Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
White House requires all private-sector employers with 100 or more employees to mandate vaccination or a weekly negative COVID-19 test
By Mike O'Brien President Biden spoke from the White House Sept. 9 to announce his new Path Out of the Pandemic Plan. Among other things, President Biden has instructed the Occupational Safety and Health Administration (OSHA) to develop rules that will require...
Is it worth the risk assessment?
By Dan Scungio As safety professionals, we know performing risk assessments is worth it—it is an integral piece of managing a safety program. Assessing risks and identifying hazards are considered the beginning steps that must be completed when approaching the...
Model Lab Workplace Vaccine Passport Policy
Although courts have yet to weigh in on the issue, guidelines from the US Equal Employment Opportunity Commission and other regulatory agencies indicate that employers may implement vaccine passports if they perform a workplace assessment and determine that...
