The Poor Lab's Guide to the Regulations 2021 edition
Westgard QC is proud to announce the publication of the 2021 edition of Dr. Sharon S. Ehrmeyer's book, The Poor Lab's Guide to the Regulations.
The Poor Lab's Guide to the Regulations 2021
Compliance and Inspection Survival Advice for CLIA, The Joint Commission, CAP and COLA
Successful Strategies and Specific Applications of the Regulations
2021, 274 pages, 11" by 9" workbook format, wire coil binding
ISBN 1-886958-35-1
ISBN-13 978-1-886958-35-7
List price: $80.00
REVISED. UPDATED. EXPANDED.
[NEW YEAR 2022 OFFER: Use coupon code HERETOHELP and save 20% off the cost of the manual. (Fine print: only 1 coupon per customer, per order. Cannot be combined with other offers. Online store only. Offer Ends February 28th, 2022)]
The SARS-CoV-2 virus taught the world what we always knew: laboratory testing is more important than ever. As the world has grappled with a profound crisis, laboratories everywhere have had to struggle with even more challenges, from the scientific challenge of detecting the virus, the antibodies, and the antigens, to the logistical calamity of supplies and PPE, to the crushing pressure on an already squeezed staff. And on top of all that, the lab has to traverse through an entirely new landscape of emergency regulations.
The 2021 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
- Proficiency Testing
- 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
- COVID-19 testing and regulations: Compliance in the Emergency Use Authorization (EUA) Era
What's New in the 2019 Edition
The 2021 edition adds a dedicated chapter to the Emergency Use Authorization (EUA) era. Not only is there a new set of rules that are not rules, just temporary allowances, there are all the accreditation requirements that derive from them. The COVID-19 era may only last a few years, but the EUA regulations may linger even longer.
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 2021 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.