Introduction-

Laboratory Quality
Management System
Learning Objectives
At the end of this activity, participants will be
able to:

Explain the importance of a quality

assurance system for labs
List the quality system essential elements
Describe the history of development of
quality principles
Discuss relationship of this quality model to
ISO and CLSI standards
Introduction Laboratory Quality Management System-Module 1 2
 The Quality Assurance System in Labs

Organization Personnel Equipment

Purchasing Information
Process
& Management
Control
Inventory

Documents Occurrence
& Management Assessment
Records

Process Customer Facilities

Improvement Service &
Safety

Introduction Laboratory Quality Management System-Module 1 3

 What is Quality Assurance

Introduction Laboratory Quality Management System-Module 1 4

 Achieving a 99% level of quality
assurance

means
1%
accepting a 1% error rate

Introduction Laboratory Quality Management System-Module 1 5

5
 In France a 1% error rate
would mean everyday
14 minutes without water or electricity
50,000 parcels lost by postal services
22 newborns falling from
midwives hands
600,000 lunches contaminated
by bacteria
3 bad landings at Orly Paris airport

Introduction Laboratory Quality Management System-Module 1 6

 Result: 1% failure

Introduction Laboratory Quality Management System-Module 1 7

7
 Essential to all aspects of
health care are laboratory
results that are

accurate,
reliable, and
timely

Introduction Laboratory Quality Management System-Module 1 8

Laboratory errors cost in

time

personnel
effort

outcomes
Introduction Laboratory Quality Management System-Module 1 9
 Organization Personnel Equipment

Purchasing Process Information

& Control Management

How do we
Inventory

achieve
excellent Documents
&
Occurrence
Management
Assessment

performance Records

in the
laboratory? Process
Improvement
Customer
Service
Facilities
&
Safety

Introduction Laboratory Quality Management System-Module 1 10

Quality Management System Definition
Coordinated activities to direct and
control an organization with regard
to quality (ISO,CLSI).

All aspects of the laboratory operation

need to be addressed to assure
quality; this constitutes
a quality management system.

Introduction Laboratory Quality Management System-Module 1 11

Complexity of a Laboratory System

Reporting Patient/Client Prep

Sample Collection
Personnel Competency
Test Evaluations
Data & Laboratory
Management
Safety
Customer Service
Sample Receipt and
Accessioning

Record Keeping

Sample Transport
Quality Control
Testing

Introduction Laboratory Quality Management System-Module 1 12

 Path of Workflow
THE PATIENT Test selection Sample Collection

Preexamination Phase

Sample Transport

Laboratory Analysis
Examination Phase

Report Transport Report Creation

Result Interpretation Postexamination Phase

Introduction Laboratory Quality Management System-Module 1 13

WHY is the Path of Workflow essential
to consider in health laboratories?

The entire process of managing a

sample must be considered:
the beginning: sample collection
the end: reporting and saving of results
all processes in between.

Introduction Laboratory Quality Management System-Module 1 14

Laboratory tests are influenced by
laboratory environment
knowledgeable staff
competent staff
reagents and equipment
quality control
communications
process management
occurrence management
record keeping
Introduction Laboratory Quality Management System-Module 1 15
Twelve Quality System Essentials

set of
Organization Personnel Equipment

coordinated
activities that Purchasing Information
function as
Process
& Control Management
Inventory

building blocks
for Documents
quality
Occurrence
& Assessment
Management
Records

management
Process Customer Facilities
Improvement Service &
Safety

Introduction Laboratory Quality Management System-Module 1 16

 Organization Personnel Equipment

Purchasing Process Information

& Control Management
Inventory

Path of Workflow
Documents Occurrence
& Assessment
Management
Records

Process Customer Facilities

Improvement Service &
Safety

Introduction Laboratory Quality Management System-Module 1 17

 Organization
Responsibilities, Authorities

Quality
Policy

Provision Communication
of
resources

Introduction Laboratory Quality Management System-Module 1 18

Personnel
human resources
job qualifications
job descriptions
orientation
training
competency assessment
professional development
continuing education

Introduction Laboratory Quality Management System-Module 1 19

Equipment
acquisition
installation
validation
maintenance
calibration
troubleshooting
service and repair
records
Introduction Laboratory Quality Management System-Module 1 20
 Purchasing and Inventory

vendor qualifications
supplies and reagents
critical services
contract review
inventory management

Introduction Laboratory Quality Management System-Module 1 21

Process Control

quality control
sample management
method validation
method verification

Introduction Laboratory Quality Management System-Module 1 22

 Information Management
confidentiality
requisitions
logs and records
reports
computerized laboratory
information systems (LIS)

Introduction Laboratory Quality Management System-Module 1 23

 Documents Records
creation collection
revisions and review review
control and distribution storage
retention

Introduction Laboratory Quality Management System-Module 1 24

 Occurrence Management

complaints
mistakes and problems
documentation
root cause analysis
immediate actions
corrective actions
preventive actions

Introduction Laboratory Quality Management System-Module 1 25

Laboratory Assessment
Internal
Internal External

Proficiency
testing (EQA)

Inspections

Accreditations

Introduction Laboratory Quality Management System-Module 1 26

Process Improvement
opportunities for improvement (OFIs)
stakeholder feedback
problem resolution
risk assessment
preventive actions
corrective actions

Introduction Laboratory Quality Management System-Module 1 27

Customer Service
customer group identification
customer needs
customer feedback

Introduction Laboratory Quality Management System-Module 1 28

Facilities and Safety
safe working environment
transport management
security
containment
waste management
laboratory safety
ergonomics

Introduction Laboratory Quality Management System-Module 1 29

 Implementing
Quality Management
does not But it detects
guarantee errors that may
an occur and
ERROR-FREE prevents them
Laboratory from recurring

Introduction Laboratory Quality Management System-Module 1 30

 Organizatio Personnel Equipment
n

Laboratories not
Purchasing
&
Process
Control
Information
Management
implementing a
Inventory
quality management
Documents Occurrence system guarantees
& Manageme Assessmen
Records nt t
UNDETECTED
ERRORS
Process Customer Facilities
Improvement Service &
Safety

Introduction Laboratory Quality Management System-Module 1 31

Laboratory
Quality Management System
Coordinated activities to direct
and control an organization
with regard to quality.

ISO 9000:2000

Introduction Laboratory Quality Management System-Module 1 32

Innovators of Quality

Walter W. Edwards
Shewhart Deming
1891-1967 1900-1993

Joseph Juran Philip Crosby Robert Galvin

1904-2008 (103 years) 1926-2001 b. 1922
Introduction Laboratory Quality Management System-Module 1 33
 A Brief History of Quality Management
Quality Management is not new.
Innovator Date Cycle
Walter A.Shewhart 1920s Statistical Process
Control
W. Edwards Deming 1940s Continual
Improvement
Joseph M. Juran 1950s Quality Toolbox
Philip B. Crosby 1970s Quality by
Requirement
Robert W. Galvin 1980s Micro Scale Error
Reduction

Introduction Laboratory Quality Management System-Module 1 34

 Standards Organizations
ISO CLSI
International Organization Clinical and Laboratory
for Standardization Standards Institute
(formerly known as NCCLS)
Guidance for quality in Standards, guidelines, and
manufacturing and service best practices for quality in
medical laboratory testing
industries
Broad applicability; used Detailed; applies
by many kinds of specifically to medical
organizations laboratories
Uses consensus process in Uses consensus process in
developing standards developing standards
Introduction Laboratory Quality Management System-Module 1 35
ISO Documents - Laboratory
ISO 9001:2000 Quality Management
System Requirements
Model for QA in design, development
production, installation, and servicing

ISO/IEC 17025:2005 General

requirements for the competence of
testing and calibration laboratories

ISO 15189:2007 Quality management

in the clinical laboratory

Introduction Laboratory Quality Management System-Module 1 36

 ISO 15189:2007

The foundation of international

medical laboratory quality
management
Medical laboratoriesParticular
requirements for quality
and competence

Introduction Laboratory Quality Management System-Module 1 37

CLSI Quality Documents
HS1-A2 A Quality Management System Model
for Health Care
describes quality system model, 12 essentials
aligns to ISO 15189 and parallels ISO 9000
applies to all health care systems

GP26-A3 Application of Quality Management

System Model for Laboratory Services
describes laboratory application of quality system model
relates the path of workflow to the quality system essentials
assists laboratory in improving processes
relates to HS1-A2 and ISO 15189

Introduction Laboratory Quality Management System-Module 1 38

In summary
Quality management is not new.

Quality management grew from the

good works of innovators who defined
quality over a span of 80 years.

Quality management is as applicable

for the medical laboratory as it is for
manufacturing and industry.

Introduction Laboratory Quality Management System-Module 1 39

 Key Messages
A laboratory is a complex system and
all aspects must function properly to
achieve quality.
Approaches to implementation will vary
with local situation.
Start with the easiest, implement in
stepwise process.
Ultimately, all quality management
system elements must be addressed.

Introduction Laboratory Quality Management System-Module 1 40

 Organization Personnel Equipment

Questions?
Purchasing Process Information

Comments?
& Control Management
Inventory

Documents Occurrence
& Assessment
Management
Records

Process Customer Facilities

Improvement Service &
Safety

Introduction Laboratory Quality Management System-Module 1 41