National Association of Testing Authorities, Australia
Scope of Accreditation
NSW Health Pathology
Site
NSW Health Pathology Concord Hospital Laboratory
Accreditation No.
2146
Site No.
2107
Date of Accreditation
13 Sep 1985
Address
2 Hospital Road
Concord Repatriation Hospital, NSW 2139
Australia
Contact
Ms Wafa Jeha
P: +61 (02) 98285082
Availability
Services available to external clients
Supervision
GX (General)
Scope of Accreditation
Anatomical Pathology/Cytology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
24 Jan 2027
Last Activity Date
05 Jul 2023
| Service | Product | Determinant |
|---|---|---|
| Anatomical pathology - Cytopathology - Non-gynaecological cytological investigations of body fluids, exudates, washings and brushings from non-squamous mucosal sites for the detection of malignancy | Aspirates; Bronchial lavage; Cerebrospinal fluid (CSF); Ocular specimens; Other body fluids; Sputum; Tumour tissue; Urine; Vitreous specimens; Washings or brushings from other sites | Cytological examination; Immediate imprint cytology diagnosis; Rapid onsite evaluation (ROSE); Review and reporting of cytology samples |
| Anatomical pathology - Cytopathology - Non-gynaecological cytological investigations on samples obtained via fine needle aspiration biopsy | Fine needle aspirates (FNA) | Cytological examination; Immediate imprint cytology diagnosis; Rapid onsite evaluation (ROSE); Review and reporting of fine needle aspiration samples |
| Anatomical pathology - Tissue pathology - Examination of biopsy material | Brain - Whole; Brain tissue; Formalin fixed tissue; Fresh tissue; Muscle; Nerve biopsy; Smears; Spinal cord | Review and reporting of biopsy material to identify or exclude morphological abnormalities |
| Anatomical pathology - Tissue pathology - Examination of biopsy material by electron microscopy | Fluids; Formalin fixed tissue; Fresh tissue; Gluteraldehyde tissue; Leucocyte (leukocyte) buffy coat; Nasal brushings; Platelets; Smears | Review and reporting of biopsy material to identify or exclude ultra-structural morphological abnormalities; Structured reporting |
| Anatomical pathology - Tissue pathology - Gene probes using paraffin fluorescence in-situ hybridisation (FISH) | Formalin-fixed paraffin-embedded (FFPE) tissues | Detection of nucleic acid targets - Various |
| Anatomical pathology - Tissue pathology - Immediate frozen section diagnosis | Fresh tissue; Sentinel node; Smears; Tissue imprint | Immediate imprint cytology diagnosis; Intra-operative consultation and examination of biopsy material; Rapid onsite evaluation (ROSE) |
| Anatomical pathology - Tissue pathology - Immunohistochemical investigation | Fixed cytological smears; Formalin-fixed paraffin-embedded (FFPE) tissues; Fresh tissue; Frozen sections of fresh tissue | Detection of antigenic targets - Various |
Diagnostic Pathology Unit
ISO 15189 (2022)
Human Pathology
Medicare expiry date
24 Jan 2027
Last Activity Date
05 Jul 2023
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Analysis of calculus | Calculi | Calcium; Carbonate; Cysteine; Magnesium; Oxalate; Phosphate; Uric acid |
| Chemical pathology - Analysis of drugs for toxicological (non-legal) purposes and ingested or absorbed toxic chemicals | Serum | Ethanol |
| Urine | Benzodiazepines; Cannabinoids; Cocaine; Ethylglucuronide (ETG); Methadone; Opiates; Sympathomimetic amines | |
| Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring | Plasma; Serum | Amikacin; Carbamazepine; Gentamicin (cidomycin, septopal, genticyn, garamycin); Lithium; Methotrexate; Paracetamol (acetaminophen); Phenytoin (dilantin); Valproate (valproic acid, epilim); Vancomycin |
| Digoxin | ||
| Chemical pathology - Detection and/or quantitation of tumour markers | Faeces | Blood |
| Plasma; Serum | β2-Microglobulin (B2M) | |
| Serum | Prostate specific antigen (PSA); Prostate specific antigen (PSA) fractions and derived index | |
| CA125 antigen (CA125); CA15-3 antigen (CA15-3); Carcinoembryonic antigen (CEA); α-Fetoprotein (AFP) | ||
| Human chorionic gonadotropin (hCG) | ||
| Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) | Plasma; Serum | Cortisol; Follicle stimulating hormone (FSH); Luteinising hormone (LH); Oestradiol; Parathyroid hormone (PTH); Prolactin; Sex hormone binding globulin (SHBG); Testosterone |
| Serum | Procalcitonin | |
| Chemical pathology - Diagnosis and management of diabetes mellitus | Blood | Glycated haemoglobin (HbA1c) |
| Plasma; Serum | Blood glucose | |
| Chemical pathology - Further investigation of cardiac function | Plasma; Serum | Creatine kinase MB (CKMB); N-Terminal-pro b-type natriuretic peptide (NT-proBNP); Troponin T |
| Pleural fluid | N-Terminal-pro b-type natriuretic peptide (NT-proBNP) | |
| Chemical pathology - Further investigation of renal and/or hepatic function | Plasma; Serum | Prealbumin |
| Urine | Uric acid | |
| Chemical pathology - Haem related pigments and precursors (excluding porphyria) | Serum | Haptoglobins |
| Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Ascitic fluid; Drainage fluid | Albumin; Cholesterol - Total; Glucose; Lactate dehydrogenase (LDH); Protein - Total; Triglycerides |
| Cerebrospinal fluid (CSF) | Glucose; Protein - Total | |
| Plasma; Serum | Alanine aminotransferase; Albumin; Alkaline phosphatase; Amylase; Aspartate aminotransferase; Bicarbonate; Bilirubin - Any fractions; C-reactive protein (CRP); Calcium - Total; Chloride; Creatine kinase; Creatinine; Glucose; Lactate dehydrogenase (LDH); Lipase; Magnesium; Phosphate; Potassium; Protein - Total; Sodium; Urea; Uric acid; γ-Glutamyltransferase | |
| Cholesterol - LDL; Cholesterol - Total; HDL - Quantitation; Triglycerides | ||
| Pleural fluid | Albumin; Amylase; Bilirubin - Total; Cholesterol - Total; Glucose; Lactate dehydrogenase (LDH); Lipase; Protein - Total; Triglycerides; Uric acid | |
| Serum | Carbohydrate deficient transferrin | |
| Serum; Urine | Osmolality | |
| Urine | Calcium - Total; Chloride; Creatinine; Microalbumin; Phosphate; Potassium; Protein - Total; Sodium; Urea | |
| Chemical pathology - Investigation for folate deficiency | Serum | Folate |
| Chemical pathology - Iron studies | Serum | Ferritin; Iron; Transferrin |
| Chemical pathology - Markers of bone metabolism | Plasma; Serum | Procollagen type 1 N-terminal propeptide (P1NP); β-Crosslaps (CTX) |
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Base excess; Calcium - Ionised; Carboxyhaemoglobin; Creatinine; Deoxyhaemoglobin (HHb); Glucose; Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH |
| Base excess; Calcium - Ionised; Carboxyhaemoglobin; Chloride; Glucose; Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH | ||
| Chemical pathology - Quantitation of precursor and intermediary metabolites | Urine | Citrate |
| Chemical pathology - Quantitation of vitamins | Serum | Cobalamin (vitamin B12) |
| 1,25-Dihydroxyvitamin D; 25-Hydroxyvitamin D | ||
| Holotranscobalamin (active vitamin B12) | ||
| Chemical pathology - Tests for thyroid function | Plasma; Serum | Thyroid stimulating hormone (TSH); Thyroxine (T4) - Free; Triiodothyronine (T3) - Free |
| Haematology - Bone marrow examination | Bone marrow | Examination of aspirated material |
| Haematology - Examination of blood films by special staining | Blood | Malaria |
| Iron | ||
| Blood; Bone marrow; Urine | Haemosiderin; Iron | |
| Haematology - Full blood examination | Blood | Differential number; Morphology |
| Erythrocyte count (red blood cell count, RBCC); Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Leucocyte count (white blood cell count, WBCC); Platelet count; Red blood cell index or indices; Reticulocytes | ||
| Haematology - Haemostasis related analysis (including special coagulation testing and platelet function tests) | Blood | Activated partial thromboplastin time (APTT); Activated protein C (APC) resistance; Anti-Xa - Apixaban; Anti-Xa - Dabigatran; Anti-Xa - Rivaroxaban; Anti-Xa activity; Anti-Xa activity - Clexane - Low molecular weight heparin; Anti-Xa activity - Fragmin - Low molecular weight heparin; Anti-Xa activity - Heparin activity; Anti-Xa activity - Unfractionated heparin; Anti-thrombin III; D-dimer; Echis test; Factor II; Factor IX; Factor V; Factor VII; Factor VIII; Factor X; Factor XI; Factor XII; Fibrinogen; Heparin induced thrombotic thrombocytopenia (HITT); Lupus anticoagulant; Mixing studies - APTT; Protein C and protein S; Prothrombin time (PT); Prothrombin time (PT) mixing studies; Thrombin time (TT); Tinzaparin anti-XA assays; Von Willebrand factor (vWF) antigen - Quantitation |
| Plasma | Vaccine-induced thrombotic thrombocytopenia (VITT) | |
| Haematology - Investigation of haemolysis | Blood | Cold agglutinins |
| Haematology - Limited blood examination | Blood | Erythrocyte (RBC) sedimentation rate (ESR) |
| Immunohaematology - Blood group antibody detection | Blood; Plasma | Duffy system; Kell system; M and N factors; Other blood group systems; Rh phenotypes |
| Immunohaematology - Blood grouping | Blood; Plasma | ABO; RhD |
| Immunohaematology - Determination of compatibility of blood donor units | Blood; Plasma | Direct antiglobulin test (DAT, direct Coombs test); Electronic crossmatch; Examination for blood group antibodies; Group checks of patient and donor; Identification of detected antibodies; Indirect antiglobulin test (IAT) |
| Immunohaematology - Identification and quantitation of blood group antibodies | Blood | Antibody elution |
| Blood; Plasma | Antibody absorption; Antibody titration | |
| Other blood group antibodies; Red blood cell phenotyping; Rh | ||
| Immunohaematology - Investigation of blood transfusion reactions | Blood; Blood products | Antibodies; Contamination - Microbiological; Direct antiglobulin test (DAT, direct Coombs test); Examination for blood group antibodies; Group checks of patient and donor; Identification of detected antibodies |
| Immunohaematology - Issue and release of blood and blood product for transfusion | Blood; Blood products; Cryoprecipitate; Fresh frozen plasma (FFP); Platelets | Issue and release of blood and blood products for transfusion |
| Immunohaematology - Storage and distribution of blood and blood components | Blood; Blood products; Cryoprecipitate; Fresh frozen plasma (FFP); Platelets | Issue and release of blood and blood products for transfusion |
| Immunopathology - Characterisation of leucocyte surface antigens (including immunophenotyping) | Aspirates; Blood; Bone marrow; Cerebrospinal fluid (CSF); Disaggregated tissues specimen; Fresh tissue; Lavage; Serous fluid | CD10; CD103; CD117; CD11b; CD11c; CD123; CD13; CD138; CD14; CD15; CD16; CD19; CD1a; CD2; CD20; CD200; CD22; CD23; CD235a; CD25; CD27; CD28; CD3; CD30; CD33; CD34; CD38; CD4; CD45; CD5; CD57; CD61; CD64; CD7; CD71; CD79a; CD8; FMC7; HLA-DR1; Immunoglobulin D (IgD); Immunoglobulin M (IgM); Kappa light chains; Lambda light chains; Myeloperoxidase; T-cell receptor aβ (TCRab); Terminal deoxynucleotidyl transferase (TdT) |
| Immunopathology - Procedures related to the collection, processing, storage and issue of human haemopoietic progenitor cells | Blood | Enumeration of CD34+ cells |
| Infertility and pregnancy tests including assisted reproductive technology - Diagnosis of pregnancy | Serum | Human chorionic gonadotropin (hCG) |
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Blood | Malaria |
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Blood | Infectious mononucleosis |
Emergency Department
ISO 15189 (2022)
Human Pathology
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Base excess; Calcium - Ionised; Carboxyhaemoglobin; Chloride; Glucose; Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH |
Intensive Care Unit
ISO 15189 (2022)
Human Pathology
Medicare expiry date
24 Jan 2027
Last Activity Date
05 Jul 2023
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Blood | Calcium - Ionised; Chloride; Creatinine; Glucose; Potassium; Sodium; Total carbon dioxide (TCO2); Urea |
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Base excess; Bicarbonate; Lactate; Oxygen saturation (sO2); Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Total carbon dioxide (TCO2); pH |
| Base excess; Calcium - Ionised; Carboxyhaemoglobin; Deoxyhaemoglobin (HHb); Glucose; Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH | ||
| Haematology - Full blood examination | Blood | Haematocrit (packed cell volume, PCV); Haemoglobin (Hb) |
Microbiology and Infectious Diseases
ISO 15189 (2022)
Human Pathology
Medicare expiry date
24 Jan 2027
Last Activity Date
05 Jul 2023
| Service | Product | Determinant |
|---|---|---|
| Microbiology - Bacteriology - Detection of pathogenic bacteria | Bacterial isolates | Streptococcus group B screening; Carbapenem resistant Enterobacteriaceae (CRE); Extended spectrum beta-lactamases (ESBL); Methicillin resistant Staphylococcus aureus (MRSA); Vancomycin resistant Enterococci (VRE) |
| Blood | Pathogenic identification and antibiotic susceptibility | |
| Cerebrospinal fluid (CSF); Ear swabs; Eye swabs; Fluids; Genital swabs; Nasopharyngeal swabs; Respiratory specimens; Sputum; Synovial fluid; Tissues; Wound swabs | Pathogenic identification and antibiotic susceptibility | |
| Faeces | Clostridioides difficile toxin | |
| Pathogenic identification and antibiotic susceptibility | ||
| Fat globules | ||
| Gastric biopsy | Helicobacter pylori | |
| Synovial fluid | Crystals | |
| Urine | Eosinophils | |
| Legionella antigen; Streptococcus pneumoniae antigen | ||
| Pathogenic identification | ||
| Pathogenic identification and antibiotic susceptibility | ||
| Casts | ||
| Microbiology - Environmental investigations and/or infection control | Blood transfusion bags; Environmental swabs; Gastrointestinal endoscopes; Vascular catheter tips | Detection and characterisation of organisms (including identification and typing); Pathogenic identification and antibiotic susceptibility |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (bacteria) | Bacterial isolates | Microbial identification |
| Vancomycin resistant Enterococci (VRE) | ||
| Carbapenem resistant Enterobacteriaceae (CRE) | ||
| Bacterial isolates; Blood culture | Methicillin resistant Staphylococcus aureus (MRSA) | |
| Blood culture | Methicillin resistant Staphylococcus aureus (MRSA) | |
| Faeces | Clostridioides difficile | |
| Campylobacter spp.; Clostridioides difficile; Salmonella spp.; Shigella spp. | ||
| Rectal swabs | Vancomycin resistant Enterococci (VRE) | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (fungi) | Fungal isolates | Fungi identification |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (mycobacteria) | Sputum | Mycobacterium rifampicin resistance rpoB; Mycobacteria identification |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (protozoan parasites) | Faeces | Cryptosporidium spp.; Dientamoeba fragilis; Entamoeba histolytica; Giardia spp. |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) | Bronchial washings; Bronchoalveolar lavage; Endotrachael aspirate; Nasal swabs; Nasopharyngeal aspirate; Nasopharyngeal swabs; Throat swabs | Influenza A virus; Influenza B virus; Respiratory syncytial virus (RSV) |
| Bronchoalveolar lavage; Endotrachael aspirate; Nasopharyngeal aspirate; Nasopharyngeal swabs; Sputum; Throat swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Faeces | Norovirus | |
| Nasal swabs; Nasopharyngeal aspirate; Nasopharyngeal swabs; Throat swabs | Influenza A virus; Influenza B virus; Respiratory syncytial virus (RSV) | |
| Microbiology - Molecular biology - Microbial DNA and/or RNA extraction | Bacterial isolates; Blood; Body fluids; Bronchial swabs; Bronchial washings; Bronchoalveolar lavage; Endotrachael aspirate; Faeces; Fluids; Fungal isolates; Hair; Liver aspirate; Nasal swabs; Nasopharyngeal and throat swab; Pleural fluid; Sputum; Tissues | DNA storage for future analyses; Purified PCR product; RNA storage for future analyses; Viable DNA; Viable DNA for sequencing; Viable RNA; Viable RNA for sequencing |
| Microbiology - Mycobacteriology - Detection and identification of mycobacteria | Faeces; Other body fluids; Respiratory specimens; Tissues; Urine | Mycobacteria detection; Mycobacteria identification |
| Microbiology - Mycology - Detection, isolation and/or identification of yeasts and/or fungal elements | Bronchial lavage; Nails; Respiratory specimens; Skin scrapings; Tissues; Wound swabs | Fungi identification; Fungi susceptibility; Yeast susceptibility; Yeasts identification |
| Cerebrospinal fluid (CSF); Serum | Cryptococcus antigen | |
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Blood; Faeces; Urine | Cysts; Ova; Parasites |
| Cysts; Ova; Parasites | ||
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Plasma | Hepatitis A virus antibody (anti-HAV) - IgM; Hepatitis A virus antibody (anti-HAV) - Total; Hepatitis B virus core antibody (anti-HBc) - Total; Hepatitis B virus surface antibody (anti-HBs); Hepatitis B virus surface antigen (HBs Ag); Hepatitis C virus (HCV); Hepatitis C virus antibody (anti-HCV); Human immunodeficiency virus (HIV) p24 antigen; Human immunodeficiency virus type 1/2 (HIV-1/2) 1/2 antibodies |
The only data displayed is that deemed relevant and necessary for the clear description of the activities and services covered by the scope of accreditation.
Grey text appearing in a SoA is additional freetext providing further refinement or information on the data in the preceding line entry.
Accreditation No.
2146
Site No.
2107
Print date
04 Jul 2024
END OF SCOPE
