Error limits and quality control.
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Biomedical subjects
Publications and source records attributed to R N Barnett.
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To establish medically useful guidelines for analytic precision of commonly used clinical laboratory procedures, the authors conducted a mail survey of physicians selected randomly from national lists of specialists. They were asked to review, briefly, outlined clinical problems and select the change in test results that would alter their diagnosis or treatment or prompt further assessment of the patient's condition. The responses were used to calculate goals for laboratory precision that are sufficient to meet the present requirements of the average physician. The medically useful limits were compared with existing performance of laboratories as reported in national proficiency surveys and regional quality control programs. Almost all the common laboratory procedures they studied are being assayed at a precision level adequate for the perceived needs. The authors suggest that, for the more common constituents, further progress in clinical laboratory testing will depend on factors other than the improvement of analytic precision.
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The authors performed a comparative study of the values of 18 serum constituents of blood specimens taken simultaneously from the arm into which an intravenous solution was flowing, using a site distal to the intravenous needle, and from the other arm. Subjects of the study were 15 patients at the Norwalk Hospital. Statistical analysis showed no clinically significant difference between the levels in the two arms except for elevation of glucose in the "iv arm" when the intravenous solution contained glucose.
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Although Stat tests are one of the most important features of clinical laboratory performance, the indexed literature is devoid of significant discussion of the subject. The authors, undertook a study by querying hospital laboratories about their current practices and received 38 useable answers dealing with the types of tests done on an urgent basis, the turn-around time for reports, the limitations on ordering, the use of special Stat laboratories and instruments, and decisions regarding priorities.
Bone marrow acid phosphatase values were studied in 24 patients (12 men and 12 women) selected at random, including 6 at autopsy. False positive results were noted in 8 of the 18 patients who were alive and in all 6 patients studied at autopsy. The possible causes for these falsely elevated results are discussed. The bone marrow acid phosphatase is a test of poor specificity and should not be used as the sole test on which vital decisions regarding management of the patient are based.
Forty-three kits for clinical chemical analysis of GOT (aspartate aminotransferase) were evaluated. The reference method was the kinetic method performed on the Abott ABA-100 Bichromatic Analyzer. Specific data are tabulated for each kit and include ease and speed of testing and performance data. Most kits failed to provide completely adequate labelling information. Reproducibility CV for the kits varied widely (4.20 to 21.26 for the normal pool and 1.57 to 20.51 for the high pool). Many kits gave significant numbers of false positive and false negative results on patient samples. There is a need for manufacturers to either derive their own normal ranges or to establish exact equivalency values with the method used to establish the normal values. No difference was demonstrated between performance by two skilled technologists. However, we did detect lot-to-lot variation and differences in performance between narrow bandpass and wide bandpass spectrophotometers.
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