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Templates, ORPHF

ORPHF sentinel and serious untoward event procedure template

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

Updated . Mapped to ORPHF's published framework1.

SOP-SUE-01SOP

Templatev1.0, ORPHF edition

[Clinic name]

Controlled document

[Address]
[Registration or licence number]

Document
Sentinel and serious untoward event procedure
Reference
SOP-SUE-01
Version
1.0
Owner
[Name, role]
Approved by
[Clinical lead]
Effective from
[Date]
Next review
[Date]
Regulator
Office for Regulation of Private Healthcare Facilities, Department of Health, Hong Kong

Sentinel and serious untoward event procedure

1Purpose

  1. 1.1This procedure sets out how [Clinic name] recognises, reports and reviews sentinel and serious untoward events.

2Reporting

  1. 2.1The person who sees the event makes the patient safe first, then tells the Chief Medical Executive at once.
  2. 2.2Report a sentinel or serious untoward event to the Director of Health within 24 hours.
  3. 2.3The report records what happened, when, who was involved and what was done at once.

3Review

  1. 3.1The Chief Medical Executive leads a review of each event, using the record and the access log, with times and names.
  2. 3.2The review names the causes, the actions, an owner and a date for each action, and is kept on file.

4Learning

  1. 4.1What changed is shared with every member of staff, and checked [3] months later to confirm it held.
  2. 4.2Drug formulary, sterilising, equipment and fire drill records are reviewed at the same time where the event touches them.

5Review

  1. 5.1The Chief Medical Executive reviews this document every [12] months, and sooner after an incident, a complaint or a change in the regulator's requirements.
  2. 5.2Each review is recorded with the date, the reviewer and what changed, and the previous version is kept.
  3. 5.3Staff are told of each change, and their acknowledgement is recorded.

6Where this sits in the ORPHF framework

  • Records, incidents and dataSentinel and serious untoward events reported to the Director of Health within 24 hours
  • The Code of Practice for ClinicsRisk management and contingency

AAppendix, Medical record audit, per record

  1. A.1Unique identifier ______ Name, sex, date of birth ______
  2. A.2Address and phone ______ Drug allergies ______
  3. A.3Consultation notes ______ Investigations ______
  4. A.4Treatment ______ Sick leave or referral ______

Awaiting sign-off

[Name]

[Role], [registration number]

Signed [date], [time]

Questions

Has ORPHF approved this sentinel and serious untoward event procedure?

No. ORPHF does not approve templates or software. This template is built from ORPHF'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. 1Office for Regulation of Private Healthcare Facilities, 2026Regulation of private healthcare facilitiesRead source

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