Regulatory Roundup is your resource for regulatory and compliance changes and updates, offered up in digestible, easy-to-understand summaries. With the roundup, learn:
- What’s happening and why
- Who’s affected
- How you should prepare
Effective date: November 1, 2017
The Association for the Advancement of Medical Instrumentation (AAMI) has released updated healthcare sterilization guidelines in the Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities.
FDA Bans Triclosan in Hand Hygiene Products
Effective date: December 19, 2017
The FDA has released a final ruling that Triclosan, an antibacterial and antifungal agent, can no longer be used as an active ingredient in hand hygiene products used in healthcare settings.
Conditions of Participation for Home Health Agencies
Effective date: January 13, 2018
CMS has released revised Conditions of Participation (CoPs) that home health agencies must meet in order to participate in the Medicare and Medicaid programs.
PAMA Lab Reimbursement Changes
Effective date: January 1, 2018
CMS is mandating new lab reimbursement rates in the Clinical Laboratory Fee Schedule (CLFS) under the Protecting Access to Medicare Act (PAMA).
FDA Flu Reclassification
Effective date: January 12, 2018
The Food and Drug Administration (FDA) is reclassifying rapid influenza antigen detection tests, mandating that Visually Read Rapid Flu Tests must adhere to higher performance standards.
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