A pilot experiment of joint assessments by accreditation and certification bodies in clinical laboratories

When the quality system of the health care organization is certified and the laboratory accredited, two different types of assessments are also performed. To reduce the extra work caused by these different assessments the Finnish Accreditation Service FINAS and SFS-Certification have made a pilot experiment in combining the assessments. Joint assessments have been a positive experience to the laboratory as well as to the assessing bodies, and we find this operating model worth developing.     

Implementation of a quality system in a clinical laboratory

The effects of a quality system are measured with the aid of quality indicators, which can be used for both decision-making by the management of the laboratory and for process control. The need for economic appraisal is stressed since the development of a quality system is very time- and labour-consuming. The aspects of both the customer and the personnel involved should be considered to evaluate the quality system. It is also important to define practical means to build up and maintain a quality system especially in smaller laboratories. For instance, simple tools to evaluate uncertainty of measurement and availability of inexpensive national reference materials are needed.     

The effects of quality-management systems on external quality-assessment performance in Finnish clinical chemistry laboratories

The effects of the implementation of quality-management systems and technological changes on the performance of 23 Finnish clinical chemistry laboratories were studied in external quality-assessment (EQA) schemes organized by Labquality Ltd., Finland, during 1993 to 1999. The investigated serum analytes were sodium, calcium, glucose, cholesterol, and alanine aminotransferase. According to the results, the improvements in analytical quality due to the quality programs were rather small. The effects to the proportions of satisfactory results in terms of precision and deviation from the target value were 5–15% (95% confidence intervals for the proportions ±1–5%). At the same time the laboratories were implementing quality-management systems new technology and characteristics of quality-control materials affected the EQA performance. Both improvements and deteriorations in analytical quality due to these factors were identified. The effects and their total outcomes differed substantially between the five analytes.     

Implementation of a quality system in a clinical laboratory – Evaluation of quality indicators

 The aim of this study was to evaluate the primary experience of implementing a quality system in a clinical laboratory. The second interrelated aim was to evaluate the quality and financial indicators needed for continuous measurement of quality, decision making in the laboratory management and everyday process control in analytical work. The quality process itself should be evaluated because the building up of a quality system requires a considerable amount of resources. The most effective and practical ways of using a quality system as a management tool should be found and the need for financial appraisal when the quality system is implemented is stressed. According to our study, when the effects of the quality system were evaluated, the managers of the laboratory had not considered the appropriate financial indicators. The quality indicators considered to be the best were internal quality control, external quality assessment and customer satisfaction surveys. The first benefits of the quality system evaluated by the personnel were other than the purely financial benefits, they include a more systematic and empowering approach to laboratory management, better working instructions, better knowledge of the methods and equipment, and fewer errors. The financial evaluation of a quality process in a public-owned clinical laboratory is complicated due to the fact that financial indicators are not as far developed and diverse as in industrial organisations. When starting to implement a quality system, it is important to pay attention to all measures that motivate the staff and help them benefit from the practical effects of the system. Received: 10 November 1999 / Accepted: 12 January 2000