Top Banner
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
38

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

Jul 16, 2015

Download

Health & Medicine

Sandro Esteves
Welcome message from author
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
Page 1: What are the benefits of QMS for a fertility centre and how do we measure them

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. EstevesBrazil

23-24 January 2015 - Hamburg, Germany

Page 2: What are the benefits of QMS for a fertility centre and how do we measure them

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

Page 3: What are the benefits of QMS for a fertility centre and how do we measure them

http://www.androfert.com.br/review

Page 4: What are the benefits of QMS for a fertility centre and how do we measure them

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

Page 5: What are the benefits of QMS for a fertility centre and how do we measure them

ISO 9001: Conceptual Model

Page 6: What are the benefits of QMS for a fertility centre and how do we measure them

Customers are not only our patients…

• Doctors who use our services

• Our employees

• Suppliers

• People in our community

• Regulatory authorities

Page 7: What are the benefits of QMS for a fertility centre and how do we measure them

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

Page 8: What are the benefits of QMS for a fertility centre and how do we measure them

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

Page 9: What are the benefits of QMS for a fertility centre and how do we measure them

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

Page 10: What are the benefits of QMS for a fertility centre and how do we measure them

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

Page 11: What are the benefits of QMS for a fertility centre and how do we measure them

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

Page 12: What are the benefits of QMS for a fertility centre and how do we measure them

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)

Page 13: What are the benefits of QMS for a fertility centre and how do we measure them

A powerful “wedge”

Page 14: What are the benefits of QMS for a fertility centre and how do we measure them

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

Page 15: What are the benefits of QMS for a fertility centre and how do we measure them

QMS benefits can only be achieved if evidence is provided

Page 16: What are the benefits of QMS for a fertility centre and how do we measure them

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

n T

oo

ls

Page 17: What are the benefits of QMS for a fertility centre and how do we measure them

17

Page 18: What are the benefits of QMS for a fertility centre and how do we measure them

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

Page 19: What are the benefits of QMS for a fertility centre and how do we measure them

Pareto Diagram

Prioritize problems to be solved

Page 20: What are the benefits of QMS for a fertility centre and how do we measure them

Diagram of cause and effectPrioritize factors that may cause undesired effect

Page 21: What are the benefits of QMS for a fertility centre and how do we measure them

Control chart Monitor the stability or instability of a process

Page 22: What are the benefits of QMS for a fertility centre and how do we measure them

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

Page 23: What are the benefits of QMS for a fertility centre and how do we measure them

Histogram

Page 24: What are the benefits of QMS for a fertility centre and how do we measure them

Flow chart Visualize a process and identify improvement

opportunities

Page 25: What are the benefits of QMS for a fertility centre and how do we measure them

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

Page 26: What are the benefits of QMS for a fertility centre and how do we measure them

PDCA Method to monitor, correct and

improve a process

Page 27: What are the benefits of QMS for a fertility centre and how do we measure them

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

Page 28: What are the benefits of QMS for a fertility centre and how do we measure them

6 Sigma Provides a general map that helps to reduce

variability

Page 29: What are the benefits of QMS for a fertility centre and how do we measure them

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

Page 30: What are the benefits of QMS for a fertility centre and how do we measure them

1996 – Androfert

Foundation

2000 – IVF Program

started

2006 – Started QMS implementation

2010 – ISO Certification

2013 – Recertification

What we achieved…

Page 31: What are the benefits of QMS for a fertility centre and how do we measure them

Main reasons we implemented QMS

Core reasonsConcerns about quality of servicesRegulatory directive

Beyond the coreImage and reputationCustomer satisfactionMarket share (customer

retention/acquisition)Profitability

Page 32: What are the benefits of QMS for a fertility centre and how do we measure them

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

Page 33: What are the benefits of QMS for a fertility centre and how do we measure them

Qu

ali

ty o

f L

ab

ora

tori

es

Page 34: What are the benefits of QMS for a fertility centre and how do we measure them

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)

Page 35: What are the benefits of QMS for a fertility centre and how do we measure them

0

5

10

15

20

25

Total number of doctors associated to the IVF program

Market share

ISO 9001

Page 36: What are the benefits of QMS for a fertility centre and how do we measure them

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

Page 37: What are the benefits of QMS for a fertility centre and how do we measure them

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

Page 38: What are the benefits of QMS for a fertility centre and how do we measure them

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