Division of Industry and Consumer Education
CDRH-Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
What are their safeguards? What training IS required for whoever is reporting the CBC results? Critical values calling? Sending to a licensed lab with non-CLIA waived trained techs to do a manual differential (if and WHEN)? This is what I do, and do well. I have 25 years experience and ASCP certification both as a MT and SH, and I CANNOT work in a NYC lab doing any lab work (without a NYS license). And I know what I am doing. So, how come a high school graduate with no training can read my CBC in a doctors office (anywhere in the country, including NYC?). I am all about accuracy. I was taught that the work and results I release should be good enough (as if they were) for my mother or someone I love dearly. This cannot be the case when there are only partial results. I say, if you want the "top", just the CBC without the diff, maybe it is okay to make it a CLIA waived test, but not a CBCD.Somethings are worth waiting for, and accurate and complete results, reported by trained techs and QC'ed and problem solved and reviewed and assessed results prior to release are worth waiting for. Also, if they are run by untrained personell and the test is not a full test, with reflex manual diff as needed and slide review for RBCM as needed, they should get a discount fee and a half-test. It would be better to not allow this partial test. with a 3-part diff, and no manual diff, and no trained tech. The FDA is wrong to go against the procedure manual of every lab everywhere for a CBCD procedure. I say we APPEAL as a profession. Where is ASCP and ASCLS leadership on this?