National Association of Testing Authorities, Australia
Scope of Accreditation
Medihealth Pathology P/L
Site
Medihealth Pathology
Accreditation No.
20759
Site No.
24916
Date of Accreditation
19 May 2021
Address
Level 1 , 243 High Street
Penrith, NSW 2750
Australia
Contact
Mr Serge Peric
P: +61 (02) 86082070
Availability
Services available to external clients
Supervision
GX (General)
Scope of Accreditation
Medihealth Pathology
ISO 15189 (2012)
Human Pathology
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring | Serum | Carbamazepine; Digoxin; Lithium; Phenytoin (dilantin); Valproate (valproic acid, epilim) |
| Chemical pathology - Detection and/or quantitation of tumour markers | Serum | CA125 antigen (CA125); CA15-3 antigen (CA15-3); CA19-9 antigen (CA19-9); Carcinoembryonic antigen (CEA); Prostate specific antigen (PSA) - Free; α-Fetoprotein (AFP) |
| Chemical pathology - Detection of faecal occult blood | Faeces | Haemoglobin (Hb) |
| Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) | Serum | Dehydroepiandrosterone sulfate (DHEAS); Follicle stimulating hormone (FSH); Luteinising hormone (LH); Oestradiol; Progesterone; Prolactin; Sex hormone binding globulin (SHBG); Testosterone |
| Cortisol; Insulin | ||
| Chemical pathology - Diagnosis and management of diabetes mellitus | Blood | Glycated haemoglobin (HbA1c) |
| Chemical pathology - Further investigation of cardiac function | Serum | Troponin |
| Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Serum | Alanine aminotransferase; Alkaline phosphatase; Amylase; Aspartate transaminase; Bilirubin - Direct; Bilirubin - Total; C-reactive protein (CRP); Calcium - Total; Carbon dioxide (CO2); Chloride; Cholesterol - LDL; Cholesterol - Total; Creatine kinase; Creatinine; Glucose; HDL - Quantitation; Lactate dehydrogenase (LDH); Lipase; Magnesium; Phosphate; Potassium; Protein - Total; Sodium; Triglycerides; Urea; Uric acid; γ-Glutamyltransferase |
| Urine | Protein - Total | |
| Microalbumin | ||
| Chemical pathology - Investigation for folate deficiency | Serum | Folate |
| Chemical pathology - Iron studies | Serum | Ferritin; Iron; Transferrin |
| 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 |
| Clinical governance - Level 2 - Designated person assessment | Not applicable | Not applicable |
| Haematology - Full blood examination | Blood | 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); Platelet count; Red blood cell distribution width (RDW); Reticulocytes |
| Differential number; Morphology; Reticulocytes | ||
| 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) |
| Haematology - Limited blood examination | Blood | Erythrocyte (RBC) sedimentation rate (ESR) |
| Immunohaematology - Blood group antibody detection | Blood | Other blood group systems |
| Immunohaematology - Blood grouping | Blood | ABO; RhD |
| 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 |
| Immunopathology - Quantitation of complement proteins | Serum | Complement components C3 and C4 |
| 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 |
| Microbiology - Bacteriology - Detection of pathogenic bacteria | Faeces; General swabs; Sputum | Antibiotic susceptibility; Pathogenic microorganisms |
| Urine | Bacteria; Crystals; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC) | |
| Glucose; Haemoglobin (Hb); Leucocyte esterase; Proteins | ||
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (bacteria) | Combined nose and throat swabs; Nasal swabs; Nasopharyngeal swabs; Oropharyngeal swabs | Bordetella pertussis; Bordetella spp.; Legionella spp.; Mycoplasma pneumoniae |
| Faeces | Aeromonas spp.; Campylobacter jejuni; Clostridioides difficile; Shigella spp.; Yersinia enterocolitica | |
| Genital swabs; Urine | Chlamydia trachomatis; Mycoplasma genitalium; Neisseria gonorrhoeae | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (fungi) | Hair; Nails; Skin scrapings | Dermatophyte identification |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (protozoan parasites) | Faeces | Cryptosporidium spp.; Giardia spp. |
| Genital swabs; Urine | Trichomonas vaginalis | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) | Combined nose and throat swabs; Nasal swabs; Nasopharyngeal swabs; Oropharyngeal swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) |
| Faeces | Adenovirus; Astrovirus; Norovirus | |
| Nasopharyngeal and throat swab; Nasopharyngeal swabs; Throat swabs | Adenovirus; Enterovirus; Human metapneumovirus; Influenza A virus; Influenza B virus; Parainfluenza virus type 1/2/3/4; Respiratory syncytial virus (RSV); Rhinovirus | |
| Skin swabs | Herpes virus; Varicella zoster virus (VZV) | |
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Faeces | Amoebae; Ova; Parasites; Worms |
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Serum | Infectious mononucleosis |
| Cytomegalovirus antibody (anti-CMV) IgG; Cytomegalovirus antibody (anti-CMV) IgM; Epstein-Barr virus nuclear antigen IgG antibody; Epstein-Barr virus viral capsid antigen IgG antibody; Epstein-Barr virus viral capsid antigen IgM antibody; Hepatitis A virus antibody (anti-HAV) - IgG; Hepatitis A virus antibody (anti-HAV) - IgM; 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) - Confirmatory; Hepatitis B virus surface antigen (HBs Ag) - Quantitative; Hepatitis C virus antibody (anti-HCV); Rubella IgG antibody; Syphilis Treponema pallidum antibody; Toxoplasma spp. IgG antibody; Toxoplasma spp. IgM antibody | ||
| Helicobacter pylori IgG antibody | ||
| Syphilis Treponema pallidum antibody |
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.
20759
Site No.
24916
Print date
22 May 2022
END OF SCOPE