Call for Nominations: Evaluation Protocols
NEW: Laboratory EQC Protocols Based on Manufacturer’s Risk Mitigation Information and the Laboratory’s Environment

Clinical and Laboratory Standards Institute’s Area Committee on Evaluation Protocols has requested nominations to serve as subcommittee members for a new project described below: 
 
Title of guideline to be developed: 
 
Laboratory EQC Protocols Based on Manufacturer’s Risk Mitigation Information and the Laboratory’s Environment 

Description: 
This document is primarily intended for users of moderate complexity/Point-of-Care (POC) test systems; however, all laboratories will find the manufacturer’s test limitations and risk mitigation information useful. All laboratories will receive clear, concise scientific guidance in the development of QC processes and procedures to reduce the potential negative impact of these limitations, while considering certain laboratory environmental factors like personnel competency, temperature, etc. and to monitor immediate and extended test performance. Nonwaived (moderate and high complexity) laboratories will receive guidance that will enable them to develop effective, cost-efficient QC protocols that will ensure consistent and appropriate application of CLIA QC regulatory requirements, based on the technologies selected by the laboratory and reflective of that laboratory’s unique environmental aspects.  This document should cross-refer to EP22, the CLSI Risk Management guidance document.
 
Table of Contents:
1    Scope
2    Introduction
3    Standard Precautions
4    Terminology  (Definitions/Acronyms)
5    Understanding & Using  Manufacturers’ Risk Assessment Methods & Outcomes
In this section of the document, the labs will be given information regarding how to take the information provided in the package insert and make it work in their laboratory:
·  How to understand alt-QC information provided by the manufacturer
·  What is a risk assessment and how should the lab apply it?            
6    Laboratory Environmental Factors Impacting Total Test Process Quality
In this section of the document, labs will get concrete instructions regarding how to identify their own unique factors, for example, personnel, technology, and environment, and how they may impact their QC needs.  The lab director will understand that he/she is responsible for quality control, with assistance from the manufacturers. 
7    Effectiveness of Traditional QC Mechanisms to Monitor/Mitigate Immediate & Over-time Errors
In this section of the document, a discussion will be provided regarding traditional standards of practice.  Also, a section will be provided describing other ways to mitigate risk (e.g. training and competency testing).  Finally, a discussion regarding QC’s role in mitigating immediate errors as well as monitoring trends over time.
8  Alternative QC Mechanisms & Other Lab Error Identification & Avoidance Techniques
This section is a how-to guide to mitigating any risks identified in section 6.   It helps the lab address high-risk areas.  It provides a table of common problems and potential ways to solve issues.  It serves as a kind of troubleshooting guide.
9    Development of Lab-Specific QC Protocols
This section pulls it altogether into a QC testing protocol:  what they have to test and at what frequency.
10  Surveillance
This section describes the need to continue to monitor and modify the program where necessary.  The section describes the concept of continuous quality improvement, including the need for appropriate documentation, site visits, evaluation, and re-evaluation.
References

Specific Expertise/Work Experience Needed: 
—Laboratorians with significant experience/expertise in current laboratory (small and large) operations and technology;
—IVD manufacturers of current technology and their government relations personnel;
—Representatives of government agencies responsible for oversight of the CLIA program (CDC, CMS, FDA) with technical and administrative expertise;
—Representatives of CMS-approved accrediting organizations under CLIA;
—Physician office laboratory (POL) directors and/or testing personnel.

Second Notice

Clinical and Laboratory Standards Institute’s Area Committee on Evaluation Protocols has requested nominations to serve as subcommittee members for a new project described below:  

PROJECT 1:  (New guideline)  Interference With Immunoassay Results by Heterophile Antibodies and Other Binders
Description:  The intended users of the guideline are laboratorians performing immunoassays, manufacturers of immunoassay reagents, and organizations responsible for regulatory oversight of immunoassay reagents.  The guideline will describe various types of interferences by heterophile antibodies and other binders as well as their effect on patient results. Methods to identify and characterize the interferences will be addressed along with assessment of these methods and their effectiveness in eliminating interference. The guideline will not address other types of immunoassay interference, such as hemolysis, cross-reacting substances, and drug interference, except when the drug is an antibody. 
Table of Contents:
1. Scope
2. Introduction
3. Definitions/Acronyms
4. Identification of immunoassay interference by binders
5. Mechanisms of interference
6. Effects of interference
7. Elimination of interference
8. References
Specific Expertise/Work Experience Needed: 
* Laboratorians with significant experience/expertise in performing and assuring quality of immunoassays
* Laboratory directors responsible for verification and validation of immunoassays to be performed in their laboratories
* IVD manufacturers of immunoassay reagents and test systems
* Representatives of government agencies responsible for reviewing manufacturers' data for clearance or approval of immunoassay reagents and tests
* Representatives of clinical laboratory accrediting agencies

PROJECT 2:  (Revision of Approved Guideline):  Apolipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline (I/LA15-A)
Description:  I/LA15-A, which was reaffirmed in 2001, describes the characterization and preparation of immunogens, antibodies, samples, and methods, and provides guidance for immunochemical testing of apolipoproteins. I/LA15-A will be updated as a basic apolipoprotein document to serve as a highly practical new document on the need, measurement, interpretation, and applications of apos B and A-I. These two apolipoproteins have become of widespread use in research laboratories and are of great interest in control and prevention research programs in cardiovascular diseases and other chronic diseases.
Specific Expertise/Work Experience Needed: 
* Laboratorians with significant experience/expertise in performing and assuring quality of apolipoprotein immunoassays
* IVD manufacturers of apolipoprotein immunoassay reagents and test systems
* Representatives of government agencies responsible for reviewing manufacturers' data for clearance or approval of immunoassay reagents and tests
* Representatives of clinical laboratory accrediting agencies

PROJECT 3:  (Revision of Approved Document):  Evaluation Methods and Analytical Performance Characteristics of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies of Defined Allergen Specificities; Approved Guideline (I/LA20-A)
Description:  I/LA20-A, which was reaffirmed in 2001, provides guidance for the design, analytical performance, standardization, and quality assurance of laboratory assays used in the measurement of total serum IgE and IgE antibodies of defined allergen specificity. The revision of I/LA20 will include updating document content with advances in this area, and reorganizing the guideline for ease of use into two parts: the general text and an appendix listing all the allergens. 
Specific Expertise/Work Experience Needed: 
* Laboratorians with significant experience/expertise in performing and assuring quality of immunological assays for human immunoglobulin E (IgE) antibodies
* IVD manufacturers of immunoassay reagents and test systems
* Representatives of government agencies responsible for reviewing manufacturers' data for clearance or approval of immunoassay reagents and tests
* Representatives of clinical laboratory accrediting agencies

Review the objective of the proposed project, and the requested volunteer expertise, and:  submit a nomination.

The deadline to submit the nomination form, including a curriculum vitae and disclosure of interests form, is 1 December 2005.  Send to CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087.

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