EMERGING TECHNOLOGIES
ICANL OFFERS ACCREDITATION PATHWAY FOR LABORATORIES UTILIZING
NEW SOFTWARE ALGORITHMS AND NEW CAMERA TECHNOLOGIES
Camera and software technology are evolving at a rapid pace, as evidenced by the displays of innovation and improvements showcased during the annual meetings of both the American Society of Nuclear Cardiology and the Society of Nuclear Medicine.
The rapid advancement is especially true for the technology specific to Nuclear Cardiology and is often promoted as offering improved resolution and faster scan times. In fact, there are now several new cameras utilizing novel technology and new reconstruction techniques on the market.
At this point in time, the availability of both peer reviewed, published literature and large scale, multi-centered clinical trials providing validation of these emerging technologies is limited. Therefore, it has been a challenge for the related professional organizations to diligently examine and incorporate these new developments into their published guidelines. Since its inception, the ICANL has relied on its sponsoring organizations to first recognize the validity of and update guidelines for any new technology before incorporating it into the accreditation process. However, the role of the ICANL is not to impede emerging technologies, but rather to evaluate and recognize the provision of quality patient care.
With that philosophy in mind, in June of 2008, the ICANL Board of Directors made the decision to begin accepting accreditation applications from laboratories utilizing new technologies and other novel imaging approaches that, to date, are not included within the guidelines published by the professional societies. Such laboratories will apply for accreditation via the ICANL Online Accreditation application and undergo further evaluation by way of the new Emerging Technologies Pathway.
With emphasis on ensuring quality patient care, the following provisions have been established:
When there is a new technology that utilizes parameters that are outside of the currently accepted ICANL Standards, utilization of the new technology must demonstrate the following:
- Clinical validation — The technology must perform, as intended, to produce clinical results that are equal to or better than currently accepted technologies, based on published, peer-reviewed data. This would include a clear delineation of the clinical scenario to which it applies (indications/diagnoses) and the method of utilization (procedure).
- Reproducibility — For instrumentation, there must be clearly defined quality control procedures and data to show stability of the device, when used as indicated.
Laboratories that apply through the new Emerging Technologies Pathway will be eligible for accreditation; however, following notification from the Board of Directors they will have one year to submit supplementary material and undergo the additional review. Such laboratories are required to provide additional documentation beyond what is included in the current application, including but not limited to, phantom images, acceptable quality control measures, and documentation of training and clinical competency of the technologists. Laboratories applying through the new Emerging Technologies Pathway may potentially incur additional fees. If the laboratory fails to submit the additional documentation within one year, their accreditation may be suspended.
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Laboratories falling under the new Emerging Technologies Pathway will apply for accreditation utilizing the existing Online Accreditation application. The applicant laboratory will be notified of the additional documentation required, based on the decision tree shown to the right.
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