Managing the pre- and post-analytical phases of the total testing process

Area of Science:

• Clinical Laboratory Science
• Healthcare Quality Improvement
• Patient Safety

Background:

• Clinical laboratories have historically achieved high analytical quality (4-5 sigma).
• Growing awareness highlights significant errors and patient harm potential in pre- and post-analytical testing phases.
• Accreditation bodies (JCI, CAP) now mandate broader laboratory responsibility for total testing processes.

Purpose of the Study:

• To address the challenge of managing the extra-laboratory phase of the total testing cycle.
• To emphasize the clinical laboratory's role in reducing errors beyond analytical procedures.
• To improve patient safety by extending quality management principles.

Main Methods:

• Review of accreditation requirements (JCI, CAP) for pre- and post-analytical phases.
• Identification of available online resources for managing extra-analytical processes.
• Consideration of quality indicators and performance benchmarks from IFCC.

Main Results:

• Accreditation bodies increasingly require robust procedures for patient identification and critical result communication.
• Online resources and IFCC benchmarks offer valuable tools for managing extra-analytical quality.
• The clinical laboratory possesses the foundational expertise to manage these extended quality processes.

Conclusions:

• Managing the extra-laboratory phase is the next frontier for laboratory medicine.
• Clinical laboratories are well-positioned to leverage their expertise in quality management, IT, and scientific principles.
• Expanding laboratory oversight to the total testing cycle is essential for reducing errors and enhancing patient safety.