Checklist Phase 2 - Customer Focus

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Does the laboratory have a service manual that includes the following: [tick-off]

  • Description of which tests are available at the laboratory, including information on which the clinical situations require this test to be performed.
  • What sample is needed for each test, the volume/amount needed and, if applicable, special timing of collection.
  • How this sample must be collected, including:
    • Identification of the patient and verification that the patient meets the pre-examination requirements (e.g. for some examinations the patient must be sober; the sample collector must verify that the patient is indeed sober).
    • How to prepare the patient.
    • How to label the patient.
    • The type of container in which the sample must be collected.
  • How and under which conditions it must be packed and sent to the laboratory, including:
    • Time frame within which the sample must be sent to the laboratory.
    • Temperature interval in which it must be transported.
    • The method of packing the sample container to prevent leaks.
  • If applicable, requirements regarding patient consent.
  • The procedure for requesting routine laboratory testing, including how to complete the Request Form.
  • The procedure for requesting urgent laboratory testing.
  • The normal turnaround time for each test.
  • The biological reference intervals and, if applicable, the critical/alert values for specific tests.
  • A list of factors known to affect the performance of the examination or the interpretation of results of each examination.
  • The routine method of reporting.
  • A guideline to interpreting the Result Report.
  • The procedure for reporting urgent testing results.
  • Requesting additional testing, including the time-frame in which this is possible.
  • The laboratory’s policy on protection of patient information.
  • The laboratory’s complaint procedure (this will not yet be included in phase 2 as this will be developed in phase 4).

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Has the Laboratory Service Manual been sent to all the clients of the laboratory?

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When changes are made to the service manual, is the new version directly printed and sent to the clients of the laboratory, with the note that they have to destroy the previous version?

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Are correct biological reference intervals/decision values and alert/critical interval values included for all the examinations performed by the laboratory in the Laboratory Service Manual?

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If the biological reference interval/diagnostic decision value and/or alert/critical interval values turn out to be incorrect after changing the methodology of an examination, is this value directly adapted in both the Laboratory Service Manual and the Laboratory Result Report format and is the new version of the Laboratory Service Manual sent directly to the clients of the laboratory?

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Does the laboratory have a database/register with regular customers?

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Are correct biological reference intervals/decision values and alert/critical interval values included for all the examinations performed by the laboratory in the Laboratory Result Reports?

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Is the correctness of the biological reference intervals/diagnostic decision values and alert/critical interval values regularly verified for all the examinations performed by the laboratory?

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If the methodology of an examination is changed, does the laboratory verify if the biological reference interval/diagnostic decision value and alert/critical interval value is still correct for that examination?

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