29 Electronic clinical laboratoryreporting for public healthsurveillancePerry F. Smith1, Guthrie S. Birkhead2, & J.A. Magnuson3

1State University of New York at Albany, School of Public Health, Albany, NY, USA2New York State Department of Health and School of Public Health, University at Albany,Albany, NY, USA3Oregon Health Authority, Portland, OR, USA

Introduction

Laboratories play an essential role in public healthsurveillance since positive test results are often the firstindication of a reportable condition. In the USA, pos-itive laboratory test results are required by nationalsurveillance case definitions to confirm over 80%of nationally reportable diseases [1]. The case def-inition criteria for the rest of these diseases oftenrequire epidemiologic links to a laboratory-confirmedcase. Rapid, accurate disease reporting by laboratoriesto public health jurisdictions is especially importantbecause other reporters, such as physicians or hospi-tals, may not report promptly or completely.

Most laboratories already use electronic informa-tion management systems with capability to reportelectronically. Electronic laboratory reporting (ELR)increases the completeness and timeliness of reportingto public health, helps to route reports to the correctjurisdictions, and reduces reporting cost [1–6].

Nevertheless, implementing ELR presents chal-lenges for both laboratories and health departments[7]. For example, small laboratories may not have thecapability to report data electronically. Large regionallaboratories may have incompatible systems, may nothave all the patient demographic information at thetime the test results are ready to report, and may needto report data to several different states. This chap-ter will describe the components of an ELR systemand the process for implementing ELR. The ElectronicClinical Laboratory Reporting System (ECLRS) in

New York and the ELR system in Oregon aredescribed, as case studies, to illustrate how ELR sys-tems may be developed.

National context for electroniclaboratory reporting in the USA

The rapid increase in electronic health informationexchange is revolutionizing public health surveil-lance. The wider use of electronic health records,electronic laboratory test ordering, greater nationalstandardization in coding and reporting test results,and new Medicare and Medicaid incentive paymentsto hospitals that report test results electronically topublic health [8] are making ELR to public healthincreasingly feasible. In the USA, approximately 17%of physicians were using electronic health records byearly 2008 [9].

One of the surveillance challenges in collecting elec-tronic data from multiple sources, including labora-tories, is the variety of non-standardized data typesthat exist in different electronic “languages.” The USCenters for Disease Control and Prevention (CDC),along with the Council of State and Territorial Epi-demiologists, play an important role in establishingstandards for surveillance in the USA, including stan-dards for development of electronic systems for publichealth surveillance. The CDC’s vision is encapsu-lated in the National Electronic Disease Surveil-lance System (NEDSS) initiative, which specifies a

Infectious Disease Surveillance, Second Edition. Edited by Nkuchia M. M’ikanatha, Ruth Lynfield, Chris A. Van Beneden and Henriette de Valk.C© 2013 John Wiley & Sons, Ltd. Published 2013 by Blackwell Publishing Ltd.

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technical framework for reporting of communicabledisease surveillance data in a secure electronic format.The NEDSS vision recommends specific standards rel-evant to ELR [10], such as use of the Logical Observa-tion Identifier Names and Codes (LOINC R©) and Sys-tematized Nomenclature of Medicine (SNOMED R©) asa uniform way to code test and result data. (LOINCand SNOMED will be discussed later in this chapter.)

While the CDC has provided national leadershipand funding for ELR in the USA, much of thework of developing ELR systems necessarily falls onstate and local health departments because localitieseach have their own specific reporting authority andrequirements and many of the technical details ofreporting from local laboratories are best handledby state/local health departments. Collaboration andsharing of lessons learned has been promoted amongstate and local health departments in the USA througha monthly national conference call sponsored by theCouncil of State and Territorial Epidemiologists. In2009, nearly all US jurisdictions had some level ofoperational ELR systems although less than half ofthem reported receiving the majority of reports elec-tronically [11].

Nearly all the ELR systems in the USA currentlyhave reports flowing directly from laboratory sys-tems to public health systems. However, this modelof data flow could change in the future, with therise of health information exchange organizations.These organizations are being developed to allowpatient and physician access to a patient’s medicalinformation from multiple sources. These informationexchange organizations will allow authorized personsto access information on patients wherever they havereceived medical care. In principle, public health couldaccess laboratory and other medical information onreportable diseases from these organizations. How-ever, such exchanges are still in their infancy and notwidely used for public health reporting. Using healthinformation exchanges for public health reporting cre-ates challenges which are beyond the scope of this dis-cussion. Since virtually all ELR in the USA today flowsdirectly from laboratories to public health, this modelwill be discussed here.

The New York and Oregon ELR systems will bepresented later in this chapter as examples to illustratehow ELR systems have been established in the USA.For a discussion on the use of electronic public healthsurveillance in Germany, see Chapter 28.

Considerations in designing anelectronic laboratory reporting system

There are a number of steps to take and decisions tomake when a public health agency decides to imple-ment ELR (Box 29.1). First, a major considerationis the national standards for electronic medical infor-mation exchange [e.g., American National StandardsInstitute Health Level 7 (HL7), a major messaging for-mat that will be discussed later in this chapter]. Sincemany laboratories report to more than one jurisdic-tion and since laboratories cannot efficiently maintainmore than one standard for file formats, codes, andmessaging, it is important to be informed about andutilize the current national standards and practices.

Second, it is critical to ensure that there is ade-quate legal authority for laboratory reporting. Are

Box 29.1 General considerations fordeveloping an electronic laboratory reportingsystem

� What electronic reporting standards will beused?� What is the legal authority for collectinglaboratory reports?� What funding is available?� Who are the stakeholders to include in ELRplanning?� Which test results will be reported? Forexample:

– Infectious disease� Culture� Serology

– Chronic disease� Pathology for cancer� Hemoglobin A1c for diabetes

– Environment-related disease� Lead, heavy metals, water testing

– Animal test results� Rabies� Mosquitoes (West Nile virus, etc.)

� What frequency of reporting is needed?� What is the content of the reports?� How will the quality of the reporting be mon-itored over time?

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laboratory reports that are indicative of conditions ofpublic health importance legally reportable by clinicallaboratories? Can the health department requirereporting in a particular format or within a specifictime frame? These factors must be determined earlyin the process. In the USA, each state establishes thereporting requirements for physicians, hospitals, andlaboratories. Most states require laboratory reportingof test results that indicate a diagnosis of a reportabledisease. For select diseases that require immediatepublic health intervention (e.g., botulism or measles),laboratories are often required to telephone thetest results to local or state public health officialsin addition to subsequently submitting the routinedetailed test report. For a more detailed discussionon the legal basis for conducting infectious diseasesurveillance, see Chapter 39.

Third, adequate and sustainable funding must beavailable. The CDC provides some funding throughthe NEDSS initiative, but states and other jurisdictionsalso need to financially support their ELR systems.

A fourth key factor is that development of ELR sys-tems requires a collaborative approach; state and localhealth departments and public and private clinical lab-oratories must be involved to ensure success. Also,a complete and functional ELR system cannot standalone, but must link to other public health systems tofacilitate response and ultimately lead to knowledgeto inform public health and clinical decision-making.Collaborative development of methods to connect sys-tems, discussed later in detail, must be considered dur-ing ELR planning. Finally, it should be recognizedthat ELR system development is a process and thata “final” system will probably never be achieved; thesystem will undergo constant development as labora-tory tests, and information technology, and standardschange.

Test report considerations

In designing an ELR system, decisions must be maderegarding which test results will be reported, the fre-quency of reports, and the content of the reports. Asystem that handles only human infectious disease testresults may be relatively simple, whereas a systemthat handles other reports—for example, diagnosticpathology reports for state cancer registries containingopen text fields, childhood lead poisoning test reports

where parental information is critical, environmentalsample test results, or animal test results—may needto be more sophisticated in design. The frequency ofreporting should also be considered early in the plan-ning phase. Many infectious disease results are neededby public health staff within 24 hours so that interven-tions, such as preventive treatment of close contacts,can be promptly instituted. However, some chronicinfectious disease test results, such as CD4 lympho-cyte count reporting to acquired immunodeficiencysyndrome (AIDS) registries, may not be needed imme-diately. In these situations, transmitting test results inbatches every few days or weeks can save laboratoriestime and simplify public health processing of reports.Finally, the content of the reports should be basedon what information laboratories can realistically beexpected to have. Most laboratory reports for publichealth surveillance purposes generally need to include,at minimum, patient and physician information, speci-men source, test type and result, and dates of specimencollection and test completion.

Technical considerations

There are three important technical areas to considerin developing an ELR system: the format of reports,coding of test type and results, and secure transmis-sion of reports from laboratory to health department.While these issues require the involvement of infor-mation technologists, it is very important for publichealth epidemiology and laboratory staff who use theelectronic surveillance systems to have a basic knowl-edge of these technical considerations. The successof ELR depends on, as illustrated by the experiencesreviewed in this chapter, involving all stakeholders inall aspects of ELR development.

Format refers to how each report is structured inelectronic form. To have a workable surveillance sys-tem, all parties must agree on the record format sothat they can communicate. There are different for-mats, each with its strengths and weaknesses. Oneof the simplest is direct data entry via the Internet:laboratory staff enter data into a fixed data entryscreen. This method is very time-consuming if thereare a large number of reports to be entered. Anothercommon format is a fixed-length American StandardCode for Information Interchange (ASCII) file. Sucha file, with one text line for each laboratory result,

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can be constructed at the laboratory from previouslyentered data using common software packages andtransmitted via a secure means to the health depart-ment. It is also relatively simple and commonly used,but is not very flexible since it cannot be adapted tovarying message contents. A third, more flexible androbust format which is especially useful for systemswith multiple test types, is the HL7 format, which hasemerged as the standard for exchange of clinical infor-mation [12]. HL7 is a defined set of rules for sendingsimple text characters in groups that represent datafields. HL7 has a variable length message designed toaccommodate relational data and thus has the poten-tial to meet many different messaging needs. HL7 isalso more difficult to implement since there are multi-ple message types and a “reader” is required to parsethe message into meaningful units of information. Aswith any electronic standard, HL7 format is evolv-ing; there are several versions currently being used,and improved versions are being developed. A signifi-cant challenge in ELR system development is to decidewhich version of HL7 to use and when to upgrade tonewer versions. Although many laboratories do notcurrently utilize HL7 format, it is increasingly becom-ing the standard for ELR and is used by most largelaboratories and vendors of medical information sys-tems. Implementing HL7 for ELR, and deciding whichversion to use, require expert consultation.

The lack of standardized coding of report testresults creates another challenge for electronic report-ing. Some laboratories use free text for specifying testresults. Free text refers to data fields in which a resultcan be notated in any number of different ways (e.g.,Staphylococcus aureus, Staph aureus, S. aureus, etc.).Other laboratories have their own individual propri-etary coding system to designate results. This vari-ation makes it difficult to process large numbers oftest results electronically, without using sophisticatednatural language processing that recognizes free textresults and/or writing a computer program to translateeach laboratory’s coded results into standard codes.Natural language processing has shown promise inidentifying reportable laboratory test results in freetext [13] but is not widely available. To handle mul-tiple coding schemes, some public health departmentsin the USA are writing for each laboratory “cross-walk tables” which “translate” laboratory tests intocodes. Other public health departments require thatlaboratories take on this task and translate their

results into a standard format before transmitting theirresults. There are two commonly used coding stan-dards that are increasingly becoming national stan-dards for laboratory reporting. The first is the LOINCsystem, which includes codes for different types ofmedical observations, including laboratory tests [14].The second is the SNOMED coding system [15],which is used to identify specific test results (e.g., spe-cific bacteriologic organisms). The two systems arebest used together to give a complete description ofthe laboratory test done and the test results. Until alllaboratories are capable of sending results using thesecodes, public health agencies are best advised to con-sider accepting results in other codes or in free text orin both.

The third major technical consideration is the securetransfer of confidential test results with patient iden-tifying information from laboratories to public healthdepartments. Routine email and Internet transfer aregenerally not secure. However, there are industry stan-dards for the safe transfer of confidential informa-tion that should be incorporated into ELR systemdesign. One example of specifications for the secureelectronic exchange of information is the ElectronicBusiness eXtensible Markup Language (ebXML) [16].The CDC has developed specifications for automatedsystem-to-system exchange of information, based onebXML. An added challenge is the frequent need todistribute selected test results in a secure form to cer-tain program areas or jurisdictions. Authentication ofsystem users (e.g., through the use of passwords ordigital certificates) and verification of receipt of filesare important aspects of designing secure messagingcapability.

There are several other technical issues that needto be considered. Maintaining a help desk shouldbe considered for providing ready assistance by tele-phone to answer technical and reporting questionsfrom both laboratories and public health users of thesystem. Disaster recovery planning is critical to anysystem; it is necessary that data be recovered in theevent of a system failure. Related to this is a planfor archiving files for long-term storage. Edit check-ing for incomplete data fields or incompatible dataentries may be built into the system, if desired. It mayalso be desirable to include automatic alerting capa-bilities so that, whenever certain test results of urgentpublic health importance are received, the appropri-ate person is immediately notified automatically. For

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example, the New York State ELR system is pro-grammed to generate automatic telephone alerts whenlaboratory reports of diseases requiring urgent atten-tion, such as meningococcal meningitis and measles,are received (see below).

Process for implementing electroniclaboratory reporting

The process (Box 29.2) for implementing ELR is justas important as the design decisions. ELR involves get-ting different types of reports from multiple laborato-ries that use different information management sys-tems to many different end-users rapidly and securely.Designing and implementing any large electronicinformation system involving multiple participantsrequires careful planning and management. Projectmanagement provides a standard approach to plan-ning and executing these types of implementations

Box 29.2 A process for implementing anelectronic laboratory reporting system

� Planning phase– Designate responsible unit(s) and appointproject manager– Conduct stakeholder sessions to discussuser needs and business rules– Provide executive leadership– Ensure financial support

� Development and implementation phase– Institute a change control process to enablemodifications during development– Conduct a pilot phase to test the system andensure the system is meeting program goals– Conduct training– Certify laboratories to submit electronicdata

� Operations phase– Operate a help desk to assist laboratorieswith questions– Conduct a quality assurance programto ensure complete, timely, and accuratereporting

with a greater likelihood of meeting the needs of thestakeholders. The use of good project managementskills is critical to success. The project manager isthe person who coordinates all aspects of develop-ment and implementation and serves the importantrole of translating epidemiology and laboratory pro-gram needs into technologic solutions. This personoversees the definition of the project’s specific objec-tives to avoid conceptual confusion, ensures the fiscalcommitment and executive leadership necessary forsuccess, develops the timetable for completing eachtask during the process, and watches for and coordi-nates response to difficulties as they arise.

Planning an ELR system must involve all stake-holder groups from the beginning, regardless of thesystem development methodology that is used. Stake-holder meetings, chaired by the project manager,include discussions of the objectives of the project,with very detailed decisions about the business rulesfor the system. These meetings must be attended bytechnical informatics experts and staff knowledgeableabout laboratory testing and public health surveil-lance procedures, preferably using a collaborativeapproach. The public health and laboratory programneeds should drive the design decisions with the tech-nical informatics staff providing expert consultationon how to meet program needs. For example, surveil-lance staff can explain how laboratory results need tobe processed to generate a suspect case report needingpublic health investigation. This may entail an elec-tronic solution so that the laboratory report automat-ically generates an electronic case report, which avoidsunnecessary data re-entry. Likewise, public health lab-oratory staff may wish to electronically access infor-mation collected by surveillance staff and link it toinformation on specimens that have been submittedfor testing at the laboratory. Including representativesof all user groups ensures that the final system meetsas many needs as possible. Users included in designdecisions can also understand the compromises thatinvariably have to be made. The support of execu-tive leaders, including top management of all involvedentities, and a solid financial commitment to supportthe system’s development and ongoing future mainte-nance are essential.

Other important process considerations includechange control, piloting the system, training, certi-fication of laboratories for using the system, andmonitoring the system for quality assurance. Change

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control refers to an explicit written process for mod-ifying part of the system during development andimplementation. As development proceeds, changeswill invariably be needed; key participants need toknow about the changes and have the opportunity toreview them before they are approved. Before the sys-tem is fully implemented, there should be a pilot testof the system to identify any problems so that theycan be corrected before full implementation. Train-ing of all users before they are expected to use thesystem is critical for success. Without good user train-ing and a commitment on the part of users, the sys-tem will not function well or perhaps not even beused. Also, before each laboratory is allowed to stopsending paper reports to public health authorities,there needs to be a certification process that ensuresthat each laboratory is sending valid, complete, andtimely reports electronically. This certification pro-cess should be explicitly defined before implementa-tion of the system. Lastly, once the system is running,there needs to be a monitoring system that periodicallyevaluates each laboratory’s electronic submissions toensure the quality of submitted reports. Some con-siderations include whether all the reports are beingreceived, and whether the information in each reportis complete. It is also important to determine whetherreports are being received promptly. Initial and ongo-ing quality assurance is critical in ELR, just as it iswith any reporting system.

New York’s electronic clinicallaboratory reporting system

The New York State’s ECLRS provides a case studyfor the development of a state-based system.

New York State has a population of nearly 20 mil-lion people and a well-developed public health infras-tructure that includes 58 local health departments,including New York City. There are approximately240 acute care hospitals and 600 clinical laborato-ries that provide medical services to New York resi-dents. Laboratories are required to report evidence ofmost reportable conditions to the local health depart-ment in the jurisdiction of the patient’s residence. Thelocal health department then prepares a case reportwhich is forwarded to the state health department.Other reportable conditions [e.g., cancer, human

immunodeficiency virus (HIV)/AIDS, heavy metaltests] are reportable only to the state.

With the full support of the state health commis-sioner and with a commitment of several million dol-lars of state funding, the ECLRS project was launchedover a 3-year development period starting in 2000.The health department contracted the development toan outside company and followed the project manage-ment process described above. Following the buildingof ECLRS, its maintenance, updates, and continuingsupport require six full-time employees.

ECLRS is built on the state’s existing Web-basedHealth Commerce System (HCS) that allows allcounty, regional, and state health departments, hos-pitals, laboratories, and other health providers toexchange information securely within a centralizeddatabase via a Web browser. The two major func-tional units of the HCS—New York’s Health ProviderNetwork and Health Information Network—aredescribed in detail elsewhere [17]. Most laboratoriesdo not have the capability of submitting results inHL7 format, and New York wanted a system thatcould be implemented rapidly by many laboratories.ECLRS does not require the use of HL7, but is able toprocess HL7 messages. ECLRS also accepts messagesin a New York standardized ASCII format that canbe generated by many software packages. To encour-age use of ECLRS by small laboratories which maynot utilize HL7 or ASCII format or may not wishto develop necessary interfaces, the system also has adirect Web-page entry screen. Web entry has proven tobe extremely popular for the many laboratories thathave very few test results to report to public healthauthorities.

The need for report routing affected several designdecisions. ECLRS automatically forwards selected testresults to the appropriate public health program areaat the state level and to the appropriate local countyhealth department (Figure 29.1). Some laboratoriesuse LOINC and SNOMED codes, which make it easyto identify what the report is and to which publichealth program it should go. However, most labo-ratories do not use these codes. For these laborato-ries, New York designed ECLRS so that laboratoriescould submit separate files (e.g., files each for can-cer, HIV/AIDS, blood lead levels, sexually transmit-ted diseases, tuberculosis, other communicable diseaseresults) that allow for appropriate routing of reportsbased on the type of file that is submitted.

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LaboratoryHL-7

LaboratoryASCII file

LaboratoryWeb data entry

ECLRS

Communicable STD TB

Local health departments

Internet

Internet

Cancer

HIV/AIDS

Heavymetals

State program areas

Communicablediseases

Figure 29.1 Diagram showing the flowof information in the New York StateElectronic Clinical LaboratoryReporting System (ECLRS).Laboratories send test results via theInternet to New York State’s ECLRSdatabase, using direct Web data entry,American National Standards InstituteHealth Level 7 (HL7) or AmericanStandard Code for InformationInterchange (ASCII) format. ECLRSautomatically routes each report to theappropriate state and local healthdepartment program area forcommunicable, sexually transmitteddisease (STD), and tuberculosis (TB)reports, and only to the state programareas for cancer, humanimmunodeficiency virus (HIV)/acquiredimmunodeficiency syndrome (AIDS),and heavy metals since these arereportable only to the state.

Under New York regulation, each communicabledisease report also needs to go to the county healthdepartment where the patient resides. However, largenational laboratories often do not have demographicinformation, including patient address, linked to thetest result at the time of reporting. In this situation,ECLRS forwards the report to the local jurisdictionbased on a hierarchical decision tree according toavailable information: first to the county of patientresidence if the information is available, next to thejurisdiction of the physician, and lastly to staff at thestate health department who telephone the submit-ting laboratory to ask for the jurisdiction so that thereport may be appropriately forwarded. As a secondapproach to address the problem of missing informa-tion at the time of reporting, New York added systemfunctionality to allow a laboratory to update a previ-ously submitted report. This capability allows a labo-ratory to add patient address and other demographicinformation once it becomes available electronicallyin the laboratory information management system.When electronic health records with electronic lab-oratory ordering become more common, full patientinformation should be more readily available to lab-oratories at the time that they first report to publichealth.

ECLRS also has automatic alerting capabilities.When a laboratory report for a disease requiringurgent public health attention (e.g., meningococcal

disease) is received, the system generates automatictelephone calls to staff at the county and state healthdepartments. Experience with this alerting capabilityhas shown that most of the time local public healthstaff are already aware of the test result owing to a tele-phone report from the laboratory. Thus, ELR auto-matic alerting provides a back-up notification systemfor urgent test results.

New York has implemented the following certifi-cation process before laboratories may discontinuesending their reports on paper. Laboratories begin bysending reports both by paper and through ECLRS.Usually, two or three local health departments agreeto monitor the completeness and accuracy of the elec-tronic reports by comparing them with the paperreports. Once the electronic reports have been shownto match (or even exceed) the quality of the paperreports, the laboratory is certified and is allowed todiscontinue reporting by paper.

To monitor the quality of reporting after a labo-ratory is certified, each laboratory’s reports are con-tinuously evaluated by the New York State ECLRSstaff for any changes in the frequency and numberof reports (that might suggest missing submissions),for completeness of data elements, and for timeliness.As an additional check on the completeness of labo-ratory reporting, the following process has also beeninstituted. The New York State Health Departmentregulates and approves all laboratories that perform

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LaboratoriesState and local health department programs

Automatedpopulation ofcase reports

with laboratoryresults

ECLRSECLRS/CDESS

interfaceCDESS

Print hard copy“Dear Doctor”

letters

Figure 29.2 The integration of theElectronic Clinical Laboratory ReportingSystem (ECLRS) and CommunicableDisease Electronic Surveillance System(CDESS) in New York was designed toexpedite public health processing oflaboratory reports in two ways. First, itallowed the automated populating ofCDESS case reports from an ECLRSreport. Second, CDESS was programedto automatically generate hard copyletters to physicians (“Dear Doctor”letters) asking them for needed clinicalinformation to complete the case reports.

diagnostic testing on New York residents. As part ofthat program, New York investigators make site vis-its to every laboratory every 2 years. During thosevisits, they review laboratory logs and abstract a sam-ple of test results that should have been reported viaECLRS. These test results are then compared againstthe ECLRS database to ensure that they were reported.Laboratories with missing reports are contacted andreporting problems are corrected.

New York has evaluated the effect of ECLRS onreporting for one large national laboratory and foundthat the median time from specimen collection dateto its report to the local public health jurisdictiondecreased from 14 to 5 days [18]. The percent ofreports with missing data elements was 4% for patientdate of birth (compared with 6% for paper reports)and was 51% for patient address (compared with 17%for paper reports). Electronic reporting can greatlyreduce delays in reporting, but obtaining completeinformation electronically continues to be a challengefor some laboratories [18]. By comparison, an evalua-tion of electronic disease reporting from three clinicallaboratories in Hawaii showed that electronic report-ing resulted in a 2.3-fold increase in the number ofreports, that electronic reports arrived an average of3.8 days earlier than conventional reports, and thatthey were more complete [2].

Following broad implementation of ELR, NewYork experienced an increase in the number of reportsfor which public health staff needed to investigate andcomplete case reports. With limited staff, the work-load was unmanageable for some high-volume com-municable diseases, such as hepatitis and Lymedisease. Three technologic approaches were taken toaddress this problem: the electronic generation of

communicable disease case reports from laboratoryreports, the automated generation of letters to physi-cians to request additional information, and randomsampling of laboratory reports for case investigation.

The generation of case reports from laboratoryreports required building an interface between ECLRSand New York’s existing Communicable DiseaseElectronic Surveillance System (CDESS). CDESS isanother Web-based application on the health depart-ment’s statewide network, which allows county healthdepartments to enter communicable disease case infor-mation, share it with the state health department,and maintain a registry of all reported communica-ble diseases. CDESS can also be queried for ad hocanalyses. The interface between ECLRS and CDESSallowed automated populating of CDESS case reportsfrom ECLRS reports, saving staff data entry time(Figure 29.2).

To assist public health staff in collecting completecase information on patients with reportable diseases,New York built a function in CDESS to allow staff toautomatically generate a letter to the ordering physi-cian on the ECLRS record to request needed epi-demiologic information to complete the case report(Figure 29.2).

The third technologic approach to address theincrease in laboratory reports was the developmentof a laboratory report sampling function that wasapplied to Lyme disease. Since the main purposeof Lyme disease surveillance is the geographic anddemographic tracking of the disease, rather than pub-lic health intervention in response to each reportedcase, there is limited value in fully investigating everycase of Lyme disease as long as reliable estimatesof disease occurrence can be determined. Selecting a

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sample of laboratory reports for full investigation pro-vides a way to decrease case investigation workloadwhile allowing calculation of disease burden throughextrapolation from the investigated cases. ECLRSwas programmed to randomly select a 20% sam-ple of Lyme disease laboratory reports as they werereceived and forward them through the CDESS inter-face to the appropriate county health departmentsfor investigation of accuracy of geographic acquisi-tion of disease and demographic information. Evalua-tion of this system has shown a considerable decreasein workload while still allowing estimates of Lymedisease that are consistent with the full surveillanceinvestigation approach (Bryon Backenson, New YorkState Department of Health, 2010, personal commu-nication). The appropriate diseases to target for thisapproach will likely vary among states, provinces, andcountries.

Oregon’s electronic laboratoryreporting system

The Oregon case study illustrates a system built on asimpler model than New York’s; since many statesmay not have significant and sustained resourcesavailable for their ELR system, the Oregon casestudy is perhaps more representative of the aver-age ELR system in the USA. Oregon’s population of3 825 657 [19] resides in 96 006 square miles, an area

divided into a densely populated western 30% and asparsely populated eastern 70%. While there are 456moderate- and high-complexity laboratories in Ore-gon and around 70 acute care hospitals, fewer than50 laboratories have a public health reporting volumehigh enough to warrant participation in ELR. Labora-tories are mandated to report notifiable conditions tothe local health department in the patient’s countyof residence, or to the state ELR program whichthen routes the data to the appropriate local healthdepartment.

The Oregon ELR project [20] began in 2000, withone full-time employee; after 10 years, the ELR staffconsists of one full-time dedicated position and onepart-time non-dedicated position. With ELR the Ore-gon state health department began serving a new role,functioning as an electronic hub to accept, route, andprocess HL7 messages containing laboratory and clin-ical data. This system replaced traditional paper-basedreporting in which laboratories reported directly to thelocal health departments by mail, fax, or telephone.

The general model of ELR in Oregon can be thoughtof as a tripod supported by participation of laborato-ries, local health departments, and the state healthdepartment (Figure 29.3). For states that fit this gen-eral schematic, one of the first steps in establish-ing ELR must be gaining the endorsement of thelocal health departments. In Oregon, the case forELR was proposed to the Coalition of Local HealthOrganizations, which represents the 34 local health

Laboratory:notifiable condition

reporting

Local healthdepartment: case

investigation

State healthdepartment:surveillance

Laboratory data flow before ELR

Laboratory data flow with ELR

Figure 29.3 Illustration of the electroniclaboratory reporting (ELR) “tripod” inOregon—laboratories, local healthdepartments, state health department.This figure shows the change in therouting of data with ELR. With ELR,laboratories submit their data to a singlepoint, the state health department, andall public health partners continue theirtraditional roles such as caseinvestigation for local healthdepartments and reporting to the USCenters for Disease Control andPrevention by the state healthdepartment. Other important datastreams, such as return of caseinvestigation data to the state healthdepartment by local health departments,are not included in this laboratory datadiagram.

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departments (representing 36 counties) in the state.The ELR proposal emphasized that the essential rolesof all partners would remain unchanged, that the datatransfer to the counties would be virtually immediate,and that the counties would continue to perform theirroutine investigative and other responses.

From practical experience, Oregon found threebasic approaches effective for enlisting participationof laboratories in ELR: persuasion, incentives, andlegal mandates. Oregon ELR used each of theseapproaches in a strategy that may be suitable forany jurisdiction launching ELR. The first ELR over-tures were made to large national laboratories, sincethe national laboratories tended both to have moreresources available for such efforts and to be morewilling to venture into the—at that time—relativelyuncharted territory of ELR. The first laboratory part-ner to send production data through Oregon’s ELRsystem was a national laboratory; the effort from startto production took around 7 months. The second lab-oratory partner, also a national laboratory, enteredproduction status 2 months later. The next enlistmentphase expanded the target range to include regionaland large local laboratories. The second enlistmentapproach involved monetary incentives: a limited

amount of grant funding was allocated to help defraylaboratory start-up costs of ELR. On a first-come first-served basis, grant-recipient laboratories were selectedbased on their ability to meet a published set of report-ing criteria. The funds were also made available to lab-oratories that were already participating in apprecia-tion for their involvement in ELR. Oregon was able tofinance three separate funding cycles, in 2004, 2006,and 2008, distributing around $18, 000 to each of 10qualifying laboratories and thus recruiting several pre-viously unresponsive laboratories. In 2010, Oregonused a third enlistment approach by legislatively man-dating ELR for high-volume reporting laboratories(those reporting an average of more than 30 reportsper month to public health). Although the majority ofeligible laboratories were already participating in ELRat the time of this legislation, it is expected to compelcompliance from the few remaining qualifying labo-ratories that are not current participants.

Every ELR system must have the ability to acceptand translate incoming laboratory data files. OregonELR (Figure 29.4) accepts only HL7 format and uti-lizes a set of translation and messaging applicationsthat were selected at the start of the ELR project. Thatselection process was performed collaboratively by the

Laboratory datafiles

HL7Data reports

Data reports

ELR translation,messaging

Automated processes

Data upload

LHDs CDC

Deidentified data

Deidentified dataState integrated

data system

Stateprograms

Figure 29.4 Electronic laboratory reporting (ELR) dataflow in Oregon. This simplified schematic illustrates thegeneral flow of ELR data within the Oregon ELR system.Laboratory data files are received and processed into theautomated ELR system, data reports are provided to state

and local health department (LHD) partners, data areuploaded into the state data system, and finally,de-identified data are provided to the US Centers forDisease Control and Prevention (CDC). HL7, AmericanNational Standards Institute Health Level 7.

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CDC and a three-state panel. The translation applica-tion selected was actually designed for business use,and so had full support for business standards trans-lation (specifically X12 business and e-commerce-related standards) but only limited HL7 translationcapabilities. Oregon ultimately had to write some ofthe HL7 definition libraries for the ELR application,in order to accommodate messaging requirements.Three years into the project, Oregon reached out toother states in the northwestern USA to collabora-tively develop a regional message format that couldbe accepted by all of the partners. The NorthwestRegional Standard implementation guide was devel-oped for an HL7 ORU R01 version 2.3.z message for-mat, and was a useful aid to the ELR laboratories [21].

Standardization of both format and data contenthas been strongly endorsed nationally by jurisdictionstrying to implement ELR. In Oregon, adoption of for-matting standards (i.e., HL7) has not been problem-atic; all laboratory partners send data via HL7 ORUR01 messages, although employing several differentversions. Utilization of data standards, such as stan-dardized test and result codes, has been less pervasive.The initial goal requiring laboratories to send onlystandardized codes (LOINC test codes and SNOMEDresult codes) was soon realized to be impractical, atleast during the program’s inception. It should benoted that standardized codes, while critical to pub-lic health and other data exchange efforts, are oftenof limited or no benefit to the participating labora-tories themselves. Most laboratory information sys-tems incorporate proprietary codesets for internal usewithin the system or a superset parent health informa-tion system, and do not always incorporate a built-in capacity for inclusion and maintenance of addi-tional standardized codes. In the early stages of ELRin Oregon, most laboratories were unable to incorpo-rate standard codes, and so it was decided to acceptreports with laboratory local codes as necessary toenable reporting. However, there has been a steadygrowth in the number of reports containing standardtest codes (primarily LOINC) over the years. And withcontinued national emphasis on use of standards, thistrend will only continue to grow.

Summary

ELR has the potential to significantly improve pub-lic health surveillance by speeding reports, decreasing

staff time and cost in reporting, and increasing accu-racy of the information. However, implementing ELRcan be difficult. Eventually, we can expect that all lab-oratories and healthcare providers will use commonor at least related standards, which will promote effi-cient and easy exchange of medical information. Untilthen, implementing ELR will continue to have its chal-lenges, but it can be done and is well worth the effort.

In the interest of providing guidance to those whoare embarking on a new ELR system, here are somelessons that have been learned by those who haveimplemented ELR in New York and Oregon:� Involve all actual and potential system users earlyin the planning process and keep them informed asdevelopment proceeds. This effort will pay off in thelong run by increasing user satisfaction and by avoid-ing mistakes that may require system redesigns.� Allow more time for development than you expect.You will probably need it.� Be flexible as you implement ELR. Currently, thereis great variation among laboratories in file formatand coding. The more flexibility in the ELR system,the more laboratories will be able to use it rapidly.� Always have a trial period before discontinuingpaper reports for each laboratory. It may not be pos-sible for electronic reports to totally replace paperreports for some laboratories.� If your ELR system generates 24/7 alerts for urgentreports, be prepared for the continuing need forhuman-to-human communication. Most computer-generated alerts are not public health emergencies butdo require immediate staff assessment.� Consider mandating electronic laboratory reportingin your jurisdiction. Because there is an initial cost tolaboratories to implement ELR, there are always somethat decide to continue to report on paper unless thereis a legal mandate requiring ELR. In 2009, almostone-fourth of US jurisdictions reported that they hadsome form of law or regulation requiring laboratoriesto report electronically [11].� When ELR is implemented, be prepared for anincrease in the number of laboratory reports that pub-lic health staff will be expected to process or investi-gate. Consideration should be given to managing thisincrease through automated generation of case reportsand letters to physicians requesting further clinicalinformation, and sampling.

In conclusion, ELR provides significant advantagesto the public health surveillance enterprise, in addition

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to specific challenges. Laboratory reports are oftenthe first evidence that initiates public health investiga-tions and interventions. Assuring complete and timelylaboratory reporting is a critical step to realizing thiscapability. However, there are significant issues forstate and local health departments in planning andimplementing these complex systems. Collaborationis necessary, not only among state and local healthdepartments and clinical laboratories, but also amongepidemiologists, public health field staff, and healthinformation technology specialists. NEDSS providescritical standards that can enhance development ofELR systems in many state and local jurisdictions,while still permitting collation of data into a nationalsystem. Many localities have embarked on this pro-cess [11]. Their success will be critical to current andfuture public health efforts to prevent and controldisease.

References

1 Silk BJ, Berkelman RL. A review of strategies for enhanc-ing the completeness of notifiable disease reporting.J Public Health Manag Pract 2005;113:191–200.

2 Effler P, Ching-Lee M, Bogard A, et al. Statewide systemof electronic notifiable disease reporting from clinical lab-oratories. JAMA 1999;282:1845–50.

3 Panackal AA, M’ikanatha NM, Tsui F, et al. Automaticelectronic laboratory-based reporting of notifiable infec-tious diseases at a large health system. Emerg Infect Dis2002;8:685–91.

4 Moore KM, Reddy V, Kapell D, Balter S. Impact ofelectronic laboratory reporting on hepatitis A surveil-lance in New York City. J Public Health Manage Pract2008;14:437–41.

5 Overhage JM, Grannis S, McDonald CJ. A comparison ofthe completeness and timeliness of automated electroniclaboratory reporting and spontaneous reporting of noti-fiable conditions. Am J Public Health 2008;98:344–50.

6 Nguyen TQ, Thorpe L, Makki HA, Mostashari F. Bene-fits and barriers to electronic laboratory results reportingfor notifiable diseases: the New York City Departmentof Health and Mental Hygiene experience. Am J PublicHealth 2007;97:S142–5.

7 M’ikanatha NM, Southwell B, Lautenbach E. Automatedlaboratory reporting of infectious diseases in a climate ofbioterrorism. Emerg Infect Dis 2003;9:1053–7.

8 Blumenthal D, Tavenner M. The “meaningful use” reg-ulation for electronic health records. N Engl J Med2010;363:501–4.

9 DesRoches CM, Campbell EG, Rao SR, et al. Electronichealth records in ambulatory care—a national survey ofphysicians. N Engl J Med 2008;359:50–60.

10 Centers for Disease Control and Prevention. Progress inimproving state and local disease surveillance—UnitedStates, 2000–2005. MMWR Morb Mortal Wkly Rep2005;54:822–5.

11 Magnuson JA. 2009 national electronic laboratoryreporting (ELR) snapshot survey. [Monograph online.]Available at: http://www.coast2coastinformatics.com/ReferenceMaterial.html. Accessed October 29, 2012.

12 Health Level Seven International, Ann Arbor, MI.Available at: http://hl7.org/. Accessed November 16,2012.

13 Friedlin J, Grannis S, Overhage JM. Using natural lan-guage processing to improve accuracy of automatednotifiable disease reporting. AMIA Annu Symp Proc2008;207–11.

14 McDonald C, Huff S, Mercer K, et al. (eds.). LogicalObservation Identifiers Names and Codes (LOINCR):Users’ Guide. Indianapolis, IN: LOINC, 2012. Avail-able at: http://loinc.org/downloads/files/LOINCManual.pdf. Accessed October 24, 2012.

15 The International Health Terminology Standards Devel-opment Organisation. SNOMED Clinical Terms R© UserGuide. Copenhagen, Denmark: The International HealthTerminology Standards Development Organisation,2009, International Release. Available at: http://www.ihtsdo.org/fileadmin/user_upload/Docs_01/SNOMED_CT/About_SNOMED_CT/Use_of_SNOMED_CT/SNOMED_CT_User_Guide_20090731.pdf. AccessedOctober 24, 2012.

16 The OASIS ebXML Joint Committee for OASIS.The Framework for eBusiness. [Monograph online.]Burlington, MA; Organization for the Advancementof Structured Information Standards, 2006. Avail-able at: http://www.ebxml.org/. Accessed October 24,2012.

17 Gotham IJ, Smith PF, Birkhead GS, Davisson MC. Policyissues in developing information systems for public healthsurveillance of communicable diseases. In: O’Carroll PW,Yasnoff WA, Ward ME, et al. (eds.) Public HealthInformatics and Information Systems. New York, NY:Springer-Verlag, 2003: 537–73.

18 Smith PF, Chang H, Noonan-Toly C, et al. Evaluationof data quality from an electronic laboratory report-ing system, New York State. In: Proceedings of theInternational Conference on Emerging Infectious Dis-eases, Atlanta, GA, February 29–March 3, 2004. Atlanta,GA: Centers for Disease Control and Prevention, 2004:66–7.

19 US Census Bureau. State and County QuickFacts.Washington, DC: US Census Bureau. Available at:

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http://quickfacts.census.gov/qfd/states/41000.html.Accessed October 24, 2012.

20 Oregon Health Authority. Oregon Electronic Labora-tory Reporting Program. Portland, OR: Oregon HealthAuthority. Available at: http://oregon.gov/DHS/ph/elr/index.shtml. Accessed October 24, 2012.

21 Health and Human Services Region IX and X RegionalBlood Lead Reporting HL7 Message, 2003. Available at:http://www.dhs.state.or.us/dhs/publichealth/elr/contact.cfm. Accessed October 27, 2010.

Additional resources

Centers for Disease Control and Prevention’s National Elec-tronic Disease Surveillance System Laboratory Reporting:http://wwwn.cdc.gov/nndss/script/MU_ELR.aspx. Access-ed October 29, 2012.

Centers for Disease Control and Prevention’s PHIN:Vocabulary Standards and Specifications: www.cdc.gov/

phin/vocabulary/index.html. Accessed October 24,2012.

ebXML—eXtensible Markup Language: www.ebxml.org.Accessed October 24, 2012.

Health Level 7: www.hl7.org. Accessed October 24, 2012.Logical Observation Identifiers Names and Codes

(LOINC R©)—Regenstrief Institute, Inc: www. regenstrief.org/loinc. Accessed October 24, 2012.

National ELR Working Group: www.coast2coastinformatics.com. Accessed October 24, 2012.

NYS Electronic Clinical Laboratory Reporting Sys-tem (ECLRS): www.health.state.ny.us/professionals/reportable_diseases/eclrs/index.htm. Accessed October24, 2012.

Public Health/Health Administration (PH/HA) ElectronicLaboratory-based Reporting: www.phha.mlanet.org/activities/elr.html. Accessed October 24, 2012.

SNOMED R© International, a division of the College of Amer-ican Pathologists: www.snomed.org. Accessed October24, 2012.

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