[Histonet] High complexity test

Wed Feb 6 16:47:22 CST 2013

The CLIA definition of High Complexity testing is not absolute, rather High Complexity Testing is determined by a scored algorithm of the entire "Test System" (preanalytical through Post Analytical).

As such, it clearly takes into account the laboratory or other personnel performing all the specimen collection, grossing, processing, cutting in the pre-analytical phase, and the "Testing Personnel" (CLIA Definition) performing the analytical phase (preparing slides, reagents, applying reagents, quality control, etc) and post analytical phase(interpretation) .

The Pathologist's role is only part of that and is scored accordingly. CLIA clearly considers the IHC Test System as High Complexity and requires a technologist for the IHC portion with at least and Associates degree (or equivalent, including course and experience in appropriate science and testing) for Testing Personnel.

So, I don't think it is correct to dismiss any personnel standards as irrelevant simply because a pathologist will do the interpretation.

Note that if ANY High Complexity tests are performed in the lab then the lab must have a CLIA certification for High Complexity Testing.

References: 

CLIA website with the personnel regulations:  http://wwwn.cdc.gov/clia/regs/subpart_m.aspx

CAP Q&A about personnel standards for IHC, ISH and IF  http://www.cap.org/apps/docs/education/lapaudio/pdf/031710_qa.pdf

Relevant IHC question reproduced below:
Q 17. My question refers more specifically to 
immunofluorescence, in situ 
hybridization and 
immunohistochemistry. Are the techs 
that perform these tests considered 
high complexity testing personnel?  If 
the techs are reporting any kind of 
preliminary result, they must be 
qualified to do high complexity testing.  
If all they are doing is applying the 
stain, then that is considered 
processing.
A: Personnel performing immunofluorescence, 
immunohistochemistry and in-situ hybridization 
techniques require qualifications applicable to high 
complexity testing. Personnel performing histology 
processing using routine standardized staining 
procedures (not classified as molecular) do not fall 
under CLIA as testing personnel and do not have 
qualification requirements define

CLIA website detailing test categorization: http://wwwn.cdc.gov/clia/regs/subpart_a.aspx#493.17

Excerpt here about High vs Moderate complexity (low complexity are basically home use tests)

    Sec. 493.17  Test categorization.

    (a) Categorization by criteria. Notices will be published in the
      Federal Register which list each specific test system, assay, and
      examination categorized by complexity. Using the seven criteria
      specified in this paragraph for categorizing tests of moderate or high
      complexity, each specific laboratory test system, assay, and examination
      will be graded for level of complexity by assigning scores of 1, 2, or 3
      within each criteria. The score of "1" indicates the lowest level of
      complexity, and the score of "3" indicates the highest level. These
      scores will be totaled. Test systems, assays or examinations receiving
      scores of 12 or less will be categorized as moderate complexity, while
      those receiving scores above 12 will be categorized as high complexity.

    Note: A score of "2" will be assigned to a criteria heading when
      the characteristics for a particular test are intermediate between the
      descriptions listed for scores of "1" and "3."

    (1) Knowledge.
    (i) Score 1. (A) Minimal scientific and technical knowledge is
      required to perform the test; and
    (B) Knowledge required to perform the test may be obtained through
      on-the-job instruction.
    (ii) Score 3. Specialized scientific and technical knowledge is
      essential to perform preanalytic, analytic or postanalytic phases of the
      testing.
    (2) Training and experience.
    (i) Score 1. (A) Minimal training is required for preanalytic,
      analytic and postanalytic phases of the testing process; and
    (B) Limited experience is required to perform the test.
    (ii) Score 3. (A) Specialized training is essential to perform the
      preanalytic, analytic or postanalytic testing process; or
    (B) Substantial experience may be necessary for analytic test
      performance.
    (3) Reagents and materials preparation.
    (i) Score 1. (A) Reagents and materials are generally stable and
      reliable; and
    (B) Reagents and materials are prepackaged, or premeasured, or
      Require no special handling, precautions or storage conditions.
    (ii) Score 3. (A) Reagents and materials may be labile and may
      require special handling to assure reliability; or
    (B) Reagents and materials preparation may include manual steps such
      as gravimetric or volumetric measurements.
    (4) Characteristics of operational steps. (i) Score 1. Operational
      steps are either automatically executed (such as pipetting, temperature
      monitoring, or timing of steps), or are easily controlled.
    (ii) Score 3. Operational steps in the testing process require close
      monitoring or control, and may require special specimen preparation,
      precise temperature control or timing of procedural steps, accurate
      pipetting, or extensive calculations.
    (5) Calibration, quality control, and proficiency testing materials.
    (i) Score 1. (A) Calibration materials are stable and readily
      available;
    (B) Quality control materials are stable and readily available; and
    (C) External proficiency testing materials, when available, are
      stable.
    (ii) Score 3. (A) Calibration materials, if available, may be
      labile;
    (B) Quality control materials may be labile, or not available; or
    (C) External proficiency testing materials, if available, may be
      labile.
    (6) Test system troubleshooting and equipment maintenance.
    (i) Score 1. (A) Test system troubleshooting is automatic or self-
      correcting, or clearly described or requires minimal judgment; and
    (B) Equipment maintenance is provided by the manufacturer, is seldom
      needed, or can easily be performed.
    (ii) Score 3. (A) Troubleshooting is not automatic and requires
      decision-making and direct intervention to resolve most problems; or
    (B) Maintenance requires special knowledge, skills, and abilities.
    (7) Interpretation and judgment. (i) Score 1. (A) Minimal
      interpretation and judgment are required to perform preanalytic,
      analytic and postanalytic processes; and
    (B) Resolution of problems requires limited independent
      interpretation and judgment; and
    (ii) Score 3. (A) Extensive independent interpretation and judgment
      are required to perform the preanalytic, analytic or postanalytic
      processes; and
    (B) Resolution of problems requires extensive interpretation and
      judgment.

Tim Morken
Supervisor, Electron Microscopy/Neuromuscular Special Studies
Department of Pathology
UC San Francisco Medical Center

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Mark Tarango
Sent: Wednesday, February 06, 2013 2:07 PM
To: Jesus Ellin
Cc: histonet <@t> lists.utsouthwestern.edu
Subject: Re: [Histonet] High complexity test

Just to clarify, this is not my interpretation.  This is what CAP will tell you when you give them a call.

Mark

On Wed, Feb 6, 2013 at 1:07 PM, Jesus Ellin <JEllin <@t> yumaregional.org> wrote:

> I would say this is high complexoty testing and the tech performing 
> this has to have knowledge of the process and troubleshooting in case 
> there is issues with the results.  I do not agree with the 
> interpretation some people give,, but this is based on individual 
> institutions
>
> Sent from my iPad
>
> On Feb 6, 2013, at 2:05 PM, "Rene J Buesa" <rjbuesa <@t> yahoo.com> wrote:
>
> > This issue has been discussed at length recently (please go to 
> > HistoNet
> files).
> > The "complexity" does not deals with the "actual test" but with the
> ability of the technician to go above and beyond the "robotic tasks" 
> but also able to think and apply knowledge when something goes wrong.
> > Sometimes dismissal of complexity is rooted on the desire in 
> > management
> to pay less for tasks that require a higher licensure grade.
> > René J.
> >
> > From: Sara Baldwin/mhhcc.org <sbaldwin <@t> mhhcc.org>
> > To: histonet <@t> lists.utsouthwestern.edu
> > Sent: Wednesday, February 6, 2013 2:54 PM
> > Subject: [Histonet] High complexity test
> >
> > Hi histonetters
> > Is ventana Ultra IHC only doing antibodies no FISH or CISH is this
> considered High complexity testing?  We are doing ER/PR and some others.
> >
> > Thanks
> > Histology/Cytology Supervisor
> > S. Kathy Baldwin, SCT (ASCP)
> > Memorial Hospital and Health Care Center sbaldwin <@t> mhhcc.org Ph 
> > 812-996-0210, 0216, Fax 812-996-0232, Pager 812-481-0897, Cell 
> > 812-887-3357 _______________________________________________
> > Histonet mailing list
> > Histonet <@t> lists.utsouthwestern.edu
> > http://lists.utsouthwestern.edu/mailman/listinfo/histonet
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