IVDR—The Impact of COVID-19Sherri Fraser, PhD | February 26, 2021 Industry concerns about IVDR implementation timelines
IVDR: The EU’s In Vitro Diagnostic Regulation for Medical Diagnostic TestsSherri Fraser, PhD | February 5, 2021 Frequently asked questions about IVDR
When is it Ethical to Stop a Clinical Trial?Nicholas G. Evans, PhD | September 4, 2020 The benefits of ending a trial early must be weighed carefully against the risks
Safety Measures to Prevent Laboratory-Acquired InfectionKaren L. Stiles, MT(ASCP) , Susanne Peters, MT(ASCP) | May 1, 2020 Diagnostic laboratories must improve their level of safety to protect laboratorians from infections
Getting on Track with Quality AssessmentsMargaret Blaetz | April 30, 2020 Laboratories often struggle with quality assessments because they don't fully understand the impact these reviews can have on patient care
Legal and Regulatory Hurdles in Digital Pathology and TelepathologyKimberly Scott | February 23, 2020 Pathologists must consider licensing requirements, data privacy, consent, and quality control
What the Passing of the LAB Act Means for Clinical LabsClinical Laboratory Management Association | February 19, 2020 The Laboratory Access for Beneficiaries Act will delay PAMA data reporting by one year
Steps to a Safer Clinical LabMari Ishak Gabra, MS | August 31, 2019 How to apply OSHA guidelines in a clinical setting
Bloodborne and Airborne Transmissible Pathogens in the LabMari Ishak Gabra, MS | June 12, 2019 Precautions must be taken to minimize staff exposure to biological agents
Coverage of NGS Cancer Testing RevisitedKimberly Scott | May 31, 2019 CMS has reopened it's decision on next-generation sequencing in patients with advanced cancers
New Reporting Requirements for Hospital Outreach LabsKimberly Scott | March 31, 2019 Hospital outreach labs are now challenged to collect and report private payer pricing, but there may be an upside
How Government Shutdowns Impact HealthcareMindy Levine, PhD | January 9, 2019 The immediate and lingering effects on agencies and people
FDA Suggests Complete Overhaul of IVD RegulationKimberly Scott | December 1, 2018 Proposal of a single regulatory pathway for kits and LDTs spurs controversy
SponsoredRobots for Regulatory ComplianceTecan | December 1, 2018 How an automated workstation can create an audit-ready clinical lab
Biobanks as Mediators Between Researchers and DonorsMichelle Dotzert, PhD | November 21, 2018 Better communication about privacy and confidentiality can help encourage potential biobank donors
CLIA Compliance for Pre-Analytic, Analytic, and Post-Analytic Testing PhasesJohn A. Bilello, PhD | October 24, 2018 Regulatory requirements aim to get the right results to the right patients