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Tag No.: A2400
Based on interview and record review, the hospital staff failed to implement the Emergency Medical Treatment and Labor Act (EMTALA) and related policies and procedures (P&P) when the hospital failed to ensure:
1. Patients were signed into the EMTALA Labor and Delivery Log.
2. Patient transfer forms were completed for three (3) out of 25 sampled patients (Patients 16, 19, and 22).
3. An employee (RN 3) had verification of EMTALA training and medical screening exam (MSE) competencies.
4. MSE competencies were not validated per hospital's P&P for two (2) out of 3 sampled employees (RN 1 &
RN 2).
5. The hospital's MSE P&P for the obstetric (OB) registered nurse (RN) correlated with the medical staff rules and regulations.
6. Patient transfer consent forms were completed for three (3) out of 25 sampled patients for
a) Patient 16
b) Patient 22
c) Patient 14
7. A P&P was developed for high-risk pregnancies.
8. The hospital's EMTALA P&Ps were not approved by the governing body (GB) before being implemented.
These failures placed patients at risk of not being aware of their rights upon transfer, not being aware of the risks and benefits upon transfer, and potentially not being declared stable at time of transfer. Secondly, these failures contributed to inexperienced nurses assessing and triaging OB patients, who may not have been competent or qualified, to perform MSE's, and without a written P&P for high-risk pregnancies, may have led to the inappropriate discharge of Patient 25. Lastly, the hospital's governing body failed to assume full legal responsibility for reviewing, revising, and approving EMTALA policies prior to implementation, and failing to provide oversight for quality health care in a safe environment.
Findings:
1. During a concurrent interview and record review on 4/23/24, at 5:00 p.m., with the director of perinatal services (DOPS), the paper EMTALA L&D triage logs from 4/20/24 to 4/23/24 were reviewed. When asked if all OB patients were signed into the paper triage logs, DOPS verbalized this triage log is only for the unscheduled, walk-in observation patient. The scheduled OB patients are not signed into the paper log.
During a review of the facility's policy and procedure titled, " Medical Screening Exam Performed by the OB RN" revised date 1/24, indicated in part ... " b. Unscheduled OB Patient: any obstetric patient who presents to labor & delivery unannounced, unplanned, or unanticipated ...by registering the patient as an obstetric triage patient, the patient's name will be placed on the electronic central log ...the patient's information will also be written in the paper log in labor and delivery ...c. Scheduled OB Patient: an obstetric patient who is prescheduled for a cesarean section, induction of labor, nonstress test, or other outpatient procedure ...these patients are registered as inpatients, clinical patients, or outpatients as appropriate, and will be listed in the paper log in labor & delivery ..."
During a concurrent interview and record review on 4/24/24, at 5:28 p.m., with the DOPS and the chief nursing officer (CNO), the paper EMTALA L&D triage logs from 4/20/24 to 4/23/24 were reviewed along with the above policy and procedure "Medical Screening Exam Performed by the OB RN". The DOPS and the CNO both acknowledged the unscheduled and scheduled OB patient should be signed into the paper triage log in labor and delivery, the CNO verbalized the policy and procedure was not being followed.
2. During a review of Patient 16's medical record, dated 8/22/23, the medical record indicated Patient 16 was 29 weeks pregnant and came to labor and delivery for bleeding and abdominal pain. The medical record further indicated Patient 16 was in preterm labor and needed to be stabilized and transferred to another acute care hospital for higher level of care, and where there was a NICU (neonatal intensive care unit) for the delivery of a preterm baby. Upon further review of Patient 16's medical record, there was no documentation of Patient 16's Transfer Summary Form.
During a concurrent interview and record review on 4/24/24, at 6:20 p.m., with the director of perinatal services (DOPS), Patient 16's medial record was reviewed. DOPS acknowledged there was no documentation of Patient 16's Transfer Summary Form in the medical record and further acknowledged it was missing. DOPS verbalized the transfer form is supposed to be in the medical record and signed by the physician.
During a review of Patient 19's medical record, dated 6/14/23, the medical record indicated Patient 19 was 29 weeks pregnant and came to labor and delivery for sharp pain and vomiting. The medical record further indicated Patient 19 had preeclampsia (high blood pressure in pregnancy), and needed to be stabilized and transferred to another acute care hospital for higher level of care, and where there was a NICU (neonatal intensive care unit) for the delivery of a possible preterm baby. Upon further review of Patient 19's medical record, the Patient Transfer Summary Form was incomplete. The accepting physician's name was left blank, the accepting nurse's name was left blank, the level of care for transportation was blank, the transportation agency name was left blank, and the time called, time of arrival, and time of departure was left blank. Further review of the transfer form indicated the transferring physician's certification, for the reasons for transfer, were left blank, and the patient condition at time of transfer was left blank, and was unable to tell if the patient had been stabilized prior to transfer.
During a concurrent interview and record review on 4/24/24, at 3:45 p.m., with the director of perinatal services (DOPS), Patient 19's medial record was reviewed. DOPS acknowledged Patient 19's Transfer Summary Form was incomplete.
During a review of Patient 22's medical record, dated 5/5/23, the medical record indicated Patient 22 was 35 weeks pregnant and came to labor and delivery for contraction pain. The medical record further indicated Patient 22 was in preterm labor and needed to be stabilized and transferred to another acute care hospital for higher level of care, and where there was a NICU (neonatal intensive care unit) for the delivery of a preterm baby. Upon further review of Patient 22's medical record, there was no documentation of Patient 22's Transfer Summary Form.
During a concurrent interview and record review on 4/24/24, at 6:20 p.m., with the director of perinatal services (DOPS), Patient 22's medial record was reviewed. DOPS acknowledged there was no documentation of Patient 22's Transfer Summary Form in the medical record and further acknowledged it was missing. DOPS verbalized the transfer form is supposed to be in the medical record and signed by the physician.
During a review of the facility's policy and procedure titled, "Emergency Medical Treatment and Active Labor Act (EMTALA); Patient Transfer to Other Facility" date revised 5/22, indicated in part ... "f. Transfer of Patients with an Emergency Medical Condition : Any patient who is in active labor or who has an emergency medical condition will not be transferred unless the following conditions are met: ...2) the transferring physician has signed a certification that, based upon the reasonable risks and benefits to treat the patient, and based upon the information available at the time of the patient examination, the medical benefits reasonably expected from provision of emergency medical treatment at another facility outweigh the increased risks to the individual's medical condition ...e. 3) A Patient Transfer Summary, signed by the physician, will accompany the patient and will include, at a minimum, the following information:.. a) all available personal and demographic information from the patient's medical record ... b) Name of the physician at the receiving hospital consenting to the transfer, with the time and date of the consent ...c) Reason for transfer ... d) Declaration of the transferring physician that the patient has been stabilized for safe transport ...e) a statement of the physician that the method of transport is safe for the patient ..."
3. During a concurrent interview and record review on 4/25/24, at 9:50 a.m., with the director of perinatal services (DOPS), the employee file for RN 3 was reviewed. RN 3 was a traveling nurse and had no EMTALA training that was performed at this hospital. Further review of RN 3 employee file had no documentation of medical screening exam (MSE) competencies validated by a physician at this hospital. DOPS acknowledged the annual training was missing and should have been completed.
During a review of the facility's policy and procedure titled, " Medical Screening Exam Performed by the OB RN" revised date 1/24, indicated in part ...a. Qualified Medical Personnel (QMP): an individual, approved by the hospital's Board of Trustees, who demonstrated current competence in the performance of a medical screening exam ...for the obstetric RN to be considered a QMP for labor status, the following education and competency requirements must be met: ...4) Successful completion of education on the Emergency Medical Treatment and Labor Act (EMTALA) and the medical screening examination (MSE) ...5) Validation of MSE competency by OB/GYN medical staff chairperson, or RN deemed competent by OB/GYN validation ..."
4. During a concurrent interview and record review on 4/25/24, at 9:40 a.m., with the director of perinatal services (DOPS), 2 employee's (RN 1 & RN 2) "Annual Medical Screening Exam (MSE) Competency Assessment Tool" was reviewed. DOPS verbalized the OB physician signs off the assessment tool competencies. The MSE Competency Assessment Tool had 12 Competency Elements:
1. Review Patient health information and interview patient
2. Assess and document patients chief complaint and gestational age (weeks of pregnancy)
3. Obtain a reactive NST or gestational age appropriate fetal monitoring tracing for fetal well being
4. Assess for uterine activity through evaluation of contraction intensity, frequency, and duration by palpation, maternal response, and continuous toco (device that measures contractions and documents on a fetal tracing)
5. Assess membrane (bag of water) status intact or ruptured, Rapid Assay Test (Amnisure)
6. Collect Ffn sample (fetal fibronectin sample can detect if at risk for premature birth) via sterile speculum exam
7. Assess for the presence/absence of vaginal bleeding
8. Verbalize 3 reasons why sterile vaginal exam is contraindicated
9. Perform and document sterile vaginal exam to include: dilation, effacement, station, cervical position, cervical consistency, fetal presentation
10. Identify abnormal assessment parameters
11. Provide physician with telephone or verbal report of complete findings and abnormal findings
12. Give discharge instructions to patient with appropriate handouts.
All 12 elements had a column for the date each element was assessed and validated by the validators initials. Further review of RN 1 and RN 2 's MSE Competency Assessment Tool, showed all 12 elements were left blank with no date of assessment, and the physician had one initial and signature dated at the bottom of the assessment tool. When asked if the physician observed all the elements on the tool for RN 1 and RN 2, to validate their competencies, DOPS verbalized the physician does not observe he just signs off over the phone. DOPS verbalized the physician verifies verbally over the phone that the nurse is competent, but does not observe, evaluate, or ask for return demonstration. DOPS acknowledged observing, evaluating, and asking for return demonstration, demonstrates competency. DOPS acknowledged the 12 elements were left blank on the assessment tool, with no dates of when each competency was assessed.
During a review of the facility's policy and procedure titled, " Medical Screening Exam Performed by the OB RN" revised date 1/24, indicated in part ...a. Qualified Medical Personnel (QMP): an individual, approved by the hospital's Board of Trustees (governing body), who demonstrated current competence in the performance of a medical screening exam ...for the obstetric RN to be considered a QMP for labor status, the following education and competency requirements must be met: ... 5) Validation of MSE competency by OB/GYN medical staff chairperson, or RN deemed competent by OB/GYN validation ..."
5. During a review of the facility's policy and procedure titled, "Medical Screening Exam Performed by the OB RN" revised date 1/24, indicated in part ... "Purpose: to provide an appropriate assessment and treatment for the obstetric patient at 18 weeks of gestation or greater who presents to the hospital as an unscheduled OB patient ...Background: A physician or qualified medical personnel (QMP) will perform the medical screening exam (MSE) for all patients who present to the labor and delivery for care ...as approved by the Board of Trustees (governing body), the obstetric registered nurse with demonstrated competency can act as the QMP in labor and delivery, to perform the medical screening exam (MSE) for labor status ..."
During a review of the facility's "Rules and Regulations of the Medical Staff" dated 1/1/24, indicated in part ... "Any individual who comes to the hospital requesting or in need of examination or treatment of a medical condition will be provided a medical screening exam (MSE), within the capacity of the hospital, to determine whether or not an emergency medical condition exists ...3. Requirements for the MSE: b. if an individual presents to the emergency department with a condition related to pregnancy, after 20 weeks, the MSE may be provided by the qualified staff in labor & delivery ..."
During a concurrent interview and record review on 4/25/24, at 10:15 a.m., with the director of perinatal services (DOPS), the "Medical Screening Exam Performed by the OB RN" policy and procedure (P&P), and the above "Rules and Regulations of the Medical Staff", pertaining to the requirements for the MSE on labor and delivery, were reviewed. The "Medical Staff Rules and Regulations" indicated a qualified medical personnel (QMP) on labor and delivery can perform the MSE if the OB patient is 20 weeks or more pregnant. The "MSE performed by the OB RN" P&P indicated the MSE can be performed if the OB patient is 18 weeks or more pregnant. When asked why these two documents do not match, the DOPS verbalized the "MSE performed by the OB RN" P&P was recently changed from 20 weeks to 18 weeks, for the OB patient to be seen on labor and delivery. DOPS verbalized weeks gestation can be plus or minus 2 weeks and stated, "We tell the ED (emergency department) to send the 18 week OB patients to us". The DOPS was informed the two documents need to match because the Medical Staff Rules and
Regulations, which are approved and governed by the Board of Trustees (governing body), gives the authority to the labor and delivery nurse to act as a QMP, to perform the MSE, on an OB patient at 20 weeks, not at 18 weeks. The DOPS acknowledged the two documents did not match.
6. a) During a review of Patient 16's medical record, dated 8/22/23, the medical record indicated Patient 16 was 29 weeks pregnant and came to labor and delivery for bleeding and abdominal pain. The medical record further indicated Patient 16 was in preterm labor and needed to be stabilized and transferred to another acute care hospital for higher level of care, and where there was a NICU (neonatal intensive care unit) for the delivery of a preterm baby. Upon further review of Patient 16's medical record, there was no documentation of Patient 16's Patient Transfer Consent Form.
During a concurrent interview and record review on 4/24/24, at 6:20 p.m., with the director of perinatal services (DOPS), Patient 16's medial record was reviewed. DOPS acknowledged there was no documentation of Patient 16's Transfer Consent Form in the medical record and further acknowledged it was missing and should be there. DOPS verbalized the Transfer Consent Form is supposed to be in the medical record and signed by the patient. Further review of the Patient Transfer Consent Form indicated when the patient signs the consent, the patient is attesting to the medical condition which had been explained, and the reason for transfer had been explained, and the potential risks and benefits associated with the transfer had been explained, and understands them. The physician and the nurse also sign the Patient Transfer Consent Form.
6. b) During a review of Patient 22's medical record, dated 5/5/23, the medical record indicated Patient 22 was 35 weeks pregnant and came to labor and delivery for contraction pain. The medical record further indicated Patient 22 was in preterm labor and need to be stabilized and transferred to another acute care hospital for higher level of care, and where there was a NICU (neonatal intensive care unit) for the delivery of a preterm baby. Upon further review of Patient 22's medical record, there was no documentation of Patient 22's Patient Transfer Consent Form.
During a concurrent interview and record review on 4/24/24, at 6:20 p.m., with the director of perinatal services (DOPS), Patient 22's medial record was reviewed. DOPS acknowledged there was no documentation of Patient 22's Transfer Consent Form in the medical record and further acknowledged it was missing and should be there.
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6. c) During a review of Patient 14's medical record, dated 10/6/23, the medical record indicated Patient 14 was 35 weeks pregnant and came to labor and delivery for contractions and UTI (urinary tract infection). The medical record further indicated Patient 14 was in preterm labor for pre-eclampsia (high blood pressure in pregnancy) with severe range blood pressures requiring stabilization and transport to another acute care hospital for a higher level of care, and where there was a NICU (neonatal intensive care unit) for the delivery of a preterm baby. Upon further review of Patient 14's medical record, there was no evidence of a patient transfer consent.
During a concurrent interview and record review on 4/24/24 at 6:20 p.m., with the Director of Perinatal Services (DOPS) acknowledged the "Consent to Transfer Form" was missing from Patient 14's medical record.
During a review of the facility's policy and procedure titled, "Emergency Medical Treatment and Active Labor Act (EMTALA); Patient Transfer to Other Facility" date revised 5/22, indicated in part ... 5) An appropriate Patient Consent to Transfer to Another Facility will be signed by the patient or a representative of the patient. This will document that the signer has been notified of the transfer and of the reasons for the transfer ..."
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7. During a concurrent review of the EMTALA, Transfer, and L & D policies and interview with the chief nurse officer (CNO) and director of prenatal services (DOPS) on 4/24/24 at 3:44 p.m., the CNO and DOPS were asked if the hospital had a policy and procedure delineating the criteria that qualify pregnant patients as high-risk patients to assist the obstetric registered nurse (RN) to triage patients and identify these high-risk patients to ensure appropriate care is provided to this population. The CNO and DOPS indicated hospital did not have a policy. The CNO and DOPS were asked how does the obstetric RN decipher the OB triage, care management and transfer between a regular and a high-risk pregnant patient? What is the process to manage the high-risk patients that come into the L & D unit? What are the resources available for the management of this patient population ...?
During a concurrent review of the INTERFACILITY TRANSPORT PROTOCOL transfer documents (packet) use to transfer patients to another hospital, provided by the DOPS and interview with DOPS and chief of quality (COQ) on 4/24/24 at 6:20 p.m., DOPS indicated the hospital uses this packet to transfer pregnant patients for higher level of care to another hospital. DOPS was asked if this packet was attached to a high-risk patient policy or any other policy. DOPS stated "No, this is not or has nothing to do with high-risk pregnancy patients." Furthermore, DOPS reconfirmed the hospital does not have a policy or protocol for the management and care of high- risk pregnant patients. The COQ acknowledged the hospital needs to have a policy regarding the management of high-risk pregnant patients and stated "Yes, I know what you mean a policy with the criteria and management for high-risk pregnancies."
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8. During a concurrent interview and record review on 4/25/24 at 1:16 p.m. with the chief nursing officer (CNO), CNO confirmed that the facility's policy and procedures (P&Ps) titled, "Obstetrical Clearance and Postpartum Considerations in the Emergency Department", revised 1/2024; "ED Triage; Emergency Severity Index Triage", revised 7/2022; "EMTALA: Physician On-Call Responsibilities", revised 5/22/2022; Medical Screening Examination: ED, revised 5/22; Observation of Patients for Admission, Discharge, or Transfer in Labor and Delivery, revised 4/24; and Medical Screening Exam Performed bythe OB RN, revised 01/24, were not approved by the GB before they were implemented. Additionally, the CNO stated, "We have to change the process."
During a review of the facility's policy and procedure (P&P) titled, "Review & Approval of Polices, Guidelines & Procedures", revised 10/21/2021, the P&P indicated in part ... "Purpose: To codify the organization's process for the review and approval of polices, guidelines, and procedures. Responsibility: The governing body is responsible for assuring the organization develops and periodically reviews polices, guidelines, and procedures. The governing body authorizes the final approval of all policies and procedures from all delegated departments to support the organization's mission and scope of service ..."
During an interview with OBMD 1 on 4/24/24 at 10:25 a.m., OBMD 1 was asked if he was aware of any hospital's L & D policies regarding high-risk pregnancies criteria or care management. OBMD 1 stated "No, none in hospital that I am aware of."
Tag No.: A2402
Based on observation, interview and record review, the hospital failed to post signs visible to all in the Emergency Department (ED) entrances and treatment areas which specified the rights of individuals under the Emergency Medical Treatment and Active Labor Act (EMTALA), regarding examination and treatment for emergency medical conditions and women in labor (ready to give birth).
This failure had the potential for patients and families to be unaware of their rights under EMTALA.
Findings:
During a concurrent observation and interview on 4/23/24 at 1:10 p.m. with the emergency department director (EDD), no signs were posted that specify the rights of individuals to examination and treatment for emergency medical conditions (EMC) and women in labor at the emergency room entrances and treatment room, confirmed by EDD.
During an interview on 4/25/24 at 12:30 p.m. with the director of quality (DOQ), DOQ stated the facility does not have a policy and procedure regarding required posted EMTALA signage we just follow the regulation.
Tag No.: A2405
Based on interview and record review the facility failed to maintain the accuracy and completeness of the Emergency Department (ED) and Labor and Delivery (L&D) Emergency Medical Treatment and Active Labor Act (EMTALA) Central Logs when:
1. Against Medical Advice (AMA) was documented as the disposition (how the patient left the facility) for patients who Left Without Being Seen (LWBS).
2. No times were documented when patients arrived, were admitted, transferred, or discharged.
These failures resulted in the ED and L&D EMTALA Central Logs to be inaccurate, incomplete, and out of compliance per regulation.
Findings:
During a concurrent interview and record review on 4/23/24 at 4:53 p.m. with the emergency department director (EDD) and the chief nursing officer (CNO), EDD and CNO confirmed that the ED EMTALA central logs reviewed for January 2024, February 2024, and March 2024 that the disposition is not accurate, the disposition is documented as AMA however the patients' disposition was LWBS.
During a concurrent interview and record review on 4/23/24 at 5:28 pm with the registered nurse (RN 4), RN 4 stated the disposition is not accurate on the EMTALA Central Logs reviewed for January, February, and March 2024, LWBS and AMA are not the same. RN 4 confirmed that the information on the EMTALA Central Log in the disposition column should have the correct information.
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2. During a concurrent interview and record review on 4/24/24, at 5:23 p.m., with the director of quality (DOQ) and the chief nursing officer (CNO), the Labor and Delivery (L&D) EMTALA Central Logs dated from 4/2023 to 4/2024, the past 12 months, were reviewed. The L&D EMTALA Central Log had the date when the OB patient arrived to Labor and Delivery, and the date the OB patient was discharged, transferred, or admitted. Further review of the L&D EMTALA Central Log did not have the time the OB patient arrived and did not have the time the OB patient was discharged, transferred, or admitted. The DOQ and the CNO both acknowledged the arrival and departure/disposition times were missing from the L&D EMTALA Central Log. The DOQ verbalized the CMS (Centers for Medicare & Medicaid) EMTALA regulations apply to both, the ED (emergency department) and to L&D. The DOQ and CNO both acknowledged the purpose of the EMTALA Central Log is to track the care provided to each individual who comes to the hospital seeking care for an emergency medical condition or women in labor. The DOQ verbalized the ED EMTALA Central Log has the elements of time; time when the patient arrives, time when the patient is seen, and time when the patient is dischagred, transferred, or admitted. The DOQ verbalized the L&D EMTALA Central Log does not include the elements of time and stated, "It does not exist in the log only in the medical record." The DOQ acknowledged there are discrepancies between the ED EMTALA Central Logs and the L&D EMTALA Central Logs and further acknowledged they should be the same.
Tag No.: A2406
Based on interview and record review Hospital A failed to ensure the obstetric registered nurse (RN 1) working in the labor and delivery (L & D) unit and obstetric physician (OBMD 1) who was on-call for L & D on 11/6/23 perform an appropriate medical screening examination (MSE) on Patient 25 to determine if a medical emergency condition (MEC) exist while in the L & D unit. Furthermore, OBMD 1 failed to obtain prenatal records to determine and verify if patient was a high-risk pregnancy patient, failed to consult with patient's primary (OBMD 2) to decide the best approach to manage her pregnancy condition when patient came to the hospital's L & D unit seeking medical attention because baby (fetus) had significantly decrease movement throughout the day.
The failure of the hospital's obstetric RN and physician of not performing an appropriate MSE, resulted in not determining if Patient 25 had an MEC at the time. Patient was not transferred to another hospital for higher level of care to manage patient's high-risk pregnancy. Patient did not receive all the medication doses for the (fetus) baby's lung development before an emergency C-section (surgical procedure to remove baby from uterus) had to be performed at another hospital [Hospital B] to prevent fetus demise.
Finding:
A review of Hospital A policy and procedure (P & P) entitled "Medical Screening Exam Performed by OB RN", dated 01/24, indicated "A physician or qualified medical personnel (QMP) will perform the MSE for all patients who present to the L & D unit for care. Emergency Medical Treatment and Active Labor Act (EMTALA): Under this law individuals who come to [hospital's name] with an emergency medical condition (MEC) must receive an appropriate medical screening examination (MSE), within that capability of [hospital's name], to determine whether an EMC exists. If an EMC exists, the patient must receive treatment within [hospital's name] capabilities until the patient is stable for transfer or discharge ..." In part 3 (b) Unscheduled OB Patient indicated "Any obstetric patient who presents to the L & D unannounced, unplanned, or unanticipated. Regardless of whether the ... physician has notified L & D that the patient is coming. The hospital will provide an MSE ..."
A complaint was submitted to the California Department of Public Health CDPH on 4/14/24. According to the complaint Patient 25 had been on bedrest for low fetal weight. Patient's physician was [OBMD 2's name] an OB/GYN-Perinatology specialist- a subspecialty of obstetrics concerned with the care of the fetus and complicated, high-risk pregnancies. Patient had not felt the baby move all day. Patient called her doctor (OBMD 2) who told her to go to the closest emergency department (ED) which was Hospital A's ED. Upon arrival to ED, patient was taken directly to the L & D unit. RN 1 stated calling OBMD 1 concerned because "patient is a high-risk patient of [OBMD 2's name] and that patient is having category 2 strips". OBMD 1 told RN 1 that OBMD 2 is not taking patients and that there is no way patient (Patient 25) is his. RN 1 also stated that OBMD 1 said there is nothing for him to do and send patient home. OBMD 1 did not speak to the patient, nor did he come in and check on her. Patient ended up going straight to Hospital B, was immediately admitted, and was put on medication drips for the baby's lung development because they knew she (Patient 25) would be having the baby soon due to her condition. Patient had an emergency C-section within 30 hours of arrival to Hospital B. They couldn't wait any longer and the baby did not get all the needed medications prior to the emergent C-section.
A review of Hospital A, Patient 25's medical record was conducted on 4/17/24 and on 4/25/24. Patient is 24-year-old female who is approximately 30 weeks pregnant. The OB Triage, dated 11/6/23 at 8:12 p.m., indicated chief complaint anterior (front positioned) placenta, noticed significantly less baby movements throughout the day. Patient reports drinking and poking belly to stimulate baby and still noticed decreased fetal movement.
The LD-Flowsheet, dated 11/6/23 at 8:30 p.m., indicated an (Toco) external uterine fetus activity monitor was applied, baseline fetal (unborn baby) heart rate of 150 (normal 120-160), with moderate variability (fluctuations in the FHR baseline of 2 cycles per minute or greater, with irregular amplitude and inconstant frequency) and prolonged accelerations rated as Category 1. Variability is measured within a 10-minute window and is described as absent, minimal (<5 beats/per-minute bpm), moderate (6 to 25 bpm), or marked (>25 bpm). Moderate variability is thought to be a reassuring finding as it reliably excludes significant hypoxia and acidosis. The classification of Category strip tracings; Category 1 means the result is normal. Category 2 means further observation or testing is necessary. Category 3 typically means the doctor will recommend delivery right away.
The LD Flowsheet dated 11/6/23 at 8:35 p.m., indicated RN 1 called OBMD 1 with patient's report of decreased fetal movement.
The LD Flowsheet dated 11/6/23 at 9:00 p.m., indicated Category 11 ...with periods of minimal variability, X 2 decelerations (fetal decelerations refer to short-term but clear decreases of the fetal heart rate (FHR) identified during fetal heart monitoring).
The LD Flowsheet dated 11/6/23 at 9:23 p.m., indicated OBMD 1 was called with update on patient's vital signs VS, fetal heart rate FHR, tracing, no accelerations, and X 2 decelerations ... verbal order for BPP. Accelerations are short-term rises in the heart rate of at least 15 beats per minute, lasting at least 15 seconds. Accelerations are normal and healthy indicating that the (fetus) baby has an adequate oxygen supply. A biophysical profile (BPP) measures the health of the baby during pregnancy. The BPP checks the baby's heart rate, muscle tone, movement, and breathing. It also measures the amount of amniotic fluid around the baby. The results of the BPP are added for a score between zero and 10. A score between eight and 10 is considered normal.
The LD Flowsheet dated 11/6/23 at 9:30 p.m., indicated Category 2 ...with periods of minimal variability.
The LD Flowsheet dated 11/6/23 indicated the BBP ultrasound test was conducted from 9:38 p.m., to 10:03 p.m.
The LD Flowsheet dated 11/6/23 at 10:27 p.m., indicated OBMD 1 was called by RN 1 with BPP of 8/8 ... verbal orders received to discharge patient home and to follow up with primary OB in Santa Barbara tomorrow.
The LD Flowsheet dated 11/6/23 at 10:30 p.m., indicated Category 2 with brief period of minimal variability, X 1 deceleration.
The LD Flowsheet dated 11/6/23 at 10:38 p.m., indicated strip tracing reviewed, moderate variability with periods of minimal variability noted, no accelerations noted, occasional decelerations noted.
The LD Flowsheet dated 11/6/23 at 10:40 p.m., indicated discharge instructions were reviewed with patient. Informed patient that [OBMD 1's name] recommends patient to follow up with [OBMD 2's name] tomorrow 11/7/23. Patient was communicating with [OBMD 2's name] at this time and he recommends she come to [Hospital B's name]. Patient will be driving with S/O to [Hospital B's name] for further monitoring ...
The [Hospital A's name] OB Triage Discharge, undated, document indicated "Follow up with [OBMD 2's name]."
During a concurrent review of Patient 25's medical record and interview with director of perinatal services (DOPS) on 4/25/24 at 10:40 a.m., the OB Triage, dated 11/6/23 at 8:12 p.m., appeared short only 2 pages. The DOPS indicated and confirmed the OB triage document was missing some areas that were not completed or documented by RN 1. Further review of the record indicated nowhere in the record there was documentation by provider indicating patient was not having a medical emergency condition (MEC) at the time and that the patient was stable to be discharge home. DOPS reviewed the record and stated, "I agree there is no documentation in the record indicating whether patient had an MEC or not while in the L & D unit or that the patient was stable to be discharge home."
During a concurrent review of Patient 25's medical record and interview with OBMD 1 on 4/24/24 from 8:34 a.m., to 10:30 a.m., OBMD 1 was asked if aware Patient 25 was a "high risk pregnancy patient" being followed by OBMD 2 an OB/GYN-Perinatology specialist. OBMD 1 stated "I did not know she (Patient 25) was high risk. I did not have her prenatal (purpose of the prenatal record is to provide information regarding the past and present health of the patient and serves as a database and flow sheet for subsequent prenatal visits and is essential for helping identify high-risk patients) records. I did not know she was a private patient of [OBMD2's name]. [OBMD 2's name] is not taking or seeing private patients. [OBMD 2's name] only does consults." OBMD 1 was asked if patient (Patient 25) says she is high-risk and sees OBMD 2, would you have called [OBMD 2's name] for a consult? OBMD 1 stated "It's difficult to get a hold of consults in the middle of the night. If I knew he (OBMD 2) had sent her to the hospital, I would have called him (OBMD 2)." OBMD 1 was asked if he would have come to see patient in L & D unit to validate patient was a high-risk patient if he had seen the prenatal records. OBMD 1 stated "hindsight 20/20 we get this a lot, patients come saying they are high risk. We look at BPP, is the best test we have. I saw the strip for 30 minutes and thought it looked okay. If I had looked at the prenatal record maybe I have done something different. I did not have all the information." OBMD 1 was asked if he knew the baby was having absent end diastolic flow (AEDF) and patient had been on bedrest for abnormal fetus growth. AEDF is indicative of increased placental resistance and is associated with poor fetal/neonatal outcomes. OBMD 1 stated "No." OBMD 1 confirmed not coming to see patient while in the L & D unit and not speaking with her during the L & D visit of 11/6/23. OBMD 1 was asked if he would have called OBMD 2 to have a conversation regarding the patient's condition of having intermittent or absent end diastolic flow, needing to be on bedrest, and being high risk ..., would he still have had discharge the patient home. OBMD 1 indicated if he had known all this information he would have had a different plan for this patient. OBMD 1 was asked if he knew [OBMD2's name]. OBMB 1 stated "Yes, I know [OBMD 2's first name] we are buddies, we are attached by the hip. He always answers my calls when I call him." OBMD 1 was asked the reason for not calling him (OBMD 2) on 11/6/23 to discuss Patient 25's condition and verify if patient was a high-risk patient ... OBMD 1 was silent for a period of time then stated, "I don't' know." OBMD was asked if aware Patient 25's (baby) had been having absent end diastolic flow (AEDF). OBMD 1 stated "Ohh, I don't know anything about that (AEDF). I don't know what it is. If I would have known all this information, I would have made a different plan for this patient .... If I knew Dr [OBMD 2's name] had sent her here to the hospital I would have called him. I would have investigated more to make an educated decision."
A review of Hospital B, Patient 25's medical record was conducted on 4/17/24. The Nursing Note, dated 11/7/23 at 1:39 a.m., indicated patient presents to antepartum AP for prolonged monitoring per [OBMD 2's name] due to decrease fetal movement ... Patient came from [Hospital A's name] ... patient states "non-stress test (NST) had few accelerations and some decelerations ..."
The Nursing Note, dated 11/7/23 at 4:14 a.m., indicated [OBMD 2's name] alerted of FHR tracing and decelerations ... Orders received for first dose of Betamethasone (steroid therapy for fetus neuroprotection) to be given.
The Nursing Note, dated 11/7/23 at 4:21 a.m., indicated per [OBMD 2's name], patient has been followed for abnormal dopplers by himself.
The Consultation Note, dated 11/7/23 at 4:24 a.m., authored by OBMD 2 indicated Patient 25 is a 24-year-old at 31 weeks, calling last night with complaints of decreased fetal movement (DFM). She was asked to present for evaluation and was evaluated at [Hospital A's name] where she was found to have a reportedly reassuring BPP but asked to present to [Hospital B's name] for further evaluation. On arrival the FHR tracing was found to have ... intermittent spontaneous variable and late appearing decelerations. On last scan two weeks ago, the fetus had an abdomen circumference AC < 1% and intermittent absent end diastolic flow. Abnormal umbilical artery flow with absent end-diastolic flow (AEDF) during pregnancy is a strong indication of placental insufficiency. ASSESSMENT: 1. Intrauterine pregnancy IUP @ 31 weeks by good dates. 2. Lagging fetal growth with AC < 1 %, 3. Abnormal fetal doppler studies. 4. Decreased fetal movement. 5 Spontaneous fetal decelerations. RECOMMENDATIONS: Fetal steroid therapy, Continuous estimated fetal weigh (EFW), Expect need for early delivery.
The Obstetric History and Physical (H&P), dated 11/7/23 at 2:25 p.m., authored by OBMD 2 indicated Patient 25 is a 24-year-old who has been admitted for concerns of an ominous fetal tracing with lagging fetal growth and intermittent fetal decelerations with absent end diastolic flow on uterine artery UA doppler now. Ideally would like to prolong pregnancy but given that intermittently non reassuring fetal tracing expect patient will qualify for delivery in the next 24 to 48 hours.
The Antepartum Update Note, dated 11/8/23 at 2:30 a.m., authored by OBMD 2 indicated Patient 25 is a 24-year-old at 31 weeks followed with a lag in AC growth and abnormal doppler studies on continuous external fetal monitor EFM and noted tonight to have increasing prolonged repetitive variable decelerations and decreasing variability with an ominous fetal tracing category 3. Notified by RN's and agreed to proceed to C-section now and not wait fetal steroid therapy.
The C-Section Operative Note, dated 11/8/23 at 4:03 a.m., authored by OBMD 2 indicated Patient 25 admitted for decreased fetal movement followed with fetal growth restriction and abnormal doppler flow in the uterine artery UA. She was admitted for prolonged fetal monitoring and had a steady deterioration to category 3 tracing with increasing spontaneous repetitive prolonged fetal deceleration. Recommendation was made for proceeding to cesarean delivery. Findings were a "small appearing calcified placenta and thin (fetus umbilical) cord."
The Neonatal ICU History and Physical, dated 11/8/23 at 3:38 a.m., indicated the pregnancy was complicated by an anterior placenta and lagging growth; on the last scan two weeks ago, the fetus had an abdominal circumference below the first percentile and intermittently absent end diastolic flow ...At [Hospital B's name] doppler studies showed absent end diastolic flow. A dose of betamethasone (steroid medication) was given, and magnesium sulfate was initiated for neuroprotection. However, monitoring showed increasing prolonged repetitive variable decelerations and decreasing variability. The fetal tracing was assessed as category 3 and [OBMD 2's name] advised proceeding to C-section without completing antenatal fetal steroid therapy ... At birth, the baby was slow to gain color. Oxygen saturation in the 70s prompted application of CPAP (continuous positive airway pressure-is a machine that uses mild air pressure to keep breathing airways open. CPAP also may treat preterm infants who have underdeveloped lungs.) The baby was transferred to the neonatal intensive care unit (NICU).
Tag No.: A2409
Based on interview and record review Hospital A failed to ensure the obstetric registered nurse (RN 1) working in the labor and delivery (L & D) unit and obstetric physician (OBMD 1) who was on-call for L & D on 11/6/23 perform an appropriate transfer for Patient 25 who was a high-risk pregnancy patient due to abnormal dopplers scans, low fetal growth, and experiencing Category 2 strip tracing with episodes of minimal variability and decelerations, seeking medical attention because baby (fetus) had significantly decrease movement throughout the day.
The failure of the hospital's obstetric RN and physician of not transferring patient to another hospital to receive higher level of care for continuation of monitoring of Category 2 strip tracings with episodes of minimal variability and decelerations place patient and fetus at risk of experiencing condition deterioration while driving in their own car to another hospital [Hospital B].
Finding:
A review of Hospital A policy and procedure (P & P) entitled "Observation of Patients for Admission, Discharge, or Transfer in Labor and Delivery", dated 04/24, indicated "Any individual who request services ... will receive a medical screening and a physician will determine the disposition of the patient... Patient disposition will be determined within two hours of physician notification ... If patient requires a higher level of care, she will be transported following the treatment and transfer guidelines per policy."
A review of Hospital A, Patient 25's medical record was conducted on 4/17/24 and on 4/25/24. Patient is 24-year-old female who is approximately 30 weeks with a high-risk pregnancy. Patient presented to the L & D unit on 11/6/23 at 8:12 p.m., with complaint of anterior (front positioned) placenta, noticed significantly less baby movements throughout the day. Patient reports drinking and poking belly to stimulate baby and still noticed decreased fetal movement. Patient had been on bedrest for low fetal weight, intermittent and absent end diastolic flow (AEDF), who had been followed by OBMD 2 an OB/GYN-Perinatology specialist- a subspecialty of obstetrics concerned with the care of the fetus and complicated, high-risk pregnancies.
The LD-Flowsheet, dated 11/6/23 at 8:30 p.m., indicated an (Toco) external uterine fetus activity monitor was applied, the strip tracing indicated moderate variability and prolonged accelerations rated as Category 1. At 8:35 p.m., RN 1 called OBMD 1 with patient's report of decreased fetal movement. At 9:00 p.m., tracing strip indicated Category 11, moderate with periods of minimal variability, X 2 decelerations (fetal decelerations refer to short-term but clear decreases of the fetal heart rate (FHR) identified during fetal heart monitoring). At 9:23 p.m., OBMD 1 was called with update on patient's vital signs VS, fetal heart rate FHR, tracing, no accelerations, and X 2 decelerations ... verbal order for BPP. At 9:30 p.m., tracing strip indicated Category 2, moderate with periods of minimal variability. At 10:27 p.m., OBMD 1 was called by RN 1 with BPP of 8/8 ... verbal orders received to discharge patient home and to follow up with primary OB in Santa Barbara tomorrow. After receiving OBMD 1 discharge order, at 10:30 p.m., tracing strip indicated Category 2 with brief period of minimal variability, X 1 deceleration. At 10:38 p.m., strip tracing was reviewed, moderate variability with periods of minimal variability noted, no accelerations noted, occasional decelerations noted. Then, at 10:40 p.m., discharge instructions were reviewed with patient. Informed patient that [OBMD 1's name] recommends patient to follow up with [OBMD 2's name] tomorrow 11/7/23. Patient was communicating with [OBMD 2's name] at this time and he (OBMD 2) recommends she come to [Hospital B's name]. Patient will be driving with S/O to [Hospital B's name] for further monitoring ...
During a concurrent review of Patient 25's medical record and interview with director of perinatal services (DOPS) on 4/25/24 at 10:40 a.m., the record indicated nowhere in the record there was documentation by provider indicating patient was not having a medical emergency condition (MEC) at the time and that the patient was stable to be discharge home. DOPS reviewed the record and stated, "I agree there is no documentation in the record indicating whether patient had an MEC or not while in the L & D unit or that the patient was stable to be discharge home."
During a concurrent review of Patient 25's medical record and interview with OBMD 1 on 4/24/24 from 8:34 a.m., to 10:30 a.m., OBMD 1 was asked if aware Patient 25 was a "high risk pregnancy patient" being followed by OBMD 2 an OB/GYN-Perinatology specialist. OBMD 1 stated "I did not know she (Patient 25) was high risk. I did not have her prenatal records. I did not know she was a private patient of [OBMD2's name]. OBMD 1 was asked if he would have come to see patient in L & D unit to validate patient was a high-risk patient if he had seen the prenatal records. OBMD 1 stated "hindsight 20/20 ... I saw the strip for 30 minutes and thought it looked okay. If I had looked at the prenatal record maybe I have done something different. I did not have all the information." OBMD 1 was asked if he would have called OBMD 2 to have a conversation regarding the patient's condition of having intermittent or absent end diastolic flow, needing to be on bedrest, low fetal growth thus patient being high risk ..., would he still have had discharge the patient home. OBMD 1 stated " ...if I had known all this information, I would have had a different plan for this patient .... If I knew Dr [OBMD 2's name] had sent her here to the hospital I would have called him. I would have investigated more to make an educated decision." OBMD 1 was ask if he was aware of the baby having low diastolic flow and with the fetal strips that patient had, would he have transferred the patient instead of discharging her home. OBMD 1 acknowledged and confirmed that if he had contacted OBMD 2 that night (11/6/23) both would have agreed to transfer ... and would not have sent patient home if not safe.
A review of Hospital B, Patient 25's medical record was conducted on 4/17/24. The record indicated patient presented to antepartum AP on 11/7/23 at 1:39 a.m., for prolonged monitoring per [OBMD 2's name] due to decrease fetal movement ... Patient drove from [Hospital A's name]. On arrival the FHR tracing was found to have ... intermittent spontaneous variable and late appearing decelerations. Patient was admitted for concerns of an ominous fetal tracing with lagging fetal growth and intermittent fetal decelerations with absent end diastolic flow on uterine artery (UA) doppler. OBMD 2's H & P, dated 11/7/23 at 2:25 p.m., indicated "Ideally would like to prolong pregnancy but given that intermittently non reassuring fetal tracing expect patient will qualify for delivery in the next 24 to 48 hours." Patient's condition deteriorated by have increasing prolonged repetitive variable decelerations and decreasing variability with an ominous fetal tracing category 3. Patient had an emergency C-section surgical procedure on 11/8/23 at 4:03 a.m., where they found a "small appearing calcified placenta and thin (fetus umbilical) cord."
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