Procedural rules for issuing the ÖQUASTA quality mark

  1. List of quality regulations
    The requirement for issuing the ÖQUASTA quality mark for successful participation in external quality assurance (external quality assessments) of medical and diagnostic laboratory tests, organized by ÖQUASTA, complies with the analytical possibilities for the procedures employed in the Medical Laboratory and with medical requirements.
    Survey Management for the various surveys sets the permitted acceptance levels for individual analytes in consultation with the ÖQUASTA Executive Board.
    ÖQUASTA informs the survey participants of the permitted acceptance levels.
  2. Issuing procedure
    1. Authorization
      Authorization to participate in external quality assessments is at the discretion of the specialist laboratories following due registration and payment of fees for the provided test materials and test analysis.
    2. Decision on issuance
      Following approval of the completed analysis of ÖQUASTA external quality assessments by Survey Management using the appropriately permitted acceptance ranges and based on calculation of the overall survey performance in a calendar year in the form of a numerical total score, ÖQUASTA awards the quality mark for the relevant survey. This quality mark is issued retrospectively for one calendar year per survey program and is valid for the following year.
      1. Exclusion criteria:
        The quality mark is generally not awarded:
        • in case of deregistering during or at the end of the calendar year;
        • if the frequency is not fully observed each year (results must be sent in for all surveys in the program);
        • if the same analyte is outside the acceptance limits for all surveys in a calendar year, even if the total score for this survey program falls below the calculated limit.
      2. Assessment of surveys with numerical results
        1. Acceptance limits (constant % deviation)
          Clinical chemistry, POCT/blood glucose, HbA1, urine chemistry quantitative, TDM (Therapeutic Drug Monitoring), tumour markers, cardiac markers, hormones, serum proteins, blood gases, haematology, reticulocytes/automated differentiation, coagulation, POCT/INR, heparin monitoring, coagulation factors

          Calculation of score
          The total percentage deviations of all results (without consideration for the plus or minus sign) from the consensus value of a survey program is divided by the number of values sent in.
          Scores are ranked and this quality mark is issued retrospectively for one calendar year to the top 30% of verified laboratories per survey program.
        2. Acceptance interval (manual)
          Flow cytometry, CD 34, residual leukocytes, hepatitis A quantitative

          Calculation of score
          Total deviations (without consideration for the plus or minus sign) from results outside the acceptance range is divided by the number of values sent in.
          The quality mark is awarded to all laboratories, which do not exceed the calculated minimum score.
        3. Assessment of surveys with nominal results

          Calculation of score
          Correct result = 1, incorrect result = 0. Total of scores per laboratory and calendar year is divided by the number of results.
          The quality mark is awarded to all laboratories, which do not fall below the calculated maximum score.
          1. All results in the calendar year must be correct for the following survey programmes
            Blood group serology, toxoplasmosis antibodies, rubella antibodies, hepatitis A, hepatitis B, hepatitis C, hepatitis C-PCR
          2. The score is calculated for the survey programmes set out below;
            the quality mark is awarded to all laboratories, which do not fall below the calculated maximal score:
            Stool parasites, auto-immunology, APC resistance, haematological diagnostics
            (Erythrocytes, leukocytes, thrombocytes morphology; diagnosis)
  3. Notification of participants
    Participants in the ÖQUASTA external quality assessments receive the quality mark for the survey program in which they take part within a calendar year if the annual score of survey results complies with the specified criteria and no obstacles exist, as set out in section 2.2.1. The quality mark displays the calendar year of successful participation in the survey and is valid for the following year.
  4. Publication of issued licences
    Publication of the quality marks awarded to specific laboratories by ÖQUASTA is not possible in view of the absolute protection of the anonymity of participants.
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