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News & Press: General News

Attention ASHI-Accredited Laboratories

Tuesday, November 3, 2015   (0 Comments)
Posted by: Rebecca Riedesel
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Please be aware of the following CMS approved ASHI Standards that are effective October 1, 2014. The mandatory compliance date for the final rule regarding Patient Access to Test Reports is October 6, 2014.

Within the last several months, CMS published two Final Rules that affect CLIA.

1. Federal Register, Vol. 79, No. 25, CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports; Final Rule. HIPAA covered entities must comply with the applicable requirements of this final rule by October 6, 2014. http://www.gpo.gov/fdsys/pkg/FR-2014-02-06/pdf/2014-02280.pdf

2. Federal Register, Vol. 79, No. 91, Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Part II. Effective May 12, 2014. http://www.gpo.gov/fdsys/pkg/FR-2014-05-12/pdf/2014-10687.pdf

CMS-approved laboratory accreditation programs and CLIA-exempt State licensure programs must ensure that their requirements are updated to meet the regulation changes published in the Final Rules. The Quality Assurance and Standards Committee (QAS) has been working on updates to the 2013 ASHI Standards to address these regulation changes. These updates have been submitted to CMS and have been approved. To assist you in maintaining your compliance, a crosswalk listing the applicable regulations and corresponding CMS approved ASHI Standards is provided here in Attachment A.

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