2. manajemen laboratorium
TRANSCRIPT
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Manajemen Laboratorium
Kimia Klinik
Rochmy Istikharah
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Clinical Laboratory
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Introduction Laboratory Quality Management System-Module 1
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Achieving a 99% level of quality
means
accepting a 1% error rate1%
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Introduction Laboratory Quality Management System-Module 1
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Result: 1% failure
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Introduction Laboratory Quality Management System-Module 1
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Essential to all aspects of health care are laboratory results that are
accurate,
reliable, and
timely
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Introduction Laboratory Quality Management System-Module 1 7
Laboratory errors cost in
time
personnel effort
patient outcomes
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Lab Kimia Klinik yang Efektif
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Lab KlinikLab KlinikLab KlinikLab Klinik Hasil lab Hasil lab terpercaya terpercaya Hasil lab Hasil lab
terpercaya terpercaya
Total Quality Total Quality ManagementManagementTotal Quality Total Quality ManagementManagement
AccreditedAccreditedAccreditedAccredited
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Organization Personnel Equipment
Purchasing &
Inventory
Process Control
Information Management
Documents&
Records
Documents&
Records
Occurrence Management Assessment
Process Improvement
Customer Service
Facilities &
Safety
Facilities &
Safety
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Quality Management
Quality System
Quality Assurance
Quality Control
Total Quality Management
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Quality at a macro level
Tujuan: Pengawasan menyeluruh dari sampling sampai hasil
QM QS
Quality Management & Quality System
• Overall management function
• Tujuan: Implementasi kebijakan kualitas pd semua lini (Q planning, QA, QC)
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Monitoring thd hasil & menekankan pd isu yg lebih luas
Tujuan: hasil produksi yg konsisten
MENCEGAH KESALAHAN
QC QA
Quality Control & Quality Assurance
• Kontrol thd person, alat, metode & reagen/material
• Tujuan: Hasil yg akurat & presisi
• IDENTIFIKASI KESALAHAN
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The Quality Assurance Cycle
•Data and Lab Management
•Safety•Customer
Service
Patient/Client PrepSample Collection
Sample Receipt and Accessioning
Sample TransportQuality Control
Record Keeping
Reporting
Personnel CompetencyTest Evaluations
Testing
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QC dilakukan antar lab yg berbeda
Contoh: uji profisiensi
Internal QC Eksternal QC
Quality Control
• QC thd prosedur dlm internal lab
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Alat : kondisi baik dan terkalibrasiMetode analisis : tepat dan tervalidasi
Person : skill sesuai & bersertifikasiMaterial: kualitas baik & bersertifikat
(CoA)
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Glossary
• Presisi (teliti)
• Akurasi (tepat)
• Sensitivitas
• Selektifitas
Syarat Uji Kualitatif ??
Syarat Uji Kuantitatif ??
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www.bsn.go.id
www.iso.org
Akreditasi Lab
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• ISO17025:2008 General requirements for the competence of testing and calibration labs
• ISO 15189:2009 Quality management in the clinical laboratory
Akreditasi Lab
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Reading Materials
• Chapter 8. Clinical Chemistry. Kent Lewandrowski
• Shinton K. Standardization of quality management in the medical laboratory. Accred Qual Assur (1999) 4:442-445
Next Chapter:
Lab Safety
• Sebagian slides diambil dari Laboratory Quality Management System training toolkit WHO
http://www.who.int/ihr/training/laboratory_quality/introduction/en/index.html