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Templates, HIS

HIS adverse event reporting and learning procedure template

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

Updated . Mapped to HIS's published framework1.

SOP-INC-01SOP

Templatev1.0, HIS edition

[Clinic name]

Controlled document

[Address]
[Registration or licence number]

Document
Adverse event reporting and learning procedure
Reference
SOP-INC-01
Version
1.0
Owner
[Name, role]
Approved by
[Clinical lead]
Effective from
[Date]
Next review
[Date]
Regulator
Healthcare Improvement Scotland

Adverse event reporting 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. 3.1The person who sees the incident reports it to [Name, role] the same day, and makes the patient safe first.
  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 HIS framework

  • ResultsLessons learned and plans to apply
  • Implementation and deliveryRisk management and business continuity

AAppendix, Improvement action plan, one row per item

  1. A.1Requirement or recommendation, number and wording ______
  2. A.2Regulation or standard cited ______
  3. A.3HIS timescale ______
  4. A.4What we will change ______
  5. A.5Owner ______ Due ______
  6. A.6Evidence it is done, and where it is kept ______
  7. A.7Reviewed at governance on ______

Awaiting sign-off

[Name]

[Role], [registration number]

Signed [date], [time]

Questions

Has HIS approved this adverse event reporting and learning procedure?

No. HIS does not approve templates or software. This template is built from HIS'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. 1Healthcare Improvement Scotland, 2022Quality Assurance Framework, September 2022Read source

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