The Poor Lab's Guide 2023-2024
Compliance and Inspection Survival Advice for CLIA, The Joint Commission, CAP and COLA
Successful Strategies and Specific Applications of the Regulations
2023, 274 pages, 11" by 9" workbook format, wire coil binding
List price: $80.00
REVISED. UPDATED. EXPANDED.
As the official emergency of the pandemic subsides, laboratories continue to grapple with the Emergency Use Era (EUA). Learning what regulations are phasing out and which rules are going to endure is one of the next great challenges.
On top of that, the greatest change in proficiency testing criteria since their original 1992 introduction is happening NOW. 2024 will see significant tightening of PT goals, and dozens of new tests added to direct regulation under CLIA.
The 2023-2024 Poor Lab's Guide is here to help.
More than 250 years ago, one of the founding fathers, Benjamin Franklin, published a yearly almanac that contained a collection of useful information and advice for the American colonists. Titled Poor Richard's Almanack, it was one of the first bestsellers of America. For decades, Franklin's almanac provided indispensable advice and encouragement to struggling settlers in the new world.
Summoning that spirit, Dr. Sharon S. Ehmeyer has written The Poor Lab's Guide to the Regulations, a plain-language discussion of the rules, requirements and regulations that govern medical laboratories, with a focus on US medical laboratories.
Achieving and maintaining compliance isn't an easy task. But with the new Poor Lab's Guide, getting the right advice is very easy.
In 11 concise chapters, Dr. Ehrmeyer describes a common-sense path to compliance:
- An overview of regulations from CLIA, CAP, TJC, and COLA - and how TJC no longer recognizes COLA
- Proficiency Testing - highlighting the 2024 changes to CLIA
- Procedure Manuals
- Method Verification, Calibration and Calibration Verification
- Quality Control for the small laboratory
- Individual Quality Control Plans (IQCPs)
- Quality Assurance
- Personnel Competency Requirements
- Inspection Tips, Tools for Self-preparedness
- Point-of-Care testing requirements
- Pandemic testing regulations, past, present and future: how much of the Emergency Use Authorization (EUA) will endure
What's New in the 2023-2024 Edition
The 2023-2024 edition highlights the greatest change in PT goals in a generation. Some goals are tightening up to 40%, a massive change after three decades of status quo. While updates to the performance standards were overdue, laboratories might be forgiven if they experience a wave of whiplash.
Even as the official Public Health Emergency ends, the EUA era lives on. What regulations - or lack of regulations - will endure into the future is discussed. As well as key points for preparedness for the inevitable coming of the next new pandemic.
And of course, the accreditation organizations, The Joint Commission (TJC), the College of American Pathologists (CAP), and COLA have issued updated requirements.
All this and more is covered in the 2023-2024 edition of the Poor Lab’s Guide, the essential compliance tool for laboratories large and small.
About the Author
Sharon Ehrmeyer, Ph.D., MT(ASCP), is Professor of Pathology and Laboratory Medicine and Director of the Clinical Laboratory Science/Medical Technology Program at the University of Wisconsin's Medical School in Madison, Wisconsin. She currently is the secretary for AACC's POCT Division and completed a 6-year term on the Board of Directors for CLSI (formerly NCCLS) and the chairmanship of AACC's Government Relations Committee. Dr. Ehrmeyer's research areas focus on laboratory quality issues, laboratory regulations impact on laboratory practices, and POCT. She has written numerous book chapters and journal articles and has presented these interests nationally and internationally.
For decades, Dr. Sharon S. Ehrmeyer, Ph.D., has been guiding laboratories in their compliance efforts. She speaks frequently on CLIA, CAP, The Joint Commission, and COLA. She is an expert at decoding bureaucratic jargon and translating it into easily-understood tasks. Her down-to-earth tips and pragmatic advice have made her a favorite at conferences around the world. Now all of her recommendations (and more) are available in this reference manual.