How the CQC uses clinical research in onsite and offsite inspections

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In a webinar that took place on June 22, 2022, the CQC explained that the clinical research it developed is now routinely used by CQC inspectors in offsite and onsite inspections of GP practices.

Clinical research was developed in response to the COVID-19 pandemic and its purpose is to assess how practices provide clinical care to patients. Research focuses on areas of clinical importance and aims to identify potential clinical risks related to the delivery of safe and effective care.

The hope is that the research will improve quality and ensure a more consistent regulatory approach.

CQC is working with Ardens Healthcare Informatics on a 12 month pilot project to create, review and deliver clinical research. Practices can access clinical research through the Ardens website.

How will the research be used?

During the CQC webinar, the presenter said that clinical research is becoming a more important part of the inspection process. The CQC was keen to emphasize, however, that searches should not be used as a substitute for existing practice governance systems, nor as a means of managing day-to-day care.

Each clinical research is risk-based and identifies a cohort of patients who may require closer monitoring. The CQC will research from some of the following areas and select research for review based on perceived risk:

  • Disease-modifying antirheumatic drugs
  • Monitoring of high-risk drugs
  • Medication Review
  • Medication use
  • Identify a possible missed diagnosis
  • Security Alerts
  • Management of long-term conditions

Our experience

I recently spoke with a GP who had received an unfavorable draft inspection report from the CQC. The draft report alleged that the provider had breached Regulation 12 of the Health and Social Care (Regulated Activities) Act 2008 Regulations 2014 which relate to the safe care and treatment of service users.

The draft report alleged that the provider had failed to do everything reasonably possible to mitigate risks to the health and safety of service users receiving care and treatment. He said: “Our research into clinical records showed that the practice did not always have an effective process in place to monitor patient health with respect to medication use, including high-risk medications.”

When I spoke to the practice director about it, he explained to me that the CQC had harshly criticized the practice for not performing blood tests for patients with diabetes. The practice director said the patients were asked to come to the practice for a blood test, but did not go.

Another GP I spoke to recently had received a Notice of Proposal (NOP) to cancel the practice’s registration as a provider. One of the main criticisms in the NOP was that the practice did not have a plan in place for patients who needed medication monitoring but had missed their medication reviews.

These experiences show that risk-based clinical research is at the forefront of CQC inspectors’ concerns. Suppliers should pay close attention to this and ensure their governance systems are robust to identify issues.

Difficult inaccuracies

Our firm has seen an increase in CQC enforcement activity in the industry and if you are criticized in relation to clinical research, it is important to challenge any inaccurate findings. There are always concerns about how inspectors ensure the validity of the data on which they base their risk assessments. The CQC must ensure that any information collected is properly verified and used to inform proportionate decision-making.

Practices should challenge misleading or inaccurate CQC inspection reports through the Factual Accuracy Feedback process. This is the only opportunity to challenge the factual content of a report.

Sometimes firms decide not to challenge reports because they think it won’t make a difference or they don’t want to damage an existing relationship with their inspector. However, the consequences of not disputing an inaccurate report can be very serious. If an inspection report is not challenged and then published, there is a presumption that the report is accurate and that the contents of the report become the truth.

  • Anna Lemmer is a senior associate attorney at Ridouts
  • If you need assistance or advice regarding issues with CQC, including inspections and assessments, our specialist lawyers can help. Please contact Ridouts Professional Services Ltd using [email protected] email address or by calling 020 7317 0340.
Ridouts Professional Services Ltd

Ridouts is a law firm that acts only for healthcare providers. We provide legal, operational and strategic advice when suppliers face issues that could negatively impact their business, such as poor CQC inspections and enforcement actions. www.ridout-law.com

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