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  • 1.  FDA LDT Proposed Rule

    Posted 11-16-2023 11:02
    Edited by Jennifer Pence 11-17-2023 16:28

    Is your lab or community having discussions on this topic? Does your lab or community have a Call-to-Action campaign to comment on the FDA LDT Proposed rule before the Dec. 4th deadline? 



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    Jennifer Pence, BS HTL(ASCP)Team Lead - FISH/PCR

    CompuNet Clinical Laboratories

    Work location:  Miami Valley Hospital

    (p) 937-208-3891 | (f) 937-208-4280

    jmpence@compunetlab.com | www.compunetlab.com


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  • 2.  RE: FDA LDT Proposed Rule

    ASCP Ambassador
    Posted 11-17-2023 15:08

    We haven't started anything, but I'm going to put a request out to our providers who order "modified" tests that would fall in this category. My hope is that they will send letters to their professional societies as well.



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    Christina Nickel, MHA, MLS(ASCP)cm, CPHQ
    Laboratory Director
    Bryan Medical Center, Lincoln NE
    christina.nickel@bryanhealth.org
    402-481-5018
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    Original Message


  • 3.  RE: FDA LDT Proposed Rule

    Posted 11-17-2023 16:16
      |   view attached

    Dear Jennifer,

     

    Good afternoon – hope you are doing well.  Thank you for your e-mail; however, after a 50 year career in Clinical Pathology/Laboratory Medicine, I am currently fully retired and no longer review the literature and/or publish articles on Laboratory Developed Tests (LDTs) or other topics.

     

    A close-up of a card Description automatically generated with low confidence

     

     




    Attachment(s)

    pdf
    CV_Oct_2023.pdf   2.69 MB 1 version
    Original Message


  • 4.  RE: FDA LDT Proposed Rule

    ASCP Ambassador
    Posted 11-18-2023 16:39

    Hi Jennifer,

    I spend a lot of time thinking about the FDA LDT oversight proposed rule and discussing it with my colleagues. My primary role is developing laboratory tests (LDTs) and this would greatly impact the day-to-day of my job. I do not have insight to share on my employer's stance on the proposed rule or what they plan to do for commenting, but I have personally spent quite a bit of time considering exactly how and what to include in a comment in response the FDA. I think what is important to highlight in responses to the FDA is the impact the proposed rule would have on the timely access to LDTs used to inform patient care. What would be helpful is real-world examples for the FDA to consider describing exactly how this would impact patient care. When Call-to-Action campaigns are issued, I believe it is important to avoid a copy-and-paste comments to the FDA that become white noise. Instead, I think Calls-to-Action should encourage people to submit individualized comments that highlight their specific concerns. 



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    Michelle R. Campbell
    MS, MLS, MB, SC
    Senior Developer
    Mayo Clinic
    Rochester, MN
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    Original Message


  • 5.  RE: FDA LDT Proposed Rule

    ASCP Ambassador
    Posted 11-19-2023 09:00

    Michelle and all,

    Thank you for this "example" of how the #medicallaboratory, #pathology, #patients, and #healthcare should be thinking about for the FDA LDT comments. Like most, I think we all get busy and sometimes the "copy and paste" example is what is sent in. While that is better than no action, I would encourage each of us to start thinking about our comment / letters and put them on paper now. Prior to my life in academia, I worked in public health and LDTs were used for all sorts of testing that was important to not only individuals but to the community health.

    Have a wonderful week and Blessed Thanksgiving everyone!
    Doc R



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    Rodney E. Rohde, PhD, MS, SM(ASCP)CM,SVCM,MBCM, FACSc
    Regents' Professor, Texas State University System
    University Distinguished Chair & Professor, Medical Laboratory Science [MLS] Program
    TEDx Speaker & Global Fellow – Global Citizenship Alliance
    Texas State Honorary Professor of International Studies
    Associate Director, Translational Health Research Initiative @txst_THR
    Past President, Texas Association for CLS

    Texas State University
    MLS Program, Encino Hall 350B [office ENC 363]
    601 University Drive
    San Marcos, TX 78666-4616
    512-245-3500 [CLS suite]; 512-245-2562 [office]
    Email: rrohde@txstate.edu
    Pronouns: he/him/his
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    Original Message


  • 6.  RE: FDA LDT Proposed Rule

    Posted 11-19-2023 08:54

    For reference, I wanted to post a slide deck regarding the proposal as well as the proposal itself. My thoughts are that it's taking an overly broad approach to something that needs more specific focus and ultimately inhibits the ability of labs to keep up with the increasing research data to provide options for improving patient care.

    FDA LDT Slide Deck

    FDA LDT Proposal



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    Jonathan Perry, MLS(ASCP)
    President-Elect
    ASCP West Virginia Chapter
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    Original Message


  • 7.  RE: FDA LDT Proposed Rule

    ASCP Ambassador
    Posted 11-20-2023 07:38
    Edited by Kristen Pesavento 11-20-2023 07:39

    I agree, Jonathan and Rodney.

    I my letter I included how it was an LDT that identified the first case of Novel 2009 H1N1 Influenza in Chicago, how it allowed us to develop and validate an assay to detect SARS CoV2 in early 2020 (well before shut downs) based off WHO genetic data, and allows laboratories to provide equitable and agile healthcare.  

    I think the more personal examples including how our perspective has been shaped and informed on the topic of LDTs is important.  Look at the points FDA wants to assess and one by one address how they impact laboratories, patients, and overall public health.



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    Kristen Pesavento, EdD, MA, MLS(ASCP)cmMBcm

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    Original Message