Minor skin surgery and specimen handling policy (dermatology)

1. What the regulation says

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))

ensuring that persons providing care or treatment to service users have the qualifications, competence, skills and experience to do so safely, (Reg 12(2)(c) (staff competence))

where responsibility for the care and treatment of service users is shared with, or transferred to, other persons, working with such other persons, service users and other appropriate persons to ensure that timely care planning takes place to ensure the health, safety and welfare of the service users. (Reg 12(2)(i) (shared / transferred responsibility))

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

2. Plain-English summary

Care and treatment must be provided in a safe way. The regulation lists the areas a provider must address, including risk assessment, risk mitigation, staff competence, safe premises, safe equipment, sufficient equipment and medicines, medicines safety, infection prevention and shared-care planning. Regulation 12 is central to CQC's safety expectations.

3. Purpose

A dermatology service removes and biopsies skin lesions. Two things must not go wrong: the right lesion must be removed from the right patient, and the specimen must reach the laboratory, be matched to the patient, and the result acted on. A lesion excised but never sent, or a malignant result never seen, is a serious harm. This policy sets out how the Service carries out minor skin surgery safely and handles specimens and results so none is lost.

The Service must verify this policy against current British Association of Dermatologists and Royal College of Pathologists guidance before adoption.

4. Sources to verify before adoption

• British Association of Dermatologists, surgical and skin-cancer guidance: https://www.bad.org.uk/
• Royal College of Pathologists, guidance on specimen handling and request information: https://www.rcpath.org/
• National Safety Standards for Invasive Procedures (NatSSIPs): https://www.england.nhs.uk/patient-safety/natssips/
• 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:

• minor skin surgery, including excisions, biopsies and curettage
• the handling of every specimen and the acting on every result
• the clinicians who operate and the staff who label, send and track specimens and results

6. Roles and responsibilities

• Registered Manager: makes sure the local invasive-procedure pathway is approved, resourced, audited and corrected when a control fails.
• Clinical lead: defines which procedures each clinician may perform, approves the local safety checks and reviews unexpected or malignant results and clinical incidents.
• Operating clinician: confirms the patient, lesion and site, obtains consent, performs the procedure within competence and remains responsible for reviewing and acting on the result unless a documented handover is accepted.
• Procedure assistant: supports the safety check, labels the specimen at the patient's side and challenges any mismatch before the specimen leaves the room.
• Results coordinator or named administrator: maintains the specimen log, checks for overdue results and escalates them to the responsible clinician. This role does not interpret results.
• All staff: stop the pathway if identifiers, site, specimen pot or request details do not agree.

7. Right patient, right lesion, right site

• the patient's identity is confirmed against the record using at least three identifiers
• the lesion to be removed is identified and marked before surgery, with the patient confirming it, so the correct lesion at the correct site is removed
• where a patient has several lesions, each is documented and, where more than one is treated, kept clearly separate through to the laboratory

8. Consent and the procedure

• informed consent is taken, covering the procedure, the likely scar, the risk of incomplete removal, infection and bleeding, and that the lesion will be sent for analysis
• the procedure uses an aseptic technique and the infection-prevention arrangements appropriate to minor surgery
• the procedure performed, the site, the local anaesthetic used and any complication are recorded

9. Specimen handling

Every specimen is handled so it reaches the laboratory correctly matched to the patient:

• the specimen pot is labelled with the patient's identifiers and the exact site at the time of removal, at the patient's side, before the next case
• where more than one lesion is removed, each goes in its own correctly labelled pot, with no risk of mix-up
• the request form gives the clinical details the pathologist needs, including the clinical suspicion
• the specimen is stored and transported as required and a record is kept of what was sent and when

A lesion that may be cancer is never simply discarded; it is sent for histology, or referred for the patient to be diagnosed by a service that will.

10. Acting on results: the fail-safe

The single most important step after surgery is that the result is seen and acted on:

• every specimen sent is logged and tracked until its result is back
• results are reviewed by a clinician, acted on, communicated to the patient, and recorded
• a result that does not arrive within the expected time is chased; the system does not rely on the result simply turning up
• a malignant or unexpected result triggers prompt action: further treatment, urgent referral, and clear communication with the patient

11. Required procedure and specimen record

The record includes:

• the patient's three identifiers and the identity of the staff who completed the check
• the lesion description, exact anatomical site and site-mark confirmation
• the procedure, consent discussion, local anaesthetic, operator and assistant
• the specimen-pot identifier, specimen type, anatomical site and time placed in the container
• the laboratory, request date, transport or collection details and expected result date
• the named clinician responsible for the result and any accepted handover
• the date the result arrived, the clinician's interpretation, action and urgency
• how and when the patient was told, including unsuccessful contact attempts and safety-netting
• follow-up, referral or further treatment arranged and evidence it was completed

The specimen log and clinical record must reconcile. A blank field, conflicting site or missing responsible clinician is corrected before the specimen leaves the service wherever possible.

12. Wound care and follow-up

The patient is given clear aftercare advice, including wound care, the signs of infection, when stitches come out, and how to get help. The follow-up needed to give the result and any further treatment is arranged and recorded.

13. When something goes wrong

A wrong-lesion excision, a labelling mismatch, a lost specimen, or a missed or delayed result is treated as a patient-safety incident and logged in the incident register on the day it is identified. The Service investigates the event, considers the duty of candour threshold and changes the system to prevent a repeat.

Repeated delays, an unresolved laboratory-interface risk or a backlog that could affect patients is also entered in the risk register. Every investigation or audit action has an owner, due date and closure evidence in the improvement action plan. Closing the incident does not close the action automatically.

14. Training

Clinicians performing minor skin surgery are trained and competent for the procedures they do, and staff who handle specimens and results are trained in labelling, tracking and the fail-safe. The Service records who is competent and the next refresher date.

15. Audit cadence

The clinical lead checks the outstanding-specimen log every working week. Each month, they audit 10 completed procedures or all procedures if fewer than 10 occurred, and confirm that:

• the correct patient and lesion were confirmed and the site marked before surgery
• every specimen was labelled at the patient's side and matched to the patient through to the laboratory
• every result was tracked, seen, acted on and communicated, with none outstanding unnoticed
• wrong-lesion, lost-specimen or missed-result events were investigated and learned from

The Registered Manager and the clinical lead review the results each month and record the improvement actions that follow. Any unaccounted-for specimen, unreviewed result or overdue urgent action is escalated on the day it is found rather than waiting for the meeting.

16. Related policies in this pack

• Consent policy
• Infection prevention and control policy
• Record keeping and documentation standards policy
• Incident reporting, investigation and learning policy
• Risk management and risk register policy

17. 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 12: Safe care and treatment
• NICE / specialist guidance
• histopathology fail-safe guidance
• infection control guidance
• British Association of Dermatologists, surgical and skin-cancer guidance
• Royal College of Pathologists, guidance on specimen handling and request information
• National Safety Standards for Invasive Procedures (NatSSIPs)
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (https://www.legislation.gov.uk/uksi/2014/2936/regulation/12)

18. 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.

19. Document control

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