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Standardisation

Regulation

Purpose

Trusts are overseen by a combination of statutory and advisory regulators.

Statutory regulators are:

NHS Improvement: replaced the functions of Monitor, the foundation trust regulator, and the Trust Development Authority, the regulator of non-foundation trusts. It holds providers – including independent providers who supply NHS-funded care – to account and, where necessary, intervenes to help organisations meet their short-term challenges and secure their future.

Care Quality Commission (CQC): monitors and inspects services to ensure they meet standards of quality and safety. Its reports are published to help patients choose where they receive care.

NHS England: leads the NHS in England, setting its priorities and direction. It dispenses more than £100 billion to organisations which it holds to account for spending it effectively for patients and efficiently for the taxpayer. It commissions services through contracts with GPs, pharmacists and dentists and by supporting local health services led by CCGs. It has devised a strategic vision for the NHS, the Five Year Forward View.

There are also professional advisory bodies such as the royal colleges and NICE as well as other specific regulatory organisations including the MHRA.

Regulation graphic

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GovernanceRegulation graphic
A clear governance framework and standards that each site understands it is expected to adhere to are key to providing assurance to regulators.

Even with different models of care within a network, standardisation of types of service offered and central monitoring of compliance should ensure quality and safety and provide assurance for regulators.

Provider-host relationships
If the two parties are not clear about who is doing what, the regulator will be unclear too. Our research has frequently highlighted the need for robust agreements between specialty provider and host trust to be in place before the new service starts. SLAs can be very useful to describe the relationship, what each partner is supposed to be doing for the other and to inform regular reviews. However, they do not usually have the legal standing that formal contract documents offer.

Cultural issues
In some networked models – for instance one where the host trust continues to count the activity provided by the partner in its performance reports – provider trust staff can sometimes feel more part of the host organisation than their own. In this case enforcing the provider’s standards can be a particular challenge and will rely heavily on strong local leadership.

Inspection challenges
Because inspectors are less familiar with the networked model, organisations can have difficulties explaining how some aspects work. For example, a manager on one site will be responsible for staff in her area but not for staff in her specialty on another site. Having structures with clear lines of responsibility that staff clearly understand will mitigate this.

Another issue can arise when it is not clear to an inspector where the line is drawn between areas of responsibility for patient care, for instance during surgery and on a post-operative ward. Again, being able to provide evidence of agreed protocols and accountabilities will provide assurance.

“One inspector expected the pharmacist to know about all pharmacy staff’s mandatory training across the network, not just at her site, whereas she knew that was not her responsibility.”

“As the provider we were responsible for the day case procedure but not for the post-operative nursing and when an issue arose about analgesia on the recovery ward, the inspector didn’t understand why we hadn’t administered it.”