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Tag No.: A2400
Based on interview, record review, and policy review, the hospital failed to follow policy to ensure 1 patient (P20) of 20 sampled patients received a medical screening examination and was provided treatment to stabilize an obstetrical patient's emergency medical condition. The hospital further failed to include P20 on its central log.
Findings include:
A. During interview on 1/24/2024 9:55 AM, the Director of Quality validated the hospital did not have a policy specific to the ED/OB Log.
B. Review of facility policy "Triage Care of Unscheduled Pregnant or Recently Pregnant Patients by Labor and Delivery Staff", approved 11/6/2023, revealed in part, "Obstetric patients presenting for an unscheduled evaluation will receive an initial MSE within the capabilities of the Labor and Delivery Unit or ED to determine the presence of an emergency medical condition (EMC), testing or services. Fetal status may be assessed as part of the treatment process and documentation in the medical record on a case-by-case basis depending on the chief complaint of the patient and gestational age."
C. Review of the policy titled "Emergency Services", approved 1/11/23, revealed, "The hospital shall have the ability to address the care needs of patients with a medical emergency consistent with its scope of services and within the limits of its capabilities. Patients shall receive safe and adequate initial assessment and treatment for a medical emergency. Patients shall be afforded initial treatment for a medical emergency within the capabilities of the location of care and its scope of services. A medical screening examination will be provided to any person presenting himself/herself anywhere on hospital property and seeking exam or treatment for a possible emergency medical condition or in the Emergency Department seeking exam or treatment for a medical condition, to determine whether that person has an emergency medical condition."
D. Review of the facility's "Medical Staff Rules and Regulations", last revised 5/3/23 revealed, "the MSE must be the same MSE that the Medical Center would perform on any individual coming to the Medical Center's ED with those signs and symptoms."
E. Review of the facility's "Medical Staff Rules and Regulations", last revised 5/3/23 revealed that an "MSE is not an isolated event. It is an ongoing process. The record must reflect continued monitoring according to the patient's needs and must continue until he or she is stabilized or appropriately transferred. There should be evidence of this evaluation prior to discharge or transfer."
F. Review of facility policy "Refusal of Service/Release against Medical Advice", approved 6/13/23, revealed, "If the patient refuses examination, treatment, tests or offered services, complete the Refusal of Service form (#M791)."
G. Review of the OB logs requested during the entrance conference and received on 1/10/24 revealed that Patient #20 (P20) is not entered on the OB log for date of service of 11/28/23.
H. Facility was unable to produce a medical record for P20 with a date of service of 11/28/2023.
I. Registered Nurse (RN-C) (Director of Organizational Quality) confirmed that the facility does not have a policy regarding the ED/OB logs during an interview on 1/24/24 at 9:55 AM.
J. During an interview on 1/16/24 at 4:10 PM, (RN-F) (Manager of Maternity Services) revealed that RN-B (Labor and Delivery Charge Nurse) had called RN-F for guidance on how to handle P20's presentation to the DED on 11/28/2023. RN-F stated that she had not considered P20 an individual to whom the hospital's EMTALA obligations applied since P20 "was not taken back to a room". RN-F also instructed RN-B that a refusal of service form did not need to be completed.
K. Review of an internal incident report pertaining to P20's presentation provided by the hospital revealed that the hospital's subsequent review concluded the hospital's "protocol [was] followed" and erroneously determined that "upon review of GIRMC's [Grand Island Regional Medical Center's] noted handling, there does not appear to be any EMTALA violation."
Cross reference to A2405, A2406 and A2407
Tag No.: A2405
Based on review of the OB (obstetric) log, Emergency Department (ED) log, policy review, record review, review of surveillance video, and staff interviews, the facility failed to ensure that at least 1 (Patient #20, "P20") of 20 sampled patients who presented at the hospital's dedicated emergency department requesting examination or treatment for a medical condition was recorded on the hospital's central log. This failed practice has the potential to affect all patients treated by or presenting to the facility. Interviews, policy review, and record review suggest that the failed practice is likely systemic with potential impacts and policy and regulatory requirement misunderstandings that extend beyond Patient #20. According to the facility provided patient log information, the hospital sees an average of 937 patients per month in their dedicated emergency departments, but the true number of individuals who present seeking emergency care but who do not appear on the hospital's log is unknowable.
Findings include:
A. Review of a closed outpatient medical record provided by P20's primary obstetrical clinic, dated 11/28/2023, revealed that P20 was a 37-year-old woman who was 30 weeks 2 days pregnant and underwent a scheduled outpatient ultrasound performed by medical doctor MD-D, her primary obstetrical physician, at or around 1:09 PM that day. The record indicated that P20's fetus had "absent cardiac activity" (no heartbeat), and MD-D commented, "Intrauterine fetal demise [death] noted by ultrasound today along with marked hydrops fetalis [a severe and often life-threatening build-up of fluid in a fetus's soft tissues and body cavities and organs]. Breech presentation [bottom-down fetal positioning, as opposed to head-down] noted. Discussed finding with the patient. Will proceed with induction of labor." The records indicated that P20 had been undergoing outpatient care by MD-D and other specialists for multiple weeks for hydrops fetalis and was receiving weekly scheduled ultrasounds to evaluate her fetus, which had been alive at the time of prior ultrasounds.
B. Review of surveillance camera video records displayed by the facility to surveyors by RN-C (Director of Organizational Quality), RN-F (Manager of Maternity Services) and RN-H (Chief Nursing Officier) on 1/16/24 at 2:35 PM revealed that P20 entered the lobby of the hospital's OB/labor and delivery area on 11/28/2023 at approximately 7:59:20 PM, according to video embedded timestamps, accompanied by her spouse. RN-C viewed the video with surveyors and identified the individuals in the video as P20 and her spouse. Based on RN-C's firsthand knowledge of staff members who were pictured speaking with P20 in the video and RN-C's subsequent conversations and interviews with those staff, RN-C reported that the individuals in the video identified themselves as P20 and her spouse. At 7:59:53 PM, the video shows a hospital staff member, identified as RN-A (obstetrical nurse), based on RN-C's firsthand knowledge of the staff member, approaching P20 in the waiting area, pulling up a chair, and conversing with P20. RN-A leaves the waiting area and walks to a work area in the labor and delivery unit at 8:03:55 PM, appears to make a phone call, and returns to the waiting area with P20 at 8:10:00 PM. RN-A continues conversing with P20 until 8:15:36 PM and then walks back to the work area. Around 8:18:00 PM, P20 is observed removing her coat and stocking cap and rubbing her gravid (pregnant) abdomen. At 8:23:40 PM, the video shows P20 placing her hand behind her back, as if uncomfortable, standing up, and walking to the adjacent restroom. She returns to the chair in the waiting area at 8:26:15 PM, where she arranges her coat behind her lower back, as if to improve her comfort in the chair. RN-A returns at 8:29:40 PM and converses with P20 and her spouse and then returns to the work area at 8:32:15 PM. At 8:40:51 PM, RN-A returns to the waiting area accompanied by RN-B (Labor and Delivery Charge Nurse), and both hospital staff members converse with P20 and her spouse until 8:47:50 PM, when P20 is observed crying. From 8:49:10 through 8:49:24 PM, P20 is observed putting her coat and hat back on and standing up from her chair with the assistance of her spouse. P20 and her spouse exit the hospital lobby doors at 8:49:49 PM, and RN-A and RN-B return to the labor and delivery work area at 8:50:15 PM and 8:50:31 PM respectively.
C. Review of "Maternal/childbirth event" report #158750 provided by RN-C to surveyors on 1/16/24 includes "Entered Date: 11-28-2023." "Owner: [name of RN-A]", and "File state: Closed." The "Brief Factual Description" contains, in part, "When this RN went out to the waiting room to bring patient to her room, the patient stated that she wanted to discuss plan of care. Patient stated that she felt fetal movements this afternoon and that she wants an ultrasound done "because we believe in miracles" and that she did not want an induction, but a c-section instead. She stated that she was afraid the baby would get stuck, and she knows that it is breech. She stated that she had been having contractions today. When asked how frequently, she stated sometimes 5-6 contractions an hour. She stated she was having some pink tinged mucus discharge today but no watery discharge. Placed a phone call to [MD-D] and left message to call back. After 20 minutes [RN-B] placed a second call to [MD-D]. [MD-D] stated that "the patient could come back in the morning, and that she would do the ultrasound in the morning." [MD-D] educated RN-B by stating "This is not an emergency to call in staff, [sic] and would come in the morning and do the ultrasound and discuss plan of care with patient.'' I discussed the phone call with the patient and informed her of what [MD-D] had said. Patient stated that she doesn't understand why [MD-D] can't come in to do the ultrasound. Patient asked if there was another doctor that she could see. Another doctor was not offered to the patient. Patient stated that if "[MD-D] doesn't have time to come and do an ultrasound tonight then I think I'm just going to go to the other hospital.'' Discussed conversation with charge RN [RN-B]. [RN-B] placed another call to [MD-D]. [RN-B] informed [MD-D] of patient's plan. [MD-D] reinforced her above statement and informed [RN-B] that she (MD-D) had privileges at the other hospital. [MD-D] also told [RN-B] that she has already done two ultrasounds for this patient. [RN-B] and [RN-A] both went to talk to the patient. [RN-B] informed the patient of [MD-D]'s and [RN-B]'s conversation. [RN-B] stated that ''the hospital is unable to provide the ultrasound and that it is not [an] emergency for the doctor or tech to come in.'' The patient then stated,''That this is an emergency- [;] it's my baby." The patient then also informed [RN-B] of back pain, headache, belly button pain, and contractions. The description of "follow-up action" in the event report includes "Discussed at length with [RN-A] and [RN-B]. Followed up with [MD-D] also. We cannot make a patient stay; she wasn't admitted and didn't want to be admitted. Protocol followed." Additional "follow-up" documented in the event report by [hospital risk manager] dated 12-06-2023 revealed, "Patient's allegation raised EMTALA concerns. Upon review of GIRMC's [Grand Island Regional Medical Center] noted handling, there does not appear to be any EMTALA violation."
D. During an interview on 1/17/24 at 1:40PM with P20, she stated that she learned "I lost my baby" and that her fetus did not have a heartbeat on ultrasound during her appointment with MD-D the afternoon of 11/28/23 around 2PM. P20 stated that MD-D instructed her to present to GIRMC at 7 PM for induction of labor. She reported that she had vaginal bleeding after leaving the clinic and was in pain. On 11/28/23 at or around 8:00 PM, P20 reported that she presented to the hospital labor and delivery lobby and "asked if someone could check [her]." P20 stated she "didn't know if she was in labor but was having an increase in pain." P20 stated she was "refused care" at the facility and the "nurses told her to go home and come back in the morning at 7:00 AM" and that they "didn't have a provider in the facility" and that they "didn't have anyone to do an epidural." P20 stated that she waited in the labor and delivery lobby for approximately 1 hour "for a doctor order/communication" and that her impression from the conversation was that "[MD-D] told them not to admit me." P20 reported telling RN-A and RN-B that her "pain was strong" and told them that when she used the restroom at the hospital, she was bleeding with watery discharge. P20 reported that "they refused to admit [her]" and that "the head nurse" eventually told her to go to another hospital, so she and her husband left and went to [Hospital B]. Review of medical records from Hospital B revealed that P20 arrived there on 11/28/23 at 9:19 PM and was found to have "presented in labor" with contractions every 1-2 minutes and her cervix 8 cm dilated. She was admitted as an inpatient and spontaneously delivered a stillborn fetus on 11/29/23 at 1:40 AM.
E. During an interview on 1/17/24 at 11:00 AM, RN-C confirmed that P20 was not entered into the OB log and that P20 was not registered in the electronic health record on 11/28/23, as the log pulls registration information from that record.
F. RN-C later confirmed on 1/24/24 at 9:55 AM that the facility does not have a policy regarding the ED/OB logs or defining which individual must be entered on ED/OB logs.
G. Review of the facility's provided OB log received on 1/10/24 (requested past 6 months during entrance conference) revealed that Patient #20 was not entered on the OB log for date of service of 11/28/23.
H. The facility was also unable to produce a medical record for P20 for date of service 11/28/23 and provided a "chart abstract" that indicated an outpatient appointment on 11/28/23 with MD-D but had no documentation of an emergency encounter, pre-admission registration, or OB/labor and delivery record for 11/28/23 or 11/29/23.
Cross reference to A2406 and A2407
Tag No.: A2406
Based on record review, facility policy review, obstetrical physician on-call schedules, review of surveillance video, and staff and patient interviews, the facility failed to ensure 1 (Patient #20, P20) of 20 sampled patients received an appropriate medical screening examination (MSE) upon presentation to the facility's DED requesting examination or treatment for a medical condition and/or upon presentation on hospital property requesting examination or treatment for what may be an emergency medical condition, namely that she was a pregnant woman having contractions such that there was inadequate time to effect a safe transfer and/or that transfer may pose a threat to her health or safety. This failed practice has the potential to affect all patients that present to the DED and placed P20 and subsequent future patients at risk for deterioration of their health and well-being as a result of unidentified and/or untreated emergency medical conditions. According to facility-provided patient log information, the hospital sees an average of 937 patients per month in their dedicated emergency departments.
Findings include:
A. Review of facility policy "Triage Care of Unscheduled Pregnant or Recently Pregnant Patients by Labor and Delivery Staff", approved 11/6/2023, revealed, "Obstetric patients presenting for an unscheduled evaluation will receive an initial MSE within the capabilities of the Labor and Delivery Unit or ED to determine the presence of an emergency medical condition (EMC), testing or services. Fetal status may be assessed as part of the treatment process and documentation in the medical record on a case-by-case basis depending on the chief complaint on the patient and gestational age."
B. Review of the policy titled "Emergency Services", approved 1/11/23, revealed, "The hospital shall have the ability to address the care needs of patients with a medical emergency consistent with its scope of services and within the limits of its capabilities. Patients shall receive safe and adequate initial assessment and treatment for a medical emergency. Patients shall be afforded initial treatment for a medical emergency within the capabilities of the location of care and its scope of services. A medical screening examination will be provided to any person presenting himself/herself anywhere on hospital property and seeking exam or treatment for a possible emergency medical condition or in the Emergency Department seeking exam or treatment for a medical condition, to determine whether that person has an emergency medical condition."
C. Review of the facility's "Medical Staff Rules and Regulations", last revised 5/23/23, revealed, "the MSE must be the same MSE that the Medical Center would perform on any individual coming to the Medical Center's ED with those signs and symptoms."
D. Review of RN-A's hospital credentialling file document showed she was an "OB traveler" and "Travelers were not allowed to be a Qualified Medical Professional (QMP)" (medical professionals who are qualified to perform the medical screening examination under EMTALA).
E. The facility was unable to produce a medical record for P20 for date of service 11/28/23 or any documentation that it provided an appropriate MSE, but review of surveillance camera video recordings, "Maternal/childbirth event" report #158750 provided by the facility, and an interview on 1/17/24 at 1:40 PM with P20 established that she "came to the emergency department" as that term is defined in §489.24(b), on 11/28/23 at or about 8:00 PM complaining of contractions at 30 weeks 2 days of pregnancy and was reporting 5-6 contractions per hour, "strong" abdominal pain, back pain, headache, and vaginal bleeding with watery discharge.
F. During an interview on 1/17/24 at 11:00 AM, RN-C confirmed that P20 was not entered into the OB log and that P20 was not registered in the electronic health record on 11/28/23, as the log pulls registration information from that record.
G. During an interview on 1/17/24, RN-A stated that when P20 presented to the DED on 11/28/23 she reported to RN-A that she had some questions and wanted an ultrasound because she was not feeling well, had felt fetal movements, and had been having contractions off and on all day that were more painful. RN-A informed P20, under the direction of MD-D, that an ultrasound would not be performed at this time due to it "not being an emergency" and that P20 could return to the hospital in the morning for an ultrasound. P20 asked RN-A if there were any other physicians available, and RN-A identified there was an OB on-call physician (MD-G), but RN-A did not contact her because she had a "high suspicion" the physician "would not come in" to see P20 because of a diagnosis of fetal demise.
H. During an interview on 1/17/24 at 12:09 PM, MD-D stated she saw P20 in her clinic on 11/28/23, and P20 reported to the clinic nurse that she was having contractions. MD-D stated she was contacted by RN-B when P20 presented to the DED on 11/28/23 and was requesting evaluation, including an ultrasound. MD-D stated that she informed RN-B that P20's request for an ultrasound was "not an emergency" and that the ultrasound could be done in the morning.
I. During an interview on 1/17/24 at 1:40 PM, P20 stated she was seen by [MD-D] at the OB physician's clinic at 2:00 PM on 11/28/23. She stated [MD-D] had instructed [her] to go to GIRMC that evening at 7:00 PM for induction of labor. P20 stated that [MD-D] told her that she [MD-D] wasn't on the schedule to work at GIRMC that evening, but the "other" doctor would take care of her. P20 stated she was "in pain" and "started bleeding" after she left the OB clinic appointment that afternoon. P20 stated she presented to the Labor and Delivery lobby area of GIRMC on 11/28/23 around 8:00 PM and asked if someone could "check [her] because she didn't know if she was in labor, but the pain was increasing." P20 stated she requested an ultrasound but was informed by [RN-A] that [MD-D] said "no" and "not to admit her." She stated she remained in the lobby area for about an hour and during this time she informed [RN-A] she was "bleeding", had a "watery discharge", and that the "pain was strong." P20 stated [RN-A] told her to "go home and to come back in the morning at 7:00 AM" or "go to another hospital." P20 stated she was "refused care and ordered to be seen the next day." P20 stated she was never asked to get "checked-in" and the entrance door into the labor and delivery department was locked.
J. Review of the facility's "Medical staff on-call schedule" showed MD-G was "on-call" for obstetrics/labor and delivery on 11/28/23.
K. Review of the facility's "Medical Credentialing File" showed MD-D was appointed OB/GYN medical privileges on 10/13/20.
L. The facility was unable to provide documentation that P20 was provided an appropriate medical screening exam or refused examination or treatment, nor that they secured her written informed refusal.
Cross reference to A2405 and A2407
Tag No.: A2407
Based on record review, facility policy review, review of surveillance video, and staff and patient interviews, the facility failed to ensure that 1 (Patient #20, "P20") of 20 sampled patients received, within the capabilities of the staff and facilities available, further medical examination and treatment as required to stabilize the emergency medical condition it identified, namely a pregnant patient having contractions and pain contractions such that there was inadequate time to effect a safe transfer and/or that transfer may pose a threat to her health or safety. This failed practice has the potential to affect all patients that present to the DED and placed P20 and subsequent future patients at risk for deterioration of their health and well-being as a result of unidentified and/or untreated emergency medical conditions and creates a reasonable expectation that an adverse outcome resulting in serious injury, harm, impairment, or death will occur if not corrected. According to facility-provided patient log information, the hospital sees an average of 937 patients per month in their dedicated emergency departments.
Findings include:
A. Review of facility policy "Triage Care of Unscheduled Pregnant or Recently Pregnant Patients by Labor and Delivery Staff," approved 11/6/2023, revealed, "Obstetric patients presenting for an unscheduled evaluation will receive an initial MSE within the capabilities of the Labor and Delivery Unit or ED to determine the presence of an emergency medical condition (EMC), testing or services. Fetal status may be assessed as part of the treatment process and documentation in the medical record on a case-by-case basis depending on the chief complaint of the patient and gestational age."
B. Review of facility policy "Emergency Services," approved 1/11/23, revealed, "Patients shall receive safe and adequate initial assessment and treatment for a medical emergency. Patients shall be afforded initial treatment for a medical emergency within the capabilities of the location of care and its scope of services."
C. The facility was unable to produce a medical record for P20 for date of service 11/28/23. Despite the absence of medical record documentation or provision of an appropriate MSE, review of surveillance camera video recordings, "Maternal/childbirth event" report #158750 provided by the facility, interviews with P20, and interviews with hospital staff established that P20 "came to the emergency department," as that term is defined in §489.24(b), on 11/28/23 at or about 8:00 PM complaining of contractions at 30 weeks 2 days pregnancy and was reporting 5-6 contractions per hour, "strong" abdominal pain, back pain, headache, and vaginal bleeding with watery discharge. RN-A, RN-B, and MD-D reported in interviews that they had actual knowledge of P20's pregnancy status, presence of contractions, frequency of contractions, and complaints of abdominal and back pain.
D. The facility was unable to provide documentation that a physician, certified nurse-midwife, or other qualified medical personnel acting within his or her scope of practice as defined in hospital medical staff bylaws and State law had certified that, after a reasonable time of observation, P20 was in false labor.
E. Review of medical records from Hospital B revealed that P20 arrived there on 11/28/23 at 9:19 PM and was found to have "presented in labor" with contractions every 1-2 minutes and her cervix 8 cm dilated. She was admitted as an inpatient and spontaneously delivered a stillborn fetus on 11/29/23 at 1:40 AM.
F. There was no evidence that Patient #20 had delivered her fetus and placenta before her movement outside of the facility.
G. The facility was unable to provide documentation that P20 refused examination or treatment nor that they secured her written, informed refusal.
Cross reference to A2405 and A2406