Workshops on quality management, accreditation and managing the human side of change in genetic testing laboratories:

EuroGentest, Network for test development, harmonization, validation and standardization Genetic testing in Europe - EU FP6-512148

Workshop organizers:

• Elisabeth Dequeker & Sarah Berwouts: University of Leuven, Centre for Human Genetics, Leuven, Belgium
• Michael A. Morris: Geneva University Hospitals, Service of Genetic medicine, Geneva, Switzerland
• An Wynants & Mieke Gielis: Management Consulting & Research, Heverlee, Belgium

This work was supported by:

• EuroGentest, a European Network of Excellence (EU FP6-512148), coordinator Jean-Jacques Cassiman
• Management Consulting and Research, a spin-off of the university of Leuven, chief executive officer, Peter Rosseel

We wish to thank the following individuals for their contribution to the workshops:

• Workshop on accreditation: Bert Bakker, Anne-Mieke Neary Smit, Claudia Ruivenkamp, Els Voorhoeve (LUMC, Leiden)
• Workshop on IT: Gunter Baelus (Bitos, Vosselaar), Martin Bowman, Brian Dodson (Gael Quality, Kilbride), Craig Bunn, Colin Christie, Nina Dempsey, Paul Douglas (Genial Genetic Solutions, Cheshire), Jean-Pierre Beerli, François Godet, Michel Lefort, Laurent Seydoux (Lysoft, Geneva), Arjen van den Broecke (Pilgrim Software, Hilversum), Mike Bendall, Robert Oakley (Qualsys, Sheffield), John Goehring (Laboratoire MGD, Geneva), Jean Pernet, Rudy Rys (KUL, Leuven), Simon Patton (NGRL, Manchester)
• Workshop on internal audit: Paul Kyle, Peggy Ruymbeeck, Annemie Vergote (Innogenetics, Ghent), Ros Hastings, Bettina Quellhorst-Pawley (UKNEQAS, Oxford)
• Workshop on management review, internal quality control and external quality assessment: David Barton (Our Lady’s Children’s Hospital, Crumlin, Dublin)
• Workshop on validation: Milan Macek (University Hospital Motol and 2nd School of Medicine, Prague), Gert Matthijs (Centre for Human Genetics, Leuven), Chris Mattocks (NGRL, Salisbury), and Elfriede Swinnen (Centre for Human Genetics, Leuven)
• New trainers: Peter Declercq (Virga Jesse, Hasselt), Bénédicte Gérard (Hôpital Robert Debré, Paris), Emmanuelle Girodon (CHU Henri Mondor, Créteil), Tony Herbert (NGRL, Salisbury), Anne-Françoise Roux (CHU Montpellier, Montpellier), Su Stenhouse (Duncan Guthrie Institute of Medical Genetics, Glasgow), Els Voorhoeve (VUMC, Amsterdam)
• Anniek Corveleyn, Romy Gentens, Nick Nagels, Iris Rens, Ivo Salden (KUL and UZ, Leuven)

Table of contents

1. Introduction
   1. Background
   2. Aims
   3. Approach
2. Workshop on accreditation - Leiden
   1. Focus and approach
   2. Outcome
   3. Discussion
3. Workshop on IT support for quality management - Leuven
   1. Focus and approach
   2. Outcome
   3. Discussion
4. Workshop on internal audit - Oxford
   1. Focus and approach
   2. Outcome
   3. Discussion
5. Workshop on managing the human side of change – Nice
   1. Focus and approach
   2. Outcome
   3. Discussion
6. Workshop on fulfilling the requirements of ISO 15189 for management review, internal quality control and external quality assessment – Berlin
   1. Focus and approach
   2. Outcome
   3. Discussion
7. Workshop on diagnostic validation – Prague
   1. Focus and approach
   2. Outcome
   3. Discussion
8. Opinions of participants
   1. Dr. Tony Herbert, Wessex Regional Genetics Laboratory, Salisbury, UK
   2. Uta Malburg, Department of Human Genetics, University Würzburg, Germany
9. Conclusions
10. References

Introduction

a. Background

The demand and provision of genetic testing within medicine is clearly increasing in all European countries, thanks to the completion of the Human Genome Project and other scientific and technical advances. Moreover, a genetic test is usually carried out only once in a lifetime and can impact on the life of other family members. It is therefore essential to assure the quality of the different elements of genetic testing, including laboratory testing, interpretation and reporting, and genetic counselling. In this context, data from several organizations (Cystic Fibrosis Network) ¹ , European Molecular Genetics Quality Network ² , European Science and Technology Observatory Network ³ , ⁴ , Organization for Economic Co-operation and Development ^5-7 have revealed the need for improving quality and harmonization in genetic testing services within Europe. The quality of genetic testing could be increased by setting standards, providing training, promoting laboratory accreditation, participation in External Quality Assessment (EQA) schemes and the use of reference materials ⁸ . The EuroGentest Network of Excellence (NoE), a European funded project (Contract no: FP6-512148. Website: www.eurogentest.org ), was created to address these challenges. ^a

b. Aims

EuroGentest ⁹ , ¹⁰ aims to harmonize and improve the overall quality of genetic testing services in Europe. A part of the project (Unit 1) aims to measurably improve the quality of management and provision of genetic laboratory services, and for laboratory accreditation to be considered as the standard. In a focus on training and continuous education of personnel, key parameters in improving quality, a series of workshops has been organized with the aim of aiding laboratories in their processes of developing quality management systems (QMS) and working towards accreditation. Furthermore, the provision of international workshops also contributes to the harmonization of QMS and approaches to accreditation of genetic testing services throughout Europe.

c. Approach

The workshops brought together people from laboratories that are either already accredited or in the process of developing a QMS and working towards accreditation. The same group of participants was invited each time, including laboratory directors, scientists, technicians and quality managers, from cytogenetic, biochemical and molecular genetic laboratories in whole Europe. The first workshop had broad aims and addressed implementing and living with quality systems, comparing the different standards for accreditation in Europe and sharing experiences by examining cases of concrete situations related to quality processes in laboratories. This workshop revealed a need for and an interest in IT support for QMS in medical laboratories, which logically became the main topic of the second workshop. During the third workshop another crucial but difficult topic, internal audit, was tackled. A mixture of video clips and role-playing gave the participants an overview of all aspects of auditing from preparing and reporting the audit to communication and behaviour skills of the auditor. Besides dealing with concrete aspects of quality systems, a fourth type of workshop, on managing the human and behavioral side of change, was organized. The fact of natural resistance in the team could be inherent to the implementation of a quality system in the laboratory.

Finally, two separate workshops were organized on more advanced elements of a quality system including internal quality control, external quality assessment, management review and diagnostic validation.
The workshops in general are designed to be very interactive, with a maximum of time for targeted group discussions and occasional presentations on specific topics. To facilitate the active involvement of everybody, the number of participants is kept low, with a maximum of about 30 people. The workshops are organized and animated by a team consisting of a director of an accredited laboratory (MAM), a laboratory quality manager who conducts accreditation audits for the Belgian Organization for Accreditation (BELAC) and who is a member of ISO Technical Committee 212 (ED), a EuroGentest scientist (SB), and collaborators of EuroGentest partner ‘Management, Consulting & Research’ (MCR) Leuven, specialists in the “human side of change processes” (MG, AW).

This report describes the outcomes and summarizes the discussions of the pilot workshops, organized since 2005.

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. 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 discussion in small groups and ending with a whole group debate to reach final conclusions.

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, appendix 2). The case studies addressed situations that could arise in any laboratory and formed a basis for broader discussions 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.

BOX 1 - CASE STUDY

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Johan is preparing a PCR reaction for hereditary haemochromatosis. He fills in the worksheet of the lab and determines the necessary amounts of reagents. He enters the set-up room for the PCR reaction, puts the laminar flow on and takes his reagents out of the freezer. The temperature of the freezer is above the allowed range: he measures -15°C, whereas the accepted range is between -30°C and -20°C.

1. How should Johan react, in your quality system, when the temperature is higher than allowed? How do you follow corrective/preventive actions?
2. How are the thermometers calibrated in your lab?
3. How many times is the temperature logged in your lab? How are the 'acceptable ranges' determined for fridges, freezers etc?
4. How long are worksheets stored in your lab? What should be included on a worksheet for PCR? Draft a template for the ideal worksheet.

During the workshop, special attention was paid to the current available accreditation standards used within Europe. The International Organization for Standardization (ISO) ¹¹ has developed an international standard for testing laboratories in general (ISO 17025), and one specifically for medical laboratories (ISO 15189). ISO 15189 emphasizes the quality of contributions to patient care, as well as of laboratory and management procedures, and is therefore the preferred standard for genetic testing laboratories. In contrast, ISO 17025 is written in more general terms and is applicable to a wide range of testing environments. However, as the standard is designed for a wide range of laboratories, a certain effort of reflexion and interpretation may be necessary to apply it in the context of genetic testing. ISO standards are not public domain but a personal electronic version can be easily bought via the website of ISO (www.iso.org) or via your National Standards Organization (for example, NBN in Belgium, DIN in Germany, AFNOR in France ...). An overview of these bodies can be found on the website of the European Committee for Standardization (CEN): www.cen.eu/cenorm/members/national+members/. Some countries do not use international accreditation standards, but national ones, such as CCKL (Coördinatie Commissie ter bevordering van de Kwaliteitsbeheersing van het Laboratoriumonderzoek op het gebied van de CCKL Gezondheidszorg) ¹¹ in The Netherlands and CPA (Clinical Pathology Accreditation) ¹² in the UK. Participants were trained to compare and use these standards in actual practice. An overview of the different quality standards for genetic testing laboratories in European countries is in box 2.

Apart from the accreditation standards, the Organization for Economic Co-operation and Development (OECD) (6) has published specific guidelines on quality assurance in molecular genetic testing, which might be considered as a sector-specific document to use in combination with the existing accreditation standards. The contents of the guidelines are not formal requirements, but can be a useful complement to laboratories for improvement and harmonization. The minimum common requirements described address general principles and best practices, quality assurance, EQA, reporting of results and training for laboratory personnel. Laboratories can download these guidelines freely from the EuroGentest website or the OECD website in English, French or Spanish: http://www.oecd.org/dataoecd/43/6/38839788.pdf

There is persistent misunderstanding about the difference between accreditation and certification .

Certification is defined by ISO as the "Procedure by which a third party gives written assurance that a product, process or service conforms to specific requirements". Its requirements address only the quality management system, including procedures, a quality manual, document control, defining non- conformities, corrective and preventive actions, performing internal audits and enhance customer satisfaction; it does not necessarily include requirements of technical or analytical competence.

Accreditation , in contrast, is defined by ISO as the "Procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks". While accreditation also considers the quality management system, it has additional formal requirements of technical competence, including initial and continuous training of personnel, validation of methods and instruments, and internal and external quality control.

As a result, certification (typically according to ISO 9001) should not be interpreted to mean that a laboratory has demonstrated the technical competence to produce valid data and results. On the other hand, ISO 15189 and ISO 17025 are accreditation standards, assuring technical competence of a laboratory.

Apart from the difference in the objectives of certification and accreditation, there is also a difference in the body that carries out the assessment and that delivers the certification or accreditation certificate. Laboratories applying for ISO 9001 certification will be audited by a certification body, a third party, which is accredited by an accreditation body. Each country has multiple certification bodies. A few examples are: AENOR, AFNOR, BVQI, CERMET, IQNet, TüV, ... In contrast, there is only one recognized national accreditation body (NAB) in each country which assesses laboratories, against internationally-agreed standards. In Belgium this is BELAC (Belgian Accreditation Body), in Switzerland SAS (Swiss Accreditation Service). Other recognized national accreditation bodies can be found in figure 1.

FIGURE 1 – NATIONAL ACCREDITATION BODIES IN EUROPE

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The European co-operation for Accreditation (EA, www.european-accreditation.org), is a non profit association and the European network of the recognized NABs located in the European geographical area. A similar organization exists in other regions: IAAC (InterAmerican Accreditation Co-operation), APLAC (Asia Pacific Laboratory Accreditation Co-operation) and SADCA (Southern African Development Community in Accreditation).

One of its purposes is to develop and promote accreditation criteria and guidelines which will ensure harmonised performance of national accreditation bodies throughout the European economic area.

Most of the EA accreditation body members signed a Multilateral Agreement (MLA) to recognize the equivalence, reliability and therefore acceptance of accreditations and certifications across Europe. A certificate or inspection report issued by an accredited body in one country is recognized as equivalent to a certificate or inspection report issued by an accredited body in any of the countries signatories to the EA MLA.

International Laboratory Accreditation Cooperation (ILAC) is the international ”umbrella” organization which covers all national and regional accreditation organizations (figure 2).

FIGURE 2 – NATIONAL, REGIONAL AND INTERNATIONAL ACCREDITATION ORGANIZATIONS

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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 ¹⁴ , 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. Managing the human side of change will be discussed in chapter 5 in more detail.

BOX 3 - CHANGE PROCESSES

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1. People need to experience that the situation can not be maintained. Make people realize that the current situation is not suitable anymore. Involvement and responsibility of everybody is important.
2. People need to have time to observe and reflect .
3. People will form ideas and theories. Do not explain what the most relevant option is (implement quality system, accreditation), but let them come with solutions.
4. People will test these ideas to see whether they are viable. The results of these experiences can then form the basis of reflection, new ideas etc. When people experience by themselves, they go along with change. Let people start with easy tasks. Give positive feedback. Finally new things become routine.

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 ^15-17 . Repeated comments during the group discussions 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.

Workshop on IT support for quality management - Leuven

September 15-16, 2005, held at the Catholic University of Leuven, Campus Arenberg III, Leuven, Belgium

a. Focus and approach

Based on feedback from the first workshop, the decision was made to address software packages to support quality management systems. The successful format of mixing lectures and interactive sessions was maintained.

A quality management system should at least include document control, auditing, training of personnel, follow-up of corrective and preventive actions, maintenance and calibration of equipment and reagent and batch control (figure 3). All these aspects can be included in a software package, to optimally support the quality system. Laboratory Information Management Systems (LIMS), which only include tracking and monitoring of laboratory data, were not included in the scope of the workshop.

FIGURE 3 - ASPECTS OF A QUALITY MANAGEMENT SYSTEM

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During the first part of the workshop, three companies presented their software solutions. Afterwards, all participants had the chance to work hands-on with the software, alternating with brief question-and- answer sessions. On day two, further time was available for working with the software, and presentations were given by three further companies. To exchange and analyse experiences best, a full group debate was held, after individual analysis and sub-group discussions. A number of advantages and disadvantages of implementing a software package became clear, and a group consensus was reached for a list of criteria for selecting a software system. A significant finding and a subject of animated discussion, were the relative advantages of managing the QMS in a database-centred or a document-centred fashion. The conclusion was essentially that both approaches can work and the choice is a matter of preference.

b. Outcome

A thorough internet search (using combinations of the following key words: compliance, quality, management, software, ISO, laboratory, audit, document control) was performed to identify QMS software on the market. EuroGentest has no intention to sell or to give preference to any package, and consequently the list in box 4 is only a random selection and could be a starting-point in the selection of a proper software programme that fits a particular laboratory’s workflow. It will help to give an idea what IT support could include, or rather what the different approaches and possibilities are to support a quality management system. The software companies marked, contributed to the workshop either by a presentation alone (*) or by a presentation and providing installed demo versions (**), permitting the participants to evaluate and test the software. These companies were also asked to provide details of the different modules in their software, the technical requirements, the possibility to link with other programmes (e.g. hospital information systems), support, maintenance, training and prices. This comparison revealed huge differences between the available software solutions.

BOX 4 - QMS SOFTWARE SYSTEMS IDENTIFIED BY INTERNET SEARCHING
(this list is provided 'as is' - EuroGentest does not sell or give preference to any package)

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Amadeus Solutions - eQRP (France)	Master - ControlIntegrated Quality Suite (US)
http://www.amadeussolutions.com/	http://www.mastercontrol.com/
AssurX - CATSWeb (Germany)	Noweco - JKT9000 (Germany)
http://www.assurix.com/	http://www.noweco.com/
Autoscribe - >Matrix LIMS (UK)	Pilgrim Software - SmartSolve (The Netherlands)
http://www.autoscribe.co.uk	http://www.pilgrimsoftware.com/
Bitos - Mithras (Belgium) **	PQ Systems - Quality Workbench Professional (UK)
http://www.bitos.com/	http://www.pqsystems.com/
bizzApps - Quality Manager (The Netherlands)	Quality On-Line - Quality On-Line (The Netherlands)
http://www.bizzapps.com/	http://www.qualityonline.com/
Gael Quality - Q-Pulse (UK) **	Qualsys - EQMS (UK) *
http://www.gaelquality.com/	http://www.qualsys.co.uk/
Genial Genetic Solutions - iPassport (UK) **	SoftTech Health - SoftTech Lab QMS (US)
http://www.genialgenetics.com/	http://www.softtechhealth.com/
Infoland - Kwaliteitssuite (The Netherlands)	Software Compliance - ISOXPERT (US)
http://www.interaxgrp.com/	http://www.softwarecompliance.com/
Interax Group - Paradigm II (US)	Sparta Systems - TrackWise (Israel)
http://www.interaxgrp.com/	http://www.spartta-systems.com/
LabWare - LabWare LIMS (UK)	Vivaldi Software - Vivaldi QMS (Belgium)
http://www.labware.com/	http://www.vivaldisoftware.com/
Lysoft - Quallys laboratoire (Switzerland) *
http://www.quallys.ch/

The test sessions on the computers were focused with concrete questions, exercises and road maps developed by EuroGentest and the companies. Through the exercises and the 's, participants developed their understanding of the different elements of a quality system, for example document control (see figure 2, based on David Burnett, A practical guide to accreditation in laboratory medicine, p71-72 ¹⁸ ). So participants not only had an overview of how IT can support their QMS, but were also introduced to different ways of organizing quality systems.

The motivation to change to a software-based quality management system could include issues like saving time due to reduced paperwork, better traceability, simplified follow-up of audits and corrective actions, and programmable notifications. Furthermore, a central data store, accessible from everywhere, makes work more efficient and well-organized. On the other hand, besides the initial cost, it will take significant time and effort to implement the system and to win everybody over to its advantages.
A necessary starting point when selecting a system is compiling a requirements list of what is needed to fit with the own laboratory workflow. Define what is essential for your laboratory, based on what you have already in place, the size of the laboratory, IT experience, long-term expectations and existing data. During the workshop, such a list of criteria was drawn up during group discussions (see box 5), which can provide a starting point or guidance for each laboratory.

c. Discussion

During the discussions it became clear that everybody was strongly in favour of implementing a software package to support their quality system. Some barriers were identified, including convincing the management, or extra workload and costs; suggestions were formulated to overcome these problems.

The principles of managing change processes can be applied. Start by involving all relevant people from the beginning, including technicians, secretaries and the IT personnel, as well as the quality manager and laboratory director. Listen to their ideas and distribute responsibilities to increase motivation. When people have the impression that they contribute to the decision-making, they will be more open to implement and to put effort into the new system.

Take your time to educate yourself via colleagues, internet and demo versions. Visiting a laboratory that uses a system could help convince personnel of the value of changing. To reduce the excess workload, invest in training and work in a phase-to-phase approach, implementing and optimizing one module before you start implementing others; to reduce or spread the costs, purchasing of modules can be phased.

General consensus was reached on criteria which should be taken into consideration before choosing a software system. When comparing currently available software with these criteria, it was evident that all packages had interesting aspects, but that none yet really fulfilled all the ideal criteria for quality management in genetics laboratories.

Based on the feedback afterwards, it was clear that every participant took something out of this workshop, despite the difference in experience with software packages. Existing users had the opportunity to discover which features their software has (or not), in comparison with other packages; new ideas were obtained for optimizing their own system. Non-users became aware of the usefulness of software for their QMS, and now have an idea how to choose and implement a system. In addition to the benefit for participants, the companies present – who could participate freely in all sessions – collected information and feedback. They were able to talk to users or potential clients and hear their concerns and wishes. Based on the criticism and comments they received, promising new versions were released by Gael Quality and Genial Genetics Solutions. Some of the participants are now in the process of selecting a system; some have already acquired a software package that was shown at the workshop.

Workshop on internal audit - Oxford

June 22-23, 2006, held at the Oxford Spires Four Pillars Hotel, Oxford, United Kingdom

a. Focus and approach

The first workshop of 2006 was dedicated to internal auditing ¹⁹ . The aim was to train participants to efficiently and effectively direct and/or participate in a laboratory audit in the spirit of peer review and education. Participants were motivated to exchange ideas and learn from each other and the experts, through general presentations, role-play, video clips and group discussions.

b. Outcome

A general presentation, alternated with practical exercises, touched upon all the different aspects of auditing, categorized in the “why, what, who and how” of internal audit (box 6).

The exercises, including role-play, short video clips and group 's, were divided into three categories: the execution of an audit, completed by communication and behaviour skills, the preparation beforehand and finally the reporting and follow-up afterwards.

Experienced auditors and people who never performed an audit before were mixed and divided into small groups, each of which received a case description of a realistic laboratory situation. The group had to enact the situation, in which both auditors and auditees were present. Based on the feelings and experiences of auditor and auditee during the role play, a list was compiled of what went well and what could be improved when doing an audit. Furthermore, small video fragments gave extra information how you should behave and handle situations during an audit. All the raised elements were discussed further.

It is important that the auditor starts with and mostly uses open questions, which are simple and straightforward. If necessary, subsequent questions may be asked to develop deeper answers, but ‘why’ questions should be avoided as they often trigger defensive reactions. It is preferable to start with ‘how’ questions, based on what can be seen. The use of words like ‘maybe’, ‘a little bit’, ‘could’, etc. may have miscellaneous effects. On the one hand, they make the message less direct or threatening; on the other, they may give the impression that the auditor is not sure about himself. The auditor should mention when something is not conforming to the procedure, so that the auditee already understands during the audit that not everything was perfect. At the end of an internal audit, the auditor should focus on solutions and improvement and should include suggestions as well as positive feedback.

The behaviour of an auditor, as well as his way of communicating, can be crucial for a successful audit. When the auditor begins, he should make the auditee feel at ease by being polite and not too formal. He should explain the planning and make clear that it is the system and not the person that is being audited; no “blame” will be attached to the person. It is essential to find the balance between confrontation and empathy. Although it is essential not to hide or minimize when something is wrong, the auditor should stay calm and must not raise his voice. A good auditor always stays objective and independent, and will adapt to the behaviour of the auditee. Finally, he has regular eye contact and does not interrupt the auditee, which additionally helps in monitoring the body language.

It is impossible to perform a good audit without thorough preparation. The audit plan should be flexible to permit changes, and should include the objectives and scope of the audit. Furthermore, the individuals who have direct responsibilities, should be identified and informed if a date and time is known, as well as the people who will be directly involved in the audit. The preparation should also include the identification of all reference documents (Standard Operating Procedures, standards etc.). Working documents, like checklists and observation forms, are helpful to facilitate the auditor’s investigations and to document and report the results.

Taking accurate notes during the audit is essential. Based on these, the auditor will make a clear and structured audit report within a defined time limit. This report should include the major and minor non- conformities, as well as mentioning positive points. Following the report, an action plan must be developed, identifying for each action the responsible person and a deadline. General elements, like the auditor’s name, the date and the standard used should be present, in addition to specific details such as the Standard Operating Procedure (SOP) number, equipment number etc. An example of a report is shown in figure 5.

FIGURE 5 - EXAMPLE OF AN AUDIT REPORT

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Date	Auditor(s)	SOP
1/06/2006	Paul Delia	PP00129 revision 2 LiPA compounds and test analysis
Audit type	Auditee	Application date
Vertical audit	Kyle Neath	21/10/2005
Norm	Section advisor	Section
ISO 15189:2003	/	LiPA compounds test analysis room
Description Item Class Action Responsible Deadline The audit took place in the LiPA compounds test analysis room, during routine working conditions. All necessary documents were readily available. The SOP was easy to follow, well documented. Good lab practice was observed throughout. Several non compliances were detected and these need to be addressed. Document control 4.3 1. It was noted that there had been an amendment to the working document where the incubation time had been decreased from 30 to 20 minutes. There appeared to be no technical validation of this critical step. The change was made by pencil. 4.3.2 B Amendments should be in pen and announced at the weekly meeting. Sue Davids 10/06/06 2. A database system exists to follow-up changes. 4.3.2 + Identification and control of non-conformities 4.9 1. Documentation of non-conformity concerning the storage of reagents was well documented, however, it was noted that a reagent had frozen during storage. 4.9.1 + Personnel 5.1 1. Training records were not up to date, last record training states from 2004 5.1.2 + +* All training files will be checked if they are up to date. Brian Alvey 01/07/06 Laboratory equipment 5.3 1. Maintenance records for the main incubation machine was two weeks overdue for calibration due to Holiday of responsible person 5.3.2 B A better follow-up of absences is necessary. Action plan will be set up at next weekly meeting. Richard Torn 15/08/06 2. Equipment is uniquely labelled and the status of calibration is indicated 5.3.3 5.3.9 + +
Signature	Following classification with the definition of the codes is used
	A Major non-conformity which is a direct danger for the quality and means that the quality system is not conform the pre-defined accreditation criteria B Non-conformity that could influence the reliability of the results and the effectiveness of the quality system on the long-term +* Recommendation, will be evaluated next time + Is implemented or operational conform with the standard

c. Discussion

A laboratory is committed to constantly evaluate its activities and to maintain and improve its quality. Performing internal audits is one tool to evaluate and improve a quality system and to detect non- conformities. Other possibilities are participating in external quality assessment (EQA) schemes or undergoing an external audit, conducted by an external independent organization such as a national accreditation body. An internal audit is conducted by the laboratory itself on different aspects of the laboratory. The auditor could be confronted with some minor and major non-conformities during the audit. Consequently, an action plan needs to be set up to eliminate the non-conformity in the future. During the next internal audit, these elements could be checked again to evaluate if the action plan was effectively implemented.

This process refers to the Plan-Do-Check-Act (PDCA) circle, also known as the 'Deming wheel' ²⁰ . It is a very simple concept which helps coordinate your quality improvement efforts: just as a circle has no end, the PDCA cycle repeatedly executes in pursuit of continual improvement. It emphasizes and demonstrates that improvement programs must start with careful planning, must result in effective action, and must move on again to careful planning in a continuous cycle (figure 6).

FIGURE 6 - DEMING WHEEL FOR CONTINUAL IMPROVEMENT

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Plan : Evaluate the current situation. Define a plan how and which activities need improvement.
Do : Conduct a small-scale implementation of the plan.
Check : Monitor and evaluate the plan. Adopt and adjust the plan where necessary.
Act : Implement the definitive plan.

The process is not finished; a new circle starts, in order to continually improve the system and assure the quality (QAu).

In conclusion, internal audits are designed and should be used to continually improve the quality system, and not to inspect the people working within the quality system. The involvement of the whole group is important to achieve successful improvement. A thorough knowledge of the quality standard and of the quality manual is essential when performing audits.

Workshop on managing the human side of change - Nice

February 7-8, 2008, held at the Novotel Nice Centre, Nice, France

a. Focus and approach

One of the biggest challenges in implementing a quality system in the laboratory lies in overcoming natural reluctance of team members, and convincing them of the value of quality assurance to justify the effort that will be required.
This workshop aimed to give insight in the human and behavioural aspects of change, including the different (psychological) phases in the whole process. Furthermore, techniques were presented to manage these aspects and to communicate during change processes. Case studies and role play provided illustration and practical training, to help to apply these insights in the own laboratory.

b. Outcome

Implementing a specific change in the laboratory is a linear process . For example, the head of the laboratory decides together with his staff members to implement a quality system. The different steps (writing SOPs, tracking non-conformities …) and when they should be implemented is definable. This linear process is usually organised with the help of techniques like project management and is restricted in time. However, the reaction of the technicians in the laboratory, or what we call behavioural change, cannot be planned in time as it is a cyclic process . The technicians will need to go through a learning process during which they receive new information, experience certain emotions, try out new things etc. This process is individually different and can not be managed in the same linear way. Tension will emerge between those two processes and this will causes resistance during a change process (figure 5). This resistance cannot be avoided, but when managed well, it could increase effectiveness and efficiency of the change you would like to implement.

FIGURE 7- CHANGE MANAGEMENT: TWO INTERFERING PROCESSES

The cyclic process mentioned above encloses different phases people may go through when confronted with change:
Initially, people deny the impending change and continue with their work. They progressively become aware that the change is significant and may begin to doubt and become angry. Consequently, people will negotiate and try to maintain the status quo. When it is accepted that change is inevitable, they may become depressed. After a period of inner struggle, people see new opportunities, start exploring them, and develop alternatives to go about with the changes. In the last phase they accept the situation and plans can be made to continue. Each individual will go through these phases, but at different speeds, resulting in the need for flexibility, in particular from the management. Figure 8 gives an overview of the different phases as well as how you should react accordingly when you are implementing change. First, patiently repeat the message and the facts to people in the ‘shock and denial phase’. Secondly, give them the opportunity to blow of some steam and listen. If they start to negotiate, be firm, which can be followed by encouragement. Once people accept what is going to happen, do not minimize their efforts and be positive.

FIGURE 8- PHASES PEOPLE GO THROUGH IN TIMES OF CHANGE

A useful tool to manage the human side of change is force field analysis, which helps you to go through the phases of change in a participative way with your team or department (group problem solving tool). It is based on the fact that every situation involves a balance between conflicting forces, called driving forces and restraining forces. Driving forces or enablers are actions, skills, equipment, procedures, people etc. that help to move towards the desired objectives, while restraining forces or disablers inhibit you from reaching the goals. Force field analysis is usefully done as a group exercise, involving identifying the different forces together. The forces can be prioritized and appropriate actions should be defined to minimize the disablers and to stimulate enablers so that change becomes possible. In figure 9 the force field analysis is applied on implementing an IT support system in the laboratory.

FIGURE 9- FORCE FIELD ANALYSIS EXAMPLE: IMPLEMENTING AN IT SUPPORT SYSTEM

A second tool to improve insight in the change process is stakeholder analysis . Stakeholders are individuals who have a direct interest in the change process (positive or negative); they have the information, resources and expertise important for the success of the change process or they have the authority to influence the success. The inclusion of all relevant stakeholders in this analysis is essential for the success of the change process. Here is how it works. First create a list of all stakeholders ( stakeholder map ): e.g. laboratory technicians, quality manager, laboratory director, physicians and patients. Split all stakeholders up into clusters, based on influence and impact (cluster 1-4 in figure 10). This enables you to assign priorities within the stakeholders group (high, low, critical, important for decision making etc.). Finally, strategies should be developed to involve, inform or mobilize the different stakeholders ( stakeholder management plan ). For example the strategy for stakeholders that have a low influence, but high impact (cluster 3) should be oriented towards empowerment, which encloses involvement by giving limited power to decide.

FIGURE 10- STAKEHOLDER ANALYSIS

In case of major change processes, it can be worthwhile to develop a structured communication plan. The stakeholder map acts then as a starting point to identify the people you have to communicate with. The communication plan should include these stakeholders, the message you want to communicate, the actions needed, how and when you will communicate your change process to the stakeholders and finally who will be responsible for the actions. In addition, individuals think in different ways, therefore they should be approached differently. Gardner identified seven levers (“7 RE’s”) that aid or thwart the process of mind change. These levers are: reason, research, resonance, re-descriptions, resources and rewards, real-world events and resistance 21 (figure 11). Consider these levers to bring about significant changes in perspective and behaviour in order to reach all collaborators and to improve your communication plan.

FIGURE 11- 7 RE’s, H. GARDNER

The tension between the cyclic and linear process results mostly in resistance. This resistance is not problematic and if managed well, it could have a positive impact or even optimize the change process. When confronted with resistance you could make an appeal to the following four steps:

1. Listen and reward:
   That is a good question. It is indeed important to take that into account. I understand why you have difficulties with that.
2. Summarize to check if you understood your collaborator:
   If I understand well … So you think that …
3. Keep asking questions:
   Could you give some examples? What do you mean exactly?
4. React, depending on the time you have, the emotion of the collaborator or the difficulty of the question:
   • Park or move the issue: Is it ok that I make a note and come back to it later on?
   • Give more explanation: When you think a collaborator does not understand everything, explain it again in a different way.
   • Start the discussion: If you want to know how others think about it. If it is obvious you cannot continue before a certain point is discussed.
   • Take away the objective / give in: Sometimes a small concession could raise a lot of goodwill of the collaborators.
   • Hold on to your point: If unrealistic questions are asked, stay friendly, but firm.

c. Discussion

When implementing When implementing a change process you should be aware that individuals will go through a psychological process, as described by Kübler-Ross ²² , which causes resistance. Tools, such as a force field analysis and a stakeholder analysis, help to navigate more efficiently through the whole change process, to stimulate behavioural change and to involve all stakeholders. In addition, a good structured approach, by using for example a communication plan, will help to develop better strategies to overcome resistance. It is essential not to answer resistance with resistance. On the other hand, it is not just enough to listen and acknowledge. It might be a challenge for a manager to dare to deviate from the original change process when it is clear that the resistance revealed some precious indications to do so. It might be a contradiction to defend change while refusing to have an open attitude to change oneself.

Workshop on fulfilling the requirements of ISO 15189 for management review, internal quality control and external quality assessment – Berlin

October 9-10, 2008, held at the NH Berlin-Mitte Hotel, Berlin, Germany

a. Focus and approach

For this more ‘advanced’ workshop, we assumed that the participants had a basic knowledge of quality systems and the principles of the ISO 15189 standard. The main objective was to attain an in- depth understanding of what the standard requires regarding internal quality control (IQC), external quality assessment (EQA) and management review (MR), and how this can be translated into practical measures in the laboratory.

ICQ and EQA are two distinct aspects, yet complementary components to assure continuously the quality of your examination procedures, while MR should determine the effectiveness and adequacy of the overall quality system. The results of a MR should be incorporated into a plan, including goals and actions in order to improve your quality system. By analogy with other workshops, tools such as case-work, interactive presentations and role play were applied.

b. Outcome

Internal quality control (IQC) ²³
ISO 15189 requires that “the laboratory shall design internal quality control systems that verify the attainment of the intended quality of results”. However, the standard does not specify which systems should be implemented in the laboratory to conform the requirements. In addition, the World Health Organization (WHO) defines IQC as “the set of procedures undertaken by the staff of a laboratory for continuously assessing laboratory work and the emergent results, in order to decide whether they are reliable enough to be released ” ²⁴ . During the workshop possible approaches to IQC were discussed.

On the one hand, the laboratory should avoid mistakes (ISO 15189, 5.6.1) in the process of handling samples, requests, examinations, reports etc.; on the other hand, the laboratory should determine uncertainty (ISO 15189, 5.6.2) where relevant and possible.
For each test in the laboratory you should first define the potential errors, risks and challenges, which vary per test. Secondly, you should determine how to cover each of them. Write the defined IQCs down in a standard operating procedure ^{25 - 26} . Practically, errors could be reduced by keeping records of batch numbers of all laboratory solutions to improve traceability and troubleshooting. Another example is labelling each tube with a unique code and this code should be checked before, during and after transferring samples by a qualified person. To minimize the risks of contamination, pre and post PCR areas should be separated and filter tips used. Laboratories should always include negative, positive normal and specific mutation controls when appropriate. IQC is an internal verification that the test gives consistent results day after day, in other words the identification of the degree of precision, but not necessarily accuracy.

External quality assessment (EQA) EQA is defined by the WHO as “a system of objectively checking laboratory results by means of an external agency. The checking is necessarily retrospective, and the comparison of a given laboratory’s performance on a certain day with that of other laboratories cannot be notified to the laboratory until some later. The main objective of EQA is not to bring about day-to-day consistency, but to establish inter-laboratory compatibility" ²⁴ . EQA is an important complement to IQC in which a large number of laboratories are provided with the same material and they have to send results back to a coordinating centre. The results are compared against each other which enable to verify the accuracy of the individual laboratory. In addition, EQA provides continuous education and training for the laboratories as well ^27-31 .

Laboratories accredited according ISO 15189 or ISO 17025 should participate in EQA schemes when they are available. The schemes should as far as possible cover the entire examination process from sample reception, sample preparation over the analysis and interpretation (ISO 15189, 5.6.4). Interlaboratory comparison programmes shall be in substantial agreement with ISO/IEC Guide 43-1 ³² .
When a formal EQA scheme is not available, other approaches are required such as inter-laboratory exchange. Inter-laboratory comparisons should cover the scope of services offered and there should be a formal mechanism of review and comparison of the results. Box 7 gives an overview of the main EQA providers within Europe in alphabetical order.

It is essential to follow-up EQA results and to discuss the reports in the regularly laboratory meetings; not only the negative remarks, but positive results as well. Proper actions (preventive and corrective) should be implemented directly and documented. If appropriate, the laboratory can report back to the EQA provider. EQA results will be used also during the management review.

Used together, IQC and EQA provide a method of ensuring accuracy and consistency of results and are vital tools in the quality assurance of the laboratory. The relationship between precision and accuracy may be illustrated by the familiar example of shooting arrows at a target (figure 12).

FIGURE 12 – ACCURACY AND PRECISION

Management review ¹⁹
According to the accreditation standards the “laboratory management shall review the quality management system to ensure continuing suitability and effectiveness in support of patient care and to introduce any necessary changes or improvements. The results of the review shall be incorporated into a plan that includes goals, objectives and action plans (ISO 15189, 4.15.1).”

During a management review the emphasis is on linking different elements of a QMS such as the results of IQC, EQA, internal audits and external audits, previous management reviews, quality indicators, turnaround times, status of preventive and corrective actions, non-conformities, complaints, feedback and evaluation of suppliers. ‘Do we still support our objectives and quality vision?’, ‘Are we still satisfied about the way certain elements of the QMS are implemented?’ are questions to be asked. The management should dare to change directions or to lower criteria when initial objectives were too ambitious, but they should still aim for continuous improvement. The standard states that a MR typically occurs once every 12 months. However, in some laboratories it may be more efficient to perform segmental management reviews, ensuring that by the end of the year all elements are tackled.
As the information discussed during the MR is extensive, a good preparation is essential. The whole process is driven by the management, but they can delegate tasks to the quality manager to collect all the data, to decide what need to be discussed and how the data will be presented. In other words he or she defines the agenda, invites the participants of the meeting (management or staff and usually the quality responsible(s)) and contacts the people in the laboratory responsible to collect the necessary data summarized above, which forms the input of the MR. Usually the quality manager or laboratory director chairs the MR, but is not the only person who talks.

One way to prepare the meeting efficiently is to have a preparation meeting in advance with all the people who will collect data. It might be useful to have ‘guidelines’ in order to standardize the way the results are presented. Then the collected data are provided to the management beforehand in a structured manner. This leads to a MR meeting focused on the right topics, finished within a reasonable time. Difficult or technical sub topics could be addressed in a separate meeting with fewer participants.
The outcome of the MR should include an action plan (what, who, by when) and the objectives of the next year leading to a continuous improvement for the patients. In addition, resource needs or important decisions could be enclosed. All this information should be written in a report which is absolutely necessary as it is a way of registering your quality. The report is dated and signed or approved afterwards. The quality manager should take care of the follow-up of the action plan. It is important that all laboratory staff be informed on the results of the review.

Quality indicators are important input elements used in a management review. The standard mentions that “Laboratory management shall implement quality indicators for systematically monitoring and evaluating the laboratory’s contribution to patient care. When this program identifies opportunities for improvement, laboratory management shall address them regardless of where they occur (ISO 15189, 4.12.4).” In the workshop, a list of quality indicators was drawn up during group discussions (see box 8), which can provide a starting point for each laboratory.

c. Discussion

Internal quality control and external quality assessment are two complementary components of a quality system. They both evaluate performance in the laboratory and are essential to assure the quality in a laboratory. IQC is a daily check that results are reliable and consistent, while EQA is a retrospective comparison with other laboratories. In addition, EQA has an important educational purpose. EQA and IQC provide useful information for the management review of the laboratory. A MR is inevitable to continuously improve and to evaluate the objectives and goals of the laboratory. In order to have a smooth MR, the techniques of the ‘Motivation and Change Workshop’ could be applied. Use a logical structure, in an understandable and meaningful way, to present the information. Start with some positive elements, show solutions, but keep focus and respect the timing. Listen actively and check whether everybody understands and agrees. Finally, a MR is a process in which the whole laboratory is involved, not only management and quality manager. All people working in the laboratory can help to collect data where appropriate and should be informed about the outcome and the action plan.

Workshop on diagnostic validation – Prague

January 8-9, 2009, held at the Novotel Praha Wenceslas Square, Prague, Czech Republic

a. Focus and Approach

It is a formal requirement of accreditation standards, including ISO 17025 and ISO 15189, that (genetic) tests must be validated before diagnostic use to ensure reliable results for patients, clinicians or referring laboratories. These requirements were examined and practical ways of meeting them in the laboratory were addressed during this workshop. The aim was to cover basic principles of diagnostic validation and to find pragmatic solutions, without going into advanced theory or details of complex statistical calculations. The workshop was organized in collaboration with the EuroGentest workgroup involved in writing a generic verification/validation form and a best practice guidance document, specifically addressing diagnostic validation of molecular genetic tests (www.eurogentest.org/laboratories/info/unit1/validation.xhtml). Therefore, only some general principles will be discussed in this report and we refer to the forthcoming guidance document for more detail. The workshop was structured into four main subjects: regulatory framework, parameters for validation, validation plan and validation report. In order to let participants formulate answers on questions that arise when thinking about validation, cases were developed. The cases formed a basis for more elaborate group discussions.

b. Outcome

Regulatory framework
Laboratory tests and instruments must be validated before their application as diagnostic tools and their quality must be maintained throughout use. In other words the laboratory should demonstrate that they fit for the intended use. Box 9 gives a summary of what the ISO 15189 standard states with regard to validation. The standard only claims what must be in place, not how it can be done.

Verification and validation are two slightly different procedures (box 10). The technical committee ISO/TC 212 (Clinical laboratory testing and in vitro diagnostic test systems) is revising ISO 15189. The revised version, foreseen in 2012 will be more elaborate on validation requirements. Below are some of the proposals to be included in this new version:

• “The laboratory shall validate examination procedures from non standard methods, laboratory designed or developed methods, standard methods used outside their intended scope and modified validated methods.”
• “When examination procedures have been validated by the method developer (i.e. the manufacturer or author of a published procedure), the laboratory shall obtain information from the method developer to confirm that the performance characteristics of the method are appropriate for its intended use. When changes are made to a validated examination procedure, the influence of such changes shall be documented and, if appropriate, a new validation shall be carried out.”
• “Examination procedures from method developers that are used without modification shall be subject to verification before being introduced into routine use. The verification shall confirm, through provision of objective evidence (performance characteristics) that the performance claims for the examination method have been met. The performance claims for the examination method confirmed during the verification process shall be those relevant to the intended use of the examination results.”

Parameters for validation
During the workshop the participants developed a list of key parameters that should be taken into account for validation:

• Precision
  • Definition: “Closeness of agreement between results of replicate measurements”
  • Includes:
    • Repeatability: within-run variation
    • Reproducibility: between-run variation
    • Robustness: variation when confronted with relevant challenges
  • Challenges can include: sample type, extraction methods, DNA concentrations, environmental conditions…
• Trueness
  • Definition: “Closeness of agreement with a reference value”
  • Appropriate reference materials are essential
    • Characterized by another technique
    • Positive and negative/normal controls
    • EQA material
    • Samples from other laboratories (reliability?)
    • Synthetic materials
    • Certified reference materials (CRM)

Technique-specific parameters and appropriate experiments to evaluate them, including the question of “How many samples must I run?” were discussed and developed by groups working on specific cases, as well as ways to select relevant control and “challenge” samples.

Recording, reporting and follow-up
The importance of thorough documentation was addressed, especially in the context of accreditation audits. A validation report was analysed in detail, and suggestions for improvement discussed. Pragmatic approaches, reconciling the formal requirements of accreditation standards while respecting the aim that “Validation must be practical” were presented, including:

• approaches to determining measurement uncertainty;
• the use of the “Rule of 3” to determine test sensitivity based on experimental data generated by the laboratory;
• the design of internal quality control based on validation results;
• making full use of data that laboratories were already collecting, for example from IQC or EQA, for continuous validation (“validation is never finished”).

Further reading
The Clinical and Laboratory Standards Institute (CLSI) is a global, non-profit, standards-developing organization within the health care community. They published some guidelines which might be worth to read when implementing validation procedures:

• Molecular Diagnostic Methods for Genetic Diseases; Approved Guideline, MM01-A2
  Clinical and Laboratory Standards Institute, 2006, ISBN: 1562386158
• Verification and Validation of Multiplex Nucleic Acid Assays, Approved Guideline, MM17-A
  Clinical and Laboratory Standards Institute, 2008, ISBN: 1562386611

James O. Westgard, the guru of quality control, wrote a book on validation which focuses on the essentials for validating the performance of laboratory methods for moderate or high complexity tests.

• Basic Method Validation, 3rd Edition. Westgard, J.O., 2008, ISBN: 1-886958-25-4

c. Discussion

It is clear that there are no specific guidelines which tell you when you have done enough, how many samples or repeats for example you need for validation; furthermore, accreditation standards have no specific details about how to fulfil their requirements. The laboratory has to decide on this, based on the performance requirements and has to feel confident that the test provided for the patient is correct. Think intelligently about what samples to repeat and record the results obtained and the procedure used for the validation or verification. Finally, validation is never finished. The implementation of quality indicators (see chapter 6) for systematically monitoring and evaluating the laboratory’s contribution to patient care is a good way to continuously validate diagnostic tests, apart from IQC, EQA and other data.

Opinions of participants

a. Dr. Tony Herbert – Assistant Director & Quality Manager of Wessex Regional Genetics Laboratory, Salisbury, United Kingdom – CPA accredited laboratory

I have been fortunate to attend most of the Unit 1 EuroGentest workshops on Quality Management over the last two years. I first attended the workshop in Leiden as a newly appointed UK Quality Manager with these new duties occupying about 1/6th of my time. I was somewhat apprehensive about what would be expected of me and the amount of bureaucracy this job would entail, however, since quality management was seen as a mandatory requirement of an accredited laboratory and I had been instrumental in preparing for previous successful accreditation visits, the mantle of Quality Manager naturally fell to me. The role can be seen as either a chore or as an essential component of a properly organized service laboratory. I view it as the latter and have formed a committee with shared responsibilities to promulgate this ethos throughout the laboratory.
The joy of being involved in EuroGentest workshops comes from the realization that you are not alone; that there are quality managers in laboratories throughout Europe, all striving to improve standards in our individual laboratories. This role is new to all of us and much time can be saved by sharing ideas gained from experience.
The workshops start with an ice-breaker; usually a task designed to encourage delegates to interact with one another. These ice-breakers immediately put one at ease and set the tone for the rest of the meeting. Sessions are introduced and led by Unit co-ordinators and delegates are then arranged into small workgroups. This is the main attraction for me and the reason I keep returning to the workshops. The interactive nature of the workshops allows personal involvement and the opportunity to take part in make-believe ‘real-life’ scenarios, sometimes even visiting the host laboratory. The experience provides the opportunity to learn which strategies will work and which will not in real-life situations.
For example, on returning from the workshop on internal auditing, I re-designed our audit forms and audit strategy as a direct result of what I had learnt at the workshop. The workshop on Quality Management Software afforded the opportunity to identify what elements we thought were essential in a QM package and what features were desirable extras, making the life of the quality management team and the laboratory as easy as possible.
Having now attended different EuroGentest workshops, I still return to the laboratory with renewed enthusiasm and new ideas - and look forward to the next one!

b. Uta Malburg - Quality Manager of the Department of Human Genetics, University Würzburg, Germany – preparing for ISO accreditation

As professionally offered training courses often refer to quality management in general or to the more common certification standard ISO 9001, it is nearly impossible to find a workshop that concentrates on aspects of quality management which are relevant especially to medical or even genetic laboratories.
I attended several EuroGentest workshops because I wanted to take this special chance to exchange experiences with colleagues who have to solve the same problems and overcome the same obstacles in their (genetic) laboratories. Participants with less knowledge/experience from laboratories that are undergoing the accreditation process can learn from participants with more experience. Even people who have worked in the field of quality management for a long time can profit from new ideas and solutions that are brought up during the workshops.
All workshops had quite a convenient size for a productive working and learning atmosphere and were prepared very professionally and thoroughly.
For me as a staff member of a non-accredited laboratory, the first workshop on accreditation in Leiden was very informative, particularly because of the visits to the Molecular Genetics and Cytogenetics laboratories. It was possible to explore the implementation of the theoretically discussed issues in practice on-site.
The ' of the case studies with the other participants revealed that, even if there exist different accreditation standards over Europe, all have much the same requirements and aims. Nevertheless the practical implementation of these requirements is handled variously from laboratory to laboratory. So I left the workshop with several new ideas how to solve some tricky problems.
The workshop on IT support for quality management provided a useful survey of different IT systems that are on the market. It was very helpful that there were not only presentations of some software-solutions but also the possibility to test several programmes to find out the advantages and disadvantages of these tools for use in our laboratory. For specific questions the participants had the chance to talk to representatives of the software companies.
This workshop helped me to make the decision that for us as a rather small laboratory the implementation of IT support is not indicated at the moment, for different reasons. But if we come to the decision that we want to start working with an IT system, I now know which companies I can contact.
The workshop on internal audit delivered useful insight to the formal issues that have to be considered during the audit process. It was helpful for me to exercise the preparation of an audit plan and an audit report with non-conformities and action plan. I have an idea now how to proceed when planning and executing an internal audit.

6. Conclusions

Implementing a quality management system is a process with different phases starting from choosing an appropriate standard, delegating responsibilities and collecting information, through to writing down all standard operating procedures, offering training and performing validation and audits. This requires a lot of energy and time for laboratory personnel. However, all the invested time will return as an increased quality for the patient and confidence in the test results as well as a higher efficiency and traceability.
By bringing all kinds of genetic testing laboratories together, the training workshops offer a platform for accredited and non-accredited laboratories to meet colleagues experiencing the same and to discuss specific issues as there are not many other possibilities to do this. The common situation of all participants encourages them to start or continue implementing, harmonizing and improving quality systems within Europe, which is one of the major aims of EuroGentest.

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