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




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





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)





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)





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





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





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





52. Pleural fluid FEME

Appearance Visual


RBC Count )

pH Roche Combur 10 Urine

Protein, total ) Abbott ArchitectPlus c8000

Glucose ) Analyser

53. Peritoneal fluid FEME

Appearance Visual


RBC Count )


Glucose ) Analyser

54. Pericardial fluid FEME

Appearance Visual


RBC Count )


Glucose ) Analyser

55. Synovial fluid FEME

Appearance ) Visual


RBC Count )


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





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





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


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





9. FISH for Tumour Fluorescence in-situ


(commercial) for tumours

10. FISH for Tumour on paraffin sections Fluorescence in-situ


(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





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.

certificate no. : la-2003-0291-h kkh laboratory ... · wbc count ) kova glasstic slide rbc count )...

Documents