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Manajemen Laboratorium

Kimia Klinik
Rochmy Istikharah

Clinical Laboratory

Achieving a 99% level of quality


means

accepting a1% error rate 1%


Introduction Laboratory Quality Management System-Module 1 4

Result:

1% failure

Introduction Laboratory Quality Management System-Module 1

Essential to all aspects of health care are laboratory results that are

accurate,
reliable, and timely
Introduction Laboratory Quality Management System-Module 1 6

Laboratory errors cost in

time

personnel effort patient outcomes

Introduction Laboratory Quality Management System-Module 1

Lab Kimia Klinik yang Efektif

Lab Klinik

Total Quality Management


Accredited

Hasil lab terpercaya

Organization

Personnel

Equipment

Purchasing & Inventory

Process Control

Information Management

Documents & Records

Occurrence Management

Assessment

Process Improvement

Customer Service

Facilities & Safety

Total Quality Management

Quality Management

Quality System
Quality Assurance Quality Control

+
QM

Quality Management & Quality System


QS
Quality at a macro level

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Overall management function Tujuan: Implementasi kebijakan kualitas pd semua lini (Q planning, QA, QC)

Tujuan: Pengawasan menyeluruh dari sampling sampai hasil

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+
QC

Quality Control & Quality Assurance


QA
Monitoring thd hasil & menekankan pd isu yg lebih luas

12

Kontrol thd person, alat, metode & reagen/material Tujuan: Hasil yg akurat & presisi IDENTIFIKASI KESALAHAN
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Tujuan: hasil produksi yg konsisten


MENCEGAH KESALAHAN

The Quality Assurance Cycle

Patient/Client Prep Sample Collection


Reportin g Personnel Competency Test Evaluations

Data and Lab Management Safety Customer Service

Sample Receipt and Accessioning

Record Keeping Quality Control Testing

Sample Transport

+
Internal QC

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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)
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Glossary
Presisi (teliti) Akurasi (tepat) Sensitivitas Selektifitas

Syarat Uji Kualitatif ??


Syarat Uji Kuantitatif ??

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