Unit 3: Interoperability Standards in Public Health IT Lecture c – ONC Certification of Public Health Functions and an Overview of the Standards Employed Welcome to Public Health IT, Unit 3. In this Unit we will be discussing interoperability standards in public health IT. This material (Comp13_Unit3c) was developed by Columbia University, funded by the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology under Award Number 1U24OC000003. This material was updated by Columbia University under Award Number 90WT0004. This work is licensed under the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/4.0/.

Interoperability Standards in Public Health IT Learning Objectives Objective 1: Explain and describe the Meaningful Use and MIPS Advancing Care Public Health Objective Objective 2: Describe the Public Health Engagement process required for Meaningful Use compliance Objective 3: Know the ONC Certified Capabilities of EHRs that support public health capabilities Objective 4: List and discuss the public health IT standards used for Meaningful Use and MIPS Advancing Care public health objectives or referred to in the ONC Standards Advisory The learning objectives for the interoperability standards in public health IT unit are: 1) Explain and describe the Meaningful Use and MIPS Advancing Care Public Health Objective, 2) Describe the Public Health Engagement process required for Meaningful Use compliance, 3) Know the ONC Certified Capabilities of EHRs that support public health capabilities, and 4) List and discuss the public health IT standards used for Meaningful Use and MIPS Advancing Care public health objectives or referred to in the ONC Standards Advisory. This lecture will focus on the specific certification capabilities of ONC certified health information technology as well as on the interoperability standards for public health are used to develop these capabilities.

Certified health information technology required Meaningful Use Modified Stage 2 ONC 2014 MIPS and Meaningful Use Stage 3 ONC 2015 Vendors obtain ONC 2014 or ONC 2015 certification for specific standards – based electronic public health reporting capabilities as part of the certification process You may recall that the Meaningful Use and MIPs programs require that certified health information technology be used. For Modified Stage 2, ONC 2014 certified technology is required. For Meaningful Use Stage 3 and MIPS, ONC 2015 certified technology is required. Vendors obtain ONC 2014 or ONC 2015 certification for specific standards-based electronic public health reporting capabilities as part of the certification process. The next slides discuss the certifications that vendors can obtain for public health reporting capabilities. Health IT Workforce Curriculum Version 4.0

ONC 2014 certification capabilities for public reporting health Transmission to immunization registries Transmission to public health agencies – syndromic surveillance Inpatient setting only – transmission of reportable laboratory tests and values / results Optional – ambulatory setting only – cancer case information Optional – ambulatory setting only – transmission to cancer registries ONC 2014 Certification Capabilities for Public Reporting Health included: Transmission to immunization registries, Transmission to public health agencies – syndromic surveillance, Inpatient setting only - transmission of reportable laboratory tests and values / results, Optional – ambulatory setting only - cancer case information and Optional – ambulatory setting only - transmission to cancer registries. The National Institute for Standards and Testing or NIST provided test methods for each of these capabilities and called out data standards that were required. Health IT Workforce Curriculum Version 4.0

ONC 2015 certification capabilities for public reporting health Transmission to immunization registries Transmission to public health agencies – syndromic surveillance Transmission of reportable laboratory tests and values / results Transmission to cancer registries Transmission to public health agencies – electronic case reporting Transmission to public health agencies – antimicrobial use and resistance reporting Transmission to public health agencies – health care surveys ONC 2015 certified systems can be certified to have the following public health capabilities: Transmission to immunization registries, Transmission to public health agencies – syndromic surveillance, Transmission of reportable laboratory tests and values/results, Transmission to cancer registries, Transmission to public health agencies – electronic case reporting, Transmission to public health agencies – antimicrobial use and resistance reporting and Transmission to public health agencies – health care surveys. Each of these has interoperability standards associated with them with the exception of electronic case reporting. As of August, 2016 a specific standard has not yet been named for electronic case reporting although HL7 CDA or HL7 FHIR are both discussed as possible options in the certification testing guide. Lets look at the rest of the certified capabilities for ONC 2014 and 2015 and observe the standards required. Health IT Workforce Curriculum Version 4.0

Immunization capabilities of certified systems ONC 2014 and ONC 2015 Create immunization information for electronic transmission using required standards ONC 2015 Enable a user to request, access, and display a patient’s evaluated immunization history and the immunization forecast from an immunization registry using required standards Meaningful Use Stage 2 and Modified Stage 2 requires the use of ONC 2014 certified systems. Meaningful Use Stage 3 as well as other programs such as the Merit Incentive Program System or MIPS requires ONC 2015 certified systems. Both include the capability for immunizations to be recorded on EHRs and then transmitted to a public health authority. ONC 2015 adds a new capability. It enables a user to request, access, and display a patient’s evaluated immunization history and the immunization forecast from an immunization registry using required standards. Health IT Workforce Curriculum Version 4.0

HL7 Version 2.5.1 Implementation Guide for Immunization Messaging The standard used is the HL7 Version 2.5.1 Implementation Guide for Immunization Messaging. This picture shows two EHRs communicating with an Immunization Information System or IIS. The IIS is most likely the public health authority. Using ONC 2014 certified functionality, EHRs were only able to send immunizations. The IIS would be the only system with a complete picture of a person’s immunization history over time if the person was seen at multiple locations. This is shown with EHR-A Sending an immunization to the IIS. Note that it is using the VXU or Unsolicited Vaccination Update message to send the immunization information. With ONC 2015 certified technology, an EHR can first query for a complete history of a patient’s immunizations and even a forecast of what immunizations will be required using the HL7 QBP message. The IIS responds with the history and forecast using the RSP message. Then the clinician is able to have a full picture of the patient’s immunization records as he or she makes immunization decisions. If the clinician then immunizes the patient, a VXU message would be sent to notify the IIS of the new immunization administration. The data flow between EHR-B and the IIS depict this scenario. 3.2 Figure (V. Lorenzi, 2016) Health IT Workforce Curriculum Version 4.0

Immunization data standards required for ONC certification Messaging: HL7 Version 2.5.1 Implementation Guide for Immunization Messaging Terminology: ONC 2014 HL7 CVX Vaccine Codes – Vaccinations Administered ONC 2015 HL7 CVX Codes – Vaccine History NDC Codes – Vaccinations Administered ONC 2015 Vaccinations Administered ONC certification requires that standards are used to communicate immunization information between systems. The standard for the immunization messaging is HL7 Version 2.5.1. In specific the HL7 Version 2.5.1 Implementation Guide for Immunization Messaging. Standard code systems are used to represent the type of immunization being communicated. For ONC 2014 certification HL7 CXV was used. For ONC 2015 certification, HL7 CVX can still be used for historical immunizations. However, to communicate about newly administered immunizations, NDC codes are now required. Health IT Workforce Curriculum Version 4.0

Example HL7 unsolicited vaccination update message (abridged) MSH|…VXU… PID|1||D26376273^^^NISTMPI^MR||Snow^Madelynn^Ainsley… ORC|RE||IZ-783274^NDA… RXA|0|1|20120814||33332-0010-01^Influenza, seasonal, injectable, preservative free^NDC|0.5|mL^MilliLiter [SI Volume Units]^UCUM||00^New immunization record^NIP001|7832-1^Lemon^Mike^A^^^^^NIST-AA-1^^^^PRN|^^^X68||||Z0860BB|20121104|CSL^CSL Behring^MVX|||CP|A RXR|C28161^Intramuscular^NCIT|LD^Left Arm^HL70163 OBX|1|CE|64994-7^Vaccine funding program eligibility category^LN|… OBX|2|CE|30956-7^vaccine type^LN|2|88^Influenza, unspecified formulation^CVX||||||F … Madelynn Snow received the flu vaccination. The doctor recorded the vaccination on the EHR. The EHR then creates a message containing the vaccination information and sends it to the immunization information system or rather the local public health authority of the vaccination. This slide shows the message that might be created. The message is formatted according to the HL7 Version 2.5.1 Implementation Guide for Immunization Messaging and uses the HL7 message type VXU which stands for Unsolicited Vaccination Update. The code for the vaccination is from the National Drug Code system or NDC. The code is 3332-111—01 for Influenza, seasonal, injectable, preservative free. Health IT Workforce Curriculum Version 4.0

Syndromic surveillance capabilities of certified systems Create syndrome – based public health surveillance information for electronic transmission in accordance with the standard ONC 2014 PHIN Messaging Guide for Syndromic Surveillance: Emergency Department, Urgent Care, Inpatient and Ambulatory Care Settings, Release 1.1 ONC 2015 PHIN Messaging Guide for Syndromic Surveillance: Emergency Department, Urgent Care, Inpatient and Ambulatory Care Settings, Release 2.0 ONC 2014 and ONC 2015 both include the capability for syndromic surveillance information to be formatted in a standard format and transmitted to a public health authority. The standard specification is published by the Center for Disease Control Public Health Information Network, or PHIN. That’s why the specification is called the PHIN Messaging Guide. Health IT Workforce Curriculum Version 4.0

PHIN guide for syndromic surveillance messaging release 2 The standard used is the Public Health Information Network or PHIN Guide for Syndromic Surveillance. Which uses HL7 Version 2 Patient Administration messaging. This diagram shows a sick patient visiting a hospital. A message is generated with information about the visit including information about the reason for the visit and sent to the local public health authority. The public health authority is notified of all inpatient admissions with the HL7 A01 message, all emergency and urgent care visits with the A04 message, all discharges with the HL7 A03 message, and updates to information of interest for syndromic surveillance with the HL7 A08 message. 3.3 Figure (V. Lorenzi, 2016) Health IT Workforce Curriculum Version 4.0

Example syndromic surveillance message (abridged) MSH|^~\&||ChildHospBigCity^1331231234^NPI… EVN||201002200900|||||BgCtyChldrnUrgntCar^1231231234^NPI PID|1||11111^^^BgCtyChldrnUrgntCar&1231231234&NPI^MR||^^^^^^~^^^^^^S|||M||2106-3^White^CDCREC~2028-9^Asian^CDCREC~2076-8^Native Hawaiian or Other Pacific Islander^CDCREC|… PV1|1|O|||||||||||||||||1111_001^^^BgCtyChldrnUrgntCare… OBX|1|CWE|SS003^Facility/Visit Type^PHINQUESTION||261QU0200X^Urgent Care… OBX|2|NM|21612-7^Age at Time Patient Reported^LN||6|mo^age^UCUM|||||F OBX|3|TX|8661-1^Chief complaint:Find:Pt:Patient:Nom:Reported^LN||Mother states that patient has fever, cough, and earache||||||F DG1|1||4871^Influenza with other respiratory manifestations^I9CDX|||W… Imagine a child is brought into an Urgent Care Center with a fever, cough, and earache and the doctor diagnoses influenza. A message is generated signaling that the visit occurred and provides de-identified information about the patient as well as information about the reason why they visited the urgent care center and information about the condition. The message is formatted according to the PHIN messaging guide for syndromic surveillance. Health IT Workforce Curriculum Version 4.0

Reportable results capabilities of certified systems (for inpatients only) ONC 2014 and ONC 2015 Create reportable laboratory tests and values / results for electronic transmission using required standards HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (U.S. Realm) Both ONC 2014 and ONC 2015 include the capability for hospital systems to reportable laboratory tests and values/results for electronic transmission using required standards. The functionality and standards are the same for both editions of certified technology. They use the HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (U.S. Realm) specification. Health IT Workforce Curriculum Version 4.0

HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (U.S. Realm) The standard used is the HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (U.S. Realm) which uses HL7 Version 2 lab result messaging. Imagine an inpatient at the hospital has lab tests done for reportable results and has an abnormal result. Examples of reportable results include infectious diseases. A message is generated with information about the abnormal lab result and formatted as an HL7 ORU message as specified in the standard. It is then sent to the public health authority. 3.4 Figure (V. Lorenzi, 2016) Health IT Workforce Curriculum Version 4.0

Example reportable results message (abridged) MSH…(omitted)…ORU^R01…(omitted) PID|1||12346^^^NISTMPI&2.16.840.1.113883.3.72.5.30.2&ISO^MR^&2.16.840.1.113883.3.0&ISO||Caddis^Carol^^^^^L||19851113|F ORC|RE|… OBR|1|PN-F20120325-^^2.16.840.1.113883.3.72.5.24^ISO|… OBX|1|SN|5609-3^Cadmium [Mass/volume] in Blood^LN^8682^Cadmium, Blood^L^2.40||^19.5|ug/L^microgram per liter^UCUM|0.5-2.0 ug/L|H^Above High Normal^HL70078|||F|||20120729|||||20120802||||Diagnostic Lab Works^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^22D2212212|55 East Carson Street^Suite 44^Pittsburgh^PA^15204 … Carol Caddis had a blood test for cadmium level in her blood. The results came back as an abnormally high value. The local public health authority is collecting all instances of abnormal levels of heavy metals in blood work. Since the local health authority has requested that abnormal values for this test be reported, a message is formatted according to the HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (U.S. Realm) and sent to the local public health authority. Health IT Workforce Curriculum Version 4.0

Electronic case reporting As of 2016, there is no standard implementation guide for electronic case reporting named in the ONC 2015 regulation or in the ONC Standards Advisory However, HL7 has standards in this area that it is continuing to improve As of 2016, there is no standard implementation guide for electronic case reporting named in the ONC 2015 regulation or in the ONC Standards Advisory. However, HL7 has standards in this area that it is continuing to improve. Health IT Workforce Curriculum Version 4.0

Communication to specialized registries Health care Surveys: HL7 Implementation Guide for CDA Release 2: National Health Care Surveys (NHCS), Release 1 – U.S. Realm, Draft Standard for Trial Use, December 2014 Antimicrobial Use Resistance Reporting HL7 Implementation Guide for CDA® Release 2 – Level 3: Healthcare Associated Infection Reports, Release 1, U.S. Realm, August 2013 Transmission to Cancer Registries HL7 Implementation Guide for CDA® Release 2: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, Release 1; DSTU Release 1.1, April 2015 ONC 2015 certified systems can be certified to electronically report health care survey, antimicrobial use resistance, and cancer case information to specialized registries. Each uses an implementation of the HL7 Clinical Document Architecture or CDA. Health care Surveys Reporting uses the HL7 Implementation Guide for CDA Release 2: National Health Care Surveys (NHCS), Release 1 – U.S. Realm, Draft Standard for Trial Use. Antimicrobial Use Resistance Reporting uses the HL7 Implementation Guide for CDA® Release 2 – Level 3: Healthcare Associated Infection Reports, Release 1, U.S. Realm and finally, Cancer Transmission to Cancer Registries uses HL7 Implementation Guide for CDA® Release 2: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, Release 1; DSTU Release 1.1. Health IT Workforce Curriculum Version 4.0

Certification is not always required What if there is not a certified EHR capability in ONC 2014 or ONC 2015 certification to support that data type? The hospital or provider can implement the interoperability without using a certified function That is not a reason to not use standards Example: HL7 Version 2.5.1 Implementation Guide: Vital Records Death Reporting, Release 1 What if a provider or hospital wants to attest to being in active engagement with a public health or clinical data registry but there is not a certified EHR capability in ONC 2014 or ONC 2015 certification to support that data type? For example, a registry that keeps track of deaths and reasons for death does not have a related certified capability to communicate this information in ONC 2014 or ONC 2015 certification. In this and other cases, the hospital or provider can implement the interoperability without using a certified function. However, they are advised to use standards whenever possible. For example, if you are implementing public health reporting to a death registry, HL7 provides a standard implementation guide that could be used for this purpose called the HL7 Version 2.5.1 Implementation Guide: Vital Records Death Reporting, Release 1. Health IT Workforce Curriculum Version 4.0

How to find public health interoperability standards Check the latest ONC Standards Advisory to see if there is a standard for the data they want to communicate https://www.healthit.gov/standards-advisory Contact the ONC Systems and Interoperability Framework for more information Check HL7’s public health standards as well: http://www.hl7.org/implement/standards/product_section.cfm?section=3 Contact HL7 or the HL7 Public Health and Emergency Response Workgroup for more information If the regulations do not name a specific standard, you should refer to the current ONC Standards Advisory to find the best standard for the public health reporting you are trying to do. HL7 is the primary developer of public health interoperability standards. You can check their standards pages and look under the public health category. Also it is smart to ask for guidance on standards selection. You can ask the ONC Systems and Interoperability Framework and the HL7 Public Health and Emergency Response Workgroup for advice. Health IT Workforce Curriculum Version 4.0

Unit 3: Interoperability Standards in Public Health IT, Summary – Lecture c ONC 2014 and ONC 2015 certified systems provide several public health reporting capabilities Certified functions use HL7 standards to electronically report immunizations, syndromic surveillance, reportable results, notifiable conditions, cancer cases, health care associated infections, and cancer cases Hospitals and providers can implement electronic reporting to other types of registries that certified health IT does not support but should make sure they still use standards ONC 2014 and ONC 2015 certified systems provide several public health reporting capabilities. Vendors are certified to provide standards-based EHR electronic reporting capabilities to communicate with public health authorities and clinical data registries. Certified functions use HL7 standards to electronically report immunizations, syndromic surveillance, reportable results, notifiable conditions, cancer cases, health care associated infections, and cancer cases. Hospitals and providers can implement electronic reporting to other types of registries that certified health IT does not support but should make sure they still use standards.

Unit 3: Data Standards in Public Health IT, Unit Summary The EHR Incentive Program and the Merit Incentive Payment System Program include an objective for electronic public health reporting There are numerous public types of public health data that can be communicated such as immunizations, syndromic surveillance, reportable lab results, case reporting, and registry reporting ONC certified systems use public health specific interoperability standards to provide public health interoperability capabilities The EHR Incentive Program and the Merit Incentive Payment System Program include an objective for electronic public health reporting. There are numerous public types of public health data that can be communicated such as immunizations, syndromic surveillance, reportable lab results, case reporting, and registry reporting. ONC certified systems use public health specific interoperability standards to provide public health interoperability capabilities.

Interoperability Standards in Public Health IT References – Lecture c Accredited Standards Committee X12. Retrieved on July 10th, 2010 from http://www.x12.org/ Agency for Toxic Substances & Disease Registry. Retrieved on July 10th, 2010 from http://www.atsdr.cdc.gov/ American College of Radiology national Electrical Manufactures Association (ACR- NEMA). AHIMA Industry Standards and Activities. Retrieved on July 10th, 2010 from http://www.ahima.org/advocacy/healthinformationexchange.aspx American Dental Association. Retrieved on July 10th, 2010 from http://www.ada.org/ American Society for Testing & Materials. Retrieved on July 10th, 2010 from http://www.astm.org/ Analysis of Unique Patient Identifier Options Final report. Association for Information and Image Management:. Retrieved on July 10th, 2010 from http://www.aiim.org/ No audio.

Data Standards in Public Health IT References – Lecture c (Cont’d – 2) CCHIT. Clinical and Laboratory Standards Institute (CLSI). Retrieved on July 10th, 2010 from http://www.clsi.org/ Clinical Data Interchange Standards Consortium. Retrieved on July 10th, 2010 from http://www.cdisc.org/ Computer Security Division Community Security Resource Center. Retrieved on July 10th, 2010 from http://csrc.nist.gov/index.html Designated Standard Maintenance Organization (DSMO). Retrieved on July 10th, 2010 from http://www.cdisc.org/ Gartner Healthcare Presentation. Retrieved on July 10th, 2010 from http://www.gartner.com/it/content/530400/530411/ks_hc_nov.pdf Global Patient Identifiers. Retrieved on July 10th, 2010 from http://gpii.info/ Health Industry Business Communications Council (HIBCC). Retrieved on July 10th, 2010 from http://www.hibcc.org/ HIMSS Health Information Exchange http://www.himss.org/ASP/topics_rhio.asp No audio.

Data Standards in Public Health IT References – Lecture c (Cont’d – 3) https://www.healthit.gov/policy-researchers-implementers/2014-edition-final-test-method http://hl7v2-ss-r2-testing.nist.gov/ss-r2/ - /doc http://hl7v2-elr-testing.nist.gov/mu-elr/ http://hl7v2-iz-r1.5-testing.nist.gov/iztool/#/cf HIMSS Overview of HIE & RHIOs. HL7. Retrieved on July 10th, 2010 from http://www.hl7.org/ HL7 Public Health Standards. Institute of Electrical and Electronics Engineers. Retrieved on July 10th, 2010 from http://www.ieee.org/index.html Institute of Medicine Recommendation for a National Chronic Disease Surveillance System http://www.iom.edu/Reports/2011/A-Nationwide-Framework-for-Surveillance-of-Cardiovascular-and-Chronic-Lung-Diseases.aspx International Organization for Standardization (ISO). Retrieved on July 10th, 2010 from http://www.iso.org/iso/home.htm No audio. Health IT Workforce Curriculum Version 4.0

Data Standards in Public Health IT References – Lecture c (Cont’d – 4) Mapping and Public Health. MIPS Proposed Regulation. MU Stage 3 Regulation. National Council for Prescription Drug Programs. National Institute of Standards and Technology. Retrieved on July 10th, 2010 from http://www.nist.gov/index.html Nationally Notifiable Diseases Surveillance System. Retrieved on July 10th, 2010 from http://www.cdc.gov/osels/ph_surveillance/nndss/nndsshis.htm National Standards Advisory. Office of Surveillance, Epidemiology, and Laboratory Services. ONC 2014 regulation ONC 2015 regulation Public Health Informatics Institute. Retrieved on July 10th, 2010 from http://www.phii.org/ Public Health Informatics and Information Systems edited by Patrick W. O’Carroll, William A. Yasnoff, M. Elizabeth Ward, Laura H. Ripp, & Ernest L. Martin, 2003 ISBN 0-387-95474-0 No audio. Health IT Workforce Curriculum Version 4.0

Data Standards in Public Health IT References – Lecture c (Cont’d – 5) National Information Standards Organization (NISO). Retrieved on July 10th, 2010 from http://www.niso.org/home/ National Uniform Billing Committee (NUBC). Retrieved on July 10th, 2010 from http://www.nubc.org/ Reliable Patient Identification Project. Sample Universal Healthcare Identifier. Shapiro, J. S. Evaluating Public health uses of health information exchange. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2137930/ White Paper Unique Health Identifier for Individuals. Retrieved on July 10th, 2010 from http://epic.org/privacy/medical/hhs-id-798.html No audio. Chart, Tables and Figures: 3.2 Figure: Lorenzi, V., (2016) 3.3 Figure: Lorenzi, V., (2016) 3.4 Figure: Lorenzi, V., (2016) Health IT Workforce Curriculum Version 4.0

Unit 3: Interoperability Standards in Public Health IT This material (Comp 13 Unit 3c) was developed by Columbia University, funded by the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology under Award Number IU24OC000013. This material was updated in 2016 by Columbia University under Award Number 90WT0005. No audio. End.