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Templates, HPCSA and OHSC

HPCSA and OHSC adverse event and complaints procedure template

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

Updated . Mapped to HPCSA and OHSC's published framework1.

SOP-INC-01SOP

Templatev1.0, HPCSA and OHSC edition

[Clinic name]

Controlled document

[Address]
[Registration or licence number]

Document
Adverse event and complaints procedure
Reference
SOP-INC-01
Version
1.0
Owner
[Name, role]
Approved by
[Clinical lead]
Effective from
[Date]
Next review
[Date]
Regulator
Health Professions Council of South Africa and Office of Health Standards Compliance

Adverse event and complaints 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 HPCSA and OHSC framework

  • Adverse events and waiting timesRegulation 21(1), a system to monitor and report all adverse events
    Regulation 21(2)(a), a register for all adverse events
    Regulation 21(2)(b), reporting to a structure or responsible authority
  • User rightsRegulation 4(2)(a)(iv), a complaints, compliments and suggestions system

AAppendix, Complaints and adverse events register

  1. A.1Reference ______ Date ______ Complaint or adverse event ______
  2. A.2Complainant or patient ______ Summary ______
  3. A.3Investigated by ______ Finding ______
  4. A.4Outcome sent to complainant on ______ By letter, email or report ______
  5. A.5Reported to ______ On ______
  6. A.6Change made ______ Owner ______ Date ______

Awaiting sign-off

[Name]

[Role], [registration number]

Signed [date], [time]

Questions

Has HPCSA and OHSC approved this adverse event and complaints procedure?

No. HPCSA and OHSC does not approve templates or software. This template is built from HPCSA and OHSC'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.