National Association of Testing Authorities, Australia
Scope of Accreditation
Australian Clinical Labs
Site
Bella Vista Laboratory
Accreditation No.
3427
Site No.
18703
Date of Accreditation
24 Feb 2011
Contact
Ms Cherie Winterburn P: +61 (02) 88879999
Availability
Services available to external clients
Supervision
GY (General)
Scope of Accreditation
Bella Vista Laboratory
ISO 15189 (2022)
- This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.
Human Pathology
Medicare expiry date
10 Jul 2027
Last Activity Date
03 May 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 | Other body fluids; Sputum; Washings or brushings from other sites | 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 | Review and reporting of biopsy material to identify or exclude morphological abnormalities |
| 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 - VariousHER2 |
| Anatomical pathology - Tissue pathology - Immediate frozen section diagnosis | Fresh tissue | Intra-operative consultation and examination of biopsy material |
| Anatomical pathology - Tissue pathology - Immunohistochemical (immunofluorescence) investigation | Formalin-fixed paraffin-embedded (FFPE) tissues | Detection of antigenic targets - Various |
| Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring | Serum | Digoxin |
| Carbamazepine; Lithium; Valproate (valproic acid, epilim) | ||
| Chemical pathology - Detection and/or quantitation of tumour markers | Serum | CA19-9 antigen (CA19-9) |
| CA125 antigen (CA125); CA15-3 antigen (CA15-3); Carcinoembryonic antigen (CEA); Prostate specific antigen (PSA); α-Fetoprotein (AFP) | ||
| Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) | Serum | C-peptide |
| C-peptide; Cortisol; Dehydroepiandrosterone sulfate (DHEAS); Follicle stimulating hormone (FSH); Insulin; Luteinising hormone (LH); Oestradiol; Parathyroid hormone (PTH); Progesterone; Prolactin; Sex hormone binding globulin (SHBG); Testosterone; Testosterone - Free | ||
| Chemical pathology - Diagnosis and management of diabetes mellitus | Serum | Glycated haemoglobin (HbA1c) |
| Chemical pathology - Further investigation of cardiac function | Serum | Troponin |
| Chemical pathology - Further investigation of lipid profiles for diagnosis of types III and IV hyperlipidaemia | Serum | HDL - Quantitation |
| Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Serum | Alanine aminotransferase; Albumin; Alkaline phosphatase; Amylase; Aspartate aminotransferase; Bilirubin - Any fractions; Bilirubin - Total; C-reactive protein (CRP); Calcium - Total; Carbon dioxide (CO2); Chloride; Cholesterol - Total; Creatine kinase; Creatinine; Glucose; Lactate; Lactate dehydrogenase (LDH); Lipase; Magnesium; Phosphate; Potassium; Protein - Total; Sodium; Triglycerides; Urate; Urea; γ-Glutamyltransferase |
| Urine | Calcium - Total; Chloride; Creatinine; Glucose; Magnesium; Microalbumin; Phosphate; Potassium; Protein - Total; Sodium; Urate; Urea | |
| Chemical pathology - Investigation for folate deficiency | Serum | Folate; Red blood cell folate |
| Chemical pathology - Investigation of Helicobacter pylori colonisation or eradication | Breath | C14 |
| Chemical pathology - Investigation of malabsorption - Quantitation of solid tissue enzymes | Intestinal tissue | Lactase; Maltase; Sucrase |
| Chemical pathology - Iron studies | Serum | Ferritin |
| Iron; Transferrin | ||
| Chemical pathology - Quantitation of precursor and intermediary metabolites | Serum | Homocysteine |
| Chemical pathology - Quantitation of vitamin B markers | Serum | Holotranscobalamin (active vitamin B12) |
| Chemical pathology - Quantitation of vitamins | Serum | Cobalamin (vitamin B12); Vitamin D |
| Chemical pathology - Tests for thyroid function | Serum | Thyroid stimulating hormone (TSH); Thyroxine (T4) - Free; Triiodothyronine (T3) - Free |
| Haematology - Diagnosis of thalassemia | Blood | Haemoglobin A2 (HbA2) - Quantitation; Haemoglobin F (HbF) - Quantitation |
| Haemoglobin A2 (HbA2) - Quantitation; Haemoglobin F (HbF) - Quantitation | ||
| Haemoglobin A2 (HbA2) - Quantitation; Haemoglobin F (HbF) - Quantitation | ||
| Haematology - Examination of blood films by special staining | Blood | Malaria |
| Haematology - Full blood examination | Blood | Reticulocytes |
| 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 | ||
| Morphology | ||
| Morphology | ||
| Haematology - Haemostasis related analysis (including special coagulation testing and platelet function tests) | Plasma | Activated partial thromboplastin time (APTT); D-dimer; Fibrinogen; International normalised ratio (INR); Prothrombin time (PT); Thrombin time (TT) |
| Haematology - Investigation of haemoglobinopathy (excluding thalassemia) | Blood | Haemoglobin S (HbS) - Presence; Haemoglobin bands; Haemoglobin fraction (S, C, D, E) - Quantitation; Haemoglobin instability; Other abnormal haemoglobins |
| Haemoglobin S (HbS) - Presence; Haemoglobin fraction (S, C, D, E) - Quantitation; Haemoglobin instability; Other abnormal haemoglobins | ||
| Haemoglobin S (HbS) - Presence | ||
| Haematology - Limited blood examination | Blood | Erythrocyte (RBC) sedimentation rate (ESR) |
| Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies | Serum | Anti-cyclic citrullinated peptide antibodies (CCP); Anti-thyroglobulin antibodies (Tg); Anti-thyroid peroxidase antibodies (TPO) |
| Rheumatoid factor | ||
| Anti-dense fine speckle 70 antibodies; Anti-gastric parietal cell antibodies (GPC/PCA); Anti-intrinsic factor antibodies (IF) | ||
| Anti-deamidated gliadin IgG antibodies; Anti-double stranded DNA antibodies (dsDNA); Anti-extractable nuclear antigen antibodies (ENA); Anti-myeloperoxidase antibodies (MPO); Anti-proteinase 3 antibodies (PR3); Anti-tissue transglutaminase IgA antibodies (tTG) | ||
| Anti-neutrophil cytoplasmic antibodies (ANCA); Anti-nuclear antibodies (ANA) | ||
| Immunopathology - Quantitation of complement proteins | Serum | Complement components C3 and C4 |
| Immunopathology - Quantitative and/or qualitative investigation of proteins | Serum | Cryoglobulins |
| Detection and amount of paraproteins | ||
| Immunopathology - Quantitative investigations of immunoglobulins and immunoglobulins subclasses | Serum | Total immunoglobulin A; Total immunoglobulin E; Total immunoglobulin G; Total immunoglobulin M |
| Infertility and pregnancy tests including assisted reproductive technology - Diagnosis or follow up of threatened abortion and/or diagnosis of ectopic pregnancy | Serum | Human chorionic gonadotropin (hCG) - Quantitative total |
| Infertility and pregnancy tests including assisted reproductive technology - Semen analysis (other than post vasectomy) | Semen | Morphology |
| 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 - 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 |
ISO 15189 (2022)
- This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.
Legal
Medicare expiry date
10 Jul 2027
Last Activity Date
03 May 2023
| Service | Product | Determinant |
|---|---|---|
| Medico legal drug testing AS/NZS 4308:2008, section 2 Specimen collection, storage, handling and dispatch | Urine | Colour; Creatinine; Temperature; pH |
Microbiology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
10 Jul 2027
Last Activity Date
03 May 2023
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Detection of faecal occult blood | Faeces | Blood |
| Chemical pathology - Investigation of malabsorption | Faeces | Reducing substances |
| Microbiology - Bacteriology - Detection and identification of crystalline material | Synovial fluid | Crystal detection and identification |
| Microbiology - Bacteriology - Detection of pathogenic bacteria | Aspirates; Blood; Cerebrospinal fluid (CSF); Faeces; Fluids; Genital swabs; Respiratory specimens; Tissues; Urine; Wound swabs | Bacteria; Pathogenic microorganisms |
| Aspirates; Blood; Cerebrospinal fluid (CSF); Genital swabs; Respiratory specimens; Tissues; Wound swabs | Bacteria; Crystals; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC) | |
| Bacterial isolates | Bacteria; Pathogenic identification; Pathogenic microorganisms | |
| Antibiotic susceptibility | ||
| Bacteria; Pathogenic identification; Pathogenic microorganisms | ||
| Antibiotic susceptibility | ||
| Blood | Bacteria; Pathogenic microorganisms | |
| Faeces | Crystals; Erythrocytes (red blood cells, RBC); Fat globules | |
| Clostridium difficile glutamate dehydrogenase | ||
| Fluids | Bacteria; Pathogenic microorganisms | |
| Urine | Bacteria; Casts; Crystals; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC); Red blood cell morphology | |
| Blood; Glucose; Ketones; Proteins; pH | ||
| Legionella antigen; Streptococcus pneumoniae antigen | ||
| Bacteria; Casts; Crystals; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC) | ||
| Blood; Glucose; Ketones; Proteins; pH | ||
| Microbiology - Bacteriology - Detection of pathogenic bacteria for epidemiological infection control surveillance | Faeces; Rectal swabs | Vancomycin resistant Enterococci (VRE) |
| Microbiology - Environmental investigations and/or infection control (Clinical non-human testing) | Environmental swabs | Bacterial organism identification - Acinetobacter; Bacterial organism identification - Carbapenem resistant Enterobacteriaceae (CRE); Bacterial organism identification - Extended spectrum β-lactamases (ESBL); Bacterial organism identification - Gram negative multi-drug resistant organisms (MRO); Bacterial organism identification - Methicillin-resistant Staphylococcus aureus (MRSA); Bacterial organism identification - Vancomycin-resistant Enterococcus (VRE) |
| Gastrointestinal endoscopes; Vascular catheter tips | Bacterial growth - Sterility | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (bacteria) | Cerebrospinal fluid (CSF) | Escherichia coli K1; Haemophilus influenzae; Listeria monocytogenes; Neisseria meningitidis; Streptococcus agalactiae (Streptococcus group B); Streptococcus pneumoniae |
| Dry swabs; Liquid based cytology specimens; Urine | Neisseria gonorrhoeae | |
| Chlamydia trachomatis; Neisseria gonorrhoeae | ||
| Dry swabs; Urine | Mycoplasma genitalium | |
| Faeces | Clostridioides difficile toxin | |
| Nasal swabs; Nasopharyngeal swabs; Oropharyngeal swabs; Respiratory specimens; Throat swabs | Bordetella parapertussis; Bordetella pertussis; Mycoplasma pneumoniae | |
| Nasopharyngeal swabs | Bordetella parapertussis; Bordetella pertussis | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (fungi) | Cerebrospinal fluid (CSF) | Cryptococcus gattii; Cryptococcus neoformans |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (mycobacteria) | Sputum | Mycobacterium tuberculosis |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (protozoan parasites) | Dry swabs; Liquid based cytology specimens; Urine | Trichomonas vaginalis |
| Faeces | Blastocystis hominis; Cryptosporidium spp.; Dientamoeba fragilis; Entamoeba histolytica; Giardia intestinalis | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) | Cerebrospinal fluid (CSF) | Cytomegalovirus (CMV); Enterovirus; Herpes simplex virus type 1 (HSV1); Herpes simplex virus type 2 (HSV2); Human herpes virus type 6 (HHV6); Human parechovirus; Varicella zoster virus (VZV) |
| Faeces | Adenovirus; Adenovirus F40; Adenovirus F41; Enterovirus; Norovirus G1; Norovirus G2; Rotavirus A; Sapovirus | |
| Nasal aspirates/washes; Nasal swabs; Nasopharyngeal swabs; Oropharyngeal swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | ||
| Nasal swabs; Nasopharyngeal swabs | Influenza A virus; Influenza B virus; Respiratory syncytial virus (RSV) | |
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | ||
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | ||
| Nasal swabs; Nasopharyngeal swabs; Oropharyngeal swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | ||
| Nasal swabs; Nasopharyngeal swabs; Oropharyngeal swabs; Respiratory swabs; Throat swabs | Adenovirus; Enterovirus; Human metapneumovirus; Influenza A virus; Influenza B virus; Parainfluenza virus type 1/2/3; Respiratory syncytial virus (RSV); Rhinovirus | |
| Nasal swabs; Nasopharyngeal swabs; Throat swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | ||
| Nasopharyngeal swabs | Adenovirus; Human metapneumovirus; Influenza A virus; Influenza B virus; Parainfluenza virus type 1/2/3/4; Respiratory syncytial virus (RSV); Rhinovirus | |
| Microbiology - Mycobacteriology - Detection and identification of mycobacteria | Aspirates; Respiratory specimens; Tissues; Wound swabs | Mycobacteria detection |
| Microbiology - Mycology - Detection, isolation and/or identification of yeasts and/or fungal elements | Blood; Cerebrospinal fluid (CSF); General swabs; Genital swabs; Respiratory swabs; Tissues | Fungi identification; Yeasts identification |
| Fungi identification; Yeasts identification | ||
| Isolates | Fungi identification; Yeasts identification | |
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Faeces | Cryptosporidia; Giardia spp. |
| Cysts; Ova; Parasites | ||
| Genital swabs | Trichomonad | |
| Urine | Schistosoma spp. | |
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Serum | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) antibody |
| Cytomegalovirus (CMV) total antibody; Cytomegalovirus antibody (anti-CMV) IgM; Epstein-Barr virus nuclear antigen; Epstein-Barr virus viral capsid antigen IgG antibody; Epstein-Barr virus viral capsid antigen IgM antibody; Helicobacter pylori IgG antibody; Varicella zoster virus (VZV) IgG antibody | ||
| Measles IgG antibody; Mumps virus IgG antibody | ||
| Bordetella pertussis toxin A IgA; Bordetella pertussis toxin G IgA; Herpes simplex virus type 2 antibody (anti-HSV2) - IgG; Herpes simplex type 1 antibody (anti-HSV1) - IgG; Measles IgM antibody; Mumps virus IgM antibody; Mycoplasma pneumoniae IgG antibody; Mycoplasma pneumoniae IgM antibody; Varicella zoster virus IgM antibody | ||
| Hepatitis A virus (HAV); 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 envelope antibody (anti-HBe); Hepatitis B virus envelope antigen (HBe Ag); Hepatitis B virus surface antibody (anti-HBs); Hepatitis B virus surface antibody (anti-HBs) - Total; Hepatitis B virus surface antigen (HBs Ag); Hepatitis B virus surface antigen (HBs Ag) neutralisation; Hepatitis C virus (HCV); Human immunodeficiency virus (HIV); Rubella IgG antibody; Syphilis Treponema pallidum IgG antibody; Toxoplasma spp. IgG antibody; Toxoplasma spp. IgM antibody | ||
| Microbiology - Virology - Detection of pathogenic viruses | Faeces | Adenovirus; Rotavirus |
| Norovirus |
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.
3427
Site No.
18703
Print date
23 Nov 2024
END OF SCOPE