9-Part Series
Clinical Lab Compliance
This series explores compliance in the clinical lab space, including regulations around medical and diagnostic devices, preparing for and conducting lab inspections, regulations around laboratory-developed tests, and more.
Articles in this Series
FDA, CLIA, and ISO—Which Regulations Apply to Your Clinical Lab?
FDA, CLIA, and ISO—Which Regulations Apply to Your Clinical Lab?
How to Create a HIPAA Data Breach Notification Policy
How to Create a HIPAA Data Breach Notification Policy
How to Implement an OSHA Recordkeeping Compliance Plan
How to Implement an OSHA Recordkeeping Compliance Plan
Preparing to Be a Clinical Laboratory Peer Inspector
Preparing to Be a Clinical Laboratory Peer Inspector
Revised ISO 15189 Standards Place More Focus on Mitigating Risk, Patient Care
Revised ISO 15189 Standards Place More Focus on Mitigating Risk, Patient Care
The Benefits of Peer-Based Lab Inspections
The Benefits of Peer-Based Lab Inspections
Clinical Labs in the Spotlight: Compliance Is More Important Than Ever
Clinical Labs in the Spotlight: Compliance Is More Important Than Ever
Changes to FDA Oversight of Lab-Developed Tests
Changes to FDA Oversight of Lab-Developed Tests
