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What is TQM
1. Sandro C. Esteves, MD., PhD.
Director, ANDROFERT
Andrology & Human Reproduction Clinic
Campinas, BRAZIL
What is Total Quality
Management (TQM)?
Life Summit 2014 - ART TQM Forum, CHINA
ISO 9001:2008
2. Outline
o TQM definition
o Applying TQM in Healthcare and IVF
• Performance Management
• Quality Management
• Risk Management
o How to evaluate success of an IVF
center according to TQM
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4. Definitions
TOTAL
Complete; absolute;
comprehensive
MANAGEMENT
Administration; the
process of dealing
with or controlling
things or people
QUALITY
Characteristic; nature;
essential character;
something that distinguishes
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5. o It varies from person to
person, and it’s influenced
by feelings;
o Existing only in the mind;
imaginary
Quality is
subjective…
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6. The only objective and measurable
aspect of quality is the PROCESS
Process = Any activity or set of activities that uses
resources to transform raw material, supplies and
labor (inputs) into products or services (outputs)
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7. Process within the organization that
will ensure that the service provided is
performed in a standardized way, and
that results are analyzed and
improvements are done constantly,
to guarantee a service of excellence
with consistent and stable results
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8. Process
service standardized
results analyzed
improvements constantly done
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9. IVF is process-based, so TQM
can be applied to IVF
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10. Why a Process is so Important
for Quality
Every work is a set of interrelated processes;
Every process is subject to variation;
The key to the ongoing improvement is
systematically tackling and reducing
processes’ variations
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11. Key points (1)
The only objective and measurable aspect
of quality is the PROCESS
= set of activities that uses resources to
transform inputs into outputs
TQM is a process ensuring that service is
performed in a standardized way, and that
results are analyzed and improvements are
done constantly, thus guaranteeing a
service of excellence with consistent and
stable results
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13. ANDROFERT
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Resources,
training and
opportunities
for staff to
develop and
improve
OHSS, multiparity, biosafety,
health issues
QM
system
Applying TQM in IVF
14. ANDROFERT
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QMS: ISO 9001:2008
Determine needs and expectations of customers
and others (legislation, professional societies, etc.)
Mission
Establish a quality policy, quality objectives, and
quality indicators for the organization,
QM focus
Determine processes/procedures to achieve the
quality objectives; Identify and provide necessary
resources
Process
Determine means to prevent nonconformities (NC)
(variation) and eliminate their causes; Register
quality actions; Verify compliance
NC;
Registering;
Auditing
Establish and apply methods to measure
effectiveness/efficiency of each process
Monitoring
Establish and implement a process that involves all
personnel for continuous improvement
Continuous
improvement
15. Mission Statement
Define who your patients are
WHO
Define what you do, and the services you
provide
WHAT
Define how you do it: methods used,
philosophy, objectives, etc.
HOW
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Our mission is to help couples with conception difficulties
become parents, especially when the difficulty is partially
or totally related to men, through counseling, diagnosis
and treatment, offering personalized professional service
of excellence, and using all available technologic
resources
16. Quality Management Focus
Brief, simple and direct statements that
define the focus of your quality
management system
Quality
Policy
Objectives of each statement of your
quality policy (they have to be
measurable)
Quality
Objectives
How you monitor your quality objectives
(tools to check if your objectives, and
therefore your policy is being achieved)
Quality
Indicators
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18. Processes and Procedures
Any activity or set of activities that uses
resources to transform raw material,
supplies and labor (inputs) into products or
services (outputs)
Process
Sequence of steps to execute a task
Important for standardization and
replication
Procedure
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20. !
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Non-conformities
Every deviation
from what is
established.
Important to
identify
inconsistencies,
weaknesses,
and
improvement
opportunities
21. Registering Quality Actions &
Auditing
Actions taken to improve the service
provided
Improvement
Actions
Actions taken to avoid a potential non-
conformity detected before it actually
happen
Preventive
Actions
Actions taken after a non-conformity has
been detected to correct it
Corrective
Actions
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26. Continuous Improvement
Fabiola Bento, MBE
Quality Manager, ANDROFERT
Establish unity of
purpose and direction of
the internal environment
Create an environment
where people are fully
involved in achieving the
organization’s objectives
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29. • Know your patients
• Define the processes to meet their
expectations
• Define your goals and objectives, so that your
procedures and processes help you achieve
them
• Measure your performance and your patients’
satisfaction periodically to detect changes and
new demands
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30. • Involve all personnel in continuous
improvement
• Make changes, adjustments, and improvements
based on facts and not on assumptions
• And, last but not least, satisfy your patients!
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31. What a TQM guarantees is…
Key points (2)
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o A very well-organized workflow
o Excellence in service provided
o Focus on patient needs and
satisfaction
o Continuous improvement
o Increased operational efficiency
and profitability
32. ANDROFERT
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How to evaluate success of an
IVF center according to TQM
Is your
Center
Successful?
33. ü Development of 298 quality indicators
ü Twenty-four indicators selected based on
consensus of importance; Six quality dimensions
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34. Consensus Quality Indicators
Safety
• Complications, Errors/Mistakes, Procedures/Techniques/Medication
Effectiveness
• Live birth rates according to age groups and time periods
Patient centeredness
• Psychological counseling/support available, individualized treatment, patient
discussion groups, information, effective communication
Efficiency
• Diagnostic work-up prior to IVF, Clinic website with information, number of care
providers relative to number of patients
Timeliness
• Focus on urgent consultation and waiting time; average duration of waiting time
before and during treatment, and after failed attempt
Equity
• Explicit criteria for treatment indication, vision of the clinic concerning ethical
limitations, protocols in accordance with international/regulatory guidelines
Adapted from Dancet et al. HR 2013
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35. Top 3 Quality Indicators of Infertility Care
How professionals and patients perceive them?
Dancet et al.
Hum Reprod 2013
0% 20% 40% 60% 80% 100%
Doctors/embryologists
Nurses
Patients
Safety
Effectiveness
Patient-centeredness
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36. ANDROFERT
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Fertility care providers considered success rates
(effectiveness) to be the most important factor,
while patients valued the physicians’ attitudes
(patient-centeredness) the most
37. ANDROFERT
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Prove it, but
take into
account what
our needs are!
38. n Established 2009
n 100 babies born
n Few credentials experience
n IVF first treatment line
n No poor responders
n Record of errors/pat. complaints
n High multiple PR
n Advertise a lot
n Established1994
n >1,000 babies born
n Lots of credentials/experience
n All treatment options available
n Individualized approach
n Rare errors/patient complaints
n Low multiple PR
n Educational marketing
Doctor ‘Look Good’
PR/cycle = 50%
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Pregnancy rates not enough
Doctor ‘Look Bad’
PR/cycle = 30%
39. ANDROFERT
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Input Process Output
Efficiency
indicator
Effectiveness
indicator
Resources
Process Mapping
40. ANDROFERT
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Infertile
couple IVF cycle Pregnancy
Efficiency
indicator
Resources Clinic A = 40%
Clinic B = 40%
Pregnancy
Example 1
Quality Indicator = Effectiveness
41. ANDROFERT
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Infertile
couple IVF cycle Pregnancy
Efficiency
indicator
Resources
Pregnancy
Clinic B > A
Clinic A = drug 1
Clinic B = drug 2
+3 oocytes retrieved with drug 2 by same dosage
Pregnancy
(cumulative)
Clinic A = 45%
Clinic B = 55%
Example 1
Quality Indicator = Effectiveness
42. ANDROFERT
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Infertile
couple IVF cycle
Pregnancy
(per ET)
Efficiency
indicator
Clinic A = 40%
Clinic B = 40%
Resources
Example 2
Quality Indicator = Safety
43. ANDROFERT
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Infertile
couple IVF cycle Pregnancy
Efficiency
indicator
Clinic A = 40%
Clinic B = 30%
Resources
Clinic A = cCOS
Clinic B = iCOS
Clinic A = 10%
Clinic B = 0%
OHSS
(moderate/
severe)
Clinic B > A
Example 2
Quality Indicator = Safety
44. ANDROFERT
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Non-
obstructive
azoospermia
IVF cycle Pregnancy
Efficiency
indicator
Clinic A = 40%
Clinic B = 30%
Resources
Example 3
Indicator = Patient-centeredness
45. ANDROFERT
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Non-
obstructive
azoospermia
IVF cycle Pregnancy
Efficiency
Effectiveness
Clinic A = TESE/donor sperm
Clinic B = micro-TESE
Clinic A = 20%
Clinic B = 30%
Pregnancy
(biological
offspring)
Clinic B > A
Example 3
Indicator = Patient-centeredness
Resources
46. Quality cannot be determined by a single parameter
such as pregnancy rates
Effectiveness, safety and patient-centeredness are
amongst the most important quality indicators in
infertility care, but the latter is often neglected by
doctors/nurses/embryologists
TQM offers an opportunity to rethink our systems
and fully address all quality dimensions of
infertility care, including our customers’ needs
Key points (3)
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47. ANDROFERT
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Patient-
centeredness
Increase
patient
satisfaction
PregnancyPregnancy
Results of
satisfaction
surveys
Safety
Reduce
errors /
mistakes
PregnancyPregnancy
Number of Non-
conformities
registered
Effectiveness
Increase
pregnancy
rates
PregnancyPregnancy
Cumulative
pregnancy
rates
Quality
Dimension
Quality
Objective
Indicator
48. ANDROFERT
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Patient-
centeredness
Guarantee
biological
offspring
PregnancyPregnancyNo. cases using
sperm bank
Safety
Reduce
multiparity
and OHSS
PregnancyPregnancy
No. embryos
transferred per
cycle; No. cycles
using iCOS
Effectiveness
Increase
PRs
(biological)
in NOA
PregnancyPregnancyNo. NOA cases
with micro-TESE
Quality
Dimension
Quality
Objective
Indicator
49. “The real voyage of discovery
consists not in seeking new
landscapes, but in having new
eyes.”
Marcel Proust
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