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.

Technology assessment in anatomic pathology. An illustration of test evaluation using fine-needle aspiration biopsy.

Although anatomic pathology diagnoses are the standard on which treatments often are based, many facets of anatomic pathology have not been rigorously examined. These areas include the evaluation of a procedure's technical and diagnostic characteristics, clinical utility, and cost. Technology assessment is the disciplined scientific and systematic evaluation of a test or procedure, and it can be used to evaluate these areas in anatomic pathology. To illustrate and promote the use of technology assessment in anatomic pathology, we show examples in fine-needle aspiration biopsy, which is a subspecialty of cytopathology. We discuss some of the more commonly encountered problems and misconceptions of test evaluation and also the need for further fine-needle aspiration biopsy evaluation. We conclude that technology assessment is a powerful but underutilized tool for test evaluation in fine-needle aspiration biopsy and in anatomic pathology.

Utility of Gomori methenamine silver stains in bronchoalveolar lavage specimens.

Bronchoalveolar lavage (BAL) with Gomori methenamine silver (GMS) stain is commonly used to detect Pneumocystis carinii and fungal organisms as causes of infectious pulmonic disease in immunosuppressed patients. However, several reports have indicated that GMS stains are not any more sensitive than conventional cytologic stains in detecting Pneumocystis organisms in select patient populations, such as those with acquired immunodeficiency syndrome (AIDS). To examine the utility of GMS stains in our laboratory, we retrospectively reviewed 243 BALs from 188 patients. Sensitivity of the GMS stain for Pneumocystis and for fungi detection was 100%. Sensitivity for Pneumocystis and for fungi detection by Papanicolaou stain alone was 79% and 88%, respectively; by Diff-Quik stain alone it was 68% and 88%, respectively; and by combined Papanicolaou and Diff-Quik stains it was 79% and 100%, respectively. In four additional cases, fungi were detected by other methods (culture, biopsy) and not by BAL. The GMS stain result was correlated with a number of risk variables to determine which variables were associated with GMS positivity. Using stepwise logistic regression, Pneumocystis positivity by GMS stain correlated (P < 0.0001) only with the variable of history of AIDS or AIDS risk factors. Fungal organism positivity by GMS stain correlated (P = 0.02) only with the variable of history of BAL positivity for fungus. Cost savings analyses were performed, estimating the cost of the GMS stain at $45 (total cost of GMS in 243 BALs was $10,935).(ABSTRACT TRUNCATED AT 250 WORDS)

Sampling of radical prostatectomy specimens. How much is adequate?

Prostate glands from 52 patients with clinical stage B carcinoma were examined using two sampling techniques. After fixation and conization of the apical portions, each gland was serially sectioned with sections mounted whole on oversized glass slides and examined for pathologic features of prognostic importance. A second examination was subsequently conducted on the same tissue using only alternate sections. No differences in tumor type, grade, Gleason score, multiplicity, or capsular penetration were detected in 75% of cases. The discrepancies that did occur were most often minor variations in multiplicity and Gleason score. Of the 20 glands with capsular penetration observed with the serial sectioning method, 17 (85%) were detected using alternate sectioning. The surgical margin was involved in two of the three invasive foci that would have been missed. Although the topography is better displayed, the authors' examinations indicated no significant advantage to whole mount sections compared with sections mounted on standard-sized glass slides. Considering the most effective use of resources, as well as the current modalities available for patient monitoring, the results support the use of an alternate sectioning method for pathologic examination of specimens removed for clinically localized prostate cancer.

The palpable breast nodule. A cost-effectiveness analysis of alternate diagnostic approaches.

BACKGROUND: Traditionally, open biopsy has been considered the optimal procedure for the diagnosis of breast nodules. Fine-needle aspiration biopsy (FNAB) has been proposed as an alternate method for the diagnosis of many palpable breast lesions. METHODS: The authors compared the diagnostic utility of open biopsy and FNAB using decision tree and cost-effectiveness analyses. RESULTS: When compared with two-step excisional biopsy, FNAB achieved a savings of over $700 at the cost of 0.1% decrease in 10-year overall survival. CONCLUSIONS: These data indicate FNAB to be a reasonable alternative to open biopsy for the diagnosis of palpable breast lesions in many patients.

Limited lists and the purchase of pharmaceutical products by government agencies in the RSA.

The use of a limited list to restrict the range and type of medication used by medical institutions that operate under the auspices of the provincial authorities has been mooted as one possible method of cost containment. This study discusses the implementation of such measures in other countries and then quantifies the cost savings that might be obtained in the South African case. The possible savings are somewhat offset by other costs such a measure would introduce.