Laboratory quality control, quality assurance and laboratory management.
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Biomedical subjects
Publications and source records attributed to D W Penner.
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During 1990-1991, all patients seen at the surgical out-patient clinic at the Kenyatta National Hospital (KNH) with breast lumps had a fine-needle aspiration biopsy for diagnosis prior to open biopsy. Out of 105 that had corresponding surgical biopsies, 82 aspirates were considered satisfactory. Of these, the correct diagnosis was made in 59 (71%), another 12 (21%) were called benign but the correct histologic diagnosis was not made, 7 (8.5%) were correctly called negatives. The diagnostic accuracy of this method in differentiating benign from malignant was 95% in this study.
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Eleven surgical pathologists studied microscopic sections from 45 mastectomy specimens of node positive breast cancer patients who had been entered into ECOG clinical trials. Inter-observer reproducibility for histoprognostic features was examined as a prerequisite before a subsequent evaluation of their possible clinical applicability could be undertaken. Histological type, nuclear grade, tubular formation, and lymphoid reactions were studied in the cancerous tissues. Lymph nodal responses (follicular and pulp prominence, sinus histiocytosis) were also examined in a manner that stimulated slide review in routine surgical pathology practice. Numerous two-way comparisons of the pathologists' findings resulted in low levels of agreement (usually much less than 90%). The degree of inter-observer reliability is clinically unacceptable using customary slide review analysis. New ways of examining breast cancer tissues need to be explored in the search for prognostic features which can be applied to the clinical management of breast cancer patients.
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The Workload Recording System, initially developed by the Canadian Association of Pathologists, with subsequent and joint active participation with the College of American Pathologists and numerous other medical laboratory specialist societies, is a powerful tool for the management of medical laboratories. This article describes the system and its implementation.
Nine surgical pathologists participated in a microscopic review of 35 cases of pT1-2 N0 M0 breast carcinoma. The pathologists outlined strict criteria for the identification of intramammary lymphatics and blood vessels and for the identification of cancerous emboli in these vascular channels. Each mastectomy case was studied by three different pathologists. All three concurred on the presence or absence of intralymphatic cancer in 12 of the 35 cases. Observers agreed on the absence of blood vessel invasion in 30 of the 35 cases. There was no consistent bias on the part of a single reviewer, either alone or with another pathologist, in identifying the emboli. We conclude that the identification of intralymphatic cancerous emboli in mastectomy specimens is not a reliably reproducible prognostic finding on which recommendation of systemic chemotherapy in stage I breast carcinoma patients can be based.
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The 1982 edition of the Laboratory Workload Recording Method manual will reflect a reduction in unit values assigned to some clinical chemistry procedures. In this article, the author explains why the changes have been made, what they mean, and offers guidelines on coping with the ever changing but valuable Workload Recording Method.
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