Chapter 5: Regulators
Structure
76.There is no one regulator for homecare services.135 The CQC and the General Pharmaceutical Council each regulate different activities within homecare provision. Also relevant are the Medicines and Healthcare products Regulatory Agency, and the Parliamentary and Health Services Ombudsman. We were told: “We are all looking at different aspects”.136
77.While the General Pharmaceutical Council regulates 26 providers (all those providing pharmacy activities), the CQC regulates only ten (those providing regulated activities pursuant to the Health and Social Care Act 2008).137 These criteria for regulation are separate from the key performance indicators mentioned in chapter 3.138 Sarah Billington, Deputy Director of Medicines Optimisation at the CQC, acknowledged, “there is no one saying overarchingly, ‘This provider is not doing this and this.’”139 Neither the CQC nor the General Pharmaceutical Council believed, though, that there were significant gaps in regulation: “we are not overlapping, but we are all making sure there are no gaps between the work we do”.140
78.The regulatory structure was criticised by Dr Christian Selinger, a Consultant Gastroenterologist and Chair of the Inflammatory Bowel Disease section of the British Society for Gastroenterology, for lacking an arbitrator who can make a final, binding decision. He drew comparisons with the regulation of medics:
“If I as a doctor do something wrong, there is an ultimate arbitrator, the GMC [General Medical Council], that will hold me to account regardless of what my employer thinks. If a pharmacist does something wrong, there is the General Pharmaceutical Council. For nurses, there is the Nursing and Midwifery Council. Yet for these companies there seem to be several bodies and none of them is the ultimate arbitrator.”141
Awareness
79.The British Society for Rheumatology argued that homecare was a “blind spot” for regulators. They reported: “we were surprised to discover that the issues were not on their radar”.142 Several elements of the CQC’s evidence would seem to support claims that it lacks awareness of the homecare sector.
(a)The CQC told us that between June 2022 and July 2023 it had conducted three homecare provider inspections.143 Set against the concerns raised to it, this is a very small number of inspections.
(b)The CQC was unable to identify the number of complaints received about homecare services due to the way that its systems categorise care—it has no specific category for homecare services.144
(c)In reference to the performance of the sector, Sarah Billington repeated the figure given by the National Clinical Homecare Association which stated that 98.8% of deliveries were delivered on the day intended.145 This, as we have pointed out in paragraph 38, was described as “cherry picked”146 as it measures a very particular part of the process.
(d)Neither the CQC nor the General Pharmaceutical Council has conducted data collection on harms to patients arising from failures in the service.147
(e)The CQC does not always ask hospital providers about homecare.148
80.Thematic reviews are designed to look at whole systems, on the understanding that this can yield more information than individual inspections. The CQC has undertaken 14 such reviews over the last three years. While the General Pharmaceutical Council is undertaking a “short, themed review of a small sample of pharmacies … within homecare service settings”,149 the CQC has no plans to run a thematic review.150
Appetite for enforcement
81.Sarah Billington told us: “we are regulating individual providers and we are holding them to account. We do require them to meet the standards and we take action where they do not.”151 However, some witnesses thought that there was insufficient action taken against homecare providers. The British Society for Rheumatology described a “toothless enforcement culture”,152 and Crohn’s & Colitis UK recommended “stronger enforcement … [with] financial penalties for failures in services that cause additional burden on the NHS.”153
82.Healthcare at Home (now Sciensus) was inspected by the CQC in November 2020. The report notes that there were 9,885 patients whose medicines were missed or delayed, and that there had been “avoidable harm to some patients”. The CQC issued a safety rating of “inadequate”. The enforcement process was complex but culminated in placing the provider in ‘special measures’. This means that the service would be inspected again within six months and, if the provider remained at inadequate for any core service, action would begin to prevent operations.154
83.The CQC initiated 87 prosecutions between April 2015 and February 2023 across the whole of their sector. This included very few prosecutions of large hospital trusts. There is a range of severity—while some cases were of avoidable deaths, rapes and life-altering injuries, one provider was prosecuted for failing to publish the most recent CQC inspection report prominently on their website.155 We have seen no evidence of prosecutions initiated against homecare companies.
84.The regulatory model for homecare is failing to ensure the safety and quality of patient care. The regulators appear to have a limited understanding of the sector and there appears to be no appetite to find more information. Enforcement action taken against providers, even where avoidable harm has taken place, is feeble. There appears to be no appetite to issue penalties against non-compliant homecare providers. Poor performance can go unchecked. We note the discrepancy between the approach the CQC takes towards small residential homes and that taken towards homecare medicines providers.
85.The Secretary of State should review the regulatory regime for homecare medicines services, considering in particular the lack of enforcement action taken by the CQC against homecare providers where avoidable harm has occurred. The review should identify a lead regulator with the skill and the breadth necessary to take necessary action against providers which are under-performing. These urgent actions should also be reflected in the longer-term review of healthcare regulation.
86.The Secretary of State for Health and Social Care should instruct the CQC to conduct a thematic review of homecare medicines services.
136 Ibid.
137 Q 24. See Health and Social Care Act 2008, Schedule 1
142 Q 3 (Sarah Campbell) and supplementary written evidence from British Society for Rheumatology (HMS0010).
150 Q 25 (Sarah Billington) and supplementary written evidence from Care Quality Commission (HMS0018)
154 Care Quality Commission, Healthcare at home - Head office: inspection report (14 May 2021): https://api.cqc.org.uk/public/v1/reports/ab248133-cba7-4563–809a-69199ce412ac?20210514000508 [accessed 19 September 2023]
155 The report took the inspector “more than 15 minutes to find”. This case, resulting in a fine of £500, cost over £5,000 in court costs. See Care Quality Commission, ‘List of prosecutions brought by CQC’,
(3 October 2023): https://www.cqc.org.uk/about-us/how-we-do-our-job/prosecutions [accessed 2 November 2023]