INTRODUCTION

The Standards for a Patient Blood Management Program (PBM Standards) was prepared by the Patient Blood Management Standards Committee (PBM SC) and the Standards Program Committee (SPC) of the AABB. The Goal of the PBM Standards is to maintain and enhance the quality and safety of care for patients who may or may not require transfusion. The following frequently asked questions will help users of this publication better understand this 3rd edition of PBM Standards.

What activities are covered by the PBM Standards?
For the purposes of this publication, a patient blood management program encompasses all aspects of patient evaluation and clinical management surrounding the transfusion decision-making process, including the application of appropriate indications, as well as minimization of blood loss and optimization of patient red cell mass.

When does this edition go into effect?
The effective date of this edition is January 1, 2021.

Are the standards requirements or recommendations?
The PBM Standards contains requirements. A requirement contains the word "shall," which indicates that the statement is mandatory. There are rare instances in which an AABB standard uses the term "may." A statement that uses "may" is not a requirement.

How does this publication relate to laws and regulations?
The PBM Standards was developed on the basis of good medical practice and, when available, scientific and evidence-based data. The requirements in this publication can be followed by a patient blood management program located anywhere in the world, but they do not preempt any federal, state, and/or local laws and regulations. Although the majority of the standards here are intended to be consistent with these applicable laws and requirements, no assurances and be given that compliance with PBM Standards will result in compliance with all applicable laws and requirements. The PBM Standards is not intended as a substitute for legal advice and the content should not be relied upon for legal purgoses. Therefore, users must make their own determinations as to how best to ensure compliance with all applicable laws and requirements, including consultation with legal counsel familiar with these issues.

Does the publication require me to follow my own local laws and regulations?
Yes. In many standards, the PBM SC chose to use the term "specified requirements." This phrase is defined in the glossary to include any applicable requirement under which a program might operate. These requirements could include, but are not limited to, federal regulations, costomer agreements, practive standards, instructions for the intended use of a device, or requirements of and accrediting organization.

What is meant by program activity levels?
The PBM Standards recognizes that differences exist among hospitals concerning the range of clinical services offered. As a result, the PBM SC created three program activity levels (Level 1, 2, and 3) based upon the functions provided at an individaul facility. For example, a small hospital may have a clinical program and services that meet the program level activities described as Level 3. Likewise, a large hospital might incorporate all the activities that are described and a Level 1. It should be recognized that one level is not superior to another, and merely reflects differences in activities performed by the hospital in which the program resides.

What does the pen symbol mean?
When the pen symbol precedes a standard, users must maintain a record of that activity in order to meet the standard. Readers should refer to Reference Standard 6.2A at the end of Chapter 6 to determine what that record must contain.

What other tools are available to help me implement the PBM Standards?
There are several other resources to assist users. This publication also includes:
ㆍ A glossary, which reflects the usage of specific words or phrases in the context of these PBM Standards.
ㆍ A crosswalk that corss-references the standards in this edition of PBM Standars with those in the previous edition.

In addition, users of this edition may also want to:
ㆍ Visit www.aabb.org for a document that details the disposition and resolution of all comments received to this edition. This document is entitled, "Response to Public Comments" to this 3rd edition. When a public comment is the source of a change, or where the PBM SC did not make a change suggested by a comment, an explanation is porvided.
ㆍ Follow guidance to the 3rd edition of PBM Standars, found in the printed publication or online in the electronic version of the 3rd edition in the Standars Portal (standars.aabb.org). The guidance provides rationales behind significant changes to this edition of PBM Standards, and provides recommendations on how to meet the intent of certain standards.
ㆍ Contact standardsⓐaabb.org for interpretations or to submit a variance request. Variances to standards are effective for the edition of PBM Standards for which they are received. Request forms for variances can be found at http://www.aabb.org.

TABLE OF CONTENTS

PREFACE

INTRODUCTION

1. ORGANIZATION

1.0 Organization
1.1 Executive Management
1.2 Quality Plan
1.3 Policies, Processes, and Procedures
1.4 Disaster Preparedness
1.5 Operational Continuity
1.6 Communication of Concerns

2. RESOURCES

2.0 Resources
2.1 Human Resources

3. EQUIPMENT

3.0 Equipment
3.1 Information Systems
3.2 Equipment Controlled by Other Departments

4. SUPPLIER AND CUSTOMER ISSUES

4.0 Supplier and Customer Issues
4.1 Supplier Qualification
4.2 Agreements

5. PROCESS CONTROL

5.0 Process Control
5.1 General Elements
5.2 Phlebotomy
5.3 Consents, Approvals, and Notifications
5.4 Transfusion Orders
5.5 Pre- and Posttransfusion Patient Care
5.6 Preoperative or Preintervention Patient Care
5.7 Methods for PBM During Surgery and Invasive Procedures
5.8 Postoperative or Postintervention Patient Care
5.9 Patients Who Do Not Require Invasive Procedures
5.10 Anemia Cae Inpatients
5.11 PBM for Obstetric Patients
5.12 Massive Blood Loss and Emergent Care
5.13 Reversal of Acquired Coagulopathy
5.14 PBM for Pediatric Patients
5.15 PBM for Outpatients
5.16 High Blood Use Service Lines
5.17 Performance Indicators

6. DOCUMENTS AND RECORDS

6.0 Documents and Records
6.1 Documents
6.2 Records
6.3 Policies, Processes, and Procedures Controlled by Other Departments
6.2A Retention of Records

7. DEVIATIONS, NONCONFORMANCES, AND ADVERSE EVENTS

7.0 Deviation, Nonconformances, and Adverse Events
7.1 Nonconformances

8. ASSESSMENTS: INTERNAL AND EXTERNAL

8.0 Assessments: Internal and External
8.1 Review Process
8.2 Management of Assessment Results
8.3 Reporting
8.4 Quality Monitoring

9. PROCESS IMPORVEMENT THROUGH CORRECTIVE AND PREVENTIVE ACTION

9.0 Process Improvement Thorugh Corrective and Preventive Action
9.1 Data Collection
9.2 Corrective Action
9.3 Preventive Action

10. FACILITIES AND SAFETY

10.0 Facilities and Safety

GLOSSARY

"CROSSWALK" BETWEEN THE 2nd AND 3rd EDITIONS OF PBM STANDARDS FOR PATIENT BLOOD MANAGEMENT PROGRAM

INDEX