Standards for Immunohematology Reference Laboratories

The sixth edition of Standards for Immunohematology Reference Laboratories, has been revised to include updated quality system requirements. Significant changes have been made that focus on minimum inventory resources, follow-up, compliance with Clinical Laboratory Improvement Amendments (CLIA) and more.

Significant changes:

• Two lectin proteins moved from Reference Standard 2.2A, Minimum Inventory Resources, to Reference Standard 2.2B.
• New standard addresses customer issues, with details on information regarding testing that must be provided to the customer.

Table of Contents

Preface
Introduction

1.0 ORGANIZATION

• 1.0 Organization
• 1.1 Executive Management
• 1.2 Quality System
• 1.3 Policies, Processes, and Procedures
• 1.4 Emergency Preparedness

2.0 RESOURCES

• 2.0 Resources
• 2.1 Human Resources
• 2.2 Inventory Resources
• 2.3 Educational Resources
• 2.2A Minimum Inventory Resources
• 2.2B Additional Inventory Resources

3.0 EQUIPMENT

• 3.0 Equipment
• 3.1 Selection of Equipment
• 3.2 Qualification of Equipment
• 3.3 Unique Identification of Equipment
• 3.4 Equipment Monitoring and Maintenance
• 3.5 Computer Systems

4.0 SUPPLIER AND CUSTOMER ISSUES

• 4.0 Supplier and Customer Issues
• 4.1 Supplier Qualification
• 4.2 Inspection of Materials
• 4.3 Customer Issues
• 4.4 Agreements

5.0 PROCESS CONTROL, FINAL INSPECTION, AND HANDLING

• 5.0 Process Control
• 5.1 General Elements
• 5.2 American Rare Donor Program
• 5.3 Serologic Investigation
• 5.4 Investigation Reports
• 5.4.1A Requirements for Investigation Reports

6.0 DOCUMENTS AND RECORDS

• 6.0 Documents and Records
• 6.1 Documents
• 6.2 Records
• 6.3 Electronic Records
• 6.2A Retention of Records

7.0 DEVIATIONS, NONCONFORMANCES, AND ADVERSE EVENTS

• 7.0 Deviations, Nonconformances, and Adverse Events
• 7.1 Nonconformances

8.0 ASSESSMENTS: INTERNAL AND EXTERNAL

• 8.0 Assessments: Internal and External
• 8.1 Management of Assessment Results

9.0 PROCESS IMPROVEMENT THROUGH CORRECTIVE AND PREVENTIVE ACTION

• 9.0 Process Improvement through Corrective and Preventive Action
• 9.1 Corrective Action
• 9.2 Preventive Action

10. FACILITIES AND SAFETY

• 10.0 Facilities and Safety
• 10.1 Safe Environment
• 10.2 Biological, Chemical, and Radiation Safety
• 10.3 Discard of Infectious Agents

GLOSSARY

“CROSSWALK” BETWEEN 5TH AND 6TH EDITIONS OF STANDARDS FOR IMMUNOHEMATOLOGY REFERENCE LABORATORIES

INDEX