Laboratory testing within VA performed for the diagnosis, prevention, or treatment of any disease or impairment of, or health assessment of, human beings must meet, at a minimum, requirements established under the following subparts of 42 CFR part 493 as implemented by VA. Except as noted below, functions and responsibilities assigned to the Centers for Medicare & Medicaid Services (CMS) in 42 CFR part 493 are implemented by VA at VA laboratories and outreach clinics, as well as with contracted laboratory services performed on site at VA laboratories or other testing sites. Provisions that are specific to oversight by state licensure programs are not applicable. VA administers the application of the relevant provisions of 42 CFR part 493 to VA laboratories as follows:

(a) General provisions. All provisions in subpart A of 42 CFR part 493 apply to VA with the following exceptions:

(1) Functions assigned to HHS in this subpart are performed by VA.

(2) While 42 CFR part 493 requires laboratories that perform waived, moderate and high complexity tests to meet the regulations, VA requires VA laboratories meet or exceed the requirements of 42 CFR part 493.

(b) Certificate of waiver. All provisions in subpart B of 42 CFR part 493 apply to VA, except that:

(1) Certificates issued by HHS under this subpart are instead issued by VA pursuant to an agreement between CMS and VA.

(2) CMS does not require remittance of a fee from laboratories for any certificate issued by the VA under this subpart.

(c) Registration certificate, certificate for provider-performed microscopy procedures, and certificate of compliance. All provisions in subpart C of 42 CFR part 493 apply to VA, except that:

(1) Certificates issued by HHS under this subpart are instead issued by VA pursuant to an agreement between CMS and VA.

(2) CMS does not require remittance of a fee from laboratories for any certificate issued by VA under this subpart.

(d) Certificates of accreditation. All provisions in subpart D of 42 CFR part 493 apply to VA, except that:

(1) Certificates issued by HHS under this subpart are instead issued by VA pursuant to an agreement between CMS and VA.

(2) CMS does not require remittance of a fee from laboratories for any certificate issued by VA under this subpart.

(e) Accreditation by a private, nonprofit accreditation organization or exemption under an approved state laboratory program. All provisions in subpart E of 42 CFR part 493 apply to VA, to the extent that this subpart addresses accreditation by a private, nonprofit accreditation organization. VA applies this subpart as follows:

(1) VA relies on CMS to grant deeming authority for accreditation organizations. VA uses only an accreditation agency with deeming authority to determine whether a laboratory is in compliance with standards established by the accreditation organization. VA determines whether the laboratory is in compliance with any additional standard established by VA which is:

(i) More stringent than that required for accreditation purposes, or

(ii) Not addressed by accreditation standards or 42 CFR part 493.

(2) VA uses only CMS-approved proficiency testing providers.

(3) Proficiency testing providers release proficiency testing results directly to VA.

(4) VA, rather than CMS, performs inspections of VA laboratories.

(5) Oversight and enforcement functions under this subpart are performed by VA.

(f) General administration. Subpart F of 42 CFR part 493 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 and the Federal validation of accredited laboratories and of CLIA-exempt laboratories. This subpart is inapplicable to VA, as CMS does not collect fees for certification of VA laboratories.

(g) Participation in proficiency testing for laboratories performing nonwaived testing. All provisions in subpart H of 42 CFR part 493 apply to VA, except that all enforcement and oversight functions related to proficiency testing which are assigned to HHS in this subpart are performed by VA.

(h) Proficiency testing programs for nonwaived testing. All provisions in subpart I of 42 CFR part 493 apply to VA, and VA employs scoring criteria under this subpart. VA uses only CMS approved proficiency testing providers. Enforcement and oversight functions related to proficiency testing which are assigned to HHS in this subpart are performed by VA.

(i) Facility administration for nonwaived testing. VA applies standards established in Subpart J of 42 CFR part 493.

(j) Quality system for nonwaived testing. VA applies standards established in Subpart K of 42 CFR part 493.

(k) Personnel for nonwaived testing. VA applies standards established in subpart M of 42 CFR part 493, except that requirements regarding maintaining a license in the state where the laboratory is located are not applicable.

(l) Inspection. VA applies standards established in subpart Q of 42 CFR part 493, except that all enforcement and oversight functions, which are assigned to HHS in this subpart are performed by VA.

(m) Enforcement procedures. VA applies standards established in subpart R of 42 CFR part 493, except:

(1) Enforcement and oversight functions which are assigned to HHS in this subpart are performed by VA.

(2) Due process protections afforded by CMS to CMS certified laboratories facing sanctions are not applicable to laboratories operating under this section.

(3) Suspension of the right to Medicare or Medicaid payments as an available sanction is not applicable. VA does not participate in these programs.

(4) State onsite monitoring and monetary penalties imposed by CMS as an alternate sanction under 42 CFR 493.1806(c) are not applicable.

(5) VA may cease laboratory testing immediately at any site subject to this section upon notification of immediate jeopardy to patients.

(6) VA does not participate in laboratory registry under 42 CFR 493.1850. VA may disclose laboratory information useful in evaluating the performance of laboratories under 5 U.S.C. 552.

(n) Consultations. Subpart T of 42 CFR part 493 requires HHS to establish a Clinical Laboratory Improvement Advisory Committee (CLIAC) to advise and make recommendations on technical and scientific aspects of the provisions of part 493. This subpart does not apply to VA.

[86 FR 24498, May 7, 2021]