[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493.15]

[Page 964-965]
 
                         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. 493.15  Laboratories performing waived tests.

    (a) Requirement. Tests for certificate of waiver must meet the 
descriptive criteria specified in paragraph (b) of this section.
    (b) Criteria. Test systems are simple laboratory examinations and 
procedures which--
    (1) Are cleared by FDA for home use;
    (2) Employ methodologies that are so simple and accurate as to 
render the likelihood of erroneous results negligible; or
    (3) Pose no reasonable risk of harm to the patient if the test is 
performed incorrectly.
    (c) Certificate of waiver tests. A laboratory may qualify for a 
certificate of waiver under section 353 of the PHS Act if it restricts 
the tests that it performs to one or more of the following tests or 
examinations (or additional tests added to this list as provided under 
paragraph (d) of this section) and no others:
    (1) Dipstick or Tablet Reagent Urinalysis (non-automated) for the 
following:
    (i) Bilirubin;
    (ii) Glucose;
    (iii) Hemoglobin;
    (iv) Ketone;
    (v) Leukocytes;
    (vi) Nitrite;
    (vii) pH;
    (viii) Protein;
    (ix) Specific gravity; and

[[Page 965]]

    (x) Urobilinogen.
    (2) Fecal occult blood;
    (3) Ovulation tests--visual color comparison tests for human 
luteinizing hormone;
    (4) Urine pregnancy tests--visual color comparison tests;
    (5) Erythrocyte sedimentation rate--non-automated;
    (6) Hemoglobin--copper sulfate--non-automated;
    (7) Blood glucose by glucose monitoring devices cleared by the FDA 
specifically for home use;
    (8) Spun microhematocrit; and
    (9) Hemoglobin by single analyte instruments with self-contained or 
component features to perform specimen/reagent interaction, providing 
direct measurement and readout.
    (d) Revisions to criteria for test categorization and the list of 
waived tests. HHS will determine whether a laboratory test meets the 
criteria listed under paragraph (b) of this section for a waived test. 
Revisions to the list of waived tests approved by HHS will be published 
in the Federal Register in a notice with opportunity for comment.
    (e) Laboratories eligible for a certificate of waiver must--
    (1) Follow manufacturers' instructions for performing the test; and
    (2) Meet the requirements in subpart B, Certificate of Waiver, of 
this part.

[57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5221, Jan. 19, 1993]