Timothy.Morken at ucsf.edu
Wed Nov 23 17:55:07 CST 2016
Jennifer, good question! That's why I listed the tasks and who may do them. From what I understand, in the clin lab simply loading samples on an analyser is considered moderate complexity - no prep of reagents. Just load pre-packaged reagents and the samples and push START. It seems that would apply to loading pre-dilute antibodies, pre-packaged detection kits, and loading slides. Maybe even programming the instrument if is not interfaced to an LIS.
I think that CAP has invented the "test system" concept (I think they are the only ones using that term and concept) in order to convey that everyone one in the sample chain has a role in producing a valid result. I think that is a good idea to promote quality lab work.
The "test system" expands the CLIA regulatory definition that a "test" is the interpretation and reporting of the final result and all the rest is "processing" a sample. Under CLIA the complexity concept does not apply at all to "processing personnel" (and so no competency testing is required). A "test system" implies that everyone in the chain has responsibility and must be competent
Where CAP falls down is in not defining what parts of a "test system" are covered under the moderate- and high-complexity education requirements. They list their qualifications for various "testing personnel" in a chart, but the chart does not define which parts of any "test system" system are moderate or high complexity, or where complexity does not apply to personnel at all (is coverslipping high complexity if it is for a high complexity "test system?". How about sectioning?)
Below is the algorithm used by FDA to score test as waived, medium or high complexity.
Run a few common histology tasks thru this and see how many are high complexity.
According the CLIA regs, all the complexity rolls up to the person interpreting and reporting results. They are responsible for the entire process.
Score test according to criteria below
Score 2 if any item is between 1 and 3
If it scores 12 and below it is moderate complexity
Above 12 it is high complexity
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, accurate pipetting, 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.
· 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.
Pathology Site Manager, Parnassus
Supervisor, Electron Microscopy/Neuromuscular Special Studies
Department of Pathology
UC San Francisco Medical Center
From: Jennifer Valentine-Williams [mailto:jennifer.valentine-williams at neogenomics.com]
Sent: Wednesday, November 23, 2016 2:02 PM
To: Morken, Timothy; Jesus Ellin
Subject: RE: [Histonet] Personel
I would like to branch off from this topic... Should a lab aid be allowed to load/unload slides/reagents from an automated IHC machine?
Should they be permitted to print the labels that tell the machine which tests to run?
I say no, but others say otherwise, so I'm interested in what everyone else here thinks.
All lab tests have pre and post analytical components and I believe they all contribute to the High-complexity status of the "test". It surely cannot be that the interpretation is the only portion that is considered the "High-complexity test". I am open to hearing why this may be the case though.
Jennifer Valentine-Williams, HT (ASCP)
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