1. A quality management system for a medical laboratory seeks to efficiently achieve the objectives of providing accurate test results to physicians and contributing to patient care. 2. Key aspects of a quality management system include personnel management, equipment management, process control, purchasing and inventory, and continuous improvement. 3. Implementing a quality management system can help detect and prevent errors, saving time, personnel costs, and improving patient outcomes compared to an error-prone laboratory.

1. ByPRATIK P POLADIA

2. DEFINATION
An ongoing process that seeks to efficiently
achieve the objectives of a medical laboratory.
The objectives of a medical laboratory are
providing its customers (physicians on behalf of
patients) accurate answers which contribute to
clinical treatment”..

3. Lab manager
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A good manager studies management as a daily
practice. The high-performance manager is:
A strategist: one who looks to the future.
A Problem solver: one who uses his factors under
his or her control to redirect the course of action to
achieve the organisation objectives
A teacher: One who guides and helps others to
identify and solves problems

4. LAB PLAN
• Each laboratory must have a strategic plan that describes its long-term
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goals, such as a move toward more automation or any modern
diagnostic techniques.
Each employee’s role should be clearly defined, and written job
descriptions should be provided so personnel know what they are
expected to do. Therefore, it is a not an easy task for a manger to
strike a balance among the clinical laboratory regulations, fiscal
responsibility, and employee competence and morale to maintain the
overall quality of patient care.
it is appropriate to remember that the two most important
components of management are
common sense
open communication with laboratory staff

5. Lab DIRECTOR
He/She must be a physician or a doctoral scientist
qualified to assume professional , scientific , consultative ,
organizational , administrative , and educational
responsibility for the services offered by the lab .
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If a non-pathologist physician or doctoral scientist
service as director , he/she must be qualified by virtue of
documented training ,expertise , and experience in areas of
analytic testing offered by the lab .
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He/She must have sufficient training and experience in
clinical medicine , sciences basic to medicine , clinical lab
sciences
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6. DUTIES
• The following directorial functions are :
1- interpretation , correlation , and communication of lab
data
2- interaction with physicians and/or medical staff , patient ,
administration .
3- monitoring of standard of performance , QC , QI.
4- provision of education programs , planning , research.
5- ensuring sufficient personnel with adequate documented
training and experience to meet the needs of the lab .
6- he/she must be decision-maker in the selection of all lab
equipments and supplies .

7. SUPERVISOR
Bachelor degree in chemical or clinical lab / medical
technology science with at least one year experience .
Is reponsible for day-to-day supervision of the lab
operation , as well as personnel performing testing
and reporting test results .

9. Quality Management System Definition
All aspects of the laboratory operation need to be
addressed to assure quality; this constitutes a quality
management system

10. Complexity of a Laboratory System
Reporting
Patient/Client Prep
Sample Collection
Personnel Competency
Test Evaluations
•Data & Laboratory
Management
•Safety
•Customer Service
Sample Receipt and
Accessioning
Record Keeping
Quality Control
Testing
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Quality Management
System-Module 1
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Sample Transport

11. Why Medical Labs need Quality
Management
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Medical Laboratories
Highly complex operations
Individuals doing complex tasks
Absolute need for Accuracy
Absolute need for Confidentiality
Absolute need for Time Effectiveness
Absolute need for Cost Effectiveness
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12. Path of Workflow
THE PATIENT
Test selection
Sample Collection
Preexamination Phase
Sample Transport
Laboratory Analysis
Examination Phase
Report Transport
Result Interpretation
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Quality Management
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Report Creation
Postexamination Phase
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13. Personnel
 human resources
 job qualifications
 job descriptions
 orientation
 training
 competency assessment
 professional development
 continuing education

14. Equipment
• acquisition
• installation
• validation
• maintenance
• calibration
• troubleshooting
• service and repair
• records

15. Purchasing and
Inventory
 vendor qualifications
 supplies and reagents
 critical services
 contract review
 inventory management

16. Process Control
 quality control
 sample management
 method validation
 method verification

17. Information Management
 confidentiality
 requisitions
 logs and records
 reports
 computerized laboratory
information systems (LIS)

18. Documents
creation
revisions and review
control and distribution
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Records
collection
review
storage
retention

19. Occurrence Management
 complaints
 mistakes and problems
 documentation
 root cause analysis
 immediate actions
 corrective actions
 preventive actions

20. Laboratory Assessment
Internal
Internal
External
Proficiency
testing (EQA)
Inspections
Accreditations
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21. Process Improvement
 opportunities for improvement (OFIs)
 stakeholder feedback
 problem resolution
 risk assessment
 preventive actions
 corrective actions

22. Customer Service
 customer group identification
 customer needs
 customer feedback

23. Facilities and Safety
 safe working environment
 transport management
 security
 containment
 waste management
 laboratory safety
 ergonomics

24. Implementing
Quality Management
does not
guarantee
an
ERROR-FREE
Laboratory
But it detects
errors that may
occur and
prevents them
from recurring
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25. Laboratory errors cost in
time
personnel
effort
patient
outcomes
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26. ECONOMY MANAGEMENT
Economic model may be used to improve business
performance of laboratories by
removing weaknesses,
minimizing threats,
 using external opportunities and
internal strengths.
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27. INTERNAL /EXTERNAL FACTORS
Strength and Weaknesses refer to internal
characteristics of a clinical laboratory, whereas
Opportunities and Threats are external factors
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29. STRENGTHS & WEAKNESS
Strengths describe advantages of the laboratory in
comparison with other similar laboratories in the
same geographical region.
Weaknesses refer to shortcomings in the work of
laboratory and removing the weaknesses would create
new opportunities that could improve the quality of
workand, consequently, increase profitability.
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30. OPPORTUNITIES & THREATS
 Opportunities refer to conditions in the laboratory
that may lead to the improvement in business
operations.
Threats represent conditions that may lead to
difficulties in business operations
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31. PROFIT OF LAB
The operating profit as a measure of profitability of
the clinical laboratory was defined as
total revenue minus total expenses
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32. HOW?
Quality Management and good work organization
aimed at achieving a continuous improvement in preanalytical ,analytical, and post-analytical phases are
part of a good laboratory practice
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33. CONT…..
Successful quality management in a clinical
laboratory setting reduces both the
need to repeat tests and
raw material consumption,
Leading to increased business effectiveness.
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34. CONCLUSION
The fact that making profit is not the primary
function of the health system.
 Every health department should have basic
knowledge of economic principles and their
application.
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