Validation

Lot to Lot Validation

From Maureen (Mo) Tacke, St Luke’s Health System: Hi George, our institution is coming to the joyous time of lot roll over in coagulation, and it’s got me wondering… Is our process a little (or a lot) overkill? Current process: Normal ref range studies (20 normals) for PT, PTT, FIB, AT, TT, PC, PS, DRVVT, […]

Validation: Multiple Lots

George received this question for our quality assurance experts. When validating a procedure, do you work with a single lot or multiple lots?

Multi-site Reference Intervals Revisited

Please return to our September 17, 2017 multi-site reference intervals discussion, and in particular to Heather DeVries’s comment and question about a combined INR and reportable range. So many of us are grappling with multi-site services, George hopes our participants can provide some advice on this topic. Thank you.

CoaguCheck Test Strip Recall

Thanks to Ali Sadeghi-Khomami PhD, Precision BioLogic, and Joan Polancic, MS MLS, Denver Health, for the heads-up on this announcemment: Roche Diagnostics, the manufacturer of CoaguChek meters and test strips, is recalling the CoaguChek XS PT Test Strips due to inaccurate INR test results, when compared to laboratory results. Roche re-calibrated the CoaguChek XS PT […]

Anticoagulant Therapy

Reference Intervals

I recently became reacquainted with colleague Madeline Ducate, PhD, who supports pharmaceutical houses with the laboratory needs for international clinical trials. Madeline is occasionally confronted with a lack of laboratory reference intervals in under-resourced countries, where cultural norms or the lack of funding limit specimen collection and processing from healthy subjects. In vitro diagnostics companies […]

Bleeding Disorders

Coag Test Utilization

While visiting the University of Texas Medical Branch campus in Galveston, George had the opportunity to become acquainted with Mayukh Sarkar, PhD, Medical Laboratory Scientist in the Division of Hematopathology, Laboratory Services. Dr. Sarkar recently published Sarkar MK, Botz CM, Laposata M. An assessment of overutilization and underutilization of laboratory tests by expert physicians in […]

Specimen Management

Minimally Prolonged PT

George visited the University of Texas Medical Branch in Galveston on Thursday, August 9 to discuss the American Society for Clinical Laboratory Science partnership with the American Board of Internal Medicine Choosing Wisely initiative. A great day with Eddie Salazar, PhD and the Clinical Laboratory Science faculty. Our afternoon included a coagulation diagnostic management team […]

January, 2018 Quick Question: RIs

Here are the results of our January, 2018 Quick Question, How do you establish a coag factor reference interval? A. Use a published RI from an article or textbook: 3 votes, 7% B. Validate manufacturer’s RI using ~ 20 locally collected aliquots: 16 votes, 39% C. Validate manufacturer’s RI using ~30 locally collected aliquots: 11 […]

Quick Question Archive

Yet More on Reference Intervals

This is a follow-up comment from Bob Gosselin on Griselle Font-Bonet’s December 31 post about reference intervals. The original post drew many thoughtful and provocative comments from Dave McGlasson, and Drs. Ali Sadeghi-Khomami and Emmanuel Favaloro; consequently, it became so long that an add-on comment would make it unwieldly. Bob says these “last thoughts”… Lest […]

Bleeding Disorders

Reference Intervals

From Griselle Font-Bonet: We are having problems establishing the reference ranges for the intrinsic coagulation factors VIII, IX, and X. We are using normal plasmas from volunteers, but we are getting results above the upper limit of the manufacturer range (60-150%). Calibration and QC values are good. Does anyone have a recommendation?From George: Hello, and […]

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George Fritsma is a medical laboratory scientist, educator, and author. George holds faculty appointments with Rutgers University and Michigan State University, and is a member of the International Society on Thrombosis and Hemostasis, American Association of Clinical Chemists, and American Society for Clinical Laboratory Science.

Cheat Sheets from George

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