Title

Establish an archive ensuring protection of laboratory information but also enables quick retrieval of information

Why

Up to now many folders for specific types of records have been created. It is important that access to the information contained in these records is controlled and that the records are stored safely, protected from deteriorating influences.

What

Establish the laboratory archive. The most important requirements the laboratory archive should comply with:

  • Access to the archive is controlled; staff members should be authorized to either:
    • Access the archive
    • Access the archive and add records to the archive
    • Access the archive, add records and change records already present in the archive
    • Clinical staff (requesters of tests) are also allowed to have access to certain medical records stored in the laboratory archive.

  • Logically following the previous point: the archive must be lockable
  • The information stored in the archive must be easily retrievable: a logical system should be implemented for the way records are stored so that they can be found quickly and easily
  • The records stored in the archive must be protected from deteriorating influences such as humidity, sunlight, insects, fire, etc.


Note that countries may also have additional national regulations with which the archive should comply.

How & who

Laboratory Manager:

  1. Draft a SMART action plan for upgrading/establishing the laboratory archive and make it comply with the above requirements.
  2. Start monitoring timely implementation of the action plan. Do this by adding the action points to the minutes of the weekly staff meeting. This way you can go through the action points every staff meeting and ask for the status of implementation. As the laboratory manager also attends these meetings the staff members that have not yet implemented action points after the deadlines can be forced to implement the action points as soon as possible by the laboratory manager.
  3. Adapt the Authorization Matrix to regulate access to the laboratory archive and who may enter, and who may enter and change records. Also include the position of test requester and define the authorizations for this position (mostly requesters may only consult medical records, not enter and change information in the archive).

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This activity belongs to the QSE Information Management

 

ISO15189:2007: 4.13.1 4.13.2 5.2.9 5.8.6 C7.1 C7.2 C8.1
ISO15189:2012: 4.1.1.3 4.13 5.2.2 5.2.3 5.10.2 5.10.3
ISO15190:2003: