A meeting of EA Healthcare Sector Laboratory Medicine (WG HCLM) WG took place in Helsinki (Finland) in the period between 15th and 16th June 2010.
The meeting was attended by members of the EA WG HCLM, representatives of accreditation bodies and interested parties (total of 22). Dr Rolf Straub, representative of the Accreditation Board of Switzerland, presided at the meeting. Furthermore, the meeting was attended by the following representatives of interested parties: Mr Simon Zerah, Dr Claude Giroud and Dr Huisman Wim.
After the meeting agenda has been approved and after the conclusions from the Report of previous WG Meeting held in Madrid in December 2009, the following topics were discussed:
1. Information on the EA/LC and ILAC meetings held in 2010:
It was emphasised at the EA/LC meeting (Amsterdam, March 2010) that it was necessary to use calibration as an indicator of traceability in medical laboratories. As recommended by the Committee, each medical laboratory should be accredited as per ISO/IEC 17025 or ISO 15189 (Medical Laboratories-Particular Requirements for Quality and Competence).
- Reference medical laboratories must meet the requirements of ISO/IEC 17025 and ISO 15195 (Laboratory medicine-Requirements for reference measurement laboratories). Those reference laboratories that have not been accredited as per the said standards must do so by the end of the year.
-Activities to start application of new ISO standard for the accreditation of PT providers, ISO/IEC 17043:2010 (Conformity assessment - General requirements for proficiency testing), are being implemented.
- ISO guide 34:2000 (General requirements for the competence of reference material producers) pertaining to producers of reference materials could also be useful for medical laboratories.
-Cooperation with WADA (World Anti-Doping Agency) could be significant; trained WADA assessors could perform accreditation activities in this area.
At the EA/GA meeting (Zurich, May 2010), it was decided that both ISO 15189 and ISO 22870:2006 (Point-of-care testing POCT - Requirements for quality and competence) should be used as an accreditation criterion for POCT (Point of Care Testing) testing.
2. Briefs from the EA WG HCLM members
-Accreditation in the field of forensic testing (crime scene investigators-CSI) will be based on ISO/IEC 17020 and ISO/IEC 17025. New guidelines covering the entire process are being prepared (including storage of materials/samples).
-16th meeting entitled “Clinical Laboratory Testing and in Vitro Diagnostic Test Systems” was organised by EDMA (European Diagnostic Manufacturers Association) in Seoul in June 2010. It was concluded that the association was interested in cooperating with EFCC (European Federation of Clinical Chemistry and Laboratory Medicine). In addition to this conclusion the following conclusions followed:
-Information about the status of revised ISO 15189.
Interested parties requested ISO 15189:2007 to be revised, whereas minor revision would relate to the part pertaining to management system requirements, while the major one would pertain to technical requirements. Draft document was made and accepted by ISO / TC 212, while a vote on the issue is being taken.
-It was proposed to reject NWIP (New Work Item Proposal), and to revise ISO 15190:2003 (Medical Laboratories – Requirements for Safety) specifying the requirements pertaining to the safety of those performing activities in medical laboratories.
-With the aim of drafting simplified approach to calculating uncertainty of measurement in laboratory medicine, ISO 25680 (Medical laboratories - Calculation and expression of measurement uncertainty) is under revision. Details on the revised form harmonisation status were presented during the meeting.
A discussion in terms of validation of kits for medical devices took place, when it was taken into account the meaning of CE mark to be used.
- EC4/EFCC WG meeting to be held in October in Lisbon will be dedicated to accreditation of medical laboratories in France. All medical laboratories in France (about 5,000) must be accredited by 2016.
3. Cooperation with parties interested in specific fields of medicine:
-Project on breast cancer that is being established (radiological testing) was presented by Dr Tuija Sinervo (FINAS). The key concern at the EA is whether this field should be part of accreditation or certification scheme. There are guidelines and standards that include information about breast cancer screening, treatment and diagnostics. If there should be any advancement in this field, accreditation/certification activities would have to include other fields and cancer types. (UKAS has experience in accreditation of radiological tests that are of importance to different types of cancer).
-Future cooperation with EFI (European Federation for Immunogenetics) is being defined on the basis of Memorandum of Cooperation between EA and EFI of 2008. EFI has a special system of accreditation that is different from accreditation performed by accreditation bodies. It is necessary to establish cooperation between EA and EFI, and a joint accreditation system. With that end in view, a Procedure for collaboration between EA and EFI was drafted in 2008. It pertains to the process of joint assessment to be performed by these two organisations.
4. WG members’ discussion
-Harmonisation of attitudes is considered to be the best way of achieving harmonisation of accreditation process when answers to frequently asked questions (FAQ) are concerned, and these information can be available on the EA website and websites of accreditation bodies.
-POCT (point of care testing)-discussion about types, place and performers of POCT testing, and experience of certain accreditation bodies in this type of accreditation.
-Medical technology / non-invasive measurements – INAB raised the issue of possible accreditation of non-invasive testing methods in cardiology.
Requirements (standard and assessors) and possibilities of accreditation of the said tests were discussed as follows: measurement of bone density/mass, pulse oximetry, blood pressure, 24-hour blood pressure monitoring, electrocardiogram (ECG), ECG holter monitor, ergometry, echocardiography (in adults, children, transesophageal, pharmacological).
The conclusion was that relevant calibration instruments and full traceability of measurement must be provided.
Ljubinka Gligić PhD attended the meeting of EA WG in the Health Care Sector Laboratory Medicine in Finland on behalf of the Accreditation Board of Serbia.