Yourgene-Health

On this page

• Overview
• Assessing needs
• Delivering evidence-based care and treatment
• How staff, teams and services work together
• Supporting people to live healthier lives
• Monitoring and improving outcomes
• Consent to care and treatment

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 2 quality statements from the effective key question. Our detailed findings can be found in the services section of this report.

We looked at the quality statements; how staff, teams and services work together and monitoring and improving outcomes.

We observed that staff worked cohesively to deliver a good quality service. Team collaboration was evident, with positive communication between managers and staff. The service showed a strong culture of continuous improvement. Routine monitoring, audits, and assessments drove improvements and consistently supported positive outcomes.

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

The judgement for Assessing needs is based on the latest evidence we assessed for the Effective key question.

The judgement for Delivering evidence-based care and treatment is based on the latest evidence we assessed for the Effective key question.

The provider worked effectively across teams and services. Clinics communicated through the service portal, and the laboratory manager or customer service representatives contacted clinics by phone or in person when needed. Although a system existed to collect feedback from external clinics, it was not used, and the service relied on clinics reaching out with concerns.

Staff said they used the portal daily to request clarification, confirm information, and exchange routine messages. The customer care team logged queries, and the quality team reviewed them with operational staff. Staff also noted that a recent in‑person visit from a clinic had been positive.

Staff reported regular two‑way communication with clinics. They visited some local clinics to collect samples and held weekly conversations with several nearby clinics. As part of onboarding, they met clinic staff in person and reviewed all tests in detail. Staff said they preferred direct meetings to explain processes and emphasised that the team was always available for support. However, they did not request feedback directly.

The NIPT team worked closely with the Yourgene-Health UK Ltd Technical Support Team, routinely sharing processes, technical knowledge, and learning across IONA installation users worldwide.

Each clinic received face‑to‑face IONA training during onboarding. After any updates or major changes to the IONA test, Yourgene-Health delivered a webinar presentation. These sessions were recorded and available on request.

The service used specific packaging materials compliant with UN3373 and worked with suppliers when product reviews were needed. Samples were posted and the service monitored performance through monthly targets.

The organisation issued a monthly newsletter for all national and international staff. It focused on staff engagement and included welcomes for new starters, long‑service awards for staff with more than 5 years’ service, and self‑care tips. It also celebrated colleagues through a “cheers for peers” scheme, highlighted charity work for children’s organisations and food banks, and shared personal achievements and announcements such as recent baby births. The newsletter also promoted local sports activities which staff were encouraged to join in.

In April 2025, the provider carried out an engagement survey open to all 207 employees, with 99 responses. However, it was difficult to identify feedback specific to the NIPT team or assess how accurately the organisational responses reflected their experiences because the results were not separated by department

Staff worked closely with other departments, including customer care, health and safety, and culture and performance. The customer‑service team maintained communication with clinics and supported engagement on behalf of the service. We observed good working relationships within the NIPT team.

Staff also collaborated with other healthcare disciplines and external agencies when needed. Managers gave examples of working with maternity service providers, including holding face to face joint meetings to discuss NIPT testing.

The service kept a clear schedule of meetings, including monthly board meetings, business reviews, genomic‑services quality meetings, equipment meetings, and organisation‑wide meetings.

We spoke with 3 external clinics who told us that was very easy to make contact with the service and they tend to do this using the portal. Clinics told us that they usually received a response within 2 hours. One told us that previously there could be a delay if trying to speak by telephone, but this had improved with the new laboratory manager in post. They told us that they can communicate with the laboratory manager easily.

Another clinic told us that the team was not always easy to reach by phone. They raised this with the service, and they now use the internal portal during working hours to request a call back. They said they now received quick replies to both routine and urgent queries.

The judgement for Supporting people to live healthier lives is based on the latest evidence we assessed for the Effective key question.

The service routinely monitored quality and outcomes. They had a strong culture of continuous improvement, and staff used findings to drive change and achieve positive results.

They ensured results were consistent and met the clinical turnaround‑time (TAT) target and clinic expectations. Since the previous CQC inspection in July 2023 the service revised its NIPT targets. The TAT target required 95% of samples to be reported within 5 working days of receipt. Between 1 January 2025 and 31 December 2025, the service received 1,465 NIPT samples and issued 1,333 reports, with some repeat samples requested. Of the 1,333 reports, 1,254 (94.07%) were completed within 5 days. The target was achieved in 7 of 12 months. There was a 4‑month period in summer 2025 when the service did not meet the target, which managers attributed to a manufacturing problem outside their control.

The service had an internal audit schedule for 2025 and 2026. They completed 9 audits in 2025 and planned 13 for 2026. Managers and staff used audit findings to improve practice, and investigations and actions were completed when issues occurred. Staff conducted repeat audits to monitor progress, and managers shared results with the team to ensure learning was understood and applied. UKAS last accredited the service in March 2025 to ISO 15189, the international standard for quality and competence in laboratory settings.

The laboratory manager told us that external quality assurance (EQA) checks were completed annually, as required for ISO 15189 accreditation. The EQA provider sent “blind” samples with unknown values for analysis, and results were compared against expected values. The most recent 2025 results had not yet been returned, but we reviewed the 2024 results, which were satisfactory. Managers emphasised that EQA provided independent confirmation that results were accurate and reliable.

Managers said they requested feedback through onboarding checks, CQC reports, and online reviews. Another manager explained that the development team continually worked on NIPT projects, checking reliability, reproducibility, and internal controls. When possible, the service also sought birth‑outcome data from clinics to support internal monitoring. The development team reported that the screening process was 99.9% accurate.

Monthly quality meetings took place with all NIPT staff, where outcomes were reviewed and monitored.

We spoke with external clinics that used the service. They told us that samples were managed promptly within the required 5 days and that they were happy with the service, describing it as “very streamlined and straightforward with a very good quality of service."

The judgement for Consent to care and treatment is based on the latest evidence we assessed for the Effective key question.