CMS Publishes Final Rules

On September 30, 2019, CMS published Final Rules in the Federal Register (linked below) that affect acute care hospitals, critical access hospitals, and ambulatory surgery centers, as well as other deemed status healthcare facilities. All regulations are effective November 29, 2019 with the exceptions of those regarding QAPI in CAHs and the antibiotic stewardship programs…

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Food and Drug Administration Categorization Notification

Food and Drug Administration Categorization Notification for McKesson Consult Immunochemical Fecal Occult Blood Test Attention:  Clinical Laboratories, Acute Care Hospitals, Critical Access Hospitals Please share this announcement with the following: Medical Director, Laboratory Services Administrative Director and Managers, Laboratory Services On May 4, 2018, the Food and Drug Administration published notice for “McKesson Consult Immunochemical Fecal Occult Blood…

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CMS QSO (FORMERLY S&C) MEMO #18-14-CLIA

“Clarification Regarding Fine Needle Aspiration (FNA) Specimen Adequacy Assessment, Rapid On-site Evaluation (ROSE) and Workload Limits.” Attention: Clinical Laboratories, Acute Care Hospitals, Critical Access Hospitals Please share this announcement with the following: Medical Director, Laboratory Services Administrative Director and Managers, Laboratory Services This CMS Quality, Safety and Oversight memo was issued on March 16, 2018.…

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CMS QSO Memo #18-11-CLIA Release of RFI

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…

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