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Based on review of hospital documentation and interviews with hospital personnel, the Governing Body failed to ensure that the Department of Surgery Chairperson met the position qualifications according to the hospital's bylaws. Please reference A0356.



19952

Based on review of clinical records, review of hospital policies, review of hospital documentation and interviews with hospital personnel for a neonatal adverse event, the hospital failed to ensure adequate medical care oversight during high risk deliveries. See A 0049

Based on review of clinical records, review of hospital policies, review of hospital documentation and interviews with hospital personnel for 3 of 5 neonatal patients (Patients #2, #6 and #10), the hospital failed to ensure that resources were readily available (including the pediatrician's presence at delivery) to meet the patients' needs. The findings include:

1. Patient #1, a 31year old (y.o.) pregnant female, gravida 2 para 1 (G2P1) at 35 6/7 weeks gestation, was admitted to the hospital on 4/14/10 at 2:17 PM for induction of labor due to a nonreactive NST (non-stress test). Review of the clinical record identified that the patient received Cervidil for cervical ripening, Pitocin augmentation, artificial rupture of membranes (AROM) and had a spontaneous vaginal delivery at 5:26 AM. The neonate, Patient #2 was delivered without respiratory effort, cry and tone. Neonatal Admission Assessment noted Apgars 1 at 1 minute, 1 at 5 minutes and 0 at 10 minutes (Apgar scale 0-10; 3 and below = critically low, 4 to 6 = fairly low, and 7 to 10 = generally normal). Review of the clinical records and interviews with the obstetrician, MD #1, RN #1 and RN #3 indicated that initial interventions (warmth, airway clearance, stimulation) were unsuccessful and that cardiopulmonary resuscitation (CPR) was implemented while the infant was transported to the nursery. Review of the records, review of hospital documentation and interviews with hospital personnel identified that the pediatrician, MD #4 was not present at the delivery and that the anesthesiologist, MD #2 intubated the infant twice (documentation reflects intubation time discrepancies). Review of the Pediatrician Progress Note dated 4/15/10 and interview with MD #4 on 5/17/10 identified that he believed that he arrived just prior to 6 AM. MD #4 identified that MD #2 and an Emergency Department (ED) physician, MD #5 were present when he arrived. MD #5 had inserted two umbilical vein catheters during the 2 hour resuscitation. Review of clinical records and interviews with MD #1, MD #2 and MD #4 identified that CPR was continued for 2 hours after delivery and that resuscitation efforts proved futile. Patient #2 was pronounced dead at 7:32 AM. Although review of hospital obstetric policies failed to address neonatal management of high risk maternity patients, review of the Conditions Requiring Pediatric Presence at Delivery dated/revised January 2010 indicated that a pediatrician would attend fetal distress deliveries, as well as estimated gestational age < 35 weeks. Interviews with MD #2 and the charge nurse, RN #3 identified that they were not sure who directed the neonatal code. Interview with the Vice President and Chief Medical Officer on 5/12/10 identified that the pediatrician would direct the neonatal resuscitation. Review of the Code 10-CPR Policy identified that the Emergency Room Physician directs the code. Interview with the Nursing Director of Perinatal Services on 4/28/10 identified that the hospital lacked a policy specific to neonatal resuscitation. Review of hospital documentation and interviews with hospital personnel failed to reflect that resources were readily available for the patients' needs, as well as policies that identified neonatal resuscitation leadership, roles, pediatrician availability and mechanism for coverage (when not present) for neonatal medical management.
2. Patient #5, a 44 y.o. pregnant female, at 34 2/7 weeks gestation, was admitted to the hospital on 9/1/09 at 9:45 AM for a stat cesarean section (C-section) due to a non-reassuring fetal tracing. Review of the Anesthesia Record dated 9/1/09 indicated that the infant (Patient #6) was delivered at 12:11 PM. Review of the Operative Report dated 9/1/09 indicated that the infant was handed off to the nurse. The clinical record reflected that Apgars were 8 at 1 minute and 9 at 5 minutes (Apgar scale 0-10; 3 and below = critically low, 4 to 6 = fairly low, and 7 to 10 = generally normal). Review of the Pediatrician Progress Note dated 9/1/09 (not timed) identified that the baby was delivered prior to the pediatrician's arrival. Review of the clinical record failed to reflect the pediatrician's time of arrival. The clinical record identified that Patient #6 had respiratory distress syndrome, received oxygen via blow-by and subsequently, via the oxyhood. At 2:45 PM the baby was transferred to a higher level of care at another hospital. Review of the Conditions Requiring Pediatric Presence at Delivery dated/revised January 2010 indicated that a pediatrician would attend fetal distress deliveries, as well as estimated gestational age < 35 weeks. The hospital failed to ensure that the pediatrician was present at the delivery as per policy.
3. Patient #9, a 34 y.o. pregnant female, at 34 2/7 weeks gestation, was admitted to the hospital on 9/15/09 at 6:42 AM for heavy vaginal bleeding and a stat C-section. Review of the Anesthesia Record dated 9/15/09 indicated that the infant (Patient #10) was delivered at 7:23 AM. The Operative Report dated 9/15/09 identified that the infant was handed to the nurse. The clinical record reflected that Apgars were 3 at 1 minute, 7 at 5 minutes and 9 at 10 minutes (Apgar scale 0-10; 3 and below = critically low, 4 to 6 = fairly low, and 7 to 10 = generally normal). The Pediatrician Progress Note dated 9/15/09 at 8:00 AM reflected that the baby was delivered prior to the pediatrician's arrival and that Anesthesia was unable to intubate. Patient #10 had received oxygen via blow-by, positive pressure ventilation (PPV), as well as nasal CPAP. The Progress Note also identified that Patient #10 had respiratory distress syndrome and was transferred to a higher level of care at another hospital. Review of the Conditions Requiring Pediatric Presence at Delivery Policy dated/revised January 2010 indicated that a pediatrician would attend fetal distress deliveries, as well as estimated gestational age < 35 weeks. The hospital failed to ensure that the pediatrician was present at the delivery as per policy.

Based on review of clinical records, review of hospital policy, review of hospital documentation and interviews with hospital personnel for one reported neonatal adverse event, the hospital's QAPI program failed to reflect thorough analysis and identify the mechanism for neonatal medical coverage for high risk maternity patients during delivery. The findings include:

1. Review of hospital documentation and review of clinical records identified that Patient #1, a 31year old (y.o.) pregnant female, gravida 2 para 1 (G2P1) at 35 6/7 weeks gestation, was admitted to the hospital on 4/14/10 at 2:17 PM for induction of labor due to a nonreactive NST (non-stress test). Review of the clinical record identified that the patient received Cervidil for cervical ripening, Pitocin augmentation, artificial rupture of membranes (AROM) and had a spontaneous vaginal delivery at 5:26 AM. The neonate, Patient #2 was delivered without respiratory effort, cry and tone. Neonatal Admission Assessment noted Apgars 1 at 1 minute, 1 at 5 minutes and 0 at 10 minutes (Apgar scale 0-10; 3 and below = critically low, 4 to 6 = fairly low, and 7 to 10 = generally normal). The neonate was subsequently intubated and received CPR for 2 hours. The resuscitation ended at 7:32 AM and the baby was pronounced. The Corrective Action Plan (CAP) submitted to the Department of Public Health (DPH) on 4/20/10 identified three areas to prevent reoccurrence that included: 1. Pitocin policy review and 2. education that was completed in January, prior to the event. The third item identified was a neonatal mega code utilzing a revised neonatal code record to be completed in May 2010. The CAP failed to reflect neonatal resuscitation resource issues that were identified during the investigation. Review of the Quality Improvement Process Policy identified that the Department Directors would survey department functions and develop areas to be monitored that included high risk, problem prone and low volume services. Interview with MD #4 on 5/17/10 identified that the event had not been reviewed by the medical staff. Although review of the Perinatal Committee Minutes dated 4/21/10 identified that the neonatal adverse event had been reported to the Department of Public Health, the minutes failed to reflect that quality improvement process and/or indicators regarding the neonatal adverse event had been analyzed and/or reviewed. The QAPI process failed to identify a mechanism for medical coverage during the delivery. Interviews with the Director of Quality Assurance and the Director of Perinatal Services on 4/28/10 and review of hospital documentation failed to reflect that a thorough and in-depth analysis of the event was completed in order to prevent reoccurrence.

Based on review of clinical records, review of hospital policy, review of hospital documentation and interviews with hospital personnel for 3 of 5 neonatal patients, the hospital failed to ensure that resources were readily available to meet patient needs. (See A 0347)

Based on review of clinical records, review of hospital policies, review of hospital documentation and interviews with hospital personnel for 3 of 5 neonatal patients (Patients #2, #6 and #10), the hospital failed to ensure that resources were readily available (including the pediatrician's presence at delivery) to meet the patients' needs. The findings include:

1. Patient #1, a 31year old (y.o.) pregnant female, gravida 2 para 1 (G2P1) at 35 6/7 weeks gestation, was admitted to the hospital on 4/14/10 at 2:17 PM for induction of labor due to a nonreactive NST (non-stress test). Review of the clinical record identified that the patient received Cervidil for cervical ripening, Pitocin augmentation, artificial rupture of membranes (AROM) and had a spontaneous vaginal delivery at 5:26 AM. The neonate, Patient #2 was delivered without respiratory effort, cry and tone. Neonatal Admission Assessment noted Apgars 1 at 1 minute, 1 at 5 minutes and 0 at 10 minutes (Apgar scale 0-10; 3 and below = critically low, 4 to 6 = fairly low, and 7 to 10 = generally normal). Review of the clinical records and interviews with the obstetrician, MD #1, RN #1 and RN #3 indicated that initial interventions (warmth, airway clearance, stimulation) were unsuccessful and that cardiopulmonary resuscitation (CPR) was implemented while the infant was transported to the nursery. Review of the records, review of hospital documentation and interviews with hospital personnel identified that the pediatrician, MD #4 was not present at the delivery and that the anesthesiologist, MD #2 intubated the infant twice (documentation reflects intubation time discrepancies). Review of the Pediatrician Progress Note dated 4/15/10 and interview with MD #4 on 5/17/10 identified that he believed that he arrived just prior to 6 AM. MD #4 identified that MD #2 and an Emergency Department (ED) physician, MD #5 were present when he arrived. MD #5 had inserted two umbilical vein catheters during the 2 hour resuscitation. Review of clinical records and interviews with MD #1, MD #2 and MD #4 identified that CPR was continued for 2 hours after delivery and that resuscitation efforts proved futile. Patient #2 was pronounced dead at 7:32 AM. Although review of hospital obstetric policies failed to address neonatal management of high risk maternity patients, review of the Conditions Requiring Pediatric Presence at Delivery dated/revised January 2010 indicated that a pediatrician would attend fetal distress deliveries, as well as estimated gestational age < 35 weeks. Interviews with MD #2 and the charge nurse, RN #3 identified that they were not sure who directed the neonatal code. Interview with the Vice President and Chief Medical Officer on 5/12/10 identified that the pediatrician would direct the neonatal resuscitation. Review of the Code 10-CPR Policy identified that the Emergency Room Physician directs the code. Interview with the Nursing Director of Perinatal Services on 4/28/10 identified that the hospital lacked a policy specific to neonatal resuscitation. Review of hospital documentation and interviews with hospital personnel failed to reflect that resources were readily available for the patients' needs, as well as policies that identified neonatal resuscitation leadership, roles, pediatrician availability and mechanism for coverage (when not present) for neonatal medical management.
2. Patient #5, a 44 y.o. pregnant female, at 34 2/7 weeks gestation, was admitted to the hospital on 9/1/09 at 9:45 AM for a stat cesarean section (C-section) due to a non-reassuring fetal tracing. Review of the Anesthesia Record dated 9/1/09 indicated that the infant (Patient #6) was delivered at 12:11 PM. Review of the Operative Report dated 9/1/09 indicated that the infant was handed off to the nurse. The clinical record reflected that Apgars were 8 at 1 minute and 9 at 5 minutes. Review of the Pediatrician Progress Note dated 9/1/09 (not timed) identified that the baby was delivered prior to the pediatrician's arrival. Review of the clinical record failed to reflect the pediatrician's time of arrival. The clinical record identified that Patient #6 had respiratory distress syndrome, received oxygen via blow-by and subsequently, via the oxyhood. At 2:45 PM the baby was transferred to a higher level of care at another hospital. Review of the Conditions Requiring Pediatric Presence at Delivery dated/revised January 2010 indicated that a pediatrician would attend fetal distress deliveries, as well as estimated gestational age < 35 weeks. The hospital failed to ensure that the pediatrician was present at the delivery as per policy.
3. Patient #9, a 34 y.o. pregnant female, at 34 2/7 weeks gestation, was admitted to the hospital on 9/15/09 at 6:42 AM for heavy vaginal bleeding and a stat C-section. Review of the Anesthesia Record dated 9/15/09 indicated that the infant (Patient #10) was delivered at 7:23 AM. The Operative Report dated 9/15/09 identified that the infant was handed to the nurse. The clinical record reflected that Apgars were 3 at 1 minute, 7 at 5 minutes and 9 at 10 minutes (Apgar scale 0-10; 3 and below = critically low, 4 to 6 = fairly low, and 7 to 10 = generally normal). The Pediatrician Progress Note dated 9/15/09 at 8:00 AM reflected that the baby was delivered prior to the pediatrician's arrival and that Anesthesia was unable to intubate. Patient #10 had received oxygen via blow-by, positive pressure ventilation (PPV), as well as nasal CPAP. The Progress Note also identified that Patient #10 had respiratory distress syndrome and was transferred to a higher level of care at another hospital. Review of the Conditions Requiring Pediatric Presence at Delivery Policy dated/revised January 2010 indicated that a pediatrician would attend fetal distress deliveries, as well as estimated gestational age < 35 weeks. The hospital failed to ensure that the pediatrician was present at the delivery as per policy.

Based on review of hospital documentation and interviews with hospital personnel, documentation and interviews failed to reflect that the Department of Surgery Chairperson met the position qualifications according to the hospital's bylaws. The findings include:

Review of facility documentation dated 11/1/09 to 10/31/10 identified that MD #2 was the the Sugery Department Chairperson. Review of hospital documentation and interview with MD #2 on 5/17/10 at 9 AM identified that he was board certified in anesthesiology and critical care. MD #2 indicated that he has been the Surgical Chairperson since October 2009. Although the hospital Bylaws of the Medical and Dental Staff identified that each Chairman shall be a member of the active staff, and shall be certified by an appropriate specialty board, the medical staff bylaws failed to identify qualifications of the chairperson based on education, training and/or certification in the area for which the physician is chairperson.

Based on review of clinical records, review of hospital policy/documentation and interviews with hospital personnel for one neonatal adverse event, the medical records were inaccurate and incomplete. The findings include:

1. Patient #1, a 31 y.o pregnant female, at 35 6/7 weeks gestation, was admitted to the hospital on 4/14/10 at 2:17 PM for induction of labor due to a nonreactive NST. Review of the clinical record identified that the patient received Cervidil for cervical ripening, Pitocin augmentation, AROM and had a spontaneous vaginal delivery at 5:26 AM. The neonate, Patient #2 was delivered without respiratory effort, cry and tone. Neonatal Admission Assessment noted Apgars 1/1/0. Review of clinical records and interviews with MD #1, MD #2 and MD #4 identified that CPR was continued for 2 hours after delivery and that resuscitation efforts proved futile. Patient #2 was pronounced dead at 7:32 AM. Review of the Code 10 Record dated 4/15/10 failed to reflect the neonate's heart rate and rhythm during the resuscitation from 5:26 AM through 6:05 AM; from 6:20 AM through 6:55 AM and from 7:00 AM to the end of the resuscitation at 7:32 AM when the infant was pronounced dead. Review of the clinical record and interviews with MD #2, MD #4, RN #1 and RN #3 identified heart rate discrepancies. Although interviews identified that cardiac leads were applied to the neonate during CPR, no cardiac monitor rhythm strips were produced. Review of hospital documentation and interview with the VP of Patient Care Services on 5/4/10 identified that the cardiac monitor was a 1993 model, the monitor memory was small and not obtainable. The medical record failed to reflect cardiac assessment, interventions as well as response to interventions during the neonatal resuscitation.