Rules-based detection of discrepancies between TSH and free T4 results.
BACKGROUND
Analytical errors in clinical laboratory testing are unavoidable. Recent reports have suggested the idea of "physiological profiling" which uses several results from a given patient to identify clinically unlikely results. The objective of this study was to establish rules-based criteria for identifying physiologically unlikely TSH and free T(4) (fT(4)) results.


METHODS
For a 30-month period, all samples with fT(4) concentrations >2 ng/dl and TSH concentrations >0.1 micro IU/ml were investigated.


RESULTS
Among 7918 plasma samples for which both TSH and fT(4) concentrations were measured, 18 (0.23%) had fT(4) and TSH exceeding the investigated limits. Of these, two were due to heterophile antibody interference (with the TSH assay), one was proven to be due to random error, four could be explained by the patients' conditions, three were from infants <1 week of age, and the remaining eight were unresolved, primarily due to insufficient sample, discarded samples, and inability to obtain patient histories.


CONCLUSIONS
This study defined a rules-based alert system for clinically unlikely combinations of TSH and fT(4) results. This pilot study demonstrates that this system is capable of detecting at least two different types of laboratory errors that would have otherwise gone undetected.
Mitchell
Douglas R
DR
Department of Pathology and Immunology, Division of Laboratory Medicine, Washington University School of Medicine, 660 South Euclid Avenue, Box 8118, St. Louis, MO 63110, USA.
Parvin
Curtis A
CA
Gronowski
Ann M
AM
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000910:Antibodies, Heterophile / Q000032:analysis / Q000097:blood; D003951:Diagnostic Errors / Q000517:prevention & control* / Q000592:standards; D005189:False Positive Reactions; D006801:Humans; D007231:Infant, Newborn; D008875:Middle Aged; D011786:Quality Control; D012016:Reference Values; D012680:Sensitivity and Specificity; D013959:Thyroid Diseases / Q000097:blood / Q000175:diagnosis*; D013972:Thyrotropin / Q000097:blood* / Q000592:standards; D013974:Thyroxine / Q000097:blood* / Q000592:standards
D000910:Antibodies, Heterophile; D013972:Thyrotropin; D013974:Thyroxine