A Survey of the Accuracy of Chemical Analyses in Clinical Laboratories

Belk, William P.; Sunderman, F. William

doi:10.1093/ajcp/17.11.853

Cited by 160 publications

(43 citation statements)

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“…Except for serum K, AutoAnalyzer methods generally gave more results closer to the mean. These figures are similar to or better than those reported in surveys elsewhere (Belk and Sunderman, 1947;Desmond, 1964;Hendry, 1961-66;Holtz, 1959;Rootwelt and Nesvik, 1966;Snavely et al, 1952;Tonks, 1963;Vanzetti, 1966;Wootton, 1956;Wootton and King, 1953).…”

Section: Classification Of Resultssupporting

confidence: 79%

Results of an Interlaboratory Trial in Britain

Gowenlock

1969

Ann Clin Biochem

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about the stability of the aqueous solution and the reproducibility of the amount of dried serum in the vials. As this information was not available, both factors were investigated experimentally. Stability ofaqueous solution EFour reference laboratories were selected each using AutoAnalyzer (Technicon Instruments Co., Chertsey, Surrey) methods for all four constituents. Ampoules of solution E were stored either at 4°C in the refrigerator or at room temperature exposed to daylight. Four ampoules from each group were analysed in one batch at intervals of one to two weeks over the two months of the main survey and the results were assessed by plotting the regression of the mean values for each day against time.Sodium, potassium and inorganic phosphorus concentrations remained constant with both methods of storage. For urea, results from individual laboratories decreased insignificantly with time. Appropriate combination of all results from the four laboratories still showed no significant change for storage at 4°, but at room temperature the rate of deterioration, 0.17 mg/loo ml per week, was just significant (p < 0.05). As laboratories in the main trial had been asked to store their ampoules at 4°and as the deterioration at higher temperatures was so small, the survey results were not corrected for date of analysis.The mean figures found by these four reference laboratories for each constituent differed. Although there was significant variation in precision between the four laboratories, the coefficient of variation (C.V.) was always least for sodium. Expressed as the within-batch precision this figure was 0.44-0.57 %.Accordingly this constituent was chosen to examine variability between ampoules. Variability between ampoulesTen ampoules of each serum A, B, C and D were reconstituted by one operator using the same pipette. After dissolving, each of the 40 samples was divided between two of the reference laboratories used earlier. The 40 samples were analysed in the same random order in one batch in both laboratories on each of two days. In both laboratories on both days the first specimen in the batch gave anomalous results, being 7 % lower than the remaining figures. 126This paper reports details of the findings of a trial carried out for the Association of Clinical Biochemists by its Scientific and Technical Committee, in which 175 clinical laboratories each analysed the same specimens for sodium, potassium, urea and inorganic phosphorus. ORGANISATION OF THE TRIALThe survey involved the distribution during September and October, 1965, to each of 230 laboratories in Britain of four ampoules of dried sera labelled A, B, C and D and of two ampoules of a sterile aqueous solution labelled E. Participants were asked to store these at 4°C until used. Sera A and B were reconstituted on one day by adding 5 ml water to each and then analysed with one of the aqueous solutions, henceforward called El, in one routine batch of specimens. On a second day, sera C and D were similarly reconstituted and analysed with the second ...

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Section: Classification Of Resultssupporting

confidence: 79%

Results of an Interlaboratory Trial in Britain

Gowenlock

1969

Ann Clin Biochem

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“…As recently stated by Miller [7], the history of the awareness of the importance of standardization can be traced back to the seminal paper by Belk and Sunderman [8] who, in 1947, demonstrated wide discrepancies between results of 59 US hospital laboratories. The findings made in their survey paved the way for the development of external quality assurance (EQA)/proficiency testing (PT) programs and prompted efforts to establish the hierarchy of certified reference materials (CRMs) and reference measurement procedures (RPMs) that could be accepted as high-order references for the standardization of measurand results [9,10].…”

Section: Harmonization In Laboratory Medicine As a Complete Picturementioning

confidence: 99%

Harmonization in laboratory medicine: more than clinical chemistry?

Plebani

2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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Abstract:The goal of harmonizing laboratory information is to contribute to quality in patient care, ultimately improving upon patient outcomes and safety. The main focus of harmonization and standardization initiatives has been on analytical processes within the laboratory walls, clinical chemistry tests in particular. However, two major evidences obtained in recent years show that harmonization should be promoted not only in the analytical phase but also in all steps of the testing process, encompassing the entire field of laboratory medicine, including innovative areas (e.g. "omics") rather than just conventional clinical chemistry tests. A large body of evidence demonstrates the vulnerability of the extra-analytical phases of the testing cycle. Because only "good biological samples" can assure good analytical quality, a closer interconnection between the different phases of the cycle is needed. In order to provide reliable and accurate laboratory information, harmonization activities should cover all steps of the cycle from the "pre-preanalytical" phase (right choice of test at right time for right patient) through the analytical steps (right results with right report) to the "post-post-analytical" steps (right and timely acknowledgment of laboratory information, right interpretation and utilization with any necessary advice as to what to do next with the information provided). In addition, modern clinical laboratories are performing a broad menu of hundreds of tests, covering both traditional and innovative subspecialties of the discipline. In addition, according to a centered viewpoint, harmonization initiatives should not be addressed exclusively to clinical chemistry tests but should also include all areas of laboratory medicine.

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“…PT for the assessment of clinical laboratories dates back to the 1940s. 5,6 NSQAP provides training in the preparation of DBS materials and test methods. The program staff also compiles and distributes 21 data reports annually for comparative and assessment use by participants.…”

Section: Quality Assurance Program Operationsmentioning

confidence: 99%