Adopting Standards for Laboratory Requirements, 24494-24498 [2021-08157]

Download as PDF 24494 Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Rules and Regulations significant effect on the human environment. This rule involves a special local regulation lasting twelve hours that will prohibit entry from MM 48.5 to 52.0 on the Clinch River. It is categorically excluded from further review under paragraph L61 in Table 3– 1 of U.S. Coast Guard Environmental Planning Implementing Procedures 5090.1. A Memorandum for Record supporting this determination is available in the docket where indicated under ADDRESSES. (c) Enforcement period. This section will be enforced from 6 a.m. to 6 p.m. from May 8, 2021 to May 9, 2021. (d) Information broadcast. The COTP will issue Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and Marine Safety Information Bulletins (MSIBs) about this special local regulation so that waterway users may plan accordingly for this short restriction on transit, and the rule would allow vessels to request permission to enter the zone. G. Protest Activities Dated: May 4, 2021. A.M. Beach, Captain, U.S. Coast Guard, Captain of the Port Sector Ohio Valley. The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels. [FR Doc. 2021–09725 Filed 5–6–21; 8:45 am] BILLING CODE 9110–04–P DEPARTMENT OF VETERANS AFFAIRS List of Subjects in 33 CFR Part 100 38 CFR Part 17 Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways. RIN 2900–AP64 Adopting Standards for Laboratory Requirements ACTION: 1. The authority citation for part 100 continues to read as follows: ■ Authority: 46 U.S.C. 70041; 33 CFR 1.05– 1. 2. Add § 100.T08–0215 to read as follows: ■ § 100.T08–0215 Oak Ridge, TN. Clinch River mile 48.5 to 52.0. (a) Location. The regulations in this section apply to the following area: All navigable waters of the Clinch River from mile 48.5 to mile 52.0, extending the entire width of the river. (b) Regulations. (1) All nonparticipants are prohibited from entering, transiting through, anchoring in, or remaining within the regulated area described in paragraph (a) of this section unless authorized by the Captain of the Port Sector Ohio Valley or a designated representative. (2) To seek permission to enter, contact the COTP or the COTP’s representative by Sector Ohio Valley Command Center at 502–779–5422. Those in the regulated area must comply with all lawful orders or directions given to them by the COTP or the designated representative. 16:08 May 06, 2021 Jkt 253001 The Department of Veterans Affairs (VA) adopts as final, with changes, a proposed rule amending its medical regulations to establish standards for VA clinical laboratories. The Department of Health and Human Services (HHS) has established standards for the staffing, management, procedures, and oversight of clinical laboratories that perform testing used for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. VA is required, in consultation with HHS, to establish standards equal to those applicable to other clinical laboratories. As a matter of policy and practice VA has applied HHS standards to its VA laboratory operations, and this rule formalizes this practice. In response to public comments this final rulemaking amends proposed language to more accurately reflect VA’s utilization of CMS-deemed accreditation organizations in the process of inspection, oversight, and operational approval of VA clinical laboratories. DATES: This final rule is effective June 7, 2021. FOR FURTHER INFORMATION CONTACT: Quynh Vantu, Health Science Specialist, Pathology and Laboratory Service (1011DIAG2), Office of Clinical Care Services, Veterans Health SUMMARY: PART 100—SAFETY OF LIFE ON NAVIGABLE WATERS VerDate Sep<11>2014 Department of Veterans Affairs. Final rule. AGENCY: For the reasons discussed in this preamble, the Coast Guard amends 33 CFR part 100 as follows: PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 Administration, Department of Veterans Affairs, 810 Vermont Ave NW, Washington, DC 20420, (202) 632–8418. (This is not a toll-free number.) SUPPLEMENTARY INFORMATION: In a document published in the Federal Register on October 17, 2018, VA proposed to amend its medical regulations to establish standards for VA clinical laboratories. 83 FR 52345. We provided a 60-day comment period, which ended on December 17, 2018, and we received four comments. The Clinical Laboratory Improvement Amendments of 1988 (Public Law (Pub. L.) 100–578) amended section 353 of the Public Health Service Act to establish legal requirements for the staffing, management, procedures, reporting of results and oversight of clinical laboratories that perform testing used for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings. These statutory requirements are codified at 42 U.S.C. 263a. The Centers for Medicare & Medicaid Services (CMS), within HHS, has primary responsibility for the administration of the Clinical Laboratory Improvement Amendments (CLIA) program and implementing regulations for CLIA at 42 Code of Federal Regulations (CFR) part 493. Section 101 of Pub. L. 102–139 (enacted October 28, 1991), required VA, within a specified time-frame and in consultation with HHS, to ‘‘establish standards [by regulation] equal to that [sic] applicable to other medical facility laboratories in accordance with the requirements of section 353(f) of the Public Health Service Act.’’ VA’s regulations must ‘‘include appropriate provisions respecting compliance with such requirements [set forth in section 353(f) of the Public Health Service Act]’’ and may include appropriate provisions respecting waivers and accreditations as described in section 353(d) and 353(e), respectively, of the Public Health Service Act. This final rule complies with the requirement for rulemaking by amending VA’s medical regulations to reference the portions of 42 CFR part 493 adopted by VA as they apply to VA medical facility laboratories and clinics, and to clarify that these standards are subject to VA oversight and enforcement by VA only. In addition, this final rule allows VA laboratories to be accredited by an accreditation organization granted deeming authority by CMS under the CLIA program, in accordance with the accreditation requirements in the CLIA regulations at subpart E of 42 CFR part 493, and participate in an HHS approved proficiency testing program. E:\FR\FM\07MYR1.SGM 07MYR1 Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Rules and Regulations As explained in the preamble to the proposed rule, VA policy and practice regarding CLIA compliance was developed in consultation with HHS in 1994 and 1998. Additionally, in 2000, after further consultation, VA and CMS entered into an interagency agreement (IAA), which documented the history of the parties’ consultations and agreements and granted VA limited authority to act on behalf of CMS. In 2018, CMS and VA met to begin the process to review and update the 2010 agreement and it was proposed to replace the IAA with a memorandum of understanding (MOU), and to review and renew every six years thereafter. The IAA was converted to an MOU and approved on May 22, 2020. In addition, CMS and VA agreed to meet annually to discuss program issues of mutual importance. To ensure VA operated laboratories remain current with CMS CLIA requirements, VA participates in the CMS Partners in Laboratory Oversight group, consults with CMS as needed, and participates in at least one formal consultative meeting per year. Additionally, VA provides updated data to CMS for each VA laboratory assigned a CLIA number at least every two years, or as changes occur. Furthermore, VA provides CMS with any requested information regarding the operation and performance of VA laboratories and the operations of the oversight program. This final rulemaking formalizes VA’s application of the CLIA requirements to VA laboratory operations by adding a new section 17.3500 to 38 CFR, ‘‘VA application of 42 CFR part 493 standards for clinical laboratory operations,’’ to its medical regulations. Section 17.3500 addresses CLIA regulations found at 42 CFR part 493, by subpart, and how VA will apply those regulations. This rule will also allow VA to continue to assure that medical facility laboratories across our system perform and report out consistent, accurate, and reliable laboratory testing, ensuring the provision of quality testing for our patients in a manner comparable to non-VA laboratories. In response to the proposed rule, VA received four comments. One commenter expressed support for the rule, and we thank the commenter for supporting the rule. Another commenter noted a grammatical error in the preamble but did not suggest any edits be made to the rule. Specifically, the commenter noted that in the first paragraph of the Supplemental Information section, we referred to the definition of ‘‘laboratory or clinical laboratory’’ found at 42 U.S.C. 263a(a) and quoted from that VerDate Sep<11>2014 16:08 May 06, 2021 Jkt 253001 statutory definition without using quotation marks. The commenter is correct, however no change in the regulatory text is needed. We are not making any edits to this rulemaking based on this comment, and we thank the commenter for their feedback. Another commenter provided the same comment twice. The comment was supportive of the rule, but provided multiple recommendations regarding: (1) Personnel requirements; (2) scope of practice; and (3) accreditation organizations. The commenter also attached a comment that was submitted to CMS in March 2018 in response to a request for information. In this rulemaking, we will only address the comment that was directed to VA and will not address the comment directed to CMS. 1. Personnel Requirements. The commenter raised concerns over the academic and clinical training requirements for high complexity laboratory personnel to broaden the potential labor force of laboratory professionals while simultaneously ensuring they are properly qualified to provide high quality testing. The commenter recommended that we modify the CLIA personnel requirements to: (1) Allow an earned baccalaureate degree with at least 30 hours (or equivalent) of coursework in biological and chemical sciences (appropriate to a major in one of these sciences) to satisfy the academic degree requirement; (2) clarify that all high complexity testing personnel must complete clinical training, either from an accredited clinical training program or documented laboratory training prior to testing patient samples; (3) create personnel standards for histotechnology professionals, requiring that they complete an associate degree (or equivalent) in the chemical or biological sciences, and complete either an accredited or structured training program under the auspices of a board certified pathologist or designee; and (4) require all high complexity laboratory personnel to pass a national certification examination. The purpose of this rulemaking is to fulfill the requirements of section 101 of Public Law 102–139 for rules equal to those applicable to other medical facility laboratories subject to the CLIA requirements as implemented under the Public Health Service Act . As previously stated, CMS implemented CLIA regulations at 42 CFR part 493, and VA is amending its medical regulations to incorporate those portions of 42 CFR part 493 as adopted by VA. Personnel requirements for performing non-waived testing are addressed in PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 24495 subpart M of 42 CFR part 493, and VA will apply all standards from this subpart except the requirements to maintain a license in the state where the laboratory is located. In other words, in formalizing VA’s application of the CLIA requirements implemented by CMS, VA cannot adopt less rigorous standards than those of CMS. While VA cannot adopt less rigorous standards, if deemed necessary, VA will further delineate higher personnel qualifications in policy. For example, VA currently maintains a higher personnel qualification standard for medical technologists in policy. Medical technologists are required to possess a combination of a bachelor’s degree, or higher, and clinical practice experience. Additionally, medical technologists must possess, or obtain within one year from date of appointment, an appropriate certification from the American Society for Clinical Pathology or the American Medical Technologists. Furthermore, in areas where VA has not implemented a more rigorous standard than CMS, it is because we believe their standards satisfy our specific needs and ensure the safety, efficiency, and reliability of our laboratories. Like all public institutions, VA must balance the goals of verifying staff competency with creating a flexible enough barrier to entry that we can attract the best minds from all areas of clinical laboratory science. We are not making any changes to this rulemaking based on this comment. 2. Scope of Practice. The commenter sought to confirm their interpretation that this rule does not impact the scope of practice for advanced practice registered nurses (APRNs) to ‘‘order laboratory and imaging studies and integrate the results into clinical decision making, but not to perform or interpret any laboratory test.’’ The commenter also ‘‘urged the VA to maintain this policy.’’ The commenter is correct that this rule does not impact APRN scope of practice. In a document published in the Federal Register on May 25, 2016, VA proposed to amend its regulation to permit full practice authority of four types of APRNs. 81 FR 33155. Proposed 38 CFR 17.415(d)(1)(i)(B) stated in part that a certified nurse practitioner (CNP) may order, perform, or supervise laboratory and imaging studies. Several commenters were concerned with the language, and VA agreed with commenters that the language may be construed as allowing CNPs to perform laboratory studies. In a document published in the Federal Register on December 14, 2016, VA published its final rulemaking and amended E:\FR\FM\07MYR1.SGM 07MYR1 24496 Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Rules and Regulations § 17.415(d)(1)(i)(B) to state in part that a CNP may order laboratory and imaging studies and integrate the results into clinical decision making. 81 FR 90198. With that background, we agree with the commenter that this rulemaking does not impact § 17.415 and reiterate that the intent of this rule is to fulfill the requirements of section 101 of Public Law 102–139 for formal rulemaking to adopt standards equal to those applicable to other medical facility laboratories in accordance with the Public Health Service Act. Additionally, VA maintains requirements in policy that specify all testing must be performed under the authority of a Pathologist serving as the Chief of Pathology (Laboratory Director) and that all point of care testing must be overseen by a Medical Technologist Point of Care Coordinator. We are not making any changes to this rulemaking based on this comment. 3. Accreditation Organizations. The commenter questioned whether CMSapproved accrediting agencies will assess whether VA clinical laboratories are in full compliance with VA requirements and recommended that VA ‘‘require all accrediting agencies providing services to VA laboratories attest that they assess VA laboratories in compliance with applicable VA regulations.’’ There are no accrediting organizations that have standards equivalent to VA, and therefore, no accreditation organization can effectively inspect VA laboratories to ensure they are compliant with all VA regulations. VA uses outside accreditation organizations with deeming authority to assess thirdparty compliance with CLIA regulations. The requirements VA has implemented that are more stringent than CLIA, or unique to the government, are overseen by the VA Office of Inspector General, the Veterans Health Administration (VHA) Office of Medical Inspector, and VHA Pathology and Laboratory Medicine Service National Enforcement Office. We believe this rigorous internal and external oversight provides more thorough oversight than could be accomplished by only an external accreditation organization. In response to the issues raised by the commenter, VA believes it is necessary to amend the language in proposed § 17.3500(e)(1) to more accurately reflect VA’s utilization of CMS deemed-status accreditation organizations in the process of inspection, oversight, and operational approval of VA clinical laboratories. ‘‘Operational approval’’ for VA clinical laboratories includes compliance with both standards established by a CMS deemed-status VerDate Sep<11>2014 16:08 May 06, 2021 Jkt 253001 accreditation organization and meeting relevant VA standards. Generally, accreditation organizations determine whether a laboratory is in compliance with the standards established by that organization. If the accrediting organization determines that the laboratory complies with those standards, it issues a certificate of accreditation. That is only one element considered by VA in determining whether the laboratory meets all VA standards. In addition to attaining a certificate of accreditation, the laboratory must also meet relevant VA standards, which may be more stringent than those set by the accrediting organization. Also, in some cases VA establishes a standard for testing that is not covered by standards established by the accrediting organization or addressed in 42 CFR part 493. If the laboratory meets applicable accreditation standards and also relevant VA standards, VA issues a certificate of compliance, meaning that the laboratory is CLIA certified by VA. We also note that VA laboratories performing minimally complex tests are not required to be inspected and accredited by CMS deemed-status accreditation organizations, but rather are inspected and CLIA certified by VA. Similarly, VA laboratories that perform provider performed microscopy testing as outlined in 42 CFR 493.19, are not required to be inspected and accredited by CMS deemed-status accreditation organizations, but rather are inspected and CLIA certified by VA. We amend § 17.3500(e)(1) to state that 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. In addition to public comments received, HHS was afforded the opportunity to review the rule and provided the following comments and suggestions, which we are adopting. First, HHS noted that VA cannot enforce 42 CFR part 493 because it is a function of CMS and suggested that language in the first sentence of the proposed introductory paragraph of § 17.3500 be rephrased to reflect that VA laboratories must meet VA’s alternative requirements under 38 CFR. We agree with this suggestion and have removed PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 the phrase ‘‘administered, and enforced’’ from the first sentence, and combined the first and second sentences to clarify that 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 subparts 42 CFR part 493 as implemented by VA. We also removed the phrase ‘‘comply with the listed requirements established by the Department of Health and Human Services (HHS) under the following subparts of 42 CFR part 493’’ in the first sentence and replaced it with ‘‘requirements established under the following subparts of 42 CFR part 493’’ because we believe the previous reference to HHS is superfluous since 42 CFR part 493 is a regulation established by HHS. We believe these revisions clarify that VA laboratories must meet VA’s additional standards as well as CLIA regulations. Second, HHS commented that the intent of the third sentence in the proposed introductory paragraph was adequately addressed in the three sentences immediately following it. We agree with this comment and have removed it; however we have added the phrase ‘‘as well as contracted laboratory services performed on site at VA laboratories, outreach clinics or other’’ to the fourth sentence to clarify that VA implements the functions and responsibilities assigned to CMS in 42 CFR part 493 at VA laboratories and outreach clinics, as well as with contracted laboratory services performed on site at VA laboratories or other testing sites. Third, HHS questioned the legal basis for the language used in the fourth sentence of the proposed introductory paragraph regarding VA’s assumption of the functions and responsibilities assigned to CMS in 42 CFR part 493. Upon review of HHS’ comment, we have amended this sentence by replacing the phrase ‘‘assumed by VA’’ with ‘‘implemented by VA.’’ We believe this revision clarifies that VA only performs the functions and responsibilities assigned to CMS in 42 CFR part 493 at VA laboratories and outreach clinics, as well as with contracted laboratory services performed on site at VA laboratories or other testing sites. Fourth, HHS questioned if VA staff have the requisite knowledge to perform validation inspections of VA laboratories as proposed in paragraph (e)(4) and suggested that the phrase ‘‘performs validation inspections,’’ be replaced with ‘‘performs inspections.’’ E:\FR\FM\07MYR1.SGM 07MYR1 Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Rules and Regulations We agree with the suggestion provided by HHS because a validation inspection is performed by CMS whereas VA performs inspections on VA laboratories. We are amending the phrase by removing the term ‘‘validation.’’ Fifth, HHS noted that the language provided in (m)(2) was not clear and suggested we revise the sentence. Proposed (m)(2) stated ‘‘Due process protections afforded by CMS-certified for laboratories facing sanctions are not applicable to laboratories operating under this section.’’ We agree that this sentence is unclear and have amended it to state, ‘‘Due process protections afforded by CMS to CMS certified laboratories facing sanctions are not applicable to laboratories operating under this section.’’ Based on the rationale set forth in the proposed rule and in this document, VA is adopting the provisions of the proposed rule as a final rule with the changes noted above. Paperwork Reduction Act This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3521). Regulatory Flexibility Act The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601–612). It would affect only the operations of VA medical facility laboratories and any small entity which chooses to enter into a contract with VA to provide laboratory services. VA estimates that this final rule potentially impacts 37 small entities within NAICS Code 621511 (Medical Laboratories), which represents 1.3 percent of small entities covered by NAICS Code 621511. The small medical laboratories impacted by this rulemaking provide contracted medical laboratory services at various VA medical facilities, to include VA outpatient clinics and VA Community Based Outpatient Clinics. This rulemaking decreases the regulatory burden for the 37 small entities who provide contract medical laboratory services to VA. Under this rulemaking functions and responsibilities assigned to the Centers for Medicare & Medicaid Services (CMS) in 42 CFR part 493 are assumed by VA, and provisions that are specific to oversight by state licensure programs are not applicable. For services performed under a VA contract for medical laboratory services the contractors would not be subject to VerDate Sep<11>2014 16:08 May 06, 2021 Jkt 253001 potential CMS sanctions under subpart R of 42 CFR part 493 because VA does not participate in Medicare or Medicaid programs, and VA is responsible for both oversight and enforcement of clinical laboratory standards. In addition, state onsite monitoring and monetary penalties imposed by CMS as an alternate sanction are not applicable. However, VA may cease laboratory testing immediately at any site subject to this section upon notification of immediate jeopardy to patients. Therefore, pursuant to 5 U.S.C. 605(b), the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604 do not apply. Executive Order 12866 and 13563 Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. The Office of Information and Regulatory Affairs has determined that this rule is not a significant regulatory action under Executive Order 12866. VA’s impact analysis can be found as a supporting document at https:// www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VA’s website at https:// www.va.gov/orpm/, by following the link for ‘‘VA Regulations Published from FY 2004 Through Fiscal Year to Date.’’ Unfunded Mandates The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule will have no such effect on State, local, and tribal governments, or on the private sector. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), the Office of Information and Regulatory Affairs PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 24497 designated this rule as not a major rule, as defined by 5 U.S.C. 804(2). Catalog of Federal Domestic Assistance The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.008—Veterans Domiciliary Care; 64.011—Veterans Dental Care; 64.029— Purchase Care Program; 64.033—VA Supportive Services for Veteran Families Program; 64.040—VA Inpatient Medicine; 64.041—VA Outpatient Specialty Care; 64.042—VA Inpatient Surgery; 64.043—VA Mental Health Residential; 64.044—VA Home Care; 64.045—VA Outpatient Ancillary Services; 64.046—VA Inpatient Psychiatry; 64.047—VA Primary Care; 64.048—VA Mental Health clinics; 64.049—VA Community Living Center; 64.050—VA Diagnostic Care; 64.054— Research and Development. List of Subjects in 38 CFR Part 17 Administrative practice and procedure, Alcohol abuse, Alcoholism, Claims, Day care, Dental health, Drug abuse, Government contracts, Grant programs-health, Grant programsveterans, Health care, Health facilities, Health professions, Health records, Homeless, Medical and Dental schools, Medical devices, Medical research, Mental health programs, Nursing homes, Reporting and recordkeeping requirements, Travel and transportation expenses, Veterans. Signing Authority Denis McDonough, Secretary of Veterans Affairs, approved this document on March 22, 2021 and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Jeffrey M. Martin, Assistant Director, Office of Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs. For the reasons set forth in the preamble, VA amends 38 CFR part 17 as follows: PART 17—MEDICAL 1. The general authority citation for part 17 continues, and an entry for § 17.3500 is added in numerical order, to read as follows: ■ Authority: 38 U.S.C. 501, and as noted in specific sections: * * * * * Section 17.3500 is also issued under Pub. L. 102–139 sec. 101. * E:\FR\FM\07MYR1.SGM * * 07MYR1 * * 24498 Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Rules and Regulations 2. Add an undesignated center heading following § 17.3250 to read as follows: ■ Clinical Laboratory Standards ■ 3. Add § 17.3500 to read as follows: § 17.3500 VA application of 42 CFR part 493 standards for clinical laboratory operations. 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. VerDate Sep<11>2014 16:08 May 06, 2021 Jkt 253001 (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 PO 00000 Frm 00016 Fmt 4700 Sfmt 9990 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. [FR Doc. 2021–08157 Filed 5–6–21; 8:45 am] BILLING CODE 8320–01–P E:\FR\FM\07MYR1.SGM 07MYR1

Agencies

[Federal Register Volume 86, Number 87 (Friday, May 7, 2021)]
[Rules and Regulations]
[Pages 24494-24498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08157]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AP64


Adopting Standards for Laboratory Requirements

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: The Department of Veterans Affairs (VA) adopts as final, with 
changes, a proposed rule amending its medical regulations to establish 
standards for VA clinical laboratories. The Department of Health and 
Human Services (HHS) has established standards for the staffing, 
management, procedures, and oversight of clinical laboratories that 
perform testing used for the diagnosis, prevention, or treatment of any 
disease or impairment of, or the assessment of the health of, human 
beings. VA is required, in consultation with HHS, to establish 
standards equal to those applicable to other clinical laboratories. As 
a matter of policy and practice VA has applied HHS standards to its VA 
laboratory operations, and this rule formalizes this practice. In 
response to public comments this final rulemaking amends proposed 
language to more accurately reflect VA's utilization of CMS-deemed 
accreditation organizations in the process of inspection, oversight, 
and operational approval of VA clinical laboratories.

DATES: This final rule is effective June 7, 2021.

FOR FURTHER INFORMATION CONTACT: Quynh Vantu, Health Science 
Specialist, Pathology and Laboratory Service (1011DIAG2), Office of 
Clinical Care Services, Veterans Health Administration, Department of 
Veterans Affairs, 810 Vermont Ave NW, Washington, DC 20420, (202) 632-
8418. (This is not a toll-free number.)

SUPPLEMENTARY INFORMATION: In a document published in the Federal 
Register on October 17, 2018, VA proposed to amend its medical 
regulations to establish standards for VA clinical laboratories. 83 FR 
52345. We provided a 60-day comment period, which ended on December 17, 
2018, and we received four comments.
    The Clinical Laboratory Improvement Amendments of 1988 (Public Law 
(Pub. L.) 100-578) amended section 353 of the Public Health Service Act 
to establish legal requirements for the staffing, management, 
procedures, reporting of results and oversight of clinical laboratories 
that perform testing used for the diagnosis, prevention, or treatment 
of any disease or impairment of, or assessment of the health of, human 
beings. These statutory requirements are codified at 42 U.S.C. 263a. 
The Centers for Medicare & Medicaid Services (CMS), within HHS, has 
primary responsibility for the administration of the Clinical 
Laboratory Improvement Amendments (CLIA) program and implementing 
regulations for CLIA at 42 Code of Federal Regulations (CFR) part 493.
    Section 101 of Pub. L. 102-139 (enacted October 28, 1991), required 
VA, within a specified time-frame and in consultation with HHS, to 
``establish standards [by regulation] equal to that [sic] applicable to 
other medical facility laboratories in accordance with the requirements 
of section 353(f) of the Public Health Service Act.'' VA's regulations 
must ``include appropriate provisions respecting compliance with such 
requirements [set forth in section 353(f) of the Public Health Service 
Act]'' and may include appropriate provisions respecting waivers and 
accreditations as described in section 353(d) and 353(e), respectively, 
of the Public Health Service Act. This final rule complies with the 
requirement for rulemaking by amending VA's medical regulations to 
reference the portions of 42 CFR part 493 adopted by VA as they apply 
to VA medical facility laboratories and clinics, and to clarify that 
these standards are subject to VA oversight and enforcement by VA only. 
In addition, this final rule allows VA laboratories to be accredited by 
an accreditation organization granted deeming authority by CMS under 
the CLIA program, in accordance with the accreditation requirements in 
the CLIA regulations at subpart E of 42 CFR part 493, and participate 
in an HHS approved proficiency testing program.

[[Page 24495]]

    As explained in the preamble to the proposed rule, VA policy and 
practice regarding CLIA compliance was developed in consultation with 
HHS in 1994 and 1998. Additionally, in 2000, after further 
consultation, VA and CMS entered into an interagency agreement (IAA), 
which documented the history of the parties' consultations and 
agreements and granted VA limited authority to act on behalf of CMS.
    In 2018, CMS and VA met to begin the process to review and update 
the 2010 agreement and it was proposed to replace the IAA with a 
memorandum of understanding (MOU), and to review and renew every six 
years thereafter. The IAA was converted to an MOU and approved on May 
22, 2020. In addition, CMS and VA agreed to meet annually to discuss 
program issues of mutual importance.
    To ensure VA operated laboratories remain current with CMS CLIA 
requirements, VA participates in the CMS Partners in Laboratory 
Oversight group, consults with CMS as needed, and participates in at 
least one formal consultative meeting per year. Additionally, VA 
provides updated data to CMS for each VA laboratory assigned a CLIA 
number at least every two years, or as changes occur. Furthermore, VA 
provides CMS with any requested information regarding the operation and 
performance of VA laboratories and the operations of the oversight 
program.
    This final rulemaking formalizes VA's application of the CLIA 
requirements to VA laboratory operations by adding a new section 
17.3500 to 38 CFR, ``VA application of 42 CFR part 493 standards for 
clinical laboratory operations,'' to its medical regulations. Section 
17.3500 addresses CLIA regulations found at 42 CFR part 493, by 
subpart, and how VA will apply those regulations. This rule will also 
allow VA to continue to assure that medical facility laboratories 
across our system perform and report out consistent, accurate, and 
reliable laboratory testing, ensuring the provision of quality testing 
for our patients in a manner comparable to non-VA laboratories.
    In response to the proposed rule, VA received four comments. One 
commenter expressed support for the rule, and we thank the commenter 
for supporting the rule.
    Another commenter noted a grammatical error in the preamble but did 
not suggest any edits be made to the rule. Specifically, the commenter 
noted that in the first paragraph of the Supplemental Information 
section, we referred to the definition of ``laboratory or clinical 
laboratory'' found at 42 U.S.C. 263a(a) and quoted from that statutory 
definition without using quotation marks. The commenter is correct, 
however no change in the regulatory text is needed. We are not making 
any edits to this rulemaking based on this comment, and we thank the 
commenter for their feedback.
    Another commenter provided the same comment twice. The comment was 
supportive of the rule, but provided multiple recommendations 
regarding: (1) Personnel requirements; (2) scope of practice; and (3) 
accreditation organizations. The commenter also attached a comment that 
was submitted to CMS in March 2018 in response to a request for 
information. In this rulemaking, we will only address the comment that 
was directed to VA and will not address the comment directed to CMS.
    1. Personnel Requirements. The commenter raised concerns over the 
academic and clinical training requirements for high complexity 
laboratory personnel to broaden the potential labor force of laboratory 
professionals while simultaneously ensuring they are properly qualified 
to provide high quality testing. The commenter recommended that we 
modify the CLIA personnel requirements to: (1) Allow an earned 
baccalaureate degree with at least 30 hours (or equivalent) of 
coursework in biological and chemical sciences (appropriate to a major 
in one of these sciences) to satisfy the academic degree requirement; 
(2) clarify that all high complexity testing personnel must complete 
clinical training, either from an accredited clinical training program 
or documented laboratory training prior to testing patient samples; (3) 
create personnel standards for histotechnology professionals, requiring 
that they complete an associate degree (or equivalent) in the chemical 
or biological sciences, and complete either an accredited or structured 
training program under the auspices of a board certified pathologist or 
designee; and (4) require all high complexity laboratory personnel to 
pass a national certification examination.
    The purpose of this rulemaking is to fulfill the requirements of 
section 101 of Public Law 102-139 for rules equal to those applicable 
to other medical facility laboratories subject to the CLIA requirements 
as implemented under the Public Health Service Act . As previously 
stated, CMS implemented CLIA regulations at 42 CFR part 493, and VA is 
amending its medical regulations to incorporate those portions of 42 
CFR part 493 as adopted by VA. Personnel requirements for performing 
non-waived testing are addressed in subpart M of 42 CFR part 493, and 
VA will apply all standards from this subpart except the requirements 
to maintain a license in the state where the laboratory is located. In 
other words, in formalizing VA's application of the CLIA requirements 
implemented by CMS, VA cannot adopt less rigorous standards than those 
of CMS.
    While VA cannot adopt less rigorous standards, if deemed necessary, 
VA will further delineate higher personnel qualifications in policy. 
For example, VA currently maintains a higher personnel qualification 
standard for medical technologists in policy. Medical technologists are 
required to possess a combination of a bachelor's degree, or higher, 
and clinical practice experience. Additionally, medical technologists 
must possess, or obtain within one year from date of appointment, an 
appropriate certification from the American Society for Clinical 
Pathology or the American Medical Technologists. Furthermore, in areas 
where VA has not implemented a more rigorous standard than CMS, it is 
because we believe their standards satisfy our specific needs and 
ensure the safety, efficiency, and reliability of our laboratories. 
Like all public institutions, VA must balance the goals of verifying 
staff competency with creating a flexible enough barrier to entry that 
we can attract the best minds from all areas of clinical laboratory 
science.
    We are not making any changes to this rulemaking based on this 
comment.
    2. Scope of Practice. The commenter sought to confirm their 
interpretation that this rule does not impact the scope of practice for 
advanced practice registered nurses (APRNs) to ``order laboratory and 
imaging studies and integrate the results into clinical decision 
making, but not to perform or interpret any laboratory test.'' The 
commenter also ``urged the VA to maintain this policy.''
    The commenter is correct that this rule does not impact APRN scope 
of practice. In a document published in the Federal Register on May 25, 
2016, VA proposed to amend its regulation to permit full practice 
authority of four types of APRNs. 81 FR 33155. Proposed 38 CFR 
17.415(d)(1)(i)(B) stated in part that a certified nurse practitioner 
(CNP) may order, perform, or supervise laboratory and imaging studies. 
Several commenters were concerned with the language, and VA agreed with 
commenters that the language may be construed as allowing CNPs to 
perform laboratory studies. In a document published in the Federal 
Register on December 14, 2016, VA published its final rulemaking and 
amended

[[Page 24496]]

Sec.  17.415(d)(1)(i)(B) to state in part that a CNP may order 
laboratory and imaging studies and integrate the results into clinical 
decision making. 81 FR 90198.
    With that background, we agree with the commenter that this 
rulemaking does not impact Sec.  17.415 and reiterate that the intent 
of this rule is to fulfill the requirements of section 101 of Public 
Law 102-139 for formal rulemaking to adopt standards equal to those 
applicable to other medical facility laboratories in accordance with 
the Public Health Service Act. Additionally, VA maintains requirements 
in policy that specify all testing must be performed under the 
authority of a Pathologist serving as the Chief of Pathology 
(Laboratory Director) and that all point of care testing must be 
overseen by a Medical Technologist Point of Care Coordinator. We are 
not making any changes to this rulemaking based on this comment.
    3. Accreditation Organizations. The commenter questioned whether 
CMS-approved accrediting agencies will assess whether VA clinical 
laboratories are in full compliance with VA requirements and 
recommended that VA ``require all accrediting agencies providing 
services to VA laboratories attest that they assess VA laboratories in 
compliance with applicable VA regulations.''
    There are no accrediting organizations that have standards 
equivalent to VA, and therefore, no accreditation organization can 
effectively inspect VA laboratories to ensure they are compliant with 
all VA regulations. VA uses outside accreditation organizations with 
deeming authority to assess third-party compliance with CLIA 
regulations. The requirements VA has implemented that are more 
stringent than CLIA, or unique to the government, are overseen by the 
VA Office of Inspector General, the Veterans Health Administration 
(VHA) Office of Medical Inspector, and VHA Pathology and Laboratory 
Medicine Service National Enforcement Office. We believe this rigorous 
internal and external oversight provides more thorough oversight than 
could be accomplished by only an external accreditation organization.
    In response to the issues raised by the commenter, VA believes it 
is necessary to amend the language in proposed Sec.  17.3500(e)(1) to 
more accurately reflect VA's utilization of CMS deemed-status 
accreditation organizations in the process of inspection, oversight, 
and operational approval of VA clinical laboratories. ``Operational 
approval'' for VA clinical laboratories includes compliance with both 
standards established by a CMS deemed-status accreditation organization 
and meeting relevant VA standards. Generally, accreditation 
organizations determine whether a laboratory is in compliance with the 
standards established by that organization. If the accrediting 
organization determines that the laboratory complies with those 
standards, it issues a certificate of accreditation. That is only one 
element considered by VA in determining whether the laboratory meets 
all VA standards. In addition to attaining a certificate of 
accreditation, the laboratory must also meet relevant VA standards, 
which may be more stringent than those set by the accrediting 
organization. Also, in some cases VA establishes a standard for testing 
that is not covered by standards established by the accrediting 
organization or addressed in 42 CFR part 493. If the laboratory meets 
applicable accreditation standards and also relevant VA standards, VA 
issues a certificate of compliance, meaning that the laboratory is CLIA 
certified by VA.
    We also note that VA laboratories performing minimally complex 
tests are not required to be inspected and accredited by CMS deemed-
status accreditation organizations, but rather are inspected and CLIA 
certified by VA. Similarly, VA laboratories that perform provider 
performed microscopy testing as outlined in 42 CFR 493.19, are not 
required to be inspected and accredited by CMS deemed-status 
accreditation organizations, but rather are inspected and CLIA 
certified by VA. We amend Sec.  17.3500(e)(1) to state that 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. In 
addition to public comments received, HHS was afforded the opportunity 
to review the rule and provided the following comments and suggestions, 
which we are adopting. First, HHS noted that VA cannot enforce 42 CFR 
part 493 because it is a function of CMS and suggested that language in 
the first sentence of the proposed introductory paragraph of Sec.  
17.3500 be rephrased to reflect that VA laboratories must meet VA's 
alternative requirements under 38 CFR. We agree with this suggestion 
and have removed the phrase ``administered, and enforced'' from the 
first sentence, and combined the first and second sentences to clarify 
that 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 subparts 42 CFR part 493 as implemented by VA. We 
also removed the phrase ``comply with the listed requirements 
established by the Department of Health and Human Services (HHS) under 
the following subparts of 42 CFR part 493'' in the first sentence and 
replaced it with ``requirements established under the following 
subparts of 42 CFR part 493'' because we believe the previous reference 
to HHS is superfluous since 42 CFR part 493 is a regulation established 
by HHS. We believe these revisions clarify that VA laboratories must 
meet VA's additional standards as well as CLIA regulations.
    Second, HHS commented that the intent of the third sentence in the 
proposed introductory paragraph was adequately addressed in the three 
sentences immediately following it. We agree with this comment and have 
removed it; however we have added the phrase ``as well as contracted 
laboratory services performed on site at VA laboratories, outreach 
clinics or other'' to the fourth sentence to clarify that VA implements 
the functions and responsibilities assigned to CMS in 42 CFR part 493 
at VA laboratories and outreach clinics, as well as with contracted 
laboratory services performed on site at VA laboratories or other 
testing sites.
    Third, HHS questioned the legal basis for the language used in the 
fourth sentence of the proposed introductory paragraph regarding VA's 
assumption of the functions and responsibilities assigned to CMS in 42 
CFR part 493. Upon review of HHS' comment, we have amended this 
sentence by replacing the phrase ``assumed by VA'' with ``implemented 
by VA.'' We believe this revision clarifies that VA only performs the 
functions and responsibilities assigned to CMS in 42 CFR part 493 at VA 
laboratories and outreach clinics, as well as with contracted 
laboratory services performed on site at VA laboratories or other 
testing sites.
    Fourth, HHS questioned if VA staff have the requisite knowledge to 
perform validation inspections of VA laboratories as proposed in 
paragraph (e)(4) and suggested that the phrase ``performs validation 
inspections,'' be replaced with ``performs inspections.''

[[Page 24497]]

We agree with the suggestion provided by HHS because a validation 
inspection is performed by CMS whereas VA performs inspections on VA 
laboratories. We are amending the phrase by removing the term 
``validation.''
    Fifth, HHS noted that the language provided in (m)(2) was not clear 
and suggested we revise the sentence. Proposed (m)(2) stated ``Due 
process protections afforded by CMS-certified for laboratories facing 
sanctions are not applicable to laboratories operating under this 
section.'' We agree that this sentence is unclear and have amended it 
to state, ``Due process protections afforded by CMS to CMS certified 
laboratories facing sanctions are not applicable to laboratories 
operating under this section.''
    Based on the rationale set forth in the proposed rule and in this 
document, VA is adopting the provisions of the proposed rule as a final 
rule with the changes noted above.

Paperwork Reduction Act

    This final rule contains no provisions constituting a collection of 
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521).

Regulatory Flexibility Act

    The Secretary hereby certifies that this final rule will not have a 
significant economic impact on a substantial number of small entities 
as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-
612). It would affect only the operations of VA medical facility 
laboratories and any small entity which chooses to enter into a 
contract with VA to provide laboratory services. VA estimates that this 
final rule potentially impacts 37 small entities within NAICS Code 
621511 (Medical Laboratories), which represents 1.3 percent of small 
entities covered by NAICS Code 621511. The small medical laboratories 
impacted by this rulemaking provide contracted medical laboratory 
services at various VA medical facilities, to include VA outpatient 
clinics and VA Community Based Outpatient Clinics. This rulemaking 
decreases the regulatory burden for the 37 small entities who provide 
contract medical laboratory services to VA. Under this rulemaking 
functions and responsibilities assigned to the Centers for Medicare & 
Medicaid Services (CMS) in 42 CFR part 493 are assumed by VA, and 
provisions that are specific to oversight by state licensure programs 
are not applicable. For services performed under a VA contract for 
medical laboratory services the contractors would not be subject to 
potential CMS sanctions under subpart R of 42 CFR part 493 because VA 
does not participate in Medicare or Medicaid programs, and VA is 
responsible for both oversight and enforcement of clinical laboratory 
standards. In addition, state onsite monitoring and monetary penalties 
imposed by CMS as an alternate sanction are not applicable. However, VA 
may cease laboratory testing immediately at any site subject to this 
section upon notification of immediate jeopardy to patients. Therefore, 
pursuant to 5 U.S.C. 605(b), the initial and final regulatory 
flexibility analysis requirements of 5 U.S.C. 603 and 604 do not apply.

Executive Order 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess the 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, and other advantages; distributive impacts; 
and equity). Executive Order 13563 (Improving Regulation and Regulatory 
Review) emphasizes the importance of quantifying both costs and 
benefits, reducing costs, harmonizing rules, and promoting flexibility. 
The Office of Information and Regulatory Affairs has determined that 
this rule is not a significant regulatory action under Executive Order 
12866.
    VA's impact analysis can be found as a supporting document at 
https://www.regulations.gov, usually within 48 hours after the 
rulemaking document is published. Additionally, a copy of the 
rulemaking and its impact analysis are available on VA's website at 
https://www.va.gov/orpm/, by following the link for ``VA Regulations 
Published from FY 2004 Through Fiscal Year to Date.''

Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 
1532, that agencies prepare an assessment of anticipated costs and 
benefits before issuing any rule that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any one year. This final rule will have no such effect on 
State, local, and tribal governments, or on the private sector.

Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
the Office of Information and Regulatory Affairs designated this rule 
as not a major rule, as defined by 5 U.S.C. 804(2).

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance numbers and titles for 
the programs affected by this document are 64.008--Veterans Domiciliary 
Care; 64.011--Veterans Dental Care; 64.029--Purchase Care Program; 
64.033--VA Supportive Services for Veteran Families Program; 64.040--VA 
Inpatient Medicine; 64.041--VA Outpatient Specialty Care; 64.042--VA 
Inpatient Surgery; 64.043--VA Mental Health Residential; 64.044--VA 
Home Care; 64.045--VA Outpatient Ancillary Services; 64.046--VA 
Inpatient Psychiatry; 64.047--VA Primary Care; 64.048--VA Mental Health 
clinics; 64.049--VA Community Living Center; 64.050--VA Diagnostic 
Care; 64.054--Research and Development.

List of Subjects in 38 CFR Part 17

    Administrative practice and procedure, Alcohol abuse, Alcoholism, 
Claims, Day care, Dental health, Drug abuse, Government contracts, 
Grant programs-health, Grant programs-veterans, Health care, Health 
facilities, Health professions, Health records, Homeless, Medical and 
Dental schools, Medical devices, Medical research, Mental health 
programs, Nursing homes, Reporting and recordkeeping requirements, 
Travel and transportation expenses, Veterans.

Signing Authority

    Denis McDonough, Secretary of Veterans Affairs, approved this 
document on March 22, 2021 and authorized the undersigned to sign and 
submit the document to the Office of the Federal Register for 
publication electronically as an official document of the Department of 
Veterans Affairs.

Jeffrey M. Martin,
Assistant Director, Office of Regulation Policy & Management, Office of 
the Secretary, Department of Veterans Affairs.

    For the reasons set forth in the preamble, VA amends 38 CFR part 17 
as follows:

PART 17--MEDICAL

0
1. The general authority citation for part 17 continues, and an entry 
for Sec.  17.3500 is added in numerical order, to read as follows:

    Authority:  38 U.S.C. 501, and as noted in specific sections:
* * * * *
    Section 17.3500 is also issued under Pub. L. 102-139 sec. 101.
* * * * *

[[Page 24498]]


0
2. Add an undesignated center heading following Sec.  17.3250 to read 
as follows:

Clinical Laboratory Standards

0
3. Add Sec.  17.3500 to read as follows:


Sec.  17.3500  VA application of 42 CFR part 493 standards for clinical 
laboratory operations.

    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.

[FR Doc. 2021-08157 Filed 5-6-21; 8:45 am]
BILLING CODE 8320-01-P