Abstract
The authorization operation for acquired images as the data intended for diagnostic use and legal electronic storage is required according to the MHWL guideline in Japan. For installing the imaging systems meeting the guideline, workflow of quality assurance (QA) procedure with authorization operation should be standardized. In DICOM Part15, management of image file status is specified as the online electronic storage profile, and attributes such as SOP Instance Status of the image, and Authorization Date and Time are defined. Introducing Instance Status and attributes changing rules, the IHE integration profile is proposed as a standardized workflow of QA and the authorization procedure. Instance Status of acquired images is set to OR (Original) in the modality at first. OR status implies that this is the primary SOP instance for the purpose of storage. When images are admitted as authorized and authorization operation is done, OR is changed to Authorized Original (AO) status. AO status indicates that the image files cannot be deleted nor modified. Not specified (NS) status indicates that the image files can be deleted. The status management should be installed in Evidence creator, Image Display, Modality, and Image management Actors. QA and authorization operation can be done by Evidence Creator. All the Actors in this integration profile are the same as those in the Scheduled workflow profile and transactions are defined to contain Instance Status and related attributes. In case of health care information exchange specified by XDS–I, PDI, IRWF integration profiles in IHE, same instance status control as SWF can be introduced. The healthcare enterprise that provides source data by IHE profiles, sets status as AC (Authorized Copy) to distinguish AO for electronic storage. Other enterprise importing the shared data with AC status should storage data as AO status, when they are used for diagnosis. With the use of these profiles and instance status, the images with authorized status, can be easily discriminated and protected from rejection by the human error. For the information exchange beyond community, status management is also effective in XCA–I.
In this paper, DICOM Part15 status management is introduced for the authorization operation in the image QA procedure for electronic storage, and proposed for the QA workflow IHE integrated profile and its extended use to healthcare information exchange.
