Ensure that confidentiality of patient information is maintained by all personnel


Patient data are privacy sensitive data and must be protected from unauthorized access and must remain confidential. To that end, all laboratory staff members must promise to keep patient data confidential in word and in writing.


Each staff member must sign a confidentiality agreement which needs to be stored in his/her personnel file. In a confidentiality agreement requirements are formulated that are aimed at protecting patient data and keeping it confidential. By signing the agreement the staff members promise to comply with these requirements.

In the right-hand column an example confidentiality agreement is provided.

How & who

Laboratory Manager:

  1. Make a Confidentiality Agreement Form. You can use the example provided in the right-hand column but add requirements specific to your laboratory when you deem this necessary. If needed request assistance from a lawyer to be sure that the form is of good quality.
  2. Once the confidentiality agreement is finalized ask all staff members to sign it.
  3. When new staff is hired ask them to sign the agreement at the same time that they sign their contract (or even better: make it part of their contract).

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This activity belongs to the QSE Information Management
ISO15189:2007: 4.1.5 C6.1
ISO15189:2012: 5.10.1