C19-Stage2 UKAS Appraisal

Background

As testing for SARS-CoV2 has become more widespread, there has been increasing interest in procuring testing for COVID-19 privately. DHSC has recently introduced requirements for private providers wishing to offer testing of international arrivals (Stage 1 in the process to achieving accreditation).  UKAS has been working closely with DHSC to understand how best these requirements can be implemented in a way that testing activity can expand whilst maintaining confidence in the quality.

Through Stage 1: UKAS Application, DHSC have set up capability for testing providers to self-declare against minimum requirements through online registration on the gov.uk website.  UKAS performs an assessment of the provider’s declaration and where the assessment demonstrates requirements have been met, providers will appear on a published list on the gov.uk website.

A requirement of the self-declaration is to apply for UKAS accreditation and begin the accreditation process for either ISO 15189 or ISO/IEC 17025 and that accreditation is achieved by June 2021.  To facilitate the ability to achieve accreditation and to continue to actively demonstrate progress towards achieving UKAS accreditation, a formal second stage (Stage 2 UKAS Appraisal) has been introduced at the request of DHSC.  Once UKAS accreditation is awarded, this is the final stage, stage 3.

Stage 2: UKAS Appraisal

The UKAS Appraisal stage is intended to demonstrate that providers are progressing towards accreditation, clearly understanding the relevant international standard and implementing 13 key requirements.  Providers will need to submit evidence to UKAS to demonstrate that they do this.  Providers for Test to Release and General Testing are currently required to submit evidence to meet Stage Two by whichever is latest of:

• 18th January, for providers of Test to Release
• 31st January, for providers of General Testing
• Four weeks after they passed Stage One (i.e. when they submitted their self-declaration to indicate that they meet the minimum standards and they (or their sub-contractors) submitted the relevant applications for UKAS accreditation).

Requirements are:

1. Provider has obtained a copy of the relevant ISO standard for accreditation and conducted a gap analysis.  Plans are provided outlining how the requirements of the standard will be met in full.
2. Provider has defined its governance and management structure with reporting lines and responsibilities defined
3. Provider shall have adequate liability insurance (assume the requirement is for professional liability insurance but also public and employee)
4. Provider shall have access to relevant clinical expertise (expectations vary depending on ISO 15189 or ISO/IEC 17025)
5. Provider shall have sufficient trained and competent staff and records of training and competence assessment shall be available
6. Provider shall use validated technical methods and demonstrate that they can achieve the stated performance characteristics on a consistent basis (further guidance on validation protocol will be provided)
7. Provider shall have documented procedures for sample collection, transport, storage and analysis
8. Provider shall implement appropriate IQC and have registered in a suitable EQA scheme or ILC
9. Provider shall have and maintain suitable facilities that meet relevant containment level requirements.  The environment shall be appropriately managed and monitored to prevent cross contamination.
10. Provider shall have appropriate interpretation criteria, including the need to validate any software used and reports shall be authorised for release by designated staff in a set format
11. Provider shall have appropriate procedures in place to ensure testing is performed five days post self-isolation and/or for other agreed turnaround times and for reporting of the outcome of testing (both positive and negative results) in accordance with the statutory regulations for reporting SARS-CoV 2 testing
12. Provider shall have appropriate procedures in place to resolve and report adverse incidents including clinical incidents
13. Provider shall have in place appropriate procedures to safely dispose of clinical waste

Providers will receive a report from UKAS on the outcome of the assessment of their documentation confirming whether they do or do not meet the 13 key requirements within seven days.  Where further evidence is required, this must be submitted to UKAS within seven days.  UKAS will then perform a second review within seven days of that. Providers will need to address any gaps and feed into their gap analysis that will be established to meet Requirement 1, above (the format for which will be available shortly).  UKAS will propose next steps after the Stage 2 assessments including when initial assessment can proceed.

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