Rule2022-24990
Clinical Laboratory Improvement Amendments (CLIA) Proficiency Testing Related to Analytes and Acceptable Performance; Correction
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 17, 2022
Effective
July 11, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
In the July 11, 2022 issue of the Federal Register, we published a final rule that updated proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to address current analytes (that is, substances or constituents for which the laboratory conducts testing) and newer technologies. The effective date was August 10, 2022, except for the amendments in amendatory instructions 2 and 5 through 21, which are effective July 11, 2024. This document corrects one technical error identified in the July 11, 2022 final rule.
Full Text
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<title>Federal Register, Volume 87 Issue 221 (Thursday, November 17, 2022)</title>
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[Federal Register Volume 87, Number 221 (Thursday, November 17, 2022)]
[Rules and Regulations]
[Page 68912]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-24990]
[[Page 68912]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 493
[CMS-3355-F2]
RIN 0938-AT55
Clinical Laboratory Improvement Amendments (CLIA) Proficiency
Testing Related to Analytes and Acceptable Performance; Correction
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Final rule; correction.
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SUMMARY: In the July 11, 2022 issue of the Federal Register, we
published a final rule that updated proficiency testing (PT)
regulations under the Clinical Laboratory Improvement Amendments of
1988 (CLIA) to address current analytes (that is, substances or
constituents for which the laboratory conducts testing) and newer
technologies. The effective date was August 10, 2022, except for the
amendments in amendatory instructions 2 and 5 through 21, which are
effective July 11, 2024. This document corrects one technical error
identified in the July 11, 2022 final rule.
DATES: This document is effective July 11, 2024, and is applicable
beginning August 10, 2022.
FOR FURTHER INFORMATION CONTACT: Sarah Bennett, CMS, (410) 786-3531; or
Heather Stang, CDC, (404) 498-2769.
SUPPLEMENTARY INFORMATION:
I. Background
In FR Doc. 2022-41513 (87 FR 41240), the final rule entitled
``Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency
Testing Regulations Related to Analytes and Acceptable Performance''
(hereinafter referred to as the July 11, 2022 final rule), there was a
technical error that is identified and corrected in the regulation text
of this correction. The provision of this correction revises a
regulation that become effective on July 11, 2024.
II. Summary of Errors
On page 41240 of the July 11, 2022 final rule, we made a technical
error in ``Table 2 to Paragraph (c)(2)'' of Sec. 493.933. In this
table, we inadvertently noted the units for ``Carcinoembryonic antigen
(CEA)'' as ``ng/dL'' when the correct units are ``ng/mL.'' Accordingly,
we are revising ``Table 2 to Paragraph (c)(2)'' of Sec. 493.933.
III. Waiver of Proposed Rulemaking and Delay in Effective Date
We ordinarily publish a notice of proposed rulemaking in the
Federal Register to provide a period for public comment before the
provisions of a rule take effect in accordance with section 553(b) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). However, we
can waive this notice and comment procedure if the Secretary finds, for
good cause, that the notice and comment process is impracticable,
unnecessary, or contrary to the public interest, and incorporates a
statement of the finding and the reasons therefore in the rulemaking.
Section 553(d) of the APA ordinarily requires a 30-day delay in
effective date of final rules after the date of their publication in
the Federal Register. This 30-day delay in effective date can be
waived, however, if an agency finds for good cause that the delay is
impracticable, unnecessary, or contrary to the public interest, and the
agency incorporates a statement of the findings and its reasons in the
rule issued.
This correction merely corrects an error in one analyte unit of
measurement in the regulation text of the July 11, 2022 final rule. We
are correcting this technical error to ensure that the table accurately
reflects the policy adopted in the final rule. Therefore, we find that
undertaking further notice and comment procedures to incorporate this
minor technical correction into the final rule is unnecessary and
contrary to the public interest.
For the same reasons, we are also waiving the 30-day delay in
effective date for this correction. We believe that it is in the public
interest to ensure that the July 11, 2022 final rule accurately states
the correct units. Thus delaying the effective date of this correction
would be contrary to the public interest. Therefore, we also find good
cause to waive the 30-day delay in effective date.
Correction
0
Effective July 11, 2024, in FR Doc. 2022-41513, appearing at 87 FR
41194 in the Federal Register of July 22, 2022, on page 41240, in
amendatory instruction 18 for Sec. 493.933, in table 2 to paragraph
(c)(2), the entry for ``Carcinoembryonic antigen (CEA)'' is corrected
to read as follows:
Sec. 493.933 [Corrected]
* * * * *
(c) * * *
(2) * * *
Table 2 to Paragraph (c)(2)--Criteria for Acceptable Performance
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The criteria for acceptable performance are--Analyte or
test Criteria for acceptable performance
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* * * * * * *
Carcinoembryonic antigen (CEA)......................... Target value <plus-minus>15% or <plus-minus>1 ng/mL
(greater).
* * * * * * *
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* * * * *
Elizabeth J. Gramling,
Executive Secretary to the Department, Department of Health and Human
Services.
[FR Doc. 2022-24990 Filed 11-15-22; 4:15 pm]
BILLING CODE 4120-01-P
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