Washington State's Experience Applying ISO 2859 Validation Methods to Healthcare Associated Infections (HAI) Reporting

BACKGROUND:  To ensure all hospitals in our data supply chain maintain a pre-specified quality level in the sensitivity and specificity of their reporting to CDC’s National Healthcare Safety Network (NHSN), we adapted a quality management approach widely used in other industries. 

METHODS:  It was pilot tested successfully in 2009, implemented for annual central-line-associated bloodstream infection (CLABSI) validation in 2010, and has been running successfully ever since.  We are now designing and piloting an SSI validation module to add by 2014, using the same ISO 2859 approach.  Methodology details have been published previously.

RESULTS:  Our approach involves shared responsibility: an annual internal self-assessment component that takes hospitals of all sizes less than 6 hours per year to complete, and subsequent validation verification visits by one state program staff member that take 1 day per hospital to complete.  All hospitals in our state reporting network have been participating since January 2010, and our approach has been favorably reviewed by several divisions of the American Society for Quality.

CONCLUSIONS:  ISO 2859 defines an international standard for acceptance sampling; that approach has been used widely in other manufacturing and service industries since the 1940s but Washington State is the first to apply it in validating reliable accuracy of HAI reporting.  This presentation describes working details of a validation method that has proven practical, efficient, sustainable and sufficiently statistically powerful in our experience, and also is credible to quality professionals across all industries.  Full details of theory and practice are available in our technical reference manual, and in this presentation we also will discuss the essential legal framework under which our validation program operates.