The Poor Lab's Guide 2021
The New Poor Lab's Guide to the Regulations - 2021 edition
JUST PUBLISHED!
274 pages, 11" by 9" workbook format, wire coil binding
ISBN 1-886958-35-1
ISBN-13 978-1-886958-35-7
REVISED, UPDATED, EXPANDED.
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.
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 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
- Individualized Quality Control Plans (IQCPs)
- Quality Assurance
- Personnel Competency Requirements
- Inspection Tips, Tools for Self-preparedness
- Point-of-Care testing requirements
- COVID-19 testing methodologies and regulations
What's New in this 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 guide to compliance for laboratories large and small.