[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: 42CFR493.3]



[Page 984]

 

                         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.  493.3  Applicability.



    (a) Basic rule. Except as specified in paragraph (b) of this 

section, a laboratory will be cited as out of compliance with section 

353 of the Public Health Service Act unless it--

    (1) Has a current, unrevoked or unsuspended certificate of waiver, 

registration certificate, certificate of compliance, certificate for PPM 

procedures, or certificate of accreditation issued by HHS applicable to 

the category of examinations or procedures performed by the laboratory; 

or

    (2) Is CLIA-exempt.

    (b) Exception. These rules do not apply to components or functions 

of--

    (1) Any facility or component of a facility that only performs 

testing for forensic purposes;

    (2) Research laboratories that test human specimens but do not 

report patient specific results for the diagnosis, prevention or 

treatment of any disease or impairment of, or the assessment of the 

health of individual patients; or

    (3) Laboratories certified by the Substance Abuse and Mental Health 

Services Administration (SAMHSA), in which drug testing is performed 

which meets SAMHSA guidelines and regulations. However, all other 

testing conducted by a SAMHSA-certified laboratory is subject to this 

rule.

    (c) Federal laboratories. Laboratories under the jurisdiction of an 

agency of the Federal Government are subject to the rules of this part, 

except that the Secretary may modify the application of such 

requirements as appropriate.



[57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5221, Jan. 19, 1993; 60 

FR 20043, Apr. 24, 1995; 68 FR 3702, Jan. 24, 2003]