LABORATORY

MANAGEMENT
Laboratory Quality Essentials

ARIEL M. MARTICIO, RMT, MBA

Faculty, Medical Laboratory Science
OBJECTIVES:
• Introduction the quality program of the clinical
laboratory.
• Define quality management system model
• Enumerate and discuss the 12 quality system
essentials.
• Minimizing laboratory error by Quality Management
System
“12 Quality System Essentials”
framework developed by CLSI
Laboratory Laboratory quality can be defined as accuracy, reliability and
timeliness of reported test results.
Quality
The laboratory results must be as accurate as possible, all aspects of
the laboratory operations must be reliable

Reporting must be timely in order to be useful in a clinical or public

health setting.
Level of The challenge is to reduce the level of inaccuracy as much as
possible, given the limitations of our testing systems
Accuracy
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
• unnecessary treatment
• treatment complications
• failure to provide the proper treatment
• delay in correct diagnosis
• additional and unnecessary diagnostic
testing.
 Negative consequences of
laboratory error
• unnecessary treatment
• treatment complications
• failure to provide the proper These consequences result in
treatment increased cost in time and
• delay in correct diagnosis personnel effort, and often in poor
patient outcomes.
• additional and unnecessary
diagnostic testing.
 Minimizing laboratory error by
Quality Management System
• QMS is a “coordinated activities to
direct and control an organization
with regard to quality”. (ISO) (CLSI).

• 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.
 Complexity of laboratory
processes
• 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.
 Path of workflow

• Path of workflow is the entire set of

operations that occur in testing.
• The path of workflow begins with the
patient and ends in reporting and results
interpretation.
 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.
• the laboratory environment
• quality control procedures
• communications
• record keeping
• competent and knowledgeable staff
• good-quality reagents and equipment.
 The quality management system
model
• 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
• Assuring accuracy and reliability
throughout the path of workflow
depends on good management of all
of the quality essentials.
 1. Organization

• 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.
 2. 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.
 3. 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 program.
4. Purchasing and Inventory

• 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.
 5. Process Control

• Process control is comprised of

several factors that are important in
ensuring the quality of the laboratory
testing processes.
• quality control for testing,
• appropriate management of the
sample, including collection and
handling,
• method verification and validation.
6. 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.
 7. Documents and 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.
 8. Occurrence

• 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.
 9. 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).
10. Process Improvement

• The primary goal in a quality

management system is continuous
improvement of the laboratory
processes.
 11. Customer Service

• The laboratory should understand

who the customers are, and should
assess their needs and use customer
feedback for making improvements.
 12. Facilities and Safety
• Many factors must be a part of the quality
management of facilities and safety
• 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.
 International laboratory
standards
• The ISO 9000 documents provide guidance for quality
in manufacturing and 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.
 International laboratory
standards
• CLSI developed the quality management system model.
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.