Title

Make a fixed format for the Result Reports

Why

The laboratory is responsible for ensuring that the requester receives all the results completely and that the results are clear and interpretable, supplied with biological reference intervals/decision values and all the details of the patient, the laboratory and the requester.

What

Make a fixed format for the Result Report. First decide on the medium for reporting of results: electronically or on paper. The format of the report needs to be developed in discussion with the clients of the laboratory, as they are the ones that need to retrieve all the information from the reports.


Reserve room for at least the following data in the report:

  • 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
  • Interpretation of results if appropriate
  • A box that can be checked when immediate notification is required
  • Details of the laboratory staff member reviewing the results and authorizing the report for release
  • Date and time of release of the report


Especially for TB laboratories the WHO has developed the “Definitions and Reporting Framework for tuberculosis”. This manual contains templates of various forms needed by TB laboratories. One of these template is a “Request for examination of a biological specimen for TB” on which the results are also recorded (a request and report form at the same time). Find this template in section B3.1 of this manual.


The International Union against Tuberculosis and Lung Disease also has published a guideline for bacteriology services in tuberculosis control. This guideline also contains templates for Result Reports especially for TB laboratories.

How & who

Laboratory Manager:

  1. Develop the first draft of the Result Report Template or adapt the template from the WHO Definitions and Reporting Framework for tuberculosis. Include the above listed elements and any other elements deemed necessary.
  2. Discuss the template with several clients that regularly request various types of laboratory tests to see if any changes need to be made to make it more convenient for the clients to retrieve data from the report and interpret results.
  3. Process these changes into a final template.
  4. Present the template to the laboratory staff in a weekly staff meeting.
  5. Provide the report to the Quality Officer for inclusion in the document control system.


Quality Officer:

  1. Print multiple copies of the form and place them at a location you've indicated to the staff members.
  2. Store the final template of the Result Report temporarily at a secure location. Later in phase 2 the SOP for Recording, Reporting and Archiving of Results will be developed. The new format of the Result Report will be put into use when the SOP is finalized.

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This activity belongs to the QSE Information Management

 

ISO15189:2007: 5.8.1 5.8.3 5.8.5
ISO15189:2012: 5.8.1 5.8.2 5.8.3
ISO15190:2003: