Standards for Immunohematology Reference Laboratories, 10th Edition - Print and Digital - Product Image

Standards for Immunohematology Reference Laboratories, 10th Edition - Print and Digital

  • ID: 4464968
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  • AABB
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Standards for Immunohematology Reference Laboratories relies on a matrix of quality management system and detailed operational requirements, such as those defining minimum antisera resources.

Significant changes in the 10th edition include:

  • Standard 1.3.1 allows for there to be exceptions to existing policies, processes, and procedures on a case-by-case basis with the approval of the laboratory director.
  • Standard 2.3 requires that all laboratories have a written plan for the implementation of allele determinations for RHCE variants.
  • Standard 4.1.2.2 allows facilities located outside of the United States to use testing centers in their country that have been approved by their Competent Authority.
  • Standard 5.1.5.2.1 requires laboratories that receive oral requests for blood components to record the request and maintain the record.
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Preface                        
Introduction                     

1. ORGANIZATION                 
1.0 Organization                
1.1 Executive Management         
1.2 Quality System              
1.3 Policies, Processes, and Procedures         
1.4 Emergency Preparedness             
1.5 Communication of Concerns           

2. RESOURCES                      
2.0 Resources                   
2.1 Human Resources                
2.2 Inventory Resources               
2.3 RHCE Variants                 
2.4 Educational Resources          
2.2A Minimum Inventory Resources   
2.2B Additional Inventory Resources

3. EQUIPMENT                    
3.0 Equipment                
3.1 Selection of Equipment         
3.2 Qualification of Equipment     
3.3 Use of Equipment               
3.4 Unique Identification of Equipment         
3.5 Equipment Monitoring and Maintenance      
3.6 Storage Devices for Blood, Blood Components, and Reagents              
3.7 Alarm Systems         
3.8 Information Systems   

4. SUPPLIER AND CUSTOMER ISSUES            
4.0 Supplier and Customer Issues           
4.1 Supplier Qualification             
4.2 Agreements                  
4.3 Incoming Receipt, Inspection, and Testing of Materials             
4.4 Customer Issues    

5. 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 Molecular Tests              
5.5 Investigation Reports        
5.5.1A Requirements for Investigation Reports        

6. DOCUMENTS AND RECORDS               
6.0 Documents and Records             
6.1 Documents              
6.2 Records                
6.2A Retention of Records   

7. DEVIATIONS, NONCONFORMANCES, AND ADVERSE EVENTS                
7.0 Deviations, Nonconformances, and Adverse Events               
7.1 Nonconformances             
7.2 Adverse Events                

8. ASSESSMENTS: INTERNAL AND EXTERNAL        
8.0 Assessments: Internal and External         
8.1 Management of Assessment Results
8.2 Quality Monitoring               

9. 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 Materials, Blood, and Components            

GLOSSARY                       
“CROSSWALK” BETWEEN THE 9TH AND 10TH EDITIONS OF STANDARDS FOR IMMUNOHEMATOLOGY REFERENCE LABORATORIES                    
INDEX   

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