Management implications of clinical laboratory accreditation in Malta

Abstract

Medical laboratory accreditation is an essential part of quality management. It deals with peer review by an independent third party of all processes within the laboratory. In Malta, medical laboratory accreditation is still at an early stage and furthermore it is voluntary. There are several managerial implications of local accreditation, which have not yet been investigated. It is important for the manager to be aware of such implications, to be able to determine the feasibility of embarking on accreditation of the laboratory. These implications may be divided into two categories - the benefits resulting from accreditation and the resources required to achieve accreditation. Some of the main benefits resulting from accreditation are those due to better customer perception of services. On the other hand, most of the resources required for accreditation are those needed to bring the laboratory up to accreditation standard. Thus, the objectives of this study are: 1. To investigate customers' perceptions on medical laboratory accreditation in the local context. 2. To develop a method by which a manager can comprehensively identify and analyse the gaps between accreditation standards and the actual situation for all aspects of the laboratory organisation. Customer perceptions were investigated through a questionnaire distributed to medical doctors. The instrument ascertained customers' knowledge and understandings of accreditation, how they distinguish between accredited and non-accredited organisations, their quality expectations of accredited laboratories, their preference for accredited laboratories and their willingness to pay more for an accredited service. The methods utilized for the second objective involved identifying the accreditation standards that are most suitable for use in the local context; carrying out an audit on a local medical laboratory to identify gaps between the accreditation standards and the actual situation; and analyzing then identified non-conformities (gaps) to give an indication of the resources required to correct the non-conformities and bring the laboratory up to accreditation standard. The questionnaire results demonstrated a stated lack of knowledge about laboratory accreditation by the customers. Notwithstanding this, the majority of respondents were able to give a correct explanation of the term accreditation, as well as how to recognize whether the laboratory was accredited. An overwhelming majority of customers expected that quality of service would improve upon accreditation and almost all respondents expressed a preference for accredited laboratories. However, only about half of the doctors were willing to pay more for an accredited service. The accreditation standards that were found to be most suitable for the local context were ISO 15189. The non-conformities identified through the audit were graded and classified into groups, such that the tasks required to achieve accreditation were identified and the related resources estimated. From these results, a Gantt chart for an accreditation project was drawn up, together with a step-by-step recommended course of action that a laboratory manager could follow to determine the feasibility of and eventually achieve accreditation. This study clearly demonstrated that accreditation would confer a distinct competitive advantage to local medical laboratories. On the other hand, it is highly recommended that the laboratory manager should use the method demonstrated in this study to determine the effort and resources required to achieve this objective.