10
Annex III List of examinations for which accreditation has been terminated (Notification Letter No. HOKLAS810P-26; Effective date of termination: 31 December 2017) Hospital Authority - North District Hospital, Department of Pathology 醫院管理局,北區醫院,病理部 Haematology Laboratory and Blood Bank: 2/F, North District Hospital, 9 Po Kin Road, Sheung Shui 香港新界上水保健路九號北區醫院二樓 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. Haematology Coagulation Citrate blood Coagulation studies by Automated method, including Automated coagulation system: - Prothrombin time (PT) ACL TOP coagulometer - Activated partial thromboplastin time (APTT) Haematology – General EDTA whole blood Complete blood count by Automated method, including Automated systems: - Haemoglobin Beckman LH755 Haematology System - Haematocrit - Leucocyte count (WBC count) - Mean corpuscular volume (MCV) - Mean corpuscular haemoglobin concentration (MCHC) - Mean corpuscular haemoglobin (MCH) - Mean Platelet Volume (MPV) - Platelet count - Red cell count - Red cell distribution width (RDW) Leucocyte differential count by Automated method Beckman LH755 Haematology System Reticulocyte count by Automated method Beckman LH755 Haematology System Immunology Autoantibodies Serum Rheumatoid factor by Latex agglutination Method as documented in NH-TM-05-04 NL No. HOKLAS810P-26, Annex III Page 1 of 2

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Page 1: Hospital Authority - North District Hospital, Department ... · Spectrophotometry Beckman Coulter UniCel DxC880i AMY7 Assay . Plasma Aspartate Transaminase (AST) by . Spectrophotometry

Annex III

List of examinations for which accreditation has been terminated (Notification Letter No. HOKLAS810P-26; Effective date of termination: 31 December 2017)

Hospital Authority - North District Hospital, Department of Pathology 醫院管理局,北區醫院,病理部 Haematology Laboratory and Blood Bank: 2/F, North District Hospital, 9 Po Kin Road, Sheung Shui 香港新界上水保健路九號北區醫院二樓

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.

Haematology Coagulation Citrate blood Coagulation studies by

Automated method, including Automated coagulation system:

- Prothrombin time (PT) ACL TOP coagulometer

- Activated partial thromboplastin time

(APTT)

Haematology – General

EDTA whole blood Complete blood count by

Automated method, including Automated systems:

- Haemoglobin Beckman LH755 Haematology System

- Haematocrit

- Leucocyte count (WBC count)

- Mean corpuscular volume (MCV)

- Mean corpuscular haemoglobin concentration (MCHC)

- Mean corpuscular haemoglobin (MCH)

- Mean Platelet Volume (MPV)

- Platelet count - Red cell count - Red cell distribution width (RDW) Leucocyte differential count by Automated method Beckman LH755 Haematology System Reticulocyte count by Automated method Beckman LH755 Haematology System

Immunology Autoantibodies

Serum Rheumatoid factor by Latex agglutination Method as documented in NH-TM-05-04

NL No. HOKLAS810P-26, Annex III Page 1 of 2

Page 2: Hospital Authority - North District Hospital, Department ... · Spectrophotometry Beckman Coulter UniCel DxC880i AMY7 Assay . Plasma Aspartate Transaminase (AST) by . Spectrophotometry

Hospital Authority - North District Hospital, Department of Pathology 醫院管理局,北區醫院,病理部 Emergency Laboratory: 2/F, North District Hospital, 9 Po Kin Road, Sheung Shui 香港新界上水保健路九號北區醫院二樓

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.

Haematology

Coagulation

Citrate blood Coagulation studies by

Automated method, including Automated coagulation system:

- Prothrombin time (PT) ACL TOP coagulometer

- Activated partial thromboplastin time

(APTT)

Haematology – General

EDTA whole blood Complete blood count by

Automated method, including Automated systems:

- Haemoglobin Beckman LH755 Haematology System

- Haematocrit

- Leucocyte count (WBC count)

- Mean corpuscular volume (MCV)

- Mean corpuscular haemoglobin

concentration (MCHC)

- Mean corpuscular haemoglobin (MCH)

- Mean Platelet Volume (MPV)

- Platelet count - Red cell count - Red cell distribution width (RDW) Leucocyte differential count by Automated method Beckman LH755 Haematology System

NL No. HOKLAS810P-26, Annex III Page 2 of 2

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Annex II

List of examinations for which accreditation has been terminated (Notification Letter No. HOKLAS810P-22; Effective date of termination: 1 July 2016)

Hospital Authority - North District Hospital, Department of Pathology 醫院管理局,北區醫院,病理部 Chemical Pathology Laboratory: 2/F, North District Hospital, 9 Po Kin Road, Sheung Shui

香港新界上水保健路九號北區醫院二樓

MEDICAL TESTING DISCIPLINE 專科範疇

TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類

SPECIFIC EXAMINATIONS OR PROPERTIES 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 examinations has been terminated.

Chemical General chemistry Pathology Plasma Troponin I by Immunoassay (Chemiluminescent label) Access II Troponin I Assay Special chemistry Stool Occult blood by Guaiac (Chemical) Test Helena Coloscreen Tape

Emergency Laboratory: 2/F, North District Hospital, 9 Po Kin Road, Sheung Shui

香港新界上水保健路九號北區醫院二樓

MEDICAL TESTING DISCIPLINE 專科範疇

TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類

SPECIFIC EXAMINATIONS OR PROPERTIES 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 examinations has been terminated.

Chemical General chemistry Pathology Plasma Troponin I by Immunoassay (Chemiluminescent label) Access II Troponin I Assay

HOKLAS810P-22, Annex II Page 1 of 1

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Annex III

List of examinations for which accreditation has been terminated (Notification Letter No. HOKLAS810P-20; Effective date of termination: 5 January 2016)

Hospital Authority - North District Hospital, Department of Pathology 醫院管理局,北區醫院,病理部 Chemical Pathology Laboratory: 2/F, North District Hospital, 9 Po Kin Road, Sheung Shui

香港新界上水保健路九號北區醫院二樓

0 BMEDICAL TESTING 1BDISCIPLINE

2B專科範疇

3BTEST AREA 4BOR SAMPLE TYPE

5B測試範圍或樣本種類

6 BSPECIFIC EXAMINATIONS OR 7 BPROPERTIES MEASURED

8 B特定測試或量度的特性

9BMETHOD 10BOR TECHNIQUE USED

11B方法或應用技術

Accreditation of the following examinations has been terminated.

Chemical General chemistry Pathology Plasma, Body fluid Oxyhaemoglobin by Co-oximetry Siemens Rapid Lab 1265 blood gases analyser pCO2 by Potentiometry (pCO2-Sensing Electrode) Siemens Rapid Lab 1265 blood gases analyser pH by Potentiometry (Ion Selective Electrode) Siemens Rapid Lab 1265 blood gases analyser pO2 by Potentiometry (Oxygen-Sensing Amperometric Siemens Rapid Lab 1265 blood gases analyser Electrode) urine Globulin by Calculation Beckman Coulter AU2700 – Calculated from Protein, Total and Albumin Glucose, Fasting by Spectrophotometry Beckman Coulter AU2700 Glucose Assay

Haematology Laboratory and Blood Bank : 2/F, North District Hospital, 9 Po Kin Road, Sheung Shui

香港新界上水保健路九號北區醫院二樓

1 2 BMEDICAL TESTING 13BDISCIPLINE

14B專科範疇

15BTEST AREA 16BOR SAMPLE TYPE

17B測試範圍或樣本種類

1 8 BSPECIFIC EXAMINATIONS OR 1 9 BPROPERTIES MEASURED

2 0 B特定測試或量度的特性

21BMETHOD 22BOR TECHNIQUE USED

23B方法或應用技術

Accreditation of the following examinations has been terminated.

Haematology Haematology – General EDTA whole blood Erythrocyte sedimentation rate (ESR) by Manual method Manual method as documented in NH-TM-05-07

HOKLAS810P-20, Annex III Page 1 of 1

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Annex III

List of activities for which accreditation has been terminated (Notification Letter No. HOKLAS810P-18; Effective date of termination: 1 March 2015)

Hospital Authority - North District Hospital, Department of Pathology 醫院管理局,北區醫院,病理部 Chemical Pathology Laboratory: 2/F, North District Hospital, 9 Po Kin Road, Sheung Shui

香港新界上水保健路九號北區醫院二樓

0BDISCIPLINE 1B專科範疇

2BTEST AREA 3BOR SAMPLE TYPE

4B測試範圍或樣本種類

5 BSPECIFIC EXAMINATIONS OR 6 BPROPERTIES MEASURED

7 B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 examinations has been terminated.

Chemical General chemistry Pathology Plasma, body fluid Alanine transaminase (ALT) by Spectrophotometry Beckman Coulter UniCel DxC880i ALT Assay Albumin by Spectrophotometry Beckman Coulter UniCel DxC880i Albumin Assay Alkaline Phosphatase (ALP) by Spectrophotometry Beckman Coulter UniCel DxC880i ALP Assay Plasma Ammonia by Spectrophotometry Beckman Coulter UniCel DxC880i Ammonia Assay Plasma, body fluid Amylase by Spectrophotometry Beckman Coulter UniCel DxC880i AMY7 Assay Plasma Aspartate Transaminase (AST) by Spectrophotometry Beckman Coulter UniCel DxC880i AST Assay Bilirubin, Direct by Spectrophotometry Beckman Coulter UniCel DxC880i Direct Bilirubin Assay Plasma, body fluid Bilirubin, Total by Spectrophotometry Beckman Coulter UniCel DxC880i Total Bilirubin Assay Calcium by Potentiometry (Ion Selective Electrode) Beckman Coulter UniCel DxC880i Modular Calcium Assay Plasma, body fluid, CSF Chloride by Potentiometry (Ion Selective Electrode) Beckman Coulter UniCel DxC880i Chloride Assay Plasma, body fluid Cholesterol by Spectrophotometry Beckman Coulter UniCel DxC880i Cholesterol Assay Plasma Cholesterol, high density lipoproteins by Spectrophotometry Beckman Coulter UniCel DxC880i HDL-Cholesterol Assay Cholesterol, low density lipoproteins by Spectrophotometry Beckman Coulter UniCel DxC880i LDL Direct Assay

NL HOKLAS810P-18-Annex III Page 1 of 5

Page 6: Hospital Authority - North District Hospital, Department ... · Spectrophotometry Beckman Coulter UniCel DxC880i AMY7 Assay . Plasma Aspartate Transaminase (AST) by . Spectrophotometry

Hospital Authority - North District Hospital, Department of Pathology 醫院管理局,北區醫院,病理部 Chemical Pathology Laboratory: 2/F, North District Hospital, 9 Po Kin Road, Sheung Shui

香港新界上水保健路九號北區醫院二樓

11BDISCIPLINE 12B專科範疇

13BTEST AREA 14BOR SAMPLE TYPE

15B測試範圍或樣本種類

1 6 BSPECIFIC EXAMINATIONS OR 1 7 BPROPERTIES MEASURED

1 8 B特定測試或量度的特性

19BMETHOD 20BOR TECHNIQUE USED

21B方法或應用技術

Accreditation of the following examinations has been terminated.

Chemical General chemistry Pathology (cont’d) (cont’d) Plasma, body fluid Creatine kinase by Spectrophotometry Beckman Coulter UniCel DxC880i Creatine Kinase Assay Creatinine by Spectrophotometry Beckman Coulter UniCel DxC880i Modular Creatinine Assay Plasma, urine Gamma glutamyl transferase (GGT) by Spectrophotometry Beckman Coulter UniCel DxC880i GGT Assay Glucose, Fasting by Spectrophotometry Beckman Coulter UniCel DxC880i Glucose Assay Plasma, body fluid, CSF Glucose, Spot by Spectrophotometry Beckman Coulter UniCel DxC880i Glucose Assay Plasma Glucose, OGTT (Dynamic Function Test) by Spectrophotometry Beckman Coulter UniCel DxC880i Glucose Assay Iron by Spectrophotometry Beckman Coulter UniCel DxC880i Iron Assay Plasma, CSF Lactate by Spectrophotometry Beckman Coulter UniCel DxC880i Lactate Assay Plasma, body fluid Lactate Dehydrogenase (LDH) by Spectrophotometry Beckman Coulter UniCel DxC880i LDH Assay Body fluid pH by Potentiometry (Ion Selective Electrode) Beckman pH meter Plasma, body fluid Phosphate by Spectrophotometry Beckman Coulter UniCel DxC880i Modular Inorganic phosphorus Assay Potassium by Potentiometry Beckman Coulter UniCel DxC880i Potassium Assay Protein, Total by Spectrophotometry Beckman Coulter UniCel DxC880i Modular Total Protein Assay CSF Protein, Total by Spectrophotometry Beckman Coulter UniCel DxC880i Micro Total Protein Assay Plasma, body fluid Sodium by Potentiometry Beckman Coulter UniCel DxC880i Sodium Assay

NL HOKLAS810P-18-Annex III Page 2 of 5

Page 7: Hospital Authority - North District Hospital, Department ... · Spectrophotometry Beckman Coulter UniCel DxC880i AMY7 Assay . Plasma Aspartate Transaminase (AST) by . Spectrophotometry

Hospital Authority - North District Hospital, Department of Pathology 醫院管理局,北區醫院,病理部 Chemical Pathology Laboratory: 2/F, North District Hospital, 9 Po Kin Road, Sheung Shui

香港新界上水保健路九號北區醫院二樓

22BDISCIPLINE 23B專科範疇

24BTEST AREA 25BOR SAMPLE TYPE

26B測試範圍或樣本種類

2 7 BSPECIFIC EXAMINATIONS OR 2 8 BPROPERTIES MEASURED

2 9 B特定測試或量度的特性

30BMETHOD 31BOR TECHNIQUE USED

32B方法或應用技術

Accreditation of the following examinations has been terminated.

Chemical General chemistry Pathology (cont’d) (cont’d) Plasma Total Iron Binding Capacity (TIBC) by Calculation Beckman Coulter UniCel DxC880i - Calculated from Transferrin by formula Transferrin (non-reportable) by Spectrophotometry Beckman Coulter UniCel DxC880i – Transferrin Assay Plasma, body fluid Triglycerides by Spectrophotometry Beckman Coulter UniCel DxC880i Triglycerides Assay Urate by Spectrophotometry Beckman Coulter UniCel DxC880i Uric Acid plus Assay Urea by Spectrophotometry Beckman Coulter UniCel DxC880i Modular Urea/Urea Nitrogen Assay Urine Amylase by Spectrophotometry Beckman Coulter UniCel DxC880i AMY7 Assay Calcium by Potentiometry (Ion Selective Electrode) Beckman Coulter UniCel DxC880i Modular Calcium Assay Chloride by Potentiometry (Ion Selective Electrode) Beckman Coulter UniCel DxC880i Chloride Assay Creatinine by Spectrophotometry Beckman Coulter UniCel DxC880i Modular Creatinine Assay pH by Potentiometry (Ion Selective Electrode) Beckman pH meter Phosphate by Spectrophotometry Beckman Coulter UniCel DxC880i Modular Inorganic phosphorus Assay Potassium by Potentiometry Beckman Coulter UniCel DxC880i Potassium Assay Protein, Total by Spectrophotometry Beckman Coulter UniCel DxC880i Micro Total Protein Assay Sodium by Potentiometry Beckman Coulter UniCel DxC880i Sodium Assay Urate by Spectrophotometry Beckman Coulter UniCel DxC880i Uric Acid plus Assay

NL HOKLAS810P-18-Annex III Page 3 of 5

Page 8: Hospital Authority - North District Hospital, Department ... · Spectrophotometry Beckman Coulter UniCel DxC880i AMY7 Assay . Plasma Aspartate Transaminase (AST) by . Spectrophotometry

Hospital Authority - North District Hospital, Department of Pathology 醫院管理局,北區醫院,病理部 Chemical Pathology Laboratory: 2/F, North District Hospital, 9 Po Kin Road, Sheung Shui

香港新界上水保健路九號北區醫院二樓

33BDISCIPLINE 34B專科範疇

35BTEST AREA 36BOR SAMPLE TYPE

37B測試範圍或樣本種類

3 8 BSPECIFIC EXAMINATIONS OR 3 9 BPROPERTIES MEASURED

4 0 B特定測試或量度的特性

41BMETHOD 42BOR TECHNIQUE USED

43B方法或應用技術

Accreditation of the following examinations has been terminated.

Chemical General chemistry Pathology (cont’d) (cont’d) Urine Urea by Spectrophotometry Beckman Coulter UniCel DxC880i Modular Urea/Urea Nitrogen Assay Toxicology Serum Acetaminophen (Paracetamol) by Spectrophotometry Beckman Coulter UniCel DxC880i Acetaminophen Assay Ethanol by Spectrophotometry Beckman Coulter UniCel DxC880i Ethanol Assay Salicylate by Spectrophotometry Beckman Coulter UniCel DxC880i Salicylate Assay Emergency Laboratory: 2/F, North District Hospital, 9 Po Kin Road, Sheung Shui 香港新界上水保健路九號北區醫院二樓

44BDISCIPLINE 45B專科範疇

46BTEST AREA 47BOR SAMPLE TYPE

48B測試範圍或樣本種類

4 9 BSPECIFIC EXAMINATIONS OR 5 0 BPROPERTIES MEASURED

5 1 B特定測試或量度的特性

52BMETHOD 53BOR TECHNIQUE USED

54B方法或應用技術

Accreditation of the following examinations has been terminated.

Chemical General chemistry Pathology Plasma Ammonia by

Spectrophotometry Beckman Coulter UniCel DxC880i Ammonia Assay

Aspartate Transaminase (AST) by

Spectrophotometry Beckman Coulter UniCel DxC880i AST Assay

Bilirubin, Direct by

Spectrophotometry Beckman Coulter UniCel DxC880i Direct Bilirubin Assay

Calcium by

Potentiometry (Ion Selective Electrode) Beckman Coulter UniCel DxC880i Modular Calcium Assay

Creatine kinase by

Spectrophotometry Beckman Coulter UniCel DxC880i Creatine Kinase Assay

Plasma, CSF Glucose by

Spectrophotometry Beckman Coulter UniCel DxC880i Glucose Assay

Lactate by

Spectrophotometry Beckman Coulter UniCel DxC880i Lactate Assay

NL HOKLAS810P-18-Annex III Page 4 of 5

Page 9: Hospital Authority - North District Hospital, Department ... · Spectrophotometry Beckman Coulter UniCel DxC880i AMY7 Assay . Plasma Aspartate Transaminase (AST) by . Spectrophotometry

Hospital Authority - North District Hospital, Department of Pathology 醫院管理局,北區醫院,病理部 Emergency Laboratory: 2/F, North District Hospital, 9 Po Kin Road, Sheung Shui 香港新界上水保健路九號北區醫院二樓

55BDISCIPLINE 56B專科範疇

57BTEST AREA 58BOR SAMPLE TYPE

59B測試範圍或樣本種類

6 0 BSPECIFIC EXAMINATIONS OR 6 1 BPROPERTIES MEASURED

6 2 B特定測試或量度的特性

63BMETHOD 64BOR TECHNIQUE USED

65B方法或應用技術

Accreditation of the following examinations has been terminated.

Chemical General chemistry Pathology (cont’d)

Plasma Lactate Dehydrogenase (LDH) by

Spectrophotometry Beckman Coulter UniCel DxC880i LDH Assay

Liver Function Test by

Spectrophotometry , including Beckman Coulter UniCel DxC880i respective assays

- Albumin

- ALP

- ALT

- Globulin (calculated)

- Total Bilirubin

- Total Protein

Plasma Phosphate by

Spectrophotometry Beckman Coulter UniCel DxC880i Modular Inorganic

Phosphorus Assay

Urine Potassium by

Potentiometry (Ion Selective Electrode) Beckman Coulter UniCel DxC880i Potassium Assay

CSF Protein, Total by

Spectrophotometry Beckman Coulter UniCel DxC880i Micro Total Protein Assay

Plasma Renal Function Test by

Potentiometry and Spectrophotometry,

including Beckman Coulter UniCel DxC880i respective assays

- Creatinine

- Potassium

- Sodium

- Urea

Urine Sodium by

Potentiometry (Ion Selective Electrode) Beckman Coulter UniCel DxC880i Sodium Assay

Toxicology

Serum Acetaminophen (Paracetamol) by

Spectrophotometry Beckman Coulter UniCel DxC880i Acetaminophen Assay

Ethanol by

Spectrophotometry Beckman Coulter UniCel DxC880i Ethanol Assay

Salicylate by

Spectrophotometry Beckman Coulter UniCel DxC880i Salicylate Assay

Examination performed after consulting duty biochemist Chemical General chemistry Pathology Plasma Iron by

Spectrophotometry Beckman Coulter UniCel DxC880i Iron Assay

NL HOKLAS810P-18-Annex III Page 5 of 5

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Annex III

List of examinations for which accreditation has been terminated (Notification Letter No. 810P-16; Effective date of termination: 1 October 2014)

Hospital Authority - Department of Pathology, North District Hospital (NDH) 醫院管理局,北區醫院,病理部 Haematology Laboratory and Blood Bank : 2/F, North District Hospital, 9 Po Kin Road, Sheung Shui

香港新界上水保健路九號北區醫院二樓

0BDISCIPLINE 1B專科範疇

2 BTEST AREA 3BOR SAMPLE TYPE

4B測試範圍或樣本種類

5 BSPECIFIC EXAMINATION OR 6 BPROPERTY MEASURED

7 B特定測試或量度的特性

8BMETHOD 9BOR TECHNIQUE USED

10B方法或應用技術

Haematology Coagulation Citrate blood Fibrinogen by Automated method Automated coagulation system: ACL TOP coagulometer

Page 1 of 1