Guidance

Introduction

Published 27 July 2018

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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 Public Health England (PHE) have agreed that laboratories providing services to antenatal and newborn screening programmes will be quality assured by UKAS through accreditation on behalf of PHE screening quality assurance service (SQAS).

SQAS will no longer routinely carry out peer review visits to any laboratory quality 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 ‘Medical laboratories – Requirements for quality and competence’. Specific quality assurance (QA) requirements for laboratory safety, quality and performance set out how to interpret key ISO standards in antenatal and newborn screening laboratories.

The process will be governed and managed according to an Memorandum of Understanding between UKAS and PHE which is underpinned by operational frameworks. These provide for:

  • gaining consent from laboratories to the assessment process and sharing of the UKAS reports with PHE
  • UKAS visit and assessment against the ISO standards and screening QA requirements
  • UKAS provision of reports to PHE
  • management of sanctions
  • development of UKAS and PHE processes and guidance

2. Screening laboratory quality assurance process

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

2.1 UKAS

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

  • assess both the ISO 15189 requirements and the screening QA requirements as an integrated process over its 4-year cycle of laboratory accreditation, which comprises initial assessment and annual surveillance visits
  • identify and address screening non-conformities and will also identify areas of merit in the laboratories visited
  • share the screening assessments in reports to PHE in the form of a summary assessment and a brief report against each of the screening requirements

Where UKAS identifies any suspected incidents relating to screening, they will inform PHE after the visit. PHE will initiate any discussion or action in collaboration with relevant colleagues including UKAS. Any incidents would be addressed by SQAS according to the process for Managing safety incidents in NHS screening programmes.

2.2 PHE SQAS

SQAS will:

  • review the UKAS reports prior to a QA visit and use them to inform QA of the interface between the laboratory user 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 standards and guidance
  • keep these reports confidential and only accessible to PHE functions with responsibility for screening laboratory QA

2.3 Screening laboratories

Screening laboratories should participate in and comply with these arrangements and share any relevant information with UKAS to which PHE is also party.

3. Laboratory quality assurance requirements

The quality assurance requirements for screening laboratories have been established by PHE screening and draw on the NHS screening programme service specifications, standards, handbooks and laboratory handbooks.

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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