What is meant by impartiality in a laboratory?

Posted by Cathy Wylie on

There are new requirements in ISO/IEC 17025:2017 related to impartiality. Section 4.1 covers impartiality, including the requirements for laboratory activities to be undertaken impartially;  structured and managed to safeguard impartiality, as well as the requirement to identify risks to impartiality. But what does being impartial mean?

The definition in ISO/IEC 17025:2017 is "presence of objectivity" and is further clarified in a note saying, "Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities of the laboratory."

In the context of laboratory testing, being impartial includes conducting laboratory activities without bias. Lab results cannot be influenced, or have the appearance of being influenced by any relationships the laboratory or the people involved in laboratory activities may have with the client. Laboratory activities also cannot be influenced by any undue pressure being put on the people involved in conducting those laboratory activities.

Risks to impartiality can come from within the laboratory itself. For example, managers putting pressure on technicians to break from testing procedures to get better turn around time, or to overlook adverse results that will upset a client. Undue pressure would also include providing financial incentives for the number of tests conducted, or the results of tests.

There can also be external risks to impartiality. When looking for external risks, there are multiple possibilities that could cause bias, including:

  • business relationships between the laboratory and the client;
  • family or personal relationships between people in the laboratory who will be involved in laboratory activities and the client;
  • financial interests, such as ownership in a client company, or in a venture related to the test results. For example, a laboratory technician has part ownership in a land development. The engineering company is testing the soil for the site prior to getting permits for the development.

Simply having a relationship with a client does not mean there is a risk of impartiality, however, the laboratory is required to identify the potential risks and then demonstrate that the risk has been eliminated or minimized. 

For more information on the requirements of ISO/IEC 17025:2017 and how they affect your laboratory management system, click here to check out CALA's courses on the revised standard.

 


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2 comments

  • Hi again,

    I have a second question related to the new integrity clauses, especially 4.1.4:

    The laboratory shall identify risks to its impartiality on an on-going basis. This shall include those risks that arise from its activities, or from its relationship, or from the relationships of its personnel. However, such relationships do not necessarily present a laboratory with a risk to impartiality.

    Our parent organization’s values and ethics code includes a requirement that employees regularly review their obligations under the code and report any real or apparent conflicts of interest to the Departmental integrity office through a confidential reporting mechanism. We (our lab) don’t have any records that this review is done (and being confidential, we couldn’t access them anyway). Is it enough that this requirement is in our organization’s policies, or will our lab need to do more to demonstrate conformance to this part of the standard (e.g. have our staff annually sign a form acknowledging that they understand their obligations under the values and ethics code and regularly review their conformance to it)?

    Thanks again for your help!
    Jeff

    Jeff Hill on
  • Hi Cathy,

    We’re looking at the new impartiality and confidentiality requirements. It seems that we now have to set up a two-track process, where we manage risks both to the impartiality of employees and of the laboratory organization. Our parent organization has a comprehensive values and ethics code that includes provisions related to integrity and conflicts of interest, as well as reporting obligations regarding actual or potential conflicts of interest (real or perceived). But the code is directed towards employees, not the organization – to meet the new standard, do we need to do more to address our lab as an entity separate from its employees (the two tracks I mentioned)?

    Thanks,
    Jeff

    Jeff Hill on

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