Quality

The West Midlands Regional Genetics Laboratory is a UKAS Accredited Medical Laboratory number 8176. The scope of our accreditation can be seen here on the UKAS website.

There may be instances where an accredited test is performed outside the scope of accreditation. Currently FISH tests for the following gene regions/rearrangements have exceeded the manufacturer’s expiry date and are performed outside the scope of accreditation; however, the test is performed to the same internal quality control standards and procedures:

ALK, FUS, MLL/MLLT1, MLL/AFF1, PAX3, PAX7, RB1, SS18 (SYT), UBE3A, EWSR1/ERG, FLI1/EWSR1, MALT1, MYB, NUP214/DEK, NUP98, NUP98/NSD1, SNRPN, ELN, 1p36, CBFB and Centromeres 2, 3, 4, 9, 15, 16, 18, 20 and whole chromosome paints.

For further information please contact the laboratory on 0121 335 8036.

Quality control

Accreditation with UKAS implies the department has a quality management system and participates in appropriate internal quality control and external quality assessment schemes. UKAS assesses against BS EN ISO15189:2012. The department is a member of voluntary quality assessment schemes within the UK NEQAS consortium and EMQN which monitors our analytical and interpretative performance, and ensures that our clients and patients get a high quality service. We participate in all aspects of the schemes that relate to services offered in this department, and contribute to pilot schemes when appropriate. Due to the wide variety of diseases covered by genetics laboratories, the schemes offered and diseases covered vary from year to year.

Contact

The department is committed to a process of continual improvement in the quality of its services and welcomes comments and suggestions on ways to improve its services.

Nigel Coles
Quality Manager
nigel.coles@nhs.net

Tel: 0121 335 8034

Reporting times

Table of reporting times

Clinical Urgency

Category (mapping to test directory)

Sub-categories

Calendar Days

Examples

URGENT

Ultra Rapid

NA

3 days

QF-PCR for rapid trisomy detection

Urgent  haemo-oncology FISH/RT-PCR PCR based tests where the result is needed urgently for prenatal diagnosis 

URGENT

Ultra Rapid

N/A

7 days

NIPT

URGENT

Rapid

Rapid

14 days

Microarray for prenatal/urgent postnatal (e.g neonatal referrals)
Urgent Haemato-oncology karyotyping
Mutation specific molecular pathology tests
Southern blot tests where the result is needed urgently for prenatal diagnosis
PCR-based tests for predictive testing & confirmation of neonatal results

 

Complex rapid

21 days

Urgent panels and exomes for relevant indications
NIPD

 

NON-URGENT

Standard

Somatic Cancer

21 days

Standard HO karyotyping (e.g. MDS)
NGS panels for HO referrals
NGS panels for molecular pathology referrals

 

42days (6 weeks)

Standard paediatric microarray
Standard single gene and small gene panel (<10 gene) sequencing Known familial mutation testing
Standard STR based analysis
Postnatal karyotyping (e.g. fertility or familial microarray follow up)

   

NON-URGENT

Complex Standard

Rare Disease

84 days   (12 weeks)

Large gene-panels (>10 genes) or WES for standard referral indications

Part a)  42 days

Expectation for delivery of centralised WGS (from DNA sample receipt to return of vcf and/or filtered variants to GLH)

     

Part b)      42 days

Validation/reporting of centralised WGS results after receipt at GLH

     

 

reporting times
                1st Quarter 1st Quarter 1st Quarter  
          2020 2020 2020 2021 2021 2021  
Clinical Urgency Category (mapping to TD) Sub-categories Calendar Days Examples %reported in TaT Average TaT TaT at 95 percentile %reported in TaT Average TaT TaT at 95 percentile  
URGENT Ultra Rapid NA 3 days   56% 3.9 7 69% 3.7 8  
URGENT Ultra Rapid N/A 7 days   46% 8.3 13 55% 7.8 13  
URGENT Rapid Rapid 14 days   73% 12.7 24 71% 13.1 26  
    Complex rapid 21 days not HO or Mol Path 32% 28.5 49 61% 22.9 38  
NON-URGENT Standard Somatic Cancer 21 days(21a) HO+mol path 51% 25.9 51 49% 24.2 45  
Rare Disease 42   44% 79.4 247 50% 68.8 199  
NON-URGENT Complex Standard Rare Disease 84   51% 117.2 229 55% 80 119