Quality assurance handbook for veterinary laboratories / James E.C. Bellamy & Dennis W. Olexson.

Format:

Book

Author/Creator:

Bellamy, James E. C.

Contributor:

Olexson, Dennis W.

Language:

English

Subjects (All):

Veterinary laboratories--Quality control--Handbooks, manuals, etc.

Veterinary laboratories.

Quality control.

Genre:

Handbooks and manuals.

Physical Description:

x, 101 pages : illustrations ; 28 cm

Edition:

First edition.

Place of Publication:

Ames : Iowa State University Press, 2000.

Summary:

Every veterinary laboratory can benefit from a quality assurance program. A laboratory quality assurance program has one overall objective -- to provide confidence in the validity of the laboratory's test results and services.

This volume outlines the general components of quality assurance and allows for customization of procedures by individual laboratories. Sections discuss quality goals and policies; quality of resources; evaluating new procedures; quality of operations; internal and external quality monitoring procedures; and quality considerations for point-of-care testing and office laboratories.

Contents:

Overview of a Laboratory Quality Assurance Program 4

The Laboratory Quality Manual: A Framework for Quality Assurance 6

Value of a Laboratory Quality Assurance Program 8

2. Quality Goals 11

Analytic Error and Allowable Error 12

Selecting Quality Goals 13

3. Mathematical Concepts for Quality Assurance 17

Measures of Central Tendency 19

Measures of Variation 19

Data Distribution 20

Confidence Intervals 20

Accuracy, Precision, and Allowable Error 23

4. Monitoring for Quality 25

Internal Monitoring

Quality Control 25

Continuous (Interval or Ratio Scale) Measurements 25

Selecting and Preparing Quality Control Materials 25

Calculating Control Limits and Target Means 26

Levey-Jennings Control Charts 26

Which Control Rules and How Many Controls? 28

Errors and Corrective Actions for Rejection Rules 30

Calibrators, Controls, Reagents, and Instruments 31

Definitive and Reference Methods and Reference Materials 31

Categorical (Nominal Scale) Measurements 32

Controls and Inspections 32

Internal Audits for Quality Assessment 33

External Monitoring

Proficiency Testing 33

5. Quality of Operations, Policies, and Resources 39

Mandate, Services, Clients, Organizational Structure, and Budget 39

Policies, Procedures, and Laboratory Management 40

Laboratory and Equipment 42

Financial Management 43

Causes and Control of Preanalytic Variation 45

Handling of Reagents and Supplies 45

Handling of Specimens 46

Random and Cyclic Biological Variations 46

Diet-, Stress-, and Exercise-Induced Variation 46

Variations from Technique of Specimen Collection 46

Variations from Hemolysis and Intravenous Fluids 48

Labeling Specimens 48

Transportation, Centrifugation, and Storage 48

Rejection of Specimens 49

Records of Reagent and Specimen Handling 49

Chain-of-Custody Considerations 49

Laboratory Information Systems 50

Main Features of the System 51

Patient Identification 51

Test Order Entry 52

Specimen Identification and Tracking 52

Interfaces with Analytic Instruments 53

Entering Results into the System 53

Reporting Results from the System 54

Archives and Data Retention 54

Quality Assurance and Management Aspects of the System 55

Security of Laboratory Information 55

Standard Analytic Procedures 55

Standard Screening of Reports 56

Interpretation of Laboratory Tests 56

6. Evaluating Laboratory Procedures 61

Evaluating the Practicality and Potential Value 61

Evaluating the Analytic Characteristics 62

Within-Run Precision 63

Reportable Range, Linearity, and Sensitivity 64

Accuracy and Recovery 65

Specificity and Interference 65

Run-to-Run Precision 66

Comparison-of-Methods Study 66

Correlation and Regression Statistics for Method Comparisons 67

Evaluating the Medical Characteristics 68

Medical Justification for a Test 68

Medical Characteristics of a Test 69

Reference Values 74

Documenting the Procedure and Informing Clients 77

7. Laboratory Choices and Point-of-Care Testing 79

Chemistry 79

Hematology 80

Coagulation 82

Cytopathology and Parasitology 82

Bacteriology, Histopathology, and Therapeutic Drug Analysis 83

Point-of-Care Testing 83

Appendix 1 Veterinary Quality Assurance Programs 85.

Notes:

Includes bibliographical references (page 95) and index.

ISBN:

0813802768

OCLC:

43397129