Checklist Information Management

Does the laboratory have a fixed format for the Result Report?

Activity

Does the Result Report include at least the following elements: [tick off]

  • Name of the laboratory
  • Personal details of the patient, including clinical information as received by the laboratory from the requester
  • Details of the requester
  • List of examinations performed
  • Date of the primary sample collection
  • Primary sample type
  • Comments on the quality of the sample (either adequate for the examinations performed or inadequate, which could influence reliability of results)
  • Examination results
  • Biological reference intervals/decision values, including the “alert/critical” intervals for all examinations performed, with interpretive comments on results, if applicable.
  • Details of the laboratory staff member reviewing the results and authorizing the report for release
  • Date and time of release of the report

Activity

Was the format of the Result Report discussed with regular clients of the laboratory during development?

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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 a procedure in place that ensures verification of correct transcription of results on reports?

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Is a procedure in place for authorizing Result Reports for release only if review of results has taken place and correct transcription of correct results and other important information to the report has been confirmed?

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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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Does the laboratory have a procedure to ensure immediate notification of the requester in case results fall within critical intervals?

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Does the laboratory record the occurrences in which results fall within critical intervals and requesters have to be notified directly (for verification purposes)?

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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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Does the laboratory use a method for sending the Result Reports to the requesters with a minimum risk for losing reports?

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Does the laboratory use a method for sending the Result Reports to the requester that ensures that reports are delivered as soon as possible?

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

Activity

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

Activity

Are patient data (such as Request Forms, work forms, registers, copies of Result Reports, revised Result Reports, Immediate Notification Forms, etc.) stored securely, protected from unauthorized access?

Activity

Are patient data (such as Request Forms, work forms, registers, copies of Result Reports, revised Result Reports, Immediate Notification Forms, etc.) stored in a logical way enabling quick and easy retrieval of data?

Activity

Does the laboratory have an SOP for Recording, Reporting and Archiving of Results, describing at least the following procedures:

  • Recording of results
  • Reviewing and authorizing results for release
  • Normal procedure for reporting of results
  • Immediate reporting of results from urgent samples
  • Immediate reporting of results in critical intervals
  • Notification of clinician if turnaround time is exceeded
  • Reporting via telephone or other electronic means
  • Reporting of results of samples of inadequate quality but that were still tested
  • Alteration of reports
  • Archiving of results

Activity

Are the procedures in the SOP for Recording, Reporting and Archiving of Results routinely and correctly implemented in practice?

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Are all staff members that are involved in any way in recording, reporting and archiving of results aware of the contents of the SOP for Recording, Reporting and Archiving of Results?

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Is the laboratory able to trace back the staff members who signed documents based on signatures or initials?

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Have all laboratory staff members signed a confidentiality agreement?

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If the laboratory stores information digitally: are weekly backups being made?

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Are backups of the computerized system stored behind lock and key in another building than the laboratory building where the computerized system is?

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