[Histonet] High Complexity Testing

Morken, Tim Timothy.Morken <@t> ucsfmedctr.org
Tue Feb 8 11:53:02 CST 2011

The CLIA criteria are below. Note that the entire test is considered to be the combination of pre-analytic, analytic and post-analytic. It does not matter how the test is performed (manual or automated) because the FDA determines complexity of a "test" as sold by a vendor. It goes with the test, not the particular lab that performs the test. So the lab is said to perform "high complexity testing." If it does so then the personnel in the lab have to meet certain standards. 

Below is the link to the FDA database of tests. Enter Dako and you will see many of their antibodies, secondary kits, etc, all listed as high complexity tests. 

Not all tests (antibodies) are listed because most used in the IHC lab are class I exempt (don't need FDA approval for marketing). They are ancillary tests. However, antibodies like estrogen receptor are listed since they require FDA approval for marketing as a test. 


The question is, who is "performing" the test? Is it the lab tech who does the lab work? Or the pathologist who interprets the results? Or a combination?  Who is it that requires specialized knowledge and/or training?

CLIA Categorization Criteria (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124208.htm)
Each specific laboratory test system, assay, and examination is graded for level of complexity by assigning scores of 1, 2, or 3 for each of the seven criteria listed below.

A score of 1 indicates the lowest level of complexity, and the score of 3 indicates the highest level. These scores are totaled. Test systems, assays or examinations receiving scores of 12 or less are categorized as moderate complexity, while those receiving scores above 12 are 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

Tests may also be categorized as waived.1

Criteria for Categorization
(1) Knowledge.

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. 
Score 3. Specialized scientific and technical knowledge is essential to perform preanalytic, analytic or postanalytic phases of the testing. 

(2) Training and experience.

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. 
Score 3. (A) Specialized training is essential to perform the preanalytic, analytic or postanalytic testing process; or Substantial experience may be necessary for analytic test performance. 

(3) Reagents and materials preparation.

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. 
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.

Score 1. Operational steps are either automatically executed (such as pipetting, temperature monitoring, or timing of steps), or are easily controlled. 
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, accuratepipetting, or extensive calculations. 

(5) Calibration, quality control, and proficiency testing materials.

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. 
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.

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.  
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.

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 
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, Histology, IPOX
UCSF Medical Center
San Francisco, CA, USA

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Sheila Fonner
Sent: Tuesday, February 08, 2011 4:45 AM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] High Complexity Testing

Hello All,


I would really appreciate it if anyone has information on whether IHC/ISH
are considered high complexity testing for histotechs.  Our pathologist
believes that ALL histology low complexity testing since a "machine" is
doing the work.  Can anyone help me out with some guidelines, literature,
etc. that says otherwise?  I would really appreciate it.  We just want to
know which one it is.


Thanks so much Histoland!




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