National Association of Testing Authorities, Australia
Scope of Accreditation
Peter MacCallum Cancer Centre
Site
Department of Pathology
Accreditation No.
2465
Site No.
2458
Date of Accreditation
14 Sep 1988
Address
Victorian Comprehensive Cancer Centre (VCCC), 305 Grattan Street
Melbourne, VIC 3000
Australia
Contact
Ms Cathy Carolan
P: +61 (03) 85597284
Availability
Services available to external clients
Supervision
GX (General)
Scope of Accreditation
Department of Pathology
ISO 15189 (2022)
- This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.
Human Pathology
Medicare expiry date
08 Sep 2027
Last Activity Date
27 Feb 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring | Plasma; Serum | Vancomycin |
| Methotrexate | ||
| Chemical pathology - Detection and/or quantitation of tumour markers | Plasma; Serum | β2-Microglobulin (B2M) |
| Chromogranin A - Gen I | ||
| CA125 antigen (CA125); CA15-3 antigen (CA15-3); CA19-9 antigen (CA19-9); Carcinoembryonic antigen (CEA); Human chorionic gonadotropin (hCG); Prostate specific antigen (PSA); α-Fetoprotein (AFP) | ||
| 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; Progesterone; Prolactin; Testosterone |
| Chemical pathology - Diagnosis and management of diabetes mellitus | Blood | Glycated haemoglobin (HbA1c) |
| Chemical pathology - Further investigation of cardiac function | Plasma; Serum | Troponin I |
| Serum | N-Terminal-pro b-type natriuretic peptide (NT-proBNP) | |
| Chemical pathology - Further investigation of lipid profiles for diagnosis of types III and IV hyperlipidaemia | Plasma; Serum | HDL - Quantitation |
| Chemical pathology - Further investigation of renal and/or hepatic function | Plasma; Serum | Haptoglobins |
| Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Cerebrospinal fluid (CSF) | Glucose; Protein - Total |
| Other body fluids | Amylase; Glucose; Lipase; Protein - Total | |
| Plasma; Serum | Alanine aminotransferase; Albumin; Alkaline phosphatase; Amylase; Aspartate aminotransferase; Bicarbonate; Bilirubin - Any fractions; Bilirubin - Total; C-reactive protein (CRP); Calcium - Total; Chloride; Cholesterol - Total; Creatine kinase; Creatinine; Glucose; Lactate dehydrogenase (LDH); Lipase; Magnesium; Phosphate; Potassium; Protein - Total; Sodium; Triglycerides; Urate; Urea; γ-Glutamyltransferase | |
| Urine | Chloride; Creatinine; Potassium; Protein - Total; Sodium | |
| Chemical pathology - Investigation for folate deficiency | Blood; Serum | Folate; Red blood cell folate |
| Chemical pathology - Iron studies | Plasma; Serum | Iron; Transferrin |
| Ferritin | ||
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Calcium - Ionised; Carboxyhaemoglobin; Chloride; Glucose; Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH |
| Chemical pathology - Quantitation of vitamins | Plasma; Serum | Cobalamin (vitamin B12); Vitamin D |
| 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; Bone marrow | Myeloperoxidase |
| Haematology - Full blood examination | Blood | Human progenitor cells (HPC); Morphology |
| Differential number; Erythrocyte count (red blood cell count, RBCC); Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Leucocyte count (white blood cell count, WBCC); Mean platelet volume (MPV); Nucleated red blood cells (NRBC); Platelet count; Red blood cell distribution width (RDW); Red blood cell index or indices; Reticulocytes | ||
| Haematology - Haemostasis related analysis (including special coagulation testing and platelet function tests) | Plasma | Activated partial thromboplastin time (APTT); Anti-Xa activity; Anti-thrombin III; D-dimer; Fibrinogen; Prothrombin time (PT); Thrombin time (TT) |
| Haematology - Investigation of haemolysis | Blood; Plasma | Cold agglutinins |
| 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 | ABO; RhD |
| Immunohaematology - Determination of compatibility of blood donor units | Blood | Direct antiglobulin test (DAT, direct Coombs test); Examination for blood group antibodies; Group checks of patient and donor; Identification of detected antibodies |
| Immunohaematology - Identification and quantitation of blood group antibodies | Blood; Plasma | Antibody absorption; Antibody elution; Red blood cell phenotyping |
| Antibody absorption; Antibody elution; Antibody titration; Other blood group antibodies; Red blood cell phenotyping; Rh | ||
| Other blood group antibodies | ||
| Immunohaematology - Investigation of blood transfusion reactions | Blood products | Antibodies |
| Immunohaematology - Issue and release of blood and blood product for transfusion | Blood; 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; Fresh frozen plasma (FFP); Platelets | Issue and release of blood and blood products for transfusion |
| Immunopathology - Characterisation of leucocyte surface antigens (including immunophenotyping) | Blood | CD34 |
| Blood; Bone marrow; Disaggregated tissues specimen; Fresh tissue | Assessment of lymphoid cell populations; Assessment of myeloid cell populations; CD10; CD103; CD117; CD11b; CD11c; CD13; CD138; CD14; CD15; CD16; CD19; CD1a; CD2; CD20; CD22; CD23; CD25; CD27; CD28; CD3; CD33; CD34; CD38; CD4; CD45; CD5; CD56; CD64; CD7; CD79αcy; CD8; HLA-DR antigen; Kappa light chains; Lambda light chains; Myeloperoxidase; Terminal deoxynucleotidyl transferase (TdT); Total leucocyte number; Total lymphocyte number; Viable cell count | |
| Blood; Bone marrow; Disaggregated tissues specimen; Fresh tissue; Serous fluid | Assessment of lymphoid cell populations; Assessment of myeloid cell populations | |
| Haemopoietic progenitor cells | CD3; CD34 | |
| Immunopathology - Quantitative and/or qualitative investigation of proteins | Serum; Urine | Detection and quantitation of free kappa and free lambda light chains |
| Characterisation of paraproteins; Detection and amount of paraproteins | ||
| Immunopathology - Quantitative investigations of immunoglobulins and immunoglobulins subclasses | Plasma; Serum | Total immunoglobulin A; Total immunoglobulin G; Total immunoglobulin M |
| Immunopathology - Tests of cellular immunity - Lymphocyte function tests | Blood | T-cell subsets |
| Infertility and pregnancy tests including assisted reproductive technology - Diagnosis of pregnancy | Serum; Urine | Human chorionic gonadotropin (hCG) |
Anatomical Pathology
ISO 15189 (2022)
- This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.
Human Pathology
Medicare expiry date
08 Sep 2027
Last Activity Date
27 Feb 2024
| 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 | Cerebrospinal fluid (CSF); Other body fluids; Sputum; Urine; Washings or brushings from other sites | Cytological examination; Review and reporting of cytology samples |
| Anatomical pathology - Cytopathology - Non-gynaecological cytological investigations of nipple discharge or smears from squamous mucosal sites for the detection of cancerous or precancerous changes | Nipple discharge | Cytological examination; 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; Review and reporting of fine needle aspiration samples |
| Anatomical pathology - Tissue pathology - Examination of biopsy material | Formalin fixed tissue; Fresh tissue | Review and reporting of biopsy material to identify or exclude 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 - Gene probes using paraffin in-situ hybridisation techniques (chromogenic/silver) | Formalin-fixed paraffin-embedded (FFPE) tissues | Detection of nucleic acid targets - Various |
| Anatomical pathology - Tissue pathology - Immediate frozen section diagnosis | Fresh tissue; Smears; Tissue imprint | Immediate imprint cytology diagnosis; Intra-operative consultation and examination of biopsy material |
| Anatomical pathology - Tissue pathology - Immunohistochemical (immunofluorescence) investigation | Fresh tissue; Frozen tissue | Detection of antigenic targets - Various |
| Anatomical pathology - Tissue pathology - Immunohistochemical investigation | Formalin-fixed paraffin-embedded (FFPE) tissues | Detection of antigenic targets - Various |
| Detection of antigenic targets - Various | ||
| Detection of antigenic targets - Various | ||
| Detection of antigenic targets - Various |
Molecular Pathology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
08 Sep 2027
Last Activity Date
27 Feb 2024
| Service | Product | Determinant |
|---|---|---|
| Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted genes | Blood; Bone marrow | Acute myeloid leukaemia RUNX1; Nucleophosmin 1 (NPM1) mutated AML |
| Blood borne tumours; HAVCR2 mutation; VEXAS Syndrome | ||
| Blood; Bone marrow; Formalin-fixed paraffin-embedded (FFPE) tissues; Tissues | Blood borne tumours | |
| Formalin-fixed paraffin-embedded (FFPE) tissuesctDNA | Solid tumours | |
| Molecular genetics - Companion diagnostic genetic testing | Formalin-fixed paraffin-embedded (FFPE) tissues | Homologous recombination deficiency (HRD) - Ovarian cancer |
| Molecular genetics - DNA extraction | Blood; Body fluids; Bone marrow; Buccal swabs; Buffy coat; Cultured cells; Formalin-fixed paraffin-embedded (FFPE) tissues; Fresh tissue; Hair; Plasma; Saliva; Tissues | DNA storage for future analyses; Purified PCR product; Viable DNA; Viable DNA for sequencing |
| Molecular genetics - DNA sequencing | Blood; Bone marrow; Cultured cells; Extracted DNA; Formalin-fixed paraffin-embedded (FFPE) tissues; Fresh tissue; Hair; Oral fluid; Tissues | Sequenced DNA by Sanger sequencing; Sequenced DNA utilising massively parallel sequencing technologies |
| Molecular genetics - Detection and characterisation of cell free RNA (cfRNA)/cell free DNA (cfDNA) in cancer screening and/or cancer genetic testing | Plasma | Nucleic acid analysis for specific variants |
| Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted genes | Blood; Bone marrow | Haemopoietic chimerism post allogenic BMTx |
| Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Targeted genes | Blood; Bone marrow; Extracted DNA; Saliva | Blood borne tumours; Solid tumours |
| Molecular genetics - Predictive genetic testing - Targeted panels for inherited (germline) DNA/RNA changes | Blood; Extracted DNA; Saliva | Inherited solid tumours |
| Molecular genetics - RNA extraction | Blood; Bone marrow; Formalin-fixed paraffin-embedded (FFPE) tissues; Tissues | Viable RNA for sequencing |
| Molecular genetics - RNA sequencing | Extracted RNA | Sequenced RNA; Sequenced RNA by Sanger sequencing |
| Molecular genetics - Screening for an unknown mutation - Targeted genes | Blood; Bone marrow; Formalin-fixed paraffin-embedded (FFPE) tissues | Blood borne tumours; Solid tumours |
| Formalin-fixed paraffin-embedded (FFPE) tissues | Solid tumours | |
| Molecular genetics - Screening for an unknown mutation - Targeted panels for inherited (germline) DNA/RNA changes | Blood; Extracted DNA; Saliva | Inherited solid tumours |
| Molecular genetics - Screening for an unknown mutation - Targeted panels for non-inherited (somatic) DNA/RNA changes | Blood; Bone marrow; Formalin-fixed paraffin-embedded (FFPE) tissues; Fresh tissue; Saliva | Blood borne tumours; Solid tumours |
| Formalin-fixed paraffin-embedded (FFPE) tissues | Ovarian cancer biomarkers; Solid tumours | |
| Formalin-fixed paraffin-embedded (FFPE) tissues; ctDNA | Solid tumours | |
| Molecular genetics/Cytogenetics - Bioinformatic analysis | DNA sequences; FASTQ files; RNA sequences | Primary analysis - Conversion of instrument file to FASTQ or FASTA file; Secondary analysis - Alignment and variant calling; Tertiary analysis - Data annotation and interpretation |
Short Stay Unit
ISO 15189 (2022)
Human Pathology
Medicare expiry date
08 Sep 2027
Last Activity Date
27 Feb 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Calcium - Ionised; Carboxyhaemoglobin; Chloride; Glucose; Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH |
Theatre
ISO 15189 (2022)
Human Pathology
Medicare expiry date
08 Sep 2027
Last Activity Date
27 Feb 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Calcium - Ionised; Carboxyhaemoglobin; Chloride; Glucose; Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH |
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.
2465
Site No.
2458
Print date
20 Apr 2024
END OF SCOPE
