CLSI NBS01 A6 : 6ED 2013

Abstract
Committee Membership
Foreword
1 Scope
2 Standard Precautions
3 Terminology
4 Source of Blood
5 Techniques for Blood Collection on Filter Paper
6 Specimen Collection Device
7 Specifications for Specimen Matrix
8 Blood Spot Handling for DNA Analysis
9 Extended Storage of Residual Specimens
References
Appendix A - How to Collect an Acceptable
             Blood Spot Specimen
Appendix B - Simple Spot Check
Appendix C - Protocol for Testing the Absorption
             Characteristics of Filter Paper
Appendix D - Patient Conditions and Treatments
             Affecting Newborn Screening Results
Appendix E - Filter Paper Specifications
Appendix F - Blood Collection and Drying Devices
Appendix G - Long-term Storage and Retention of
             Residual Specimens
The Quality Management System Approach
Related CLSI Reference Materials

Specifies specimen collection methods, discusses acceptable techniques for applying blood drops or aliquots to the filter paper segment of the specimen collection device, and provides instructions on proper specimen handling and transport to ensure quality specimens are consistently obtained for newborn screening analysis.

The primary goal of this standard is to improve and ensure the quality of blood spots collected from newborns.3 Poor-quality and unsatisfactory specimens place an unnecessary burden on the screening system. Retesting requires additional follow-up, which, if not completed in a timely manner, could result in missed or late diagnosed cases, and can cause unnecessary trauma to the newborn and anxiety to the parents. Because of the complexity and diversity of the specimens that might be encountered and the influence of specimen quality on test results and their interpretation, the specimen criteria and handling procedures should address the common variances.4 Laboratory staff should immediately request another specimen (or the missing information) when the screening laboratory receives a poor-quality specimen (or one missing critical patient information). In all newborn screening (NBS) programs (NSPs), the turnaround time for results is critical if treatments to alter the adverse consequences of a condition (such as irreversible brain damage or death) are to commence in a timely manner.