The Standards for a Patient Blood Management Program (PBM Standards) can help facilities that are implementing or enhancing PBM efforts to have a solid foundation for maintaining and optimizing the care of patients who may or may not need transfusion. Like other AABB standards, this edition includes overarching quality standards as well as specific technical standards. Significant changes include:

ㆍA new standard, 5.3, has been added to this edition to ensure that patient blood management programs create transfusion indications that are program defined.
ㆍA new standard, 6.2.3.2, has been included to ensure that patient records are linked to those contained in the laboratory information system.

Preface　v
Introduction　vii

1. ORGANIZATION　1
　1.0 Organization　1
　1.1 Executive Management　1
　1.2 Quality Plan　5
　1.3 Policies, Processes, and Procedures　6
　1.4 Disaster Preparedness　6
　1.5 Communication of Concerns　6

2. RESOURCES　7
　2.0 Resources　7
　2.1 Human Resources　7

3. EQUIPMENT　9
　3.0 Equipment　9
　3.1 Information Systems　9
　3.2 Equipment Controlled by Other Departments　10

4. SUPPLIER AND CUSTOMER ISSUES　11
　4.0 Supplier and Customer Issues　11
　4.1 Supplier Qualification　11
　4.2 Agreements　11

5. PROCESS CONTROL　12
　5.0 Process Control　12
　5.1 General Elements　12
　5.2 Phlebotomy　13
　5.3 Consents, Approvals, and Notifications　13
　5.4 Transfusion Orders　14
　5.5 Pre- and Posttransfusion Patient Care　14
　5.6 Preoperative or Preintervention Patient Care　15
　5.7 Methods for Patient Blood Management During Surgery and Invasive Procedures　16
　5.8 Postoperative or Postintervention Patient Care　16
　5.9 Patients Who Do Not Require Invasive Procedures　16
　5.10 Massive Blood Loss and Emergent Care　17
　5.11 Performance Indicators　17

6. DOCUMENTS AND RECORDS　18
　6.0 Documents and Records　18
　6.1 Documents　18
　6.2 Records　19
　　　- 6.2A Retention of Records　22
　6.3 Policies, Processes, and Procedures Controlled by Other Departments　20

7. DEVIATIONS, NONCONFORMANCES, AND ADVERSE EVENTS　24
　7.0 Deviations, Nonconformances, and Adverse Events　24
　7.1 Nonconformances　24

8. ASSESSMENTS: INTERNAL AND EXTERNAL　26
　8.0 Assessments: Internal and External　26
　8.1 Review Process　26
　8.2 Management of Assessment Results　26
　8.3 Reporting　26
　8.4 Quality Monitoring　27

9. PROCESS IMPROVEMENT THROUGH CORRECTIVE AND PREVENTIVE ACTION　28
　9.0 Process Improvement Through Corrective and Preventive Action　28
　9.1 Data Collection　28
　9.2 Corrective Action　28
　9.3 Preventive Action　29

10. FACILITIES AND SAFETY　30
　 10.0 Facilities and Safety　30

GLOSSARY　31
“CROSSWALK” BETWEEN THE 1st AND 2nd EDITIONS OF PBM STANDARDS FOR PATIENT BLOOD MANAGEMENT PROGRAM　37

INDEX　41