LA SABIDURÍA DE LA AUSENCIA DE EGO

Conditions for a successful complication and incident registration are:

a. The information which the nurse, paramedic and/or doctor report must be treated as confidential and must be used exclusively for learning purposes.

b. The registration is conducted in such a way that follow-up research is possible. This implies that the patient’s name or number is included in the registration.

For incidents mainly condition a is relevant, while for complications it is both conditions a and b. The question is to what extent conditions a and b are in conflict with each other and can cause legal problems. Can the patient demand access to and thus come into possession of the information contained in a CIRMS because the patient’s name,

number or any other (indirectly) identifying mark is present? If so, what ways are there of solving or getting round this problem?

In the Netherlands, data—for instance those from a CIRMS—can be protected via two laws:

• The Medical Treatment Contracts Act (MTCA or, in Dutch, ‘WGBO’: ‘Wet op de Geneeskundige BehandelingsOvereenkomst’) [100].

• The Data Protection Act (DPA or, in Dutch, ‘WPR’: ‘Wet PersoonsRegistratie’) [102].

These acts are cumulative i.e. patients can derive a right from either law, whichever of the two is the most comprehensive or sweeping.

The MTCA was incorporated into the civil law (in Dutch ‘BW’: ‘Burgerlijk Wet- boek’) in March 1995. From this, it is evident that:

• The patient has the right to inspect his patient file.

• ‘Patient files’ include all forms of registration that are used by doctors, nurses and paramedics.

The patient can examine all the data which are part of the patient’s file. The ques- tion whether complication registration is a part of the patient file and comes under the MTCA, depends on the answer to the question whether complication registration is a registration which is related to the care of the individual patient. It may be argued that complication and incident registration as well as the FONA registration have no relation to the care of an individual patient.28_{In that case, at best the provisions of the DPA are} applicable.

Another but less elegant option is to interpret the registration as ‘work notes’. In this view, these work notes by the doctor in attendance do not need to be included in the medical file. This view has come in for a lot of criticism, especially since notes are meant for use between colleagues and therefore should be in the patient file.

The DPA stipulates that the person concerned must be informed of registration, and, on request, must be given access to the information. The question is whether the con- dition of ‘the notification of registration to the person concerned’ has been met, if—on being admitted to the hospital—the patient is informed that his data will be included in the registration system. A number of exceptions have been introduced in the DPA, in

28_{Complication and incident registration are aimed at analysing complications and incidents in order to}

learn from them, and to prevent future complications and incidents. The registration of a complication or an incident for this purpose has no direct relation to the care of an individual patient at that moment.

3.4 Framework for effective risk management 85

conformity with which a patient’s request for access to his file can be turned down. This is possible, for instance, when the keeper of the registration has an interest of overriding importance.

In summary, the patient’s right of inspection does not apply to complication and incident registration:

• If the registration does not relate to the care of the individual patient (MTCA). • In the case of an interest of overriding importance; i.e., in this case, research into

the causes of complications and incidents with the objective to learn from them in order to prevent future complications and incidents.

Maybe, on admission to the hospital, the patient should be notified in advance and more explicitly that all relevant information will be entered into the hospital registration sys- tem, and that for research reasons the patient’s information can be entered into a com- plication and incident registration system. However such a formal notification may have the wrong effect and might scare patients off, so one should proceed with caution here.

The methods described in this chapter were used in the OR and in the Haemodial- ysis department, except for the CIRMS which was never implemented. The results and conclusions will be presented in the following chapters.

Part II

4

Prospective and retrospective approach in the OR: FMEA

and CIIs

4.1 Introduction

The previous chapter discussed the theoretical framework: the definitions and meth- ods which were used for the risk management framework, represented in figure 3.7 on page 64. The present chapter will discuss the actual implementation of a prospective (by means of FMEA) and retrospective method (by means of CIIs) in the OR, see also ta- ble 3.5 on page 65. Chapter 5 will discuss the implementation of the IRMS; an IRMS which—in contrast to the methods discussed in the present chapter—is permanently present and in the context of which doctors and employees can report incidents directly (‘real-time’) to the IRMS. Chapter 6 will discuss risk management adjustments in the OR.

Sections 4.2 to 4.4 of this chapter will give a description of the following aspects of each of the methods used:

• The use of the method in the OR. A number of important aspects, considerations and experiences which have resulted in evaluations and adaptations of the meth- ods, are also included in the description.

• The results, i.e. the patient risks which were found.

• An evaluation of and a discussion about the experiences in using the method within the scope of risk management in the OR.

The chapter ends with a concluding section, in which a comparison is drawn between the FMEA results and those obtained through the CIIs.

This risk management research started in the function group Operating Room (OR)1 in February 1994. The decision to start the research in the OR was made by the hospital management, for reasons connected with organisational politics. The research in the OR was mainly concerned with the clinical part of the OR.

1_{The OR department as it was called at the time, see section 1.5.2.}

Table 4.1. The main processes of the clinical OR and their location in the OR.

Process Location

Preparation of the patient Preparation room

Patient receives anaesthetic Operating room/recovery

Operating and maintaining the anaesthesia Operating room

Recovery Recovery

4.2 Process model

This section describes the creation, the validation and the reliability of the OR pro- cess model, next (briefly) the result—i.e. the process model which is to be found on the CD-ROM—and finally the conclusions which could be drawn and the recommendations which could be made.