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Archives. Patient file Situation in archives Conventional Archives (paper based) Computer based Archives (DMAS, PACS) Storage. Patient file. systematic documentation of a patient's medical history and care basis for planning patient care
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Archives • Patient file • Situation in archives • Conventional Archives (paper based) • Computer based Archives (DMAS, PACS) • Storage
Patient file • systematic documentation of a patient's medical history and care • basis for planning patient care • communication between the health care provider and any other health professional contributing to the patient's care • to educate medical students • to provide data for internal hospital auditing and quality assurance
Patient file • provide data for medical research • Basis for the legal interest of the patient and the health care providers responsible for the patient's care • The hospital has the burdon of proof (in Germany) • Must be kept for 30 years after the termination of the care
ArchivesSituation Example University Hospital Heidelberg: Number of reports per year • 250 000 discharge letters • 20 000 Surgery report • Laboratory reports: • 800 000 Clinical Chemistry • 200 000 Radiologie • 100 000 Microbiology • 20 000 Pathology P. Schmücker
ArchivesSituation Amount of documentation: Number of patient's file : ca. 400 000 / ca. 20 pages Request for files per day: ca. 1000 Dimension of files per year: ca. 1700 m ca. 125 m3 Archives area: ca. 5000 qm compulsory period of record-keeping : 30 Jahre 2,5 TeraBytes per year
ArchivesWeak points of conventional archiving • lack of space • Limited opening time • Long search delay • local archives • Diverse organisations of archives • Diverse criteria for classification Schmücker: Rechnerunterstützte Dokumentenmanagement- und Optische Archivierungssysteme: Marktlage und Checkliste. In: Praxis der Informationsverarbeitung im Krankenhaus. Landsberg: ecomed 1996 http://www.gmds.de/ http://www.imia.org/
ArchivesWeak points of conventional archiving • Access usually only via one criteria for classification • Tracing and retrieving of files unsatisfying • Incomplete files • insufficient transparency of the files Order of documents within the file • Late arriving documents
ArchivesDocument Management and Archive System Consists of: • System to manage the incomming data • Mass Storage • System Management • Modules to • transfer • retrieve • visualize • Interface to HIS
DMASrequirements • Document Management • Central catalog • Query function (SQL) • Filing system with mass storage • Jukebox with WORM‘s (magnetic tapes may have problems with long term storage) • System Management • Management of data processing ressources • Management, control and implementation of assess rights • Workflow-Management
DMASrequirements • Workstations for viewing • retrieve • view • Edit and process • Requirements • High resolution • Large screen • Quality must be similar to light box and to the original document
PACSPicture Archiving and Communication SystemsRequirements • Archive Computer • Archiv • Finding station (Hard- and Software) • Viewing software (Standardhardware) • Demonstration unit (Hard- and Software) • Intranetserver • RAID
PACSfinding station • For example 4 portrait format displays • keyboard and mouse (Intellimouse with wheel) • Microphon • images turn, mirror, reverse • measuring: Density, Side-face, Distance, Angel • adequate Print • Gauged hardcopy
PACSState of finding • No finding • Image examined • Preliminary finding • Finding revised • Finding counterchecked (second opinion) • Finding counterchecked and revised • Finding and image approved
PACSViewing station • independent Application for the normal PC at the wardd • Autorouting of images from the picture archive • Query to the archive • Measuring device
PACSDemonstration Unit • PC with large storage, large disk and fast CPU • Two-Monitor-Version: • Images will be projected with a beamer • Control on a secondary monitor • High performance beamer • Fast connection to PACS-Archive Beispiel: www.imagedev.com http://www.incom.de/pioneer_7000.html?&L=
RAID Redundant Array of Inexpansive Disks Redundant Array of Independent Disks • The information is distributed to different disks. • The Information is stored redundant (= multiple). In the case of a failure of one disk the information can be restored totally.
RAID Level 0: Data Striping; no redundancy, distributing of the data on different disks Level 1: Mirroring; Data is mirrored on at least two disks Level 2: is the only RAID level of the ones defined by the original Berkeley document that is not used today Level 3: data is striped across multiple disks at a byte level. The parity information is sent to a dedicated parity disk Level 4: improves performance by striping data across many disks in blocks, and provides fault tolerance through a dedicated parity disk. Level 5: stripes both data and parity information across three or more drives http://www.storagereview.com/guide2000/ref/hdd/perf/raid/levels/singleLevel3.html
Digital archivesConcept • Extendibility • Seperation of administration and long term storage • Common structures • Documents with true colour value and true grey value • Standard formats, operation systems, programming languages, user interfaces
Digital archivesConcept • forgery-proof mass storage • Concept to substitute mass storage • User interface adaptable to the needs • access authorisation • Effective scanning of paper documents
Digital archivesFunctions • Descriptors for the documents • Order of the patient file • Changing of entries • No multiple storage of the same information • Follow the delete time limit • Documentation of the responsibilities
Digital archivesIntroduction strategy • incremental vertical introduction to selected wards • Connection to the central patient data base • Automatical insertion of digital documents • General implementation not until at least age groups of papaer files are available
Archiveslegal basic principles • Medical obligation to keep recordscomes from thecontract governing medical treatment • The patient has a legal claim on complete documentation • In the case of an action due to medical malpractice, a missing documentation can be interpreted against the physician or the hospital Geis: Rechtsaspekte der digitalen Archivierung. In: Praxis der Informationsverarbeitung im Krankenhaus. Landsberg: ecomed 1998
Digital Archiveslegal basic principles • Storage on electronical mass storage is allowed by the Medical Association's professional code • compulsory health insurance physicians have to document their services in a computer readable way and have to transmit their billing in this way to the insurance company
Digital Archiveslegal basic principles • precise organization instructions • Definition of conformity • Unchangable index • Ensure by hardware and software that the document can not be changed • Log processing • Readable during compulsory period of record-keeping (up to 30 years)
Digital Archiveslegal basic principles credibility of replications: • No signature (no document) • The hardcopy of a scanned document is the hardcopy of a copy of the originl document • The digital signature is not part of the hardcopy • The digital signature is accepted by the Signature law from 1.8.1997.
Gesetz zur digitalen Signatur (Signaturgesetz - SigG) § 2 Begriffsbestimmungen (1) Eine digitale Signatur im Sinne dieses Gesetzes ist ein mit einem privaten Signaturschlüssel erzeugtes Siegel zu digitalen Daten, das mit Hilfe eines zugehörigen öffentlichen Schlüssels, der mit einem Signaturschlüssel-Zertifikat einer Zertifizierungsstelle oder der Behörde nach § 3 versehen ist, den Inhaber des Signaturschlüssels und die Unverfälschtheit der Daten erkennen läßt. (2) Eine Zertifizierungsstelle im Sinne dieses Gesetzes ist eine natürliche oder juristische Person, die die Zuordnung von öffentlichen Signaturschlüsseln zu natürlichen Personen bescheinigt und dafür eine Genehmigung gemäß § 4 besitzt.
Digital Archivesdeleting • The data that still have to be kept are copied and the mass storate will be destroyed • The links will be deleted • The data will be made irrecognisable
IntegrationRIS - HIS - PACS 1.) Primary digital image for information and findings 2.) Digital long term archive 3.) Digital image and findings transmission to wards and health care centres 4.) transfer of analogue images into PACS KlinikumGoßhadern
Hybrides ArchivALIDA • All documents will be scanned and microfilmed at one cycle • WORM as Medium for fast access • Microfilm as legally harmless longterm storage • Integration of the paper archive Porth et al: Das Pilotprojekt ALIDA - erste Erfahrungen bei der Einführung digitaler Patientenakten. In: Medizinische Informatik, Biometrie und Epidemiologie GMDS ‘97 München MMM Verlag 1997
ALIDAAblauf Working- list prepare scan archive indexing collect