[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: 42CFR493.551]

[Page 976-977]
 
                         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 E--Accreditation by a Private, Nonprofit Accreditation 
  Organization or Exemption Under an Approved State Laboratory Program
 
Sec. 493.551  General requirements for laboratories.

    Source: 63 FR 26732, May 14, 1998, unless otherwise noted.


    (a) Applicability. CMS may deem a laboratory to meet all applicable 
CLIA program requirements through accreditation by a private nonprofit 
accreditation program (that is, grant deemed status), or may exempt from 
CLIA program requirements all State licensed or approved laboratories in 
a State that has a State licensure program established by law, if the 
following conditions are met:
    (1) The requirements of the accreditation organization or State 
licensure program are equal to, or more stringent than, the CLIA 
condition-level requirements specified in this part, and the laboratory 
would meet the condition-level requirements if it were inspected against 
these requirements.
    (2) The accreditation program or the State licensure program meets 
the requirements of this subpart and is approved by CMS.
    (3) The laboratory authorizes the approved accreditation 
organization or State licensure program to release to CMS all records 
and information required and permits inspections as outlined in this 
part.
    (b) Meeting CLIA requirements by accreditation. A laboratory seeking 
to meet CLIA requirements through accreditation by an approved 
accreditation organization must do the following:
    (1) Obtain a certificate of accreditation as required in subpart D 
of this part.
    (2) Pay the applicable fees as required in subpart F of this part.

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    (3) Meet the proficiency testing (PT) requirements in subpart H of 
this part.
    (4) Authorize its PT organization to furnish to its accreditation 
organization the results of the laboratory's participation in an 
approved PT program for the purpose of monitoring the laboratory's PT 
and for making the annual PT results, along with explanatory information 
required to interpret the PT results, available on a reasonable basis, 
upon request of any person. A laboratory that refuses to authorize 
release of its PT results is no longer deemed to meet the condition-
level requirements and is subject to a full review by CMS, in accordance 
with subpart Q of this part, and may be subject to the suspension or 
revocation of its certificate of accreditation under Sec. 493.1840.
    (5) Authorize its accreditation organization to release to CMS or a 
CMS agent the laboratory's PT results that constitute unsuccessful 
participation in an approved PT program, in accordance with the 
definition of ``unsuccessful participation in an approved PT program,'' 
as specified in Sec. 493.2 of this part, when the laboratory has failed 
to achieve successful participation in an approved PT program.
    (6) Authorize its accreditation organization to release to CMS a 
notification of the actions taken by the organization as a result of the 
unsuccessful participation in a PT program within 30 days of the 
initiation of the action. Based on this notification, CMS may take an 
adverse action against a laboratory that fails to participate 
successfully in an approved PT program.
    (c) Withdrawal of laboratory accreditation. After an accreditation 
organization has withdrawn or revoked its accreditation of a laboratory, 
the laboratory retains its certificate of accreditation for 45 days 
after the laboratory receives notice of the withdrawal or revocation of 
the accreditation, or the effective date of any action taken by CMS, 
whichever is earlier.