Evaluation of Stability of In Vitro Diagnostic Method Products
Quality Management Procedures: Systematic Approaches to Reducing Errors at the Point-of-Care

The Clinical and Laboratory Standards Institute requests volunteers to serve as subcommittee members for two new voluntary consensus projects. The project descriptions and specific qualifications needed are provided below: 

NEW PROJECT:
Evaluation of Stability of In Vitro Diagnostic Method Products

Description:
Stability testing is used by IVD method manufacturers to determine the duration over which their products remain suitable for their intended use, under defined conditions of storage and handling. This definition encompasses two classes of performance claims: shelf life and in-use. Shelf life refers to the period of time that a product remains viable prior to being put into use. In-use refers to the period of time that a product remains viable once placed into use (e.g., open or punctured vial, calibration interval, etc.) Unlike other product performance attributes such as precision and accuracy, manufacturers’ stability claims are not often verified by customers except indirectly through trending of long-term daily quality control results.

Product stability characteristics may be affected by a number of internal and external variables. Additional factors which must be considered a priori are the operating definition of stability (i.e., what is the allowable drift over a specified duration), the specific product attributes to be tested, and the desired statistical power of the resulting analyses. As such, it is not practical to provide a single protocol that is appropriate for all IVD products.

The aim of this guidance document is to provide information to manufacturers of IVD methods for the development of shelf life and in-use stability claims. The scope will include background information to be considered when creating a stability testing plan for a particular product, format of a stability plan, logistics of performing the studies, recommended data analyses, and documentation of stability claims.

This guideline will provide a statistically valid approach for the determination of product stability by in vitro diagnostic (IVD) method manufacturers. The term “method” as used here includes reagent products, calibrators, control materials, and kits. The proposed guideline would address definitions, planning needs, experimental design and data analysis options, documentation, need for product transport simulation, and use of accelerated versus real-time testing. Both final product shelf life as well as in-use shelf life (e.g., opened calibrator) would be considered.

The FDA draft guidance document Q1A(R2) (Stability Testing of New Drug Substances and Products) addresses this need for pharmaceuticals but not for IVD products. An FDA guidance document for IVD products exists (Shelf Life of Medical Products by G. S. Clark, 1991) and was included in the list of guidance documents under consideration for more work (Federal Register, 7/9/2004). The recent EN 13640:2002 document Stability Testing of In Vitro Diagnostic Reagents addresses the issue from a high-level planning and documentation perspective but gives little practical guidance on experimental design, logistics, or data analysis options.

Specific Expertise/Work Experience Needed:

The subcommittee will require representatives as specified below:

• Manufacturers who are involved in in vitro diagnostic (IVD) product research and development of a wide range of analytical systems. 
• Government agency employees who review manufacturers data for clearance or approval of IVD assays.
• Representatives of government agencies responsible for oversight of the CLIA program (CDC, CMS, FDA) with technical and administrative expertise
• Statisticians
• Clinical Chemists and Medical Technologists
• International representatives to assist with harmonization and global application of the guidelines.

The deadline to submit a nomination form, including a curriculum vitae and disclosure of interests form, is 1 June 2007. Send to Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087.

NEW PROJECT:
Quality Management Procedures: Systematic Approaches to Reducing Errors at the Point-of-Care

Description:
The proposed guideline will provide Point-of-Care testing sites with a framework of potential sources of error, corresponding performance indicators, and suggested solutions or metrics to address each analytical phase of testing. The guideline is to serve as a complementary tool to laboratory QA procedures, regardless of accrediting organization or country of origin. 

To IVD and other healthcare industries, this guideline could be a source of additional leverage as more assertive (product) solutions would result from more specific feedback that is also comparable to equivalent institutions. Accreditation, regulatory, and government sectors could use the guideline as an additional source of statistics for strategic or assessment purposes. 

Table of Contents:

1. Evolution of POCT (methods, testing personnel) would help substantiate profiling

2. Challenges in Healthcare (needs, resources or challenges specific to each facility type)

3. Roles in Quality Indicators

3.1 Laboratory director
3.2 Testing personnel
    3.3 Regulatory
    3.4 Safety/Quality Committee
   
4. Pre-analytical phase

4.1 Scope
4.2 Error type definition (e.g., specimen collection)
4.3 Performance indicators
4.4 Suggested vehicle (tool, system, etc.) for tracking
4.5 Metrics
4.6 Suggested criteria for acceptable performance
4.7 Suggested corrective action logic for unacceptable performance)

5. Analytical phase (Same sub-sections as Pre-analytical)

6. Post-analytical phase (Same sub-sections as Pre-analytical)

7. Using quality indicators to improve patient safety (reduce errors)

Specific Expertise/Work Experience Needed:

Clinical Expertise:
Hospital Administrator
Outpatient Facility Administrator
Risk Management

Laboratory Expertise:
Point of Care Coordinator
Laboratory Director

Information Technology:
Clinical Systems Design- healthcare
Systems Engineering

Manufacturers:
Medical/Technical Writing

Accreditation:
College of American Pathologists
Joint Commission
CLIA

Other experience:
IQLM
AHRQ
Statistician
ASQ

The deadline to submit a nomination form, including a curriculum vitae and disclosure of interests form, is 1 June 2007. Send to Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087. [ return to top ]