Laboratory compliance with federal government and professional society recommendations.
Quality assurance issues have assumed growing importance in the cytology laboratory. The 1988 Clinical Laboratories Improvement Amendment (CLIA '88) (United States Department of Health and Human Services, Federal Register: U.S. Government Printing Office 1990;55:9495) regulates the patient identifiers and clinical data on the requisition form but does not mandate physician compliance to provide the information. We investigated the use of patient identifiers and clinical data by laboratories as specimen acceptance/rejection criteria. We surveyed 81 board certified cytopathologists and 235 randomly selected cytology laboratories for acceptance criteria of cytology specimens and received responses from 104. Approximately two thirds of all responding laboratories had specific criteria for rejecting specimens on the basis of inadequate identification or clinical data. While the vast majority required the specimens to be identified with patient name, collection date, and specimen source, a minority of laboratories required clinical information such as LMP, prior atypical cytologic/histologic specimens, and history of previous therapy. Little correlation was found between practice setting and the use of rejection criteria.
Department of Pathology, Duke University, Durham, NC.
L J
LJ
Layfield
S
S
Zaleski
K
K
Bottles
M B
MB
Cohen
D007753:Laboratories / Q000331:legislation & jurisprudence / Q000592:standards*; D010336:Pathology / Q000331:legislation & jurisprudence / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence / Q000592:standards; D012958:Societies, Scientific; D014481:United States