CLSI Publishes a New Document on Management of Critical- and Significant-Risk Results

Industry: Publishing

The Clinical and Laboratory Standards Institute (CLSI) has published a new document titled Management of Critical- and Significant-Risk Results (GP47-Ed1).

Wayne, Pennsylvania (PRUnderground) December 10th, 2015

The Clinical and Laboratory Standards Institute (CLSI) has published a new document titled Management of Critical- and Significant-Risk Results (GP47-Ed1). This guideline provides current best practice recommendations for developing and implementing a policy and procedures for the identification, reporting, and management of critical- and significant-risk laboratory results. Emphasis is placed on management responsibilities such as development of the policy, the process, procedures, job descriptions, and monitoring systems that ensure effective reporting and compliance with regulatory requirements.

GP47_Cover.png“Compliance with regulation and accreditation standards requires a significant investment in personnel, time, and other resources. This CLSI standard provides the information needed to help health care organizations understand the requirements for reporting high-risk test results. GP47 gives organizations the ability to develop policies and procedures that promote patient safety and success during regulatory or accreditation inspections and allows for a more efficient use of their resources,” states Andrew N. Young, MD, PhD, Chairholder of the GP47 Document Development Committee and Medical Director at Quest Diagnostics in Pittsburgh, Pennsylvania, USA.

This new document refers to results as critical risk and significant risk, depending on the degree of risk to the patient. The recommendations in the standard are intended to be consistent with best practices for patient safety, and compliant with current, pertinent regulatory and accreditation requirements. GP47 includes an executive summary and appendixes with sample policies, reporting methods, escalation procedures, and monitoring tools.

This document is intended for clinical and laboratory directors, managers, and personnel who develop and implement laboratory policies and processes. The standard is also intended for health care administrators who oversee compliance with regulatory requirements, accreditation, and clinical practice standards related to patient safety. The recommendations cover every laboratory discipline and pertain to clinical laboratories of every size, scope, and complexity.

GP47 can be purchased on the CLSI Shop at or by contacting Customer Service at or +1.610.688.0100.

CLSI is a not-for-profit membership organization that brings together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine by developing and implementing medical laboratory standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global applicability. For additional information, visit the CLSI website at or call +1.610.688.0100.

Contact: Patrick McGinn
Sr. Director, Marketing and Membership
+1.610.688.0100 ext. 5933

About Clinical and Laboratory Standards Institute

A not-for-profit membership organization, the Clinical and Laboratory Standards Institute (CLSI) brings together the global laboratory community for a common cause: fostering excellence in laboratory medicine. We do so by facilitating a unique process of developing clinical laboratory testing standards based on input from and consensus among industry, government, and health care professionals.

For over 40 years, our members, volunteers, and customers have made CLSI a respected, transformative leader in the development and implementation of clinical laboratory testing standards. Through our unified efforts, we will continue to set and uphold the standards that drive quality test results, enhance patient care delivery, and improve the public’s health around the world.

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