A Quality Assurance framework for NHS procurement

8 February 2019

(News Article dated February 2019 – see our Useful Links 🔗 section for further information on CaPA and the most recent updates).

Jo Gander - Director of Clinical and Product Assurance

The Clinical and Product Assurance (CaPA) function of NHS Supply Chain plays a pivotal role in delivering a clinically assured, safe and optimised product range for our health and care system. NHS Supply Chain seeks to establish a national, rigorous and standardised assurance process for procurement.

To support this, CaPA is looking to systematically and consistently apply assurance criteria to each part of the procurement process. They are providing relevant guidance to support, and tools to measure compliance with relevant regulatory and assurance requirements. The Quality Assurance framework that the CaPA team have developed over recent months is fundamental to this new national standardised approach. To find out more about the framework and what it means for NHS organisations, we spoke to Jo Gander, Director of the Clinical and Product Assurance function and responsible for developing the framework.

Jo trained as a Registered General Nurse (RGN) in Harrogate and has a BA Hons in Business Studies as well as a Masters Degree in Leadership, Innovation and Change. She achieved Chartered Marketer status at the Chartered Institute of Marketing (CIM) and undertook a range of roles within medical devices and pharmaceutical organisations before joining the North East Lincolnshire Care Trust Plus as Commissioning Group Director. She has also operated as a senior leader within the NHS England national team prior to joining NHS Supply Chain.

What is the Quality Assurance framework? Who is it for and what does it do?

First, the framework has been developed for use by NHS Supply Chain’s category tower service providers (CTSPs). CTSPs are the specialist procurement organisations – with core areas of clinical expertise – responsible for providing a quality product range to healthcare providers.

CaPA’s Quality Assurance framework outlines the requirements of effective and consistent clinical and product assurance within the procurement process. It is intended to help CTSPs ensure compliance with all requirements of the Assurance Process for procurement. The framework gives clear direction on expectations regarding supply of products and services to the NHS which meet the required quality standard, provide value for money, and meet the needs of patients, carers and users of the health and care system. The underlying principle of the framework is to continually improve patient safety, service quality and outcomes for patients.

In summary, the process involves CaPA assuring the category strategies of CTSPs, sourcing strategies and strategies for stakeholder engagement and product evaluations. To give a few examples in practical terms, stakeholder engagement plans must demonstrate that CTSPs intend to use engagement events with key stakeholders across the health and care system (e.g. suppliers, patients and carers) to develop product range specifications. The final product specification, range or framework must then reflect all stakeholders’ needs.

Similar rigour will be applied to assuring Product Evaluation strategies. There, CTSPS must demonstrate that product evaluations applied reflect clinical product complexity, dependencies and inter-dependencies. CTSPs also need to provide evidence that a product range’s indications and contraindications for use have been defined, MHRA classifications confirmed, and that outcomes of stakeholder events have been used to inform the product/product range descriptions and the associated evaluation process. Risks and issues must also be identified and mitigated. It is really all about making sure that NHS stakeholders – clinicians as well as patients – are having significant inputs into product ranges on a national scale.

A key part of CaPA’s role is making sure that procurement proposals developed within CTSP strategies are informed by the patient

safety and safeguarding agenda and take account of any patient safety alerts identified by NHSI or concerns previously raised by NHS Supply Chain’s exception process. The exception process provides an additional layer of assurance to clinicians allowing them to raise concerns about product safety and efficiency directly with CaPA for investigation and resolution.

What does the new Quality Assurance framework mean for NHS organisations?

The new operating model for NHS Supply Chain will procure products for the NHS that are safe, fit for purpose and value for money. Establishing the Quality Assurance framework is a key step in achieving this. The aspiration is that by 2022, 100% of products supplied through NHS Supply Chain will have been through the CaPA Quality Assurance framework. This includes all products within existing and future procurement frameworks. This means that when a clinician puts on a pair of surgical gloves, selects a wound dressing or switches on an MRI scanner, they do so with the certainty that the product has gone through a rigorous and standardised process – a process that has had inputs from clinicians like themselves as well as patients and other key NHS stakeholder groups. We believe having this confidence will improve product users’ experience

How does it interact with other organisations in the health and care system?

This Assurance process is aligned with partner organisations such as NHS England, NHS Improvement, Health Tech Connect, GIRFT, Accelerated Access Collaborative, Academic Health Science Networks and the Office of Life Sciences. This ensures that suppliers are provided with consistent requirements for the standards they need to meet.

What are the next steps for this Quality Assurance framework?

We are working closely with CTSPs to embed the Quality Assurance framework at every stage of the procurement process. At the same time, we are working to refine the model collaborating with key partners so that the assurance process evolves in line with requirements and expectations of the health and care system.