A.
Define framework conditions
In the process of formation of a working group and steering committee it is important to involve all stakeholders of different departments related to radiation application for a multidisciplinary and holistic approach.
Bringing representatives of various stakeholders together provides transparency and opportunity to meet the requirements of each department.
The committee is charged with planning of acquisition,
coordination and supervision of the implementation process of the dose management system.
A business plan has to be formulated.
Information on changes in federal law and techniques need to be prepared for the executive board and approved by the business administration.
To fulfill legal requirements in time a schedule for the action plan with definition of milestones is compulsory.
Two week intervals were agreed on to give regular feedback on progress.
B.
Preparation
Additionally to the clarification of the specifications of legal requirements (certification as medical product [Food and Drug Administration in the US,
Medizinproduktegesetz in Germany],
2013/59/EUROATOM,
federal law [Strahlenschutzgesetz]),
the system also has to comply with internal requirements.
Following points have to be considered: Installation requirements,
software requirements,
scope of delivery,
service and price.
As foundation for an informed decision a specification book and an overview of any dose monitoring system of all vendors were summarized and tabulated.
Depending on the institution size and security targets either a web-based solution with local server or cloud-based software is preferred.
Independently the software must be able to be installed into existing IT structures.
This can be quite a challenge when the scanners are from different vendors.
Moreover,
the data access point has to be determined whether the data should be retrieved from the working station of each device or from the picture archiving and communication system.
Planned maintenance time for updates and upgrades should be listed.
Essential prerequisite is to determine the scope of delivery i.e.
single vs.
corporate license.
Also the limitation of numbers of users and scanners should be clarified in advance.
We have determined that following imaging modalities should be monitored by the system: radiography,
fluoroscopy,
computed tomography,
angiography,
mammography,
PET,
PET/CT,
gamma cameras and Cone-beam computed tomography.
The more modalities that are included into the monitoring the stricter are the limitations for equipment manufacturer solution.
Furthermore,
dose documentation and dose evaluation/analysis tools have a wide range of data presentation (descriptive statistics amd diagrams).
Based on the possibility to compare data to different reference values (e.g.
federal DRLs or International Commission on Radiological Protection Publication 103) an automatically reporting and alert system can established.
For process quality reasons a capacity utilization function is desirable as well as the documentation of contrast agent/tracer amount for materials management.
Aside from the price of the dose management program,
costs for implementation of hardware and software and annual service charges are important factors for the cost compilation.
Call for public bids can be performed to take all software manufactures and equipment vendors into consideration.
C.
Procurement
The procurement process consists of:
- Determination of the procurement type
- Preparation of the acquisition
- Procurement of the software
D.
Post-procurement actions
After the procurement areas of responsibility have to be determined.
The assignment fields of activities personally (IT,
radiographers,
medical physicists and physicians) guarantee a smooth operation and continuous surveillance.
Regular trainings of the staff have to be organized which are dedicated to the radiation protection software including the radiographers,
computer scientists,
medical physicists and physicians.
Learning materials need to be provided.
Establishment of internal and external audit ensures surveillance quality and avoidance of radiation aberrations.