Avoiding the risks of failed commissioning and validation of specialist healthcare environments
Our BD Manager, Garry Horrocks discusses the importance of managing the financial and operational risk associated with hospital clean room and aseptic facilities, highlighting an example in the Middle East where lack of specialist expertise in the original design led to costly and time-consuming re-design, strip out and retrofit.
With advances in treatment and an increasing focus on managing patient journeys within integrated healthcare environments, the need for aseptic and clean room environments within hospitals is growing. Here, bespoke chemotherapy and cell therapy treatments can be prepared to the highest pharmaceutical manufacturing standards to meet the individual needs of specific patients and testing can be carried out on site without the risk of contamination.
Estates managers may be aware that the design, specification and fit out standards needed to achieve commissioning and validation for such specialist facilities are much higher that the existing hospital specification culture surrounding reduced contamination risk and meticulous cleaning regimes. However, they may not realise that even engineers who routinely design high specification healthcare facilities, such as operating theatre suites, often do not have the knowledge required to design EUgGMP-compliant clean room and aseptic facilities. Section 6 of ‘HBNHealth Building Note 14-01: Pharmacy and radiopharmacy facilities’ states that ‘The design of aseptic preparation facilities should comply with the guidance laid down in ‘Rules and Guidance for Pharmaceutical Manufacturers and Distributors’ (the so-called “Orange guide”) and ‘Quality Assurance of Aseptic Preparation Services’’ and it’s vital that engineers involved in designing these facilities are familiar with these standards and experienced in delivering them.
Compliance with those standards not only requires a highly specialist approach to design and fit out, but also entails a strict and meticulously-documented process of qualification throughout project delivery, including design qualification, installation qualification, operational qualification and performance qualification; the last of which is carried out by the end user following completion. The new facility must undergo a typical commissioning process to ensure that all building services equipment is fully-operational, delivered to spec and fit for purpose and it must also pass a validation process, conducted by an independent validation engineer, to ensure that it complies with the relevant MHRA and/or FDA standard.
The Need for Joined Up Accountability
This level of complexity is a clear indication that specialist expertise is required to design, engineer and construct clean room and aseptic facilities, but, often, procurement processes put responsibility for enlisting integrated expertise to design and deliver the project with a trusted healthcare contractor. NHS procurement processes are prescriptive and do not always accommodate the specialist nature of projects of this kind because framework and design and build models often leads to a fragmented supply chain. Consequently, the main contractor brings together various specialisms and decisions are made based on what can be delivered within agreed cost and length of programme parameters, while still enabling acceptable profit margins.
In other healthcare markets too, where procurement practices are less rigid, there is often an assumption that main contractor can outsource specialist elements of the project to subcontractors. This may be driven by a strategy of assigning all accountability to a core supplier, however, it often results in a lack of cohesive, inter-disciplinary expertise on the project. This, in turn, can cause increased risk of mistakes being made or opportunities to improve the design being overlooked.
While a traditional main contractor/subcontractor project design and delivery strategy may appear to offer better financial accountability and cost assurance, in fact, a disparate supply chain cannot add value with a holistic approach to design development on technically complex clean room or aseptic facility projects. Nor can a fragmented approach 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 numerous niche providers involved from engaging directly with the facility’s end users to really understand the requirement as all client communication sits with the contractor and their design team. As a result, valuable suggestions to enhance the original specification may be missed or design issues may be overlooked.
Errors in design, compliance or installation could all lead to failure at validation stage, with serious financial implications for elements that need to be revised and onerous operational implications relating to delays in availability of the facilities and disruption to other areas of the hospital. Indeed, depending how far along a project is when errors in the specification are noticed, the hospital could even find itself paying for the same facility twice because non-compliant specification would have to be stripped out, re-designed and re-installed before commissioning and validation could be completed.
This was the case at a recent BES project at a large new build hospital in the Middle East, where the BES team was called in to redesign three facilities in the same hospital after compliance problems had been recognised at commissioning stage.
Re-designing to Reach Validation Targets
The three specialist facilities that BES was called upon to redesign at a hospital in the Middle East were all part of a showpiece new hospital and had been designed and built as part of the main programme - without the involvement of a specialist in clean room and aseptic environments.
Construction had gone to plan and the completed compounding facilities for the preparation of chemotherapy treatments had been fitted out to specification but it was clear when the commissioning process began that they would not meet the internationally-recognised USP (United States Pharmacopeia) guidance stipulated by the client for these areas of the hospital. Although the hospital as a whole had been designed and constructed to recognised healthcare standards, the two Non Toxic Sterile Compounding facilities and single Toxic Sterile Compounding facility were not compliant with the relevant standards (USP 797 and USP 800 respectively) and commissioning and validation could not be completed.
The task for BES was to examine the original specification, understand where it needed to be changed and consider the wider effects of those changes to the hospital build programme and building services provision. The team could then develop a new design that would re-use as much of the existing building services infrastructure as possible while replacing or upgrading under-specified elements to ensure commissioning and validation could be achieved second time around.
Each of the facilities is located in a different area of the hospital and each consists of a suite of rooms. As the USP guidance for the Toxic Sterile Compounding and Non-toxic Sterile Compounding facilities are different, the redesign challenges were distinct for each.
Toxic Sterile Compounding Facility Redesign
The biggest design flaw with the original design of the Toxic Sterile Compounding facility was that it did not have a full fresh air system. Unlike a conventional sterile hospital environment, where a recirculation system can re-use the air, the toxicity in this environment means that every air change needs to bring in new fresh air from outside the building while the extraction system needs to discharge its collected air directly to atmosphere.
The knock on effect of this specification error was that there was insufficient cooling in the system to maintain the temperature and humidity parameters required for compliance of the Toxic Sterile Compounding facility. This was particularly onerous due to the location of the hospital because the intake of outdoor air involves cooling air from a summer maximum outdoor temperature of 460C to provide a constant indoor temperature of 190C (+/-1). The BES team was able to utilise the existing air handling equipment with some modifications while introducing a full fresh air ventilation system and increasing the size of the cooling coil to double the cooling capacity in the Toxic Sterile Compounding facility. This also required spatial considerations to modify the layout of the facility to accommodate the larger coil.
The lack of consideration given to the toxicity of the atmosphere in this facility also prompted the BES team to recommend HEPA filtration of the extract air before it entered the extract ductwork. This ensured that any toxicity in the air from an unexpected spillage is contained within the compounding room.
There were also operational issues with the layout of the original Toxic Compounding suite. The suite includes three compounding areas; one containing a robotic compounding machine and the other two, smaller areas contain micro-biological safety cabinets for small scale drug preparation carried out by hand. The original layout had not allowed sufficient space for the operational requirements of the robotic equipment so the footprint of the Toxic Compounding facility had to be redesigned with space re-allocated from the two smaller compounding areas.
Non-toxic Sterile Compounding Areas Redesign
While the BES team did not have the calculations data for the air flow rates in the two Non-toxic Sterile Compounding facilities, the schematic drawings showed that the flow rates were not sufficient to maintain the required air change rates.
To achieve the additional flowrate, BES redesigned the configuration of the HVAC air distribution system and re-specified the air handling equipment to increase the air flow capacity. This meant that both of the suites had to be stripped back to enable the old equipment to be removed, adding additional time and cost to the project with the replacement of finishes once the new equipment had been retrofitted to the build.
There was also an air distribution issue in some of the main clean rooms of the Sterile suites which would have prevented these areas from achieving their required cleanliness levels. The original ventilation design involved a central air distribution arrangement which resulted in uneven distribution of clean air, with pockets of the room outside of the diffusion area receiving insufficient quantity of clean air. To rectify this, the BES design replaced the central air distribution point with a larger number of diffusion points and introduced swirl diffusers to aid more effective distribution across the space. The swirl air diffusion design distributes the clean air in a helical pattern, ensuring that the clean air supply mixes effectively with the air in the room.
The wide ranging changes that were required in the mechanical specification of all three specialist environments prompted a need for wider specification upgrades on the Middle Eastern hospital project. For example, the need for increased cooling in the Toxic Compounding facility meant that an increased chilled water supply was required from the centralised plant to service the larger coil, which, in turn, demanded an increase in chiller capacity to chill the water. This not only represented a high cost to the hospital but also created challenges with space availability in the rooftop plant area.
The control system was also affected because of changes to the HVAC strategy for each room. As a major part of the controls requirement was managing the airflow in each area – an element of the specification that was completely redesigned by BES – the decision was taken to develop a new control system from scratch rather than try to modify the existing system. The resulting control system has a separate control network for each of the three specialist environments, all of which are fully-integrated with the hospital-wide BMS.
While the project was a design-only brief for BES with installation and fit out completed by local contractors, the inter-disciplinary team ensured co-ordination between architectural, mechanical and electrical design elements. Importantly, the BES’ experience of delivering schemes of this kind also ensured that risk minimisation was embedded in the design approach and project management strategy from the outset. Having completed the redesign of the three facilities in just eight weeks, the BES team discussed the detailed design with a validation engineer prior to the build phase to ensure any unforeseen compliance issues were picked up before the project started on site. Regular site visits to check that the design was being implemented correctly and attend design meetings with the client were also an important part of due diligence.
Two of the three facilities have now been validated successfully, with the third nearing the end of the fit out process.
The Middle Eastern hospital project illustrates just how far reaching the financial and operational consequences can be if specialist facilities are not designed and delivered by an inter-disciplinary specialist team. This is just as relevant to refurbishments in an existing hospital as it is to new build schemes like this.
So what can be done to minimise risk?
Firstly, early engagement with a specialist provider is required to interrogate the brief and develop a user requirement specification (URS) that is agreed by all parties and clearly defines the needs of the end user. If responsibility for this is assigned to the main contractor there may be a lack of ownership for cohesive design and installation so NHS Trusts need to consider alternative procurement approaches that enable them to work collaboratively with a specialist. It is often then necessary for that specialist to work closely with the main contractor and an equipment supplier during both the planning and build phase of the project.
A specialist 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 ensures that practical considerations like workflows and cleaning regimes are factored in alongside technical and compliance deliverables.
The specialist 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 successful validation acceptance 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.
And, of course, a specialist understands both the compliance and standards involved in clean room and aseptic facilities and the complexities needed to make the design work. Developing the design using REVIT 3D modelling techniques ensures clash detection and resolution of buildability issues at design stage, while consulting a validation engineer for feedback on the completed design before the project goes to site provides an extra level of assurance that the project will pass each qualification stage, commissioning and validation without issue.
Learn more about Gary here