A specialist approach for sterile facilities

Garry Horrocks from BES discusses the importance of managing the financial and operational risk associated with hospital cleanroom and aseptic facilities

Garry Horrocks

Healthcare estates managers and specifiers are used to the high standards needed to reduce infection risk and ensure meticulous cleaning regimes in hospitals - it’s a fundamental element of both the building fabric and the building services.

NHS procurement processes are prescriptive and do not always accommodate the specialist nature of projects of this kind

For those hospitals investing in cleanroom or aseptic facilities, for the preparation of tailored chemotherapy infusions or cell therapy treatments, for example, the risk to patients from any failure to meet the required cleanliness standard is just as high and the specialist nature of the design and fit out is even greater.

As the need for on-site preparation of bespoke treatment formulations escalates, the healthcare sector has much to learn from pharmaceutical environments where consistently-controlled production environments designed to meet the highest cleanliness standards are commercially critical.

The problem is, unlike the commercial sector, where the end user can select a supply chain based on the specific project requirements; NHS procurement processes are prescriptive and do not always accommodate the specialist nature of projects of this kind.

Unfortunately, framework and design-and-build models often lead to a fragmented supply chain where the main contractor brings together various specialisms and decisions are made based on what can be delivered within agreed cost parameters, while still enabling acceptable profit margins.

Rather than putting responsibility for developing and implementing the user requirement specification in the hands of a main contractor and risking a lack of ownership for cohesive design and installation, NHS trusts need to consider alternative procurement approaches

This approach leads to a lack of joined-up accountability for specific elements of the scheme or the overall project as a whole. It may also result in opportunities for design improvements to be overlooked because the disparate supply chain cannot add value with a holistic approach to design development or identify design conflicts or clashes that may only be apparent when the scheme is considered as a whole.

This disconnected approach often also prevents the specialist providers involved from engaging directly with the facility’s end users to really understand the requirement.

As a result, they may also miss opportunities to make valuable suggestions to enhance the original specification or overlook design issues that could lead to validation failure, financial loss and operational issues.

Just like in the pharmaceutical sector, cleanroom, aseptic and sterile environments used for treatment preparation or sample testing in healthcare environments must be designed and installed to comply with the relevant standards (usually MHRA in the UK), meet GMP (Good Manufacturing Practice) guidelines and achieve validation by an independent third party.

Errors in design, compliance or installation could all lead to failure at validation stage, resulting in serious financial implications for elements that need to be revised and onerous operational implications relating to delays in availability of the facilities.

Rather than putting responsibility for developing and implementing the user requirement specification (URS) in the hands of a main contractor and risking a lack of ownership for cohesive design and installation, NHS trusts need to consider alternative procurement approaches.

Instead of putting a pre-designed facility out to tender, the procurement process needs to be focused on early engagement with a specialist that can design and install the facility aligned to the needs of both the budget and the end user.

While budgets may be inflexible, the design process should as flexible as possible and working with a specialist with an in-house team of architectural practitioners and building services engineers ensures that there is a joined-up approach to delivering the outcomes required, based on active consultation with the end user.

This integrated approach to design, delivery and compliance not only improves the likelihood of validation when the project is completed; it can also ensure that the operational efficiency of the facility is maximised throughout its service life

The specialist can work collaboratively with the end user to develop the URS, considering practical workflow issues along with technical deliverables. They can also provide a single point of contact and accountability for design, project delivery and compliance, providing a turnkey project with a multi-disciplinary team that works together for the benefit of the project rather than considering their own elements in isolation.

This integrated approach to design, delivery and compliance not only improves the likelihood of validation when the project is completed; it can also ensure that the operational efficiency of the facility is maximised throughout its service life. This includes elements such as the energy efficiency of the HVAC system, for example, and the design of workflows, drawing on the expertise of a specialist that can implement pharmaceutical best practice within a healthcare setting.

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