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Basic method validation / James O. Westgard, PhD ; with contributions from Nils Persons, PhD, Sten Westgard, MS.
Veterinary: Atwood Library (Campus) RB36.3.Q34 W468 2020
Available
- Format:
- Book
- Author/Creator:
- Westgard, James O., 1941- author.
- Series:
- Back-to-basics.
- Back to basics
- Language:
- English
- Subjects (All):
- Medical laboratories--Quality control.
- Medical laboratories.
- Diagnosis, Laboratory--Quality control.
- Diagnosis, Laboratory.
- Medical laboratories--Management.
- Quality control.
- quality control.
- Clinical Laboratory Techniques--standards.
- Quality Control.
- Laboratories--organization & administration.
- Research Design.
- Medical Subjects:
- Clinical Laboratory Techniques--standards.
- Quality Control.
- Laboratories--organization & administration.
- Research Design.
- Genre:
- programmed textbooks.
- Programmed instructional materials
- Programmed instructional materials.
- Physical Description:
- 312 pages : illustrations, maps ; 22 cm
- Edition:
- 4th edition.
- Other Title:
- Basic method validation and verification : training in analytical quality management for healthcare laboratories
- Place of Publication:
- Madison, WI : Westgard QC, Inc., [2020]
- Summary:
- "For 50 years, Dr. James O. Westgard has championed standards of quality and best practices for method validation. In this, the fourth edition of Basic Method Validation, Dr. Westgard and colleagues provide important updates on regulatory requirements, evolving standards of practice, and the latest guidelines from CLSI, FDA, CMS, and ISO : new coverage of the validation and verification of qualitative and semi-quantitative testing, a topic critically important in the age of SARS-COV-2 ; update of CLIA regulations and accreditation requirements ; discussion of Laboratory-Developed Tests (LDTs) ; full coverage of the different studies necessary for validation and verification ; detailing of strengths of different regression techniques for comparison of methods. Fully updated, revised, and expanded, Basic Method Validation also provides online access to graphing tools, videos, and extensive examples of validation and verification. In an era where the quality of methods may be in doubt, the fourth edition is even an more essential reference for the modern laboratory."-- taken from back cover.
- Contents:
- Is quality still an issue for laboratory tests?
- How do you manage quality?
- What is the purpose of a method validation study?
- What are the regulatory requirements for basic method validation?
- How is a method selected?
- What experiments are necessary to validate or verify method performance?
- How are the experimental data analyzed?
- How is the reportable range of a method determined?
- How is the imprecision of a method determined?
- How in the inaccuracy (bias) of a method determined?
- What's another way to determine accuracy?
- How do you test for specific sources of inaccuracy?
- What is the lowest test value that is reliable?
- How is a reference interval verified?
- How do you judge the performance of a method?
- What's a practical plan for validating / verifying?
- How do you validate a qualitative method?
- How can claims be evaluated on the Sigma scale?
- Self-assessment answers
- The statistical appendix.
- Notes:
- "Revised & Expanded"--front cover.
- Subtitle from front cover.
- "Nils Persons" on the title page is a misspelling of 'Nils Person'.
- Includes bibliographical references and index.
- Local Notes:
- Acquired for the Penn Libraries with assistance from the Clarence J. Marshall Memorial Library Fund.
- ISBN:
- 1886958335
- 9781886958333
- OCLC:
- 1243027483
- Publisher Number:
- 99994312412
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