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  • 1.  Regulation interpretation

    Posted 04-02-2024 08:06

    HI professionals,

    The place I am working is rewriting procedure instructions from the manufacturer.  If I remember correctly, this is not allowed without going through a validation.  Does anyone know of a CLIA or COLA regulation on this whether regarding performing testing according to manufacturer instructions or the process of changing a procedure?  My concern is that the supervisor is an MLT without the understanding of the test development processes.  

    Alice Macqueen Perry Technician (MLT, Histologic, Phlebotomy)
    Raleigh NC

  • 2.  RE: Regulation interpretation
    Best Answer

    Posted 04-02-2024 10:12

    Hi Alice, 

    For FDA-approved or FDA-cleared assays the instructions for use provided from the manufacturer should not be modified. If the laboratory (and medical director) want to modify a testing procedure, it now becomes a high-complexity test and requires and analytic validation.

    The CAP All Common checklist outlines pretty specifically what is required when modifying a test procedure. Just one example of a checklist item is below.

    COM.40250: The laboratory follows manufacturer's instructions for all test systems or provides validation records if the test has been modified. NOTE: Following manufacturer's instructions includes performing quality control, calibration,
    calibration verification, and related functions as applicable to the scope of testing. Reagents,
    fluids, and disposable materials supplied by the laboratory must meet the specifications in the
    If the laboratory modifies manufacturer's instructions, the test is no longer FDA-cleared/approved,
    and the modification(s) must be validated by the laboratory. This requirement also applies to
    laboratories not subject to US regulations for tests approved by an internationally recognized
    regulatory authority that are modified by the laboratory.
    Changes in the specimen type or collection device are examples of common modifications (see
    "modification of manufacturer's instructions" in the Definition of Terms). Additional requirements
    for validation/verification may be found in the discipline-specific checklists.
    For waived and moderately complex tests, if manufacturer instructions are modified,
    requirements for high complexity testing apply.
    Evidence of Compliance:
    ✓ Validation records of established performance specifications (accuracy, precision, analytical
    sensitivity, analytical specificity, interferences, reference interval(s), and reportable range) of any test that has been modified. 

    Laura Severs Administrative Laboratory Director
    Saint Louis MO

  • 3.  RE: Regulation interpretation

    Posted 04-03-2024 13:04
    Edited by Jonathan Perry 04-03-2024 13:05

    As long as the instructions for use are not being modified, you should be good. You can include additional items in your SOP if you wish such as where to send broken meters and certain processes unique to your facility. But modifying how the device is used or testing is done would kick it to non-waived/high complexity so that piece needs to remain intact. Best thing is to use what the manufacturer provides and tweak the format around what they have provided to standardize to your document format and processes. 

    Jonathan Perry, MLS(ASCP)
    ASCP West Virginia Chapter

  • 4.  RE: Regulation interpretation

    Posted 04-03-2024 09:30

    Good morning

    To write a procedure, instructions from manufacturer is important. Minimum and maximum detectable values, stability of sample, flags are to be considered from manufacturer instructions.

    It is equally important to establish normal range, correlation studies on new instrument. Procedure is better with combination of manufactures rules and individual laboratory criteria.