ARE PHYSICIANS OFFICE LABORATORY RESULTS OF COMPARABLE QUALITY TO THOSE PRODUCED IN OTHER LABORATORY SETTINGS

Context.-In 1995, California adopted a bill that brought laboratory la ws in line with the 1988 Clinical Laboratory Improvement Amendments' s tandards for clinical laboratories and mandated a study comparing resu lts in physicians' office laboratories (POLs) with other settings. Obj ective.-To determine whether persons conducting tests in POLs produce accurate and reliable test results comparable to those produced by non -POLs. Design.-Survey of clinical laboratories using proficiency testi ng data. Setting.-All California clinical laboratories participating i n the American Association of Bioanalysts proficiency testing program in 1996 (n=1110). Main Outcome Measures.-''Unsatisfactory'' (single te sting event failure) and ''unsuccessful'' (repeated testing event fail ure) on proficiency testing samples, Results.-The unsatisfactory failu re rate for POLs was nearly 3 times (21.5% vs 8.1%) the rate for the n on-POLs and about 1.5 times (21.5% vs 14.0%) for POLs that used labora tory professionals as testing or supervisory personnel (P<.001). The P OL unsuccessful rate was more than 4 times (4.4% vs 0.9%) the rate for non-POLs and more than twice (4.4% vs 1.8%) the rate for the POLs usi ng laboratory professionals (P<.001). Conclusions.-Significant differe nces exist among POLs, POLs using licensed clinical laboratory scienti sts (medical technologists), and non-POLs. Testing personnel in many P OLs might lack the necessary education, training, and oversight common to larger facilities, We must better understand the contributing fact ors that result in the poorer results of POLs relative to non-POLs, In the meantime, patients should be aware that preliminary findings sugg est that differences in quality of laboratory tests based on testing s ite may exist. Laboratory directors at all testing sites must ensure t hat they understand laboratory practice sufficiently to minimize error s and maximize accuracy and reliability, Directors must understand the ir obligation when they elect to oversee those assigned testing respon sibility. Legislators may wish to reconsider the wisdom of further eas ing restrictions on those to whom we entrust our laboratory specimens.