Patient understood that we do not have obstetrics at our hospital and this was the reason for transfer.” Further review of the record revealed no evidence of a pelvic or speculum exam to determine labor status and eminence of delivery, or of an ultrasound to determine fetal well-being before she was transferred to Hospital B who offered Obstetrical Services. A hospital record titled “Nursing Note” dated 11/26/23 at 1:37 PM documented “This RN called [Hospital B] L&D [Labor and Delivery] and gave them a courtesy call, that this pt [patient] was coming by EMS. The hospital medical record documented 11/26/23 at 1:20 PM Patient #15’s “ED Disposition set to Transfer to Another Facility” (19 minutes after presentation). On 11/26/23 at 1:54 PM, Patient #15 departed from Hospital A’s ED (53 minutes after her initial presentation). Patient #15’s medical record had no hospital “Transfer Form”, written consent for transfer, acceptance by a physician at the receiving facility (Hospital B), nor verification the receiving facility had capacity, available resources, and agreed to provide care to Patient #15 prior to Hospital A’s transfer. Cross Refer to 2406.”