The ICCS Advocacy Committee has been following many important issues that likely will affect the membership. At the top of the list remain cuts/changes in reimbursement for flow cytometry services in the CLFS as well as regulatory changes regarding laboratory developed tests (LDTs) enacted by the State of New York and proposed by the FDA. 

In November, 2016, the FDA informed the laboratory community that it was delaying the issuance of its final guidance on the regulation of laboratory developed tests (LDTs).  The agency appears to be watching the legislative actions/progress on this topic which has involved the E and C Committee of the House and the HELP Committee of the Senate. It remains unknown what position or impact the next Administration will have on this topic.  The importance of this issue relates to the classification of some flow cytometry services as low, moderate or high risk LDTs, since the validation/regulatory requirements will be quite different.

The New York Department of Health Wadsworth Center’s Clinical Laboratory Evaluation Program adopted a three-tiered risk based model for the review and approval of LDTs which began on November 14, 2016. There is more information on this topic on their website.

The Advocacy Committee membership continues to work with various stakeholders regarding current and future cuts to reimbursement for flow cytometry services in the CLFS. While new cuts in reimbursement started in 2016, this committee and others continue to work to try and mitigate the ongoing cuts to reimbursement for flow cytometry services. 

Finally, there is significant effort going into writing forthcoming papers/guidances on suggested flow cytometry validation procedures/protocols that the membership will find helpful. More information will be available early next year.

The Advocacy Committee welcomes input from the ICCS membership, including the suggestion of topics the membership thinks the committee should focus or address. In addition, if membership or ad hoc participation on the Advocacy Committee is of interest to you, please contact [email protected].

The most recent issue of the ICCS newsletter contains reports from the 2016 annual meeting plenary sessions.  If you could attend the meeting these articles will serve as a nice summary, and if you couldn’t, they’ll give you a flavor of the cytometry topics that are of current interest.  However, ICCS education is more than the annual meeting and course.

So for example, if you’re interested in learning more about B lymphoblastic leukemia (B-LL), you could Login on the website to the members section, and navigate to Member Services to view the video on B-cell maturation.  This video will give you a good idea of how to distinguish hematogones and B-LL. Then, if you’re thinking of introducing an assay for minimal residual disease, you could purchase a copy of the luncheon workshop given by Brent Wood from the member’s home page on the COG assay for B-LL.  You might also be interested in the “Cytometry Q&A” section on the main webpage (next to the Login) for the answer to the questions “How does one set up a validation study for lower limit of enumeration”.   

Many institutions are introducing novel therapies for B-LL, so you might also be interested learning about chimeric antigen receptor (CAR) therapy.  Several newsletter articles address this topic, and can be found by opening an issue of the newsletter from the Member Services page and performing a search for “CAR” using the “Search Newsletter” function at the top right of the page. This search will bring up the article by Trey Lee in Vol V, No. 4, Winter 2014 describing the clinical utility of this therapeutic strategy, the PowerPoint presentation in Vol VII, No2, Spring 2016 describing 3 ways of findings B lymphoblasts following anti-CD19 therapy, and the most recent issue of the newsletter Vol VII, No. 4, Fall 2016 describing the recent annual meeting plenary session on the effects of treatment on diagnosis and post therapy monitoring.  Not only does this meeting report discuss CAR-T therapy for B-LL, but also the impact of monoclonal antibody therapy on myeloma detection, and immunophenotypic changes that you might encounter following Ibrutinib/Idelalisib therapy for chronic lymphocytic leukemia.  

In future Education Committee updates, we’ll keep you posted about new educational offerings, and highlight some of the most popular existing content. 

The ICCS Quality and Standards committee has posted its first module “Lysing Methods and Reagents for Flow cytometric Immunophenotyping”. Pending modules include “Identifying appropriate reagents to assess CD5 expression”, “Instrument Optimization for BC and BD platforms”, “Reporting of CD5+ Neoplasms” and “Development of performance criteria for antibodies and guide for titration”. We have welcomed two new members to the Q&S committee, Dr. Wolfgang Kern from MLL, Germany joining the reporting group and Dr. Silvia Bunting from Children’s Healthcare of Atlanta joining the reagents group.  

The Q&S committee is comprised of 4 groups (instrument optimization, reagents and panels, specimen preparation and reporting) which will address the most common areas of variability in flow cytometry. The information will be presented in peer-reviewed “modules” with the goal to provide the laboratory staff with a practical reference guide in optimizing their procedures. 

We are pleased to announce that Module #1 is now available! Please click here to view it.