Nuffield Health

Case Study




Case Study

Guaranteed compliance
with MHRA, UKAS, HTA and FDA CFR 21 part 11

Improved reporting
of potential non-compliances and reduced inventory risk

Automated and secure
record keeping accessible by all stakeholders

Remote monitoring
and escalation delivers maximum inventory protection


Nuffield Health is the largest not-for-profit healthcare provider in the United Kingdom. Established in 1957 the charity operates 31 Nuffield Health Hospitals. Its objectives are to advance, promote and maintain health and healthcare of all descriptions and to prevent, relieve and cure sickness and ill health of any kind, all for the public benefit.

In order to fully comply with regulatory compliance and to provide the ultimate levels in continuity of service, Nuffield Hospitals Pathology Laboratories and Pharmacy departments are required to fully monitor their cold chain storage and processes.

Patient’s samples, blood, human tissue, drug, vaccines, and many other costly and highly sensitive inventory are stored in temperature-controlled environments, such as fridges and cold-rooms, throughout the 31 hospital locations, where the environmental condition of this inventory is paramount to the operation of the departments.

Any deviation from this environment (temperature, gas, power) must be reported and reacted to 24/7, 365 days per year. Early warning of any potential storage condition failure is key to safeguarding all inventory and compliance with MHRA, UKAS and HTA requirements.

Secure Web Based Data Gathering, Monitoring & Alarming

It was important for Nuffield to have a reliable temperature monitoring system backed by an ongoing maintenance and ISO17025 calibration service to reduce individual site costs and provide uniformity in their approach to reporting and managing cold chain failures.

Next Controls was perfectly placed for this project, with a wealth of experience and track record in data gathering, analysis, and remote alarming from monitored hardware, and was chosen as the sole provider of these services to Nuffield Hospitals.

Tutela hardware (Next Controls bespoke scientific monitoring sister brand) was introduced into all 31 sites across the United Kingdom as it delivered greater functionality and integration at a cost that met their budget parameters.

The Next Controls system now monitors, alarms and reports on 1,278 probes across the entire Nuffield Hospitals estate. The system monitors all Pharmacy and Pathology departments and all medical Laboratory disciplines including Category 3 containment.

The key decision-making factors were;

• 24-hour 365 day a year alarm call centre (manned telephone, text and email)
• Remote support and diagnostics capability
• User friendly web interface with intuitive remote system control
• Multi-site data collection to a single user interface (global capability)
• Alarm dashboard functionality
• Ultimate flexibility in the setup of the alarm notification with targeted and specific delivery

The powerful data gathering and manipulation tools developed by Tutela allows Nuffield to gain access to, review and download their monitoring data for each unit, room, department and across the whole estate, in real time.

The Next Controls platform meets the highest level of record security for its customers being fully compliant with FDA CFR 21 part 11 and allows comprehensive access to data at anytime, anywhere through the use of any device able to support a web browser.

Estate Wide Project Delivery & Roll Out

The Nuffield project covered a property estate of 31 Hospital locations across the United Kingdom. The installation, ISO17025 calibration, commissioning and OQ validation was carried out by the Next Controls project team and training to 300 key staff was conducted for each site by an in-house specialist.

The site schedule detailed the complete system specification plan containing all the information needed by the project team and are were supported by annotated floor plans for each site and photographs of the site locations where appropriate.

The project delivery team followed an evolved and proven quality process to deliver all site installation works efficiently and accurately. The whole process is controlled under ISO9001:2015 QMS.

The Benefits of IP & Ethernet Based Monitoring Solutions

The Tutela hardware was delivered to sites pre-configured to minimise disruption to the Nuffield departments during the installation phase. Being IP based, installation required minimal involvement of IT resources and the dedicated Next Controls IT technical specialists managed the process in partnership with Nuffield IT projects teams.

The monitoring hardware is connected to the Next Controls servers via dedicated, secure IPSEC to IPSEC VPN tunnels where temperature data and alarm data traffic is transferred. The two-way communications mean that Next Controls can remotely administer requested alterations and run diagnostics where necessary. It also means that Nuffield have complete control of their data and highly sophisticated functionality (isolating alarms, changing alarm call details, SMS lists, altering setpoint parameters, applying user comments to the alarm audit trails etc.)

Because all data collected is fed to a single source server within the Next Controls data centre, the display of data back to Nuffield Health can be tailored and presented in any format. This complies with both the global management needs originally specified as well as individual operational units requirements, all accessed through one suite of web based interfaces.

Managing Big Data Securely

Currently Next Controls manage and service data from 1,278 probes across all Nuffield sites. The data harvested from the Tutela hardware is backed up on the Next Controls servers (with off-site mirrors in separate geographic locations) for up to 30 years.

Data management is underpinned by a ISO9001:2015 management system and ISO27001 secure data centre processes. This functionality is paramount to the ongoing operation of Nuffield Health’s Pharmacy and Pathology Laboratory practices with back up and disaster recovery built in and considered at every stage.
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