August 2018—I would like to start fecal fat testing in my laboratory, using the Sudan black staining method. What is the best way to report fecal fat testing? Who developed the formula for the corrected white blood cell count for nucleated red blood cells, and how was the formula established?Read More »
July 2018—Is CD30 currently being used as a predictive marker for therapy? Due to laboratory construction, our molecular instruments were relocated within the lab. Is full test validation required in this case? Or is running at least 20 known samples enough to verify the instrument/assay performance specifications?Read More »
June 2018—What is the role of total testosterone and free testosterone in gauging the effectiveness of androgen deprivation therapy?
We are planning to validate the mismatch repair panel in our immunohistochemistry laboratory. Do we use the CAP guidelines for antibody validation for a nonpredictive marker or a predictive marker?
May 2018—Our immunohistochemistry laboratory is moving to a new building across the street. We are not getting new equipment, just moving the machines to the new building. Do we need to perform a full revalidation of all our antibodies?Read More »
April 2018—Q. A semen analysis for viability was collected at 9:30 AM and not received in the laboratory until 1:40 PM. Our standard operating procedure says this test must be analyzed one hour after collection, with no disclaimers stated for late receivables. Therefore, it is my understanding that a specimen received five hours after collection would be considered unacceptable because the viability of the semen is compromised and the collection delivery does not follow our SOP.Read More »
March 2018—Our pathology group has an unusual case of residual squamous cell carcinoma of the lung in a lobectomy specimen after chemotherapy. The lung shows a hilar scar (1.7 cm) involving the lung parenchyma and the peribronchial adipose tissue. In the scar there is residual carcinoma (0.4 cm) that focally is involving the peribronchiolar adipose tissue around the lobar bronchus. The focus is located at 0.3 cm of the final surgical resection margin of the bronchus. Because the tumor involves peribronchiolar adipose tissue, is it considered outside the lung (extension outside the lung)? Since the tumor is in the mediastinal fat around the bronchi and had to invade the viscera pleura to invade the peribronchial adipose tissue, would the tumor stage be ypT2a? Or T3 since it is invading part of the mediastinal fat? Or should it be pT1?Read More »
February 2018—I come from a core (hematology/chemistry) background, and I would like practical, how-to guidance in developing an effective QC strategy for HIV viral load testing. What performance characteristics do you verify? How many and what type of samples do you use? What are the chosen acceptable thresholds? Do you use L-J charts? If so, what do you plot, what control rules do you select, and how do you select them?Read More »
January 2018—We are in the process of validating the Stago STA Compact Max and Stago STA R Max with cap piercing. The company is stating that the open and closed modes follow the same testing pathway and therefore validation between modes is not necessary. Is this correct? Is PHI (phosphohexose isomerase), also known as GPI (glucose phosphate isomerase), mainly responsible for metastasis and circulating tumor cells?Read More »
December 2017—Is a tumor embolus in the capsule of the lymph nodes considered metastasis? Does the lung, like the lymph nodes of the breast, have the concept of isolated tumor cells? As the staging rule is “when in doubt, understage,” would the case therefore be pT2, N0?Read More »
November 2017—A laboratory owns chemistry analyzers from company X. Company X recommends that its customers use company X’s calibration material to perform their linearity studies, starting with the highest concentration and using the chemistry analyzer’s autodilution feature to provide a total of four measurable concentrations and a final zero point. Does this protocol fulfill CAP checklist requirements?Read More »