Laboratory quality management system

Definition of quality
Accuracy, reliability, and timeliness of the reported test results.

The complexity of the laboratory system requires that many factors must be addressed to assure quality
in the laboratory.

 the laboratory environment

 quality control procedures
 communications
 record-keeping
 competent and knowledgeable staff
 Good quality reagents and equipment.

Definition of quality management system

“Coordinated activities to direct and control an organization with regard to quality.” The International
Organization uses this definition for Standardization (ISO), and by the Clinical and Laboratory Standards
Institute (CLSI).

The quality model used here organizes all of the laboratory activities into twelve quality system
essentials.
These quality system essentials are a set of coordinated activities that serve as building blocks
for quality management. Assuring accuracy and reliability throughout the Path of Workflow
depends on good management of all of these 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 a 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, assuring that new equipment works properly, and
having a system for maintenance are all part of the equipment management
program in a quality management system.
 The management of reagents and supplies in the laboratory is often a challenging
Purchasing and task. However, proper management of purchasing and inventory can produce cost
Inventory savings in addition to assuring supplies and reagents are available when needed. The
procedures that are a part of management of purchasing and inventory are designed
to assure 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 is comprised of several factors that are important in assuring the
Process Control
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 laboratories; quality control was
one of the first quality practices to be used in the laboratory and continues to play a
vital role in assuring accuracy of testing.

The product of the laboratory is information, primarily in the form of test reporting.
Information
Management Information (data) needs to be carefully managed to assure 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 twelve quality system essentials overlap each other. A good example is
Documents and
Records 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, to be accurate and accessible.

An “occurrence” is an error or an event that should not have happened. A system is

Occurrence
Management 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.

The process of assessment is a tool for examining laboratory performance and

Assessment
comparing it to standards or benchmarks, or the performance of other laboratories.
Assessment may be internal, or 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.

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

Process
Improvement laboratory processes, and this must be done in a systematic manner. There are a
number of tools that are useful for process improvement.
 The concept of customer service has often been overlooked in laboratory
Customer
Service 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.

Many factors must be a part of the quality management of facilities and safety. These
Facilities and
Safety 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.
In the quality management system model, all twelve QSEs must be addressed to
assure accurate, reliable, and timely laboratory results, and to have quality
throughout the laboratory operations.