Laboratory use of the diagnosis "reactive/reparative" in gynecologic smears: impact of CLIA '88.

The Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) contain regulation 493.1257(c)(1), which states: "[A]ll gynecologic smears interpreted to be showing reactive or reparative changes are confirmed by a technical supervisor in cytology." We surveyed 500 cytology laboratories to assess the utilization of the diagnosis "reactive/reparative" (R/R) for gynecologic cytology examinations. One hundred and seventy participants (34%) returned an acceptable questionnaire that described their use of this terminology, the technical supervisor's (pathologist's) role in the evaluation of these cases, and the volume of cases with this diagnosis. Prior to CLIA '88, 86 (51%) laboratories did not forward to a pathologist gynecologic smears reported as showing R/R changes, and this decreased to 20 (12%) after implementation of CLIA '88. Thirty-six (21%) laboratories changed their criteria for reporting R/R changes after CLIA '88. No correlation was noted between the demographics of the laboratory (e.g., size, type of practice affiliation, accreditation) and familiarity with this regulation. Based on the case volumes provided in the survey results, the estimated cost to the nation of complying with this single regulation is between $4.5 million and $40 million. The interpretation of and financial impact of compliance with this one selected regulation of CLIA '88 is reported.