Consolidated Clinical Document Architecture (CCDA) (BCCD)

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RESOURCE AND PATIENT MANAGEMENT SYSTEMConsolidated Clinical DocumentArchitecture (CCDA)(BCCD)User ManualVersion 2.0September 2020Office of Information TechnologyDivision of Information Technology

Consolidated Clinical Document Architecture (CCDA) (BCCD)Version 2.0Table of Contents1.0Introduction. 11.1Purpose . 11.2Scope . 12.0System Navigation . 32.1Setup - CCDA . 32.2Setup - Hospital Course Information . 42.3Architecture . 63.0Package Management . 83.1Manage Site-Specific CCDA Parameters . 83.1.1 Edit CCDA Site Parameters. 83.1.2 Edit CCDA Clinical Site Parameters . 93.2Manage CCDA Messaging . 103.3Manage CCDA Ensemble Production. 113.4CCDA Application Status Report . 124.0Package Operation . 144.1Manually Generate One CCDA Document . 144.2Manually Regenerate All CCDA Documents . 154.3Manually Regenerate CCDA Documents for a Specified Date Range. 165.0CCDA Audit Log . 176.0Limits on the Data Included in CCDA Documents . 187.0Manage E-Mail Notifications . 258.0References and Sources . 30Appendix A Rules of Behavior . 31A.1All RPMS Users . 31A.1.1 Access . 31A.1.2 Information Accessibility . 32A.1.3 Accountability . 32A.1.4 Confidentiality . 33A.1.5 Integrity . 33A.1.6 System Logon. 34A.1.7 Passwords . 34A.1.8 Backups . 35A.1.9 Reporting . 35A.1.10 Session Timeouts . 35A.1.11 Hardware . 35A.1.12 Awareness . 36A.1.13 Remote Access . 36A.2RPMS Developers . 37User ManualSeptember 2020Table of Contentsii

Consolidated Clinical Document Architecture (CCDA) (BCCD)A.3Version 2.0Privileged Users. 37Glossary . 40Acronym List . 41Contact Information . 42User ManualSeptember 2020Table of Contentsiii

Consolidated Clinical Document Architecture (CCDA) (BCCD)Version 2.0Trademark NoticeCaché , Ensemble , and HealthShare are registered trademarks of InterSystemsCorporation.Continuity of Care Document is a registered trademark of Health Level SevenInternational.HL7 and Health Level Seven are registered trademarks of Health Level SevenInternational.Windows is a registered trademark of Microsoft Corporation.SNOMED and SNOMED CT are registered trademarks of the InternationalHealth Terminology Standards Development Organization.UNIX is a registered trademark of The Open Group.User ManualSeptember 2020Trademark Noticeiv

Consolidated Clinical Document Architecture (CCDA) (BCCD)Version 2.0PrefaceThis manual provides information for site managers regarding operations of theConsolidated Clinical Document Architecture (CCDA) v2.0 (BCCD) package. Thismanual is not intended for end users of RPMS since there is no end user functionalityin this package.The BCCD package is designed to generate industry standard Continuity of CareDocuments (CCD) in Health Level 7 (HL7) CCDA format, following the August2015 Draft Standard for Trial Use (DSTU) standard, further restricted by 2015Certified Health Information Technology (CHIT) requirements. These documents canbe transmitted to Indian Health Service (IHS) Health Information Exchange (HIE)repositories, retrieved by the Electronic Health Record (EHR) Graphical UserInterface (GUI) using web services, or viewed as export summary documents.User ManualSeptember 2020Prefacev

Consolidated Clinical Document Architecture (CCDA) (BCCD)1.0Version 2.0IntroductionThe Consolidated Clinical Document Architecture (CCDA) (namespace BCCD)software is a component of the IHS Resource and Patient Management System(RPMS). The software provides the ability to generate industry standard ClinicalSummary, Transitions of Care, Export Summary, Health Information Exchange (HIE)and Case Reporting documents that meet the Health Level Seven (HL7) August 2015DSTU standard and 2015 CHIT specifications.Clinical Summary and Transitions of Care documents are retrieved by the EHR GUIusing web services. Data Export summary documents are requested via an RPMSApplication Programming Interface (API). HIE documents are generated by a nightlybackground job or via an RPMS menu option and are transmitted to IHS HIErepositories via web services. Case Reporting documents are requested by the iCare(BQI) application, which retrieves completed documents for transmission.1.1PurposeCCDA documents can serve a variety of purposes, including enabling clinician accessto patient data in an emergency scenario, quality reporting, bio surveillance, patientaccess to the patient's own data via a Personal Health Record (PHR) system, andmedication or allergy reconciliation.Each CCDA document consists of two components: a human-readable part known asa narrative block, which can be displayed by a web browser; and a machine-readablepart intended for automated data processing. The machine-readable component maycontain more detailed information than the human-readable part.1.2ScopeA CCDA document is an Extensible Markup Language (XML) documentsummarizing current and pertinent historical information about an individual patient’shealth care record at a given facility. Although not every document type containsevery section, the current IHS implementation of the CCDA standard supports thefollowing sections: Allergies Assessment and Plan Care Team Case Reporting Discharge Diagnoses (inpatient visits only) EncountersUser ManualSeptember 2020Introduction1

Consolidated Clinical Document Architecture (CCDA) (BCCD)Version 2.0 Functional Status Goals Health Concerns Hospital Course (inpatient visits only) Hospital Discharge Instructions (displayed for observation [O]and day surgery [S]visits, in addition to inpatient visits) Immunizations Medical Equipment Medications Mental Status Patient Problems/Encounter Diagnoses Procedures Reason for Hospitalization (inpatient visits only) Reason for Referral Reason for Visit (ambulatory visits only) Results Social History (Smoking Status) Vital SignsUser ManualSeptember 2020Introduction2

Consolidated Clinical Document Architecture (CCDA) (BCCD)2.0System Navigation2.1Setup - CCDAVersion 2.0To set up CCDA at an RPMS site:1. Calculate the additional disk space required for the BCCD application andallocate disk space.2. Perform pre-install steps, including enabling Long Strings, verifying access to OSconfiguration file, designating a directory where the new CCDA database willreside, mapping BMW globals, and stopping CCDA.3. Install the provided Kernel Installation and Distribution System (KIDS) build.4. Perform post-install steps, including setting up optional encryption, optional email notifications, disabling journaling in the CCDA database, configuring theCCDA CSP Application, setting up site-specific BCCD parameters, and startingCCDA Messaging.See the CCDA Installation Manual for further details on the installation andconfiguration steps.The BCCD package has one RPMS menu used by site managers, CCDA MENU(BCCD MENU), which presents the following options: Edit CCDA Site Parameters (BCCD EDIT SITE PARAMETERS) Edit CCDA Clinical Site Parameters (BCCD EDIT CLINICAL PARAMETERS) Generate CCDA for a single patient (BCCD CCDGENONE) Generate CCDA documents for all patients in RPMS (BCCD CCDALLGEN) Generate CCDA documents for a specified date range (BCCD GEN CCDADATE RANGE) Manage CCDA transmissions (BCCD CCDA MGR) View and Purge Error Documents (BCCD ERROR PURGE) Display the CCDA application status report (BCCD APP STATUS)The BCCD package contains no menu options accessible by end users.Site managers are responsible for performing the following two tasks to ensure thatCCDA documents are successfully generated at their site:1. Ensure that site-specific CCDA parameters are set up appropriately. Section 3.1provides more information about the set up.User ManualSeptember 2020System Navigation3

Consolidated Clinical Document Architecture (CCDA) (BCCD)Version 2.02. Ensure that CCDA Messaging is running. Section 3.2 provides more informationabout managing CCDA Messaging.2.2Setup - Hospital Course InformationBCCD v2.0 added a new section to inpatient CCDA documents called HospitalCourse. The information for the Hospital Course section comes from the DischargeSummary TIU note associated with the Inpatient stay.Note: The Discharge Summary note may include additionalinformation not related to the Hospital Course.To extract only the Hospital Course information only in the CCDA from theDischarge Summary note, it is recommended that any Discharge Summary templatehave a Hospital Course header and footer. The header should be 50 hyphens on theirown line followed by the text "HOSPITAL COURSE" (without quotes) on its ownline. The footer should follow the Hospital Course information and be 50 hyphens onits own line.Later, when the provider creates the Discharge Summary note for the patient, theHospital Course information must be entered by the provider between the header andfooter; otherwise the CCDA will include all the information entered in the DischargeSummary note. To make it easier for the provider to identify what is the header andfooter, you may want to consider entering some blank lines between the header andfooter.Note: Please work with your Clinical Informaticists on enteringthe Hospital Course header and footer. An example of howto add the Hospital Course header and footer to a DischargeSummary template is shown in the Figure 2-1.User ManualSeptember 2020System Navigation4

Consolidated Clinical Document Architecture (CCDA) (BCCD)Version 2.0Figure 2-1: Adding Hospital Course Header and Footer to a Discharge Summary templateUser ManualSeptember 2020System Navigation5

Consolidated Clinical Document Architecture (CCDA) (BCCD)2.3Version 2.0ArchitectureCCDA processing can be initiated in four ways: If EHR version 1.1, patch 13 has been installed and configured at the site, thenauthorized EHR users are able to request Clinical Summary and Transitions ofCare documents for display within the EHR GUI client. If the site is a part of the IHS HIE, then HIE documents are generated nightly forall patients whose data has changed since the previous nightly upload. Data Export summary documents can be generated for specific patients or for allpatients via an RPMS API. Case Reporting documents are requested by the iCare (BQI) application, whichretrieves completed documents for transmission.To accommodate requests from the EHR GUI, Ensemble has a web service processlistening for requests for Clinical Summary and Transitions of Care documents.If the site is part of the IHS HIE, a nightly TaskMan task called BCCD NHIE PUSHJOB is automatically scheduled to run every night at the time specified by the sitemanager in option Edit CCDA Site Parameters. When BCCD NHIE PUSH JOB runsfor the first time, it creates new CCDA requests for all patients in the RPMS database.On subsequent executions, BCCD NHIE PUSH JOB finds all patients whose data haschanged since the last time it ran and creates new requests in the CCDA queue.To request Data Export summary documents, the site manager accesses an RPMSAPI. In order to prevent unintended initiation of Data Export documents, the API isnot included as an RPMS option in the menu system. Instead, the site manager mustfirst access Programmer Mode, then enter the necessary command. Because it isexpected that this Data Export functionality will rarely, if ever, be used, the IHSSoftware Quality Assurance (SQA) team will distribute instructions for generatingData Export documents on an “as needed” basis.Case Reporting documents are requested and processed by the iCare (BQI)application. Details on this process are outside the scope of this document. For furtherinformation, consult the appropriate iCare documentation.The only difference between CCDA requests created by these four mechanisms is thatthe DocType property is set to the requested document type and several flags are setto control where the documents are sent. For all CCDA requests, a new entry isplaced in the CCDA queue, recording the IDs of the requested patient and visit(s),and sets the record’s status to R (for Request).User ManualSeptember 2020System Navigation6

Consolidated Clinical Document Architecture (CCDA) (BCCD)Version 2.0The CCDA queue is monitored by BCCD BACKGROUND JOB, the main CCDAgenerator. The BCCD BACKGROUND JOB is a persistent TaskMan job started atTaskMan startup time, or manually from menu option Manage CCDA transmissionswhich constantly runs in the background until the site manager chooses to stopCCDA. When the BCCD BACKGROUND JOB finds a new CCDA request with thestatus of R in the CCDA queue, it changes the request’s status to CS (for CompileStarted) and extracts all relevant RPMS data for the specified patient and visit andadds the data to the body of the CCDA request. Depending on the amount of eligibledata in the patient’s records, it may take anywhere from under a second to over 10seconds to extract all needed data from RPMS.Once the extraction process for the patient is finished, BCCD BACKGROUND JOBchanges the status of the request to CE (for Compile Ended). The BCCDBACKGROUND JOB then checks the CCDA queue for other outstanding requestswith the status of R. If no outstanding requests are found, the BCCDBACKGROUND JOB goes into hibernation for a specific amount of time, usuallyone second.The CCDA queue is also monitored by the CCDA Ensemble production running inthe CCDA namespace. When the CCDA production finds a new request, whose statusis set to CE, it retrieves the CCDA data from the body of the request, changes thestatus to TS (for Transmission Started), and transforms it into a valid CCDAdocument. For EHR Clinical Summary and Transitions of Care requests, thedocument is sent back to the requesting EHR. For Data Export and Case Reporting,the production saves this document to a file. For HIE documents, the productiontransmits it to an IHS HIE. Finally, the production changes the status of the request toT (for Transmitted).If a site is a part of the IHS HIE, then the site manager is provided with the URL ofthe associated CCDA repository. Ensemble uses this URL to send CCDA documentsto the repository. HIE CCDA processing typically occurs at night to minimize theimpact on RPMS performance.User ManualSeptember 2020System Navigation7

Consolidated Clinical Document Architecture (CCDA) (BCCD)3.0Package Management3.1Manage Site-Specific CCDA ParametersVersion 2.0The RPMS option Edit CCDA Site Parameters (BCCD EDIT SITEPARAMETERS) has been divided into two options with different security keys.3.1.1Edit CCDA Site ParametersThe option Edit CCDA Site Parameters (BCCD EDIT SITE PARAMETERS)allows site managers to configure site-specific CCDA parameters at installation timeand modify them if necessary.Note: This menu option is locked by security key XUMGR,which site managers already have.The following four parameters can be edited using this option: TIME TO RUN NIGHTLY TASK DAYS KEEP TRANSMISSION ENTRIES REPOSITORY LOCATION ENABLEDThe first prompt is “TIME TO RUN NIGHTLY TASK” and there is no default value.If the RPMS site is not a part of the IHS HIE at this time, then skip the “TIME TORUN NIGHTLY TASK” prompt. If the RPMS site is a part of the IHS HIE and thesite manager has been provided with the location of the off-site CCDA repository,then enter the time when the site wants CCDA documents to be generated andtransmitted on a nightly basis. It is recommended to enter a time outside of the regularbusiness hours to minimize impact on the end users. The “TIME TO RUN NIGHTLYTASK “prompt accepts time values in all valid FileMan formats, e.g., 15:34 or03:34PM.The second prompt is “DAYS KEEP TRANSMISSION ENTRIES” and it is set to 30days by default. The value may be set to any value between 7 and 999 days. Thehigher the number, the more disk space the intermediate compile structures created bythe CCDA application will consume as described in Section 3.3 of this installationguide. On the other hand, if the default value is set too low, the compile data may bepurged too soon and will not be available to facilitate debugging should any problemsarise. If the site manager is not sure what value to enter, accept the default value of 30days.User ManualSeptember 2020Package Management8

Consolidated Clinical Document Architecture (CCDA) (BCCD)Version 2.0The third prompt is “REPOSITORY LOCATION” and there is no default value. Ifthe RPMS site is not a part of the IHS HIE at this time, then skip the “REPOSITORYLOCATION” prompt. If the RPMS site is a part of the IHS HIE and the site managerhas been provided with the location of the off-site CCDA repository, then enter thatlocation at the “REPOSITORY LOCATION” prompt exactly as it was provided tothe site manager. When a value is entered for both the “REPOSITORY LOCATION”and the “TIME TO RUN NIGHTLY TASK” prompts, the system will check whetherthe CCDA database has enough disk space to accommodate the process of generatingCCDA documents for all patients in the system. An error message will be displayed ifthere is not enough disk space. If not enough disk space error message displays,allocate more disk space and try again.The fourth prompt is “ENABLED”, and the default value is NO. This NO valuecontrols whether CCDA documents are generated when CCDA is running. Changethis value to YES.Figure 3-1 contains a screen capture of a typical setup session.Select CCDA Menu Option: EDITNow editing CCDA parameters:CCDA Site ParametersTIME TO RUN NIGHTLY TASK: 01:00Now editing CCD (Summarization of Episode Note)-specific parameters:DAYS KEEP TRANSMISSION ENTRIES: 30//REPOSITORY D: YES//YESFigure 3-1: Setting up CCDA Site Parameters3.1.2Edit CCDA Clinical Site ParametersThe option Edit CCDA Clinical Site Parameters (BCCD EDIT CLINICALPARAMETERS) allows clinicians to configure site-specific clinical CCDAparameters at installation time and modify them if necessary.Note: This menu option is locked by security key BCCDZCLIN,which must be assigned before the option can be used.The following four parameters can be edited using this option: ADD SOCIAL ENVIRONMENT PROB ADD INACTIVE PERS HISTORY PROB DISCHARGE PLANNER PROV TYPEUser ManualSeptember 2020Package Management9

Consolidated Clinical Document Architecture (CCDA) (BCCD) Version 2.0DISPLAY THE LAST SMOKING STATUS START/END DATE (S), THELAST MODIFIED DATE (L) OR NO DATE (N)The first prompt is “ADD SOCIAL ENVIRONMENT PROB”, which is set to NO bydefault. This NO value determines whether social environment problems will beincluded in Clinical Summary documents for the site. All other document types willalways display the social environment problems.The second prompt is “ADD INACTIVE PERS HISTORY PROB”, which is set toNO by default. This NO value specifies whether inactive personal problems areincluded in Clinical Summary documents for site. All other document types willalways display the inactive personal history problem.The third prompt is “DISCHARGE PLANNER PROV TYPE”, which has no defaultvalue. This parameter specifies the BDP DESG SPECIALTY PROVIDER type to beextracted and displayed as the discharge planner on an inpatient CCDA document.The fourth prompt is “DISPLAY THE SMOKING STATUS START/END DATE(S), THE LAST MODIFIED DATE (L) OR NO DATE (N)” parameter, which is setto L (LAST MODIFIED DATE) by default. If it is set to L (LAST MODIFIEDDATE), then the Social History section of the document will display the smokingstatus date with the label “Last Documented Date”. If it is set to S (START/ENDDATE), then the Social History section of the document will display the smokingstatus date with the label “Start Date”. If it is set to N (NO DATE), the smokingstatus date will not be displayed in the Social History section.Figure 3-2 contains a screen capture of a typical setup session.Select CCDA Menu Option: CLINEdit CCDA Clinical Site ParametersNOW EDITING CCDA CLINICAL PARAMETERS:ADD SOCIAL ENVIRONMENT PROB: YES//ADD INACTIVE PERS HISTORY PROB: YES//DISCHARGE PLANNER PROV TYPE: SECONDARY PROVIDER//DISPLAY THE SMOKING STATUS START/END DATE (S), THE LAST MODIFIED DATE (L)OR NO DATE (N): LAST DOCUMENTED//Figure 3-2: Setting up CCDA Clinical Site Parameters3.2Manage CCDA MessagingCCDA Messaging is automatically started whenever TaskMan starts, which typicallyoccurs when Ensemble is started. CCDA Messaging will not run if TaskMan is notrunning.User ManualSeptember 2020Package Management10

Consolidated Clinical Document Architecture (CCDA) (BCCD)Version 2.0CCDA Messaging should be running at all times and does not require a manual startor stop once it has been installed. However, if the need arises, CCDA Messaging canbe brought up or down using the Manage CCDA transmissions option, which isavailable in the CCDA Menu. The CCDA Menu can be accessed from the regular“OPTION NAME” prompt in RPMS.If CCDA Messaging is not running, type YES at the prompt as shown in Figure 3-3:Select CCDA Menu Option: MANG Manage CCDA transmissionsCCDA status:No configuration problems foundCCDA processing task is not runningStart CCDA? No// YES (Yes)Attempting to start CCDA (JUL 16, 2013@16:09:54).CCDA startedFigure 3-3: Starting CCDA MessagingIf CCDA Messaging is running, type NO at the prompt as shown in Figure 3-4:Select CCDA Menu Option: MANG Manage CCDA transmissionsC Messaging status:No configuration problems foundCCDA processing task is runningStop CCDA? No// NO(No)Figure 3-4: CCDA Messaging already running3.3Manage CCDA Ensemble ProductionAs described in Section 2.2, if the RPMS site is a part of the IHS HIE, CCDAdocuments are sent to outside repositories using the CCDA Ensemble production. Inaddition, if EHR version 1.1, patch 13 is installed and configured, authorized EHRusers can send requests for CCDA documents to the CCDA Ensemble production.The CCDA Ensemble production is automatically started when HealthShare starts up.During normal business operations, the CCDA Ensemble production will remainrunning and will not require maintenance. Refer to the Managing CCDA EnsembleProduction section in the CCDA Technical Manual to bring the CCDA Ensembleproduction up or down manually, if required.User ManualSeptember 2020Package Management11

Consolidated Clinical Document Architecture (CCDA) (BCCD)3.4Version 2.0CCDA Application Status ReportThe STAT (Display the CCDA application status report) option may be used todisplay a report summarizing various information about the state of the CCDAapplication, as well as information about the most recent pull, push, and errormessages. The intent of the report is to provide support personnel with a snapshot ofthe application. It is not intended to be used by site managers, and no information isprovided to assist site managers with interpreting the report.When the user runs the report, it will ask whether to display the report with pagebreaks. If the user intends to view the report on the screen, it is recommended thatpage breaks be used. If the user is running the report in order to copy and pasteinformation for the support team, then not using page breaks may be preferred.A sample report is shown in Figure 3-5:Select CCDA Menu TEST ACCOUNT Option: STATreportDisplay the report with page breaks? Yes// nDisplay the CCDA application status(No)----------------------------- CCDA SUMMARY START -----------------------------Report version: 1.1Site: 8999 (DEMO HOSPITAL)Patches installed: v1 {1,2,3,4,5,6,7,8,9}, v2 {} ZV Cache for Windows (x86-64) 2017.2.2 (Build 865 3 19466U) Tue Dec 10 2019 15:12:26 ESTCCDA background task is running.CCDA production is running.Nightly upload time: 08:00Repository URL: https://repositoryurl.com/Last upload time: 3180419.080003 (2018-04-19 08:00:03) BCCD.Xfer.QueueD: 5477Ensemble queue counts:CaseReporting: 0Ens.Actor: 0Ens.ScheduleHandler: 0GeneratePull: 0PushWebClient: ansmitPush:10000Queue documents by status:R:0CS:0CE:0TS:0T:598E:89Last 10QID-----54235422658648638pull documents:DFNType Status------ ---- --------------2018-04-03 15:11:512018-04-03 15:06:062018-03-19 14:47:552018-03-19 14:46:302018-03-19 14:35:31User ManualSeptember 2020TransmissionEndTS------------------2018-04-03 15:11:552018-04-03 15:06:062018-03-19 14:46:36Package Management12

Consolidated Clinical Document Architecture (CCDA) TTTTTLast push documents:DFNType Status------ ---- --2018-04-19 12:34:452018-04-19 12:30:572018-04-19 11:40:002018-04-19 08:03:382018-04-18 19:23:262018-04-18 08:01:382018-04-18 08:01:382018-04-18 08:01:382018-04-18 08:01:382018-04-18 18-03-19Version ssionEndTS-------------------Last 5 error documents:QIDTypeRequestTSErrorText------ ---- ------------------- -----------------------------------------5476HIE 2018-04-19 12:30:57 Transmission error: ERROR #6241: The SOAP WebClient LOCATION parameter must specify http or https transport.5475HIE 2018-04-19 11:40:00 Transmission error: ERROR #6241: The SOAP WebClient LOCATION parameter must specify http or https transport.5474HIE 2018-04-19 08:03:38 Transmission error: ERROR #6241: The SOAP WebClient LOCATION parameter must specify http or https transport.5463HIE 2018-04-12 08:01:42 Transmission error: ERROR #6241: The SOAP WebClient LOCATION parameter must specify http or https transport.5464HIE 2018-04-12 08:01:42 Transmission error: ERROR #6241: The SOAP WebClient LOCATION parameter must specify http or https transport.------------------------------ CCDA SUMMARY END -------------------------------Figure 3-5: Sample CCDA application status reportDue to different rules surrounding patient DFNs, some sites may want to preventDFNs from displaying on the report. To suppress DFNs site-wide, go to RPMSprogrammer mode and run the following command:DO DFNOFF BCCDSTATTo clear the setting and re-enable DFNs on the report, go to RPMS programmer modeand run the following command:DO DFNCLR BCCDSTATUser ManualSeptember 2020Package Management13

Consolidated Clinical Document Architecture (CCDA) (BCCD)4.0Package Operation4.1Manually Generate One CCDA DocumentVersion 2.0CCDA documents are generated automatically and the process does not requiremanual intervention. However, on occasion, the site manager may be asked toregenerate the CCDA document for one or more patients. Select the Generate CCDfor a single patient (BCCD CCDGENONE) opti

User Manual System Navigation September 2020 6 2.3 Architecture CCDA processing can be initiated in four ways: If EHR version 1.1, patch 13 has been installed and configured at the site, then authorized EHR users are able to request Clinical Summary and Transitions of Care documents for display within the EHR GUI client.

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