THE A6 CYCLE: A METHOD FOR IDENTIFYING EVIDENCE-BASED LABORATORY MEDICINE BEST PRACTICES AND A TECHNOLOGY ASSESSMENT VALIDATION

Purpose: To develop a method for systematic review of pre- and post-analytic practices in Laboratory Medicine that are effective at improving outcomes, including both published and unpublished evidence of effectiveness.

Method: In laboratory medicine, most errors occur in the pre- and post-analytical testing phases. Although more than 200 evidence-evaluation systems have been proposed, none are designed to specifically evaluate laboratory medicine quality improvement practices and outcomes. Also, there is generally insufficient published evidence in laboratory medicine, such that new methods need to accommodate unpublished evidence. Validated evidence-based medicine (EBM) methods used by the USPSTF (2008), AHRQ (2002), CASP (1993) and others were adapted to LM quality improvement issues using the “A6 cycle,” (ASK, ACQUIRE, APPRAISE, ANALYZE, APPLY and ASSESS) to develop “Laboratory Medicine Best Practices (LMBP)” systematic review methods. Key modifications allow inclusion of quality improvement study designs and unpublished evidence. 

Result: Pre-analytic patient specimen identification was a pilot topic.  (1) ASK: “Are barcoding systems (using bar-coded patient armbands and scanners) effective at reducing specimen identification errors?” (2) ACQUIRE: 81 published and 6 unpublished studies were identified. (3) APPRAISE: Application of screening criteria resulted in a total of 10 studies being fully abstracted. (4) ANALYZE: 8 studies were included in the evidence base; 6 studies were rated “good” study quality and 2 were rated “fair,” all with consistent effect sizes in favor of barcoding. Meta-analysis favoring barcoding versus no barcoding for avoiding ID errors average log odds ratio was 2.45 (95% confidence interval: 1.6-3.3).  The Expert Panel rated barcoding systems’ overall effect size “substantial,” and its strength of evidence “high.” On the basis of the evidence review, barcoding systems were recommended as effective at reducing patient specimen identification errors.  (5) APPLY: Disseminate through peer-reviewed publications, educational programs and other media. (6) ASSESS:  Ongoing data collection and evaluation will assure practice works and in what settings, and may reveal other issues/questions for future reviews.

Conclusion: The developed LMBP A6 method, adapted from validated evidence-evaluation systems, can be applied to systematically review and evaluate quality improvement practices in laboratory medicine. Practice evidence can be reliably identified, standardized and summarized to complete evidence reviews and establish best practice recommendations for improving patient outcomes and reducing medical error.