7. Responding to reports

We respond to reports differently depending on incident severity, complexity and the assumed risk of (similar) incident recurrence. In some cases, we obtain more detailed information about the incident from the organisation and from the patient and/or next of kin before deciding how to respond to the report. Table 7 shows our conclusion concerning the reports we rated as meeting the reporting criteria.

When assessing whether there is a basis for following up on a report, we look not only at the outcome for the patient, but also at the risk of a similar incident impacting other patients. In cases closed after preliminary investigations by us, our opinion is that the organisation’s internal review and actions are the most appropriate means of improving service safety and quality standards. These may be incidents that have had severe outcomes for the patient/user, but where we still believe that any further action on the part of the supervisory authorities is unwarranted.

As shown in Table 6, approximately 84 per cent of cases were forwarded to the County Governor for assessment of the need for a supervisory response. These are cases for which we consider that there is a need to conduct a more detailed investigation of the incident and in which the County Governor’s local insights may be important for correct understanding of the incident.

The Office of the County Governor has its own methods for incident assessment. The processing and conclusions of the County Governors are not presented in this document.

Figure 1 shows that the Norwegian Board of Health Supervision took supervisory action in a total of 16 cases, or on 1.8 percent of reports concerning municipal health and care services. We investigate the most complicated incidents where it may be difficult to ascertain the course of events, when multiple services and employees are involved, if severe failure/omission is suspected and/or if the incident exemplifies a particularly important topic in patient safety and quality of care.

In total, we conducted 14 incident-based regulatory inspections[1]. In some instances, we visit involved organisations to talk to managers and healthcare staff who were involved in care provision and we offer patients/next of kin an interview. Thorough investigation and analysis of these cases is necessary in order to gain an accurate picture of the incident and ascertain whether the incident is indicative of a failure in the organisation’s risk management. This forms the basis for assessments of the responsibilities of the organisation’s management and involved healthcare staff, and the organisation’s regulatory compliance. The inspection identifies and investigates organisational factors that contributed to the failure of risk management and healthcare.

In two cases, we asked the organisation to self-report in writing their assessment of the incident. The organisations set out improvement proposals that are planned to be implemented as a result of the reported incident. We focus on the organisation’s active commitment to quality improvement and patient safety in order to prevent future failures as well as on management’s responsibility for establishing effective management systems.

The purpose is to identify risk areas, which risk mitigation and harm reduction actions have been undertaken or are needed in order for our supervision to raise standards of care and trust in the services. Before we close an incident-based inspection we consider whether the case can be closed or whether it warrants further action.

[1] Two cases were inspected as one because the two incidents were indicative of similar issues a few days apart.

After conducting our inspection, we compile and issue our report to the organisation and to the patient/user or next of kin. The Norwegian Board of Health Supervision monitors the case, jointly with the County Governor if necessary, until the organisations have rectified any regulatory non-compliance/unsafe circumstances.

As a general rule, all reports are published in an anonymised version on the Norwegian Board of Health Supervision website. Our incident-based inspection reports are intended to contribute to learning and improvement beyond the particular incident and organisation(s) involved, by communicating the findings to other organisations that also stand to learn from the incident in terms of improvements in quality standards and patient safety. 

In the following, we present the themes in these cases and some common features of risk reduction and quality improvement measures.

1. High-risk pregnancy follow-up
2. Medication monitoring for at-home patients
3. Transportation and healthcare in an emergency
4. Healthcare for a patient in acute mental health crisis
5. Follow-up of patient in a case of acute exacerbation during a stay in a municipal acute inpatient unit
6. Care coordination in follow-up of a patient in a state of confusion (delirium)
7. Healthcare for agitated users in need of round-the-clock supervision
8. Clinician attendance at out-of-hours medical centre for acute chest pain
9. Pregnancy management at out-of-hours medical centre
10. Use of welfare technology (GPS tracker) by nursing home resident with dementia
11. Follow-up of sick child at refugee reception centre
12. Medication management during transition between hospital and nursing home
13. Communication and information flow in medication management in homecare
14. Follow-up care at home following short-stay hospitalisation
15. Mix-up of two patients in medication management
16. Use of medical devices in health care delivery

We concluded that there were nonconformities with best practice in all cases except one (case no. 11 in the list above). We present these cases in Appendix 2.

The Norwegian Board of Health Supervision also receives reports on incidents that do not indicate that serious harm or death occurred, or that there was any connection between the healthcare and the outcome for the patient/user. As shown in Figure 1, we considered that 652 of the reports concerning municipal health and care services did not meet the reporting scheme criteria (were non-reportable) (40 per cent).

Of the individual reports concerning municipal health and care services, 530 out of 771 – that is, more than 80 per cent – did not meet the reporting scheme criteria. The fact that this proportion is so large may indicate that it is unclear what is reportable to which entity. The individuals who submitted these reports were most likely in a difficult situation, and perceived the incidents they reported as extremely serious. Our assessments that these incidents were non-reportable rely on the wording of Norwegian law: that  for such incidents to be reportable, severe harm or death is caused as a result of healthcare. In most of these cases, we concluded that this causal connection was not sufficiently likely to be present. Many of these reports appear to be complaints concerning healthcare or rights. Examples of reports that did not meet the criteria are presented in Appendix 3.

In our response to the person submitting the report, we describe alternative recipients such as the County Governor or the organisation involved. We also refer people to one of the local branches of the Health and Social Services Ombudsman who can assist in directing them to the right recipient.

For reports submitted by municipal health and care services, we cannot tell whether we have received a report concerning the “right” incidents or to what extent all reportable incidents are actually reported. Of the incidents that both were reported by a municipal health and care service and which concerned that healthcare setting, 118 did not meet the criteria (14 per cent).

The reporting scheme is still relatively new. Local authorities may not be fully familiar with what the reporting duty entails, and there may be uncertainty regarding who can submit a report. Information about the reporting duty for municipal health and care services can be provided both through local initiatives and by the Norwegian Board of Health Supervision actively informing them of this.

We will now be discussing some of the risk and improvement areas identified in connection with the completed inspections. Some incidents include several of the described risk and improvement areas. A summary of the inspection reports is provided in Appendix 2. More detailed descriptions can be found in the incident-based inspection reports published (on the Norwegian Board of Health Supervision website).

Here we pay particular attention to problems and deficiencies that were described at the systemic level, and less on the professional practice of the individual health and care worker.

Regarding medication management, we saw problems concerning:

• non-use of the existing support tools for medicines administration. In one incident, we saw that both hospitals and nursing homes had support tools for detecting and assessing the risk of interactions, but had not put in place well-defined routines and common practices for use of the tool. One patient received too much blood thinning medication and died.
• deficiencies in internal control systems for medication management. For example, this was described when a homecare user was discharged following a short stay in hospital. There were deficiencies in medicines receipt, dispensing to the user and documentation of healthcare delivery. The user did not receive the prescribed anticoagulant therapy and suffered a massive stroke.

Care coordination is particularly important for patients/users who are followed up at multiple service locations within the municipality, in the specialist health service and in emergency situations. This imposes greater requirements as regards clear lines of responsibility, coordination and expertise within the various services. We identified issues concerning collaboration agreements between employees, between departments, with next of kin, with hospitals or between the different levels of the health and care services. This resulted in, for example, medication errors, delayed clinician attendance in the transition from hospital to nursing home and a lack of follow-up of the user following transfer to another service location.

In two incidents where seriously ill patients needed rapid transportation to hospital, we identified issues relating to decision-making when a helicopter ambulance was requested, including deficient decision support for staff in prioritising and fulfilling airlift missions. There was a risk of failure because the same individual in the organisation had to fill different roles in the process. There was no system to avert the risk of decision-making failures in situations involving conflicting considerations such as infection control considerations versus emergency preparedness

At out-of-hours medical care centres or municipal acute inpatient units, we saw that systems were not in place to:

• ensure medical supervision during busy periods
• detect a change in the patient’s condition after admission so that acute deterioration could be adequately managed

Among incidents at out-of-hours medical centres, patients were reported as having to wait longer than recommended and dying before they were seen by a doctor. High operating levels were described in both of these events.

The patient in the municipal inpatient unit suffered acute deterioration in their condition. Overall, the municipality was failing to ensure proper healthcare for patients admitted to a municipal acute inpatient unit with somatic disease and at risk of acute deterioration. National and relevant guidelines exist to guarantee proper healthcare for patients admitted to a municipal acute inpatient unit, but the organisation had not ensured familiarity and compliance with these guidelines among the healthcare professionals responsible for care delivery. The organisation had not provided adequate training on procedures and the use of ICT systems to ensure safe practices and nurse-physician coordination.

In connection with reorganisations or operational changes, it is important to perform risk assessments. We saw that this was not done, for example, before the introduction of welfare technology. This applied to a nursing home resident who was issued with a GPS tracking device. The necessary assessment of hazards and risks had not been adequately ensured before the tracker was worn by the resident. When the resident disappeared, managers and staff were unsure of how the device actually worked. In addition, the battery charge in the tracker had not been checked before use. The resident was found dead. There had also been no official decision on use of a GPS tracker as required by law.

In several inspections, we found that departments and units had reorganised their homecare services, but without fully assessing how they would need to ensure that users were not accidentally excluded from the care management system. One service user was not relisted in the new system and was found dead in their home after some time.

For another service user, a decision was made to reduce their follow-up care due to the pandemic. Daily home visits to ensure that the service user was taking vital medication were replaced by telephone calls, but the service had not established routines for what to do if patients did not respond to scheduled telephone consultations. The service user died a few days after their last contact with the homecare service.

Several reports described that previously reported nonconformities, acknowledged risk factors and regulatory inspections/audits were not put to use in improvement efforts. Nonconformity cases and audit reports had not been communicated to employees to any great extent.

We saw that procedures were missing, not known or not carried out correctly, for example for the use of medical devices. One patient did not receive professionally responsible healthcare because the medical device had been incorrectly connected. The patient did not receive the respiratory assistance they needed and died.

It is the responsibility of the organisations to ensure that the users of medical devices are trained so that they have the necessary skills and knowledge of correct and safe use at all times. Training must be systematic and documented.