Here’s an additional note confirming Denise Solieau’s February 12 discussion of PT validation and analytical measurable ranges (AMRs). Page 83 of the July 31, 2012 CAP survey references the value of AMRs in coagulation testing and includes this statement, “The new checklist requirements (meaning AMR) apply to hemostasis test methods that are calibrated and directly measure the concentration or activity of an analyte by employing enzyme immunoassay (EIA) immunoturbidity, and chromogenic methods. Clot-based methods, euglobulin lysis time, qualitative clot stability, and all platelet function assays, including ristocetin cofactor activity are exempt.”
From Purvi Jariwala, Texas Children’s Hospital:
Hi George, There is a new CAP checklist requirement published 7/31/2012. Heme.38009 AMR validation: “Validation of the analytical measurement range (AMR) is performed with matrix-appropriate materials, which include the low, mid and high range of the AMR.” I wanted to post this on your site to see how other laboratories will be addressing this requirement.
Hello, Dr. Jariwala, and thank you for your post. Let’s await comments from our correspondents.
Thanks to those who attended our American Society of Clinical Pathology Laboratory Statistics and Quality Control workshop on Friday, October 5 in Minneapolis, MN. I hope we met your needs. As promised, I’ve attached 6-per-page PDFs of my first and last lectures, Pre-analytical and Post-analytical Variables. These are the lectures that contained updated slides not provided in your original handout. Also, for those who would like to have access to our 32 audio PowerPoints, please select this link. Modules 3-6, Method Validation and Clinical Efficacy are similar to the materials we discussed during the workshop. All the audio PowerPoints are approximately 30″ long and lead to CEU credit through CACMLE. Again, thanks for participating. Geo
Preanalytical Variables
Postanalytical Variables
Hi George, Thanks for all the great information on the website. I have a question regarding the use of Six Sigma in the coagulation laboratory. Do you know of, or are there any laboratories that are using Six Sigma to monitor the quality of testing in coagulation? We know these concepts may be used in the chemistry lab as explained by Dr. Westgard during the Mayo meeting, although I don’t know of any coagulation lab using the same concepts. Thanks for any feedback, Claudia E. Escobar, MT (ASCP) SH, Diagnostica Stago, Inc., Area Manager – Latin America.
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George has had several conversations with frequent contributor and international expert Dave McGlasson (Wilford Hall USAF Medical Center, San Antonio) about normalizing the DRVVT ratio on the laboratory’s DRVVT mean of the reference interval in accordance with Zhang L, et al: A simplified algorithm for the laboratory detection of lupus anticoagulants. Am J Clin Pathol 2005;124:894–901. The author states, “The normalized ratio is recommended to correct for differences in instrument-reagent combinations and to improve discrimination between normal and low-positive LA samples. The formula for normalization is attached in this link: DRVVT Normalization Ratio.
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From Rrosales:
I am interested in purchasing a platelet aggregometer for our hematology lab, but we don’t have an existing instrument to compare it with. Some suggested H58 NCCLS (CLSI, does not really help) but I am used to validating an instrument with an old instrument (comparison/parallel testing). Can you tell me how to start the validation without an instrument to compare it with and does CAP allows this method?
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Dear George, I am using an STA Compact from Diagnostica Stago. I would like you to throw some light on validating the reportable range of the fibrinogen assay which is 60–1200 mg/dl. How can I obtain plasma with such high levels of fibrinogen? Regards, Dr. Shabnam Roohi.
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Here is a summary of our April, 2012 Quick Question:
The US FDA is planning guidelines for regulating laboratory-developed tests (LDTs). What plans have you made in response?
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Anticoagulant Therapy, Screening Assays, Validation | George Fritsma | 
February 13, 2013 11:52 am | 
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