SOURCE: Clinical and Laboratory Standards Institute

Clinical and Laboratory Standards Institute

February 03, 2010 15:36 ET

CLSI Releases New Proposed Guidelines for Review and Comment Presentation of a Manufacturer's Risk Mitigation Information for Users of In Vitro Diagnostic Devices (EP22-P) Laboratory Quality Control Based on Risk Management (EP23-P)

WAYNE, PA--(Marketwire - February 3, 2010) - The quality of laboratory test results depends on the combined efforts of in vitro diagnostic (IVD) manufacturers and the laboratory. The IVD manufacturer strives to design measuring systems that minimize the likelihood of malfunction and to provide information and recommendations to the laboratory regarding how to best detect measuring system malfunctions if they do occur. The laboratory director defines and implements quality assurance practices to minimize the risk of a measuring system malfunction in his or her environment (eg, regular maintenance of the device as recommended by the manufacturer) and quality control (QC) procedures to quickly detect any out-of-control error conditions that might occur in the laboratory.

Clinical and Laboratory Standards Institute (CLSI) recently released two new proposed-level guidelines for review and comment for a three-month period, which ends April 29, 2010.

"Presentation of a Manufacturer's Risk Mitigation Information for Users of In Vitro Diagnostic Devices; Proposed Guideline" (EP22-P) provides guidance to manufacturers on the establishment and disclosure of information they might choose to share with users regarding the scope and effectiveness of device risk mitigations intended to prevent production or release of inaccurate patient test results. The information should include a description of the device feature or recommended user intervention intended to mitigate the risk, the targeted failure mode, and how the design mitigation feature or recommended user intervention works to ensure the quality of patient test results.

This information is a key component of the laboratory decision-making process regarding the scope and character of the QC process applied in the laboratory. This information is needed so that directors of clinical laboratories can develop and implement a QC program that is appropriate for the measuring system and is designed to meet specific laboratory-defined quality goals, as well as regulatory and accreditation requirements.

"Laboratory Quality Control Based on Risk Management; Proposed Guideline" (EP23-P) provides guidance based on risk management for laboratories to develop QC plans tailored to the particular combination of the measuring system, laboratory setting, and clinical application of the test. Regulatory requirements, information provided by the manufacturer, information pertaining to the laboratory environment, and medical requirements for the test results are evaluated by the laboratory director using risk management principles to develop a QC plan specific for his or her laboratory. The effectiveness of the laboratory QC plan is monitored to detect trends, identify corrective actions, and provide continuous quality improvement.

The proposed guidelines are released for review and comment to solicit broad input on the content and presentation of the documents. This review is intended to ensure the technical accuracy, readability, and global applicability of CLSI's approved consensus documents. All comments received on the proposed-level documents will be addressed and the documents will be revised accordingly for the development of the approved-level consensus documents.

CLSI is a volunteer-driven, membership-supported, nonprofit organization dedicated to developing standards and guidelines for the health care and medical testing community through a consensus process that balances the perspectives of industry, government, and the health care professions. For additional information about CLSI and how to purchase proposed- and approved-level CLSI documents, visit the CLSI website at or call 610.688.0100.

Contact Information

  • Contact:
    Amanda Holm
    Marketing Manager
    Phone: 610.688.0100 ext. 129
    E-mail: Email Contact