[International trends in clinical laboratory testing]

Area of Science:

• Clinical Laboratory Science
• Health Economics
• Medical Technology Advancement

Context:

• The 20th century saw rapid expansion in clinical laboratory practice, driven by medical and technological advancements.
• Recent global healthcare economic shifts are significantly influencing clinical laboratory trends.
• The introduction of Diagnosis Related Groups/Prospective Payment System (DRG/PPS) in US Medicare and its expansion to out-patient care and Health Maintenance Organizations (HMOs) have drastically altered laboratory practice, especially since the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88).

Purpose:

• To analyze the impact of economic changes and new payment systems on clinical laboratory practice.
• To highlight the upcoming introduction of DRG/PPS in Japan's National Health Insurance System.
• To outline the future directions for clinical laboratories focusing on quality and efficiency.

Summary:

• Clinical laboratories face new challenges due to economic pressures and regulatory changes like DRG/PPS and CLIA'88.
• The implementation of ISO standards for clinical laboratory testing will drive quality management.
• Evidence-based laboratory medicine and systematic reviews will be crucial for optimizing the use of diagnostic tests.

Impact:

• Clinical laboratories must adapt to economic reforms and evolving regulatory landscapes.
• Future laboratory practice will integrate robust quality management systems.
• Enhanced utilization of laboratory tests through evidence-based approaches will become standard practice.