Introduction The Norwegian Board of Health Supervision inspects healthcare institutions to ensure safety and quality of health and welfare services. A planned inspection of 12 maternity units aimed to investigate the practice of obstetric care in the case of birth asphyxia, shoulder dystocia and severe postpartum hemorrhage. Material and methods The inspection was carried out at two large, four medium and six small maternity units in Norway in 2016 to investigate adverse events that occurred between 1 January and 31 December 2014. Six of them were selected as control units. The Norwegian Board of Health Supervision searched the Medical Birth Registry of Norway to identify adverse events in each of the categories and then requested access to the medical records for all patients identified. Information about guidelines, formal teaching and simulation training at each unit was obtained by sending a questionnaire to the obstetrician in charge of each maternity unit. Results The obstetric units inspected had 553 serious adverse events of birth asphyxia, shoulder dystocia or severe postpartum hemorrhage among 17 323 deliveries. Twenty‐nine events were excluded from further analysis due to erroneous coding or missing data in the patients’ medical records. We included 524 cases (3.0% of all deliveries) of adverse events in the final analysis. Medical errors caused by substandard care were present in 295 (56.2%) cases. There was no difference in the prevalence of substandard care among the maternity units according to their size. Surprisingly, we found significantly fewer cases with substandard care in the units which the supervisory authorities considered particularly risky before the inspection, compared with the control units. Seven of the 12 units had regular formal teaching and training arrangements for obstetric healthcare personnel as outlined in the national guidelines. Conclusions Prevalence of adverse events was 3% and similar in all maternity units irrespective of their size. A breach in the standard of care was observed in 56.2% of cases and almost half of the maternity units did not follow national recommendations regarding teaching and practical training of obstetric personnel, suggesting that they should focus on implementing guidelines and training their staff.
IntroductionWe aimed to determine how serious adverse events in obstetrics were assessed by supervision authorities.Material and methodsWe selected cases investigated by supervision authorities during 2009‐2013. We analyzed information about who reported the event, the outcomes of the mother and infant, and whether events resulted from errors at the individual or system level. We also assessed whether the injuries could have been avoided.ResultsDuring the study period, there were 303 034 births in Norway, and supervision authorities investigated 338 adverse events in obstetric care. Of these, we studied 207 cases that involved a serious outcome for mother or infant. Five mothers (2.4%) and 88 infants (42.5%) died. Of the 207 events reported to the supervision authorities, patients or relatives reported 65.2%, hospitals reported 39.1%, and others reported 4.3%. In 8.7% of cases, events were reported by more than 1 source. The supervision authority assessments showed that 48.3% of the reported cases involved serious errors in the provision of health care, and a system error was the most common cause. We found that supervision authorities investigated significantly more events in small and medium‐sized maternity units than in large units. Eighteen health personnel received reactions; 15 were given a warning, and 3 had their authority limited. We determined that 45.9% of the events were avoidable.ConclusionsThe supervision authorities investigated 1 in 1000 births, mainly in response to complaints issued from patients or relatives. System errors were the most common cause of deficiencies in maternity care.
Background The Norwegian Board of Health Supervision aims to contribute to the improvement of quality and patient safety in the healthcare services. Planned audits were performed to investigate how 12 selected Norwegian obstetric units reported and analyzed adverse events as the part of their quality assurance and patient safety work. Methods Serious adverse events coded as birth asphyxia, shoulder dystocia and severe postpartum hemorrhage that occurred during 2014 (the most recent year for which the quality assured data were available) were obtained from the Medical Birth Registry of Norway. The obstetric units were asked to submit medical records, internal adverse events reports, and their internal guidelines outlining which events should be reported to the quality assurance system. We identified the adverse events at each obstetric unit that were reported internally and/or to the central authorities. Two obstetricians carried out an evaluation of each event reported. Results Five hundred fifty-three serious adverse events were registered among 17,323 births that took place at the selected units. Twenty-one events were excluded because of incorrect coding or missing information. Eight events were registered in more than one category, and these were distributed to the category directly related to injury or adverse outcome. Nine of twelve (75 %) obstetric units had written guidelines describing which events should be reported. The obstetric units reported 49 of 524 (9.3 %) serious adverse events in their internal quality assurance system and 39 (7.4 %) to central authorities. Of the very serious adverse events, 29 of 149 (19.4 %) were reported. Twenty-three of 49 (47 %) reports did not contain relevant assessments or proposals for improving quality and patient safety. Conclusions This study showed that adverse event reporting and analyses by Norwegian obstetric units, as a part of quality assurance and patient safety work, are suboptimal. The reporting culture and compliance with guidelines need to be improved substantially for better safety in patient care, risk mitigation and clinical quality assurance.
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