Federal Register Notice: Department of Health and Human Services, Centers for Medicare & Medicaid Services, 42 CFR Parts 405, 491, and 493

Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attention: CMS-1443-P
P.O. Box 8013
Baltimore, MD 21244-1850

RE: Medicare Program; Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics; and Changes to Clinical Laboratory Improvement Amendments of 1988 Enforcement Actions for Proficiency Testing Referral [CMS-1443-P]

The American Society for Microbiology (ASM) appreciates the opportunity to provide comments to the Centers for Medicare & Medicaid Services (CMS) regarding proposed Changes to Clinical Laboratory Improvement Amendments of 1988 Enforcement Actions for Proficiency Testing Referral described in the Proposed Rule 1443-P. In particular, we wish to comment on proposed changes in policies allowing greater enforcement discretion in defined circumstances of inadvertent proficiency testing (PT) referral described in section IV.

The American Society for Microbiology, headquartered in Washington, D.C., is the largest single life science association, with over 38,000 members worldwide. Its members work in educational, research, industrial, and government settings on issues such as the environment, the prevention and treatment of infectious diseases, laboratory and diagnostic medicine, and food and water safety. The ASM’s mission is to advance the microbiological sciences as a vehicle for understanding life processes and to apply and communicate this knowledge for the improvement of health and environmental and economic well-being worldwide.

Many of ASM’s members have primary involvement in clinical laboratory medicine including individuals directing clinical microbiology, immunology and molecular diagnostic laboratories, individuals licensed or accredited to perform such testing, industry representatives marketing products for use, and researchers involved in developing and evaluating diagnostic tests essential for patient management. As a professional society the ASM is dedicated to excellence in the microbiologic sciences including all aspects of laboratory medicine. Therefore, the ASM has significant interest in ensuring that all aspects of laboratory medicine be conducted in full accordance with the regulations promulgated by the Clinical Laboratory Improvement Amendments of 1988.

With regard to provisions of CLIA pertaining to PT, we agree that independently conducted PT is a cornerstone of regulatory oversight to ensure accuracy and reliability of laboratory testing. At the same time, the ASM believes that that the proposal to allow greater enforcement discretion by CMS in evaluating certain provisions of CLIA regarding referral of proficiency testing samples to an outside laboratory are justified. ASM is in full agreement with the proposed amendments to 42 CFR PART 493 to establish alternate sanctions based on severity and extent of external PT referrals. We agree that this proposal allows full implementation of the Taking Essential Steps for Testing Act of 2012 (PUBLIC LAW 112–202) enacted on December 4, 2012 which allows CMS enforcement discretion to apply such alternative sanctions other than the principal sanctions of revocation of the referring laboratory’s CLIA certificate or prohibitions on laboratory ownership or operations.

We agree that the 3 categories of referrals defined in the proposal are reasonable and allow CMS the ability to respond to referral of PT samples out of compliance with CLIA regulations in an appropriately measured manner. Thus the full force of sanctions for non-compliance will be applied in instances of egregious violations of referral in which a laboratory misrepresents referral laboratory results as their own or represents the situation of repeat referral. In contrast, we agree that a certificate suspension may be reasonably applied in circumstances in which a referral of a PT sample is made, but the referring laboratory reports its’ own results and the situation is not a repeat event. Finally, we agree that in the third circumstance in which referral results are not received prior to the PT due date and can therefore not be used by the referring laboratory in reporting their own results, alternate sanctions including civil monetary penalties and a directed corrective action plan is appropriate. The latter circumstance is almost always associated with an unintentional action by the laboratory.

To conclude, the ASM fully supports the Changes to Clinical Laboratory Improvement Amendments of 1988 Enforcement Actions for Proficiency Testing Referral outlined in CMS-1443-P. We are aware on widely publicized situations in clinical laboratories involving inadvertent referral of PT samples that have had the potential to severely jeopardize patient’s access to laboratory services when a CLIA certificate is suspended. We are in complete agreement with the proposals to offer CMS greater enforcement discretion over improper PT referrals while also re-affirming the importance and value of the CLIA-directed PT processes.

Sincerely,

Vickie S. Baselski, PhD, DABMM, FAAM
Chair, Committee on Professional Affairs
Public and Scientific Affairs Board


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