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 (NEW) Poor Lab's Guide to the Regulations 2019
Compliance and Inspection Survival Advice for CLIA, The Joint Commission, CAP and COLA
Successful Strategies and Specific Applications of the Regulations
2019, 260 pages, 11" by 9" workbook format, wire coil binding
ISBN 1-886958-32-7
ISBN-13 978-1-886958-32-6
List price: $80.00
REVISED. UPDATED. EXPANDED.
[Use coupon code RICHKNOWLEDGE and save $10 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 June 30, 2020)]
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
- 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
What's New in the 2019 Edition
In early 2019, the CMS unveiled a set of proposed changes to CLIA proficiency testing criteria, the first update since those specifications were originally released in 1992. While these new proposals are not ratified yet, now is the time to consider the impact of tightened proficiency testing criteria on laboratory operations. We also discuss the final FDA guidelines for glucose meters as well as the continuing frustration of using them on “critically ill” patients. These are just a few of the significant changes in regulations that today’s laboratories must confront. 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 2019 edition of the Poor Lab’s Guide, an 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.