Quality Principles in Transfusion Medicine

Quality, as defined in the field of blood banking and transfusion medicine, has evolved from a focus on retrospective auditing and review of sampling and testing. This evolution began with a focus on compliance and meeting minimal regulations, standards, and guidelines of accrediting and regulating agencies. More recently, it moved to a focus on compliance leveraged with proactive and direct involvement in, and construction of, quality systems including change management systems and others that have a positive effect on operating efficiencies throughout an organization. Through implementation of quality management systems and voluntary accreditation, blood banks and transfusion services have developed processes designed to ensure safe and effective products and services for their customers. A well-designed and integrated quality program provides guidance, support, and oversight to all aspects of an organization. Continual improvement in quality is an important aspect of creating and maintaining efficient and effective operations.

The meaning of the term “ quality ” continues to evolve over time. Initially, quality centered on quality control , sampling, and testing, but with increasing attention from governmental agencies, including the US Food and Drug Administration (FDA), and focus from organizations such as AABB in the early 1990s, quality became a discipline of its own. For a time, “quality” became synonymous with “compliance,” that is, adherence to documented regulations and standards that defined and influenced the activities and priorities of quality departments. Then, accrediting organizations such as AABB promulgated quality system elements and standards for facilities to follow. Some facilities sought to become certified by ISO (International Organization for Standardization), thus adhering to a different and perhaps more stringent set of criteria in their compliance. Defining quality as just compliance was somewhat shortsighted, however, as it limited quality’s contribution to the overall business and focused on external agencies and organizations to ensure internal quality. Today quality has become internally defined and driven and has taken on a notion of a culture that is understood and upheld by every employee, while retaining full compliance with accrediting, registering, and licensing agencies. The quality emphasis now extends to efficiencies in operations, with quality staff providing input into business decisions where appropriate. This has not changed the requirement for independence of the quality unit but provides for the appropriate involvement of quality early on in process design and critical business practices. These additional roles have increased the likelihood of positive results for organizations. Fig. 2.1 depicts the evolution of quality as a hierarchy.

Basic Principles

Quality is defined in many ways. The Webster’s Dictionary defines quality as a distinguishing attribute, implying that it could be good or bad or just mediocre. In transfusion medicine, quality of products and services must be as high as possible, and such a definition requires that the quality of the processes by which those products and services are manufactured and delivered must be as high as possible. The safety of donors and patients is dependent on such actions and decisions, which are made every day. A quality definition that incorporates the evolving nature of the field of quality is sometimes used by this author: “Quality is doing the right things right while utilizing the least resources possible.” In other words, quality is doing things correctly each and every time in the most efficient way possible. This definition allows quality to include effectiveness and efficiency.

Quality control (QC) is a relatively narrow term, including activities such as sampling and testing, that provides information about the quality of a product and can provide assurance that something or someone is functioning at a given time as it is supposed to function. QC is performed on reagents, equipment, and products; QC also includes annual competency assessments of employees. QC activities may include reviews of documentation for accuracy and completeness, visual inspections, and measurements of product attributes. It is important to note that QC activities may be performed by staff in operations, by quality staff, or by both. The key fact here is that review of the work must be done by someone other than the person who did the work.

Quality assurance is a broader term, including all activities to ensure that processes are developed and implemented, as they are designed and assures that they achieve the anticipated results. A quality assurance program is far reaching and includes activities such as QC testing, development of standard operating procedures, deviation management, validation, training, and internal auditing. Traditionally, these activities are under the realm of the quality department and are associated with the implementation of robust quality systems. The goal of a good quality assurance program is to ensure consistency in high-quality output and to decrease errors. It is important to highlight that the quality department is the champion of quality in an organization, and that quality is everyone’s responsibility, individually and collectively. This allows a quality culture to emerge, which then provides enhanced “quality” in all areas with enhancement in operational efficiencies, thus leading to cost reductions and improvements.

Quality Management Systems

Blood banks and transfusion services should have an organized quality management system . A quality management system is a series of processes that are linked together and controlled centrally to increase assurance of product and manufacturing process quality. As part of the quality management system, blood banks and transfusion services should have a quality policy describing their overall intentions and direction with respect to quality. They should also have a quality manual , which details the various processes in the quality management system and how the organization achieves success in implementing quality throughout its operations. The number of elements in a quality system and the way they are grouped together varies depending on the organization.

With mergers and acquisitions, it is important that all of the organizations adhere to the same quality principles as soon as possible. Thus, the integration of quality becomes a high priority in these instances.

The American Association of Blood Banks

The AABB has organized its quality management system around 10 quality system essentials (QSEs) as found within the AABB Standards for Blood Banks and Transfusion Services, 31st edition ( Table 2.1 ). AABB assesses compliance with its Standards and accredits blood banks and transfusion services. This accreditation is voluntary on the part of the blood bank or transfusion service. Nonconformances or deficiencies in meeting the Standards , which are found during an AABB assessment, are issued, and correction is required for continued accreditation. A brief overview of each of the QSEs follows.

Table 2.1

AABB Quality System Essentials

Organization	Documents and records
Resources	Deviations
Equipment	Assessments: internal and external
Supplier and customer issues	Process improvement through corrective and preventive action
Process control	Facilities and safety

Organization

This QSE is intended to ensure that blood banks and transfusion services have an organizational structure in place, which is well defined and assures that quality management is implemented and working throughout the organization, including in the administrative, medical, technical, and quality areas. It is leadership’s responsibility to ensure that the organization is compliant and safe, not only for donors and patients but also for employees.

Regular reviews of the quality management system by leadership are an important element of this QSE. Reports on activities within the quality management system provide evidence as to whether the quality management system is effective. Such reports may include quality indicators that apply to both quality and operational areas. For example, a discarded product is both a quality and operational issue, as is a customer complaint; monitoring these occurrences over a period of time may lead to opportunities for quality improvements and increased operational efficiencies. Reviewing reports and discussing issues regularly can lead to valuable insights and help identify areas where process improvement is needed. Regular management reviews are encouraged.

The quality organization must have authority and responsibility for the quality management system, and there must be a process for individuals to communicate quality concerns anonymously. Most facilities accomplish this through an anonymous “hotline” where callers can report quality issues without fear of retribution.

Resources

This QSE relates to staff, requiring well-written job descriptions with job qualifications that are clearly defined. It also addresses the need for staff to have orientation training, which includes information about the company and how it operates, and training in job-related/specific tasks as well as in quality and safety. Additionally, staff should be evaluated regularly and provided opportunity for continuing education. This QSE is essential to successful quality operations.

Equipment

Equipment that is used in the blood banks and transfusion services must be identified and qualified for its intended use. If applicable, equipment should be calibrated against known standards on a routine basis according to written procedures. Equipment should be on a documented schedule for maintenance, including cleaning. If repaired, the equipment should be requalified before use. Equipment that is in disrepair or fails QC should be removed from service and clearly marked to prevent its unintentional use. There should be an investigation of the cause of any equipment failures.

Any modifications to computer systems, including software, hardware, and databases should be well planned with inclusion of an assessment of risk and validation (see Chapter 3 ). Modifications or repairs should be carefully evaluated for unrecognized adverse impact to operations before implementation and again after the modification/repair is in place to make sure that there are no untoward issues.

Storage devices must be maintained and monitored to ensure that they meet criteria for storage of supplies/reagents and products. Such storage devices should have alarms to alert users when temperatures approach unacceptable levels. They should be included in scheduled cleaning as well, and records of cleaning should be maintained.

Devices used to warm blood must have a sensor to detect malfunctions to prevent hemolysis or damage to blood and blood components during the warming process. These devices must be well maintained for patient safety.

The blood bank and transfusion service shall have processes that support the implementation and modification of software, hardware, and databases and shall maintain records of activities such as validation and monitoring of data integrity. There should also be an alternate system for backup, which is routinely tested. Computer systems must be managed in a compliant manner and access to such systems should be only to those who have authorization.

Supplier and Customer Issues

To have quality products and services, blood banks and transfusion services must ensure that their suppliers can provide materials that meet clearly defined quality criteria. This process is called supplier qualification . It defines expectations of both the blood banks and transfusion services and their respective suppliers, through written agreements, and provides a process that offers a high degree of assurance. Supplier qualification may include onsite audits of the supplier. Another key aspect is the requirement for regular reviews to ensure continued compliance with any supplier agreements.

There should also be a documented process whereby incoming materials are inspected before use, to make sure that they are indeed acceptable for use. With storage of supplies, a first in, first out (FIFO) approach is needed, along with adherence to storage requirements as specified by the manufacturer of the supplies. Finally, blood banks and transfusion services must have a methodology to know when and where supplies are used, i.e., traceability to the process or service in which the supplies were used and traceability from the donor to the patient.

Process Control

Control of processes should be engineered into those processes from development through implementation and is critical to ensuring quality from the outset. These process controls ensure that the process itself is implemented to produce quality results. Change control is essential, and processes should be well validated to provide a high degree of assurance that any changes will produce desired results. Communication of change must be clear, timely, and delivered to all impacted by the change. Once processes are implemented, controls must be in place to ensure they remain in a validated state. Accommodation for planned deviations must be incorporated; however, because in any normal operation, there may be a justifiable need to deviate from a procedure for a period of time. Such deviations must be appropriately reviewed and approved by quality staff.

Quality control and inspection are also essential to this QSE. These activities, when performed at regular intervals, ensure that criteria are met and that the processes are “in control,” that is, operating as they should be in accordance with well-written procedures and producing expected results. Additionally, records that allow traceability (details such as who, when, where) and trackability (documented logical sequence(s) of events that can be followed) are necessary to provide evidence of the work that was done and how, when, etc. it was done.

It is important that all materials and equipment are used in accordance with manufacturers’ instructions. It is also important that measures are taken to prevent contamination of blood or blood products during collection, processing, and transfusion. The blood bank or transfusion service should have methods to detect bacterial contamination, and if present, a mechanism to identify the organisms.

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