EMERGING TECHNOLOGIES [ continued ]
CATEGORY: |
EXAMPLES:
(including but not limited to) |
RATIONALE: |
ACCREDITATION REQUIREMENT: |
| Standard Conventional Technology |
Anger cameras using filtered back projection |
Multiple published, peer reviewed controlled clinical trials with incorporation into professional organization guidelines |
No additional documentation necessary |
| New Software Algorithms |
Digirad®-nSPEED
GE-Evolution
Philips-Astonish
Segami-Shine
Siemens-Flash 3D, IQ
SPECT CardioFlash
UltraSPECT -
Xpress, Cardiac™,
Xpress3, Cardiac™ |
No published or limited clinical validation studies and not incorporated into professional organization guidelines |
1. Phantom study to determine defect reproducibility using laboratory's actual imaging parameters
2. Demonstration of adherence to manufacturer's QC specifications
3. Documentation of training and clinical competency by technical staff |
| New Equipment Hardware Technology |
D-SPECT™
CardiArc®
Digirad®-Cardius® 3
XPO
GE-Discovery NM530c or NM/CT 570c
|
510K clearance with or without NEMA standards. No published or limited clinical validation studies and not incorporated into professional organization guidelines |
1. Phantom study to determine defect reproducibility using laboratory's actual imaging parameters
2. Demonstration of adherence to manufacturer's QC specifications
3. Documentation of training and clinical competency by technical staff |
| Pharmaceuticals and Radiopharmaceuticals |
Regadenoson, generic sestamibi |
FDA approved and used according to FDA labeled uses |
No additional documentation necessary |
|
Standard Conventional Technology
It is important to note that 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.
Pharmaceuticals and Radiopharmaceuticals
Likewise, laboratories using FDA approved pharmaceuticals and radiopharmaceuticals, according to FDA labeled uses, are not required to submit additional documentation for accreditation.
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 patient simulator 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.
Once a new technology is incorporated into published professional guidelines, laboratories utilizing the technology will no longer be required to undergo evaluation through a physiologic patient simulator study.
Training and Competency
Prior to implementation or incorporation of new or emerging technology into a laboratory’s practice, there must be adequate documentation of technologist training and competency. The training documentation must include topics covered and time spent in training. In addition, documentation of verification of competency by the vendor or trainer is required. Below is a list of suggested, but not limited to, training topics:
- Overview/Explanation of New Technology
- Technology Methodology
- Hardware Review (i.e. Gantry, Collimators, Patient Bed, etc.)
- Patient Positioning and Set-Up (If Applicable)
- Acquisition Parameters
- Processing and Reconstruction Techniques (i.e. Filters)
- Display
- Archiving
- Patient Safety (i.e. Emergency Stop, Table Release)
- Quality Control Procedures
- Image Quality
- Image Appearance Differences
- Errors and Artifacts: Causes, Recognition, Prevention, Corrective Measures
- Compare and Contrast Standard Technology vs. New Technology: Advantages, Disadvantages (i.e. Filtered Backprojection vs. Iterative Reconstruction, Full-Time vs. Half-Time Reconstruction)
- Review of Documentation/Manuals
- Demonstration of Technology
- Hands-on Performed With Trainer
- Technologist Demonstration of Competency
- Q and A
Download the following sample Emerging Technology Training and Competency Checklist.>> |
Laboratories applying through the new Emerging Technologies
Pathway are required to submit the following:
- Images from a physiologic patient simulator study
- Most recent QC
- Imaging protocol
- Training and competency documentation |
|
|
Laboratories will be notified of their accreditation decisions following evaluation and review of the submitted materials at the next ICANL Board of Directors' monthly meeting. If acceptable images and substantial compliance have been demonstrated, the accreditation will be extended for the remainder of the three year period.
Note: Currently accredited laboratories that plan to begin using new or emerging technology may
proceed with those plans with no need to notify the ICANL during their three year accreditation cycle. However, at the time of reaccreditation, the laboratory may be required to undergo the additional requirements for emerging technology, as outlined above.
The ICANL is dedicated to the administration of an accreditation program that is responsive to the changing needs of the nuclear medicine, nuclear cardiology, and PET communities yet steadfast in its commitment to evaluate and recognize the provision of quality patient care. The creation of the new Emerging Technologies Pathway is a direct illustration of this philosophy. For more information, please contact Mary Beth Farrell, ICANL Technical Manager at 800-838-2100.
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