Yourgene-Health

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• Overview
• Shared direction and culture
• Capable, compassionate and inclusive leaders
• Freedom to speak up
• Workforce equality, diversity and inclusion
• Governance, management and sustainability
• Partnerships and communities
• Learning, improvement and innovation

Following our responsive inspection of diagnostic and screening on 16 January 2026, the location was not rated as CQC do not rate pathological laboratories. We looked at 1 quality statement from the well-led key question. Our detailed findings can be found in the services section of this report.

At our previous inspection, the service was in breach of legal regulation in relation to standards for recruitment processes.

The service had a good standard of governance with clear responsibilities, roles, and systems of accountability. However, we found that the service did not have full oversight of recruitment checks on all staff providing regulated activities. We have requested an action plan.

Find out what we look at when we assess this area in our information about our new Single assessment framework.

The judgement for Shared direction and culture is based on the latest evidence we assessed for the Well-led key question.

The judgement for Capable, compassionate and inclusive leaders is based on the latest evidence we assessed for the Well-led key question.

The judgement for Freedom to speak up is based on the latest evidence we assessed for the Well-led key question.

The judgement for Workforce equality, diversity and inclusion is based on the latest evidence we assessed for the Well-led key question.

The provider had clear responsibilities, roles, and accountability systems. They used these to manage and deliver a good quality, sustainable service. They acted on the best available information about risk, performance, and outcomes, and shared this securely with others when appropriate. However, their staff recruitment systems required improvement.

At our previous inspection, we identified breaches in regulation 19(1)(2), requirements for effective recruitment processes and regulation 5(a)(d) for fit and proper persons directors. The service did not have an effective process for checking company directors in line with regulatory requirements and did not complete relevant checks for employed staff.

We followed up on these breaches during this inspection. The service had introduced a recruitment policy to outline required processes. However, because recruitment fell outside the scope of UKAS ISO 15189 accreditation, the service had not included it in the quality management audit system and did not have full oversight of the processes.

The recruitment policy required a minimum of current or last employer or in the case of a first employed role an academic or character reference. Not all staff had the required references. We reviewed 6 staff files, and one did not have any references. The provider had requested references but had not followed up actions when they had not been returned.

This showed the service was not following its own policy, which created potential liabilities and unfairness. Although the service took reasonable steps to obtain references, the policy did not specify what to do when previous employers failed to respond.

The policy required DBS checks based on role and the level of contact with regulated services. The service used a registered screening company to complete basic, standard, and enhanced DBS checks. We found that one staff member did not have evidence of a completed DBS check on file. The registered manager immediately acted upon this.

Although the service had begun implementing its recruitment policy, including checks for signed contracts, identity documentation, DBS checks, references, and hepatitis B immunisations, it still lacked full oversight. Not all staff had the required references or DBS checks. Following our inspection, the service updated its recruitment policy to require 2 references for all staff. However, the policy did not specify what actions would be taken if references were not received or whether staff could start work while awaiting reference checks. This was a breach of regulation 19.

The service had a risk register which clearly outlined severity scoring for certain risks. We saw that managers had oversight of this register, and updates were evident which were reviewed by the laboratory director and quality assurance team during routine monthly quality assurance meetings.

The risk management plan (RMP) outlined the procedures for identifying, assessing, and mitigating risks associated with Non-Invasive Prenatal Testing (NIPT) within the laboratory operating under ISO 15189 standards and in compliance with ISO 22367 guidelines. The plan applied to all NIPT testing activities conducted within the laboratory. It encompassed risk management strategies from the sample collection to the result reporting.

The service had risk assessments in place for each laboratory action. Staff updated these yearly, identified risks, and outlined the controls in place.

Routine staff meetings took place to discuss day‑to‑day issues and share information about performance standards and organisational objectives. Senior managers monitored performance information and shared updates through team meetings, emails, and staff newsletters.

Staff told us they attended regular monthly team meetings, scheduled to ensure full participation. Meeting minutes were available to keep staff informed of actions and updates. We saw evidence of formal meeting notes and action plans from clinical governance meetings.

The service had an electronic quality management system that stored and monitored all policies, standard operating procedures (SOPs), working instructions or guidelines, protocols, specifications, and validation and calibration plans and reports. The system stored old versions as obsolete, recorded document history, sent automatic review reminders, and allowed authors, editors, and approvers to interact electronically. The service had strong document‑management policies with clear document‑control standards.

All staff had access to the electronic policy system, which provided a list view where policies and audits were easy to find using a search function. Staff could search documents using keywords (title or subject) or by document type. New employees were introduced to the system during induction, and a user guide was available for reference. Oversight of policies and SOPs took place through quality meetings, where the “document review” target and actions relating to document management were monitored.

Staff told us they were happy at work and felt well supported. We observed that they worked well as a team and were motivated and enthusiastic. The manager was readily available, and both staff and clinics said they were knowledgeable and easy to contact.

The judgement for Partnerships and communities is based on the latest evidence we assessed for the Well-led key question.

The judgement for Learning, improvement and innovation is based on the latest evidence we assessed for the Well-led key question.