WORKSHOP QUALITY MANAGEMENT SYSTEMS (QMS)

 

 

The Ministry of Health (MOH) has adopted 11 core functions of the Public Health Laboratory (PHL) from the World Health Organization (WHO) and the Public Health Laboratory Network (PHLN)/Association of Public Health Laboratories, namely Disease Prevention, Control and Surveillance, Integrated Data Management, Reference and Specialized Testing, Environmental Health and Protection, Food Safety, Laboratory Improvement and Regulation, Policy Development, Public Health Preparedness and Response, Public Health Related Research, Training and Education, Partnership and Communication. To implement this, the Ministry of Health identified that there are currently several problems in the implementation of PHL, namely:

1. The laboratory is not yet well integrated
2. Laboratory-based surveillance of diseases and public health problems is not yet optimal
3. Network of laboratories, both government and private, has not been established
4. There is no system for monitoring laboratory resources, both in terms of human resources, equipment calibration and quality assurance, and
5. Information systems are not yet integrated. In March 2021, AIHSP supported the Technical Working Group (TWG) on Strengthening Laboratories to create a needs-based framework to improve the accessibility, quality, reliability, and timeliness of laboratory services that support effective public health decision making. A review of MOH laboratory system policies and regulations was conducted previously and has identified several priorities with regards to updating the regulatory framework.

In March 2021, the Australia Indonesia Health Security Partnership (AIHSP) supported the Technical Working Group (TWG) on Strengthening Laboratories to create a needs-based framework to improve the accessibility, quality, reliability and timeliness of laboratory services that support effective public health decision-making. A review of MOH laboratory system policies and regulations was previously conducted and identified several priorities related to updating the regulatory framework. The results of this regulatory review serve as a benchmark for improvement, refinement, and strengthening of existing regulations, as well as a foundation for the revision of the draft regulation on Health Laboratories.

Following the regulatory review, AIHSP has conducted laboratory capacity mapping in four AIHSP provinces, namely South Sulawesi, Bali, Yogyakarta Special Region, and Central Java in mid-2021, and East Nusa Tenggara Province in 2023. This mapping is an inventory of what laboratories are currently doing and capable of doing based on a management system that includes organization, human resources, facilities and equipment, laboratory services, quality management, guidelines/documents, inventory, cooperation, and information systems. The scope of mapping includes regional health laboratories, community health centers, including regional hospital laboratories and national/provincial referrals, especially in target provinces that have never been mapped by other institutions.

As a follow-up to the laboratory capacity mapping activities that have been carried out in five provinces, AIHSP collaborated with The National Serology Reference Laboratory, Australia (NRL) and Indonesia One Health University Network (INDOHUN) to carry out capacity building activities through workshops. The workshop was held for five days from Monday to Friday, January 29 – February 2, 2024 at Harper Malioboro Hotel Yogyakarta. This workshop activity was carried out with the aim of:

1. Presents a holistic overview of a laboratory’s quality management system (QMS) and its importance in managing risks to the accuracy and reliability of test results;
2. Outline the principles and requirements of the key elements (or systems) contained in a laboratory QMS;
3. Provide an understanding of the use of quality control (QC) and external quality assessment schemes (EQAS) to assess test performance and identify actual or potential problems;
4. Shows how the QMS links back to the 2012 ISO 15189 Standard: Medical laboratories – Requirements for quality and competence.
5. Facilitate a QMS quiz designed to identify specific elements or activities that require further training that can be included in subsequent workshops.

This activity was attended by participants from designated laboratory staff from the Public Health Laboratory (Labkesmas), tier 1-3, among others: 

Special Region of Yogyakarta

1. BLKK DI Yogyakarta
2. Yogyakarta Health and Calibration Laboratory Center
3. UPT Laboratorium Kesehatan Kab. Kulon Progo
4. Temon Health Center 1

Central Java

1. Central Java Provincial Labkes and PAK Center
2. Kroya Health Center, Cilacap Regency
3. Tayu Health Center l
4. UPTD Labkes Cilacap
5. Jaken Health Center, Pati District, Central Java
6. UPTD Labkesda Kab Pati
7. UPTD Puskesmas Kedawung II
8. Central Java Provincial Labkes and PAK Center
9. UPTD Puskesmas Patimuan
10. UPTD Cilacap Health Laboratory
11. UPTD Regional Health Laboratory, Pati District
12. UPTD Puskesmas Mondokan
13. Regional Health Laboratory of Sragen Regency

BALI

1. UPTD Bali Provincial Health Laboratory Center
2. Sawan Health Center 1
3. UPTD Labkes Kab. Karangasem
4. UPTD Laboratorium Kesehatan Karangasem
5. UPTD Puskesmas Karangasem II
6. Tejakula Health Center II
7. UPTD.Laboratorium Kesehatan Masyarakat Kab.Buleleng
8. Seririt I Health Center
9. UPTD Puskesmas Karangasem 1
10. UPTD Balai Labkes Kerthi Bali Sadhajiwa Bali Province

South Sulawesi

1. UPT Labkesda Bone Regency
2. UPT Puskesmas Baraka Enrekang Regency
3. Regional Laboratory and Health Service Unit 
4. Regional Laboratory and Health Service Unit
5. UPT Puskesmas Bontocani
6. UPT Puskesmas Tellu Siattinge
7. Regional Health Laboratory UPT Kab. Bone
8. UPT Puskesmas Malua Health Office, Enrekang District

East Nusa Tenggara

1. UPTD Puskesmas Watu Kawula, Kab. Southwest Sumba
2. Labkesda Southwest Sumba
3. UPTD Puskesmas Atambua City
4. Haekesak Health Center
5. UPTD Labkes Prov.NTT
6. Southwest Sumba Regional Health Laboratory

Tier 4 & 5

1. Labkesmas Center Ambon
2. Labkesmas Center Batam
3. Environmental Health Laboratory Center
4. Center for Health Biology Laboratory
5. Dit. Health Surveillance and Quarantine
6. Directorate of Public Health Governance

Member INDOHUN

1. University of Indonesia
2. Airlangga University

This activity was opened with the first speech by Prof. dr. Agus Suwandono, MPH, Dr.PH (INDOHUN Coordinator). Next, remarks as well as the opening of the workshop by dr. Endah Kusumowardani, M.Epid (Head of the Labkesmas Work Team, Directorate of SKK), and the last remarks by Mrs. Lea Suganda (AIHSP Senior Technical Program Manager). After that, participants had the opportunity to take a group photo as a memento. Then during the 5-day workshop, participants received relevant material about QMS from speakers Vee Armstrong and Innocent Mupunga from the National Serology Reference Laboratory (NRL), Australia. The materials provided are:

1. Introduction to Laboratory QMS:
   a. Risk Management
   b. Laboratory risks that will impact the quality of testing
   c. The role of QMS in controlling risk
   d. Elements of a QMS
   e. Implementation sequence
2. Documents and records (First step in QMS implementation)
3. Personnel management:
   a. Organizational and management commitment
   b. Training, competency, performance review
4. Facilities:
   a. Areas of specialization – specimen collection, testing, storage
   b. Environmental control
   c. Waste management
5. Equipment, reagents and consumables:
   a. Validation and verification
   b. Performance monitoring
6. Laboratory Processes:
   a. Pre-inspection process
   b. Inspection process
   c. Validation and verification
   d. Quality Control
   e. Importance of external quality assessment schemes (EQAS)
   f. Post-examination process
7. Performance monitoring and assessment:
   a. QMS
   b. Inspection
8. Problem & complaint management:
   a. Identification, investigation, & corrective action
   b. Prevent possible problems
9. Contract:
   a. Services received
   b. Services provided
10. QMS & ISO 15189 (How they interrelate)

Over the five days, participants engage in intensive, interactive materials, and group activities as well as real-life scenarios will be used to enhance participants’ understanding as well as a medium for knowledge and experience exchange between participants, creating a dynamic and collaborative learning environment. As part of the closing ceremony, participants were asked to complete an evaluation questionnaire to evaluate the workshop activities. It is hoped that this workshop will make a positive contribution to efforts to improve the quality of the management system. 

After the workshop, visitation activities were carried out to the Yogyakarta Health and Calibration Laboratory Center (BLKK) and Nanggulan Health Center, Kulon Progo Regency on February 5, 2024 and visitation to the UPTD Health Laboratory of Sragen Regency on February 6, 2024. The purpose of the visitation was to introduce the capacity building activities that will be carried out by the NRL team, review laboratory activities, facilities and operations, and discuss the challenges and gaps faced by laboratories, especially in implementing the Labkesmas concept.