Certificate No. : LA-2003-0291-H KKH Laboratory ... · WBC Count ) KOVA glasstic slide RBC Count )...
Transcript of Certificate No. : LA-2003-0291-H KKH Laboratory ... · WBC Count ) KOVA glasstic slide RBC Count )...
KK Women’s and Children’s Hospital Certificate No. : LA-2003-0291-H KKH Laboratory 100 Bukit Timah Road Issue No. : 14 Singapore 229899
Date : 10 January 2018 Page : 1 of 12
FIELD OF TESTING : Medical Testing
DISCIPLINES / SUBSECTIONS
TESTS / PROPERTIES STANDARD METHODS /
TECHNIQUES / EQUIPMENT
1. CYTOLOGY 1. Screening of Liquid-Based Prepared Pap SurePath Processor
Smears Microscopy
2. Screening of Non-Gynaecological
Specimens
Peritoneal fluid
Pleural fluid
Ascitic fluid
Sputum Microscopy
Urine
Cyst fluid
Bronchial washing
Cerebro-spinal fluid (CSF)
Fine Needle Aspiration (FNA) specimen
2. HISTOPATHOLOGY 1. Gross evaluation
2. Microscopic evaluation and report
3. Routine processing
4. Gross evaluation by non-pathologist Microscopy
5. Intraoperative consult (frozen section) Microtomy
6. Special Stains (histochemistry)
7. Post- mortem
8. Immunohistochemistry
3. HISTOPATHOLOGY 1. Molecular Genotyping of Hydatidiform Mole PCR-Fragment Analysis
(MOLECULAR
HISTOPATHOLOGY) 2. ALK Mutation Analysis for Neuroblastoma PCR-Sequencing
3. MLH1 Methylation Analysis Real-time PCR
Certificate No. : LA-2003-0291-H Issue No. : 14 Date : 10 January 2018 Page : 2 of 12
DISCIPLINES / SUBSECTIONS
TESTS / PROPERTIES STANDARD METHODS /
TECHNIQUES / EQUIPMENT
4. PAX3-FKHR / PAX7-FKHR gene Fusion
transcripts
5. EWS-FLI1 gene fusion Real Time RT-PCR
6. ETV6-NTRK3 gene fusion transcripts
7. KIAA1549-BRAF fusion variant 16-9, 15-9
and 16-11
8. Microsatellite Instability (MSI) PCR PCR Fragment Analysis
Testing
9. MyoD1 L122R Mutational Analysis PCR-Sequencing
4. MICROBIOLOGY 1. Aerobic / Anaerobic Bacteria Culture of
(BACTERIOLOGY) Clinical Specimens
CSF
Eye
Ear
Body fluids
Genital
Tissue Culture
Wound Antibiotic Susceptibility Tests
Miscellaneous Vitek
2. Aerobic Bacterial Culture of Clinical
Specimens
Stool
Respiratory (Upper and Lower)
Urine
Bactec Blood Aerobic Culture
Bactec Blood Paeds Aerobic Culture Bactec 9240 Blood Culture
Equipment
3. Bactec Blood Anaerobic Culture
4. CSF Latex Agglutination
5. Respiratory Latex Agglutination for Antigen detection test by
Streptococcus pneumococcus and Latex Agglutination
Haemophilus influenzae
6. Rotavirus Antigen Detection Rida Quick Rotavirus
Certificate No. : LA-2003-0291-H Issue No. : 14 Date : 10 January 2018 Page : 3 of 12
DISCIPLINES / SUBSECTIONS
TESTS / PROPERTIES STANDARD METHODS /
TECHNIQUES / EQUIPMENT
7. Acid Fast Bacilli (AFB Smear)
8. Gram Stain Smear Microscopy
9. Scabies Microscopy
10. Fungal smear Microscopic examination
11. MRSA Screening (Environment Specimens)
12. Neisseria gonorrhea Culture
13. Screening for Vancomycin Resistant
Enterococcus (VRE) & Extended
Spectrum Beta-Lactamase (ESBL) Culture
14. Sterility testing (Biological)
15. Sterility testing (Non-Biological)
16. Environment Culture
17. Carbapenem-resistent
Enterobacteriaceae (CRE) Screening
18. VP3 DNA Probe Test Rapid kit using nucleic acid
hybridization principle
5. MICROBIOLOGY 1. Respiratory Virus Antigen Detection by Direct immunofluorescence
(MOLECULAR by Immunofluorescence microscopy
PATHOLOGY-
INFECTIOUS 2. Bartonella Serology (Cat Scratch Immunofluorescence
DISEASES) Serology) microscopy
3. Dengue Virus RNA Amplification
4. Enterovirus and Parechovirus RNA
Amplification
5. Avian influenza RNA amplification Real-time RT PCR
6. Measles RNA Amplification
7. Influenza A and B virus RNA Amplification
8. MERS-Coronavirus RNA Amplification
9. Zika Virus RNA Amplification
10. Respiratory Virus Multiplex Amplification RT-PCR
11. High risk human papillomavirus (HPV) hc2 High Risk HPV DNA
Screening and Genotyping Test Screening and Genotyping Test
by Digene (QIAGEN)
Certificate No. : LA-2003-0291-H Issue No. : 14 Date : 10 January 2018 Page : 4 of 12
DISCIPLINES / SUBSECTIONS
TESTS / PROPERTIES STANDARD METHODS /
TECHNIQUES / EQUIPMENT
12. Adenovirus DNA Amplification
13. Bordetella pertussis DNA Amplification
14. Chlamydophila pneumoniae DNA
Amplification
15. Cytomegalovirus DNA amplification
16. Herpes Simplex Virus DNA Amplification Real Time PCR
17. Chlamydia trachomatis / Nesseria
gonorrhoeae DNA Amplification
18. Mycoplasma pneumoniae DNA
Amplification
19. Neisseria meningitidis DNA Amplification
20. Varicella-Zoster Virus DNA Amplification Real Time PCR
6. BLOOD BANK 1. ABO grouping ) Tube technique or
2. Rh grouping ) Autovue Innova Analyser
3. Weak D testing
4. Transfusion reaction investigation Tube technique
(blood & plasma reactions)
5. Direct Coomb’s Test Tube & gel technique
6. Antibody screening (Ortho BioVue System) or
7. NNJ Profile (neonatal jaundice Autovue Innova Analyser
investigations
8. Compatibility testing Tube & gel technique
9. Antibody titration (for ABO incompatibility) (Ortho BioVue System)
10. Rh phenotyping
11. Checks for autologous collection Tube technique or
ABO Grouping Autovue Innova Analyser
Rh Grouping Tube & gel technique or
Antibody Screening (Ortho BioVue System)
Autovue Innova Analyser
7. HAEMATOLOGY 1. Full Blood Count ) Sysmex XE-5000 Haematology
2. Reticulocytes ) analysers
3. Peripheral Blood Film Microscopy, Haematek Stainer,
Sysmex SP 1000 (Wright Stain)
Certificate No. : LA-2003-0291-H Issue No. : 14 Date : 10 January 2018 Page : 5 of 12
DISCIPLINES / SUBSECTIONS
TESTS / PROPERTIES STANDARD METHODS /
TECHNIQUES / EQUIPMENT
4. Hb-H inclusion bodies Microscopy, Manual method –
brilliant cresyl blue
5. Buffy coat smear Microscopy, Centrifugation,
Manual method – Wright /
Leishman Stain
6. Modified Kleihauer Betke Test Microscopy, Manual method -
Kleihauer Betke acid elution
Method
7. Malarial Parasite Microscopy, Manual method -
Giemsa Stain and Wright stain
8. Microfilariae Microscopy, Manual method -
Centrifugation, Giemsa Stain
9. CSF cytospin for blast cells Microscopy, Centrifugation,
using Wescor Cyto-centrifuge
Wright / Leishman Stain
10. Dengue Rapid Test SD Bioline Dengue NS1 Ag &
Ab Combo
11. Erythrocyte Sedimentation Rate ESR Stat Plus
12. Prothrombin Time (PT)
13. Activated Partial Thromboplastin Time
(APTT) Stago Compact Max
14. Thrombin Time (TT) Coagulation Analyser
15. Anti Factor-Xa
16. Fibrinogen
17. Hb Electrophoresis Sebia Capillarys
Sebia Hydrasys
8. CLINICAL 1. Acetaminophen
CHEMISTRY 2. Alanine aminotransferase
(GENERAL 3. Albumin Abbott Architect Plus c8000
CHEMISTRY) 4. Alkaline phosphatase Analyser
5. Amikacin
6. Ammonia
Certificate No. : LA-2003-0291-H Issue No. : 14 Date : 10 January 2018 Page : 6 of 12
DISCIPLINES / SUBSECTIONS
TESTS / PROPERTIES STANDARD METHODS /
TECHNIQUES / EQUIPMENT
7. Amylase
8. Aspartate aminotransferase
9. Bicarbonate
10. Bilirubin, direct
11. Bilirubin, total
12. C-reactive protein
13. Calcium
14. Chloride
15. Cholesterol, HDL
16. Cholesterol, total
17. Creatinine
18. Creatine Kinase
19. Creatinine Clearance Test
20. C3
21. C4
22. Gamma glutamyl transpeptidase
23. Gentamicin
24. Glucose
25. HbA1c Abbott Architect Plus c8000
26. Iron Analyser
27. IgA
28. IgG
29. IgM
30. Lactate
31. Lactate Dehydrogenase
32. Magnesium
33. Phosphate
34. Potassium
35. Protein, total
36. Salicylate
37. Sodium
38. Transferrin
39. Triglycerides
40. Urea
41. Uric Acid
42. Valproic Acid
43. Vancomycin
44. Free Fatty Acids
45. Bilirubin, total Radiometer ABL 90 Flex
Certificate No. : LA-2003-0291-H Issue No. : 14 Date : 10 January 2018 Page : 7 of 12
DISCIPLINES / SUBSECTIONS
TESTS / PROPERTIES STANDARD METHODS /
TECHNIQUES / EQUIPMENT
46. Blood Gas Osmetech OPTI CCA Blood
Gas Analyser
47. Osmolality Advanced Instrument Micro-
Osmometer
48. Glucose-6-Phosphate-Dehydrogenase R&D Diagnostics G6PD
screen Screening Kit
49. Blood Beta-hydroxybutyrate Abbott Optium Neo H Meter
50. Urine FEME
(a) Reagent Dipstick Roche Combur 10 Urine
SG Dipstick
pH
Leucocyte
Nitrite
Protein
Glucose
Ketone
Urobilinogen
Bilirubin
Erythrocyte
(b) Microscopic Examination KOVA glasstic slide
WBC Count
RBC Count
EC Count
Crystal
Cast
Others
51. CSF Feme
Appearance Visual
WBC Count ) KOVA glasstic slide
RBC Count )
Protein, Total ) Abbott ArchitectPlus C8000
Glucose ) Analyser
Gram's stain if ≥10 WBCs/uL
Certificate No. : LA-2003-0291-H Issue No. : 14 Date : 10 January 2018 Page : 8 of 12
DISCIPLINES / SUBSECTIONS
TESTS / PROPERTIES STANDARD METHODS /
TECHNIQUES / EQUIPMENT
52. Pleural fluid FEME
Appearance Visual
WBC Count ) KOVA glasstic slide
RBC Count )
pH Roche Combur 10 Urine
Protein, total ) Abbott ArchitectPlus c8000
Glucose ) Analyser
53. Peritoneal fluid FEME
Appearance Visual
WBC Count ) KOVA glasstic slide
RBC Count )
Protein, total ) Abbott ArchitectPlus c8000
Glucose ) Analyser
54. Pericardial fluid FEME
Appearance Visual
WBC Count ) KOVA glasstic slide
RBC Count )
Protein, total ) Abbott ArchitectPlus c8000
Glucose ) Analyser
55. Synovial fluid FEME
Appearance ) Visual
WBC Count ) KOVA glasstic slide
RBC Count )
Protein, total ) Abbott ArchitectPlus c8000
Glucose ) Analyser
56. Gram’s Stain smear Gram’s Stain
57. Stool Occult Blood Hemosure iFOBT
58. Urine-HCG Alere hCG Test Kit
59. Apt’s Test Manual method - alkaline
Denaturation
60. Urine RBCs Phase Contrast Examination Visual
Certificate No. : LA-2003-0291-H Issue No. : 14 Date : 10 January 2018 Page : 9 of 12
DISCIPLINES / SUBSECTIONS
TESTS / PROPERTIES STANDARD METHODS /
TECHNIQUES / EQUIPMENT
61. G6PD Quantitative R&D Diagnostics G6PD
Quantitative kit / StatFax 2100
9. CLINICAL 1. Alpha-fetoprotein
LABORATORY 2. Anti-HBc
(SPECIAL 3. Anti-HBe
CHEMISTRY) 4. Anti-HBs
5. Anti-HCV
6. B-HCG
7. CA-125
8. Carcinogenic embryonic antigen
9. CK-MB
10. Estradiol
11. Ferritin
12. Follicle stimulating homone
13. HBeAg
14. HBsAg Abbott Architect i2000SR
15. HIV Ag/Ab test Analyser
16. HS Troponin I
17. Insulin
18. Luteinizing hormone
19. Progesterone
20. Prolactin
21. Rubella IgG
22. Testosterone
23. Thyroid stimulating hormone
24. Thyroxine, free
25. Treponema palidum Total Antibody (CMIA)
26. Vitamin B12, Total
27. Folate
28. Cortisol
29. Anti-Mullerian Hormone ) Beckman Access II Analyser
30. 25 Hydroxy Vitamin D )
31. Free Beta- HCG
32. Alpha Fetoprotein DELFIA Xpress Analyser
33. PAPP-A
34. Unconjugated Estriol (uE3)
35. Procalcitonin Mini Vidas Analyser
Certificate No. : LA-2003-0291-H Issue No. : 14 Date : 10 January 2018 Page : 10 of 12
DISCIPLINES / SUBSECTIONS
TESTS / PROPERTIES STANDARD METHODS /
TECHNIQUES / EQUIPMENT
11. CYTOGENETICS 1. Karyotyping
Peripheral blood
Amniotic fluid
Chorionic villi
Fetal blood (cordocentesis) Preparation of Specimens
Product of conception / Skin Biopsy to obtain metaphases,
Bone marrow followed by chromosomal
Leukemic blood analysis
Tumour / Lymph Node
Stem cells
2. Tissue culture Maintenance of fibroblast
cultures
3. Direct FISH without karyotyping Fluorescence in-situ
hybridisation using DNA probes
(commercial)
4. FISH with karyotyping (blood) See Test no.1 for blood.
karyotyping. Fluorescence
in-situ hybridisation using DNA
probes (commercial /
customised)
5. Microdeletion FISH Add on An additional FISH requested
using DNA probes (commercial
/ customised) to a karyotyping
performed
6. Add on FISH An additional FISH requested
using DNA probes (commercial)
to a FISH performed
7. FISH test for Neuroblastoma (paeds) Fluorescence in-situ
hybridisation using DNA probes
for neuroblastoma (commercial).
8. FISH test for Neuroblastoma (paeds) Fluorescence in-situ
(on paraffin sections) hybridisation using DNA probes
for neuroblastoma (commercial)
on paraffin sections
Certificate No. : LA-2003-0291-H Issue No. : 14 Date : 10 January 2018 Page : 11 of 12
DISCIPLINES / SUBSECTIONS
TESTS / PROPERTIES STANDARD METHODS /
TECHNIQUES / EQUIPMENT
9. FISH for Tumour Fluorescence in-situ
hybridisation using DNA probes
(commercial) for tumours
10. FISH for Tumour on paraffin sections Fluorescence in-situ
hybridisation using DNA probes
(commercial) for tumours on
paraffin sections
11. FISH – aneuploidy panel Fluorescence in-situ
(Trisomy 13, 18, 21, X and Y) hybridisation using DNA probes
(commercial)
12. FISH – aneuploidy panel Fluorescence in-situ
(Trisomy 13, 18, 21, X and Y) hybridisation using DNA probes
on paraffin sections (commercial) for tumours on
paraffin sections
12. BIOCHEMICAL 1. Urine organic acid profile GC-MS (gas chromatography
GENETICS (qualitative) mass spectrometry)
2. Amino acids (plasma, urine, CSF) Ion exchange chromatography
With ninhydrin derivatisation
3. Galactosaemia enzyme screen (qualitative) Beutler method
4. Quantitative methylmalonic acid
5. Quantitative orotic acid GC-MS Stable Isotope
6. VLCFA (very long chain fatty acids) inc Dilution Method
phytanate and pristinate
7. Sterols (7-dehydrocholestrol, cholestanol) GC-MS analogue internal
standard method
8. GAG electrophoresis (for diagnosis of 2D electrophoresis (cellulose
mucopolysaccharide disorders) acetate plates)
13. NATIONAL 1. Primary Expanded Newborn Screen Derivatised Blood Spot Analysis
EXPANDED of Amino Acid And
NEWBORN Acylcarnitines by LC-MSMS
SCREENING
Certificate No. : LA-2003-0291-H Issue No. : 14 Date : 10 January 2018 Page : 12 of 12
DISCIPLINES / SUBSECTIONS
TESTS / PROPERTIES STANDARD METHODS /
TECHNIQUES / EQUIPMENT
2. Galactosaemia Screen Victor 2D fluorimeter
3. 2nd Tier Testing for MMA
4. Plasma Acylcarnitines LC-MSMS
5. 2nd Tier Testing for Succinylacetone
Note : A medical laboratory's fulfilment of the requirements of ISO 15189: 2012 means the laboratory meets both the technical competence requirements and the management system requirements that are necessary for it to consistently deliver technically valid test results. The management system requirements in ISO 15189 (Section 4) are written in a language relevant to a medical laboratories operations and meet the principles of ISO 9001:2008 Quality management systems - Requirements and are aligned with it pertinent requirements.