National Association of Testing Authorities, Australia
Scope of Accreditation
Australian Clinical Labs
Site
Wayville Laboratory
Accreditation No.
3427
Site No.
2361
Date of Accreditation
Contact
Mrs Natalie Taylor
P: +61 (08) 82055683
Availability
Services available to external clients
Supervision
GX (General)
Scope of Accreditation
Withdrawn
Wayville Laboratory
ISO 15189 (2012)
Human Pathology
Medicare expiry date
05 Sep 2020
Last Activity Date
28 Jun 2019
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| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Further investigation of lipid profiles for diagnosis of types III and IV hyperlipidaemia | Blood; Plasma | HDL - Quantitation; Lipoprotein subclasses |
| Blood; Serum | Lipoprotein subclasses | |
| 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 | Respiratory specimens; Sputum; Throat swabs; Wound swabs | Bacteria |
| Pathogenic identification and antibiotic susceptibility | ||
| Urine | Pathogenic identification and antibiotic susceptibility | |
| Glucose; Proteins; pH | ||
| Bacteria | ||
| Casts; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC) | ||
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (bacteria) | Faeces | Clostridioides difficile |
| Microbiology - Mycobacteriology - Detection and identification of mycobacteria | Aspirates; Blood; Cerebrospinal fluid (CSF); Faeces; General swabs; Skin swabs; Sputum; Tissues; Urine; Wound swabs | Mycobacteria identification; Other pathogenic bacteria to genus level or species level |
| Aspirates; Blood; Cerebrospinal fluid (CSF); Faeces; Sputum; Tissues; Urine | Mycobacteria identification | |
| Microbiology - Mycology - Detection, isolation and/or identification of yeasts and/or fungal elements | Aspirates; Blood; Cerebrospinal fluid (CSF); General swabs; Nails; Sputum; Tissues; Urine | Fungi identification |
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Blood; Serum | Malaria |
| Faeces | Cysts; Ova; Parasites | |
| Parasites | ||
| Microbiology - Virology - Detection of pathogenic viruses | Faeces | Adenovirus; Rotavirus |
Anatomical Pathology
ISO 15189 (2012)
Human Pathology
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| Service | Product | Determinant |
|---|---|---|
| Anatomical pathology - Cytopathology - Cervical cytological investigation for abnormalities, precancerous or cancerous changes or conditions | Cervical tissue | Cytological examination; Review and reporting of cervical cytological material |
| 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 - 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 |
| Infertility and pregnancy tests including assisted reproductive technology - Semen analysis for post vasectomy and/or examination of cervical mucus | Semen | Presence of spermatozoa |
Chemical Pathology
ISO 15189 (2012)
Human Pathology
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| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Further investigation of lipid profiles for diagnosis of types III and IV hyperlipidaemia | Blood; Plasma | HDL - Quantitation; Lipoprotein subclasses |
Chemical Pathology
ISO 15189 (2012)
Human Pathology
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| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Analysis of drugs for toxicological (non-legal) purposes and ingested or absorbed toxic chemicals | Urine | Alcohol; Amphetamines; Barbiturates; Benzodiazepines; Cannabis; Cocaine; Methadone; Opiates |
| Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring | Plasma; Serum | Digoxin; Lithium; Phenobarbitone; Valproate (valproic acid, epilim) |
| Chemical pathology - Detection and/or quantitation of tumour markers | Plasma; Serum | CA125 antigen (CA125); CA15-3 antigen (CA15-3); CA19-9 antigen (CA19-9); Carcinoembryonic antigen (CEA); Prostate specific antigen (PSA); Prostate specific antigen (PSA) fractions and derived index; α-Fetoprotein (AFP) |
| Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) | Plasma; Serum | Cortisol; Dihydrotestosterone; Follicle stimulating hormone (FSH); Insulin; Luteinising hormone (LH); Oestradiol; Parathyroid hormone (PTH); Progesterone; Prolactin; Sex hormone binding globulin (SHBG); Testosterone |
| Chemical pathology - Diagnosis and management of diabetes mellitus | Blood | Glycated haemoglobin (HbA1c) |
| 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 | Blood; Plasma | HDL - Quantitation; Lipoprotein subclasses |
| Chemical pathology - Further investigation of renal and/or hepatic function | Plasma; Serum | Alkaline phosphatase (ALP) isoenzymes |
| Caeruloplasmin; Haptoglobins; α1-Antitrypsin | ||
| Chemical pathology - Haem related pigments and precursors (excluding porphyria) | Plasma; Serum | Haptoglobins |
| Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Plasma; Serum; Urine | Alanine aminotransferase; Albumin; Alkaline phosphatase; Amylase; Aspartate aminotransferase; Bicarbonate; Bilirubin - Total; C-reactive protein (CRP); Calcium - Total; Chloride; Cholesterol - LDL; Creatine kinase; Creatinine; Glucose; HDL - Quantitation; Lactate dehydrogenase (LDH); Magnesium; Osmolality; Phosphate; Potassium; Protein - Total; Sodium; Triglycerides; Urate; Urea; γ-Glutamyltransferase |
| Chemical pathology - Investigation for folate deficiency | Blood; Plasma; Serum | Folate; Red blood cell folate |
| Chemical pathology - Iron studies | Blood; Plasma; Serum | Ferritin; Iron; Transferrin |
| Chemical pathology - Quantitation of precursor and intermediary metabolites | Plasma; Serum | Amino acids |
| Chemical pathology - Quantitation of vitamins | Blood; 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 |
| Immunopathology - Quantitation of complement proteins | Plasma; Serum | Complement components C3 and C4 |
| Immunopathology - Quantitative and/or qualitative investigation of proteins | Plasma; Serum; Urine | Cryofibrinogen; Cryoglobulins; Detection and amount of paraproteins; Detection and quantitation of free kappa and free lambda light chains |
| Immunopathology - Quantitative investigations of immunoglobulins and immunoglobulins subclasses | Plasma; Serum; Urine | Total immunoglobulin A; Total immunoglobulin E; Total immunoglobulin G; Total immunoglobulin M |
| Infertility and pregnancy tests including assisted reproductive technology - Diagnosis of pregnancy | Urine | Human chorionic gonadotropin (hCG) |
Functional Serology
ISO 15189 (2012)
Human Pathology
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| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) | Saliva | Dehydroepiandrosterone sulfate (DHEAS); Oestradiol; Progesterone; Testosterone |
| Urine | ||
| Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Faeces | Cholesterol - Total; Triglycerides |
| Chemical pathology - Investigation of malabsorption | Urine | Lactose |
| Chemical pathology - Markers of bone metabolism | Urine | n-Telopeptide (NTx) |
| Chemical pathology - Quantitation of precursor and intermediary metabolites | Blood; Serum | Essential fatty acids |
| Faeces | Short chain fatty acids | |
| Chemical pathology - Tests for thyroid function | Serum | Triiodothyronine (T3) - Reverse |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [additives] allergens) | Serum | |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [egg and fowl] allergens) | Serum | |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [fish, shellfish and molluscs] allergens) | Serum | |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [fruit and vegetable] allergens) | Serum | |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [meat] allergens) | Serum | |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [milk] allergens) | Serum | |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [miscellaneous] allergens) | Serum | |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [seeds, legumes and nuts] allergens) | Serum | |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [spices] allergens) | Serum | |
| Immunopathology - Quantitative and/or qualitative investigation of proteins | Faeces | Pancreatic elastase |
Haematology
ISO 15189 (2012)
Human Pathology
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| Service | Product | Determinant |
|---|---|---|
| Haematology - Bone marrow examination | Bone marrow | Examination of aspirated material; Histological examination |
| Haematology - Diagnosis of thalassemia | Blood | Haemoglobin A2 (HbA2) - Quantitation; Haemoglobin F (HbF) - Quantitation |
| 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); 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) | Blood; Plasma | Platelet function (PFA) |
| Activated partial thromboplastin time (APTT); Anti-thrombin III; D-dimer; Fibrinogen; International normalised ratio (INR); Lupus anticoagulant; Platelet function (PFA); Protein C and protein S; 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 |
| Haematology - Investigation of haemolysis | Blood | Haptoglobins |
| Haematology - Limited blood examination | Blood | Erythrocyte (RBC) sedimentation rate (ESR) |
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Blood; Serum | Malaria |
Immunopathology
ISO 15189 (2012)
Human Pathology
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| Service | Product | Determinant |
|---|---|---|
| Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodiesNULL | Plasma | Anti-cardiolipin antibodies (ACA); Anti-cyclic citrullinated peptide antibodies (CCP); Anti-double stranded DNA antibodies (dsDNA); Anti-endomysial antibodies (EMA); Anti-extractable nuclear antigen antibodies (ENA); Anti-gliadin antibodies (AGA); Anti-nuclear antibodies (ANA); Anti-thyroglobulin antibodies (Tg); Anti-thyroid peroxidase antibodies (TPO); Anti-tissue transglutaminase antibodies (tTG); Anti-β2-glycoprotein-I antibodies; Rheumatoid factor |
Microbiology
ISO 15189 (2012)
Human Pathology
|
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| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Detection of faecal occult blood | Faeces | Blood |
| Chemical pathology - Further investigation of lipid profiles for diagnosis of types III and IV hyperlipidaemia | Blood; Plasma | HDL - Quantitation; Lipoprotein subclasses |
| Blood; Serum | Lipoprotein subclasses | |
| Chemical pathology - Investigation of Helicobacter pylori colonisation or eradication | Breath | C14 |
| 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 | Respiratory specimens; Sputum; Throat swabs; Wound swabs | Bacteria |
| Pathogenic identification and antibiotic susceptibility | ||
| Urine | Glucose; Proteins; pH | |
| Pathogenic identification and antibiotic susceptibility | ||
| Casts; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC) | ||
| Bacteria | ||
| Microbiology - Mycobacteriology - Detection and identification of mycobacteria | Aspirates; Blood; Cerebrospinal fluid (CSF); Faeces; General swabs; Skin swabs; Sputum; Tissues; Urine; Wound swabs | Mycobacteria identification; Other pathogenic bacteria to genus level or species level |
| Aspirates; Blood; Cerebrospinal fluid (CSF); Faeces; Sputum; Tissues; Urine | Mycobacteria identification | |
| Blood; Cerebrospinal fluid (CSF); Other body fluids; Sputum; Tissues | Mycobacteria antibiotic susceptibility; Mycobacteria identification | |
| Microbiology - Mycology - Detection of dermatophytes and other fungi causing cutaneous disease | Nails; Serum; Skin; Skin scrapings | Dermatophyte identification |
| Microbiology - Mycology - Detection, isolation and/or identification of yeasts and/or fungal elements | Aspirates; Blood; Cerebrospinal fluid (CSF); General swabs; Nails; Sputum; Tissues; Urine | Fungi identification |
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Blood; Serum | Malaria |
| Faeces | Cryptosporidia; Giardia spp.; Parasites | |
| Cysts; Ova; Parasites | ||
| Parasites | ||
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitationNULL | Blood; Plasma; Serum | Chlamydial spp. IgG antibody; Chlamydial spp. IgM antibody; Coxiella burnetii (Q-fever) IgG phase 1 antibody; Coxiella burnetii (Q-fever) IgG phase 2 antibody; Coxiella burnetii (Q-fever) IgM phase 1 antibody; Coxiella burnetii (Q-fever) IgM phase 2 antibody; Coxiella burnetii (Q-fever) total antibody; Cytomegalovirus (CMV) activity index; Cytomegalovirus antibody (anti-CMV) IgG; Cytomegalovirus antibody (anti-CMV) IgM; Helicobacter pylori; Hepatitis A virus antibody (anti-HAV) - IgM; Hepatitis A virus antibody (anti-HAV) - Total; Hepatitis B virus core antibody (anti-HBc) - IgM; 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 antigen (HBs Ag); Hepatitis B virus surface antigen (HBs Ag) neutralisation; Hepatitis C virus antibody (anti-HCV); Hepatitis C virus antibody (anti-HCV) - IgG; Human T-lymphotropic virus type I/II (HTLV-I/II) antibody; Human immunodeficiency virus (HIV) p24 antigen; Human immunodeficiency virus type 1/2 (HIV-1/2) 1/2 antibodies; Human immunodeficiency virus type 1/2 (HIV-1/2) antigen; Legionella pneumophila IgM antibody; Legionella pneumophila serogroup 1 antibody; Legionella pneumophila serogroup 2 antibody; Leptospira IgM antibody; Rubella IgG antibody; Rubella IgM antibody; Streptococcus pneumoniae; Syphilis Treponema pallidum antibody; Toxoplasma spp. IgG antibody; Toxoplasma spp. IgM antibody; Toxoplasma; Infectious mononucleosis |
| Microbiology - Virology - Detection of pathogenic viruses | Faeces | Adenovirus; Rotavirus |
| Adenovirus; Rotavirus |
Toxicology
ISO 15189 (2012)
Legal
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| Service | Product | Determinant |
|---|---|---|
| Medico legal drug testing AS/NZS 4308:2008, appendix A On-site screening procedure | Urine | Amphetamine type substances; Benzodiazepines; Cannabis metabolites; Cocaine metabolites; Opiates |
| 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; Opiates |
| Medico legal drug testing AS/NZS 4308:2008, section 5 Laboratory confirmatory procedures | Urine | 11-nor-δ-9-Tetrahydrocannabinol-9-carboxylic acid; 6-Acetylmorphine; 7-Amino-clonazepam; 7-Amino-flunitrazepam; 7-Amino-nitrazepam; Amphetamines; Benzoylecgonine (ecgonine benzoate); Benzylpiperazine (BZP, 1-benzylpiperazine); Codeine; Ecgonine methyl ester; Ephedrine; Methylamphetamine; Methylenedioxyamphetamine; Methylenedioxymethylamphetamine; Morphine; Nordiazepam; Oxazepam; Phentermine; Pseudoephedrine (PSE); Temazepam; α-Hydroxyalprazolam |
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.
2361
Print date
03 Dec 2023
END OF SCOPE
