National Association of Testing Authorities, Australia
Scope of Accreditation
Clinipath Pathology
Sonic Healthcare Pty Ltd
Site
Bunbury Pathology
Accreditation No.
2619
Site No.
3492
Date of Accreditation
10 Sep 1992
Contact
Mr Alexander Pollard P: +61 (08) 97800300
Availability
Services available to external clients
Supervision
B (Branch)
Scope of Accreditation
Bunbury Pathology
ISO 15189 (2022)
- This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.
Human Pathology
Medicare expiry date
04 Jan 2026
Last Activity Date
13 Sep 2022
| Service | Product | Determinant |
|---|---|---|
| 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 |
| Anatomical pathology - Tissue pathology - Immediate frozen section diagnosis | Fresh tissue | Intra-operative consultation and examination of biopsy material |
| Anatomical pathology - Tissue pathology - Immunohistochemical investigationProcessing, embedding and microtomy and reporting only | Formalin-fixed paraffin-embedded (FFPE) tissues | Detection of antigenic targets - Various |
| Chemical pathology - Analysis of drugs for toxicological (non-legal) purposes and ingested or absorbed toxic chemicals | Serum; Urine | Alcohol |
| Urine | Methadone | |
| Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring | Plasma; Serum | Lithium |
| Chemical pathology - Detection and/or quantitation of tumour markers | Serum | Carcinoembryonic antigen (CEA); Human chorionic gonadotropin (hCG); Prostate specific antigen (PSA); Prostate specific antigen (PSA) - Free |
| 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); Progesterone; Prolactin |
| Chemical pathology - Further investigation of cardiac function | Plasma; Serum | Troponin I |
| Chemical pathology - Further investigation of lipid profiles for diagnosis of types III and IV hyperlipidaemia | Plasma; Serum | HDL - Quantitation |
| Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Other body fluids | Amylase; Lactate dehydrogenase (LDH); 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; Lactate dehydrogenase (LDH); Lipase; Magnesium; Phosphate; Potassium; Protein - Total; Sodium; Triglycerides; Urate; Urea; γ-Glutamyltransferase | |
| Serum | Calcium - Ionised | |
| Urine | Creatinine; Microalbumin; Protein - Total | |
| Chemical pathology - Investigation for folate deficiency | Serum | Folate |
| Chemical pathology - Iron studies | Plasma; Serum | Ferritin; Iron; Transferrin |
| Chemical pathology - Quantitation of vitamins | Serum | Cobalamin (vitamin B12); 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 |
| Haematology - Full blood examination | Blood | Differential number; 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 |
| Morphology | ||
| Haematology - Haemostasis related analysis (including special coagulation testing and platelet function tests) | Blood | Platelet function (PFA) |
| Plasma | Activated partial thromboplastin time (APTT); D-dimer; Fibrinogen; International normalised ratio (INR); Prothrombin time (PT); Thrombin time (TT) | |
| Haematology - Limited blood examination | Blood | Erythrocyte (RBC) sedimentation rate (ESR) |
| Immunohaematology - Blood group antibody detection | Blood | 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 |
| Immunohaematology - Investigation of blood transfusion reactions | Blood products | Antibodies |
| Immunohaematology - Issue and release of blood and blood product for transfusion | Blood; Blood products | Issue and release of blood and blood products for transfusion |
| Immunohaematology - Storage and distribution of blood and blood components | Blood; Blood products | Compliance with transport, storage and distribution requirements of blood, products and components |
| Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies | Plasma; Serum | Rheumatoid factor |
| Immunopathology - Quantitative and/or qualitative investigation of proteins | Plasma; Serum | Cryoglobulins |
| Infertility and pregnancy tests including assisted reproductive technology - Diagnosis of pregnancy | Plasma; Serum | Human chorionic gonadotropin (hCG) |
| Infertility and pregnancy tests including assisted reproductive technology - Diagnosis or follow up of threatened abortion and/or diagnosis of ectopic pregnancy | Plasma; Serum | Human chorionic gonadotropin (hCG) - Quantitative total |
| Infertility and pregnancy tests including assisted reproductive technology - Semen analysis (other than post vasectomy) | Semen | Motility; Sperm number |
| Infertility and pregnancy tests including assisted reproductive technology - Semen analysis for post vasectomy and/or examination of cervical mucus | Semen | Presence of spermatozoa |
| Microbiology - Bacteriology - Detection of pathogenic bacteria | Blood | Pathogenic microorganisms |
| Blood; Ocular specimens | Bacteria; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC) | |
| Urine | Casts; Crystals; Epithelial cells; Erythrocytes (red blood cells, RBC); Glucose; Leucocytes (white blood cells, WBC); Nitrite; Proteins; pH | |
| Bacteria; Pathogenic microorganisms | ||
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Blood | Malaria |
ISO 15189 (2022)
- This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.
Legal
Medicare expiry date
04 Jan 2026
Last Activity Date
13 Sep 2022
| Service | Product | Determinant |
|---|---|---|
| Medico legal drug testing AS/NZS 4308:2008, section 2 Specimen collection, storage, handling and dispatch | Urine | Colour; Creatinine; Temperature; pH |
| Medico legal drug testing AS/NZS 4308:2008, section 3 General laboratory requirements | Urine | General laboratory requirements as described in AS/NZS 4308 |
| Medico legal drug testing AS/NZS 4308:2008, section 4 Laboratory screening procedures | Urine | Amphetamine type substances; Benzodiazepines; Cannabis metabolites; Cocaine metabolites; Creatinine; Opiates |
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.
2619
Site No.
3492
Print date
28 Nov 2024
END OF SCOPE