Title

Write an SOP on Information Management

Why

In phase 2 and 3 measures to improve laboratory information management have been implemented, such as upgrading of the laboratory archive, ensuring backup and protection of the computerized laboratory information system, and ensuring accessibility of laboratory information at all times. The last step is standardization of all the laboratory information management procedures in an SOP.

What

Develop an SOP for Laboratory Information Management. This SOP must cover the following procedures:

  • Management and maintenance of the computerized laboratory information system, including procedures regarding:
    • Regular backup, regular virus scanning and the contingency plan protocols developed earlier in phase 3
    • Accessing laboratory information in the computerized system
    • Entering laboratory information
    • Changing laboratory information stored in the computerized system
    • Defining authorizations for accessing, accessing and entering laboratory information, and accessing, entering and changing laboratory information in the computerized system
  • Protocol for ensuring confidentiality of patient data (developed in phase 2)
  • Management and maintenance of the laboratory archive, including procedures regarding:
    • Accessing information
    • Storing information
    • Changing information in the archive
    • Ensuring protection of records from external deteriorating factors such as humidity, fire, insects, sunlight, etc.
    • Defining authorizations for accessing, accessing and storing laboratory information, and accessing, storing and changing laboratory information in the archive

      • See for all above points regarding the laboratory archive the activity in which all these measures were implemented earlier in phase 3.

How & who

Laboratory Manager:

  1. Assign a staff member to write the first draft of this SOP according to the protocol for writing a Procedure SOP in the Master SOP and using the template for a Procedure SOP attached to the Master SOP. To get the best result: choose a staff member that is closely involved in most information management procedures and is authorized to carry out most of these procedures (if a data manager is appointed in your laboratory this person is the most logical choice). The same applies to choosing the reviewers of the SOP: these should also be staff members closely involved in most information management procedures.
  2. Review and authorize the SOP in accordance with the procedures of the SOP for Document Control.
  3. When the SOP is finalized, define the staff members who must familiarize themselves with the SOP and indicate in the Read and Understand List that they must read this SOP. These are staff members that are in any way involved in information management procedures standardized in the SOP.
  4. Determine where copies of the SOP are stored and indicate these locations on the first page of the SOP according to the procedure described in the Master SOP.
  5. Present the SOP in a weekly staff meeting, explain why it was written, explain the contents and who must read the SOP. Explain where staff members can find copies of the SOP.
Back to Roadmap Activity Overview
This activity belongs to the QSE Information Management

 

ISO15189:2007: 4.1.5 4.13.1 4.13.2 5.2.9 B.4.1 B.4.2 B.4.3 B.6.4 B.6.5 B.8.5 C.6.1 C.7.1 C.7.2 C.8.1
ISO15189:2012: 4.1.1.3 4.13 5.2.2 5.2.3 5.10.1 5.10.2 5.10.3
ISO15190:2003:

LQSI tool version: 1.0

LQSI tool version: 1.0