Clinical BiochemistryStudent’s Laboratory Manual


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This document brings a comprehensive, structured approach to creating a Laboratory Quality Manual, for use in all types of analytical laboratories, based on the twelve Quality System Essentials (QSE) within a Quality Management System (QMS).


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The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. CDC, in partnership with CMS and FDA, supports the CLIA program and clinical laboratory quality.


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First of all, this book is the size and weight of ASM's Manual of Clinical Microbiology back when it was a single volume, or Henry's Clinical Diagnosis and Management by Laboratory Methods, 22nd edition, McPherson and Pincus (Elsevier, 2011) or Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 5th edition, Burtis et al. (Elsevier.


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The key to developing an effective lab manual is ensuring that it aligns with the protocol and that no detail is overlooked. When designing the manual, it is important to perform the following tasks: Outline which kit type (s) will be needed for each scheduled study visit


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Blood Specimens Step 1: Determine the Specimen Requirements In the Test Catalog, use the Specimenand Overviewtabs of each test to identify: • Patient preparation requirements • Specimen requirements •Specimen container requirements •Specimen stability (temperature) requirements •Collection instructions •Required forms or special instructions


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The procedure manual should be written at a level that everyone in the laboratory can understand. It must be useful, clear to the user, and available at the bench/work area. All testing.


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This manual appears to be current and relevant and has a strong workplace relevance for a hematology laboratory scientist. Clarity rating: 5 The manual is written in a clear and easily understood format and integrates concepts in concise paragraphs outlining cause and laboratory test results. Consistency rating: 5


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1 January 2014 | Technical document Download (1.2 MB) Overview The quality manual template is a supplement to the laboratory quality management system training toolkit, Module 16 - Documents and records.


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When manual methods dominated in most clinical laboratories, the clinical laboratory scientist was almost completely focused on the analytical performance of the test. When automated instruments arrived in the laboratory, the laboratory scientist at the bench had to develop new skills that focused on demonstrating that the instrument was.


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