Joan H. Howanitz

Laboratory Results Timeliness as a Quality Attribute and Strategy

Although timeliness of results reporting has not been a major focus in clinical laboratories, there is increasing pressure from clinicians to report results rapidly. Even though there are only sparse data, timeliness in reporting of laboratory results undoubtedly affects clinician and patient satisfaction as well as length of hospital stay. Improving turnaround time (TAT) is a complex task involving education, equipment acquisition, and planning. All the steps from test ordering to results reporting should be monitored and steps taken to improve the processes. Various strategies to improve TAT at each step in the testing process are discussed.

Paraproteins are a common cause of interferences with automated chemistry methods.

CONTEXT Previous studies have shown that paraproteins caused spurious results on individual analytes including total bilirubin (TBIL), direct bilirubin (DBIL), or HDL-cholesterol (HDL-C). Studies demonstrating paraprotein interferences with multiple analytes measured by different analyzers have not been reported. OBJECTIVE To systemically investigate interferences of paraproteins on TBIL, DBIL, and HDL-C measured by the Roche MODULAR and the Olympus AU2700. DESIGN Eighty-eight serum specimens with monoclonal gammopathies were analyzed using the Roche MODULAR and the Olympus AU2700. Paraprotein interferences with the MODULAR and AU2700 were identified by abnormal absorbance curves and confirmed by results from the Ortho Vitros 950 or inconsistent laboratory information. RESULTS Spurious results occurred in 89 of 528 measurements; 29 specimens did not demonstrate any interferences whereas 26 specimens gave spurious results in 2 to 4 of the 6 assays. Paraprotein interferences caused spuriously high levels of TBIL in 4 sera measured by the MODULAR. In contrast, paraprotein interferences on DBIL were observed by at least 1 method in 44% (39/88) of sera assayed, occurring almost exclusively with the AU2700. Paraprotein interferences with HDL-C results were present in 35% of specimens assayed with the MODULAR and 16% of specimens assayed with the AU2700. In specimens with interferences, spuriously low AU2700 DBIL, MODULAR HDL-C, and AU2700 HDL-C results occurred with 28%, 90%, and 91% of specimens, respectively. CONCLUSIONS We demonstrated that paraprotein interferences with TBIL, DBIL, and HDL-C are relatively common and provided explanations why these interferences occurred. Although it is difficult to predict which specimens cause interferences, spurious results appeared method and concentration dependent.

Comparison of pooled fresh frozen serum to proficiency testing material in college of American pathologists surveys: Cortisol and immunoglobulin E

CONTEXT The College of American Pathologists (CAP) provides proficiency testing (PT) surveys to laboratories around the world. OBJECTIVES To compare diagnostic assay methods for serum/plasma cortisol and immunoglobulin (Ig) E in terms of their bias and precision, to determine how well CAP PT specimens simulate human serum, and to reassess proficiency test grading criteria in light of these findings. DESIGN A participant-blinded, prospective trial. One vial of pooled fresh frozen serum (FFS) and 4 different admixtures of PT material (PTM) were sent to laboratories participating in PT surveys. PARTICIPANTS Laboratories providing cortisol (>1000) or IgE (>230) results among the subscribers to the CAP surveys, Ligand (General) 2003, set K/KN-A and Chemistry 2003, set C-C. MAIN OUTCOME MEASURES The main outcome measures were (1) bias among laboratories using the same method (peer groups), defined relative to the median of method means (MedMM); (2) imprecision as measured by the SD and coefficient of variation (CV) about each method mean; and (3) total error across laboratories for the FFS cortisol results, defined as |Bias Relative to Reference Method| + 2 SD. RESULTS Cortisol method biases, relative to MedMM, ranged from -22% to 9% for the FFS challenge and from -24% to 36% for comparable PTM challenges. The method biases, relative to the reference method, ranged from -3% to 19% for the FFS challenge. The cortisol method CVs ranged from 4.2% to 13.6% for the FFS challenge and from 4.7% to 12.7% for comparable PTM challenges. Total error across laboratories ranged from 1.4 to 6.9 microg/dL (39 to 190 nmol/L) for the FFS challenge. Immunoglobulin E method biases, relative to MedMM, ranged from -8% to 9% for the FFS challenge and from -7% to 5% for comparable PTM challenges. The IgE method CVs ranged from 3.6% to 6.7% for the FFS challenge and from 3.4% to 9.8% for comparable PTM challenges. CONCLUSIONS The bias for cortisol results was less with FFS than with PTM, but imprecision was comparable. The FFS MedMM was 8.5% higher than the reference value. Fresh frozen serum and PTM bias and imprecision for IgE methods were each less than 10%. Because some of the methods demonstrated greater bias when analyzing PTM than FFS, peer group grading of both these analytes is appropriate.