specifications ARIA Oncology Information System FOR MEDICAL ONCOLOGY
ARIA Oncology Information System The ARIA oncology information system for Medical Oncology is a comprehensive suite of software applications that support the medical oncology clinic. Complete oncology information management..page 4 ARIA brings the entire patient chart to the point of care. This system streamlines your department processes, eliminates the time and cost associated with paper management, and enables your staff to make more informed decisions for your patients. Chemotherapy ordering...page 8 ARIA manages the chemotherapy prescribing process from simple regimens to comprehensive treatment plans. Reports...page 12 ARIA contains more than 1,500 clinical, financial, and administrative reports. These reports support scheduling and treatment, as well as segmented financial analyses by clinic, diagnosis, treatment, or provider to compare the costs of treatment delivery and evaluate treatment outcomes. Clinical trials and decision support...page 13 ARIA supports the development and clinical management of complex clinical trials that provide the collection and registration of research data. The system also includes advanced clinical decision support triggering alerts, rules, dose delays, and reductions. Configuration management...page 14 Security is the database administration module of the ARIA for medical oncology system where users and user access rights are defined. ARIA Security also maintains all the supporting data required by ARIA Manager s functionality. Connectivity...page 15 Interfaces connecting to enterprise systems, such as HIS, RIS, PACS, lab, pathology, pharmacy, billing, and cancer registry enable the automatic population of data from previously disparate silos of information, minimizing the time spent away from the patient to track down information. Information is easily imported and exported via HL7. Data protection solution...page 18 Safeguard your clinical information with ARIA s optional warm standby database server. System information...page 18 With ARIA, you have the flexibility to adapt the system to suit the needs of your clinic. Users can personalize the specific information they wish to view, and departments can configure system-wide settings that affect all users. page 3
Complete Oncology Information Management 1.0 Manager Manager is the centerpiece of the ARIA for Medical Oncology solution, combining an oncology-specific patient electronic medical record (EMR) and functional components to support clinical operations. 1.1 Registration and appointments 1.1.1 In addition to the typical demographic information, Manager captures: Patient preferences for e-mail, communication, and information requests Configurable patient IDs (i.e., custom named, auto-generated, and required) The patient ID shown in the open patient window and in the title bar of each specific window can be controlled by the client instead of defaulting to the primary ID Primary contact- next of kin Demographics, including advance directives Provider information Referrals Patient photos Insurance, financials, and precertification control and management 1.1.2 Robust chart access to patient files, searchable by: Clinical data, such as demographics, problems, medications, test results, provider visits, and allergies Patients scheduled for appointments by facility, location, department, and provider Patient ID First or last name Provider, institution, gender, or file status Recently accessed patient charts by user Optional alias filters to protect patient privacy When in an on-demand ADT environment, users have the ability to search for patients in ARIA, when not found, the user can initiate a query of one or more external systems to find the patient and trigger sending the registration information via the interface to ARIA. 1.1.3 Scheduling Manager provides a comprehensive patient appointment scheduler. Each appointment can consist of multiple events linked with one or more providers and/or locations. Multi-event appointment scheduling that can be configured to meet individual client needs Ability to schedule any patient, resource, and location Treatment-driven schedule, identifying expected visit dates for planned chemotherapy Color-coded calendar Search capabilities to help find first available appointments, for either an individual or series of appointments Ability to copy visit details to any number of future visits Schedule multiple appointments via copy function Options to cancel, error, or mark as no shows including reason Patient calendar and appointment slip printouts Direct access to information, such as billing, demographics, questionnaires, reminders, and tests Management for over-booking by either warning or preventing overbooking, or only allowing authorized individuals to overbook resources page 4
Multiple schedule views Ability to define department-specific hours of operation, capacity, and activities performed Ability to block available times for patients, resources, and locations Scheduling templates for specific patient, provider, location, days, and times 1.2 Point-of-care documentation and management 1.2.1 Medical history Patient history data includes: Medical Procedure/surgical Gynecologic Family Social Allergies and adverse reactions - Allergies can be tracked including type, onset date, the response description, and severity - Allergies and adverse reactions are highlighted throughout the patient chart Medications Medication reconciliation process by comparing two lists of medication Diagnoses / problems Impression / plan Chief complaint / HPI Infection control Photographs Tests Comments Questionnaires 1.2.2 Patient summary The patient summary window is designed to provide the user with a quick reference of the patient to help prepare for the patient encounter. Summary: Name, age, sex, regimen including cycle and day, diagnoses, allergies/adverse reactions, medications, abnormal test results, date of previous visit, and the next visit Primary diagnosis and problem list Recent results: with the ability to graph results Last Note: displayed by discipline, job classification, author, and note type Medications: complete list of medications, including current medications and treatment Photo, general information, advance directives, billing #, medical record #, registry #, internal physicians, and referring physicians Treatment details: summary of the current chemotherapy, radiation treatment, and procedure/surgical 1.2.3 Diagnoses and problems A complete problem list can be maintained for a patient, including the primary diagnosis and other presenting problems requiring monitoring or management: Identify and submit diagnoses that are reportable to health agencies Diagnosis using International Classification of Diseases: ICD-9-CM or ICD-10 coding Pathology using ICD-O Version 2/3 Lesion tracking, including multi-focal lesion definition Extensive pathology and surgical information (e.g., margins, Oncotype Dx, invasive tumor details) page 5
Staging - Auto-staging from selection of criteria for clinical and pathologic, with the ability to custom define a stage group - Staging systems supported include: AJCC/ UICC 5th, 6th, and 7th Editions, FIGO, International Staging System (ISS) Durie-Salmon, Rai, Binet, MSTS (bone), SCLC (lung), and Ann Arbor (lymphoma) Node status presence of metastases, invasive, recurrent Tumor markers (e.g., CEA, PSA) summary from lab results with relevant cancer shown Indicators for specific types of cancer: - Breast: ER and PR Status, Her-2/Neu, FISH/IHC, and S-Phase (%) - Prostate: Gleason score and cores - Colon: KRAS The ability to record and rank multiple diagnoses and problems Diagnosis status to track changes over time 1.3 Assessments 1.3.1 Toxicities Grading criteria s supported are NCI CTCAE versions 2, 3, and 4. Ability to indicate a specific grading scheme for each chemotherapy regimen, for cases where a clinical trial dictates a specific toxicity scheme Automatic toxicity grading based on lab results Ability to enter start/stop dates for each toxicity Electronic signature for approval 1.3.2 Adverse events Adverse reaction tracking, including type, onset date, the response description, and severity A list of active adverse events defaults in reverse chronological order based on start date Automatic tracking of adverse events for all clinical trials patients with the ability to indicate non-toxicity adverse events when necessary Automatic management of adverse event progression where new adverse events are created when toxicity progresses to a higher grade 1.3.3 Review of Systems (RoS) and Physical Exam (PE) Consists of a standard set of body systems and problem areas Different RoS and PE systems associated with each site of cancer for each physician The defaults for normal and abnormal descriptions can be specified for each physician Documentation is performed through pick-list selection, free-text, or voicecapture dictation Ability to view all previous assessments and reference a previous as the basis for documenting a system for the current assessment Spell checking 1.3.4 Vital signs Recording of standard set of patient vital signs: - Height, weight, BSA - Body Mass Index (BMI) - Temperature, pulse, and respiration - Blood pressure Graphing capabilities Electronic signature for approval Pediatric formulas for BSA and IBW Pediatric patient CDC growth charts to track height and body mass index (BMI). page 6
1.3.5 Performance status Currently Eastern Cooperative Oncology Group (ECOG), Karnofsky, Gynecologic Oncology Group (GOG), World Health Organization (WHO), and Lansky are supported. Ability to specify a default scale Every chemotherapy regimen/clinical trial may indicate a specific performance scale. Electronic signature for approval 1.3.6 Disease response Disease response is documented for solid tumors through the tracking of the lesion size (in 2 or 3 dimensions). Solid tumor response, e.g., CR, PR, NED, SD, and PD 1.4 Results 1.4.1 Lab results Can represent numerical results, (e.g., blood tests and tumor markers) or textual results (e.g., urinalysis) Abnormal results are highlighted and coded using standard lab terminology. Physicians are automatically alerted of results with panic values. All results can be graphed. Ability to link scanned documents to ordered tests Results are typically received electronically via an interface directly from a lab system or device (e.g., Coulter Counter). Can create reminders and physician orders from within the test result window Ability to also manually enter lab results Estimated Creatinine Clearance using: Wright, Cockcroft and Gault, Jeliffe, Chatelut with usage preference Initiation of communication actions Flow sheet GFR formulas for estimated creatinine clearance calculation, including for pediatrics 1.4.2 Radiology results Can represent results from a variety of diagnostic imaging (e.g., CT reports) or other tests (e.g., EKG) Ability to link scanned documents to ordered tests Results can be received electronically via an interface directly from a radiology system. 1.5 Flow sheet The patient flow sheet provides a twodimensional view of labs, drug doses, toxicities, RoS/PE assessments, performance status, disease response, and notes over a time frame. Features Lists the visit date, including cycle and day when available Test results: - CBC, chemistry, chemistry-drugs, tumor markers, hematology, coagulation, urines, fluids, cytology/ path, immunology, blood bank, microbiology, pulmonary-abg, pulmonary-vbg, pulmonary-pft, vital signs, CT scan, MRI, MRA, PET, misc. imaging, US, mammogram, X-ray, cardiology, and miscellaneous. Access results for review and approval. page 7
Dose administration dose recorded or not given Graded toxicities Review of Systems (RoS) / Physical Exam (PE) Notes text notes or scanned documents Performance status shown for each scale Disease response for each primary cancer site assessed Templates can be defined for different scenarios, such as cancer/treatment specific, type of treatment and other medical problems. Ability to graph any numerical flow sheet element Ability to export information to a file Time-oriented view of vital signs for individual dates 1.6 Orders Physician orders are separated into chemotherapy/drug orders and all other orders. 1.6.1 Chemotherapy ordering A drug regimen defines the treatment, hydration and support medications, and schedule of administration. Drug regimens can be cyclical, or linear, including the ability to define negative start days. Drug regimen selection based on the type of cancer the patient has, this includes and available clinical trials. Automated dose calculations (m 2, /Kg, and AUC) and dose rounding Diluent amounts can be defined as calculated versus fixed amounts. Calculations supported are per m 2 and per kg. Dose banding Ability to capture the line of treatment, intent and use (e.g., adjuvant) with the ability for the clinic to indicate these are required fields upon regimen ordering Notation of changes made to treatment (e.g., dose reductions, changes or additions to support medications) Physician orders sheet Ability to create a department-specific, permission-based drug formulary Carboplatin dosing is calculated using GFR or EDTA. Ability to have the starting dose based on the patient s age or weight. A regimen can also indicate if there is no predetermined starting dose, requiring a provider to specify at time of ordering. Maintains dose reductions or other changes to future dose until explicitly changed again Ability to order multiple chemotherapy or other drug regimens for a patient to manage the schedules independently through treatment delays Physicians shall be required to apply changes to amended regimens if the amendments have been marked as required. Ability to modify the regimen for an individual patient, specifically changing the number of cycles, length of cycle, and dropping individual treatment days with the ability to document justification Ability to calculate diluent amounts in /kg or /m 2 Total volume calculation for IV bags Ability to display toxicity risk scores for regimens (e.g., FN, Hesketh) page 8
1.6.2 Drug ordering Selection of drugs from a commercial drug database Medi-Span for the US or First Data Bank for the UK and Australia Ability to select from commonly ordered drugs, complete with dose and administration information A set of clinical standards for support combinations (e.g., different drugs for different emoetogenic levels) Dose limit checking, including maximum daily/lifetime cumulative dose Duplicate order checking Rule-based monitoring of patient symptoms and drug ordering Drug screening (drug-drug, drugallergy, and drug-diagnosis) with the ability to control reaction sensitivity. Drug database support included: - Medi-Span for the United States - First Data Bank for UK and Australia Clinicians can indicate a reason for accepting an allergy or interaction when approving a drug order. Dose calculation mechanism to account for changes in patient s condition (weight, BSA, and serum creatinine) Ability to adjust dose (percent, mg/m 2 dose, and calculated dose) and document reasons for change Clinics can indicate if a reason for dose modifications is required. Communication of administration information to ordering physician Medical necessity checking against ICD codes for individual medications When ordering chemotherapy and non-chemotherapy drugs together in an in-patient setting, all drugs are set to the default start time for chemotherapy. Fluid rate/infusion duration calculation Ability to define the volume and quantity of individual syringes 1.6.3 Physician orders Structured point-and-click selection of: labs, diagnostics, return visits, procedures, and referrals with a time frame of when the results are expected Ability to create different order sheets to display orders relevant to different situations (e.g., lymphoma, leukemia, breast cancer, anemia, etc.) Ability to create recurring orders that will automatically appear at specified intervals (e.g., weekly blood counts); Ability to copy orders from previous visit to current visit 1.6.4 Prescription management Central management of prescription medications with the ability to reorder or remove from active list 1.7 Charting and documentation 1.7.1 Notes and documentation A multi-disciplinary collection of notes and scanned documents is supported. Note generation is supported through templates, where a template can define the information to be contained in a note and how it should be formatted. Notes generated from user-defined templates - Templates creation for any discipline (e.g., physician, nurse, nurse practitioner, social worker, and dietician) Support for voice-capture dictation Ability to update information in the chart and have the note update automatically Ability to mark a note as private, preventing it from being seen by anyone other than users of the same discipline Ability to include information from the chart on the fly Can create reminders and physician orders from within the notes window page 9
Faxing or communicating notes to physicians Scanned documents can be created by scanning paper documents or importing image files from a fax, and indexing them in the patient chart. Ability to import PDF documents, both through file import or via Information Exchange Manager (IEM) Patient journal for short entries regarding a patient s condition or care Import/export continuity of care documents (CCDs) 1.7.2 Medication administration Drug administration is supported by presenting a list of medication expected to be administered on a day-to-day basis. Users can: Medication verification using a barcode scanner matching drug to patient ID and patient to drug Signing and co-signing for medications Communication of the sequencing of drug administration, including the IV bag When two IV lines are necessary for a patient, it is possible to specify the particular IV line into which an IV bag should be loaded. Calculate total volume of IV administration Document oral take-home medications in a summary fashion Designate start/stop time and amount received - Multiple nurses can document a single administration. Adjust administration date Record adverse reactions A drug administration can be explicitly marked as not given, and displayed in the flow sheet as not given Electronic signature approval Ad Hoc administration Standing order functionality enables ordering of one or more standing order agents in a single step. Document details regarding the administration encounter (e.g., arm accessed, education and equipment used) Automatically generate HCPCS codes (in the United States) based on the type of agent ordered Users are alerted to the presence of pending dose recordings on previous dates when viewing the in-patient drug administration grid. Documentation of drug wastage with updating of drug charge capture Lot number and manufacturer can be recorded for identified immunizations. 1.7.3 Quality measures Quality measures for Stage 1 of the HITECH Act are included. Measure support includes: Manage active quality measures Automatically screen for applicable measures for individual patients Determine individual patient compliance with a measure Reporting measure statistics via PQRI 2009 XML Specification 1.7.4 Patient education Associate education content via URLs to problems, medications, and lab result values Find relevant education material for individual patients based on clinical data 1.8 Charge capture and billing Manager provides your practice with a comprehensive charge capture system tracking the specific events that occur and presenting a summary of charges for review. Export charges to your choice of billing solution via standard HL7 interfaces. Each charge event in ARIA for Medical Oncology consists of or supports the following: page 10
Automated charge capture and coding of all events (billable and non-billable) Billing code (Healthcare Financing Administration Common Procedure Coding System (HCPCS), Current Procedure Terminology (CPT ), or custom) Multiple code modifiers Ability to sequence multiple coded diagnoses Cost and charge per unit Itemization of technical and professional charges Ability to update and reverse billing events based on: - Cancellation of tests - Discontinuation of medications - Dose modifications 1.9 Pharmacy Drug preparation is supported for expected and actual orders, allowing pharmacists to prepare mixtures in advance of the patient arriving for treatment. The pharmacy dispensing module provides a pharmacy with functionality to support the preparation and dispensing of medication orders. 1.9.1 Pharmacy workflow Display of patients with approved or expected orders for a specific date Ability to display and filter patient lists and drugs with specific preparation methods (e.g., asceptic) Pharmacy approval checks prior to preparation 1.9.2 Preparation Automated selection of individual product and quantities Drug batch preparation Product expiry date calculation including combining diluents Customizable product labeling and worksheets CPT copyright 2006 American Medical Association. All rights reserved. Diluent amounts can be defined as calculated vs. fixed amounts. (Calculations supported are per m 2 and per kg.) First DataBank support: Labeling of brand and generic drugs is provided. Compliant with United Kingdom guidelines for Good Manufacturing Process (GMP) for pharmacy dispensing Different size syringes can be specified for different routes of administration. (Sizes can be defined for intra-muscular, subcutaneous and IV push.) Total volume calculation for IV bags Predefined label contents for medications with ability to extend Predefined compounding instructions for medications, both individually and in combinations 1.9.3 Dispensing List of medication orders pharmacists are to dispense each day Ability to determine which orders have been modified by the pharmacy and which have not, with an indicator light for easy identification Ability to calculate agent volume, syringe sizes and quantities Customizable labels with barcodes for verification scanning in treatment room Patient arrival notification for efficient medication dispensing Displays the age of an order with color coding to indicate the older orders 1.9.4 Inventory forecasting Report that lists the actual or expected drug for a specific date and can be sorted by drug or by patients Indicate any specific order status such as: - Ordered Drug order has been created and approved. - Pending Drug order has been created, but is not approved. page 11
- Planned Drug is scheduled to be given on a date (target or visit scheduled), but no drug order exist. Pending orders only includes patients on regimens or treatment plans. 1.10 Workflow management 1.10.1 Patient rosters and tracking Configurable patient rosters for visits show appointments scheduled for an individual person (e.g., a physician s schedule), location (e.g., treatment area or labs), or department (e.g., treatment room) Visual indicators communicate information about the patient (e.g., co-pay amount, new and clinical trial patients, allergies, and important general comments about the patient) Defined clinic locations used to track current patient location Patient tracking used to manage patient visit priority based on patient arrival 1.10.2 Provider in-box The provider in-box provides a central area in which incoming documents, results, and other information that require physician review or sign-off are communicated. Notes transcribed notes requiring review and approval Orders sign-off of verbal, telephone or written orders Reminders general communication regarding patient issues Drug Orders drug orders initiated by non-physician staff requiring approval Diagnoses documented coded diagnoses that require physician review Lab results results received via an interface requiring review and approval with the ability to identify and filter results based on the person or source of ordering to focus the result set to review. 1.10.3 Correspondence management List of notes to be sent to physicians either by fax or printed and mailed 1.10.4 Transcription List of dictation sound files that require transcription Ability to count the amount of typed text for accounting purposes 1.10.5 Physician orders List of approved physician orders that are ready to be transcribed 1.10.6 Operations Task Monitoring ability to monitor a variety of tasks for completion across all patients scheduled for a visit (e.g., are all expected doses marked as administered) Billing Review ability to monitor all charges across all patients scheduled for a visit on a date to review and approve charges 1.10.7 Reports The ARIA for Medical Oncology report library currently consists of more than 1,500 reports that are organized by categories, including: Financial: insurance listing, revenue, and costing, and super bills / fee tickets Operational: auditing, data completion, workload measures, QA, referral patterns, and form letters Charting: chart print and patient documentation Clinical / outcomes: toxicity, treatment patterns, treatment responses, population reporting, and survival Scheduling: institution, provider, patient, department, location, and clinic levels Lab: tests and results, facility calibration, face sheets, and lab statistics page 12
Pharmacy: drug inventory requirements, worksheets, prescriptions, drug administration, and dispensing reports Clinical trials: Case Report Forms, adverse event listings, variance reporting Reports can be exported in a variety of different formats including: PDF, Excel, HTML, RTF, and text formats. 1.11 Patient engagement Capabilities have been added to facilitate communication with patients in a variety of ways. This also includes methods of providing clinical information. 1.11.1 Patient communication Using different communication methods, sites can send messages to patients for various clinical needs and for follow-up. Define communication criteria and messages to send to patients Send reminders to patients via e-mail or printed content for patients who meet predefined criteria 1.11.2 Clinical summaries Different clinical summaries can be provided using a continuity of care document (CCD). CCDs can be produced that contain clinical data, consisting of demographics, medications, allergies, problems/diagnoses, and lab results. Those saved electronically are encrypted using a patient-supplied password. Visit summaries can be created for selected visits. Care summaries can be created for selected date ranges. 1.12 Compliance monitoring Dashboard that provides individual provider s compliance rates for individual Meaningful Use criteria for a reporting period. A patient listing that identifies those eligible patients who are missing individual data elements. 1.13 Privacy and auditing ARIA includes capabilities and features that will help oncology healthcare providers achieve compliance with HIPAA (US) or other privacy laws. is a HIPAA Business Associate. Specific capabilities include: Tracking of all successful and unsuccessful login attempts Expiration durations for passwords Non-trivial passwords Auto-lock after customizable idle times Ability to control access to patient charts on a user-by-user basis Track patient chart access, patient screen viewed, and patient information printed Ability to define day of week and time of day logon access 1.14 Clinical trials and decision support 1.14.1 Clinical trials support Medical Oncology provides comprehensive clinical trials support as imbedded capabilities within the EMR, not as a separate capability. Trial screening Consent form access Event scheduling of drugs, tests, assessments, and questionnaires Ability to track completion of all required data Automated toxicity management Variance detection and tracking 1.14.2 Decision support Using sophisticated If/Then logic, Manager offers rules-based processing capabilities that are used to provide decision support to a variety of tasks at the point-of-care. Specific tasks include: - Toxicity management for clinical trials - Symptom detection and management - Drug order monitoring page 13
Data accessible for rule conditions: - Demographics, cancer attributes - Labs and toxicities - Drug orders and treatment modality - Treatment status - Questionnaire responses Actions that can be carried out for successful rules: - Dose modifications, omissions, and dosing - Treatment delays and stoppages - Inclusion of questionnaires to answer - Textual notification 2.0 Planner Planner provides the functionality necessary to create all treatment guideline capabilities for Manager. 2.1 Drug regimens Planner provides the capabilities to define chemotherapy regimens and complex clinical trials. It also provides the ability to define data collection forms (questionnaires). Regimens can include: Classifications cancer type and categories Consent Ability to define agents for ordering that can be either predetermined amounts as straight doses, /m 2, /kg, or AUC, or determined based on age or weight ranges. An agent can be marked to explicitly have no starting dose. An agent can be specified to be given in a diluent, either as a fixed amount, /m 2, or /kg. When selecting an agent from Multilex, only the valid routes and forms for the agent are presented. Schedule of events medications, hydration, tests, and toxicities Rule support to monitor for toxicity and provide textual recommendations for management Access control to regimens by clinic and physician 2.2 Clinical trials Clinical trials are an extension of chemotherapy regimens. A clinical trial can include different sections of the trial: eligibility assessment, active treatment, and follow-up, each section with its own schedule of events. Classifications stage, intent, line of treatment Schedule of events questionnaires Complex rule support Access control to regimens by clinic and physician 2.3 Questionnaires Questionnaires are dynamic data collection forms that allow clients to define their own forms to collect information not already contained within ARIA. Each questionnaire can contain any number of questions with responses of the following types: Yes/No, Yes/No/NA Date Free-text and numbers Pick-lists and ranges, including scoring values Regimens can have a risk score defined for FN (febrile neutropenia), and Hesketh. Regimens can have place holder agents defined (e.g., white cell growth factor) that allow mass replacement of the place holder with an actual agent definition. 3.0 Configuration Management ARIA Security provides two general capabilities; defining and managing users and access; and system administration support for configuring the various ARIA features. 3.1 Users and user groups Users and user groups provide the basis for defining application access and preferences. Each user belongs to a user group in which all application and clinic access is defined. There are no limits to the number of user groups that can be defined. Access control includes: page 14
Which clinics a user can access Application access Feature access (inability to view, view-only, modify) on a granular level Report access 3.2 Configuration settings and preferences ARIA for Medical Oncology is a highly configurable system where many preferences and lists of information that are referenced in Manager. This includes: Lab requisitions and results Scheduling and tracking locations Medical history lists RoS/PE system wording and problem descriptions Physician orders and sheet definition; Label definition Treatment decision reasons Apply updates to billing codes (CPT and HCPCS ) and ICD diagnosis codes Designate different syringe sizes for various routes of administration Connectivity 1.0 Information Exchange Manager (IEM) IEM supports communication between ARIA and third-party patient health systems. IEM is designed using the HL7 standards as its baseline, allowing for open system functionality that provides effective communication between patient health systems. Using IEM, both outbound and inbound interfaces can be implemented. Demographic, financial, schedule, provider, lab results, and other data can be shared. 1.1 Interface message formats 1.1.1 HL7 2.3 1.1.2 Custom interfaces to convert data into HL7 format for importing and from HL7 format to a file format acceptable to the hospital system for exporting 1.2 Demographics (ADT) and provider interface 1.2.1 The IEM inbound demographics interface is designed to provide a means for keeping the OIS data up to date with patient information provided by outside systems. In response to HL7 messages received through the interface, the IEM interface will add and/or update patient information. 1.2.2 The Demographics (ADT) interface provides inbound (to ARIA) and outbound (from ARIA) processing of patient demographic data. 1.2.3 The Demographics (ADT) interface eliminates the need for duplicate patient registration in ARIA and the hospital s registration/adt system. 1.2.4 IEM supports inbound and outbound provider interfaces using HL7 MFN message format. 1.2.5 The provider interface, sometimes called the master file upload, imports referring physician information into the OIS using HL7 MFN messages. 1.2.6 The provider interface updates ARIA with provider information. More detailed information is available in the IEM Demographics (ADT) and the Provider Interface Guides. Contact your local sales representative to receive a copy of the IEM Demographics (ADT) and Provider Interface Guides. 1.3 Billing (financial) interface 1.3.1 The IEM billing interface exports clinical activity data to a billing system to be processed for payment. The transaction messages can be sent on a scheduled or manually initiated basis. 1.3.2 The billing interface provides: CPT (Current Procedural Terminology) support as the default (other procedure code sets may be implemented) page 15
Multiple billing systems to be defined, which allows for split charge exports to different systems Controls to ensure all this interaction according to strict rules so that charges are always submitted correctly. Batch message delivery, grouped on a variety of criteria Supports professional, technical and global charges More detailed specifications are available in the IEM Financial (DFT) Interface Guide. Contact your local sales representative to receive a copy of the IEM Financial (DFT) Interface Guide. 1.4 Lab results interface 1.4.1 The IEM lab results interface imports laboratory test results that are completed and released from the defined laboratory systems. HL7 messages are generated containing patient identifier and the lab results information to ensure the proper information is imported into ARIA. 1.4.2 The lab results interface provides: Lab results data import into ARIA Configuration capability to either ignore the results or report them as an error when a patient does not exist within the Varian Systems databases Message logs if/when an import problem is encountered to facilitate troubleshooting Log files for administrator review - Detailed specifications are available in the Lab Results Interface Guide. Contact your local sales representative to receive a copy of the IEM Lab Results Interface Guide. 1.5 Query/response interface Demographics (ADT) 1.5.1 The query/response interface allows one system to request patient updates from another. 1.5.2 The query interface provides: Outbound (send query) from ARIA Inbound (receive query and send response) for ARIA More detailed specifications are available in the Query/Response Interface Guide. Contact your local sales representative to receive a copy of the Query/Response Interface Guide. 1.6 Document interface 1.6.1 IEM supports inbound and outbound processing of transcriptions for ARIA using HL7 s MDM message formats. 1.6.2 The document interface provides: Importing of transcribed health care professional s documentation (progress notes) into ARIA View of the transcriptions information in ARIA Exporting of transcribed health care professional documentation (progress notes) from ARIA to another system Exporting CCDs and importing CCD/continuity of care records (CCRs) either to/from a hospital information system (HIS), health information exchange (HIE) or regional health information organization (RHIO) 1.7 Pharmacy interface 1.7.1 The pharmacy interface supports ARIA for Medical Oncology communication to pharmacy systems using two forms of HL7 messages: ORM-O01 and RDE/RXE. Available interface: pharmacy orders outbound from ARIA Available interface: agent formulary inbound to ARIA Available interface: drug administration outbound from ARIA page 16
1.8 Lab orders 1.8.1 IEM supports an outbound orders interface using HL7 s ORM message format. Users can create lab orders for patient blood work and other tests in ARIA for medical oncology. 1.8.2 The lab orders interface provides: Approved outbound order is message export to third-party system Support for order modifications and cancellations Support for integration to lab devices, such as chemistry or blood analyzers 1.9 Scheduling interface IEM supports inbound and outbound patient scheduling information using the HL7 SIU message format. Users can share scheduling information between ARIA and other patient scheduling system. The scheduling interface provides Notification of new appointment booking; Notification of appointment rescheduling, modification, cancellation or deletion Notification that patient did not show up for scheduled appointment 1.10 Ordering/images out of medical oncology - Image orders that are entered and approved in Medical Oncology are converted to an HL7 format and sent to the receiving system. 1.11 Results/image report into ARIA - Image reports are sent to ARIA, the patient is located, and the report is updated to the ARIA database. 1.12 Results/pathology report into ARIA - Pathology reports are sent to ARIA, the patient is located, and the report is updated to the ARIA database. 1.13 Correspondence interfaces Documents may be scanned and the resulting image file may be imported into a patient's chart Notes may be automatically faxed from our system to other patient providers 1.14 Public health submission Submission based on reportable diagnoses as part of the U.S. HITECH Act. Demographic and diagnosis information are included using an HL7 ADT message format. 1.15 Immunization Submission based on identifiable immunizations as part of the U.S. HITECH Act. Demographic and immunization information are included using an HL7 VXU message format. 1.16 Custom interfaces 1.16.1 Custom interfaces can be created when IEM and the hospital system cannot communicate using HL7 either because the hospital system does not support HL7 and cannot be enhanced to do so, or the information being exchanged is not supported in HL7. In some cases, it is possible to extend the HL7 formats to accommodate unsupported data thereby allowing a modified version of a standard interface to be used. 1.17 Interface connectivity 1.17.1 IEM can communicate with hospital systems through a TCP/IP sockets-based interface engine or by exchanging files across a network. In some circumstances, a manual file transfer method can also be accommodated. Using TCP/IP sockets: Directly (point to point) or through a centralized interface engine (such as Datagate or CloverLeaf). IEM supports data transfers through TCP/IP sockets using the HL7 minimum lower level protocol. Using file exchange: Shared network directories are set up with multiple system access. Systems exchange files by writing and reading from predetermined directories. Files can be exchanged with Windows or UNIX servers using protocols such as Network File System (NFS) or File Transfer Protocol (FTP). page 17
Data Protection Solution 1.0 Data Protection 1.1 Warm standby database server (Optional) Continuous replication of database data between production and backup database servers Configurable replication frequency Rapid failover to backup system Minimal loss of data in case of a database server failure during replication (<1 hour worth of data) Certified for Windows 2003 Server System Information 1.0 Load Balanced Thin Client Servers (Optional) In the event of a thin client server failure, users will be redirected to the surviving Thin Client Server Maximizes use of thin client servers as users are spread evenly among server resources when not in recovery 2.0 Minimum Hardware Recommendations Up-to-date hardware recommendations can be found at www.varian.com/aria 3.0 Available Configurations ARIA application licenses are available on per system and per user or per physician basis. A user license is defined as a concurrent floating license. In addition, ARIA for Medical Oncology offers Professional Services and Multi-Year Software Support Agreement (SSA) contracts. See list below for specific configurations. 3.1 System licenses (one per database) ARIA for Medical Oncology Server License Information Exchange Manager (IEM) - ARIA for Medical Oncology Interface License(s) (quantity and type varies dependent on customer preferred connectivity). 3.2 User licenses ARIA for Medical Oncology Comprehensive Workstation License ARIA for Medical Oncology Physician License for one (1) physician and up to a maximum of nine supporting staff. This license is for concurrent usage The ARIA for Medical Oncology Comprehensive Workstation License and Physician License include: - The Advanced Scheduling Server License - The Pharmacy Dispensing Server License - The Correspondence Management Server 3.3 Professional Services Hourly rate for Implementation and Training Services Custom work 3.4 Software Support Agreement Software Support Agreement contracts Specifications subject to change without notice. page 18
Oncology Systems 3100 Hansen Way Palo Alto, CA 94304-1038 tel 650.424.5700 tel 800.544.4636 www.varian.com USA Headquarters California Palo Alto, CA Tel: 650.424.5700 800.544.4636 Fax: 650.493.5637 www.varian.com USA Regional Offices California Corona, CA Tel: 951.280.4401 Fax: 951.280.4300 Georgia Marietta, GA Tel: 770.955.1367 Fax: 678.255.3850 European Headquarters Switzerland International AG Zug, Switzerland Tel: 41.41.749.8844 Fax: 41.41.740.3340 Austria Gesellschaft m.b.h. Brunn am Gebirge, Austria Tel: 43.1.698.56.56 Fax: 43.1.698.56.59 Belgium Belgium N.V./S.A. Diegem, Belgium Tel: 32.2.720.10.08 Fax: 32.2.720.77.07 Finland Finland Oy Helsinki, Finland Tel: 358.9.430.771 Fax: 358.9.455.4585 France France Buc, France Tel: 33.1.30.83.83.83 Fax: 33.1.30.83.83.00 Germany Deutschland GmbH Darmstadt, Germany Tel: 49.61.51.73130 Fax: 49.61.51.731313 India International (India) Pvt Ltd Mumbai, India Tel: 91.22.6785.22.52 Fax: 91.22.2838.56.14 International (India) Pvt Ltd Chennai, India Tel: 91.44.28295970 Fax: 91.44.28295980 Italy Italia, S.p.A. Cernusco s/n (MI), Italy Tel: 39.02.921.351 Fax: 39.02.921.35240 Netherlands Nederland B.V. Houten, Netherlands Tel: 31.30.634.0506 Fax: 31.30.636.2466 Scandinavia Scandinavia AS Herlev, Denmark Tel: 45.44.500.100 Fax: 45.44.500.190 Spain/Portugal Ibérica, S.L. Madrid, Spain Tel: 34.91.33.44.800 Fax: 34.91.33.44.801 UK/Ireland UK Ltd. Crawley, West Sussex, UK Tel: 44.1293.601.200 Fax: 44.1293.510.260 Asian Headquarters Hong Kong Pacific, Inc. Kowloon, Hong Kong Tel: 85.22.724.2836 Fax: 85.22.369.4280 China China Ltd. Beijing, P.R. China Tel: 8610.8785.8785 Fax: 8610.8785.8960 Japan K.K. Chuo-ku, Tokyo, Japan Tel: 81.3.3639.9700 Fax: 81.3.3639.9623 Latin American Headquarters Brazil do Brasil Ltda. São Paulo, Brazil Tel: 55.11.3457.2655 Fax: 55.11.3286.0034 Australian Headquarters Australia Australasia Pty Ltd. Sydney, Australia Tel: 61.2.9485.0111 Fax: 61.2.9485.0119 Varian,, and ARIA are registered trademarks of, Inc. All other trademarks are the property of their respective owners. RAD 9985E 2007-2011, Inc. Printed in USA 8/11