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PS-025 Quality metrics for hygiene monitoring
  1. D Hvid1,
  2. K Johnsen2
  1. 1Capital Region Pharmacy, Quality, QA, Herlev, Denmark
  2. 2Capital Region Pharmacy, Quality, Microbiology, Herlev, Denmark


Background Aseptic production is performed by approximately 100 operators. According to the Quality Management System, sampling is performed daily on all operators, both hands. The acceptance criteria established is, that on the total of two gloves; one viable microorganism is accepted.

Over some years, numerous out of specification results were observed. As the amount of data is very large (two samples from each of approx. 100 operators, every day), and as the data is structured inefficiently, it is very difficult to evaluate whether there are trends in the data and also difficult to keep the individual operator informed about her own results.

Purpose To develop an easily accessible quality indicator that can generate an overview of the hygiene data and help the operator to recognise his/her own performance so as to improve working procedures and thereby reduce the number of out of specification results.

Material and methods For three selected departments, the 2014 data were evaluated and suitable quality metrics developed. Applying these quality metrics, data were presented graphically, in order for the individual operator to be informed and aware of the results from her own glove fingerprints. Employees from Quality Assurance and Microbiology inspected the aseptic working routines, made observations and gave feedback. Once a month data are updated and the operators informed of their own results.

Results Before, results could not be measured and individual persons were unaware of their own results, After the quality metric was developed, each employee is currently informed in a manageable form, and the number of out of specifications on bacterial contaminations of gloves fingerprints has reduced.

Conclusion Using a quality metric that allows graphical presentation of data on a personal level, it was possible to make the individual employee aware of personal hygiene data and thereby to reduce the number of out of specifications to the benefit of the aseptic procedure and thereby to the safety of the patient.

References and/or acknowledgements No conflict of interest.

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