CLIA Categorization Criteria
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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.
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.
Updated 3/6/2001
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