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Based on observation, interview and record review, the hospital failed to have an effective governing body (GB) that is legally responsible for the conduct of the hospital when:

1. The hospital failed to provide care in a safe setting for Patient 1 when registered nurses (RNs) in Labor & Delivery Unit did not recognize and act on Patient 1's risk factors that identified the pregnancy as high risk. RNs did not accurately interpret and document fetal heart monitoring and did not recognize and act on Patient 1's high risk for shoulder dystocia. (Refer to A144)

2. The hospital failed to ensure registered nurses were competent to provide care to meet the patients' needs when Labor and delivery (L&D) staff did not have current competencies in fetal heart rate interpretation, mandatory simulation training classes for obstetrical emergencies, annual skills fair, and no training or competency on how to complete physical examination and determination of the presence of labor for patients. (Refer to A397)

3. The hospital did not have effective quality assurance and performance improvement (QAPI) program that collected and analyzed data and used the data to implement tracking and monitoring when the facility failed to analyze causes and implement preventive measures following the unexpected death of a newborn, Patient (Pt) 1. The internal investigation conducted by the hospital's Performance Improvement unit did not include all factors that contributed to the unexpected death of Pt 1. The actions implemented as a result of the incomplete internal investigation did not provide sufficient level of safety for newborns in the hospital and did not identify gaps in nursing competencies and training. (Refer to A 283 and A 286)


The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and professional manner.

Based on observation, interview and record review the facility failed to protect and promote each patient's rights for safety and privacy when:

1. The hospital failed to provide care in a safe setting for Patient 1 when registered nurses (RNs) in Labor & Delivery Unit did not recognize and act on Patient 1's risk factors that identified the pregnancy as high risk. RNs did not accurately interpret and document fetal heart monitoring and did not recognize and act on Patient 1's high risk for shoulder dystocia. (Refer to A144)

2. The hospital failed to follow their policy and procedure titled ""Patient-Related Complaint and Grievance Management (CGM)" when resolutions responses were not given within the required time frame for two Patients (Patient 28 and 29) and the written response for Patient (Pt) 28's mother (PM 28) was not in Spanish the language the patient understood. (Refer to A118 and A123)

The cumulative effect of these systemic problems resulted in failure to ensure patients were cared for in a safe manner, and their rights were protected and promoted at all times.

Based on interviews and record review, the facility failed to follow their policy and procedure on the grievance process when two of two patients (Patient 28 and 29) did not receive resolution responses to their filed grievances within seven days.

These failures resulted in Patient (Pt) 28 and Pt 29 not being provided resolutions to their filed grievances for over six months.

Findings:

During a review of the facility's "Grievance Log (GL)", dated 1/1/23 to 12/15/23, the "GL" indicated on 3/1/23 Pt 28's parents filed a grievance regarding their son's care in the Emergency Department (ED). The "GL" indicated, " ... The parents were concerned because they did not feel the ED doctor took them seriously. They said their son was pale, had a fast heart rate and was complaining of abdominal pain. but the doctor didn't validate their concerns. The doctor was planning to send them home but [Pt 28] started having rectal bleeding at that time and was then given fluids and transferred to a higher level of care ... stated that if they hadn't spoken up for him he would have been discharged with a serious medical condition ... [Mother] would like a return call so that she knows that the appropriate people are aware of the situation ...". The "GL" indicated, " ... '3/2 Contact made by phone. Spoke to guardian about situation. Apologies made for dissatisfaction. Staff education implimented [sic]. [ED Director, EDD]' ... GRV [grievance] letter sent [Senior Risk Analyst {SRA}] 3/9 ...". The "GL" indicated the resolution date as 3/2/23.

During an interview on 12/15/23 at 1:42 p.m. with the mother of Pt 28 (PM 28), PM 28 stated she did not get a resolution to her satisfaction. PM 28 stated she did not receive a call back from the facility after her complaint. PM 28 stated she did not receive a letter nor any communication from the facility.

During a review of the facility's "GL", the "GL" indicated on 5/3/23 Pt 29 filed a grievance regarding her treatment in the ED by the ED staff and physician. The "GL" indicated, " ... they did not discuss lab or CT [Computerized Tomography, specialized imaging study] results, pain not controlled. Patient states that the nurse came in and told her that she was going to take out the IV [intravenous, in the vein] and foley catheter [a tube inserted in the bladder to assist in urination] out and she was discharged. Patient states that she wanted to finish the IV fluids and was still in severe pain and was told no she was discharged y the doctor and had to leave. Patient was diagnosed with a Kidney Stone ..." The "GL" indicated, " ... Service recovery due 5/10. [SRA] ... 5/3Tasked to [Assistant Patient Care Executive {APCE}] and [EDD] to f/u [follow up] with patient. [SRA] 5/5 Grievance letter sent 5/10 [SRA] ...". The "GL" indicated the issue resolution date was 5/8/23.

During an interview on 12/15/23 at 2:00, p.m. with Pt 29, Pt 29 stated she was " ... kicked out ..." by the physician and no CT or lab results were shared with her. Pt 29 stated the next day she was taken by ambulance to another facility, saw a nephrologist (a doctor specializing in kidneys) and was told she had a leak in her stomach and had fluid and blood removed. Pt 29 stated she never received a phone call or letter or heard from the facility after her complaint.

During a concurrent interview and record review on 12/18/23 at 3:43 p.m. with the Risk/Quality Manager (RQM) and the Risk Management Specialist (RMS) reviewed Pt 29's "CT results", dated 5/2/23. The RQM stated the CT results indicated, " ... There is fluid in the peritoneal cavity [space between the abdominal organs] ..."

During a concurrent interview and record review on 12/18/23 at 3:49 p.m. with the Risk/Quality Manager (RQM) and the Risk Management Specialist (RMS) reviewed the "GL". The RMS stated grievances were received by the Risk Management department via email or phone call and then the grievance was forwarded to the director of the involved department to address. The RMS stated sometimes the medical director for the unit completed a chart review. The RMS stated conversations with the complainant, investigations of the grievance, and any actions taken should be documented in the "GL". The RMS stated the conversations, investigation and actions were not documented in the "GL" for Pt 29's grievance. The RMS stated the physician peer review task should be in the "GL" for Pt 29 but is not. The RQM and RMS stated they were surprised to learn two of three logged grievance complainants stated they had no contact after grievance was filed.

During a review of the facility's policy titled, "Patient-Related Complaint and Grievance Management (CGM)", dated 1/27/23, the "CGM" indicated, " ... DEFINITIONS ... Licensed Independent Practitioner (LIP) - Any practitioner permitted by state law and by the organization to provide care and service, without direction or supervision ... Overview of the grievance process ... When a grievance is received regarding a licensed independent practitioner's or allied health practitioner's competence, conduct, or professionalism, the mater will be addressed through the peer review process ... Whenever a grievance involves issues that potentially expose the facility to legal risks, the facility's risk management department should be consulted at the outset ... responsible risk manager shall determine the best approach for confidentially investigating, resolving, and communicating with the patient or patient's legal representative. The investigation conducted by Risk Management should be documented ... TIME FRAMES ... Grievances are to be resolved within seven (7) days whenever possible ... GRIEVNACE RESOLUTION ... A grievance is considered resolved when the patient or patient's legal representative is satisfied with the actions taken on their behalf ... The facility must maintain documentation of its efforts and demonstrate compliance with this policy ..."

Based on interviews and record review, the facility failed to follow their policy on grievances when, the facility's written response to Patient (Pt) 28's mother (PM 28) was in English and not in a language Pt 28 or PM 28 understood and Pt 28 and PM 28 spoke and read in Spanish only.

This failure resulted in the hospital not upholding PM 28's right to a written response describing the resolution to the grievance in a language that PM 28 could understand.

Findings:

During a review of the facility's "Grievance Log (GL)", dated 1/1/23 to 12/15/23, the "GL" indicated on 3/1/23 Pt 28's parents filed a grievance regarding their son's care in the Emergency Department (ED). The "GL" indicated, " ... The parents were concerned because they did not feel the ED doctor took them seriously. They said their son was pale, had a fast heart rate and was complaining of abdominal pain. but the doctor didn't validate their concerns. The doctor was planning to send them home but [Pt 28] started having rectal bleeding at that time and was then given fluids and transferred to a higher level of care ... stated that if they hadn't spoken up for him he would have been discharged with a serious medical condition ... [Mother] would like a return call so that she knows that the appropriate people are aware of the situation ...".

During a review of Pt 28's "Face Sheet (FS, a document with important patient information)", dated 2/21/23, the "FS" indicated the Pt 28's spoken and written language were both Spanish.

During an interview on 12/15/23 at 1:42 p.m. with the mother of Pt 28 (PM 28), PM 28 stated she speaks and reads in Spanish only.

During a concurrent interview and record review on 12/18/23 at 3:45 p.m. with the Risk Management Specialist (RMS) Pt 28's "Grievance Resolution Letter (GRL)", dated 3/8/23, was reviewed. The RMS stated the letter was in English and should be in the language the patient or patient's representative can understand.

During a review of the facility's policy and procedure titled, "Patient-Related Complaint and Grievance Management (CGM)", dated 1/27/23, the "CGM" indicated, " ... Overview of the grievance process ... A written notice of the facility's determination regarding the grievance shall be communicated to the patient or patient's legal representative in a language and manner that the patient or patient's legal representative understands ..."

Based on interview and record review, the hospital failed to provide care in a safe setting for one of four laboring patients (Patient 1), when registered nurses (RNs) in the Labor & Delivery Unit did not accurately interpret and document fetal heart monitoring and did not recognize and act on Patient 1's high risk for shoulder dystocia.

These failures resulted in possible avoidable complications during the birth of the baby for Patient 1.

Findings:

During a review of Pt 1's clinical record, the record indicated Pt 1 was admitted by MD 1 to the hospital on 11/17/23 for an induction of labor at 39 weeks 2 days gestation. This was Patient 1's fifth pregnancy. Pt 1's obstetrician's orders and history and physical indicated Pt 1's labor was being induced due to "Fetal macrosomia (defined as a baby weighing more than 8 pounds, 13 ounces [4,000 grams], regardless of his or her gestational age) in third trimester, History of intrauterine fetal death (IUFD). Active problems include, gestational diabetes mellitus (GDM), Obesity with a Body Mass Index [BMI] of 43 [5 feet tall, weight was 220 pounds], elevated liver function tests, Beta strep positive." In addition to those pregnancy risk factors, review of Pt 1's record indicated this was a high risk pregnancy with advanced maternal age (AMA-35 years or older), a history seven years ago of a preterm delivery of a baby at 24 weeks gestation who survived with disabilities, a history of an IUFD at 24 weeks, and two other pregnancy losses at four weeks gestation. Pt 1 received prenatal care with MD 1 and also had several appointments with a perinatologist (doctors who specialize in high-risk pregnancies). Review an ultrasound done on 11/8/23 indicated an estimated fetal weight of 4206 grams and the abdominal circumference measured 393.3 mm (out of range).

Review of Pt 1's labor progress indicated, on 11/17/23 at 12 p.m. Pt 1's cervix was dilated 4 centimeters (cm; 10 cm is completely dilated) and was 100% effaced (effacement- thinning and shortening of the cervix), and a -3 station (The location of the baby's presenting part [head] is in relationship to the ischial spines of the pelvis [-3 station is 3 cm above the ischial spines]). Cervix posterior. At 9 p.m. Pt 1 was having occasional mild contractions and the FHR baseline was 130 bpm with variable decelerations. FHR interpretation Category II and RN cannot reach cervix or fetal presenting part in pelvis. Pitocin held. MD 2 examined Pt 1 on 11/18/23 at 12:10 a.m., cervix dilated to 4 cm, 60% effaced, and -3 station, cervical position posterior, Bishop score 5 of a possible 13 (Bishop score- method to rate the readiness of the cervix for induction of labor based on five pelvic exam findings. If the Bishop score is 8 or greater, the chances of having a vaginal delivery are good and the cervix is said to be favorable or "ripe" for induction).

Review of the fetal monitor strips on 11/18/23 indicated the presence of early and variable decelerations on and off throughout the day. An epidural was placed at 9:30 a.m. by an anesthesia provider, and at 1 p.m. MD 2 performed and artificial rupture of membranes. Fetal monitor strips reflect recurrent early decelerations. Pt 1 was completely dilated at 3 p.m. and the presenting part was at a 0 station, and Pt 1 began pushing. By 4:40 p.m. Pt 1 was exhausted and stopped pushing for 30 minutes and then resumed pushing. Continued variable decelerations, At 6:35 p.m. a vacuum was applied, and at 6:54 p.m. the baby's head was delivered, and a tight nuchal cord was reduced. Shoulder dystocia was identified, and nurses notes indicated at 6:54 p.m., "Shoulder dystocia nursing interventions performed-McRoberts, suprapubic pressure, position change, delivery team notified... Provider [MD 2] interventions-Episiotomy, internal rotation. delivery of posterior arm," and after failed attempts to deliver the body Pt 1 was taken to the operating room to attempt a C-section delivery. The record indicated the monitor strips reflecting the fetal heart rate ended at 7:02 p.m. when Pt 1 was taken to the OR, and the assessment of the FHR after that time is not reflected in the medical record. Efforts to deliver the baby by C/S were unsuccessful., The ED physician was able to deliver the baby vaginally at 7:18 p.m., 24 minutes after the delivery of the head. The baby had no signs of life at delivery and after two hours of attempted resuscitation the baby was pronounced dead. Pt 1 had suffered significant blood loss and also an episiotomy and fourth degree laceration, and after being stabilized Pt 1 was transferred to Hospital B for a higher level of care. The baby's death record indicated, "brain death due to anoxic brain injury due to shoulder dystocia." Pt 1's record indicated there was no documentation on 11/17/23 or 11/18/23 by MD 2. MD 1 arrived to the hospital at 7:52 p.m. and MD 3 arrived at 8: 18 p.m. (Obstetricians called by staff to help).

During an interview on 12/13/23 at 10 a.m. with emergency department physician (EDMD 1), EDMD 1 stated he was on duty in the emergency department on 11/18/23 and responded to a call for assistance in labor and delivery. Pt 1 was in the OR and the baby's head had been delivered vaginally, and Pt 1 also had an abdominal incision and the baby's legs were sticking out of that incision. EDMD 1 stated MD 2 apparently had attempted to deliver the baby by C-section, but the head was stuck, and MD 2 was unable to get the baby out that way either. EDMD 1 stated he put his hand in Pt 1's vagina and used his finger to grab the baby's arm and shoulder and was able to deliver the baby vaginally. EDMD 1 stated he and the RT were working on the baby who had no signs of life, and he also assisted MD 2 with Pt 1. who was bleeding. EDMD 1 stated MD 2 was tired. EDMD 1 stated after other doctors arrived to take over care of both patients, he had to return to the ED because he was the only physician on duty.

During an interview on 12/14/23 at 11:15 a.m. with the Director of Maternal-Child Services (DMCS), not do concurrent or retrospective fetal heart monitor strip review to assess consistency of interpretation and documentation as part of RN competency evaluation or annual evaluation of the RNs performance. The DMCS stated she did not review Pt 1's fetal monitor strips.

During a concurrent interview and record review on 12/14/23 at 1:20 p.m. with the OBE, the The OBE stated in 2023, simulation classes were held for the topics of postpartum hemorrhage, hypertensive disorders of pregnancy, vacuum assisted vaginal delivery, umbilical cord prolapse, shoulder dystocia and others. The OBE stated she also teaches fetal heart monitor interpretation, which is required for all obstetric nurses every two years. The OBE stated she is developing a competency for fetal heart monitoring interpretation, and stated that at this time there is no ongoing fetal monitor strip review (retrospective or concurrent) with the staff as a way to validate competency. The OBE stated that the nursing staff are not consistently compliant with their mandatory training including the simulation training provided this year for management of shoulder dystocia and vacuum delivery. She stated she had reported this to the director (DMCS), and it had been discussed in meetings, but does not know what is being done to correct this. The OBE estimated overall staff compliance with required training is "about 50-60%." The OBE provided copies of the spreadsheet record of staff compliance with attendance at the mandatory classes, annual skills fair, and fetal monitoring class completion. The report indicated for the fetal heart monitor class requirement 27% of the RNs were not compliant. The report indicated 59% of the nursing staff attended the mandatory shoulder dystocia/vacuum assisted delivery simulation training classes held in 2023.
Concerning Pt 1's delivery on 11/18/23, the OBE was asked about her review of Pt 1's labor and delivery and occurrence of shoulder dystocia and subsequent death of the baby. The OBE stated she was made aware of what had occurred but was not included in the RCA of this case, and was not allowed to review the record including the fetal monitor strips. Fetal monitor strips from different times in Patient 1's labor were reviewed with the OBE. On 11/18/23 between 8:25 a.m. and 8:43 a.m. the strip indicated minimal and moderate variability, no accelerations, recurrent early decelerations. Review of RN 1's notes indicated the presence of accelerations 15 x15 (an abrupt increase in FHR above baseline with onset to peak of the acceleration less than 30 seconds. Adequate accelerations are defined as greater than or equal to 15 bpm above baseline for greater than or equal to 15 seconds [15x15]), no decelerations and moderate variability. At 11 am the monitor strip indicated minimal variability, no accelerations, and variable decelerations. RN 1's notes indicated moderate variability, presence of accelerations 15x15 and variable decelerations. Between 3 p.m. and 4:20 p.m. there were multiple instances where the fetal monitor was not picking up the fetal heart rate well enough to make an assessment of the baseline rate or the characteristics of accelerations or decelerations. RN 1's notes reflect assessment of the characteristics of the FHR tracing despite the quality of the tracing. The OBE stated the documentation by the nurse doesn't reflect what is showing on the monitor strips.

During a concurrent interview and record review on 12/15/23 at 2:15 p.m. with the OB Educator (OBE), the OBE stated her review of the fetal heart monitor tracings for Pt 1 indicated staff are not always using the accepted, standardized language to describe the characteristics of the fetal heart rate, and there were instances where the nurses notes weren't consistent with what was reflected on the fetal monitor strip. The OBE stated there is not currently a system in place at the hospital for routine review of fetal monitor strips to assess the accuracy of the labor and delivery RN's interpretation as part of an ongoing competency assessment or to ensure the standardized language was being used. The OBE stated she planned to use monitor strips as part of her fetal monitoring class and that going forward regular chart review including fetal heart monitor strip review will be part of the ongoing competency assessment of each RN. The OBE provided a copy of the curriculum for the shoulder dystocia training class. The training materials indicated the risk factors for shoulder dystocia include, "Macrosomia 4000-4500 grams, preexisting maternal diabetes or gestational diabetes, maternal obesity [BMI greater than 30], protracted second stage of labor [pushing], maternal short stature, use of vacuum or forceps, previous delivery with shoulder dystocia." The OBE stated, "She [Pt 1] had almost all of them."

During an interview on 12/15/23 at 3 p.m. with the respiratory therapist (RT)1, RT 1 stated he was in the hospital on 11/18/23 visiting a family member when he was contacted by another RT about Pt 1's delivery complicated by shoulder dystocia.. RT 1 he went to the operating room to assist and after the baby was delivered with no signs of life, he along with the ED physician started resuscitation measures.. RT 1 stated a neonatologist from Hospital B arrived, participated in the resuscitation efforts and ultimately stopped the resuscitation after there were no signs of life despite lifesaving measures performed for two hours. RT 1 stated EDMD 1 was providing care to both the baby (Pt 2) and the mom (Pt 1), who was bleeding, until another obstetrician arrived. RT 1 stated MD 2 was visibly exhausted and appeared weak.

During an interview on 12/19/23 at 10:29 a.m. with the charge nurse (RN 14), RN 14 stated she was the charge nurse working at he time of the shoulder dystocia on 11/18/23. RN 14 stated that day they were short-staffed due to sick calls. RN 14 stated she wasn't aware of a problem until the head was out. RN 14 stated during Pt 1's labor, MD 2 "mentioned that she didn't like the variables [fetal heart rate variable decelerations] she was seeing." RN 14 stated MD 2 looked tired. RN 14 stated, stated MD 2 did not mention a c-section and, "When I asked [MD 2], what's your plan with this patient, she said I'm going to do a quick note, then I'm going to push with the patient." She pushed with the patient for 30-40 minutes. RN 14 stated she was in the room during the delivery after being told that a vacuum was going to be used. An RT was called for the delivery also. RN 14 stated after the head was delivered she heard MD 2 say, " We have a shoulder." RN 14 stated, "We didn't realize how big the baby was. The baby was big - 4200 grams (9.26 pounds)." RN 14 stated an ED physician responded and helped out. RN 14 stated "MD 2 was looking faint and I thought she was going to pass out. I had to act on that very quickly. I called [MD 1] but he didn't answer because other nurses were calling him, then I called MD 3 and he said it really should be MD 1, and then I called the Chief of OB." RN 14 stated she intervened on her own, MD 2 did not ask anyone to get help for her. RN 14 stated she has not reviewed the fetal monitor strips. RN 14 stated, "The patient was having variables. The doctor. noticed it, and I noticed it. There was a cord around the neck." RN 14 stated, "I've asked myself, if I should have questioned the use of the vacuum. But MD 2 was pushing for 40 minutes with the patient so she should have noticed if there was turtling effect [Turtle sign-after the fetal head is delivered, it retracts back tightly against the maternal perineum. A sign of shoulder dystocia]. Two physicians should have already established if the pelvis was big enough."

During a review of the professional reference, "American College of Obstetricians and Gynecologists, Practice Bulletin Number 178, Shoulder Dystocia," dated 5/17, the reference indicated, "...Obstetric simulation is an effective tool in preparing for shoulder dystocia because it is a high acuity/low frequency event...Evidence indicates that introduction of shoulder dystocia simulation and team training protocols at individual institutions may be associated with a reduction in transient brachial plexus injury when shoulder dystocia occurs. After the introduction of a mandatory clinical shoulder dystocia simulation for all personnel on a labor and delivery unit, the frequency of evidence-based management of shoulder dystocia was higher, and the rate of neonatal brachial injury at birth was lower.

During a review of the reference titled, "AHRQ Safety Program for Perinatal Care: Monitoring for Perinatal Safety-Electronic Fetal Monitoring, AHRQ Publication No. 17-0003-18-EF, dated 5/17, the reference indicated, "... Use of the standard National Institute for Child Health and Human Development [NICHD] nomenclature for communicating and documenting EFM findings provides a common language for use among providers and staff to decrease variation and provide accurate communication among caregivers. A complete description of an EFM tracing requires a qualitative and quantitative assessment of the following: uterine contractions, baseline FHR, baseline FHR variability, presence of FHR accelerations, periodic or nonperiodic FHR decelerations, and changes in trend over time...Key perinatal safety elements for EFM...Create a mechanism for identifying recurrent nonuse or deviation from the established unit policies or procedures by clinicians. EFM " strip rounds " refers to periodic, multidisciplinary review of actual EFM strips from past patients for the purposes of teaching and learning in a team environment. The emphasis of strip rounds is on practicing the use of standardized terminology for describing and communicating the findings from the strip. Strip rounds can be used to practice differentiating Category I, II, and III tracings, and discussion of the standard unit approach for responding to each category of tracing. Regular peer review with feedback for all staff (physicians, midwives, staff nurses) who use and interpret EFM is another strategy that can be used to support use of standard nomenclature. Last, nurse competency assessment and medical staff credentialing and privileging processes specific to EFM use may be another strategy for improving standardization of EFM interpretation and communication..."

During a review of the UpToDate article titled, "Shoulder dystocia: Risk factors and planning birth of high-risk pregnancies," dated 4/7/23, the article indicated,"...Clinicians should be aware of risk factors for shoulder dystocia, so they can discuss the possibility of scheduled cesarean birth with patients at highest risk of occurrence and appropriately manage a prolonged second stage of labor in less high-risk patients..."

During a review of internet article, "Shoulder Dystocia-StatPearls-NCBI Bookshelf," dated 1/23, the article indicated, "...Shoulder dystocia is, by definition, a mechanical problem occurring during a vaginal delivery characterized by one of the following parameters: failure to deliver the fetal shoulders using solely gentle downward traction, requirement of additional delivery maneuvers are needed to successfully deliver the baby, a documented head-to-body interval of greater than 1 minute...Several risk factors for shoulder dystocia have been identified. Fetal macrosomia is the most significant risk factor for shoulder dystocia. Other known risk factors include pregestational and gestational diabetes, prior history of shoulder dystocia, and operative vaginal delivery, particularly with the use of the vacuum..."

During a review of the professional reference, "AWHONN position statement: Fetal Heart Monitoring," dated 11/18, the reference indicated, "...The Association of Women ' s Health, Obstetric and Neonatal Nurses (AWHONN) maintains that the availability of registered nurses (RNs) and other health care professionals who are skilled in fetal heart monitoring (FHM) techniques, including auscultation and electronic fetal monitoring (EFM), is essential to maternal and fetal well-being during antepartum care, labor, and birth. Fetal heart monitoring requires advanced assessment and clinical judgment skills and should not be delegated to unlicensed assistive personnel or others who do not possess the appropriate licensure, education, and skills validation. Labor is dynamic; therefore, consideration of preferences and identification of risk factors should occur upon admission to the birth setting and should be ongoing throughout labor..."

During a review of the Journal of Maternal-Fetal and Neonatal Medicine, Volume 30, Issue 15, article titled, "Fetal macrosomia as a risk factor for shoulder dystocia during vacuum extraction," dated 5/16, the article reflected the results of a research study of macrosomic babies delivered by vacuum extraction over a 10 year period from 2003 to 2013. The study found, "The risk of shoulder dystocia [SD] was significantly higher in the study group. We found a significant association between SD and vacuum delivery...and the composite adverse neonatal outcome rate was 6.5% in the study group and 1.7% in the control group, respectively...".

During a review of the professional reference titled, "The American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin No. 173- Fetal Macrosomia," dated 11/16, the reference indicated, "... As birth weight increases, the likelihood of labor abnormalities, shoulder dystocia, birth trauma, and permanent injury to the neonate increases... Regardless of birth weight, infants of women with diabetes have an increased risk of shoulder dystocia, clavicular fracture, and brachial plexus injury...Pregnant women with suspected fetal macrosomia should be provided individualized counseling about the risks and benefits of vaginal and cesarean delivery based on the degree of macrosomia..."

During a review of American Journal of Obstetrics and Gynecology (AJOG) article titled, "Association between diabetes in pregnancy and risk of shoulder dystocia by infant birth weight," dated 1/22, the article indicated, "Diabetes in pregnancy is associated with an increased risk of shoulder dystocia, even at a lower birthweight threshold (4000-4500 grams) than currently recommended for cesarean delivery (>4500 grams)."

During a review of the Journal of Clinical Medicine Article titled Vacuum-Assisted Delivery Complication Rates Based on Ultrasound-Estimated Fetal Weight, dated 6/2022, the journal article indicated, a research study was conducted of women with singleton pregnancies at 34-41 weeks gestation, who underwent ultrasonographic pre-labor Estimated Fetal Weight (EFW) and Vacuum Assisted Delivery (VAD) over a six year period. The results of the study indicated, "... After controlling for all potential confounders, higher EFW (greater than or equal to 3700 g), maternal age, and diabetes were found to be independent risk-factors for adverse outcomes. EFW greater than or equal to 3700 grams based on ultrasound was a significant risk factor for shoulder dystocia and clavicular fracture..."

During a review of the Sage Journal Women's Health article titled, "Shoulder dystocia: prediction & management," dated 2/22/16, the article indicated,"... It is often assumed that shoulder dystocia is an unpredictable and, therefore, unpreventable complication but this fatalism is unwarranted. Although predicting with certainty that shoulder dystocia or BPI will occur in a particular case is rarely possible, our ability to identify cases in which shoulder problems are likely is improving and can help guide clinical decisions. Risk factors can be identified in the patient ' s history and during prenatal care and labor. Most prominent are a history of prior shoulder dystocia or brachial plexus injury, current fetal macrosomia, maternal obesity, diabetes mellitus, excessive weight gain and dysfunctional labor patterns, especially a long deceleration phase followed by a long second stage. Prediction of this complication is imperfect, but many cases can be avoided by taking multiple risk factors into account and delivering the highest risk cases by preemptive cesarean..."

During a review of the reference titled, "AHRQ Safety Program for Perinatal Care: Labor and Delivery Unit Safety- Shoulder Dystocia, AHRQ Publication No. 17-0003-21-EF," dated 5/17, the reference indicated, ..."Key Perinatal Safety Elements- Have situational awareness. Situational awareness refers to all staff caring for the patient...knowing what the patient's plan is through briefings and team management, being aware of what is going on and what is likely to happen next...In the context of shoulder dystocia, this includes risk awareness for all patients, timely recognition of a shoulder dystocia diagnosis, awareness and monitoring of time since diagnosis, and discussing next steps if sequential maneuvers are not successful..." key perinatal safety elements related to shoulder dystocia management. Simulation reinforces teamwork and communication related to situational awareness,, ability to get additional help quickly, use of cognitive aids, such as checklists, communication with rapid responders, communication with patient/family, and use of briefings, huddles, and debriefings. Shoulder dystocia simulation training focused on clinical/technical skills may require a mannequin or high-fidelity birthing simulator..."

Based on interview and record review, the hospital failed to maintain an effective, comprehensive, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program when the facility failed to analyze causes and implement preventive measures following the unexpected death of a newborn, Patient (Pt) 1. The internal investigation conducted by the hospital's Performance Improvement unit did not include all factors that contributed to the unexpected death of Pt 1. The actions implemented as a result of the incomplete internal investigation did not provide sufficient level of safety for newborns in the hospital and did not identify gaps in nursing competencies and training. (Refer to A 283 and A 286)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality patient care in a safe environment.

Based on observation, interview and record review, the hospital failed to set priorities for its performance improvement activities to include high-risk, high volume, or problem-prone areas when the Quality Improvement program did not collect and analyze data related to nursing quality of care in the Perinatal Department, the hospital ' s busiest unit by patient volume.

These failures resulted in the hospital not auditing the charts for women in labor to validate professional nursing practice, and had the potential to result in harm to patients in labor if changes in fetal heart rates go unnoticed. (cross-reference A-397)

Findings:

A review of the clinical record indicated Pt 1 was admitted to Labor and Delivery on 11/17/23 at 39 weeks and 2 days gestation for an induction of labor with Pitocin for "fetal macrosomia in third trimester, history of intrauterine fetal death." The record indicated Pt 1 was 35 years old (Advanced Maternal Age- [AMA], age 35 or older) had gestational diabetes and obesity with a body mass index of 43, and an ultrasound on 11/8/23 indicated an estimated fetal weight of 4206 grams (9.27 pounds) and an abdominal circumference of 393.3 mm (out of range). Continuous fetal monitoring was initiated. At 12 p.m. on 11/17/23, an exam indicated Pt 1's cervix was dilated to 4 centimeters (cm), 100% effaced and -3 station and was having occasional contractions. On 11/18/23 at 1 p.m., MD 2 performed an artificial rupture of membranes, and at 3 p.m. Pt 1 was completely dilated and began pushing. By 4:40 p.m. Pt 1 was exhausted and stopped pushing for 30 minutes and then resumed pushing. At 6:35 p.m. a vacuum was applied, and at 6:54 p.m. the baby's head was delivered, and a tight nuchal cord was reduced. Shoulder dystocia was identified, and after failed attempts to deliver the body, Pt 1 was taken to the operating room to attempt a C-section delivery which was unsuccessful. The ED physician was able to deliver the body vaginally at 7:18 p.m., 24 minutes after the delivery of the head. The baby had no signs of life at delivery and after two hours of attempted resuscitation the baby was pronounced dead. Pt 1 suffered significant blood loss and after being stabilized Pt 1 was transferred to Hospital B for a higher level of care. The baby's death record indicated, "brain death due to anoxic brain injury due to shoulder dystocia." Pt 1's record indicated there was no documentation on 11/17/23 or 11/18/23 by MD 2.

During an interview on 12/14/23 at 11:15 a.m. with the Director of Maternal-Child Services (DMCS), the DMCS stated she does not routinely audit nursing documentation to assess the quality of documentation or quality of care. The DMCS stated she does not do concurrent or retrospective fetal heart monitor strip review to assess consistency of interpretation and documentation as part of RN competency evaluation or annual evaluation of the RNs performance. The DMCS stated she did not review Pt 1's fetal monitor strips.

During an interview on 12/15/23 at 9:30 a.m. with the APCE, the APCE stated they are not doing routine chart reviews or fetal monitor strip reviews as part of their performance improvement activities for obstetrics.
During a concurrent interview and record review on 12/15/23 at 2:15 p.m. with the OB Educator (OBE), the OBE stated her review of the fetal heart monitor tracings for Pt 1 indicated staff are not always using the accepted, standardized language to describe the characteristics of the fetal heart rate, and there were instances where the nurses notes weren't consistent with what was reflected on the fetal monitor strip. The OBE stated there is not currently a system in place at the hospital for routine review of fetal monitor strips to assess the accuracy of the labor and delivery RN's interpretation as part of an ongoing competency assessment or to ensure the standardized language was being used. The OBE stated she planned to use monitor strips as part of her fetal monitoring class and that going forward regular chart review including fetal heart monitor strip review will be part of the ongoing competency assessment of each RN.

During a review of hospital document titled, " Policy: QAPI Plan " last revision date 5/25/2023, the document indicated, " ...Policy Summary/Intent: In support of the Organization's mission and vision, the purpose of Organizational Quality Assessment and Performance Improvement (QAPI) plan is to ensure that the Governing Body, Medical Staff, clinical and professional services staff deliver safe, effective and optimal patient care and assure a safe environment for patients, visitors and the workforce ...6. Performance Improvement Projects: a. The QC [Quality Committee] shall oversee performance improvement projects (performance improvement teams, focused studies,) the number and scope of which shall be proportional to the scope and complexity of the hospital ' s services and operations. The QC must also ensure there is documentation of what quality improvement projects are being the rationale behind conducting those projects, and the measurable progress achieved as evidenced on the projects. 7. Follow-up: a. The QC shall assure that steps taken to improve performance and enhance safety are appropriately implemented, measured, and tracked to determine that the steps have achieved and sustained the intended effect. 1. The FOCUS Plan, Do, Check Act (FOCUS PDCA) methodology is utilized to plan, design, measure, assess and improve functions and processes related to patient care and safety throughout the organization. "
During a concurrent interview and record review on 12/18/23 at 1:35 p.m. with RN 15, RN 15 explained the two Performance Improvement Projects that the Perinatal Department was working on. The first document, titled " Performance Improvement Report Form ...Project: Appointment Scheduling Improvement " dated 6/12/23 indicated the department was working on improving the patient scheduling process. The report did not include evidence of the FOCUS PDCA methodology. The second document, titled " Performance Improvement Report Form ...Project: Improve Outpatient Report Handoff " dated 9/13/22 indicated the department was working on improving the consistency of communication between nurses and physicians. The report did not include evidence of the FOCUS PDCA methodology, and there were no results described on the document to indicate that communication has improved.

During an interview on 12/19/23 at 9:10 a.m. in the Birthing Center with Obstetrics Educator (OBE) and the Director of OB, nursing staff were asked if they had been involved in any performance improvement projects on their unit. Monitor Technician 1 stated she had not been involved in any performance improvement projects related to quality of care and could not state any projects that were in progress. RN 14 stated she had never been involved with any projects and was not aware of projects that were in progress.

A professional reference from the National Institute of Health retrieved from indicated, " ... Implementation of standardized practices in the delivery room fosters a safe environment to ensure that newborn infants are cared for optimally, whether or not they require extensive resuscitation. Quality improvement (QI) is an excellent methodology for implementation of standardized practices due to the multidisciplinary nature of the delivery room, the complexity of the tasks involved, and opportunities to track measurable processes and outcomes ... "


During a review of the reference titled, "AHRQ Safety Program for Perinatal Care: Monitoring for Perinatal Safety-Electronic Fetal Monitoring, AHRQ Publication No. 17-0003-18-EF, dated 5/17, the reference indicated, "... Use of the standard National Institute for Child Health and Human Development [NICHD] nomenclature for communicating and documenting EFM findings provides a common language for use among providers and staff to decrease variation and provide accurate communication among caregivers. A complete description of an EFM tracing requires a qualitative and quantitative assessment of the following: uterine contractions, baseline FHR, baseline FHR variability, presence of FHR accelerations, periodic or nonperiodic FHR decelerations, and changes in trend over time...Key perinatal safety elements for EFM...Create a mechanism for identifying recurrent nonuse or deviation from the established unit policies or procedures by clinicians. EFM " strip rounds " refers to periodic, multidisciplinary review of actual EFM strips from past patients for the purposes of teaching and learning in a team environment. The emphasis of strip rounds is on practicing the use of standardized terminology for describing and communicating the findings from the strip. Strip rounds can be used to practice differentiating Category I, II, and III tracings, and discussion of the standard unit approach for responding to each category of tracing. Regular peer review with feedback for all staff (physicians, midwives, staff nurses) who use and interpret EFM is another strategy that can be used to support use of standard nomenclature. Last, nurse competency assessment and medical staff credentialing and privileging processes specific to EFM use may be another strategy for improving standardization of EFM interpretation and communication..."

During a review of the World Health Organization's (WHO) document titled "STANDARDS FOR IMPROVING QUALITY OF MATERNAL AND NEWBORN CARE IN HEALTH FACILITIES," dated 2016, the document outlined a framework for improving the quality of care for mothers and newborns around the time of childbirth. The document identified standards and quality statements to define the priorities for quality improvement. The document indicated, "Quality Statement 2.1: Every woman and newborn has a complete, accurate, standardized medical record during labor, childbirth and the early postnatal period. Complete, accurate medical recording during labor is important for documenting care, clinical follow-up, accurate hand-over, early detection of complications and health outcomes and provides information for identifying areas for improvement...2.2: Every health facility has a mechanism for data collection, analysis and feedback as part of its activities for monitoring and improving performance around the time of childbirth The purpose of data collection is to provide information that can be analyzed and used appropriately to provide feedback and improve health outcomes..."

Based on interview and record review, the facility failed to thoroughly analyze one of one adverse patient event (an event, preventable or nonpreventable, that caused harm to a patient) when the hospital's internal investigation (root cause analysis (RCA) - process of discovering the root causes of problems in order to identify appropriate solutions) did not identify gaps in nursing competencies and training.

This failure interfered with the thorough investigation into the root causes and contributing factors of Patient (Pt) 1's events that occurred during hospitalization, delayed implementation of the action plan to prevent recurrence, and had potential harm to laboring mothers and their infants. (cross-reference tag - A397).

Findings:

A review of the clinical record indicated Pt 1 was admitted to Labor and Delivery on 11/17/23 at 39 weeks and 2 days gestation for an induction of labor with Pitocin for "fetal macrosomia in third trimester, history of intrauterine fetal death." The record indicated Pt 1 was 35 years old (Advanced Maternal Age- [AMA], age 35 or older) had gestational diabetes and obesity with a body mass index of 43, and an ultrasound on 11/8/23 indicated an estimated fetal weight of 4206 grams (9.27 pounds) and an abdominal circumference of 393.3 mm (out of range). Continuous fetal monitoring was initiated. At 12 p.m. on 11/17/23, an exam indicated Pt 1's cervix was dilated to 4 centimeters (cm), 100% effaced and -3 station and was having occasional contractions. 11/18/23 at 1 p.m. Pt 1 was dilated to 8 cm, 90% effaced and -1 station and MD 2 performed and artificial rupture of membranes. Pt 1 was completely dilated at 3 p.m. and the presenting part was at a 0 station, and Pt 1 began pushing. By 4:40 p.m. Pt 1 was exhausted and requested to stop pushing. After a 30 minute break, exam indicated a +1 station and Pt 1 resumed pushing. Continued to push and at 6:35 p.m. Pt 1 agreed to the use of a vacuum. At 6:54 p.m. the baby's head was delivered with the vacuum and soon after shoulder dystocia (delivery of head followed by failure to deliver the fetal shoulders using solely gentle downward traction, requirement of additional delivery maneuvers, a documented head-to-body interval of greater than 1 minute) was identified. After failed attempts to deliver the body, Pt 1 was taken to the operating room to attempt C/S delivery which was unsuccessful. An ED physician was able to deliver the body vaginally at 7:18 p.m., 24 minutes after the delivery of the head. The baby had no signs of life at delivery and after two hours of attempted resuscitation the baby was pronounced dead. Pt 1 suffered significant blood loss and after being stabilized Pt 1 was transferred to Hospital B for a higher level of care. The record indicated there was no documentation on 11/17/23 or 11/18/23 by MD 2.

During a concurrent interview and record review on 12/14/23 at 2 p.m. with the Risk Management Specialist (RMS), the RMS showed a printed document which she stated was the Root Cause Analysis (RCA) for the investigation of the index case (Patients 1 and 2 [baby of Patient 1]). The RMS stated the RCA occurred on 11/28/23 at 1 p.m., and she attended the meeting. The document showed a timeline of events starting when Pt 1 first arrived in the birthing center and ended with the deceased newborn. The pages of the document titled " Barriers " and " Conclusions " were blank. There was no evidence of any attempt to determine if the difficult delivery should have been anticipated or if anything could have been done differently while Pt 1 was in labor that might have saved the baby ' s life. The RMS stated the document was the entire RCA and could not state any conclusions that were reached.

During an interview on 12/12/23 at 11 a.m. with the DMCS, Patient (Pt) 1 delivery on 11/18/23 was discussed. The DMCS stated Pt 1 had risk factors for shoulder dystocia since the baby had suspected macrosomia, Pt 1 was diabetic, and was obese. Pt 1 pushed for hours, was exhausted and a vacuum was used. The DMCS stated she had reviewed the record and participated in an RCA of this incident. The DMCS was asked if there was discussion with Pt 1 and/or with MD 2 about a C/S delivery at any time during Pt 1's labor or during the hours of pushing when Pt 1 was exhausted, and the DMCS stated no. The DMCS stated she did not identify anything during the RCA that she thought could have been done differently.

During an interview on 12/14/23 at 1:20 p.m. with the Obstetrics Educator (OBE), the OBE was asked about her review of Pt 1's labor and delivery and occurrence of shoulder dystocia and subsequent death of the baby. The OBE stated she was made aware of what had occurred but was not included in the RCA of this case, and was not allowed to review the record including the fetal monitor strips. She stated she asked to review the record, but the DMCS told her she could not. The OBE stated she did not know the director's reasons for not allowing her to review the record, but that "when your director tells you no" then you don't review it. The OBE stated as the OB educator and instructor of the fetal monitoring classes it is valuable for her to review the record of a serious event including the fetal monitor strips. The OBE stated in 2023 they had a mandatory simulation training class on shoulder dystocia and vacuum assisted delivery, but that there were many staff who had not attended either session. The OBE stated approximately 60% of the nursing staff attended this mandatory training.

During an interview on 12/19/23 at 10:29 a.m. with RN 14, RN 14 stated she was the Charge Nurse on the day of the incident, " I remember that we were short staffed. We had 2 sick calls that day. " She was asked to attend the RCA on 11/28/23. RN 14 stated the RCA was a review of the timeline of events, and they did not determine what the cause of the baby ' s death was. RN 14 stated the people leading the RCA "asked if we had done all of the maneuvers, which we had," and asked if a c-section was considered and if the use of the vacuum was appropriate. They mentioned the simulation training classes, and if they (the nurses) hadn ' t attended what does the Director do. RN 14 stated the irregularities in the fetal monitoring strips weren ' t discussed in the RCA, and they didn ' t review the fetal monitoring strips during the RCA. CN 1 stated, "The patient was having variables [variable heart rate decelerations]. The doctor noticed it, and I noticed it. There was a cord around the neck."

During a concurrent interview and record review on 12/15/23 8:34 a.m. with the APCE, the RQM and the RMS, the RQM presented a document which they stated was developed 12/14/23 in the evening. The document was an action plan to address the need for additional training for nurses in the Labor and Delivery department. The APCE stated this is a new action plan, and it was not created prior to the arrival of the survey team.

The Centers for Medicare & Medicaid Services (CMS) Center for Clinical Standards and Quality/Quality, Safety & Oversight Group Ref: QSO-23-09-Hospital indicated, " ... A hospital with a well-designed and well-maintained QAPI program, fully engaged in hospital-wide continuous assessment and improvement efforts can significantly enhance its ability to provide high quality and safe care to its patients, and thereby reduce the incidence of medical errors and adverse events throughout the hospital ... "

During a review of the reference titled, "AHRQ Safety Program for Perinatal Care: Monitoring for Perinatal Safety-Electronic Fetal Monitoring, AHRQ Publication No. 17-0003-18-EF", dated 5/17, the reference indicated, ..."Key Safety Element- Learn from Defects: Debrief and analyze near misses and adverse events, and the contribution of Electronic Fetal Monitoring [EFM] use, EFM interpretation, and communication of EFM findings. This allows for understanding of what went well, what could have gone better, and what could be done differently next time. Have a process in place to review severe maternal or neonatal morbidity or mortality events. Share the outcomes and process improvements from the debriefings and from formal analysis with the staff to achieve transparency and enhance organizational learning..."


During a review of the reference titled, "AHRQ Safety Program for Perinatal Care: Labor and Delivery Unit Safety- Shoulder Dystocia, AHRQ Publication No. 17-0003-21-EF," dated 5/17, the reference indicated, ..."Key Perinatal Safety Elements- Debrief and analyze near misses and adverse events related to shoulder dystocia...Share outcomes or process improvements from the informal (debriefing) and formal analysis with staff...Have situational awareness. Situational awareness refers to all staff caring for the patient...knowing what the patient ' s plan is through briefings and team management, being aware of what is going on and what is likely to happen next...In the context of shoulder dystocia, this includes risk awareness for all patients, timely recognition of a shoulder dystocia diagnosis, awareness and monitoring of time since diagnosis, and discussing next steps if sequential maneuvers are not successful..."

Based on observation, interview and record review, the hospital failed to ensure the safe provision of nursing services when the hospital failed to ensure registered nurses were competent to provide care to meet the patients' needs when Labor and delivery (L&D) staff did not have current competencies in fetal heart rate interpretation, mandatory simulation training classes for obstetrical emergencies, annual skills fair, and no training or competency on how to complete physical examination and determination of the presence of labor for patients. (Refer to A397)

The cumulative effect of these deficient practices resulted in the hospital's inability to ensure the provision of safe nursing care.

Based on observation, interview and record review, the hospital failed to ensure registered nurses were competent to provide care to meet the patients' needs when:
Labor and delivery (L&D) staff did not have evidence of current competency in fetal heart rate interpretation, L&D staff did not participate in mandatory simulation training classes for obstetrical emergencies and annual skills fair, and RN staff were performing a physical examination and determination of the presence of labor for patients coming to labor and delivery seeking care without having training or validation of competency.

These failures resulted in RNs not accurately interpreting and documenting the fetal heart rate monitoring during Patient 1's labor and delivery, and potentially not being prepared to recognize Pt 1's risk factors for shoulder dystocia in order to escalate concerns to the physician. These failures also placed all laboring patients at risk for potential harm if nursing staff are not prepared to respond appropriately to shoulder dystocia and other obstetric emergencies.
Findings:
During a concurrent observation and interview on 12/12/23 at 10:30 a.m. with the Director of Maternal-Child Services (DMCS), the labor and delivery, postpartum, and newborn units were observed. The DMCS stated the current staffing for the labor and delivery unit was a "lead" registered nurse (RN) plus three additional RNs. The DMCS stated their core (minimum) staffing was a lead RN plus two other RNs and then they add more RNs depending on the census and acuity. The DMCS stated all of the RNs are required to have Basic Life Support (BLS-Cardiopulmonary Resuscitation [CPR]), Advanced Cardiovascular Life Support (ACLS- builds on BLS, includes early recognition and management of resp and cardiac arrest, airway and medication management), Neonatal Resuscitation Program (NRP-evidence-based approach to the evaluation and resuscitation of newborns at birth), Intermediate or Advanced Fetal Monitoring, Annual Skills Fair, and simulation classes scheduled at different times during the year for OB emergencies including umbilical cord prolapse, maternal hemorrhage, hypertensive disorders of pregnancy, shoulder dystocia and vacuum assist. The DMCS stated they have an OB Educator (OBE) who coordinates the classes. The DMCS stated the labor and delivery RNs do perform an examination and evaluation of patients who come to L&D to be assessed for labor, and before discharging the patient the RN is required to call the physician. A list of RNs who were determined to be competent to perform an examination and evaluation of pregnant patients for the presence of labor and/or other pregnancy related issues and have been approved to do so as identified in the medical staff bylaws was requested of the Risk/Quality Manager (RQM) as well as the policy, competency, and standardized procedure guiding the examination and evaluation process. The hospital was not able to provide evidence of training or competency validation for the RNs.


During an interview on 12/12/23 at 11 a.m. with the DMCS, Patient (Pt) 1's delivery on 11/18/23 was discussed. The DMCS stated she was called by the nursing staff and came in after Pt 1 was already in the operating room. The DMCS stated Pt 1 was admitted at 39 weeks and 2 days gestation for induction of labor (stimulation of uterine contractions before the onset of labor) on 11/17/23 due to possible fetal macrosomia (baby weighing more than 8 pounds, 13 ounces [4,000 grams], regardless of his or her gestational age), and previous pregnancy losses. The DMCS stated this was Pt 1's fifth pregnancy and Pt 1 had three previous pregnancy losses at an early gestational age. The DMCS stated Pt 1 had one living child with disabilities who was born prematurely at 24 weeks gestation and is now seven years old. The DMCS stated Pt 1 had risk factors for shoulder dystocia (delivery of head followed by failure to deliver the fetal shoulders using solely gentle downward traction, requirement of additional delivery maneuvers, a documented head-to-body interval of greater than 1 minute) since the baby had suspected macrosomia, Pt 1 was diabetic, and was obese. Pt 1 pushed for hours, was exhausted and the pushing was not effective. The DMCS stated a vacuum was used, with one pop-off (the vacuum cup becomes disengaged) and with the vacuum assist the head was delivered. The DMCS stated after the head was out the body was stuck and a shoulder dystocia was identified. The DMCS stated the staff tried "all of the maneuvers" to get the baby delivered but they were unsuccessful, so Pt 1 was taken to the OR to do an emergency cesarean section (C/S). The DMCS stated Pt 1 had an extensive episiotomy to the rectum also. The DMCS stated they were not able to deliver the baby by C/S, but the ED physician who responded to the call for assistance was able to deliver the baby vaginally. The DMCS stated there was more than 20 minutes from the delivery of the head until the delivery of the body and the baby had no signs of life, but resuscitation was attempted but the baby did not respond. The DMCS stated she had reviewed the record and participated in a root cause analysis (RCA) of this incident. The DMCS was asked if there was discussion with Pt 1 and/or with MD 2 of having a C/S delivery at any time during Pt 1's labor or during the hours of pushing when Pt 1 was exhausted, and the DMCS stated no. The DMCS stated she did not identify anything during the RCA that she thought they could have done differently. The DMCS stated the RN (RN 1) who took care of Pt 1 on 11/18/23 was on vacation and would not be available for interview, and the lead RN (RN 13) working on 11/18/23 had just left work due to a personal issue and would be off for several days.

During a review of Pt 1's medical record, the record indicated the following: On 11/17/23 at 6:10 a.m., Pt 1 came to the hospital for an induction of labor. Pt 1 was 35 years old (Advanced Maternal Age) and was spanish-speaking. The baseline Fetal Heart Rate (FHR) was 115 beats per minute (bpm), moderate variability, contractions every 2-3 minutes. At 12 p.m. a vaginal exam indicated Pt 1's cervix was dilated to 4 centimeters (cm- 10 cm is completely dilated) and was 100% effaced (effacement- thinning and shortening of the cervix), and a -3 station (Where the baby's presenting part [head] is located in relationship to the ischial spines of the pelvis [-3 station is 3 cm above the ischial spines]). Cervix posterior. Membranes intact. At 12:20 p.m. MD 1 ordered admission for induction of labor at 39 weeks 2 days gestation for "history of fetal demise and possible macrosomia." Review of MD 1's admission history and physical (H&P) indicated, "Assessment/plan: "Fetal macrosomia in third trimester. Hx of intrauterine fetal death. Active problems include: gestational diabetes mellitus (GDM), Obesity with a Body Mass Index [BMI] of 43 [5 feet tall, weight was 220 pounds], elevated liver function tests, Beta strep positive." MD 1 orders included Pitocin induction, blood glucose every 4 hours. Review of nurses notes dated 11/17/23 at 8:30 p.m., indicated RN 2 performed a vaginal exam and was unable to reach the cervix and could not feel the presenting part in the pelvis. At 9 p.m. Pt 1 was having occasional mild contractions and the FHR baseline was 130 bpm with variable decelerations. FHR interpretation Category II. MD 2 notified that RN cannot reach cervix or fetal presenting part in pelvis. Pitocin held. MD 2 examined Pt 1 on 11/18/23 at 12:10 a.m., cervix dilated to 4 cm, 60% effaced, and -3 station, cervical position posterior, Bishop score 5 of a possible 13 (Bishop score- method to rate the readiness of the cervix for induction of labor based on five pelvic exam findings. If the Bishop score is 8 or greater, the chances of having a vaginal delivery are good and the cervix is said to be favorable or "ripe" for induction. If the Bishop score is 6 or less the chances of having a vaginal delivery are low and the cervix is said to be unfavorable or "unripe" for induction.) 11/18/23 9:25- Epidural initiated by the anesthesia provider for pain relief and at 1 p.m. vaginal exam indicated Pt 1's cervix was dilated to 8 cm, 90% effaced, and -1 station. Artificial rupture of membranes (AROM) by MD 2, clear fluid noted. Fetal monitor strips reflect recurrent early decelerations. 11/18/23 3 p.m. Pt 1 completely dilated, 100% effaced, and at a 0 station (presenting part is at the level of the ischial spines of the pelvis). Started pushing. By 4:40 p.m. Pt 1 was exhausted and asked for a break from pushing. A 30 minute break was given, and the pushing resumed at 5:10 p.m. Exam indicated +1 station. Fetal monitor strip at 5 p.m. indicated baseline fetal heart rate of 160 bpm, with recurrent decelerations. At 6 p.m. MD 2 in room pushing with Pt 1. At 6:25 p.m. Pt 1 agreed to use of a vacuum. At 6:35 the vacuum was applied with a pop-off at 6:38. Vacuum reapplied. At 6:54 p.m. vacuum assisted delivery of the baby's head occurred and there was a tight nuchal cord (the umbilical cord becomes wrapped around the fetal neck 360 degrees). Shoulder dystocia identified immediately by MD 2. Nurses notes indicated shoulder dystocia nursing interventions performed were McRoberts, suprapubic pressure, position change. Nurses notes indicated Provider interventions by MD 2 were episiotomy, internal rotation. delivery of posterior arm. Other physicians called by staff to help. Efforts to deliver baby vaginally were unsuccessful and at 7 p.m. Pt 1 was taken to the operating room to attempt delivery by emergency C/S. The record indicated recording of the FHR stopped at 7:02 p.m. when Pt 1 was taken to the OR, and the assessment of the FHR after that time is not reflected in the medical record. Efforts to deliver the baby by C/S were unsuccessful. The ED physician who responded to the call for assistance was able to deliver the baby vaginally at 7:18 p.m. (24 minutes after the head was delivered). Apgar scores 0/0/0 at 1, 5, and 10 minutes of life. (Apgar score-assessment of color, heart rate, reflexes, muscle tone, respiration, each of which is given a score of 0, 1, or 2. Assessed at 1 minute and 5 minutes after birth for all infants, and at 5-minute intervals thereafter until 20 minutes for infants with a score less than 7). After attempts to resuscitate the baby for two hours were unsuccessful the baby was pronounced dead. Pt 1 experienced significant blood loss and after receiving ten units of blood and other blood products, she was transferred to Hospital B for a higher level of care. The baby's death record indicated, "brain death due to anoxic brain injury due to shoulder dystocia." A review of the physician notes for 11/17/23 and 11/18/23 indicated there was no documentation by MD 2.


Review of Pt 1's prenatal ultrasound reports indicated on 11/8/23, Pt 1 had an ultrasound to assess fetal size. The report indicated the baby's estimated weight was 4206 grams, and the abdominal circumference of the baby measured 393.3 mm (out of range).

During an interview on 12/13/23 at 10 a.m. with emergency department physician (EDMD 1), EDMD 1 stated he was on duty in the emergency department on 11/18/23. EDMD 1 stated he is the only physician on during the shift and responded to the overhead call for assistance in labor and delivery. EDMD 1 stated he took a couple of ED nurses with him. EDMD 1 stated when he arrived in labor and delivery Pt 1 was in the OR and the baby's head had been delivered vaginally, and Pt 1 also had an abdominal incision and the baby's legs were sticking out of that incision. EDMD 1 stated there was "blood everywhere." EDMD 1 stated Pt 1 was asleep, and the anesthesia provider was there. EDMD 1 stated MD 2 apparently had attempted to deliver the baby by C-section, but the head was stuck, and MD 2 was unable to get the baby out that way either. EDMD 1 stated he put his hand in Pt 1's vagina and used his finger to grab the baby's arm and shoulder and was able to deliver the baby vaginally. EDMD 1 stated the baby was limp and had no signs of life, and he immediately took the baby to the warmer where the respiratory therapist (RT) was. EDMD 1 stated he and the RT began resuscitation measures and the resuscitation went on for a long time. EDMD 1 stated he also assisted MD 2 with Pt 1. who was bleeding. EDMD 1 stated MD 2 was tired. EDMD 1 stated after other doctors arrived to take over care of both patients, he had to return to the ED because he was the only physician on duty.


During an interview on 12/14/23 at 11:15 a.m. with the DMCS, the DMCS stated she had reviewed the record and that her opinion is "everything was fine until it wasn't." She stated she had not reviewed the fetal monitor strips, just the nurses notes which reflected the RNs interpretation of the fetal heart rate, documented at intervals during Pt 1's labor. The DMCS stated she does not do fetal heart rate monitor strip review as part of her annual evaluation of the RNs performance. The DMCS stated there was nothing in the record indicating a C/S had been considered or discussed during Pt 1's labor or prolonged second stage (Second stage- the period from complete dilation of the cervix [10 cm] until delivery of the baby) which lasted longer than 4 hours (prolonged- defined as more than 2 hours without or 3 hours with epidural analgesia in nulliparous women [women who have not had a previous birth], and 1 hour without, or 2 hours with epidural in women with at least one previous birth). As far as staffing on 11/18/23, the DMCS stated on 11/18/23 there were three RN sick calls which left a lead RN and two other RNs for the labor and delivery unit. The DMCS stated the staffing ended up being "ok; kind of," and that no one called her during the day to indicate the day was unmanageable. The DMCS stated on 11/17/23 there were also staffing issues which caused a delay in starting Pt 1's labor induction.


During a concurrent interview and record review on 12/14/23 at 1:20 p.m. with the OBE, the OBE stated she has worked for the hospital system for twenty-one years and since 6/22 she has been in the role of educator for the maternal child units. The OBE stated part of her responsibilities included coordinating and teaching an annual skills fair, organizing, and teaching simulation classes for different obstetric emergencies and other content. In 2023, simulation classes were held for the topics of postpartum hemorrhage, hypertensive disorders of pregnancy, vacuum assisted vaginal delivery, umbilical cord prolapse, shoulder dystocia and others. The OBE stated she also teaches intermediate fetal heart monitor interpretation, which is required for all obstetric nurses, and in April 2024 she will also start teaching advanced fetal monitoring classes, which is not required to be taken but is strongly recommended. The OBE stated RNs are required to take fetal monitoring classes every two years. The OBE stated she is developing a competency for fetal heart rate monitoring interpretation, and stated that at this time there is no ongoing fetal monitor strip review (retrospective or concurrent) with the staff as a way to validate competency. The OBE stated that the nursing staff are not consistently compliant with their mandatory training including the training provided this year for management of shoulder dystocia. She stated she reports this to the director (DMCS), and it has been discussed in meetings, but does not know what is being done to correct this. The OBE estimated staff compliance with required training is "about 50-60%." The OBE provided copies of the curriculum for the OB simulation training classes held during the year as well as the spreadsheet record of staff compliance with attendance at the mandatory classes, annual skills fair, and fetal monitoring class completion. Concerning Pt 1's delivery on 11/18/23, the OBE was asked about her review of Pt 1's labor and delivery and occurrence of shoulder dystocia and subsequent death of the baby. The OBE stated she was made aware of what had occurred but was not included in the RCA of this case, and was not allowed to review the record including the fetal monitor strips. She stated she asked to review the record, but the DMCS told her she could not. The OBE stated she did not know the director's reasons for not allowing her to review the record, but that "when your director tells you no" then you don't review it. The OBE stated as the OB educator and instructor of the fetal monitoring classes it is valuable for her to review the record including the fetal monitor strips. Fetal monitor strips from different times in Patient 1's labor were reviewed with the OBE. On 11/18/23 between 8:25 a.m. and 8:43 a.m. the strip indicated minimal and moderate variability, no accelerations, recurrent early decelerations. Review of RN 1's notes indicated the presence of accelerations 15 x15 (an abrupt increase in FHR above baseline with onset to peak of the acceleration less than 30 seconds. Adequate accelerations are defined as greater than or equal to 15 bpm above baseline for greater than or equal to 15 seconds [15x15]), no decelerations and moderate variability. At 11 am the monitor strip indicated minimal variability, no accelerations, and variable decelerations. RN 1's notes indicated moderate variability, presence of accelerations 15x15 and variable decelerations. Between 3 p.m. and 4:20 p.m. there were multiple instances where the fetal monitor was not picking up the fetal heart rate well enough to make an assessment of the baseline rate or the characteristics of accelerations or decelerations. RN 1's notes reflect assessment of the characteristics of the FHR tracing despite the quality of the tracing. The OBE stated the documentation by the nurse doesn't reflect what is showing on the monitor strips.

During a review of the content outline of the class on shoulder dystocia provided by the OBE, the outline indicated the risk factors for shoulder dystocia include, "Macrosomia 4000-4500 grams, preexisting maternal diabetes or gestational diabetes, maternal obesity [BMI greater than 30], protracted second stage of labor [pushing], maternal short stature, use of vacuum or forceps, previous delivery with shoulder dystocia."

During a review of the spreadsheet document provided by the OBE listing staff compliance with fetal heart monitoring education and training, the spreadsheet indicated the hospital was unable to provide evidence that eleven of the forty-one RNs (27%) who were required to take intermediate or advanced fetal monitoring classes every two years, had done so. The classes were held on four different dates in 2023, with additional classes available if needed.
During a review of the spreadsheet provided by the OBE listing nursing staff compliance with attendance at mandatory simulation classes and annual skills fair conducted during 2023, the spreadsheet indicated the topic, dates of classes, and staff attendance by name: Postpartum Hemorrhage on 2/22/23 and 2/23/2023, 65% compliance (16 of 41 did not attend); Annual Skill Fair 5/4/23, 67% compliance (21 of 64 did not attend); Hypertensive Disorders of Pregnancy/Eclampsia, Abdominal Prep/Surgical Site Infection Prevention on 6/28/23 and 6/29/23, 49% compliance (22 of 43 did not attend); Shoulder Dystocia/Operative Vaginal Delivery (Vacuum Assist) on 9/13/23 and 9/14/23, 59% compliance (21 of 51 did not attend), and Cord Prolapse/STAT C/S on 11/15/23 and 11/16/23, 62% compliance (20 of 52 did not attend).

During an interview on12/14/23 at 3 p.m. with MD 1, MD 1 stated he admitted Pt 1 on 11/17/23 for an induction of labor for possible macrosomia and her history of three pregnancy losses. MD 1 stated since estimates of fetal weight can be inaccurate, scheduling an elective C/S was not indicated. He stated MD 2 was working on 11/18/23 but that a nurse called him when the patient was in the operating room, and he came in. He arrived after the body was delivered. He stated he had not reviewed the fetal heart monitor strips. The interview ended due to MD 1 being called to a delivery.

During an interview on 12/15/23 at 9:30 a.m. with the APCE, the APCE stated they are not doing chart reviews or fetal monitor strip reviews as part of their performance improvement activities.

During a concurrent interview and record review on 12/15/23 at 2:15 p.m. with the OBE, the OBE stated her review of the fetal heart monitor tracing for Pt 1 indicated staff are not always using the accepted, standardized language to describe the characteristics of the fetal heart rate. The OBE stated is planning to use monitor strips as part of her class and that the staff will be given a test they must pass as part of the competency validation. Going forward regular chart review including fetal heart monitor strip review will be part of the ongoing competency assessment of each RN.

During an interview on 12/15/23 at 3 p.m. with the respiratory therapist (RT)1, RT 1 stated he has been a respiratory therapist at the hospital for more than 20 years. RT 1 stated in addition to working as a respiratory therapist in the hospital, he also is an NRP instructor. RT 1 stated he was in the hospital on 11/18/23 visiting a family member when he was contacted by another RT about Pt 1's delivery complicated by shoulder dystocia. RT 1 stated he went to the birthing center and Pt 1 was in the operating room, with the baby's head delivered but not the body. RT 1 stated there were a lot of people in the room. RT 1 stated MD 2 was there and an ED physician (EDMD 1). RT 1 stated he prepared the warmer in anticipation of the delivery and when EDMD 1 was able to get the baby out vaginally he brought the baby to RT 1 at the warmer. RT 1 stated the baby was floppy, showed no signs of life and was cyanotic. RT 1 stated he and EDMD 1 began resuscitation measures according to the NRP algorithm, and other staff assisted with the resuscitation efforts. RT 1 stated throughout the code lasting nearly two hours, they were not able to auscultate a heartbeat but did get a pulse showing on the monitor. RT 1 stated a neonatologist from Hospital B arrived, participated in the resuscitation efforts and ultimately stopped the resuscitation after there were no signs of life despite lifesaving measures performed. RT 1 stated during the code, EDMD 1 was providing care to both the baby (Pt 2) and the mom (Pt 1), who was bleeding, until another obstetrician arrived. RT 1 stated MD 2 was visibly exhausted and appeared weak, and EDMD 1 assisted her.

During an interview on 12/19/23 at 8 a.m. with the APCE, the APCE stated MD 2 is on vacation and is not working at the hospital again until January.
During an interview on 12/19/23 at 8:22 a.m. with the OBE and the Director of OB (DOB) at their sister hospital (covering for the DMCS), the DOB stated, "We didn ' t have a competency for the medical screening exam process," but they have developed one and have started training and validating staff competency.
During an interview on 12/19/23 at 10:29 a.m. with the charge nurse (RN 14), RN 14 stated she was the charge nurse working at he time of the shoulder dystocia on 11/18/23. RN 14 stated that day they were short-staffed due to sick calls. RN 14 stated she was told that Pt 1 was here for induction of labor for gestational diabetes mellitus (GDM- diabetes not present prior to pregnancy) and there was a delay in starting the induction because of staffing. RN 14 stated she wasn'tt aware of a problem until the head was out. Prior to that Pt 1 was tired and Pt 1's primary nurse (RN 1) called MD 2 and Pt 1 was given a 30 minute break from pushing. RN 14 stated she saw MD 2 at the bedside a few times and "MD 2 mentioned that she didn't like the variables [fetal heart rate variable decelerations] she was seeing." RN 14 stated MD 2 looked tired. RN 14 stated, "When I asked [MD 2], what's your plan with this patient, she said I'm going to do a quick note, then I'm going to push with the patient." She pushed with the patient for 30-40 minutes. RN 14 stated she was in the room during the delivery after being told that a vacuum was going to be used. A respiratory therapist was called for the delivery also. RN 14 stated after the head was delivered she heard MD 2 say, " We have a shoulder." RN 14 stated, "We didn't realize how big the baby was. The baby was big - 4200 grams (9.26 pounds)." RN 14 stated MD 2 never discussed a C/S at any time. RN 14 stated an ED physician responded and helped out. RN 14 stated "MD 2 was looking faint and I thought she was going to pass out. I had to act on that very quickly. I called [MD 1] but he didn't answer because other nurses were calling him, then I called MD 3 and he said it really should be MD 1, and then I called the Chief of OB." RN 14 stated she intervened on her own, MD 2 did not ask anyone to get help for her. RN 14 stated she has not reviewed the fetal monitor strips. RN 14 stated, "The patient was having variables. The doctor. noticed it, and I noticed it. There was a cord around the neck." RN 14 stated she was involved in the RCA, and they did not determine what the cause was. RN 14 stated the people leading the RCA "asked if we had done all of the maneuvers which we had," and asked if a c-section was considered and if the use of the vacuum was appropriate. RN 14 stated the simulation training classes were discussed too, and if they (the nurses) hadn't attended what does the Director do. RN 14 stated as far as what could have been done differently, "I've asked myself, if I should have questioned the use of the vacuum. But MD 2 was pushing for 40 minutes with the patient so she should have noticed if there was turtling effect [Turtle sign-after the fetal head is delivered, it retracts back tightly against the maternal perineum. A sign of shoulder dystocia]. Two physicians should have already established if the pelvis was big enough."

During a review of the professional reference, "American College of Obstetricians and Gynecologists, Practice Bulletin Number 178, Shoulder Dystocia," dated 5/17, the reference indicated, "...Obstetric simulation is an effective tool in preparing for shoulder dystocia because it is a high acuity/low frequency event...Evidence indicates that introduction of shoulder dystocia simulation and team training protocols at individual institutions may be associated with a reduction in transient brachial plexus injury when shoulder dystocia occurs. After the introduction of a mandatory clinical shoulder dystocia simulation for all personnel on a labor and delivery unit, the frequency of evidence-based management of shoulder dystocia was higher, and the rate of neonatal brachial injury at birth was lower.

During a review of the professional reference, "AWHONN position statement: Fetal Heart Monitoring," dated 11/18, the reference indicated, "...The Association of Women ' s Health, Obstetric and Neonatal Nurses (AWHONN) maintains that the availability of registered nurses (RNs) and other health care professionals who are skilled in fetal heart monitoring (FHM) techniques, including auscultation and electronic fetal monitoring (EFM), is essential to maternal and fetal well-being during antepartum care, labor, and birth. Fetal heart monitoring requires advanced assessment and clinical judgment skills and should not be delegated to unlicensed assistive personnel or others who do not possess the appropriate licensure, education, and skills validation. Labor is dynamic; therefore, consideration of preferences and identification of risk factors should occur upon admission to the birth setting and should be ongoing throughout labor..."

During a review of internet article, "Shoulder Dystocia-StatPearls-NCBI Bookshelf," dated 1/23, the article indicated, "...Shoulder dystocia is, by definition, a mechanical problem occurring during a vaginal delivery characterized by one of the following parameters: failure to deliver the fetal shoulders using solely gentle downward traction, requirement of additional delivery maneuvers are needed to successfully deliver the baby, a documented head-to-body interval of greater than 1 minute...Several risk factors for shoulder dystocia have been identified. Fetal macrosomia is the most significant risk factor for shoulder dystocia. Other known risk factors include pregestational and gestational diabetes, prior history of shoulder dystocia, and operative vaginal delivery, particularly with the use of the vacuum..."

During a review of the UpToDate article titled, "Shoulder dystocia: Risk factors and planning birth of high-risk pregnancies," dated 4/7/23, the article indicated,"...Clinicians should be aware of risk factors for shoulder dystocia, so they can discuss the possibility of scheduled cesarean birth with patients at highest risk of occurrence and appropriately manage a prolonged second stage of labor in less high-risk patients..."

During a review of the Journal of Clinical Medicine Article titled Vacuum-Assisted Delivery Complication Rates Based on Ultrasound-Estimated Fetal Weight, dated 6/2022, the journal article indicated, a research study was conducted of women with singleton pregnancies at 34-41 weeks gestation, who underwent ultrasonographic pre-labor Estimated Fetal Weight (EFW) and Vacuum Assisted Delivery (VAD) over a six year period. The results of the study indicated, "... After controlling for all potential confounders, higher EFW (greater than or equal to 3700 g), maternal age, and diabetes were found to be independent risk-factors for adverse outcomes. EFW greater than or equal to 3700 grams based on ultrasound was a significant risk factor for shoulder dystocia and clavicular fracture..."

During a review of the Journal of Maternal-Fetal and Neonatal Medicine, Volume 30, Issue 15, article titled, "Fetal macrosomia as a risk factor for shoulder dystocia during vacuum extraction," dated 5/16, the article reflected the results of a research study of macrosomic babies delivered by vacuum extraction over a 10 year period from 2003 to 2013. The study found, "The risk of shoulder dystocia [SD] was significantly higher in the study group. We found a significant association between SD and vacuum delivery...and the composite adverse neonatal outcome rate was 6.5% in the study group and 1.7% in the control group, respectively...".


During a review of the professional reference titled, "The American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin No. 173- Fetal Macrosomia," dated 11/16, the reference indicated, "... As birth weight increases, the likelihood of labor abnormalities, shoulder dystocia, birth trauma, and permanent injury to the neonate increases... Infants who are macrosomic because of maternal glucose intolerance tend to have greater total body fat, greater shoulder and upper-extremity circumferences, greater upper-extremity skin-fold measurements, and smaller head-to-abdominal-circumference ratios compared with macrosomic infants of women without diabetes. It has been suggested that it is this altered fetal body shape that is responsible for the higher incidence of shoulder dystocia seen among infants of women with diabetes. Regardless of birth weight, infants of women with diabetes have an increased risk of shoulder dystocia, clavicular fracture, and brachial plexus injury...Pregnant women with suspected fetal macrosomia should be provided individualized counseling about the risks and benefits of vaginal and cesarean delivery based on the degree of macrosomia..."

During a review of the professional reference titled, "The American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin No. 49 on Dystocia and Augmentation of Labor," dated 11/03, the reference indicated a prolonged second stage is defined as," more than 2 hours without or 3 hours with epidural analgesia in nulliparous women, and 1 hour without, or 2 hours with epidural in multiparous women."

During a review of the journal article in American Family Physician, Volume 102, Number 2, titled, "Shoulder Dystocia: Managing an Obstetric Emergency," dated 7/15/20, the article indicated, "...Risk factors for shoulder dystocia include fetal macro¿somia, prior shoulder dystocia, and preexisting or gestational diabetes melli¿tus. Other risk factors include maternal obesity, excessive maternal weight gain during pregnancy, oxytocin (Pitocin) use, prolonged first or second stage labor, and operative vaginal delivery (forceps or vacuum) ... ACOG and the Advanced Life Support in Obstetrics program recommend that labor and delivery teams conduct regular team train¿ing drills

45929

Based on observations, interviews and record review, the facility failed to maintain a clean and sanitary environment to avoid sources of transmission of infection when,

1. On 12/12/23 Sterile Processing Technician (SPT) 1 missed a hand washing opportunity and two of three hand sanitizer dispensers in the in the surgical area were empty and were not monitored for the level of sanitizer per facility's policy.

2. Wet sterile instruments were drying on a towel directly over an open package of sterile (free from bacteria and microorganisms) towels in conflict with sterility professional standards.

3. Two of two anesthetists (medical specialists who administer anesthetics, medication inducing insensitivity to pain) did not have their facial hair covered before and during surgical procedures in the Operating Room (OR) in accordance with the facility's policy on surgical attire.

These failures resulted in a potential for cross contamination and potential for spread of infectious diseases to patients and staff.

Findings:

1. During a concurrent observation and interview on 12/12/23 at 11:20 a.m. with SPT 1, the Surgical Services Director (SSD), and the Surgical Services Manager (SSM), SPT 1, the SSD and the SSM exited the Sterile Processing decontamination room (area in which biological debris is removed from used surgical instruments), into the main hallway and into the surgical department to the door of the sterile processing room. SPT 1 and the SSD attempted to use the hand sanitizer dispenser before entering the sterile processing room (where surgical instruments are sterilized (made free from bacteria). The SSD stated the dispenser was empty. The SSD and the SSM attempted to use the next closest hand sanitizer dispenser, outside the OR room. SPT 1 continued into the sterile processing room without performing hand hygiene. The SSD stated the second dispenser was also empty. The SSD went into the Post Anesthesia Care Unit (PACU, recovery area) and located a dispenser with hand sanitizer. The SSD and the SSM used the hand sanitizer to perform hand hygiene.

During an interview on 12/12/23 at 11:22 a.m. with the SSD and the SSM, the SSD and the SSM stated Environmental Services (EVS) fills the hand sanitizer dispensers. The SSD and the SSM stated they did not know if EVS staff checks the dispensers or if nursing staff calls EVS when the dispensers are empty.

During an interview on 12/12/23 at 2:45 p.m. with the Environmental Services General Manager (EVSM), the EVSM stated EVS staff completed a terminal clean (procedure required to ensure an area has been cleaned/decontaminated following use by a patient to ensure a safe environment for the next patient) in the surgical department after surgery was completed. The EVSM stated hand sanitizer levels in the dispensers were to be checked by the EVS team with a terminal clean and filled if dispensers were empty.

During a review of "Surgery Schedule (SS)", dated 12/12/23, the "SS" indicated only one surgery scheduled for 12/12/23 from 7:00 a.m. to 7:58 p.m.

During an interview on 12/18/23 at 1:15 p.m. with the Infection Preventionist (IP), the IP stated EVS was responsible for filling hand sanitizer dispensers, but everyone was responsible for their own hand hygiene and any staff in the area should have called EVS to have dispensers filled. The IP stated someone should have noticed two empty dispensers so close together and this indicated poor hand hygiene practices. The IP stated hand hygiene was the best way to prevent infection.

During a review of the facility's policy titled "Hand Hygiene (HH)", dated 2/8/22, "HH" indicated, " ... Use alcohol-based rub or soap and water to routinely decontaminate hands in the following clinical situations ... After contact with medical equipment in patient areas ... after removing gloves ...".

During a review of the facility's "Seven Step Cleaning Process (SSCP)" (undated), the "SSCP" indicated, " ... CLEANING IN PATIENT ROOMS ... HOSPITAL CLEAN STANDARDS ... Dispensers are free of dust, soiling and residue and restocked appropriately ... 'Go Beyond What's Expected' ...".

2. During a concurrent observation and interview on 12/12/23 at 11:25 a.m. in the sterile processing room with SPT 1, surgical instruments were drying on a towel on top of a wire shelf, which was directly over the opening of a bag of sterile towels. SPT 1 stated the drying instruments could drip water onto the sterile towels in the bag and contaminate the towels. SPT 1 stated the bag of towels should have been covered and should be re-sterilized.

During an interview on 12/18/23 at 1:19 p.m. with the IP, the IP stated surgical instruments that are washed but not sterilized can drip water and contaminate the bag of sterile towels under the drying rack. The IP stated any water on the towels could cross contaminate and carry microorganisms or bacteria on a sterile package into the OR.

During the review of a professional reference titled, "Sterilizing Practices (SP)" from the Centers for disease Control and Prevention (CDC), dated 9/18/16, the "SP" indicated, " ... Sterile items that become wet are considered contaminated because moisture brings with it microorganisms from the air and surfaces ...".

3. During an observation on 12/13/23 at 9:15 a.m. in the OR, during the preparation of and the OR for Patient (Pt) 21's surgery, Certified Registered Nurse Anesthetist (CRNA) 1 was noted to be wearing a face mask which did not cover his beard on the sides of his face and under his chin. Throughout Pt 21's surgery, CRNA 1 continued to have his facial hair exposed.

During an observation on 12/13/23 at 3:30 p.m. in the Birthing OR (operating room in labor and delivery), during the preparation for Pt 22's Cesarean section (C-section, the surgical delivery of a baby though a cut made in the mother's abdomen), Anesthesiologist (AN) 1 was noted to be wearing a face mask which did not cover his beard or sideburns. AN 1 was noted to have exposed hair at the nape of his neck, not covered by his surgical cap. AN 1's nape and facial hair continued to be exposed throughout Pt 22's C-section.

During a concurrent interview and record review on 12/18/23 at 1:17 p.m. with the IP, the facility's policy titled "Surgical Attire (SA)", dated 10/2022, was reviewed. The "SA" indicated, " ... Personnel entering the semi-restricted and restricted areas should cover the head, hair and facial hair ... personnel should wear a clean surgical head cover or hood that covers all visible hair, scalp skin, sideburns, and nape of neck ...". The IP stated "SA" is a corporate policy and all entities (facilities in the corporation) must follow the "SA". The IP stated that anesthesiology personnel were not an exception to the "SA".

During a review of a professional reference titled, "Behind the Scenes: patient safety in the operating room and central materiel service during deployments (BTS)" retrieved from https://www.ncbi.nlm.nih.gov/books/NBK20543/pdf/Bookshelf_NBK20543.pdf, the "BTS" indicated, " ... The semi-restricted area is where scrub attire and hair coverings are worn, the scrub sinks are located, and clean and sterile supplies are stored; it also includes some of the areas used to process surgical instruments. The restricted area includes operating rooms, procedure rooms, and clean-core areas. This is where full surgical attire and masks are worn ..."

During a review of a professional reference titled "Statement on Surgical Attire (SSA)" form the American Society of Anesthesiologist, dated 10/26/22, the "SSA" indicated, " ... Recommendations ... When in a restricted or semi-restricted procedural area, cover facial hair not contained within a mask ... When choosing a facial hair covering material, consider containment of shed particles, comfort and fit ... Healthy human skin and hair is colonized [settled in, establish control over] by bacteria ... and generally are not eliminated by routine bathing and shampooing ... Wearing head gear during surgical procedures is also recommended to prevent dispersion [spreading] of infectious particles shed from the scalp and hair. Hair may entrap and sequester [isolate] shed skin particles, and these may be released into the ambient [surrounding] air ... covering that completely cover the hair would most effectively prevent dispersion [distribution] ...".