ISO 9000:2000 Rumah Sakit
Dr. Dody Firmanda, SpA, MA
KOMITE MEDIK
Executive Summary :
Patient Safety, Six Sigma & ISO 9000 Quality Management Today's world health care performing to ensure the delivery of quality patient care at significantly lower level:
1. 2.
3.
An estimated 120 000 deaths occur every year due to medical mistakes?1
The IOM reported that medical mistakes in the United States cause as many as 98,000 hospital deaths per year.2
These stunningly high rates of medical errors--resulting in deaths, permanent disability and unnecessary suffering--are simply unacceptable in a medical system that “promises to do no harm." 3
Gerlin, A. How Your Hospital Could Kill You. Reader's Digest, June 2000, p. 174. Tickner, N, O'Neill M. Preventing Death and Injury From Medical Errors Requires Dramatic, Systemwide Changes. press release, Institute of Medicine, Division of Health Care Services, November 29, 1999. Ibid.
Inspection Inspection
Quality Quality Control Control
Quality Quality Assurance Assurance
Total Total Quality Quality
Understanding Understanding the business the business
a.a.Setting SettingStandards Standards b.b.Conform Conformwith withstandards standards (Audit/Akreditasi) (Audit/Akreditasi) c cMaintained Maintained&&Improve Improve
Evolusi
Understanding Understanding the customers the customers
Health Needs Assessment
NICE Clinical Clinical Governance Governance
Quality Quality System System
CQI CQI
BSI 5751 EN/ISO 9000 MBNQA EQA Benchmarking Award Deming Prize Award SQL
Balanced Scorecard (SFO)
CHImp
Evidence-based Clinical Specialities
Clinical Epidemiology
Readers’ Guides to Medical Literatures
Users’ Guides to Medical Literatures
80an
Evidencebased Medicine (EBM) 90an
Evidence-based Health Care (EBHC): • Policy • Health Technology Assessment • Others
Information Mastery
Abad 21
Quality Quality Tools Tools
Understanding the business
Benchmarking Need Assessment
Understanding the customers
PIP (Investors in People)
Total Quality Quality System
P A S/C
CQI QA Setting standard
Quality Tools
QA Model: ISO 9000 D
TQM Model: MBNQA EQA EFQM
Statistical Process Control
Wants
Goals
Demands
Aims
Needs
Objectives
Input
Process
Ouput
Outcome
Value/ Benefit
Relevance Adequacy Accessability
Efficiency Effectiveness
Maxwell
Impact Targets
Efficacy
Input
Process
Outcome
Donabedian
1. Vision : futuristic mind-setting of the organisation 2. Missions: ways of the organisation towards the vision 3. Goals : are broad statements. There is generally one goal for a service/task. 4. Aims : There are a number of aims relating to the goal. They are specific to particular problems. 5. Objectives : For each programme aim, there may be a number of objectives which are specified in measurable terms. 6. Targets/Minimal Thresholds : For each objective, there may be various points on the way to the attainment of the objective. They are defined in relation to a point in a time. Systems/Standards Criteria
Indicators
ISO 9000: 2000 The ISO 9000 Core Standards There are four Core Documents, as follows: 1. ISO 9000:2000 provides quality management principles and fundamentals. It describes what the series is about and lists basic definitions of terms for use by any organization. 2. ISO 9001:2000 states requirements for quality management systems when it is necessary to demonstrate that an organization is capable of effectively meeting customer and regulatory requirements, such as JCAHO, NCQA, URAC or state and federal requirements. 3. ISO 9004:2000 provides guidance for establishing a quality management system that goes beyond ISO 9001 requirements to meet and exceed customer expectations efficiently. 4. ISO 19011 provides guidance on planning and conducting quality audits.
Model of a process-based quality management system
Clauses in the ISO 9001 Quality Systems Standard ISO 9001:2000 consists of: • 5 primary clauses that contain 23 sub-clauses. • These requirements spell out what organization and possibly must do to conform to the standard. • All the requirements must be documented and controlled. The Clauses are as follows: 4. Quality Management System 5. Management Responsibility 6. Resource Management 7. Product Realization 8. Measurement, Analysis and Improvement
Quality Standards (Clauses/Subclauses) Quality Procedures
Quality Records
1. General 1.1. Index and revision status 1.2. Purpose and scope 1.3. Exclusions 2. Company background 2.1. Company background and history 2.2. Activities 3. Definitions and convention 3.1. Definitions and conventions 3.2. Abbreviations
D 0001 Definitions and terminology D 0002 Abbreviations D 0003 Index of the quality manual
Clause 4. Quality Management System (QMS) Quality Standards (subclauses) 4.1. General requirements 4.2. Documentation and records
Quality Procedures
Quality Records
P 421 Quality system documentation D 4301 Procedures D 4302 Process plans P 422 Control of documents D 4303 Work instructions P 423 Control of quality records D 4304 System documents D 4305 Specific documents D 4306 External documents D 4307 Paraphs D 4308 Distribution of the quality manuals D 4309 Distribution of the process files D 4310 Distribution of the personal files D 4311 Table of contents of process files D 4312 Table of contents of personal files D 4313 Document change request
Clause 5. Management Responsibility Quality Standards (sub-clauses)
Quality Procedures
P 521 Customer needs and 5.1. Management commitment 5.2. Customer focus communications 5.3. Quality policy 5.4. Quality system planning 5.5. Organization and communication P 561 Management review 5.6. Management review
Quality Records D 5301 Quality policy D 5401 Quality objectives D 5501 Organization scheme D 5502 Overview of the functions
Clause 6. Resource Management Quality Standards (sub-clauses)
Quality Procedures
Quality Records
6.1. Provision of resources 6.2. Human resources and trainings 6.3. Infrastructure 6.4. Work environment
P 621 Training and awareness
D 6201 Personnel card D 6202 Function descriptions D 6203 Training D 6301 Maintenance card D 6303 Maintenance schedule D 6304 Maintenance contracts D 6305 Different tasks
Clause 7. Product Realisation Quality Standards (sub-clauses)
Quality Procedures
Quality Records
7.1. Planning of product realisation 7.2. Customer related processes 7.3. Design control 7.4. Purchasing 7.5. Operations 7.6. Measuring and monitoring equipment
P 721 Order processing P 731 Design control P 741 Supplier evaluation P 742 Purchasing P 743 Verification of purchased product P 751 Handling, storage, packaging, preservation and delivery P 761 Measuring and monitoring equipment
D 7201 Overview of our own products D 7202 Specifications of our own products D 7203 Customer complaints D 7204 Customer feedback D 7301 Overview of product development D 7302 Design specification D 7303 Design output D 7304 Design review D 7305 Design verification D 7306 Design validation D 7307 Design changes D 7308 Design actions D 7401 Overview of the purchased products D 7402 Specifications of the purchased products D 7403 Supplier assessment D 7405 Approved suppliers D 7406 Suppliers on probation D 7601 Calibration cards D 7602 List of measuring devices D 7603 Calibration schedule D 7604 Calibration survey D 7605 Calibration results
Clause 8. Measurement, analysis and improvement Quality Standards (sub-clauses) 8.1. Planning of monitoring and measurement 8.2. Monitoring and measurement 8.3. Control of non-conforming product 8.4. Analysis of data 8.5. Continual improveme
Quality Procedures
Quality Records
P 821 Customer satisfaction P 822 Internal quality audits P 823 Inspection and test procedure P 831 Control of non-conforming product P 851 Corrective and preventive actions
D 8201 Internal auditors D 8202 Audit schedule D 8203 Audit report D 8401 Customer card D 8402 Supplier card D 8403 Internal problems since one year D 8501 Meeting schedule D 8502 System meetings D 8503 Specific meetings D 8504 Project data D 8505 Projects D 8506 Corrective action request D 8507 Executed actions D 8508 Present actions
Basic Quality Performance Wheel
Program Cost
Performance Measurement
Customer Satisfaction
Partial Wheel with Goals % F ir e /S m o k e C o n ta in m e n t D e f ic ie n c ie s R e d u c t io n
% B a c k I n ju r y R e d u c t io n R a te
EC C u sto m e r S a tis fa c ti o n
% S to r a g e D e f ic ie n c ie s R e d u c tio n
100
O v e r a ll S e r v ic e P a r tic ip a t io n
100
5
95
95 T e le p h o n e C ascade N o tif ic a ti o n C o m p le tio n
80
80
80
100
80 S taff K n o w le d g e
0
N o. of F a ls e F ire A la rm s p e r m o n th
3
S a f e ty M anagem ent
S ta ff K n o w le d g e
95 L i fe S a f e ty M g m t.
E m ergency P r e p . M g m t.
80
U ti lit y M g m t.
13 U n s c h e d u le d S h u td o w n s p e r m o n th
80
0
0
E q u ip t. M g m t.
95 80
S e c u r ity M g m t. H az/ M a t. M g m t.
13 0
0
80
80
0
80
H o t/C o ld E n v ir o n . C a lls p e r m o n th
80
25
80
90 95 P e r s o n a l ly O w n ed D e v ic e D e f ic ie n c ie s
E n v ir o n . In s p e c t. C ite d S m o k in g V io la tio n s / 6 m o n th s
90 M e d ic a l E q u ip . I n v e n to r y D a t a A c c u ra c y
95 S ta ff K n o w le d g e
M SDS P ro g ram
% C r im e R a te p e r Y ear R e d u c t io n
Hospital Based Performance Wheel Im p le m en t N ew C lin ic a l P ra c tic e G u id e lin es
In cr ea se d R evenu e
12
$ 1 5 M il % C o st R e d u c tio n
$ 1 2 M il
10
% In c r e a se d P r o d u c tiv ity
8 20
5
% D ec re a se in In v e n to ry
15
10
P ro g ra m C ost
10
C u s to m e r S a tis fa c tio n
40
20
35
P e rfo rm a n c e M e a s u re m e n t and Im p ro v e m e n t
15 20
60 T im e lin e ss o f A c c e ss
85
20
95
5
30
30
% S a tisfa c tio n per Survey
% D ec re a se A b se n te eism
0 C u sto m er C o m p la in ts
% D e c r e a se in W a itin g T im e
50 D ec re a se O p er a tin g B e d s
% D ec re a se B ed D ays of C are
Statistical Tools
C A U S E S
Data/Check Sheets Statistical Tools
Histograms
Run Charts
Control Charts Process Capability
Pareto Diagrams (Root Cause)
Analytical Tools Data/Check Sheets
C A U S E S
Statistical Tools
Histograms
Pareto Diagrams (Root Cause)
Run Charts
Control Charts Process Capability
S O L U T I O N S
Affinity Diagram
Brainstorming
Matrix Diagrams
Fishbone Diagrams
Analytical Tools Tree Diagrams
Force Field Analysis D.A Simmons 5/97
Scatter Diagram PDCA Model
Nominal Group Techniques
Flow Charts
Tools with Problem Solving Techniques Data/Check Sheets
C A U S E S
1,2,4,5,7,11
Statistical Tools
Histograms
Pareto Diagrams (Root Cause)
4,5,7,10
1,2,4,5,10 Run Charts
4,5,7,11 Control Charts
4,5,7,11 Process Capability 4,5,7,11
S O L U T I O N S
Analytical Tools
D.A Simmons 5/97
Affinity Diagram
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11.
Steps of Problem Solving Prioritize Problems Analyze Symptoms Formulate Theories Test Theories Identify Causes Evaluate Solutions Design Solutions Address Resistance Implement Solutions Check Performance Monitor Controls
Brainstorming
3
Tree Diagrams
Matrix Diagrams
12
7
Fishbone Diagrams
3 Force Field Analysis
Scatter Diagram 4,5,7
PDCA Model
Nominal Group Techniques
Flow Charts
2,4,5,6,7,9
Model: Integrated Health Care Quality Management
Integrated Health Care Quality Management PQM Process Quality Management
OQM Outcome Quality Management
Process Management (Optimization)
Hospital Manual (Documentation)
OQM System (Documentation)
Benchmarking (Evaluation)
Project Work Quality Circles
ISO System Processes/Standard Operating Procedures
Medical Outcomes Financial Results
Quality (Output) Costs (Input)
Pathway Management
Outcome Management
Controlling of Processes and Standards
Controlling of (Financial and Medical) Results
Terima Kasih http://www.members.leeds.ac.uk/d.firmanda97
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