Compliance

Theranos Whistleblowers to Give Fireside Chat at AACC 2022

Erika Cheung and Tyler Shultz—two of the key Theranos whistleblowers—will speak in a special fireside chat at AACC 2022.

Compliance

COLA Launches Toolkit for Waived Laboratories

COLA’s Waived Testing Toolkit provides guidance and tools to help staff achieve and maintain waived testing excellence, including guidance on covid-19 reporting.

Compliance

FDA Updates FAQs on Testing for Covid-19

The changes make it easier to navigate to questions by topic.

CMS Approves COLA for Virtual Laboratory Surveys

Aug 14, 2020 | Accreditation, Compliance

The virtual laboratory survey process consists of three parts: documentation, review, and a video conference.

FDA Posts New Template for Covid-19 Diagnostics for Non-Lab Settings

Jul 30, 2020 | Compliance, Covid 19

The template will help developers submit EUA requests for covid-19 diagnostics that can be performed entirely in settings such as homes, offices, or schools.

FDA Virtual Town Hall for Clinical Labs, Manufacturers

Jul 28, 2020 | Compliance, Covid 19

On July 29, the FDA will host a virtual Town Hall for clinical labs and commercial manufacturers involved in developing diagnostic tests for SARS-CoV-2.

FDA Updates Templates for Serology Test EUA Requests

Jun 26, 2020 | Compliance, Covid 19

The updates clarify FDA’s previous recommendations for demonstrating clinical performance and presenting validation data and provide new recommendations.

Managing Prior Authorizations with Artificial Intelligence

Apr 13, 2020 | Compliance, Computing Systems, Information Technology, Lab Management, Middleware & Software

AI-driven software can help labs expertly navigate the prior authorization landscape.

FDA Proposes to Reclassify Two Types of Hepatitis C Virus Diagnostic Tests

Apr 8, 2020 | Compliance, Infectious Diseases, Lab Management, Molecular Diagnostics

If the agency’s proposed reclassification is finalized, devices of this type may go through the 510(k) pathway for clearance instead of the premarket approval (PMA) pathway.

Digital Pathology Association Commends CMS for Waiving Restrictions on Remote Pathology Diagnoses

Mar 31, 2020 | Compliance, Covid 19, Emerging & Zoonotic Diseases, Infectious Diseases, Lab Management

The waiver will provide temporary relief from federal regulations requiring pathologists to render primary diagnoses onsite at healthcare facilities.

CMS Issues Change Request for HCPCS Codes

Mar 12, 2020 | Compliance, Covid 19, Emerging & Zoonotic Diseases, Infectious Diseases, Lab Management

CMS has issued a change request to inform Medicare administrative contractors about new HCPCS codes that are subject to and excluded from CLIA edits.

HHS Finalizes Historic Rules to Provide Patients More Control of Their Health Data

Mar 11, 2020 | Compliance, Information Technology

Final rules require access to health information, spur innovation, and aim to end information blocking.

FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19

Mar 9, 2020 | Compliance, Covid 19, Emerging & Zoonotic Diseases, Infectious Diseases

FDA and the Federal Trade Commission (FTC) issued warning letters to seven companies for selling fraudulent COVID-19 products.

FDA Issues Clinical Laboratory Improvement Amendments-Related Final Guidances

Mar 8, 2020 | Compliance

FDA has recently issued two guidance documents for developers of in vitro diagnostics.

Illumina Files Patent Infringement Suits against BGI in Sweden and the United Kingdom

Jan 10, 2020 | Compliance, Molecular Diagnostics

Illumina has filed two additional patent infringement suits relating to BGI’s sequencing products. Related patent suits are pending in Denmark, Germany, Switzerland, Turkey and the United States.