Abstract

i

Committee Membership

iii

Foreword

vii

1

Scope

1

2

Introduction

1

3

Standard Precautions

1

4

Terminology

2

4.1

A Note on Terminology

2

4.2

Definitions

2

4.3

Abbreviations and Acronyms

4

5

Clinical Utility

4

6

Principles of Automated Cell Counting as They Apply to Lamellar Bodies

4

6.1

Impedance Counting

5

6.2

Optical Counting

5

6.3

Flagging/Invalidations

5

6.4

Performance

5

7

Preexamination (Preanalytical) Considerations

5

7.1

Specimen Collection

5

7.2

Specimen Storage and Processing

6

7.3

Limitations

6

8

Examination (Analytical) Considerations

6

8.1

Instrument Variability

6

8.2

Protocol for Determining Lamellar Body Count

6

8.3

Quality Control

7

9

Postexamination (Postanalytical) Considerations

8

9.1

Result Reporting

8

10

Validation of the Lamellar Body Count

8

10.1

Precision

8

10.2

Linearity

8

10.3

Limits of Detection and Quantitation

8

10.4

Analytical Specificity

9

10.5

Interferences

9

10.6

Sample Stability

10

10.7

Establishing a Maturity Cutoff

11

11

Proficiency Testing

12

References

13

The Quality Management System Approach

16

Related CLSI Reference Materials

17