1 Summary of Report NOU 2015: 11

Out in the Open

Prevention and Follow-up of Adverse Events in Health and Care Services

The Committee has been asked to carry out a comprehensive review of how adverse events and suspicion of violation of the law in health and care services are followed up in society. The Committee shall review and propose relevant changes to legislation, organization and practice that can help to improve patient and client safety in the services, and ensure that the interests and legal safeguards of patients, clients and relatives, providers of health and care services and health care personnel are taken into account. In an extension of its mandate, the Committee has also been asked to assess whether it is appropriate to establish an investigation commission for health and care services, and to assess and propose the legal and organizational basis for such a commission. The Committee shall also assess whether the police should have their own or independent expertize in matters of health in cases in which they investigate serious adverse events in health and care services. In addition, the Committee shall assess whether the duty to report adverse events should also include municipal health and care services.

In its work, the Committee has in particular assessed how patients, clients and relatives can be taken better care of after an adverse event, and whether patients and clients should be given extended rights. Furthermore, the Committee has assessed in which ways the relevant authorities and arrangements can further contribute to the work in following up adverse events and improving the legal safeguards of patients and clients. In this context, the Committee has looked at providers of health and care services, the Health and Social Services Ombudsman, education of health personnel, arrangements for reporting adverse events, supervision and reporting of serious adverse events, police investigation and penalties.

The core values accountability, openness, trust, participation and legal safeguards have been in focus when the Committee has made its assessments. The choice of the title of this report «Out in the Open» illustrates how these values have guided the Committee. In its recommendations, the Committee has chosen to place great emphasis on approaches such as participation, learning and supervision.

The report has three parts:

• Chapter 1 is the summary. Chapter 2 presents the Committee’s mandate, the composition of the Committee and the way in which the Committee has worked. In this chapter, the Committee also clarifies how its mandate has been interpreted and the limitations that have been set. There then follows a description of the Committee’s open consultation on relevant topics. Several of the statements received by the Committee are referred to later in the report.

• Chapter 3 deals with the background, perspective and basic values for the work of the Committee. The Committee also explains some of the concepts and frameworks used in the report. Chapters 4 to 6 deal with national and international knowledge about the occurrence of adverse events etc., current legislation and relevant arrangements and authorities in Norway, international obligations and recommendations, and relevant conditions in some other countries.

• The Committee’s own assessments and recommendations are presented in Chapter 7, and the draft legislation in Chapter 10. Comments to the draft legislation are included in Chapter 9. The economic and administrative consequences are described in Chapter 8.

Below, a summary of the main recommendations is given. Not all the recommendations are presented here. For a more detailed presentation of the Committee’s assessments and recommendations, see Chapter 7.

The Committee’s Main Recommendations:

Improved follow-up of patients, clients and relatives, better care of them, and greater rights for them

The Committee has discussed how authorities, care providers, other relevant organizations and personnel in the health and care services can ensure that patients, clients and relatives are taken better care of and have greater legal safeguards. The Committee has focussed its attention on how, among other things, health and care services can follow up and take care of patients, clients and relatives after an adverse event. The Committee recommends making it a statutory requirement that establishments shall offer the patients, clients and relatives meetings when serious adverse events have occurred. The first meeting should take place within twenty-four hours after the serious adverse event. Further meetings may be needed later. The aim of the meetings shall be to facilitate openness and better follow up and care of patients, clients and relatives. The personnel must provide information in an open and honest manner, and give the opportunity to ask questions about the event and how it will be followed up.

The Committee recommends that patients, clients and relatives should be given the right to report serious adverse events to the supervision authorities for a prompt assessment of whether there is a need for local supervision (visiting the place where the serious adverse event happened as soon as possible after the event) or a need to follow up the serious adverse event with another kind of supervision. The Committee stresses that the final letter in supervision cases and other documents should be formulated in such a way that it is understandable for the general public and individuals. The Committee gives its support to the developmental work that the supervision authorities have initiated to increase the participation of patients, clients and relatives in supervision work more generally.

In addition, the Committee recommends that patients, clients and relatives should be given the right to report adverse events to the Reporting and Learning System of Adverse Events in order to contribute to the work with patient safety.

The opinion of the Committee is that the police, when notified about an unexpected death connected with the health and care services, as a routine, should inform the relatives that the case has been referred to the supervision authorities, and that the relatives can contact the police if they wish to provide information. At the same time, the Committee recommends that the police in these cases should make their own assessment of whether it is necessary to obtain information from the relatives before they decide whether to carry out an investigation.

The Health and Social Services Ombudsman

The Committee recommends that the Health and Social Services Ombudsman should be made more well known. The Ombudsman has an important function, both in general and especially when an adverse event has occurred. The ombudsman can act as adviser for patients, clients and relatives, and can also be an important go-between in relation to the service. With its knowledge about the health and care services, the Ombudsman can be a prudent and constructive guide in a landscape in which it can be difficult for patients, clients and relatives to find their way. The Committee also recommends that the health authorities should clarify the area of work for the Ombudsman, and consider expanding this to include all health and care services.

Providers of health and care services

It is estimated that adverse events affect one out of ten patients in Norwegian hospitals. How often adverse events occur in municipal health and care services is not known, but the Committee assumes that adverse events also occur in these services. It is not possible to avoid all adverse events, but many can be prevented. The experiences of patients, clients and relatives, and also of health personnel themselves, show that adverse events are not always followed up as they should be. Many providers of health and care services carry out good work with preventing and dealing with adverse events, but the Committee believes that managers and health personnel, both in municipal health and care services and in specialized health services, can be even more aware of risks, and can be better at preventing and dealing with adverse events. The Committee recommends changes to the legislation and practice, with the aim of improving both safety for patients and clients and follow-up of adverse events by the providers of health and care services.

As already mentioned, the Committee recommends making it a statutory requirement that providers of health and care services shall give the patient, the client or the relatives the offer of having meetings with them when serious adverse events have occurred. A meeting can help to create greater openness and to improve or re-establish trust in the health and care services.

The Committee stresses that work with revising the Internal Control Regulation for the Health and Care Services should be completed. The Committee recommends that a review of adverse events should be included as an explicit requirement in the Regulation, and thus be an integrated part of the management system. Such a review can be used to support the work carried out by the providers of health and care services to learn from adverse events and to improve patient safety. The Committee stresses that a good, educational plan for both the municipalities and the health enterprises (hospital trusts) should be developed when the new regulation is implemented, and recommends that this plan should, for example, be included in the Patient Safety Programme.

The Committee regards it as positive that, in another context, an assessment is being made about whether the use of accreditation and certification should be introduced in order to improve the structural and professional part of the management of hospitals.

The Committee believes that qualification of managers in health enterprises (hospital trusts) and in the municipal health and care services should be developed further and improved. The health and care services need managers who are aware of risks and who prevent and deal with adverse events. In this context, the Committee also stresses how important it is that employers react and intervene when an employee is shown not to have adequate professional qualifications or language skills that are needed in order to carry out his or her task in accordance with sound professional standards.

The Committee recommends that the Norwegian Directorate of Health should revise the report Dealing Adequately with Adverse Events in the Health Service1 to be an instruction manual for the services. Such an instruction manual can be a concrete and practical aid in the working day.

Education of health personnel

In line with international recommendations, the Committee recommends that education authorities must lay down requirements in the overall education plan for health personnel that health personnel must have knowledge about patient safety, quality improvement work and understanding of risk. In addition, education authorities must make patient safety and work with quality improvement visible by describing in the education programmes the value of these topics. The programmes must include relevant practical exercises, using, for example, simulation and exercises in interdisciplinary teamwork. This teaching can be linked to existing education programmes.

The Reporting and Learning System for Adverse Events

Since 2012 the specialized health services have had a duty to report adverse events to the sanction-free reporting system. At present, feedback is given for each report in addition to making reviews etc. The Committee recommends that the Reporting and Learning System for Adverse Events should be organized in such a way that reports, primarily, are used to gain increased insight into areas of risk, types of damage and the causes of damage, by making reviews and summaries. The Committee also recommends that the criteria for reporting should be adjusted. The Committee has been asked to assess whether it is appropriate to extend the reporting system. The majority of the members of the Committee – all except two members – recommends that the duty to report adverse events should be extended to include all service providers in municipal health and care services and in specialized health services (including services provided outside health institutions), and that research should be carried out to evaluate this change. In line with international recommendations, the Committee recommends that patients, clients and relatives should also be given the right to report adverse events, so that these reports are included in the material obtained by the Reporting and Learning System for Adverse Events. The Committee supports the work being carried out to establish a common reporting portal for adverse events for many of the different reporting requirements for health and care services.

Supervision

The Committee argues that there is a need to change the organization of the supervision authorities in order to improve control of patient and client safety in the services, and in order to follow up serious adverse events more quickly. The Committee points to several challenges concerning the supervision authorities. Among the challenges are long time for dealing with cases and large differences in expertise and standardization among the supervision authorities. The Committee argues that re-organization into four or five regional supervision units could remedy this and thus improve legal safeguards. The Committee outlines two different models. In the first model, regional units directly under the Norwegian Board of Health Supervision would be the first authorities for all supervision cases, and would have the authority to make administrative decisions. In the second model, the supervision tasks would be divided between the offices of the county governors in each county and regional units allocated to some of the offices of the county governors. In both models the Norwegian Board of Health Supervision would be the highest supervision authority and the administrative appeal body. The two models would entail a simplification and a rationalization to a different extent, which the Committee has weighed up against other advantages and disadvantages of the two models.

Furthermore, the Committee recommends that the Norwegian Board of Health Supervision should be given overall sector responsibility with a co-ordinating function for supervision of health and care services. In cooperation with other supervision authorities, the Norwegian Board of Health Supervision must ensure that a comprehensive assessment can be made of all relevant factors, including in cases that also involve the areas of responsibility of other supervision authorities.

The Committee is of the opinion that the Reporting System for Serious Adverse Events in Specialized Health Services of the Norwegian Board of Health Supervision should be further developed, and be extended so that all service providers in health and care services have a duty to report serious adverse events. The Committee also recommends that patients, clients and relatives should be given the right to report serious adverse events.

The Committee recommends a change to the Health Personnel Act, to indicate that the threshold should be adjusted down slightly for using some of the administrative reactions against health personnel in cases of professional practice that is not in accordance with sound professional standards. With regard to administrative reactions against providers of health and care services, the Committee means that it should be possible to use the same types of administrative reaction against service providers in all sectors of the health and care services. This should comprise orders to correct deficiencies in services, closure of services and coercive fines. It is also recommended that fines should be introduced for breaches of the legislation as a new form of administrative reaction, to be used in cases of breach of the duty to report serious adverse events.

The Committee recommends a new Act relating to governmental supervision of provision of health and care services, which will replace the existing act and give a more co-ordinated regulation of supervision activities.

Police investigation and penalties

In the Committee’s mandate, suspicion of a breach of the legislation is mentioned along with serious adverse events. The supervision authorities carry out administrative control of whether relevant legislation is complied with, but the police, the prosecuting authority and the court of law are responsible for dealing with the criminal aspect. In the view of the Committee, there is no reason to give criminal prosecution a more prominent position when following up adverse events. However, the Committee points out areas of improvement in dealing with reports to the police regarding cases of unexpected death in health and care services and in other cases relating to health and care services. Among other things, the police, to a greater extent, should make their own assessment of whether there is reason to initiate an investigation. The Committee stresses that the possibility for the police districts to seek assistance from the National Criminal Investigation Service (Kripos) should be used more often, but does not recommend that the police should employ professionals with medical expertise. The Committee also recommends a routine in which the public prosecutors are involved in issues of dropping current cases.

An Investigation Commission for Health and Care Services

In line with the additional mandate, the Committee clarifies how a possible investigation commission for health and care services could be organized, and how the judicial basis for the commission could be formulated. The Committee has discussed thoroughly whether it would be appropriate to establish an investigation commission, and the Committee is divided in its recommendation. A majority – 10 out of 14 members – recommends that an investigation commission should not be established. The opinion of the majority of the Committee – all except one member – is that an investigation commission should not be established if fresh funding is not allocated to this.