Subpart F--General Administration
Source: 57 FR 7138 and 7213, Feb. 28, 1992, unless otherwise noted.
Sec. 493.602 Scope of subpart.
This subpart sets forth the methodology for determining the amount
of the fees for issuing the appropriate certificate, and for determining
compliance with the applicable standards of the Public Health Service
Act (the PHS Act) and the Federal validation of accredited laboratories
and of CLIA-exempt laboratories.
[60 FR 20047, Apr. 24, 1995]
Sec. 493.606 Applicability of subpart.
The rules of this subpart are applicable to those laboratories
specified in Sec. 493.3.
[58 FR 5212, Jan. 19, 1993]
Sec. 493.638 Certificate fees.
(a) Basic rule. Laboratories must pay a fee for the issuance of a
registration certificate, certificate for PPM procedures, certificate of
waiver, certificate of accreditation, or a certificate of compliance, as
applicable. Laboratories must also pay a fee to reapply for a
certificate for PPM procedures, certificate of waiver, certificate of
accreditation, or a certificate of compliance. The total of fees
collected by HHS under the laboratory program must be sufficient to
cover the general costs of administering the laboratory certification
program under section 353 of the PHS Act.
(1) For registration certificates and certificates of compliance,
the costs include issuing the certificates, collecting the fees,
evaluating and monitoring proficiency testing programs, evaluating which
procedures, tests or examinations meet the criteria for inclusion in the
appropriate complexity category, and implementing section 353 of the PHS
Act.
(2) For a certificate of waiver, the costs include issuing the
certificate, collecting the fees, determining if a certificate of waiver
should be issued, evaluating which tests qualify for inclusion in the
waived category, and other direct administrative costs.
(3) For a certificate for PPM procedures, the costs include issuing
the certificate, collecting the fees, determining if a certificate for
PPM procedures should be issued, evaluating which procedures meet the
criteria for inclusion in the subcategory of PPM procedures, and other
direct administrative costs.
(4) For a certificate of accreditation, the costs include issuing
the certificate, collecting the fees, evaluating the programs of
accrediting bodies, and other direct administrative costs.
[[Page 908]]
(b) Fee amount. The fee amount is set annually by HHS on a calendar
year basis and is based on the category of test complexity, or on the
category of test complexity and schedules or ranges of annual laboratory
test volume (excluding waived tests and tests performed for quality
control, quality assurance, and proficiency testing purposes) and
specialties tested, with the amounts of the fees in each schedule being
a function of the costs for all aspects of general administration of
CLIA as set forth in Sec. 493.649 (b) and (c). This fee is assessed and
payable at least biennially. The methodology used to determine the
amount of the fee is found in Sec. 493.649. The amount of the fee
applicable to the issuance of the registration certificate or the
issuance or renewal of the certificate for PPM procedures, certificate
of waiver, certificate of accreditation, or certificate of compliance is
the amount in effect at the time the application is received. Upon
receipt of an application for a certificate, HHS or its designee
notifies the laboratory of the amount of the required fee for the
requested certificate.
[60 FR 20047, Apr. 24, 1995]
Sec. 493.639 Fee for revised certificate.
(a) If, after a laboratory is issued a registration certificate, it
changes its name or location, the laboratory must pay a fee to cover the
cost of issuing a revised registration certificate. The fee for the
revised registration certificate is based on the cost to issue the
revised certificate to the laboratory.
(b) A laboratory must pay a fee to cover the cost of issuing a
revised certificate in any of the following circumstances:
(1) The fee for issuing an appropriate revised certificate is based
on the cost to issue the revised certificate to the laboratory as
follows:
(i) If a laboratory with a certificate of waiver wishes to perform
tests in addition to those listed in Sec. 493.15(c) as waived tests, it
must, as set forth in Sec. 493.638, pay an additional fee for the
appropriate certificate to cover the additional testing.
(ii) If a laboratory with a certificate for PPM procedures wishes to
perform tests in addition to those specified as PPM procedures or listed
in Sec. 493.15(c) as waived tests, it must, as set forth in
Sec. 493.638, pay an additional fee for the appropriate certificate to
cover the additional testing.
(2) A laboratory must pay a fee to cover the cost of issuing a
revised certificate when--
(i) A laboratory changes its name, location, or its director; or
(ii) A laboratory deletes services or wishes to add services and
requests that its certificate be changed. (An additional fee is also
required under Sec. 493.643(d) if it is necessary to determine
compliance with additional requirements.)
[57 FR 7213, Feb. 28, 1992, as amended at 60 FR 20047, Apr, 24, 1995]
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
[[Page 909]]
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.
(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 Clinical 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.
[[Page 910]]
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 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]
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]
Sec. 493.646 Payment of fees.
(a) Except for CLIA-exempt laboratories, all laboratories are
notified in writing by HHS or its designee of the appropriate fee(s) and
instructions for submitting the fee(s), including the due date for
payment and where to make payment. The appropriate certificate is not
issued until the applicable fees have been paid.
(b) For State-exempt laboratories, HHS estimates the cost of
conducting validation surveys within the State for a 2-year period. HHS
or its designee notifies the State by mail of the appropriate fees,
including the due date for payment and the address of the United States
Department of Treasury designated commercial bank to which payment must
be made. In addition, if complaint investigations are conducted
[[Page 911]]
in laboratories within these States and are substantiated, HHS bills the
State(s) the costs of the complaint investigations.
[57 FR 7138 and 7213, Feb. 28, 1992, as amended at 60 FR 20048, Apr. 24,
1995]
Sec. 493.649 Methodology for determining fee amount.
(a) General rule. The amount of the fee in each schedule for
compliance determination inspections is based on the average hourly rate
(which includes the costs to perform the required activities and
necessary administration costs) multiplied by the average number of
hours required or, if activities are performed by more than one of the
entities listed in paragraph (b) of this section, the sum of the
products of the applicable hourly rates multiplied by the average number
of hours required by the entity to perform the activity. The fee for
issuance of the registration certificate or certificate of compliance is
based on the laboratory's scope and volume of testing.
(b) Determining average hourly rates used in fee schedules. Three
different entities perform activities related to the issuance or
reissuance of any certificate. HHS determines the average hourly rates
for the activities of each of these entities.
(1) State survey agencies. The following costs are included in
determining an average hourly rate for the activities performed by State
survey agencies:
(i) The costs incurred by the State survey agencies in evaluating
personnel qualifications and monitoring each laboratory's participation
in an approved proficiency testing program. The cost of onsite
inspections and monitoring activities is the hourly rate derived as a
result of an annual budget negotiation process with each State. The
hourly rate encompasses salary costs (as determined by each State's
civil service pay scale) and fringe benefit costs to support the
required number of State inspectors, management and direct support
staff.
(ii) Travel costs necessary to comply with each State's
administrative requirements and other direct costs such as equipment,
printing, and supplies. These costs are established based on historical
State requirements.
(iii) Indirect costs as negotiated by HHS.
(2) Federal agencies. The hourly rate for activities performed by
Federal agencies is the most recent average hourly cost to HHS to staff
and support a full time equivalent employee. Included in this cost are
salary and fringe benefit costs, necessary administrative costs, such as
printing, training, postage, express mail, supplies, equipment, computer
system and building service charges associated with support services
provided by organizational components such as a computer center, and any
other oversight activities necessary to support the program.
(3) HHS contractors. The hourly rate for activities performed by HHS
contractors is the average hourly rate established for contractor
assistance based on an independent government cost estimate for the
required workload. This rate includes the cost of contractor support to
provide proficiency testing programs to laboratories that do not
participate in an approved proficiency testing program, provide
specialized assistance in the evaluation of laboratory performance in an
approved proficiency testing program, perform assessments of cytology
testing laboratories, conduct special studies, bill and collect fees,
issue certificates, establish accounting, monitoring and reporting
systems, and assist with necessary surveyor training.
(c) Determining number of hours. The average number of hours used to
determine the overall fee in each schedule is HHS's estimate, based on
historical experience, of the average time needed by each entity to
perform the activities for which it is responsible.
[57 FR 7138 and 7213, Feb. 28, 1992, as amended at 60 FR 20048, Apr. 24,
1995]
|