§ 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