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Kimia Klinik
Rochmy Istikharah
Clinical Laboratory
Result:
1% failure
Essential to all aspects of health care are laboratory results that are
accurate,
reliable, and timely
Introduction Laboratory Quality Management System-Module 1 6
time
Lab Klinik
Organization
Personnel
Equipment
Process Control
Information Management
Occurrence Management
Assessment
Process Improvement
Customer Service
Quality Management
Quality System
Quality Assurance Quality Control
+
QM
11
Overall management function Tujuan: Implementasi kebijakan kualitas pd semua lini (Q planning, QA, QC)
11
+
QC
12
Kontrol thd person, alat, metode & reagen/material Tujuan: Hasil yg akurat & presisi IDENTIFIKASI KESALAHAN
12
Sample Transport
+
Internal QC
14
Quality Control
Eksternal QC
QC dilakukan antar lab yg berbeda Contoh: uji profisiensi QC thd prosedur dlm internal lab
Alat : kondisi baik dan terkalibrasi Metode analisis : tepat dan tervalidasi Person : skill sesuai & bersertifikasi Material: kualitas baik & bersertifikat (CoA)
14
Glossary
Presisi (teliti) Akurasi (tepat) Sensitivitas Selektifitas
Akreditasi Lab
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
Chapter 8. Clinical Chemistry. Kent Lewandrowski Shinton K. Standardization of quality management in the medical laboratory. Accred Qual Assur (1999) 4:442-445
Reading Materials
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