Published: 01/09/2005, Volume II5, No. 5971 Page 18 19

Under the replacement for star-ratings, trusts will be asked to assess themselves against a set of core requirements. But do they really understand the significance of the changes?

Paul Stanton looks at the practicalities behind Standards for Better Health

By next month, the board of every trust and primary care trust must complete its draft declaration to the Healthcare Commission on compliance with core elements of Standards for Better Health, the successor to star-ratings.

In the experience of the NHS Clinical Governance Support Team, which works with more than 150 organisations, many boards have failed to grasp fully the significance or scale of the challenge. And the government could be underestimating what will be revealed when organisations really scrutinise their own performance against the standards.

As the Department of Health made clear when it published the standards in July last year, they 'sit at the heart' of the new relationship between government and the NHS.

However, in the same report it said the core elements 'do not themselves set out new expectations of the NHS, but are based on a number of requirements that already exist'. In short, they describe an acceptable level of service, and demand that it be universally applied.

'Meeting the core standards is not optional, ' the report states.

'Healthcare organisations must comply with them from the date of [their] publication.' The initial self-assessment could merely confirm that all is as it should be. However, it remains unclear what may be revealed (and what may remain obscure) if boards seek, from rigorous self-assessment, the 'reasonable assurance' necessary to sign off compliance with the 24 core standards (which are broken down into 90 elements).

The commission is clear that, first and foremost, the board has a corporate duty to ensure its organisation is meeting the core standards. If it is not, the board must take appropriate steps.

A number of chairs, chief executives and boards - not least because of financial pressures and new structural imperatives set out in Commissioning a Patient-Led NHS - have not yet initiated the processes necessary to meet this duty.

Although some strategic health authorities have, from autumn 2004, helped organisations address these issues, others have remained predominantly passive while the clock ticks.

Each board must ensure a systematic and thorough selfassessment has been undertaken, in line with the commission's guidance.

Based on evidence arising from the assessment, it must then make one of the following declarations:

Assured compliance: other than exclusions in the next two parts, the board must have reasonable assurance that there have been no significant lapses in core standards.

Absence of clear assurance: details of standards where the board is unclear whether there have been significant lapses.

Evidenced significant lapses: details of where assurances received by the board make it clear that standards have not been met.

If there is a lack of assurance or evidence over lapses, the board must submit an action plan detailing what will be done to achieve evidenced compliance by April 2006.

Deciding, on a standard-bystandard basis, which category the organisation falls into requires a systematic approach and two crucial decisions. The first is what each board corporately understands by 'reasonable assurance'. What is the breadth of evidence that must underpin a judgement that there have been no significant lapses?

There must also be an informed consensus about what constitutes a 'significant' lapse. The evidence the board has scrutinised is not sent to the commission, but it is still necessary in case of a subsequent reality check.

It appears that evidence can be reviewed and judgements made only on an element-by-element and standard-by-standard basis. To determine if any identified lapse was significant, a board would need to consider the frequency and consequences of the lapse before reaching a judgement. What, for example, might constitute a significant lapse in relation to food preparation and diet will be very different from a lapse in childprotection guidance.

For PCTs, the task is more complex. Boards must be reasonably assured of compliance in the care they provide through their own staff and have taken 'reasonable steps' to promote compliance among their 'independent' contractors. They must also seek assurances for commissioning processes.

While the commission is sensitive to the difficulty this poses, the challenge of reaching robust but realistic judgement is huge.

To help them, the CGST is providing a series of web-based workshops for PCTs to explore the complexities of the process.

A key question for boards is how they obtain evidence of compliance.

For the majority of the standards, this is through clinical governance and evidenced outcomes.

But not all trusts and SHAs understand the evidential relationship between clinical governance and Standards for Better Health. Some believe that standards have 'replaced' clinical governance, others that the two are unrelated.

Core standards address the safety and quality of existing provision - the primary focus of clinically governed care. On behalf of the board, the clinical governance committee and designated lead have vital roles in generating the evidence to underpin clinical assurance - or identifying its absence.

In other words, standards compliance places governance at the heart of the new performancemeasurement process. As part of NHS clinical governance director Professor Aidan Halligan's remit to re-energise governance, CGST is developing a model to embed it at every level of an organisation's activity.

Effective and embedded clinical governance is a prerequisite for safe, continuously improving and standards-compliant care. But it takes years to embed across all elements of a complex organisation.

There is a danger that organisations with the most rigorous and systematic clinical governance will be more likely to identify significant lapses than those with less robust systems. The most important element of any regulatory system is that it is viewed as fair and robust by those whose fate hangs on its outcomes. So it is vital that the commission's targeted and random reality checks differentiate the selfcritical from the complacent. .

Paul Stanton is director of board development for the NHS National Clinical Governance Support Team.

www. cgsupport. nhs. uk