AT the end of 2017, it was proposed that a accredited register for Life Sciences sector staff who interact routinely and directly with NHS frontline staff or patients would be established.

It would be voluntary and it would be drawn up in consultation with the NHS and Healthcare companies and overseen by the Professional Standards Authority (PSA).

It was also proposed that Medical/Pharmaceutical Industry employees would fall into Tiers 1, 2 or 3 depending on the requirement of interaction within non-critical care and critical care areas of the hospital.

They would also be required to prove evidence of training, DBS check, inoculation status and professional indemnity.

To date, this is still a work in progress. Meanwhile, Hospitals/Trusts are increasingly looking to credentialing companies to enable them to risk-manage the healthcare company representatives across the medical device and pharmaceutical industry who are essential to support the safe use of technology in hospitals.

Hospitals rely on credentialing companies, such as lntellicentrics, Life Science Industry (LSI)/ Medical Industries Association (MIA). to verify the training and competency status of all industry personnel allowed into clinical areas.

In this era of clinical governance and increasing medical negligence, reliable proof of competence, professionalism, indemnity and the necessary inoculations is essential.

Hospitals must be able to trust that what people do or say on their premises is competent and appropriate, and that the training programmes they complete and the qualifications they gain are benchmarked.

This unarguable assurance guarantees the protection of all concerned – from the patient, to medical device and pharma companies and their representatives, to surgical teams and hospital boards or trusts.

Hospitals have benchmarked the minimum standard of healthcare assistant grade (NVQ level 2) for their own employees in clinical areas.

A key role of credentialing services used by hospitals and trusts should be to verify that every healthcare company representative matches this same level of competence. The most ethically sound solution would be for credentialing companies to verify all training to a National Occupational Standard.

The present situation with some credentialing services is of concern, as it is possible to achieve “qualifications” that are purported to be “Theatre Access” in nature but are not issued by an awarding body and have none of the necessary benchmarked competencies required by the hospital for personnel to be allowed into critical care areas.

If a healthcare company representative whose “certification” does not meet a formal occupational standard is involved in an adverse event involving patient care, the hospital would struggle to defend any resulting legal action.

In this case, the hospital would be likely to pass liability to the credentialing company for failing to properly vet the individual, and the credentialers would, in turn, look to the training provider to take the liability and responsibility.

However, the training provider might deny liability, leaving the medical device or pharmaceutical company exposed, since it holds vicarious liability for its own employees.

Failure to consider liability within the education/qualification/credentialing chain raises fundamental questions of credibility.

The hospital is responsible for the actions of all personnel in its clinical areas (whether employed directly or not). The verification of a benchmarked standard that reflects the hospital’s own basic requirement would mitigate the risk associated with granting access to industry personnel who have no experience working in a critical care environment.

Qualifications – Competence

Any “qualification” verified by a credentialing company should cover the requirements of statutory legislation (employers’ liability, the Medical Device Regulations, Health and Safety at Work Act), taking into account the patient’s legal rights and the hospital’s risk management.

The existing National Occupational Standards

• Hospital Access Level 3 (NQF) is valid for presence in Hospital areas that do not include critical care areas.
• Theatre Access is Level 5 (NQF) and is valid for critical care areas (theatres, anaesthetics, ITU, HDU, A&E, day surgery, interventional radiology)

These standards exist to meet the requirements as determined by SQA, EduQual and Cogent skills (National Occupational Standards).

Several training providers offer both on-line and face-to-face courses in Theatre Access but not all meet the National Qualifications framework (NQF) used by Hospitals as a minimum for their own staff.

When Hospitals/Trusts accept credentialing company confirmation of the training and competencies associated with “Theatre Access” courses which are below minimum hospital employee standards (NVQ Level 2, or healthcare support worker – level 3 or above), hospital managers mistakenly assume benchmarked standards have been met.

We believe that the public would expect and deserve transparency, consistency and adherence to benchmarked national standards for all personnel allowed access to any hospital’s critical care areas.

The message is clear for everyone – for industry, for hospitals, for credentialers and ultimately for the benefit/safety of patients – clarity, consistency and adherence to verifiable, officially recognised standards of training and qualification are vital.

This article also appeared in the May 2020 edition (No 356) of The Operating Theatre Journal.





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