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Based on records reviewed and interviews the Hospital failed to ensure quality activities conducted a thorough investigation including analysis of all obstetric care, substantially implemented re-education regarding Electronic Fetal Monitoring that was identified as a corrective action and monitor for compliance, following a newborn's (Patient #1's) death.

Findings included:

1.) The Hospital failed to ensure a thorough investigation (collection of data) through its Quality Assessment and Performance Improvement Program's processes of operations including analysis, and measure or monitor the quality of care regarding Electronic Fetal Monitoring interpretation.

Refer to TAG: A-0273.

2.) The Hospital failed to ensure their QAPI Program conducted and analyzed, a thorough investigation, and implemented preventative, performance improvement activities (corrective actions) following Patient #1's adverse event.

Refer to TAG: A-0286.

Based on records reviewed and interview, the Hospital failed to ensure, for one patient (Patient #1) of ten patients sampled, a thorough investigation (collection of data) through its Quality Assessment and Performance Improvement (QAPI) Program's processes of operations including analysis, and measure or monitor the quality of care regarding Electronic Fetal Monitoring (EFM) interpretation.

Findings included:

The Hospital Report, dated 8/31/2022, indicated the Hospital reported a newborn (Patient #1) death following an Induction of Labor (IOL). The Fetal Heart Rate (FHR) pattern showed a FHR generally in the 140s with periods of early decelerations, with recovery, to late decelerations, including slow recovery with pushing with the midwife and obstetrician present for a vaginal delivery. Patient #1 was initially placed on the mother's (Patient #2) chest, and it was noted Patient #1 was not breathing; resuscitation was started, Apgar scores were 1,1,1 at one, five and ten minutes respectfully. Patient #1 was transferred to the Hospital's Special Care Nursery, then to a tertiary hospital and four days later died.

The article titled NICHD Definitions and Classifications: Application to Electronic Fetal Monitoring Interpretation, NCC Monograph, Volume 3, No. 1, dated 2010, indicated: the following definitions:

Accelerations: an abrupt increase of the Fetal Heart Rate (FHR).

Late Decelerations: decrease in FHR and return to baseline associated with uterine contractions.

Variable Decelerations: decrease in fetal heart, may or may not be associated with uterine contractions.

FHR Pattern Classification and Interpretation
-Category I is normal.
-Category II is indeterminate and neither normal nor abnormal.
-Category III is abnormal.

By-Laws of the Medical Staff Organizational Manual, dated 12/1/2019, indicated functions of Department Chairpersons included, to monitor and evaluate the quality and appropriateness of patient care provided to confirm competence.

The Quality Management Plan, dated 8/18/2022, indicated its QAPI Plan. The QAPI Plan indicated the Hospital's QAPI Plan was to improve the overall performance of the organization. The QAPI Plan indicated the Board Quality Committee reported to the Board of Trustees (Governing Body) and was responsible to provide effective quality, performance improvement and oversee the Hospital's safety activities. The QAPI Plan indicated improvement actions were evaluated, took actions aimed at performance improvement and after implementing those actions, the Hospital must measure its success and trace performance to ensure improvements were sustained.

During the interview, at 3:30 P.M. on 4/4/2023, Risk Manager #1 said an identified quality improvement activity (data collected through investigation) was re-education on Electronic Fetal Monitoring (EFM, interpretation) for all Obstetric Providers. Risk Manager #1 said the mandatory periFACTS (https://www.urmc.rochester.edu/institute-innovative-education/center-experiential-learning/perifacts.aspx) Electronic Fetal Monitoring (an online course) started on 1/1/2023 and completion was due by 9/30/2023. Risk Manager #1 said the Hospital had no documentation that the Certified Nurse Midwife (CNM) #2 or #3 had completed the periFACTS EFM Course.

The Email, dated 1/15/2023, indicated the Hospital identified a corrective action with the Hospital investigation regarding Patient #1's death. The Email indicated an online periFACTS EFM Course implemented 1/1/2023 with deadline for completion of 9/30/2023 for all Obstetric Providers, inpatient Nurses and outpatient Nurses, as the corrective action.

During the interview, at 4:00 P.M. on 4/4/2023, the Chief of Obstetrics said he did not receive information (did not know) if the three Providers (CNM #2, CNM #3, or Obstetrician #1) providing obstetric care to Patients #1 (fetus) and Patient #2 (mother) had completed the EFM re-education corrective action. The Chief of Obstetrics said the Hospital monitored for trend concerns (competency) using the Hospital's electronic event reporting system and there were no more similar cases, there was no more intensive monitoring (identified or implemented as a corrective action) and the Hospital continued with the same standard as before (Patient #1's death); there was no additional ongoing monitoring (regarding CNM #2, CNM #3, Obstetrician #1).

The Hospital provided no documentation to indicate the three Providers, providing obstetric care, completed the EFM re-education following Patient #1's death on 8/21/2022, by the time of the Survey, on 4/4/2023. The Hospital provided no documentation of more intensive monitoring deeming the three Providers re-educated, consistent with QAPI preventative activities and in accordance with By-Laws of the Medical Staff Organizational Manual to monitor and evaluate the quality and appropriateness of patient care provided to confirm competence.

Refer to TAG: 0286, Patient Safety, Medical Errors & Adverse Events.

Based on records reviewed and interviews, the Hospital failed to ensure for one patient (Patient #1) of ten patients sampled to conduct and analyze a thorough investigation, and implement preventative, performance-improvement activities (corrective actions) by the time of the Survey, seven months, following Patient #1's adverse event.

Findings included:

A.) The policy titled Sentinel Event Review and Analysis, dated 10/24/2022, indicated a sentinel event, a patient safety event, unexpected event, would be analyzed by the Root Cause Analysis (RCA, Hospital investigation) process and implementation of an appropriate action plan would be monitored by the committees responsible for quality improvement. An RCA was a process for identifying the most basic or causal factors(s) that underlies variation in performance, including the occurrence of an adverse event. It involved studying the steps in a process; identifying people, actions, and equipment that produced desired outcomes; and finding links between variables in performance. It focused primarily on systems, processes, not individual performance, and determined what can be done to prevent reoccurrence of the event. The Sentinel Event policy indicated monitoring was overseen by the Quality Steering Committee process until activities were complete. Departmental directors and medical staff leaders were responsible for assuring that performance improvement actions were carried out.

1.) Regarding Brief Summary, of Timeline for Oxytocin (medication used to induce uterine contractions) administration and Fetal Heart Rate (FHR).

Late decelerations are abnormal Fetal Heart Rate (FHR) patterns during labor usually caused by uteroplacental insufficiency (decreased blood flow from the uterus to the placenta and oxygen to the fetus that can signify an impending fetal acidemia (fetal distress) following a maternal contraction. Treatment includes maternal repositioning, intravenous hydration, administration of supplemental oxygen and discontinuing uterotonics (Oxytocin): by discontinuing uterotonics, there is a relaxation of the uterine muscles which has been proven to increase uteroplacental blood flow (https://www.ncbi.nlm.nih.gov/books/NBK539820/).

The Labor & Delivery Time Line, dated 8/21/2022, indicated at 12:28 A.M., Oxytocin started at a dose of 1 milli-units/minute and increased to a dose at 8:58 A.M. of 10 milli-units/minute. Decelerations started at 8:12 A.M. on 8/21/2022 until 9:15 A.M. with Patient #1 delivering at 10:20 A.M. on 8/21/2022.

Policy: Use of Oxytocin for the Induction, Augmentation of Labor, dated 12/2022, indicated Oxytocin was used to promote safe and effective use for cervical ripening, induction and or augmentation of labor. The Oxytocin policy indicated the following regarding FHR Categories:

Category I pattern was a normal FHR, with a FHR between 110-160, with FHR accelerations and without FHR decelerations.

Category II pattern was an indeterminate FHR pattern, not categorized as Category I or III.

Category III pattern was an abnormal FHR pattern with recurrent late and or variable FHR decelerations.

Neonatology Delivery Note, dated 12:17 P.M. on 8/21/2022, indicated Pediatric Providers were called to attend Patient #1's delivery. Patient #1 was delivered without respiratory effort, a very low heart rate, and a gestational age of 41 weeks and 1 day (pregnancy usually last about 40 weeks, https://www.marchofdimes.org/). The Neonatology Note indicated Patient #1 with a Category II FHR pattern and meconium-stained fluid.

Meconium is the first stool, of the newborn. Meconium aspiration syndrome occurs when a newborn breathes a mixture of meconium and amniotic fluid into the lungs around the time of delivery.

Nursing Note, dated at 6:10 P.M. on 8/21/2023, indicated at 11:30 A.M. Patient #1 had no muscle tone, no spontaneous movements, did not respond to any stimuli and had fixed and dilated pupils and at 2:40 Patient #1 was transported (to a Neonatal Intensive Care Unit).

2.) Regarding Detailed Summery of Timeline for Oxytocin administration and FHR.

The Labor & Delivery Time Line, dated 8/21/2022, indicated at:

12:28 A.M., Oxytocin started at a dose of 1 milli-units/minute; at 1:00 A.M. Oxytocin was increased to 2 milli-units/minute, at 1:30 A.M., increased to 2 milli-units/minute, and at 2:00 A.M. and increased to 4 milli-units/minute.

2:55 A.M., CNM #2 was called to bedside for two late decelerations, Oxytocin was administered at 4 milli-units/minute,

CNM Labor Note, dated 8/21/2023 at 3:00 A.M., indicated Patient #1 had a run of late decelerations at 2:00 A.M. that resolved with repositioning, the FHR was a Category II without fetal acidemia, given moderate (FHR) variability and (FHR) accelerations and to continue with the Oxytocin titration (dose increase).

The Labor & Delivery Time Line, dated 8/21/2022, indicated at:

3:06 A.M., the Oxytocin dose was increased to 5 milli-units/minute, and at 4:02 A.M., the Oxytocin dose was increased to 6 milli-units/minute and at 6:30 A.M., The Oxytocin dose was 6 milli-units/minute with FHR Variable Decelerations and Category I (Normal and without late or variable decelerations).

Change of Shift to RN #1 at 7:10 A.M., and CNM #3 notified at 7:30 A.M. and at 7:31 A.M. Patient #2 cervical dilation was complete.

7:45 A.M., Oxytocin dose was increased to was 7 milli-units/minute, 7:48 A.M., Patient #2 pushing and at 7:50 A.M., Patient #1 had a prolonged deceleration,

8:12 A.M., Oxytocin dose was increased to was 8 milli-units/minute, at 8:20 A.M., Oxytocin dose was increased to was 9 milli-units/minute, and at 8:30 A.M., 8:45 A.M., 8:58 A.M., Oxytocin dose was increased to 10 milli-units/minute, 9:00 A.M. and 9:15 A.M. the FHR with Late Decelerations and at 10:20 A.M. Patient #1 delivered.

The Oxytocin policy indicated appropriate times to discontinue Oxytocin included FHR pattern with recurrent variable or late decelerations.

The Hospital provided no documentation to indicate the Hospital investigation analyzed the Oxytocin administration consistent with Hospital policy.

B.) Regarding re-education on Electronic Fetal Monitoring Implementation:

During the interview, at 3:00 P.M. on 4/5/2023, Risk Manager #1 said the Hospital had no documentation that CNMs #2, #3 or Obstetrician #1 completed the EFM course (identified as a corrective action following the death of Patient #1 seven months earlier).

During the interview, at 3:30 P.M. on 4/4/2023, Risk Manager #1 said an identified quality activity was re-education on Electronic Fetal Monitoring for all Obstetric Providers, inpatient and outpatient Obstetric Nurses (Obstetric Department). Risk Manager #1 said the mandatory periFACTS Electronic Fetal Monitoring (EFM, an online course) started on 1/1/2023 and completion was due by 9/30/2023. Risk Manager said 23% of the Obstetric Department had completed the periFACTS EFM Course.

During the interview, at 4:00 P.M. on 4/4/2023, the Chief of Obstetrics said three Providers(CNM #2, CNM #3, and Obstetrician #1) provided obstetric care to Patients #1 (fetus) and Patient #2 (mother).

During the interview, at 8:30 A.M. on 4/6/2023, CNM #2 said she had not completed the EFM course.

During the interview, at 3:00 P.M. on 4/6/2023, CNM #3 said she had not completed, the 6 to 10 eight hour, periFACTS EFM course because it was not due until 9/2023.

The Hospital provided no timely documentation of a substantial percentage of obstetric staff completion of EFM, identified as a corrective action, seven months following Patient #1's death.

The Hospital provided no documentation to indicate EFM re-education as an immediate corrective action for CNMs #2, #3, and Provider #1.

C.) Regarding Communication & Situational Awareness:

Potential threats to patient safety at the bedside need to be identified, addressed, and discussed, but doing so requires balancing the tension between efficiency and situational awareness. Situational awareness involves the careful and deliberate perception, understanding, and prediction of events in an environment of interest (psnet.ahrq.gov/web-mm/situational-awareness-and-patient-safety).

During the interview, at 9:00 A.M. on 4/5/2023, the Obstetric Nurse Director said there were no concerns about Patient #1's EFM pattern to activate the chain of command policy (Hospital policy on escalation patient care concerns to Hospital leaders). There was an Obstetric Resource Nurse and Obstetric Charge Nurse in Labor & Delivery on that day (821/2022), and Patient #1's, FHR increased to approximately 160 to 170 beats per minute (tachycardia, sign of fetal distress, normal FHR 110 to 160 beats per minute), at approximately 8:00 A.M., prior to delivery,

During the interview, at 1:00 P.M. on 4/5/2023, the Obstetric Resource Nurse said she was not sure of RN#1's (appropriateness of the) assignment, there was a dedicated Obstetric Charge Nurse on duty the day of 8/21/2022, and RN#1 did not communicate to the Resource Nurse any concerns regarding Patient #1's EFM pattern.

During the interview, at 2:15 P.M. on 4/5/2023, the Obstetric Charge Nurse said, at approximately 8:30 to 8:45 A.M. she saw the FHR deceleration pattern on the monitor (at the Nurses Station), did not like the pattern and called Obstetrician #1, as Patient #2 was in the pushing stage of labor to deliver Patient #1; she was concerned, however there were Providers, CNM #3 and Obstetrician #1, were at Patient #2's bedside.

During the interview, at 11:00 A.M. on 4/11/2023, Obstetrician #1 said the Obstetric Charge Nurse notified her to evaluate Patient #1's EFM pattern (for well-being).

Obstetrician #1's Note, dated at 2:42 P.M. on 8/21/2022, indicated Obstetrician #1 entered Patient #2's room at about 9:05 to 9:10 A.M. on 8/21/2022, Patient #2 was in the pushing stage of labor with CNM #3, the FHR (Patient #1) had been having FHR decelerations, and Patient #1 delivered.

When the FHR pattern is indeterminate (category II) or abnormal (category III), communication amongst members of the perinatal team is essential in ensuring appropriate and timely response to the clinical situation (NCC Monograph, Volume 3, No. 1, 2010).

The Hospital provided no documentation to indicate the Hospital investigation addressed Communication or Situational Awareness for the Obstetric Provider and Nursing Staffs.

D.) Regarding Uterotonics (medication used to induce uterine contractions):

During the interview, at 9:00 A.M. on 4/5/2023, the Obstetric Nurse Director said three Providers (CNMs #2 & #3 and Obstetrician #1) were managing the Oxytocin (a uterotonic medication).

During the interview, at 1:00 P.M. on 4/5/2023, the Obstetric Resource Nurse said she was not aware of Patient #1's FHR decelerations and if the Oxytocin was shut off.

During the interview, at 3:15 P.M. on 4/5/2023, the Obstetric Nurse Director said increasing the Oxytocin with FHR decelerations was inappropriate.

During the interview, at 3:00 P.M. on 4/6/2023, CNM #3 said the RCA did not discuss the Oxytocin administration, because the RCA was discussing systems.

The Report, dated 8/23/2022, indicated no investigation regarding administration of uterotonics

The article titled Late Decelerations, dated 1/30/2023, indicated, after completing a detailed assessment of the etiology of late declaration, immediate intrauterine resuscitative measures are initiated to prevent fetal acidemia and to decrease fetal morbidity and mortality. The resuscitative measures included discontinuing uterotonics: by discontinuing uterotonics (Oxytocin), there was a relaxation of the uterine muscles which has proven to increase uteroplacental blood flow (https://www.ncbi.nlm.nih.gov/books/NBK539820/).

The Report, dated 8/23/2022, indicated no investigation regarding Oxytocin administration in accordance with Hospital policy.

E.) Regarding Shift Change:

During the interview, at 9:00 A.M. on 4/5/2023, the Obstetric Nurse Director said Patient #1's event happened around the change of shift,

Shift change updates are widely believed to be a point of vulnerability in complex systems with high consequences for failure. Erroneous actions stemming from shift changes have caused a wide variety of problems including inaccurate evaluations (psnet.ahrq.gov/web-mm/dangerous-shift).

The Hospital provided no documentation to indicate discussion regarding change of shift.

F.) Regarding Nursing Experience:

During the interview, at 9:00 A.M. on 4/5/2023, the Obstetric Nurse Director said:

-RN #1 was fairly new, completed orientation, and this was her first day back from a Leave of Absence (LOA) of approximately four months,

-The Hospital had no particular plan for Obstetric Nurse orientation or Obstetric Nurses returning form an extended Leave of Absence (LOA) to investigate and analyze opportunities for improvement regarding titration of the medication Oxytocin,

During the interview, at 1:00 P.M. on 4/5/2023, the Obstetric Resource Nurse said she was not sure of RN#1's (appropriateness of the) assignment and there was no formal transition (re-orientation for Obstetric nurses) following a LOA,

During the interview, at 2:15 P.M. on 4/5/2023, the Obstetric Charge Nurse said it was RN #1's first day back to work after a LOA and RN#1 was relatively inexperienced, had completed orientation, then had a LOA.

The Hospital provided no documentation to indicate discussion regarding RN #1's labor and delivery experience.

F.) Regarding Meconium Aspirator:

The Neonatology Delivery Note, dated at 12:17 P.M. on 8/21/2022, indicated Patient #2 (mother) had meconium-stained amniotic fluid.

Meconium is the first stool, of the newborn. Meconium aspiration syndrome occurs when a newborn breathes a mixture of meconium and amniotic fluid into the lungs around the time of delivery

The Newborn Admission History & Physical, dated at 2:45 P.M. on 8/21/2022, indicated meconium as a perinatal complication.

The Event Note, dated at 11:00 A.M. on 8/21/2022, indicated Patient #1 had a large amount of thick secretions covering the airway and (Anesthesia) asked for a Yankauer suction (an oral suctioning device) and was given a bulb syringe and a flexible pediatric suction catheter, bag mask resuscitation resumed with repeated request for a rigid suction.

The Hospital provided no documentation to indicate the Hospital investigated the use of a Meconium Aspirator [a device attached to an endotracheal (breathing) tube for intermittent suction of a newborn's airway].

G.) Regarding the Hospital investigation:

During the interview, at 2:15 P.M. on 4/5/2023, the Obstetric Charge Nurse said she was not involved with the RCA nor remember an interview with the Obstetric Nurse Director.

During the interview, at 8:30 A.M. on 4/6/2023, CNM #2 said she was not present for the RCA.

During the interview, at 11:00 A.M. on 4/11/2023, Obstetrician #1 said the focus of the RCA was Patient #1's neonatal resuscitation.

The Report, dated 8/23/2022, indicated the RCA focused on neonatal care and neonatal resuscitation, however the report indicated no focus to include maternal-fetal obstetric care.