Workshops - Accreditation in genetic testing laboratories

Aims

The specific objectives are to compare and share experiences of implementing and working with quality systems and to examine cases of concrete situations related to quality processes that may arise in laboratories, like non-conformities, reporting, training etc.

Furthermore the common deficiencies in a quality management system and the ways to proceed for accreditation will be discussed during expert-led interactive sessions in small groups.

ISO 15189 will be used as the reference standard during the workshop.

Target group

For those who would like to learn more on quality management and accreditation.
For those who would like to improve their current quality system.
These workshops are of equal value to accredited and non-accredited genetic testing laboratories.
Participants include laboratory directors, scientists, technicians and quality managers.
The number of participants is limited to 25.

The workshops are in English.

List of workshops on accreditation

• 14/15-04-2005 Leiden
• 02/03-03-2006 Basel
• 18/19-09-2006 Leuven
• 12/13-04-2007 Athens
• 15/16-06-2007 Nice
• 30/31-05-2008 Barcelona
• 22/23-05-2009 Vienna
• 22/23-09-2009 Paris
• 14/15-01-2010 Birmingham
• 15/16-04-2010 Paris

Review of 'Workshop on accreditation - Leiden'

April 14-15, 2005, held at the Centre for Human and Clinical Genetics LUMC, Leiden, The Netherlands

a. Focus and approach

The initial workshop consisted of a debate on quality systems and breakout sessions. The workshop was complemented by visits to the Molecular Genetics and Cytogenetics laboratories in Leiden, which were amongst the first genetics laboratories in Europe to be accredited ^c. Structured questionnaires were used to help participants formulate their opinions, positive and negative, during the workshops. These questionnaires started with an individual reflection, followed by ' in small groups and ending with a whole group debate to reach final conclusions.

c Molecular Genetics is accredited by RvA (www.rva.nl) since 1998 and the Cytogenetics laboratory is accredited by CCKL and RvA since 2000, according to ISO 17025 and ISO 15189.

b. Outcome

The first task for the participants was to answer some questions individually, for example on their motivation to come to work every day, on the (dis)advantages of accreditation and implementing a quality system and their idea of a uniform quality system in European genetic testing laboratories.

Working in a genetic testing laboratory is a challenging job for technicians as well as for quality managers and laboratory directors, because of the dynamic field, the social and scientific aspects and the fact that 'you can make a difference'. Besides a positive motivation, sometimes the frustration of all the paperwork, lack of space, time and budget and unmotivated colleagues is present. Despite everybody sees the advantages of implementing a QMS and working under accreditation, some fears were brought to the surface. It is clear that a good QMS leads to a better organization of laboratory workflow, more traceability, better results and national recognition. On the other hand, people are afraid of changing their existing system or of losing flexibility, especially if quality systems should be harmonized within Europe. The fear of increased workload and lack of staff and personnel motivation restrains laboratories from starting to implement a quality management system. A realistic suggestion formulated by the participants was to stimulate and improve communication between all staff grades and to appreciate the work of everybody. The importance of quality and the consequences of making a mistake should be emphasized.

The second part of the workshop included breakout sessions, in which small groups of about six participants get a case study accompanied by questions (box 1). The case studies addressed situations that could arise in any laboratory and formed a basis for broader 's on topics including non-conformities, reporting, lab results, document control, auditing, equipment, personnel training etc. Moreover, participants shared experiences, learned from each other and got new ideas to put into practice.

The mixture of experienced and less-experienced people, and of technicians and laboratory directors, gave an extra dimension to the debates. All people could contribute with their point of view.

During the workshop, special attention was paid to the current available accreditation standards used within Europe. The International Organization for Standardization (ISO) 1 has developed an international guideline for testing laboratories in general (ISO 17025), and one in particular for medical laboratories (ISO 15189). Some countries prefer a 'local' guidelined such as CCKL 2 in The Netherlands and CPA 3 in the UK. Participants were trained to compare and use these norms in actual practice. An overview of the different quality standards for genetic testing laboratories in European countries is outlined in box 2.

c. Discussion

It was remarkable that all the participants agreed on the positive side of accreditation and implementing a quality management system, but at the same time they shared the same fear of changing approaches or of convincing and motivating colleagues to change. It is inherent to human beings to have negative attitudes and perceptions towards change. To get people behind the new idea of implementing a QMS, they need to realize and understand that the change will really happen, before they completely accept it. People typically perceive change processes in different phases; the learning cycle of Kolb 4 , adapted by MCR, is used to explain and teach approaches for change processes in laboratories (box 3). The most important element is to include everybody in the laboratory and to give responsibilities to all. If they can start helping - for example in collecting and re-writing procedures - the rest will follow.

As mentioned above, some countries use different accreditation standards, but their aims are all the same: implementing and assuring good quality in testing laboratories, for the benefit of patients. However, ISO 15189 is now the preferred standard for accreditation of genetic testing laboratories 5-7 . Repeated comments during the group 's revealed that everybody had the 'same goal', the 'same questions' and the 'same problems'. Although formal requirements may vary between standards, it was evident that the commonality of approaches between laboratories will make a significant degree of harmonization a feasible and relatively natural outcome.

d CCKL: Coördinatie Commissie ter bevordering van de Kwaliteitsbeheersing op het gebied van Laboratoriumonderzoek in de Gezondheidszorg in The Netherlands. CPA: Clinical Pathology Accreditation in UK.

(The whole report can be downloaded in html or pdf .)

References

1. International Organization of Standardization (ISO): http://www.iso.org/ .
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2. S. Slagter, J.G. Loeber. Accreditation of medical laboratories in The Netherlands. Clin Chim Acta 309, 155-161 (2001).
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3. D. Burnett, C. Blair, M.R. Haeney, S.L. Jeffcoate, K.W. Scott, D.L. Williams. Clinical pathology accreditation: standards for the medical laboratory. J Clin Pathol 55, 729-733 (2002).
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4. D.A. Kolb. Experimental learning: Experience as the source of learning and development., (Prentice Hall, Englewood Cliffs, NJ, 1984).
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5. D. Kelly. ISO and CEN documents on quality in medical laboratories. Clinica Chimica Acta 309, 121-125 (2001).
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6. D. Burnett. ISO 15189:2003 - Quality management, evaluation and continual improvement. Clin Chem Lab Med 44, 733-739 (2006).
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7. D. Burnett, C.B. Standards for the medical laboratory - harmonization and subsidiarity. Clinica Chimica Acta 309, 137-145 (2001).
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Last changed: 2009-11-05