Laboratory performance and director qualifications

Area of Science:

• Clinical Laboratory Science
• Healthcare Quality Assurance
• Regulatory Science

Background:

• Federal regulations mandate doctoral degrees for clinical laboratory directors since 1971.
• Private agencies and some states also require doctoral directors for accredited labs.
• Empirical evidence supporting the necessity of doctoral directors for laboratory quality is lacking.

Purpose of the Study:

• To investigate the necessity of a doctoral degree for clinical laboratory directors.
• To compare the quality of doctoral- vs. non-doctoral-directed laboratories.
• To assess the performance of regulated vs. unregulated laboratories.

Main Methods:

• Analysis of 1983 proficiency testing data from Medicare-certified independent laboratories in California.
• Statistical comparison of doctoral- and non-doctoral-directed laboratories.
• Comparison of regulated non-doctoral-directed laboratories with unregulated physician office laboratories (POLs).

Main Results:

• No statistically significant differences in quality were found between doctoral- and non-doctoral-directed laboratories.
• Regulated non-doctoral-directed laboratories outperformed unregulated POLs.
• Doctoral directorship is neither necessary nor sufficient for assuring laboratory performance.

Conclusions:

• Government regulation, rather than director's doctoral degrees, appears to be the key factor in ensuring clinical laboratory quality.
• The findings challenge existing regulatory and accreditation requirements for laboratory directors.
• Effective regulation provides substantial quality assurance in the clinical laboratory field.