[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: 42CFR493.645]



[Page 1008]

 

                         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 F_General Administration

 

Sec.  493.645  Additional fee(s) applicable to approved State laboratory



programs and laboratories issued a certificate of accreditation, 

certificate of waiver, or certificate for PPM procedures.



    (a) Approved State laboratory programs. State laboratory programs 

approved by HHS are assessed a fee for the following:

    (1) Costs of Federal inspections of laboratories in that State (that 

is, CLIA-exempt laboratories) to verify that standards are being 

enforced in an appropriate manner.

    (2) Costs incurred for investigations of complaints against the 

State's CLIA-exempt laboratories if the complaint is substantiated.

    (3) Costs of the State's prorata share of general overhead to 

develop and implement CLIA.

    (b) Accredited laboratories. (1) In addition to the certificate fee, 

a laboratory that is issued a certificate of accreditation is also 

assessed a fee to cover the cost of evaluating individual laboratories 

to determine overall whether an accreditation organization's standards 

and inspection policies are equivalent to the Federal program. All 

accredited laboratories share in the cost of these inspections. These 

costs are the same as those that are incurred when inspecting 

nonaccredited laboratories.

    (2) If a laboratory issued a certificate of accreditation has been 

inspected and followup visits are necessary because of identified 

deficiencies, HHS assesses the laboratory a fee to cover the cost of 

these visits. The fee is based on the actual resources and time 

necessary to perform the followup visits. HHS revokes the laboratory's 

certificate of accreditation for failure to pay the assessed fee.

    (c) If, in the case of a laboratory that has been issued a 

certificate of accreditation, certificate of waiver, or certificate for 

PPM procedures, it is necessary to conduct a complaint investigation, 

impose sanctions, or conduct a hearing, HHS assesses that laboratory a 

fee to cover the cost of these activities. Costs are based on the actual 

resources and time necessary to perform the activities and are not 

assessed until after the laboratory concedes the existence of 

deficiencies or an ALJ rules in favor of HHS. HHS revokes the 

laboratory's certificate for failure to pay the assessed costs. If a 

complaint investigation results in a complaint being unsubstantiated, or 

if an HHS adverse action is overturned at the conclusion of the 

administrative appeals process, the costs of these activities are not 

imposed upon the laboratory.



[60 FR 20047, Apr. 24, 1995]