Quality assurance in North America

Abstract

Quality insurance (QA) in North America traditionally has been aimed at insuring accuracy and precision of the analytical process in clinical laboratory determinations, Almost all hospital laboratories in the United States and Canada subscribed to programs sponsored by the College of American Pathologists (COP) assessing analytical accuracy and precision, A recent change in these programs includes establishment of CRP programs for physician office laboratories. Proposed regulatory changes for 1990 will require laboratories to demonstrate adequate performance In proficiency testing (PT) programs. Laboratories falling PT will be required to participate in enhanced PT. In 1987 a major change occurred when the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) redefined QA in terms of patient outcomes, thereby establishing activities involving the analytical process as quality control (QC). During on-site inspections, JCAHO representatives require demonstration studies relating laboratory quality and patient care, institutions without these studies have had accreditation withheld. New programs have been established evaluating pathologists’ performance, and assessing the preanalytical and post-analytical aspects of laboratory testing, and linking these with patient outcomes. One of these programs of the CAP, Q-Probes, has over 800 participating institutions for its first subscription year in 1989. Data will be presented from Q Probe Pilot study in 36 hospitals, and subscription program studies already complete.