Currently the NHS in England carries out 93% of sterile services work in-house on site.1 With this in mind Foundation Trusts are taking the initiative to develop new facilities or refurbish existing SSDs. Standards are being driven due to the real issue of healthcareassociated infections (HCAIs), and it is thus vital that clinical staff and hospital management establish upgraded facilities on their sites. The national decontamination review1 undertaken in 2008 indicates that the fabric of existing sterile services departments varies across the country, with many in need of extensive refurbishment. All facilities should comply with the principles contained within Health Building Note HBN 13, to ensure that the built environment does not compromise the process of decontamination and that optimum standards are achieved. The nature of the service is becoming increasingly technical, with efficient and high quality operation dependent on factors such as qualified management, high specification of technology, instrument tracking systems, and compliance with all regulations and accreditations, alongside logistics planning. With these advanced changes it is becoming a very specialised area. NHS Trusts therefore need to look for guidance and support from experienced and qualified supply networks. Yeovil District Hospital (YDH) NHS Foundation Trust recently decided to build a new SSD within Yeovil Hospital. Local demand and the requirement to upgrade the existing sterile services facilities identified that development of the new SSD in a strategic location within the existing hospital complex should be a priority. YDH invited tenders for the contract, estimated at around £2.5 million, via the competitive OJEU route, to ensure that the most experienced specialist contractors were assigned for the complex design and build. cfes Medical Construction, a division of cfes, was selected as the preferred contractor for the design, build, commissioning, and certification of the new SSD.
Changing operational culture
Our key approach at cfes when building specialist SSD facilities is to change the operational culture of the centres by working closely with all parties involved at the hospital throughout the entire decontamination cycle. Fundamentally, working in unison with the Trust is essential. However, cfes also recognises and values the importance of working closely with those at the heart of the day-to-day running of the department, including critical care matrons and SSD managers. These relationships are created and nurtured right through the design, build, commissioning, and validation stages. We also recognise the importance of effective training and continual professional development, and will work within an operations support role for YDH, assisting the SSD manager in developing training plans, writing a Quality Management System (to conform to HTM 01-01 Decontamination), and staff development reviews. The new SSD will comply with the requirements of Directive 93/42/EEC and ISO 13485 and 9001. ISO 13485 is focused on implementing and maintaining an effective quality management system (QMS) for, in the case of an SSD, the correct re-processing of medical devices. To ensure stringent standards, objectives of the QMS are met and easily sustained providing that the correct working environment and efficient layout/workflow process are both key. This is where our knowledge of HBN 13 and the relevant HTMs (01-01, 03-01, 2010, 2030, 2031 etc.) comes into play, alongside our previous project experience, which enables us to make informed decisions on key process items.
Correct workflow and layout
From an estates perspective, the workflow function and internal room layouts need to be correct to ensure, for example, that SSD technicians gown up correctly and have access to the correct services, thus ensuring that procedures laid down in the QMS are adhered to. The goal is for the right environment to be created and maintained without the building user intervening, while the process services function must have built-in resilience and duality to ensure continued service and minimal failures /downtime. cfes will be working with the Trust and its selected notified body through the process. Regular management reviews will be carried out by the Trust, along with internal quality audits to ensure the facility’s continued success, development of staff, and compliance with statutory requirements. cfes prides itself in offering assistance via this turnkey package outside the normal scope for a construction company. The design, construction, daily process management, and policies and procedures, are intrinsically linked, and we believe a joinedup approach with client and contract is essential for successful accreditation. Extensive experience is essential for this type of healthcare development. cfes has already successfully built six fully accredited CSSDs for Nuffield Health. The same quality management will be implemented with YDH to gain full accreditation for the Trust’s SSD. cfes staff will take an active hands-on approach through the complex accreditation procedure, and provide management support through regular internal audits and external assessments from a notified body, as well as navigating YDH through the process to enable a smooth transition of services to the new facility, and ensure an efficient and effective instrument management practice. This service could benefit YDH by enabling the hospital to provide a full decontamination and processing service of procedure packs, trays, and single instruments, for other healthcare providers.
Off-site approach
YDH required the fully compliant SSD to be built on a flat roof space, adjacent to existing theatre suites, and situated directly above accident and emergency and the hospital’s training academy. The design was developed by cfes in conjunction with the Trust to facilitate the best use of available rooftop space. Off-site construction methods (see panel opposite) will be utilised for the structural build. cfes identified this construction method as the optimal solution due both to the restricting location, and to enable continued operation of the hospital – with the building structure fabricated off-site in a controlled factory environment and then secured into place on the existing rooftop. Site disruption will thus be minimised. Efficient hospital operation was a fundamental factor considered by cfes following recent trends for all decontamination services to be controlled under one department. The YDH Trust required an upgrade to its existing endoscope disinfection process, and cfes will move the current endoscopy washing unit from level 3 of the hospital to the new SSD to create the new central decontamination unit within a carefully controlled environment. Centralising its decontamination activities will have numerous benefits for the hospital. It will achieve a central, fully compliant centre for undertaking all decontamination functions by trained staff and technicians, which will in turn release clinical staff to focus on patient care. cfes designed the endoscope decontamination unit to exceed HBN 52 and meet the requirements due to be published in the forthcoming endoscopy HTM 01-06.
A faster process
The Trust’s decision to move from paper wrapping the instrument trays / wire baskets within IAP (clean rooms) to using metal containers will bring a multitude of benefits. It will minimise damage (failed packs), reduce “wet” loads, provide a faster process in the IAP, and more secure storage for valuable precision surgical instruments. The move to a containerised solution will give way to the requirement for increased washing capacity. In order to achieve this, cfes will carry out throughput calculations to determine the operational benefits of a fully containerised service and the revised requirements for specialist equipment. Additional washers will be required to deal with washing the containers, and a change to the sterilised product storage racking arrangements will be made in order to provide functional and efficient storage of metal containers, rather than the original wrapped product. The entire project was designed by cfes with a clear focus on BREEAM (the BRE Environmental Assessment Method). With the specialist equipment within an SSD generating large amounts of wastewater and heat, cfes also adopted solutions to minimise water consumption and capture waste heat and utilise it to satisfy the continued demand for hot water. These measures, which will include recovering high temperature condensate from the sterilisers using flash steam recovery for low pressure hot water and heating, and using dynamic filling on washers and reverse osmosis water as feedwater for the steam boilers, are designed to minimise the demand on metered primary energy sources.
Robust standards
Applying these methods will have a positive influence on the design and construction of the facility, and a positive influence on its management. It sets and maintains a robust technical standard with rigorous quality assurance and certification. The target rating to be achieved by the new facility, which will be assessed under bespoke methodology developed by BRE, is “Excellent”. Yeovil Trust acknowledged that it awarded cfes the project due to its passion and commitment, and we are proud to have been selected by Yeovil District Hospital to design, build, commission, and certify its new Sterile Services Department. Our primary objectives are to work closely with the YDH team to deliver a fully accredited facility, and to put into place effective management control systems to cover all aspects of the decontamination lifecycle. We will draw upon our previous project experience and success to ensure an effective environment is created with correctly segregated processes for the cleaning and sterilisation of medical devices. We will offer a dedicated aftercare service for the continued effective operation of the building, ensuring that it performs as designed, and that users within the department are educated in the control functions to assist Yeovil District Hospital meet its energy targets. Director of estates and facilities at Yeovil District Hospital Robert Steele adds: “We are very impressed with cfes, the design team, and their commitment to the project. We are very much looking forward to getting our new unit up and running.”
Reference 1 Department of Health – Decontamination Programme 2008. Strategy for Modernising the Provision of Decontamination Services.