Updated, and Expanded 2015 Edition!
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
getting the right advice is very
In 9 concise chapters, Dr. Ehrmeyer describes a common-sense path to
- An overview of regulations from CLIA, CAP, TJC, and COLA
- Procedure Manuals
- Method Verification, Calibration and Calibration
- Quality Control for the small laboratory
- Personnel Competency Requirements
- Inspection Tips, Tools for
- Point-of-Care testing requirements, IQCP and the
What's New in the 2015 Edition
The last few years (2012 through 2014) have been tumultuous ones for
laboratories. Healthcare reform has brough rushing financial pressures to bear
on many labs. Major regulatory changes are also in the works for Point of Care
devices - where EQC is going to be replaced by IQCP. This 2015 edition of the
PLG explains the theory of IQCP, the specific components of a QCP, and provides
simplified guidance on how to develop an IQCP for each of your tests. Also
covered is the contentious topic of glucose meters being used "off label" on the
"critically ill." Finally, the updated requirements of the Joint Commission,
College of American Pathologists, and COLA are explained.
More than ever, the Poor Lab's Guide is an essential compliance tool for
laboratories large and small.