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Diagnostic legislation changes

Pathology Quality Manager Jessica Dixon looks at safety and quality assurance practices in relation to expanded testing due to the pandemic.

For the general public, the safety of diagnostic tests is often accepted, however, this fails to acknowledge the long history of legislation and quality improvements that have ensured this to be the case. MHRA, NICE, UKAS and CQC have all played their part in ensuring that diagnostic tests perform as expected, to a clinically acceptable standard. Pathology laboratories have long been acquainted with UKAS accreditation to ISO 15189 and CQC regulation and have succeeded in working to these standards for some time. In meeting these standards, we can be assured of quality and safety, but what happens if there is a national imperative to expand testing to a wider range of providers as we have seen during the last year?

Previous legislation

In pre-COVID times, legislation described that diagnostic testing services offered to the public must be performed by a CQC-approved healthcare provider. Therefore, any company or laboratory that would offer such services would have to undergo regulatory inspections by CQC to determine that they were safe to provide this service – which could be via direct regulatory assessment from CQC or as part of wider healthcare provision, such as an NHS trust.

“We must acknowledge ourselves  as exemplars in providing high-quality and safe testing to our service users”

New legislation

Following the emergence of COVID-19, the demands for mass testing and improved access to testing became essential. This meant testing needed to be expanded beyond only hospitals and healthcare settings, without losing the safety and quality assurance practices. If anything, these became more paramount to ensure public safety and effectiveness of testing amid the pandemic.

In order to meet this demand, the government needed to utilise other means for testing provisions and services; however, the legislation for diagnostic testing limited the ability to achieve this upscaling, using the previous governance approach. This has since been revised, using the international standard ISO 15189 to deliver the same governance standard and therefore patient safety.

Private laboratories and testing facilities have since been established to achieve the ever-moving goal posts of national daily tests, and general public demand on independent providers for tests. In order to provide governance and assurances of patient safety they must meet specified requirements before being able to do so.

The demands for mass testing and improved access to testing became essential

The government has published new guidance on the minimum standards that private providers are required to meet in order to self-declare as a COVID-19 testing provider, offering services to the public. They need to meet 10 criteria (see box, bottom).

This new legislation means that COVID-19 testing has been removed as a CQC-regulated activity under the Health and Social Care Act 2008 Regulations 2014 and instead the new Coronavirus, Testing Requirements and Standards (England) Regulations 2020 require all private coronavirus test providers to become accredited by UKAS.

It must be noted though – this applies specifically to COVID-19 testing only, but covers the whole testing pathway from sampling to result. This is inclusive of RT-PCR testing, antigen and antibody testing. Whilst CQC would regulate a specific activity, UKAS ensures that the entire end-to-end process is assessed against the ISO 15189 standard requirements.

It is expected that UKAS accreditation to ISO 15189 or ISO/IEC 17025 will become a mandatory minimum standard by summer 2021 for any company or laboratory providing COVID-19 testing. It is also worth highlighting that sampling can be accredited as part of a wider lab-based activity, or sampling can be the scope of a standalone, separately accredited legal entity.

What this means…

This essentially is approving UKAS as the gold-standard accrediting body to ensure practices are safe, of a high standard and meet the minimum quality assurance needs. As biomedical scientists, the majority of us have previously undergone the significant transition to ISO 15189 and have been working at this standard for quite some time. We, therefore, must acknowledge ourselves as exemplars in providing high-quality and safe testing to our service users. The NHS-based services, often referred to as Pillar 1 in recent times, have shone as professional services and it is important that we continue to uphold these quality assurance requirements.

As a criticism, the requirements of criteria 6 and 8 should be highlighted. If companies and laboratories that are “working towards” or an “applicant to” UKAS accreditation are permissible, this begs the question of what if they then go on to be unsuccessful at their accreditation assessment visit?  Further, more future considerations for us as a profession include whether this legislation will continue to be limited to this COVID-19 pandemic or whether this will evolve to include a larger scope of diagnostic testing provided by self-declared private providers?   

Jessica Dixon is a Pathology Quality Manager in the Core Clinical and Support Services Division at Milton Keynes University Hospital NHS Foundation Trust.


COVID-19 criteria

  • Requirement for a clinical or medical director or equivalent and a healthcare scientist
  • The test product must have a CE (or UKCA) mark to ensure fitness for purpose and quality assurance
  • Ensure that the provider is using the test in line with its intended, published scope as determined by the MHRA and used in the appropriate target settings
  • Reporting of results must be in line with legal requirements to PHE
  • Must have systems to reportand escalate adverse incidents
  • Samples shall be taken by a provider meeting or working towards ISO standard ISO 15189 or ISO/IEC 17025
  • The provider must have clear clinical governance procedures in place
  • For lab-based COVID-19 testing: be or use a UKAS-accredited lab or applicant laboratory to either ISO 15189 (Medical Laboratories – requirements for quality and competence) or ISO/IEC 17025 (general requirements for the competence of testing and calibration laboratories)
  • For point-of-care testing: providers need to meet ISO standards ISO 15189 and ISO 22870 “point-of-care testing (POCT) – requirements for quality and competence”. Samples shall be processed by a UKAS-accredited or applicant provider
  • Compliant with all legal and regulatory requirements for sample collection, analysis and reporting/recording of results, including the requirements of data protection legislation.
Image Credit | Getty Images

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