Clinical and Laboratory Standards Institute (CLSI) Evaluation Protocols (EP) will be the topic of this year’s spotlight workshop, Facing the Challenge: Practical Approaches to Evaluate Analytical Performance, one day of conference sessions held in conjunction with the 2007 CLSI Leadership Conference, taking place 18-20 April in Baltimore, Maryland USA.

Jennifer McGeary, MT(ASCP), MSHA, CLSI Director, Standards and Quality, believes the time has come for a workshop to be focused entirely on evaluating analytical performance and describing how CLSI documents are helpful in meeting regulatory and accreditation requirements. “CLSI EP documents have never been more critical to the success of manufacturers, regulatory agencies, and laboratory professionals seeking to establish and monitor analytical performance and to maintain compliance. This workshop is a necessary addition to the meeting line-up at the CLSI Leadership Conference and offers a valuable experience to attendees.” 

The diverse program includes conference sessions on how to use CLSI documents to meet CLIA requirements; the most commonly cited accreditation and compliance obstacles; and practical approaches for using CLSI EP documents and global applications, including ISO 15189 and ISO 17025. The workshop includes conference sessions, open forum discussions, and breakout groups that cover virtually every aspect of EP.

The workshop features in-depth content including:

Morning Plenary Session

8:00 a.m. - 8:15 a.m.

Introduction 
Luann Ochs, MS, Roche Diagnostics Corporation - Moderator

This workshop will identify and describe how to use CLSI documents to establish and monitor the analytical performance of laboratory assays. Manufacturers use CLSI documents to establish performance claims to support submissions for regulatory approvals or clearance of in vitro diagnostic assays. Laboratory professionals use CLSI documents to meet local and regional requirements for accreditation, e.g., checking assay performance against manufacturer's claims; setting up quality control programs; and taking appropriate action to quality control failures.

CLSI consensus documents are recognized and used worldwide and can be integrated into practice within the requirements of local and regional regulations. For example, in the United States regulatory agencies of in vitro diagnostics and accrediting agencies of clinical laboratories recognize and reference many CLSI consensus documents. Implementation of these recognized CLSI consensus documents is helpful in complying with regulatory and accrediting requirements.

8:15 a.m.-8:45 a.m.

How CLSI Documents Fit Into a Quality Management System
Daniel W. Tholen, MS, A2LA

This session will explain evaluation of laboratory methods as required by CLIA, and how it fits within the CLSI Quality System Essentials. Method evaluation is a very small part of a documented quality management system (QMS), but ongoing evaluation is an essential part of a functioning QMS. This session will provide an overview of CLSI documents that address sources of method error. Some sources are best addressed by developers of methods (establishing claims); others are addressed by laboratories (verifying claims, controlling uncertainty).

8:45 a.m. – 9:15 a.m.

Overview of FDA's Perspective on CLSI Evaluation Protocols (EP) Documents
Steven I. Gutman, MD, MBA, FDA Center for Devices and Radiological Health

FDA has a long-standing interest in finding standard evaluative tools for regulatory decision making. FDA's commitment to this effort has been actualized in a formal standards recognition program. To date FDA has formally recognized numerous CLSI EP documents and uses others in an informal manner to inform its work processes. From FDA’s perspective, the quality and quantity of these documents have undergone welcome growth. CLSI clearly is a world class leader in this arena. The challenge to both FDA and its stakeholders is to find ways to expand the use of these valuable documents, to better mine the gold being generated from them.

9:15 a.m. - 9:45 a.m.

The European IVD Directive 98/79 – What does it mean to me?
Anders Kallner, MD, PhD , Karolinska Hospital 
 
The EU IVD Directive and the legislation following is supported by a series of standards and practices. Its impact reaches outside Europe and it seems difficult to market reagents and instruments for use in the health care laboratories unless fulfilling the EU criteria and thus having been CE marked. The directive as such is not always detailed enough for practical work and therefore needs supporting standards and other documents. A brief review of the philosophy of the IVD Directive will be given and its consequences for laboratory medicine in Europe.

10:00 a.m. – 10:30 a.m.

Use of CLSI Evaluation Protocols (EP) to Establish Performance Claims for In Vitro Medical Devices
George P. Brotea, PhD, Ortho-Clinical Diagnostics, Inc.

This presentation will discuss the relevant CLSI EP documents currently used by the IVD industry for test design and data analysis to verify, validate, and establish performance claims for in vitro medical devices.

The session will include practical examples of the use of EP documents for establishing product performance claims for assays as well as instrumentation. In addition, it will address practical issues encountered when using CLSI EP documents and present solutions developed to overcome them.

10:30 a.m. – 11:00 a.m.

CLIA QC and CLSI Evaluation Protocols (EP) Documents
Judith A. Yost, MA, MT(ASCP), Centers for Medicare & Medicaid Services

The objectives of this presentation will be to 1) clarify the existing CLIA Quality Control (QC) requirements and mechanisms for compliance, and 2) to elucidate the relationship of CLIA QC to the use of the forthcoming CLSI EP QC documents and the guidance provided for manufacturers and laboratories.

The presentation will begin with a brief overview of CLIA QC and alternative quality control (i.e., "EQC") options currently in effect. It will then focus on the laboratory-related CLSI EP documents that address alternative mechanisms for QC. This session will describe how CLSI EP documents might be utilized to meet CLIA QC requirements while providing guidance for development of a QC program customized for the laboratory’s specific test systems and environmental conditions. Using manufacturers' detailed information about their test systems will facilitate the success of the laboratory’s QC program and ensure better quality testing and more efficient and effective utilization of scarce resources.

11:00 a.m. – 11:30 a.m.

Using CLSI Evaluation Protocols (EP) to Validate Assay Performance in the Laboratory
R. Neill Carey, PhD, Peninsula Regional Medical Center

Laboratories perform similar method evaluations to those done by manufacturers. When laboratories utilize assays (or instruments) that are not FDA-approved they must validate the performance of these assays. Most of the CLSI EP guidelines are useful in these situations, and laboratories should perform the procedures recommended for manufacturers. The scale of the evaluation work is smaller when the assays being evaluated are FDA-approved, because the laboratories are verifying manufacturers’ claims. Several EP guidelines have specific recommendations for verifying manufacturers’ claims. This session will provide attendees with guidance on validating assay performance in the laboratory.

11:30 a.m. – 12:00 noon

Manufacturer Validation and Laboratory Utilization of QC Protocols: A CLSI EP22 and EP23 Update
W. Greg Cooper, CLS, MHA, Bio-Rad Laboratories, Inc., QSD Division
James H. Nichols, PhD, DABCC, FACB, Baystate Medical Center

CLSI document EP22 describes the manufacturer validation of QC recommendations; document EP23 indicates how manufacturer recommendations should be integrated into the laboratory’s QC protocols in light of the laboratory’s unique environment. This presentation will provide a progress update on the devopment of these documents.

After attending this session, the audience will be able to identify the scope of documents EP22 and EP23; recognize the value of EP22 and EP23 to industry, government regulatory, and laboratory/hospital fields; and determine how to use EP22 and EP23 in practice.

Q & A
Panel

Afternoon Breakout Sessions
Concurrent afternoon breakout sessions will allow participants to hear case studies and get targeted training for their specific areas of interest. Participants will choose two afternoon training sessions from the following topics:

2:00 p.m. – 4:30 p.m.

• Streamlining Laboratory Compliance Using CLSI Evaluation Protocols (EP) Documents
      R. Neill Carey, PhD, Peninsula Regional Medical Center
      Anders Kallner, MD, PhD, Karolinska Hospital
      James H. Nichols, PhD, DABCC, FACB, Baystate Medical Center
      Judith A. Yost, MA, MT(ASCP), Centers for Medicare & Medicaid Services

While comparing and contrasting the accreditation organization and regulatory requirements for each major component of QC, experts will present proven mechanisms and detailed guidance that will enable laboratories to meet these standards. This informative, interactive session will illustrate how this can be easily accomplished for different laboratory settings using the relevant CLSI EP QC documents.

During the session, the presenters will describe aspects of QC;  attendees then will learn applicable documents and methods to achieve compliance in varying testing environments (i.e., traditional and point-of-care testing ([POCT]).

Specific topics to be covered include:  calibration and calibration verification; test method validation/verification of manufacturers’ specifications; instruments, reagents, etc.

• How Manufacturers Get FDA Submissions Approved Using CLSI Evaluation Protocols (EP) Documents
      Marina Kondratovich, PhD, FDA Center for Devices and Radiological Health
      Jan S. Krouwer, PhD, Krouwer Consulting
      Kristen L. Meier, PhD, FDA Center for Devices and Radiological Health 

Manufacturers have a variety of tactics for getting FDA submissions approved. This includes understanding what the FDA expects as well as some of the softer management issues such as how to interact with FDA reviewers. CLSI EP documents are part of the strategy since it is perceived that EP documents facilitate the submissions process. This benefits both manufacturers and FDA. FDA will also share experiences of how they work with manufacturers. Documents covered in detail include: EP6-A - the most recent linearity document which has several advantages over its predecessor;  EP21-A estimates total error and plays a key role in the new FDA waiver guidance; EP17-A provides terminology, study designs and analysis related to the performance of the assays at low levels (limit of blank, limit of detection and limit of quantitation). Other topics will be covered as times permits including traceability, measurement uncertainty, risk analysis (EP18), qualitative assays (EP12), and software applications.

McGeary explains, “The visionaries slated to speak at the workshop are among an elite group of top leaders changing the shape of the industry. The variety of conference and breakout sessions will cover a spectrum of useful information about EP for clinical and laboratory professionals; manufacturers involved in verifying, validating, troubleshooting, and supporting laboratory test systems; representatives from regulatory and accrediting organizations; and students in clinical laboratory sciences. We look forward to a dynamic and insightful discussion from the workshop and breakout sessions on the future needs for standardization of analytical performance evaluation.”

Continuing education credits in the form of ACCENT© and PACE® contact hours will be made available to conference attendees.

About the 2007 CLSI Leadership Conference

The 2007 CLSI Leadership Conference will include a comprehensive lineup of meetings, special events, and an awards program recognizing the exceptional effort of volunteers who participate in the development of CLSI documents and products.