514 Jad

Issue date: 10 May 2011 Valid until: 10 May 2014
NO: SAMM 514

LABORATORY LOCATION:
(PERMANENT LABORATORY)
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JABATAN PATOLOGI HOSPITAL RAJA PEREMPUAN ZAINAB II 15586 KOTA BAHRU KELANTAN
The standard used for assessment of this laboratory is MS ISO 15189:2007 FIELD OF MEDICAL TESTING: CYTOPATHOLOGY SCOPE OF ACCREDITATION:
Specimen tested 1.Gynae (Cervical Scraping) Type of tests/ Properties measured Pap Smear Screening with Papanicolaou Stain a. Conventional b. Fluid Based 2.Non-Gynae Specimen Cytological Examination with Papanicolaou and May Grunwalds Giemsa (MGG) Stain Test method, specification/ Equipment/Techniques used THIN PREP 2000 (SEM/CY/002), LEICA AUTO STAINER XL (SEM/CY/005) as Documented in STM/CY/001, STM/CY/005A, STM/CY/005B, STM/CY/006, STM/CY/009, STM/CY/012. Papanicolaou and MGG Stains / LEICA AUTOSTAINER XL (SEM/CY/005) / as Documented in STM/CY/001, STM/CY/002, STM/CY/003, STM/CY/004, STM/CY/006, STM/CY/007, STM/CY/009, STM/CY/011, STM/CY/012, STM/CY/013. Papanicolaou and MGG Stains / LEICA AUTOSTAINER XL (SEM/CY/005) / as Documented in STM/CY/001, STM/CY/006, STM/CY/007, STM/CY/008, STM/CY/009, STM/CY/010, STM/CY/011, STM/CY/012.
3.Fine Needle Aspiration Specimen
Cytological Examination with Papanicolaou and May Grunwalds Giemsa (MGG) Stain
NO: SAMM 514

FIELD OF MEDICAL TESTING: HISTOPATHOLOGY SCOPE OF ACCREDITATION:
Specimen tested 1.Formalin-Fixed Tissue Type of tests/ Properties measured Histopathological Examination with a. H&E Stain
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Test method, specification/ Equipment/Techniques used Tissue Processor SHANDON EXCELSIOR (SEM/HO/013), LEICA Histoembedder (SEM/HO/012), LEICA Microtome (SEM/HO/014), Automatic Stainer Sakura Tissue Tek DRS (SEM/HO/002) / as Documented in STM/HO/001, STM/HO/002, STM/HO/003, STM/HO/004, STM/HO/005, STM/HO/006, STM/HO/007, STM/HO/011, STM/HO/012, STM/HO/017. Manual Staining / as Documented in STM/HO/004, STM/HO/006, STM/HO/008 A-O, STM/HO/017. Manual Staining / as Documented in STM/HO/004, STM/HO/006, STM/HO/009, STM/HO/017. Microtome (Cryostat) LEICA CM 1800 (SEM/HO/015) Manual Rapid H&E Staining and Diff Quik Staining / as Documented in STM/HO/005, STM/HO/006, STM/HO/010, STM/CY/008.
b. Histochemical Stain
c.
Immunohistochemical Stain
2.Fresh Tissue
Frozen Section
NO: SAMM 514

FIELD OF MEDICAL TESTING: CHEMICAL PATHOLOGY SCOPE OF ACCREDITATION:
Specimen tested General Chemistry Serum, Plasma Alanine Transaminase Type of tests/ Properties measured
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Test method, specification/ Equipment/Techniques used
L-Alanine, IFCC 37C / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/001, STM/CP/061, STM/CP/062 and STM/CP/063. Modified without Pyridoxal-5-Phosphate (P5P) / Olympus AU2700 (SEM/CP/030, SEM/CP/031) as Documented in STM/CP/064.
Albumin
Bromocresol Purple (BCP) / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/002, STM/CP/061, STM/CP/062 and STM/CP/063. Bromocresol Green (BCG) / Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/065.
Alkaline Phosphatase
P-nitrophenylphosphate / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/003, STM/CP/061, STM/CP/062 and STM/CP/063. Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/066.
Serum, Plasma, Urine
Amylase
2 chloro-4-nitrophenyl Linked Substrates (Non Blocked Maltotrioside-CNP-G3) / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/004, STM/CP/061, STM/CP/062, STM/CP/063. Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/067.
Plasma
Ammonia
Glutamate Dehydrogenase / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/005, STM/CP/061, STM/CP/062 and STM/CP/063.
NO: SAMM 514

Specimen tested Serum, Plasma Type of tests/ Properties measured Aspartate Transaminase
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Test method, specification/ Equipment/Techniques used L-Aspartate, IFCC with P5P / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/006, STM/CP/061, STM/CP/062 and STM/CP/063. L-Aspartate, IFCC without Pyridoxal-5Phosphate (P5P / Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/068.
Serum, Plasma
Bilirubin Direct
Diazotised Sulfanilic Acid / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/012, STM/CP/061, STM/CP/062 and STM/CP/063. 3,5 Dichlorophenyl Diazonium Tetrafluoroborate (DPD) Method / Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/074.
Bilirubin Total
Diazotised Sulfanilic Acid / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/024, STM/CP/061, STM/CP/062 and STM/CP/063. 3,5 Dichlorophenyl Diazonium Tetrafluoroborate (DPD) Method / Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/084.
Calcium, Total
Cresolpthalein Complexone / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/008, STM/CP/061, STM/CP/062 and STM/CP/063. Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/070.
NO: SAMM 514

Specimen tested Serum, Plasma Type of tests/ Properties measured Cholesterol, Total
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Test method, specification/ Equipment/Techniques used Cholesterol Esterase / Dimension RxL (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/025, STM/CP/061, STM/CP/062 and STM/CP/063. Cholesterol Peroxidase / Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/085.
Serum, Heparinised Plasma
Creatine Kinase
Creatine Phosphate, IFCC 37C / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/009, STM/CP/061, STM/CP/062, STM/CP/063. Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/071.
Serum, Heparinised Plasma
Creatine Kinase-MB
Enzyme Immunoinhibition, 37C / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/010, STM/CP/061, STM/CP/062, STM/CP/063. Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/072.
Creatinine
Jaffe / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/011, STM/CP/061, STM/CP/062, STM/CP/063. Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/073.
Electrolytes (Sodium, Potassium, Chloride)
Indirect Ion Selective Electrode / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/023, STM/CP/061, STM/CP/062, STM/CP/063. Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/083.
NO: SAMM 514

Specimen tested Serum, Plasma Type of tests/ Properties measured Gamma Glutamyl Transferase
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Test method, specification/ Equipment/Techniques used Gamma-glutamyl-3-Carboxy-4-nitroanilide Substrate (GCNA, IFCC) Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/014, STM/CP/061, STM/CP/062, STM/CP/063. Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/076.
Serum, Plasma, Cerebrospinal Fluid, Body Fluid
Glucose
Hexokinase / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/016, STM/CP/061, STM/CP/062, STM/CP/063. Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/077.
Serum, Plasma
HDL-Cholesterol
Homogenous Selective Detergent / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/017, STM/CP/061, STM/CP/062, STM/CP/063. Immunological Inhibition / Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/078.
Serum
Iron
Ferene / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/013, STM/CP/061, STM/CP/062, STM/CP/063. TPTZ [2,4,6-Tri-(2-pyridyl)-5-triazine] as the Chromogen / Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/075.
Plasma, Cerebrospinal Fluid, Body Fluid
Lactate
Lactate Dehydrogenase / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/019, STM/CP/061, STM/CP/062, STM/CP/063. IFCC, Lactate Oxidase / Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/090.
NO: SAMM 514

Specimen tested Serum, Plasma, Body Fluid Type of tests/ Properties measured Lactate Dehydrogenase
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Test method, specification/ Equipment/Techniques used Lactate, IFCC 37C / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/020, STM/CP/061, STM/CP/062, STM/CP/063. IFCC, Pyruvate-Lactate / Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/080.
Magnesium
Methylthymol Blue / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/021, STM/CP/061, STM/CP/062, STM/CP/063. Xylidyl Blue / Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/081.
Phosphate Inorganic
Phosphomolybdate / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/018, STM/CP/061, STM/CP/062, STM/CP/063. Molybdate, UV / Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/079.
Serum, Plasma
Protein, Total
Modified Biuret / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/026, STM/CP/061, STM/CP/062, STM/CP/063. Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/086.
Urine, Cerebrospinal Fluid, Body Fluid
Protein
Pyrogallol Red Molybdate / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/022, STM/CP/061, STM/CP/062, STM/CP/063. Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/082.
NO: SAMM 514

Specimen tested Serum, Plasma Type of tests/ Properties measured Triglycerides
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Test method, specification/ Equipment/Techniques used Lipoprotein Lipase / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/027, STM/CP/061, STM/CP/062, STM/CP/063. Glycerol Phosphate Oxidase-Peroxidase (GPO-POD) / Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/087.
Urea
Urease / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/007, STM/CP/061, STM/CP/062, STM/CP/063. Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/069.
Serum, Plasma
Uric Acid
Uricase / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/028, STM/CP/061, STM/CP/062, STM/CP/063. Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/088.
Serum, Plasma
Total Iron Binding Capacity (TIBC)
Ferene, Direct / Dimension RxL Max (SEM/CP/002 to SEM/CP/004) as Documented in STM/CP/029, STM/CP/061, STM/CP/062, STM/CP/063. Olympus AU2700 (SEM/CP/030 and SEM/CP/031) as Documented in STM/CP/089.
Osmolality
Freezing Point Osmometry / The Advanced Micro Osmometer Model 3300 (SEM/CP/012) as Documented in STM/CP/052, STM/CP/061, STM/CP/062 and STM/CP/063. Reagent Strips BAYER CLINITEX Microalbumin / Bayer Clinitex 50 (SEM/CP/022) as Documented in STM/CP/054, STM/CP/061, STM/CP/062 and STM/CP/063.
Urine
Microalbumin and Creatinine
NO: SAMM 514

Specimen tested Type of tests/ Properties measured
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General Chemistry : Blood Gases and Co-oximetry Whole Blood Arterial Blood Gases (ABG) and pH Direct Ion Selective Electrode / Rapid Lab 1265 Blood Gas Analyzer (SEM/CP/013) as Documented in STM/CP/048, STM/CP/061, STM/CP/062 and STM/CP/063. Ion Selective Electrode / Rapid Lab 1265 Blood Gas Analyzer (SEM/CP/013) as Documented in STM/CP/049, STM/CP/061, STM/CP/062 and STM/CP/063.
Serum, Plasma, Whole, Blood
Calcium, Ionised
Special Chemistry Serum, Amniotic Fluid Alpha-Fetoprotein (AFP) Chemiluminescene / ADVIA Centaur and ADVIA Centaur XP Immunoassay System (SEM/CP/006 and SEM/CP/007) as Documented in STM/CP/030, STM/CP/061, STM/CP/062 062 and STM/CP/063. Chemiluminescene / ADVIA Centaur and ADVIA Centaur XP Immunoassay System (SEM/CP/006 and SEM/CP/007) as Documented in STM/CP/031, STM/CP/061, STM/CP/062 and STM/CP/063. Chemiluminescene / ADVIA Centaur and ADVIA Centaur XP Immunoassay System (SEM/CP/006 and SEM/CP/007) as Documented in STM/CP/032, STM/CP/061, STM/CP/062 and STM/CP/063. Chemiluminescene / ADVIA Centaur and ADVIA Centaur XP Immunoassay System (SEM/CP/006 and SEM/CP/007) as Documented in STM/CP/033, STM/CP/061, STM/CP/062 and STM/CP/063. Chemiluminescene / ADVIA Centaur and ADVIA Centaur XP Immunoassay System (SEM/CP/006 and SEM/CP/007) as Documented in STM/CP/034, STM/CP/061, STM/CP/062 and STM/CP/063. Chemiluminescene / ADVIA Centaur and ADVIA Centaur XP Immunoassay System (SEM/CP/006 and SEM/CP/007) as Documented in STM/CP/035, STM/CP/061, STM/CP/062 and STM/CP/063.
Serum, Plasma
B12 Vitamin
Serum, Plasma
Beta Human Chorionic Gonadotropin (B-hcG)
Serum
Carcinoembryonic Antigen (CEA)
Serum, Urine
Cortisol
Serum
Estradiol
NO: SAMM 514

Specimen tested Serum, Plasma Type of tests/ Properties measured Ferritin
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Test method, specification/ Equipment/Techniques used Chemiluminescene / ADVIA Centaur and ADVIA Centaur XP Immunoassay System (SEM/CP/006 and SEM/CP/007) as Documented in STM/CP/036, STM/CP/061, STM/CP/062 and STM/CP/063. Chemiluminescene / ADVIA Centaur and ADVIA Centaur XP Immunoassay System (SEM/CP/006 and SEM/CP/007) as Documented in STM/CP/037, STM/CP/061, STM/CP/062 and STM/CP/063. Chemiluminescene / ADVIA Centaur and ADVIA Centaur XP Immunoassay System (SEM/CP/006 and SEM/CP/007) as Documented in STM/CP/038, STM/CP/061, STM/CP/062 and STM/CP/063. Chemiluminescene / ADVIA Centaur and ADVIA Centaur XP Immunoassay System (SEM/CP/006 and SEM/CP/007) as Documented in STM/CP/041, STM/CP/061, STM/CP/062 and STM/CP/063. Chemiluminescene / ADVIA Centaur and ADVIA Centaur XP Immunoassay System (SEM/CP/006 and SEM/CP/007) as Documented in STM/CP/042, STM/CP/061, STM/CP/062 and STM/CP/063. Chemiluminescene / ADVIA Centaur and ADVIA Centaur XP Immunoassay System (SEM/CP/006 and SEM/CP/007) as Documented in STM/CP/043, STM/CP/061, STM/CP/062 and STM/CP/063. Chemiluminescene / ADVIA Centaur and ADVIA Centaur XP Immunoassay System (SEM/CP/006 and SEM/CP/007) as Documented in STM/CP/045, STM/CP/061, STM/CP/062 and STM/CP/063. Chemiluminescene / ADVIA Centaur and ADVIA Centaur XP Immunoassay System (SEM/CP/006 and SEM/CP/007) as Documented in STM/CP/046, STM/CP/061, STM/CP/062 and STM/CP/063.
Serum, Red Blood Cell
Folate
Serum
Follicle Stimulating Hormone (FSH)
Serum
Luteinizing Hormone (LH)
Serum
Progesterone
Serum
Prolactin
Serum
Prostatic Specific Antigen (PSA), Total
Serum
Testosterone, Total
NO: SAMM 514

Specimen tested Serum, Cord Blood Type of tests/ Properties measured Thyroxine, Free (fT4)
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Test method, specification/ Equipment/Techniques used Chemiluminescene / ADVIA Centaur and ADVIA Centaur XP Immunoassay System (SEM/CP/006 and SEM/CP/007) as Documented in STM/CP/040, STM/CP/061, STM/CP/062 and STM/CP/063. Chemiluminescene / ADVIA Centaur and ADVIA Centaur XP Immunoassay System (SEM/CP/006 and SEM/CP/007) as Documented in STM/CP/047, STM/CP/061, STM/CP/062 and STM/CP/063. Chemiluminescene / ADVIA Centaur and ADVIA Centaur XP Immunoassay System (SEM/CP/006 and SEM/CP/007) as Documented in STM/CP/039, STM/CP/061, STM/CP/062 and STM/CP/063.
Serum, Cord Blood
Thyroid Stimulating Hormone (TSH)
Serum
Tri-iodothyronine, Free (fT3)
Toxicology: Drug of Abuse Testing in Urine Urine Morphine Enzyme Immunoassay and Thin Layer Chromatography / Dimension RxL (SEM/CP/005) & TLC Plate as Documented in STM/CP/056, STM/CP/059 STM/CP/061, STM/CP/062 and STM/CP/063. Enzyme Immunoassay and Thin Layer Chromatography / Dimension RxL (SEM/CP/005) & TLC Plate as Documented in STM/CP/057 & STM/CP/060, STM/CP/061, STM/CP/062 and STM/CP/063. Enzyme Immunoassay / Dimension RxL (SEM/CP/005) as Documented in STM/CP/058 & STM/CP/061, STM/CP/062 and STM/CP/063.
11-Nor-Delta-9Tetrahydrocannabinol-9Carboxylic Acid ( 9-THC)
Amphetamines
NO: SAMM 514

FIELD OF MEDICAL TESTING: HAEMATOLOGY SCOPE OF ACCREDITATION:
Specimen tested General Blood FBP Type of tests/ Properties measured
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Blood Smear / Leishmans Staining & Wright Staining / Sysmex (SEM/HM/002, SEM/HM/008, SEM/HM/011, SEM/HM/032, SEM/HM/033), Manual & Hematex Analyzer (SEM/HM/021) as Documented in STM/HM/001, STM/HM003, STM/HM/037, STM/HM/044. Fully Automated Haematology Analyzer / Sysmex (SEM/HM/002, SEM/HM/008, SEM/HM/011, SEM/HM/032, SEM/HM/033) & Coulter (5part) (SEM/HM/015, SEM/HM/022, SEM/HM/023, SEM/HM/025, SEM/HM/026) as Documented in STM/HM/001, STM/HM/003. Manual, Fully Automated Haematology Analyzer / Sysmex (SEM/HM/002, SEM/HM/008, SEM/HM/011, SEM/HM/032, SEM/HM/033) & Coulter (5part) (SEM/HM/015, SEM/HM/022, SEM/HM/023, SEM/HM/025, SEM/HM/026) as Documented in STM/HM/008, STM/HM/001, STM/HM/003. High Performance Liquid Chromatography / Variant (SEM/HM/018) and Sebia Analyzer (SEM/HM/014, SEM/HM/027) as Documented in STM/HM/012, STM/HM/010. Imunophenotyping Method Using Automated FACS Calibur (SEM/HM/013, SEM/HM/020, SEM/HM/024, SEM/HM/028) as Documented in STM/HM/013. Manual Westergen Method and Automation as Documented in STM/HM/029 and Automated ESR Plus (SEM/HM/001, SEM/HM/030) STM/HM/047. Modified Manual Beutler Method as Documented in STM/HM/011.
FBC
White Blood Cell Differential Count
Hb. Analysis
CD4/CD8
ESR
G6PD
NO: SAMM 514

Specimen tested Blood Type of tests/ Properties measured Retic Count
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Test method, specification/ Equipment/Techniques used Manual Supravital Stain & Automated Sysmex (SEM/HM/002, SEM/HM/008, SEM/HM/011, SEM/HM/032, SEM/HM/033) as Documented in STM/HM/015, STM/HM/003. Manual / Cytochemical Reagent Kit Detection of Alkaline Phosphatase Activity in Leucocytes as Documented in STM/HM/023, STM/HM/007. Manual / Cytochemical Reagent Kit Peroxidase Staining as Documented in STM/HM/022, STM/HM/005. Manual / Cytochemical Reagent Kit Periodic Acid Schiff Staining as Documented in STM/HM/024, STM/HM/006. Cytochemical Reagent Kit Esterase Staining as Documented in STM/HM/026. Cytochemical Reagent Kit Acid Phosphatase Staining as Documented in STM/HM/025.
Cytochemical Staining
Bone Marrow Aspirate
Bone Marrow Aspiration
May Grundwald Giemsa Staining as Documented in STM/HM/020. Manual Pearls Stain for Iron Detection Staining as Documented in STM/HM/021. Manual / Cytochemical Reagent Kit Peroxidase Staining as Documented in STM/HM/022, STM/HM/005. Cytochemical Reagent Kit Esterase Staining as Documented in STM/HM/026. Cytochemical Reagent Kit Acid Phosphatase Staining as Documented in STM/HM/025.
Urine Urine
Urine Hemosiderin Urine Hemoglobin
Manual Pearls Stain Method as Documented in STM/HM/030. Manual Dry Strip Method as Documented in STM/HM/028.
NO: SAMM 514

Specimen tested Coagulation Plasma PT APTT Type of tests/ Properties measured
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Fully Automated Analyzer / STA COMPACT (SEM/HM/029) as Documented in STM/HM/034. Fully Automated Analyzer / STA COMPACT (SEM/HM/029) as Documented in STM/HM/035. Mechanical Clot Detection / STA COMPACT (SEM/HM/029) as Documented in STM/HM/040. Mechanical Clot Detection / STA COMPACT (SEM/HM/029) as Documented in STM/HM/009. Mechanical Clot Detection / STA COMPACT (SEM/HM/029) as Documented in STM/HM/046. Mechanical Clot Detection / STA COMPACT (SEM/HM/029) as Documented in STM/HM/041.
Plasma
Fibrinogen
Plasma
Lupus Anticoagulant
Plasma
Factor Assay
Plasma
Factor Assay Inhibitor
Plasma
Mixing Test
Immunohaematology Blood and Serum ABO, Rh Grouping Agglutination Technique / Tube Method, Microplate Method as Documented in STM/BB/046, STM/BB/056. Column Agglutination / Gel Card as Documented in STM/BB/051. Column Agglutination / Gel Card as Documented in STM/BB/065. Column Agglutination / Gel Card as Documented in STM/BB/050. Column Agglutination Technology (Gel Card) as Documented in STM/BB/068. Agglutination Technique / Tube Method, Column Agglutination Technology (Gel Card) as Documented in STM/BB/046, STM/BB/064.
Blood Blood Blood Serum / Plasma Serum / Plasma
Rh Genotyping RBC Phenotype Direct Coombs Test Antibody Screening Group, Screen and Hold
NO: SAMM 514

Specimen tested Serum / Plasma Type of tests/ Properties measured Cross Matching
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Test method, specification/ Equipment/Techniques used Agglutination Technique / Tube Method as Documented in STM/BB/020. Agglutination Technique / Gel Card as Documented in STM/BB/019. Agglutination Technique / Gel Card as Documented in STM/BB/046, STM/BB/063.
Serum / Plasma
Antibody Identification
Agglutination Technique / Tube Method as Documented in STM/BB/018, STM/BB/049, STM/BB/052, STM/BB/053, STM/BB/054 STM/BB/066. Agglutination Technique / Gel Card as Documented in STM/BB/064, STM/BB/048.
Serum / Plasma Serum / Plasma Serum / Plasma
Weak D Indirect Coombs Test Haemolysin Test for Emergency O Blood Cold Agglutinin Detection
Agglutination Technique / Tube Method as Documented in STM/BB/057. Column Agglutination / Gel Card as Documented in STM/BB/064. Tube Method as Documented in STM/BB/045. Agglutination Technique / Tube Method, Column Agglutination Technology Gel Card as Documented in STM/BB/049, STM/BB/048.
NO: SAMM 514

FIELD OF MEDICAL TESTING: MEDICAL MICROBIOLOGY SCOPE OF ACCREDITATION:
Page: 16 of 24
Isolation and Identification of Bacteria Feces or Stool Stain, Culture and Antibiotic Sensitivity Testing Gram Stain, Vitek 2 Compact Identification Card, API Identification Card, Kirby-Bauer / Manual / Giles Scientific Biomic Reader / CLSI 2010 / as Documented in STM/BT/022. Direct Microscopic / as Documented in STM/BT/048. Colorimetric Assay / Manual / as Documented in STM/BT/021. Gram Stain, Vitek 2 Compact Identification Card, API Identification Card, Kirby-Bauer / Manual / Giles Scientific Biomic Reader / CLSI 2010 / as Documented in STM/BT/023. KOVA Counting Chamber as Documented in STM/BT/017. Multi Parameter Test strip/ Urisys 1800 as Documented in STM/CP/055, STM/CP/061, STM/CP/062 and STM/CP/063, SEM/MC/50, SEM/MC/51. Heat Test / Manual / as Documented in STM/BT/018. Gram Stain, Vitek 2 Compact Identification Card, API Identification Card, Kirby-Bauer / Manual / Giles Scientific Biomic Reader / CLSI 2010 / as Documented in STM/BT/024. Gram Stain, Vitek 2 Compact Identification Card, API Identification Card / Manual / as Documented in STM/BT/006, STM/BT/049. Gram Stain, Vitek 2 Compact Identification Card, API Identification Card, Kirby-Bauer / Manual / Giles Scientific Biomic Reader / CLSI 2010 / as Documented in STM/BT/025.
Hanging Drop Test for Vibrio cholerae Stool for Occult Blood Urine Stain, Culture and Antibiotic Sensitivity Testing
Urine Microscopic Examination Urine Biochemical-SG, pH, Leukocytes, Nitrite, Protein, Glucose, Ketone, Urobilinogen, Bilirubin, Blood (RBC) and Haemoglobin Urine for Bence Jones Protein Throat, Mouth, Nasal, Nasopharyngeal Stain, Culture and Antibiotic Sensitivity Testing
Throat Swab for Corynebacterium diphtheriae Pus, Wound, Tissue, Bone, Slough Stain, Culture and Antibiotic Sensitivity Testing
NO: SAMM 514

Page: 17 of 24
Isolation and Identification of Bacteria Ear Stain, Culture, and Antibiotic Sensitivity Testing Gram Stain, Vitek 2 Compact Identification Card, API Identification Card, Kirby-Bauer / Manual / Giles Scientific Biomic Reader / CLSI 2010 / as Documented in STM/BT/026. BACTEC Blood Culture Bottle, Gram Stain, Vitek 2 Compact Identification Card, API Identification Card, Kirby-Bauer / Manual, Semi-Automation / Slide Culture / Lactophenol Cotton Blue / Indian Ink / Giles Scientific Biomic Reader / CLSI 2010 / BACTEC 9240 Fluorescent System / BACTEC FX Fluorescent System / Vitek 2 Compact / as Documented in STM/BT/004, STM/BT/027, SEM/MC/11, SEM/MC/01. Gram Stain, Vitek 2 Compact Identification Card, API Identification Card , Kirby-Bauer / KOVA Counting Chamber / Manual, Semi-automation / Giles Scientific Biomic Reader / CLSI 2010 / Vitek 2 Compact / as Documented in STM/BT/004, STM/BT/028, SEM/MC/05. Gram Stain, Vitek 2 Compact Identification Card, API Identification Card, Kirby-Bauer / Manual / Giles Scientific Biomic Reader / CLSI 2010 / as documented in STM/BT/030. Gram Stain, Vitek 2 Compact Identification Card, API Identification Card, Kirby-Bauer / Manual / Giles Scientific Biomic Reader / CLSI 2010 / as Documented in STM/BT/029. Gram Stain / as Documented in STM/BT/047. Gram Stain, Vitek 2 Compact Identification Card, API Identification Card, Kirby-Bauer / Manual / Giles Scientific Biomic Reader / CLSI 2010 / as Documented in STM/BT/031.
Blood (Aerobic, Anaerobic, Fungal)
Stain, Culture and Antibiotic Sensitivity Testing
Cerebrospinal Fluids
Body Fluids or Effusions (Tracheal Aspirates, Peritoneal, Pleural, FNAC, Gastric Lavage, etc.) Eye, Corneal Scrapping
Eye Smear for Gonococcus Urogenital (Urethral, Cervical, Vaginal, etc) Stain, Culture and Antibiotic Sensitivity Testing
NO: SAMM 514

Specimen tested Sputum Type of tests/ Properties measured Stain, Culture and Antibiotic Sensitivity Testing
Page: 18 of 24
Test method, specification/ Equipment/Techniques used Gram Stain, Vitek 2 Compact Identification Card, API Identification Card, Kirby-Bauer / Manual / Giles Scientific Biomic Reader / CLSI 2010 / as Documented in STM/BT/032. Gram Stain, Vitek 2 Compact Identification Card, API Identification Card, Kirby-Bauer / Manual / Giles Scientific Biomic Reader / CLSI 2010 as Documented in STM/BT/055.
Skin Scrapping
Isolation and Identification of Fungi Sputum, Urine, Eye, Ear, HVS, Skin, Body Fluids (CSF, Tracheal Aspirates, Peritoneal Fluid, Pleural, FNAC) Stain and Culture KOH / Lactophenol Cotton Blue / Indian Ink / Gram Stain, / Manual Culture / Slide Culture / Vitek 2 Compact Identification Card - Yeast Card, SEM/MC/01.
Isolation and Identification of Mycobacteria Sputum, Urine, Eye, Ear, HVS, Skin, Body Fluids (CSF, Tracheal Aspirates, Peritoneal Fluid, Pleural, FNAC) Pus, Wound, Tissue, Slough Stain and Culture Ziehl-Neelsen Stain, Ogawa or Lowenstein Jensen Media / Semiautomation / BACTEC MGIT 960 Mycobacterial Detection System as Documented in STM/BT/009, STM/BT/016, STM/BT/033, SEM/MC/53. Ziehl-Neelsen Stain, Ogawa or Lowenstein Jensen Media / Semiautomation / BACTEC MGIT 960 Mycobacterial Detection System as Documented in STM/BT/009, STM/BT/016, STM/BT/033, SEM/MC/53. Ziehl-Neelsen Stain, Ogawa or Lowenstein Jensen Media / Semiautomation / BACTEC MGIT 960 Mycobacterial Detection System as Documented in STM/BT/009, STM/BT/016, STM/BT/033, SEM/MC/53. Ziehl-Neelsen Stain, Ogawa or Lowenstein Jensen Media / Semiautomation / BACTEC MGIT 960 Mycobacterial Detection System as Documented in STM/BT/009, STM/BT/016, STM/BT/033, SEM/MC/53.
Stain and Culture
Urine
Stain and Culture
Feces or Stool
Stain and Culture
NO: SAMM 514

Specimen tested Blood Type of tests/ Properties measured Stain and Culture
Page: 19 of 24
Test method, specification/ Equipment/Techniques used Ziehl-Neelsen Stain, Ogawa or Lowenstein Jensen Media / Semiautomation / BACTEC 9240 Fluorescent System, BACTEC MGIT 960 Mycobacterial Detection System as Documented in STM/BT/009, STM/BT/016, STM/BT/027, STM/BT/033, SEM/MC/11, SEM/MC/53.
Direct Examination and Identification of Parasites Faeces or Stool Stool FEME / Ova & Cysts / Trophozoites Direct Microscopic (Stool Concentration Technique), Trichrome Stain, Lugols Iodine Stain as Documented in STM/BT/019, STM/BT/020, STM/BT/046. Direct Smear, Modified Ziehl-Neelsen / Trichrome Stain as Documented in STM/BT/010, STM/BT/019, STM/BT/046. Direct Smear, Giemsa Stain as Documented in STM/BT/008. Direct Smear, Giemsa Stain as Documented in STM/BT/008, STM/BT/034. Direct Smear, Giemsa Stain as Documented in STM/BT/008. Direct smear,Modified Ziehl Neelsen Stain as Documented in STM/BT/010.
Cryptosporidium, Cyclosporidium, Microsporidium, Isospora belli Blood Leishmania Malarial Parasite Filariasis Sputum Pneumocystis carinii pneumoniae
Serological Diagnosis of Infections Serum Leptospiral lgM Antibodies Anti-Mycoplasma Pneumonia Antibody Anti-Streptolysin O Titer Antibodies (ASOT) Cryptococcal Antigen Infectious Mononucleosis / Epstein-Barr Virus Antibodies Rapid Immunochromatographic Card Test / Manual as Documented in STM/SR/011. Particle Agglutination Test / Manual as Documented in STM/SR/012. Rapid Latex Agglutination Test / Manual as Documented in STM/SR/015. Latex Agglutination Test / Manual as Documented in STM/SR/017. Rapid Latex Particle Agglutination Test / Manual as Documented in STM/SR/018.
NO: SAMM 514

Specimen tested Serum Type of tests/ Properties measured Syphilis (RPR or VDRL) Antigen Anti-Treponema Pallidum Antibodies (TPHA) Amoebic Serology or Amebiasis Antibodies
Page: 20 of 24
Test method, specification/ Equipment/Techniques used Rapid Latex Agglutination Slide Test / Manual as Documented in STM/SR/020. Indirect Haemagglutination Method (IHA) / Manual as Documented in STM/SR/021. Enzyme Immunoassay / Manual / Statfax ELISA Reader as Documented in STM/SR/025, SEM/MC/25. Microparticle Enzyme Immunoassay (MEIA) / Abbott Axsym System as Documented in STM/SR/028, SEM/MC/54.
Anti-Toxoplasma lgG/lgM Antibodies
Antigen Detection for the Diagnosis of Infections Feces or Stool Smear of Cervical or Urethral Specimens Clostridium difficile Toxin A & B Detection Chlamydia trachomatis Antigen Rapid Immunoassay Test / Manual as Documented in STM/SR/016. Direct Immunofluorescent Test / Manual as Documented in STM/SR/009.
Immunological Diagnostics Serum Anti-Mitochondrial Antibody (AMA) Anti-Microsomol Antibody (AMC) Double Stranded DNA (DsDNA) Anti-Nuclear Antibody (ANA) Anti-Neutrophil Cytoplasmic Autoantibody (ANCA) Anti-Smooth Muscle Antibody (ASMA) Extractable Nuclear Antigen (ENA) Anti-Thyroglobulin Antibody (ATG) Indirect Immunofluorescent Antibody Test / Manual as Documented in STM/SR/001. Particle Agglutination Test / Manual as Documented in STM/SR/002. Indirect Enzyme Antibody Test / Manual as Documented in STM/SR/003. Indirect Enzyme Antibody Test / Manual as Documented in STM/SR/004. Indirect Immunofluorescent Antibody Test / Manual as Documented in STM/SR/005. Indirect Immunofluorescent Antibody Test / Manual as Documented in STM/SR/006. Immunoblot Nucleic Antigens Strip / Manual as Documented in STM/SR/007. Particle Agglutination Test / Manual as Documented in STM/SR/008.
NO: SAMM 514

Specimen tested Viral Isolation Specimen for Virus Study Viral Serology Serum Herpes Simplex Virus 1+2 lgM Virus Isolation and Antigen Detection Type of tests/ Properties measured
Page: 21 of 24
Manual as Documented in STM/BT/036, STM/BT/054.
Immunoenzymatic Capture Method / Manual as Documented in STM/SR/010, SEM/MC/25. lgM Capture ELISA / Statfax 2600 Microtiter Plate Washer , Statfax 2100 ELISA Reader as Documented in STM/SR/013, SEM/MC/25. Rapid Immunochromatographic Card Test / Manual as Documented in STM/SR/014. Rapid Latex Particle Agglutination Test / Manual as Documented in STM/SR/018. Microparticle Enzyme Immunoassay (MEIA) / Abbott Axsym System as Documented in STM/SR/027, SEM/MC/54. Microparticle Enzyme Immunoassay (MEIA) / Abbott Axsym System as Documented in STM/SR/028, SEM/MC/54. Microparticle Enzyme Immunoassay (MEIA) / Abbott Axsym System as Documented in STM/SR/030, SEM/MC/54. Microparticle Enzyme Immunoassay (MEIA) / Abbott Axsym System as Documented in STM/SR/031, SEM/MC/54. Chemiluminescence / ADVIA Centaur Immunoassay System as Documented in STM/SR/043, SEM/MC/58, SEM/MC/59.
Dengue lgM Antibodies
Dengue Rapid Duo lgG / lgM Infectious Mononucleosis / Epstein-Barr Virus Antibodies Anti-Rubella lgM Antibodies
Anti-Cytomegalovirus IgM Antibodies
Serum
Hepatitis A lgM Antibody (AntiHAV lgM) Hepatitis B Surface Antigen (HBsAg)
Serum
Serum
Hepatitis B Surface Antibody (Anti-HBs)
Microparticle Enzyme Immunoassay (MEIA) / Abbott Axsym System as Documented in STM/SR/032, SEM/MC/54. Chemiluminescence / ADVIA Centaur Immunoassay System as Documented in STM/SR/045, SEM-58, SEM-59.
NO: SAMM 514

Specimen tested Serum Type of tests/ Properties measured Hepatitis C Antibody (Anti-HCV)
Page: 22 of 24
Test method, specification/ Equipment/Techniques used Microparticle Enzyme Immunoassay (MEIA) / Abbott Axsym System as Documented in STM/SR/033, SEM/MC/54. Chemiluminescence / ADVIA Centaur Immunoassay System as Documented in STM/SR/044, SEM-58, SEM-59.
Serum
HIV 1 & 2 Antibodies (HIV)
Chemiluminescence / ADVIA Centaur Immunoassay System as Documented in STM/SR/034, SEM/MC/58, SEM/MC/59. Particle Agglutination Test / Manual as Documented in STM/SR/035. Rapid Immunographics Card Test / Manual as Documented in STM/SR/036.
Anti-HIV 1 & 2 Particle Agglutination (PA HIV) HIV 1 & 2 Rapid Test
Non-Culture Methods for Detection of Viral Pathogens (Nucleic Acid Detection) Plasma HIV Viral Load Nucleic Acid Amplification Test / Cobas Amplicor, Ampliprep, Taqman Analyzer as Documented in STM/SR/037, STM/SR/038, SEM-60, SEM-61, SEM-62. Nucleic Acid Amplification Test / Liquid Handler, Rotogen Q as Documented in STM/SR/041 and STM/SR/42, SEM-65.
Throat Swab / Tracheal Aspirate
PCR for H1N1
Non-Culture Methods for Detection of Viral Pathogens (Antigen Detection) Feces or Stool Rotavirus Antigen Test Latex Agglutination Test / Manual as Documented in STM/SR/019.
NO: SAMM 514

Laboratory Key Personnel: Name 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. Dr. Mukarramah binti Che Ayub Dr. Saleena binti Awang Dr. Nik Faizah binti Nik Hussein Dr. Azura binti Hussin Ms. Noorehan binti Hamid Ms. Ros Azeana binti Abdul Hamid Dr. Mukarramah binti Che Ayub Dr. Saleena binti Awang Dr. Nor Hidayah binti Abu Bakar Dr. Mukarramah binti Che Ayub Dr. Nor Hidayah binti Abu Bakar Dr. Saleena binti Awang Mr. Mat Nasir bin Loman Mr. Kasmiyusree bin Yusof Ms. Noriza binti Shamshudden Mr. Nazli bin Nawi Mr. Kasmiyusree bin Yusof Ms. Noriza binti Shamshudden Dr. Nik Faizah binti Nik Hussein Mr. Nik Muhammad bin Mahmood Ms. Pra Pai A/P Le Ah Ms. Norzita binti Mohamed Dr. Nik Faizah binti Nik Hussein Mr. Nik Muhammad bin Mahmood Ms. Pra Pai A/P Le Ah Dr. Nik Faizah binti Nik Hussein Mr. Nik Muhammad bin Mahmood Ms. Pra Pai A/P Le Ah Ms. Norzita binti Mohamed Designation Laboratory Director
Page: 23 of 24
Deputy Laboratory Director Quality Manager Deputy Quality Manager Document Manager Document Manager Technical Manager (Histopathology)
Technical Manager (Cytopathology: Pap Smear, Fine Needle Aspiration (FNAC) and Non Gynaecology (NG)) Technical Manager (Cytopathology: No Intraepithelial Lesion / Malignancy (NILM) - No signs and symptoms )
Technical Manager (Cytopathology: Non Gynaecology (Negative Sputum)) Technical Manager (Chemical Pathology: General Chemistry)
Technical Manager (General Chemistry: (Plasma Protein)) Technical Manager (Chemical Pathology: Toxicology)
Technical Manager (Chemical Pathology: Specialised Chemistry) Technical Manager (Chemical Pathology: Limited Specialised Chemistry)
NO: SAMM 514

Laboratory Key Personnel: Name 30. 31. 32. 33. 34. 35. 36. 37. 38. 39. 40. 41. Dr. Ilunihayati binti Ibrahim Dr. Salimah binti Abdullah Dr. Majdan bin Ramli Mr. Anuar bin Ali Dr. Ilunihayati binti Ibrahim Dr. Salimah binti Abdullah Dr. Majdan bin Ramli Ms. Shabihah binti Lazin Dr. Ilunihayati binti Ibrahim Dr. Salimah binti Abdullah Dr. Majdan bin Ramli Ms. Shabihah binti Lazin Designation
Page: 24 of 24
Technical Manager (Haematology: Routine & Specialised)
Technical Manager (Haematology: Routine) Technical Manager (Haematology: Coagulation)
Technical Manager (Immunohaematology)
Technical Manager (Immunohaematology excluding Antibody identification and investigation for transfusion reaction) Technical Manager (Medical Microbiology: Bacteriology/ Fungi/ Molecular) Technical Manager (Viral & Bacterial Serology)
42. 43. 44. 45. 46. 47. 48. 49.
Dr. Nurahan binti Maning Dr. Azura binti Hussin Dr. Nurahan binti Maning Dr. Azura binti Hussin Mr. Mohd. Sanusi Che Lah Ms. Aliyaisma binti Ariffin Ms. Normaizura binti Mokhter Ms. Nik Nurhafiza binti Nik Badrul Alam
Laboratory Clinical Personnel: Name 1. 2. 3. 4. 5. 6. 7. 8. 9. Dr. Mukarramah binti Che Ayub Dr. Saleena binti Awang Dr. Nor Hidayah binti Abu Bakar Dr. Nik Faizah binti Nik Hussein Dr. Ilunihayati binti Ibrahim Dr. Salimah binti Abdullah Dr. Majdan bin Hj Ramli Dr. Nurahan binti Maning Dr. Azura binti Hussin I/C No. 610421-03-5438 650418-03-5062 730102-11-5672 661102-03-5262 620518-05-5688 580216-03-5258 691103-03-5309 620625-10-6532 730924-03-5460 Discipline Cytopathology/Histopathology Cytopathology/Histopathology Cytopathology/Histopathology Chemical Pathology Haematology Haematology Haematology Medical Microbiology/Virology Medical Microbiology/Virology

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Issue date: 10 May 2011 Valid until: 10 May 2014

NO: SAMM 514

3.Fine Needle Aspiration Specimen

Issue date: 10 May 2011 Valid until: 10 May 2014

NO: SAMM 514

Issue date: 10 May 2011 Valid until: 10 May 2014

NO: SAMM 514

Test method, specification/ Equipment/Techniques used

Serum, Plasma, Urine

Issue date: 10 May 2011 Valid until: 10 May 2014

NO: SAMM 514

Serum, Plasma, Urine

Issue date: 10 May 2011 Valid until: 10 May 2014

NO: SAMM 514

Serum, Heparinised Plasma

Serum, Heparinised Plasma

Serum, Plasma, Urine

Serum, Plasma, Urine

Electrolytes (Sodium, Potassium, Chloride)

Issue date: 10 May 2011 Valid until: 10 May 2014

NO: SAMM 514

Serum, Plasma, Cerebrospinal Fluid, Body Fluid

Plasma, Cerebrospinal Fluid, Body Fluid

Issue date: 10 May 2011 Valid until: 10 May 2014

NO: SAMM 514

Serum, Plasma, Urine

Serum, Plasma, Urine

Urine, Cerebrospinal Fluid, Body Fluid

Issue date: 10 May 2011 Valid until: 10 May 2014

NO: SAMM 514

Serum, Plasma, Urine

Total Iron Binding Capacity (TIBC)

Serum, Plasma, Urine

Microalbumin and Creatinine

Issue date: 10 May 2011 Valid until: 10 May 2014

NO: SAMM 514

Test method, specification/ Equipment/Techniques used

Serum, Plasma, Whole, Blood

Beta Human Chorionic Gonadotropin (B-hcG)

Carcinoembryonic Antigen (CEA)

Issue date: 10 May 2011 Valid until: 10 May 2014

NO: SAMM 514

Serum, Red Blood Cell

Follicle Stimulating Hormone (FSH)

Luteinizing Hormone (LH)

Prostatic Specific Antigen (PSA), Total

Issue date: 10 May 2011 Valid until: 10 May 2014

NO: SAMM 514

Serum, Cord Blood

Thyroid Stimulating Hormone (TSH)

Tri-iodothyronine, Free (fT3)

11-Nor-Delta-9Tetrahydrocannabinol-9Carboxylic Acid ( 9-THC)

Issue date: 10 May 2011 Valid until: 10 May 2014

NO: SAMM 514

Test method, specification/ Equipment/Techniques used

White Blood Cell Differential Count

Issue date: 10 May 2011 Valid until: 10 May 2014

NO: SAMM 514

Bone Marrow Aspirate

Bone Marrow Aspiration

Urine Hemosiderin Urine Hemoglobin

Issue date: 10 May 2011 Valid until: 10 May 2014

NO: SAMM 514