Health Level Seven (HL7) 2.5.1 Specifications For Electronic

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Health Level Seven (HL7) 2.5.1 Specifications forElectronic Laboratory Based ReportingGuideline for ImplementationOct 9, 2015

Florida Department of Health HL7 2.5.1 Specifications for ELR Implementation GuideTABLE OF CONTENTSDocument Summary . 31. Introduction . 41.1 Background . 41.2 Scope . 41.3 Contact . 42. Definitions . 52.1 Message Structure Definitions . 52.2 Message Construction Rules . 53. Unsolicited Observation Message . 73.1 FLDOH required ORU Message Structure . 83.2 FLDOH specific Segment Mapping . 93.2.1 MSH segment - Message Header Segment . 93.2.2 SFT Segment – Software .103.2.3 PID Segment – Patient Identification .103.2.4 NK1 Segment – Next of Kin / Employer.113.2.5 PV1 Segment - Patient Visit Information .113.2.6 PV2 Segment – Additional Patient Visit Information .123.2.7 ORC Segment – Test Order .123.2.8 OBR Segment – Observation Request .133.2.8.1 Additional discussion on OBR Segment (26) – Parent Result .143.2.9 OBX Segment – Observation / Result .153.2.9.1 Additional discussion on OBX Segment (4) – Sub-ID.173.2.9.2 Antimicrobial Susceptibility Results .183.2.10 SPM Segment – Specimen .184. CONCLUSION . 19Appendix 1 - Antimicrobial Susceptibility Testing . 20Testing Method .20Results .20Reference Ranges.20Page 205/15/2015

Florida Department of Health HL7 2.5.1 Specifications for ELR Implementation GuideDocument SummaryThis document is a guide for the implementation of electronic communication of reportableinformation from laboratories to the Florida Department of Health (FLDOH), in accordance withRule 64D-3, Florida Administrative Code. This FLDOH standard is a supplement to the HL7Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release1 (US Realm) – February, 2010 with errata (September, 2011).Health Level 7 (HL7) is anaccredited and nationally recognized standard of electronic data exchange in healthcareenvironments, which allows for communication between separate and different types ofinformation systems. The HL7 2.5.1 Standard contains the order and structure of data fields indetail and the HL7 2.5.1 Implementation Guide contains constraints specific to public healthreporting and focuses on one type of HL7 Message, the HL7 V2.5.1 ORU R01 Message. Thisguide contains FLDOH constraints and exceptions to the HL7 implementation guide as well asadditional requirements specific to FLDOH to support electronic interchange of laboratoryresults of reportable diseases/conditions in the State of Florida.For sharing laboratory-based reports of Florida public health findings; three coding systems arerequired by the Florida Department of Health:1) Logical Observation Identifiers Names and Codes (LOINC ) for laboratory procedure (test)codes/names and laboratory order codes/names. LOINC code databases and value sets can be obtained from the Regenstrief Instituteat (www.regenstrief.org). These LOINC codes facilitate exchange of results and areuniversal identifiers for laboratory and other clinical observations.2) Systematized Nomenclature of Medicine – Clinical Terms (SNOMED CT ) for description offindings, notably organism names, discrete result values, and the description of Specimensources.3) Unified Code for Units of Measure (UCUM ) for units of quantitative laboratory results.Laboratories sending ELR messages to the Florida Department of Health will be required totranslate their local code tables to standards codes from these coding systems prior or duringtesting for acceptance. The most current version of LOINC and SNOMED codes should be usedfor this translation.Laboratories unable to meet the HL7 2.5.1 standards at the time of implementation are notexempt from sending HL7 messages for ELR reporting. The FLDOH utilizes an interface enginecapable of accepting other versions of HL7. The FLDOH specific requirements defined in thisguide can be followed in lower HL7 versions. Exceptions to these requirements will be reviewedon a case by case basis.For those labs seeking Meaningful Use certification, the HL7 2.5.1 standard is the requiredmessaging format. There are no exceptions to this requirement.Laboratories are encouraged to use the ELR HL7 V2.5.1 Validation Tool to validate messageformat and some content requirements at the start of an implementation project. FLDOH willprovide feedback on errors generated by the tool; however most errors can be cleared byfollowing the HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting toPublic Health formatting rules. The tool can be found at http://hl7v2-elr-testing.nist.gov/mu-elr/.Page 305/15/2015

Florida Department of Health HL7 2.5.1 Specifications for ELR Implementation Guide1. Introduction1.1 BackgroundMonitoring the occurrence of disease is a cornerstone of public health and is aligned with themission of the Florida Department of Health. This monitoring, referred to as public healthsurveillance, can be used to trigger case or outbreak investigations, follow trends, evaluate theeffect of prevention measures such as immunizations, and suggest public health priorities.Because disease occurrence and disease trends have the potential to shift rapidly, especiallywith infectious diseases, surveillance needs to be ongoing, timely, and complete.The Florida Department of Health has requirements for laboratories to report certain findings tohealth officials. These requirements are outlined in Rule 64D-3, Florida Administrative Code.With the increasing capacity of laboratories to leverage technology, it is now possible forlaboratories to send reportable disease data electronically to the Florida Department of Health.F.A.C. 64D-3 requires laboratories to submit results electronically in Health Level Seven (HL7)messaging format or ASCII delimited flat files, which reflect comparable content to HL7 version2.5.1 utilized by DOH.1.2 ScopeThis Florida Department of Health specification guide should not be used as a tutorial for eitherHL7 or electronic interfaces, in general. The reader and laboratory trading partners areexpected to have a basic understanding of interface concepts, HL7, and electronic laboratorybased reporting of public health information. This guide is an implementation guide, based onthe final release of HL7 version 2.5.1. DOH defined variations from the HL7 standard, areclearly described and clarification of content expectation for the attributes is outlined forparticipating trading partners.Please note: ELR does not remove the requirement to report by telephone those diseases withnotification timeframes of Suspect Immediately and Immediately in the Table of ReportableDiseases or Conditions to Be Reported (see pages 9-18 in Laboratory Reporting Guidelines forReportable Diseases and Conditions in Florida).1.3 ContactLaboratories should contact the DOH ELR Business Analyst for enrollment information andguidelines to begin the process of meeting this standard in the shortest possible timeframe.Please visit http://floridahealth.gov/meaningfuluse for information on Meaningful Use for ELR.ELR Business AnalystBureau of EpidemiologyFlorida Department of Health4052 Bald Cypress Way, Bin A-12Tallahassee, FL th.govPage 405/15/2015

Florida Department of Health HL7 2.5.1 Specifications for ELR Implementation Guide2. DefinitionsThe specifications presented in this guide were developed using HL7 Version 2.5.12.1 Message Structure DefinitionsMessage:A message is the entire unit of data transferred between systems in a singletransmission. It is a series of segments in a defined sequence, with amessage type and a trigger event.Segment:A segment is a logical grouping of data fields. Segments within a definedmessage may be required or optional, may occur only once, or may beallowed to repeat. Each segment is named and is identified by a segment ID,a unique three-character code.Field:A field is a string of characters. Each field is identified by the segment it is inand the position within the segment (e.g., PID-5 is the fifth field of the PIDsegment). Optional data fields need not be valued.Component:A component is one of a logical grouping of items that comprise the contentsof a coded or composite field. Within a field having several components, notall components are required to be valued, and some components may beignored. A component may, in turn, be logically grouped into subcomponents.Message Syntax:The abstract message is defined in special notation that lists the threeletter segment identifiers in the order they will appear in the message. Braces(“{” and “}”) indicate that one or more of the enclosed group of segments mayrepeat. Brackets (“[” and “]” indicate that the enclosed group of segments isoptional.Delimiters:The delimiters to be used for laboratory messages are as follows: “ CR ” –Segment Terminator; “ ” – Field Separator; “ ” – Component Separator; “&” –Sub-Component Separator; “ ” – Repetition Separator; and “\” – EscapeCharacter (see section 1.5 Use of Escape Sequences in Text Fields). Anytrailing delimiters found after the last field in a segment, while not accepted,will not cause any errors in the receiving application.2.2 Message Construction Rulesa. Components, subcomponents, or repetitions that are not valued at the end of a field donot need to be represented by separators.b. If a data segment that is expected is not included, it will be treated as if all data fieldswithin the segment were not present.c. If a data segment is included that was not expected, it will be ignored and will notgenerate an error.Page 505/15/2015

Florida Department of Health HL7 2.5.1 Specifications for ELR Implementation Guided. If unexpected data fields are found at the end of a data segment, they will be ignoredand will not generate an error.e. Filler values such as “XXX” should be avoided in any field.f.Exceeding the length of a field/component/subcomponent as listed in the HL7implementation guide will not generate an error. Exceptions to length requirementsshould be discussed with FLDOH and agreed prior to implementation.g. Lab Result data types shall be restricted to Coded with Exceptions ‘CWE’ forqualitative results and Structured Numeric ‘SN’ for quantitative results. FLDOHreceives ELR from many different facilities that use many different software types andversions. It is impossible to program for all variations found in textual results.h. Standard vocabulary is required. Such vocabulary coding systems include:a. LOINC – Logical Observation Identifiers Names and Codesb. SNOMED – Systemized Nomenclature of Medicinec. UCUM – Unified Code for Units of Measurei.Notes or associated result information should be sent in NTE segments not CWEsegments. This is to include amplifying information, nurse’s notes, etc.j.Messages are constrained to include only one patient per message. A messagecontaining more than one PID segment will be rejected.k. The order group is required and can repeat. This means that multiple ordered tests maybe performed on a specimen. FLDOH expects that each OBR/OBX grouping mustinclude a single SPM segment.l.Snapshot processing of the result message involves processing as a snapshot all therepeats of the ORDER OBSERVATION group together as a group. This is especiallyimportant when dealing with parent/child results (such as cultures and sensitivities)which will span multiple ORDER OBSERVATION groups. All these must be processedfrom both a message sender and message receiver perspective as a single snapshot.m. Parent / Child result matching is critical to message processing within FLDOHsurveillance systems. Particular attention must be paid to formatting requirementsdescribed in section 3.2.8.1 Additional discussion on OBR Segment (26) - Parent Resultand section 3.2.9.1 Additional discussion on OBX Segment (4) - Observation Sub-ID.n. Multiple results may be associated with an order. There will always be a single OBX inthe results group.o. Additional Clinical information such as Pregnancy Status, Onset Date of Illness,Symptoms, etc. may be sent in an OBR/OBX grouping at the end of a message. Sincethe actual clinical information may be in the form of a data or string text (TX or ST),these OBX will be the only exception to rule g. and i. above. It must be stated again thatPage 605/15/2015

Florida Department of Health HL7 2.5.1 Specifications for ELR Implementation Guidelab result information and general notes concerning the lab test should be sent in anNTE segment. Clinical information OBR/OBX groupings must be discussed and agreedupon prior to implementation.p. RE fields are required, but can be empty if the information is not known. Conformantsystems are required to be able to send this information.q. Batch processing will be utilized. Please refer to Table 3-4 in the HL7 Version 2.5.1 IG:Electronic Lab Reporting to Public Health, R1 (US Realm) for Batch Message definition.r.Preliminary results (P), final results (F), and corrected results (C) are required to be sentby FLDOH and should be properly documented in [OBX-11] (Observation Result Status).Proper serialization must be followed, i.e. a final result cannot precede a preliminaryresult, and only a corrected result can succeed a final result.s. Every message must contain one and only one ORC segment and it should precede thefirst OBR/OBX/SPM group.t.Acknowledgement messages will not be sent from FLDOH.u. PD1, TQ1, TQ2, CTD, FTI, and CTI segments are not required by the State of Floridaand will be ignored if sent by trading partner. If any of these segments are sent, thesegments should be properly formed as described by the normative content. (Please seeTable 4-1 in the HL7 implementation guide)v. [MSH-11] (Processing ID) The value “P” (Production) shall be included when comingfrom the trading partner’s production system. The value “T” (Training) should be includedwith coming from the trading partner’s test system. Note: Testing or Training messagesshould not be sent via a feed that routed to the FLDOH production system.w. It is expected that ELR will include lab reports for tests performed both in-house and byreference lab facilities with the performing organization appropriately documented in theELR message. If you are unable to appropriately format the lab results or document theperforming organization in the ELR message for those labs sent to reference labs,continuance of paper lab reporting of these lab results will be expected.x. Data types to be used within ELR messages sent to FLDOH are defined in the HL7Version 2.5.1 IG: Electronic Lab Reporting to Public Health, R1 (US Realm).3. Unsolicited Observation MessageLaboratory information is reported through the Observation Report – Unsolicited (ORU)message to public health agencies using event R01. The ORU R01 message structure requiredby the Florida Department of Health is outlined below.Page 705/15/2015

Florida Department of Health HL7 2.5.1 Specifications for ELR Implementation Guide3.1 FLDOH required ORU Message StructureUsing the basic “building blocks” of PID, OBR, and OBX segments (in bold type below), aclinical report can be constructed as a three-level hierarchy with the patient information (PID)segment at the upper level, an order record (OBR) at the next level, and one or moreobservation records (OBX) at the bottom. Note: all segments except the PD1, PV2, TQ1, NTE,and OBX associated with the SPM are required segments on the FLDOH message.MSHMessage Header{SFT}Software SegmentPIDPatient Identification[PD1]Additional Demographics[{NTE}] Notes and Comments related to the PID only{NK1}Next of Kin/Employer/Guardian/ other Associated PartiesPV1Patient Visit[PV2]Patient Visit – Additional Information{ORDER OBSERVATION Begin[ORC] Order CommonOBRObservations Request[{NTE}] Notes and Comments related to the OBR{OBSERVATION BeginOBXObservation related to OBR[{NTE}] Notes and Comments related to the OBX} OBSERVATION EndsSPMSpecimen Information related to the OBR[{OBX}] Observation related to Specimen} ORDER OBSERVATION EndMessages with data populating non-required fields will not be rejected by the FLDOH interfacebroker. There is no further discussion of these non-required segments in this implementationguide.The following deviations from the HL7 Standard Version 2.5.1 message syntax should be noted:ORU SegmentHL7 Standard Version 2.5.1SoftwareSegmentOptionalRepeatingPatient ResultGroupPatient GroupRepeatingSingle instanceOptional within the Patient ResultGroupRequired within the Patient ResultGroupPage 8FLDOH Laboratory-BasedReportingRepeating05/15/2015

Florida Department of Health HL7 2.5.1 Specifications for ELR Implementation ngle InstanceOptional within Order ObservationGroupTiming QTYgroupOptionalRepeatingRequiredSingle InstanceRequired within Order ObservationGroup. ORC is only contained in thefirst Order Observation GroupNot required for FLDOH, notexpectedObservationGroupRepeatingOptional within Order ObservationRepeatingRequired within Order ObservationOBXRepeatingOptional within OBRRepeatingRequired within OBRFTIRepeatingOptional within Order ObservationNot required for FLDOH, notexpectedCTIRepeatingOptional within Order ObservationNot required for FLDOH, notexpectedDSCOptionalNot required for FLDOH, notexpected3.2 FLDOH specific Segment MappingFLDOH specific requirements, constraints, and exceptions to the HL7 Version 2.5.1Implementation Guide: Electronic Laboratory Reporting to Public Health, are listed below.Note: Segments, fields, and data elements not specifically mentioned in this guide, but requiredby the HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to PublicHealth, are still required as defined in the HL7 2.5.1 guide.3.2.1 MSH segment - Message Header SegmentThe Message Header Segment (MSH) contains information describing how to parse andprocess the message. This includes identification of message delimiters, sender, receiver,message type, timestamp, etc.The following are FLDOH specific MSH field requirements:MSH FieldMSH-3: SendingApplicationMSH-4: SendingFacilityFLDOH RequirementThe Sending application Name must be the name of the sendingapplication of the FLDOH ELR trading partner. MSH-3.2 should be thesending application OID and MSH-3.3 should be ‘ISO.The Sending Facility Name must be the text name of the sending lab.The Sending Facility ID must be the CLIA number of the sending lab.The Sending Facility ID Type must be “CLIA “, indicating that the universalID is a nationally assigned unique identifier.The Department uses the CLIA to map to a standard Name, Address andPhone number for each facilityPage 905/15/2015

Florida Department of Health HL7 2.5.1 Specifications for ELR Implementation GuideMSH-5: ReceivingApplicationMSH-6: ReceivingFacilityThe Receiving Application must be“FDOH-ELR 2.16.840.1.114222.4.3.3.8.1.3 ISO”.The Receiving Facility must be “FDOH 2.16.840.1.114222.1.3645 ISO”.3.2.2 SFT Segment – SoftwareThe software segment provides information about the sending application or other applicationsthat manipulate the message before the receiving application processes the message. TheLaboratory Result Sender actor is required to populate the first SFT segment.3.2.3 PID Segment – Patient IdentificationThe PID segment is used as the primary means of communicating patient identificationinformation. This segment contains permanent patient identifying and demographic informationthat is not likely to change frequently.FLDOH requires the following patient identifying and demographic information in the PIDsegment:FLDOH Required Patient DataHL7 field commentsFirst name, Last name andMiddle initialPID-5: The Name Type Code (PID-5.7) should always be “L”,indicating a legal name.Address including street, city,state and zip codePID-11: State or Province field should have a valueconsistent with the USPS two character State designations.Zip or Postal Code field should have a value consistent withthe USPS five digit codesPhone number, including areacodePID-13: Follow XTN Data type definition; equipment typePID-13.3 required along with components for phone number.This field may also be used to send patient e-mail address ina separate repeat.Date of BirthPID-7: Use the abbreviated Timestamp format YYYYMMDDGenderPID-8: Gender code from HL7 table 0001. IF the patient’sSex is not available, use “U” to denote sex is unknownRacePID-10: Race code from HL7 table 0005. IF the patient’sRace is not available, use “U” to denote Race is unknownEthnicity (Hispanic/nonHispanic)PID-22: Ethnic Group from HL7 table 0189. IF the patient’sEthnicity is not available, use “U” to denote Ethnicity isunknownSocial Security NumberPID-3: repeat with SS as the ID type codeMedical Record NumberPID-3: repeat with MR as the ID type codePage 1005/15/2015

Florida Department of Health HL7 2.5.1 Specifications for ELR Implementation Guide3.2.4 NK1 Segment – Next of Kin / EmployerThe NK1 segment is used as the primary means of documenting the next of kin of the patient.This is particularly important for lead testing of minors, since the NK1 is used to documentinformation about the parent or guardian. This is also where the employment information for thepatient is documented. For animal patients, the NK1 documents the person or organization thatowns or is responsible for the animal.FLDOH requires that any contact information as described above be sent in NK1 segments asin the format as defined in HL7 Version 2.5.1 Implementation Guide: Electronic LaboratoryReporting to Public Health. Particular attention must be paid to the relationship sent in NK1-3 asthis is where the distinction is made between an employer and a family member.FLDOH requires the following minimum data to be sent in the NK1 field if available:FLDOH Required PV1 DataNameRelationshipAddressPhone NumberOrganization NameContact Person’s NameContact Person’s TelephoneNumberContact Person’s AddressHL7 field commentsNK1-2: Name of next of Kin or employer;if employer is the name of a business use NK1-13NK1-3: Use codes from table 0063 HL7version 2.5.1NK1-4: Address of the next of kin/associated party.NK1-5: Telephone number of the next of kin/associated partyNK1-13: If next of kin or associated party is an organizationuse this fieldNK1-30: Required if NK1-13 is populated.NK1-31: Required if NK1-13 is populated.NK1-32: Required if NK1-13 is populated.3.2.5 PV1 Segment - Patient Visit InformationThe PV1 segment contains basic inpatient or outpatient encounter information which is useful toFLDOH surveillance efforts.FLDOH requires the following minimum data to be sent in the PV1 field:FLDOH Required PV1 DataPatient ClassAssigned Patient LocationDischarge DispositionAdmit Date/TimeDischarge Date/TimeHL7 field commentsPV1-2:PV1-3: required only if PV1-2 is ‘Inpatient’PV1-36PV1-44PV1-45Page 1105/15/2015

Florida Department of Health HL7 2.5.1 Specifications for ELR Implementation Guide3.2.6 PV2 Segment – Additional Patient Visit InformationThe PV2 segment is a continuation of information contained on the PV2 segment.FLDOH requires the following minimum data to be sent in the PV2 field:FLDOH Required PV2 DataAdmit ReasonEmployment Illness Related IndicatorHL7 field commentsPV2-3PV2-153.2.7 ORC Segment – Test OrderThe ORC segment is used as the primary means of communicating test order relatedinformation. This segment contains test order and ordering provider information which areimportant to the public health community.FLDOH requires the following data to be sent in the ORC segment:FLDOH Required ORC DataPlacer Order NumberFiller Order NumberOrdering Provider NameOrdering Provider PhoneNumberOrdering Facility NameOrdering Facility AddressHL7 field commentsORC-2: In the second component (Namespace ID) use theHospital name or acronym.In the third component (Universal ID) use the Hospital orEnterprise OID rather than the software OID.These two elements, help make the Placer Order Numberunique between facilities.ORC-3: In the second component (Namespace ID) use theHospital name or acronym.In the third component (Universal ID) use the Hospital orEnterprise OID rather than the software OID.These two elements, help make the Filler Order Numberunique between facilities.ORC-12: The National Provider Identifier (NPI) should beused as the identifier in ORC-12.1.ORC-14: Follow XTN Data type definition; equipment typeORC-14.3 required along with components for phonenumber. This field may also be used to send the orderingprovider’s e-mail address in a separate repeat.ORC -21: IF the test ordered is not from a hospital oridentifiable medical facility, the value should reflect the nameof the ordering medical doctor or clinical care provider whoordered the test.The National Provider Identifier (NPI) or CLIA should be usedas the identifier in ORC-21.10.ORC-22: State or Province field should have a valueconsistent with the USPS two character State designations.Zip or Postal Code field should have a value consistent withthe USPS five digit codesPage 1205/15/2015

Florida Department of Health HL7 2.5.1 Specifications for ELR Implementation GuideOrdering Facility PhoneNumberOrdering Provider AddressORC-23: Follow XTN Data type definition; equipment typeORC-23.3 required along with components for phonenumber. This field may also be used to send patient e-mailaddress in a separate repeat.ORC-24: State or Province field should have a valueconsistent with the USPS two character State designations.Zip or Postal Code field should have a value consistent withthe USPS five digit codes3.2.8 OBR Segment – Observation RequestThe Observation Request (OBR) segment is used to transmit information specific to an order fora diagnostic study or observation, physical exam, or assessment. The OBR defines theattributes of a particular request for diagnostic services or clinical observations. For laboratorybased reporting, the OBR defines the attributes of the original request for laboratory testing.FLDOH requires the following data to be sent in the OBR segment:FLDOH Required OBR DataPlacer Order NumberFiller Order NumberSpecimen collected date/timeHL7 field commentsOBR-2: In the second component (Namespace ID) use theHospital name or acronym.In the third component (Universal ID) use the Hospital orEnterprise OID rather than the software OID.These two elements, help make the Placer Order Numberunique between facilities.OBR-3: In the second component (Namespace ID) use theHospital name or acronym.In the third component (Universal ID) use the Hospital orEnterprise OID rather than the software OID.These two elements, help make the Filler Order Numberunique between facilities.OBR-7: Use of the abbreviated Timestamp format YYYYMMDDis permitted.Specimen collected enddate/timeOBR-8: This field should only be populated if a specimen iscollected over a period of time. Not normally populated forPublic Health lab result reporting to FLDOH.Ordering Provider NameOBR-16: The National Provider Identifier (NPI) should be usedas the identifier in OBR-16.1.Ordering Provider PhoneNumberOBR-17: Follow XTN Data type definition; equipment typeOBR-17.3 required along with components for phone number.This field may also be used to send ordering provider’s e-mailaddress in a separate repeat.Order StatusOBR-25: This status should pertain to the entire order.Page 1305/15/2015

Florida Department of Health HL7 2.5.1 Specifications for ELR Implementation GuideParent ResultOBR-26: This fie

The HL7 2.5.1 Standard contains the order and structure of data fields in . This Florida Department of Health specification guide should not be used as a tutorial for either HL7 or electronic interfaces, in general. The reader and laboratory trading partners are expected to have a basic understanding of interface concepts, HL7, and electronic .

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