§17.3500. VA application of 42 CFR part 493 standards for clinical laboratory operations.
38 C.F.R. § 17.3500
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:
General provisions. All provisions in subpart A of 42 CFR part 493 apply to VA with the following exceptions:
Functions assigned to HHS in this subpart are performed by VA.
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.
Certificates issued by HHS under this subpart are instead issued by VA pursuant to an agreement between CMS and VA.
CMS does not require remittance of a fee from laboratories for any certificate issued by the VA under this subpart.
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:
Certificates issued by HHS under this subpart are instead issued by VA pursuant to an agreement between CMS and VA.
CMS does not require remittance of a fee from laboratories for any certificate issued by VA under this subpart.
Certificates of accreditation. All provisions in subpart D of 42 CFR part 493 apply to VA, except that:
Certificates issued by HHS under this subpart are instead issued by VA pursuant to an agreement between CMS and VA.
CMS does not require remittance of a fee from laboratories for any certificate issued by VA under this subpart.
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:
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:
More stringent than that required for accreditation purposes, or
Not addressed by accreditation standards or 42 CFR part 493.
VA uses only CMS-approved proficiency testing providers.
Proficiency testing providers release proficiency testing results directly to VA.
VA, rather than CMS, performs inspections of VA laboratories.
Oversight and enforcement functions under this subpart are performed by VA.
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.
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.
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.
Facility administration for nonwaived testing. VA applies standards established in Subpart J of 42 CFR part 493.
Quality system for nonwaived testing. VA applies standards established in Subpart K of 42 CFR part 493.
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.
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.
Enforcement and oversight functions which are assigned to HHS in this subpart are performed by VA.
Due process protections afforded by CMS to CMS certified laboratories facing sanctions are not applicable to laboratories operating under this section.
Suspension of the right to Medicare or Medicaid payments as an available sanction is not applicable. VA does not participate in these programs.
State onsite monitoring and monetary penalties imposed by CMS as an alternate sanction under 42 CFR 493.1806(c) are not applicable.
VA may cease laboratory testing immediately at any site subject to this section upon notification of immediate jeopardy to patients.
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.
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.
Notes, amendments, and revision history
Amendments
[86 FR 24498, May 7, 2021]
Authority
Authority: 38 U.S.C. 501, and as noted in specific sections. Section 17.30 also issued under 38 U.S.C. 1701. Section 17.32 also issued under 38 U.S.C. 7331-7334. Section 17.35 is also issued under 38 U.S.C. 1724. Section 17.37 is also issued under 38 U.S.C. 101, 1701, 1705, 1710, 1720J, 1721, 1722. Section 17.38 is also issued under 38 U.S.C. 1701 and 1703. Section 17.43 also issued under 38 U.S.C. 109, 1784, 8111, and 8153. Section 17.44 also issued under E.O. 10122, 15 FR 2173, 3 CFR, 1949-1953 Comp., p. 313, E.O. 10400, 17 FR 8648, 3 CFR, 1949-1953 Comp., p. 900, and E.O. 11733, 38 FR 20431, 3 CFR, 1971-1975 Comp., p. 792. Section 17.46 is also issued under 38 U.S.C. 1710. Section 17.47 is also issued under 38 U.S.C. 1701, 1710, 1721, 1722, 1729, 3104(a)(9), 7333, Pub. L. 99-272; 42 U.S.C. 1396 et seq. Section 17.52 is also issued under 38 U.S.C. 1701, 1703, 1710, 1712, and 3104. Section 17.55 is also issued under 38 U.S.C. 513, 1703, and 1728. Section 17.56 is also issued under 38 U.S.C. 1703 and 1728. Sections 17.61 through 17.74 are also issued under 38 U.S.C. 1730. Section 17.86 also issued under 38 U.S.C. 1785. Section 17.101 is also issued under 38 U.S.C. 101, 1701, 1705, 1710, 1721, 1722, 1729. Section 17.102 also issued under 38 U.S.C. 109, 1711, 1729, 1784, 1784A, 1785, 8111, 8153. Section 17.105 is also issued under 38 U.S.C. 501, 1721, 1722A, 1724, and 1725A. Section 17.108 is also issued under 38 U.S.C. 501, 1703, 1710, 1725A, 1720J, and 1730A. Section 17.110 is also issued under 38 U.S.C. 501, 1703, 1710, 1720D, 1720J, 1722A, and 1730A. Section 17.111 is also issued under 38 U.S.C. 101(28), 501, 1701(7), 1703, 1710, 1710B, 1720B, 1720D, 1722A, and 1730A. Section 17.125 is also issued under 38 U.S.C. 7304. Sections 17.156 and 17.157 are also issued under 38 U.S.C. 3901 and 3902. Section 17.158 is also issued under 38 U.S.C. 3902 and 3903. Section 17.169 is also issued under 38 U.S.C. 1712C. Sections 17.243 through 17.248 are also issued under 38 U.S.C. 7302 note. Sections 17.270, and 17.272 through 17.277 are also issued under 38 U.S.C. 1781. Section 17.271 is also issued under 38 U.S.C. 1720G(a)(7)(A) and 1781. Section 17.278 is also issued under 38 U.S.C. 1781 and 42 U.S.C. 2651. Section 17.279 is also issued under 5 U.S.C. 552 and 552a; 38 U.S.C. 1781, 5701, and 7332. Sections 17.380, 17.390 and 17.412 are also issued under sec. 260, Pub. L. 114-223, 130 Stat. 857, and sec. 236, Public Law 115-141, 132 Stat. 348, and sec. 236, div. J, Pub. L 115-141, 132 Stat. 348. Section 17.395 is also issued under 38 U.S.C. 1788. Section 17.410 is also issued under 38 U.S.C. 1787. Section 17.415 is also issued under 38 U.S.C. 7301, 7304, 7402, and 7403. Section 17.417 also issued under 38 U.S.C. 1701 (note), 1709A, 1712A (note), 1722B, 1730C, 7301, 7306, 7330A, 7331, 7401-7403, 7405, 7406, 7408. Section 17.419 also issued under 38 U.S.C. 1701 (note), 7301, 7306, 7330A, 7401-7403, 7405, 7406, 7408). Section 17.450 is also issued under 38 U.S.C. 1703E. Sections 17.525 through 17.531 are also issued under 38 U.S.C. 7691 through 7697. Sections 17.545 through 17.553 are also issued under 38 U.S.C. 7698, 7699, 7699A, and 7699B. Sections 17.600 through 17.612 are also issued under 38 U.S.C. 7601-7619, 7633, 7634, 7636, and sec. 104(a), div. V, Public Law 117-328. Sections 17.613 through 17.618 are also issued under Pub. L. 115-182, sec. 304. Sections 17.640 and 17.647 are also issued under sec. 4, Pub. L. 114-2, 129 Stat. 30. Sections 17.641 through 17.646 are also issued under 38 U.S.C. 501(a) and sec. 4, Pub. L. 114-2, 129 Stat. 30. Section 17.655 also issued under 38 U.S.C. 501(a), 7304, 7405. Sections 17.1200 through 17.1230 are also issued under 38 U.S.C. 1720J. Section 17.3200 also issued under 38 U.S.C. 1162, 1701, 1707, 1710, 1714, 1717, 3901. Section 17.3210 also issued under 38 U.S.C. 1701, 1710. Section 17.3220 also issued under 38 U.S.C. 1701(6)(F), 1710. Section 17.3230 also issued under 38 U.S.C. 1701(6)(F), 1710, 1714(a). Section 17.3250 also issued under 38 U.S.C. 1701, 1710, 1725, 1728. Section 17.3500 is also issued under Pub. L. 102-139 sec. 101. Sections 17.4000 through 17.4040 also issued under 38 U.S.C. 1703, 1703B, and 1703C. Section 17.4100 et seq. is also issued under 38 U.S.C. 1703A. Section 17.4600 is also issued under 38 U.S.C. 1725A and 1730A.
Amendments
[86 FR 24498, May 7, 2021]