Basic Method Validation

Download or read book Basic Method Validation written by James O. Westgard and published by AACC Press. This book was released on 2003-01-01 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the publication of the Final CLIA Rule, new method validation responsibilities came to the laboratory. Previously, moderately complex methods did not need to be validated. But the Final Rule combined moderately and highly complex methods into a category of non-waived methods. Now Laboratories must validate all non-waived methods introduced after April 24, 2003. To help laboratory professionals comply with these new regulatory changes, a second edition of this manual was prepared. Book jacket.