LATITUDE Patient Management. Purpose. Objectives

Transcription

1 Contents Purpose...1 Objectives...1 Application Overview...2 Component Definitions...3 Follow-up Information Retrieval...4 Patient Record Dismissal...6 Follow-up Information Transfer..10 Patient Record Sign-off...12 Appendix A HL7 Message Structures...16 LATITUDE HL7 Message Specification...16 GE CPO HL7 Message Specification...25 Appendix B LATITUDE Terms...26 Appendix C Patient Matching...40 LATITUDE Patient Management Purpose This document provides a high-level description of the technical architecture and data flows of the Boston Scientific LATITUDE Patient Management System to GE Healthcare Centricity Physician Office (CPO) (formerly Logician) integration solution. CPO is GE Healthcare s outpatient electronic medical record (EMR) system. LATITUDE is Boston Scientific s remote patient monitoring system. Personnel that are responsible for administering CPO at a clinic can use this document to understand the technical components of the integration solution. A base understanding of the system components, processes, and associated terminology can help administrators support the system and troubleshoot problems. Objectives The objective of the LATITUDE EMR Integration software is to provide a quick and easy mechanism for downloading implanted cardiac device follow-up summary data from LATITUDE into the EMR and also to provide quick access from the EMR back into LATITUDE to review detailed cardiac device data for a patient. Your existing Logician / CPO technical and user documentation should be used to understand the proper use of the Logician / CPO product. Page 1

2 Application Overview The following diagram is a model that depicts the major technology components and data flows of the integration solution. Technology components are defined in Table 1 - Component Definitions below. There are four major data flow processes that are described in subsequent sections of this document. Follow-up information retrieval Patient record dismissal Follow-up information transfer Patient record sign-off Page 2

3 Component Definitions Table 1 - Component Definitions Component or Actor Name Clinic Environment Clinician DTS Home Environment Implanted Cardiac Device Internet LATITUDE Communicator LATITUDE Secure Server LinkLogic Inbox Folder Logician / CPO Client Logician / CPO Database Logician / CPO Server LTS Patient Web Browser Definition The clinic where the CPO applications are installed and used. This person has the role of following the patient with the implanted device. This could be a physician or an allied health professional. CPO Data Transfer Station (DTS). DTS is the CPO software component responsible for transferring data from external systems into the CPO database. The patient s home (or other location) where remote follow-ups of the implanted cardiac device takes place. Implanted Cardiac Devices operate within the human body in both monitoring and therapy delivery capacities. These devices are categorized as Pacemakers, Implantable Cardioverter Defibrillators (ICDs), and Cardiac Resynchronization Therapy (CRT) devices. Each of these electronic devices delivers a controlled electric shock to the heart to return the heart back to a normal rhythm. The public network that is used to securely transfer data. NOTE: All data flows in this system are secured and encrypted using standard encryption and data transfer techniques. A communications device that interrogates the implanted cardiac device, collects information from the device, and transfers collected data to the LATITUDE server. The LATITUDE secure server is a centralized computer database that stores patient data, implanted device data sent from patients LATITUDE Communicators, and physician and clinician configuration information. The LATITUDE secure server provides the data for presentation on the LATITUDE website, which is readily available over the Internet to authorized users. The local file system on the LTS / DTS server that stages the transformed LATITUDE download files prior to DTS processing. The CPO software component that provides a user interface for physicians to access EMR information. The relational database that contains and manages the CPO system data. The CPO server component that hosts the LTS and DTS software processes. LATITUDE Transfer Station (LTS). LTS is responsible for periodically polling the LATITUDE WebDAV Service and securely transferring and transforming new information for input into CPO. The person that has the implanted cardiac device that is being followed. The Internet browser used by the clinician to access the LATITUDE system. Page 3

4 Follow-up Information Retrieval LATITUDE retrieves information from the Home Environment LATITUDE - GE Logician / CPO Integration Interrogation Clinic Environment Clinician Web Browser Logician / CPO Client Home Environment Internet Logician / CPO Server LATITUDE Patient Communicator with Implanted Cardiac Device LTS LinkLogic Inbox Folder DTS Logician / CPO Database LATITUDE Secure Server Boston Scientific Page 4

5 Assumptions: Patient has implanted cardiac device. LATITUDE Communicator has been installed and configured. 1 At defined periods the LATITUDE Communicator interrogates the implanted device. 2 The implanted device sends data, concerning device and patient status, to the LATITUDE Communicator. 3 The LATITUDE Communicator processes the device data and utilizes a phone line to establish a secured Internet network connection to the LATITUDE server. 4 The LATITUDE Communicator securely transfers the device data to the LATITUDE server. 5 The LATITUDE secure server processes the device data and stores it into the patient s record in the LATITUDE database. Page 5

6 Patient Record Dismissal Patient records on the Patient for Review screen are reviewed by a clinician or clinicians and subsequently dismissed. LATITUDE - GE Logician / CPO Integration Dismissal Clinic Environment Clinician Web Browser Logician / CPO Client Home Environment Internet Logician / CPO Server LATITUDE Patient Communicator with Implanted Cardiac Device LTS LinkLogic Inbox Folder DTS Logician / CPO Database LATITUDE Secure Server Boston Scientific Page 6

7 1 The clinician logs into the LATITUDE web application 2 And navigates to the Patients For Review screen. Page 7

8 3 The clinician selects a patient follow-up record and reviews patient data on the clinically appropriate LATITUDE screens. 4 The clinician dismisses the patient, triggering the creation of a LATITUDE HL7 device summary message, which is stored in the LATITUDE secure server. Patients are dismissed by clicking on the Dismiss patient icon. This function can also be performed from the Patient Detail screens. Patient is selected using check box. Page 8

9 There may be circumstances where a download of a patient follow-up record needs to be rerun. LATITUDE has a mechanism for rerunning a patient follow-up record download. By clicking on the menu options Patient Utilities / EMR Log a page will be displayed that contains a function to place already downloaded Patient follow-up records into the EMR outbox. This will cause LTS to see and transfer the HL7 file again. The data will be identical to the initial download. Select patient record using the check box. Move previously downloaded records into the EMR Outbox by clicking on icon Page 9

10 Follow-up Information Transfer Follow-up information is transferred from LATITUDE to CPO. Page 10

11 Assumptions: The LATITUDE HL7 Device Summary message files have been written to storage on the LATITUDE secure server that is accessible from the clinic. Each file includes summary follow-up information and a direct URL link to the corresponding patient detail summary screen in LATITUDE. 1 LTS running on the CPO server in the clinic monitors the clinic s LATITUDEhosted web folder for new HL7 files by polling the LATITUDE secure server on a periodic basis using a secure WebDAV protocol. The frequency of polling is specified in the LTS configuration file LTS.INI which should be set to 60 seconds. 2 When LTS polling finds a new HL7 file on the LATITUDE secure server, it transfers the file using a secure WebDAV protocol. 3 LTS performs the processing needed to generate appropriate files for importing into the EMR. LTS creates two CPO HL7 files for every LATITUDE HL7 file. One file is a lab report (HL7 ORU message) and has an extension HR. The other file is an image file (HL7 MDM message) and has an extension HT. Once the HL7 file is transferred, the LATITUDE secure server automatically removes access, but retains the data for retransmission purposes. If specified in LTS.INI, a copy of the HL7 file will be saved on the Logician CPO server. NOTE: Details concerning the content of the HL7 files are contained in Appendix A HL7 Message Structures of this document. 4 LTS writes the CPO HL7 files to the LinkLogic Inbox Folder. 5 DTS imports the data from the LinkLogic inbox folder into the CPO Database. The HL7 ORU message file is first imported into a CPO lab report document. Next, the HL7 MDM message file, which contains the specified URL, is imported and attached to the lab report. 6 During the import process lab codes, document types, physician information, and patient information are cross-referenced and mapped from LATITUDE to CPO. See Appendix C for more information on Patient Matching. 7 DTS writes the device follow-up information to the CPO Database. 8 DTS changes the extensions of processed files in the LinkLogic Inbox Folder from HR to HRQ and from HT to HTQ. Page 11

12 Patient Record Sign-off Clinician reviews and signs the EMR record in CPO. Page 12

13 1 The clinician logs into the CPO client and observes new patient documents. 2 The clinician opens up the patient s device follow-up document and reviews the information. Clicking on paperclip icon automatically links to LATITUDE Patient Detail pages The clinician performs other clinical processes that may include linking to the LATITUDE web application for further follow-up data review. The clinician will Page 13

14 not need to re-enter username and password if already logged into LATITUDE, and the IE browser is configured to open a new session in an existing window. 3 The clinician signs the device follow-up report. Page 14

15 The flow sheet is available in the patient record after sign off. Page 15

16 Appendix A HL7 Message Structures The LATITUDE to EMR Integration solution relies on HL7 structured messages for the transferring of information. The out-of-box solution provides mappings and transformations of HL7 messages to internal GE CPO data structures. This section provides details concerning the structure and semantics of the HL7 messages for those doing custom work. It is assumed that readers of this section are familiar with HL7 2.x terminology, specification syntax, data types, message structures and semantics for ORU messages. For more information concerning HL7 messaging visit HL7 s web site at The LATITUDE to GE Healthcare EMR Integration solution consists of two sets of HL7 messages. HL7 messages generated by LATITUDE HL7 messages created by the LTS component for consumption by GE CPO LATITUDE HL7 Message Specification The LATITUDE application generates one HL7 message for each remote device follow-up. These messages are retrieved by LTS for use within GE CPO. See the Follow-up Information Transfer section of this document for details concerning this process. The LATITUDE HL7 file is structured according to the HL Observation Result Unsolicited (ORU) message type, which provides for the transmission of new observation information about patients in the form of a lab report document. LATITUDE s ORU message will contain useful follow-up summary data, including information from LATITUDE s Quick Notes report plus leads information and device counters. The message consists of the following segment structures. Message Structure Segment Description Usage MSH Message Header The MSH segment contains information about the Sender and Receiver of the message, the type of the message, a time stamp, etc., and is the first segment in each ORU message. PID Patient Identification The PID segment contains demographic information about the patient such as name, id codes, zip code, and so on. This information is used for patient matching. [{ NTE }] Notes and comments THE NTE segment contains alerts and events that have occurred for a particular patient. PV1 Patient Visit The PV1 (Patient Visit) segment contains information regarding the patient's encounter, such as location assigned, referring doctor, etc. { --- grouping BEGIN OBR Observations Request The OBR segment contains information regarding the characteristics of the last interrogation observation. {[OBX]} Observation result The OBX segment contains the parameters and values of the last interrogation observation. } --- grouping END ZU1 Custom Segment The ZU1 custom segment contains a URL link description. ZU2 Custom Segment The ZU2 custom segment contains the LATITUDE message version. Page 16

17 MSH Segment LATITUDE Patient Management ELEMENT NAME SEQ SUB SEQ DT LEN USAGE CARD TBL# ITEM # Fixed Example Value Field Separator 1 ST 1 R [1..1] Y Encoding Characters Sending Application 2 ST 4 R [1..1] Y ^~\& 3 HD 180 R [1..1] Y LATITUDE Sending Facility 4 HD 180 R [1..1] Y Boston Scientific Receiving Facility 6 HD 180 RE [0..1] Clinic Name Date/Time Of Message 7 TS 26 R [1..1] Message Type 9 MSG 15 R [1..1] message code 1 ID 3 R [1..1] 0076 Y ORU trigger event 2 ID 3 R [1..1] 0003 Y R01 Message Control ID 10 ST 20 R [1..1] Processing ID 11 ID 1 R [1..1] P Version ID 12 ID 5 R [1..1] Y Accept Acknowledgement Type 15 ID 2 R [1..1] Y NE Character Set 18 ID 6 R [1..1] Y 8859/1 Page 17

18 PID Segment LATITUDE Patient Management ELEMENT NAME SEQ SUB SEQ DT LEN USAGE CARD TBL# ITEM # Fixed Example Value Set ID PID 1 SI 1 R [1..1] Y 1 Patient ID 2 CX 20 R [1..1] ID 1 ST 20 R [1..1] see NOTE 2 Patient Identifier List 3 CX 20 R [1..1] ID 1 ST 20 R [1..1] ~ abc see NOTE 2 & 3 Patient Name 5 XPN 140 R [1..1] family+last name prefix 1 CM 40 R [1..1] Doe given name 2 ST 40 R [1..1] John middle initial or name 3 ST 40 RE [0..1] Jimmy suffix 4 ST 20 RE [0..1] Jr. Date/Time Of Birth 7 TS 1 RE [0..1] Sex 8 IS 1 RE [0..1] M zip or postal code 5 ST 10 RE [0..1] PID NOTES 1. The PID segment contains data used for patient matching (see Appendix C Patient Matching) 2. Patient ID and Patient Identifier List contains a unique patient number that is generated and maintained by LATITUDE. 3. LATITUDE allows an authorized user to enter their own patient identifier. The Patient Identifier List may contain the user entered patient identifier as a second patient identifier. Page 18

19 NTE Segment LATITUDE Patient Management ELEMENT NAME SEQ SUB SEQ DT LEN USAGE CARD TBL# ITEM # Fixed Example Value Set ID - NTE 1 SI 1 R [1..1] Source of comment 2 ID 8 R [1..1] Y LATITUDE Comment 3 FT R [1..*] See content descriptions in NOTE 1 NTE NOTES 1. There is the potential for 4 NTE segments within each device follow-up message. The Set ID and description for these segments will be as follows: o Set ID 1 This NTE segment contains a report consisting of an array of alerts that have occurred for a particular patient. There may be more than one alert associated with the given patient/physician pair. The alerts are sorted such that all red alerts appear first followed by yellow alerts. Secondary sorting within each alert type is newest to oldest. o Set ID 2 This NTE segment contains information concerning the LATITUDE patient record dismissal. It will contain information about who performed the dismissal and when it was performed. o Set ID 3 This NTE segment contains a report consisting of an array of events (stored episodes) that have occurred for a particular patient since the last device follow-up. There may be more than one event associated with the given patient/physician pair. Events are sorted newest to oldest. o Set ID 4 This NTE segment contains information about the device if it is in a fault condition. It will contain a fault warning statement and information concerning the fallback mode. Page 19

20 PV1 Segment LATITUDE Patient Management ELEMENT NAME SEQ SUB SEQ DT LEN USAGE CARD TBL# ITEM # Fixed Example Value Set ID - PV1 1 SI 4 R [1..1] Y 1 Patient Class 2 IS 1 R [1..1] Y R Attending Doctor 7 XCN 60 RE [0..1] ID Number (ST) 1 ST 8 R [1..1] JHopkins see NOTE 1 family+last name prefix 2 CM 40 R [1..1] Hopkins given name 3 ST 40 RE [0..1] John middle initial or name 4 ST 1 RE [0..1] L suffix 5 ST 20 RE [0..1] Sr. PV1 NOTES 1. Attending Doctor ID Number is the LATITUDE login name of the responsible physician. Page 20

21 OBR Segment LATITUDE Patient Management ELEMENT NAME SEQ SUB SEQ DT LEN USAGE CARD TBL# ITEM # Fixed Example Value Set ID OBR 1 SI 4 R [1..1] Y Filler Order Number 3 EI 22 R [1..1] entity identifier 1 ST 10 R [1..1] Universal Service ID 4 CE 200 R [1..1] identifier 1 ST 10 R [1..1] text 2 ST 50 R [1..1] Observation Date/Time # 7 TS 26 R [1..1] Observation End Date/Time # 8 TS 26 RE [0..1] Ordering Provider 16 XCN 120 RE [0..1] ID Number 1 ST 10 RE [0..1] Placer Field 1 18 ST 2 R [1..1] Y Results Rpt/Status Chng Date/Time + 22 TS 26 RE [0..1] thru 4 see NOTE 1 Unique identifier see NOTE 2 Boston Scientific - LastInterrogation see NOTE 1 Last Interrogation see NOTE JHopkins see NOTE 3 DR see Note 4 Result Status + 25 ID 1 R [1..1] Y F OBR Notes 1. The LATITUDE ORU message supports four OBRs (Observation Reports). Each OBR will contain multiple OBX records with context specific observations. Details concerning the specific OBX observations are listed in the OBX Segment section of this documentation. CPO will initially support two flow sheet views for the LATITUDE interface one for the Lead Information OBR, and one for the remaining three OBRs. The CPO flow sheet groups observation results into columns by date/time stamp of the observation. As a result, one LATITUDE HL7 export file will be disbursed into separate CPO flow sheet columns for each Last Interrogation, Implant, and Leads Information OBR, plus each unique last in-office lead test date. The four types of OBRs will have different Set IDs, and Universal Service IDs as follows ORU Name Description Set ID Universal Service ID identifier Universal Service ID text Last Interrogation Implant Last In- Office Lead Test This OBR contains observations from the last remote monitoring session. This OBR contains observations generated at the time the PG was implanted. This OBR contains observations from the latest in-office Lead Test. 1 Boston Scientific- LastInterrogation 2 Boston Scientific- Implant 3 Boston Scientific- LastInOffice Last Interrogation Implant Lead Test: In- Office Page 21

22 ORU Name Description Set ID Universal Service ID identifier Universal Service ID text Lead Information This OBR contains information about implanted leads. 4 Boston Scientific- Leads Lead Information 2. Filler Order Number is a unique identifier generated by LATITUDE for all four OBRs. The Filler Order Number will not change for observations that are resent. 3. Ordering Provider is the LATITUDE login name of the responsible physician. 4. Placer Field 1 is a value that CPO uses to identify the type of observation being sent. It is always set to DR which stands for Diagnostic Report. Page 22

23 OBX Segment ELEMENT NAME SEQ SUB SEQ DT LEN USAGE CARD TBL# ITEM # Fixed Example Values Set ID - OBX 1 SI 4 R [1..1] Sequential Integer starting with 1 Value Type 2 ID 2 R [1..1] ST or NM or DT see NOTE 1 Observation Identifier 3 CE 80 R [1..1] identifier 1 ST 80 R [1..1] see NOTE 2 text 2 ST 256 R [1..1] see NOTE 2 name of coding system 3 ST 20 R [1..1] Y GDT-LATITUDE Observation Value RE [0..1] see NOTE 3 Units 6 CE 60 RE [0..1] identifier 1 ST 20 RE [0..1] see NOTE 4 Observation Result Status 11 ID 1 R [1..1] Y F Date/Time of the Observation 14 TS 26 R [0..1] OBX Notes 1. The value types will be ST String, NM Number, or DT Date. 2. All observations are coded using LATITUDE specific terms. Specifications concerning these terms are in Appendix B LATITUDE Terms. 3. Observation Value is the value of the observation and will be of the type Value Type. 4. Units of the observation if applicable Page 23

24 Z Segments LATITUDE Patient Management ELEMENT NAME SEQ SUB SEQ DT LEN USAGE CARD TBL# ITEM # Fixed Example Value Segment Type 1 ST 3 R [1..1] Y ZU1 or ZU2 see NOTE 1 Value 2 ST 40 R [1..1] URL or Report Type see NOTE 1 Z NOTES 1. The Z Segments are customized segments used to transfer LATITUDE specific information. The two types of Z segments used are described below. o ZU1 Value contains the URL string that allows a system user to link to the Patient Details screen. Ex. o ZU2 Value contains Latitude message description and version. Ex. Device Summary Report Version 1 Page 24

25 GE CPO HL7 Message Specification The LATITUDE HL7 message is transferred and transformed by the LTS component (see section Follow-up Information Transfer for details). Refer to the GE CPO documentation for specifics concerning the structure of the resulting HL7 ORU and MDM messages that are imported directly into CPO. The terms used in the LTS transformed OBX records generally remain unchanged from the original LATITUDE HL7 message. Some conversions such as unit identifiers are performed. The ZU1 segment is transformed into an MDM message. Refer to Appendix B LATITUDE Terms for detailed information concerning OBX terminology. Page 25

26 Appendix B LATITUDE Terms OBR Section Last Interrogation Implant Lead Test Lead Information Term Name Description Data Type Unit CPO Flow Sheet Label CPO MLI Code GDT Code Result Source The Result Source identifies the source of the data (e.g., Remote Interrogation, In-office Lead Test, Implant, etc.) T RESULTSOURCE MLI GDT X X X Device Manufacturer Device manufacturer company name T DEV_COMPANY MLI GDT X X X Device Type The type of device T DEV_TYPE MLI GDT X X X Device Name The name given to a device by the manufacturer T DEVICE NAME MLI GDT X X X Device Model Name The device model name T DEVMODELNAME MLI GDT X X X Device Model Number The device model number T GENRT MOD# MLI GDT X X X Device Serial Number The device serial number T GENERATSERNO MLI GDT X X X Device Implant Date Implant date of the device T DEVIMPLANTDT MLI GDT X X X Battery Gauge The percentage that represents the battery life. N % BATT GAUGE MLI GDT X Battery Status Represents an alert or notification about the current status of the battery. T BATT STATUS MLI GDT X Monitoring Voltage The battery voltage measurement taken by the implanted device. T V MNTR VOLTAGE MLI GDT X Charge Time The length of time required for the last high voltage capacitor charge. This is representative of battery status in some implanted devices. T s CHG TIME MLI GDT X Last Reform The date of last capacitor reformation in the implanted device. T LST CAP RFRM MLI GDT X Page 26

27 OBR Section Last Interrogation Implant Lead Test Lead Information Term Name Description Data Type Unit CPO Flow Sheet Label CPO MLI Code GDT Code Counters Since The starting date that the counter values are calculated from T COUNTRSSINCE MLI GDT X X VF Episodes Total Ventricular Fibrillation Episodes: The number of episodes in the highest tachy zone detected since the Counters Since date T VF EPISODES MLI GDT X VT Episodes VT Episodes: VT Zone arrhythmias detected since the Counters Since date T VT EPISODES MLI GDT X VT-1 Episodes VT-1 Episodes: VT-1 Zone arrhythmias detected since the Counters Since date T VT1 EPISODES MLI GDT X Non-Sustained Ventricular Episodes Total Ventricular Tachycardia Non-Sustained Episodes: The number of Non-Sustained VT episodes detected since the Counters Since date T NSVTEPISODES MLI GDT X ATR Mode Switches ATR Mode Switches: The number of mode switches detected since the "Counters Since" date T ATRMODESWCHS MLI GDT X AFib Episodes Atrial Fibrillation Episodes: Atrial Fibrillation episodes detected since the "Counters Since" date T AF EPISODES MLI GDT X SVT Episodes Supraventricular (Atrial) Tachycardia Episodes: SVT (AT) episodes detected since the "Counters Since" date T AT EPISODES MLI GDT X Atrial Percent Paced Right Atrial Pacing Percent: The percent of all Right atrial events detected since the Counters Since date that were paced. N % RA % PACED MLI GDT X Page 27

28 OBR Section Last Interrogation Implant Lead Test Lead Information Term Name Description Data Type Unit CPO Flow Sheet Label CPO MLI Code GDT Code RV Percent Paced Right Ventricular Pacing Percent: The percent of all Right ventricular events detected since the Counters Since date that were paced. N % RV % PACED MLI GDT X LV Percent Paced Left Ventricular Pacing Percent: The percent of all left ventricular events detected since the Counters Since date that were paced. N % LV % PACED MLI GDT X Right Atrial Lead Status The current status of the Right Atrial Lead determined by the device based on analysis of the lead amplitude and impedance. If a value encountered is outside of the expected range, its status is presented. T RALEADSTATUS MLI GDT X RA Intrinsic Amplitude Right Atrial Intrinsic Amplitude (P-Wave) measured during an Intrinsic Amplitude Test. T mv RA INTRNSAMP MLI GDT GDT GDT X X RA Pace Impedance Right Atrial Lead Impedance measured during a Lead Impedance Test. T ohms RA PACE IMPD MLI GDT GDT GDT X X Right Ventricular Lead Status The current status of the Right Ventricular Lead determined by the device based on analysis of the lead amplitude and impedance. If a value encountered is outside of the expected range, its status is presented. T RVLEADSTATUS MLI GDT X RV Intrinsic Amplitude Right Ventricular Intrinsic Amplitude (R- Wave) measured during an Intrinsic Amplitude Test. T mv RV INTRNSAMP MLI GDT GDT GDT X X X RV Pace Impedance Right Ventricular Lead Impedance measured during a Lead Impedance Test. T ohms RV PACE IMPD MLI GDT GDT GDT X X X Page 28

29 OBR Section Last Interrogation Implant Lead Test Lead Information Term Name Description Data Type Unit CPO Flow Sheet Label CPO MLI Code GDT Code LV Lead Status The current status of the Left Ventricular Lead determined by the device based on analysis of the lead amplitude and impedance. If a value encountered is outside of the expected range, its status is presented. T LVLEADSTATUS MLI GDT X LV Intrinsic Amplitude Left Ventricular Intrinsic Amplitude (R-Wave) measured during an Intrinsic Amplitude Test. T mv LV INTRNSAMP MLI GDT GDT GDT X X X LV Pace Impedance Left Ventricular Lead Impedance measured during a Lead Impedance Test. T ohms LV PACE IMPD MLI GDT GDT GDT X X X Shock Vector Status The current status of the Shock Vector determined by the device based on analysis of the impedance. If a value encountered is outside of the expected configuration, its status is presented. T SHCKVCTRSTAT MLI GDT X Shock Impedance Last Delivered Ventricular Shock Lead Impedance: The shocking impedance from the last ventricular shock delivered. T ohms SHCKLEADIMPD MLI GDT GDT GDT X X X V-Tachy Mode Ventricular Tachy therapy mode T V-TACHY MODE MLI GDT X A-Tachy Mode Atrial Tachy therapy mode T A-TACHY MODE MLI GDT X Brady Mode Brady Mode (i.e., pacing mode): The manner in which a device provides rate and rhythm support. T BRADY MODE MLI GDT X Lower Rate Limit Lower Rate Limit (LRL) is the rate at which the implanted device paces the atrium and/or ventricle in the absence of sensed intrinsic activity. N bpm LRL MLI GDT X Page 29

30 Term Name Description Data Type Unit CPO Flow Sheet Label CPO MLI Code GDT Code Page 30 OBR Section Last Interrogation Implant Lead Test Lead Information Maximum Tracking Rate Maximum Tracking Rate: In the DDD(R) and VDD(R) modes, the Maximum Tracking Rate (MTR) is the maximum rate at which the ventricular pacing will track 1:1 with nonrefractory sensed atrial events. T bpm MTR URL MLI GDT X Maximum Sensor Rate The fastest sensor-driven pacing rate that can be achieved in a rate-adaptive pacing system. T bpm MAXSENSRATE MLI GDT X Sensitivity RA Right Atrial Sensitivity: The Atrial Sensitivity parameter indicates the smallest signal that will be sensed in the right atrium. T SENSTVTY-RA MLI GDT X Sensitivity RV Right Ventricular Sensitivity: The Right Ventricular Sensitivity parameter indicates the smallest signal that will be sensed in the right ventricle. T SENSTVTY-RV MLI GDT X Sensitivity LV Left Ventricular Sensitivity: The Left Ventricular Sensitivity parameter indicates the smallest signal that will be sensed in the left ventricle. T SENSTVTY-LV MLI GDT X Paced AV Delay The value of the AV Delay setting. T ms PACEDAVDELAY MLI GDT X Sensed AV Offset Sensed AV Offset: The AV Delay is shortened by the programmed Sensed AV Offset after a sensed atrial event. T ms SENSEDAVOFFS MLI GDT X AV Search Hysteresis Search Interval Number of paced AV cycles between A-V rate searches T AVSRCHHYS-SI MLI GDT X AV Search Hysteresis AV Increase The percentage increase in AV delay to be applied to the next cardiac cycle when AV Search is active. T % AVSRCHHYSAVI MLI GDT X

31 Term Name Description Data Type Unit CPO Flow Sheet Label CPO MLI Code GDT Code Page 31 OBR Section Last Interrogation Implant Lead Test Lead Information A-Refractory (PVARP) Post-Ventricular Atrial Refractory Period (PVARP) is the time period after a ventricular event, either paced or sensed, when activity in the atrium does not reset the cardiac cycle nor trigger a ventricular stimulus. T ms PVARP MLI GDT X RV-Refractory (RVRP) Right Ventricular Refractory Period is the time period following a right ventricular event, either paced or sensed, when sensed electric activity in the right ventricle does not reset the timing cycles. T ms RVRP MLI GDT X LV-Refractory (LVRP) Left Ventricular Refractory Period (LVRP) is defined as the time period following a left ventricular event, either paced or sensed, when intrinsic LV events will not be used to reset the timing cycles. T ms L VRP MLI GDT X LV Protection Period Left Ventricular Protection Period (LVPP): LVPP is the period after a left ventricular event, either paced or sensed, when the device will not pace the left ventricle T ms L VPP MLI GDT X Ventricular Pacing Chamber Pacing Chamber: This parameter determines the ventricular pacing configuration - either right or bi-ventricular pacing. T CHMBR PACED MLI GDT X Ventricular Pacing Chamber LV Offset Offset between delivery of RV and LV pacing pulses. The offset is applied to the LV pacing pulse, based on the timing of the RV pacing pulse. The offset may have a negative or positive value. T ms LVPCELVOFFST MLI GDT X Pacing Output - RA The combination of the Right Atrial Amplitude and the Right Atrial Pulse Width. T PACEOUTPUTRA MLI GDT X

32 Term Name Description Data Type Unit CPO Flow Sheet Label CPO MLI Code GDT Code Page 32 OBR Section Last Interrogation Implant Lead Test Lead Information Pacing Output - RV The combination of the Right Ventricular Amplitude and the Right Ventricular Pulse Width. T PACEOUTPUTRV MLI GDT X Pacing Output - LV The combination of the Left Ventricular Amplitude and the Left Ventricular Pulse Width. T PACEOUTPUTLV MLI GDT X ATR Mode Switch Mode ATR Mode Switch Mode: Non-tracking pacing mode change when patient experiences atrial tachyarrhythmia. T MODESWTCH ST MLI GDT X ATR Mode Switch Rate Atrial Tachy Response Rate is the pacing rate to which the mode switches in a new therapy setting. T bpm MODESWCHRATE MLI GDT X AFib Zone AFib Rate Threshold: The rate above which an A-A interval is classified in the AFib zone. T bpm AFIB ZONE MLI GDT X AFib Zone ATP1 Type ATP Therapy for the first therapy set T AFATP1TYPE MLI GDT X AFib Zone ATP1 Number of Bursts The programmed number of atrial Antitachy Pacing bursts delivered in the AFib Zone by an implanted device for the first programmed atrial therapy set. T AFATP1 #BRST MLI GDT X AFib Zone ATP2 Type ATP Therapy for the second programmed therapy set. T AFATP2TYPE MLI GDT X AFib Zone ATP2 Number of Bursts The programmed number of atrial Antitachy Pacing bursts delivered in the AFib Zone by an implanted device for the second programmed atrial therapy set. T AFATP2 #BRST MLI GDT X AFib Zone Shock 1 Energy AFib Shock 1 Energy: The amount of energy delivered in the first shock of the AFib zone. T joules AFIB SHOCK 1 MLI GDT X

33 Term Name Description Data Type Unit CPO Flow Sheet Label CPO MLI Code GDT Code Page 33 OBR Section Last Interrogation Implant Lead Test Lead Information AFib Zone Shock 2 Energy AFib Shock 2 Energy: The amount of energy delivered in the second shock of the AFib zone. T joules AFIB SHOCK 2 MLI GDT X AFib Zone Shock 3 Energy AFib Shock 3 Energy: The amount of energy delivered in the third shock of the AFib zone. T joules AFIB SHOCK 3 MLI GDT X SVT Zone SVT (AT) Rate Threshold: The rate above which an A-A interval is classified in the SVT Zone (i.e., AT Zone). N bpm AT ZONE MLI GDT X SVT Zone ATP1 Type The type of atrial Antitachy Pacing bursts delivered in the SVT Zone (i.e., AT Zone) by an implanted device for the first programmed atrial therapy set. T ATATP1TYPE MLI GDT X SVT Zone ATP1 Number of Bursts The number of atrial Antitachy Pacing bursts delivered in the SVT Zone (i.e., AT Zone) by an implanted device for the first programmed atrial therapy set. T ATATP1 #BRST MLI GDT X SVT Zone ATP2 Type The type of atrial Antitachy Pacing bursts delivered in the SVT Zone (i.e., AT Zone) by an implanted device for the second programmed atrial therapy set. T ATATP2TYPE MLI GDT X SVT Zone ATP2 Number of Bursts The number of atrial Antitachy Pacing bursts delivered in the SVT Zone (i.e., AT Zone) by an implanted device for the second programmed atrial therapy set. T ATATP2 #BRST MLI GDT X SVT Zone Shock 1 Energy SVT (AT) Shock 1 Energy: The amount of energy delivered in the first shock of the SVT Zone (i.e., AT Zone). T joules AT SHOCK1 MLI GDT X

34 Term Name Description Data Type Unit CPO Flow Sheet Label CPO MLI Code GDT Code Page 34 OBR Section Last Interrogation Implant Lead Test Lead Information SVT Zone Shock 2 Energy SVT (AT) Shock 2 Energy: The amount of energy delivered in the second shock of the SVT Zone (i.e., AT Zone). T joules AT SHOCK2 MLI GDT X SVT Zone Shock 3 Energy SVT (AT) Shock 3 Energy: The amount of energy delivered in the third shock of the SVT Zone (i.e., AT Zone). T joules AT SHOCK3 MLI GDT X VF Zone VF Rate Threshold: The rate above which an R-R interval is classified in the VF zone N bpm VF ZONE MLI GDT X VF Shock 1 Energy VF Shock 1 Energy: The amount of energy delivered in the first shock of the VF zone. N joules VF SHOCK 1 MLI GDT X VF Shock 2 Energy VF Shock 2 Energy: The amount of energy delivered in the second shock of the VF zone. N joules VF SHOCK 2 MLI GDT X VF Max Shock Energy VF Maximum Shock Energy: The amount of energy delivered in each remaining shock after the second shock of the VF zone. N joules VF MAX SHOCK MLI GDT X VF Number Of Additional Shocks VF Number Of Additional Shocks: The number of additional max energy shocks in the VF zone programmed for delivery. T VF ADDL SHKS MLI GDT X VT Zone VT Rate Threshold: The rate above which an R-R interval is classified in the VT zone N bpm VT ZONE MLI GDT X VT Zone ATP1 Type The type of ventricular Antitachy Pacing bursts delivered in the VT Zone by an implanted device for the first programmed ventricular therapy set. T VTATP1TYPE MLI GDT X

35 Term Name Description Data Type Unit CPO Flow Sheet Label CPO MLI Code GDT Code Page 35 OBR Section Last Interrogation Implant Lead Test Lead Information VT Zone ATP1 Number of Bursts The number of ventricular Antitachy Pacing bursts delivered in the VT Zone by an implanted device for the first programmed ventricular therapy set. T VTATP1 #BRST MLI GDT X VT Zone ATP2 Type The type of ventricular Antitachy Pacing bursts delivered in the VT Zone by an implanted device for the second programmed ventricular therapy set. T VTATP2TYPE MLI GDT X VT Zone ATP2 Number of Bursts The number of ventricular Antitachy Pacing bursts delivered in the VT Zone by an implanted device for the second programmed ventricular therapy set. T VTATP2 #BRST MLI GDT X VT Shock 1 Energy VT Shock 1 Energy: The amount of energy delivered in the first shock of the VT zone. T joules VT SHOCK1 MLI GDT X VT Shock 2 Energy VT Shock 2 Energy: The amount of energy delivered in the second shock of the VT zone. T joules VT SHOCK2 MLI GDT X VT Max Shock Energy VT Maximum Shock Energy: The amount of energy delivered in each remaining shock after the second shock of the VT zone. T joules VT MAXSHOCK MLI GDT X VT Number Of Additional Max Energy Shocks VT Number Of Additional Shocks: The number of additional max energy shocks in the VT zone programmed for delivery. T VT ADDL SHKS MLI GDT X VT-1 Zone VT-1 Rate Threshold: The rate above which an R-R interval is classified in the VT-1 zone N bpm VT1 ZONE MLI GDT X VT-1 ATP1 Type The type of ventricular Antitachy Pacing bursts delivered in the VT-1 Zone by an implanted device for the first ventricular therapy set T VT1ATP1TYPE MLI GDT X

36 OBR Section Last Interrogation Implant Lead Test Lead Information Term Name Description Data Type Unit CPO Flow Sheet Label CPO MLI Code GDT Code VT-1 ATP1 Number of Bursts The number of ventricular Antitachy Pacing bursts delivered in the VT-1 Zone by an implanted device for the first ventricular therapy set T VT1ATP1#BRST MLI GDT X VT-1 ATP2 Type The type of ventricular Antitachy Pacing bursts delivered in the VT-1 Zone by an implanted device for the second ventricular ATP therapy set. T VT1ATP2TYPE MLI GDT X VT-1 ATP2 Number of Bursts The number of ventricular Antitachy Pacing bursts delivered in the VT-1 Zone by an implanted device for the second ventricular ATP therapy set. T VT1ATP2#BRST MLI GDT X VT-1 Shock 1 Energy VT-1 Shock 1 Energy: The amount of energy delivered in the first shock of the VT-1 zone. T joules VT1 SHOCK 1 MLI GDT X VT-1 Shock 2 Energy VT-1 Shock 2 Energy: The amount of energy delivered in the second shock of the VT-1 zone. T joules VT1 SHOCK 2 MLI GDT X VT-1 Max Shock Energy VT-1 Maximum Shock Energy: The amount of energy delivered in each remaining shock after the second shock of the VT-1 zone. T joules VT1 MAXSHOCK MLI GDT X VT-1 Number Of Additional Max Energy Shocks VT-1 Number Of Additional Shocks: The number of shocks in the VT-1 zone programmed for delivery. T VT1ADDL SHKS MLI GDT X RA Pace Threshold The minimum electrical stimulation (pacemaker output pulse) required to consistently initiate Right Atrial depolarization. T RA PACETHRSH MLI GDT GDT X X X Page 36

37 OBR Section Last Interrogation Implant Lead Test Lead Information Term Name Description Data Type Unit CPO Flow Sheet Label CPO MLI Code GDT Code RV Pace Threshold The minimum electrical stimulation (pacing output pulse) required to consistently initiate Right Ventricular depolarization. T RV PACETHRSH MLI GDT GDT X X X LV Pace Threshold The minimum electrical stimulation (pacing output pulse) required to consistently initiate Left Ventricular depolarization. T LV PACETHRSH MLI GDT GDT X X Lead 1: Implant Date The Implant Date of this lead. T LEAD1-IMPTDT MLI GDT X Lead 1: Manufacturer The Manufacturer of this lead. T LEAD1-MNFCTR MLI GDT X Lead 1: Model Number The Model of this lead. T LEAD1-MODEL# MLI GDT X Lead 1: Serial Number The Serial number of this lead. T LEAD1-SERL# MLI GDT X Lead 1: Polarity The Polarity of this lead. T LEAD1-POLRTY MLI GDT X Lead 1: Position The Position of this lead. T LEAD1-POSTN MLI GDT X Lead 1: Status The status of this lead. T LEAD1-STATUS MLI GDT X Lead 2: Implant Date The Implant Date of this lead. T LEAD2-IMPTDT MLI GDT X Lead 2: Manufacturer The Manufacturer of this lead. T LEAD2-MNFCTR MLI GDT X Lead 2: Model Number The Model of this lead. T LEAD2-MODEL# MLI GDT X Lead 2: Serial Number The Serial number of this lead. T LEAD2-SERL# MLI GDT X Lead 2: Polarity The Polarity of this lead. T LEAD2-POLRTY MLI GDT X Lead 2: Position The Position of this lead. T LEAD2-POSTN MLI GDT X Lead 2: Status The status of this lead. T LEAD2-STATUS MLI GDT X Lead 3: Implant Date The Implant Date of this lead. T LEAD3-IMPTDT MLI GDT X Lead 3: Manufacturer The Manufacturer of this lead. T LEAD3-MNFCTR MLI GDT X Page 37

38 OBR Section Last Interrogation Implant Lead Test Lead Information Term Name Description Data Type Unit CPO Flow Sheet Label CPO MLI Code GDT Code Lead 3: Model Number The Model of this lead. T LEAD3-MODEL# MLI GDT X Lead 3: Serial Number The Serial number of this lead. T LEAD3-SERL# MLI GDT X Lead 3: Polarity The Polarity of this lead. T LEAD3-POLRTY MLI GDT X Lead 3: Position The Position of this lead. T LEAD3-POSTN MLI GDT X Lead 3: Status The status of this lead. T LEAD3-STATUS MLI GDT X Lead 4: Implant Date The Implant Date of this lead. T LEAD4-IMPTDT MLI GDT X Lead 4: Manufacturer The Manufacturer of this lead. T LEAD4-MNFCTR MLI GDT X Lead 4: Model Number The Model of this lead. T LEAD4-MODEL# MLI GDT X Lead 4: Serial Number The Serial number of this lead. T LEAD4-SERL# MLI GDT X Lead 4: Polarity The Polarity of this lead. T LEAD4-POLRTY MLI GDT X Lead 4: Position The Position of this lead. T LEAD4-POSTN MLI GDT X Lead 4: Status The status of this lead. T LEAD4-STATUS MLI GDT X Lead 5: Implant Date The Implant Date of this lead. T LEAD5-IMPTDT MLI GDT X Lead 5: Manufacturer The Manufacturer of this lead. T LEAD5-MNFCTR MLI GDT X Lead 5: Model Number The Model of this lead. T LEAD5-MODEL# MLI GDT X Lead 5: Serial Number The Serial number of this lead. T LEAD5-SERL# MLI GDT X Lead 5: Polarity The Polarity of this lead. T LEAD5-POLRTY MLI GDT X Lead 5: Position The Position of this lead. T LEAD5-POSTN MLI GDT X Lead 5: Status The status of this lead. T LEAD5-STATUS MLI GDT X Lead 6: Implant Date The Implant Date of this lead. T LEAD6-IMPTDT MLI GDT X Page 38

39 OBR Section Last Interrogation Implant Lead Test Lead Information Term Name Description Data Type Unit CPO Flow Sheet Label CPO MLI Code GDT Code Lead 6: Manufacturer The Manufacturer of this lead. T LEAD6-MNFCTR MLI GDT X Lead 6: Model Number The Model of this lead. T LEAD6-MODEL# MLI GDT X Lead 6: Serial Number The Serial number of this lead. T LEAD6-SERL# MLI GDT X Lead 6: Polarity The Polarity of this lead. T LEAD6-POLRTY MLI GDT X Lead 6: Position The Position of this lead. T LEAD6-POSTN MLI GDT X Lead 6: Status The status of this lead. T LEAD6-STATUS MLI GDT X Lead 7: Implant Date The Implant Date of this lead. T LEAD7-IMPTDT MLI GDT X Lead 7: Manufacturer The Manufacturer of this lead. T LEAD7-MNFCTR MLI GDT X Lead 7: Model Number The Model of this lead. T LEAD7-MODEL# MLI GDT X Lead 7: Serial Number The Serial number of this lead. T LEAD7-SERL# MLI GDT X Lead 7: Polarity The Polarity of this lead. T LEAD7-POLRTY MLI GDT X Lead 7: Position The Position of this lead. T LEAD7-POSTN MLI GDT X Lead 7: Status The status of this lead. T LEAD7-STATUS MLI GDT X Page 39

40 Appendix C Patient Matching LATITUDE Patient Management Patient records sent from LATITUDE will be matched to patient records in CPO using the matching algorithm depicted in the following CPO screen. See your CPO technical documentation for details on configuring Patient Matching. The first time data for a particular patient is sent to CPO, a demographics match will need to occur. If such a match cannot be made, the imported file goes into an exception queue waiting for the LinkLogic Manager to manually resolve the problem. Upon a successful match (either automatically via a demographics match, or manually by the LinkLogic manager), LATITUDE's External ID for the patient will be automatically paired with the CPO Patient ID in a CPO table. 1 For that patient, subsequent transmissions will then match on LATITUDE s External ID for the patient and either Birth Date or Last Name. There can be duplicate patient records in LATITUDE that later get combined through a merge. Prior to the merge, the duplicate records will have different external patient IDs. Thus, the interface should be configured to update the external patient ID upon a successful demographics match, in order to record the one external ID for the patient that is retained following a merge. 1 LinkLogic can be configured to create a new ID set and associate it with a specific interface. Page 40

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