CACTIS - Protocols

Archival Procedures

This standard operating procedure is applicable to any CT imaging procedure on the SIEMENS SENSATION64 scanner located on the ground floor of the Dulles building at the Hospital of the University of Pennsylvania. These standards pertain to all individuals performing these scans in the CT section.

Overview
This SOP is intended to provide direction and information about conducting consistent, HIPPA compliant data storage and retrieval for Investigators performing studies in the CT facility.

Definitions
Study is the overall set of images reconstructed during a session of CT scanning. There are three types:

  1. Human Study - Images generated while scanning a patient or normal volunteer during a session. These studies can be one of two sub-types:
    • Anonymous Trial Study - Studies can be anonymized after the exam is performed however all exams require patient information to be entered into the scanner.
    • Routine Trial Study - These studies require the header information to contain pertinent patient identifying information. These do not require anonymization because images are not forwarded outside the health system.
  2. Animal Study - Images generated scanning an animal on the CT systems
  3. Phantom or Specimen Study - Images generated scanning ex-vivo tissue or a prepared substance or object.

Header Information - Information entered into the CT system specifying demographics or other information about the subject being scanned.

PACS (Central Archive) - Picture Archiving and Communicating System is the standard central archiving system.

CD-ROM - Write only CD archival. Investigators must provide their own CD's.

MRN (Medical Record Number) - This is an 8-digit identification number used for patient identification and tracking throughout the University Hospital System.

DOB - Date of Birth

HIPAA - The Health Insurance Portability and Accountability Act addresses the security and privacy of health data.

DICOM - Digital Imaging and Communication in Medicine

Raw Data - data that is taken and stored on the disc in some other format that does not enter it as an image in the image database.

Information Requirements

  • All Patients must have an established MRN. No person will be scanned without this number. To establish this number call Central Registration (215) 615-2240.
  • All animal research must contain identifiers for both the ULAR number and Investigator.
  • All scans are documented as entries in the logbook.

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Entry of Patient Information
All human studies are entered as routine studies. All appropriate patient information is entered into the appropriate 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, which allows identification of the animal scanned and the investigator managing the session. No entries in the header fields for Animal Research can be in a form that may be seen as human subject data. Any questions about this issue are handled through the technologists. If you are uncertain what is acceptable the technologists can assign identifiers.

Personnel Qualifications
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 operators certificate for the CACTIS files.

All individuals responsible for entering, copying, or transferring Human Study data will have an understanding of HIPPAA regulations pertaining to the 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 Scanners
All data scanned by technologists are sent to PACS. All Human Studies are verified within the PACS. It is the responsibility of the PI to provide CD's for personal archiving. The technologists can send the study 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. For research studies requiring anonymization of patient information, CACTIS has a technologist available, however, due to the amount of research protocols that require this task, please allow one week per subject for your de-identified CD.

Investigators are responsible for their Animal Research Data. The same procedure as above can be followed for animal studies. Phantom and Specimen archival is the responsibility of the investigators as well.

Raw Data
All raw data archival is the responsibility of the investigator unless otherwise arranged through CACTIS. No raw data will be stored on the systems. Raw data found on the systems can and will be deleted.

Data Records and Management
Header information entered into the scanner must be specific to each animal (e.g. animal ULAR number) and cannot be in a form that the central archive can register 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 investigator's name must be entered into the system logbook. Data from a study are not kept on the system disc. No films are generated for any animal research study.

Quality Control and Assurance
Quality Assurance of the system is done though routine Preventative Maintenance done by the CT manufacturer (Siemens). Records of this preventative maintenance 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 is posted in the control area of each scanner.

Anonymization of a CT Exam for Research Purposes
Sponsors often request the CT exam images to be transferred to them as part of the study data collection. All images must be de-identified prior to leaving UPMC. The following procedure has been introduced to accommodate such requests. De-identification is part of the CACTIS charge for research protocols that are using the service center. Protocols using hospital billing services (family account) will have a service charge of $25.00 per CT scan for anonymization. Non-CACTIS users must apply for this service prior to study start.

CACTIS accounts procedure (charge: free)

  1. Fill out the “Request for CD” form located on the forms page
  2. Bring or email the completed form to the CT reading room and give it to one of the CACTIS techs (3DLab@uphs.upenn.edu)
  3. Please allow up to one week for de-identification

Family account procedure (charge: $25.00 per CT exam)
An account must be established through CACTIS prior to any de-identification requests can be made.

  1. Apply to CACTIS using the “Image Anonymization Account Request” form. This is an expedited submission and does not need to go on the committee meeting agenda.
  2. Once approval is granted, follow the above procedure.

This service is ONLY for CT exams. All other radiology exams must be de-identified through their specific radiology section of origination.

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