In this study, we found that the obstetric units in Norway reported less than 10 % of adverse events with birth asphyxia, shoulder dystocia or severe postpartum hemorrhage in their own internal quality assurance and adverse event reporting system, and only 7.4 % were reported further to the central authorities. Less than one fifth of the very serious events were reported. It is worrying that even in a highly developed, high-income country with a national universal healthcare insurance coverage, a patient injury compensation system and sanction-free mandatory reporting required by law, so few events are reported and analyzed as part of quality assurance and patient safety work. As transparent reporting and appropriate analyses of adverse events is a prerequisite for learning, risk management and preventing patient injuries, improving reporting culture is essential. In addition to laws and government directives, better education and training of healthcare professionals in patient safety and risk management, as well as improving awareness and providing incentives for transparent reporting, may be required to motivate and engage them in clinical quality assurance.
In this study, we wanted to take a closer look at serious adverse clinical events. An adverse event is usually defined as an accidental injury to the patient that occurs in connection with medical/surgical treatment. The injury can have different levels of severity such as death, permanent disability or extended hospital stay . The supervisory authorities wanted to assess events that fell into these categories. They obtained information from MBRN on the number of patients who had birth asphyxia, shoulder dystocia or severe postpartum hemorrhage and verified events reported by evaluating the medical records of the patients in question from each obstetric care unit. To our knowledge, no studies with a similar design have previously been reported. The method had advantages since we were able to obtain information on all the serious clinical adverse events in each category.
Our study showed that only a very small fraction of severe adverse obstetric events was reported internally and to the central authorities, although the majority of these events should have been reported, either because there was a patient injury or because the events could have led to serious injury (cf. the Specialist Health Services Act, Chap. 3). The purpose of the notification scheme is for the healthcare institutions to learn from adverse events. Therefore, especially in the case of events where there was a failure, these should have been reported, reviewed and analyzed. We have previously shown that there was a failure in diagnoses and treatment in 56.2 % of the events in this material, but no significant differences were observed between small, medium and large birth units . In that study, we also found that a greater number of adverse events occurred in the control group, rather than in the maternity units considered to be at high-risk by the supervisory authorities. The supervisory authorities´ assessments of which units to consider as high-risk should be based on several parameters, not only on their experiences from previous inspections.
According to Norwegian law, these events should have been reported, but the text of the law is open to a certain discretionary assessment of whether the events must be reported or not. It is important to note that most obstetric care units (75 %) had their own guidelines for what events that should be reported. However, we have previously shown that the guidelines are not followed to a great extent [18, 21]. Furthermore, even among the very serious adverse events, which should have been reported in accordance with Norwegian law (Specialist Health Services Act §§ 3–3 and 3-3a) and national guidelines , less than one fifth were reported. Thus, there was significant under-reporting, and our findings are in concordance with other studies [22,23,24].
The survey also shows that there are statistically significant differences in reporting frequency between different sized obstetric units. It is striking that the reporting frequency seems to be highest in the medium-sized units. However, our study design does not make it possible to deduce any information about the reasons for these differences. Nevertheless, it might be reasonable to assume that the differences are related to the institutions’ organizational culture and clinical governance.
The secondary aim of our current study also was to evaluate if there were differences in reporting of adverse events between units selected by the supervisory authorities for closer surveillance and those randomly allocated as a control group. There were no significant differences between the two groups. This may indicate that the size of the obstetric units had the greatest significance for whether serious adverse events were reported, not the units considered as high-risk.
In Norway, anonymized reporting was introduced in 2012, which led to an increase in the number of events reported to central authorities . However, our findings show that there are still many adverse obstetric events that are not reported. The data, which central authorities receive through the reporting schemes, therefore provide little information about the extent of adverse events in obstetric care and the types of events that occur [10, 11]. Several measures are needed to ensure that adverse events are reported correctly, transparently and comprehensively. Healthcare personnel must not only be familiar with the legal text that describes what needs to be reported, but must also know and follow the national guidelines from the professional society of obstetrics and gynecology .
Several studies have shown an underreporting of adverse events , including in obstetric units [2, 10, 23]. There may be several reasons for underreporting. The units that do not have a traditional culture of reporting and learning from serious events are less likely to have midwives and obstetricians reporting serious events . Some obstetricians fail to report because they feel guilt or shame, others because they fear punishment . It has been shown that reporting culture may be different among different healthcare professionals. Midwives seem to report adverse events more often than doctors, although often these are events without serious injury .
In our study, less than half of the reports contained relevant assessments and analyses of the adverse events or suggestions for improvements. In Norway, the incidents are assessed by the hospital’s quality assurance council. Members of this council consists of different healthcare professionals who are not always familiar with obstetric assessments. In our opinion, it was possible to make adequate assessment of the incidents if all information available in the medical record had been assessed by health personnel with the right competence.
According to Norwegian law, patients or relatives must receive information (Patient and User Rights Act § 3 − 2) about adverse events: what happened and what measures can be taken to prevent similar events from happening again. In addition, they must be informed about the possibility of applying for financial compensation. Our review of medical records showed that less than half received information about the birth process and only 0.9 % were informed about the possibility of applying for financial compensation to the Norwegian System of Compensation to Patients (NPE), a government agency under the Ministry of Health and Care Services (https://www.npe.no/en/). However, as our findings were based on the information obtained from medical records, it is not possible to rule out that this information was provided without being recorded. Sound information and good communication, which also mentions failures, help to create and build trust in health professionals. At the same time, it can help to facilitate the patients’ own processing of a traumatic birth process .
Strengths and limitations
The strength of our study is that the information from MBRN made it possible to get a comprehensive overview of all adverse events in the three categories studied in each obstetric unit. The implementation of a planned inspection by to the Norwegian Board of Health Supervision ensured that all patient records and non-conformance reports were sent to the supervising authority. The weakness of the study is that the material is relatively small, especially the number of very serious adverse events. This means that the statistical analyses must be interpreted with caution. The data are from 2014, and may not reflect the current situation in Norway as there might have been changes in routines and practices regarding which incidents are to be reported and analyzed.