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Photo of the publication cover. Clinical Laboratory Improvement Act Historical Information Program Operations - General May 18, 2015

The Clinical Laboratory Improvement Act began in the late 1960's when problems arose in the cytology laboratories that read PAP smears. The personnel in these laboratories were overworked and had a very high error rate. In 1967, the Clinical Laboratory Improvement Amendment was passed and the first laboratory regulations were born. These regulations primarily covered independent and hospital laboratories.