The Poor Lab's Guide
2017, 252 pages, 11" by 9" workbook format, wire coil binding
REVISED, UPDATED, EXPANDED.
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
The 2017 edition devotes an entire new chapter to the new IQCP requirement, explaining how to structure your IQCP so it can survive inspection.
More than ever, The Poor Lab's Guide is an essential guide to compliance for laboratories large and small.