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Linking Newborn Screening to
                  Electronic Health records

                  MENA NBS DD conference, Doha, Qatar
                  April 29th 2010
                  Kari Klossner
                  Director, Market and Sales Development




1   © 2009 PerkinElmer
My Topics

    Overview of EHRs, HL7 and how they can benefit NBS
    Practical considerations in this field
    Lessons learned
    Q&A




2
EHR, HL7,
                  EHR HL7 and NBS




3   © 2009 PerkinElmer
What is an EHR… (also electronic / computerized patient record)

                  A textbook definition from Wikipedia.com
     An EHR is… a collection of electronic health information about individual patients or
     populations. It is a record in digital format that is capable of being shared across
     different health care settings… Such records may include… demographics, medical
     history, medication and allergies, immunization status, laboratory test results,
     radiology images, and billi iinformation.
       di l     i           d billing f       ti

     An EHR is… and maintained within an institution, such as a hospital, integrated
     delivery network, clinic, or physician office

     The purpose is… a complete record… allows to automate and streamline workflow
          p p                 p
     in health care settings and to increase safety through evidence-based decision
     support, quality management, and outcomes reporting



4
Why EHR – Key motivations to invest

               Reduce costs
                           Elimination of duplicated efforts
                           Reduction of errors


Improved quality of care
        Can reduce medical errors by providing HC workers with decision support.
        Fast
        F t access t medicall literature & best practices improve h lth
                   to di lit t             b t      ti i          healthcare efficacy.
                                                                              ffi



               Promote evidence based medicine
                       evidence-based
                           EHRs give access to unprecedented amounts of clinical data for research
                           Can accelerate the level of knowledge of effective medical practices.


Support record keeping and mobility
        EHR’s can connect to many electronic medical record systems.
        In the current global medical environment patients are shopping for their procedures.
                                      environment,                                procedures


5
Introduction to EHR and HL7

    HL7 is an organization
        Founded 1987, HQ in Ann Arbor, MI, USA,
        Non profit, ANSI-accredited standards development organization
        Exchange, integration, sharing, and retrievall of electronic h lth
        E h         i t   ti    h i       d ti          f l t i health
        information
        > 2,300 members worldwide
        > 500 corporate members… > 90% of healthcare IT vendors
                  p

        Name (Health Level 7) refers to the application level of the ISO seven
        layer communications model


    HL7 is a language, a standard… an IT tool
        Allows for non compatible IT systems exchange information in a standard manner



    HL7 is what is used to achieve interoperability in healthcare



6
Interoperability in newborn screening

     Where can newborn screening realize the greatest benefits?



    Birthing center                           NBS Lab                          HC Provider

                                                             Results
                                                             R lt
                        Demographics                         Recommendations
                                                             Requests




     Manual manipulation of data = Opportunity to apply interoperability




7
Change in process… the Old Way vs the New Way
                Birthing
                Bi thi center
                          t                                                Birthing
                                                                           Bi thi center
                                                                                     t
    1. Sample is taken                                        1. Sample is taken
    2. Demographics are recorded                              2. Demographics are recorded
    3. Blood card is mailed to the lab                        3. Blood card is mailed to the lab




          Newborn Screening Lab                                     Newborn Screening Lab
    4. Blood card is received at the lab                      4. Blood card is received at the lab
    5. Information is recorded into computer
                                                Opportunity      (Entry automated via interoperability)
    6. Analysis is p
           y       performed                    for Human
                                                              5. Analysis
                                                              5 A l i iis performed
                                                                             f    d
    7. Report is printed                           Error
                                                                 (Reporting automated via interoperability)
    8. Report is mailed to provider
                                                Redundant,
                     Report                      non value
                                                  adding,
                                                 repetitive
                 HC Provider                                                 HC Provider
                                                   work
    9.
    9 Report is received
                                                                 (Receiving automated via interoperability)
    10. Information is recorded into computer
                                                ELIMINATED
    11. Results are communicated to family                    6. Results are communicated to family
8
The challenge is shared and seen by many….


     Differences in regional practices & regulations
        Test panels are very different
             p             y
        Testing and reporting methods differ customer to
        customer
                                                                                    Solutions
        There are no blood card data or format standards
                                                                                    tailored to
                                                                                     customer
                                                                                      specific
     Developing interoperability standards
                                                                                       needs
        Universal electronic coding and transmission
        standards are just now becoming available
        (HRSA / NLM)




99                                                         …but solutions are different and diverse
Practical considerations
                   on
                   EHR/HL7
                   interoperability in NBS
                         p        y




10   © 2009 PerkinElmer
Key goals for laboratories to pursue with EHR interoperability
                                                                                       Statistical accuracy
          Reduce                                                                       Laboratory efficiency



       Demographic data entry errors
       Time spent in data entry                                                               Increase
       Turn around time


       Typically, following areas of application considered:


                                                 Laboratory
                                                                          Results



                                                                     nd
                                           nd




                                                                          Recommendations


                                                               Outboun
                                      Inboun




             Demographic import
             D          hi i
                                                                          Repeat requests
             Testing requests
                                                                          Follow-up ST & LT
                                                                          Billing




11
Highlighting a few real life
       g g g
            examples…




12
Alberta, Canada
       British Columbia, Canada
                                               Outbound only                             Leeds, UK
           Inbound/Outbound
                                      Customized solution, HL7 v2.2
     Customized solution, HL7 v2.3
                                     Integration with provincial health                Go-live 2Q 2010
        Integration with a HIMS
                                                  network                            Inbound + Outbound
                                                                                       xChange, HL7 v3
                                                                                 Integration with NHS Spine


                                                                                     Zurich, Switzerland

                                                                                      Go-live 2H 2010
                                                                                    Inbound + Outbound
                                                                                     xChange, HL7 v2.2
                                                                               Integration to national hospital
                                                                                           network



                                                Ohio, USA
            Kentucky, USA                                                      Illinois, USA
                                             Go-live 2Q 2010
           Go-live 2Q 2010                                                Requirements gathering
                                           Inbound + Outbound
            Outbound only                                                  Inbound + Outbound
                                      Customized solution, HL7 v2.3
         xChange, HL7 v2.5.1                                               xChange, HL7 v2.5.1
                                      (upgrade to v2.5.1 + HITSP IS
     HITSP IS 92 NBS standards,
        S S9          S s a da ds,                                        Use HITSP IS 92 NBS
                                                                                  S S9        S
                                     92 NBS standards), Integrations
                                               t d d ) I t        ti
     Integration with state health                                         standards (proposed)
                                     with multiple hospital information
        information exchange                                                 Integrations TBD
                                                  systems
13
Typical NBS Interoperability Architecture – Big Picture

      Laboratory Information System                 Interoperability Layer




       Message             Outbound      Outbound
       Triggering          Message       Messages        LIMS Vendor’s
         Event             Procedure      Table             Service

                                                                                  EHR
                                                            Partner
                    System Data Tables
                                                           Outsource             System
                                                           Laboratory

             Data            Inbound      Inbound
           Validation       Message      Messages
            Engine          Procedure       Table

                        LIMS Database

              Typically a PRODUCT                   a PRODUCT, a SERVICE       Typically regional
      developed by a commercial LIMS vendor            or a combination       health organization
                                                        developed by a
                                                        LIMS vendor, a       e.g. NHS SPINE in UK
                                                        Partner, or the
                                                          Laboratory

 14
14
Alberta – outbound only, laboratory managed messaging

      Laboratory Information System                Interoperability Layer




      Message             Outbound      Outbound
      Triggering          Message       Messages
        Event             Procedure                                         HL7 V2.2
                                         Table

                                                                                          EHR
                                                           Partner
                   System Data Tables                                                    System
                                                          Laboratory




                      LIMS Database
                                                         CloverLeaf                    Provincial H l h
                                                                                       P i i l Health
                                                                                           Network




 15
15
Kentucky – outbound only, partner managed messaging

         Laboratory Information System                                          Interoperability Layer




          Message              Outbound           Outbound
          Triggering           Message            Messages
            Event              Procedure                                                                       HL7 V2.5.1
                                                   Table



                       System Data Tables
                                                                                          Partner                                 KHIE
                                                                                         Outsource




                                                                                                                 HITSP IS* 92
                                                                                                               Interoperability
                          LIMS Database
                                                                                                                              Commonwealth of
                                                                                                                              C           lh f
                                                                                                                               Kentucky Health
                                                                                                                            Information Exchange
                                                                                   http://www.mirthcorp.com/



      * The Healthcare Information Technology Standards Panel (HITSP) Interoperability Specification (IS)


 16
16
Leeds – bidirectional, partner managed messaging

      Laboratory Information System                Interoperability Layer




      Message             Outbound      Outbound
      Triggering          Message       Messages
        Event             Procedure                                         HL7 V3
                                         Table

                                                                                           NHS
                                                           Partner
                   System Data Tables
                                                          Outsource                        Spine

            Data            Inbound      Inbound
          Validation       Message      Messages
           Engine          Procedure       Table

                       LIMS Database
                                                        SmartWorks                   National H l h S i
                                                                                     N i l Health Service
                                                                                       network backbone




 17
17
Leeds and the NHS Connecting for Health (CfH) program
     P t of the UK Nationall Health System (NHS)
     Part f th     N ti      H lth S t                                              Birmingham
                                                                                       Bristol
     CfH goal: make EHRs available for all NHS patients                             Cambridge
                                                                                       Cardiff
         Anywhere in the country                                                     Newcastle
                                                                                      Glasgow
         By means of the NHS spine network                                             Leeds
                                                                                      Liverpool
                                                                                Great Ormond Street
                                                                                 Central Middlesex
     Pilot project: Leeds St. James Hospital                                        Carshalton
                                                                                     Lewisham
                                                                                     L i h
         First step outbound data                                                   Manchester
                                                                                       Oxford
         Go live April 2010                                                         Portsmouth
                                                                                      Sheffield
         Second step inbound data
         Next roll out from region to country
                                                   Goal to connect all UK NBS labs to NHS net




18
Key motivations* at St James’ to implement NBS interoperability

     Ensure every baby gets screened by                                            Much quicker data entry
     checking against birth records                                                  Get better data faster

     Missing a baby would have
     - disastrous consequences
     - major financial liability        Safeguard                          Speed



     No printing                                                                           Eliminate human
     No envelopes
     No stampsp
                                        Efficiency                      Accuracy      errors in transcription

     No mailman




 * Based on an interview with Dr. Mick Henderson, St.James’ Hospital, Leeds, UK
19
Lessons learned
                                                                                Laboratory
      All typical lessons learned from an IT project
      apply… cannot overstate the importance of:                                               Submitter
                                                              Consultant(s)
                                                                                               (hospital)
          Getting buy-in from stakeholders & key p y
                g y                            y players
                                                                              Several key
          Setting right expectations                                           players all
          Creating a solid specification                                      have to work
                                                                                together
          Professional execution and monitoring
                                              g
                                                              HIMS vendor                    HL7 integrator



                                                                               LIMS vendor




      Key Challenge: the submitters (hospitals) are key players but most of the greatest
      key benefits are realized on the lab side
          Submitters may only see the cost side and can be reluctant to sing up
          Have to “sell” to submitters – “what’s in it for us”



20
Benefits realized by the community

                                                                               “The effects on turnaround time are huge” 1
                                                                                       No postal delay for reporting results saves 2-3 days

                                                                               “HL7 increases the lab’s efficiency” 1,2
                                                                                       Reduces the lab’s call volume
                                                                                       Data transfers are automatic



           “We know what babies haven’t had a newborn screen” 1,2
                   Birth records can be compared to blood cards received




                                                              “HL7 increases our data accuracy” 1,2
                                                                      Validates and reduces the amount of manually entered demographic data
                                                                      No manual entry of results into downstream electronic systems

                                                              “Our data is more accessible” 1,2
                                                                      Downstream systems offer 24x7 access to results
                                                                      Doctors can access patients’ results online, from almost anywhere
                                                                                         p                       ,               y


     1.   Shaina Archer, Genetic Counselor, Alberta Health Services, Edmonton, Alberta CA
21   2.   Graham Sinclair, Biochemical Geneticist, BC Children’s Hospital, Vancouver, British Columbia CA
What should you expect from your vendor…


      Provide the            • Support common messaging stds & xmission protocols

      best solution          • HIT SP IS92 for NBS, HL7, LOINC, SNOMED
                                                    ,    ,        ,
                             • Maintain awareness of national and regional standards

        available              while meeting customer data exchange requirements
                             • Develop innovative solutions to interoperability challenges

         today
         t d                 • Adhere to privacy laws and regulations




         Develop             • Collaborate w/ interoperability standardization
                               initiatives internationally and regionally
                                                                                      HRSA
                                                                                      NLM

      standardized           • Offer system architecture for common communication
                               interface to products

      solutions for          • Proactively make interoperability tools as features of
                               future product
                             • Provide flexible interoperability capabilities
        the future           • S
                               Support customer needs as their regulations change
                                                        d      h i      l i    h

 22
22                           …to stay flexible to meet customer expectations
Summary

     Interoperability hold great promise for NBS
         Inbound data
         Outbound data                                       Safeguard     Speed

     Key benefits can be realized several areas……

                                                             Efficiency   Accuracy
     EHR is the other party your lab connects with

     HL7 is the preferred method to do it
                p

     Implementing interoperability is similar to any other
     IT project with several parties involved
         Keep stakeholders involved
         Sell the benefits




23
For the Better

24

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Leveraging EHR and HL7 for Newborn Screening Integration

  • 1. Linking Newborn Screening to Electronic Health records MENA NBS DD conference, Doha, Qatar April 29th 2010 Kari Klossner Director, Market and Sales Development 1 © 2009 PerkinElmer
  • 2. My Topics Overview of EHRs, HL7 and how they can benefit NBS Practical considerations in this field Lessons learned Q&A 2
  • 3. EHR, HL7, EHR HL7 and NBS 3 © 2009 PerkinElmer
  • 4. What is an EHR… (also electronic / computerized patient record) A textbook definition from Wikipedia.com An EHR is… a collection of electronic health information about individual patients or populations. It is a record in digital format that is capable of being shared across different health care settings… Such records may include… demographics, medical history, medication and allergies, immunization status, laboratory test results, radiology images, and billi iinformation. di l i d billing f ti An EHR is… and maintained within an institution, such as a hospital, integrated delivery network, clinic, or physician office The purpose is… a complete record… allows to automate and streamline workflow p p p in health care settings and to increase safety through evidence-based decision support, quality management, and outcomes reporting 4
  • 5. Why EHR – Key motivations to invest Reduce costs Elimination of duplicated efforts Reduction of errors Improved quality of care Can reduce medical errors by providing HC workers with decision support. Fast F t access t medicall literature & best practices improve h lth to di lit t b t ti i healthcare efficacy. ffi Promote evidence based medicine evidence-based EHRs give access to unprecedented amounts of clinical data for research Can accelerate the level of knowledge of effective medical practices. Support record keeping and mobility EHR’s can connect to many electronic medical record systems. In the current global medical environment patients are shopping for their procedures. environment, procedures 5
  • 6. Introduction to EHR and HL7 HL7 is an organization Founded 1987, HQ in Ann Arbor, MI, USA, Non profit, ANSI-accredited standards development organization Exchange, integration, sharing, and retrievall of electronic h lth E h i t ti h i d ti f l t i health information > 2,300 members worldwide > 500 corporate members… > 90% of healthcare IT vendors p Name (Health Level 7) refers to the application level of the ISO seven layer communications model HL7 is a language, a standard… an IT tool Allows for non compatible IT systems exchange information in a standard manner HL7 is what is used to achieve interoperability in healthcare 6
  • 7. Interoperability in newborn screening Where can newborn screening realize the greatest benefits? Birthing center NBS Lab HC Provider Results R lt Demographics Recommendations Requests Manual manipulation of data = Opportunity to apply interoperability 7
  • 8. Change in process… the Old Way vs the New Way Birthing Bi thi center t Birthing Bi thi center t 1. Sample is taken 1. Sample is taken 2. Demographics are recorded 2. Demographics are recorded 3. Blood card is mailed to the lab 3. Blood card is mailed to the lab Newborn Screening Lab Newborn Screening Lab 4. Blood card is received at the lab 4. Blood card is received at the lab 5. Information is recorded into computer Opportunity (Entry automated via interoperability) 6. Analysis is p y performed for Human 5. Analysis 5 A l i iis performed f d 7. Report is printed Error (Reporting automated via interoperability) 8. Report is mailed to provider Redundant, Report non value adding, repetitive HC Provider HC Provider work 9. 9 Report is received (Receiving automated via interoperability) 10. Information is recorded into computer ELIMINATED 11. Results are communicated to family 6. Results are communicated to family 8
  • 9. The challenge is shared and seen by many…. Differences in regional practices & regulations Test panels are very different p y Testing and reporting methods differ customer to customer Solutions There are no blood card data or format standards tailored to customer specific Developing interoperability standards needs Universal electronic coding and transmission standards are just now becoming available (HRSA / NLM) 99 …but solutions are different and diverse
  • 10. Practical considerations on EHR/HL7 interoperability in NBS p y 10 © 2009 PerkinElmer
  • 11. Key goals for laboratories to pursue with EHR interoperability Statistical accuracy Reduce Laboratory efficiency Demographic data entry errors Time spent in data entry Increase Turn around time Typically, following areas of application considered: Laboratory Results nd nd Recommendations Outboun Inboun Demographic import D hi i Repeat requests Testing requests Follow-up ST & LT Billing 11
  • 12. Highlighting a few real life g g g examples… 12
  • 13. Alberta, Canada British Columbia, Canada Outbound only Leeds, UK Inbound/Outbound Customized solution, HL7 v2.2 Customized solution, HL7 v2.3 Integration with provincial health Go-live 2Q 2010 Integration with a HIMS network Inbound + Outbound xChange, HL7 v3 Integration with NHS Spine Zurich, Switzerland Go-live 2H 2010 Inbound + Outbound xChange, HL7 v2.2 Integration to national hospital network Ohio, USA Kentucky, USA Illinois, USA Go-live 2Q 2010 Go-live 2Q 2010 Requirements gathering Inbound + Outbound Outbound only Inbound + Outbound Customized solution, HL7 v2.3 xChange, HL7 v2.5.1 xChange, HL7 v2.5.1 (upgrade to v2.5.1 + HITSP IS HITSP IS 92 NBS standards, S S9 S s a da ds, Use HITSP IS 92 NBS S S9 S 92 NBS standards), Integrations t d d ) I t ti Integration with state health standards (proposed) with multiple hospital information information exchange Integrations TBD systems 13
  • 14. Typical NBS Interoperability Architecture – Big Picture Laboratory Information System Interoperability Layer Message Outbound Outbound Triggering Message Messages LIMS Vendor’s Event Procedure Table Service EHR Partner System Data Tables Outsource System Laboratory Data Inbound Inbound Validation Message Messages Engine Procedure Table LIMS Database Typically a PRODUCT a PRODUCT, a SERVICE Typically regional developed by a commercial LIMS vendor or a combination health organization developed by a LIMS vendor, a e.g. NHS SPINE in UK Partner, or the Laboratory 14 14
  • 15. Alberta – outbound only, laboratory managed messaging Laboratory Information System Interoperability Layer Message Outbound Outbound Triggering Message Messages Event Procedure HL7 V2.2 Table EHR Partner System Data Tables System Laboratory LIMS Database CloverLeaf Provincial H l h P i i l Health Network 15 15
  • 16. Kentucky – outbound only, partner managed messaging Laboratory Information System Interoperability Layer Message Outbound Outbound Triggering Message Messages Event Procedure HL7 V2.5.1 Table System Data Tables Partner KHIE Outsource HITSP IS* 92 Interoperability LIMS Database Commonwealth of C lh f Kentucky Health Information Exchange http://www.mirthcorp.com/ * The Healthcare Information Technology Standards Panel (HITSP) Interoperability Specification (IS) 16 16
  • 17. Leeds – bidirectional, partner managed messaging Laboratory Information System Interoperability Layer Message Outbound Outbound Triggering Message Messages Event Procedure HL7 V3 Table NHS Partner System Data Tables Outsource Spine Data Inbound Inbound Validation Message Messages Engine Procedure Table LIMS Database SmartWorks National H l h S i N i l Health Service network backbone 17 17
  • 18. Leeds and the NHS Connecting for Health (CfH) program P t of the UK Nationall Health System (NHS) Part f th N ti H lth S t Birmingham Bristol CfH goal: make EHRs available for all NHS patients Cambridge Cardiff Anywhere in the country Newcastle Glasgow By means of the NHS spine network Leeds Liverpool Great Ormond Street Central Middlesex Pilot project: Leeds St. James Hospital Carshalton Lewisham L i h First step outbound data Manchester Oxford Go live April 2010 Portsmouth Sheffield Second step inbound data Next roll out from region to country Goal to connect all UK NBS labs to NHS net 18
  • 19. Key motivations* at St James’ to implement NBS interoperability Ensure every baby gets screened by Much quicker data entry checking against birth records Get better data faster Missing a baby would have - disastrous consequences - major financial liability Safeguard Speed No printing Eliminate human No envelopes No stampsp Efficiency Accuracy errors in transcription No mailman * Based on an interview with Dr. Mick Henderson, St.James’ Hospital, Leeds, UK 19
  • 20. Lessons learned Laboratory All typical lessons learned from an IT project apply… cannot overstate the importance of: Submitter Consultant(s) (hospital) Getting buy-in from stakeholders & key p y g y y players Several key Setting right expectations players all Creating a solid specification have to work together Professional execution and monitoring g HIMS vendor HL7 integrator LIMS vendor Key Challenge: the submitters (hospitals) are key players but most of the greatest key benefits are realized on the lab side Submitters may only see the cost side and can be reluctant to sing up Have to “sell” to submitters – “what’s in it for us” 20
  • 21. Benefits realized by the community “The effects on turnaround time are huge” 1 No postal delay for reporting results saves 2-3 days “HL7 increases the lab’s efficiency” 1,2 Reduces the lab’s call volume Data transfers are automatic “We know what babies haven’t had a newborn screen” 1,2 Birth records can be compared to blood cards received “HL7 increases our data accuracy” 1,2 Validates and reduces the amount of manually entered demographic data No manual entry of results into downstream electronic systems “Our data is more accessible” 1,2 Downstream systems offer 24x7 access to results Doctors can access patients’ results online, from almost anywhere p , y 1. Shaina Archer, Genetic Counselor, Alberta Health Services, Edmonton, Alberta CA 21 2. Graham Sinclair, Biochemical Geneticist, BC Children’s Hospital, Vancouver, British Columbia CA
  • 22. What should you expect from your vendor… Provide the • Support common messaging stds & xmission protocols best solution • HIT SP IS92 for NBS, HL7, LOINC, SNOMED , , , • Maintain awareness of national and regional standards available while meeting customer data exchange requirements • Develop innovative solutions to interoperability challenges today t d • Adhere to privacy laws and regulations Develop • Collaborate w/ interoperability standardization initiatives internationally and regionally HRSA NLM standardized • Offer system architecture for common communication interface to products solutions for • Proactively make interoperability tools as features of future product • Provide flexible interoperability capabilities the future • S Support customer needs as their regulations change d h i l i h 22 22 …to stay flexible to meet customer expectations
  • 23. Summary Interoperability hold great promise for NBS Inbound data Outbound data Safeguard Speed Key benefits can be realized several areas…… Efficiency Accuracy EHR is the other party your lab connects with HL7 is the preferred method to do it p Implementing interoperability is similar to any other IT project with several parties involved Keep stakeholders involved Sell the benefits 23