B y the time this editorial is published, proficiency testing (PT) for those professionals involved in the screening and/or interpretation of gynecologic smears will be underway. Late in 2004, The Midwest Institute for Medical Education (MIME) obtained approval from the Centers for Medicare and Medicaid Services (CMS) to conduct the testing. This dormant provision of the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) suddenly became a reality. In December 2004, CMS posted compliance dates on their website; laboratories must ensure the enrollment of individuals performing gynecologic cytology testing by June 2005 and all such individuals must be tested at least once by April 2006 by the CMS-approved testing group. Finally, by December 31, 2006, all professionals involved in the screening and/or interpretation of gynecologic smears must pass this test. 1 The state of Maryland remains the lone exception because this state has had an approved program for gynecologic cytology PT for a number of years. To say all of the above came as a great shock to the cytopathology community would be quite an understatement. How did we get to this point and what may be the implications' The history goes back nearly 40 years.
The year 1966 saw the enactment of The Public Health Service Amendments that created the Comprehensive Health Planning Program of the Federal government, and Medicare also was introduced that year. This comprehensive legislation authorized the first regulatory activity of health services by the Federal government, with a focus on independent laboratories and personnel standards. Revisions to the Medicare regulations in 1968 required independent laboratories to participate in performance evaluation and PT to qualify those personnel who did not meet the Medicare standards. The Centers for Disease Control (CDC) assisted the Division of Medicare Administration in providing guidelines for internal quality control, PT, and on-site inspections. Cytology was exempt from PT because a doctoral degree was required for the position of director or technical supervisor of the laboratory. To confound the issue, the Clinical Laboratory Improvement Act of 1967 (CLIA 67) was created by the Partnership for Health Amendments of 1967 and focused on interstate laboratories (i.e., those accepting 100 or more specimens in interstate commerce in any specialty during any calendar year). Laboratories