[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: 42CFR493.575]

[Page 983-985]
 
                         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. 493.575  Removal of deeming authority or CLIA exemption and final determination review.

    (a) CMS review. CMS conducts a review of the following:
    (1) A deeming authority review of an accreditation organization's 
program if the comparability or validation review produces findings, as 
described at Sec. 493.573. CMS reviews, as appropriate, the criteria 
described in Secs. 493.555 and 493.557(a) to reevaluate whether the 
accreditation organization continues to meet all these criteria.
    (2) An exemption review of a State's licensure program if the 
comparability or validation review produces findings, as described at 
Sec. 493.573. CMS reviews, as appropriate, the criteria described in 
Secs. 493.555 and 493.557(b) to reevaluate whether the licensure program 
continues to meet all these criteria.
    (3) A review of an accreditation organization or State licensure 
program, at CMS's discretion, if validation review findings, 
irrespective of the rate of disparity, indicate widespread or systematic 
problems in the organization's accreditation or State's licensure 
process that provide evidence that the requirements, taken as a whole, 
are no longer equivalent to CLIA requirements, taken as a whole.
    (4) A review of the accreditation organization or State licensure 
program whenever validation inspection results indicate a rate of 
disparity of 20 percent or more between the findings of the organization 
or State and those of CMS or a CMS agent for the following periods:
    (i) One year for accreditation organizations.
    (ii) Two years for State licensure programs.
    (b) CMS action after review. Following the review, CMS may take the 
following action:
    (1) If CMS determines that the accreditation organization or State 
has failed to adopt requirements equal to, or more stringent than, CLIA 
requirements, CMS may give a conditional approval for a probationary 
period of its

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deeming authority to an organization 30 days following the date of CMS's 
determination, or exempt status to a State within 30 days of CMS's 
determination, both not to exceed 1 year, to afford the organization or 
State an opportunity to adopt equal or more stringent requirements.
    (2) If CMS determines that there are widespread or systematic 
problems in the organization's or State's inspection process, CMS may 
give conditional approval during a probationary period, not to exceed 1 
year, effective 30 days following the date of the determination.
    (c) Final determination. CMS makes a final determination as to 
whether the organization or State continues to meet the criteria 
described in this subpart and issues a notice that includes the reasons 
for the determination to the organization or State within 60 days after 
the end of any probationary period. This determination is based on an 
evaluation of any of the following:
    (1) The most recent validation inspection and review findings. To 
continue to be approved, the organization or State must meet the 
criteria of this subpart.
    (2) Facility-specific data, as well as other related information.
    (3) The organization's or State's inspection procedures, surveyors' 
qualifications, ongoing education, training, and composition of 
inspection teams.
    (4) The organization's accreditation requirements, or the State's 
licensure or approval requirements.
    (d) Date of withdrawal of approval. CMS may withdraw its approval of 
the accreditation organization or State licensure program, effective 30 
days from the date of written notice to the organization or State of 
this proposed action, if improvements acceptable to CMS have not been 
made during the probationary period.
    (e) Continuation of validation inspections. The existence of any 
validation review, probationary status, or any other action, such as a 
deeming authority review, by CMS does not affect or limit the conduct of 
any validation inspection.
    (f) Federal Register notice. CMS publishes a notice in the Federal 
Register containing a justification for removing the deeming authority 
from an accreditation organization, or the CLIA-exempt status of a State 
licensure program.
    (g) Withdrawal of approval-effect on laboratory status--(1) 
Accredited laboratory. After CMS withdraws approval of an accreditation 
organization's deeming authority, the certificate of accreditation of 
each affected laboratory continues in effect for 60 days after it 
receives notification of the withdrawal of approval.
    (2) CLIA-exempt laboratory. After CMS withdraws approval of a State 
licensure program, the exempt status of each licensed or approved 
laboratory in the State continues in effect for 60 days after a 
laboratory receives notification from the State of the withdrawal of 
CMS's approval of the program.
    (3) Extension. After CMS withdraws approval of an accreditation 
organization or State licensure program, CMS may extend the period for 
an additional 60 days for a laboratory if it determines that the 
laboratory submitted an application for accreditation to an approved 
accreditation organization or an application for the appropriate 
certificate to CMS or a CMS agent before the initial 60-day period ends.
    (h) Immediate jeopardy to patients. (1) If at any time CMS 
determines that the continued approval of deeming authority of any 
accreditation organization poses immediate jeopardy to the patients of 
the laboratories accredited by the organization, or continued approval 
otherwise constitutes a significant hazard to the public health, CMS may 
immediately withdraw the approval of deeming authority for that 
accreditation organization.
    (2) If at any time CMS determines that the continued approval of a 
State licensure program poses immediate jeopardy to the patients of the 
laboratories in that State, or continued approval otherwise constitutes 
a significant hazard to the public health, CMS may immediately withdraw 
the approval of that State licensure program.

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    (i) Failure to pay fees. CMS withdraws the approval of a State 
licensure program if the State fails to pay the applicable fees, as 
specified in Secs. 493.645(a) and 493.646(b).
    (j) State refusal to take enforcement action. (1) CMS may withdraw 
approval of a State licensure program if the State refuses to take 
enforcement action against a laboratory in that State when CMS 
determines it to be necessary.
    (2) A laboratory that is in a State in which CMS has withdrawn 
program approval is subject to the same requirements and survey and 
enforcement processes that are applied to a laboratory that is not 
exempt from CLIA requirements.
    (k) Request for reconsideration. Any accreditation organization or 
State that is dissatisfied with a determination to withdraw approval of 
its deeming authority or remove approval of its State licensure program, 
as applicable, may request that CMS reconsider the determination, in 
accordance with subpart D of part 488.