I AS OTRAS REALIDADES

• The occurrence ratio of complications must be closely monitored. Knowing the frequency and nature of complications is the beginning of and the basis for an effective complication policy. In this thesis, this is called level 1 registration. • The aim is to minimise the occurrence of complications. This means that in addi-

tion to reporting and registering complications, all possible causal factors must be registered and analysed. In this thesis, this is called level 2 registration.

This section describes a Complication and Incident Reporting and Management Sys- tem (CIRMS) which could be used for the continuous assessment and analysis of both incidents and complications. In the risk management framework of figure 3.7 on page 64, this is represented as ‘voluntary incident reports’ and ‘complication reports’.

The CIRMS is in fact an IRMS with additional elements for the reporting and anal- ysis of complications. The objective of an IRMS was to determine the structural failure factors of incidents in order to prevent future incidents (see section 3.4.7). The objective of the CIRMS is more or less the same as the objective for the IRMS, but it now includes both incidents and complications. In other words, the objective of a CIRMS is to deter- mine the structural failure factors of incidents in order to prevent future incidents, to

3.4 Framework for effective risk management 81

measure the frequency of occurrence of complications, and to try to prevent complica- tions by registering possible causes/factors. These possible causes/factors are registered and analysed to determine the causes for the development of complications. If the causes are known, complications may be prevented.

In accordance with the definitions of incident and complication in section 3.2 and with the causation model presented in figure 3.3 on page 54, it is clear that incidents and complications should be registered and analysed together, because:

• Incidents and complications both result in undesirable physical harm for patients, and should both be registered and analysed in order to be able to prevent this harm.

• Incidents may result in complications and for a complete understanding of the causal path of complications, it is necessary that both incidents and complications are registered.

So, it may be concluded that the registration and analysis of incidents and complica- tions should not be done separately from each other. However, defining the deviation as an incident (causes known, see the definition on page 44) or a complication (causes unknown, see the definition on page 44) results in different registration and analysing paths. Complications must be registered and analysed differently from incidents because the causes are (largely) unknown. This means that the data which have to be registered and the data analysis are different, i.e. all factors which may have contributed to the de- velopment of a complication should be registered, and the determination of whether a factor is a cause in the development of a complication must be performed by statistical analysis.27 _{This amounts to an epidemiological approach to complications as opposed} to a causal-deterministic approach to incidents.

The aim is, eventually, a level 2 registration for all complications. For this purpose is needed:

• A list of all possible complications.

• For each complication, a list of factors that should be registered. This list of complications and factors can be obtained by:

• Brainstorming session(s) with doctors, nurses and paramedics.

27_{E.g. there may be a positive correlation between the complication wound infection and the operating room}

(i.e. the factor location, see figure 3.4 on page 56) in which patients were operated on, which may indicate that there is a sterility problem (i.e. an indication of a cause) in this particular location.

• Periodically updating the list in the course of the operational use of the registration system.

Alternatively, the complication registration may have to be limited for reasons of re- stricted staffing capacity. However, a level 1 registration for all complications is a mini- mum requirement. An extension of this with a level 2 registration may be initiated, based on the results of this level 1 registration. Level 2 registration implies that many different reporting forms are necessary, since every complication may require, at least in theory, the registration of different factors. For practical reasons, the registration of the compli- cation data and, of course, their analysis justify the use of a computer with supporting dedicated software.

Table 3.8 on page 78 presents a description of a Complication and Incident Reporting and Management System (CIRMS). The description is based on the IRMS presented in section 3.4.7.

An elucidation of a CIRMS described in table 3.8 on page 78:

Activity 1 The reporting of incidents is performed by filling in a reporting form in which the reporter can give a description of the facts of the incident and of the (possible) effects on the patient (see also appendix I).

The reporting of complications is performed by entering the relevant data on a ‘form’. This ‘form’ consists of several fields on a computer screen and the data are fed directly into the computer. A computer is used for efficiency reasons because, for instance, the number of different forms may be large. Complications are classi- fied into categories in which every category describes the (physical) effects on the patient and every ‘form’ contains at least one category.

Activity 2 The effects on the patient are described of both incidents and complications. In the case of incidents the causes, and in the case of complications the relevant factors, are included in the description.

Activity 3 Each week, the incidents are classified on the basis of their structural causes into clusters. Complications are clustered per category and counted automatically by the computer the moment the complication is fed into the computer (activity 1). Activity 4 Periodically, all incidents are examined and, if necessary, new clusters are cre- ated and/or existing clusters altered or adapted. A list is generated of structural failure factors of incidents, of the number of complications per category and—if possible—of (possible) causes of complications.

3.4 Framework for effective risk management 83

Trend analysis of incidents and complications can and must be performed, such as, for instance, comparing standard performance indicators of complications and incidents:

• Over time.

• Between departments of different organisations. As a result of trend analysis, conclusions may be drawn.

Activity 5 As a result of the list with the structural failure factors, and the trend and cause analysis of incidents and complications, conclusions can be drawn and rec- ommendations can be made.

Activity 6 Improvements can be generated, initiated, implemented and guaranteed.

Activity 7 Periodically, e.g. after an analysis, an evaluation of the system can be made:

• An evaluation of the data which have been registered, both for incidents and complications. An evaluation of complications, for instance, can be made by consultations between doctors and employees about the possible addition and/or elimination of causal factors that have been registered.

• If necessary, altering or adapting the reporting form.

• If necessary, the implementation of other improvements to the system. Activity 8 The feedback on analysis results and improvements to doctors and employees

is essential for the willingness to (continue to) report.