1. James M. Hevezi, Ph.D., FACR/FAAPM On behalf of American College of Radiology Chair, ACR Commission on Medical Physics Director of Medical Physics CyberKnife Center of Miami

2. Q. 1 Manufacturer Training Yes, manufacturers should provide training on newly installed equipment for operating instructions, capabilities & limitations of equipment, fail-safe mechanisms, safety features, software operation and error codes. Should also list features of the equipment that have dose change capabilities that should only be operated by Qualified Medical Physicist Imaging capabilities should be covered in depth

3. Q.2 Personnel Training All staff who will be operating equipment for both patient treatment and quality assurance measurements should be trained on the use of the equipment. Dept administrators need not have training but have reports from staff regarding equipment operation Physicians should participate in this training If equipment has imaging capabilities, all personnel involved with this mode should be trained on it

4. Q.3 Training Timing & Frequency Personnel should be trained at manufacturer’s facility Personnel visits to clinics using similar equipment should be scheduled if possible Personnel should be trained on equipment at installation and commissioning on site Manufacturers clinical staff should be available at “go live” time and for few days thereafter On site revisit for training 1-2 months following “go live” Periodic in-service training; web-based training; procedure manual available for staff

5. Q.4 Software Verify & Validation Software testing should follow guidelines of manufacturer and professional society recommendations Patches & Upgrades should follow above guidelines History of hazard analysis of software and past errors at clinics reported in section A of this meeting should be available to staff; record of clinic “glitches” kept on file Fixes from previous reported “glitches” from beta testing and other site uses should be available to staff Web-based training/education should be made available to staff for any new/upgraded software

6. Q.5 Standardized Terminology We believe standardized terminology to be important in the avoidance of errors between different systems IHERO should be implemented to insure connectivity between differing systems and standardized terminology offered on these systems will be an aid We understand manufacturer’s need to “separate” their equipment design from competitors – but nomenclature and operational systems should have some commonality for aiding users in their understanding of the systems – Glossary ??

7. Q.6 Educational Materials Any materials that would aid staff in correct and safe operation of equipment and software should be made available to staff, eg. web-based education Manuals should be comprehensive and readable and software errors that appear on the screen should have detailed explanation in the manual concerning their occurrence and steps taken to acknowledge errors “Fast Fact” summary sheets from manuals should be available to staff - especially emergency procedures None of above should replace personal user training