Checklist Phase 3 - Information Management

Does the laboratory have an archive for laboratory records that is constructed in a logical way allowing for quick and easy access to information?

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Is the laboratory archive lockable?

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Does the laboratory archive protect records from deteriorating influences such as fire, humidity, insects, sunlight, etc.?

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Is access to the laboratory archive controlled?

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Is the computerized system properly protected by a firewall?

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Is the computerized system scanned for viruses on a weekly basis by a proper, up to date virus scanner?

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Are specific staff members authorized to either I) access digital laboratory information, or II) access and enter digital laboratory information, or III) access, enter and change digital laboratory information, and is the Authorization Matrix adapted to indicate who is authorized to perform these activities?

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Are the Personal Job Descriptions adapted of the staff members who are authorized to access and who are authorized to access and change laboratory information?

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Is a documented contingency plan present in the laboratory that should be followed in case of downtime of the computerized information system, to ensure access to laboratory information at all times?

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Has the laboratory standardized the procedures for information management in an SOP?

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Does the SOP on management of laboratory information include at least 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
    • 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
  • 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

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