business case for quality: international standards rogerio rabelo, md, phd, mba – senior...
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Business Case for Quality:
International Standards
Rogerio Rabelo, MD, PhD, MBA – Senior Consultant and Product Manager
Fleury Diagnostics
International Standards:understanding the ISO
• ISO:– International Organization for
Standardization– Non-governmental organization with
members from international institutes of more than a hundred countries
– Central office in Geneva, Switzerland
– “ The main purpose of ISO is to develop standards internationally recognized, contributing to make the development, manufacturing and supply of products and services more efficient, safer and cleaner”Certification and Accreditation:• According to ISO, a company which is found compliant to its standards and requirements is called “certified”• In the accreditation process, the term used is ”accredited”• For ISO, the company responsible for certifying an organization, after being checked and recognized by the authority bodies, is the one called “accredited”
What are the main ISO standards applicable to clinical
laboratories?ISO 9001:2000 - Quality Management System – Requirements
ISO 15189:2003 – Medical laboratories- particular requirements for quality and competence
ISO 14001:2004 - Environmental management systems - Requirements with guidance for use
* ISO standards can be generic (used for certification purposes) or specific (guidelines for orientation)
ISO 9001 certificates – Worldwide and the USA
Source: The ISO survey of ISO 9001:2000 and ISO 14001 certificates - 2003
30294USA
ISO 9001: 2000• Generic standard that states the requirements for the
implementation of Quality Management System• Main objectives: to increase patient satisfaction and to promote
continual improvement, leading to better results in the overall performance of the company
• Based on eight principles:– Customer/patient-focused organization– Leadership– Involvement of people– Process approach– Systemic approach– Continual improvement– Factual approach to decision making
– Mutually beneficial supplier relationships
Quality Management from ISO 9001:2000 perspective
Quality Management from ISO 9001:2000 perspective
Quality Management fromISO 15189:2003 perspective
ISO 15189:2003• It states the main points to implement a
Quality Management System in a clinical laboratory, using a more specific terminology
• Its objective is to allow laboratories to organize their operational procedures efficiently, meet the expectations of their clients and improve their service
• It includes Requirements for:– Pre-examination procedures– Examination procedures– Post-examination procedures– Equipment– Advisory services– Reporting of results, etc.
ISO 14001:2004 • Requirements for the implementation of
Environmental Management Systems• It intends to improve the environmental
performance of laboratories and other organizations– Providing them with tools to implement
efficient environmental management systems
– Making them able to achieve financial goals in a sustainable way
• It is based on:– The identification of environmental aspects
and impacts of an organization, and the measures taken to control them
– Prevention of pollution– Compliance to environmental legal
requirements
Environmental issues fromISO 14001:2004 perspective
• IMS: it is defined as the management of two or more internationally recognized standards in a compatible way by integrating common management principles shared by them– ISO 9001:2000 + ISO 14001:2004– OHSA 18000 + ISO 14001:2004– SA8000 + OHSA 18000 + ISO14001
Integrated Management System (IMS)
QualityManagement
EnvironmentalManagement
Common
Requirements
IMSIMS((IntegratedIntegrated
ManagementManagementSystemSystem))
QualityManagement
EnvironmentalManagement
Common
Requirements
IMSIMS((IntegratedIntegrated
ManagementManagementSystemSystem))
Integrated Management System (IMS) - Benefits
• Better integration and more effective management of related processes and departments
• Cost reduction• Process standardization/optimization• Better control of documents and
records• Continual improvement• Definition of a set of indicators
oriented to the overall performance of the laboratory
• Assurance of quality and safety patient needs and satisfaction
• If ISO 14001:2004 is part of it:• Compliance to environmental legal
requirements• Pollution prevention
P D
A C
Plan
Check
Act
Do
Business case for Quality: why did Fleury Diagnostics choose
ISO?• Because ISO standards are applicable to
the laboratory as a whole, including administrative and financial areas
• Because we wanted to standardize the processes before applying a more specific standard
• Because ISO standards have a generic approach– They can be used as the basis for more
specific accreditation standards (CAP, JCAHO)
– They can be used as the basis for other management tools (Lean, Six Sigma)
• Because ISO can also be used as a management standard to help the organization to achieve all expected results
Fleury Diagnostics Background: Knowing the Lab to understand our
IMS
Where are we?
Fleury Diagnostics –
the Laboratory
Fleury Diagnostics –the history and a philosophy
• Private laboratory, founded in 1926 by Dr. Fleury• Patient focus as the main foundation
• Physician-owned• Technology-driven• Knowledge-based• Intellectual capital• Teamwork & matrix structure• Ethics, respect and excellence• Equal opportunity
• Very strong brand name: top-of-mind for patients and physicians• Control of the full process (from blood drawing to result reporting) One-stop testing
Fleury Diagnostics – High-Quality Patient Service
Centers• 16 Patient Service Centers for
sample collection and diagnostic procedures:– 12 in metropolitan São Paulo– 1 in Jundiaí– 1 in Campinas– 1 in Brasília– 1 in Rio de Janeiro
• 2 hospital-based fast-response labs• State-of-art, centralized
technical/administrative headquarter• A very busy call center
– 24 hours/day, 365 days/year– 60 attending positions, 130
employees (no outsourcing at all)
– 5,000 calls/day
Fleury Diagnostics –Integrated Diagnostic Services
Laboratory Medicine:
Clinical Chemistry
Special Chemistry
Immunology/Serology
Microbiology
Parasitology
Hematology/Cytology
Coagulation
Anatomical Pathology
Molecular Diagnostics
Cytogenetics
Toxicology
Point-of-care testing
Diagnostic Services:
Nuclear Medicine
Imaging
Cardiology
Neurology
Endoscopy
Gynecology
Fetal Medicine
GI motility
Ear, nose and throat
Pneumology
Urology
Ophthalmology
Genetic counselling
Check-up services
Non-diagnostic Services:
Diabetes Center
Immunization Center
Travel Medicine Center
Outpatient Surgery Center
Fleury’s Mission and Values
Our missionProvide and develop services and medical procedures, with ethics and technical excellence, to fulfill the needs of our clients
Our values• Respect, trust, honesty and ethics on all relations with internal and external clients• Permanent investment in knowledge, talent, technological and scientific innovation• Equal opportunity for everyone, based on professional and personal competence• The company goals are above personal objectives• Commitment in service excellence
To perform and develop, with technical excellence and ethics, customer services and medical procedures, committing itself to the continual improvement of the services provided by:
• Implementation and maintenance of the Integrated Management System (IMS)
• Respect to the environment and prevention of pollution by complying with the applicable legislation and by treating the waste produced
Fleury’s ISO Integrated Management Policy
This policy is guided by five objectives:
• Provide efficient management tools that contribute to continual improvement
• Develop customer services in an efficient and respectful way, in order to answer the needs of our clients and exceed their expectations
• Perform, with technical excellence and ethics, diagnostic and therapeutic procedures
• Reduce the environmental impact of the medical procedures and services by the rational usage of natural resources and complying with legal requirements
• Ensure continuous improvement of our IMS by setting up goals and effectively monitoring them
Fleury’s ISO Integrated Management Policy –
Objectives
The Kids ISO’s 14000 Programme
ISO Standards at Fleury Diagnostics
1999
Quality Assurance:ISO9001:1994
2002
Integrated Management System:
ISO 9001:2000ISO 14001:1996
2001
Transition:ISO 9001:1994 ISO 9001:2000 +ISO 14001:1996
Fleury’s ISO 9001:1994 –the beginning
ISO 9001:1994 – focus on Quality Assurance
• Implementation of process and operational indicators
• Useful for monitoring specific processes and departments
• Difficulties to identify the connection between the ISO System and its contribution to the overall performance of the laboratory and patient satisfaction
• System considered by many employees as “bureaucratic and with plenty of papers to fill out”
Quality Indicators –the beginning
Focus / Process1999
ISO9001:1994 - Quality Assurance
Technical Procedures- Proficiency Testing Performance (National and
International Programs)- Punctuality: Number of Test Results released on time
Customer satisfaction- Number of customer complaints- Response time to customer inquiries
Human resource’s continual
Improvement- Hours of training provided to employees
IT Systems- Downtime of IT Systems:
• Internal and external• All different user areas: from LIS to Internet
Quality Assurance- Number of non-conformity reports- Number of internal audits performed- Number of preventive actions
Scientific papers/projects -
Fleury’s ISO 9001:2000 – the transition
• Transition from Quality Assurance approach to Quality Management approach
• Clear distinction between management and process indicators
• Better definition of different groups responsible for evaluating the performance at different levels of the laboratory
• The set of indicators were a mix of process and management indicators
ISO 9001:2000 - Focus on Quality Management
Quality & Management Indicators – the transition
Focus / Process
2002
Transition from ISO9001:1994 (Quality Assurance) to ISO9001:2000 (Quality
Management)
Technical Procedures
- Proficiency Testing Performance (National and International Programs)- Percentage of incorrect reports released in the system- Percentage of new tests available to patients
Customer satisfaction
- Number of customer complaints- Results of customer satisfaction surveys with:
Patient / physicians Health plans and insurance companies CRO’s and pharmaceutical companies Other laboratories
Human resource’s continual Improvement
- Hours of training provided to employees- Training Efficacy Evaluation- Competency Evaluation
IT Systems- Downtime of IT Systems:
• Internal and external• All different user areas: from LIS to Internet
Quality Assurance- Number of non-conformity reports- Number of internal audits performed- Number of preventive actions
Scientific papers/projects
-
Fleury’s ISO 9001:2000 + ISO 14001:1996 – our current IMS
Integrated Management System: ISO 9001:2000 + ISO 14001:1996• Based on the strategic planning of the
laboratory• Identification of patient satisfaction-
oriented process indicators • Establishment of a more concise set
of management indicators• Quality indicators monitoring the
technical excellence of the analytical processes, but also providing information on patient needs and health care market
• Use of the Balanced Scorecard approach to monitor them, with five strategic objectives– Defined by the strategic
planning
Fleury Diagnostics’Integrated Management System
PATIENT FOCUS:Reliability
Problem solvingPleasant experience
HIGHLY QUALIFIED HUMAN CAPITAL
STATE-OF-THE-ART TECHNOLOGY
Counseling to physicians
Technical excellence
Personalized service
Fleury’s Differentials and strategic planning
The Balanced Scorecard Approach
FINANCIAL
CUSTOMERINTERNAL BUSINESS PROCESS
LEARNING AND GROWTH
VISION AND STRATEGY
To succeed financially, how should we appear to our shareholders?”
To satisfy our shareholders and customers, what business processes must we excel at?
To achieve our vision, how will we sustain our ability to change and improve?
To achieve our vision, how should we appear to our customers?
Better results and performanc
e improveme
nt
Linking our mission, values and strategy to action: Balanced
Scorecard
Macro
bje
cti
ves
Mac
roob
ject
ives
Indicator 19
Indicator 5
Indicator 6
Indicator 29 Indicator 38
Indicator 30
Indicator 31
Obtain sustained growth and value generation for
Fleury business and brand
Sponsor: Cláudio
Indicator 15
Indicator 16
Sponsor: Lino
Indicator 20
Indicator 17
Indicator 13Indicator 21
Indicator 22
Serve our client in a personalized, humanized
way, exceeding their expectations
Systematically establish an effective relationship
with our client
Sponsor: Vivien
Fina
ncia
l Indicator 9
Inte
rnal
Pro
cess
Indicator 14
Indicator 1
Indicator 2
Indicator 7
Lear
ning
and
Gro
wth
Cus
tom
ers
Indicator 10
Indicator 33
Indicator 8
Indicator 26
Indicator 3
Indicator 4
Indicator 23
Indicator 35Indicator 27Indicator 12
Fleury's Strategic Indicators
Make all our staff and medical team totally
focused on our client, developing and
capacitating them to provide the best care,
assuring the perpetuation of our company’s culture
Sponsor: Dr. Rui
Indicator 24 Indicator 32
To be recognized as a knowledge company, socially responsible
Indicator 39
Indicator 11
Indicator 18
Indicator 37
Sponsor: Dra Maria Lúcia
Indicator 36
Indicator 25
Indicator 28
Indicator 34
Learning and
growth
Internal business processes
Customer
Financial
Obtain sustained
growth and value
generation for Fleury
business and brand
Serve our client in a
personalized, humanized
way, exceeding
their expectations
Systematically establish an
effective relationship
with our client
Make all our staff and medical team totally focused on our client,
developing and capacitating them to provide the best care,
assuring the perpetuation of our company’s culture
To be recognized as a knowledge
company, socially
responsible
Indicator
39
Quality Management Indicators/BSC metrics – continual improvement
challenge
Focus / Process
2004
ISO9001:2000 – Quality Management (Integrated Management System with the Balanced Scorecard Approach)
Technical Procedures
- Proficiency testing Performance (National and International Programs)- Punctuality: Number of Test Results released on time- Percentage of incorrect reports released in the system- Percentage of new tests available to patients- Percentage of results delayed/postponed- Percentage of patients in which blood had to be redrawn
Customer satisfaction
- Number of customer complaints- Results of customer satisfaction surveys: patient and physicians, health plans and insurance companies, CRO’s and pharmaceutical companies, other laboratories- Response time to customer and physician inquiries- Percentage of new clients and ordering physicians- Client retention rate- Share of mind survey- Top of Mind survey- Market Share- Number of clients and number of tests performed- Percentage of consulting services to clients and physicians- Average duration of calls (Call Center) and average length of time the patient stays in the PSCs- Average waiting time (Call Center and Patient Service Centers)
Human resource’s Continual
Improvement
- Hours of training provided to employees- Training Efficacy Evaluation- Competency Evaluation- Employee satisfaction survey- Percentage of employees participating in internal educational programs
IT Systems- Downtime of IT Systems: Internal and external
All different user areas: from LIS to Internet
Quality Assurance
- Number of non-conformity reports- Number of internal audits performed- Number of preventive actions- Number of continual improvement reports
Scientific papers/projects
- Number of scientific publications produced by the laboratory- Quality of external educational programs and medical events
Fleury’s IMS indicators/BSC metrics:
Patient Perspective
September/20044,684,87CUSTOMER SATISFACTION SCORE
STATUSPERIODGOALCURRENT
VALUEINDICATOR
C u s t o m e r s a t i s f a c t i o n s c o r e
01234567
2 0 0 3 2 0 0 4 ( 1 ) 2 0 0 4 ( 2 )
%
V a lo r
M e t a
BALANCED SCORECARD – DECEMBER/2004 ver.02 (02/25/2005)
Serve our client in a personalized, humanized way, exceeding their expectations
Fleury’s IMS indicators/BSC metrics:
Patient satisfaction surveys
2002 2003 2004
Call center
Waiting time 3.84 4.26 4.55
Quality of information 4.46 4.69 4.82
Cordiality 4.60 4.79 4.88
Reception (order entry)
Waiting time 4,14 4,37 4,75
Cordiality 4,59 4,77 4,91
Nursing
Waiting time 4.06 4.26 4.74
Professionalism 4.58 4.74 4.90
Cordiality 4.63 4.81 4.92
The clients were requested to give a 1 to 5 score to the quality of our services:
1 = “very unsatisfied”
5 = “very satisfied”
Fleury’s IMS indicators/BSC metrics:
Physician’s Perspective BALANCED SCORECARD – DECEMBER/2004 ver.02 (02/25/2005)
Make all our staff and medical team totally focused on our client, developing and capacitating them to provide the best care,
assuring the perpetuation of our company’s culture
INDICATORCURRENT VALUE
GOAL PERIOD STATUS
Top of Mind Survey with physicians– Best Clinical Laboratory (Quality)
87 % > 87% September/2004
Fleury’s IMS indicators/BSC metrics:
Internal Process Perspective BALANCED SCORECARD – DECEMBER/2004 ver.02 (02/25/2005)
Obtain sustained growth and value generation for Fleury business and brand
December/2004< 0,2 %0,191 %Percentage of patients in which blood had
to be redrawn
STATUSPERIODGOALCURRENT VALUE
INDICATOR
Percentage of patients in which blood had to be redrawn
STATUSPERIODGOALCURRENT VALUE
INDICATOR
Redraw 2004
020406080
100120
Jan
Feb MarApr M
ayJu
n JulAug
Sep OctNovDec
Months
Nu
mb
er o
f P
atie
nts
00,050,10,150,20,250,3
%redraws% Clients
Fleury’s IMS indicators/BSC metrics:
From Operation to Management
1999
Quality Assurance:ISO9001:1994
2004
Balanced ScorecardApproach
2002
Integrated Management System:
ISO 9001:2000ISO 14001:1996
2001
Transition:ISO 9001:1994 ISO 9001:2000 +ISO 14001:1996
The future of ISO and Quality Indicators in the Lab: Fleury
Diagnostics’ perspective• Promote the continual improvement of
the set of indicators• Supply information to guide strategic
decisions and strategic planning • Bring clear and measurable gains to
the company – from market share to patient satisfaction
• Contribute to the sustainability of the Healthcare System
• Provide measurements to develop the best practices for patient safety
• Promote sustainable development (Financial + Social + Environmental)
• Integrate certification and accreditation processes and systems through ISO15189:2003
Brazil: ISO 9001 certification ISO 15189 accreditation
USA: ISO 15189 accreditation ISO 9001 certification
The future of ISO and Quality Indicators:
ISO’s Perspective (2005-2010)• Developing a consistent and multi-
sector collection of globally relevant international standards
• Ensuring the involvement of stakeholders
• Raising the awareness and capacity of developing countries
• Being open to partnerships for the efficient development of international standards
• Promoting the use of voluntary standards as an alternative or as a support to technical regulations
• Being the recognized provider of international standards and guides relating to conformity assessment
• Providing efficient procedures and tools for the development of a coherent and complete range of deliverables
Source: ISO Strategic Plan 2005-2010
