[Histonet] High complexity test
Mark Tarango
marktarango <@t> gmail.com
Thu Feb 7 10:55:25 CST 2013
FISH is definitely high complexity. The tech who scores the slide must
meet the qualifications to perform high complexity testing. I understood
Kathy's question to be about the person who loads and runs the
slide stainer.
I still say give CAP or whomever you accrediting agency is a call and see
what they say. Histonet advice is just that.
Mark
On Thu, Feb 7, 2013 at 7:22 AM, Rene J Buesa <rjbuesa <@t> yahoo.com> wrote:
> I only hope that Tim's posting sets this issue to rest. The histotech
> doing IHC, FISH, or grossing and some other complex tasks has to have
> special training and studies because all those are high complexity tests.
> Even those histotechs reading FISH results (counting the reactive nuclei
> for latter signing by the pathologist) have to receive special training.
> I will just point out again that some administrators try to "underrate"
> these tests in order to train "their monkeys" and pay less even when the
> ratio billing/cost is extremely high.
> Management greed drives sometimes these issues.
> René J.
>
> From: "Morken, Timothy" <Timothy.Morken <@t> ucsfmedctr.org>
> To: "histonet <@t> lists.utsouthwestern.edu" <histonet <@t> lists.utsouthwestern.edu
> >
> Sent: Wednesday, February 6, 2013 5:47 PM
> Subject: RE: [Histonet] High complexity test
>
> 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 _______________________________________________
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