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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. EstevesBrazil

23-24 January 2015 - Hamburg, Germany

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

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 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

ISO 9001: Conceptual Model

Customers are not only our patients…

• Doctors who use our services

• Our employees

• Suppliers

• People in our community

• Regulatory authorities

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

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

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

Concerns about quality of services

Dancet et al.

Hum Reprod 2013

0% 50% 100%

Doctors &embryologists

Nurses

PatientsSafety

Effectiveness

Patient-centeredness

How stakeholders value the top 3 quality dimensions of infertility care

QM focuses on customer requirementsand satisfaction

Lack of psychological support and poor quality of service ~60% treatment discontinuation

22 studies sampling 21,453 patients from 8 countries

A QMS will ensure that two important requirements are met…

1. Customer’s requirementsConfidence in the ability of the center to deliver the desired service consistently meeting their needs and expectations

2. Fertility center’s requirementsBoth internally and externally, and at an optimum cost with the efficient use of the available resources (materials, human, technology and information)

A powerful “wedge”

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

QMS benefits can only be achieved if evidence is provided

How to get information

Internal and external audits

Registration of quality actionsNon-conformities, preventive actions, improvement actions, complaints

Satisfaction surveys/questionnaires QC and QA reports

Key performance indicators

Mai

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17

How to measure & analyze

Pareto diagram

Diagram of cause and effect

Control chart

Histogram

Flowchart

Qu

alit

y To

ols

PDCA

Balanced score card (BSC)

Six sigmaQu

alit

y M

eth

od

s

Pareto Diagram

Prioritize problems to be solved

Diagram of cause and effectPrioritize factors that may cause undesired effect

Control chart Monitor the stability or instability of a process

0

2

4

6

8

10

12

Q12010

Q22010

Q32010

Q42010

Q12011

Q22011

Q32011

Q42011

Q12012

Q22012

Q32012

Q42012

Number of non-conformities

HistogramDistribute data and shows how a given

process varies

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

Qu

alit

y To

ols

PDCA

Balanced score card (BSC)

Six sigmaQu

alit

y M

eth

od

s

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/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

QualityISO recertification approval

Non-conformities No. year reduction -10%

Balanced Score Card Provide a hierarchized view of the organization’s

performance management system

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 of (key performance indicators)

Applying quality tools Pareto diagram, diagram of cause/effect, histogram, flow chart

Integrating quality tools with quality methodsPDCA, BSC & 6 Sigma

1996 – Androfert

Foundation

2000 – IVF Program

started

2006 – Started QMS implementation

2010 – ISO Certification

2013 – Recertification

What we achieved…

Main reasons we implemented QMS

Core reasonsConcerns about quality of servicesRegulatory directive

Beyond the coreImage and reputationCustomer satisfactionMarket share (customer

retention/acquisition)Profitability

Core Reasons Achieved

•Quality of servicesCertified and recertified with “zero” non-conformities during external auditing

First in Brazil to obtain ISO 9001 certification

•Full compliance with regulatory authorities

Qu

ali

ty o

f L

ab

ora

tori

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Image and Reputation

Recognized as “Model” fertility center by national government agency

• Germinative cell and tissue division; ANVISA

• Training center for ANVISA inspectors (Brazilian GerminativeTissue Directive)

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

Pe

rce

nt

gro

wth

pe

r ye

ar

Year

IVF Program

Profitability

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

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