LDT Regulation: New Survey Asks Readers for Their Views About Two Bills Before Congress

Survey respondents can give their opinions about the proposed VALID and VITAL acts Two bills are pending in Congress, and each is written to change the current regulatory scheme for laboratory-developed tests (LDTs) and in vitro clinical tests (IVCTs). The bills go by the acronyms of the VALID Act and VITAL Act. Many clinical laboratories offering LDTs today may be unaware of the details within each bill as currently written. An LDT is a proprietary diagnostic test developed and performed by...

Mayo Clinic Laboratories Used Ingenuity, Flexibility, and Teamwork to Fast-Track COVID-19 Testing Capacity, Including Hiring Hundreds of Lab Workers

As coronavirus pandemic emerged, the Minnesota reference laboratory surged its testing capacity from 2,600 to 20,000 samples per day in an effort to meet ever-increasing demand Over the past several years, medical laboratory workforce shortages worldwide have challenged clinical laboratory managers to process increasing numbers of clinical laboratory tests with fewer staff. But that did not prepare them for the Herculean task of processing millions of tests each week! According to the CDC’s...

House Bill HR 1313 Would Allow Employers to Demand Workers’ Genetic Test Results or Face Up to 30% Increase in Healthcare Premiums

Critics claim the bill would remove genetic privacy and discrimination protections provided by the 2008 GINA Act and other federal laws and might cause medical laboratories performing these tests to become embroiled in employee-employer disputes Pathology groups and clinical laboratories are closely watching how society reacts to information that comes from genetic testing. Thus, the groundswell of opposition against a House bill that would require employees participating in workplace wellness...

FDA Looks to Clamp Down on Laboratory-Developed Tests and Put an End to ‘Wild West of Medicine’: Might CLIA Problems at Theranos Support FDA’s Position?

The Wall Street Journal examines the FDA’s position on LDTs and looks at the pros and cons of LDT regulation by the federal agency National news coverage over the deficiencies uncovered by Clinical Laboratory Improvement Amendments (CLIA) inspections of the clinical laboratory operated by Theranos in Newark, Calif., may have an interesting consequence that affects all medical laboratories and pathology groups. Over the past 30 months, Theranos has regularly asserted that its...

Congress Passes Law Changing How Medicare Sets Prices for Clinical Laboratory Tests; Lab Industry Groups Differ on Which Labs Will Be Winners and Losers

Leaders from ACLA, AdvaMedDx, CAP, NILA will be at Executive War College on April 29-30 for first medical lab industry debate about the best and worst of the new law Clinical laboratories will face new financial challenges following passage of a new federal law two weeks ago that makes deep changes in the way Medicare officials will establish prices for the Medicare Part B Clinical Laboratory Fee Schedule (CLFS). Many medical laboratory administrators, hospital lab managers, and pathologists...
;