# Presentation: 176221

## TRACEABILITY

- Implementation
- &
-  Efficacy Evaluation

**Notes:**
Focus of this group is to anticipate implementation challenges that arise from the traceability activities and devise strategies that make the implementation process as successful and painless as possible.

## IMPLEMENTATION

- ACHIEVING THE INTENDED PURPOSESCraig M. Jackson,  Ph.D.cjackson@hemosaga.com
- Team Coordinator

**Notes:**
Purpose seen as improving the comparability of  laboratory test results. 

## PRACTICAL TIMEFRAMES

- Establishing an appropriate timetable for IVD manufacturers to change from existing reference materials and methods to materials and methods deemed compliant with ISO 15194 (Materials)and ISO 15193 (Methods).

**Notes:**
Timetable mandates from the European Medical Device Directive and the associated ISO documents pertaining to reference materials, reference methods and reference laboratories. Discussion has centered on 18 mo’s to 2 years, although it is the JCTLM that will decide – not the teams within working groups that are providing recommendations.

## COMMUNICATIONS

- Establishing effective mechanisms for IVD manufacturers to be informed of changes in listed reference materials and methods.

**Notes:**
Database of listed materials and methods, generally accessible to all. Communicating through various professional  organizations (this meeting is an example) of what is occurring within the JCTLM and its working groups. This is viewed as key to achieving the goals of the traceability requirements effectively and with minimal “pain”. Pain is chosen as the word, because change is always painful, but no pain – no gain is certainly applicable.

## PROCEDURAL SIMPLICITY

- Establishing a process for review of procedures being used to determine compliance with ISO regulations for the purpose of obtaining the greatest simplicity and consistency possible.

**Notes:**
Several teams are working to identify the materials and methods that qualify forlisting under ISO 15194 and ISO 15193. HOWEVER, because of the vast differences in our knowledge and the level of the technology employed, it is  clear that glucose, cholesterol and electrolyte reference materials are much simpler to deal with than genetic markers, probes, blood group substances and substances that are traditionally covered as biologicals and are components of complex, not necessarily constant matrices.

In this activity the goal is to foster continuous improvement while at the same time limiting bureaucratic activities to the fewest possible. 

## COMMUTABLE MATERIALS

- Establishing a process for receiving information from industry and reference material providers regarding the commutability of the listed and proposed reference materials. Fostering exchange of information between the reference material producers and the reference material users.

**Notes:**
Listed reference materials can be anticipated to be unsuitable for use in practical, routine methods. Such unsuitability, most frequently problems with commutability are most likely to be identified by and/or through the manufacturers of reagents. This could occur during the manufacturer’s evaluations or from customer communications such as “I used to use your calibrators for our ..., but they no longer give the same results,  including some materials that used to work fine ....

New technologies should  not be impeded by materials SECONDARY REFERENCE MATERIALS that may be unsuitable for use with the new technologies.  The increased use of HPLC coupled to mass spectrometer is a technology that might be an example. 

## RESPONSIVENESS

- Establishing a process for receiving requests to obtain and/or develop reference materials and methods for measurands that are not currently available.

**Notes:**
Perhaps, the goal here can be described as: To promote and foster cooperation in improving the delivery of diagnostic information.

## FOSTER PROGRESS

- Establishing appropriate mechanisms by which new candidate reference materials and methods can be submitted for review by JCTLM for inclusion in the lists of ISO compliant materials and methods

**Notes:**
Making the procedural aspects as simple and as well know as possible so that new materials and methods can be incorporated into the lists of suitable materials. 

## EVALUATION

- Promoting and supporting consistent processes for evaluating the improvement in comparability and commutability that is anticipated to occur from the implementation of the traceability requirements.

**Notes:**
If the aim of traceability requirements is comparability of assay results, then evidence that this aim is being achieved should be readily available from existing proficiency testing activities, EQUAS programs, etc. The goal is to ensure that there is evidence for this. Perhaps there is even a biblical reference that applies,e.g. Judge  not that you be not judged”

## Contributors - Active

- Richard Miller – Dade Behring
- Robert Wielgosz - BIPM
- Chandra Jain – Beckman Coulter
- Kazuo Fujihashi – Eiken Chem Co, Ltd.
- Christian Zeine – LGC Promoche
- Elaine Gray – NIBSC (UK)
- ALL OF YOU – PLEASE CONTRIBUTE

- cjackson@hemosaga.com