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The Poor Lab's Guide

The latest guide to compliance with CLIA, CAP, TJC and COLA rules, regulations, and requirements.
The New Poor Lab's Guide to the Regulations - 2017 edition
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252 pages, 11" by 9" workbook format, wire coil binding
ISBN 1-886958-32-7
ISBN-13 978-1-886958-32-6


Compliance and Inspection Survival Advice for CLIA, The Joint Commission, CAP and COLA

Successful Strategies and Specific Applications of the Regulations

The Poor Lab's Guide is 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.

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.

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
  • Individualized Quality Control Plans (IQCPs)
  • Quality Assurance
  • Personnel Competency Requirements
  • Inspection Tips, Tools for Self-preparedness
  • Point-of-Care testing requirements

What's New in this 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, the essential guide to compliance for laboratories large and small.


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