EPPO Workshop for heads of laboratories
Vienna, AT, 2011-10-13/14
The first Workshop for Heads of plant pest diagnostic laboratories was organized in Vienna on 2011-10-13/14 at the kind invitation of AGES (AT). 43 heads and deputy heads of plant pest diagnostic laboratories from 22 countries attended the Workshop.
This was the first meeting of Heads of plant pest diagnostic laboratories and the main objective was to promote exchanges of views on strategic issues for diagnostics. Participants had been given the opportunity to suggest topics for discussion and the main theme of the Workshop “quality assurance and accreditation” was decided based on these suggestions.
The Workshop started with presentations from different laboratories of their experience with quality assurance and accreditation. It was followed by two presentations on national reference laboratories and how they are organized. The Workshop concluded with a presentation on the Qbank database and of a recent initiative for phytopathogenic bacteria collections.
In addition to the plenary presentations, three subgroups were formed to discuss the following topics:
- Experience in the different laboratories with quality assurance or accreditation
- Validation of tests
- Interlaboratory comparisons (test performance studies and proficiency testing)
- National Reference Laboratories
- Collections of regulated pests (and look-alikes)
- Training: how to promote exchange of experience?
- Constraints of working with quarantine pests
Each group reported back to the plenary. Discussions in subgroups were very active and several actions have been identified as a result of these discussions. A summary of the discussions are presented below.
Participants - View more pictures
Experience in the different laboratories with quality assurance or accreditation
Members of the Workshop were positive about the overall advantages of having quality systems in place as well as accreditation. It was agreed that implementing a quality system in the laboratory should be required for all plant pest diagnostic activities. However, a requirement that a laboratory should be accredited for all tests on pest/matrices combinations used in the laboratory is neither realistic nor needed. Generally it was noted that accreditation is most needed for tests used for routine diagnostics.
Examples of benefits of accreditation were given e.g.: improvement of the management structure of the laboratory, improvement of equipment because of calibration requirements, increased confidence in the test results both internally for clients and between different laboratories, improvement of transparence and traceability, improvement of staff training, ease of incorporation of new or temporary staff in the laboratory due to availability of clearly written procedures, continuous review of the efficiency of the work performed, better justification of staff needs…
Drawbacks were also noted such as: costs involved for laboratories (for the initiation steps of the accreditation process as well as for maintaining accreditation), paperwork burden, metrology requirements which are costly and time consuming, lack of flexibility of accreditation under a fixed scope, lack of availability of assessors to perform audits. There was also a perception that the level of accreditation requirements increases continuously.
Accreditation of laboratories with a flexible scope was discussed at the end of the meeting. In most cases, the accreditation of laboratories has been usually based on a fixed scope which should define clearly and unambiguously the range of tests covered by the laboratory’s accreditation (e.g. immunofluorescence test for the detection of Ralstonia solanacearum on potato tubers). However, this does not readily allow new or modified tests to be added to a laboratory’s scope, even when the competence of the laboratory in performing and validating related tests has already been evaluated by an accreditation body. Although applications for an extension to scope can be made at any time, the timescales involved may actually prevent quick reactions the need for a new test. A flexible scope of accreditation allows a laboratory to undertake certain tests, and to report the results as accredited, even though these tests are not explicitly stated in the laboratory’s scope (‘Requirements for the Accreditation of Flexible Scopes’EA-2/15, 2008).
The concept of flexible scope encompasses a degree of flexibility which is usually agreed in consultation with the accreditation body. Participants noted that this degree of flexibility has a varying interpretation at the national level (some accreditation bodies do even not allow the laboratories to apply for flexible scope in plant health). It was noted that EA is organizing a survey on the implementation of flexible scope in their different member countries. It was suggested that EPPO should follow these developments and consider incorporating more guidance on flexible scope when preparing the revision of PM 7/98 'Specific requirements for laboratories preparing accreditation for a plant pest diagnostic activity'.
Validation of tests and Interlaboratory comparisons
The EPPO Secretariat presented a validation report sheet which was finalized during the Panel on Diagnostics and Quality Assurance which preceded the Workshop. The intention is to use this format to collect validation data on tests validated in different laboratories in the region. The participants were also informed that a standard on interlaboratory comparison i.e. test performance studies (often called 'ring tests') and proficiency tests was being developed by the EPPO Panel on Diagnostics and Quality Assurance. Some participants noted that there was a need to raise awareness concerning the EPPO standard PM 7/98 'Specific requirements for laboratories preparing accreditation for a plant pest diagnostic activity' as experts may not know that it includes specific guidance on validation of tests.
The main difficulties encountered by laboratories in validation were discussed and are highlighted below.
- Variability of the biological material (e.g. lack of homogeneity of infected/infested material, lack of knowledge about possible variability); lack of biological material easily available
- Regulatory constrains for exchanging infected material for performing interlaboratory comparison which often create an administrative burden.
- Lack of expertise in the laboratories on statistical analysis which are an integral part of interlaboratory comparison.
- Duration of the validation process often not compatible with the need for rapid development of tests (which is essential for new pests).
- Lack of guidance on how to determine limit of detection or threshold (e.g. cut off value for real time PCR)
All participants agreed that there was a need for collaboration in the region at different levels.
- Share information on plans to develop new tests on a yearly basis
- Share plans for validation of existing tests on a yearly basis
- Share validation data at the regional level to avoid duplication of work (use the validation sheet format for such exchange)
- Share reference material
- Identify laboratories potentially interested in participating in proficiency testing or test performance studies.
- Organize training courses/workshops
Regarding validation of morphological identification it was noted that a specific meeting should be organized with experts from the different relevant disciplines i.e. botany, entomology/acarology, mycology, nematology. The objective of the meeting should be to identify the criteria under which a morphological identification can be validated.
National Reference Laboratories (NRL)
It was noted that some countries have already established national reference laboratories. National reference laboratories should be involved in organizing proficiency testing/test performance studies, in the confirmation of test results when needed, in the training of laboratory staff, in the development and validation of new tests. Participants from EU countries mentioned recent discussions at the EU levels that plant health being brought within the scope of the Food and Feed Control Regulation, EU reference laboratories would be designated for this sector. Participants noted that there are no guidelines on how to establish national reference laboratories, and suggested that EPPO should play an active role in developing such guidelines to harmonize the approach in the entire region. It was noted that some criteria had already been proposed and an article was published in the EPPO bulletin on this topic (Mueller, 2008). Once NRL will be established a network should be established.
Collections of regulated pests (and look-alikes)
Participants noted that access to reference collections was essential for test development but also for interlaboratory tests. Mapping of existing collections is essential and it was noted that several initiatives have recently been launched to achieve this mapping e.g. in the framework of EUPHRESCO. Participants noted that quality criteria should be established for collections and that linking collections was essential (networks should be established). It was noted that financial sustainability was always a critical issue.
Training: how to promote exchange of experience?
Participants noted that a platform should be established where offers for training should be posted. It was also essential to get information on the need for training (a laboratory may decide to organize a training course if a sufficient number of experts are interested in participating). It was suggested that EPPO should investigate how such a platform could be established in the framework of the database on Diagnostic Expertise. More generally participants were in favour of the development of a forum where laboratories could exchange information.
Constraints of working with quarantine pests
The EPPO secretariat informed the participants that an EPPO standard has been developed which describe confinement conditions for laboratories (PM 3/64(1) Intentional import of organisms that are plant pests or potential plant pests). It was noted that establishing a dedicated page on diagnostics on the EPPO website where all documents and databases relevant for diagnostics would be grouped would raise awareness.
It was noted again that exchanging plant material was one of the difficulties encountered by plant pest laboratories (see also validation above). Participants recommended that it should be investigated whether exchange of material can be made easier. Participants noted that organizing a workshop on confinement conditions in laboratories would be beneficial (with site managers) and that environmental sustainability of waste treatment should be taken into account when developing new tests or selecting them to be included in EPPO diagnostic protocols. It was also noted that it would be useful to develop an inventory of waste treatments.
The recommendations made during the meeting will be presented to the Working Party on Phytosanitary Regulations, Executive Committee and Council. Participants recommended that a Workshop for heads of plant pest diagnostics laboratories should be organized every eighteen months.
Plant Health at Austrian Agency for Health and Food Safety
- Experience in the different laboratories with quality assurance or accreditation pros and cons
Quality assurance & accreditation at the Federal Plant Health Laboratory AT - AGES
QA / accreditation for Diagnostic of Plant Pests - Experiences from Denmark
Accreditation for plant health diagnosis: a view from the Food & Environment Research Agency, UK
Quality assurance in Plant Health Laboratory : the 15 years experience in France
Experiences of quality assurance and accreditation in Finland
Experience with implementation of a quality system and accreditation in National Phytosanitary Laboratory of Latvia
Quality assurance system in Slovenia and at the National Institute of Biology - the perspective of a small laboratory
Experience with accreditation in Russia
- Validation: what are the main difficulties with validation of tests? Can validation for morphological identification be performed in the same way as tests such as ELISA, PCR? How can the organization of validation be improved in the region? Is there a possibility to share the workload?
Experiences in performing proficiency tests in Germany for the detection of Clavibacter michiganensis ssp. sepedonicus and R. solanacearum in potato extracts
Experience with accreditation in the plant protection office of Lower Saxony and activities in promoting accreditation in other federal states of Germany
- National Reference Laboratories (how are they established?)
Reference Laboratories in Spain
National reference laboratories: the Italian experience
- Collections of regulated pests (and look-alikes): importance in plant pest diagnostics and needs for the future
Sharing knowledge through Q-bank, a database of quarantaine organism
Initiative - Collaboration collections bacteria in the EU