1. QUALITY MANAGEMENT Suzanne Kamel-Mohamed PhD, MBA, MT (ASCP) Associate
Clinical Laboratories Consultants
Sanford, Florida

2. LABORATORY QUALITY
Accuracy
Reliability
Timeliness

3. High LEVEL OF ACCURACY IS REQUIRED
At first glance, 99% accuracy is good; however, the resulting 1% error can become quite large as in a system where many events occur, such as laboratory testing.

4. NEGATIVE CONSEQUENCES OF LABORATORY ERROR
Examples:
Failure to provide the proper treatment
No treatment
Delay in correct diagnosis and treatment
Additional and unnecessary testing
Increased cost (labor and supplies)
Death of patient

5. Achieving Excellent Laboratory Performance and Minimizing Errors
How?
A quality management system is Essential

6. QUALITY MANAGEMENT SYSTEM
Processes and procedures that are well coordinated to achieve excellency in lab performance

7. Laboratory Processes ISO Standards CAP Standards pre-examination,
post-examination
CAP Standards
pre-analytic
analytic
post-analytic processes

8. COMPLEXITY OF LABORATORY PROCESSES
An error in any part of the cycle can produce a poor laboratory result.
A method of detecting errors at each phase of testing is needed if quality is to be assured.

9. THE PATH OF WORKFLOW
The entire set of operations that occur in testing
It begins with the patient and ends in reporting and results
Is a key in quality management system.

10. QUALITY MANAGEMENT SYSTEM MODEL
This quality management system model was developed by the Clinical Laboratory Standard Institute (CLSI)
It is made of12 Quality system Essentials (QSE)
It is fully compatible with ISO standards
It Assures accuracy and reliability throughout the Path of Workflow

11. Quality system Essentials
Organization
Laboratory Structure and Management
Mechanism of implementing and monitoring
Personnel
Qualified and Competent, motivated staff
Equipment
Quality equipment , properly functioning and maintained
Purchasing and Inventory
Quality reagents and supplies
Reduce production interruption due to shortage of reagents and supplies

12. Quality system Essentials
Process Control
Quality control for testing
Sample collection, handling, and processing
Method verification and validation.
Information Management
Test result reporting.
Data confidentiality,
Accessibility to the laboratory staff and to the health care providers.

13. Quality system Essentials
Documents and Records
Documents and Records are accurate, accessible and properly maintained
Occurrence Management
Detect and handle occurrences properly, and take corrective actions to avoid reoccurrence
Assessment
Internal Assessment
External Assessment
Process Improvement
The primary goal in a quality management system is continuous improvement of the laboratory processes, and this must be done in a systematic manner.

14. Quality system Essentials
Customer Service
It is essential that clients of the laboratory receive what they need.
The laboratory should understand who the customers are, and should assess their needs and use customer feedback for making improvements.
Facilities and Safety
Security
Containment
Safety
Ergonomic

15. QUALITY MANAGEMENT SYSTEM MODEL WITH ALL 12 QSEs
In the quality management system model all twelve QSEs must be addressed to assure accurate, reliable, and timely laboratory results, and to have quality throughout the laboratory operations.

16. KEY MESSAGES
A laboratory is a complex system and all aspects must function properly to achieve quality.
Approaches to implementation will vary with each lab situation.
Start with changes that can be easily accomplished and have the biggest impact.
Implement in stepwise process but ultimately, all quality essentials must be addressed.

17. THANK YOU!