IVD Technology
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NIST workshop sets course on measurement traceability
Last
November, representatives of government, the IVD industry, and
the medical professions gathered at the National Institute of
Standards and Technology (NIST; Gaithersburg, MD) to participate
in a Workshop on Measurement Traceability for Clinical Laboratory
Testing and In Vitro Diagnostic Test Systems. The goal of the
workshop was to develop recommendations regarding measurement
traceability for health status markers, which is required by
the European Union's IVD Directive.
"Traceability to internationally recognized and accepted standards is an important component in assuring the accuracy and comparability of clinical laboratory measurements," says conference cochair William F. Koch, deputy director of the NIST chemical science and technology laboratory. "In addition, the global marketplace is presenting new demands for measurement traceability."
NIST convened the workshop to address the need of IVD manufacturers for a systematic means of compliance with such international standards. The two-day workshop was attended by 135 scientific experts and stakeholders, a quarter of whom were from outside the United States.
Presentations on the first day of the workshop provided the background and current status of measurement traceability in clinical laboratories. Leading European authorities focused on the IVD Directive and related support activities.
Representing the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), Lothar Siekmann, a professor of clinical chemistry at the University of Bonn (Germany), discussed the European concept of traceability as applied to the field of clinical chemistry. Observing that traceability probably provides the most important strategy for achieving standardization in laboratory medicine, Siekmann went on to illustrate the German process for credentialing reference materials, methods, and laboratories. (A version of this presentation begins on p. 41 of this issue.)
Neil Greenberg, regulatory affairs project manager at Ortho-Clinical Diagnostics (Rochester, NY), presented an industry view of the IVD Directive's requirement for calibrator traceability. He made special note of the fact that the IVD Directive does not specifically call for the development of new or improved reference materials, but only requires that available reference materials and measurement procedures of higher metrological order be used for traceability purposes.
Nevertheless, the ISO committee draft standard on metrological traceability (ISO CD 17511) states that it is the aim of metrology in laboratory medicine to improve traceability by supplying missing reference materials and methods according to international consensus. As a result, it is likely that national matrology institutes and others will initiate projects to develop reference materials and methods in the name of the directive.
Although it is unlikely that IVD manufacturers will take a lead role in advocating new standards at this time, it is essential that industry scientists and experts in IVD standards be included in projects led by professional, government, and public health groups. (A version of this presentation will appear in the March issue of IVD Technology.)
The second day of the workshop was devoted to breakout sessions and general discussions to plan the direction of future activities. Breakout sessions were devoted to the following topics.
- Priorities for investment in reference systems.
- Reference materials and methods to support the IVD Directive.
- The impact of method-material matrix interactions on traceability protocols.
- Development of international consensus on the credentialing process for reference systems.
- Creating and sustaining reference laboratory networks.
Each breakout group brought forward unique perspectives and recommendations based on its topic. In addition, the attendees developed general agreement on some critical attributes of a calibration traceability system. "Most important is the need for a global reference system composed of reference materials, reference methods, and a mechanism for demonstrating competence and equivalence," says Koch. "Attendees agreed that internationally recognized reference laboratories should implement such a reference system, using a networked approach."
There was concurrence that a properly implemented traceability program can reduce manufacturer costs in the long run. Attendees emphasized, however, that such a program must be designed to minimize bureaucratic redundancy and barriers, encourage new technologies, and facilitate global collaborations.
The closing session of the workshop achieved consensus on the need to take the following actions.
- Develop a Web-enabled database of currently available reference methods and internationally recognized certified reference materials (CRMs). NIST will begin this effort. If the EU proposal for a similar database is funded, NIST will coordinate its efforts with those of the EU.
- Organize an internationally accepted, industry-led oversight group comprising government and industry experts as well as medical professionals. The group's responsibilities will be to set priorities for the development of new reference materials and methods based on medical importance, need, and commutability; identify sources and secure funding for developing reference materials and methods; and develop the process for international consensus on reference systems.
- Develop interpretive guidance on traceability requirements.
- Develop a global process for approving reference methods and distributing CRMs.
- Identify alternative approaches to analytes for which SI-traceable reference materials or methods are impossible at this time.
- Convene a follow-up meeting in Dublin, Ireland, preceding the ISO TC 212 meeting in June 2001.
"This workshop was only the beginning," says Koch. "But we are encouraged by the broad geographic and sector representation of the attendees, as well as by the high levels of effort, enthusiasm, and commitment they exhibited."
A complete set of the workshop proceedings is available from NIST. For further information, contact William F. Koch at 301/975-8301 or via william.koch@nist.gov.–Steve Halasey
