By-
PRATIK P POLADIA
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”..
Lab manager
• 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
LAB PLAN
• Each laboratory must have a strategic plan that describes its
long-term 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
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 .
• 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 .
• He/She must have sufficient training and experience in
clinical medicine , sciences basic to medicine , clinical lab
sciences
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 .
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 .
Quality Management System Definition
 All aspects of the laboratory operation need to be
addressed to assure quality; this constitutes a
quality management system
Introduction Laboratory
Quality Management
System-Module 1 10
Complexity of a Laboratory System
•Data & Laboratory
Management
•Safety
•Customer Service
Patient/Client Prep
Sample Collection
Sample Receipt and
Accessioning
Sample Transport
Quality Control
Testing
Record Keeping
Reporting
Personnel Competency
Test Evaluations
Why Medical Labs need Quality
Management
 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
January 2009 11
Introduction Laboratory
Quality Management
System-Module 1 12
Path of Workflow
THE PATIENT Test selection Sample Collection
Sample Transport
Laboratory Analysis
Examination Phase
Report Creation
Report Transport
Preexamination Phase
Result Interpretation Postexamination Phase
Personnel
human resources
job qualifications
job descriptions
orientation
training
competency assessment
professional development
continuing education
Equipment
• acquisition
• installation
• validation
• maintenance
• calibration
• troubleshooting
• service and repair
• records
Purchasing and
Inventory
vendor qualifications
supplies and reagents
critical services
contract review
inventory management
Process Control
quality control
sample management
method validation
method verification
Information Management
confidentiality
 requisitions
 logs and records
 reports
 computerized laboratory
information systems (LIS)
Introduction Laboratory
Quality Management
System-Module 1 18
Documents Records
creation collection
revisions and review review
control and distribution storage
retention
Occurrence Management
complaints
mistakes and problems
documentation
root cause analysis
immediate actions
corrective actions
preventive actions
Introduction Laboratory
Quality Management
System-Module 1 20
Laboratory Assessment
External
Proficiency
testing (EQA)
Inspections
Accreditations
Internal
Internal
Process Improvement
opportunities for improvement (OFIs)
stakeholder feedback
problem resolution
risk assessment
preventive actions
corrective actions
Customer Service
customer group identification
customer needs
customer feedback
Facilities and Safety
safe working environment
transport management
security
containment
waste management
laboratory safety
ergonomics
Introduction Laboratory Quality Management
System-Module 1 24
Implementing
Quality Management
does not
guarantee
an
ERROR-FREE
Laboratory
But it detects
errors that may
occur and
prevents them
from recurring
Laboratory errors cost in
time
personnel
effort
patient
outcomes
Introduction Laboratory Quality Management
System-Module 1 25
ECONOMY MANAGEMENT
Economic model may be used to improve
business performance of laboratories by
 removing weaknesses,
 minimizing threats,
 using external opportunities and
 internal strengths.
Introduction Laboratory Quality Management
System-Module 1 26
INTERNAL /EXTERNAL FACTORS
 Strength and Weaknesses refer to internal
characteristics of a clinical laboratory, whereas
 Opportunities and Threats are external factors
Introduction Laboratory Quality Management
System-Module 1 27
Introduction Laboratory Quality Management
System-Module 1 28
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.
Introduction Laboratory Quality Management
System-Module 1 29
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
Introduction Laboratory Quality Management
System-Module 1 30
PROFIT OF LAB
 The operating profit as a measure of profitability
of the clinical laboratory was defined as
 total revenue minus total expenses
Introduction Laboratory Quality Management
System-Module 1 31
HOW?
 Quality Management and good work
organization aimed at achieving a continuous
improvement in pre-analytical ,analytical, and
post-analytical phases are part of a good
laboratory practice
32
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.
Introduction Laboratory Quality Management
System-Module 1 33
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.
Introduction Laboratory Quality Management
System-Module 1 34

lab management presentation in clinical laboratory

  • 1.
  • 2.
    DEFINATION  An ongoingprocess 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 • Agood 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 • Eachlaboratory must have a strategic plan that describes its long-term 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/Shemust 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 . • 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 . • He/She must have sufficient training and experience in clinical medicine , sciences basic to medicine , clinical lab sciences
  • 6.
    DUTIES • The followingdirectorial 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 degreein 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 SystemDefinition  All aspects of the laboratory operation need to be addressed to assure quality; this constitutes a quality management system
  • 10.
    Introduction Laboratory Quality Management System-Module1 10 Complexity of a Laboratory System •Data & Laboratory Management •Safety •Customer Service Patient/Client Prep Sample Collection Sample Receipt and Accessioning Sample Transport Quality Control Testing Record Keeping Reporting Personnel Competency Test Evaluations
  • 11.
    Why Medical Labsneed Quality Management  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 January 2009 11
  • 12.
    Introduction Laboratory Quality Management System-Module1 12 Path of Workflow THE PATIENT Test selection Sample Collection Sample Transport Laboratory Analysis Examination Phase Report Creation Report Transport Preexamination Phase Result Interpretation Postexamination Phase
  • 13.
    Personnel human resources job qualifications jobdescriptions 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 suppliesand reagents critical services contract review inventory management
  • 16.
    Process Control quality control samplemanagement method validation method verification
  • 17.
    Information Management confidentiality  requisitions logs and records  reports  computerized laboratory information systems (LIS)
  • 18.
    Introduction Laboratory Quality Management System-Module1 18 Documents Records creation collection revisions and review review control and distribution storage retention
  • 19.
    Occurrence Management complaints mistakes andproblems documentation root cause analysis immediate actions corrective actions preventive actions
  • 20.
    Introduction Laboratory Quality Management System-Module1 20 Laboratory Assessment External Proficiency testing (EQA) Inspections Accreditations Internal Internal
  • 21.
    Process Improvement opportunities forimprovement (OFIs) stakeholder feedback problem resolution risk assessment preventive actions corrective actions
  • 22.
    Customer Service customer groupidentification customer needs customer feedback
  • 23.
    Facilities and Safety safeworking environment transport management security containment waste management laboratory safety ergonomics
  • 24.
    Introduction Laboratory QualityManagement System-Module 1 24 Implementing Quality Management does not guarantee an ERROR-FREE Laboratory But it detects errors that may occur and prevents them from recurring
  • 25.
    Laboratory errors costin time personnel effort patient outcomes Introduction Laboratory Quality Management System-Module 1 25
  • 26.
    ECONOMY MANAGEMENT Economic modelmay be used to improve business performance of laboratories by  removing weaknesses,  minimizing threats,  using external opportunities and  internal strengths. Introduction Laboratory Quality Management System-Module 1 26
  • 27.
    INTERNAL /EXTERNAL FACTORS Strength and Weaknesses refer to internal characteristics of a clinical laboratory, whereas  Opportunities and Threats are external factors Introduction Laboratory Quality Management System-Module 1 27
  • 28.
    Introduction Laboratory QualityManagement System-Module 1 28
  • 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. Introduction Laboratory Quality Management System-Module 1 29
  • 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 Introduction Laboratory Quality Management System-Module 1 30
  • 31.
    PROFIT OF LAB The operating profit as a measure of profitability of the clinical laboratory was defined as  total revenue minus total expenses Introduction Laboratory Quality Management System-Module 1 31
  • 32.
    HOW?  Quality Managementand good work organization aimed at achieving a continuous improvement in pre-analytical ,analytical, and post-analytical phases are part of a good laboratory practice 32
  • 33.
    CONT…..  Successful qualitymanagement in a clinical laboratory setting reduces both the  need to repeat tests and  raw material consumption, Leading to increased business effectiveness. Introduction Laboratory Quality Management System-Module 1 33
  • 34.
    CONCLUSION  The factthat making profit is not the primary function of the health system.  Every health department should have basic knowledge of economic principles and their application. Introduction Laboratory Quality Management System-Module 1 34

Editor's Notes

  • #20 Proficiency Testing is the equivalent of External Quality Assessment (EQA).