Dr. Westgard had the honor of participating in the 5th CICLO INTERACIONAL De CONFERENCIAS DE LA CALIDAD “Reunion de Expertos” in Cancun, Mexico, from June 30 to June 2, 2010. While Hurricane Alex passed by the area the weekend before, high winds weren't the only things whipping about at the conference.

The 5th CICLO INTERACIONAL De CONFERENCIAS DE LA CALIDAD “Reunion de Expertos” in Cancun, Mexico, from June 30 to June 2, 2010

Conference Work Groups

This conference was organized into workgroups that discussed different topics, then the outcomes of those discussions were reported and videocast to many countries around Latin America on the last day of the conference.  Each workgroup had 8 to 10 participants from different countries in Latin America. The topics for the workgroups were the following:

• How to achieve appropriate and adequate quality in laboratory medicine;
• Effective control of the examination process;
• Education as the foundation for laboratory quality;
• Risk assessment in the laboratory and the critical role of laboratories to patient care;
• Preparing laboratories to handle crisis.

I participated in the work group on “Effective Control of the examination process,” which was further targeted to address specific questions on the frequency of QC, the importance of manufacturer’s recommendations for QC together with the need for the laboratory to be responsible for the QC system, and the role and frequency of EQA.  Some of the references that were provided to this working group were from training materials from Westgard QC [1-3].  Another reference was to work by Curt Parvin and John Yundt-Pacheco [4], and work group was  fortunate to have John present for part of the discussion.  Reports from each working group will be presented later as part of a recommendations from this conference.

The workgroup on Effective Control of the Examination Process

Comparability of Laboratory Tests

I also presented a plenary address on the “Need for Comparability of Laboratory Tests.”  This presentation needs some supporting materials and my purpose here to identify some links to help you follow up on this discussion.   HbA1c provides a good example of the issues involved in achieving comparability and I used this example to illustrate the problems.  If you are interested in further discussions of the problems, the HbA1c example has been described in detail in a series of essays on “Real World Learning 2010,” which were developed for my CLS class last semester.  These discussions reference a recent paper by Lenters and Slingerland on the evaluation of several Point-of-Care HbA1c instruments in the January 2010 issue of Clinical Chemistry [5], as well as an editorial by Bruns and Boyd in the same issue on the quality requirements for HbA1c measurements [6].  

Our series on Real World Learning includes 11 “episodes” the examine the application of quality management in the medical laboratory:

• HbA1c in the news again!
• How do you read an abstract of a method validation study?
• What quality is required for a HbA1c test?
• What does the evaluation study say?
• What does the test measure?
• Statistics vs Errors!
• Errors vs Quality requirements!
• Decisions on acceptability of performance
• A graph is worth at least 260 statistics!
• Back in the real world!
• Feedback from the authors

As you can see, the focus in this series is on the validation of analytical methods, not QC!  Method validation is critical for assuring quality in the establishment of a new analytical method, after which QC becomes a critical mechanism for the ongoing validation of performance to assure the desired quality is still being achieved in routine operation.  

To show the ongoing interest in the performance of HbA1c methods, the July 2010 issue of clinical chemistry contains a further discussion by Lenters and Slingerland of an additional Point-of-Care method [7].  That same issue also contains a paper of related interest on the performance requirements for glucose meters used in monitoring tight glycemic control [8].

Traceability

I also want to provide a reference for the discussion of traceability, which is the mechanism by which comparability of results can be achieved.  Traceability, though well-accepted scientifically, has yet to be widely implemented in medical laboratory testing due to the need for reference materials and reference methods. And, in some cases, “medical traceability” is even more difficult to achieve due to the “physicochemical complexity” of patient samples and the sought-for substance that is to be measured, as discussed by Thienpont [9].  Thienpont has discussed various traceability models and pointed out the importance of national and international reference methods and materials to establish medical traceability.  

The International Committee of Weights and Measures (CIPM) and the International Bureau of
Weights and Measures (BIPM) have created the Joint Committee for Traceability in Laboratory
Medicine (JCTLM) to identify, review, and publish lists of higher order certified reference
materials and reference measurement procedures.  JCTLM maintains databases for reference materials and reference methods that can be accessed at their website www.bipm.org/jctlm.

Spanish edition of Basic QC Practices

At the meeting, it was announced that the 3rd edition of our Basic QC Practices book would soon be available in Spanish.  Dr. Gabriel Migliarino has performed the translation as part of an AACC project supported by the Coulter Foundation.  The book is expected to be available from AACC Press in July at the AACC meeting in Anaheim, CA.

Many, many thanks!

Muchas gracias to all of you who made the meeting such a memorable experience.  I especially want to thank Hugo Biaz, a good friend who has been supportive of my interests in education and training to achieve quality in the laboratory, and Dr. Rosa Sierra Mora, the conference leader and organizer who is also committed to improving education in the medical laboratory.  Also, many thanks to all the members of the workgroups for their contributions to the discussions and the recommendations that were developed.

Hugo Baez addresses the conference.

Dr. Rosa Sierra Mora addresses audience members.

References

1. Westgard JO. Chapter 16. The Sigma-Metric QC Selection Tool. In Basic QC Practices, 3rd Edition.  Westgard QC, Inc., Madison, WI, 2010, pp 231-248.
2. Westgard JO. Chapter 9. “How to Use the Sigma-Metric QC Selection Tool.”  In Assuring the Right Quality Right.  Westgard QC, Inc., Madison, WI, 2007, pp125-146.
3. Westgard JO.  Chapter 16 “How to Determine the Frequency and Location of Controls.” In Assuring the Right Quality Right.  Westgard QC, Inc, Madison, WI 2007, pp 261-272.
4. Yundt-Pacheco J, Parvin CA.  The impact of QC frequency on patient results. Med Lab Observer 2008;(September).
5. Lenters-Westra E, Slingerland RJ. Six of Eight Hemoglobin A1c Point-of-Care Instruments Do Not Meet the General Accepted Analytical Performance Criteria. Clin Chem 2010;56:44-52.
6. Bruns DE, Boyd JC.  Few Point-of-Care Hemoglobin A1c Assay Methods Meet Clinical Needs.  Clin Chem 2010;56:4-6.
7. Lenters-Westra E, Slingerland RJ. Letter. Evaluation of the Quo-Test Hemoglobin A1c Point-of-Care Instrument: Second Chance. Clin Chem 2010;56:1191-1193.
8. Karon BS, Boyd JC, Klee GG.  Glucose Meter Performance Criteria for Tight Glycemic Control Estimated by Simulation Modeling.  Clin Chem 2010;56:1091-1097.
9. Thienpont LM, Van Utfanghe K, Cabaleiro DR. Metrological traceability of calibration in the estimation and use of common medical decision-making criteria.  Clin Chem Lab Med 2004;42:842-850.