The Laboratory Assurance System: A Manual of Quality Procedures and Forms

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Editorial Reviews

Provides the user with the means to create a quality assurance manual that will satisfy the needs of his or her particular laboratory while meeting the requirements of any regulatory or accrediting body with which the organization may be associated. This second edition has been prepared to assist Physician Office Laboratories seeking accreditation in the preparation of the quality assurance/control portions of their procedures manual as required by Federal Regulation 42 CFR 493. Five new sections have been added to cover the subjects of method validation, patient management assessment, comparison of test results, relationship of patient information to patient test results, and communications. Looseleaf in a 3-ring binder. Annotation c. Book News, Inc., Portland, OR (
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Product Details

  • ISBN-13: 9780442014704
  • Publisher: Wiley, John & Sons, Incorporated
  • Publication date: 7/1/1993
  • Edition description: 2nd ed
  • Edition number: 2
  • Pages: 250

Table of Contents

Pt. 1 Laboratory Quality System Elements 1
1 Introduction 1
2 Title Page 1
3 Letter of Promulgation 1
4 Quality Goals and Objectives 1
5 Quality Policies 2
6 Organization for Quality 2
7 Management of the Quality Manual 3
8 Quality Planning 3
9 Quality in Procurement 4
10 Sample Handling, Identification, Storage, and Shipping 5
11 Chain-of-Custody Procedures 6
12 Laboratory Testing and Analysis Control: Intra- and Interlaboratory Proficiency Testing 7
13 Quality Documentation and Records 12
14 Control of Measuring and Test Equipment 13
15 Preventive Maintenance 17
16 Reference Standards and Standard Reference Materials 18
17 Data Validation 18
18 Environmental Controls 19
19 Customer Complaints 20
20 Subcontracting 20
21 Personnel 20
22 Statistical Methods 22
23 Nonconformity 24
24 Corrective (Remedial) Action 24
25 Quality Cost Reporting 25
26 Quality Audits 27
27 Reliability 28
28 Method Validation 30
29 Patient Test Management Assessment 32
30 Comparison of Test Results 32
31 Relationship of Patient Information to Patient Test Results 33
32 Communications 33
Pt. 2 How to Write a Laboratory Quality Assurance Manual 35
33 Introduction 35
34 Organizing for Preparation of the Manual 35
35 Establishing Objectives and Priorities 35
36 Collection and Review of Existing Applicable Procedures 36
37 Preparation of a Flow Chart 36
38 Identification of Program Requirements 38
39 Identification of Shortfalls and the Assignment of Priorities 38
40 Writing the Manual 38
Pt. 3 XYZ Laboratory Quality Assurance Manual 39
Pt. 4 Sample Quality Assurance Forms 197
Index 248
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