[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: 42CFR493.575]



[Page 1003-1005]

 

                         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 Sec. Sec.  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 

Sec. Sec.  493.555 and 493.557(b) to reevaluate



[[Page 1004]]



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 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.



[[Page 1005]]



    (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.

    (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 Sec. Sec.  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.