What's to Be Done About Laboratory Quality? Process Indicators, Laboratory Stewardship, the Outcomes Problem, Risk...

Area of Science:

• Laboratory Medicine
• Healthcare Quality Improvement
• Health Services Research

Background:

• Healthcare quality assessment has long relied on structure, process, and outcomes measures.
• Clinical laboratory quality has primarily used structural inspection and process quality indicators (QIs).
• Demonstrating links between laboratory quality measures and patient outcomes remains a challenge.

Purpose of the Study:

• To review global publications on clinical laboratory quality assessment.
• To inform the development of improved clinical laboratory quality systems.
• To identify effective strategies for enhancing laboratory quality and its impact.

Main Methods:

• Selective worldwide review of publications on clinical laboratory quality assessment.
• Analysis of existing quality indicators (QIs) and their impact on process improvement.
• Exploration of risk assessment methodologies for surrogate outcome measures.

Main Results:

• Some QIs demonstrate significant process improvement; others highlight needs in test selection and result management.
• Risk calculations from failure mode effects analysis are used as surrogate outcome measures.
• Demonstrating the economic value of clinical laboratory quality is challenging.

Conclusions:

• Clinical laboratories should adopt a focused set of 7-14 process monitors covering all testing steps, prioritizing high-risk specimen-quality QIs.
• Clinical laboratory stewardship, combining education and revised ordering/reporting, improves test ordering but not result reception.
• Integrating fewer consensus QIs, active stewardship, and formal risk assessment enhances economic value and quality.