CMS QSO (formerly Survey and Certification) Memo #18-11-CLIA “Clinical Laboratory Improvement Amendments (CLIA) Release of Request for Information (RFI).”

Attention:  Clinical Laboratories, Acute Care Hospitals, Critical Access Hospitals

On January 5, 2018, CMS published Quality, Safety and Oversight (formerly Survey & Certification) Memo # 18-11-CLIA, “Clinical Laboratory Improvement Amendments (CLIA) Release of Request for Information (RFI).”

Key Points:

The Centers for Medicare & Medicaid Services (CMS) published an RFI on January 5, 2018.

The RFI is seeking public comment and information related to the following areas:

  • Personnel requirements: nursing and physical science degrees, competency assessment, laboratory training and experience requirements and documentation
  • Proficiency testing referral: Discretion for Category 1, alternative sanctions imposed for Certificate of Waiver (CoW)
  • Histocompatibility
  • Compliance and additional fees

CMS is also seeking public comment related to appropriate sanctions in situations where we determine that a laboratory has referred its proficiency testing (PT) samples to another laboratory and has reported the other laboratory’s result as their own.

To Submit Public Comments:

CMS encourages comments, questions, or thoughts on this RFI and will accept comments until March 12, 2018. The RFI can be downloaded from the Federal Register by clicking here.

Click here to read the full CMS QSO #18-11.

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