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www.excemed.org
IMPROVING THE PATIENT’S LIFE
THROUGH
MEDICAL EDUCATION
What are the benefits of QMS for a fertility centre...
Learning objectives
At the completion of this presentation,
participants should be able to:
• Understand how an organizati...
http://www.androfert.com.br/review
Know your customers and define the processes to
meet their expectations
Define goals and objectives, so that processes and...
ISO 9001: Conceptual Model
Customers are not only our patients…
• Doctors who use our services
• Our employees
• Suppliers
• People in our community
...
Adoption of QMS is a strategic decision of a
fertility center
Influenced by:
 Regulatory directives
 Concerns about qual...
Worldwide tendency is IVF guidelines
including QMS become mandatory
Australia Code of practice for assisted
reproductive t...
What regulatory bodies ask for
Document control system
Personnel training
Periodic audits
Procedures for detection, re...
Concerns about quality of services
Dancet et al.
Hum Reprod 2013
0% 50% 100%
Doctors &
embryologists
Nurses
Patients
Safet...
QM focuses on customer requirements
and satisfaction
Lack of psychological support and
poor quality of service ~60%
treatm...
A QMS will ensure that two important
requirements are met…
1. Customer’s requirements
Confidence in the ability of the cen...
A powerful “wedge”
Key points (1)
The benefits are…
1. Enables fertility center to provide consistency
in terms of methods, materials, equipm...
QMS benefits can only be achieved if
evidence is provided
How to get information
Internal and external audits
Registration of quality actions
Non-conformities, preventive
actions, ...
17
How to measure & analyze
Pareto diagram
Diagram of cause and effect
Control chart
Histogram
Flowchart
Quality
Tools
PDCA
B...
Pareto Diagram
Prioritize problems to be solved
Diagram of cause and effect
Prioritize factors that may cause undesired effect
Control chart
Monitor the stability or instability of a process
0
2
4
6
8
10
12
Q1
2010
Q2
2010
Q3
2010
Q4
2010
Q1
2011
Q2
2011
Q3
2011
Q4
2011
Q1
2012
Q2
2012
Q3
2012
Q4
2012
Number of ...
Histogram
Flow chart
Visualize a process and identify improvement
opportunities
How to measure & analyze
Pareto diagram
Diagram of cause and effect
Control chart
Histogram
Flowchart
Quality
Tools
PDCA
B...
PDCA
Method to monitor, correct and
improve a process
Category Metric Target Status
Customer
satisfaction
Repeat customer % IVF drop-out <50% 50%
Service % IVF cycles
w/complai...
6 Sigma
Provides a general map that helps to reduce
variability
Key points (2)
Measurement is carried out by…
Getting information
Audits, registration of quality actions, data
collection...
1996 – Androfert
Foundation
2000 – IVF Program
started
2006 – Started QMS implementation
2010 – ISO Certification
2013 – R...
Main reasons we implemented QMS
Core reasons
Concerns about quality of services
Regulatory directive
Beyond the core
Image...
Core Reasons Achieved
•Quality of services
Certified and recertified with
“zero” non-conformities during
external auditing...
QualityofLaboratories
Image and Reputation
Recognized as “Model”
fertility center by
national government
agency
• Germinative cell and
tissue di...
0
5
10
15
20
25
Total number of doctors associated
to the IVF program
Market share
ISO 9001
0
2
4
6
8
10
12
14
16
18
20
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
Percentgrowthperyear
Year
IVF Prog...
And more…
Set direction & met customers’
expectations
Improved process control & reduced
wastage
Created a proper docum...
Key points (3)
What we achieved was …
 A very well-organized workflow
 Excellence in service provided
 Focus on custome...
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What are the benefits of QMS for a fertility centre and how do we measure them

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What are the benefits of QMS for a fertility centre and how do we measure them

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What are the benefits of QMS for a fertility centre and how do we measure them

  1. 1. www.excemed.org IMPROVING THE PATIENT’S LIFE THROUGH MEDICAL EDUCATION What are the benefits of QMS for a fertility centre and how do we measure them S. Esteves Brazil 23-24 January 2015 - Hamburg, Germany
  2. 2. Learning objectives At the completion of this presentation, participants should be able to: • Understand how an organization could benefit from establishing an effective QMS • Learn how to measure quality as per QMS perspective • Learn what we achieved at Androfert after having implemented ISO 9001
  3. 3. http://www.androfert.com.br/review
  4. 4. Know your customers and define the processes to meet their expectations Define goals and objectives, so that processes and procedures help you achieve them Offer resources and infrastructure to fulfill objectives Systematically correct and prevent non-conformities Measure your performance and your customers’ satisfaction periodically Make changes, adjustments, and improvements based on measured results and not on assumptions Essentials of a successful QMS
  5. 5. ISO 9001: Conceptual Model
  6. 6. Customers are not only our patients… • Doctors who use our services • Our employees • Suppliers • People in our community • Regulatory authorities
  7. 7. Adoption of QMS is a strategic decision of a fertility center Influenced by:  Regulatory directives  Concerns about quality of services Effectiveness & efficiency Safety Customer requirements/satisfaction
  8. 8. Worldwide tendency is IVF guidelines including QMS become mandatory Australia Code of practice for assisted reproductive technology units, Reproductive Technology Accreditation Committee (RTAC) Brazil RDC 33 and 23, National Agency of Sanitary Surveillance (ANVISA) European Union EU directive 2004/23/EG, 2006/17/EG, 2006/86/EG South Africa National Health Act 61/2003; Human Tissue Act USA CLIA for Andrology laboratories; FDA for cryobiology
  9. 9. What regulatory bodies ask for Document control system Personnel training Periodic audits Procedures for detection, registration, correction and prevention of errors and non- conformities Compliance with biosafety regulations System to evaluate and control materials and equipment
  10. 10. Concerns about quality of services Dancet et al. Hum Reprod 2013 0% 50% 100% Doctors & embryologists Nurses Patients Safety Effectiveness Patient- centeredness How stakeholders value the top 3 quality dimensions of infertility care
  11. 11. QM focuses on customer requirements and satisfaction Lack of psychological support and poor quality of service ~60% treatment discontinuation 22 studies sampling 21,453 patients from 8 countries
  12. 12. A QMS will ensure that two important requirements are met… 1. Customer’s requirements Confidence in the ability of the center to deliver the desired service consistently meeting their needs and expectations 2. Fertility center’s requirements Both internally and externally, and at an optimum cost with the efficient use of the available resources (materials, human, technology and information)
  13. 13. A powerful “wedge”
  14. 14. Key points (1) The benefits are… 1. Enables fertility center to provide consistency in terms of methods, materials, equipment, etc. Safety and effectiveness 2. Ensures that services conform with customers' needs and requirements Customer-centeredness 3. Allows an increase in efficiency Profitability
  15. 15. QMS benefits can only be achieved if evidence is provided
  16. 16. How to get information Internal and external audits Registration of quality actions Non-conformities, preventive actions, improvement actions, complaints Satisfaction surveys/questionnaires QC and QA reports Key performance indicators MainTools
  17. 17. 17
  18. 18. How to measure & analyze Pareto diagram Diagram of cause and effect Control chart Histogram Flowchart Quality Tools PDCA Balanced score card (BSC) Six sigma Quality Methods
  19. 19. Pareto Diagram Prioritize problems to be solved
  20. 20. Diagram of cause and effect Prioritize factors that may cause undesired effect
  21. 21. Control chart Monitor the stability or instability of a process
  22. 22. 0 2 4 6 8 10 12 Q1 2010 Q2 2010 Q3 2010 Q4 2010 Q1 2011 Q2 2011 Q3 2011 Q4 2011 Q1 2012 Q2 2012 Q3 2012 Q4 2012 Number of non-conformities Histogram Distribute data and shows how a given process varies
  23. 23. Histogram
  24. 24. Flow chart Visualize a process and identify improvement opportunities
  25. 25. How to measure & analyze Pareto diagram Diagram of cause and effect Control chart Histogram Flowchart Quality Tools PDCA Balanced score card (BSC) Six sigma Quality Methods
  26. 26. PDCA Method to monitor, correct and improve a process
  27. 27. Category Metric Target Status Customer satisfaction Repeat customer % IVF drop-out <50% 50% Service % IVF cycles w/complaints <5% 2% Financial No. IVF cycles % Annual growth >5% 8% No. tests Andrology lab % Annual growth +/- 10% 8% Payment rate sperm/embryo bank % clients in debt <35% 40% Employee satisfaction Turnover 2-yr. period <5% 9% Absenteeism Days year/employee 4 2 Quality ISO recertification approval Non-conformities No. year reduction -10% Balanced Score Card Provide a hierarchized view of the organization’s performance management system
  28. 28. 6 Sigma Provides a general map that helps to reduce variability
  29. 29. Key points (2) Measurement is carried out by… Getting information Audits, registration of quality actions, data collection of (key performance indicators) Applying quality tools Pareto diagram, diagram of cause/effect, histogram, flow chart Integrating quality tools with quality methods PDCA, BSC & 6 Sigma
  30. 30. 1996 – Androfert Foundation 2000 – IVF Program started 2006 – Started QMS implementation 2010 – ISO Certification 2013 – Recertification What we achieved…
  31. 31. Main reasons we implemented QMS Core reasons Concerns about quality of services Regulatory directive Beyond the core Image and reputation Customer satisfaction Market share (customer retention/acquisition) Profitability
  32. 32. Core Reasons Achieved •Quality of services Certified and recertified with “zero” non-conformities during external auditing First in Brazil to obtain ISO 9001 certification •Full compliance with regulatory authorities
  33. 33. QualityofLaboratories
  34. 34. Image and Reputation Recognized as “Model” fertility center by national government agency • Germinative cell and tissue division; ANVISA • Training center for ANVISA inspectors (Brazilian Germinative Tissue Directive)
  35. 35. 0 5 10 15 20 25 Total number of doctors associated to the IVF program Market share ISO 9001
  36. 36. 0 2 4 6 8 10 12 14 16 18 20 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 Percentgrowthperyear Year IVF Program Profitability
  37. 37. And more… Set direction & met customers’ expectations Improved process control & reduced wastage Created a proper documentation system Facilitated training Involved staff & raised morale Improved communication & feed-back with all team members
  38. 38. Key points (3) What we achieved was …  A very well-organized workflow  Excellence in service provided  Focus on customers needs/satisfaction  Increased operational efficiency and profitability  Continuous improvement

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