Clinical Principles of Transfusion Medicine

Robert W Maitta

• Publisher: Elsevier
• Year: 2018
• ISBN:
  9780323544597
• Topic: Medizin
• Subtopic: Notfallmedizin & Intensivmedizin

Offering a concise overview of transfusion medicine, including best practices for specific clinical settings, this practical resource by Dr. Robert W. Maitta covers the key information you need to know. Holistic, multidisciplinary coverage and a succinct, easy-to-read format make it essential reading for transfusion specialists, as well as practitioners in other specialties whose patients undergo blood transfusions.

• Covers the latest advancements in transfusion therapies, hematopoietic stem cells, infectious and non-infectious complications of transfusions, and future directions in transfusion medicine.
• Discusses special populations, including organ transplant patients; pediatric, obstetric, and geriatric patients; and patients undergoing emergency care.
• Consolidates fundamental clinical concepts and current practice of transfusion medicine into one convenient resource.

Chapter 1

Quality Concepts in Transfusion Medicine

Judith A. Sullivan, MS, MT(ASCP)SBB, CQA(ASQ)

Abstract

Quality is integral to ensure that the best possible blood component is manufactured and then transfused to the right patient at the right time. A quality systems approach in transfusion medicine provides the backbone upon which the day-to-day operations of a transfusion service rest. It provides an organizational structure with leadership that supports a quality environment. Staff are well-trained and competent to perform their duties. Equipment is selected to meet the laboratory's needs, and is properly qualified, calibrated, and maintained. Suppliers who can provide good-quality materials are selected, and supplies are maintained and used properly. Procedures are developed and followed as written, and changes to processes and procedures are controlled. Documents and records are created, maintained, and archived according to the requirements. When deviations occur, they are investigated and corrected so that they do not recur. Process improvement becomes a part of the daily life of the laboratory. Audits are performed on a regular basis to ensure compliance with requirements. Finally, the laboratory maintains an environment that is safe for the employees, visitors, donors, and patients.

Keywords

Assessments; Deviation management; Equipment; Organization; Process control; Quality systems; Resources

Until 1997, “quality” in transfusion medicine was a concept that related to quality control, that is, testing performed to ensure that reagents and equipment functioned as expected. Transfusion medicine (indeed, most of healthcare) lagged behind other industries in introducing the concepts of quality assurance and quality systems. In 1997, AABB (formerly known as the American Association of Blood Banks) introduced the concept of quality systems to the blood banking community for the first time in its 18th edition of Standards for Blood Banks and Transfusion Services. Since then, transfusion services and blood banks have embraced quality concepts and, especially, quality systems as a means of providing superior patient care.

What is a quality system? The AABB defines a quality system as “the organizational structure, responsibilities, policies, processes, procedures, and resources established by executive management to achieve quality.”¹ In essence, it is the support structure put in place by those in authority to ensure that a quality product or service can be provided to a customer on a consistent basis.

One could question the applicability of a quality systems approach in the transfusion medicine arena. After all, we collect and transfuse blood components, not manufacture automobiles. We do not provide a product that can be reproduced within certain tolerance limits. However, the inherent variability of the components that we provide to patients necessitates the implementation of a quality system. The provision of the best possible component in any reproducible manner demands a quality framework including:

1. • Management knowledgeable in, and committed to, quality concepts
2. • Well-developed policies, processes, and procedures
3. • Staff who are trained and competent, and who follow processes and procedures as written
4. • Equipment that is selected with care, qualified before use, and well maintained
5. • Quality supplies from qualified vendors
6. • Processes to make changes in a controlled manner and to manage documents and records
7. • Means to identify and correct errors so that they do not recur
8. • Methods to assess effectiveness and continuously improve
9. • Safe environment for personnel and patients

Accrediting organizations such as the AABB, the College of American Pathologists, and The Joint Commission have established requirements for the implementation of quality functions that support operations. The AABB defines 10 Quality System Essentials (QSEs) that form the framework for a quality system (see Table 1.1). Each of these elements, integrated into the day-to-day activities of transfusion service, provides the structure that allows the provision of the right component to the right patient on a consistent basis.

Organization

An effective quality system is not simply a vague notion that is discussed at periodic meetings. It must be defined and documented, implemented, and maintained. The development, implementation, and maintenance of a quality system rests with executive management: the personnel within the organization having the authority to establish or change quality policy. For a quality system to be truly effective, the oversight and responsibility must reside at the highest possible level within the organization. “Executive management” may be one individual or a group of individuals. In either case, the organization must clearly define its executive management. However, the quality system cannot exist with executive management alone. All personnel must be trained so that they:

• 1. know what the quality system is;
• 2. understand its importance; and
• 3. recognize and act on their role in the system.

Other important elements under the QSE organization are as follows.

Table 1.1

Quality System Essentials

1	Organization
2	Resources
3	Equipment
4	Supplier and customer issues
5	Process control
6	Documents and records
7	Deviations, nonconformances, and adverse events
8	Assessments: internal and external
9	Process improvement
10	Facilities and safety

Data from American Association of Blood Banks (AABB). Committee Quality System Essentials (QSEs); August 2017. Available at: http://www.aabb.org/membership/governance/committees/Documents/AABB-Committee-QSEs.pdf.

Defined Structure

The transfusion service of the blood bank must identify the individuals responsible for providing products and services, the individuals responsible for key quality functions, and the relationship among personnel. Organizational charts are often used to visually define personnel and relationships.

Medical Director Responsibilities

The medical director has the ultimate responsibility for the establishment of policies, processes, and procedures of the transfusion service of the blood bank.

Management Review of the Quality System

A quality system must be evaluated periodically if it is to provide any lasting benefit to the organization. The executive management is responsible for evaluating the effectiveness of the quality system on an ongoing basis and to make changes to the system based on the results of the review. The effectiveness of the quality system may be evaluated through such reviews as:

1. • Findings from internal and external assessments and subsequent follow-up actions
2. • Error reports, root cause analysis, and corrective action
3. • Customer surveys and complaints
4. • Process improvement activities

Reviews must be documented, along with any changes to the quality system resulting from the review.

Policies, Processes, and Procedures

Written policies, processes, and procedures form the backbone of any qual...