[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: 42CFR493.555]



[Page 998]

 

                         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.  493.555  Federal review of laboratory requirements.



    CMS's review of an accreditation organization or State licensure 

program includes, but is not limited to, an evaluation of the following:

    (a) Whether the organization's or State's requirements for 

laboratories are equal to, or more stringent than, the condition-level 

requirements for laboratories.

    (b) The organization's or State's inspection process to determine 

the comparability of the full inspection and complaint inspection 

procedures and requirements to those of CMS, including, but not limited 

to, inspection frequency and the ability to investigate and respond to 

complaints against its laboratories.

    (c) The organization's or State's agreement with CMS that requires 

it to do the following:

    (1) Notify CMS within 30 days of the action taken, of any laboratory 

that has--

    (i) Had its accreditation or licensure suspended, withdrawn, 

revoked, or limited;

    (ii) In any way been sanctioned; or

    (iii) Had any adverse action taken against it.

    (2) Notify CMS within 10 days of any deficiency identified in an 

accredited or CLIA-exempt laboratory if the deficiency poses an 

immediate jeopardy to the laboratory's patients or a hazard to the 

general public.

    (3) Notify CMS, within 30 days, of all newly--

    (i) Accredited laboratories (or laboratories whose areas of 

specialty/subspecialty testing have changed); or

    (ii) Licensed laboratories, including the specialty/subspecialty 

areas of testing.

    (4) Notify each accredited or licensed laboratory within 10 days of 

CMS's withdrawal of the organization's deeming authority or State's 

exemption.

    (5) Provide CMS with inspection schedules, as requested, for 

validation purposes.