Quality assurance

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The Newborn Screening Laboratory is accredited as part of Clinical Biochemistry and the Willink Laboratory as part of the Genomic Diagnostics Laboratory (along with molecular genetics and cytogenetics). Both laboratories have full CPA accreditation status.

CPA is now part of UKAS (United Kingdom Accreditation Service) and from October 2013, CPA accredited laboratories are assessed against ISO 15189.

Both laboratories are currently awaiting inspection. Work is in progress nationally, to map the NHS Newborn Blood Spot Screening Programme standards to ISO 15189. It is anticipated document will be finalised for use by laboratory inspectors early in 2017.

External Quality Assessment

Both laboratories participate in the combined UK NEQAS scheme for Newborn Screening and the CDC EQA scheme. The Newborn Screening Laboratory also takes part in the UK NEQAS Newborn Sickle Screening scheme.

Governance arrangements

The CMFT Antenatal and Newborn Screening Board meets quarterly. Membership comprises the programme leads for all of the antenatal and newborn programmes, commissioners and representatives from all healthcare professional groups involved in delivery of the programmes. The Director of Newborn Screening reports to the board on behalf of the Newborn Bloodspot Programme. In addition programme Specific Operational and Quality Groups for Cystic Fibrosis and Sickle screening which include all stakeholders meet on a 6-monthly basis.

Matters in relation to Congenital Hypothyroid Screening are discussed as part of weekly MDT meeting with paediatric endocrinology. Matters in relation to metabolic screening are discussed at the monthly Willink Unit Heads of Department meeting (attended by clinicians, dieticians, laboratory and administration leads) and the Newborn Screening Operational Group Meeting (held every other month) which has representation from both the clinical and operational leads of the Newborn Screening and Willink laboratories. The Newborn Screening Laboratory also reports to the Greater Manchester, Lancashire and Cumbria Northumberland Tyne and Wear Quality and Commissioning Groups.

National standards

See Guidance and standards for NHS newborn blood spot screening