Adverse events reporting by obstetric units in Norway as part of their quality assurance and patient safety work: an analysis of practice.

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.

How common is substandard obstetric care in adverse events of birth asphyxia, shoulder dystocia and postpartum hemorrhage? Findings from an external inspection of Norwegian maternity units.

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.

Are stipulated requirements for the quality of maternity care complied with? / Følges fastsatte kvalitetskrav i fødselsomsorgen?

BACKGROUND: The Directorate of Health's national guide Et trygt fødetilbud ­ kvalitetskrav til fødselsomsorgen [A safe maternity service ­ requirements regarding the quality of maternity care] was published in December 2010 and was intended to provide a basis for an improved and more predictable maternity service. This article presents data from the maternity institutions on compliance with the quality requirements, including information on selection, fetal monitoring, organisation, staffing and competencies. MATERIAL AND METHOD: The information was acquired with the aid of an electronic questionnaire in the period January­May 2015. The form was sent by e-mail to the medical officer in charge at all maternity units in Norway as at 1 January 2015 (n=47). RESULTS: There was a 100 % response to the questionnaire. The criteria for selecting where pregnant women should give birth were stated to be in conformity with the quality requirements. Some maternity institutions failed to describe the areas of responsibilities of doctors and midwives (38.5 % and 15.4 %, respectively). Few institutions recorded whether the midwife was present with the patient during the active phase. Half of the maternity departments (level 2 birth units) reported unfilled doctors' posts, and a third of the university hospitals/central hospitals (level 1 birth units) reported a severe shortage of locum midwives. Half of the level 2 birth units believed that the quality requirements had resulted in improved training, but reported only a limited degree of interdisciplinary or mandatory instruction. INTERPRETATION: The study reveals that there are several areas in which the health enterprises have procedures that conform to national quality requirements, but where it is still unclear whether they are observed in practice. Areas for improvement relate to routines describing areas of responsibility, availability of personnel resources and staff training.

Neonatal deaths and injuries.

BACKGROUND: It is rare for babies to die or be injured during birth in Norway. We aimed to investigate whether maternity care was inadequate in cases reported to the Norwegian Board of Health Supervision and to single out areas in maternity care where there is potential for improvement. MATERIAL AND METHOD: The material consists of cases reported to the Norwegian Board of Health Supervision in the three-year period 2006-2008 in which babies died or were severely injured during delivery. We recorded data on: maternity unit, fetal monitoring, delivery method, personnel involved and type of inadequate maternity care. RESULTS: The material consists of 81 cases. Babies died during or after deliver in 58 cases and were severely injured in 23 cases. The health trusts reported 42 of these events to the Board of Health Supervision; the remainder were reported by the patient ombudsman or the parents. There was inadequate fetal monitoring in 68 % of the births and delayed delivery in 67 %. A gynaecological specialist was not called for 44 % of the births. The number of cases of injuries in relation to the number of deliveries reported to the Board of Health Supervision was significantly higher for small maternity units (< 1000 births per year) than for larger units. INTERPRETATION: Doctors and midwives need a better knowledge of fetal monitoring. Maternity units must develop sound procedures for singling out high-risk births, use of fetal monitoring, calling for a doctor and reporting to the Board of Health Supervision. Exercises in dealing with acute situations should be held. Small maternity units appear to be most vulnerable to adverse events.