This document discusses the process of incorporating Public Health England's antenatal and newborn screening standards into UKAS accreditation to ISO 15189 for laboratories performing infectious diseases in pregnancy screening. The objectives are to reduce assessment burden, improve communication and patient safety through a coordinated accreditation and quality assurance process. PHE screening requirements have been mapped to ISO 15189. Laboratories must meet both PHE and ISO standards to receive and maintain accreditation, with information sharing between UKAS and PHE's quality assurance program. The process aims to strengthen oversight of screening laboratories while minimizing duplicate efforts.

1. Accreditation of IDPS screening laboratories by UKAS
The incorporation of PHE
Antenatal/Newborn screening standards into
UKAS accreditation to ISO 15189
Delia Geary, UKAS Technical Manager for Healthcare
NHS Infectious Diseases in Pregnancy Screening Programme (IDPS)
National Laboratory Workshop March 2019

2. Scope of presentation
a) Setting the scene – background
b) Objectives
c) Process
d) Expected outcome

3. Setting the scene
People involved:
Public Health England/Screening Quality Assurance
Jane Woodland – Regional Head of QA, Midlands and East
Rowena Clayton – PH Consultant – Laboratory QA project
lead
Pam Tarn – Senior QA Advisor North
Angela Dietrich – Senior QA Advisor London
Sheila Miller, QA Advisor North
Jodie Price, Senior QA Advisor Midlands and East
Emma Procter, Senior QA Advisor South
Delia Geary UKAS/ Gwen Guthrie CPA

4. Some acronyms…
UKAS – United Kingdom Accreditation Service
CPA – Clinical Pathology Accreditation
PHE – Public Health England
SQAS – Screening Quality Assurance Service
ANNB – Antenatal and Newborn

5. Antenatal and New Born Screening – what does
it include?
Antenatal.
Fetal Anomaly/Down’s, Edwards’ & Patau’s syndromes
Infectious Diseases (HIV; Hepatitis B; Syphilis)
Sickle Cell and Thalassaemia
Newborn Blood Spot
Cystic Fibrosis; Congenital hypothyroidism (CHT); Glutaric
aciduria type 1 (GA1); Homocystinuria (HCU); Inherited
metabolic diseases (IMDs); Isovaleric acidaemia (IVA); Maple
syrup urine disease (MSUD); Medium-chain acyl-CoA
dehydrogenase deficiency (MCADD); Phenylketonuria (PKU);
Sickle cell disease

6. Background
• The interaction with the national screening programme
began with CPA prior to the ISO 15189 transition
• Gwen Guthrie from CPA pioneered the initial work alongside
Elizabeth Dormandy from Screening QA
• In 2012/2013 the overall responsibility passed to UKAS but
with continued involvement of Gwen
• Upon Gwen’s retirement the responsibility to progress this
transferred to Delia Geary
• 2015 Memorandum of understanding signed

7. Objectives
• Reduction of assessment/inspection burden on laboratories
and minimising duplication of activities
• Limited assessor resource
• Increasing liaison between bodies involved in monitoring the
quality of services across a clinical pathway therefore
providing a ‘joined up approach

8. Objectives
• Enhanced communication and patient safety
• Multi faceted improvement mechanism
• Frequency of UKAS visits leading to increased awareness of
any patient safety issues

9. Process
Laboratories offering an Antenatal and Newborn (ANNB)
screening service in England:
• Assessments by UKAS will address screening programme
requirements through assessments to ISO 15189
• PHE Service Specifications make it clear that laboratories
must engage with UKAS in assessments against the
screening requirements
• Laboratories must meet the screening programme quality
assurance requirements mapped to ISO 15189 and use ISO
15189 accredited referral laboratories

10. Process
All ANNB screening laboratories must:
• be accredited by the United Kingdom Accreditation Service
(UKAS) to ISO 15189. 'Medical laboratories – Requirements
for quality and competence’ (for the specific examinations)
• participate in EQA schemes accredited to ISO/IEC 17043.
'Conformity assessment. General requirements for
proficiency testing schemes’

11. Process
• Screening laboratory requirements - screening programme
standards, service specifications and laboratory guidance
“mapped” to ISO 15189 to generate a programme specific
document (QA requirements) which is used and referred to by
UKAS Lead assessors
• https://www.gov.uk/government/publications/antenatal-and-
newborn-screening-laboratory-quality-assurance

12. Process

13. Process
• Laboratories will need to agree to a sharing of information
between UKAS and SQAS (Screening Quality Assurance
Service) and to sign a confidentiality waiver
• Increase in effort for UKAS assessments
• Relevant documentation: National standards, laboratory
handbooks & service specifications; laboratory quality
assurance evidence requirements
• Screening laboratory will need to demonstrate to UKAS how
they ensure all screening requirements are satisfied and
audited against

14. Process
• Relevant UKAS assessment outcomes to be shared with
SQAS including relevant non conformities and a summary
report
• This information to be reviewed and used by SQAS to inform
whether SQAS need to take any additional action
• SQAS QA visits to maternity services will focus on the
laboratory communication strategies and user interface from
the (user) maternity perspective

15. Process
Process piloted – four visits generally found to be
satisfactory – no negative comments from customers
Approach during assessments:
• Surveillance visits: vertical audit
• Reassessment visits – horizontal
• Assessments completed by Lead Assessor
• Once in the accreditation cycle a technical assessor
with screening experience to be included in the
team.
• All non conformities will be closed out by UKAS

16. Outcomes
• Common findings to be trended
• Feedback on process to be sought (from customers) on an
ongoing basis
• Trends and learning will be fed into the national
development of each programme

17. Queries
Please direct any questions associated with the programmes
and the requirements to SQAS or the contacts for the national
programmes
Any queries about the UKAS assessment approach to be
directed to me (delia.geary@ukas.com) or your Assessment
Manager

18. Thank you!

19. Accreditation of IDPS screening laboratories by UKAS
The incorporation of PHE
Antenatal/Newborn screening standards into
UKAS accreditation for ISO 15189
Delia Geary, UKAS Technical Manager for Healthcare
NHS Infectious Diseases in Pregnancy Screening Programme (IDPS)
National Laboratory Workshop March 2019