Business Case for Quality: International Standards

1
Business Case for QualityInternational
Standards

• Rogerio Rabelo, MD, PhD, MBA Senior Consultant
  and Product Manager
• Fleury Diagnostics

2
International Standardsunderstanding 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

3
What are the main ISO standards applicable to
clinical laboratories?
ISO 90012000 - Quality Management System
Requirements ISO 151892003 Medical
laboratories- particular requirements for quality
and competence ISO 140012004 - Environmental
management systems - Requirements with guidance
for use ISO standards can be generic (used
for certification purposes) or specific
(guidelines for orientation)
4
ISO 9001 certificates Worldwide and the USA
Source The ISO survey of ISO 90012000 and ISO
14001 certificates - 2003
5
Quality Management from ISO 90012000 perspective

• 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

6
Quality Management from ISO 90012000 perspective
7
Quality Management fromISO 151892003 perspective

• ISO 151892003
• 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.

8
Environmental issues fromISO 140012004
perspective

• ISO 140012004
• 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

9
Integrated Management System (IMS)

• 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 90012000 ISO 140012004
• OHSA 18000 ISO 140012004
• SA8000 OHSA 18000 ISO14001

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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 140012004 is part of it
• Compliance to environmental legal requirements
• Pollution prevention

11
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

12
Fleury Diagnostics Background Knowing the Lab
to understand our IMS
Where are we?
13
Fleury Diagnostics the Laboratory
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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
15
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/administrativ
  e 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

16
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

17
Fleurys Mission and Values
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Fleurys ISO Integrated Management Policy

• 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
•  

19
Fleurys ISO Integrated Management Policy
Objectives

• 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

20
ISO Standards at Fleury Diagnostics
21
Fleurys ISO 90011994 the beginning

• ISO 90011994 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

22
Quality Indicators the beginning
Focus / Process 1999
Focus / Process ISO90011994 - 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 resources 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 -
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Fleurys ISO 90012000 the transition
ISO 90012000 - Focus on Quality Management

• 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

24
Quality Management Indicators the transition
Focus / Process 2002
Focus / Process Transition from ISO90011994 (Quality Assurance) to ISO90012000 (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 CROs and pharmaceutical companies Other laboratories
Human resources 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 -
25
Fleurys ISO 90012000 ISO 140011996 our
current IMS

• Integrated Management System
• ISO 90012000 ISO 140011996
• 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

26
Fleury DiagnosticsIntegrated Management System
27
Fleurys Differentials and strategic planning
Counseling to physicians
Best services
PATIENT FOCUS Reliability Problem
solving Pleasant experience
Personalized service
Technical excellence
HIGHLY QUALIFIED HUMAN CAPITAL STATE-OF-THE-ART
TECHNOLOGY
28
The Balanced Scorecard Approach
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Linking our mission, values and strategy to
action Balanced Scorecard
Macrobjectives
30
Quality Management Indicators/BSC metrics
continual improvement challenge
Focus / Process 2004
Focus / Process ISO90012000 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, CROs 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 resources 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
31
Fleurys IMS indicators/BSC metrics Patient
Perspective
BALANCED SCORECARD
DECEMBER/2004 ver.02 (02/25/2005)Serve
our client in a personalized, humanized way,
exceeding their expectations
32
Fleurys IMS indicators/BSC metricsPatient
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
33
Fleurys IMS indicators/BSC metrics Physicians
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 companys culture
INDICATOR CURRENT VALUE GOAL PERIOD STATUS
Top of Mind Survey with physicians Best Clinical Laboratory (Quality) 87 gt 87 September/2004
34
Fleurys IMS indicators/BSC metrics Internal
Process Perspective
BALANCED SCORECARD
DECEMBER/2004 ver.02 (02/25/2005)Obtai
n sustained growth and value generation for
Fleury business and brand
CURRENT
CURRENT
STATUS
PERIOD
GOAL
INDICATOR
STATUS
PERIOD
GOAL
INDICATOR
VALUE
VALUE
Percentage of patients in which blood had
Percentage of patients in which blood had to be
redrawn
December/2004
lt 0,2
0,191
to be redrawn
Redraw 2004
120
0,3
0,25
100
0,2
80

60
0,15
Patients
40
0,1
Number of
20
0,05
0
0
Jul
Jan
Feb
Mar
Apr
May
Jun
Aug
Sep
Oct
Nov
Dec
Months
redraws
Clients
35
Fleurys IMS indicators/BSC metrics From
Operation to Management
36
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 ISO151892003

Brazil ISO 9001 certification ? ISO 15189
accreditation USA ISO 15189 accreditation ? ISO
9001 certification
37
The future of ISO and Quality Indicators ISOs
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
38
Thank you!
rogerio.rabelo_at_fleury.com.br Tel
55-11-5014-7637 www.fleury.com.br