2. Manajemen Laboratorium

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