HospitalInspections.org

Based on interview, clinical record review, and facility policy review, the facility failed to ensure policies for patient advocacy and communication of care concerns, fetal monitoring, and labor management were implemented for one of 30 sampled patients (Patient 1) when:

1. Licensed Nurse (LN) concerns with Patient 1's fetal heart rate (FHR) monitoring and corresponding physician response were not communicated or escalated through the facility's defined line of authority.

2. A LN did not notify an anesthesiologist (a physician specializing in administration of medications for pain reduction prior to surgical procedures) and surgical delivery team to prepare for a Cesarean (a surgical operation for delivering a child by cutting through the wall of the mother's abdomen) or operative vaginal delivery based on concerning FHR changes. Further, a LN did not immediately alert the anesthesiologist and surgical team for an emergent cesarean procedure when Patient 1's vaginal exam revealed a prolapsed umbilical cord (a labor and birth emergency when the umbilical cord exits the cervical opening before the presenting part of the fetus that requires immediate delivery of the baby usually by cesarean section).

These failures caused a delay in physician and surgical response time to a laboring patient exhibiting signs of fetal distress which potentially contributed to in the death of the newborn baby.

Findings:

1. Review of Patient 1's medical record revealed the following documents:

An Admission History & Physical Summary, dated 9/19/18, indicated Patient 1 presented to the facility for the purpose of inducing labor for being over 40 weeks pregnant with her second child. The summary also indicated a review of systems was within normal limits.

A patient Flowsheet, dated 9/19/18, indicated continuous fetal monitoring beginning at 9:00 a.m., and exhibited Category 1 "Normal Tracings" (Category 1 fetal heart tracings are considered normal, and no intervention is necessary) with a noted FHR of 140 (normal being between 110-160 heart beats per minute). The flowsheet also indicated FHR decelerations (temporary but distinct decreases of the fetal heart rate caused by decreased blood flow to the placenta during contractions) were absent.

A Medication Administration Record Summary dated 9/19/18-9/21/18, indicated an infusion of oxytocin (a medication administered through the vein to promote contractions of the uterus to induce labor) was initiated at 10:51 a.m. on the day of admission.

The same patient Flowsheet, dated 9/19/18, indicated at 1:00 p.m. the continuous fetal monitoring exhibited a change to Category 2 "Intermediate Tracings" (Category 2 fetal heart tracings include a broad spectrum of abnormalities that may require intervention) with a noted FHR of 130 and variable decelerations (common and irregular, often jagged dips in the fetal heart rate that often occur when the baby's umbilical cord is temporarily compressed) present. The interventions documented in the record indicated a LN administered oxygen and repositioned Patient 1.

The same patient Flowsheet, dated 9/19/18, indicated at 2:00 p.m. the continuous fetal monitoring exhibited the same Category 2 "Intermediate Tracings" with a change to coupling of uterine contractions (the presence of two or more successive contractions without return to baseline between contractions). The interventions documented indicated the LN decreased the oxytocin infusion rate (less medication provided over time).

The same patient Flowsheet, dated 9/19/18, indicated at 4:00 p.m. the continuous fetal monitoring exhibited significant FHR decelerations present with more than half of the patient's contractions. The flowsheet further indicated a LN stopped the oxytocin infusion.

At 5:00 p.m., the flowsheet indicated FHR accelerations (normal short-term rises in the heart rate of at least 15 beats per minute, lasting at least 15 seconds indicating the baby has an adequate oxygen supply) were then absent with variable FHR decelerations. The interventions documented indicated a LN utilized vibroacoustic stimulation (the application of a vibrated sound to the abdomen of a pregnant woman to stimulate and accelerate the heart rate of the fetus in the womb), and the FHR tracings were reviewed by the physician. Further, the flowsheet indicated the physician would be arriving to evaluate the patient.

At 5:30 p.m. (thirty minutes after the initial noted absent FHR accelerations), the flowsheet indicated FHR monitoring exhibited "Late, Variable" decelerations (where the fetal heart rate decrease occurs after the contraction which could cause concern for lack of oxygen to the fetus) and continued absent FHR accelerations. The Flowsheet indicated deceleration interventions for the laboring mother as oxygen administration, increasing intravenous fluids, and position changes. Further, the flowsheet at this time indicated the OB (Obstetrician - a doctor that specializes in pregnancy and childbirth) was still on their way to the facility to evaluate the patient and perform a sterile vaginal exam.

The same patient Flowsheet, indicated at approximately 6:30 p.m. (nearly an hour after the initial noted late and variable FHR decelerations) the physician had arrived at the bedside of Patient 1. Further, the FHR monitoring continued to exhibit "Late, Variable" decelerations, with new minimal variability (a decrease in the fluctuations of the fetal heart rate which could indicate further stress to the newborn).

The flowsheet indicated at 6:38 p.m., the OB ordered to restart the oxytocin infusion. The record contained no documented evidence the physician remained with the patient after ordering to restart the infusion. Further, the record contained no documented evidence nursing staff escalated concerns with patient presentation and the physician's order to re-start a medication to induce stronger contractions to supervisors, directors, or other physicians.

The Medication Administration Record Summary dated 9/19/18-9/21/18, indicated a LN re-started the infusion of oxytocin at 6:42 p.m.

At 7:00 p.m., the flowsheet indicated the FHR monitoring exhibited "Prolonged, Variable" decelerations (an abnormal fetal heart rate finding that could indicate a risk of fetal death from lack of oxygen, and usually requires the presence of a surgical team in preparation for an emergent cesarean section) with minimal variability. The Flowsheet indicated the nurse's deceleration interventions for the laboring mother as position changes, oxygen administration, increasing intravenous fluids, and stopping the oxytocin infusion. The record contained no documented evidence a physician was notified of the initial prolonged variables. Further, the record contained no documented evidence the concerning prolonged variables were escalated to a supervisor, director or other physician.

The patient Flowsheet indicated additional "Prolonged, Variable" decelerations with minimal variability at 7:15 p.m., 7:30 p.m., and at 7:45 p.m. Again, the record contained no documented evidence concerns with patient presentation were escalated to a supervisor, director, or other physician.

At 7:49 p.m. (nearly 50 minutes after the initial prolonged, variable deceleration), the flowsheet indicated the OB was called to come back in.

The flowsheet further indicated at 8:00 p.m. (an hour after the initial prolonged and variable FHR decelerations were noted), the OB was back at the bedside of Patient 1.

An Anesthesia Record, dated 9/19/18, indicated newborn delivery was documented at 8:46 p.m., resuscitation efforts were made to the newborn but were unsuccessful and the newborn time of death was 9:10 p.m.

An Operative Report, dated 9/19/18 at 11:01 p.m., indicated, "There were no signs of life of the baby."

A concurrent interview and record review was conducted with the Director of the Family Birth Center (DFBC), on 12/22/22 at 1:00 p.m. The DFBC confirmed Patient 1 was admitted to the unit for a scheduled induction of labor (when a pregnancy care provider starts labor instead of letting labor start on its own, usually with the use of medications) and was the only laboring patient on the floor.

In the same interview on 12/22/22 with the DFBC, Patient 1's fetal heart rate (FHR) monitoring record was reviewed. DFBC indicated fluctuations (changes) in fetal heart rate are not uncommon during labor, but late prolonged variable decelerations (a gradual decrease in FHR, with the onset, lowest point, and recovery of the deceleration occurring after a contraction) with minimal variability can be concerning because it could mean the baby is not getting enough oxygen after a contraction.

The DFBC further stated the records reflected Patient 1 was exhibiting the prolonged decelerations at staff change of shift (day shift handing off to night shift) and nurses did not call the OB until after the third noted prolonged deceleration, which was not in accordance with facility policy.

A concurrent interview and record review of Patient 1's clinical record was conducted with Licensed Nurse (LN) 1 on 2/14/23 at 2:46 p.m. LN1 indicated the OB triage (assessment of a patient) evaluation indicated Patient 1 was admitted to the unit for induction of labor and the patient history completed confirmed the patient had no risk factors and was considered a "low risk" of having complications. Further, LN 1 confirmed the record revealed Patient 1's fetal monitoring began between nine and ten in the morning.

In the same interview and record review on 2/14/23, LN 1 indicated the "absent" fetal heart rate accelerations documented at 5:00 p.m. in Patient 1's chart were concerning and the nurse should have let the doctor know because "we don't want that." LN 1 confirmed the documented evidence in the record indicated the physician was aware of the fetal heart tracings at 5:26 p.m.; and confirmed continued concerning absent fetal heart accelerations with late variable decelerations were documented at 5:30 p.m., 6:00 p.m., and again at 6:30 p.m. LN 1 indicated the physician arriving more than an hour after the initial absent fetal heart rate accelerations were noted, was a concerning amount of time.

LN1 further indicated she would have questioned the physician's order to re-start the oxytocin infusion based on the FHR tracings and would have requested a thirty minute FHR strip to show no additional recurrent late FHR decelerations before restarting the medication. LN1 stated in her experience, a physician would be notified immediately for prolonged decelerations, as well as the charge nurse. Further, the nurse supervisor or director would be called if nursing staff felt the physician was not being responsive.

A concurrent interview and record review was conducted on 2/15/23 at 10:39 a.m., with the DFBC and LN 2. LN 2 indicated she was the nighttime nurse shift manager at the time of Patient 1's labor and delivery. LN 2 reviewed the FHR tracings present in Patient 1's record and indicated the 4:00 p.m. strip revealed long contractions with minimal variability and recurrent decelerations in the FHR. LN 2 stated the oxytocin infusion was stopped around this time to prevent further stress to the baby in accordance with the oxytocin protocol.

In the same interview with LN 2, additional FHR tracings for Patient 1 were reviewed. LN 2 indicated the late decelerations present after the 5:00 p.m. mark were concerning because they could indicate insufficient oxygen to the baby.

LN 2 confirmed the physician arrived at the patient's bedside an hour after notification of the late, variable decelerations with absent accelerations and it was concerning to the nurses because of the baby's presentation. LN 2 stated the physicians do have access to review FHR tracings remotely, but for Patient 1's type of concerning FHR tracings over a long period of time, there should have been more of a physician presence at the bedside. LN 2 confirmed, as the shift manager that night, she did not follow the chain of command to communicate the nurse's concerns.

Additionally, LN 2 indicated she felt patient interventions would have been expedited if the physician had stayed with the patient after ordering to restart the oxytocin infusion. LN 2 indicated there may have been a lack of communicated level of concern to the physician related to Patient 1's FHR tracings that contributed to the physician not staying at the bedside.

In the same interview, the DFBC confirmed she was not notified of any issues related to Patient 1 until after the event took place, and expected to be called if nurses have any concerns related to patient care on the unit.

A concurrent tour of the labor and delivery unit and interview was conducted with LN 3 on 2/16/23 at 11:26 a.m. LN 3 indicated each shift (day shift or night shift) on the labor and delivery unit had a designated team lead nurse and/or a shift manager. LN 3 indicated an escalation process was available should nursing staff express patient care concerns. LN 3 indicated nurses would alert their team lead or shift manager, and if concerns were still not alleviated, the unit director or hospital nurse supervisor would be notified to assist with addressing or resolving concerns. LN 3 further stated the OB chief was very involved with the unit, and nurses could go as far as contacting him for progressing care concerns.

Review of facility policy, "Chain of Command (COC): Communication of Patient Care Concerns," approval date 2/28/18, indicated "[Hospital System] is committed to providing timely and appropriate care to every patient. Patient care should not be delayed and prompt progression is essential through the chain of command process." The policy further directed, "The Chain of Command policy should be followed: 1. In resolving administrative, clinical (quality of care or safety of a patient is in question) or service issues."

Review of the same Chain of Command policy further directed, "PROCEDURE: A. Examples of when to invoke the Chain of Command include but are not limited to: 2. In a clinical situation where a nurse or other clinician believes a Licensed Independent Practitioner (LIP) has not responded in a timely manner to fully address the issues raised that may present an immediate risk to the patient, or in instances where a LIP has not responded in a timely manner to a deteriorating patient condition. 4. When a nurse or other clinician believes in his/her clinical knowledge or judgment that implementing a LIP order or plan of care may potentially have an adverse effect on patient safety or condition."

The Chain of Command policy further indicated, "1. When a clinician is aware of a potential or actual issue, (s)he is accountable to: c. Alert immediate supervisor of the potential or actual issue if unable to elicit timely and appropriate response. 2. If still unresolved or in the event that the issue is with an immediate supervisor, notify the next level of command. Continue escalating until resolution or you have reached the highest level."

Review of facility policy "Fetal Monitoring," dated 4/26/17, indicated the provider will be notified when: 6. Category II [2] FHR tracings with: i. Prolonged deceleration greater than 2 minutes but less than 10 minutes. The policy further indicated an algorithm for the management of significant category 2 fetal heart tracings. The algorithm indicated for an assessment of FHR variability as "Minimal or Absent," to then provide interventions and notify the physician. Next, for development of significant (or prolonged) decelerations, to "Notify Team for Delivery Cesarean or Operative Vaginal Delivery."

2. Review of Patient 1's medical record revealed the following documents:

A patient Flowsheet, dated 9/19/18, indicated at 7:00 p.m., the FHR monitoring exhibited "Prolonged, Variable" decelerations (an abnormal fetal heart rate finding that could indicate a risk of fetal death from lack of oxygen, and usually requires the presence of a surgical team in preparation for an emergent cesarean section) with minimal variability. The Flowsheet indicated the oxytocin infusion was stopped, and the record contained no documented evidence a physician was notified of the initial prolonged variables, or a surgical team was called in to prepare for an emergent delivery.

The patient Flowsheet indicated additional "Prolonged, Variable" decelerations with minimal variability at 7:15 p.m., 7:30 p.m., and at 7:45 p.m. Again, the record contained no documented evidence a surgical team was called in to prepare for an emergent delivery.

A Nurse Progress Note, indicated on 9/19/18 at 8:16 p.m., the patient was "set for delivery" and at 8:20 p.m., an anesthesiologist was notified of the "decision to attempt a vacuum delivery [A medical procedure where a vacuum cup/device is attached to the baby's head by suction to assist with a vaginal birth]and requested he come to the hospital." The note further indicated from 8:25 p.m. to 8:31 p.m., the physician at the bedside attempted the vacuum, had a loss of suction, and upon the second attempt to apply the vacuum stated that she felt the umbilical cord. The note indicated, " ...MD [physician] able to push cord back behind head and another attempt was made. Then decision made to take pt [patient] to OR [Operating Room]."

An Anesthesia Preoperative Record, dated 9/19/18, indicated the anesthesiologist was called at 8:20 p.m. by a Registered Nurse (RN) to inform them of Patient 1's planned vacuum assisted vaginal delivery (a method of assisting the newborn through the birth canal by placing a suction cup device to the newborn's head), and requested the anesthesiologist to arrive for standby in case a cesarean section was needed. The records further indicated the anesthesiologist was called again at 8:32 p.m. with an update the patient was proceeding to the OR for a cesarean section, and the anesthesiologist arrived at 8:43 p.m. to the OR where the cesarean was already in progress under local anesthesia.

An Operative Report, dated 9/19/18 at 11:01 p.m., indicated the OB attempted a vacuum procedure in the laboring patient's room. The report indicated the OB was unable to get a good seal with the vacuum, and on the second attempt, palpated (felt) a prolapsed umbilical cord. The report indicated the anesthesiologist was on his way in and, "Preparations were made to move to the C-section [cesarean section] room for an emergent cesarean section." The report further indicated, "Due to the urgency of the situation, I started the surgery under local anesthesia."

A concurrent interview and record review was conducted with the Director of the Family Birth Center (DFBC), on 12/22/22 at 1:00 p.m. DFBC indicated Patient 1 did not have an epidural (a procedure done by an anesthesiologist to reduce pain during labor), which meant there was no anesthesiologist present in the hospital at the time of the patient's labor.

In the same interview on 12/22/22, the DFBC indicated Patient 1 should have been moved to the OR, and anesthesia notified to prepare for an emergent cesarean section with the noted prolonged decelerations.

A concurrent interview and record review was conducted on 2/15/23 at 10:39 a.m., with the DFBC and LN 2. LN 2 indicated she was the nighttime nurse shift manager at the time of Patient 1's labor and delivery. LN 2 reported an additional concern related to Patient 1's care was the physician attempting to continue with a vacuum procedure to deliver the baby vaginally after palpating a prolapsed umbilical cord. LN 2 indicated based on nursing experience; an identified prolapsed cord meant an automatic emergent cesarean section.

Review of facility policy "Fetal Monitoring," dated 4/26/17, indicated an algorithm for the management of significant category 2 fetal heart tracings. The algorithm indicated for an assessment of FHR variability as "Minimal or Absent," to then provide interventions and notify the physician. Next, for development of significant (or prolonged) decelerations, to "Notify Team for Delivery Cesarean or Operative Vaginal Delivery."

Review of facility "Labor Management Policy," originated date 3/2015, indicated "If cord prolapse occurs: 3. IMMEDIATELY notify Anesthesiologist, Obstetrician and Perinatal Tech and Neonatal Resuscitation Provider (NRP) team. 7. Prepare patient for immediate cesarean section."

Review of website American Journal of Obstetrics and Gynecology revealed an article "Umbilical cord prolapse: revisiting its definition and management," published 6/25/21. The article indicated, "Umbilical cord prolapse is an unpredictable obstetrical emergency with an incidence ranging from 1 to 6 per 1000 pregnancies ....the mainstay of treatment of cord prolapse is urgent delivery, which means cesarean delivery in most cases, unless vaginal delivery is imminent. The urgency depends on the fetal heart rate pattern, which can be bradycardia, recurrent decelerations, or normal." https://www.ajog.org/article/S0002-9378(21)00744-4/fulltex.