FDA Updates 2008 Guidance on Categories of Lab Testing

The Food and Drug Administration (FDA) released March 12 an updated guidance on categorization of laboratory tests. The document, “Administrative Procedures for CLIA Categorization: Guidance for … [Read more...]

April Update of CLIA-Waived Tests, Billing Codes

The April 4, 2014, update to the list of tests waived under the Clinical Laboratory Improvement Amendments (CLIA) includes eight new tests approved by the Food and Drug Administration. When billing … [Read more...]

Joint Commission Clarifies Stance on IQCP

The Joint Commission has published a list of frequently asked questions (FAQs) to address its expectations related to the Individualized Quality Control Plan (IQCP) for clinical laboratories. On Jan. … [Read more...]

CMS Divides PT Sanctions Into 3 Categories, Limits Reach of Ban

The Centers for Medicare and Medicaid Services (CMS) has finalized a proposal to divide proficiency testing (PT) sanctions into three categories based on the severity and extent of the violation. In … [Read more...]

Hospitals Urge FDA to Delay Final Guidance On Blood Glucose Monitoring Systems

The American Hospital Association (AHA) in a recent comment letter criticized a Food and Drug Administration (FDA) draft guidance on prescription point-of-care (POC) use blood glucose monitoring … [Read more...]

Stakeholder Group Calls for Reform of CLIA Waiver Process

A newly formed stakeholder group wants the Food and Drug Administration (FDA) to ease restrictions on where diagnostic tests can be performed. James Boiani, head of the Coalition for CLIA Waiver … [Read more...]

LDT Guidance Unlikely to Be Released Anytime Soon

Draft guidance from the Food and Drug Administration (FDA) of lab-developed tests appears to be stuck at the Office of Management and Budget and likely will not be released any time soon, according to … [Read more...]

FDA Plans to Regulate Lab-Developed Tests Could Increase Time and Cost of Development

While it’s too soon to say what effect the Food and Drug Administration (FDA) decision to move forward with plans to regulate lab-developed tests (LDTs) will have on clinical and anatomic pathology … [Read more...]

Lab Execs Air Concerns Over FDA Regulation of LDTs

The U.S. Food and Drug Administration (FDA) late last week officially issued its draft framework for how the agency plans to regulate laboratory-developed tests (LDTs). The 41-page framework, which … [Read more...]

Labs Urged to Coordinate With CDC on Ebola Testing

The Centers for Medicare and Medicaid Services (CMS) is urging clinical laboratories to coordinate with the Centers for Disease Control and Prevention (CDC) and state public health laboratories before … [Read more...]