Guidance

Introduction

Updated 28 January 2026

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This publication is available at https://www.gov.uk/government/publications/antenatal-and-newborn-screening-laboratory-quality-assurance/introduction

1. Background

The United Kingdom Accreditation Service (UKAS) and NHS England (NHSE) have agreed that laboratories providing services for antenatal and newborn screening programmes will be quality assured via UKAS assessment on behalf of NHSE screening quality assurance service (SQAS).

SQAS will no longer routinely carry out peer review visits to any laboratory assessed by UKAS. This will reduce duplication and the assessment burden to those laboratories.

This guidance explains the UKAS requirements and the evidence they will assess. It covers the:

NHS service specifications require all screening laboratories to be accredited to International Standards Organisation (ISO) 15189:2022 ‘Medical laboratories – Requirements for quality and competence’. Specific quality assurance (QA) requirements for laboratory safety, quality and performance set out specific requirements in relation to ISO 15189:2022 in antenatal and newborn screening laboratories.

The process will be governed and managed according to a Memorandum of Understanding between UKAS and NHSE which is supported by an operational framework. This includes:

  • gaining consent from laboratories to the assessment process and sharing of relevant information including UKAS reports with NHSE
  • UKAS assessment against ISO 15189:2022 and screening QA requirements
  • UKAS provision of relevant information (including reports) to NHSE
  • management of key changes to screening work and voluntary/imposed UKAS sanctions.

2. Screening laboratory quality assurance process

UKAS and NHSE will jointly maintain oversight and governance of the arrangements and ensure effective arrangements for communication and collaboration.

2.1 UKAS

UKAS will undertake this process as an integral part of ISO accreditation of laboratories. It will:

  • assess both the ISO 15189:2022 requirements and the screening QA requirements as an integrated process over its 4-year cycle of laboratory accreditation, which comprises Initial/Extension to Scope assessment and annual Surveillance/Reassessment visits
  • identify screening non-conformities and areas of merit in the laboratories visited
  • share the screening assessment reports with NHSE
  • where UKAS is made aware of screening incidents potentially impacting on patient safety, they will inform NHSE. NHSE will initiate any discussion or action in collaboration with relevant colleagues including UKAS. Incidents would be addressed by SQAS according to the process for Managing safety incidents in NHS screening programmes.

2.2 NHSE SQAS

SQAS will:

  • share intelligence to UKAS prior to the assessment, this will include but not limited to performance data such as test turnaround times and information about screening safety incidents
  • review the UKAS reports prior to a QA visit and use them to inform QA of the interface between the laboratory user for example maternity services and the laboratory
  • refer to the UKAS assessment in QA reports produced following visits to the provider(s) that use the screening laboratory
  • monitor the findings from the UKAS reports to inform the review of national screening standards and guidance
  • keep these reports (and any other relevant information provided by UKAS) confidential and only accessible to NHSE functions with responsibility for screening laboratory QA.

2.3 Screening laboratories

Screening laboratories shall sign the confidentiality waiver and participate in and comply with these arrangements.

3. Laboratory quality assurance requirements

The quality assurance requirements for screening laboratories are established by NHSE screening and draw on the NHS screening programme service specifications, standards, handbooks, laboratory handbooks and learning from screening safety incidents.

They are set out for each programme in the appendices to this publication. They define the key issues for screening laboratories and map them to the corresponding ISO requirements, to assist in how those ISO requirements may be assessed for screening laboratories. Many ISO requirements do not have any additional screening requirement, so these are not referenced in the following tables.

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