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Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Rules and Regulations
17.415d1iB 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 102139 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 17.3500e1 to more accurately reflect VAs 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
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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 17.3500e1 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 VAs alternative requirements under 38 CFR. We agree with this suggestion and have removed
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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 VAs 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 VAs 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 e4 and suggested that the phrase performs validation inspections, be replaced with performs inspections.

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