The people who get on in this world

are the people get up and look for the circumstances they want, and if they cannot find them, make them
George B. Shaw

Why Reinvent The Wheel?

International Harmonized Quality System for Healthcare Services

By: Nashat Nafouri

BS, CLS, CSO, RI(CAP), QA(AABB)

MediLogic Services Consulting, Inc. (BC, Canada)

Service & Product

Can you tell the difference!

What is Service Marketing?

All functions involved in the process of causing a
service to move from where it is created, to the customer, whereby the performance, activity, or benefit of the service is essentially intangible and dose not result in any permanent ownership, physical transfer or exchange of the service
Seaboard Life Sponsor: Chapter 1-3:1990-93 RJ Lindsey Services Marketing Consulting 1- 3:1990-

Service Characteristics
Intangibility Perishability Heterogeneity Simultaneity Customer Involvement Human Interaction Delivery

Major 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

Service 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

The Triangle of Service

Focus on customer needs moments of truth!
1.

Service Strategy commitment to satisfy customers Service Delivery Systems customer friendly methods, corrective feedback loops Service People customer oriented, informed, empowered, trained, high performance, well rewarded

2.

3.

Service Quality Characteristics

1. 2. 3.

Reliability timeliness, competence Responsiveness timeliness, accessibility Assurance knowledge, courtesy, credibility, trustworthiness, believability, honesty, security

Tangibles 5. Empathy courtesy, understanding,

4.

communication

Quality failures in services are due to variation in human performance!

Are we sure about PP & PE of Quality in Healthcare?

Present Perception with limited

resources, it is taken for granted by those who fund, receive, and provide healthcare services that quality is integral (diagnosis, treatment, medication).

Present Expectations administration, blood collection, reception, purchasing, providing care (food, housekeeping, safety, security).

TimeTimeTime
Time to appointment! Delay time! Service time! Right Collection time! Donation time! Right time for surgery! Right time for Medication!

Time!!!

Quality Hierarchy
State Total Quality Management (TQM) Quality Management (QM) Quality System (QS) Quality Assurance (QA) Quality Control (QC) Activities Performed Management approach centered on quality, focused on long-term success through customer satisfaction. Includes the stages below & also the economic aspects of cost of quality. Comprehensive & coordinated efforts to meet quality objectives. Planned & systematic activities to provide confidence that an organization fulfills requirements for quality. Operational techniques to fulfill requirements for quality and regulatory compliance.

The Fact

QC & QA !!!!!!!!!

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.

GLOBAL INDUSTRY STATUS

The entire spectrum of the healthcare industry consolidates including hospitals, diagnostics, devices and drug development/pharmaceutical companies.

THE PRIMARY REASON IS SURVIVAL!

Investors are concerned and becoming selective.

The Solution
QC, provides a platform for continuous improvement and further movement up the quality hierarchy. Integrated quality system.

The Result

Delivering consistent, high quality. Cost effective health care. Simplify all processes. Comply with the stringent regulations and accreditation requirements.

Quality System Essentials (QSEs)

123456789Organization Personnel Equipment Purchasing and Inventory Process control Documents and Records Occurrence management Process improvement Service and satisfaction

Quality System Model Quality System Essentials Organization

ISO 9001 H* Clauses 4.1 Management responsibility 4.2 Quality system 4.3 Contract review 4.18 Training 4.11 Control of inspection, measuring, and test equipment 4.6 Purchasing 4.7 Control of customer-supplied product 4.4 4.8 4.9 4.10 4.11 4.15 4.20 Design control Product identification and traceability Process control Inspection and testing Inspection and test status Handling, storage, packaging, preservation and delivery Statistical techniques

Personnel Equipment Purchasing and Inventory Process Control (includes process validation, quality control, proficiency testing, process control, facilities, and safety)

Documents and Records Occurrence management Internal assessment Process improvement Service and satisfaction

4.5 Document and data control 4.16 Control of quality records 4.13 Control of nonconforming product 4.17 Internal quality audits 4.14 Corrective and preventive action 4.19 Servicing

* 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.

Structure for a Quality System Mode

Quality System Essentials Services Path of Workflow

Organization Personnel Equipment Purchasing and Inventory Process control Documents/Records Occurrence management Internal assessment Process i t Service and Satisfaction

PULMONARY DIAGNOSTIC PATH

Pulmonary Diagnostics Path of Workflow
Pretest Patient Assessment Test Request Patient Preparation Equipment Preparation Testing Session Patient Training Test Performance Results Review and Selection Patient Assessment for Further Testing Post-test Results Report Interpretation Information Management Information System Clinical Consult

Quality System Essentials

Organization Personnel Equipment Purchasing/ Inventory Process control Documents/ Records Occurrence management Internal assessment Process improvement Service and Satisfaction

Quality system essentials apply to all operations in the path of workflow

LABORATORY SERVICE
Laboratory Path of Workflow
Post Analytical Information Management
Laboratory Interpretation/ Information Consultation Testing System

Quality System Essentials

Organization Personnel Equipment Purchasing/ Inventory Process control Documents/ Records Occurrence management Internal assessment Process improvement Service and Satisfaction

Preanalytical
Patient Assessment Test Request Specimen Collection Specimen Transport Specimen Receipt

Analytical
Testing Review

Laboratory Results Post-test Interpretation Report Specimen Management

Quality system essentials apply to all operations in the path of workflow

MEDICATION WORKFLOW

Medication Use Path of Workflow

Quality System Essentials
Organization Personnel Equipment Purchasing/ Inventory Process control Documents/ Records Occurrence management Internal assessment Process improvement Service and Satisfaction

Initial Ordering Assessessment

Preparing/ Administration Patient Information Dispensing Monitoring Managment

Clinical Consult

Quality system essentials apply to all operations in the path of workflow

Linking the QS to Patient Care

PT T A IEN
P atient A ssessm ent S erviceP rovider C linical C onsultation

Patient is the ultimate recipient of the services outputs. QS should directly link to the patient

P of W ath orkflow Q Es S

Patient as the Central Focus of Quality in Selected Examples

P a t ie n t

P a t ie n t A ssessm ent

R e h a b ilit a t io n S e r v ic e s H o s p it a l C a r e H o m e H e a lt h C a r e H e a lt h c a r e P la n D ia g n o s t ic S e r v ic e s A m b u la t o r y C a r e P a t h o f W o r k f lo w Q SEs

C lin ic a l C o n s u lt a t io n

QSE: Organization Executive management support. Establish and maintain quality culture by all involved stakeholders. Services management must plan for quality and take the leadership role. The service should conduct periodic reviews of its quality system.

QSE: Personnel
Job qualification. Job description. Processes for orientation & Training. Assessing competence & overall performance in specific job duties. Training when changing SOP or when needed.

QSE: Equipment

Installation. Calibration. Maintenance. Use accordance to manufacturers instructions

QSE: Purchasing and Inventory

Identify critical supplies Partnership with organizations purchasing function. Receiving. Special handling. Managing inventory.

QSE: Process Control

o o o o o

Flowcharting. Validation. Well-written SOPs. Consistency in performance. Quality controls.

QSE: Documents and Records

Documents: include written policies, process descriptions, procedures and blank forms either paper or electronic that are used communicate information to the services staff. Records are the completed worksheets, forms, computer printouts, labels, and tags that capture the information obtained, activities performed, or results achieved when performing a procedure. Both need to be managed and archived, including storage and destruction.

QSE: Occurrence Management Capture and analyze information about systematic problems. Gain managements commitment to remove the cause. Linked to risk management.

QSE: Internal Assessment

Gap analysis= Periodic assessment between QS and operations and compare them against internal and external 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 between documentations and actual practice.

QSE: 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.

Problem 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.

QSE: 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.

TIME 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 for organization of 500 or fewer employees.

CATEGORIES OF QUALITY COSTS Prevention Costs: Incurred to prevent or avoid quality Problems.
Examples:
SUPPLIER REVIEWS OPERATIONS QUALITY PLANNING QUALITY EDUCATION TRAINING WORKERS QUALITY IMPROVEMENTS

CATEGORIES OF QUALITY COSTS

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

CATEGORIES OF QUALITY COSTS

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

CATEGORIES OF QUALITY COSTS

EXTERNAL FAILURE: Incurred to remedy defects discovered by customer. Examples:
COMPLAINT INVESTIGATION LIABILITY COSTS PENALTIES CUSTOMER GOODWELL ACCREDITAION/CERTIFICATION LOSSES REPUTATION

SUCCESS 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.

THOUGHTS TO TAKE HOME

Communication Consideration Collaboration Cooperation

References & Useful Websites

1.

Quality System Model for Health Care As per Approved NCCLS GP 26-A Guidelines, Vol. 19 No. 20, October 1999

2. 3. 4. 5. 6. 7. 8. 9. 10.

Principles Practices of TQM, T. J. Cartin, ASQ Quality Press, 1993 www.nccls.org www.cap.org www.jcaho.org www.fda.gov www.csa.ca www.hc-sc.gc.ca www.bccdc.org www.aabb.org

! THANK YOU