§ 493.645 - Additional fees applicable to laboratories issued a certificate of accreditation, certificate of waiver, or certificate for PPM procedures.

§ 493.645 Additional fee(s) fees applicable to approved State laboratory programs and laboratories issued a certificate of accreditation, certificate of waiver, or certificate for PPM procedures.

Cross Reference

Link to an amendment published at 88 FR 90036, Dec. 28, 2023.

(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

A laboratory that is issued a certificate of accreditation is

also

assessed

a

an additional 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.

performing validation inspections described at § 493.563. All accredited laboratories share in the cost of these inspections. These costs are 5 percent of the same costs as those that are incurred when inspecting nonaccredited laboratories of the same schedule (or range) and are paid biennially by each accredited laboratory whether the accredited laboratory has a validation inspection or not. HHS revokes the laboratory's certificate of accreditation for failure to pay the fee.

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

followup

follow-up visits are necessary because of identified deficiencies, HHS assesses the laboratory

a

an additional fee to cover the cost of these visits. The fee is based on the actual resources and time necessary to perform the

followup

follow-up visits. HHS revokes the laboratory's certificate of accreditation for failure to pay the

assessed

fee.

(

c

b) Complaint surveys. 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, as amended at 88 FR 90037, Dec. 28, 2023]