Efforts

The SafeChemo pilots lead the validation effort which includes the following activities:

1. Assessing quality before and after SafeChemo introduction
Assessing the effectiveness of the SafeChemo service as a solution for the issues raised above, goes beyond simply assessing the user-friendliness of the system and its relevance to the context.

The SafeChemo partners will have to set up a validation methodology which involves a strong healthcare component. This validation methodology will have to be agreed upon by the pilot partners and will have to start with an analysis of the current situation:

1.1 analysis of the frequency of preparation errors
1.2. analysis of the hazard risks of cytostatics handling
1.3. analysis of costs due to inefficient handling of cytostatics preparation (e.g. spoiled drugs)
1.4. analysis of human factors (patients, operators)

A similar analysis will have to be performed after the implementation of the SafeChemo service, as to identify advantages and/or disadvantages of the new approach.

2. Assessing SafeChemo reliability
A second set of activities will have to be linked to the assessment of the reliability level of the SafeChemo service. Reliability will be measured with objective, technical approach, as it will be based on a series of repeated controls on both hardware and software.
Reliability of the system will be measured in terms of error-free transmission of prescription data, precision of the compounding equipment, validation of aseptic technique etc.

3. Assessing SafeChemo safety
A third element of the SafeChemo validation is connected to the potential hazards of the specific application field. Safety issues are connected to both patients and operators:

3.1. Preparation of cytostatics needs to grant sterility of the finished product that will be administered to the patient. As cancer patients are typically immune-depressed, sterility is crucial for patient safety.
3.2. The preparation cycle needs to protect operators from potential exposure to toxic agents.

4. Assessing SafeChemo cost-effectiveness
As a fourth step, the SafeChemo partners will have to look at the overall cost of the cytostatics cycle. This means addressing a mix of tangible and intangible aspects, such as drug costs, reduced operator time, reduced waste etc.

An analysis of costs prior to the SafeChemo implementation and a second analysis towards the end of the project lifetime will give insight on the cost-effectiveness of the SafeChemo service.

Adjustment for price changes and different local policies will have to be taken into account.


5. Documentation and record keeping
The last step of the SafeChemo validation methodology will have to take into account all information produced within the cytostatics drug use cycle (from prescription to administration). The SafeChemo service will be evaluated also in terms of improvement in the overall availability of information, from long distance access to drug bar-coding allowing bedside scanning.


The SafeChemo validation will be divided in the following steps:

Time frame	Action	Comments
Months 0-7	Discussion of validation methodology, agreement on procedures, preparation of validation protocols. Assessment of current situation (errors, occupational danger, costs). Localization of the SafeChemo platform. Training.	During the first three months the business partners will concentrate on the localization effort, while the pilots will define the details of the validation method.
Months 8-12	Continued assessment of current situation Series of dry-runs to assess service efficiency, precision and reliability (performed with non-hazardous drugs) Test of reliability of software platform (both in-house and through web access)	From month 4 the validation itself starts. The first months will be devoted to verifying that the SafeChemo service is reliable, efficient, safe. Business partners will also focus on market analysis.
Months 13-17	Involve real cytostatic drugs and inject SafeChemo preparations (inpatients and outpatients)	After having successfully validated the SafeChemo service and after having proven its reliability and safety, the system will be fully integrated inside the cytostatics workflow and the compounds will be administered to patients.
Months 18-20	Assessment of SafeChemo performance (errors, occupational danger, costs)	Analysis of the overall system performance over time. Comparison with the previous, manual system.
Months 21-22	Preparation and issue of full validation report	Pilot results and final version of the business plan.

Validation will occur with the same methodology and timing in all the three validation sites. In this way, a consolidated validation report will be issued, containing comparable data. Environmental specificity of the hospitals is likely to be an interesting variable in the validation process and will therefore be taken into account.