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Based on staff interview, medical record and document review, the hospital failed to safely provide nursing services when:

A. Experienced nurse staff and nurse leadership failed to provide adequate monitoring, direction and oversight to a new graduate registered nurse (RN 1), with limited experience and competence, who failed to recognize fetal distress in a laboring patient (Patient 1) (Refer to A397);

B. RN 1 failed to follow unit policies and procedures for fetal heart rate monitoring and management of labor (refer to A398); and,

C. RN 1 failed to administer a high-risk medication used for the induction of labor in accordance with physician order (Refer to A405).

These failures placed laboring patients at increased risk for harm and caused a significant delay in response time to Patient 1 exhibiting prolonged signs of fetal distress, resulting in the birth of a nonresponsive baby which required resuscitation efforts and transfer to another hospital for a higher level of care.

The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the Condition of Participation: Nursing Services.

Based on interview and record review, the facility failed to ensure a registered nurse (RN 1) with the skills and experience necessary to provide safe competent care was assigned to a patient (Patient 1) who was in active labor and receiving a high alert medication (drugs that bear a heightened risk of causing significant patient harm when they are used in error) for labor induction (intervention that stimulates the onset of labor using artificial methods).

This failure resulted in RN 1 failing to recognize prolonged fetal distress, which contributed to a traumatic birth injury.

Findings:

Review of RN 1's personnel record indicated RN 1 was hired to the Family Birthing Center (FBC, a labor and delivery unit) on 8/9/22. The file included a document titled "Labor & Delivery Skills Checklist." The Checklist indicated, "Directions: 1. Orientee: Complete the self-assessment. Obtain the initials and date from your preceptor. 2. Preceptor: Review the self-assessment. Validate items on the list, INITIAL & DATE appropriate column." The Self-Assessment column on the Checklist was blank. The Preceptor Assessment column had several blank entries next to demonstrated or verbalized competencies. The Preceptor Assessment column indicated initials and the month and day of the assessment but did not indicate the year. The Checklist indicated "Skill Checklist completed by," and next to it a signature with the date 1/15/23.

Further review of RN 1's personnel file indicated a document titled "Post-Partum/Newborn Skills Checklist." The Checklist indicated, "Directions: 1. Orientee: Complete the self-assessment ... 2. Preceptor: Review the self-assessment. Validate items on the inventory and place your initial and date in the appropriate column ..." The Self-Assessment column on the Checklist was blank. The Preceptor Assessment column indicated initials and the month and day of the assessment but did not indicate the year. The end of the document indicated "Date Completed 12/27/23 [a future date]," and a signature next to "Director/Clinical Coordinator signature reviewed."

Review of Patient 1's "History and Physical (H&P)" dated 8/14/23, indicated Patient 1 was admitted to the facility for increased labor contractions at 39 weeks of pregnancy and expected delivery of her first child. The H&P indicated good fetal movement, and an order for "Fetal Monitor per Policy."

During a review of a Physician Note, dated 8/15/23 at 2:26 a.m., the physician note indicated the patient was assessed, the fetal heart rate (FHR) was in the 120's (normal FHR between 110-160 beats per minute) with variable decelerations (temporary but distinct decreases of the fetal heart rate caused by decreased blood flow during contractions) and ordered to stop the oxytocin (a medication used to promote contractions of the uterus to induce labor) infusion.

Review of the nursing assignment for the day shift (7 a.m. to 7 p.m.) on 8/15/23 indicated RN 1 was assigned to the care of Patient 1. The assignment sheet indicated RN 1 was assigned to only Patient 1 that day.

During a review of Patient 1's flowsheet, dated 8/15/23, the flowsheet indicated, at 8:20 a.m., Patient 1 was dilated to 9.5 centimeters (cm, a unit of measure) and at 8:30 a.m., the continuous FHR monitoring exhibited Category 1/Normal Tracings with 3.5 contractions in a ten-minute period. The flowsheet indicated the FHR baseline was 125.

During a review of Patient 1's medication administration record (MAR), dated 8/15/23, the MAR indicated an infusion of oxytocin was restarted at approximately 9:27 a.m. at 2 milliunits (mUnit - a measure of volume) per minute. The MAR indicated the infusion of oxytocin was increased by 2 mUnits approximately every thirty minutes starting at 10:20 a.m. At 12:00 p.m., the MAR indicated the oxytocin infusion had been increased to 10 mUnits per minute.

During a review of the same patient flowsheet, dated 8/15/23, the flowsheet indicated, at 12:28 p.m. Patient 1 started pushing. The flowsheet indicated, at 12:30 p.m. the FHR tracings were Category 2/Intermediate (Category 2 fetal heart tracings include a broad spectrum of abnormalities that may indicate increased stress to the fetus and require intervention such as repositioning, hydration and physician notification) with variable FHR decelerations and significant decelerations present with greater than 50% of the contractions. The flowsheet indicated the FHR baseline was up to 150. The flowsheet contained no documentation to indicate a physician was notified of the increased FHR baseline, the Category 2/Intermediate tracings or the significant decelerations present with greater than 50% of the contractions.

During a review of Patient 1's MAR, dated 8/15/23, the MAR indicated the infusion of oxytocin was increased to 12 mUnits per minute at approximately 12:32 p.m.

During a review of the same patient flowsheet, dated 8/15/23, the flowsheet indicated, at 1:00 p.m. the FHR tracings continued to be Category 2/Intermediate with variable FHR decelerations and significant decelerations present with greater than 50% of the contractions. The flowsheet indicated the FHR baseline continued to be 150.

During a review of Patient 1's MAR, dated 8/15/23, the MAR indicated the infusion of oxytocin was again increased by 2 mUnits to 14 mUnits per minute at approximately 1:05 p.m.

During a review of a Physician Note, dated 8/15/23 at 2:04 p.m., the note indicated Patient 1 had been pushing for 90 minutes. The note further indicated the physician would return to check the patient in another 90 minutes unless called back sooner. The note contained no documentation to indicate the physician was aware of the sustained Category 2/Intermediate FHR tracings with variable FHR decelerations, the significant decelerations present with greater than 50% of the contractions, or the increased FHR baseline to 150 beats per minute for the previous 90 minutes. Additionally, the note contained no documentation to indicate the physician had been made aware the oxytocin infusion had been consistently increased to a rate of 14mUnits per minute and was still infusing.

During a review of the same patient flowsheet, dated 8/15/23, the flowsheet indicated, at 2:30 p.m. the uterine contractions were now at 5.5 in a 10-minute period (tachysystole - more than five uterine contractions within 10 minutes, increases the amount of time a fetus is deprived of oxygen) with Category 2/Intermediate FHR tracings and prolonged FHR decelerations (Prolonged decelerations - an abnormal fetal heart rate finding that could indicate a risk of fetal death from lack of oxygen) with greater than 50% of the contractions. The flowsheet indicated broken tracings (where the continuous reading of the fetal heart rate is periodically not detectable on the monitor) due to the patient pushing. The flowsheet indicated the FHR baseline continued to be 150. The flowsheet contained no documentation to indicate a physician was notified of the tachysystole, prolonged decelerations, broken FHR tracings, and continued oxytocin infusion at 14mUnits per minute.

During a review of the same patient flowsheet, dated 8/15/23, the flowsheet indicated the same concerning FHR tracings at 3:00 p.m. and at 3:20 p.m. The flowsheet indicated, at 3:20 p.m. the physician was at the bedside.

During a review of a Discharge Summary, dated 8/15/23 at 4:15 p.m., the discharge summary indicated the physician was called to the room and could not hear fetal heart tones. The note indicated the nurse was asked to readjust the monitor and told the physician the FHR was in the 120's at first, and then 110 when the physician asked again. The note further indicated the patient had stopped pushing, refused to push anymore and the baby was delivered with the assistance of a vacuum procedure (where the vaginal delivery of a baby is performed with the help of a vacuum device).

During a review of a Nursing Progress Note, dated 8/15/23 at 6:30 p.m., the note indicated Patient 1 started pushing at 12:28 p.m., the FHR tracings "looked good," and there were no audible decelerations. The note indicated the nurse went to a lunch break from 2:37 p.m. to 3:07 p.m., and another nurse assumed care. The note further indicated the physician came to the bedside at 3:20 p.m. and after the baby was delivered, the respiratory therapist " ...took over because the baby wasn't crying."

During a review of a Nursing Progress Note, dated 8/15/23 at 7:00 p.m., the note indicated the neonatal resuscitation nurse received the newborn, "limp, no color and no respiratory effort." The note indicated, at nine minutes of life, the baby was moved to the nursery for further monitoring.

During a review of a Nursing Progress Note, dated 8/15/23 at 9:10 p.m., the note indicated the infant was transferred to a hospital with a neonatal intensive care unit transport team.

During a review of the facility's policy titled, "Fetal Monitoring Policy," undated, the policy indicated, "Provider Notification... A. The provider shall be notified when: 1. Fetal heart tones are not detectable...3. Fetal Tachycardia [Fetal heart rate above 160]...5. Category II [two] FHR tracing that is not resolving to Category I [one] 6. Category II FHR tracings with: i. Prolonged deceleration greater than 2 minutes but less than 10 minutes ii. Moderate and/or marked variability with significant decelerations occurring with more than 50% of contractions over a 30 minute period iii. Minimal and/or absent fetal heart rate variability with significant decelerations occurring with more than 30% of contractions over a 30-minute period... 7. Category III [three] tracing."

During further review of the facility's policy titled, "Fetal Monitoring Policy," undated, the policy indicated an algorithm for the management of significant Category II fetal heart tracings. The algorithm indicated for an assessment of FHR variability as "Moderate or Marked" with Significant Decelerations with greater than 50% of contractions for 30 minutes, to then provide interventions and notify the physician.

During a review of the facility's policy titled "Labor Management Policy," last revised 9/23/21, the policy indicated, "Nursing care includes the recognition of abnormal labor or emergency medical conditions that require intervention...Physician Notification: Report the following to physician...5. Persistent or worsening category II tracing or category III FHR tracing."

During a review of the facility's policy titled, "Cervical Ripening [a process of softening and opening the cervix before labor starts], Induction and Augmentation [the process of stimulating the uterus in order to increase the frequency, duration or intensity]," dated 1/27/22, the policy indicated, "PURPOSE: To provide nursing guidelines and promote a safe and effective use of medications for cervical ripening, induction, and/or augmentation for labor." The policy further indicated, "Contraindications to Cervical Ripening/Induction/Augmentation of Labor include, but are not limited to the following... 10. Tachysystole... 13. Fetal distress."

During a review of the same facility policy titled, "Cervical Ripening, Induction and Augmentation," dated 1/27/22, the policy indicated, "7. Oxytocin infusion is titrated to maternal-fetal response to labor. Oxytocin dose is increased only if: a. Less then five contractions in 10 minutes averaged over a 30 minute window... c. The FHR tracing shows no signs of fetal compromise."

During an interview with Nurse Shift Manager (NSM) 2 on 11/28/23 at 1:20 p.m., NSM 2 stated the Team Lead created the daily nursing assignments. NSM 2 stated the Team Lead would consider a nurse's skill level when making patient care assignments. NSM 2 stated the FBC recently had two new nursing school graduates complete their orientation and training on the unit. NSM 2 stated, the Team Lead would assign themselves as their "buddy" during their shift to provide on-going oversight and support.

During an interview with RN 2 on 11/28/23 at 3:55 p.m., RN 2 stated she was a preceptor for newly hired nurses to the FBC and was willing to precept RN 1 only once, because she felt RN 1 lacked understanding and the willingness to learn. RN 2 stated RN 1 should have never been taken off orientation to work on her own, and stated, "She was not ready to be on her own." RN 2 further stated, "We brought this to our educator, and she knew."

During an interview with the Director of Quality and Patient Safety (DQPS) on 11/29/23 at 10:54 a.m., the DQPS stated RN 1 was not available for interview because she was on a leave of absence.

During an interview with RN 6 on 11/29/23 at 1:25 p.m., RN 6 stated she assigned RN 1 to Patient 1 on 8/15/23 as the primary nurse because RN 1 was newly off orientation and needed to experience a delivery. RN 6 stated Patient 1 was not high risk, was close to delivery at the start of the morning shift but the contractions were not strong. RN 6 stated RN 1 did not verbalize concerns throughout the day related to the FHR monitoring.

During an interview with NSM 1 on 11/30/23 at 11:45 a.m., NSM 1 stated RN 1 still had a lot of learning to do. NSM 1 stated, because RN 1 was a new nurse graduate, she would follow physician instructions without questioning them.

During an interview with the Director of the FBC (DFBC) on 11/30/23 at 2:15 p.m., the DFBC stated the new graduate orientation program for RN 1 was initially planned for 22 weeks, however, RN 1 needed "significantly more time." DFBC stated she recalled RN 1 finished the new graduate orientation program in May 2023. DFBC stated RN 1 had several preceptors and not all preceptors would sign off on RN 1's Skills Checklist. DFBC stated some nurses expressed general concerns regarding RN 1's level of competency, while others provided positive feedback on RN 1's progress. The DFBC acknowledged the gaps on RN 1's Skills Checklist, and stated it was her expectation that the unit educator and preceptor meet with the preceptee regularly to evaluate their progress. The DFBC stated she did not have documented evidence the unit educator met with RN 1 to discuss her progression and competency level.

During the same interview with the DFBC on 11/30/23 at 2:15 p.m., the DFBC stated RN 1 was only taking care of Patient 1 on 8/15/23. DFBC stated Patient 1 was considered a low-risk patient and an uncomplicated delivery was expected. DFBC stated, when the traumatic birth injury occurred, she reviewed the FHR tracing strips with RN 1 to understand why RN 1 failed to act appropriately to signs of prolonged fetal distress. DFBC stated RN 1 was unable to recognize that anything was wrong with the FHR, and RN 1 stated that that was what it always looked like. When asked if the concerns the DFBC had with the FHR tracing strip were clear, the DFBC stated, "abundantly clear." The DFBC stated she was surprised that RN 1 was unable to see the prolonged fetal distress on the FHR tracing strip given the many classes RN 1 took that included FHR monitoring. When asked about the level of support and oversight RN 1 received as a new graduate nurse, the DFBC stated, shortly after the completion of RN 1's orientation, the unit educator went on an extended leave of absence for 2 months. The DFBC stated, during that time, the unit experienced an increase in patient volume and a need to bring on additional contracted nurses. The DFBC stated the focus had shifted to the orientation of the contracted nurses. The DFBC stated this may have contributed to RN 1 receiving less oversight and support.

Review of a facility policy titled "Nursing Orientation, Staff Development and Ongoing Competency Validation," dated 10/26/23, indicated, "The role of the preceptor is to assist in the completion of the orientation checklist; completion of ongoing evaluations with the preceptee, educator and unit leader, utilize the orientation checklist to guide the process; review documentation of the preceptee; and validate competency in key areas."

Based on interview, clinical record review and facility policy review, the facility failed to ensure policies for fetal (or fetus - refers to a baby in the womb/prior to birth) monitoring and labor management were adhered to for one of 14 laboring patients (Patient 1) when appropriate assessment and corresponding interventions were not performed to address critical changes in Patient 1's fetal heart rate (FHR) monitoring.

This failure caused a significant delay in response time to Patient 1, exhibiting prolonged signs of fetal distress, and resulted in the birth of a nonresponsive baby (Patient 2) which required stimulation efforts, oxygen support, and transfer to another hospital for a higher level of care.

Findings:

During a review of Patient 1's "History and Physical (H&P)," dated 8/14/23, the H&P indicated Patient 1 was admitted to the facility for increased labor contractions at 39 weeks gestation (the period of development of an unborn baby) of pregnancy and expected delivery of her first child. The H&P also indicated good fetal movement and an order to "Fetal Monitor per Policy."

During a review of Patient 1's flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated on 8/14/23 beginning at 3:30 p.m. an external monitor device was placed on the patient to continuously monitor uterine contractions (when the muscles of the uterus tighten up and then relax to help push the baby out) and the FHR. The flowsheet further indicated 4 moderate contractions in a 10-minute period and Category 1 "Normal Tracings" (Category 1 fetal heart tracings are considered normal, and no intervention is necessary) with a baseline FHR of 130 (heart beats per minute, normal being between 110-160 heart beats per minute), and absent FHR decelerations (temporary but distinct decreases of the fetal heart rate caused by decreased blood flow to the placenta during contractions).

During a review of Patient 1's "Medication Administration" record (MAR) dated, 8/14/23-8/15/23, the MAR indicated an infusion of oxytocin (a medication used to stimulate the frequency and strength of uterine contractions during labor) was initiated on 8/14/23 at approximately 10:36 p.m.

During a review of the Patient 1's flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated monitoring documented every 30 minutes where the FHR tracings continued to exhibit Category 1/Normal tracings and absent FHR decelerations.

During a review of Patient 1's flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated at 2:00 a.m. on 8/15/23 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 indicate increased stress to the fetus and require intervention such as repositioning, hydration and physician notification) with an FHR of 130 and early, variable (a sudden change in fetal heart rate with a quick return to baseline) decelerations present. The flowsheet indicated 5 uterine contractions in a 10-minute period. The interventions documented indicated oral fluids for hydration were provided to Patient 1, and at 2:15 a.m., the patient had dilated to 7 cm (centimeters, a unit of measurement where the opening of the cervix is measured and 10cm is fully dilated and ready for delivery of the fetus).

During a review of a Physician Note, dated 8/15/23 at 2:26 a.m., the physician note indicated the patient was assessed, the FHR was in the 120's with variable decelerations and ordered to stop the oxytocin infusion.

During a review of the same patient flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated at 8:20 a.m. on 8/15/23, Patient 1 was dilated to 9.5 cm and at 8:30 a.m., the continuous fetal monitoring exhibited Category 1/Normal Tracings with 3.5 contractions in a ten-minute period. The flowsheet indicated the FHR baseline was 125.

During a review of the same patient flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated at 9:27 a.m. on 8/15/23, Patient 1 was restarted on the oxytocin infusion and continuously monitored every 30 minutes by Registered Nurse (RN) 1.

During a review of Patient 1's MAR dated 8/15/23, the MAR indicated the infusion of oxytocin was increased by 2 units approximately every thirty minutes starting at 10:20 a.m., and at 12:00 p.m., the MAR indicated the oxytocin infusion had been increased to 10mUnits per minute by RN 1.

During a review of a Physician Note, dated 8/15/23 at 12:04 p.m., the physician note indicated Obstetrician (OB - a physician who specializes in caring for people during pregnancy and childbirth) 1 noted Patient 1 was on the oxytocin infusion, was assessed as fully dilated, and would start pushing. The note further indicated a noted Category 1/Normal FHR tracing.

During a review of the same patient flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated at 12:28 p.m. on 8/15/23, Patient 1 started pushing. The flowsheet contained documentation by RN 1 to indicate at 12:30 p.m., the FHR tracings were Category 2/Intermediate with variable FHR decelerations and significant decelerations present with greater than 50% of the contractions. The flowsheet indicated the FHR baseline was up to 150.

During a review of Patient 1's MAR dated 8/15/23, the MAR indicated the infusion of oxytocin was increased to 12mUnits per minute on 8/15/23 at approximately 12:32 p.m. by RN 1.
The flowsheet contained no documentation to indicate RN 1 notified OB 1 of the increased FHR baseline or the significant decelerations present with greater than 50% of the contractions.

During a review of the same patient flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated at 1:00 p.m., 1:30 p.m., and 2:00 p.m., RN 1 documented the FHR tracings continued to be Category 2/Intermediate with variable FHR decelerations and significant decelerations present with greater than 50% of the contractions. The flowsheet indicated the FHR baseline continued to be 150.

During a review of Patient 1's MAR dated 8/15/23, the MAR indicated the infusion of oxytocin was again increased by 2 units to 14mUnits per minute on 8/15/23 at approximately 13:05 p.m. by RN 1.

During a review of a Physician Note, dated 8/15/23 at 2:04 p.m., the physician note indicated Patient 1 had been pushing for 90 minutes. The note further indicated OB 1 would return to check the patient in another 90 minutes unless she was called back sooner. The note contained no documentation to indicate the physician was made aware of the sustained Category 2/Intermediate FHR tracings with variable FHR decelerations, the significant decelerations present with greater than 50% of the contractions, or the increased FHR baseline to 150 beats per minute for the previous 90 minutes.

During a review of the same patient flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated at 2:30 p.m., RN 1 noted the uterine contractions were now at 5.5 in a 10-minute period (tachysystole - more than five uterine contractions within 10 minutes, increases the amount of time a fetus is deprived of oxygen) with Category 2/Intermediate FHR tracings and prolonged FHR decelerations (Prolonged decelerations - an abnormal fetal heart rate finding that could indicate a risk of fetal death from lack of oxygen) with greater than 50% of the contractions. The flow sheet indicated RN 1 noted broken tracings (where the continuous reading of the fetal heart rate is periodically not detectable on the monitor) due to the patient pushing. The flowsheet indicated the FHR baseline continued to be 150.

The flowsheet contained no documentation to indicate a OB 1 was notified of the tachysystole, prolonged decelerations, broken FHR tracings, and continued oxytocin infusion at 14mUnits per minute.

During a review of the same patient flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated RN 1 noted the same concerning FHR tracings at 3:00 p.m. and at 3:20 p.m. The flowsheet indicated at 3:20 p.m., the OB 1 was at the bedside.

During a review of a Discharge Summary, dated 8/15/23 at 4:15 p.m., the discharge summary indicated the OB 1 was called to the room and could not hear FHTs (Fetal heart tones). The note indicated the nurse was asked to readjust the monitor and told the physician the FHR was in the 120's at first, and then 110 when the physician asked again. The note further indicated the patient had stopped pushing, refused to push anymore and the baby was delivered with the assistance of a vacuum procedure (where the vaginal delivery of a baby is performed with the help of a vacuum device).

During a review of a Nursing Progress Note, dated 8/15/23 at 6:30 p.m., the note indicated Patient 1 started pushing at 12:28 p.m., the FHR tracings "looked good," and there were no audible decelerations. The note indicated the nurse went to a lunch break from 2:37 p.m. to 3:07 p.m., and another nurse assumed care. The note further indicated the physician came to the bedside at 3:20 p.m. and after the baby was delivered, the respiratory therapist " ...took over because the baby wasn't crying."

During a review of a Nursing Progress Note, dated 8/15/23 at 7:00 p.m., the note indicated the neonatal resuscitation nurse (a nurse who specializes in emergency airway, breathing and circulation of a newborn) received the newborn, "limp, no color and no respiratory effort." The note indicated at nine minutes of life; the baby was moved to the nursery for further monitoring.

During a review of a Nursing Progress Note, dated 8/15/23 at 9:10 p.m., the note indicated the infant was transferred to a hospital with a neonatal intensive care unit (NICU).

During an interview with the Director of Quality and Patient Safety (DQPS) on 11/29/23 at 10:54 a.m., the DQPS stated RN 1 was not available for interview because she was on a leave of absence.

During an additional interview with the Director of Quality and Patient Safety (DQPS) on 11/29/23 at 3:00 p.m., the DQPS stated OB 1 was declining to be interviewed.

During a concurrent interview and record review on 11/30/23 at 10:22 a.m. with OB 2, Patient 1's FHR tracings, dated 8/15/23, were reviewed. OB 2 stated the tracings at 11:54 a.m. timestamp indicated a FHR baseline in the 140's. P1 stated the tracings at 12:34 p.m. timestamp indicated Patient 1 may have been pushing with the contractions and it appeared the FHR rose above the normal threshold (above 160 beats per minute) which was "noteworthy."

During the same concurrent interview and record review on 11/30/23, of Patient 1's FHR monitoring record, OB 2 stated at the 12:50 p.m. timestamp, the strips indicated there were recurrent decelerations happening with more than 50% of the contractions. OB 2 stated recurrent decelerations are a prompt for assessment, intervention, and physician notification by the nurse. OB 2 stated there would be no need to increase the oxytocin at this point because the baby may be showing signs of decreased oxygen and blood flow. Ob 2 stated the FHR tracings showed continued evidence of recurrent and substantial decelerations at the 12:58 p.m., 1:05 p.m., and the 1:14 p.m. timestamp. OB 2 stated these were further prompts of needed intervention and physician notification because the elevated fetal heart rate and the recurrent variable decelerations are indicators of compromised blood flow to the baby.

During the same concurrent interview and record review on 11/30/23, of Patient 1's FHR monitoring record, OB 2 stated at the 2:18 p.m. timestamp, the FHR tracings appeared to be Category 3/Abnormal (Non-reassuring tracings indicative of significant fetal stress and decreased blood flow to the fetus) and would expect this type of FHR tracing to be immediately conveyed to the physician for imminent delivery planning. OB 2 stated at 2:42 p.m. timestamp, the FHR tracings indicated no interpretable readings of the fetal heart rate, the heart rate was not consistent, and the tracing was not reassuring. OB 2 stated it did not appear the significant FHR tracings were recognized due to the timing of the OB 1's presence at the bedside and vacuum assisted delivery nearly an hour later.

During an interview on 11/30/23 at 2:10 p.m. with the Director of the Family Birth Center (DFBC), DFBC stated she reviewed Patient 1's record after the event took place and could find no documentation to support RN 1 had notified or been in communication with the OB 1 regarding the continuous and concerning FHR tracings. DFBC further stated the absence of communication between the nurse and the physician caused the outcome of a nonresponsive baby to be unexpected.

During a review of the facility's policy titled "Labor Management Policy," last revised 9/23/21, the policy indicated, "Nursing care includes the recognition of abnormal labor or emergency medical conditions that require intervention."

During further review of the facility's policy titled "Labor Management Policy," last revised 9/23/21, the policy indicated, "Physician Notification: Report the following to physician...5. Persistent or worsening category II [2] tracing or category III [3] FHR tracing."

During a review of the facility's Job Description for the Registered Nurse (RN) for the Family Birth Center department, dated 3/31/22, the job description indicated "Job Specific Duties 1.11 Communication: Communicates clearly and effectively...Includes reporting abnormals or change in patient condition to appropriate personnel in a timely manner."

During a review of the facility's policy titled, "Fetal Monitoring Policy," undated, the policy indicated, "Provider Notification A. The provider shall be notified when: 1. Fetal heart tones are not detectable...3. Fetal Tachycardia [Fetal heart rate above 160]...5. Category II FHR tracing that is not resolving to Category I [one] 6. Category II FHR tracings with: i. Prolonged deceleration greater than 2 minutes but less than 10 minutes ii. Moderate and/or marked variability with significant decelerations occurring with more than 50% of contractions over a 30 minute period iii. Minimal and/or absent fetal heart rate variability with significant decelerations occurring with more than 30% of contractions over a 30-minute period 7. Category III tracing."

During further review of the facility's policy titled, "Fetal Monitoring Policy," undated, the policy indicated an algorithm for the management of significant Category II fetal heart tracings. The algorithm indicated for an assessment of FHR variability as "Moderate or Marked" with Significant Decelerations with greater than 50% of contractions for 30 minutes, to then provide interventions and notify the physician.

During a review of the facility's policy titled, "Cervical Ripening [a process of softening and opening the cervix before labor starts], Induction [the process or treatment that stimulates childbirth and delivery] and Augmentation [the process of stimulating the uterus in order to increase the frequency, duration or intensity]," dated 1/27/22, the policy indicated, "PURPOSE: To provide nursing guidelines and promote a safe and effective use of medications for cervical ripening, induction, and/or augmentation for labor." The policy further indicated, "Contraindications to Cervical Ripening/Induction/Augmentation of Labor include, but are not limited to the following: 10. Tachysystole 13. Fetal distress."

During a review of the same facility policy titled, "Cervical Ripening, Induction and Augmentation," dated 1/27/22, the policy indicated, "7. Oxytocin infusion is titrated [increased or decreased in dose depending on patient response] to maternal-fetal response to labor. Oxytocin dose is increased only if: a. Less then five contractions in 10 minutes averaged over a 30 minute window. c. The FHR tracing shows no signs of fetal compromise."

Based on interview, clinical record review and facility policy review, the facility failed to ensure a medication was administered in accordance with a physician's order and facility policy for one of 14 laboring patients (Patient 1) when an infusion of oxytocin (a medication administered through the vein to promote contractions of the uterus to induce labor) was inappropriately administered by Registered Nurse (RN) 1.

This failure resulted in a continuous infusion, increased in dose every thirty minutes, of medication to further intensify uterine contractions that caused oxygen deprivation to a fetus (Patient 2) and resulted in the birth of a nonresponsive baby which required stimulation efforts, oxygen support, and transfer to another hospital for a higher level of care.

Findings:

During a review of Patient 1's "History and Physical (H&P)," dated 8/14/23, the H&P indicated Patient 1 was admitted to the facility for increasing labor contractions at 39 weeks gestation of pregnancy and expected delivery of her first child. The H&P also indicated good fetal movement. Continued review of the same H&P, dated 8/14/23, indicated an order to "Fetal Monitor per Policy."

During a review of Patient 1's flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated on 8/14/23 beginning at 3:30 p.m. an external monitor device was placed on the patient to continuously monitor uterine contractions (when the muscles of the uterus tighten up and then relax to help push the baby out) and the fetal heart rate. The flowsheet further indicated 4 moderate contractions in a 10-minute period and Category 1 "Normal Tracings" (Category 1 fetal heart tracings are considered normal, and no intervention is necessary) with a baseline FHR of 130 (normal being between 110-160 heart beats per minute), and absent FHR decelerations (temporary but distinct decreases of the fetal heart rate caused by decreased blood flow to the placenta during contractions).

During a review of Patient 1's physician orders dated 8/14/23 at 9:49 p.m., an order indicated to administer oxytocin (a medication used to stimulate the frequency and strength of uterine contractions during labor) infusion at 2 milliunits (mUnit - a measure of volume) per minute and increase the infusion by 2 mUnits per minute every thirty minutes "until adequate uterine activity defined as: i. 3-5 contractions in a 10-minute period with a maximum not to exceed 5 contractions in a 10-minute period."

During a review of the same physician order for oxytocin infusion, the order indicated to decrease the infusion rate for "Tachysystole: [more than five uterine contractions within 10 minutes] After 10 MORE MIN, if UC's [Uterine Contractions] NOT returned to normal, D/C [Discontinue] Oxytocin until UC's are 5 or less in 10 minutes. DISCONTINUE Instructions: I. Cat II [Category 2/Intermediate fetal heart tracings include a broad spectrum of abnormalities that may indicate increased stress to the fetus and require intervention such as repositioning, hydration and physician notification] with Significant decels [decelerations]... notify provider ii.Cat III Fetal Heart Rate (Category 3 fetal heart tracing is indication of an abnormal fetal status, meaning that the fetus is not getting enough oxygen and can require emergency intervention) and notify provider."

During a review of Patient 1's "Medication Administration" record (MAR) dated, 8/14/23-8/15/23, the MAR indicated an infusion of oxytocin was initiated on 8/14/23 at approximately 10:36 p.m. at 2mUnits per minute.

During a review of the same patient flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated monitoring documented every 30 minutes from 10:30 p.m. to 11:00 p.m. where the FHR tracings continued to exhibit Category 1/Normal tracings with a FHR baseline of 125-130 and absent FHR decelerations.

During a review of Patient 1's MAR, dated 8/14/23-8/15/23, the MAR indicated the infusion of oxytocin was increased (by 2 units) to 4 mUnits per minute on 8/14/23 at approximately 11:06 p.m.

During a review of the same patient flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated at 12:00 a.m., FHR tracings continued to exhibit Category 1/Normal tracings with a FHR baseline of 125 and absent FHR decelerations, however the uterine contractions had increased to 6 over a ten-minute period.

During a review of Patient 1's MAR, dated 8/14/23-8/15/23, the MAR indicated the infusion of oxytocin was decreased to 3mUnits per minute on 8/15/23 at approximately 12:01 a.m.

During a review of Patient 1's MAR, dated 8/14/23-8/15/23, the MAR indicated the infusion of oxytocin was decreased again to 2mUnits per minute on 8/15/23 at approximately 12:28 a.m.

During a review of the same patient flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated at 2:00 a.m. on 8/15/23 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 indicate increased stress to the fetus and require intervention such as repositioning, hydration and physician notification) with an FHR of 130 and early, variable decelerations present. The flowsheet indicated 5 uterine contractions in a 10-minute period. The interventions documented indicated oral fluids for hydration were provided to Patient 1, and at 2:15 a.m., the patient had dilated to 7 cm (centimeters, a unit of measurement where the opening of the cervix is measured, and 10 cm is fully dilated and ready for delivery of the fetus).

During a review of Patient 1's MAR, dated 8/14/23-8/15/23, the MAR indicated the infusion of oxytocin was stopped on 8/15/23 at approximately 2:15 a.m.

During a review of a Physician Note, dated 8/15/23 at 2:26 a.m., the physician note indicated Patient 1 was assessed, the FHR was in the 120's with variable decelerations and ordered to stop the oxytocin infusion.

During a review of the same patient flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated at 8:20 a.m. on 8/15/23, Patient 1 was dilated to 9.5 cm and at 8:30 a.m., the continuous fetal monitoring exhibited Category 1/Normal Tracings with 3.5 contractions in a ten-minute period. The flowsheet indicated the FHR baseline was 125.

During a review of Patient 1's MAR, dated 8/15/23, the MAR indicated the infusion of oxytocin was restarted on 8/15/23 at approximately 9:27 a.m. at 2mUnits per minute by Registered Nurse (RN) 1.

During a review of the same patient flowsheet, dated 8/15/23, the flowsheet indicated at 9:27 a.m. on 8/15/23, RN 1 had documented Patient 1 was restarted on the oxytocin infusion.

During a review of Patient 1's MAR, dated 8/15/23, the MAR indicated the infusion of oxytocin was increased by 2 units approximately every thirty minutes by RN 1 starting at 10:20 a.m. At 12:00 p.m., the MAR indicated the oxytocin infusion had been increased by RN 1 to 10mUnits per minute.

During a review of a Physician Note, dated 8/15/23 at 12:04 p.m., the physician note indicated Obstetrician (OB - a physician who specializes in caring for people during pregnancy and childbirth) 1 noted Patient 1 was on the oxytocin infusion, was assessed as fully dilated, and would start pushing. The note further indicated OB 1 noted a Category 1/Normal FHR tracing.

During a review of the same patient flowsheet, dated 8/15/23, the flowsheet indicated RN 1 documented at 12:28 p.m. on 8/15/23, Patient 1 started pushing. The flowsheet indicated at 12:30 p.m., RN 1 documented the FHR tracings were Category 2/Intermediate with variable FHR decelerations and significant decelerations present with greater than 50% of the contractions. The flowsheet indicated the FHR baseline was up to 150.

During a review of Patient 1's MAR, dated 8/15/23, the MAR indicated the infusion of oxytocin was increased to 12mUnits per minute on 8/15/23 at approximately 12:32 p.m. by RN 1.

Patient 1's flowsheet contained no documentation to indicate RN 1 notified a physician of the increased FHR baseline, the Category 2/Intermediate tracings or the significant decelerations present with greater than 50% of the contractions. The flowsheet contained no documentation to indicate RN 1 stopped or decreased the oxytocin infusion per physician order.

During a review of the same patient flowsheet, dated 8/15/23, the flowsheet indicated at 1:00 p.m., RN 1 documented the FHR tracings continued to be Category 2/Intermediate with variable FHR decelerations and significant decelerations present with greater than 50% of the contractions. The flowsheet indicated the FHR baseline continued to be 150.

During a review of Patient 1's MAR, dated 8/15/23, the MAR indicated the infusion of oxytocin was again increased by 2 units to 14mUnits per minute on 8/15/23 at approximately 1:05 p.m. by RN 1, not in accordance with physician order.

During a review of a Physician Note, dated 8/15/23 at 2:04 p.m., the physician note indicated OB 1 noted Patient 1 had been pushing for 90 minutes. The note further indicated OB 1 would return to check the patient in another 90 minutes unless she was called back sooner. The note contained no documentation to indicate OB 1 was made aware of the sustained Category 2/Intermediate FHR tracings with variable FHR decelerations, the significant decelerations present with greater than 50% of the contractions, or the increased FHR baseline to 150 beats per minute for the previous 90 minutes. Additionally, the note contained no documentation to indicate OB 1 had been made aware the oxytocin infusion had been consistently increased every 30 minutes to a final rate of 14mUnits per minute and was still infusing.

During a review of the same patient flowsheet, dated 8/15/23, the flowsheet indicated RN 1 documented at 2:30 p.m., the uterine contractions were now at 5.5 in a 10-minute period (tachysystole - more than five uterine contractions within 10 minutes, which increases the amount of time a fetus is deprived of oxygen) with continued Category 2/Intermediate FHR tracings and prolonged FHR decelerations (Prolonged decelerations - an abnormal fetal heart rate finding that could indicate a risk of fetal death from lack of oxygen) with greater than 50% of the contractions. The flow sheet indicated RN 1 documented broken FHR tracings (where the continuous reading of the fetal heart rate is periodically not detectable on the monitor) due to the patient pushing. The flowsheet indicated the FHR baseline continued to be 150. The flowsheet contained no documentation to indicate RN 1 notified a physician of the tachysystole, prolonged decelerations, broken FHR tracings, and continued oxytocin infusion at 14mUnits per minute, which was not in accordance with physician order.

During a review of the same patient flowsheet, 8/15/23, the flowsheet indicated the same concerning FHR tracings documented by RN 1 at 3:00 p.m. and at 3:20 p.m. The flowsheet indicated at 3:20 p.m., the physician was at the bedside.

During a review of a Discharge Summary, dated 8/15/23 at 4:15 p.m., the discharge summary indicated OB 1 was called to the room and could not hear fetal heart tones (FHTs). The note indicated the nurse was asked to readjust the monitor and told the physician the FHR was in the 120's at first, and then 110 when the physician asked again. The note further indicated the patient had stopped pushing, refused to push anymore and the baby was delivered with the assistance of a vacuum procedure (where the vaginal delivery of a baby is performed with the help of a vacuum device).

During a review of a Nursing Progress Note, dated 8/15/23 at 6:30 p.m., the note indicated RN 1 documented Patient 1 started pushing at 12:28 p.m., the FHR tracings "looked good," and there were no audible decelerations. The note indicated the nurse went to a lunch break from 2:37 p.m. to 3:07 p.m., and another nurse assumed care. The note further indicated the physician came to the bedside at 3:20 p.m. and after the baby was delivered, the respiratory therapist " ...took over because the baby wasn't crying."

During a review of a Nursing Progress Note, dated 8/15/23 at 7:00 p.m., the note indicated the neonatal resuscitation nurse received the newborn, "limp, no color and no respiratory effort." The note indicated at nine minutes of life; the baby was moved to the nursery for further monitoring.

During a review of a Nursing Progress Note, dated 8/15/23 at 9:10 p.m., the note indicated the infant was transferred to a hospital with a neonatal intensive care unit (NICU).

During a concurrent interview and record review on 11/28/23 at 2:29 p.m. with Nurse Shift Manager (NSM) 2, Patient 1's MAR and flowsheet, dated 8/15/23 were reviewed. NSM 2 confirmed Patient 1's record indicated the oxytocin infusion was increased by 2 units every thirty minutes with Category 2 tracings present, and stated this was against facility policy. NSM 2 stated it would be important to decrease or stop the oxytocin infusion because the medication causes increased uterine contractions, and this cuts off blood supply to the baby. NSM 2 stated it was also contraindicated (should not be done because it may be harmful) to keep increasing the infusion rate if contractions were greater than 5 in a ten-minute period, or with late or variable recurrent decelerations present with more than 50% of contractions. NSM 2 confirmed Patient 1's record indicated the oxytocin infusion was increased by RN 1 and never turned off and stated, "that is against policy."

During an interview with the Director of Quality and Patient Safety (DQPS) on 11/29/23 at 10:54 a.m., the DQPS stated RN 1 was not available for interview because she was on a leave of absence.

During a concurrent interview and record review on 11/29/23 at 1:25 p.m. with Registered Nurse (RN) 4, Patient 1's FHR tracings, dated 8/15/23 were reviewed. RN 4 stated there was not a continuous reading of the FHR after the 12:34 p.m. timestamp and the oxytocin should have been decreased or stopped altogether. RN 4 stated continuing or increasing the oxytocin infusion in the presence of increased uterine contractions was also contraindicated.

During an additional interview with the Director of Quality and Patient Safety (DQPS) on 11/29/23 at 3:00 p.m., the DQPS stated OB 1 declined to be interviewed.

During a concurrent interview and record review on 11/30/23 at 10:22 a.m. with OB 2, Patient 1's FHR tracings, dated 8/15/23 were reviewed. OB 2 stated the tracings at 11:54 a.m. timestamp indicated a FHR baseline in the 140's. P1 stated the tracings at 12:34 p.m. timestamp indicated Patient 1 may have been pushing with the contractions and it appeared the FHR rose above the normal threshold (above 160 beats per minute) which was "noteworthy."

During the same concurrent interview and record review on 11/30/23 at 10:22 a.m., of Patient 1's fetal heart rate (FHR) monitoring record, OB 2 stated at the 12:50 p.m. timestamp, the strips indicated there were recurrent decelerations happening with more than 50% of the contractions. OB 2 stated recurrent decelerations are a prompt of assessment, intervention, and physician notification by the nurse. OB 2 stated there would be no need to increase the oxytocin at this point because the baby may be showing signs of decreased oxygen and blood flow.

During the same concurrent interview and record review on 11/30/23 at 10:22 a.m., of Patient 1's fetal heart rate (FHR) monitoring record, OB 2 stated the FHR tracings showed continued evidence of recurrent and substantial decelerations at the 12:58 p.m., 1:05 p.m., and 1:14 p.m. timestamp. OB 2 stated these were further prompts of a need to decrease or stop the oxytocin infusion rate altogether because the elevated fetal heart rate and the recurrent variable decelerations are indicators of compromised blood flow to the baby.

During the same concurrent interview and record review on 11/30/23 at 10:22 a.m., of Patient 1's fetal heart rate (FHR) monitoring record, OB 2 stated at the 2:18 p.m. timestamp, the FHR tracings appeared to be Category 3/Abnormal (Non-reassuring tracings indicative of significant fetal stress and decreased blood flow to the fetus) and would expect this type of FHR tracing to be immediately conveyed to the physician for imminent delivery planning. OB 2 stated at 2:42 p.m. timestamp, the FHR tracings indicated no interpretable readings of the fetal heart rate, the heart rate was not consistent, and the tracing was not reassuring. OB 2 stated the oxytocin infusion should have been decreased or stopped altogether when the FHR tracings became concerning at the 12:50 p.m. timestamp, and it did not appear the significant FHR tracings were recognized due to the timing of the physician presence at the bedside and vacuum assisted delivery nearly an hour after the 2:42 p.m. timestamp.

During an interview on 11/30/23 at 2:10 p.m. with the Director of the Family Birth Center (DFBC), DFBC stated she reviewed Patient 1's record after the event took place and could find no documentation to support RN 1 had notified or been in communication with the physician regarding the continuous and concerning FHR tracings. DFBC further stated the absence of communication between RN 1 and the physician caused the outcome of a nonresponsive baby to be unexpected and did not realize the oxytocin played a role in the outcome until after an in-depth chart review.

During a review of the facility's policy titled, "Fetal Monitoring Policy," undated, the policy indicated, "2. Electronic Fetal Monitoring b. Category II [2] FHR - clinically indicated interventions, as ordered by provider, may include but are not limited to...4) Discontinue or decrease oxytocin ....d. Category III [3] (Abnormal) FHR - clinically indicated interventions, as ordered by provider, may include, but are not limited to...5. Discontinue oxytocin ..."

During a review of the facility's policy titled, "Medication Management Administration," last revised 12/9/2021, the policy indicated that the administration of medication is to be administered using "all of the components of the seven rights for every medication administered," which includes the right reason for the medication. The policy further indicated orders that include a range of doses are to be followed by "the parameters specified by the physician in writing the order."

During a review of the facility's policy titled, "Cervical Ripening [a process of softening and opening the cervix before labor starts], Induction [the process or treatment that stimulates childbirth and delivery] and Augmentation [the process of stimulating the uterus in order to increase the frequency, duration or intensity]," dated 1/27/22, the policy indicated, "PURPOSE: To provide nursing guidelines and promote a safe and effective use of medications for cervical ripening, induction, and/or augmentation for labor." The policy further indicated, "Contraindications to Cervical Ripening/Induction/Augmentation of Labor include but are not limited to the following...10. Tachysystole...13. Fetal distress."

During a review of the same facility policy titled, "Cervical Ripening, Induction and Augmentation," dated 1/27/22, the policy indicated, "7. Oxytocin infusion is titrated [increased or decreased based on a patient response] to maternal-fetal response to labor. Oxytocin dose is increased only if: a. Less than five contractions in 10 minutes averaged over a 30 minute window... c. The FHR tracing shows no signs of fetal compromise."