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.

The Background

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 of NHS England, initiated a project to establish a Register for company personnel.  The aim was to harmonise requirements for those entering NHS 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 (DBS) 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 (PSA).  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 by NHS England.  The criteria registrants need to meet have been set in consultation with the NHS 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 be DBS checked.

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 the NHS organisations 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 by PSA differentiates it significantly from commercial credentialing providers.  Furthermore, LSI is a not-for-profit organisation.

Given that LSI is the only system with PSA accreditation, has the backing of not only the industry but also NHS England and that it is underpinned by robust governance and disciplinary mechanisms, any NHS 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.

Firstly, it’s important that people should understand the distinction between a register, a credentialing system and an appointment booking system.  LSI is a register while Intellicentrics and MIA operate credentialing and appointment booking services for hospitals.  For a register to be established, there needs to be third-party accreditation of the system; in the case of the LSI National Register this has been carried out by the Professional Standards Authority.  Credentialing systems require no such accreditation and as such are not subject to any sort of outside governance or oversight.  Appointment booking systems are there simply to manage engagement between industry representatives and hospital staff and while they are often linked with credentialing, this need not be the case.

The HCS piece focuses solely on theatre access training and fails to mention that the LSI Register and, to an extent, credentialing systems in general cover a whole range of training other than theatre access and that company representatives will be present in hospitals for many reasons other than attendance in theatre: training, clinical research, servicing equipment etc.  The LSI Register requires training on products, NHS behaviours and values, industry codes of practice, competition law and information governance as well on attendance in high-risk areas of the hospital as appropriate.  It is important that readers understand that the tier categories under the Register have been designed such that the level of training, DBS checking and inoculations are appropriate for the activities that company representatives are carrying out.  The training requirements and inoculations required have all been arrived at in consultation with NHS representatives and have been endorsed by NHS England.  None of this background has been given.  Indeed, it’s actually industry that has instigated the Register where nothing of the kind has existed hitherto.  To suggest that industry is somehow looking to get an easy ride in respect of training is far from the truth.

The criteria for training for entry on the Register are continually under review and indeed have been amended since it was first launched.  One such requirement was to require all those whose jobs require them to be present in the operating theatre to undertake comprehensive (face-to-face or equivalent) training on a regular basis and that this should be carried out immediately in the case of either those new to the role or to new starters at a company regardless of previous experience.  The Register requires that the training should be appropriate to the role and should meet the criteria set out in the Standards.  The Register does not ‘approve’ training but any training provider, including where it is carried out by companies themselves, must be able to demonstrate that it they meet the standards.

It is disingenuous to suggest that there is a direct equivalence between company personnel in the operating theatre and NHS staff.  One of the primary tenets of theatre access training for company personnel is that under no circumstances should they in any way participate in the clinical procedures.  They should be outside the sterile field and they are present usually either to observe or to provide advice on request, particularly if a new product is involved.

While it is a perfectly reasonable thing to suggest that theatre access training should be to a particular level, it is again disingenuous to argue that this should necessarily be to the same NVQ level as for NHS staff.  An important point not mentioned is the time and cost that would be involved in getting all industry personnel up to this level.  Neither is there any mention of any risk analysis indicating that this is necessary.  We are not aware of any incidents where a patient has suffered as a direct result of company personnel in the operating theatre even though this has been going on for decades.  Given that their non-participation in the clinical procedure is a given, it is difficult to see that the case you make holds water.

I shall also be writing to the Operating Theatre Journal to highlight some of these issues.  It is important that the clinical community understands what we are doing with the Register, its background and the motivations.  We welcome dialogue and discussion on these issues but we need to do so while acknowledging that this is quite a new concept for the industry and the NHS.  Indeed, the process has largely been instigated by the industry rather than by the NHS though it ultimately benefits all parties, including patients.

Finally, the LSI Register is the only system offering transparency to the NHS and the public and which has a rigorous system whereby complaints against individual registrants can be made.  We believe that all hospitals should take an active interest in the subject and seriously consider whether credentialing or the Register is the appropriate system for them and for patients.

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