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Manajemen Laboratorium
Kimia Klinik
Rochmy Istikharah
Clinical Laboratory
Introduction Laboratory Quality Management System-Module 1
4
Achieving a 99% level of quality
means
accepting a 1% error rate1%
Introduction Laboratory Quality Management System-Module 1
5
5
Result: 1% failure
Introduction Laboratory Quality Management System-Module 1
6
Essential to all aspects of health care are laboratory results that are
accurate,
reliable, and
timely
Introduction Laboratory Quality Management System-Module 1 7
Laboratory errors cost in
time
personnel effort
patient outcomes
8
+
Lab Kimia Klinik yang Efektif
8
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
Organization Personnel Equipment
Purchasing &
Inventory
Process Control
Information Management
Documents&
Records
Documents&
Records
Occurrence Management Assessment
Process Improvement
Customer Service
Facilities &
Safety
Facilities &
Safety
Quality Management
Quality System
Quality Assurance
Quality Control
Total Quality Management
11
+
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)
11
12
+
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
12
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
14
+
QC dilakukan antar lab yg berbeda
Contoh: uji profisiensi
Internal QC Eksternal QC
Quality Control
• QC thd prosedur dlm internal lab
14
Alat : kondisi baik dan terkalibrasiMetode analisis : tepat dan tervalidasi
Person : skill sesuai & bersertifikasiMaterial: kualitas baik & bersertifikat
(CoA)
Glossary
• Presisi (teliti)
• Akurasi (tepat)
• Sensitivitas
• Selektifitas
Syarat Uji Kualitatif ??
Syarat Uji Kuantitatif ??
www.bsn.go.id
www.iso.org
Akreditasi Lab
• ISO17025:2008 General requirements for the competence of testing and calibration labs
• ISO 15189:2009 Quality management in the clinical laboratory
Akreditasi Lab
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
