Bio-Rad Laboratories Q U A L I T Y C O N T R O L

2011 Convocation of Experts on Laboratory Quality

With the collaboration of Bio-Rad Laboratories

Working Group: 2

Chairman: Callum Fraser (United Kingdom)

Topic: Defining appropriate analytical objectives in the laboratory: How to set meaningful error limits with respect to clinical needs.

For Discussion: • How does the use of Total Error in the lab compare to the use of uncertainty of measurement? - Should both statistics be used by the lab or only one? - Will uncertainty eventually replace use of Total Error?

• Are there means to internationally harmonize total allowable error? How would that be structured?

• Total allowable error is typically estimated using desirable bias and desirable imprecision. Could other total allowable errors be estimated for the same test using combinations of optimum, desirable and minimum bias and imprecision? If not, why not?

• Is there a next step now that total error has been fully characterized?

• How should total allowable error / uncertainty of measurement be defined in the context of multiple instruments testing the same analyte?

• Are analytical goals adopted for daily rejection or acceptance of daily QC or just for long term monitoring of performance? What are the pros and cons?

• How can the laboratory best present information in the test report - with reference interval, medical decision limit, or RCV?

Working Group: 3

Chairman: Mauro Panteghini (Italy)

Topic: Implementation of metrological traceability and estimation of uncertainty of measurements in the context of ISO 15189 requirements.

For Discussion: • Does uncertainty have real value to the clinician? If yes, how would laboratories characterize that value? If not, why does the lab community remain largely silent on the issue?

• When (under what conditions) should the laboratory report uncertainty?

• How can the laboratory provide uncertainty data that is timely and useful to the clinician?

• What are the best practices for handling traceability issues in the laboratory? Do you document traceability or do you merely accept manufacturer traceability data?

• What aspects of laboratory operations other than the analytical methods are affected by traceability requirements? (eg. thermometers, gauges etc). How can the laboratory effectively manage these issues?

Working Group: 4

Chairman: Michael Hubmann (Austria)

Topic: Transforming advanced concepts in analytical quality to everyday laboratory practice: Supporting and promoting best practices surrounding changes and implementation of internal quality control.

For Discussion: • What aspects of laboratory operation can affect the quality of patient test results and how can these be controlled or eliminated?

• What aspects of laboratory operation or laboratory conditions can influence the laboratory’s QC protocols including the frequency with which the laboratory should test QC?

• What remain as the most persistent, on-going challenges to assuring the quality of patient test results? What guidance can be given to laboratories for dealing with:

- How to handle QC rejections? Are all patient data rejected or only those between two sets of controls? Are controls retested? Should they be retested without investigation into the cause of failure?

- What are some common practices for handling complaints?

- What are the important differences between system validation and internal QC process that laboratories must understand?

Working Group: 5

Chairman: Ortwin Adams (Germany)

Topic: Quality Control for qualitative assays: special challenges and best practices in Virology and Serology Labs

For Discussion: • How is performance assessed in the laboratory for qualitative, semi-quantitative tests? How should it be assessed? Is it important to calculate a ratio, or is +/- enough? What special challenges confront the Blood Bank and Virology laboratory?

• Is it feasible to apply some traditional clinical lab QC procedures (Levy Jennings chart, CV monitoring, peer group comparison) to this type of testing? What traditional QC techniques and tools could be easily applied? What tools should be developed?

• Can analytic performance for semi-quantitative/qualitative tests be expressed as a sigma metric? What information would be required to create such a measure?

April 4-6, 2011 • Salzburg, Austria

Hotel Crowne Plaza Salzburg - The Pitter • Rainerstrasse 6-8 • 5020 Salzburg

Aim:

The 2011 Convocation will bring together selected European opinion leaders to share experiences with ISO 15189 requirements and to discuss open issues surrounding modern concepts in laboratory quality control such as the definition of adequate analytical objectives, the estimation of uncertainty of measurement, and how to support best practices in the implementation of Internal quality control. A session will be dedicated to a discussion of special challenges in establishing QC procedures with qualitative assays in virology labs. The 2011 Convocation will pay special attention to acknowledging success stories, noting best practices, and providing practical guidance that can be applied by laboratories.

The proceedings of the Convocation will be submitted for publication in a recognized European journal.

Program

Monday, 4th of April

16.00 – 16.15 Welcome, Introduction of Working Group leaders and logistics (Max Williams)

16.15 – 16.30 Quality…Variations as a Theme (Niels de Jonge)

16.30 – 16.45 Topic Introduction – Working Team n.1

16.50 – 17.05 Topic Introduction – Working Team n.2

17.10 – 17.25 Topic Introduction – Working Team n.3

17.30 – 17.45 Topic Introduction – Working Team n.4

17.50 – 18.05 Topic Introduction – Working Team n.5

18.15 – 19.15 Magistral Lecture (James Nichols ) Title: Towards a New Paradigm in Managing Risk in the Clinical Laboratory

20.00 Dinner

Tuesday, 5th of April

8.30 – 10.30 Working Teams (1st part)

10.30 – 11.00 Break

11.00 – 13.00 Working Teams (2nd part)

13.00 – 14.30 Lunch

14.30 – 17.00 Working Teams (3rd part)

17.30 – 19.30 Tour in Salzburg

20.00 Dinner at St. Peter Stiftskeller Restaurant

Wednesday, 6th of April

9.00 – 10.00 Work Preparation & Check out

10.00 – 10.30 Team 1 Report

10.30 – 11.00 Team 2 Report

11.00 – 11.30 Team 3 Report

Working Group: 1

Chairman: Michel Vaubourdolle (France)

Topic: Using ISO 15189 as the Key to Quality: Practical experience and peer guidance for success

For Discussion: • How have laboratories embarked on meeting the requirements of ISO 15189?

• What has been enlightening or memorable and would benefit others to know? What practical solutions are best in class? What success stories can serve as models to other laboratories? What technical guidance will be needed in the future ?

• Does the lack of consistency in interpretation of ISO 15189 requirements from country to country create a problem? Does the lack of consistent enforcement of ISO 15189 destabilize the intent of the standard itself? Is there a need for accrediting organizations to certify to ISO 17011?

• With respect to the examination process in ISO 15189, what internal QC practices best support achieving and maintaining accreditation? What types of information from EQA and interlaboratory comparison can be useful for meeting accreditation requirements? What is the best use of this information? What characteristics (or services) of an EQA program are most important to the laboratory? Working Group: 2

Participants:

Participation is by special invitation only and is limited to 50 persons, so early acceptance of the invitation is important. Please go to

http://www.labopinions.com/qsd10/szbrgreg.htm

to register. During registration, you will be requested to kindly indicate your top three choices for assignment to a Discussion Group. Since the number of participants in each Discussion Group will be determined by the total number of Registrants, the Organizers will make every effort to accommodate your preference when assigning you to a Discussion Group but no guarantee can be made. Please note, Group 5 is available as a choice only to those who specialize in Virology and/or Blood Banking. Discussions will be conducted in English.

Wednesday, 6th of April (cont‘d)

11.30 – 12.00 Discussion 1-2-3

12.00 – 13.30 Lunch

13.30 – 14.00 Team 4 Report

14.00 – 14.30 Team 5 Report

14.30 – 15.00 Discussion 4-5

15.00 – 16.00 Summation and Adjournment (Greg Cooper)