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Quality Programmes, Certification and Accreditation

The Division strives to provide high clinical laboratory standards by engaging in well-accepted quality assurance activities. The Division’s Laboratory Quality Committee, consisting of members from all disciplines in the department, meets regularly and works closely together with each other and with clients to solve problems and to ensure a high standard of laboratory service. The quality and appropriateness of services are reviewed regularly in order to pursue opportunities to improve patient care, customer satisfaction and resolve identified problems. The aim is for clients to be confident that the test results and reports generated are accurate, reliable and clinically relevant and reported in a timely manner.

The Division’s laboratories are accredited or certified by the following locally/ internationally recognised accreditation or certification programmes:

Certification/Accreditation Programme Since Section/Laboratory Accredited or Certified
College of American Pathologists Laboratory Accreditation Programme (CAP) Mar 2003 All Clinical Laboratories in Department of Pathology
BSL-3 Laboratory Certification Dec 2003 SGH BSL-3 Facility, Academia, Level 13
Joint Commission International (JCI) Jul 2005 Hospital-wide, all laboratories in Department of Pathology

Business Continuity Management (BCM) Sep 2005
Business Continuity Management (BCM-TR19:2005) Aug 2007
World Health Organization 1998 National Polio Laboratory

The laboratories participate in proficiency testing, maintain and regularly review standard operating procedures and quality control procedures, conduct on-going personnel training and competency assessment, review specimen handling, test methodologies, test reporting and safety, among others. Feedback given by clients is important to help us improve our services and respond to their needs. Our laboratories participate in several well-established, locally and internationally recognised proficiency testing programmes. These programmes are useful to gauge our performance and standard against other laboratories which participate in the programmes. They are also useful from an educational point of view, and are important sources of information and clinical material. We have been obtaining good results for these proficiency testing programmes which cover the full spectrum of tests that are offered by our laboratories. The external quality programmes that are used for proficiency testing are listed in the table.

External Quality Assessment Programmes

Blood Bank Laboratory

Disciplines                     Programme Title Frequency
Blood Bank (Transfusion

CAP Comprehensive Transfusion Medicine 3/year
CAP Direct Antiglobulin Testing 2/year
CAP Transfusion Medicine, Automated Testing 3/year
CAP Transfusion Medicine Competency Assessment – Comprehensive Transfusion Medicine 3/year
CAP Transfusion Medicine Competency Assessment – Direct Antiglobulin Test 2/year
National External Quality Assessment Programme for Immunohaematology
(Blood Services Group, Health Sciences Authority)
National Proficiency Testing Scheme for ABO Group/Rhesus (D) Type Testing
(Blood Services Group, Health Sciences Authority)

Clinical Biochemistry


Disciplines                     Programme Title Frequency
Clinical Biochemistry

CAP Accuracy Based Lipids  2/year
CAP Accuracy Based Urine 2/year 
CAP Accuracy-Based Testosterone, Estradiol 2/year
CAP Aldolase 2/year
CAP Blood Gas CVL 2/year 
CAP Blood Lead 3/year
CAP Blood Oximetry 3/year
CAP Body Fluid Chemistry 2/year
CAP Body Fluid Chemistry 2 2/year 
CAP Bone Markers and Vitamin survey 2/year 
CAP B-Type Natriuretic Peptide,5 Challenges 3/year 
CAP Cadmium (B2M urine, cadmium blood, cadmium urine) 6/year
CAP Cardiac Markers (CKMB, TNT, Myoglobin) 3/year 
CAP Cardiac Risk (hsCRP & Homocysteine)
CAP Cerebrospinal Fluid Chemistry & Oligoclonal Bands 2/year
CAP Chemistry/Therapeutic Drugs Monitoring 3/year
CAP Clinical Microscopy (urine casts and crystals) 2/year
CAP Competency Assessment 2/year
CAP Critical Care Aqueous Blood Gas 3/year
CAP Creatinine accuracy CVL 2/year
CAP Electrophoresis 2/year
CAP Everolimus 2/year
CAP Fructosamine 2/year
CAP Glucose-6-phospate Dehydrogenase 2/year
CAP Harmonized thyroid 2/year
CAP Hemocytometer Fluid Count (WBC and RBC cell count) 2/year
CAP Hemoglobin A1c,5 Challenges 3/year
CAP Immunology 3/year
CAP Immunology Special 3/year
CAP Immunosuppressive Drugs 2/year
CAP Instrumentation 3/year
CAP Ketones 2/year
CAP Kidney Stone Risk Assessment (for citrate and oxalate) 2/year
CAP Ligands (General) 3/year
CAP Ligands (Special) 2/year
CAP Maternal Screening 3/year
CAP Mycophenolic acid 2/year
CAP Myoglobin, Urine 2/year
CAP Neonatal Bilirubin, 5 Challenges 3/year
CAP Porphobilinogen, urine 2/year
CAP Procalcitonin 2/year
CAP Reproductive Endocrinology CVL 2/year
CAP Rheumatic Disease Special Serology  2/year
CAP Serum Free Light Chains 2/year
CAP Trace Metals 2/year
CAP Trace Metals, Urine 2/year
CAP Trace Metals, whole blood 2/year
CAP Tumor Markers 2/year
CAP Urine Chemistry (General) 2/year 
CAP Urine Chemistry (Special) 2/year
CAP Antifungals drug monitoring 2/year
CAP 25-OH Vitamin D 2/year
HSA Chemistry 2/year
HSA HbA1C 2/year
RCPA BNP 12/year
RCPA Condensed General Serum Chemistry and Therapeutic Drug 12/year
RCPA C-Reactive Protein 12/year
RCPA CSF chemistry 12/year
RCPA Cyclic Citrullinated Peptide 8/year
RCPA Endocrine 12/year
RCPA PSA 12/year
RCPA RBC Folate 12/year
RCPA IgE 8/year
RCPA IGF-1 / C-Peptide 12/year
RCPA IgG Subclasses 8/year
RCPA Neonatal Bilirubin 12/year
RCPA Paraproteins 8/year
RCPA Rheumatoid factor 8/year
RCPA Special Lipids 12/year
RCPA Special Drugs 12/year
RCPA Immunosuppressants 12/year
RCPA Specific Proteins 12/year
RCPA Trace Elements (Serum, Urine, Whole blood) 12/year
RCPA Urine Chemistry 12/year
RCPA Thyroid antibodies 8/year
RCPA Urine Amylase 12/year
RCPA Biogenic Amines 12/year
RCPA Vitamins 12/year
RCPA Whole Blood Glycohaemoglobin 3/year
RCPA Plasma Metanephrines 12/year
UKNEQAS Maternal Serum Screening 12/year
UKNEQAS Antifungal 6/year
UKWEQAS Calculi 6/year

Cytogenetics Laboratory

Disciplines                     Programme Title Frequency
Molecular Cytogenetics

CAP Cytogenetics Survey for Chromosome Abnormalities 2/year
CAP Fluorescence in Situ Hybridization Survey for Constitutional & Hematologic Disorders  2/year 
CAP Fluorescence in Situ Hybridization Survey for Paraffin-Embedded Tissue – Breast Cancer (HER2 Gene Amplification) 2/year
CAP Fluorescence in Situ Hybridization Survey for Paraffin-Embedded Tissue – Brain/Glioma Tissue  2/year
CAP Fluorescence in Situ Hybridization Survey for Paraffin-Embedded Tissue – Solid Tumor 2/year
CAP Fluorescence in Situ Hybridization Survey for Paraffin-Embedded Tissue – Lymphoma Tissue 2/year
CAP Cytogenomic Microarray Analysis for Oncologic Abnormality   2/year


Disciplines                             Programme Title Frequency

CAP Interlaboratory Comparison Program in Gynecologic Cytopathology 2/year
CAP Interlaboratory Comparison Program in Non-Gynecologic Cytopathology 4/year
RCPA Cytology QAP – Gynaecological Cytopathology (Conventional Cytopathology and Fluid-Based Gynaecological Cytopathology) 4/year
RCPA Cytology QAP – Non-Gynaecological Cytopathology (General Cytopathology and FNA Cytopathology) 4/year

Haematology Laboratory

Disciplines                       Programme Title Frequency

CAP Blood Parasite 3/year
CAP Bone Marrow Cell Differential 2/year
CAP Clinical Microscopy Colour Photography 2/year
CAP Coagulation, Extended 2/year
CAP Coagulation, Limited 3/year
CAP Coagulation Special Testing, Series 4, Heparin 2/year
CAP Erythrocyte Sedimentation Rate 2/year 
CAP Fetal RBC and F Cell Determination 2/year
CAP Flowcytometry CD34+ 2/year
CAP Flowcytometry – Immunophenotypic Characterisation of PNH   2/year 
CAP Flowcytometry – Immunophenotyping Leukaemia/Lymphoma 2/year
CAP Flowcytometry – Lymphocyte Phenotyping 3/year
CAP Hematology – Comprehensive, Automated Differential with Micrograph        3/year
CAP Hemoglobinopathy 2/year
CAP Heparin LMW CVL  2/year 
CAP Minimal Residual Disease (p190) 2/year
CAP Minimal Residual Disease (p210)  2/year
CAP Molecular Genetics (Fa V Leiden / Prothrombin) 2/year
CAP Molecular Genetics (Hb S/C)   2/year 
CAP Molecular Hematological Oncology, Leukaemia only 2/year
CAP Molecular Hematological Oncology, Lymphoid Malignancy 2/year 
CAP Monitoring Engraftment 3/year
CAP Quality Cross Check Haematology 2/year 
CAP Reticulocyte 2/year
CAP Thrombophilia CVL  2/year 
CAP Urine Haemosiderin 2/year
CAP VWF Antigen CVL  2/year 
RCPA CD34+ Programme 3/year
RCPA Full Blood Count Programme 12/year
RCPA Hemoglobinopathy 4/year
RCPA Hemostasis Programme 8/year
RCPA Molecular Diagnostics – Module 3 (BCR-ABL) 1/year
RCPA Molecular Diagnostics – Module 4 (BCL1/BCL2, TCR/IHCG) 1/year 
RCPA Molecular Diagnostics – Module 5 (Chimerism) 1/year
RCPA Molecular Diagnostics – Module 7 (JAK2) 2/year 
RCPA Molecular Diagnostics – Module 8 (PML-RAR-a 1/year 
RCPA Molecular Diagnostics – Module 9 (FLT-3ITD) 1/year
RCPA Morphology with Differential 4/year



Disciplines Programme Title Frequency

College of American Pathologists Performance Improvement Program in Surgical Pathology (PIP) 4/year
College of American Pathologists Immunohistochemistry Survey 2/year
NSH/CAP Histo QIP 2/year
CAP Her-2 immunohistochemistry, tissue microarray 2/year
CAP In Situ Hybridisation Survey 2/year
CAP DNA mismatch repair by immunohistochemistry 2/year
CAP CD117 1/year
CAP ER and PR 2/year
CAP CD20 1/year
CAP PDL1 1/year
CAP Anaplastic Lymphoma Kinase IHC 1/year
CAP/NSH Gynecologic Biopsy 2/year
CAP/NSH HistoQIP Mismatch Repair IHC 2/year
HQIP Non-small Cell Lung Carcinoma IHC 2/year


Disciplines Programme Title Frequency
Mycology, Parasitology

CAP Bacterial Antigen Detection 2/year
CAP Bacteriology 3/year
CAP Chlamydia trachomatis (IF) Antigen Detection 3/year
CAP Clinical Microscopy – (Clinical Microscopy Miscellaneous Photographs and Occult Blood) 2/year
CAP Pneumocystis jiroveci – GMS stain  2/year 
CAP Fungal Serology (for Histoplasma) 2/year
CAP GC Culture  3/year
CAP Gram Stain   3/year
CAP India Ink 2/year
CAP Methicillin Resistant Staphylococcus aureus Screen 2/year
CAP Mycology 3/year
CAP Parasitology 3/year
CAP Vancomycin-Resistant Enterococcus  2/year 
RCPA Microbiology QAP – Bacteriology 8/year
RCPA Microbiology QAP – Mycology 4/year
RCPA Microbiology QAP – Parasitology 4/year
WHO GC Antimicrobial Susceptibility Programme (GASP) 1/year

Central Tuberculosis Laboratory

Disciplines                     Programme Title Frequency

CAP Molecular MTB detection and Resistance (MTBR)  2/year 
CAP Mycobacteriology 2/year
CAP Mycobacterium Tuberculosis Stimulated Infection Detection 2/year
CAP Nucleic Acid Amplification 2/year
National Proficiency Testing (NPT) Scheme for AFB (Smear) Testing 2/year
RCPA Microbiology QAP – Mycobacteriology 4/year

Immunology & Serology

Disciplines                     Programme Title Frequency
Immunology, Serology,
STD, Allergy  

CAP Anti-Phospholipid Antibody 2/year
CAP Anti-Saccharomyces cerevisiae Antibody   2/year
CAP Bacterial Antigen Detection 2/year
CAP Bacteriology 3/year
CAP Celiac Serology 2/year
CAP Diagnostic Allergy 3/year
CAP Diagnostic Immunology 3/year
CAP Fungal Serology   2/year
CAP Galactomannan 2/year
CAP Gastrointestinal & Hepatic Diseases  2/year 
CAP H. pylori Antigen, Stool 2/year
CAP Immunology Special 3/year
CAP Infectious Disease Serology 2/year
CAP Rheumatic Disease Special Serology 2/year
CAP Syphilis Serology 3/year
CAP Tick Transmitted Disease 2/year
CAP Total Hemolytic Complement 2/year
CDC Syphilis Serology 3/year
RCPA Immunology QAP – Tissue Autoantibodies 8/year
RCPA Immunology QAP – Type I Diabetes Antibodies 8/year 
RCPA Immunology QAP – Myositis and Scleroderma  6/year  
RCPA Immunology QAP – Neuronal Antibodies  6/year
RCPA Immunology QAP – Fungal and Avian Antibodies  4/year 
RCPA Serology QAP – Bacterial Serology 6/year
RCPA Serology QAP – Parasite & Spirochaete Serology 4/year
UK NEQAS Antibody to Fungal  and Related Antibodies 6/year 

Molecular Laboratory

Disciplines                     Programme Title Frequency
Molecular Diagnostics

CAP Chlamydia/GC by Nucleic Acid Amplification 3/year
CAP Clostridium difficile  2/year 
CAP HIV-1 Viral Load 3/year
CAP HLA-B27 Typing 2/year
CAP Human Papillomavirus 3/year
CAP Microsatellite Instability  2/year 
CAP Molecular Hematologic Oncology  2/year  
CAP Norovirus  2/year  
CAP Nucleic Acid Amplification, Organisms (CP, MP, BP, LP) 2/year
CAP Nucleic Acid Amplification, Respiratory Viruses (ADV, CorV, HRV, MPV, FluA/B, PIV, RSV) 3/year
CAP Nucleic Acid Amplification, Viruses 2/year
CAP Solid Tumor - BRAF  2/year 
CAP Solid Tumor - EGFR  2/year 
ESP Colon EQA (NRAS/KRAS/BRAF)  1/year
QCMD Epstein-Barr Virus DNA  2/year
QCMD HBV Drug Resistance  2/year 
QCMD HCV Genotyping  2/year 
QCMD Human Cytomegalovirus DNA 2/year
QCMD Human Herpes Virus 6 DNA 2/year
QCMD BK Virus DNA 2/year
QCMD Toxoplasma gondii 2/year 
QCMD MERS Coronavirus 2/year 
QCMD Zika Virus  2/year 
RCPA Molecular Alphavirus/Flavivirus 2/year 
RCPA Mutation Detection in Melanoma (BRAF) 1/year
RCPA Mutation Detection in Lung Cancer (EGFR) 1/year 
RCPA Mutation Detection in Colorectal Cancer (KRAS/NRAS)  1/year 
RCPA Molecular HIV RNA Viral Load  2/year
RCPA Serology QAP – Molecular Avian Influenza 3/year
RCPA Serology QAP – Molecular HBV DNA Quantitative 2/year
RCPA Serology QAP – Molecular HCV RNA Qualitative & Quantitative 2/year
WHO (HK) EQA Avian Influenza / Flu A and B PCR 1/year


Disciplines                        Programme Title Frequency

CAP Diagnostic Immunology 3/year
CAP Herpes Ag Detect (DFA)  3/year 
CAP Herpes Simplex Virus Culture  3/year  
CAP Infectious Disease Serology 2/year
CAP Viral Markers Survey 3/year
CAP Virology Antigen Detection (DFA) 3/year
CAP Virology Antigen Detection (Non-IF) 3/year
CAP Virology Culture 3/year
National Proficiency Testing for HIV 3/year
RCPA Serology QAP – Antenatal Serology 4/year
RCPA Serology QAP – Bacterial Serology 2/year
RCPA Serology QAP – Hepatitis Serology 2/year
RCPA Serology QAP – Lymphadenopathy Serology 4/year
RCPA Serology QAP – Retroviral Serology 6/year
RCPA Serology QAP – Vaccine Preventable Diseases Serology 4/year
RCPA Serology QAP – Viral Serology 4/year
WHO Proficiency Testing for Intratypic Differentiation of Poliovirus (rRT-PCR ITD PT and rRT-PCR VDPV PT) 1/year
WHO Proficiency Testing for Polio and Non-Polio Enterovirus Culture and Identification 1/year
WHO Proficiency Testing for Poliovirus Diagnostic Sequencing  1/year 

Satellite Laboratories

Disciplines                     Programme Title Frequency
Clinical Biochemistry,

CAP Whole Blood Coagulation Survey  3/year 
MLE Blood Cell Identification 3/year
MLE CoaguChek XS Plus 3/year
MLE Glucose, Whole Blood 3/year
MLE HbA1c 3/year
MLE Hematology with 3-Part Automated Differential  3/year 
MLE Hematology with 5-Part Automated Differential  3/year 
MLE Neonatal Bilirubin 3/year
MLE Prothrombin Time  3/year 
MLE Sedimentation Rate 3/year
MLE Urinalysis Dipstick 3/year
MLE Urine hCG 3/year
MLE Urine Sediment Identification 3/year
RCPA Automated Differential 4/year 
RCPA Full Blood Count Programme 12/year

Translational Pathology Centre

Disciplines Programme Title Frequency
Molecular Diagnostics
CAP Next-Generation Sequencing (NGS) 2/year
CAP Multigene Tumor Panel (MTP) 2/year
EMQN BRCA (Full scheme) 1/year
EMQN NextGen DNA Sequencing  1/year
EMQN Oncogene panel testing 1/year


CAP College of American Pathologists
CDC Centre for Disease Control and Prevention
EMQN European Molecular Genetics Quality Network
EQA External Quality Assessment
ESP European Society of Pathology
HK Hong Kong
HSA Health Sciences Authority
MLE Medical Laboratory Evaluation
NSH National Society of Histotechnology
QAP Quality Assurance Programme
QCMD Quality Control for Molecular Diagnostics
RCPA Royal College of Pathologists of Australia
UKNEQAS United Kingdom National External Quality Assessment Service
UKWEQAS United Kingdom Wales External Quality Assessment Scheme
WHO World Health Organisation

Last Modified Date :18 Mar 2019