Newly Approved Documents
Validation of INR and Local Calibration of PT/INR Systems (H54-A); Proficiency Testing (External Quality Assessment) for Molecular Methods (MM14-A)

Second Notice (Available in August):

Validation of INR and Local Calibration of PT/INR Systems; Approved Guideline (H54-A)
CLSI document H54 reviews limitations of the INR system and provides a rationale for performing local PT/INR verification with recommendations as to when calibration may be indicated. The method of certified plasma preparation and method of INR value assignments are described in detail.  Also included are the recommended INR range that certified plasmas should cover and recommended number of certified plasmas required for local ISI calibration. A protocol for performing calibration of PT systems is provided. Methods of calculating local ISI are included, as well as the procedure for creating a calibration line in order to interpolate a direct INR.
Purchase H54-A.

Proficiency Testing (External Quality Assessment) for Molecular Methods; Approved Guideline (MM14-A)
MM14-A is a best-practices reference for organizations that provide molecular testing services.  It will serve clinical laboratories with a benchmark for evaluation of new programs or, taken in principle, to guide their own program development when necessary.  The guideline includes recommendations for
* reliable databases;
* design control in the choice of materials and analytes;
* good manufacturing processes;
* documentation procedures;
* complaint handling;
* corrective and preventive action plans; and
* responsive timing of reports.
Purchase MM14-A.

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