1.

Introduction to
quality
 1-1: The importance of laboratory quality
Definition of Laboratory quality can be defined as accuracy, reliability and timeliness of reported
quality 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 When making measurements, there is always some level of inaccuracy. The
required 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 Laboratories produce test results that are widely used in clinical and public
consequences of health settings, and health outcomes depend on the accuracy of the testing
laboratory error 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 In order to achieve the highest level of accuracy and reliability, it is essential
laboratory error 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.

8 Laboratory Quality Management System

 1-2: Overview of the quality management system
Definition of A quality management system can be defined as “coordinated activities to direct
quality and control an organization with regard to quality”. This definition is used by
management the International Organization for Standardization (ISO) and by the Clinical and
system Laboratory Standards Institute (CLSI). Both groups are internationally recognized
laboratory standards organizations, and will be discussed later in this handbook.
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.

Patient client prep

Sample collection Pre-
exa
m
i

na
Reporting

tio
n
on
xaminati

Personnel competency
test evaluations

HIGH

Sample receipt and

accessioning
Post-e

LOW

Record keeping

Sample transport

Quality control
Ex testing
amin
ation

Complexity There are many procedures and processes that are performed in the laboratory,
of laboratory and each of these must be carried out correctly in order to assure accuracy
processes 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.

Laboratory Quality Management System 9

 1-2: Overview of the quality management system

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.

Test
The patient selection
Sample
collection
Pr e e xa mi na t
i o n ph
ase Sample
transport

Laboratory analysis
Examination phase
t io n p a s e
h

Report
i na

creation
am

Report
transport ex
st
Po
ti on
R e s ult int e r p r e t a

Quality The complexity of the laboratory system requires that many factors must be
management addressed to assure quality in the laboratory. Some of these factors include:
system addresses  the laboratory environment
all processes  quality control procedures
 communications
 record keeping
 competent and knowledgeable staff
 good-quality reagents and equipment.

10 Laboratory Quality Management System

 1-3: The quality management system model
Overview of When all of the laboratory procedures
the quality and processes are organized into Organization Personnel Equipment

management an understandable and workable

system model structure, the opportunity to ensure
that all are appropriately managed
Purchasing
is increased. The quality model used and
Process Information
control management
here organizes all of the laboratory inventory

activities into 12 quality system Path of workflow

essentials. These quality system
Documents
essentials are a set of coordinated and
Occurrence
Assessment
management
activities that serve as building blocks records
for quality management. Each must be
addressed if overall laboratory quality
improvement is to be achieved. This Process Customer
Facilities
and
quality management system model improvement service
safety
was developed by CLSI,1 and is fully
compatible with ISO standards.2,3
Assuring accuracy and reliability throughout the path of workflow depends on
good management of all of the quality essentials.

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.

1 CLSI/NCCLS. A quality management system model for health care; approved guideline—second edition, CLSI/NCCLS document HS1-A2.
Wayne, PA, NCCLS, 2004.
2 ISO 15189:2007. Medical laboratories–particular requirements for quality and competence. Geneva: International Organization for
Standardization, 2007.
3 ISO 9001:2000. Quality management systems–requirements. Geneva: International Organization for Standardization, 2000.

Laboratory Quality Management System 11

 1-3: The quality management system model

Purchasing and The management of reagents and supplies in the laboratory is often a challenging
inventory 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 The product of the laboratory is information, primarily in the form of test
management 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.

Many of the 12 quality system essentials overlap. A good example is the close
Documents and relationship between "Documents and records" and "Information management".
records 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 An “occurrence” is an error or an event that should not have happened. A system
management 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.

12 Laboratory Quality Management System

 1-3: The quality management system model

Process The primary goal in a quality management system is continuous improvement of

improvement 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 The concept of customer service has often been overlooked in laboratory practice.
service 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 Many factors must be a part of the quality management of facilities and safety.
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.

Quality In the quality management system model, all 12 quality system essentials must
management be addressed to ensure accurate, reliable and timely laboratory results, and to
system model have quality throughout the laboratory operations. It is important to note that
the 12 quality system essentials may be implemented in the order that best suits
the laboratory. Approaches to implementation will vary with the local situation.

Laboratories not implementing a good quality management system are

guaranteed that there will be many errors and problems occurring that may
go undetected. Implementing a quality management system may not guarantee
an error-free laboratory, but it does yield a high-quality laboratory that detects
errors and prevents them from recurring.

Laboratory Quality Management System 13

 1-4: History of laboratory quality management
Definition ISO 9000 defines quality management as “coordinated activities to direct and
of quality control an organization with regard to quality”. This is intimately related to the
management definition of a quality system—“organizational structure, resources, processes
and procedures needed to implement quality management”. Quality management
concepts in use today had their onset in the 20th century, and are primarily an
outgrowth of manufacturing and shop processes.

Principal One of the earliest concepts of the quality management movement was that
innovators of quality control of the product. Shewhart developed a method for statistical
and their process control in the 1920s, forming the basis for quality control procedures in
contributions the laboratory. Quality control methods were not applied in the laboratory until
the 1940s. Other critical thinkers and innovators, including Arman Feigenbaum,
Kaoru Ishikawa and Genichi Taguchi, added to the concepts. The most recent
method that is of importance to the laboratory is Galvin’s work on micro-scale
error reduction.

Quality management is not new.

14 Laboratory Quality Management System

 1-5: International laboratory standards
Need for international A part of quality management is assessment, measuring performance against
laboratory standards a standard or benchmark. The concept of quality management requires that
standards be set, and again industry has been in the lead.

Important laboratory Using a set of standards established by the United States of America military for
standards organizations the manufacture and production of equipment, the ISO established standards for
industrial manufacturing; we know these standards as ISO standards.
The ISO 9000 documents provide guidance for quality in manufacturing and
ISO service industries, and can be broadly applied to many other kinds of organizations.
ISO 9001:2000 addresses general quality management system requirements
and applies to laboratories. There are two ISO standards that are specific to
laboratories:
 ISO 15189:2007. Medical laboratories—particular requirements for quality and
competence. Geneva: International Organization for Standardization, 2007.
 ISO/IEC 17025:2005. General requirements for the competence of testing and
calibration laboratories. Geneva: International Organization for Standardization,
2005.
Another important international standards organization for laboratories is the
CLSI Clinical and Laboratory Standards Institute, or CLSI, formerly known as the
National Committee for Clinical Laboratory Standards (NCCLS). CLSI uses a
consensus process involving many stakeholders for developing standards. CLSI
developed the quality management system model used in this handbook. This
model is based on 12 quality system essentials, and is fully compatible with ISO
laboratory standards.
CLSI has two documents that are very important in the clinical laboratory:
 A quality management system model for health care; approved guideline—second
edition. CLSI/NCCLS document HS1-A2. Wayne, PA, NCCLS, 2004.
 Application of a quality management system model for laboratory services; approved
guideline—third edition. CLSI/NCCLS document GP26-A3. Wayne, PA, NCCLS,
2004.
The information in this handbook is based on the CLSI quality
management system model and the ISO 15189 standard.
There are many other standards organizations, and many examples of laboratory
Other standards. Some countries have established national laboratory quality standards
standards that apply specifically to laboratories within the country. Some laboratory
standards apply only to specific areas in the laboratory or only to specific tests.
The World Health Organization has established standards for some specific
programmes and areas.

Laboratory Quality Management System 15

 1-6: Summary
Quality Quality management is not new; it grew from the work of innovators who defined
management quality over a span of 80 years. Quality management is as applicable for the medical
laboratory as it is for manufacturing and industry.

Key messages  A laboratory is a complex system and all aspects must function properly to
achieve quality.
 Approaches to implementation will vary with the local situation.
 Start with changes that can be easily accomplished and have the biggest impact.
 Implement in a stepwise process but ultimately, all quality essentials must
be addressed.

16 Laboratory Quality Management System