Australian Clinical Labs

Site

Wayville Laboratory

Accreditation No.

3427

Site No.

2361

Date of Accreditation

Address

1 Goodwood Road
Wayville, SA 5034
Australia

clinicallabs.com.au

Contact

Mrs Natalie Taylor P: +61 (08) 82055683

Availability

Services available to external clients

Supervision

GX (General)

Scope of Accreditation

Withdrawn

ISO 15189 (2012)

Human Pathology

Medicare expiry date

05 Sep 2020

Last Activity Date

28 Jun 2019

Withdrawn
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 Clostridiodes 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 identification of yeasts and 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

ISO 15189 (2012)

Human Pathology

Withdrawn
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

ISO 15189 (2012)

Human Pathology

Withdrawn
Service Product Determinant
Chemical pathology - Further investigation of lipid profiles for diagnosis of types III and IV hyperlipidaemia Blood; Plasma HDL - Quantitation; Lipoprotein subclasses

ISO 15189 (2012)

Human Pathology

Withdrawn
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)

ISO 15189 (2012)

Human Pathology

Withdrawn
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

ISO 15189 (2012)

Human Pathology

Withdrawn
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

ISO 15189 (2012)

Human Pathology

Withdrawn
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

ISO 15189 (2012)

Human Pathology

Withdrawn
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 identification of yeasts and 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

ISO 15189 (2012)

Legal

Withdrawn
Service Product Determinant
Medico legal drug testing AS/NZS 4308, appendix A On-site screening procedure Urine Amphetamine type substances; Benzodiazepines; Cannabis metabolites; Cocaine metabolites; Opiates
Medico legal drug testing AS/NZS 4308, section 2 Specimen collection, storage, handling and dispatch Urine Colour; Creatinine; Temperature; pH
Medico legal drug testing AS/NZS 4308, section 3 General laboratory requirements Urine General laboratory requirements as described in AS/NZS 4308
Medico legal drug testing AS/NZS 4308, section 4 Laboratory screening procedures Urine Amphetamine type substances; Benzodiazepines; Cannabis metabolites; Cocaine metabolites; Opiates
Medico legal drug testing AS/NZS 4308, 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

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