[Code of Federal Regulations]
[Title 12, Volume 1]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493.555]

[Page 989-990]
 
                         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    (i) Had its accreditation or licensure suspended, withdrawn, 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

[[Page 990]]

    (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.