SPECIAL REPORT | Better CLIA Compliance: Reviewing Top Deficiencies from Accreditors and Looking to Future CLIA Reform
Fast-track identifying costly compliance gaps in your lab, achieve better CLIA compliance, and get ready for changes in 2024.
This 36-page special report—brought to you by The Dark Report and The Dark Intelligence Group—supports those aiming for excellence in compliance-focused lab operations. Better CLIA Compliance: Reviewing Top Deficiencies from Accreditors and Looking to Future CLIA Reform is designed to give lab directors and compliance officers knowledge and confidence to better oversee their labs’ compliance with the regulations under the Clinical Laboratory Improvement Amendments of 1988 and updates.
Developed from candid conversations with all the key players in clinical laboratory accreditation, certification, and regulatory interpretation, each chapter is designed to build on and deepen the lab leader’s knowledge of essential components of CLIA compliance. Easily add this valuable workbook to the training and education component of your lab’s regulatory compliance program.
Right now, every clinical laboratory has some measure of CLIA compliance risk and weakness, and lab directors will need to meet with their teams to assess what has been missed. Better CLIA Compliance: Reviewing Top Deficiencies from Accreditors and Looking to Future CLIA Reform will educate your entire team and support those aiming for excellence in compliance-focused lab operations.
The following chapters in the Better CLIA Compliance: Reviewing Top Deficiencies from Accreditors and Looking to Future CLIA Reform Special Report will assist lab teams in developing action steps, facilitating growth opportunities, and implementing corrective actions.
Table of Contents
CHAPTER 1 Foundation of Clinical Laboratory Quality: FDA, CDC, CMS, and Now a Diverse Group of Different and Sometimes Conflicting Agendas
CHAPTER 2 Review and Insights from 2023 Clinical Lab Accreditation Roundtable Sessions: Do Problems Found in Clinical Lab Inspections Reveal Widening Quality Gaps?
CHAPTER 3 Hidden Traps in Competency Assessments, Proficiency Testing | Competency Assessments: Secrets to the Big Six Elements | Proficiency Testing: Investigate Ungradable PT
CHAPTER 4 Issues That Keep New CLIA Laboratory Directors Up at Night: Changes in Regulatory Requirements, Changes in Enforcement, Overlooked Sources of Risk
Denise Driscoll, MS, MT(ASCP), SBB, Senior Director, Laboratory Accreditation and Regulatory Affairs, College of American Pathologists
Lindsay Strotman, PhD, Board-Certified, Laboratory Director, Lighthouse Laboratory Services
Carlyn Mathews, Clinical Program Manager, American Association for Laboratory Accreditation, CLIA, CLIP, Platinum, ISO 15189 Programs, A2LA
Kathy Nucifora, MPH, MLS(ASCP), Chief Operating Officer, COLA
Amy Null, MBA, MT(ASCP), SBB, Associate Director, Standards Interpretation Group, Laboratory Accreditation Program, The Joint Commission
Nora Hess, MBA, MT(ASCP), Senior Consultant, Accumen