Impartiality and Confidentiality Policy SOP template (ISO 15189:2022)

An impartiality and confidentiality policy states how the laboratory protects professional judgement and safeguards information obtained through its work. It should address both inappropriate influence over laboratory decisions and inappropriate access to patient or service information. The scope needs to include employees, temporary staff, contractors and others whose activities could affect laboratory decisions or information handling.

A good version makes the commitments understandable through relevant examples: pressure to alter results, commercial interests affecting choices, personal relationships influencing decisions and disclosure through informal conversations or digital channels. It assigns responsibility for declaring interests, evaluating threats and deciding appropriate safeguards. Confidentiality arrangements should distinguish authorised access and disclosure from exceptional situations governed by applicable law or other legitimate obligations.

The policy should connect these commitments to practical procedures for induction, access permissions, incident reporting and periodic review. Explain where staff can raise concerns, including concerns involving their own manager, and how management reviews whether safeguards remain effective. Avoid promising absolute secrecy when lawful disclosure may be necessary. A concise policy supported by clear reporting routes and documented follow-up is more useful than broad assurances that staff cannot translate into daily behaviour.