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Appendixes

Archive: 1999 Session - Appendix 22

1999 Session of the Research Group of the Standing Technical Committee of EuFMD

 

 

Introduction Of a Quality Assurance System: THE IVI Experience
"Quality is fitness for use"

 

C. Griot, S. Bossy, H.P. Ottiger
Institute of Virology and Immunoprophylaxis, Swiss Federal Veterinary Office, 3147 Mittelh­usern, Switzerland

 

Importance of quality assurance

Since the beginning of the early 1990`s, a marked increase of free circulation of animals and animal products in international trade has been recorded, and it was previously suggested that the peak of animal movements between countries or regions has not been reached yet. Unfortunately, epidemics of highly contagious diseases have been the consequence of this markedly increased animal traffic. A striking example is the past epidemic of the classical swine fever outbreak in the Netherlands in 1997 resulting in enormous direct and indirect costs for the national economy of the country (Horst et al., 1999).

Since the issuing of an international veterinary certificate for animal movements between two different countries is a complex procedure in which several authorities are involved, organizations such as the Office International des Epizooties (OIE Paris) have discussed the future implementation of a quality assurance system for government veterinary services (Kihm, personal communication). In this context it is important to recognize, that the overall quality of the final product (e.g. an import/export certificate) is assured only by the quality of each individual process involved. Within the making of a certificate, the veterinary diagnostic laboratory is an important provider of critical data (Caporale et al., 1998). Since the reliability and the quality of the certification of animals and animal products depends strongly on the laboratoryÎs ability to provide diagnostic results of a defined standard, the laboratory should be able to guarantee the quality of these test results. Recently it has been suggested by the Research Group of the Standing Technical Committee of the European Commission for the Control of Foot-and-Mouth Disease (FMD) that all laboratories carrying out FMD diagnostic assays, at least in context of international trade, should participate in a quality assurance (QA) program (De Clerq, 1996; De Clercq and Donaldson, 1997; De Clercq, 1998).

As a result of increased trade and the accompanying risk of introducing highly contagious disease there will clearly be an extended demand for high quality veterinary certification. In addition, veterinary certification has arisen to ensure high public health as well as animal health standards and to facilitate the development of free trade in animals and their products (Ottiger et al., 1998).

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The situation in Switzerland

Switzerland implemented in its Federal Animal Disease Legislation in 1995 that all laboratories offering diagnostic testing for the 77 reportable diseases need to be accredited according to Euronorm (EN) 45001 (equivalent to ISO/IEC Guide 25) as of January 1, 2000 (Animal Disease Legislation, Article 25). This affects 32 laboratories, including the Institute of Virology and Immunoprophylaxis (IVI) which is the national reference laboratory for the OIE list A diseases (Murray, 1998). In addition, cantonal (equivalent to state), privately operated laboratories and university operated laboratories, and the analytical laboratories of the Swiss Federal Veterinary Office serve as disease reference centers (Anonymous, in press). To date 13 laboratories have passed the audit of the Swiss Accreditation Service (SAS; http://www.sas.admin.ch), and most other laboratories are still in the process of fulfilling the necessary requirements (Miserez, personal communication). After more than 3 years of preparation, the IVI passed the three day audit in September, 1998 and since March 15, 1999 has been officially recognized as an EN 45001 accredited laboratory.

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Quality assurance program implementation

Any laboratory applying for laboratory accreditation must have mandatory a clearly defined organizational system and infrastructure, adequate management, and technically competent personnel with appropriate authority and resources to carry out their mandate. This necessitates the implementation of a QA system that is capable of (self) monitoring and operating in an integrated and efficient manner of various aspects of operation (Caporale et al., 1998). The implementation of such a QA system is a time consuming process in which all personnel need to be involved.

The first step which was taken was to draw up the "quality policy" which defined the strategic objectives of the entire laboratory. The document was made in accordance with the reference standards, and was implemented by the laboratory director. It included the application of quality principles (competence) to all areas of operation, in particular in (I) employee expertise, (II) technical infrastructure, and (III) management. At the IVI, the slogan "quality is fitness for use" was created and used in context of all quality policy issues (Figure 1).

Next, the "accreditation task force", headed by the QA manager, was implemented. In this task force, all sections, including those not directly involved in the accreditation process (e.g. physical plant management, biosafety and human resource office), were represented. An in-depth analysis of the main processes performed at the IVI was carried out. This included operational aspects such as the IVI management and personnel policy, laboratory infrastructure and procedures, etc. The analysis was overseen by an "external" expert in close collaboration with the accreditation task force. The results of this analysis were then used as a basis for the following meeting with the SAS, and it was decided to accredit (I) the laboratory of diagnostics, (II) the laboratory for batch control of immunobiologicals, and (III) the cell culture laboratory (Figure 2).

In the following months, all necessary documents (e.g. standard operating procedures; SOPs) were prepared. All employees were informed of the progress on a regular basis either by newsletters, workshops or site visits.

In September 1998, the entire QA system was inspected by two appointed experts for three days. A total of 18 conditions were made for compliance, most of which were minor and corrected within a reasonable time-frame. Overall, the implemented system was found to be of high quality, and the audit was passed. In the SAS directory, the IVI has been listed since March 15, 1999 as "Testing laboratory for the diagnosis of highly contagious viral diseases of animals, and quality control of biologicals for veterinary use". The scope of the accreditation (list with all groups of products or materials and fields of activity) is available upon request by the national accreditation body.

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Outlook

Veterinary diagnostic laboratories are suppliers of critical analytical data that are used in animal health control and monitoring programs. The reliability of international veterinary certification depends for example on the ability of the laboratory to provide results of high quality. Diagnostic results are therefore important tools for the control of the health of live stock and the hygienic status of foods of animal origin.
From our experiences at the IVI thus far, it is strongly suggested not only to accredit a single diagnostic assay but to include as many methods as possible in the given QA system. Too many "interfaces" between non-accredited and accredited units within the same laboratory are not desirable.
Whether the previously proposed accreditation of laboratories performing FMD diagnostics will be of success will depend heavily upon the factors discussed above. In particular, the costs and the time frame to achieve the accreditation are not to be underestimated.

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Acknowledgments

The authors thank Travis Thayer for the critical review of the manuscript and Marlies Schlatter for final editing of the manuscript.

 

 

Selected references

 

  • Anonymous (1999): Animal and public health report, Swiss Federal Veterinary Office, 2/99. In press.
  • Horst, H.S., de Vos, C.J., Tomassen, F.H.M., Stelwagen, J. (1999): The economic evaluation of control and eradication of epidemic livestock diseases. Rev. sci. tech. Off. int. Epiz., 18 (2), 367-379.
  • Caporale, V., Nannini, D., Ricci, L. (1998): Quality assurance in veterinary diagnostic laboratories. Rev. Sci. tech. Off. Int. Epiz. 17 (2), 459-468.
  • De Clercq, K. (1996): OIE guidelines for laboratory quality evaluation and proficiency testing as a bases for the implementation of a quality assurance program in national FMD laboratories. Report of the Session of the FAO Research Group of the Standing Technical Committee of the European Commission for the Control of Foot-and-Mouth Disease, September 2-6, Kibbutz Ma'ale Hachmisha, Israel, 208-218.
  • De Clercq, K. and Donaldson, A. (1997): Requirement for a program of quality assurance and compliance monitoring for foot-and-mouth laboratories: a possible role for the organization for economic co-operation and development (OECD): Report of the Session of the FAO Research Group of the Standing Technical Committee of the European Commission for the Control of Foot-and-Mouth Disease, September 23-27, Poiana-Brasov, Romania, 106-113.
  • De Clercq, K. (1998): Movement Towards a Generic Veterinary Diagnostic testing Laboratory Accreditation Scheme. Report of the Session of the FAO Research Group of the Standing Technical Committee of the European Commission for the Control of Foot-and-Mouth Disease, September 15-18, Pirbright, UK, 219-222.
  • Murray, P.K. (1998): An overview of the roles and structure of international high-security veterinary laboratories for infectious animal diseases. Rev. sci. tech. Off. int. Epiz. , 17 (2), 426-443.
  • Ottiger, H.P., Bossy, S., Griot, C. (1998): Akkreditierung - Vertrauen schaffen durch Normen. IVI Annual report, 15-20.
  • Figure 1: Competence of the laboratory is based on personnel, infrastructure and management

  • Figure 2: The accredited units of the IVI

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