[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR493.15]



[Page 985]

 

                         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

    (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]