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WHEN THE WRIT
        HITS THE FAN:
       MANAGING EHRs
    AS BUSINESS RECORDS


         Deborah Kohn
1                         © 2007
Learning Objectives
1. Understand the importance of managing Electronic
   Health Records (EHRs) as business records.

2. Manage the process of electronic records management
   for evidentiary discovery purposes.

3. Review information systems capable of creating
   electronic health records, such as eMail systems,
   dynamic Web site systems, and PACS.

4. Create a comprehensive plan for the life cycle
   management of the organization’s electronic business
   records.

                                                       © 2007
Today’s Healthcare Organization

Mounds of analog paper and film records
               still exist.




                                      © 2007
Today’s Healthcare Organization

  However, more digital / electronic
   records are created than analog
   records.
  EVERY MINUTE:
    servers log thousands of network interactions
    staff members create hundreds of eMail
     messages
    databases record gigabytes of information

                                                 © 2007
Trade Off?

 Digital / electronic records / film
  might take up less physical space
  than their predecessors, but they
  remain business records that
  might be subpoenaed for medical
  malpractice lawsuits or other
  legal actions.



                                        © 2007
Managing Electronic Records/Film

  As such, the management of
   electronic records / film
   requires the same rigorous
   principles applied to analog
   paper records / film.



                                  © 2007
Way Back When… 1970s
 Acknowledging Subpoenas

  COURTS REQUIRED

     The physical delivery of ―original,‖
      analog source documents / records.

         Only rudimentary paper photocopy
          machines existed (thermo facsimiles)


                                                 © 2007
Way Back When… 1970s


 Deborah’s cardboard box approach!




                                 © 2007
Way Back When… 1980s - 1990s

  Acknowledging Subpoenas

  COURTS ACCEPT

  – Photocopies of ―original,‖ electronic
    source documents and records




                                            © 2007
2010
  Acknowledging Subpoenas

  COURTS ACCEPT

  – Secured electronic files of ―original,‖
    electronic source documents and
    records

  – Hard copy computer printouts of
    ―original,‖ electronic source documents
    and records
                                              © 2007
2010
 Secured electronic files and hard copy
  computer printouts are admissible in court as
  long as the healthcare organization can
  substantiate
  – the trustworthiness of the system(s) used to store
    and retrieve the documents and records
  – the accuracy of the organization’s records
    management policies and procedures
  – the documents and records were not created just
    for a court case.

  It is important to verify the courts’ acceptance
    of digital records on a state-by-state basis.

                                                     © 2007
2010
  Acknowledging the humungous
   number of other requests for
   Release of Information (RoI) /
   Disclosure of Information

  PATIENTS / ATTORNEYS / … ETC.

   – Demanding and, in most cases, entitled
     to ―any and all records‖ connected to
     an episode of care
                                              © 2007
No Longer Cardboard Boxes
 Organizational intranets and Web portals
  allowing designated Custodians of Records,
  RoI professionals, and even patients —
  after rigorous authorization and
  authentication processes — to
   click on hyperlinks
   instantaneously retrieve ―original‖ electronic
    source documents and objects required by
    subpoenas or other requests
   securely transmit them to the requesters



                                                     © 2007
Electronic Source Records


     All related digital (electronic)
      patient financial records from
      financial data repositories




                                         © 2007
Electronic Source Records
     All related digital (electronic)
      patient medical records from
      clinical data repositories, such
      as
           acute care health records
           ambulatory care health records
           long-term care health record
           mental health care records

                                             © 2007
Electronic Source Records

     Includes all related:
         Digital ―conversations,‖ including
          eMail messages, vMail messages, e-
          annotations (the equivalent of
          electronic Post-it notes), text
          messages, and digitized telephone
          consults



                                               © 2007
Electronic Source Records

     Includes all related:
         Digital diagnostic images from
          diagnostic image repositories,
          including digital X-rays as well as
          CT, MR, and nuclear medicine




                                                © 2007
Electronic Source Records

     Includes all related:
         Cine, including cardiac
          catheterization and ultrasound
          images (video files) from video
          repositories

         Digital medical dictation (audio
          files) from audio repositories

                                             © 2007
Electronic Source Records

     Includes all related:
         Medical transcription (text files)
          from text repositories

         Digital photographs, including those
          taken from pathology digital
          cameras-on-a-stick


                                                 © 2007
Electronic Source Records

     Includes all related:
         Waveforms (signal trace or graphic
          files) from signal trace repositories,
          including ECGs, fetal traces, and
          output from other electronic, point-
          of-care medical devices




                                                   © 2007
Electronic Source Records
                   Handwritten Notes       Laboratory Orders / Results
                    and Drawings
                                                      Orders / Medication Orders / MARs

Signed Patient
                                                                         Online Charting
Consent Forms                  Original,                                      and
                               Analog         Discrete,                  Documentation
                             Documents-      Structured
                              Document          Data
                             Image Data                                    Detailed
   Radiology                                                               Charges
    Reports                                    Diagnostic
                           Text Data                                     CT
Transcribed                                    Image Data                MR
  Reports                       Video                                    Ultrasound
                                         Signal                          Nuclear Med
     UBs and                    Data
                                   Audio Tracing
  Itemized Bills                          Data
                                   Data                              Pathology
    Ultrasound and                                                    Images
 Cardiac Catheterization
                                                          EKG/EEG/Fetal
     Examinations           Heart Voice Dictations       Monitoring Signal
                           Sounds & Annotations             Tracings                   © 2007
Electronic Health Records

   Encompass health information
    recorded on any digital medium
    as read-only or rewritable
    formats
   – Magnetic tape / disk
   – WORM optical disk
   – CD / DVD

                                     © 2007
Electronic Health Records
  Are evidence of transactions or
   events that
   – have legal or business value (i.e.,
     the records reflect the business
     objectives of the organization,
     such as receiving reimbursement
     for services provided)
   – indicate an intention to be
     memorialized
                                           © 2007
Electronic Health Records =
Business Records


Subject to Evidentiary Discovery




                                   © 2007
Electronic Health Records =
Not Business Records

 Reproductions of the electronic
  records that are provided by the
  organization to an individual or
  another healthcare organization
  for convenience purposes


                                     © 2007
Electronic Health Records =
Not Business Records
 Ad hoc or draft electronic record
  documents, such as some eMail,
  some vMail, some eAnnotations,
  text messages, work sheets, work
  lists, works-in-progress, and
  database manipulations

                                      © 2007
Electronic Health Records =
Not Business Records
 Personal Health Records (PHRs),
  which are patient owned,
  managed, and populated -- and
  might include copies of the
  healthcare organization’s business
  record files.


                                   © 2007
Caveat?
   BUSINESS RECORDS IF
    the records are subsequently used by the
     healthcare organization in evaluating or
     treating the patient, such as providing care,
     reviewing data, and documenting
     observations, actions, or instructions

   FOR EXAMPLE
    patient-owned, managed, and populated
     ―tracking‖ records, such as electronic
     medication tracking records, glucose and
     insulin tracking records, etc.


                                                     © 2007
Caveat?


  THE FEDERAL RULES OF CIVIL
   PROCEDURE GOVERNING
   ELECTRONIC DISCOVERY, effective
   December 1, 2006.

  For example:




                                     © 2007
Caveat?

  Rule 26 – the Rule that describes
   the legal obligation to maintain and
   disclose relevant records – specifies
   that ―a party must now, without
   awaiting a discovery request,
   provide to other parties a copy of, or
   description by category and location
   of, electronically stored
   information‖.


                                            © 2007
Think About That …
  Without awaiting a Discovery
   Request

  Provide a Copy of, or Description by
      Category And
      Location Of
    Electronically Stored Information

  CAN YOU DO THIS NOW?


                                          © 2007
Electronic Records Management


   The process by which
    electronic records are created
    and preserved for evidentiary
    discovery (i.e., legal /
    business) and, now, electronic
    discovery purposes


                                     © 2007
Electronic Records Management


   Requires astute decision
    making throughout the life
    cycle of the electronic record




                                     © 2007
Electronic Record Decision Making

 What electronic records to keep?
 How long to keep?
 How to assign record authorities and
  responsibilities?
 How to design the process?
 How to administer the process?
 How to audit the process?
 How to review the process?

                                         © 2007
Electronic Record Life Cycle
     Creating / Receiving
     Indexing
     Searching
     Retrieving
     Processing
     Routing / Distributing
     Storing
     Maintaining
     Securing
     Purging / Archiving / Destroying
                                         © 2007
Health
Electronic ^ Records Management
 Example healthcare information
  systems capable of creating electronic
  records and then processing,
  distributing, maintaining, storing,
  retrieving, archiving, and destroying
  the records…



                                           © 2007
Health
Electronic ^ Records Management
 Patient billing and accounts
  receivable systems

 Healthcare information systems

 Clinical information systems


                                   © 2007
Health
Electronic ^ Records Management

 Cardiology, laboratory, radiology, and
  pharmacy information systems

 Picture Archiving and
  Communications Systems (PACS)



                                           © 2007
Health
Electronic ^ Records Management

 Digital dictation systems and speech
  recognition systems

 Word processing (i.e., transcription)
  systems



                                          © 2007
Health
Electronic ^ Records Management
 Electronic document management
  systems (EDMSs)

 Report, print, and output management
  systems (e.g., reproduction systems)




                                     © 2007
Health
Electronic ^ Records Management
 eMail systems (e.g., Microsoft
  Outlook)

 Collaboration systems (e.g., project
  extranets and online conferencing
  systems)


                                         © 2007
Health
Electronic ^ Records Management

 Dynamic Web site systems with online
  forms, transactions, and metadata




                                         © 2007
Health
Electronic ^ Records Management
  It’s now time for healthcare
   organizations to address the new
   challenges involved in the ongoing
   maintenance and management of the
   EHR.

  This requires:

     management strategies
     knowledge and leadership skills to
      shape and deploy the strategies

                                           © 2007
Health
Electronic ^ Records Management
   Creating and maintaining EHR retention and
    disposition schedules based on administrative,
    legal, fiscal, and historical needs

   Establishing documented procedures for the
    scheduled destruction of obsolete EHRs and
    retaining proof of such destruction

   Developing, implementing, and maintaining
    efficient EHR filing systems

   Quickly locating and organizing EHRs
                                                     © 2007
Health
Electronic ^ Records Management
  Training personnel in the use and
   function of EHR management processes

  Ensuring the confidentiality, security, and
   integrity of the information contained in
   the EHRs

  Monitoring / auditing the completeness
   and accuracy of the EHR content

                                                 © 2007
Automated EHRM Functions

  Record capture, where a predefined set of
   metadata is established supporting
   accurate representation of the record
   with disciplined disposition and retention
   actions

  Record classification, where appropriate
   categories of records are established with
   applied rules

                                                © 2007
Automated EHRM Functions
  Record preservation format, where a
   format, such as eXtensible mark-up
   language (XML) or portable document
   format (PDF), is established for retrieval
   and cross-departmental interchange

  Record retention calculation, where
   ―triggers‖ automatically save electronic
   documents or Web content as records
   according to pre-established business
   rules
                                                © 2007
Automated EHRM Functions
  Record disposition control, where rules
   provide electronic notifications to
   managers that certain records or
   documents have met their retention
   dates and require manual confirmation
   to delete, save, or destroy

  Record deletion and destruction and
   suspension of record deletion and
   destruction to support litigation.

                                             © 2007
Health
Electronic ^ Records Management
  LONG TERM STRATEGIES

   Develop a comprehensive plan for
    EHR life cycle management

   Incorporate the plan into the
    organization’s IT strategic plan

   Dictate the plan to the users
                                       © 2007
Health
Electronic ^ Records Management
  SHORT TERM PLANS

   Develop EHR policy / procedure
    guidelines for existing
    information systems

   Develop EHR policy / procedure
    guidelines before buying new
    EHR technologies / systems
                                     © 2007
Health
Electronic ^ Records Management
• A ________ information system shall allow users
  to create folder hierarchies, wherein users can
  place electronic documents or records that contain
  PHI.
• A ________ information system shall be capable of
  automatically applying classification and retention
  schedules that are established by the healthcare
  organization.
• A ________ information system shall be capable of
  taking Web site snapshots, allowing users to
  record the sequence of the screens encountered
  during a Web site transaction.

                                                        © 2007
Health
Electronic ^ Records Management
TECHNICAL CONSIDERATIONS

 Identify all existing enterprise-wide
  repositories that securely store EHR
  records and documents which merit
  evidentiary discovery handling

 Move all inactive or semi-active files
  to separate, secure storage

                                           © 2007
Health
Electronic ^ Records Management
TECHNICAL CONSIDERATIONS

 Implement a regular sweep of EHR
  information to ensure that the archive
  is kept accurate and up to date

 Trawl the archive and assign retention
  flags to information

                                           © 2007
Health
Electronic ^ Records Management
TECHNICAL CONSIDERATIONS

 Destroy unflagged files from the
  archive

 Manage large files and file types for
  security purposes


                                          © 2007
Health
Electronic ^ Records Management
  COLLABORATION OF EXPERTS

      Legal professionals
      HIT professionals
      HIM professionals
      Risk / Compliance professionals
      Clinical professionals


                                         © 2007
Questions & Answers



     dkohn@daksystcons.com

  www.daksystemsconsulting.com



                                 © 2007

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Ahima2010 Summer Presentation Writ Kohn

  • 1. WHEN THE WRIT HITS THE FAN: MANAGING EHRs AS BUSINESS RECORDS Deborah Kohn 1 © 2007
  • 2. Learning Objectives 1. Understand the importance of managing Electronic Health Records (EHRs) as business records. 2. Manage the process of electronic records management for evidentiary discovery purposes. 3. Review information systems capable of creating electronic health records, such as eMail systems, dynamic Web site systems, and PACS. 4. Create a comprehensive plan for the life cycle management of the organization’s electronic business records. © 2007
  • 3. Today’s Healthcare Organization Mounds of analog paper and film records still exist. © 2007
  • 4. Today’s Healthcare Organization  However, more digital / electronic records are created than analog records.  EVERY MINUTE:  servers log thousands of network interactions  staff members create hundreds of eMail messages  databases record gigabytes of information © 2007
  • 5. Trade Off?  Digital / electronic records / film might take up less physical space than their predecessors, but they remain business records that might be subpoenaed for medical malpractice lawsuits or other legal actions. © 2007
  • 6. Managing Electronic Records/Film  As such, the management of electronic records / film requires the same rigorous principles applied to analog paper records / film. © 2007
  • 7. Way Back When… 1970s  Acknowledging Subpoenas COURTS REQUIRED  The physical delivery of ―original,‖ analog source documents / records.  Only rudimentary paper photocopy machines existed (thermo facsimiles) © 2007
  • 8. Way Back When… 1970s Deborah’s cardboard box approach! © 2007
  • 9. Way Back When… 1980s - 1990s  Acknowledging Subpoenas COURTS ACCEPT – Photocopies of ―original,‖ electronic source documents and records © 2007
  • 10. 2010  Acknowledging Subpoenas COURTS ACCEPT – Secured electronic files of ―original,‖ electronic source documents and records – Hard copy computer printouts of ―original,‖ electronic source documents and records © 2007
  • 11. 2010  Secured electronic files and hard copy computer printouts are admissible in court as long as the healthcare organization can substantiate – the trustworthiness of the system(s) used to store and retrieve the documents and records – the accuracy of the organization’s records management policies and procedures – the documents and records were not created just for a court case. It is important to verify the courts’ acceptance of digital records on a state-by-state basis. © 2007
  • 12. 2010  Acknowledging the humungous number of other requests for Release of Information (RoI) / Disclosure of Information PATIENTS / ATTORNEYS / … ETC. – Demanding and, in most cases, entitled to ―any and all records‖ connected to an episode of care © 2007
  • 13. No Longer Cardboard Boxes  Organizational intranets and Web portals allowing designated Custodians of Records, RoI professionals, and even patients — after rigorous authorization and authentication processes — to  click on hyperlinks  instantaneously retrieve ―original‖ electronic source documents and objects required by subpoenas or other requests  securely transmit them to the requesters © 2007
  • 14. Electronic Source Records  All related digital (electronic) patient financial records from financial data repositories © 2007
  • 15. Electronic Source Records  All related digital (electronic) patient medical records from clinical data repositories, such as  acute care health records  ambulatory care health records  long-term care health record  mental health care records © 2007
  • 16. Electronic Source Records  Includes all related:  Digital ―conversations,‖ including eMail messages, vMail messages, e- annotations (the equivalent of electronic Post-it notes), text messages, and digitized telephone consults © 2007
  • 17. Electronic Source Records  Includes all related:  Digital diagnostic images from diagnostic image repositories, including digital X-rays as well as CT, MR, and nuclear medicine © 2007
  • 18. Electronic Source Records  Includes all related:  Cine, including cardiac catheterization and ultrasound images (video files) from video repositories  Digital medical dictation (audio files) from audio repositories © 2007
  • 19. Electronic Source Records  Includes all related:  Medical transcription (text files) from text repositories  Digital photographs, including those taken from pathology digital cameras-on-a-stick © 2007
  • 20. Electronic Source Records  Includes all related:  Waveforms (signal trace or graphic files) from signal trace repositories, including ECGs, fetal traces, and output from other electronic, point- of-care medical devices © 2007
  • 21. Electronic Source Records Handwritten Notes Laboratory Orders / Results and Drawings Orders / Medication Orders / MARs Signed Patient Online Charting Consent Forms Original, and Analog Discrete, Documentation Documents- Structured Document Data Image Data Detailed Radiology Charges Reports Diagnostic Text Data CT Transcribed Image Data MR Reports Video Ultrasound Signal Nuclear Med UBs and Data Audio Tracing Itemized Bills Data Data Pathology Ultrasound and Images Cardiac Catheterization EKG/EEG/Fetal Examinations Heart Voice Dictations Monitoring Signal Sounds & Annotations Tracings © 2007
  • 22. Electronic Health Records  Encompass health information recorded on any digital medium as read-only or rewritable formats – Magnetic tape / disk – WORM optical disk – CD / DVD © 2007
  • 23. Electronic Health Records  Are evidence of transactions or events that – have legal or business value (i.e., the records reflect the business objectives of the organization, such as receiving reimbursement for services provided) – indicate an intention to be memorialized © 2007
  • 24. Electronic Health Records = Business Records Subject to Evidentiary Discovery © 2007
  • 25. Electronic Health Records = Not Business Records  Reproductions of the electronic records that are provided by the organization to an individual or another healthcare organization for convenience purposes © 2007
  • 26. Electronic Health Records = Not Business Records  Ad hoc or draft electronic record documents, such as some eMail, some vMail, some eAnnotations, text messages, work sheets, work lists, works-in-progress, and database manipulations © 2007
  • 27. Electronic Health Records = Not Business Records  Personal Health Records (PHRs), which are patient owned, managed, and populated -- and might include copies of the healthcare organization’s business record files. © 2007
  • 28. Caveat?  BUSINESS RECORDS IF  the records are subsequently used by the healthcare organization in evaluating or treating the patient, such as providing care, reviewing data, and documenting observations, actions, or instructions  FOR EXAMPLE  patient-owned, managed, and populated ―tracking‖ records, such as electronic medication tracking records, glucose and insulin tracking records, etc. © 2007
  • 29. Caveat?  THE FEDERAL RULES OF CIVIL PROCEDURE GOVERNING ELECTRONIC DISCOVERY, effective December 1, 2006. For example: © 2007
  • 30. Caveat?  Rule 26 – the Rule that describes the legal obligation to maintain and disclose relevant records – specifies that ―a party must now, without awaiting a discovery request, provide to other parties a copy of, or description by category and location of, electronically stored information‖. © 2007
  • 31. Think About That …  Without awaiting a Discovery Request  Provide a Copy of, or Description by  Category And  Location Of  Electronically Stored Information  CAN YOU DO THIS NOW? © 2007
  • 32. Electronic Records Management  The process by which electronic records are created and preserved for evidentiary discovery (i.e., legal / business) and, now, electronic discovery purposes © 2007
  • 33. Electronic Records Management  Requires astute decision making throughout the life cycle of the electronic record © 2007
  • 34. Electronic Record Decision Making  What electronic records to keep?  How long to keep?  How to assign record authorities and responsibilities?  How to design the process?  How to administer the process?  How to audit the process?  How to review the process? © 2007
  • 35. Electronic Record Life Cycle  Creating / Receiving  Indexing  Searching  Retrieving  Processing  Routing / Distributing  Storing  Maintaining  Securing  Purging / Archiving / Destroying © 2007
  • 36. Health Electronic ^ Records Management  Example healthcare information systems capable of creating electronic records and then processing, distributing, maintaining, storing, retrieving, archiving, and destroying the records… © 2007
  • 37. Health Electronic ^ Records Management  Patient billing and accounts receivable systems  Healthcare information systems  Clinical information systems © 2007
  • 38. Health Electronic ^ Records Management  Cardiology, laboratory, radiology, and pharmacy information systems  Picture Archiving and Communications Systems (PACS) © 2007
  • 39. Health Electronic ^ Records Management  Digital dictation systems and speech recognition systems  Word processing (i.e., transcription) systems © 2007
  • 40. Health Electronic ^ Records Management  Electronic document management systems (EDMSs)  Report, print, and output management systems (e.g., reproduction systems) © 2007
  • 41. Health Electronic ^ Records Management  eMail systems (e.g., Microsoft Outlook)  Collaboration systems (e.g., project extranets and online conferencing systems) © 2007
  • 42. Health Electronic ^ Records Management  Dynamic Web site systems with online forms, transactions, and metadata © 2007
  • 43. Health Electronic ^ Records Management  It’s now time for healthcare organizations to address the new challenges involved in the ongoing maintenance and management of the EHR.  This requires:  management strategies  knowledge and leadership skills to shape and deploy the strategies © 2007
  • 44. Health Electronic ^ Records Management  Creating and maintaining EHR retention and disposition schedules based on administrative, legal, fiscal, and historical needs  Establishing documented procedures for the scheduled destruction of obsolete EHRs and retaining proof of such destruction  Developing, implementing, and maintaining efficient EHR filing systems  Quickly locating and organizing EHRs © 2007
  • 45. Health Electronic ^ Records Management  Training personnel in the use and function of EHR management processes  Ensuring the confidentiality, security, and integrity of the information contained in the EHRs  Monitoring / auditing the completeness and accuracy of the EHR content © 2007
  • 46. Automated EHRM Functions  Record capture, where a predefined set of metadata is established supporting accurate representation of the record with disciplined disposition and retention actions  Record classification, where appropriate categories of records are established with applied rules © 2007
  • 47. Automated EHRM Functions  Record preservation format, where a format, such as eXtensible mark-up language (XML) or portable document format (PDF), is established for retrieval and cross-departmental interchange  Record retention calculation, where ―triggers‖ automatically save electronic documents or Web content as records according to pre-established business rules © 2007
  • 48. Automated EHRM Functions  Record disposition control, where rules provide electronic notifications to managers that certain records or documents have met their retention dates and require manual confirmation to delete, save, or destroy  Record deletion and destruction and suspension of record deletion and destruction to support litigation. © 2007
  • 49. Health Electronic ^ Records Management LONG TERM STRATEGIES  Develop a comprehensive plan for EHR life cycle management  Incorporate the plan into the organization’s IT strategic plan  Dictate the plan to the users © 2007
  • 50. Health Electronic ^ Records Management SHORT TERM PLANS  Develop EHR policy / procedure guidelines for existing information systems  Develop EHR policy / procedure guidelines before buying new EHR technologies / systems © 2007
  • 51. Health Electronic ^ Records Management • A ________ information system shall allow users to create folder hierarchies, wherein users can place electronic documents or records that contain PHI. • A ________ information system shall be capable of automatically applying classification and retention schedules that are established by the healthcare organization. • A ________ information system shall be capable of taking Web site snapshots, allowing users to record the sequence of the screens encountered during a Web site transaction. © 2007
  • 52. Health Electronic ^ Records Management TECHNICAL CONSIDERATIONS  Identify all existing enterprise-wide repositories that securely store EHR records and documents which merit evidentiary discovery handling  Move all inactive or semi-active files to separate, secure storage © 2007
  • 53. Health Electronic ^ Records Management TECHNICAL CONSIDERATIONS  Implement a regular sweep of EHR information to ensure that the archive is kept accurate and up to date  Trawl the archive and assign retention flags to information © 2007
  • 54. Health Electronic ^ Records Management TECHNICAL CONSIDERATIONS  Destroy unflagged files from the archive  Manage large files and file types for security purposes © 2007
  • 55. Health Electronic ^ Records Management COLLABORATION OF EXPERTS  Legal professionals  HIT professionals  HIM professionals  Risk / Compliance professionals  Clinical professionals © 2007
  • 56. Questions & Answers dkohn@daksystcons.com www.daksystemsconsulting.com © 2007