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Templates, HAS

HAS eigs declaration and learning procedure template

A eigs declaration and learning procedure for clinics regulated by HAS, written as steps a team can follow and mapped to HAS's own standards. Read it in full below, and take the editable version by email.

Updated . Mapped to HAS's published framework1.

SOP-EIGS-01SOP

Templatev1.0, HAS edition

[Clinic name]

Controlled document

[Address]
[Registration or licence number]

Document
EIGS declaration and learning procedure
Reference
SOP-EIGS-01
Version
1.0
Owner
[Name, role]
Approved by
[Clinical lead]
Effective from
[Date]
Next review
[Date]
Regulator
Haute Autorité de santé

EIGS declaration and learning procedure

1Purpose

  1. 1.1This procedure sets out how [Clinic name] reports, investigates and learns from incidents and near misses, so that each one leads to a change that sticks.
  2. 1.2Staff report without fear of blame, and the clinic looks for causes in its systems before it looks at individuals.

2What to report

  1. 2.1Any event that harmed or could have harmed a patient, a visitor or a member of staff, including near misses.
  2. 2.2Medication errors, missed or delayed results, records shared in error, and any breach of patient data.

3Reporting

  1. 3.1Volet 1 of an EIGS declaration goes to the ARS sans délai, and volet 2 within three months, on the national portal.
  2. 3.2The report records what happened, when, where, who was involved, and what was done at once.
  3. 3.3Where a patient was harmed, the patient is told, given an apology and kept informed of what the clinic finds.

4Investigation

  1. 4.1[Name, role] grades each incident by severity within [2] working days, and decides the level of review.
  2. 4.2The review uses the record and the audit trail to establish what happened, in order, with times and names.
  3. 4.3The review names the causes, the actions, an owner and a date for each action.

5Learning

  1. 5.1Each incident and its actions are discussed at the next governance meeting, and the discussion is minuted.
  2. 5.2What changed is shared with every member of staff, and checked [3] months later to confirm it held.

6Review

  1. 6.1[Name, role] reviews this document every [12] months, and sooner after an incident, a complaint or a change in the regulator's requirements.
  2. 6.2Each review is recorded with the date, the reviewer and what changed, and the previous version is kept.
  3. 6.3Staff are told of each change, and their acknowledgement is recorded.

7Where this sits in the HAS framework

  • EIGS and inspectionArticles L.1413-14 and R.1413-68 of the Code de la santé publique
    Volet 1 sans délai, volet 2 within three months, on the national portal
    Critère impératif 3.1-04 in the référentiel 2025

AAppendix, EIGS record

  1. A.1Date and time of the event ______ Service ______
  2. A.2Consequence ______ Unexpected, yes or no ______
  3. A.3Volet 1 sent on ______ Portal reference ______
  4. A.4Patient informed on ______ By ______
  5. A.5Analysis led by ______ Contributing factors ______
  6. A.6Volet 2 sent on ______ Actions and owners ______

Awaiting sign-off

[Name]

[Role], [registration number]

Signed [date], [time]

Questions

Has HAS approved this eigs declaration and learning procedure?

No. HAS does not approve templates or software. This template is built from HAS's own published standards and our guides, and your clinic adapts it, signs it off and owns it.

Can we use it as it is?

Use it as a starting point. Replace every part in square brackets with your clinic's own details, check it against your services, and have your clinical lead sign it off before it is used.

How do we get the editable version?

Enter your work email on this page and we send the editable document. The full template is on this page to read before you ask.

In wai, the records this procedure depends on are versioned and signed, from notes and letters to consent forms and the audit trail.

See the signed record behind this procedure on your own clinic, in a 15 minute video call.

Sources

  1. 1Haute Autorité de santé, 2025Référentiel, Certification des établissements de santé pour la qualité des soins, version 2025Read source

This is a template, not legal advice. HAS does not approve templates or software, wai included.