3. What is Quality ?
Philip B Crosby
⢠The customer is the one you need
to make successful. You have to
learn what they need and give it to
themâ.
Joseph M Juran (Father of
Quality Management)
⢠Some products give little or no
dissatisfaction; they do what the
producer said they would do. Yet
they are not saleable because
some competing product has
features that provide greater
customer satisfaction
David Gravin
⢠8 dimensions to quality-
⢠Performance based
⢠Feature based
⢠Reliability
⢠Conformance
⢠Durability
⢠Serviceability
⢠Aesthetics
⢠Perceived quality
4. What is Quality ?
ISO 9001:2005
⢠âthe degree to which a set of inherent characteristics meet
requirementsâ.
Management
⢠GET IT DONE !!!!!
5. What are Quality metrics/indicators?
Established measures used to determine how well an
organization meets needs and operational and
performance expectations
⢠Laboratory shall implement quality indicators to
systematically monitor and evaluate its contribution to
patient care. ISO 15189 [4.12.4]
⢠When the programme identifies opportunities for
improvement, the laboratory management shall address
them, regardless of where they occur.
⢠Laboratory management shall ensure that the laboratory
participates in quality improvement activities that deal
with relevant areas and outcomes of patient care.
6. How to manage Quality ?
⢠Plan- Define course of action toward a measurable goal.
⢠Organize- How and How much
⢠Staff- Who does what
⢠Lead/ Direct- Do it
⢠Control- system functions in line with the plan
7. How to manage Quality ?
PLAN
ORGANIZE
STAFF
LEAD
CONTROL
CUSTOMER SATISFACTION
8. Quality Management System
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.
9. 9
Complexity of a Laboratory System
â˘Data & Laboratory
Management
â˘Safety
â˘Customer Service
Patient/Client Prep
Sample Collection
Sample Receipt and
Accessioning
Sample Transport
Quality Control
Testing
Record Keeping
Reporting
Personnel Competency
Test Evaluations
10. 10
THE PATIENT Test selection Sample Collection
Sample Transport
Laboratory Analysis Examination
Phase
Report CreationReport Transport
Preexamination Phase
Result Interpretation Postexamination Phase
Path of Workflow
11. Factors influencing analytical variables
EQUIPMENT RELIABILITY:
Meet technical needs, Compatible,
User & maintenance friendly, Cost
effective, Validated
Procedural
reliability using
Standard
Operating
Procedures
REAGENTS STABILITY, INTEGRITY AND
EFFICIENCY:
Stable, Efficient, Desired quality,
Continuously available, Validated
SPECIFICITY & SENSITIVITY
OF SELECTED TEST:
Adequate ST, Sufficient SP,
cost effective, compatible
with, available
infrastructure and
expertise, interpretable,
meets the needs/
objectives, validated
PROFICIENCY OF PERSONNEL:
Education, Training, Aptitude,
Competence, Commitment,
Adequate number, CME,
Supervision, Motivation
USE OF APPROPRIATE CONTROLS:
⢠Internal: Labs, Calibrated
against national
⢠External: Supplied by
manufacturer, National,
International
DOCUMENTATION:
All the written policies, plans, procedures,
instructions and records, quality control
procedures and recorded test results
involved in providing a service or the
manufacture of a product
Assessment
ANALYTICAL FACTORS
12. WHY is the Path of Workflow essential to consider in
health laboratories?
12
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.
13. Laboratory tests are influenced by
13
Laboratory Environment
Knowledgeable Staff
Competent Staff
Reagents and Equipment
Quality Control
Communications
Process Management
Occurrence Management
Record Keeping
14. Quality Management System Core
Customer
focus
Top
management
initiation
Involve all
staff
Process
oriented
approach
System
orientation
Factual
decision
making
Mutually
beneficial
supplier
relationship
15. Quality Management System Elements
Documenting and
Recording strategies
⢠Organizational
structure (Organogram)
⢠Staff job descriptions
and specific roles
⢠Equipment/
instruments
⢠Inventory
management systems
⢠Statistical Process
control
16. The 7 common tools of Quality Management
Cause and
effect
diagram
Flow
charts
Checklist
Control
chart
Scatter
diagrams
Pareto
analysis
Histograms
17. Quality Management System Components
Set of coordinated
activities that function
as building blocks for
quality management
23. Quality assurance vs Quality control
Quality
assurance
An overall
management plan
to guarantee the
integrity of data
(The âsystemâ)
Quality control
A series of
analytical
measurements
used to assess the
quality of the
analytical data
(The âtoolsâ)
29. External Quality Assessment
Procedures used to compare the performance of
different laboratories
These two procedures are complimentary
⢠Internal QC- daily monitoring of precision & accuracy
⢠External QA- long term accuracy of analytical methods
30. EQA results evaluate performance of the laboratory against
other laboratories participating in the same program
Different programs do this in different ways. When the diff. is
significant lab. is alerted
Results are instrument and protocol specific
EQA results should be formally documented within the lab
and should be available on request
External Quality Assessment
32. Laboratories should all enroll and
satisfactorily participate in a performance
evaluation/assessment program
⢠Non-availability of conventional PT ď Alternative
performance assessment system for determining
the reliability of analytic testing should be
exercised.
⢠If the lab has more than one method-system for
performing tests for an analyte, it must be checked
against each other at least twice a year for
correlation of patient results
Proficiency testing (PT)
33. â˘Six Sigma process
â˘Lean Production
â˘Joint Committee for
Traceability in
Laboratory Medicine
(JCTLM) Guidelines.
Several new
quality
initiatives
have been
developed &
implemented
New quality initiatives
34. Process Improvement
Opportunities for improvement (OFIs)
Stakeholder feedback
Problem resolution
Risk assessment
Preventive actions
Corrective actions
39. Summary
Managing quality is essential for
successful running of a laboratory and
high customer satisfaction
You canât fix what you canât measure,
so quality metrics is important
Focus should be on patient as well as
metric
Donât assume metrics will always work