Clinical and Laboratory Standards Institute's Area Committee on Quality Systems and Laboratory Practices has requested nominations to serve as subcommittee members to revise the CLSI guidelines described below.

PROJECT REVISION:
Clinical Laboratory Waste Management (GP5-A2)

Description: 
GP5-A2, which was published in 2002, provides a brief summary of the relevant U.S. federal regulations and laws related to laboratory waste management; addresses chemical, infectious, radioactive, sharps, multihazardous, and nonhazardous waste; emphasizes methods for avoiding waste generation (source reduction) and reducing the volume and toxicity of unavoidable wastes (waste minimization); and, provides options for handling, packaging, labeling, storing, recycling, transporting, treating, and disposal of each type of waste are also described. While this document will serve as a useful resource for a wider audience, it is based on US regulations, and is intended for use primarily in the United States.

Specific Expertise/Work Experience Needed:

• Individuals with strong background in laboratory waste management. 
• National and international representatives familiar with regulatory requirements for laboratory waste management.
• Individuals with quality management systems experience.

The deadline to submit notification of interest in serving on the subcommittee with a curriculum vitae is 30 April 2008.

Upon receipt of your statement of interest in serving on the subcommittee a disclosure of interests form will be sent to you for completion. 

Send to Donna Connery (dconnery@clsi.org) at Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087, or via Fax at +610.688.0700.

PROJECT REVISION:
Selecting and Evaluating a Referral Laboratory (GP9-A)

Description:
GP9-A, published in 1998, outlines steps to be used when evaluating a referral laboratory, including the reasons for choosing a referral laboratory, the criteria for selection, and information on how to evaluate the quality of referral laboratory services, facilities, equipment, personnel, quality control protocol, quality assurance/improvement activities, and instrument maintenance.

This guideline also provides information on evaluating referral laboratories with regard to efficiency, scope of testing, specimen collection, test ordering, transportation, turnaround time, and result reporting. GP9 is useful for and applicable to selecting a referral laboratory and for the ongoing monitoring and evaluation of the selected laboratory.

Specific Expertise/Work Experience Needed:

• National and international representatives with knowledge of accreditation requirements related to referral laboratories.
• Individuals familiar with internationally-accepted standards related to referral laboratories (ie, ISO 15189, ISO 17025).
• Individuals with quality management systems experience.

The deadline to submit notification of interest in serving on the subcommittee with a curriculum vitae is 30 April 2008.

Upon receipt of your statement of interest in serving on the subcommittee a disclosure of interests form will be sent to you for completion. 

Send to Donna Connery (dconnery@clsi.org) at Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087, or via Fax at +610.688.0700.

PROJECT REVISION:
Tubes and Additives for Venous Blood Specimen Collection (H1-A5)

Description:
H1-A5, last published in 2003, contains information on venous blood collection tubes and additives. It is written for manufacturers of venous blood collection tubes, additives, and related devices; for all clinical laboratory personnel; and those who are responsible for acquisition, handling, and using the equipment described in this document.

H1 addresses requirements for the materials, construction, and labeling of venous blood collection tubes, and it provides methods for the evaluation of venous blood collection tube and closure assemblies. Specifications for the additives heparin, ethylenediaminetetraacetic acid (EDTA), and sodium citrate are also included.

While H1 is a useful resource for a wider audience, it is intended primarily to help the US user navigate through stringent US regulations.

Specific Expertise/Work Experience Needed:

• Manufacturers of venous blood collection tubes, additives, and related devices.
• Individuals performing method evaluation of venous blood collection systems.
• National and international representatives with knowledge of regulatory requirements related to venous blood collection tubes, additives, and related devices.
• Individuals responsible for acquisition, handling, and using venous blood collection systems.
• Individuals with quality management systems experience.

The deadline to submit notification of interest in serving on the subcommittee with a curriculum vitae is 30 April 2008.

Upon receipt of your statement of interest in serving on the subcommittee a disclosure of interests form will be sent to you for completion. 

Send to Donna Connery (dconnery@clsi.org) at Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087, or via Fax at +610.688.0700.

Clinical and Laboratory Standards Institute's Area Committee on Molecular Methods has requested nominations to serve as subcommittee members to revise the CLSI guideline described below: 

PROJECT REVISION:
Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline (MM5-A)

Description: 
MM5-A, which was published in 2003 addresses the performance and application of assays for gene rearrangement and translocations by both polymerase chain reaction (PCR) and reverse-transcriptase polymerase chain reaction (RT-PCR) techniques and includes information on specimen collection, sample preparation, test reporting, test validation, and quality assurance.

In revising MM5 the following issues/revisions will be considered:

• Narrow the scope to focus on neoplastic processes
• Provide more emphasis on minimal residual disease testing for leukemia, stabilization of RNA using trizol or paxgene/tempus type preservatives), how to calibrate and control quant assays.
• Provide examples of application of Nucleic Acid Amplification Assay in diagnosis, differential diagnosis, or classification be given to each type of disorders listed on the Table 1.
• Address point mutation testing (e.g. JAK2, NPM1) as it is moving away from RE digest and towards melt curve and sequencing strategies

Specific Expertise/Work Experience Needed:

• Nominees should have experience in developing and verifying assays for hematologic malignancies and/ or evaluating them (i.e. PT providers or inspectors in this area).

 The deadline to submit notification of interest in serving on the subcommittee with a curriculum vitae is 30 April 2008.

Upon receipt of your statement of interest in serving on the subcommittee a disclosure of interests form will be sent to you for completion. 

Send to Donna Connery (dconnery@clsi.org) at Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087, or via Fax at +610.688.0700.
[ return to top ]