[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493.643]

[Page 986-988]
 
                         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. 493.643  Fee for determination of program compliance.

    (a) Fee requirement. In addition to the fee required under 
Sec. 493.638, a laboratory subject to routine inspections must pay a fee 
to cover the cost of determining program compliance. Laboratories issued 
a certificate for PPM procedures, certificate of waiver, or a 
certificate of accreditation are not subject to this fee for routine 
inspections.
    (b) Costs included in the fee. Included in the fee for determining 
program compliance is the cost of evaluating qualifications of 
personnel; monitoring proficiency testing; conducting onsite 
inspections; documenting deficiencies; evaluating laboratories' plans to 
correct deficiencies; and necessary administrative costs. HHS sets the 
fee amounts annually on a calendar year basis. Laboratories are 
inspected biennially; therefore, fees are assessed and payable 
biennially. If additional expenses are incurred to conduct follow up 
visits to verify correction of deficiencies, to impose sanctions, and/or 
for surveyor preparation for and attendance at ALJ hearings, HHS 
assesses an additional fee to include these costs. The additional fee is 
based on the actual resources and time necessary to perform the 
activities.
    (c) Classification of laboratories that require inspection for 
purpose of determining amount of fee. (1) There are ten classifications 
(schedules) of laboratories for the purpose of determining the fee 
amount a laboratory is assessed. Each laboratory is placed into one of 
the ten following schedules based on the laboratory's scope and volume 
of testing (excluding tests performed for quality control, quality 
assurance, and proficiency testing purposes).
    (i) (A) Schedule A Low Volume. The laboratory performs not more than 
2,000 laboratory tests annually.
    (B) Schedule A. The laboratory performs tests in no more than 3 
specialties of service with a total annual volume of more than 2,000 but 
not more than 10,000 laboratory tests.

[[Page 987]]

    (ii) Schedule B. The laboratory performs tests in at least 4 
specialties of service with a total annual volume of not more than 
10,000 laboratory tests.
    (iii) Schedule C. The laboratory performs tests in no more 3 
specialties of service with a total annual volume of more than 10,000 
but not more than 25,000 laboratory tests.
    (iv) Schedule D. The laboratory performs tests in at least 4 
specialties with a total annual volume of more than 10,000 but not more 
than 25,000 laboratory tests.
    (v) Schedule E. The laboratory performs more than 25,000 but not 
more than 50,000 laboratory tests annually.
    (vi) Schedule F. The laboratory performs more than 50,000 but not 
more than 75,000 laboratory tests annually.
    (vii) Schedule G. The laboratory performs more than 75,000 but not 
more than 100,000 laboratory tests annually.
    (viii) Schedule H. The laboratory performs more than 100,000 but not 
more than 500,000 laboratory tests annually.
    (ix) Schedule I. The laboratory performs more than 500,000 but not 
more than 1,000,000 laboratory tests annually.
    (x) Schedule J. The laboratory performs more than 1,000,000 
laboratory tests annually.
    (2) For purposes of determining a laboratory's classification under 
this section, a test is a procedure or examination for a single analyte. 
(Tests performed for quality control, quality assurance, and proficiency 
testing are excluded from the laboratory's total annual volume). Each 
profile (that is, group of tests) is counted as the number of separate 
procedures or examinations; for example, a chemistry profile consisting 
of 18 tests is counted as 18 separate procedures or tests.
    (3) For purposes of determining a laboratory's classification under 
this section, the specialties and subspecialties of service for 
inclusion are:
    (i) The specialty of Microbiology, which includes one or more of the 
following subspecialties:
    (A) Bacteriology.
    (B) Mycobacteriology.
    (C) Mycology.
    (D) Parasitology.
    (E) Virology.
    (ii) The specialty of Serology, which includes one or more of the 
following subspecialties:
    (A) Syphilis Serology.
    (B) General immunology
    (iii) The specialty of Chemistry, which includes one or more of the 
following subspecialties:
    (A) Routine chemistry.
    (B) Endocrinology.
    (C) Toxicology.
    (D) Urinalysis.
    (iv) The specialty of Hematology.
    (v) The specialty of Immunohematology, which includes one or more of 
the following subspecialties:
    (A) ABO grouping and Rh typing.
    (B) Unexpected antibody detection.
    (C) Compatibility testing.
    (D) Unexpected antibody identification.
    (vi) The specialty of Pathology, which includes the following 
subspecialties:
    (A) Cytology.
    (B) Histopathology.
    (C) Oral pathology.
    (vii) The specialty of Radiobioassay.
    (viii) The specialty of Histocompatibility.
    (ix) The specialty of Cytogenetics.
    (d) Additional fees. (1) If after a certificate of compliance is 
issued, a laboratory adds services and requests that its certificate be 
upgraded, the laboratory must pay an additional fee if, in order to 
determine compliance with additional requirements, it is necessary to 
conduct an inspection, evaluate personnel, or monitor proficiency 
testing performance. The additional fee is based on the actual resources 
and time necessary to perform the activities. HHS revokes the 
laboratory's certificate for failure to pay the compliance determination 
fee.
    (2) If it is necessary to conduct a complaint investigation, impose 
sanctions, or conduct a hearing, HHS assesses the laboratory holding a 
certificate of compliance a fee to cover the cost of these activities. 
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 government's costs 
of these activities are not imposed upon

[[Page 988]]

the laboratory. Costs for these activities 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 of compliance for failure to pay the assessed 
costs.

[57 FR 7138 and 7213, Feb. 28, 1992, as amended at 60 FR 20047, Apr. 24, 
1995]