Introduction to the Life Science Industry National Credentialing Register

WHY IS THIS REGISTER NEEDED?

Staff from the Life Science industry engage with NHS staff and patients on a daily basis. It is important that these interactions take place within a professional, ethical and safe framework.

We know that Trusts are looking to confirm the identity, credentials and training status of individuals who visit their sites.

Currently the responsibility for this lies with each individual Trust and they have sought a variety of means to address this challenge. This has led to variable practices in the standards and processes used within the NHS to check the status of industry staff on site – there has been a lack of consistency.

WHAT DOES THE REGISTER DO?

The LSI National Credentialing Register, in collaboration with the NHS and the Academy for Healthcare Science provides a route to protect the public and assure the NHS that company representatives admitted to sensitive areas are properly trained and are fully aware of their responsibilities.

In turn this will ensure the NHS and private sectors fulfil its duty of care to protect patients and ensure safe surgical and clinical outcomes.

The LSI National Credentialing Register is an efficient and effective national solution for industry and the NHS.

IN PROVIDING A ROUTE TO PROTECT THE PUBLIC AND ASSURE THE NHS, THIS REGISTER;

  • Establishes, and periodically validates against, minimum acceptable standards for registrants and training provision
  • Maintains the required standards of conduct, education, training and health & safety criteria
  • Provides a single point for NHS staff and the public to verify an individual’s status against agreed criteria and eligibility to engage with the NHS
  • Supports Trusts with regard to credentialing and management of conflicts of interest
  • Supports the improvement of standards without restricting access to approved individuals

To ensure the highest standards of governance, the Register has been independently accredited by the Professional Standards Authority. This is the same Body that accredits other significant registers: https://www.professionalstandards.org.uk/

Registrants apply to join one of three risk-based ‘Tiers’ (1, 2 or 3) related to the areas of a healthcare facility they expect to visit and their likely level of contact with patients and the public.

Tier 1: Interaction with healthcare professionals but no contact with patients and public other than incidentally in areas open to the general public

Tier 2: Interaction with healthcare professionals and with patients and public in areas where no invasive procedures are taking place

Tier 3: Interaction with healthcare professionals and with patients and public in areas where invasive procedures are taking place

Training requirements are determined by the tiers with additional elements for Tiers 2 and 3 specific to the clinical areas they are likely to visit.  Training for higher-risk areas includes infection prevention and control for clinical settings and on appropriate behaviour in specific areas such as operating theatres.

All registrants are expected to receive training on their company’s products as well as on NHS values, ethical business practice, and competition and procurement legislation as appropriate.  The full list of training elements is as follows:

  • Products
  • NHS Values & Behaviours
  • Industry Codes of Practice
  • Information Governance
  • Competition & Procurement
  • Environment, Health & Safety
  • Adverse Event Management
  • Infection Prevention & Control
  • Training for High-Risk Areas

These were determined through consultation with industry and NHS experts taking into account:

  • the potential risks posed by registrants to NHS staff, patients and the public;
  • the professional standards expected by the NHS;
  • the key learning outcomes and the body of knowledge necessary for safe and effective practice by those registered;
  • the minimum standards required to remain fit to practise.

The training status of all new applicants to the register is checked by the AHCS administration team and is rechecked at the annual renewal.

Further and more detailed information on Tiers, Training and Registration can be found in the LSI Guidance documents: Guidance – The Academy For Healthcare Science (ahcs.ac.uk)

IMPORTANT INFORMATION

Medical Industry Accredited (MIA) members will be issued with a joint credentialing badge confirming registration, once register standards and have been achieved, and the MIA appointment system access.

Work is underway to develop a register only route and will be open to industry shortly.

We are also working with GS1 colleagues to link up with the Scan4Safety work that many Trusts are already signed up to.

  1. Before starting the registration process applicants should decide which tier is relevant for them in their role, and for training managers (or equivalents) to deem what is appropriate by way of product training.
  2. Training can be provided by companies in-house or purchased from any recognised training provider.
  3. Hitherto, applicants going through the registration process have been designated as ‘Tier X’.  In order to avoid confusion with Tiers 1, 2 and 3 which apply to successful applicants, this term will no longer appear and ‘pre-registration’ will be used instead.  This will also ensure consistency with the approach taken for other AHCS registers.

MIA Membership: £105 + VAT per person

LSI Registration: £20 VAT exempt per person

For any specific queries relating to the LSI National Credentialing Register, its standards, governance or training requirements, please call the Academy for Healthcare Science team on lsiadmin@ahcs.ac.uk