New CLSI Guidelines for the Management of Nonconforming Laboratory Events

Managing nonconforming events is an integral part of continuous quality improvement, which maximizes patient safety and advances quality initiatives. The value of a program to manage nonconforming events is to balance time spent on event reporting, event analysis, and implementing interventions.

The Clinical and Laboratory Standards Institute has recently published a new guideline, Management of Nonconforming Laboratory Events; Proposed Guideline (GP32-P), which provides an application example for the laboratory to develop a program for detecting, documenting, investigating, analyzing, and following up on events that do not conform with established policies, processes, and procedures (occurrence management).

A nonconforming event management program is based on principles of quality management and patient safety. The program is structured, organized, and used consistently throughout the laboratory or healthcare organization to report, investigate, act on, track and trend nonconformances, and identify opportunities for improving the efficiency and effectiveness of work processes, as well as improve patient safety.

Elements of a nonconforming event management program addressed in the document include:
• identification and reporting;
• remedial action;
• investigation and documenting;
• classifying;
• analysis and data presentation; and
• management review and referral to process improvement.

The guidance provided in the document is best used within an individual clinical service; however, the concepts may be expanded to function in a larger scope, if needed.

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