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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
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


DisciplinesProgramme TitleFrequency
Clinical Biochemistry ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​   ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​CAP Accuracy Based Lipids2/year
CAP Accuracy Based Urine 2/year
CAP Accuracy-Based Testosterone, Estradiol2/year
CAP Aldolase2/year
CAP Blood Gas CVL2/year
CAP Blood Lead3/year
CAP Blood Oximetry3/year
CAP Body Fluid Chemistry2/year
CAP Body Fluid Chemistry 22/year
CAP Bone Markers and Vitamin survey2/year
CAP B-Type Natriuretic Peptide,5 Challenges3/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 Bands2/year
CAP Chemistry/Therapeutic Drugs Monitoring3/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 CVL2/year
CAP Electrophoresis2/year
CAP Everolimus2/year
CAP Fructosamine2/year
CAP Glucose-6-phospate Dehydrogenase2/year
CAP Harmonized thyroid2/year
CAP Hemocytometer Fluid Count (WBC and RBC cell count)2/year
CAP Hemoglobin A1c,5 Challenges3/year
CAP Immunology3/year
CAP Immunology Special3/year
CAP Immunosuppressive Drugs2/year
CAP Instrumentation3/year
CAP Ketones2/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, Urine2/year
CAP Neonatal Bilirubin, 5 Challenges3/year
CAP Porphobilinogen, urine2/year
CAP Procalcitonin2/year
CAP Reproductive Endocrinology CVL2/year
CAP Rheumatic Disease Special Serology  2/year
CAP Serum Free Light Chains2/year
CAP Trace Metals2/year
CAP Trace Metals, Urine 2/year
CAP Trace Metals, whole blood2/year
CAP Tumor Markers2/year
CAP Urine Chemistry (General)2/year
CAP Urine Chemistry (Special)2/year
CAP Antifungals drug monitoring2/year
CAP 25-OH Vitamin D2/year
HSA Chemistry 2/year
HSA HbA1C 2/year
RCPA BNP12/year
RCPA Condensed General Serum Chemistry and Therapeutic Drug12/year
RCPA C-Reactive Protein12/year
RCPA CSF chemistry12/year
RCPA Cyclic Citrullinated Peptide8/year
RCPA Endocrine 12/year
RCPA PSA12/year
RCPA RBC Folate12/year
RCPA IgE8/year
RCPA IGF-1 / C-Peptide12/year
RCPA IgG Subclasses8/year
RCPA Neonatal Bilirubin12/year
RCPA Paraproteins8/year
RCPA Rheumatoid factor8/year
RCPA Special Lipids12/year
RCPA Special Drugs 12/year
RCPA Immunosuppressants12/year
RCPA Specific Proteins12/year
RCPA Trace Elements (Serum, Urine, Whole blood)12/year
RCPA Urine Chemistry 12/year
RCPA Thyroid antibodies8/year
RCPA Urine Amylase12/year
RCPA Biogenic Amines12/year
RCPA Vitamins12/year
RCPA Whole Blood Glycohaemoglobin3/year
RCPA Plasma Metanephrines12/year
UKNEQAS Maternal Serum Screening 12/year
UKNEQAS Antifungal6/year
UKWEQAS Calculi6/year


Cytogenetics Laboratory


Disciplines

Programme Title

Frequency

Cytogenetics,
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


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 TitleFrequency
Histopathology ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​College of American Pathologists Performance Improvement Program in Surgical Pathology (PIP)4/year
College of American Pathologists Immunohistochemistry Survey2/year
NSH/CAP Histo QIP2/year
CAP Her-2 immunohistochemistry, tissue microarray2/year
CAP In Situ Hybridisation Survey2/year
CAP DNA mismatch repair by immunohistochemistry2/year
CAP CD1171/year
CAP ER and PR2/year
CAP CD201/year
CAP PDL11/year
CAP Anaplastic Lymphoma Kinase IHC1/year
CAP/NSH Gynecologic Biopsy2/year
CAP/NSH HistoQIP Mismatch Repair IHC2/year
HQIP Non-small Cell Lung Carcinoma IHC2/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 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,
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

​UKWEQASUnited Kingdom Wales External Quality Assessment Scheme

WHO

World Health Organisation