June 12, 2009 – The Intersocietal Commission for the Accreditation of Nuclear Medicine Laboratories (ICANL) announced that it will accept accreditation applications from laboratories utilizing new technologies and other novel imaging approaches, such as new software algorithms and new camera technologies, 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.
New Software Algorithms or New Equipment Hardware Technology
Laboratories using standard imaging equipment but utilizing imaging reconstruction algorithms not currently incorporated in the published imaging guidelines (i.e. half-time) or laboratories using new hardware technology with FDA 510K clearance that is not incorporated into professional organization guidelines, are required to perform a physiologic
phantom study to determine defect/image reproducibility using the laboratory's actual imaging parameters. These laboratories are also required to demonstrate compliance with manufacturers' recommended quality control by submitting results of quality control testing. In addition, documentation of adequate training and competency of the technical staff, relevant to the new technology is required.
Pharmaceuticals and Radiopharmaceuticals
Laboratories using FDA approved pharmaceuticals and radiopharmaceuticals, according to FDA labeled uses, are not required to submit additional documentation for accreditation.
Standard Conventional Technology
For laboratories using standard conventional technology and imaging approaches currently incorporated in the guidelines published by the professional societies, no further documentation is required as part of the accreditation process. For instance, laboratories utilizing SPECT imaging based on Anger camera equipment using filtered back projection reconstruction are required to adhere to published guidelines and thus no additional documentation is necessary.
Quality Assessment Patient Simulator Program
Offered jointly by the ICANL and the Society of Nuclear Medicine (SNM), the newly launched Quality Assessment Patient Simulator Program provides laboratories with the physiologic phantom required to identify and quantify areas of abnormality and determine the diagnostic significance of these findings. Laboratories applying through the Emerging Technologies Pathway are required to submit the results of the patient simulator
program to the ICANL for evaluation and grading, based upon objectives judging defect reproducibility and image quality. Laboratory reporting of images will also be evaluated.
The first module to be released, the Cardiac SPECT Phantom, is available to test the applicant laboratory's ability to acquire and process SPECT rest/stress myocardial perfusion studies, identify and quantify areas of perfusion abnormality and determine the diagnostic significance of these findings. Participating laboratories will purchase the Quality Assessment Patient Simulator Program from the ICANL for $500 and will have thirty (30) days from receipt of the patient simulator to submit the results. Laboratories will be required to submit the phantom results/questionnaire and all images used to make the clinical diagnosis, in addition to their laboratory's imaging protocol. The laboratory's submitted results will be graded by the ICANL using objective criteria.
As part of the Quality Assessment Patient Simulator Program, phantoms for general nuclear medicine and PET technology are under development.
"The ICANL seeks a balance between maintaining standards for quality patient care while not impeding the evolution of technology. By offering the new Emerging Technologies Pathway and making available the corresponding ICANL/SNM Quality Assessment Patient Simulator Program, we are providing laboratories with the means and tools by which to evaluate these new technological developments and ensure that they are providing
quality patient care", remarked Sue Abreu, MD, FACNP, President of the ICANL Board of Directors.
To learn more about the ICANL's new Emerging Technologies Pathway and the Quality Assessment Patient Simulator Program during the SNM's 2009 Annual Meeting in Toronto, plan to attend the SNM Arena exhibit hall presentation with Mary Beth Farrell, MS, CNMT, NCT, RT(N), ICANL Technical Manager, and Sue Abreu, MD, FACNP, ICANL President, (Sunday, June 14th at 12pm) or visit the ICANL in booth 115 in the exhibit hall.