Validating New Reagents: Roadmaps Through the Wilderness

Autor:	Cheryl A. Vesso, Jean S. Der, Roberta A. Martindale, Donald F. LeGatt, Jennifer L. Crawford, George S. Cembrowski, Lucille J. Journault, Carol Shalapay, Chi Tran, Cathy W. Revers, Connie Prosser, Tammy L. Hofer, Bev J. Rintoul
Rok vydání:	2006
Předmět:	Computer science media_common.quotation_subject Biochemistry (medical) Clinical Biochemistry Control (management) Patient data Reliability engineering Reagent Range (statistics) Quality (business) In patient Reset (computing) Laboratory Director media_common
Zdroj:	Laboratory Medicine. 37:347-351
ISSN:	1943-7730 0007-5027
DOI:	10.1309/brc6y37nm3bu97wx
Popis:	One of the most frequent quality control issues faced by laboratory professionals is how to respond appropriately to a shift in quality control (QC) following a reagent lot change. Possible actions include adjusting the control range, checking for shifts in patient data, or simply ignoring the QC shift. We offer a systematic approach to shifted quality control and/or patient data following a reagent lot change. We divide laboratory tests into 3 types, (1) tests for which the analysis of QC specimens is sufficient, (2) tests which demonstrate between reagent lot shifts infrequently, and (3) tests with between lot variation. Depending on the test type, specific information is gathered about the magnitude of the shifts in either the QC and/or the patient data. The control mean is reset following an isolated quality control shift. Evaluation of the shift in patient data is initiated by the laboratory director when the shift exceeds a multiple of the allowable error.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::1eda1e4e8538165769cf5c4a51bcd61d https://doi.org/10.1309/brc6y37nm3bu97wx Zobrazit plný text záznamu