The Poor Lab's Guide to the Regulations
Westgard QC is proud to announce the publication of the latest edition of Dr. Sharon S. Ehrmeyer's book, The Poor Lab's Guide to the Regulations.
The Poor Lab's Guide to the Regulations
Compliance and Inspection Survival Advice for CLIA, The Joint Commission, CAP and COLA
Successful Strategies and Specific Applications of the Regulations
2025, 9" by 6" paperback
List price: $80.00
REVISED. UPDATED. EXPANDED.
In December 2024, the CLIA personnel qualifications changed. Then in June 2025, they changed again. Some of the changes cancelled each other out. Some of them didn't. In any case, confusion abounds over who is still qualified to work and supervise laboratories, and what skills - and additional training - they might now need.
On top of that, the greatest change in proficiency testing criteria since their original 1992 introduction finally took effect on January 1st, 2025, reducing the criteria for acceptability by 20 to 40% or more on some directly regulated analytes, and even larger reductions for newly regulated analytes.
The 2025-2026 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 10 concise chapters, Dr. Ehrmeyer describes a common-sense path to compliance:
- An overview of regulations from CLIA, CAP, TJC, and COLA
- Proficiency Testing - highlighting the 2025 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 - updated and reconciled to all the new changes
- Inspection Tips, Tools for Self-preparedness
- Point-of-Care testing requirements
- Downloadable electronic forms, to help you with personnel, competency, quality indicators, mock inspection, and mock tracers
What's New in the 2025-2026 Edition
The new personnel requirements across all roles and responsibilities are outlined, and a set of downloadable, interactive forms are included with the purchase of the manual.
The PT criteria that became official on January 1st, 2025 are detailed.
And of course, all the updates on the accreditation organizations, The Joint Commission (TJC), the College of American Pathologists (CAP), and COLA
All this and more is covered in the latest 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.