INTRODUCTION TO QUALITY

The importance of laboratory quality

Definition of quality

 Laboratory quality can be defined as

accuracy, reliability and timeliness of
reported test results. The laboratory
results must be as accurate as possible,
all aspects of the laboratory operations
must be reliable, and reporting must be
timely in order to be useful in a clinical
or public health setting.
Level of accuracy required

 When making measurements, there is

always some level of inaccuracy. The
challenge is to reduce the level of
inaccuracy as much as possible, given
the limitations of our testing systems. An
accuracy level of 99% may at first glance
appear acceptable, but the resulting 1%
error can become quite large in a system
where many events occur, such as
laboratory testing.
Negative consequences of laboratory error

 Laboratories produce test results that are widely used in

clinical and public health settings, and health outcomes
depend on the accuracy of the testing and reporting. If
inaccurate results are provided, the consequences can be
very significant, including:
 unnecessary treatment
 treatment complications
 failure to provide the proper treatment
 delay in correct diagnosis
 additional and unnecessary diagnostic testing.


 These consequences result in increased cost in time and

personnel effort, and often in poor patient outcomes.
Minimizing laboratory error

 In order to achieve the highest level of accuracy

and reliability, it is essential to perform all
processes and procedures in the laboratory in
the best possible way. The laboratory is a
complex system, involving many steps of activity
and many people. The complexity of the system
requires that many processes and procedures be
performed properly. Therefore, the quality
management system model, which looks at the
entire system, is very important for achieving
good laboratory performance.
Definition of quality management
system
: Overview of the quality management
system
 A quality management system can be defined as
“coordinated activities to direct and control an
organization with regard to quality”. This definition
is used by the International Organization for
Standardization (ISO) and by the Clinical and
Laboratory Standards Institute (CLSI). Both groups
are internationally recognized laboratory standards
organizations
 In a quality management system, all aspects of the
laboratory operation, including the organizational
structure, processes and procedures, need to be
addressed to assure quality.
Pre examination (pre analytic):
patient client prep sample collection
test evaluation sample receipt and sample transport
Examination (Analytic):
quality control testing
Post examination (Post analytic)
recod keeping and reporting
There are many procedures and processes
that are performed in the laboratory, and
each of these must be carried out correctly
in order to assure accuracy and reliability of
testing. An error in any part of the cycle can
produce a poor laboratory result.A method
of detecting errors at each phase of testing
is needed if quality is to be assured.
ISO standards group laboratory
processes into pre-examination,
examination and post-examination
categories. Comparable terms in current
laboratory use include: pre-analytic,
analytic and post-analytic processes; or
pre-test, test and post-test processes.
Path of workflow
The entire set of operations that occur in testing is
called the path of workflow. The path of workflow
begins with the patient and ends in reporting and
results interpretation, as shown in the figure below.
The concept of the path of workflow is a key to the
quality model or the quality management system,
and must be considered when developing quality
practices. For example, a sample that is damaged
or altered as a result of improper collection or
transport cannot provide a reliable result. A medical
report that is delayed or lost, or poorly written, can
negate all the effort of performing the test well.
Quality management system addresses all processes

The complexity of the laboratory system

requires that many factors must be
addressed to assure quality in the laboratory.
Some of these factors include:
 the laboratory environment

 quality control procedures

 communications

 record keeping

 competent and knowledgeable staff

 good-quality reagents and equipment.

:The quality management system model

 When all of the laboratory procedures

and processes are organized into an
understandable and workable structure,
the opportunity to ensure that all are
appropriately managed is increased.
The quality model used here organizes
all of the laboratory activities into 12
quality system essentials.
 These quality system essentials are a set of
coordinated activities that serve as building
blocks for quality management. Each must be
addressed if overall laboratory quality
improvement is to be achieved. This quality
management system model was developed
by CLSI,1 and is fully compatible with ISO
standards.
Assuring accuracy and reliability throughout
the path of workflow depends on good
management of all of the quality essentials.
12 quality system essentials

Organization
Personnel
Equipment
Purchasing and inventory
Process control
Information management
Documents and records
Occurrence management
Assessment
Process improvement
Customer service
Facilities and safety
Organization

 In order to have a functioning quality

management system, the structure and
management of the laboratory must be
organized so that quality policies can be
established and implemented. There
must be a strong supporting
organizational structure—management
commitment is crucial—and there must
be a mechanism for implementation and
monitoring.
Personnel
 The most important laboratory resource
is competent, motivated staff.The quality
management system addresses many
elements of personnel management and
oversight, and reminds us of the
importance of encouragement and
motivation.
Equipment
 Many kinds of equipment are used in the
laboratory, and each piece of equipment
must be functioning properly. Choosing
the right equipment, installing it
correctly, ensuring that new equipment
works properly, and having a system for
maintenance are all part of the
equipment management programme in
a quality management system.
Purchasing and
inventory
 The management of reagents and supplies in
the laboratory is often a challenging task.
However, proper management of purchasing
and inventory can produce cost savings in
addition to ensuring supplies and reagents are
available when needed. The procedures that
are a part of management of purchasing and
inventory are designed to ensure that all
reagents and supplies are of good quality, and
that they are used and stored in a manner
that preserves integrity and reliability.
Process control
 Process control is comprised of several factors
that are important in ensuring the quality of the
laboratory testing processes.These factors include
quality control for testing, appropriate
management of the sample, including
collection and handling, and method verification
and validation. The elements of process control
are very familiar to laboratorians; quality control
was one of the first quality practices to be used in
the laboratory and continues to play a vital role in
ensuring accuracy of testing.

Information management

 The product of the laboratory is

information, primarily in the form of test
reporting. Information (data) needs to be
carefully managed to ensure accuracy and
confidentiality, as well as accessibility to
the laboratory staff and to the health care
providers. Information may be managed
and conveyed with either paper systems or
with computers; both will be discussed in
the section on information management.
Documents and records

 Many of the 12 quality system essentials

overlap. A good example is the close
relationship between "Documents and
records" and "Information management".
Documents are needed in the laboratory
to inform how to do things, and
laboratories always have many
documents. Records must be
meticulously maintained so as to be
accurate and accessible.
Occurrence management

 An “occurrence” is an error or an event

that should not have happened.A system
is needed to detect these problems or
occurrences, to handle them properly,
and to learn from mistakes and take
action so that they do not happen again.
Assessment
 The process of assessment is a tool for
examining laboratory performance and
comparing it to standards, benchmarks or
the performance of other laboratories.
Assessment may be internal (performed
within the laboratory using its own staff) or it
may be external (conducted by a group or
agency outside the laboratory). Laboratory
quality standards are an important part of
the assessment process, serving as
benchmarks for the laboratory.
Process improvement

 The primary goal in a quality

management system is continuous
improvement of the laboratory
processes, and this must be done in a
systematic manner.There are a number
of tools that are useful for process
improvement.
Customer service

 The concept of customer service has often

been overlooked in laboratory practice.
However, it is important to note that the
laboratory is a service organization;
therefore, it is essential that clients of the
laboratory receive what they need.The
laboratory should understand who the
customers are, and should assess their
needs and use customer feedback for
making improvements.

Facilities and safety

 Many factors must be a part of the quality

management of facilities and safety. These include:
 Security—which is the process of preventing
unwanted risks and hazards from entering the
laboratory space.
 Containment—which seeks to minimize risks and
prevent hazards from leaving the laboratory space and
causing harm to the community.
 Safety—which includes policies and procedures to
prevent harm to workers, visitors and the community.
 Ergonomics—which addresses facility and equipment
adaptation to allow safe and healthy working
conditions at the laboratory site.