[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: 42CFR493.563]



[Page 1001-1002]

 

                         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.



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    (3) Evaluation of State inspection results and the licensure or 

approval decision-making process.

    (4) Interviews with State employees.