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NL HOKLAS833P-22 Annex III of 1

Annex III

List of examinations for which accreditation has been terminated

(Notification Letter No. HOKLAS833P-22; Effective date of termination: 1 September 2020)

Hospital Authority ‒ Kwong Wah Hospital, Department of Pathology

醫院管理局 ‒ 廣華醫院病理部 Special Chemical Pathology & Haematology Laboratory: 6/F, Yu Chun Keung Memorial Medical Centre

余振強紀念醫療中心六樓

MEDICAL TESTING

DISCIPLINE

專科範疇

TEST AREA

OR SAMPLE TYPE

測試範圍或樣本種類

SPECIFIC EXAMINATION OR

PROPERTY MEASURED

特定測試或量度的特性

METHOD

OR TECHNIQUE USED

方法或應用技術

Accreditation of the following examination has been terminated.

Chemical Hormones

Pathology Serum Tri-iodothyronine, Total (TT3) by

Immunoassay Abbott ARCHITECT i2000SR System, Total T3 assay

(Chemiluminescent Label)

Annex III

List of examinations for which accreditation has been terminated (Notification Letter No. HOKLAS833P-17)

Hospital Authority - Kwong Wah Hospital, Department of Pathology 醫院管理局 - 廣華醫院病理部 Core Chemical Pathology & Haematology Laboratory: 5/F, Yu Chun Keung Memorial Medical Centre

余振強紀念醫療中心五樓

0BMEDICAL TESTING 1BDISCIPLINE

2B專科範疇

3BTEST AREA 4BOR SAMPLE TYPE 測試範圍或樣本種類

5BSPECIFIC EXAMINATION OR 6BPROPERTY MEASURED

7B特定測試或量度的特性

8BMETHOD 9BOR TECHNIQUE USED

10B方法或應用技術

Accreditation of the following examination has been terminated. Chemical General Chemistry Pathology Serum Alanine Aminotransferase (ALT) by .1.

Spectrophotometry Beckman Coulter Synchron Clinical System, ALT assay Serum, fluid Albumin by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, ALBm assay Serum Alkaline Phosphatase (ALP) by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, ALP assay Plasma Ammonia by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, AMM assay Serum, fluid Amylase by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, AMY7 assay Serum Aspartate Aminotransferase (AST) by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, AST assay Bilirubin – Direct by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, DBIL assay Bilirubin – Total by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, TBIL assay Plasma Calcium by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, Calcium Arsenazo assay Serum, fluid Chloride by .1. Indirect Ion Selective Electrode Beckman Coulter Synchron Clinical System, Chloride assay

NL No. HOKLAS833P-17 Annex III Page 1 of 5




13B專科範疇






Accreditation of the following examination has been terminated. Chemical General Chemistry Pathology (cont’d) .1. (cont’d) Serum Cholesterol by Spectrophotometry Beckman Coulter Synchron Clinical System, CHOL assay Cholesterol High Density Lipoprotein, .1. (HDL-C) by Spectrophotometry Beckman Coulter Synchron Clinical System, HDL assay (Direct measurement) Creatine Kinase (CK) by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, CK assay Serum, fluid Creatinine by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, CREm assay Serum Gamma Glutamyl Transpeptidase (GGT) by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, γ-GT assay Fluoride plasma, fluid, Glucose by .1. CSF Spectrophotometry Beckman Coulter Synchron Clinical System, GLUH assay Serum, fluid, CSF Lactate dehydrogenase (LDH) by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, LD assay Serum Magnesium by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, MG assay Phosphate by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, PHOSm assay Serum, fluid Potassium by .1. Indirect Ion Selective Electrode Beckman Coulter Synchron Clinical System, K assay Protein, Total by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, TPm assay CSF Protein, Total by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, M-TP assay Serum, fluid Sodium by .1. Indirect Ion Selective Electrode Beckman Coulter Synchron Clinical System, NA assay





24B專科範疇






Accreditation of the following examination has been terminated. Chemical General Chemistry Pathology (cont’d) (cont’d) Serum Triglycerides by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, TG assay Urate by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, URIC assay Serum, fluid Urea by .1. Conductivity Beckman Coulter Synchron Clinical System, UREAm assay Urine Calcium by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, Calcium

A

assay Chloride by .1. Indirect Ion Selective Electrode Beckman Coulter Synchron Clinical System, Chloride assay Creatinine by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, CREm assay Phosphate by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, PHOSm assay Protein, Total by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, M-TP assay Potassium by .1. Indirect Ion Selective Electrode Beckman Coulter Synchron Clinical System, K assay Sodium by .1. Indirect Ion Selective Electrode Beckman Coulter Synchron Clinical System, NA assay Urate by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, URIC assay Urea by .1. Conductivity Beckman Coulter Synchron Clinical System, UREAm assay





35B專科範疇






Accreditation of the following examination has been terminated. Chemical Toxicology Pathology Serum Acetaminophen (Paracetamol) by .1. (cont’d) Immunoturbidimetry Beckman Coulter Synchron Clinical System, ACTM assay Ethanol by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, ETOH assay Salicylate by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, SALY assay Haematology Haematology – General EDTA whole blood Complete blood count including Beckman Coulter LH750 .2.

- Haemoglobin - Haematocrit - Leucocyte count (WBC count) - Mean corpuscular volume (MCV) - Mean corpuscular haemoglobin concentration (MCHC) - Mean corpuscular haemoglobin (MCH) - Platelet count - Red cell count - Red cell distribution width (RDW) - Mean Platelet Volume (MPV) Leucocyte differential count, automated Beckman Coulter LH750 .2.


Hospital Authority - Kwong Wah Hospital, Department of Pathology 醫院管理局 - 廣華醫院病理部 Special Chemical Pathology & Haematology Laboratory: 6/F, Yu Chun Keung Memorial Medical Centre 余振強紀念醫療中心六樓


46B專科範疇






Accreditation of the following examination has been terminated. Chemical General Chemistry Pathology Serum Iron by .1. Spectrophotometry Beckman Coulter Synchron Clinical System, FE assay Iron Binding Capacity, Total (IBCT) by .1. Calculation Beckman Coulter Synchron Clinical System, UIBC-SL assay

Note: .1. Effective date of termination: 12 September 2018.

.2. Effective date of termination: 1 April 2019.


Annex III List of examinations for which accreditation has been terminated

(Notification Letter No. HOKLAS833P-15)

Hospital Authority - Kwong Wah Hospital, Department of Pathology 醫院管理局 - 廣華醫院病理部 Special Chemical Pathology & Haematology Laboratory: 6/F, Yu Chun Keung Memorial Medical Centre 余振強紀念醫療中心六樓

MEDICAL TESTING

DISCIPLINE 專科範疇

TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類

SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性

METHOD OR TECHNIQUE USED


Accreditation of the following examinations is terminated

Chemical Hormones Pathology Serum Thyroxine, Total (TT4) by .1. Immunoassay Abbott ARCHITECT i2000SR System (SN#ISR01586 and (Chemiluminescent Label) 50741), Total T4 assay Immunology Autoantibodies Serum Rheumatoid Factor by .2. Latex agglutination Biokit rheumajet RF Clinical Bacteriology - Serology Microbiology Serum Streptolysin O antibody by .2. and Infection Latex agglutination test Dade Behring RapiTex ASL

Note: .1. Effective date on 11 January 2018

.2. Effective date on 22 June 2018

Page 1 of 1



Annex III List of examinations for which accreditation has been terminated

(Notification Letter No. HOKLAS833P-11; Effective date of termination: 28 July 2016)

MEDICAL TESTING

DISCIPLINE 專科範疇





Accreditation of the following examinations is terminated with effect from 28 July 2016

Chemical General Chemistry Pathology Plasma Calcium by Spectrophotometry Beckman Coulter Synchron Clinical System, CA assay Serum Cholesterol High Density Lipoprotein, (HDL-C) by Spectrophotometry Beckman Coulter Synchron Clinical System, HDLD assay (Direct measurement) Fluoride plasma, fluid, CSF Glucose by Spectrophotometry Beckman Coulter Synchron Clinical System, GLU assay Urine Calcium by Spectrophotometry Beckman Coulter Synchron Clinical System, CA assay

HOKLAS 833P-11 Annex III Page 1 of 4

Hospital Authority - Kwong Wah Hospital, Department of Pathology 醫院管理局 - 廣華醫院病理部 Special Chemical Pathology & Haematology Laboratory: 6/F, Yu Chun Keung Memorial Medical Centre


MEDICAL TESTING DISCIPLINE 專科範疇






Chemical Tumor Markers Pathology Serum β-2 microglobulin by Immunoassay (Enzyme based) Abbott Axsym System, β-2 Microglobulin assay

Alpha-fetoprotein (AFP) by

Immunoassay Abbott ARCHITECT i2000SR System (SN#ISR03653), AFP

(Chemiluminescent Label) Immunology Autoantibodies Serum Rheumatoid Factor by Latex agglutination Arthri-Slidex BIOMERIEUX

Thyroid Autoantibodies by Haemagglutination

Abbott ARCHITECT i2000SR System (SN#ISR03653), Anti-TG & TPO assay

Protein, quantitative analysis Serum C3 Complement (C3) by

Immunonephelometry Beckman Immage 800 System, C3 assay

C4 Complement (C4) by Immunonephelometry Beckman Immage 800 System, C4 assay

Haptoglobin by Immunonephelometry Beckman Immage 800 System, HPT assay

Immunoglobulin A (IgA) by Immunoturbidimetry Beckman Immage 800 System, IGA assay

Immunoglobulin G (IgG) by Immunoturbidimetry Beckman Immage 800 System, IGG assay

Immunoglobulin M (IgM) by Immunoturbidimetry Beckman Immage 800 System, IGM assay

Protein, quantitative analysis Serum C-Reactive Protein (CRP) by Immunonephelometry Beckman Immage 800 System, CRP assay










Clinical Virology - Serology Microbiology Serum Hepatitis A virus antibody (IgM) by and Infection Immunoassay Abbott ARCHITECT i2000SR System (SN#ISR03653) (Chemiluminescent Label) Anti-HAV IgM assay Hepatitis A virus antibody (IgG) by Abbott ARCHITECT i2000SR System (SN#ISR03653) Immunoassay HAVAB-IgG reagent assay

(Chemiluminescent Label)

Hepatitis B surface antibody, Semi- Quantitative by Immunoassay Abbott ARCHITECT i2000SR System (SN#ISR03653) (Chemiluminescent Label) HBsAb (AUSAB) assay Hepatitis B Surface Antigen by Immunoassay Abbott ARCHITECT i2000SR System (SN#ISR03653)

(Chemiluminescent Label) HBsAg assay

Abbott ARCHITECT i2000SR System (SN#ISR03653) HBsAg Confirmatory assay Human immunodeficiency virus I & II antibody and p24 antigen by Immunoassay Abbott ARCHITECT i2000SR System (SN#ISR03653) (Chemiluminescent Label) anti-HIV Combo assay Rubella IgG antibody by Immunoassay Abbott ARCHITECT i2000SR System (SN#ISR03653) (Chemiluminescent Label) Rubella IgG assay Bacteriology - Serology Syphilis TP Assay by Immunoassay Abbott ARCHITECT i2000SR System (SN#ISR03653) (Chemiluminescent Label) Syphilis TP antibody assay


Hospital Authority - Kwong Wah Hospital, Department of Pathology 醫院管理局 - 廣華醫院病理部 Microbiology Laboratory: 7/F, Yu Chun Keung Memorial Medical Centre

余振強紀念醫療中心七樓







Clinical Bacteriology - General Microbiology Blood Culture Culture and antimicrobial susceptibility tests for and infection pathogens by - Conventional method Method as documented in WI-MIC-BAC-BLOOD - Broth Culture BACT/ALERT Urinalysis and/or urine microscopy Urine Urine formed elements by Microscopic examination with fixed volume Method as documented in WI-MIC-BAC-URINE in microtitre plate Urine chemical test Method as documented in WI-MIC-BAC-URINE - Glucose - Protein -

- -


Annex II

List of examinations for which accreditation has been terminated (Notification Letter No. HOKLAS833P-10; Effective date of termination: 10 March 2015)

Hospital Authority - Kwong Wah Hospital, Department of Pathology 醫院管理局 - 廣華醫院病理部 Mycobacteriology Laboratory: 9/F, Yu Chun Keung Memorial Medical Centre

余振強紀念醫療中心九樓 DISCIPLINE 專科範疇





Accreditation of the following examinations has been terminated.

Medical Molecular Genetics Genetics Culture isolates Identification of Mycobacterium

b l i

complex or Mycobacterium avium l b

Nucleic acid hybridisation Method as documented in WI-MIC-MYC-IDMTB and (Target region: rRNA) WI-MIC-MYC-IDMAC using Accuprobe Culture Identification Test Kit Identification of Neisseria gonorrhoeae by Nucleic acid hybridisation Method as documented in WI-MIC-BAC-IDGCC using (Target region: rRNA) Accuprobe Culture Identification Test Kit

HOKLAS833P-10, Annex II Page 1 of 1

Annex III

List of examinations for which accreditation has been terminated (Case ID: HOKLAS833P.005; Notification Letter No. HOKLAS833P-8)



0BDISCIPLINE 1B專科範疇






10BAccreditation of the following examinations has been terminated.

Chemical Blood gases and Pathology Co-oximetry

Heparinized whole blood Blood Gas include: pCO2 by Potentiometry (pCO2-Sensing Siemens, Rapid Lab 800 series Electrode) pH by Potentiometry (Ion Selective Siemens, Rapid Lab 800 series Electrode) pO2 by Polarography (Oxygen-Sensing Siemens, Rapid Lab 800 series

Amperometric Electrode) Base Excess by Calculation Siemens, Rapid Lab 800 series Bicarbonate by

Calculation Siemens, Rapid Lab 800 series CO2 by Calculation Siemens, Rapid Lab 800 series O2 Saturation by

Calculation Siemens, Rapid Lab 800 series Carboxyhaemoglobin by Co-oximetry Siemens, Rapid Lab 800 series Ionized Calcium by Potentiometry (Ion Selective Siemens, Rapid Lab 800 series Electrode) Methaemoglobin by Co-oximetry Siemens, Rapid Lab 800 series

HOKLAS833P-8, Annex III Page 1 of 2



11BDISCIPLINE 12B專科範疇






21BAccreditation of the following examinations has been terminated.

Immunology Autoantibodies Serum Thyroid Autoantibodies by Haemagglutination SERODIA-ATG & AMC Kits

HOKLAS833P-8, Annex III Page 2 of 2

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