Controlling access to healthcare facilities by industry staff has assumed increasing importance over the past few years. There are a number of different elements to this and there is often a degree of confusion of both systems and terminology.
Historically, access to hospitals and other healthcare facilities was managed on an ad hoc basis. Company reps often had longstanding relationships with hospital staff and would turn up either by arrangement or on a more casual basis. Other company staff might arrive with more forewarning, for instance to service or repair essential equipment. Training and product demonstrations are also common reasons for company staff to visit.
Early in the millennium hospitals began to look at implementing ‘credentialing’ systems to manage access to their facilities. Credentialing was already commonplace in the US and required visitors to meet certain pre-defined criteria and to formally book their appointments.
Credentialing has a somewhat chequered reputation with industry, principally over staff needing to sign up with and pay different operators depending on which facilities they routinely visit. There are also concerns that criteria are sometimes set on a rather arbitrary basis and that, particularly in terms of training requirements, the credentialing operator benefits both through registration fees and through being the approved training provider.
Against this background, industry, with the support ofEngland, initiated a project to establish a Register for company personnel. The aim was to harmonise requirements for those entering facilities and to provide a robust and credible system of registering staff and raising standards.
How do systems differ?
The simplest way to control access to facilities is to require pre-booked appointments. This will be a familiar process to most people and can be managed either formally or informally. For those working in small organisations a system such as Outlook is probably sufficient and provides a quick and easy tool to manage visits. In the case of larger organisations, one will normally make a formal appointment and that will be entered into a central system so that the person is expected, can collect a badge, be directed to the right location and so forth.
So far, so familiar. A credentialing system adds a further layer of structure in that certain information about the visitor will be known in advance of their visit. In the case of life-science industry staff this may include information on training (e.g. for theatre access), background checks () and vaccination status (Hep B, flu etc). These criteria are usually set by the credentialing organisation but they may vary from hospital to hospital.
A quirk of the credentialing model is that while the customer for the service is the hospital, it is generally provided free-of-charge and the service provider makes their money from registration fees from industry. These fees can be considerable: in the US they can run to several hundred dollars per year and here in the UK they have increased significantly since credentialing was first introduced.
A professional Register covers staff whose roles are not regulated by law but where a degree of oversight is desirable. They are widely used in the UK healthcare system with over 80,000 staff currently on such registers. Examples of those covered are clinical physiologists, medical illustrators and healthcare scientists. Registers are subject to accreditation and oversight by the Professional Standards Authority ( ). Their activities are open to public scrutiny and there are rigorous governance procedures in place. Complaints against registrants are subject to formal investigation processes and, if proven, may result in the individual being suspended or permanently excluded from the Register.
The Life Science Industry (LSI) Register is supported by all the major industry associations and has been endorsed byEngland. The criteria registrants need to meet have been set in consultation with the experts. Training providers are independent of the Register but they must demonstrate that their courses meet pre-defined standards.
Registrants apply to join one of three Tiers depending on where in a healthcare facility that the individual will expect to visit. For the highest-risk areas, such as the operating theatre, registrants must undertake regular training with periodic repeating of a detailed ‘classroom’ or equivalent course. They are also required to have a number of different vaccinations and to bechecked.
Establishing the LSI Register
The LSI Register is open to staff from any life-science company whose activities require them to visit healthcare facilities. The aim is for this to be the system whereby theorganisations can satisfy themselves that those attending their premises have the correct training, background checks and vaccinations and that they understand the standards of behaviour expected of those in their role.
The fact that the Register is subject to accreditation and oversight bydifferentiates it significantly from commercial credentialing providers. Furthermore, LSI is a not-for-profit organisation.
Given that LSI is the only system withaccreditation, has the backing of not only the industry but also England and that it is underpinned by robust governance and disciplinary mechanisms, any provider choosing not to use the Register should probably ask themselves the question “Why not?”
An appointment-booking system is available to any facilities that require it and GS1 barcoding is being implemented on registrants’ ID cards.
Further detailed information on the Register, its standards and the processes can be found on the LSI website.