Introduction-
Laboratory Quality
Management System
Learning Objectives
At the end of this activity, participants will be
able to:
◼ Explain the importance of a quality
management system
◼ 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 Management System
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?
Introduction Laboratory Quality Management System-Module 1 4
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
Introduction Laboratory Quality Management System-Module 1 5
Achieving a 99% level of quality
means
wrong diagnosis, wrong treatment (1% is big)
accepting a 1%
1% error rate
The patient trust the lab based on:
- Experience
- Reputation
- Accreditation
Introduction Laboratory Quality Management System-Module 1 6
6
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 7
Result: 1% failure
try to minimize and decrese the error
Introduction Laboratory Quality Management System-Module 1 8
8
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.
Introduction Laboratory Quality Management System-Module 1 9
Essential to all aspects of
health care are laboratory
results that are
▪ accurate,
▪ reliable, and
▪ timely
Introduction Laboratory Quality Management System-Module 1 10
Laboratory errors cost in
waste of for personnel and patient
eg: wrong tube means ask
time the patient to come again
and let them go through the
experience again
personnel
effort
Repeat again and put some samples on waiting= Delay
patient
outcomes
Wrong results = Wrong diagnosis = Wrong treatment
Introduction Laboratory Quality Management System-Module 1 11
Negative consequences of laboratory error
◼ Unnecessary treatment
◼ Treatment complications
◼ Failure to provide the proper treatment
◼ Delay in correct diagnosis
◼ Additional and unnecessary diagnostic testing.
Introduction Laboratory Quality Management System-Module 1 12
QMS
QA= Pre, analytical, post
Organization Personnel Equipment
QC= Analytical
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 13
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 14
Complexity of a Laboratory System
Preex
am Collection
i processing (Enter in system,
check data)
na
Reporting Patient/Client Prep
tio
n Sample Collection
n
stexaminatio
Personnel Competency
Test Evaluations
•Data & Laboratory
Management
•Safety
•Customer Service Sample Receipt and
Accessioning
Po
after testing
Record Keeping
Sample Transport
Quality Control
Testing
Examination
Introduction Laboratory Quality Management System-Module 1 15
Path of Workflow The entire set of operations that occur in
testing is called the 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 16
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 17
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 18
Twelve Quality System Essentials
set of
Organization Personnel Equipment
coordinated
activities that Purchasing Information
function as
Process
& Control Management
Inventory
building blocks
for Documents Occurrence
quality &
Records
Management
Assessment
management
Process Customer Facilities
Improvement Service &
Safety
Introduction Laboratory Quality Management System-Module 1 19
Organization Personnel Equipment
pre-testing
Purchasing Process Information post-testing
& Control Management
Inventory
Path of Workflow
Documents Occurrence
& Assessment
Management
Records
Process Customer Facilities
Improvement Service &
Safety
Introduction Laboratory Quality Management System-Module 1 20
Lab director= Management, communication
Organization with external agency
Supervisor= Watch . respo= assign teams, revise
reposts
Technologist
Technician
Responsibilities, House keepers
Authorities
Quality
Policy
Provision
Communication
of
resources
TAT:
Turn Aroud Time (total time taken from when a test or sample is received until the results are reported)
Not long time neither short as it depends on the timing needed to perform the test
The time is sat by the SOP
Introduction Laboratory Quality Management System-Module 1 21
Personnel Any human in lab
Continous improvement by profiency testing
▪ human resources
▪ job qualifications
▪ job descriptions
▪ orientation
▪ training
▪ competency assessment
▪ professional development
▪ continuing education
A manual is in the lab DOCUMENTED
Introduction Laboratory Quality Management System-Module 1 22
Equipment
▪ acquisition
▪ installation
▪ validation
▪ maintenance
▪ calibration
▪ troubleshooting
▪ service and repair
▪ records
Introduction Laboratory Quality Management System-Module 1 23
Purchasing and Inventory
▪vendor qualifications
▪supplies and reagents
▪critical services
▪contract review
▪inventory management
Introduction Laboratory Quality Management System-Module 1 24
Process Control
always in analytical phase
▪quality control
▪sample management
▪method validation
▪method verification
Introduction Laboratory Quality Management System-Module 1 25
Information Management
CPR, Barcode are unique identifier
Barcode will generate a number (YEAR-DATE-DEPARTMENT NUMBER- SAMPLE NUMBER) 2024925101
Patient can come with multiple sample and each lab has its own code for the patient (Different number for each department)
This is for retrival and to avoid mixing up. NO CODE=NO TESTING "reject"
▪ confidentiality
▪ requisitions
▪ logs and records
▪ reports
▪ computerized laboratory
information systems (LIS)
Introduction Laboratory Quality Management System-Module 1 26
Documents Records
creation collection
revisions and review review
control and distribution storage
retention
Introduction Laboratory Quality Management System-Module 1 27
Occurrence Management
▪complaints
▪mistakes and problems
▪documentation
▪root cause analysis
▪immediate actions
▪corrective actions
▪preventive actions
documented
Introduction Laboratory Quality Management System-Module 1 28
Laboratory Assessment
Internal
Internal External
Proficiency
Quality indicators
testing (EQA)
Audit program
Audit review
Inspections
Accreditations
Introduction Laboratory Quality Management System-Module 1 29
Process Improvement
▪opportunities for improvement (OFIs)
▪stakeholder feedback
▪problem resolution
▪risk assessment
▪preventive actions
▪corrective actions
Introduction Laboratory Quality Management System-Module 1 30
Customer Service
▪ customer group identification
▪ customer needs
▪ customer feedback
Introduction Laboratory Quality Management System-Module 1 31
Facilities and Safety
▪ safe working environment
▪ transport management
▪ security
▪ containment
▪ waste management
▪ laboratory safety
▪ ergonomics
Introduction Laboratory Quality Management System-Module 1 32
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 33
manage errors by meeting the standards
Organizatio Personnel Equipment
n
Laboratories not
Purchasing
&
Process
Control
Information
Management implementing a
Inventory
quality management
Documents Occurrence
Assessmen
system guarantees
& Manageme
UNDETECTED
Records nt t
ERRORS
Process Customer Facilities
Improvement Service &
Safety
Introduction Laboratory Quality Management System-Module 1 34
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 35
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 36
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 focus on services provided
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 37
ISO Documents - Laboratory memorize the numbers
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 38
ISO 15189:2007
◼ The foundation of international
medical laboratory quality
management
◼ Medical laboratories–Particular
requirements for quality
and competence
Introduction Laboratory Quality Management System-Module 1 39
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 40
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 41
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 42
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 43
