Medical Device Link.

FINAL THOUGHTS

The traceability of diagnostic test results to materials and measurement procedures of a higher metrological order came to the fore when the European Union (EU) issued its Directive 98/79/EC on In Vitro Diagnostic Medical Devices. However, the requirement for traceability is not unique to the EU. The U.S. quality system regulation, which predated the IVD Directive, also requires IVD manufacturers to use calibration standards that are traceable to national or international standards. IVD manufacturers have been cited by FDA for violating this requirement. The Joint Committee for Traceability in Laboratory Medicine (JCTLM) has addressed traceability requirements by creating lists of materials and measurement procedures that are formally identified as being of a higher metrological order. Today, JCTLM has identified more than 200 certified reference materials (CRM), and 125 reference measurement methods and procedures.

There have been other developments in traceability. In 2006, the Clinical and Laboratory Standards Institute (CLSI; Wayne, PA) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC; Milan, Italy) jointly produced “X5-R—Metrological Traceability and Its Implementation; A Report.” This report is intended to explain traceability, how it is established, and how it benefits the IVD industry and the practice of clinical laboratory medicine. Two ISO standards (15194 for reference materials and 15193 for reference measurement procedures) are also being revised. Such revisions are being done partly as a result of JCTLM’s experience in identifying CRMs and reference measurement methods for its lists, and the release of the 3rd edition of the International Vocabulary of Metrology. Updated yearly, the JCTLM lists can be searched on the Bureau International des Poids et Mesures’ Web site (www.bipm.org).

At its inception, JCTLM recognized that IVD companies could have difficulty or be reluctant to establish in-house measurement service facilities to meet traceability requirements. Consequently, JCTLM now provides a list of reference measurement service providers. This list offers linked contact information. The reference measurement services are provided by laboratories that employ materials and methods listed by JCTLM to assign values to an IVD company’s proprietary calibrators and control materials. The reference measurement service providers are compensated by the companies that use their services.

To assure that the providers perform adequately, the IFCC operates a specialized external quality assessment scheme. In order to qualify to be listed by JCTLM, the providers must participate in such an assessment scheme for laboratories of this level metrological order. To remain on the JCTLM list, the providers must be accredited by an International Laboratory Accreditation Cooperation (ILAC) member organization. There is a three-year transition period for laboratories applying for such accreditation.

Calling for Nominations

With the introduction of reference measurement services by JCTLM, the expert teams that reviewed materials and methods for inclusion on the lists of CRMs and reference measurement methods also started reviewing the providers’ applications. Membership on the expert review teams is voluntary, and individuals willing to participate are encouraged to apply or be nominated to serve on these teams. Because of the increased work load and the exclusion of team members due to potential conflicts of interest, more individuals are needed to serve on the review teams. The members serve as peer educators since they evaluate nominations of materials and methods for biological analytes. In addition, IVD companies that sponsor participation by their employees accrue advantages for themselves and support the services provided by JCTLM for improving laboratory medicine.

Every year, a call for nominations for CRMs and reference measurement methods is issued. The 2007 call is now open, and all forms and instructions for nominating are available on the JCTLM Web site.

Craig M. Jackson, PhD, is quality system pro - cedures team leader of JCTLM Working Group 1 and is president and cofounder of Hemosaga Diagnostics Corp. (San Diego). He can be reached at cjackso2@ san.rr.com.	Robert I. Wielgosz, PhD, is JCTLM secretariat and head of the chemistry section of the Bureau International des Poids et Mèsures (Sèvres, France). He can be reached at rwielgosz@ bipm.org.	Willie E. May, PhD, is cochair of JCTLM Working Group 1 and director of the Chemical Science and Technology Laboratory at the National Institute of Standards and Technology (Gaithersburg, MD). He can be reached at willie.may@ nist.gov.