The Care Quality Commission (CQC) has launched a public consultation with the aim of introducing changes to its current inspection methodology (CQC, 2021). The move was precipitated by the COVID-19 pandemic, which has driven the regulator to consider amending its inspection strategies to alleviate unnecessary pressures on the NHS.
The decision recognises that the CQC needs to balance its statutory responsibilities with the need to allow hospitals and other providers to concentrate on delivering care while coping with the stresses of increased patient flow. The initiative, which runs until 23 March, reflects the CQC's quest to continue to develop a more targeted, responsive and collaborative approach to regulation in a changing landscape of health and social care.
Background
The original regulator for health care in the guise of the Commission for Healthcare Improvement (CHI) was developed following the Health Act of 1999 with the specific remit of ensuring that clinical governance was fully embedded across the NHS. After 2003, when CHI became part of the Healthcare Commission, a more formal role of inspecting NHS providers was implemented to assess their performance against national standards.
The CQC was created in 2009 following the merger of three regulatory organisations: the Healthcare Commission, better known by health professionals as the Commission for Healthcare Audit and Inspection (CHAI), the Commission for Social Care Inspection and the Mental Health Act Commission. The primary function of the CQC is to regulate and inspect health and social care services in England to ensure that they provide safe, effective, compassionate, high-quality care. (NB the other countries of the UK have similar regulatory bodies.)
However, the original mode of CQC inspection was to change in the aftermath of two specific failures: scandals that occurred at Mid Staffordshire NHS Foundation Trust and Winterbourne View private hospital in South Gloucestershire, the latter providing care for people with learning disabilities and challenging behaviour. Both institutions were subject to public inquiries that exposed unacceptable levels of patient abuse, revealing fundamental flaws in the provision of health care (Department of Health (DH), 2012; Francis, 2013).
The CQC acknowledged that, despite its pre-public inquiry inspections, the harms perpetrated on patients at Mid Staffordshire were not uncovered by its inspectors or specialist advisors, and it was against this backdrop that the CQC introduced new strategies to ensure that patients are always the recipients of optimum care. The CQC responded to the findings of the two reports, and to what were seen as weaknesses in its inspection processes, by introducing a more stringent methodology.
In June 2013, the CQC announced that the old system of inspections would be replaced by one that would involve posing more focused questions about the quality and safety of care provided by health or social care institutions. To achieve this, inspection teams were mandated to pose five questions during any inspection/:
- Is it safe?
- Is it effective?
- Is it caring?
- Is it responsive to people's needs?
- Is it well led?
New, more robust inspections were introduced to build up a much more detailed picture of care in hospitals than had been obtained previously. Furthermore, the inspections were supported by an improved method for identifying risks and included obtaining much more information directly from patients and their families, as well as staff.
The new inspections were configured as a mixture of unannounced and announced visits. They also included carrying out visits in the evenings and at weekends, when care delivery practices were potentially thought to be less than optimum. The new CQC inspection regimen was designed to avert future scandals on the scale of the Mid Staffordshire tragedy. Since then, the CQC has seen many NHS trusts make significant improvements in their quality of care provision. Furthermore, the regulator considers that strong leadership and a positive open culture have been important drivers of change in hospitals (Glasper, 2019).
Despite the more rigorous and focused inspections, the findings of yet another public inquiry, which probed maternal deaths at the Shrewsbury and Telford NHS Trust (Ockenden, 2020), revealed continuing problems. This scandal is now being compared in scale to that of Mid Staffordshire and is yet another example of NHS failings.
Comprehensive checks
In the wake of the Mid Staffordshire and Winterbourne View scandals, the new-style inspections became more comprehensive, involving specific teams of inspectors and specialist advisors for specific identified clinical services within a trust, and sometimes all of them. Lasting up to 4 days and involving as many as 80 CQC personnel, these visits were considered by some to be overly intrusive. However, it should be stressed that all members of the CQC inspection teams are fully briefed about not compromising patient care at all stages of an inspection.
There have been accusations that CQC inspections have failed to raise standards or improve patient safety, with arguments that the resource-intensive, high-profile system of inspections and ratings of a hospital's clinical services have only a small and mixed effect on performance indicators (Hawkes, 2018; Iacobucci, 2018). Castro-Avilia (2019) has suggested that CQC external inspections are not associated with positive, clinically significant effects on the rate of adverse events and that any improvements have occurred prior to the announced CQC inspections and then slowed after the inspections. It should be noted that prior to the onset of the pandemic the CQC had already introduced unannounced inspections of NHS trusts.
Inspections during the pandemic
As the true magnitude of the pandemic became clear in spring last year, the CQC made the decision to implement changes to the way it conducted its regulatory activities. This was a pragmatic decision because the CQC relies heavily on frontline nurses to act as specialist advisers during its inspections. As the pandemic worsened it became clear that, given the pressures on staff delivering care, it would not be possible or appropriate to take frontline nurses away from clinical duties to participate in inspections. Consequently, the CQC adopted a longer-arm approach to its activities, using data to monitor services through its intelligence monitoring, coupled with focused telephone discussions with key NHS trust informants.
As the pandemic entered its second year, the CQC decided to overhaul its inspection processes and on 7 January 2021 it published a formal consultation on a new strategy. The draft proposals have been informed by over 10 000 interactions with stakeholders and set out a 5-year vision for the organisation.
The proposed strategy is designed to enable more effective regulation for the foreseeable future and help services such as NHS trusts keep people safe. The CQC has identified four primary themes to help drive up standards of care in the NHS and reduce health inequalities:
- People and communities: regulation of health care should be informed by people's experiences and what they expect and need from health and social care services
- Smarter regulation: the inspection processes should be more flexible and dynamic, with regular trust rating updates and a more targeted use of intelligence data to inform areas that need closer examination
- Safety through learning: all health and social care services should be enabled to develop stronger safety cultures, within which learning from safety concerns and events is fully embedded. In particular, when safety fails to improve and services do not take on board lessons, the CQC will take regulatory action to protect service users
- Accelerating improvement: the regulator seeks to do more to make improvement happen within services, such as NHS trusts, and to see improvement in the way services work together as a system to make sure people get the care they need at all times.
The regulator is planning to move away from using former pre-pandemic comprehensive on-site inspections as the primary way to update NHS trust ratings or assess quality in other services. Instead, it will use wider sources of evidence, tools and techniques. Despite the proposed changes, inspection will remain an important part of how quality is assessed. Hence, on-site inspections, where the CQC has identified information about significant risks to people's safety, will continue to take place as a mechanism of ensuring that the rights of vulnerable people remain protected.
The proposed changes equate to the expanded use of information that the CQC holds and acquires from its intelligence monitoring activities to update ratings of NHS trusts, meaning that it won't always be necessary to carry out a site visit when it wishes to update a rating. However, the CQC will carry on using more targeted inspections to enable it to carry out its regulatory activities in a more focused and proportionate way.
As part of this modernisation of regulatory activities, the CQC is proposing to simplify how it reports ratings for NHS trusts by publishing a single rating at overall trust level, in contrast to the old system, which used complex and aggregated ratings for each core service within each trust. This will allow the CQC to focus on the culture and leadership of an individual trust. The single rating of an organisation will be based on an overall assessment of its performance against key question 5 (Is it well led?), including findings from service-level assessments.
Once the CQC implements this new approach it will no longer publish separate trust-level ratings for the other four key questions—on safety, effectiveness, caring and responsiveness to people's needs—but will continue to publish these ratings at individual service and location level. This should help provide a clear picture of the quality of services at the level that is relevant to the people who use them.
The CQC consultation closes at 5pm on 23 March 2021. Readers wishing to respond to the online questionnaire may do so by going to https://tinyurl.com/y6waos4c (CQC, 2021).
KEY POINTS
- The Care Quality Commission (CQC) is consulting on proposed changes to its regulatory inspection processes, a decision that has been made to alleviate unnecessary pressures on the NHS caused by the COVID-19 pandemic
- The CQC aspires to develop a more targeted, responsive and collaborative approach to regulation in a changing landscape of health and social care
- The CQC is planning to move away from using its previous comprehensive, on-site inspections as the primary way to updateg NHS trust ratings, using instead a wider sources of evidence, tools, and techniques to assess quality