Quality at the West Midlands Regional Genetics Laboratory

This laboratory is accredited in accordance with the recognised International Standard ISO 15189. This accreditation demonstrates technical competence for a defined scope and the operation of a medical laboratory quality management system (refer joint ISO-ILAC-IAF communiqué dated November 2021).

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