Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
5
pubmed:dateCreated
1991-6-24
pubmed:abstractText
We have assessed the laboratory specifications necessary for ensuring that cholesterol testing processes satisfy the quality required by the U.S. National Cholesterol Education Program (NCEP). A model for setting process specifications has been developed to relate the NCEP guidelines for medical interpretation of a cholesterol test to the pre-analytical and analytical variables that can affect a test result. Using this model, we derived specifications for the imprecision (coefficient of variation, CV, or standard deviation, s) and inaccuracy (bias) that are allowable under stable operation, as well as the quality-control procedures (control rules and number of control measurements) that are necessary to detect unstable operation. The NCEP goals of an allowable CV less than or equal to 3% and an allowable bias no greater than +/- 3% are inadequate for assuring the quality of an individual or single cholesterol test when monitoring performance with many of the statistical quality-control procedures currently used in the U.S. With quality-control procedures having two control measurements per run, a CV of 3% is allowable only when bias is zero; a CV less than or equal to 2% is necessary if bias is +/- 3%. With quality-control procedures having four control measurements per run, a CV of 3% is allowable when bias is +/- 1.5%; a CV less than or equal to 2.5% is required if bias is as large as +/- 3%. For two serial tests, the NCEP 3% goals are adequate for current quality-control procedures having four control measurements per run.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
May
pubmed:issn
0009-9147
pubmed:author
pubmed:issnType
Print
pubmed:volume
37
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
656-61
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:year
1991
pubmed:articleTitle
Laboratory process specifications for assuring quality in the U.S. National Cholesterol Education Program.
pubmed:affiliation
Department of Pathology and Laboratory Medicine, Medical School, University of Wisconsin, Madison 53792.
pubmed:publicationType
Journal Article, Research Support, Non-U.S. Gov't