General
Live Blood Cell Analysis Under the Clinical Laboratory Improvement Act
Program Operations - General
September 23, 2015
Live Blood Cell Analysis is a test which is used for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of human beings. The Health Care Financing Administration (now the Centers for Medicare & Medicaid Services) Office of General Counsel determined in August, 1997, that Live Blood Cell Analysis was subject to all Clinical Laboratory Improvement Act requirements.
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.