2021 Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing (CAMLAB) Doody's Expert Review Review Questionnaire ISBN: 9781635851823 ISBN-10: 1635851823 Copyright: 2021 Edition: 1st Author: The Joint Commission, Doody's Expert Review    Score: 93 Doody's Star Rating™ and Doody's Expert Review provide by Doody Enterprises, Inc. Reviewer: Valerie Ng,  PhD MD  (Alameda County Medical Center/Highland Hospital) Description This is the 2021 edition of The Joint Commission's (TJC) comprehensive accreditation manual for laboratory and point-of-care testing (CAMLAB). The manual is updated annually; the last version was published in 2020. Purpose The purpose of this book is to provide updated information and elements of performance to achieve TJC accreditation for clinical laboratories and/or point-of-care testing (POCT) programs. These are worthy objectives once again well met by this book. Audience This book is intended for anyone involved in a clinical laboratory and/or POCT program accredited by TJC. This includes those inside the clinical laboratory to those external in healthcare organizations for which continued laboratory and/or POCT accreditation is essential for continued operations. Features This edition continues the layout and tradition of previous editions. It starts with a brief summary of updates, followed by explanatory chapters on the various TJC accreditation requirements. For clinical laboratories and/or POCT programs, the most relevant sections will be the Quality System Assessment (QSA) and Waived Testing (WT) chapters, both of which nicely displays the Clinical Laboratory Improvement Amendments (CLIA) requirements and TJC expectations for demonstration of successful compliance. There are few changes to this edition, with the most notable being for embryology labs related to revised guidelines and recommendations from the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology. There has been one substantive change for molecular testing in that "verification" was replaced with "validation" for QSA15.02.01. These two terms have created confusion within laboratories for a few decades and it would be nice if this section on molecular testing could be more detailed; specifically, a discussion of situations requiring "verification" (e.g., implementing a commercial molecular assay without deviation from manufacturer's specifications) versus "validation" (e.g., developing a test in its entirety by a laboratory, or a "laboratory developed test"). The authors should consider using the CLSI definitions, which are very clear and globally harmonized, for the next edition. Assessment If you are accredited by TJC, this is a no brainer. Get this manual and use it often. Review Questionnaire Range Question Score 1-10 Are the author's objectives met? 10 1-10 Rate the worthiness of those objectives. 10 1-5 Is this written at an appropriate level? 5 1-5 Is there significant duplication? (1=significant, 5=insignificant) 4 1-5 Are there significant omissions? (1=significant, 5=insignificant) 4 1-5 Rate the authority of the authors. 4 1-5 Are there sufficient illustrations? N/A 1-5 Rate the pedagogic value of the illustrations. N/A 1-5 Rate the print quality of the illustrations. N/A 1-5 Are there sufficient references? 5 1-5 Rate the currency of the references. 4 1-5 Rate the pertinence of the references. 4 1-5 Rate the helpfulness of the index. 4 1-5 If important in this specialty, rate the physical appearance of the book N/A 1-10 Is this a worthwhile contribution to the field? 10 1-10 If this is a 2nd or later edition, is this new edition needed? 10 ©2024 Doody Enterprises, Inc.