why reinvent the wheel by dr. nashat nafouri

7/31/2019 Why Reinvent the Wheel by Dr. Nashat Nafouri

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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




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




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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