By-PRATIK P POLADIA

DEFINATIONAn 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 DefinitionAll aspects of the laboratory operation need

to be addressed to assure quality; this constitutes a quality management system

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Complexity of a Laboratory System

•Data & Laboratory Management•Safety•Customer Service

Patient/Client PrepSample Collection

Sample Receipt and Accessioning

Sample TransportQuality Control

Testing

Record Keeping

Reporting

Personnel CompetencyTest Evaluations

Why Medical Labs need Quality Management

Medical LaboratoriesHighly complex operationsIndividuals doing complex tasksAbsolute need for AccuracyAbsolute need for ConfidentialityAbsolute need for Time EffectivenessAbsolute need for Cost Effectiveness

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Path of Workflow

THE PATIENT Test selection Sample Collection

Sample Transport

Laboratory Analysis Examination Phase

Report CreationReport Transport

Preexamination Phase

Result Interpretation Postexamination Phase

Personnelhuman 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 Inventoryvendor qualifications

supplies and reagents

critical services

contract review

inventory management

Process Controlquality control

sample management

method validation

method verification

Information Managementconfidentiality

requisitions

logs and records

reports

computerized laboratory information systems (LIS)

Introduction Laboratory Quality Management System-Module 1 18

Documents Recordscreation collection

revisions and review review

control and distribution storage

retention

Occurrence Managementcomplaintsmistakes and problemsdocumentation root cause analysis immediate actionscorrective actionspreventive actions

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Laboratory Assessment External

Proficiency testing (EQA)

Inspections

Accreditations

InternalInternal

Process Improvementopportunities for improvement (OFIs)

stakeholder feedback

problem resolution

risk assessment

preventive actions

corrective actions

Customer Servicecustomer group identification

customer needs

customer feedback

Facilities and Safetysafe working environment

transport management

security

containment

waste management

laboratory safety

ergonomics

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ImplementingQuality Management

does notguarantee

anERROR-FREE

Laboratory

But it detects errors that may occur and prevents them from recurring

Laboratory errors cost intime

personnel effort

patient outcomes

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ECONOMY MANAGEMENT Economic model may be used to improve

business performance of laboratories by removing weaknesses,minimizing threats, using external opportunities andinternal strengths.

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INTERNAL /EXTERNAL FACTORSStrength and Weaknesses refer to internal

characteristics of a clinical laboratory, whereas

Opportunities and Threats are external factors

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Introduction Laboratory Quality Management System-Module 1 28

STRENGTHS & WEAKNESSStrengths 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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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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PROFIT OF LABThe operating profit as a measure of

profitability of the clinical laboratory was defined as

total revenue minus total expenses

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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

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CONT…..Successful quality management in a clinical

laboratory setting reduces both theneed to repeat tests and raw material consumption, Leading to increased business effectiveness.

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CONCLUSIONThe 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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