Regulatory

Peer review inspection processes promote collaboration and exposure to different ideas and methods

Following safety precautions for each mode of transmission protects staff handling potentially infectious samples

A strong biosafety program can improve and streamline overall safety in clinical microbiology labs

MDCG guidance documents help interpret classification rules for EU MDR and IVDR

Dr. Steffini Stalos discusses common business and regulatory challenges and provides advice to achieving compliance

How to limit and contain lab accidents involving hazardous chemicals

Making it easy for staff to comply with lab safety regulations can help improve compliance

The decision to revoke FDA oversight of LDTs is no longer clear after HHS removed its initial statement

What to do when an emergency strikes in your clinical lab

Industry concerns about IVDR implementation timelines

Frequently asked questions about IVDR

The benefits of ending a trial early must be weighed carefully against the risks

Diagnostic laboratories must improve their level of safety to protect laboratorians from infections

Laboratories often struggle with quality assessments because they don't fully understand the impact these reviews can have on patient care

Pathologists must consider licensing requirements, data privacy, consent, and quality control

The Laboratory Access for Beneficiaries Act will delay PAMA data reporting by one year

How to apply OSHA guidelines in a clinical setting

Precautions must be taken to minimize staff exposure to biological agents

CMS has reopened it's decision on next-generation sequencing in patients with advanced cancers

Hospital outreach labs are now challenged to collect and report private payer pricing, but there may be an upside