[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493.557]

[Page 990-992]
 
                         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. 493.557  Additional submission requirements.

    (a) Specific requirements for accreditation organizations. In 
addition to the information specified in Sec. Sec. 493.553 and 493.555, 
as part of the approval and review process, an accreditation 
organization applying or reapplying for deeming authority must also 
provide the following:
    (1) The specialty or subspecialty areas for which the organization 
is requesting deeming authority and its mechanism for monitoring 
compliance with all requirements equivalent to condition-level 
requirements within the scope of the specialty or subspecialty areas.
    (2) A description of the organization's data management and analysis 
system with respect to its inspection and accreditation decisions, 
including the

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kinds of routine reports and tables generated by the systems.
    (3) Detailed information concerning the inspection process, 
including, but not limited to the following:
    (i) The size and composition of individual accreditation inspection 
teams.
    (ii) Qualifications, education, and experience requirements that 
inspectors must meet.
    (iii) The content and frequency of training provided to inspection 
personnel, including the ability of the organization to provide 
continuing education and training to inspectors.
    (4) Procedures for removal or withdrawal of accreditation status for 
laboratories that fail to meet the organization's standards.
    (5) A proposed agreement between CMS and the accreditation 
organization with respect to the notification requirements specified in 
Sec. 493.555(c).
    (6) Procedures for monitoring laboratories found to be out of 
compliance with its requirements. (These monitoring procedures must be 
used only when the accreditation organization identifies noncompliance. 
If noncompliance is identified through validation inspections, CMS or a 
CMS agent monitors corrections, as authorized at Sec. 493.565(d)).
    (7) A demonstration of its ability to provide CMS with electronic 
data and reports in compatible code, including the crosswalk specified 
in Sec. 493.553(a)(1), that are necessary for effective validation and 
assessment of the organization's inspection process.
    (8) A demonstration of its ability to provide CMS with electronic 
data, in compatible code, related to the adverse actions resulting from 
PT results constituting unsuccessful participation in PT programs as 
well as data related to the PT failures, within 30 days of the 
initiation of adverse action.
    (9) A demonstration of its ability to provide CMS with electronic 
data, in compatible code, for all accredited laboratories, including the 
area of specialty or subspecialty.
    (10) Information defining the adequacy of numbers of staff and other 
resources.
    (11) Information defining the organization's ability to provide 
adequate funding for performing required inspections.
    (12) Any facility-specific data, upon request by CMS, which 
includes, but is not limited to, the following:
    (i) PT results that constitute unsuccessful participation in a CMS-
approved PT program.
    (ii) Notification of the adverse actions or corrective actions 
imposed by the accreditation organization as a result of unsuccessful PT 
participation.
    (13) An agreement to provide written notification to CMS at least 30 
days in advance of the effective date of any proposed change in its 
requirements.
    (14) An agreement to disclose any laboratory's PT results upon 
reasonable request by any person.
    (b) Specific requirements for a State licensure program. In addition 
to requirements in Sec. Sec. 493.553 and 493.555, as part of the 
approval and review process, when a State licensure program applies or 
reapplies for exemption from the CLIA program, the State must do the 
following:
    (1) Demonstrate to CMS that it has enforcement authority and 
administrative structures and resources adequate to enforce its 
laboratory requirements.
    (2) Permit CMS or a CMS agent to inspect laboratories in the State.
    (3) Require laboratories in the State to submit to inspections by 
CMS or a CMS agent as a condition of licensure or approval.
    (4) Agree to pay the cost of the validation program administered in 
that State as specified in Sec. Sec. 493.645(a) and 493.646(b).
    (5) Take appropriate enforcement action against laboratories found 
by CMS not to be in compliance with requirements equivalent to CLIA 
requirements.
    (6) Submit for Medicare and Medicaid payment purposes, a list of the 
specialties and subspecialties of tests performed by each laboratory.
    (7) Submit a written presentation that demonstrates the agency's 
ability to furnish CMS with electronic data in compatible code, 
including the crosswalk specified in Sec. 493.553(a)(1).
    (8) Submit a statement acknowledging that the State will notify CMS 
through electronic transmission of the following:

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    (i) Any laboratory that has had its licensure or approval revoked or 
withdrawn or has been in any way sanctioned by the State within 30 days 
of taking the action.
    (ii) Changes in licensure or inspection requirements.
    (iii) Changes in specialties or subspecialties under which any 
licensed laboratory in the State performs testing.
    (9) Provide information for the review of the State's enforcement 
procedures for laboratories found to be out of compliance with the 
State's requirements.
    (10) Submit information that demonstrates the ability of the State 
to provide CMS with the following:
    (i) Electronic data and reports in compatible code with the adverse 
or corrective actions resulting from PT results that constitute 
unsuccessful participation in PT programs.
    (ii) Other data that CMS determines are necessary for validation and 
assessment of the State's inspection process requirements.
    (11) Agree to provide CMS with written notification of any changes 
in its licensure/approval and inspection requirements.
    (12) Agree to disclose any laboratory's PT results in accordance 
with a State's confidentiality requirements.
    (13) Agree to take the appropriate enforcement action against 
laboratories found by CMS not to be in compliance with requirements 
comparable to condition-level requirements and report these enforcement 
actions to CMS.
    (14) If approved, reapply to CMS every 2 years to renew its exempt 
status and to renew its agreement to pay the cost of the CMS-
administered validation program in that State.