[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: 42CFR493.563]

[Page 993]
 
                         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. 493.563  Validation inspections--Basis and focus.

    (a) Basis for validation inspection--(1) Laboratory with a 
certificate of accreditation. (i) CMS or a CMS agent may conduct an 
inspection of an accredited laboratory that has been issued a 
certificate of accreditation on a representative sample basis or in 
response to a substantial allegation of noncompliance.
    (ii) CMS uses the results of these inspections to validate the 
accreditation organization's accreditation process.
    (2) Laboratory in a State with an approved State licensure program. 
(i) CMS or a CMS agent may conduct an inspection of any laboratory in a 
State with an approved State licensure program on a representative 
sample basis or in response to a substantial allegation of 
noncompliance.
    (ii) The results of these inspections are used to validate the 
appropriateness of the exemption of that State's licensed or approved 
laboratories from CLIA program requirements.
    (b) Validation inspection conducted on a representative sample 
basis. (1) If CMS or a CMS agent conducts a validation inspection on a 
representative sample basis, the inspection is comprehensive, addressing 
all condition-level requirements, or it may be focused on a specific 
condition-level requirement.
    (2) The number of laboratories sampled is sufficient to allow a 
reasonable estimate of the performance of the accreditation organization 
or State.
    (c) Validation inspection conducted in response to a substantial 
allegation of noncompliance. (1) If CMS or a CMS agent conducts a 
validation inspection in response to a substantial allegation of 
noncompliance, the inspection focuses on any condition-level requirement 
that CMS determines to be related to the allegation.
    (2) If CMS or a CMS agent substantiates a deficiency and determines 
that the laboratory is out of compliance with any condition-level 
requirement, CMS or a CMS agent conducts a full CLIA inspection.
    (d) Inspection of operations and offices. As part of the validation 
review process, CMS may conduct an onsite inspection of the operations 
and offices to verify the following:
    (1) The accreditation organization's representations and to assess 
the accreditation organization's compliance with its own policies and 
procedures.
    (2) The State's representations and to assess the State's compliance 
with its own policies and procedures, including verification of State 
enforcement actions taken on the basis of validation inspections 
performed by CMS or a CMS agent.
    (e) Onsite inspection of an accreditation organization. An onsite 
inspection of an accreditation organization may include, but is not 
limited to, the following:
    (1) A review of documents.
    (2) An audit of meetings concerning the accreditation process.
    (3) Evaluation of accreditation inspection results and the 
accreditation decision-making process.
    (4) Interviews with the accreditation organization's staff.
    (f) Onsite inspection of a State licensure program. An onsite 
inspection of a State licensure program office may include, but is not 
limited to, the following:
    (1) A review of documents.
    (2) An audit of meetings concerning the licensure or approval 
process.
    (3) Evaluation of State inspection results and the licensure or 
approval decision-making process.
    (4) Interviews with State employees.