Health Care Financing Administration/American Society for Cytotechnology inspections: government assessment of cytology laboratory practice under the regulations of the Clinical Laboratory Improvement Amendments of 1988.

Abstract

Since 1988, the American Society for Cytotechnology has performed inspections of 206 cytology laboratories in the United States under contract to the Health Care Financing Administration. These surveys are conducted by a team of supervisory-qualified cytotechnologists, including a specially trained survey team leader. A board-certified anatomic pathologist is assigned to each team and is on call for each survey. Laboratories are assessed for compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 and, in particular, the area of quality control in cytology. These surveys are unique in that a sample of at least 0.1% of a laboratory's annual case volume is reevaluated by the survey team. Of the 206 laboratories surveyed, 116 were found to be in substantial compliance with the regulations while 90 were found to have Condition level deficiencies. Of those with Condition level deficiencies, 8 have had their Clinical Laboratory Improvement Amendments of 1988 certificates limited for cytology, and 16 have been terminated from Medicare participation.