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Nigel's surgery 12: Accessing medical records during inspections

Categories:
  • Organisations we regulate

We review medical records when we inspect GP and urgent care services. This is to assess the quality of care provided by the practice. It is not to assess the individual clinician.

Our powers to access medical records

We have powers under the Health and Social Care Act 2008 (the 2008 Act) to access medical records to exercise our functions. We balance these powers with responsibilities under the:

  • Data Protection Act 2018
  • Human Rights Act 1998
  • common law duty of confidentiality.

We respect and protect the privacy and dignity of patients. We maintain confidentiality of their records.

Our Code of practice on accessing confidential and personal information describes our powers to access medical records. We will look at a patient's medical records where:

  • it is necessary, and
  • intruding on that patient’s privacy is justified and proportionate.

This code outlines the necessity test we must meet. This is before we access confidential and personal information whilst exercising our powers.

Our inspection teams always follow the code when they access medical records during inspections of NHS GP practices and GP out-of-hours services.

National data opt-out

National data opt-out gives patients and the public more control over how their confidential patient information is used for research and planning. It follows:

The opt-out does not apply to our access to records. If a provider tells us that a patient does not want us to look at their records, we will respect their request. This is unless there is an overriding need to look at that particular record.

When we inspect

Why we look at medical records

We assess the quality of care against our key lines of enquiry (KLOE). We corroborate this through evidence we see in medical records. We look at this evidence alongside:

  • other evidence gathered on the inspection
  • information we have from our ongoing relationship management with the provider
  • information from CQC Insight
  • information gathered before the inspection

We do not assess an individual clinician's ability. If we identify concerns about an individual clinician, we refer them to the appropriate body. For example, GMC or NMC.

What records will we review?

The types of records we may need to review to answer specific KLOEs. Details below give further information about searches of the clinical system

KLOEs

S3.1 Are people's individual care records, including clinical data, written and managed in a way that keeps people safe?

S4.2 Are medicines appropriately prescribed, administered and/or supplied to people in line with the relevant legislation, current national guidance or best available evidence?

E1.7 Are people told when they need to seek further help and advised what to do if their condition deteriorates?

Examples of records

A sample of consultation records for a range of clinicians to check:

  • notes are contemporaneous
  • contain enough information (including clinical findings, decisions made and actions agreed)
  • medicines are appropriately prescribed

The sample should include records related to:

A sample of consultation records for a range of clinicians to check:

  • acute presentations
  • managing patients with long term conditions
  • the safeguarding register
  • a sample of patients on the register

KLOE

S3.2 Is all the information needed to deliver safe care and treatment available to relevant staff in a timely and accessible way? (This may include test and imaging results, care and risk assessments, care plans and case notes.)

Examples of records

Systems for:

  • processing test results
  • reviewing letters and communications
  • out-of-hours/A&E attendances
  • safeguarding alerts
  • responding to tasks/telephone calls/online consultation requests

Make sure:

  • problems lists and summaries are accurate
  • there is a past medical history with allergy status recorded and medications listed.

KLOE

S4.6 Are people receiving appropriate therapeutic drug and physical health monitoring with appropriate follow-up in accordance with current national guidance or evidence?

Examples of records

Search the clinical system to identify patients prescribed high risk medicines. Details are included below.

Review a sample of patients to make sure they are receiving:

  • appropriate monitoring (and medicines are not prescribed when monitoring is overdue)
  • advice about their medicines
  • safety netting is in line with guidance

KLOE

S6.5 How effective are the arrangements to respond to relevant external safety alerts, recalls, inquiries, investigations or reviews?

Examples of records

Search the clinical system to:

  • identify patients affected by patient safety alerts/alerts from the Medicines and Healthcare Products Regulatory Agency (MHRA)
  • review sample of records to make sure action has been taken

KLOE

E1.1 Are people's physical, mental health and social needs holistically assessed, and is their care, treatment and support delivered in line with legislation, standards and evidence-based guidance, including NICE and other expert professional bodies, to achieve effective outcomes?

Examples of records

  • a sample of individual care records/care plans/annual reviews for specific groups of patients. For example, patients with a mental health condition, frail older people, children with long term conditions
  • the carers register

Process for looking at medical records

  • A clinician would usually review of information on the clinical system. This may be a GP, pharmacist or practice nurse specialist advisor on the team. We feel it is appropriate for clinicians to lead this aspect of the inspection where possible. However, the 2008 Act does not require this.
  • How many records we look at depends on evidence we see in the practice and within medical records.
  • Our powers allow inspection teams to access people's records without their consent. There is no requirement for us to seek consent from people.
  • Processes for reviewing records online are set out below.

Additional information about searches of the clinical system

Where our inspections include the safe and effective key questions, they will usually include a review of information on a practice’s clinical system.

Access to clinical systems

During the COVID-19 pandemic, we have explored ways of working that reduce risk, and minimise the amount of time spent on site, whilst enabling us to continuing regulating. We have developed processes to accommodate digital access to GP clinical systems, supported by teleconferencing/web conferencing to speak with providers. This means a specialist advisor may not always need to be on site. This reduces disruption for the practice and protects patients, practice staff and CQC staff. Searches we will usually run as part of inspection activity to support us to answer the KLOEs are detailed below. With consent from providers this standard set of searches can be uploaded to run on the practice system.

The following list contains examples of the search categories we are currently using. This list is not exhaustive and will be updated periodically. Each search will be subject to updating. For example, in response to new alerts or changes to guidance. Inspection teams may need to run additional searches.

Search categories

Currently these searches are only uploaded for EMIS and TPP SystmOne practices.

1. Monitoring of patients being prescribed Disease Modifying Antirheumatic Drugs (DMARDs). See Specialist Pharmacy Service (SPS) guidance on DMARD monitoring during COVID-19. See NICE Clinical Knowledge Summary (CKS) for DMARD monitoring

  • Methotrexate monitoring
  • Azathioprine monitoring
  • Leflunomide monitoring

2. High risk drug monitoring – NICE CKS and specific data sheet/licensing requirements

  • Lithium monitoring
  • Spironolactone and eplerenone monitoring
  • ACE inhibitor or ARB monitoring
  • Amiodarone monitoring
  • Warfarin monitoring
  • DOAC monitoring
  • Mirabegron monitoring

3. MHRA/CAS/drug safety update alerts – to ensure the provider has taken appropriate action in response to the alerts

a) Single drug alerts:

  • Valproate and valproic acid – teratogenicity risk and need for Pregnancy Prevention Plan
  • Hydrochlorothiazide – skin cancer risks
  • SGLT-2 inhibitors – Fournier’s gangrene risk
  • Epipens – provision of 2 autoinjectors, recalls of some products and extensions of expiry dates
  • Febuxostat – CV risk
  • Carbimazole – teratogenicity risk
  • Citalopram in patients aged >65 – CV risk

b) Combination drug alerts:

  • Clopidogrel and omeprazole – reduced antiplatelet effect
  • Simvastatin and amlodipine – increased myopathy risk
  • ACE and ARB – increased renal risk

4. Potential missed diagnosis of diabetes

a) Repeated raised HbA1c >48 and no coded diagnosis of diabetes. See NICE CKS diagnosing diabetes.

5. Medicines usage:

  • Number of asthmatic patients issued more than 12 Short Acting Beta 2 Agonists (SABA) inhalers in the last 12 months. See Why asthma still kills 2014
  • The prescribing of gabapentinoid medicines where review is indicated
  • The prescribing of benzodiazepine and ‘Z’ drugs where frequency of issue warrants investigation

How the information from the searches is used

Searches of the clinical system are part of understanding the clinical safety and effectiveness of care delivered. They will be used to identify areas for further analysis. This may include further searches. It will include review of a sample of patient records by a clinician in line with our KLOEs.

These searches have been developed to support the regulatory function of CQC. They are not a substitute for good clinical governance and oversight of safe practice. We expect providers to have their own systems and processes in place. This is to ensure safe and effective care is being delivered to patients following national guidance.

Content and focus of the searches

  • The content and focus of the searches have been agreed by the RCGP and the BMA. They represent a reasonable approach to assessing some important features of safe and effective healthcare delivery.
  • The searches are designed to reflect current BNF/NICE recommendations. For example, in relation to drug monitoring.
  • The searches have been adapted to take account of national best practice updates to drug monitoring during the pandemic. For example, those provided by the Special Pharmacy Services (SPS).
  • During inspection it may be necessary to do additional searches
  • The searches will be regularly reviewed and updated. This will reflect changes to guidance, new alerts or areas considered to be important for additional review.
Last updated:
21 December 2020