August 2011
Cytopathology And More

Roger B. Lane, MD

The Centers for Medicare and Medicaid Services has withdrawn its notice of proposed rulemaking (NPRM) for cytology proficiency testing, according to an April 8 letter sent from the CMS to state survey agency directors. In effect, this indefinitely delays major changes to federally mandated cytology proficiency testing for the foreseeable future.

The CMS issued the NPRM in 2009 and asked for public comment and input about the proposed changes, which included recommendations made by the federal Clinical Laboratory Improvement Advisory Committee. The proposed changes included increasing the test from 10 to 20 challenges and reducing the frequency of testing to less than once a year.

The CAP in 2009 submitted a detailed response to the NPRM, in which it said the current program fails to measure competency, is not supported by science, and does not support improved health outcomes. The College proposed replacing the current flawed program with an educational program that would promote learning and keep skills on the cutting edge of medicine. Laboratory directors would oversee the program and accrediting organizations would review it, the CAP said.

The CAP-submitted response to the NPRM was one of 690 submissions to the CMS containing 6,503 individual comments. The “greater percentage” of comments requested replacement of the cytology PT program with a continuing education program, the CMS said. However, the CMS maintains that continuing education programs do not meet the statutory requirements of the Clinical Laboratory Improvement Amendments of 1988. Therefore, the CMS is continuing the current cytology PT requirements with minor changes, as follows:

• Encouraging laboratories to participate in educational lab programs in addition to individual PT.
• Changing the term “slides” to “challenges.”
• Defining a challenge as case equivalent.
• Retaining four response categories and continuing to require at least one challenge from each of the four categories in each test.
• Requiring field validation, monitoring challenges continually, and removing challenges that fail field validation.
• Requiring the vendor to disclose field validation procedures.
• Providing educational feedback for result discrepancies.
• Continuing to allow PT providers to determine proctor requirements.
• Requiring PT providers to disclose their appeals process in writing.
• Changing the language to say “individuals who score <90” instead of using the word “fail.”

In response to the withdrawal notice, the CAP issued a press release expressing concern that the CMS has not updated the PT program to keep pace with current science and technology since it was issued initially in 1992 to implement CLIA ’88. The College maintains that the current program is fatally flawed and that the proposed changes do not go far enough to correct the flaws.