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Based on interview and record review, the facility failed to have a well-organized and effective nursing service when:

1. Licensed Nurses failed to meet the needs for Patient (Pt) 23 when the nursing care plans (goals of treatment for safe nursing care) did not include nursing interventions (actions that were performed to help patients reach their goals of care) corresponding to the primary diagnoses and treatments of each patient. (Refer to A396)

2. Licensed Nurses did not monitor, assess and follow caesarean (a surgical procedure to remove a baby through a cut in the abdomen) guidelines for two of two patients (Patient 1, Patient 2) according to the facility's P&P "Fetal Monitoring and Caesarean Section Guidelines" (Refer A398).

3. The norepinephrine (a medication used to control blood pressure) was not administered in accordance to the physician order for one of one patients. (Refer to A405).


The cumulative effect of these deficient practices resulted in the facility's inability to provide care in a safe and effective manner.

Based on interview and record review, the hospital failed to develop and keep current a nursing care plan for one of 34 patients, Patient (Pt) 23, when nurses did not assess and develop a care plan for pain and history of uncontrolled diabetes in accordance with their policy and procedure titled "Core Nursing Standards of Practice".

This failure had the potential to result in pain not being treated and the patient's diabetes not being controlled.

Findings:

During a concurrent interview and record review on 7/11/24, at 2:40 p.m., with the Nurse Manager of Medical Surgical Unit (RNM 4), and Quality Management Specialist (QM 1), Pt 23's electronic health record (EHR- digital collection of medical information) was reviewed. Pt 23's "History and Physical (H&P - the formal document that physicians produce through interview with the patient, physical exam, and the summary of testing either obtained or pending)", dated 2/26/24, "Document in Plan", undated and "Flow Sheet", undated, were reviewed. Pt 23's H&P indicated Pt 23 was a admitted on 2/26/24 with a history of uncontrolled diabetes [a chronic disease characterized by elevated blood sugars], Diabetic neuropathy [a long-term complication of diabetes that occurs when high blood sugar and high levels of fats damage nerves in the body], seizures, blindness secondary to diabetic neuropathy presents to the ED [Emergency Department] on account of gangrene [death of body tissue] of the fourth/fifth fingers of his right hand. Pt 23 was prepared for surgical amputation of the fingers on his right hand. RNM 4 stated, Pt 23's nursing care plan addressed issues for blood glucose levels, impaired skin integrity, risk for fluid and electrolyte imbalance, risk for infection, knowledge deficit, fluid volume deficit and risk for impaired metabolic function. RNM 4 stated, pain management and the patient's history of non-compliance were not addressed in the care plan. RNM 4 stated, nothing was included in the chart to address the refusal of care during his hospital stay. RNM 4 stated, there should have been a nursing care plan that addressed Pt 23's pain and his non-compliance with medical and nursing care in regards to control of diabetes. . RNM 4 stated, nurses are expected to develop a care plan that matches and guides the care needs of the patient.

During a concurrent interview and record review with the Chief Nursing Officer (CNO), on 7/12/24, at 12:30 p.m., Pt 23's care was reviewed. The CNO stated the nursing care plan should have been updated to address Pt 23's needs, and it was not. The CNO stated a nursing care plan for pain was not developed and implemented. The CNO stated a nursing care plan for diabetes control was not developed and implemented. The CNO stated, nurses are expected to follow the policy to develop, document and update the care plan to meet the patient's care needs.

During a review of the facility P&P titled, "Core Nursing Standards of Practice", dated 6/2022, the P&P indicated, " 2. Nursing Diagnosis - The registered nurse analyzes assessment data to determine actual or potential nursing diagnoses, patient problems and issues. The registered nurse: ... a. Identifies actual or potential risks to the patient's health and safety or barriers to health, which may include but are not limited to interpersonal, systematic, cultural or environmental circumstances. ... b. Uses assessment data, standardized classification systems, technology, and clinical decision support tools to articulate actual or potential nursing diagnoses, patient problems, and issues. ... c. Verifies the nursing diagnoses, patient problems and issues with the patient, family, and interprofessional colleagues. ... d. Prioritizes nursing diagnoses, patient problems, and issues based on mutually established goals to meet the needs of the patients across the health-illness continuum. ... e. Documents nursing diagnoses, patient problems, and issues in a manner that facilitates the determination of the expected outcomes and plan (ANA [American Nurses Association], 2015). ... 4. Plan of Care - The registered nurse develops a plan that prescribes strategies to attain expected, measurable outcomes. The registered nurse: ... a. Partners with the patient to implement the plan in a safe, effective, efficient, timely, patient-centered, and equitable manner. ... "

During a review of a professional reference titled, "Lippincott Manual of Nursing Practice 10th Edition," dated 2014, page 16-17 indicated, " Standards of practice General Principles... 1. The practice of professional nursing has standards of practice setting minimum levels of acceptable performance for which its practitioners are accountable ...b. These standards provide patients with a means of measuring the quality of care they receive ...5. A deviation from the protocol should be documented in the patient's chart with clear, concise statements of the nurse's decisions, actions, and reasons for the care provided, including any apparent deviation ... Legal claims most commonly made against professional nurses include the following departures from appropriate care: failure to assess the patient properly or in a timely fashion, follow physician orders, follow appropriate nursing measures, communicate information about the patient, adhere to facility policy or procedure, document appropriate information in the medical record ... Failure to formulate or follow the nursing care plan ..."

Based on interview and record review, the hospital failed to ensure nurses followed hospital policies and procedures (P&P) "Intrapartum Fetal Monitoring" and the P&P titled, "Cesarean Section Guidelines (FBC-195), for two of two sampled patients Patient (Patient 1 -mom) 1 and Patient 2 (baby of Patient 1), when licensed nurses did not document the status of Patient 2, including episodic and periodic patterns; did not complete electronic fetal monitoring assessment intervals, did not notify the provider regarding abnormalities of Patient 1 and Patient 2; and did not follow criteria to perform a cesarean section within 30 minutes of making the decision to perform the procedure; and fetal heart tones for Patient 2 were not obtained in the operating room in accordance with hospital policies and procedures.

These failures resulted in delay in treatment of Patient 1's pregnancy; and resulted in inadequate fetal monitoring of Patient 2, and an incomplete clinical assessment which led to a decline in oxygenation and may have possibly contributed to the death of Patient 2.

Findings:

During a review of Patient 1's "Electronic Medical Record (EMR)," dated 5/24/24 to 5/27/24, the EMR indicated Patient 1 was a 25-year-old female, gravida (the total number of confirmed pregnancies) 5, para (the number of live births) 0, 38 weeks and 3 days pregnant. The EMR indicated Patient 1 was admitted to Labor and Delivery (L&D) on 5/24/24 at 5:45 a.m. for induction of labor (IOL-when a medical provider starts labor). Patient 1 delivered Patient 2 (baby) on 5/27/24 at 11:09 p.m., total time in labor was 89 hours and 24 minutes. Patient 1's EMR indicated Patient 1 was first assessed on 5/24/24 at 5:57 a.m. Patient 2's EMR indicated the Fetal Heart Rate (FHR) was "Category 1/Normal Tracings" (baseline FHR 110-160 beats per minute and moderate FHR variability). Patient 1's EMR indicated she was assessed on 5/24/24 at 2:43 p.m. and had no cervical change. Patient 1 was not administered the next physician ordered two doses of misoprostol a (medication used to for IOL) on 5/24/24 at 8 p.m. and 5/25/24 at 12 a.m. due to Patient 1 contracting too often (when the muscles of your uterus get tight and then relax). Patient 1's EMR indicated her medication for IOL was changed 5/25/24 at 6:52 a.m. Patients 1's EMR indicated she had had progressed to 1 centimeter (cm unit of measurement) dilated and the medication had "fell out". Patient 1's EMR indicated Medical Doctor (MD) 4 changed Patient 1's IOL medication on 5/25/24 at 8:35 p.m. Patient 1's EMR indicated MD 3 was notified on 5/26/24 at 10:18 a.m. that Patient 1 had Category 2 tracings with late and variable decelerations (when the FHR of the baby decreases after a contraction that can last from 15 seconds to 2 minutes) and fetal tachycardia (FHR greater than 180 beats per minute). Patient 1's EMR indicated on 5/26/24 at 10:33 a.m. an order to withhold food and fluids from the patient was received. On 5/26/24 at 10:39 a.m. MD 3 performed an artificial rupture of membranes (the intentional rupture of the amniotic sac by an obstetrical provider) on Patient 1, which indicated clear, blood-tinged moderate amniotic fluid. Patient 1's EMR indicated MD 3 placed a fetal scalp electrode (FSE-a spiral wire that can be placed on the scalp of the fetus to monitor their heart rate and ensure their well-being) and an intrauterine pressure catheter (IUPC-a device placed inside a pregnant woman's uterus to monitor uterine contractions during labor) on 5/26/24 at 10:42 a.m. Patient 1 received an amnioinfusion (a procedure to replace amniotic fluid lost during labor) on 5/26/24 at 11 a.m. due to FHR decelerations. Patient 1's EMR indicated Patient 1 was started on an oxytocin (a hormone that causes contractions of the uterus) infusion on 5/26/24 at 5:58 p.m. and was stopped on 5/27/24 at 1:40 a.m. MD 3 was notified on 5/27/24 at 1:45 a.m. of "[approximately] five minutes [deceleration] to 90 bpm, IUPC fell out earlier when pt voiding [urinated]. [oxytocin discontinued fetal heart tones] reassuring at this time...". Patient 1's EMR indicated she was dilated to 5 cm on 5/27/224 at 10:31 a.m. and the oxytocin was stopped on 5/27/24 at 10:48 a.m. for epidural placement (invasive pain management procedure). Patient 1's EMR indicated MD 1 was notified on 5/27/24 at 11:42 a.m. of Patient 1's oxytocin turned off during epidural placement and remained off due to late prolonged decelerations. Patient 1 EMR indicated the oxytocin infusion was again started on 5/27/24 at 12 p.m. and stopped at 7:31 p.m. Patient 1's EMR indicated MD 1 performed an assessment on 5/27/24 at 9:43 p.m., MD 1 discussed with, and Patient 1 agreed to a cesarean section. Patient 1's EMR indicated she delivered Patient 2 (baby) on 5/27/24 at 11:09 p.m.

During a review of Patient 2's (baby) "Electronic Medical Record (EMR)" the EMR indicated, Patient 2 had Apgar scores (assessment of a newborns status immediately after birth and the response to resuscitation efforts; a score of 7 or above on the test is considered in good health) of 0 at one minute, 1 at five minutes, 1 at ten minutes, 0 at fifteen minutes, and 0 at twenty minutes. Patient 2 was brought to the warming table at 30 seconds of life. Patient 2 was dusky, floppy, apneic (a condition in which a person involuntarily and temporarily stops breathing), and no had heart rate. Patient 2 was intubated (a tube inserted to provide oxygen into the lungs). Patient 2's EMR indicated resuscitation efforts were stopped, and time of death was called by the pediatric physician on 5/27/24 at 11:44 p.m.

During a review of Patient 2's EMR, the EMR indicated an autopsy was performed on 5/31/24. The provisional autopsy (the initial medical examination of a body after death) report indicated " ...intrauterine (inside the uterus) fetal death ... died as a result of sudden and unexpected intrauterine fetus death, pending causation ..."

During a review of Patient 1's "Tissue Pathology" report, dated 5/27/24, the report indicated " ...acute chorioamnionitis (an infection of the placenta and the amniotic fluid) ..."

During a review of Patient 1's EMR and "Fetal Monitoring Strip (FMS)" dated 5/24/24, the FMS indicated, Patient 2 (baby) was not monitored on 5/24/24 from 7:43 a.m. to 9:27 a.m. a time lapse of 1 hour and 43 minutes. Patient 1's EMR and FMS indicated Patient 2 not monitored on 5/24/24 from 11:12 a.m. to 2:02 p.m. a time lapse of 2 hours and 50 minutes. Patient 1's FMS indicated Patient 2 was not monitored on 5/24/24 from 8 p.m. to 10:03 p.m. a time lapse of 2 hours and three minutes. Patient 1's FMS indicated, Patient 2 had a deceleration when attached to the monitor at 10:03 p.m. Patient 1's FMS indicated, another late deceleration at 10:06 p.m. Patient 1's EMR indicated, nursing staff notified physician about a late deceleration on 5/24/24 at 10:30 p.m. Patient 1's EMR had no documentation indicating a reason for extended time with no fetal monitoring and no physician order.

During a concurrent interview and record review on 7/10/24 at 10:25 a.m. with Registered Nurse (RN) 5, the facility's P&P titled, "Intrapartum Fetal Monitoring," dated 10/2023 and Patient 1's EMR dated 5/24 /24 to 5/27/24 was reviewed. RN 5 stated, she was familiar with the facility's P&P . Patient 1's EMR indicated, Patient 1 had an oxytocin infusion running, and fetal status was documented every 30 minutes. RN 5 verified her nursing documentation for 5/27/24 was every 30 minutes. RN 5 stated, her documentation should have been completed every 15 minutes according to policy.

During a concurrent interview and record review on 7/10/24 at 10:30 a.m. with RN 5, Patient 1's EMR and "FMS", dated 5/27/24 from 7 a.m. to 3 p.m. were reviewed. The EMR and "FMS" indicated, Patient 1's baby (Patient 2) had prolonged decelerations, and late decelerations. The FMS indicated the IUPC was off scale (resting uterine tone below readable level on monitor) from 6:58 a.m. to 7:43 a.m. RN 5 validated the baby had late decelerations, variable decelerations, and moments of marked (FHR rising greater than 25 bpm) and minimal variability. RN 5 verified, the IUPC did not record accurate contractions from 6:58 a.m. to 7:43 a.m. on 5/27/24. RN 5 stated, when contractions were not recorded accurately, the physician and nursing staff may not have an accurate view of labor.

During a concurrent interview and record review on 7/11/24 at 9:11 a.m. with RN 4, the facility's P&P titled, "Intrapartum Fetal Monitoring," dated 10/2023 was reviewed. RN 4 stated she was familiar with the P&P and that she followed the policy.

During a concurrent interview and record review on 7/11/24 at 9:20 a.m. with RN 4, Patient 1's EMR and "FMS" dated 5/27/24 were reviewed. RN 4 stated, she cared for Patient 1 on the evening of 5/27/24 and was Patient 1's delivery nurse. RN 4 stated, no oxygen was administered to Patient 1 during her shift on 5/27/24 from 7:30 p.m. to 10:45 p.m. RN 4 stated according to the facility P&P the algorithm for the FHR late decelerations interventions were not followed for Patient 1. The interventions should have been to turn Patient 1 administer a bolus to replace water and electrolytes, turning off oxytocin, and administering oxygen if necessary. These interventions were not done according to P&P.

During a concurrent interview and record review on 7/11/24 at 9:25 a.m. with RN 4, Patient 1's EMR and "FMS" dated 5/24/24 to 5/27/24 were reviewed. Patient 1's FMS indicated, category 2 FHR tracings and documentation of interpretation of the FMS did not include category 2 tracings. RN 4 validated she documented physician at bedside on 5/27/24 at 9:43 p.m. Patient 1's EMR indicated MD 1 performed a clinical assessment at 9:44 p.m. and Patient 1 was 6 cm dilated with significant molding (shaping of the fetal head) and caput (swelling of the scalp) in the occiput posterior (OP) (not the usual position for delivery- baby is facing the mother's front instead of her back) position. Patient 1's EMR indicated a C/S decision time was 5/27/24 at 9:46 p.m. Patient 1's EMR indicated, an urgent (to be performed within 30 minutes) C/S for failure to progress. Patient 1's FMS indicated, a prolonged deceleration at 10:15 p.m., a variable deceleration at 10:24 p.m. and a three-minute prolonged deceleration at 10:39 p.m. RN 4 validated her documented turning Patient 1 to the right side at 10:23 p.m., no additional interventions were noted. Patient 1 was moved to the Operating Room (OR) on 5/27/24 at 10:46 p.m. a one-hour time lapse from the decision for an urgent c/s was made. Patient 1's EMR indicated, last provider notification for deceleration was at 10 p.m. RN 4 stated, she was "comfortable" in the OR and was the circulating nurse for Patient 1's C/S. RN 4 stated, she did not obtain Fetal Heart tones in the OR per P&P. RN 4 stated, MD 1 called the C/S urgent (soon) and not emergent (immediately). RN 4 stated, an "urgent" C/S meant "not right, right now, but means soon," within an hour. RN 4 stated, Patient 1's FMS was a "concerning strip" and she "agreed" nursing interventions were "not working." RN 4 validated there was no documentation where the charge nurse or physician were notified about Patient 1 baby had late and prolonged decelerations on 5/27/24.

During a concurrent interview and record review on 7/11/24 at 10:03 a.m. with RN 14, Patient 1's EMR and FMS dated 5/24/24 and 5/25/24 were reviewed. RN 14 stated she worked the p.m. shift from 7 p.m. to 7:30 a.m. RN 14 stated, she cared for Patient 1 on 5/24/24 overnight and the early morning of 5/25/24. RN 14 stated Patient 1's first night of induction was the night of 5/24/24. RN 14 stated, Patient 1 was difficult to monitor due to her weight. RN 14 stated she found Patient 1's baby (Patient 2) difficult to keep on the monitor. RN 14 stated, she did not inform the physician when she first determined Patient 1 was difficult to monitor per P&P. RN 14 stated on 5/24/24, she did not remember why she did not document Patient 2's the late deceleration at 5 a.m. and validated she did not notify the physician per facility P&P. RN 14 validated she did not document any interventions during this time for the late deceleration. RN 14 stated she should document all decelerations on the FMS. RN 14 stated she did not remember why Patient 1 was off the monitor on 5/24/24 from 8 p.m. to 10:03 a.m. RN 14 validated there was no physician order documented to allow Patient 1 to be off the monitor and it was RN 14's responsibility to ensure Patient 1 was on the monitor at all times and to notify the MD when the patient was not.

During a concurrent interview and record review on 7/11/24 at 10:08 a.m. with RN 17, Patient 1's EMR and FMS dated 5/25/25 and 5/26/24 were reviewed. RN 17 stated, she worked the p.m. shift from 7 p.m. to 7:30 a.m. RN 17 stated, she cared for Patient 1 on the night of 5/25/24 and the early morning of 5/26/24. RN 17 stated, Patient 1 was on a wireless fetal monitoring during her shift. RN 17 stated, the wireless monitoring would lose signal when Patient 1 was up to the restroom or was in certain positions. RN 17 documented signal loss in Patient 1's EMR. Patient 1's baby was unmonitored on 5/25/24 from 9:36 p.m. to 11:53 p.m. Patient 1's baby was unmonitored for 2 hour and 17 minutes. RN 17 did not document the reason for extended time with no fetal monitoring. RN 17 did not notify physician about inability to monitor baby during her shift. On 5/26/24 at 2:30 a.m. RN 17 documented absent (no) decelerations, when the FMS indicated a late deceleration at 2:01 a.m. that dropped down to 100 bpm. RN 17 validated a late deceleration at 2:01 a.m. on the FMS. RN 17 stated, she did not know why she documented no decelerations at 2:30 a.m. RN 17 stated, she should have notified physician when she was unable to monitor Patient 1's baby for an extended length of time.

During a concurrent interview and record review on 7/11/24 at 10:30 a.m. with RN 13, Patient 1's EMR and FMS dated 5/24/25 to 5/27/24 were reviewed. RN 13 stated, she worked the p.m. shift from 7 p.m. to 7:30 a.m. RN 13 stated, she admitted Patient 1 on the morning of 5/24/24. RN 13 stated, she cared for Patient 1 on the evening of 5/26/24 and early morning of 5/27/24. On 5/26/24 at 8:04 p.m. Patient 1 had a variable deceleration. RN 13 had no documentation in the EMR for a variable at 8:04 p.m. Patient 1's FMS indicated, a late deceleration at 9:44 p.m., 9:48 p.m., and 9:52 p.m. Patient 1's EMR indicated, no documentation of physician notification. Patient 1's FMS indicated, Patient 1 had a five-minute prolonged deceleration at 9:56 p.m. Patient 1's EMR indicated, no documentation of physician notification. RN 13 stated, Patient 1 had a seven-minute deceleration at 1:37 a.m. on 5/27/24. RN 13 stated, Patient 1 was sitting on a bed pan bearing down when the deceleration occurred. RN 13 stated, Patient 1 was turned to her left side, Oxytocin was discontinued, an IV bolus of Lactated Ringers begun, and the provider was notified. RN 13 stated, the FHR recovered and returned to a Category 1 tracing by 3:30 a.m.

During a concurrent interview and record review on 7/11/24 at 11:05 a.m. with the Family Birth Center Director (FBCD) and RN 15, Patient 1's EMR dated 5/27/24 was reviewed. RN 15 stated, she was the Charge Nurse on 5/27/24 the night of Patient 1's delivery. RN 15 stated, she worked the p.m. shift, from 7 p.m. to 7:30 a.m. RN 15 stated, her role as a charge nurse was to be a resource for the other nursing staff on the floor. RN 15 stated, she helped in the OR, she attended vaginal deliveries, she watched the fetal monitoring strips and called the physician for deliveries when needed. RN 15 stated, on 5/27/24 she remembered coming on shift at 7:10 p.m. after the nursing huddle (pre shift meeting) and assessed Patient 1's FMS with the primary nurse. RN 15 stated, Patient 1 had late decelerations, had prolonged rupture of membranes (water broken for over 18 hours), and had not made cervical change. RN 15 stated, she advised RN 4 to turn off oxytocin, reposition patient, and perform a cervical exam, and if there was no cervical change from previous cervical exam, they would discuss plan of care with the physician and a possible C/S. RN 15 stated, Patient 1's FMS began to look "better" when oxytocin was turned off, the strip no longer had recurrent late decelerations. RN 15 stated, she became "busy" with other patients no longer focused on Patient 1. RN 15 stated, she remembered RN 4 coming to her a "couple" times about Patient 1 having prolonged and late decelerations. RN 15 had no documentation that RN 4 had informed her about any decelerations. RN 15 stated, she was not aware Patient 1 had multiple prolonged decelerations on 5/27/24 from 9:46 p.m. to 10:46 p.m. RN 15 stated, if she had known about the late decelerations and prolonged decelerations, she would have escalated the urgency of the C/S to the physician. RN 15 stated, typically nursing staff obtained fetal heart tones when a patient was moved to the OR. RN 15 stated, when a patient had an FSE, they "always" get fetal heart tones in the OR. RN 15 stated, she informed RN 4 not to remove the FSE prior to patient's transfer to the OR. RN 15 stated, MD 1 removed the FSE when patient was moved to the OR. RN 15 stated, Patient 1's FSE was never attached to the monitor in the OR.

During an interview on 7/11/24 at 2 p.m. with Physician (MD) 1, MD 1 stated, a Laborist (physician who specializes in caring for women in labor and delivery of babies) shift was 24 hours from 8 a.m. to 8 a.m. the following day. MD 1 stated, he was Patient 1's delivery doctor. MD 1 stated, Patient 1 delivered on 5/27/24 by C/S after a time lapse of 89 hours and 24 minutes of labor, and a time lapse of 36 hours and 50 minutes from artificial rupture of membranes. MD 1 stated, he reviewed Patient 1's FMS throughout the day, or if the nursing staff called him with concerns. MD 1 stated, he would "glance" at the FMS in the "call room [area he stayed waiting for deliveries]". MD 1 stated, he did not recall "offhand" if the nursing staff called him about any decelerations, late, prolonged or variables. MD 1 stated, "generally" there were no calls from nursing staff. MD 1 stated, he reviewed Patient 1's chart on his own. MD 1 stated, he did not believe Patient 1 received enough oxytocin or misoprostol. MD 1 stated, the oxytocin was turned off due to decelerations but there was "always recovery during my shift [the FMS would have variability and accelerations]." MD 1 stated, he is available to nursing staff and they can call him with any questions or concerns. MD 1 stated, he remained on the unit and carried a cell phone. MD 1 stated, he did not remember all the details of the day. MD 1 stated, he remembered Patient 1 had two late decelerations in a row within 15 minutes. MD 1 stated, "I just know we were very, very busy". MD 1 stated, it was possible that Patient 1 had more prolonged decelerations and late decelerations but could not remember the details. MD 1 stated, he could not comment on the three days of Patient 1's care before he took over. MD 1 stated, he did have concerns about Patient 1 being in labor for 89 hours and 24 minutes. MD 1 stated, Patient 1's SVE was 4 cm when he took over care from the previous physician. MD 1 stated, overall, "the strip was good." MD 1 stated, he noted a lot of caput (swelling of the baby's scalp) and molding (shaping of the fetal head) when he performed his vaginal exam, but there were not any acute tolerance issues at that time. MD 1 stated, he did not recall nursing staff telling him anything about late decelerations or prolonged decelerations, only that the baby had recovery and oxytocin was restarted. MD 1 stated, facility staff did not rush to do the C/S. MD 1 stated, once the C/S was called oxytocin was discontinued. MD 1 stated, obtaining fetal heart tones in the OR is routine practice. MD 1 stated, he did not recall a fetal heart tone being done in the OR and it was "news to me" that it was not done. MD 1 stated, nursing staff should have obtained a fetal heart tone in the OR.

MD 1 stated, nothing "in particular" about Patient 1's case was different in the OR. MD 1 stated, when Patient 2 (baby) was delivered he was limp, his eyes were opened, no cry, no color. MD 1 stated, he massaged the baby, stimulated the baby, clamped the baby's cord quickly, and handed the baby to nursing staff.

MD 1 stated, he did not feel he had a detailed physician sign out from the off going physician, "basically all that was said was she's in labor". MD 1 stated, even though Patient 1's strip did not look "all that good", it was a Category 1 or Category 2 it was clear to him the patient was not making cervical change. MD 1 stated, Patient 1's C/S was performed due to arrest of dilation (Patient 1 was not making additional cervical change).

During a concurrent interview and record review on 7/11/24 at 2:37 p.m. RN 16, Patient 1's EMR and FMS dated 5/24/27 to 5/27/24 was reviewed. The EMR indicated, RN 16 assumed care of Patient 1 at 3 p.m. until 7:30 p.m. on 5/27/24. RN 16 verified Patient 1 was on oxytocin during her shift. RN 16 stated, when Patient 1 vomited on 5/27/24 at 4:12 p.m. the baby would have decelerations. RN 16 stated, Patient 1 was repositioned to her side after the deceleration. RN 16 documented Patient 1's fetal status every 30 minutes. RN 16 stated, she should have documented every 15 minutes per P&P because her patient was on oxytocin.

During a review of Patient 1's "Physician Note (PN)", dated 5/27/24, the "PN" indicated, " ... I was notified by phone at [9:54 p.m.] this evening by the Laborist on duty [MD 1 name] to plan to assist with an upcoming primary cesarean section ...presented a brief SBAR (report) ...arrived to the hospital at [10:30 p.m.] ... a short while later, the patient was taken to the operating room ..."


During an interview on 7/11/24 at 3:10 p.m. with MD 2, MD 2 stated, he was the assistant to the primary Physician on 5/27/24 for Patient 1's C/S. MD 2 stated he had a "general recollection" of Patient 1 having prolonged decelerations and late decelerations. MD 2 stated, Patient 1's FMS was not "warm and fuzzy (was not a category 1 strip)". MD 2 stated, "it was time to call it.". MD 2 stated, "it" was a C/S.

During a concurrent interview and record review on 7/11/24 at 3:23 p.m. with the FBCD, the hospital's P&P titled, "Intrapartum Fetal Monitoring," revised 10/2023 was reviewed. The FBCD stated, this was a system policy, and the hospital staff should be following this policy. The FBCD stated, she expected the hospital staff to follow the policy by documenting in the EMR every 15 minutes when the patient was on oxytocin and every 30 minutes with risk factors. The FBCD stated, it was common practice to get a fetal heart tone when a patient was in the OR this was not done for Patient 1's baby.

During a concurrent interview and record review on 7/12/24 at 10:15 a.m. with the Obstetric Department Chair (OBC), the OBC stated, the event was an "unanticipated outcome" and there were some opportunities to look at the FHR tracing "differently." The OBC stated, the cord blood gases for Patient 2 were "abnormal." The OBC stated, there was a mixture of respiratory (when your lungs cannot remove all the carbon dioxide produced by your body) and metabolic acidosis (too much acid in your blood). The OBC stated, it was the hospital's protocol to check fetal heart tones in the OR before a C/S procedure. The OBC stated, he recently learned the fetal heart tone was not checked for Patient 1's baby in the OR. The OBC stated, the tracing was a not category 3 (requires immediate action, when a baby is not getting enough oxygen) so there was a 10 to15 minutes reserve of oxygen to get the baby out safely. Patient 1 had a fetal heart tone on 5/27/24 at 10:46 p.m. before moving to the OR. Patient 1's baby did not have fetal heart tones performed by nursing staff in the OR. Patient 2 was delivered on 5/27/24 at 11:09 p.m., a time lapse of 38 minutes after last fetal heart tone was obtained.

During an interview on 7/12/24 at 12:37 p.m. with the Chief Nursing Officer (CNO), the CNO stated, she expected hospital staff to obtain a fetal heart tone in the OR before the start of the C/S procedure. The CNO stated, she expected hospital staff to follow the policy for FMS documentation.

During a review of Patient 1's EMR and FMS dated 5/24/24 to 5/27/24 the EMR indicated Patient 1's Physician decided for urgent C/S on 5/27/24 at 9:43 p.m. and the order was entered at 9:46 p.m. Patient 1's FMS indicated, Patient 1 had a total of three prolonged late declarations from 9:45 p.m. to 10:43 p.m. Patient 1's EMR indicated Patient 1's physician was not notified by nursing staff of any late or prolonged decelerations after the C/S decision at 9:43 p.m. Patient 1 was moved to the OR on 5/27/24 at 10:46 p.m. Patient 1's EMR did not have fetal heart tones performed by nursing staff in the OR. Patient 2 was delivered on 5/27/24 at 11:09 p.m., a time lapse of 38 minutes after last fetal heart tone was obtained. Patient 2 time of death was called at 11:44 p.m.

During a review of the facility's P&P titled, "Intrapartum Fetal Monitoring (FBC-206)" , dated 10/2023, indicated, " ... The frequency and method of intrapartum fetal monitoring will be determined by the following factors ... Provider's order ... Maternal-fetal status ... Clinical diagnosis ... Associated risk factors ... Continuous fetal monitoring is interpreted as EFM with temporary removal of monitors to accommodate the following activities, as ordered by physician: ... Bathroom privileges (BRP) ... During bedside ultrasound ... Continuous monitoring can be temporarily discontinued as ordered by the provider for a specific reason and period of time ... Electronic Fetal Monitoring Interpretation ... Decelerations: ... Determine FHR Category: ... Category 1 (Normal): ...Baseline rate of 110-160 beats per minute (bpm) ... Moderate FHR baseline variability ... Absent late or variable decelerations ... Present or absent early decelerations ...Present or absent accelerations ... Category [2] (Indeterminate): ... Bradycardia not accompanied by absent baseline variability ...Tachycardia ... Recurrent variable decelerations accompanied by minimal or moderate baseline variability ... Prolonged deceleration greater than 2 minutes but less than 10 minutes ... Variable decelerations with other characteristics ... Significant decelerations ... Category [2] FHR - clinically indicated interventions ... Physician notification ... Lateral positioning or change in maternal positioning ... O2 administration ... IV fluid bolus (500 mL) ... Discontinue or decrease oxytocin ... Cervical exam ... Consider amnioinfusion for recurrent variable decelerations ... Follow the Category [2] FHR Management Algorithm ... Moderate and/or marked variability with significant decelerations occurring with more than 50% of contractions over a 30 minute period ... Minimal and/or absent fetal heart rate variability with significant decelerations occurring with more than 30% of contractions over a 30 minute period ... Patients undergoing cesarean section ... Unscheduled Surgery: ... Continue fetal surveillance in the OR suite until the abdominal sterile preparation has begun ... The provider shall be notified when ... Category [2] FHR tracings ... Prolonged deceleration ... Moderate and/or marked variability with significant decelerations ... If the FHR tracing is abnormal, the RN will notify the provider and request that the provider review the FHR tracing ... EFM Assessment Intervals ... Latent Phase (< 4 cm) ... With Oxytocin or risk factors ... Every 15 minutes with Oxytocin. Every 30 minutes without ... Documentation of interpretation should include: ... Procedures, interventions, and evaluation of response and effectiveness ...Communication with provider ... Significant Decelerations - are defined as: o Variable decelerations >60 seconds with a nadir >60 bpm below the baseline o Variable decelerations >60 seconds with a nadir <60 bpm regardless of the baseline. o Any late decelerations of any depth o Any prolonged deceleration ..."

During a review of the facility's P&P titled, "Cesarean Section Guidelines (FBC-195)" , dated 9/2021, indicated, " ...The Licensed Independent Practitioners (LIP) and Family Birth Center (FBC) Staff will communicate ...The LIP will communicate to FBC staff the indication for Cesarean delivery as well as the urgency/type of cesarean Section ...Schedule ...Non-emergent ... Emergent (STAT) ...In general, an unscheduled Cesarean Section should occur within approximately 30 minutes from the decision to operate ...FHR monitoring should be resumed in the OR until prep is completed ..."

During a review of the facility's P&P titled, "Cervical Ripening with Synthetic Protaglandin PGE1, e.g., misoprostol) or Prostaglandin E2 (PGE2, e.g. dinoprostone vaginal insert) (FBC-188)", dated 07/2022, indicated, " ...Maternal vital signs and FHR are taken every 15 minutes after administration of misoprostol tablet for 1 hour and 2 hours for dinoprostone; then per labor protocol, maternal/fetal assessment or if lack of labor every 1-2 hours while the patient is awake ... With misoprostol, after 4 hours the patient is re-evaluated by the LIP or RN ... Assessment of Fetal Heart tones and contraction pattern to determine indications for further doses. If the woman was assessed to have strong regular contractions, defined as 3 in 10 minutes with each lasting more than 30 seconds, the next dose is to be held. If the contractions space out then the next dose can be administered ...LIPs will be notified immediately for ...Fetal heart rate decelerations ..."

During a review of the facility's P&P titled, "Pitocin Augmentation/Induction (FBC-191)", dated 7/2022, indicated, " ...There should be documentation of the following prior to the start of all Inductions and Augmentation of labor: ... Documented estimated fetal weight (EFW) ...Documentation of moderate variability without recurrent late or variable deceleration prior to administration of Oxytocin ...Electronic fetal monitoring and uterine contraction monitoring will continue as long as oxytocin is being administered ...Following are conditions for decreasing or discontinuing the oxytocin: ... Fetal stress ... Treatment for Fetal Stress: ... Oxytocin is to be turned off ...Blood pressure and pulse every 30-60 minutes as indicated by the patient's condition ..."

During a professional reference review on The American College of Obstetricians and Gynecologists Clinical website at https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2015/10/the-apgar-score, "The Apgar Score", dated October 2015, indicated, " ...The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. Thus, the Apgar score quantitates clinical signs of neonatal depression such as cyanosis or pallor, bradycardia, depressed reflex response to stimulation, hypotonia, and apnea or gasping respirations. The score is reported 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 7The Apgar score describes the condition of the newborn infant immediately after birth and, when properly applied, is a tool for standardized assessment ...It also provides a mechanism to record fetal-to-neonatal transition. Apgar scores do not predict individual mortality or adverse neurologic outcome. However, based on population studies, Apgar scores of less than 5 at 5 minutes and 10 minutes clearly confer an increased relative risk of cerebral palsy, and the degree of abnormality correlates with the risk of cerebral palsy. Most infants with low Apgar scores, however, will not develop cerebral palsy ...."




49884

Based on interview, and record review, the hospital failed to ensure medications were administered in accordance with the physician orders, facility policies and accepted standards of practice for one (Patient (Pt) 22) of 32 sampled patients when Pt 22's norepinephrine (a medication used to increase blood pressure) was not titrated according to the physician orders.

These failures had the potential for Patient 22 to experience excessive high blood pressure and increased risk of complications related to the medication.

Findings:

During a concurrent interview and record review on 7/10/24, at 9:15 a.m., with the Nurse Manager of ICU (RNM 1), Nurse Manager for Education (RNM 2) and ICU Registered Nurse (RN 12), Pt 22's electronic health record (EHR- digital collection of medical information) was reviewed. Pt 22's "History and Physical (H&P - the formal document that physicians produce through interview with the patient, physical exam, and the summary of testing either obtained or pending)", dated 7/4/24, "Medications", undated and "Flow Sheet", undated, were reviewed. Pt 22's H&P indicated Pt 22 was brought to the hospital "past medical history of hypertension, alcohol abuse, obesity, and depression ... He presents after suicide attempt via overdose on diphenhydramine [medication to suppress the body's immune response] , alcohol, and lisinopril [a medication for high blood pressure]. last known well time was 1930 [7:30 p.m.] on July 3, 2024. The patients presenting blood pressure was 77/47 [mm Hg -millimeters of Mercury, normal blood pressure for men is 124/77 mm Hg]; the patient remained persistently hypotensive for the next 90 minutes or greater. Intravenous norepinephrine [mediation used to raise the blood pressure] was initiated 125 minutes after ... arrival. .... Pt 22's "Flow Sheet" indicated, on 7/5/24 the norepinephrine was started at 2 mcg/min [micrograms/minute] when the Pt 22's blood pressure was 100/66 mm Hg and the mean arterial pressure (MAP-average pressure in a patient's arteries during one cardiac cycle) was 78. RNM 2 stated the nurse should not have restarted the medication as the MAP was greater than 65 and there was no indication of a new order.

During a record review of Patient 22's "Medications", undated, the order indicated, "norEPINEPHrine ... titration Range 0 - 50 mcg/min [microgram/minute], Titrate by 2 mcg/min as often as every minute to max [maximum] 50 mcg/min. TARGET GOAL: MAP greater than 65 ... "

During an interview the Chief Nursing Officer (CNO), on 7/121/24, at 12:30 p.m., Pt 22's care was reviewed. The CNO stated the nurse caring for Pt 22 should follow the orders as indicated in the record. The CNO stated the nurse should call the doctor if she felt there was a need to start the medication. The CNO stated nurses are expected to follow the policies for about medication administration and obtaining orders for patient care.

During a review of the facility P&P titled, "Core Nursing Standards of Practice", dated 6/2022, the P&P indicated, " ... viii. Medication Administration ... 1. Medications should be administered according to the 6 rights of medication safety (patient, drug, dose, route, time, reason) LP [licensed provider] orders, and hospital policies ... DOCUMENTATION EXPECTATIONS ... When clarification is required or in the event of an unexpected outcome, a note should be entered by the nurse providing detail and summarization. ..."

During a review of a professional reference titled "Lippincott Manual of Nursing Practice (11th ed.)," dated 2018, indicated, "Legal claims most commonly made against professional nurses include the following departures from appropriate care: failure to assess the patient properly or in a timely fashion, follow physician orders, follow appropriate nursing measures, communicate information about the patient, adhere to facility policy or procedure, document appropriate information in the medical record, administer medications as ordered, and follow physician's orders that should have been questioned or not followed, such as orders containing medication dosage errors."