[106376]
To summarize the points: 1) the original sufficiency criteria published in the cytyc morphology manual do not work. 2) the co's attempt to redefine the lowest limits of "satisfactory" should not be defined by pictures from isolated cases but by a look at the empirical data. The true definition of unsatisfactory is the percent coverage at which recovery of lesions falls off. Rptr believes that the failure of the co to have had a credible defintion has created undefined risk in sampling. 3) following receipt of the pictures, dr at the co said that what the definition of sufficiency in the morphology manual meant was that the specimen was satisfactory if 40% of the fields had cells. When rptr asked him how many cells per field (1,000 or 500, etc), he said that he didn't know. Clearly, this number makes an enormous difference. Also, clearly the manual did not state this interpretation. 4) in the clinical trial, results from the reported use of a single filter and the reported use of the bethesda sys conflict with rptr's observation of results in clinical practice. One of those things must not be true. 5) because the original written criteria do not work, users, in practice, must be currently using widely different criteria. Other findings of concern in rptr's use of the thin preparation are: 1) some repeated thin preparations do not have reproducible findings. This finding has been stated by others. 2) use of misleading advertising in marketing the product. Specifically, cytyc researchers have quoted the study by dr in which it was established that much of the cell sample was not used in preparing conventional slides, and was recovered in the vial, the implication taken away by many physicians and women is that without the thin preparation, you would lose that sample. The truth of the matter is that the increased cell sample that goes into the vial gets thrown out. What is used in the diagnosis is a cell sample that is about 25% of that of a conventional smear. Rptr has heard this study quoted repeatedly, misleading the listener, both physician and pt into thinking that one is getting a much larger sample with the use of the thin preparation. It has really frightened some women to whom rptr has talked to. 3) it has been rptr's experience that facility is seeing a poorer definition between high grade sil and low grade sil. The number of cases in which facility makes the diagnoses "cin i cannot rule out cin ii" has increased, and rptr personally, attributes this to the lower cell count and dispersion of the dysplastic cells. Facility has also seen a rise in the category "atypical squamous metaplasia cannot rule out high grade sil". These groups need further definition, and, if it is a pattern seen by others, has an impact on colposcopy rates, and hence, med costs.
Patient Sequence No: 1, Text Type: D, B5