Application of 3-D Δ check graphs to HbA1c quality control and HbA1c utilization

Delta checking is a laboratory information system (LIS)-based tool that detects patient and laboratory quality control errors. By using hemoglobin A(lc) (HbA(1c)) data, we developed a novel approach to summarizing and presenting patient Delta values to address limitations of current Delta check algorithms. Delta values were calculated from intrapatient pairs of HbA(1c) (n = 55,327) measured during 2 years in a single referral or a university hospital laboratory. Three-dimensional Delta-time (Delta T) and percentile limit graphs were constructed. Cumulative distribution function analysis was used to explore clinical utilization. The Delta T graphs showed that HbA(1c) Delta values increase asymmetrically over time. Although the 2.5 to 97.5 and 5.0 to 95.0 percentile Delta check limits were similar for both sites, the referral laboratory's 0.5 to 99.5 percentile limits were wider. For acute patient care environments, we recommend limits of -3.5% and 1.8% for measurements between 0 and 60 days and -4.0% and 2.0% for measurements between 60 and 120 days. For the outpatient environment, we recommend limits of -4.2% and 2.1% and 5.0% and 2.5% for measurements between 0 and 60 days and 60 and 120 days, respectively. Delta checking can be significantly improved with customization of limits set by population and interobservation period. Because LIS systems are incapable of these customizations, customers must become advocates for these modifications.