National Association of Testing Authorities, Australia
Scope of Accreditation
NSW Health Pathology
Site
NSW Health Pathology JHH Molecular Medicine
Accreditation No.
3561
Site No.
25007
Date of Accreditation
11 Sep 2020
Address
Level 2 Pathology Building, John Hunter Hospital, 2 Lookout Road
New Lambton Heights, NSW 2305
Australia
Contact
Availability
Services available to external clients
Supervision
B (Branch)
Scope of Accreditation
ISO 15189 (2022)
- This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.
Human Pathology
Medicare expiry date
27 Jun 2027
Last Activity Date
13 Mar 2023
Service | Product | Determinant |
---|---|---|
Cytogenetics - Detection of defined, balanced and/or unbalanced chromosomal abnormalities by in situ hybridisation techniques | Amniotic fluid; Blood; Bone marrow; Chorionic villus tissue; Tissues | Chromosomal rearrangement; Constitutional genetic abnormalities; Cytogenetic analysis and reporting; Pathogenic copy number changes; Variations of unknown significance |
Cytogenetics - Karyotype detection of balanced and/or unbalanced chromosome abnormalities | Amniotic fluid; Blood; Bone marrow; Chorionic villus tissue; Tissues | Acquired genetic abnormalities; Constitutional genetic abnormalities; Haematological abnormalities; Pathogenic copy number changes |
Cytogenetics - Molecular karyotype (SNP microarray) detection of unbalanced chromosome abnormalities | Amniotic fluid; Blood; Bone marrow; Chorionic villus tissue | Absence of heterozygosity; Aneuploidy detection for chromosomes; Chromosomal rearrangement; Cytogenetic analysis and reporting; Pathogenic copy number changes |
Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted genes | Blood; Bone marrow; Formalin-fixed paraffin-embedded (FFPE) tissues; Tissues | Blood borne tumours; Solid tumours |
Blood; Tissues | Birt-Hogg-Dubé syndrome; Cowden syndrome (multiple hamartoma syndrome); Inherited cancer syndromes; Juvenile polyposis; Li-Fraumeni syndrome; Peutz-Jeghers syndrome; Von Hippel Lindau disease | |
Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted panels for inherited (germline) DNA/RNA changes | Blood | Inherited cancer syndromes |
Breast cancer | ||
Molecular genetics - DNA extraction | Amniotic fluid; Blood; Bone marrow; Buccal swabs; Buffy coat; Chorionic villus tissue; Formalin-fixed paraffin-embedded (FFPE) tissues; Products of conception (POC); Saliva; Tissues | DNA storage for future analyses; Purified PCR product; Viable DNA; Viable DNA for sequencing |
Formalin-fixed paraffin-embedded (FFPE) tissues | DNA storage for future analyses; Purified PCR product; Viable DNA; Viable DNA for sequencing | |
Molecular genetics - DNA sequencing | Blood; Buccal swabs; Formalin-fixed paraffin-embedded (FFPE) tissues; Oral fluid | DNA sequence analysis; DNA sequencing reaction purification step; Sequenced DNA by Sanger sequencing; Sequenced DNA utilising massively parallel sequencing technologies |
Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted panels for non-inherited (somatic) DNA/RNA changes | Blood; Bone marrow; Cytology smears; Formalin-fixed paraffin-embedded (FFPE) tissues | Leukaemia; Lymphoproliferative disorders; Myelodysplastic syndromes; Myeloproliferative neoplasms |
Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted panels for non-inherited (somatic) DNA/RNA changesData analysis and reporting only | Formalin-fixed paraffin-embedded (FFPE) tissues | Microsatellite instability analysis; Multi-nucleotide variants (MNV); Single nucleotide variants (SNVs); Solid tumours; Tumour mutation burden (TMB) |
Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Targeted genes | Blood | Factor V Leiden; Prothrombin variant |
Haemochromatosis | ||
Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Targeted panels for inherited (germline) DNA/RNA changes | Blood | Inherited cancer syndromes |
Molecular genetics - Predictive genetic testing - Targeted genes | Blood | Nucleic acid analysis for specific variants |
Molecular genetics - Predictive genetic testing - Targeted panels for inherited (germline) DNA/RNA changes | Blood | Inherited cancer syndromes |
Molecular genetics - RNA extraction | Amniotic fluid; Blood; Bone; Buccal swabs; Buffy coat; Formalin-fixed paraffin-embedded (FFPE) tissues; Saliva; Tissues | Purified PCR product; RNA storage for future analyses; Viable RNA; Viable RNA for sequencing |
Formalin-fixed paraffin-embedded (FFPE) tissues | Purified PCR product; RNA storage for future analyses; Viable RNA; Viable RNA for sequencing | |
Molecular genetics - RNA sequencing | Extracted RNA | Sequenced RNA by Sanger sequencing |
Molecular genetics - Screening for an unknown mutation - Targeted panels for inherited (germline) DNA/RNA changes | Blood | Inherited cancer syndromes |
Molecular genetics - Screening for an unknown mutation - Targeted panels for non-inherited (somatic) DNA/RNA changes | Blood; Bone marrow; Cytology smears; Formalin-fixed paraffin-embedded (FFPE) tissues | Leukaemia; Lymphoproliferative disorders; Myelodysplastic syndromes; Myeloproliferative neoplasms |
Molecular genetics/Cytogenetics - Bioinformatic analysis | DNA sequences | Primary analysis - Conversion of instrument file to FASTQ or FASTA file; Secondary analysis - Alignment and variant calling; Tertiary analysis - Data annotation and interpretation |
ISO 15189 (2022)
Human Pathology
Service | Product | Determinant |
---|---|---|
Molecular genetics - DNA extraction | Extracted DNA | Quantification of DNA |
Molecular genetics - DNA sequencing | Extracted DNA | DNA sequence analysis; DNA sequencing reaction purification step; Sequenced DNA utilising massively parallel sequencing technologies |
Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted panels for non-inherited (somatic) DNA/RNA changesExcludes data analysis and reporting | Formalin-fixed paraffin-embedded (FFPE) tissues | Microsatellite instability analysis; Multi-nucleotide variants (MNV); Single nucleotide variants (SNVs); Solid tumours; Tumour mutation burden (TMB) |
Molecular genetics - RNA extraction | Extracted RNA | Quantification of RNA |
Molecular genetics - RNA sequencing | Extracted RNA | RNA sequence analysis; RNA sequencing reaction purification step; Sequenced RNA utilising massively parallel sequencing technologies |
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.
3561
Site No.
25007
Print date
03 Nov 2024