Dermoscopy and lesion documentation policy (dermatology)

1. What the regulation says

Systems or processes must be established and operated effectively to ensure compliance with the requirements in this Part. (Reg 17(1): the umbrella duty)

maintain securely an accurate, complete and contemporaneous record in respect of each service user, including a record of the care and treatment provided to the service user and of decisions taken in relation to the care and treatment provided. (Reg 17(2)(c): accurate service-user record)

Regulation 12 adds the safe-care duties this policy operationalises:

Care and treatment must be provided in a safe way for service users. (Reg 12(1) (the headline duty))

assessing the risks to the health and safety of service users of receiving the care or treatment, (Reg 12(2)(a) (risk assessment))

doing all that is reasonably practicable to mitigate any such risks, (Reg 12(2)(b) (risk mitigation))

The full text is at https://www.legislation.gov.uk/uksi/2014/2936/regulation/17 and https://www.legislation.gov.uk/uksi/2014/2936/regulation/12. Where this policy and the regulation diverge, the regulation wins.

2. Plain-English summary

You have to run effective systems and processes to comply with everything else in Part 3. The regulation lists six things those systems must enable in particular: quality assessment and improvement, risk management, accurate service-user records, accurate employment and management records, seeking and acting on feedback, and continually evaluating and improving how you process all this. If CQC requests a written report on quality and risk plus your improvement plans, you have 28 days from the day after the request. Care and treatment must also be provided in a safe way: Regulation 12 lists the areas a provider must address, including risk assessment, risk mitigation and staff competence, which apply directly to using dermoscopy and recording lesions so they can be compared safely over time.

3. Purpose

Dermoscopy improves the accuracy of skin lesion diagnosis, and good documentation, including clinical images, lets a clinician see whether a lesion has changed over time. Because those images are sensitive personal data, they must be handled carefully. This policy sets out how the Service uses dermoscopy, records lesions and stores clinical images safely.

The Service must verify this policy against current British Association of Dermatologists guidance and data protection law before adoption.

4. Sources to verify before adoption

• British Association of Dermatologists, guidance on dermoscopy and clinical photography: https://www.bad.org.uk/
• NICE NG14, Melanoma: assessment and management: https://www.nice.org.uk/guidance/ng14
• Data Protection Act 2018 and the UK GDPR (clinical images are special-category personal data): https://www.legislation.gov.uk/ukpga/2018/12/contents
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 12 (safe care and treatment): https://www.legislation.gov.uk/uksi/2014/2936/regulation/12

5. Scope

This policy applies to:

• the use of dermoscopy in assessing skin lesions
• the taking, storing and use of clinical and dermoscopic images
• the clinicians who use dermoscopy and the staff who handle images

6. Using dermoscopy

• dermoscopy is used by clinicians who are trained and competent in it, as one part of the assessment, not a substitute for clinical judgement
• the dermoscopic findings are recorded in the patient's record, with the lesion clearly identified by site
• where dermoscopy is uncertain or the clinical picture is worrying, the clinician refers or excises rather than relying on a reassuring image

7. Clinical and dermoscopic images

• a clinical or dermoscopic image is taken with the patient's consent, with the reason explained, and the consent recorded
• the lesion is photographed in a way that identifies its exact site, so the same lesion can be found and compared later
• where the Service offers monitoring of lesions over time, it records baseline images and compares them at review, acting on any change

8. Lesion records that support comparison

The Service records each lesion clearly enough to compare it over time:

• the site is described precisely, and a body map or numbering is used where a patient has many lesions
• the size, appearance and dermoscopic features are recorded
• a change at review triggers reassessment and, where the criteria are met, referral

9. Protecting images as personal data

Clinical images are sensitive personal data and are protected accordingly:

• images are stored securely within the Service's systems, not on personal phones or unprotected devices
• images are linked to the right patient and not mixed up
• access is limited to those who need it, and images are kept and disposed of in line with the Service's retention and data protection arrangements
• the loss or exposure of clinical images is treated as a possible data breach and reported at once

10. Consent for any wider use

An image is used only for the purpose the patient agreed to. Any wider use, such as teaching or publication, needs separate, specific and informed consent, and the patient can decline without affecting their care.

Operational controls to adapt

Roles and responsibilities

• Registered Manager: owns this policy, confirms image governance is in place, and reviews incidents, data breaches and audit findings.
• Clinician using dermoscopy: confirms competence, records the clinical and dermoscopic findings, decides whether monitoring, biopsy, excision or referral is needed, and safety-nets the patient.
• Clinical photographer or trained staff member: takes images only under the approved process, confirms identity and lesion site, and uploads images to the secure record.
• Information Governance Lead: controls storage, access, retention, transfer and breach response for clinical images.
• Governance lead: reviews missed lesion concerns, image-quality failures, data incidents and improvement actions.

Dermoscopy and lesion-documentation procedure

1. Confirm identity and consent. Confirm the patient, explain why the image or dermoscopy record is needed, and record consent for clinical use.
2. Identify the lesion. Record precise anatomical site, side, size, body-map reference or lesion number, and whether other lesions are being monitored.
3. Capture the minimum image set. Take an overview image, close-up clinical image and dermoscopic image where dermoscopy is used, unless the reason for not doing so is recorded.
4. Record clinical features. Document symptoms, duration, change, patient concern, risk factors, clinical appearance and dermoscopic features.
5. Make and record the decision. State whether the lesion is reassured, monitored, biopsied, excised or referred, and the reason for that decision.
6. Set follow-up or referral. If monitoring is chosen, set a review date and comparison method. If cancer is suspected, use the urgent referral pathway.
7. Protect and review images. Store images only in the approved system, check they are linked to the correct patient, and review quality and access through audit.
8. Escalate concerns. Open an incident for image mix-up, missing image, missed cancer concern, delayed referral, data breach or failure to act on change.

Records and register links

The lesion record should include:

• patient identity, lesion number, body-map site, side, size and date
• image set captured, image quality and where the images are stored
• consent for clinical image use, and separate consent for any teaching or publication use
• clinical and dermoscopic features, risk factors and patient concern
• decision, safety-net advice, follow-up date, referral or excision plan
• comparison result at review and action taken
• incident, data-breach record, risk entry or improvement action where relevant

Missed lesion concerns, delayed referrals and image mix-ups are opened on the incident register. Image-storage weaknesses, recurring poor image quality and follow-up failures are tracked through the risk register and improvement-actions register.

11. Training

Clinicians using dermoscopy keep their competence current and are refreshed on a stated cadence. Staff who handle images are trained in consent, identification and data protection. The Service records who is competent and the next refresher date.

12. Audit cadence

The Service checks, on a stated cadence, that:

• dermoscopy is used by competent clinicians and the findings are recorded
• clinical images are taken with recorded consent, correctly identified, and stored securely
• monitored lesions have baseline and review images that are compared and acted on
• image losses are reported as possible data breaches

The Registered Manager and the clinical lead review the results and record the improvement actions that follow.

13. Sources and further reading

This template is based on CQC's guidance for providers and managers, the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, and other topic-specific legislation and guidance listed below. It is a starting point for adaptation, not a substitute for legal, clinical, HR, safeguarding or specialist professional advice.

• CQC Regulation 17: Good governance
• CQC Regulation 12: Safe care and treatment
• British Association of Dermatologists / Primary Care Dermatology Society guidance on dermoscopy and clinical photography
• Clinical image and data protection guidance: UK GDPR; Data Protection Act 2018; ICO guidance on special-category personal data
• NICE NG14, Melanoma: assessment and management
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (https://www.legislation.gov.uk/uksi/2014/2936/regulation/17)

Related reading

• Related policy: Skin cancer recognition and urgent referral policy
• Related policy: Teledermatology and remote consultation policy
• Related policy: Record Keeping and Documentation Standards Policy
• Related policy: Personal Data Breach Notification Policy

14. When to seek further advice

Seek specialist advice where the issue involves serious harm, safeguarding, deprivation of liberty, restraint, children, professional misconduct, controlled drugs, radiation, termination of pregnancy, infection outbreak, water safety, employment dismissal, DBS barring referral, or regulatory enforcement.

15. Document control

This sample policy template was issued by Verivius. It is a template, not a substitute for legal advice or the tenant's own policy-development process. Where this template and live law or regulator guidance diverge, the live source wins.