quality control in the medical laboratory
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Adnan S Jaran PhD.
Quality Control in theQuality Control in theMedical laboratoryMedical laboratory
Introduction and Overview
FD lecture 1
Adnan S Jaran PhD.
How do we achieve QUALITY performance in the laboratory?
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Adnan S Jaran PhD.
QUALITY is ACHIEVED BY: Determining the customer’s precise requirements
Ensuring that all resources, facilities and skills required to meet the customer’s requirements are available
Planning, documenting and implementing management procedures to ensure that the customer’s requirements are met consistently
Ensuring that staff are trained and provided with the resources to do the job right the first time
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Adnan S Jaran PhD.
QUALITY is ACHIEVED BY:[cont]
Ensuring that all activities are undertaken correctly
Ensuring that when things go wrong, effective corrective action is taken to avoid repetition of errors
Undertaking regular reviews and audits of all processes
Total and organised commitment from management
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Adnan S Jaran PhD.
The Quality Assurance Cycle
•Data and Lab Management•Safety•Customer Service
Patient/Client PrepSample Collection
Sample Receipt and Accessioning
Sample TransportQuality Control
Testing
RecordKeeping
ReportingPersonnel CompetencyTest Evaluations
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What is Quality?
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Achieving a 99% level of quality
means
accepting a 1% error rate1%
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Adnan S Jaran PhD.
In France a 1% error rate would mean everyday
14 minutes without water or electricity
50,000 parcels lost by postal services
22 newborns falling from midwives’ hands
600,000 lunches contaminatedby bacteria
3 bad landings at Orly Paris airport
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Result: 1% failure
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Adnan S Jaran PhD.
Laboratory errors cost in
time
personnel effort
patient outcomes
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Adnan S Jaran PhD.
How do we achieve excellent performance in the laboratory?
Organization Personnel Equipment
Purchasing &
Inventory
Process Control
Information Management
Documents&
Records
Occurrence Management Assessment
Process Improvement
Customer Service
Facilities &
Safety
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Adnan S Jaran PhD.
Quality Management System Definition
Coordinated activities to direct and control an organization with regard to quality (ISO,CLSI).
All aspects of the laboratory operation need to be addressed to
assure quality; this constitutes a quality management system.
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11/04/23 Dr. Adnan S. Jaran13
QUALITY CONTROL Every analysis in the lab. generates a result The validity of that result cannot be taken for
granted, however, without some body of supporting evidence.
The most convincing evidence is the establishment of a rigorous comprehensive Quality control program that is faithfully followed
This is the only way to guard against the possible deterioration of an analytic system, to become altered to imprecision of results when they occur, and have confidence in test result when everything is in control
11/04/23 Dr. Adnan S. Jaran14
QUALITY CONTROL
A comprehensive quality control (QC) program consist of all the means used by a laboratory to ensure the reliability of every assay performed on specimens arriving in the lab.
The program includes much more than the analysis of a control serum with every run, and it involves: (1) lab. Director, (2) Technologists, (3) all other personnel who are an integral part of the specimen collecting, and (4) The analytical system.
Adnan S Jaran PhD.
Essential to all aspects of health care are laboratory results that are
accurate,
reliable, and
timely
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Adnan S Jaran PhD.
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
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Adnan S Jaran PhD.
Path of Workflow
THE PATIENT Test selection Sample Collection
Sample Transport
Laboratory Analysis Examination Phase
Report CreationReport Transport
Preexamination Phase
Result Interpretation Postexamination Phase
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Adnan S Jaran PhD.
Laboratory tests are influenced by
laboratory environment
knowledgeable staff
competent staff
reagents and equipment
quality control
communications
process management
occurrence management
record keeping
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Adnan S Jaran PhD.
OrganizationResponsibilities, Authorities
CommunicationProvision of
resources
Quality Policy
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Adnan S Jaran PhD.
Personnel
human resources job qualifications job descriptionsorientationtrainingcompetency assessmentprofessional development continuing education
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Adnan S Jaran PhD.
Equipmentacquisition installationvalidationmaintenancecalibration troubleshooting service and repair records
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Adnan S Jaran PhD.
Process Control
quality control
sample management
method validation
method verification
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Adnan S Jaran PhD.
Information Management
confidentiality
requisitions
logs and records
reports
computerized laboratory information systems (LIS)
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Adnan S Jaran PhD.
Documents Recordscreation collection
revisions and review review
control and distribution storage
retention
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Adnan S Jaran PhD.
Occurrence Management
complaintsmistakes and problemsdocumentationroot cause analysisimmediate actionscorrective actionspreventive actions
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Adnan S Jaran PhD.
Laboratory Assessment External
Proficiency testing (EQA)
Inspections
Accreditations
InternalInternal
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Adnan S Jaran PhD.
Process Improvement
opportunities for improvement (OFIs)
stakeholder feedback
problem resolution
risk assessment
preventive actions
corrective actions
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Adnan S Jaran PhD.
Facilities and Safety
safe working environment
transport management
security
containment
waste management
laboratory safety
ergonomics
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Adnan S Jaran PhD.
ImplementingQuality Management
does notguarantee
anERROR-FREE
Laboratory
But it detects errors that may occur and prevents them from recurring
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Adnan S Jaran PhD.
Organization
Personnel Equipment
Purchasing &
Inventory
Process Control
Information Management
Documents&
Records
Occurrence Manageme
nt
Assessment
Process Improvement
Customer Service
Facilities &
Safety
Laboratories notimplementing aquality managementsystem guaranteesUNDETECTED ERRORS
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Adnan S Jaran PhD.
Laboratory Quality Management System
Coordinated activities to direct and control an organization with regard to
quality.
ISO 9000:2000
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Adnan S Jaran PhD.
A laboratory is a complex system and all aspects must function properly to achieve quality.
Approaches to implementation will vary with local situation.
Start with the easiest, implement in stepwise process.
Ultimately, all quality management system elements must be addressed.
Key Messages
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Adnan S Jaran PhD.
Questions?
Comments?
Organization Personnel Equipment
Purchasing &
Inventory
Process Control
Information Management
Documents&
Records
Occurrence Management Assessment
Process Improvement
Customer Service
Facilities &
Safety
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