[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493.17]

[Page 977-979]
 
                         TITLE 42--PUBLIC HEALTH
 
  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
                  HEALTH AND HUMAN SERVICES (CONTINUED)
 
PART 493_LABORATORY REQUIREMENTS--Table of Contents
 
                      Subpart A_General Provisions
 
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.

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    (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.
    (b) Revisions to the criteria for categorization. The Clinical 
Laboratory Improvement Advisory Committee, as defined in subpart T of 
this part, will conduct reviews upon request of HHS and recommend to HHS 
revisions to the criteria for categorization of tests.
    (c) Process for device/test categorization utilizing the scoring 
system under Sec. 493.17(a). (1)(i) For new commercial test systems, 
assays, or examinations, the manufacturer, as part of its 510(k) and PMA 
application to FDA, will submit supporting data for device/test 
categorization. FDA will determine the complexity category, notify the 
manufacturers directly, and will simultaneously inform both CMS and CDC 
of the device/test category. FDA will consult with CDC concerning test 
categorization in the following three situations:
    (A) When categorizing previously uncategorized new technology;
    (B) When FDA determines it to be necessary in cases involving a 
request for a change in categorization; and
    (C) If a manufacturer requests review of a categorization decision 
by FDA in accordance with 21 CFR 10.75.
    (ii) Test categorization will be effective as of the notification to 
the applicant.
    (2) For test systems, assays, or examinations not commercially 
available, a laboratory or professional group may submit a written 
request for categorization to PHS. These requests will be forwarded to 
CDC for evaluation; CDC will determine complexity category and notify 
the applicant, CMS, and FDA of the categorization decision. In the case 
of request for a change of category or for previously uncategorized new 
technology, PHS will receive the request application and forward it to 
CDC for categorization.
    (3) A request for recategorization will be accepted for review if it 
is based on new information not previously submitted in a request for 
categorization or recategorization by the same applicant and will not be 
considered more frequently than once per year.
    (4) If a laboratory test system, assay or examination does not 
appear on the lists of tests in the Federal Register notices, it is 
considered to be a test of high complexity until PHS, upon request, 
reviews the matter and notifies the applicant of its decision. Test 
categorization is effective as of the notification to the applicant.
    (5) PHS will publish revisions periodically to the list of moderate 
and high complexity tests in the Federal

[[Page 979]]

Register in a notice with opportunity for comment.

[57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5222, Jan. 19, 1993]