1. HL7 Immunization User Group First Meeting April 10, 2014

2. Agenda Welcome Presentation on IIS Interoperability Status Check Organization Updates Future Work Group Topics Open Discussion Next Meeting

3. Welcome Introducing co-chairs: Kim Salisbury-Keith Nathan Bunker Welcome to the HL7 community – Chuck Jaffe HL7 was founded in 1987, and now has over 2,000 members. Global authority for healthcare information interoperability and standards Announced establishment of this User Group meeting on April 2 Welcome to the AIRA community – Alison Chi The American Immunization Registry Association (AIRA) is a membership organization that promotes the use of Immunization Information Systems (IIS)

4. Group Charter and Purpose Provide support for implementers associated with: Immunization Information System (IIS) Electronic Health Record (EHR) Focus on the following topics: Education and training on how to use HL7 messages Share lessons learned Ask questions Provide feedback that the Public Health and Emergency Response (PHER) work group and the AIRA Standards and Interoperability Steering Committee (SISC) can use to make further improvements to the immunization standards

5. Welcome Meeting Schedule Second Thursday of every month 2:00 PM Eastern / 11: AM Pacific User Group Membership Members of HL7 Members of AIRA Special HL7 User Group Membership

6. IIS Interoperability Status Check Independent Report by Nathan Bunker Dandelion Software & Research Inc.

7. Background Certified Electronic Health Record (EHR) systems must be able to demonstrate the ability to support seven (7) scenarios Developed in the Summer of 2012 by NIST with cooperation from the Immunization Information System (IIS) community EHR system vendors are now building support and upgrading systems This certification process is good news for IIS Status Check project is designed to verify if IIS are ready to work with these soon to be upgraded EHR systems Short CDC project conducted in spring of 2013.

8. MT WY ID WA OR NV UT CA AZ ND SD NE CO NM TX OK KS AR LA MO IA MN WI IL IN KY TN MS AL GA FL SC NC VA WV OH MI NY PA MD DE NJ CT RI MA ME VT NH AK HI PR SDIR IM SA NYC PHIL Status Check Participation Guam American Samoa RIDE DC PARTICIPATED WILLING

9. Status Check Process 1.Seven (7) NIST test messages were submitted to each IIS 2.The results were reviewed to determine if each message was accepted 3.If a message was rejected, changes were made to the message, and the process was repeated starting from step 1 4.After all messages are accepted, the changes made to the message were documented and analyzed 5.Any change made that was not anticipated by NIST certification was labeled as a “local requirement” or in other words local constraint

10. Results Overall All IIS that participated supported the HL7 2.5.1 or HL7 2.3.1 standard The IIS that didn’t participate are known to already have or will have soon HL7 2.5.1 interfaces IIS have shown great support for the HL7 community standard by universally adopting it There are minor local variations that must be considered by any EHR system integrating with IIS across the US

11. Results The most common reasons for minor local variations are: Local requirements for identifying the sender of the message Inability to correctly handle vaccination refusals or history of disease Rigid enforcement of minor technical requirements based on local interpretations of current or previous standards Problems correctly accepting or ignoring certain types of vaccination information

12. Identifying the sender of the message IIS have several different methods used for identifying and authenticating the sender of the message: Transport Layer MSH-4 Sending Facility MSH-4.2 Sending Facility – Universal Id MSH-8 Security RXA-11.4 Administered-at-Location Facility Combinations of any of these fields Problem of identifying the sender is common to all IIS IIS are solving this problem in different ways

13. Vaccination Refusals or History of Disease Many IIS are not prepared to accept vaccination refusals or history of disease (such as history of varicella) IIS are not required to store either of these types of information, but shouldn’t reject messages that contain them NIST requires EHR systems to be able to report this information All IIS will potentially receive vaccination refusals and history of disease information All IIS should ensure that HL7 interface can: Accept or ignore RXA segments with a CVX code of 998 in RXA-5 Accept or ignore RXA segments with Completion Status of RE in RXA-20

14. Too Rigid Enforcement of HL7 Rules Rejection of messages for optional or required-but-may be empty fields that are generally not critical to IIS functions: Rejecting message because RXA-4 Date/Time End of Administration field is empty Rejecting message because the ethnicity code was not recognized Rejecting message because value in RXA-9.2 was not what was expected Rejecting messages because the LOINC in OBX-3 was not recognized IIS should not reject entire message if: Problem occurs in optional or required-but-may-be-empty fields Does not severly impact quality of core data received

15. Certain Types of Vaccination Information NIST requires EHR systems to report the following information in OBX segments: VIS type VIS published date VIS given date VFC status for immunization Many IIS complained or rejected messages with these types of fields in them IIS may warn sender that these fields were not accepted IIS should not reject messages when these fields are present

16. Other Local Rules Some other local rules were identified: Requiring insurance information (IN1 segment) Requiring address (very common requirement) Requiring consent on child and/or adult records Requiring that the sender NOT submit SSN Requiring vaccinations for new patient records Many of these requirements should be documented nationally for EHR system implementers Some of these requirements could be captured as comments or defined optional uses in the national guide

17. Recommendations Short Term for 2013 Create a companion document to the CDC Implementation Guide that details known local requirements IIS should provide EHR vendors with regular and ongoing access to the IIS test system – In Process, IIS are working to improve and establish test systems IIS should work towards reducing local requirements and aligning to the national standard, particularly in areas that do not directly impact local IIS policies and project requirements – In Process, release 1.5 gives guidance to prevent rejection of messages for small issues

18. Recommendations Medium Term for 2013-2015 IIS community should discuss and harmonize standards for authenticating and identifying submitters – In Process, SISC is discussing IIS community should discuss and harmonize the format and contents of Acknowledgement (ACK) messages – Completed, included in release 1.5 guide IIS should continue adopting the national transport standard recommended by the Transport Layer Expert Panel – In Process, IIS are increasing adoption of this standard

19. Recommendations Long Term for 2013-2020 IIS Interoperability Status Check or equivalent process should be conducted on a regular basis – In Process, at least a few major vendors and other IIS have implemented a version of the Status Check process in their software quality assurance process The process of identifying local requirements and aligning them to national standards should continue, either by encouraging the adoption of national standards at the local level or by defining and creating a national standard to support the common local usage – In Process, issues are being identified and discussed by SISC. Certification standard or conformance process for IIS HL7 interfaces should be developed

20. Get Involved and Next Steps The IIS Interoperability Status Check project has completed A continuation project is now in beta stage of testing Open Immunization Software project IIS HL7 Tester application Testing application can be used to automatically test a real-time HL7 interface Self-directed Next steps for community Exploring creation of an HL7 user group Expansion of input of testing process to entire community For more information please visit: http://openimmunizationsoftware.net/interfacing/IIS%20HL7%20Tester.html

21. Organization Updates Rob Savage

22. Public Health and Emergency Response (PHER) Covers the following topics: Immunization Electronic Lab Reporting Case Reporting Vital Records Public Health-related CMETs Meets every Thursday at 4:00 pm Eastern HL7 wiki: http://wiki.hl7.org/index.php?title=Public_Health_and_Emergency_R esponse_work_group_%28PHER%29

23. Standards and Interoperability Steering Committee (SISC) Provides technical support and guidance to interoperability efforts of AIRA members and the IIS community Changes to the CDC HL7 Immunization guide are discussed and planned in this committee Activities in March: Reviewed improvements for CDC HL7 Immunization Guide release 1.5. Reviewed proposed changes to CDC WSDL Dissolved Web Services Workgroup Began discussions on Office of National Coordinator (ONC) Notice of Proposed Rulemaking (NPRM) relating to an update to EHR certification

24. CDC Implementation Guide release 1.5 March 11, 2015 latest version published here: http://www.cdc.gov/vaccines/programs/iis/technical- guidance/hl7.html http://www.cdc.gov/vaccines/programs/iis/technical- guidance/hl7.html Some of the areas that were updated: Processing of errors Acknowledgement and error handling Query/response Corrected error and no match acknowledgement Query for requesting evaluated history and forecast

25. Future Work Group Topics Nathan Bunker

26. Proposed Future Topics Identify gaps or areas of confusion in current standards Demonstrations or updates on test systems Updates from NIST on EHR and IIS testing systems Review of the Open Immunization Software (OIS) test process Updates from HL7 on conformance testing software Others? Review of systems that support automated onboarding processes Discussion on recruiting additional user group members Other topics?

27. Examples of Identifying Gaps Use of PID-3 for transmitting the Medical Record Number Use of RXA-11.4 Defined for transmitting location of administration Used by many IIS for inventory tracking purposes Old administered vaccinations An administered vaccination from 10 years ago with no lot number What standard should be used for two factor authentication on web service messages?

28. Homework Assignment Identify Gaps What gaps have you seen in the standards? What areas do you have questions on? Are there items that have been problematic that you think need to be clarified? Other Topics Review list of topics proposed Propose any other topics that need to be discussed

29. Open Discussion Kim Salisbury-Keith

30. Open Discussion Questions Issues Suggestions

31. Next Meeting May 8, 2014 – 2:00 pm EDT / 11:00 am PDT Assignments before next meeting: Complete survey that will appear after the meeting Forward list of gap, questions, and problem areas in the current standards to Nathan.Bunker@gmail.com so they can be collected and discussed in the next meeting Nathan.Bunker@gmail.com Think of other topics that could be discussed by the group

32. More Information Web Links Subscribe to immunization group http://www.hl7.org/participate/UserGroups.cfm?UserGroup=Immunization http://www.hl7.org/participate/UserGroups.cfm?UserGroup=Immunization Public User Group Wiki http://www.hl7.org/special/committees/iug/index.cfm http://www.hl7.org/special/committees/iug/index.cfm Private User Group Wiki http://iugwiki.hl7.org/ http://iugwiki.hl7.org/ HL7 Press Release http://www.hl7.org/documentcenter/public_temp_F760602A-1C23-BA17- 0C0D326E635471F9/pressreleases/HL7_PRESS_20140402.pdf http://www.hl7.org/documentcenter/public_temp_F760602A-1C23-BA17- 0C0D326E635471F9/pressreleases/HL7_PRESS_20140402.pdf AIRA Press Release http://www.immregistries.org/events/2014/04/10/hl7-immunization-user-group http://www.immregistries.org/events/2014/04/10/hl7-immunization-user-group

33. Contact Information If you have any questions or comments: Kim Salisbury-Keith Kim.SalisburyKeith@health.ri.govKim.SalisburyKeith@health.ri.gov Nathan Bunker Nathan.Bunker@gmail.comNathan.Bunker@gmail.com Thank you!