Quality error rates in point-of-care testing.

ABSTRACT

BACKGROUND: Although a theoretical consideration suggests that point-of-care testing (POCT) might be uniquely vulnerable to error, little information is available on the quality error rate associated with POCT. Such information would help inform risk/benefit analyses when one considers the introduction of POCT. METHODS: This study included 1 nonacute and 2 acute hospital sites. The 2 acute sites each had a 24-h central laboratory service. POCT was used for a range of tests, including blood gas/electrolytes, urine pregnancy testing, hemoglobin A(1c) (Hb A(1c)), blood glucose, blood ketones, screening for drugs of abuse, and urine dipstick testing. An established Quality Query reporting system was in place to log and investigate all quality errors associated with POCT. We reviewed reports logged over a 14-month period. RESULTS: Over the reporting period, 225 Quality Query reports were logged against a total of 407 704 POCT tests. Almost two-thirds of reports were logged by clinical users, and the remainder by laboratory staff. The quality error rate ranged from 0% for blood ketone testing to 0.65% for Hb A(1c) testing. Two-thirds of quality errors occurred in the analytical phase of the testing process. These errors were all assessed as having no or minimal adverse impact on patient outcomes; however, the potential adverse impact was graded higher. CONCLUSIONS: The quality error rate for POCT is variable and may be considerably higher than that reported previously for central laboratory testing.