Cyto-SAT: A self-assessment tool for safe handling of cytotoxic medicines

This assessment tool aims at assisting healthcare facilities with ongoing quality and safety improvement of handling of cytotoxic medicines in resource-contraint settings. The tool is designed to be used in different contexts, however some adaptations or addition of items may be considered by some facilities to evaluate some internal procedures.

The tool covers the different steps of the cytotoxic medicines circuit and includes 134 items.
The quality and safety criteria have been organised in 10 categories and 28 sub categories.

The tool includes criteria specific to cytotoxic process but does not address the general procedures for drug management . Although it is largely self-explanatory, basic knowledge about pharmaceutical process is needed. Some preventive measures may also need to refer to the literature for further information.

Existing national and international recommendations for safe handling of cytotoxic drugs have been consulted by a working group of the University Hospitals of Geneva (Switzerland) to preselect 137 quality and safety standards. Finally 134 standards were validated and prioritized by a consensus of 28 international pharmaceutical experts in oncology practice (through a Delphi method)
Participation of experts from both developed countries and developing countries aimed to make the tool applicable in settings with limited resources while respecting the quality and safety of the process.

We would like to thank all the experts for their volontary participation in the validation of the tool

Different types of documents published in English or French such as recommendations from scientific societies, guidelines and regulations from organ of workers’protection and regulatory framework were reviewd to derive items on quality and safety aspects.

All the references below are available online on a free access.

Before starting the assessment, please read carefully the instructions and go through all the items.

The standard is outlined in the first column and is completed by additional information in the second column

The item priority reflects the experts' opinion on the importance to fulfill the standards, considering the probability of occurrence of the prevented risks, the criticality of the risk, the effectiveness of the measure, how easy it is to implement, etc. the priority was classified as follow:

Prioritization was added in order to guide you in the elaboration of an action plan to improve the cytotoxic medicines flow and management.

*A differentiation is made if a consensus had been obtained or not among the experts at the end of the Delphi survey. The capital letter indicated that an experts’consensus had been reached while the lowercase letter indicated no consensus. Consensus was defined as more than 75% of the experts agreeing with the prioritiy.

It is recommended to establish an interdisciplinary team to complete the self-assessment.

Please evaluate each item according to the scoring system below. As necessary, investigate and verify the level of implementation with other healthcare practitioners and staff.

** 3 and 4 scores can be used only if there is a real implementation. Procedures or guidelines that are not applied are nor not enough.

The last column allows to write some comments in order to justify the score or point out some ambiguity.

At the end of the self-assessment, design an action plan by elaborating short/middle and long term objectives based on your observations and the summary of your results in order to improve your practices.

N.B: The approximate time to complete the self-assessment is about 3 hours. This can be performed in several sessions  but don't forget to save your data at the end of each session. 

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