B. Background and History
B1. What is “CLIA”?
“CLIA” is the acronym used to refer to the Clinical Laboratory Improvement Amendments of 1988, Public Law 100-578. CLIA regulates facilities that perform tests for health purposes on human specimens. In an effort to establish quality standards for all such laboratories and to ensure the accuracy and reliability of patient test results, the Congress decided that virtually all laboratories would be subject to CLIA. Under that authority laboratories must apply for and maintain an appropriate CLIA certificate in order to operate. Certificates are issued upon submission of an acceptable application and payment of the applicable certificate fee.
B2. Does CLIA require proficiency testing for individuals who screen Pap smears?
Yes. Congress explicitly provided for the “. . . periodic confirmation and evaluation of the proficiency of individuals involved in screening or interpreting cytological preparations, including announced and unannounced on-site proficiency testing of such individuals, with such testing to take place, to the extent practicable, under normal working conditions,”
Under this authority, CMS set forth final regulations on, among other things, cytology proficiency testing in the February 28, 1992 Federal Register. Following acomment period, these regulations became effective on September 1, 1992. These cytology proficiency testing requirements remain in effect and the affected individuals include cytotechnologists and pathologists.
B3. Why was the Clinical Laboratory improvement Act of 1967 (CLIA’67) revised – especially in regards to cytology?
The impetus behind the promulgation of CLIA was Congress’ realization that there were significant problems in, among other things, enforcing compliance with CLIA’67 standards, ineffective proficiency testing, inadequate oversight for cytology testing, and the proliferation of unregulated laboratories.
CLIA’67 did not regulate all laboratories performing testing on gynecologic specimens. It did not provide for a limit on the number of Pap smears that could be examined by an individual in a 24-hour period. Consequently, a number of “Pap Mills” appeared that produced Pap smear results that were erroneous and life threatening. (There is a direct relationship between a cytology test finding and the diagnosis of a specific clinical disease. Gynecologic cytology specimens are frequently the first indication of cervical cancer.) Congress promulgated CLIA to resolve these and other concerns.
The CMS has been delegated the responsibility for administering the CLIA program. Currently, there are 3,500 laboratories certified in the subspecialty area of cytology, which includes gynecologic and non-gynecologic cytology testing. Only those laboratories that conduct gynecologic testing are presently subject to cytology PT and they number approximately 2400.
B4. Are these cytology proficiency testing regulations new?
No. CLIA included statutory requirements for cytology proficiency testing when it was signed into law by President Reagan on October 31, 1988. The regulations implementing these statutory requirements were published in the Federal Register on February 28, 1992 and became effective on September 1, 1992. They are still in effect.
B5. Will the current cytology PT regulations ever be changed?
CMS and CDC, based on concerns expressed by the cytology laboratory community, are convening the Secretary of HHS’ technical advisory committee, Clinical Laboratory Improvement Advisory Committee (CLIAC) work group, to consider changes to the regulations. The work group will be comprised of pathologists, cytotechnologists and government agency representatives who are subject matter experts and who will provide their expertise, data and experiential information to CMS and CDC. Based on this input, the subsequent recommendations of CLIAC to HHS and the data from the initial year of cytology PT, CDC and CMS will develop a Notice of Proposed Rulemaking (NPRM) to revise the cytology PT regulations.