Prestigious ISRS certification awarded to Italian center using Versa HD
Santa Maria Annunziata Hospital earns stamp of excellence for stereotactic radiotherapy treatments with Elekta linac
Florence, Italy’s Santa Maria Annunziata Hospital is just one of a few medical centers worldwide to earn “Certification” from the International Stereotactic Radiosurgery Society (ISRS) for their commitment to delivering exceptional stereotactic radiosurgery (SRS) treatments. Earning the ISRS Certification also demonstrates best practices and standards in treatment planning, dosimetry and patient care. The center received the stamp of excellence from ISRS in late 2024 and is the first ISRS-certified institution in the world to complete the process using an Elekta Versa HD™ linear accelerator.
“The ISRS Certification is incredibly important to us, as it confirms that the treatments we perform at Santa Maria Annunziata Hospital conform with the latest ISRS guidelines and international standards.”
“The ISRS Certification is incredibly important to us, as it confirms that the treatments we perform at Santa Maria Annunziata Hospital conform with the latest ISRS guidelines and international standards,” says Dr. Silvia Scoccianti, MD, head of the Radiation Oncology Unit.
She adds that while her center has abundant experience using stereotactic radiotherapy to treat single and multiple brain metastases, the ISRS Certification allows radiotherapy staff to treat multiple lesions with a single isocenter and to take on more challenging cases, such as patients with lesions in critical sites.
“We follow a strict quality system to ensure the highest quality treatments as well as safe procedures for patients. The ISRS certification demonstrates the possibility to reach extremely high technological precision with a high definition linac as Versa HD,” says Dr. Serenella Russo, MSc, Senior Medical Physicist Expert.
“The advanced technology of Versa HD, equipped by the Agility™ MLC, HexaPOD™ evo RT robotic patient positioning system and surface guidance technology, allows us to offer a wide range of intracranial radiosurgery treatments that were previously possible only with dedicated radiosurgery devices,” Dr. Russo observes.
Two-phase certification process
The ISRS Certification is divided into two phases, a one-day pre-audit and a two-day onsite visit which includes an end-to-end dosimetric test. In both instances, a device-agnostic team performs independent external assessments of a center’s practices, in addition to conducting a physical dosimetry audit. External dosimetric audits are now strongly recommended or even mandatory in some countries, and the ISRS Certification satisfies this requirement.
During the pre-audit, the hospital worked with Elekta and RTsafe to verify that from mechanical, electronic and dosimetric perspectives the Versa HD system was fine-tuned to ensure a successful dosimetric end-to-end test over a phantom simulating three brain metastases located in a challenging position around the brainstem.
“The collaborative work with Elekta and RTsafe proved to be very effective in enabling us to pass this phase successfully and give everyone confidence that from a technical point-of-view the quality of the treatment could be achieved according to international standards.”
“The collaborative work with Elekta and RTsafe proved to be very effective in enabling us to pass this phase successfully and give everyone confidence that from a technical point-of-view the quality of the treatment could be achieved according to international standards,” Dr. Russo says. “Both companies were key in helping us verify all machine parameters, TPS consistency and accuracy and worked in perfect sync to ensure a pre-audit that gave us certainty that everything was correctly set up to perform the full ISRS audit.”
Dr. Russo adds that the RTsafe pre-audit confirmed the hospital’s “meticulous approach to implementing small-field quality assurance procedures and ensuring dosimetric accuracy for both intracranial and extracranial radiotherapy.”
The second phase with ISRS comprised another full end-to-end dosimetric test and a full review of all the aspects of the radiotherapy department’s quality system, including procedures, prescriptions, documentation, training, measuring devices and calibrations. Led by internationally acclaimed SRS medical physicist and Co-Chair of the ISRS Certification Committee Prof. Ian Paddick, PhD, Dr. Laura Fariselli – former ISRS president – and other notable experts, this was done to ensure that the center adheres to international stereotactic radiosurgery standards.
“Achieving certification was the result of collaboration between the ISRS Certification Service, the clinical team and Elekta.”
“Achieving certification was the result of collaboration between the ISRS Certification Service, the clinical team and Elekta,” says Dr. Scoccianti. “With this combination we were able to improve technical tolerances, reduce margins and improve the quality of all future SRS treatments at the center.”
A fulfilling final outcome
“It was a rewarding experience for our hospital RT department to engage with this international community of experts to ensure the safest and most advanced treatments for our patients,” adds Dr. Scoccianti.
“The successful dosimetric test results for the two end-to-end procedures demonstrate the high performance of Versa HD when combined with surface guidance for SRS treatments.”
“The feedback on our procedures was positive as were the results of our dosimetric tests. We received minor corrective actions to achieve the full certification, but we successfully implemented them and provided the necessary evidence to make them part of our standard routine,” continues Dr. Russo. “The successful dosimetric test results for the two end-to-end procedures demonstrate the high performance of Versa HD when combined with surface guidance for SRS treatments.”
Dr. Russo emphasizes that to ensure machine accuracy is maintained, her team leverages their existing, robust QA process – used in their intracranial SRS program – to verify the stability of machine parameters and that these parameters have been audited by ISRS to achieve certification. The hospital also is able to rely on Elekta field service support in the event it is needed.
Her advice to other users of Elekta SRS/SBRT solution is to include the RTsafe pre-audit, as it will give the center the assurance that everything is set up correctly for ISRS Certification.
Another important point is to have all the needed documentation of the quality system available to facilitate the document part of the audit,” she adds.
"For the first time ever, a center has successfully achieved ISRS Certification for their Elekta Versa HD - an accomplishment that marks a new era in precision stereotactic radiosurgery (SRS),” says Paddick. “This collaboration between Elekta, ISRS, and RTsafe ensures that the highest global standards in SRS are now accessible to more patients, with unparalleled accuracy and safety."
"This historic ISRS certification of the first Elekta Versa HD-equipped center is a testament to our commitment to precision, safety, and clinical excellence,” says Prof. Evangelos Pappas Founder and CEO of RTsafe. “RTsafe is proud to have played a key role in this achievement, ensuring that rigorous quality assurance supports world-class radiosurgery for the benefit of patients everywhere."
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