SISTIM MANAJEMEN MUTU

LAYANAN LABORATORIUM

Sri Hartini
Surveior KALK
 CURRICULLUM VITAE
PERSONAL DATA
Name : Dr. dr Sri Hartini SpPK (K), MARS
Office : Clinical Pathology Lab, Dharmais National Cancer Center, Jakarta
EDUCATION
2015 : Doctor in Biomedical Science, Faculty of Medicine, Gadjah Mada
University , Jogyakarta
2008 : Clinical Pathologist – Oncology Consultant , Collegium of IACPaLM Jakarta
1999 : Magister of Hospital Management University of Indonesia, Jakarta
1985 : Clinical Pathologist , University of Indonesia, Jakarta
1973 : MD, Faculty of Medicine, Gadjah Mada University , Jogyakarta
APPOINTMENT
2016 - present : Surveior of Laboratory Accreditation Committee, Dept of Health,
2012 – present : Consultant of Molecular Diagnostic Center, Siloam Hospital Group, Jkt
2010 – present : Member of Council of National Accreditation Committee, BSN, Jkt
2007 – present : Surveior of Hospital Accreditation Committee, Jkt
2007 – present : Lecturer Postgraduate Studies Biomedic Sciences Majoring Oncology,
University of Indonesia
2005 – 2008 : Director of General Affair & Operational Dharmais National Cancer
Center Hospital, Jakarta
2002 - 2005 : Director of Medical Support, Dharmais National Cancer Center Hospital
2001 – 2002 : Head of Clinical Pathology Laboratory, Dharmais National Cancer
Center Hospital, Jakarta
1993 – present : Functional Medical Staff, Clinical Pathology Laboratory, Dharmais
National Cancer Center Hospital
 Outline
1. Definisi & pengertian QMS
2. Dimensi Mutu Layanan Kesehatan
3. Komplexitas Layanan Lab
4. Quality system elements
5. Hubungan QMS dgn Akreditasi
 MUTU PELAYANAN
KESEHATAN
Definisi Mutu
Tingkat Layanan Bagi Individu Dan Populasi Yang Dapat
Meningkatkan Keluaran (Outcome) Kesehatan Yang Optimal,
Diberikan Sesuai Dengan Standar Pelayanan, Perkembangan
Ilmu Pengetahuan Terkini Serta Memperhatikan Hak Dan
Keterlibatan Pasien-masyarakat.

(The degree to which health services for individuals

and populations increase the likelihood of desired
health outcomes and are consistent with current
professional knowledge (IOM, 2001) )
 Quality Management System Definition

Coordinated activities to direct and control an

organization with regard to quality (ISO,CLSI).

All aspects of the laboratory operation

need to be addressed to assure
quality; this constitutes
a quality management system.

Introduction Laboratory
Quality Management 5
System-Module 1
 The Quality Management System

Organizatio Personnel Equipment

n

Purchasing
Process Information
&
Management
How do we Inventory Control

achieve Documents Occurrence

excellent &
Records
Management Assessment

performance in
the laboratory? Process
Improvement
Customer
Service
Facilities
&
Safety

Introduction Laboratory
Quality Management System- 6
Module 1
 Complexity of a Laboratory System

Reporting Patient/Client Prep

Sample Collection
Personnel Competency
Test Evaluations
•Data & Laboratory
Management
•Safety
•Customer Service
Sample Receipt and
Accessioning

Record Keeping

Sample Transport
Quality Control
Testing

Introduction Laboratory
Quality Management 8
System-Module 1
 Path of Workflow
THE PATIENT Test selection Sample Collection

Preexamination Phase

Sample Transport

Laboratory Analysis
Examination Phase

Report Transport Report Creation

Result Interpretation Postexamination Phase

Introduction Laboratory
Quality Management 9
System-Module 1
 WHY is the Path of Workflow essential to consider in
health laboratories?

The entire process of managing a sample must

be considered:
 the beginning: sample collection
 the end: reporting and saving of results
 all processes in between.

Introduction Laboratory
Quality Management 10
System-Module 1
 Laboratory tests are influenced by
 laboratory environment
 knowledgeable staff
 competent staff
 reagents and equipment
 quality control
 communications
 process management
 occurrence management
 record keeping
Introduction Laboratory
Quality Management 11
System-Module 1
Twelve Quality System Essentials

set of
Organization Personnel Equipment

coordinated
activities that Purchasing Information
function as
Process
& Control Management
Inventory

building blocks
for Documents
quality
Occurrence
& Assessment
Management
Records

management
Process Customer Facilities
Improvement Service &
Safety

Introduction Laboratory
Quality Management 12
System-Module 1
 Organization Personnel Equipment

Purchasing Process Information

& Control Management
Inventory

Path of Workflow
Documents Occurrence
& Assessment
Management
Records

Process Customer Facilities

Improvement Service &
Safety

Introduction Laboratory
Quality Management 13
System-Module 1
 Quality System Management
Requirements

• A Management Policy and System

• Standardisation of Procedures
• Documentation of :
- Quality Policies
- Management Procedures
- Operational Procedures
• Internal Audits
• External Assessment
Quality System
Elements
Organisation
Personnel
Equipment
Process Control
Documents and Records
Purchase and
Inventory
Internal Assessment
Process Improvement
Occurrence
Management
Service and
Satisfaction
 Organization
Responsibilities, Authorities

Quality
Policy

Provision Communication
of
resources
Introduction Laboratory
Quality Management 17
System-Module 1
 Personnel
 human resources
 job qualifications
 job descriptions
 orientation
 training
 competency assessment
 professional development
 continuing education

Introduction Laboratory
Quality Management 18
System-Module 1
 Equipment
 acquisition
 installation
 validation
 maintenance
 calibration
 troubleshooting
 service and repair
 records
Introduction Laboratory
Quality Management 19
System-Module 1
 Process Control

quality control
sample management
method validation
method verification

Introduction Laboratory
Quality Management 20
System-Module 1
 Documents Records
creation collection
revisions and review review
control and distribution storage
retention

Introduction Laboratory
Quality Management 21
System-Module 1
 Purchasing and Inventory

vendor qualifications
supplies and reagents
critical services
contract review
inventory management

Introduction Laboratory
Quality Management 22
System-Module 1
 Laboratory Assessment
Internal
Internal External

Proficiency
testing (EQA)

Inspections

Accreditations

Introduction Laboratory
Quality Management 23
System-Module 1
 Essential of Laboratory
Accreditation

Quality Management System

Proficiency
Environmen Testing
t

Compete
method personnel
nce

sample equipment
 Laboratory Accreditation
is an evaluation process by which an
authoritative body gives formal recognition that
a laboratory is competent to carry out QMS

Competen
Technical ce to carry
competence out
Evaluati specific
on Management testing
System and/or
calibration
 Process Improvement
opportunities for improvement (OFIs)
stakeholder feedback
problem resolution
risk assessment
preventive actions
corrective actions

Introduction Laboratory
Quality Management 26
System-Module 1
 Occurrence Management

complaints
mistakes and problems
documentation
root cause analysis
immediate actions
corrective actions
preventive actions
Introduction Laboratory
Quality Management 27
System-Module 1
 Customer Service

 customer group identification

 customer needs
 customer feedback

Introduction Laboratory
Quality Management 28
System-Module 1
 Information Management

 confidentiality
 requisitions
 logs and records
 reports
 computerized laboratory
information systems (LIS)

Introduction Laboratory
Quality Management 29
System-Module 1
 Facilities and Safety
 safe working environment
 transport management
 security
 containment
 waste management
 laboratory safety
 ergonomics

Introduction Laboratory
Quality Management 30
System-Module 1
 Evaluation focus

Technical
competence

 Personnel

 Equipmen
t
 Sample

 Method
Environme
nt Process
Results
Control
BUDAYA MUTU…
“AN ORGANIZATION
WICH CREATE A
WORKING
ENVIRONMENT”:

WHERE WICH IS OPEN

EDUCATION PARTICPATIVE
AND
RESEARCH
ARE VALUE

WHERE
BLAME IS WHERE
USED IDEAS AND
EXEPCIONA GOOD
LLY PRACTICE
SHARE
 Implementing
Quality Management
does not But it detects
guarantee errors that may
an occur and
ERROR-FREE prevents them
Laboratory from recurring

Introduction Laboratory
Quality Management 33
System-Module 1
 Organizatio Personnel Equipment
n

Laboratories not
Purchasing
&
Process
Control
Information
Management
implementing a
Inventory
quality management
Documents Occurrence system guarantees
& Manageme Assessmen
Records nt t
UNDETECTED
ERRORS
Process Customer Facilities
Improvement Service &
Safety

Introduction Laboratory
Quality Management 34
System-Module 1
Implementing a QMS cont.
Successful implementation requires:
– planning, management,
– belief in system
– understanding the “spirit” of the standard
– understanding organisation’s aims
– having staff involved at all levels
– look for real process improvements
– setting realistic time frames