A session for Hospital Management Students

1. Total Quality Management in
Medical Laboratories
Gift Ajay Sam
Sr. Demonstrator
TMIH, CMC

2. Quality?
• Philip B Crosby- Quality is free 1979- “The
customer is the one you need to make successful.
You have to learn what they need and give it to
them”.
• Joseph M Juran (Father of Quality Management)-
Juran's Quality Handbook -“Some products give
little or no dissatisfaction; they do what the
producer said they would do. Yet they are not
salable because some competing product has
features that provide greater customer
satisfaction”.

3. Quality?
• David Gravin- 8 dimensions to quality-
– Performance based
– Feature based
– Reliability
– Conformance
– Durability
– Serviceability
– Aesthetics
– Perceived quality

4. “THE DEGREE TO WHICH A SET OF
INHERENT CHARACTERISTICS MEET
REQUIREMENTS”.
ISO 9000; 2005

5. GET IT DONE!
Management?

6. How to get it done?
• 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. PLAN + ORGANIZE + STAFF + LEAD +
CONTROL = CUSTOMER SATISFACTION
Quality Management

8. Quality Management System- Core
• Customer focus
• Top management initiation
• Involve all staff
• Process oriented approach
• System orientation
• Factual decision making
• Mutually beneficial supplier relationship

9. Key elements of Quality Management
• Documenting and Recording strategies
• Organizational structure (Organogram)
• Staff job descriptions and specific roles
• Equipment/ instruments
• Inventory management systems
• Statistical Process control

10. Quality Assurance and Quality Control
Quality Assurance Quality Control
Management strategy Error detection methodology
Everybody's business
Area specific activity
performed by authorized
staff only

11. The 7 common tools of Quality
Management
• Cause and effect diagram
• Flow charts
• Checklist
• Control chart
• Scatter diagrams
• Pareto analysis
• Histograms

12. 7 tools of QC- Cause & effect diagram
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1. Ishikawa diagram or fish bone diagram.
2. Kaoru Ishikawa 1968.

13. 7 tools of QC- Flow charts
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1. Describe a process.
2. Arrows- flow of
direction.

14. Flow chart example
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15. 7 tools of QC- Checklist
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16. 7 tools of QC- Control charts
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1. Shewhart chart, 1920.
2. Mean value in centre.
3. Upper cut off limits &
lower cut off limits on
either side of mean.
4. 68% of values b/w ±
1SD; 95% of values b/w
±2SD; 99.7% values
b/w ±3 SD.

17. 7 tools of QC- Scatter diagrams
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1. Determine the correlation b/w
events.
2. Shows if a relationship exists
b/w 2 sets of data.

18. 7 tools of QC- Pareto analysis
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1. Joseph M
Juran, 1940.
2. Vilfredo
Pareto- Italian
Economist-
80/20
principle.
3. 20% of work
generate 80%
benefit.

19. Other Advanced Quality Management
strategies
LEAN 6 SIGMA
Toyota production system Motorola corp
Philosophy Metric
5s principle (Seiri, Seiton, Seiso
Sikethu, Shitsuke)
DMAIC
Eliminate waste (Waiting, Over
production, Rejection, Motion,
Processing, Inventory,
Transport)
Variation minimization
LEAN 6 Sigma= Philosophy + Metric

20. International Standards Organization
• Merger b/w ISA (International Federation of
National Standardizing Association, New York
1926) and UNSCC (United Nations Standards
Coordinating Committee, 1944 London)
• ISO set up in 1947 by 67 technical committees
• Firstly called International Standards
Coordinating Association by Americans and
Britons.
• Later on called as ISO derived from the Greek
meaning equal.

21. The Evolution of ISO standards
1 ISO 1: Standard reference temperature for industrial length
measurement
1951
2 ISO 31 (Now ISO 80000) document based on SI, ISO has set
units and how to measure them
1955
3 ISO/ TC 104 Standard on freight containers 1968
4 ISO 9001 family of standards published 1995
5 ISO 14001 environmental management standards published 1996
6 ISO 17025 Standard for testing and calibrating laboratories 1999
7 ISO 15189 Medical laboratories requirement for quality and
competence (From ISO 9001+ISO 17025)
2003
8 ISO/IEC 27001 Management system standard on information
security
2005
9 ISO 26000 Guidance on social responsibility 2010
10 ISO 50001 energy management standard 2011
11 ISO 37001 Anti bribery management systems 2016

22. Medical Laboratory Accreditation
• A process by which an authoritative body
gives formal recognition that an organization
is competent to carry out specific tasks.
• E.g. Joint commission on accreditation of
healthcare organizations (JAHO), National
committee on quality assurance (NCQA),
NABL, CAP.
• India NABL authoritative body for testing and
calibrating laboratories.

23. Accreditation vs Certification
Certification Accreditation
A procedure by which a third
party* gives a written
assurance that a product,
process or service confirms to
specific requirements.
*Third party- A person or a body that is
recognized to be independent of the
laboratory or parent organization.
A procedure by which an
authoritative body gives
formal recognition that a body
or a person is competent to
carry out specific tasks
(ISO/IEC guide 2).
eg. ISO 9000
eg. ISO 15189; 2012, ISO
17043; 2010.
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24. Accreditation- Why?
Acceptance of test
results within &
beyond borders.
Greater control of
laboratory
process.
Customer
satisfaction. &
Brand value.
Customer can
easily find an
accredited
laboratory

25. Accreditation- How?
• NABL embraces the ISO 15189 Medical
laboratories- requirements for quality and
competence.
• Accreditation given based on laboratories
capability to perform tests and provide
reliable results.
• Assessment based on the ISO 15189; 2012
standard.

26. Requirements for accreditation
• Create a policy document (Quality Manual).
• Appoint a Quality Manager.
• Establish the Quality Management system
• Appoint a technical manager.
• Process breakdown & QI identification.
• Monitor quality indicators and undertake
appropriate CA/PA.
• Documentation.
• Audits
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27. Requirements for accreditation
• Quality manual:
– Satisfy every clause mentioned in the standard
(ISO 15189).
– Greatest document of the QMS (Level 1).
– Describes laboratory policies, organization
structure, job descriptions and personnel
interrelations.
Note:
“Every lab policies traceable to its QM”.
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28. Requirements for accreditation
• Quality Manager:
– Head of the QMS.
– Reports directly to the lab director.
– Keeps the laboratory audit fit.
– Monitors process and continuously improves
them various lab processes.
– Involved in educating and training staff.
• Education- change the way people think.
• Training- change the way personnel work.
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29. Requirements for accreditation
• Quality Management system
– Quality: The degree to which a set of inherent
characteristics fulfils requirements.
– Management: Plan, organize, staff, lead and
control.
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30. Requirements for accreditation
• Technical Manager:
– Usually a senior technical person.
– Appointed by HOD.
– Technical workload management and work
distribution among existing staff.
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31. Requirements for accreditation
• Quality indicators:
– “It measures how well an organization meets the
needs and requirements of users and the quality
of all operational processes”.
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32. Requirements for accreditation
• Establishing QI & continual improvement:
– Lab process broken down to its components and
micro components.
– Identify the common failures or errors that occur
frequently.
– Log the most common errors and the reason
behind the errors.
– Appoint a person to ensure the log is maintained
and updated regularly.
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33. Requirements for accreditation
• Establishing QI & continual improvement:
– Tabulate and identify the major causes for the
errors.
– Present the data with recommended corrective
measures.
– Implement the CA and measure the rate of
success of the corrective action.
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34. Requirements for accreditation
• Properties of QI’s:
– Measurable in terms of numbers.
– Benchmarks should be predefined.
– Results should be subjected to statistical analysis.
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35. Requirements for accreditation
Pre analytical
• Sample collection
• Routing to appropriate location
• Registration into LIS
Analytical
• QC
• Sample processing
• Result genera ration
Post
analytical
• Result validation
• Result transfer.
Lab work breakdown structure and QI identification
Sample rejection.
Sample missing
Double poke
QC failure.
Unscheduled Downtime.
Human error.
Software crash
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36. Documentation
Indicators for good documentation:
• Approved, reviewed and updated regularly.
• Concise, legible, accurate and traceable.
• Amendments & revision are identifiable.
• Current version is available at points of use.
• Follows change control procedure.
• Obsolete documents separated, identified and
retained for defined amount of time.
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37. Documents of the QMS
Quality
Manual
QSP/ SOP
Forms, checklist,
Records.
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38. Document classification in QMS
Internal documents External documents Records
Documents
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39. Document classification in QMS
• Internal documents:
– Documents/ reference material created by the
laboratory for use within the laboratory.
– It is subject to the change control procedures
created by the laboratory.
– It is approved by appropriate personal before
release for use by the laboratory personnel.
– E.g. SOP, QM, QSP.
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40. Document classification in QMS
• External documents:
– Maintained by the laboratory for reference
purposes.
– Created by a third party and is formally published
for use.
– Not subject to the change control procedure of
the laboratory.
– E.g. ISO 15189; 2012 standard, published book.
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41. Document classification in QMS
Records
• Proof/ evidence of activity.
• They have a defined retention period.
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42. Other activities
• Quality Control
– Goal to identify errors before they impact the real
test.
– Also called as repeatability testing or precision.
• Proficiency testing
– Ensure the laboratory tests are accurate.
• Calibration
– All equipment's and instruments are produce
accurate results.
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43. Conclusion
• All Quality management efforts should be
primarily directed toward provision of the best
possible service at the lowest possible price.
• “Quality is Marketing redefined”.