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Accreditation and Certification

Synonym(s):

 

Quality Management System

The Department of Pathology and Laboratory Medicine (DPLM) has a Quality Management System (QMS) to ensure that testing, operations and services provided by the laboratories meet and comply with applicable/relevant regulations and customers' expectations. The QMS safeguards the high standards of care KKH aims to provide patients by offering quality laboratory service that is accurate, reliable and holistic for women and children.

 

QM.png

 

All laboratory sections in DPLM participate in external quality assurance (EQA) proficiency testing, and have established quality control programmes that monitor ongoing test performance. Laboratory sections also participate in regular quality and safety communication sessions, periodical review of section-specific policies and standard operating procedures, ongoing personnel training and competency assessments, and monthly operation meetings that include review of feedback given by customers. Feedback by customers are valuable inputs that enable the department to constantly improve.

 

Accreditations & Certifications

DPLM is licensed by Ministry of Health, Singapore under the Section 11(1)(a) of the Healthcare Services Act 2020 (HCSA). The authorised Specified Services as part of its Clinical Laboratory Service license are as listed:

  1. Anatomic pathology
  2. Chemical pathology
    • Glycated Haemoglobin
  3. Cytogenetics
  4. Cytology
  5. Haematology
    • Malaria parasite testing
  6. Immunology
    • Human immunodeficiency virus screening
  7. Medical Microbiology
    • Acid-fast bacilli smear testing
    • Molecular SARS-CoVI-2 testing for Coronavirus Disease 2019 (COVID-19)
  8. Molecular pathology
  9. Transfusion medicine

Laboratories in DPLM are accredited or certified by the following locally and internationally recognized accreditation or certification programmes to meet the quality standards and competency requirements for medical laboratories.

 

Accreditation/Certification Programme Effective Since Laboratory Section Accredited or Certified
SAC-SINGLAS ISO 15189:2022 Medical Testing 2003 All laboratory sections in DPLM
ISO 23301 Business Continuity Management (BCM) Prior to 2013 Hospital wide, all laboratory sections in DPLM

ISO 45001 standards

(*Previously ISO 9001, ISO 14001, OHSAS)

2018

(*2007)

Hospital wide, all laboratory sections in DPLM
College of American Pathologists (CAP) October 2021 All laboratory sections in DPLM

Table 1: List of Accreditation and Certification Programmes in KKH

 

 

 

DPLM is committed to providing quality clinical laboratory service for women and children by engaging in locally and internationally recognized EQA programmes. EQA testings are conducted all year round with specified frequencies depending on the different laboratory sections. Results are monitored at specified frequencies.

The external quality programmes that are used for proficiency testing are listed in Table 2 below.

 

 

Laboratory Section EQA Programme
Biochemical Genetics & National Expanded Newborn Screening
  • CAP Surveys
  • CDC Quality Assurance Programme
  • ERNDIM External Quality Assessment
  • RCPA Quality Assurance Programs
Blood Bank
  • National Proficiency Testing Scheme for ABO Group/Rh Type
  • HSA External QAP for Immunohaematology
  • CAP Surveys
Clinical Chemistry
  • CAP Surveys
  • National Proficiency Testing for HIV
  • HSA HbA1C and Chemical Metrology External Quality Assessment
  • RCPA Quality Assurance Programs
  • RIQAS External Quality Assessment
  • UK NEQAS External Quality Assessment
Cytology
  • CAP Surveys
Cytogenetics
  • CAP Surveys
Haematology
  • CAP Surveys
  • National Proficiency Testing Scheme for Malaria Parasite
  • RCPA Quality Assurance Programs
  • UK NEQAS External Quality Assessment
Histopathology
  • CAP Surveys
  • NordiQC Immunohistochemistry Proficiency Testing
  • RCPA Quality Assurance Programs
  • UK National Gynaecological Pathology Scheme
  • UK NEQAS External Quality Assessment
Molecular Pathology
  • CAP Surveys
Microbiology
  • CAP Surveys
  • National Proficiency Testing for Acid Fast Bacili (Smear)
  • RCPA Quality Assurance Programs
  • Portugal National Program for External Quality Assessment
Molecular Microbiology
  • CAP Surveys
  • RCPA Quality Assurance Programs
  • QCMD External Quality Assessment
Non-Invasive Prenatal Testing
  • CAP Surveys

Table 2: List of Proficiency Testing Specific to Different Laboratory Sections within DPLM.

 

Abbreviations

CAP

College of American Pathologists

CDC

Centre for Disease Control and Prevention

ERNDIM

European Research Network for the evaluation and improvement of screening, Diagnosis and treatment of Inherited disorders of Metabolism

HSA

Health Sciences Authority

NordicQC

Nordic Immunohistochemical Quality Control

QCMD

Quality Control for Molecular Diagnostics

RCPA

Royal College of Pathologists of Australia

RIQAS

Randox International Quality Assessment Scheme

UK National Gynaecological Pathology Scheme

United Kingdom National Gynaecological Pathology Scheme

UK NEQAS

United Kingdom National External Quality Assessment Services