[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: 42CFR493.551]



[Page 996-997]

 

                         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



[[Page 997]]



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.

    (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.