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George B. ShawGeorge B. Shaw
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Why Reinvent The Wheel?Why Reinvent The Wheel?
International Harmonized Quality System
for Healthcare Services
BS, CLS, CSO, RI(CAP), QA(AABB)
MediLogic Services Consulting, Inc. (BC, Canada)
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Service & ProductService & Product
Can you tell
the
difference!
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What is Service Marketing?What is Service Marketing?
All functions involved in the process of causing aAll functions involved in the process of causing aservice to move from where it is created, to theservice to move from where it is created, to the
customer, whereby the performance, activity, orcustomer, whereby the performance, activity, or
benefit of the service is essentially intangible andbenefit of the service is essentially intangible anddose not result in any permanent ownership,dose not result in any permanent ownership,
physical transfer or exchange of the servicephysical transfer or exchange of the service
Seaboard LifeSeaboard Life Sponsor: Chapter 1Sponsor: Chapter 1--3:19903:1990--93 RJ Lindsey Services Marketing Consulting93 RJ Lindsey Services Marketing Consulting
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Service CharacteristicsService Characteristics
IntangibilityPerishability
HeterogeneitySimultaneity
Customer Involvement
Human Interaction
Delivery
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Major Services ProcessesMajor Services Processes
Marketing Process Service brief
Design Process Service Specifications, Service
Delivery specification, Service QC Specification
Delivery Process Supplier & Customer Assessments
Performance analysis & Improvement Process -
Reporting
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Service Quality FunctionsService Quality Functions
ES = expected service, based on communication,personal needs, past experience
PS = perceived service
ES > PS : unacceptable service
ES = PS : satisfactory quality
ES < PS : ideal quality
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The Triangle of ServiceThe Triangle of ServiceFocus on customer needs moments of truth!
1. Service Strategy commitment to satisfycustomers
2. Service Delivery Systems customer friendlymethods, corrective feedback loops
3. Service People customer oriented, informed,empowered, trained, high performance, wellrewarded
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Service Quality CharacteristicsService Quality Characteristics
1. Reliability timeliness, competence
2. Responsiveness timeliness, accessibility
3. Assurance knowledge, courtesy, credibility,
trustworthiness, believability, honesty, security
4. Tangibles
5. Empathy courtesy, understanding,communication
Quality failures in services are due to
variation in human performance!
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Are we sure about PP & PE of Quality inAre we sure about PP & PE of Quality inHealthcare?Healthcare?
Present Perception with limitedresources, it is taken for granted by thosewho fund, receive, and providehealthcare services that quality is integral
(diagnosis, treatment, medication).
Present Expectations -administration, blood collection,reception, purchasing, providing care
(food, housekeeping, safety, security).
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TimeTimeTimeTimeTimeTimeTime!!!Time!!!Time to appointment!Delay time!
Service time!Right Collection time!
Donation time!
Right time for surgery!
Right time for Medication!
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Quality HierarchyQuality Hierarchy
State Activities Performed
Total QualityManagement(TQM)
Management approach centered on quality,focused on long-term success throughcustomer satisfaction.
QualityManagement (QM)
Includes the stages below & also theeconomic aspects of cost of quality.
Quality System(QS)
Comprehensive & coordinated efforts to meetquality objectives.
Quality Assurance
(QA)
Planned & systematic activities to provide
confidence that an organization fulfillsrequirements for quality.
Quality Control(QC)
Operational techniques to fulfill requirementsfor quality and regulatory compliance.
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The FactThe Fact
QC & QA !!!!!!!!!
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Millennium Patient?Millennium Patient? Drugs are effective on somewhere between
40-70% of patients receiving them.
Patients subsets will require therapy specific
to their unique needs.
Patient is knowledgeable and has access to
information. Knowledge is Power!
Patients rights and insurance.
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GLOBAL INDUSTRY STATUSGLOBAL INDUSTRY STATUS
.
THE PRIMARY REASON IS SURVIVAL!
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The SolutionThe Solution
QC, provides a platform for continuousimprovement and further movement up the
quality hierarchy.
Integrated quality system.
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The ResultThe Result
Delivering consistent, high quality.
Cost effective health care.
Simplify all processes.
Comply with the stringent regulations and
accreditation requirements.
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Quality System Essentials (QSEs)Quality System Essentials (QSEs)
1- Organization2- Personnel
3- Equipment
4- Purchasing and Inventory5- Process control
6- Documents and Records
7- Occurrence management8- Process improvement
9- Service and satisfaction
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4.19 ServicingService and satisfaction
4.14 Corrective and preventive actionProcess improvement
4.17 Internal quality auditsInternal assessment
4.13 Control of nonconforming productOccurrence management
4.5 Document and data control
4.16 Control of quality records
Documents and Records
4.4 Design control
4.8 Product identification and traceability
4.9 Process control
4.10 Inspection and testing
4.11 Inspection and test status
4.15 Handling, storage, packaging, preservation and delivery
4.20 Statistical techniques
Process Control (includes process
validation, quality control, proficiency
testing, process control, facilities, and
safety)
4.6 Purchasing
4.7 Control of customer-supplied product
Purchasing and Inventory
4.11 Control of inspection, measuring, and test equipmentEquipment
4.18 TrainingPersonnel
4.1 Management responsibility4.2 Quality system
4.3 Contract review
Organization
ClausesQuality System Essentials
ISO 9001 H*Quality System Model
* ISO.ISO 9001. QS-model for quality in design, development, production, installation and servicing. ISO Standards Compendium, 6th ed.
Geneva, Switzerland: International Organization for Standardization, 1996.
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Structure for a Quality System ModeStructure for a Quality System Mode
Services Path of WorkflowQualitySystemEssentials
OrganizationPersonnelEquipmentPurchasing and InventoryProcess controlDocuments/Records
Occurrence managementInternal assessmentProcessService and Satisfaction
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PULMONARY DIAGNOSTIC PATHPULMONARY DIAGNOSTIC PATH
Pulmonary Diagnostics Path of Workflow
Quality
System
Essentials
Organization PersonnelEquipmentPurchasing/
InventoryProcess
controlDocuments/
RecordsOccurrence
managementInternal
assessmentProcess
improvementService and
Satisfaction
Quality system essentials
apply to all operations
in the path of workflow
Pretest Testing Session Post-test Information Man agementPatient Assessment Patient Training Results Report Information System
Test Request Test Performance Interpretation Clinical Consult
Patient Preparation Results ReviewEquipment Preparation and Selection
Patient Assessment
for Further Testing
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LABORATORY SERVICELABORATORY SERVICE
Laboratory Path of Workflow
Quality
System
Essentials
OrganizationPersonnelEquipmentPurchasing/
InventoryProcess
controlDocuments/
RecordsOccurrence
managementInternal
assessmentProcess
improvement
Service andSatisfaction
Post- Information
Preanalytical Analytical Analytical Management
Quality system essentials
apply to all operations
in the path of workflow
Patient Test Specimen Specimen Specimen Testing Laboratory Results Post-test Laboratory Interpretation/Assessment Request Collection Transport Receipt Review Interpretation Report Specimen Information Consultation
Management Testing System
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MEDICATION WORKFLOWMEDICATION WORKFLOW
Medication Use Path of Workflow
Quality
System
Essentials
Organization
Personnel
Equipment
Purchasing/
InventoryProcess
control
Documents/
Records
Occurrence
management
Internal
assessment
Process
improvement
Service andSatisfaction
Quality system essentials
apply to all operations
in the path of workflow
Initial Ordering Preparing/ Administration Patient Information Clinical
Assessessment Dispensing Monitoring Managment Consult
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Linking the QS to Patient CareLinking the QS to Patient Care
Patient is the
ultimate recipientof the services
outputs.
QS should directly
link to the patient
PATIENT
Path of Workflow
QSE
Patient
Assessment
Clinical
Consultation
Service Provider
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Patient as the Central Focus of Quality in Selected ExamplesPatient as the Central Focus of Quality in Selected Examples
P a t i e n t
Q S E s
P a t h o f W o r k f lo w
A m b u la t o ry C a re
D ia g n o s t ic S e r v ic e s
H e a lt h c a r e P l a n
H o m e H e a lt h C a re
H o s p it a l C a r e
R e h a b i l it a t io n S e r v ic e sP a t i e n t
A s s e s s m e n t
C l i n i c a l
C o n s u l t a t i o n
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QSE: OrganizationQSE: Organization
Executive management support.
Establish and maintain quality culture by all
involved stakeholders.
Services management must plan for quality andtake the leadership role.
The service should conduct periodic reviews of itsquality system.
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QSE: PersonnelQSE: Personnel
Job qualification.
Job description.
Processes for orientation & Training.
Assessing competence & overall performance in
specific job duties.
Training when changing SOP or when needed.
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QSE: EquipmentQSE: Equipment
Installation.
Calibration.
Maintenance.
Use accordance to manufacturers instructions
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QSE: Purchasing and InventoryQSE: Purchasing and Inventory
Identify critical supplies
Partnership with organizations purchasingfunction.
Receiving.
Special handling.
Managing inventory.
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QSE: Process ControlQSE: Process Control
o Flowcharting.
o Validation.
o Well-written SOPs.
o Consistency in performance.
o Quality controls.
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QSE: Documents and RecordsQSE: Documents and Records
Documents: include written policies, processdescriptions, procedures and blank forms either
paper or electronic that are used communicateinformation to the services staff.
Records are the completed worksheets, forms,computer printouts, labels, and tags that capturethe information obtained, activities performed, or
results achieved when performing a procedure.
Both need to be managed and archived, includingstorage and destruction.
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QSE: Occurrence ManagementQSE: Occurrence Management
Capture and analyze information about
systematic problems.
Gain managements commitment to remove
the cause.
Linked to risk management.
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QSE: Internal AssessmentQSE: Internal Assessment
Gap analysis= Periodic assessment between QS and
operations and compare them against internal andexternal benchmarks to ensure that it is effectively
meeting the intent of stated requirements.
Quality indicators monitoring for all operations.
Periodic audits of the QS and operations will
demonstrate gaps and weaknesses betweendocumentations and actual practice.
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QSE: Process ImprovementQSE: Process Improvement
This information will come from:
Customer feedback: internal and external,
Analysis of occurrence trends,
Reports from the services through the organizations quality improvement
reporting process,
Internal audits of the QS,
External assessments through regulatory and accreditation inspections, and
External literature and sharing of the beast practices from other
organizations.
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Problem Resolution ProcessProblem Resolution Process
Problem identification, prioritization, and selection,
Analysis of current process and collection of data,
Determination of the problems root cause,
Generation of ideas for solutions, and selection of one solution
brainstorming,
Implementation of chosen solution,
Monitoring corrective effects of the chosen solution with data, and
Outcomes to be reported to the organizations quality function.
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QSE: Service and SatisfactionQSE: Service and Satisfaction
Measure internal and external satisfaction,
Provide feedback on findings,
Point out operations that need improvement, and
Use problem resolution process to improve those
operations.
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TIME TO INTERNATIONALIZATIONTIME TO INTERNATIONALIZATION
Preparation phase: contact, awareness of change
Acceptance phase: understand the change,positive perception
Commitment phase: installation, adoption,institutionalization, Internationalization
A 5 years period to reach Internationalization fororganization of 500 or fewer employees.
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Prevention Costs:Incurred to prevent or avoid quality
Problems.
Examples:- SUPPLIER REVIEWS
- OPERATIONS QUALITY PLANNING
- QUALITY EDUCATION
- TRAINING WORKERS
- QUALITY IMPROVEMENTS
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APPRASIAL COSTS:Associated with measuring and monitoring
activities related to quality.
Examples:
- PROCESS CONTROL MEASURMENTS
- EXTERNAL APPRASIAL COSTS
- REVIEW OF TEST AND INSPECTION DATA- OUTSIDE ENDORSMENTS & CERTIFICATION
- FIELD PERFORMANCE EVALUATION
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INTERNAL FAILURE COSTS:
Incurred to remedy defects discovered before service
delivered to customer.
Examples:
- SERVICE DESIGN FAILURE
- RETEST
- UNCONTROLLED MATERIAL LOSSES
- MATERIALS REVIEW
- INTERNAL FAILURE LABOR LOSSES
- EXTRA OPERATIONS
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EXTERNAL FAILURE:
Incurred to remedy defects discovered by customer.
Examples:
- COMPLAINT INVESTIGATION
- LIABILITY COSTS
- PENALTIES
- CUSTOMER GOODWELL
- ACCREDITAION/CERTIFICATION LOSSES
- REPUTATION
SUCCESS BLOKERSSUCCESS BLOKERS
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SUCCESS BLOKERSSUCCESS BLOKERS
Viewing Quality as a gain but not right!
Policy makers and peer groups reviewers
Lack of systematic mechanisms for regulations & by-laws implementations
Availability of databases that are needed to establish the infrastructure for planning process
Policies are set up at the stratosphere without realizing the limitations of resources i.e. time,money, and people.
Matrix for communication and networking
Sole ownership of decision-making process.
Lack of standardized training.
# of accrediting, awarding & recognizing bodies.
Not to Ignore global changes and challenges.
Not considering safety and environment as a top priority.
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THOUGHTS TO TAKE HOMETHOUGHTS TO TAKE HOME
Communication
Consideration
Collaboration
Cooperation
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References & Useful WebsitesReferences & Useful Websites
1. Quality System Model for Health Care As per Approved NCCLS GP 26-A Guidelines, Vol.19 No. 20, October 1999
2. Principles Practices of TQM, T. J. Cartin, ASQ Quality Press, 1993
3. www.nccls.org
4. www.cap.org
5. www.jcaho.org
6. www.fda.gov
7. www.csa.ca
8. www.hc-sc.gc.ca
9. www.bccdc.org
10. www.aabb.org
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