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 Division of Pathology
BSL-3 Laboratory Certification	Dec 2003	SGH BSL-3 Facility, Academia, Level 13
Business Continuity Management (BCM)	Sep 2005	Hospital-wide, all laboratories in Division of Pathology
Business Continuity Management (BCM-TR19:2005)	Aug 2007	Hospital-wide, all laboratories in Division of Pathology
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 Medicine)	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)	3/year
	National Proficiency Testing Scheme for ABO Group/Rhesus (D) Type Testing (Blood Services Group, Health Sciences Authority)	3/year

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)	2/year
	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
Cytogenetics, Molecular Cytogenetics	CAP Cytogenetics Survey for Chromosome Abnormalities, Online Images	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 Fluorescence in Situ Hybridization Survey for Paraffin-Embedded Tissue – Lung Cancer	2/year
	CAP Cytogenomic Microarray Analysis for Oncologic Abnormalities	2/year

Cytology

Disciplines	Programme Title	Frequency
Cytology	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
Haematology	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

Histopathology

Disciplines	Programme Title	Frequency
Histopathology	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

Bacteriology

Disciplines	Programme Title	Frequency
Bacteriology, 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

Mycobacteriology

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 KIT/PDGFRA	2/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

Virology

Disciplines	Programme Title	Frequency
Virology	CAP Virology Antigen Detection (DFA) Survey	3 / year
	CAP Virology Antigen Detection (non-DFA) Survey	3 / year
	CAP Virology Infectious Disease Serology Survey	2 / year
	CAP Virology Culture Survey	3 / year
	CAP Diagnostic Immunology Survey for Rubella Antibody	3 / year
	CAP Viral Markers Series 1,2,3,5 & 6 Survey	3 / year
	CAP Anti-HIV 1/2	3 / year
	CAP Herpes Simplex Virus Culture Survey	3 / year
	CAP SARS-CoV-2 Serology	2 / year
	RCPA QAP Alphavirus Serology	2 / year
	RCPA QAP Chlamydia genus Serology	2 / year
	RCPA QAP Cytomegalovirus Serology	4 / year
	RCPA QAP Dengue virus Serology	2 / year
	RCPA QAP Epstein Barr virus Serology	4 / year
	RCPA QAP Hepatitis D Serology	1 / year
	RCPA QAP Hepatitis E Serology	1 / year
	RCPA QAP Herpes simplex Serology	2 / year
	RCPA QAP Human Immunodeficiency Virus Serology	6 / year
	RCPA QAP Measles Serology	2 / year
	RCPA QAP Mumps Serology	2 / year
	RCPA QAP Parvovirus Serology	2 / year
	RCPA QAP Q Fever Serology	2 / year
	RCPA QAP Rubella Serology	2 / year
	RCPA QAP Varicella zoster Serology	2 / year
	WHO Poliovirus & Non-polio Enterovirus Culture PT	1 / year
	WHO Poliovirus Intra-typic Differentiation PCR PT	1 / year
	WHO Polio Sequencing PT	1 / year
	NHRL National HIV Screening Proficiency Program	3 / year

Satellite Laboratories

Disciplines	Programme Title	Frequency
Clinical Biochemistry, Haematology	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

Abbreviations

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