Division of Quality Assurance: Notifications & Updates

Attn: Wisconsin Clinical Laboratories

The following are important Clinical Lab Notifications:

1.  “Guidance for the Deployment of the Emergency Use Approval (EUA) Zika Virus Tests” (CMS Survey and Certification (S&C) Memo 16-16-CLIA)  https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-16.pdf

2.  “Personnel Policies for Individuals Directing or Performing Non-waived Tests” (CMS S&C Memo 16-18-CLIA)  https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-18.pdf

3. “Policy Clarification on Acceptable Control Materials Used when Quality Control (QC) is Performed in Laboratories: (CMS S&C Memo 16-20-CLIA)  https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-20.pdf

4. State Agency Survey Guide for Clinical Laboratories (Publication P-01227)  https://www.dhs.wisconsin.gov/publications/p01227.pdf

Please do not reply directly to this email message. If you have a question about this information, email the Division of Quality Assurance.