Standards for Perioperative Autologous Blood Collection and Administration, 7th Edition

  • ID: 4376316
  • Book
  • 70 pages
  • AABB
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The 7th edition of Standards for Perioperative Autologous Blood Collection and Administration (Perioperative Standards) contains requirements that address perioperative collection and preparation of red cell and non-red-cell components. Its goal is to maintain and enhance the quality and safety of perioperative autologous blood collection and administration and to provide a basis for the Accreditation Program. It reflects the concerns and priorities of several different aspects of the discipline, including the input of recognized experts in the field and the best interests of their patients. It was developed in the context of the global drive for quality in health care and internationally recognized principles of quality management.

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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
1.5 Communication of Concerns 
1.6 Customer Focus 

2.0 RESOURCES
2.0 Resources
2.1 Human Resources

3.0 EQUIPMENT
3.0 Equipment
3.1 Selection of Equipment
3.2 Equipment Qualification 
3.3 Use of Equipment 
3.4 Unique Identification of Equipment  
3.5 Equipment Monitoring and Maintenance 
3.6 Storage Devices and Storage Containers for Perioperative Blood Components
3.7 Warming Devices 
3.8 Information Systems  

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

5.0 PROCESS CONTROL
5.0 Process Control 
5.1 General Elements 
5.2 Consents, Approvals, and Notifications 
5.3 Perioperative Collection 
5.4 Conditions of Administration 
5.1.8A Handling, Storage, and Expiration of Perioperative Autologous Red Cell Blood Components
5.1.8B Handling, Storage, and Expiration of Perioperative Autologous Non-Red Cell Blood Components for Reinfusion
5.1.8C Handling, Storage, and Expiration of Perioperative Autologous Non-Red-Cell Blood Components for Topical Application or Injectable Application

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

7.0 DEVIATIONS, NONCONFORMING COMPONENTS OR MATERIALS, AND ADVERSE EVENTS 
7.0 Deviations, Nonconforming Components or Materials, and Adverse Events 
7.1 Deviations
7.2 Nonconforming Components or Materials
7.3 Adverse Events

8.0 ASSESSMENTS: INTERNAL AND EXTERNAL
8.0 Assessments: Internal and External 
8.1 Management of Assessment Results 
8.2 Monitoring of the Perioperative Program 
8.3 Quality Indicators 

9.0 PROCESS IMPROVEMENT 
9.0 Process Improvement Through Corrective and Preventive Action
9.1 Corrective Action 
9.2 Preventive Action 

10.0 FACILITIES AND SAFETY 
10.0 Facilities and Safety
10.1 Safe Environment 
10.2 Biological, Chemical, and Radiation Safety  
10.3 Discard of Perioperative Blood Components 

LIST OF PERIOPERATIVE BLOOD COMPONENTS AND PROCESSING METHODS 

GLOSSARY
“CROSSWALK” BETWEEN THE 6TH AND 7TH EDITIONS OF STANDARDS FOR PERIOPERATIVE AUTOLOGOUS BLOOD
COLLECTION AND ADMINISTRATION
INDEX 

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