Quality Management in

Blood Banking
Introduction

• Several dictionaries define quality as “the degree to which a

product or service meets requirements.”
• Blood banks must provide quality to their customers in many
forms, including:
• Safe, satisfying donation experiences for blood donors.
• Accurately labeled and tested blood components provided to transfusion
services.
• Timely, accurate transfusion services provided to physicians and other
health-care personnel.
• Safe and efficacious blood transfusions to patients
• Quality management (QM) is actively and continuously practiced
by the blood bank’s leaders, managers, and staff throughout all
blood bank operations.
• With QM, the blood bank is always ready for an inspection because
it validates its processes, monitors process performance, knows
where the problems are, continuously takes action to determine
root causes of problems and removes them, and documents its
actions.
Quality Control

• Most blood bank technologists are familiar with routine blood bank
QC procedures, such as :
• daily testing of the reactivity of blood typing reagents;
• calibrating serologic centrifuges;
• and monitoring temperatures of refrigerators, freezers, and thawing
devices
Quality Assurance

• QA is a set of planned actions that ensure that systems and

elements that influence the quality of the product or service are
working as expected, individually and collectively.
• QA looks beyond the performance of a test method or piece of
equipment; it addresses how well an entire process, which is a
sequence of activities, is functioning.
• This is particularly important in those processes that cross
functional or departmental lines.
Quality Management Systems

• A QMS provides a framework for applying quality principles and

practices uniformly across all blood bank operations, starting with
donor selection and proceeding through transfusion outcomes.
Quality Management System
Essentials
Process Management

• A process can be defined as a set of interrelated resources and

activities that transforms inputs into outputs.
• Process control is a set of activities that ensures a given work
process will keep operating in a state that is continuously able to
meet process goals without compromising the process itself.
• Total process control is the evaluation of the performance of a
process, comparison of actual performance to a goal, and action
taken on any significant difference.
Process Control

• It is essential to monitor processes to ensure that they are

performing as required, to correct process problems before they
affect output, and to improve processes to meet changing needs
and technology.
• Routine process controls include:
• QC of test methods and reagents
• Review of work and QC records
• Capture of occurrences when the process did not perform as expected
A Quality Management System for
Medical Laboratories
Importance of a Facility Quality
Management System

• Today, working in a QMS environment is needed to achieve the

standards of excellence necessary for surviving the changes facing
the nation’s health-care industry and providing the level of patient
safety that our donors and patients both expect and deserve.
• Purchasers of health-care services want evidence that health-care
providers such as hospitals and blood centers are involved in
organization-wide quality improvement programs that increase the
safety of donors and patients