National Association of Testing Authorities, Australia
Scope of Accreditation
Australian Red Cross Lifeblood
Site
Sydney Processing Centre – Manufacturing
Accreditation No.
18808
Site No.
3363
Date of Accreditation
13 Mar 1992
Contact
Mr Andrew Farrar
P: +61 (02) 92342011
Availability
Services available to external clients
Supervision
Not Applicable
Scope of Accreditation
Testing – Donor Chemistry Testing
ISO 15189 (2012)
Human Pathology
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Serum | Ferritin |
| Protein - Total |
Testing – Donor Protein Testing
ISO 15189 (2012)
Human Pathology
| Service | Product | Determinant |
|---|---|---|
| Immunopathology - Quantitative and/or qualitative investigation of proteins | Serum | Albumin; α1-Globulin; α2-Globulin; β-Globulin; β1-Globulin; γ-Globulin |
| Detection and amount of paraproteins | ||
| Immunopathology - Quantitative investigations of immunoglobulins and immunoglobulins subclasses | Serum | Total immunoglobulin A; Total immunoglobulin G; Total immunoglobulin M |
Testing – Infectious Disease Screening
ISO 15189 (2012)
Human Pathology
| Service | Product | Determinant |
|---|---|---|
| Microbiology - Bacteriology - Detection of pathogenic bacteria | Blood; Cord blood; Plasma; Platelet concentrates; Red cell concentrates | Bacteria; Pathogenic microorganisms |
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Cadaveric blood | Hepatitis B virus surface antigen (HBs Ag); Hepatitis C virus (HCV); Human T-lymphotropic virus type I/II (HTLV-I/II); Human immunodeficiency virus (HIV) p24 antigen; Human immunodeficiency virus type 1/2 (HIV-1/2) 1/2 antibodies; Syphilis Treponema pallidum antibody |
| Hepatitis B virus core antibody (anti-HBc) - Total | ||
| Plasma | Human immunodeficiency virus (HIV) p24 antigen; Human immunodeficiency virus type 1/2 (HIV-1/2) 1/2 antibodies | |
| Hepatitis C virus (HCV) | ||
| Plasmodium falciparum antibody; Plasmodium vivax antibody | ||
| Hepatitis C virus (HCV); Human T-lymphotropic virus type I/II (HTLV-I/II) | ||
| Plasma; Serum | Hepatitis B virus surface antigen (HBs Ag); Hepatitis B virus surface antigen (HBs Ag) neutralisation; Hepatitis C virus (HCV); Human T-lymphotropic virus type I/II (HTLV-I/II); Human immunodeficiency virus (HIV) p24 antigen; Human immunodeficiency virus type 1/2 (HIV-1/2) 1/2 antibodies; Syphilis Treponema pallidum antibody | |
| Cytomegalovirus (CMV); Hepatitis B virus core antibody (anti-HBc) - Total; Hepatitis B virus surface antibody (anti-HBs) |
Testing – Nucleic Acid Testing
ISO 15189 (2012)
Human Pathology
| Service | Product | Determinant |
|---|---|---|
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) | Cadaveric donor | Hepatitis B virus (HBV) DNA; Hepatitis C virus (HCV) viral RNA; Human immunodeficiency virus type 1 (HIV-1) RNA; Human immunodeficiency virus type 2 (HIV-2) RNA |
| Plasma | Hepatitis B virus (HBV) DNA; Hepatitis C virus (HCV) viral RNA; Human immunodeficiency virus type 1 (HIV-1) RNA; Human immunodeficiency virus type 2 (HIV-2) RNA | |
| Plasma; Serum | Hepatitis B virus (HBV) DNA; Hepatitis C virus (HCV) viral RNA; Human immunodeficiency virus type 1 (HIV-1) RNA; Human immunodeficiency virus type 2 (HIV-2) RNA |
Testing – Process Control
ISO 15189 (2012)
Human Pathology
| Service | Product | Determinant |
|---|---|---|
| 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 |
| Morphology |
Testing – Red Cell Serology
ISO 15189 (2012)
Human Pathology
| Service | Product | Determinant |
|---|---|---|
| Immunohaematology - Blood group antibody detection | Blood; Plasma; Serum | Duffy system; Kell system; M and N factors; Other blood group systems; Rh phenotypes |
| Immunohaematology - Blood grouping | Blood; Plasma; Serum | ABO; RhD |
| Immunohaematology - Identification and quantitation of blood group antibodies | Blood; Plasma; Serum | Red blood cell phenotyping |
| High titre anti-A and anti-B screening |
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.
18808
Site No.
3363
Print date
27 Jul 2024
END OF SCOPE
