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
|
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) |
|
|
Complex rapid |
21 days |
Urgent panels and exomes for relevant indications |
|
|
NON-URGENT |
Standard |
Somatic Cancer |
21 days |
Standard HO karyotyping (e.g. MDS) |
|
|
42days (6 weeks) |
Standard paediatric microarray |
||
|
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 |
| 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 | ||