Title

Develop sample acceptation/rejection criteria

Why

Samples need to be of good quality in order for the laboratory to be able to ensure quality results. The results of the laboratory will be flawed if bad quality samples are accepted, even though the rest of the testing process is completely quality controlled and quality assured. Having a well-functioning sample reception unit that checks the quality of each sample and rejects those that are of inadequate quality is thus the first step in ensuring that the testing process runs correctly and produces a quality result.

What

The first step in establishing a well-functioning sample reception unit is the formulation of sample acceptance criteria. The sample reception unit must check each sample on compliance with these criteria. If the sample doesn't completely comply with the criteria it must be rejected and a request for a new sample must be sent to the client.


In formulating the criteria, think of elements such as:

  • Correct packaging of the sample
  • Package is free from leakages
  • Sample was transported under the proper conditions
  • Sample was transported within the time frame necessary
  • Checking if sample material is of good quality (e.g. blood is not clotted, sample is sputum not saliva, etc.).
  • Sample is of adequate volume
  • Completeness of the Request Form
  • Concordance of the Request Form details with the sample details

How & who

Quality Project Team:

  1. Brainstorm in a Quality Project Team meeting to formulate the criteria for sample acceptance. Do this for all types of samples used in the laboratory. Involve technologists in this brainstorm as they know best which criteria a good sample must comply with.
  2. Formulate these criteria per sample type and test. Be clear, be specific and leave no room for multiple interpretation. The criteria will later be included in the SOP for Sample Reception and Processing and the Laboratory Service Manual (and referred to in the SOP for Sample Collection in the next activity).

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This activity belongs to the QSE Process Management

 

ISO15189:2007: 5.4.6 5.4.8 5.4.9
ISO15189:2012: 5.4.5 5.4.6
ISO15190:2003: