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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


Programme Title

Frequency

BIO-RAD EQA Services – Serum Protein Survey

Monthly

BIO-RAD EQA Services – Therapeutic Drug Monitoring

Monthly

BIO-RAD EQA Services – Tumour Marker Survey 

Monthly 

CAP Accuracy Based Lipids

2/year 

CAP Accuracy Based Urine 

2/year 

CAP Aldolase

2/year

CAP Biochemical Genetics

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 Creatinine Accuracy

2/year

CAP Critical Care Aqueous Blood Gas with Chemistry

3/year

CAP Diagnostic Immunology

3/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 HbA1C Accuracy Calibration verification/linearity 

2/year  

CAP Hemoglobin A1c,5 Challenges

3/year

CAP Hemocytometer Fluid Count (WBC and RBC cell count) 

2/year 

CAP Immunosuppressive Drugs

2/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 Myoglobin, Urine

2/year

CAP Neonatal Bilirubin, 5 Challenges

3/year

CAP Quality Cross Check, Blood Gas 

2/year 

CAP Quality Cross Check, Blood Oximetry  

2/year 

CAP Porphobilinogen, urine 

2/year  

CAP Procalcitonin

2/year

CAP Pseudocholinesterase

3/year

CAP Rheumatic Disease Special Serology 

2/year

CAP Serum Free Light Chains

2/year

CAP Special Immunology

3/year

CAP Testosterone & Estradiol Accuracy 

1/year 

CAP Trace Metals

2/year

CAP Trace Metals, Urine 

2/year 

CAP Tumour Markers

2/year

CAP Urine Chemistry (General)

2/year

CAP Urine Chemistry (Special)

2/year

HSA Chemistry & HbA1C survey

2/year

RCPA Condensed General Serum Chemistry and Therapeutic Drug

Monthly

RCPA Endocrine and PSA 

Monthly 

RCPA Trace Elements

Monthly

RCPA Vitamins

Monthly

UKNEQAS Maternal Serum Screening

Monthly


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 Title

Frequency

Histopathology

CAP CD20 – PM3

1/year

CAP CD117 – PM1

1/year

CAP DNA Mismatch Repair by Immunohistochemistry – MMR

2/year

CAP ER and PR – PM2

2/year

CAP HER-2 Immunohistochemistry, Tissue Microarray

2/year

CAP Immunohistochemistry – MK

2/year

CAP In Situ Hybridization – ISH

2/year

CAP Performance Improvement Program in Surgical Pathology (PIP)

4/year

NSH/CAP Histo-QIP Programme

2/year

CAP PDL1

1/year 

CAP Anaplastic Lymphoma Kinase IHC - PM6  

1/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 Microalbumin/Creatinine 

3/year 

MLE Urine Sediment Identification

3/year 

National Proficiency Testing Scheme for Malaria Parasite

2/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

WHO

World Health Organisation