These standards pertain to all individuals performing imaging on the SIEMENS CT scanners at the Hospital of the University of Pennsylvania, or at the Perelman outpatient center.
This standard operating procedure (SOP) is applicable to CT imaging on the SIEMENS scanners located on the ground floor of the Dulles building at the Hospital of the University of Pennsylvania or at the Perelman outpatient center.
This SOP is intended to provide investigators performing studies in the CT facility with direction and information for consistent HIPPA compliant data storage and retrieval.
- Study: The overall set of images reconstructed during a CT scanning session. There are three types:
- Human Study: Images generated while scanning a patient or normal volunteer during a CT session. These studies can be one of two sub-types:
- Header Information: Information entered into the CT system specifying demographics or other information about the study subject being scanned.
- PACS (Central Archive): Picture Archiving and Communicating System is the standard central archiving system for the electronic storage of CT images.
- CD-ROM: Write-only CD archival. Investigators must provide CD's.
- MRN (Medical Record Number): An 8 or 9-digit identification number used for patient identification and tracking throughout the University Hospital System. All human study patients must have an MRN before they can be scanned.
- FTP: File transfer protocol is an application that allows de-identified patient images to be uploaded to the sponsor for analysis. These computer applications are typically designed to de-identify and upload the data.
- DOB: Date of Birth
- HIPAAm: The Health Insurance Portability and Accountability Act addresses the security and privacy of health data. For research purposes, a patient’s health information (including CT scans) may not be transferred outside of Penn Medicine unless the information has been de-identified.
- DICOMU: Digital Imaging and Communication in Medicine
- Raw Data: Data that is taken and stored on a CD in a format that does not enter the data as an image in the image database.
- Anonymous Trial Study: Studies can be anonymized after the exam is performed. However, all exams require patient information to be entered into the scanner and stored in PACS.
- Routine Trial Study: These studies require the header information to contain applicable patient identifying information. Anonymization is not required because images are not forwarded outside the health system [de-identification may be requested].
- Animal Study: Images generated during the scanning of an animal on the CT systems. These images are never archived. Instead the images may be saved to a CD at the scanner.
- Phantom or Specimen Study: CT Images generated while scanning ex-vivo tissue or a prepared substance or object.
- All participants must have a Penn Medicine medical record number (MRN) prior to scheduling a CT study. No patient will be scanned without an MRN. To obtain this number call 800-789-7366.
- All animal research studies must contain identifiers for both the ULAR number and investigator.
- All study scans are documented in the logbook.
Entry of Patient Information
All human imaging studies are entered into the radiology PACS system as routine studies. Research imaging studies are also sent to a temporary storage archive called Terarecon, where patient identifiers are removed [for research purposes] and the participant case number or ID is entered. CT images may be saved to a CD or uploaded via the FTP site if your sponsor provides this service. All appropriate patient information is entered into the required fields. Anonymous header information is applied to the subject data fields after the original data is placed on CD-ROM and sent to PACS.
Animal Studies must have information entered in the header allowing for the identification of the animal scanned and the investigator managing the session. Entries in the header fields for Animal Research cannot be in a form that may be misinterpreted as a human study subject. The technologists handle any question regarding this issue. If you are uncertain what is acceptable, the technologists can assign identifiers.
All individuals operating within the CT environment will be trained Radiologic Technologists or approved users recognized by CACTIS. All approved users must supply a copy of their radiography/fluoroscopy operator certificate for inclusion in the CACTIS files.
All individuals responsible for entering, copying, or transferring human study data will have an understanding of HIPAA regulations pertaining to data transfers as set forward by the University of Pennsylvania and HUP. These guidelines can be found on the Office of Human Research (OHR) website.
Archival for CT Images
Only human CT studies are sent to PACS for storage. All data scanned by technologists for human studies are verified within PACS. It is the responsibility of the primary investigator to provide CD's for personal archiving. Technologists are able to send CT studies to the radiology file room for CD burning if this cannot be done at the scanner; however, the CD’s will not be de-identified.
Due to high demand for de-identified CDs, all CDs will be processed at the radiology imaging file room and researchers will be assessed a fee of $5 per CD.
De-identified CDs for CACTIS Non-service center accounts. Non-service center research accounts (family accounts) must set-up an account through the radiology file room. The fee is $5 per CD. The case number can be written on the CD label, but cannot be added to the images [a system generated number replaces the patient name on images]. Please contact the radiology imaging file room directly to set-up an account.
De-identified CDs for CACTIS service center accounts. As of May 1, 2015, the CD request form will be sent to HUP3D lab staff for de-identification and the case number will be added to images. Investigators must send a CD request via email to HUP3DLab@uphs.upenn.edu. Due to the amount of research protocols that require de-identified CDs, please allow one week per participant.
Investigators are responsible for their Animal Research Data and can follow the same procedure as above.
Phantom and Specimen archival is the responsibility of the investigator.
All raw data archival is the responsibility of the investigator, unless otherwise arranged through CACTIS. Raw data is not to be stored on the systems. Raw data found on the systems will be deleted.
Data Records and Management (Animal Studies)
Header information entered into the scanner must be specific to each animal (i.e., animal ULAR number) and cannot be in a form that the central archive can misinterpret as a patient. CT is not responsible for animal research studies going to PACS.
The investigator's name must appear in the header information. Header information, operator, and the investigator's name must be entered into the system logbook. Data obtained from a study are not kept on the system disc.
No films are generated for animal research studies.
Quality Control and Assurance
Quality Assurance of the system is done though routine preventative maintenance performed by the CT manufacturer (Siemens). Preventative maintenance records are located in the CT department.
Archival problems that arise when technological support is not available can be routed through the SIEMENS uptime service. The number for this service is posted in the control area of each scanner.
Anonymization of a CT Exam for Research Purposes
Sponsors can request CT exam images to be transferred to them as part of the study data collection. Prior to leaving UPHS, all images must be de-identified. De-identification is part of the CACTIS fee for research protocols using the service center. Protocols using the hospital billing services (family accounts) will have a service charge of $5.00 per CT scan for anonymization.
Non-CACTIS users must apply for this service prior to the start of the study.
CACTIS Service Center accounts procedure (Effective March 2015)
- Fill out a “Request for CD” form located on the forms page and email to HUP3Dlab@uphs.upenn.edu, or
- Bring the completed form to the 3D Lab located next to the CT Reading Room on the ground floor of Dulles, and hand it to one of the CACTIS technologists
Please allow up to one week for de-identification.
Family account procedure (fee: $5.00 per CT exam)
An account must be established through CACTIS prior to de-identification requests being made.
- Apply to CACTIS using the “Image Anonymization Account Request” form. [This is an expedited submission and does not need to be placed on the committee meeting agenda.]
- Once approval is granted, the above procedure is followed.
This service is ONLY for CT exams. All other radiology exams must be de-identified through their originating radiology section.