BIVDA Press Releases


BIVDA Position Statement on Credentialing

Professional Accredited Registration (‘Credentialing’) is supported by BIVDA, but the use of appointment systems increases risk and delay in services and incurs un-necessary cost for suppliers.


BIVDA (British In Vitro Diagnostics Association) is the national industry association for the manufacturers and distributors of in vitro (IVD) products in the UK, representing almost 200 organisations including multi-nationals and SME’s.


BIVDA members supply products, equipment, tests and quality pre-analytical consumables and service to NHS laboratories within a highly regulated environment.


NHS hospitals are increasingly entering into contracts with companies managing access to hospital sites through appointment booking systems. These systems are understood to be provided “free” to the NHS with a cost per individual employee being charged to the supplier. The cost applies to each employee who may need to attend a hospital laboratory site to sell or support their solutions.  Without registration, employees face being refused access to the site or in some cases permanently barred from site.


The registration requirements and evidence required varies on a site by site basis and in many cases is outside the requirements in terms of qualifying roles and is therefore prejudicial given that individuals may be forced to provide irrelevant and excessive personal  information out of proportion to that required for their role or otherwise face being disadvantaged  which is arguably inappropriate in terms of data privacy of the individual.


BIVDA members are attending the hospital site to address laboratory customer requests for products and services that have been identified by the pathology laboratory as necessary to perform the hospital service, or to perform their contractual obligations. These contracts have been procured formally through public procurement processes and the procurement processes have included validation and confirmation that employees involved in the Sales, Support, Applications Training and Project Management have the necessary formal qualifications to meet the requirements of the tender and that the organisation is compliant with employment law and privacy requirements. There is accordingly no basis for the introduction of additional checking of credentials, with only the identity of the person attending needing to be confirmed upon arrival.


Due to the nature of these contracts, companies are subject to Key Performance Indicators and service penalties for failure to meet contractual obligations. Refusal of entry to hospital sites or laboratories and to be prevented from performing their contractual obligations is unacceptable, particularly as registration with these schemes incurs a recurring annual fee on a per employee basis. There are multiple scheme operators and supplier employees registered with one scheme are potentially still refused access should the Hospital site they are visiting have contracted with an alternate scheme.


BIVDA members are required to attend hospital sites and laboratories to support the NHS and to provide their expertise and are invited, expected and accompanied. BIVDA members visiting pathology sites do not conduct unsolicited sales calls and do not generally have any differing access to vulnerable patients or restricted areas than they would as a member of the public. Company representatives should not be asked to provide information to access any hospital site above the legal requirements or comparable information required by the hospital for its own employment criteria for the areas accessed and non-qualifying roles.


BIVDA position


Company representatives who are attending hospital sites or laboratories to perform their contractual obligations and/or are invited and expected; must be able to access the laboratory at appropriate times and any specific credentialing requirements should be notified to suppliers when invited or included in the contractual terms and conditions at the point of tender.


Companies will comply with any legal or appropriate requirement to access an NHS site, for example evidence of vaccinations, evidence of a negative lateral flow test for SARS-COV2 or DBS checks at the level appropriate for the role being performed and the risk to vulnerable patients.

BIVDA expects the particular criteria set and any evidence requested to be equivalent to the levels required by staff working in the same areas that BIVDA members are likely to attend. This will be equal to other non-qualifying roles within NHS Employers guidance. NHS EMPLOYERS DBS ELIGIBILITY TOOL

The levels of evidence equivalent to NHS employees in similar roles will be provided via registration with the LSI register which has been accredited by the Professional Standards Authority (PSA) and is run by the Academy for Healthcare Science on a not-for-profit basis and which was developed and endorsed with NHS England/Improvement as a single national register Please see a letter from David Wells and Angela Douglas on Credentialing here.


The LSI Register is not an appointment system and registrants of this scheme should be recognised and afforded appropriate access to all NHS laboratories when invited and expected regardless of any appointment booking schemes that may be in place to govern other areas of the hospital. Any requirement to further improve and validate credentialing criteria should be between Industry, NHS England/Improvement, the relevant devolved nations and the LSI register and implemented in accordance with the United Kingdom General Data Protection Regulation (UK GDPR) and the Data Protection Act 2018 by individual Hospitals with any additional or bespoke criteria for specific cases being included in tender or contractual terms and conditions to allow ad-hoc requirements between individual parties to be agreed.


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