specifications ARIA Oncology Information System · 1.6.1 Chemotherapy ordering • A drug regimen deﬁnes the treatment, hydration and support medications, and schedule of administration

specifications ARIA Oncology Information SystemFOR MEDICAL ONCOLOGY

page 3 Varian ARIA specifications

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 manage-

ment 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 import-

ed 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.

ARIA Oncology Information SystemThe ARIA® oncology information system for Medical Oncology is a comprehensive

suite of software applications that support the medical oncology clinic.

Complete OncologyInformation Management1.0 Manager

Manager is the centerpiece of the ARIA for MedicalOncology solution, combining an oncology-specificpatient electronic medical record (EMR) andfunctional components to support clinical operations.

1.1 Registration and appointments

1.1.1 In addition to the typical demographicinformation, Manager captures:

• Patient preferences for e-mail,communication, and informationrequests

• Configurable patient IDs (i.e., customnamed, auto-generated, and required)

• The patient ID shown in the openpatient window and in the title bar ofeach specific window can be controlledby the client instead of defaulting tothe primary ID

• Primary contact- next of kin

• Demographics, including advancedirectives

• Provider information

• Referrals

• Patient photos

• Insurance, financials, and pre-certification 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 byfacility, location, department, andprovider

• Patient ID

• First or last name

• Provider, institution, gender, or filestatus

• Recently accessed patient charts by user

• Optional alias filters to protect patientprivacy

• When in an on-demand ADTenvironment, users have the ability tosearch for patients in ARIA, when notfound, the user can initiate a query ofone or more external systems to findthe patient and trigger sending theregistration information via theinterface to ARIA.

1.1.3 Scheduling

Manager provides a comprehensivepatient appointment scheduler. Eachappointment can consist of multipleevents linked with one or more providersand/or locations.

• Multi-event appointment schedulingthat can be configured to meetindividual client needs

• Ability to schedule any patient,resource, and location

• Treatment-driven schedule, identifyingexpected visit dates for plannedchemotherapy

• Color-coded calendar

• Search capabilities to help find firstavailable appointments, for either anindividual or series of appointments

• Ability to copy visit details to anynumber of future visits

• Schedule multiple appointments viacopy function

• Options to cancel, error, or mark as noshows including reason

• Patient calendar and appointment slipprintouts

• Direct access to information, such asbilling, demographics, questionnaires,reminders, and tests

• Management for over-booking byeither warning or preventingoverbooking, or only allowingauthorized individuals to overbookresources


• Multiple schedule views

• Ability to define department-specifichours of operation, capacity, andactivities performed

• Ability to block available times forpatients, resources, and locations

• Scheduling templates for specificpatient, provider, location, days, andtimes

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 includingtype, onset date, the responsedescription, and severity

- Allergies and adverse reactions arehighlighted throughout the patientchart

• Medications

• Medication reconciliation process bycomparing 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 isdesigned to provide the user with a quickreference of the patient to help preparefor the patient encounter.

Summary:

• Name, age, sex, regimen including cycleand day, diagnoses, allergies/adversereactions, medications, abnormal testresults, date of previous visit, and thenext visit

• Primary diagnosis and problem list

• Recent results: with the ability to graphresults

• Last Note: displayed by discipline, jobclassification, author, and note type

• Medications: complete list ofmedications, including currentmedications and treatment

• Photo, general information, advancedirectives, billing #, medical record #,registry #, internal physicians, andreferring physicians

• Treatment details: summary of thecurrent chemotherapy, radiationtreatment, and procedure/surgical

1.2.3 Diagnoses and problems

A complete problem list can bemaintained for a patient, including theprimary diagnosis and other presentingproblems requiring monitoring ormanagement:

• Identify and submit diagnoses that arereportable to health agencies

• Diagnosis using InternationalClassification of Diseases: ICD-9-CMor ICD-10 coding

• Pathology using ICD-O Version 2/3

• Lesion tracking, including multi-focallesion definition

• Extensive pathology and surgicalinformation (e.g., margins, OncotypeDx, invasive tumor details)


• Staging

- Auto-staging from selection of criteriafor clinical and pathologic, with theability to custom define a stage group

- Staging systems supported include:AJCC/ UICC 5th, 6th, and 7thEditions, FIGO, International StagingSystem (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 relevantcancer 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 multiplediagnoses and problems

• Diagnosis status to track changes overtime

1.3 Assessments

1.3.1 Toxicities

• Grading criteria’s supported are NCICTCAE versions 2, 3, and 4.

• Ability to indicate a specific gradingscheme for each chemotherapyregimen, for cases where a clinical trialdictates a specific toxicity scheme

• Automatic toxicity grading based on labresults

• Ability to enter start/stop dates for eachtoxicity

• Electronic signature for approval

1.3.2 Adverse events

• Adverse reaction tracking, includingtype, onset date, the responsedescription, and severity

• A list of active adverse events defaults inreverse chronological order based onstart date

• Automatic tracking of adverse eventsfor all clinical trials patients with theability to indicate non-toxicity adverseevents when necessary

• Automatic management of adverseevent progression where new adverseevents are created when toxicityprogresses to a higher grade

1.3.3 Review of Systems (RoS) and PhysicalExam (PE)

• Consists of a standard set of bodysystems and problem areas

• Different RoS and PE systemsassociated with each site of cancer foreach physician

• The defaults for normal and abnormaldescriptions can be specified for eachphysician

• Documentation is performed throughpick-list selection, free-text, or voice-capture dictation

• Ability to view all previous assessmentsand reference a previous as the basis fordocumenting a system for the currentassessment

• Spell checking

1.3.4 Vital signs

• Recording of standard set of patientvital signs:

- Height, weight, BSA

- Body Mass Index (BMI)

- Temperature, pulse, and respiration

- Blood pressure

• Graphing capabilities


• Pediatric formulas for BSA and IBW

• Pediatric patient CDC growth charts totrack height and body mass index(BMI).


1.3.5 Performance status

• Currently Eastern CooperativeOncology Group (ECOG), Karnofsky,Gynecologic Oncology Group (GOG),World Health Organization (WHO),and Lansky are supported.

• Ability to specify a default scale

• Every chemotherapy regimen/clinicaltrial may indicate a specificperformance scale.


1.3.6 Disease response

• Disease response is documented forsolid tumors through the tracking ofthe 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) ortextual results (e.g., urinalysis)

• Abnormal results are highlighted andcoded using standard lab terminology.

• Physicians are automatically alerted ofresults with panic values.

• All results can be graphed.

• Ability to link scanned documents toordered tests

• Results are typically receivedelectronically via an interface directlyfrom a lab system or device (e.g.,Coulter Counter).

• Can create reminders and physicianorders from within the test resultwindow

• Ability to also manually enter labresults

• Estimated Creatinine Clearance using:Wright, Cockcroft and Gault, Jeliffe,Chatelut with usage preference

• Initiation of communication actions

• GFR formulas for estimated creatinineclearance calculation, including forpediatrics

1.4.2 Radiology results

• Can represent results from a variety ofdiagnostic imaging (e.g., CT reports) orother tests (e.g., EKG)

• Ability to link scanned documents toordered tests

• Results can be received electronicallyvia an interface directly from aradiology system.

1.5 Flow sheet

The patient flow sheet provides a two-dimensional view of labs, drug doses, toxicities,RoS/PE assessments, performance status, diseaseresponse, and notes over a time frame.

Features

• Lists the visit date, including cycle and daywhen available

• Test results:

- CBC, chemistry, chemistry-drugs, tumormarkers, hematology, coagulation, urines,fluids, cytology/ path, immunology, bloodbank, microbiology, pulmonary-ABG,pulmonary-VBG, pulmonary-PFT, vitalsigns, CT scan, MRI, MRA, PET, misc.imaging, US, mammogram, X-ray,cardiology, and miscellaneous. Access results for review and approval.


Flow sheet

• Dose administration – dose recorded or “notgiven”

• 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 siteassessed

• Templates can be defined for different scenarios,such as cancer/treatment specific, type oftreatment and other medical problems.

• Ability to graph any numerical flow sheetelement

• Ability to export information to a file

• Time-oriented view of vital signs for individualdates

1.6 Orders

Physician orders are separated intochemotherapy/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, orlinear, including the ability to definenegative start days.

• Drug regimen selection based on thetype of cancer the patient has, thisincludes and available clinical trials.

• Automated dose calculations (m2, /Kg,and AUC) and dose rounding

• Diluent amounts can be defined ascalculated versus fixed amounts.Calculations supported are per m2 andper kg.

• Dose banding

• Ability to capture the line of treatment,intent and use (e.g., adjuvant) with theability for the clinic to indicate theseare required fields upon regimenordering

• Notation of changes made to treatment(e.g., dose reductions, changes oradditions to support medications)

• Ability to create a department-specific,permission-based drug formulary

• Carboplatin dosing is calculated usingGFR or EDTA.

• Ability to have the starting dose basedon the patient’s age or weight. Aregimen can also indicate if there is nopredetermined starting dose, requiringa provider to specify at time ofordering.

• Maintains dose reductions or otherchanges to future dose until explicitlychanged again

• Ability to order multiple chemotherapyor other drug regimens for a patient tomanage the schedules independentlythrough treatment delays

• Physicians shall be required to applychanges to amended regimens if theamendments have been marked as“required”.

• Ability to modify the regimen for anindividual patient, specifically changingthe number of cycles, length of cycle,and dropping individual treatment dayswith the ability to documentjustification

• Ability to calculate diluent amounts in/kg or /m2

• Total volume calculation for IV bags

• Ability to display toxicity risk scores forregimens (e.g., FN, Hesketh)


Physician orders sheet

1.6.2 Drug ordering

• Selection of drugs from a commercialdrug database Medi-Span© for the USor First Data Bank for the UK andAustralia

• Ability to select from commonlyordered drugs, complete with dose andadministration information

• A set of clinical standards for supportcombinations (e.g., different drugs fordifferent emoetogenic levels)

• Dose limit checking, includingmaximum daily/lifetime cumulativedose

• Duplicate order checking

• Rule-based monitoring of patientsymptoms and drug ordering

• Drug screening (drug-drug, drug-allergy, and drug-diagnosis) with theability 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 foraccepting an allergy or interactionwhen approving a drug order.

• Dose calculation mechanism to accountfor changes in patient’s condition(weight, BSA, and serum creatinine)

• Ability to adjust dose (percent, mg/m2

dose, and calculated dose) anddocument reasons for change

• Clinics can indicate if a reason for dosemodifications is required.

• Communication of administrationinformation to ordering physician

• Medical necessity checking against ICDcodes for individual medications

• When ordering chemotherapy andnon-chemotherapy drugs together in anin-patient setting, all drugs are set tothe 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 timeframe of when the results are expected

• Ability to create different order sheetsto display orders relevant to differentsituations (e.g., lymphoma, leukemia,breast cancer, anemia, etc.)

• Ability to create recurring orders thatwill automatically appear at specifiedintervals (e.g., weekly blood counts);

• Ability to copy orders from previousvisit to current visit

1.6.4 Prescription management

• Central management of prescriptionmedications with the ability to reorderor remove from active list

1.7 Charting and documentation

1.7.1 Notes and documentation

A multi-disciplinary collection of notesand scanned documents is supported.Note generation is supported throughtemplates, where a template can definethe information to be contained in a noteand how it should be formatted.

• Notes generated from user-definedtemplates

- Templates creation for any discipline(e.g., physician, nurse, nursepractitioner, social worker, anddietician)

• Support for voice-capture dictation

• Ability to update information in thechart and have the note updateautomatically

• Ability to mark a note as private,preventing it from being seen byanyone other than users of the samediscipline

• Ability to include information from thechart on the fly

• Can create reminders and physicianorders from within the notes window


• Faxing or communicating notes tophysicians

• Scanned documents can be created byscanning paper documents orimporting image files from a fax, andindexing them in the patient chart.

• Ability to import PDF documents,both through file import or viaInformation Exchange Manager (IEM)

• Patient journal for short entriesregarding a patient’s condition or care

• Import/export continuity of caredocuments (CCDs)

1.7.2 Medication administration

Drug administration is supported bypresenting a list of medication expectedto be administered on a day-to-day basis.Users can:

• Medication verification using a barcodescanner matching drug to patient IDand patient to drug

• Signing and co-signing for medications

• Communication of the sequencing ofdrug administration, including the IVbag

• When two IV lines are necessary for apatient, it is possible to specify theparticular IV line into which an IV bagshould be loaded.

• Calculate total volume of IVadministration

• Document oral take-home medicationsin a summary fashion

• Designate start/stop time and amountreceived

- Multiple nurses can document a singleadministration.

• Adjust administration date

• Record adverse reactions

• A drug administration can be explicitlymarked as “not given”, and displayed inthe flow sheet as “not given”

• Electronic signature approval

• Ad Hoc administration

• Standing order functionality enablesordering of one or more standing orderagents in a single step.

• Document details regarding theadministration encounter (e.g., armaccessed, education and equipmentused)

• Automatically generate HCPCS codes(in the United States) based on the typeof agent ordered

• Users are alerted to the presence ofpending dose recordings on previousdates when viewing the in-patient drugadministration grid.

• Documentation of drug wastage withupdating of drug charge capture

• Lot number and manufacturer can berecorded for identified immunizations.

1.7.3 Quality measures

Quality measures for Stage 1 of theHITECH Act are included. Measuresupport includes:

• Manage active quality measures

• Automatically screen for applicablemeasures for individual patients

• Determine individual patientcompliance with a measure

• Reporting measure statistics via PQRI2009 XML Specification

1.7.4 Patient education

• Associate education content via URLsto problems, medications, and labresult values

• Find relevant education material for individual patients based onclinical data

1.8 Charge capture and billing

Manager provides your practice with acomprehensive charge capture system – trackingthe specific events that occur and presenting asummary of charges for review. Export chargesto your choice of billing solution via standardHL7 interfaces. Each charge event in ARIA forMedical Oncology consists of or supports thefollowing:


• Automated charge capture and coding of allevents (billable and non-billable)

• Billing code (Healthcare FinancingAdministration Common Procedure CodingSystem (HCPCS), Current ProcedureTerminology (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 eventsbased on:

- Cancellation of tests

- Discontinuation of medications

- Dose modifications

1.9 Pharmacy

Drug preparation is supported for expected andactual orders, allowing pharmacists to preparemixtures in advance of the patient arriving fortreatment. The pharmacy dispensing moduleprovides a pharmacy with functionality tosupport the preparation and dispensing ofmedication orders.

1.9.1 Pharmacy workflow

• Display of patients with approved orexpected orders for a specific date

• Ability to display and filter patient listsand drugs with specific preparationmethods (e.g., asceptic)

• Pharmacy approval checks prior topreparation

1.9.2 Preparation

• Automated selection of individualproduct and quantities

• Drug batch preparation

• Product expiry date calculationincluding combining diluents

• Customizable product labeling andworksheets

• Diluent amounts can be defined ascalculated vs. fixed amounts.(Calculations supported are per m2 andper kg.)

• First DataBank support: Labeling ofbrand and generic drugs is provided.

• Compliant with United Kingdomguidelines for Good ManufacturingProcess (GMP) for pharmacydispensing

• Different size syringes can be specifiedfor different routes of administration.(Sizes can be defined for intra-muscular,subcutaneous and IV push.)

• Total volume calculation for IV bags

• Predefined label contents formedications with ability to extend

• Predefined compounding instructionsfor medications, both individually andin combinations

1.9.3 Dispensing

• List of medication orders pharmacistsare to dispense each day

• Ability to determine which orders havebeen modified by the pharmacy andwhich have not, with an indicator lightfor easy identification

• Ability to calculate agent volume,syringe sizes and quantities

• Customizable labels with barcodes forverification scanning in treatment room

• Patient arrival notification for efficientmedication dispensing

• Displays the age of an order with colorcoding to indicate the older orders

1.9.4 Inventory forecasting

• Report that lists the actual or expecteddrug for a specific date and can besorted by drug or by patients

Indicate any specific order status such as:

- Ordered – Drug order has beencreated and approved.

- Pending – Drug order has beencreated, but is not approved.


CPT copyright 2006 American Medical Association. All rights reserved.

- Planned – Drug is scheduled to begiven on a date (target or visitscheduled), but no drug order exist.

• Pending orders only includes patientson regimens or treatment plans.

1.10 Workflow management

1.10.1 Patient rosters and tracking

• Configurable patient rosters for visitsshow appointments scheduled for anindividual person (e.g., a physician’sschedule), location (e.g., treatment areaor labs), or department (e.g., treatmentroom)

• Visual indicators communicateinformation about the patient (e.g., co-pay amount, new and clinical trialpatients, allergies, and importantgeneral comments about the patient)

• Defined clinic locations used to trackcurrent patient location

• Patient tracking used to manage patientvisit priority based on patient arrival

1.10.2 Provider in-box

The provider in-box provides a centralarea in which incoming documents,results, and other information thatrequire physician review or sign-off arecommunicated.

• Notes – transcribed notes requiringreview and approval

• Orders – sign-off of verbal, telephoneor written orders

• Reminders – general communicationregarding patient issues

• Drug Orders – drug orders initiated bynon-physician staff requiring approval

• Diagnoses – documented codeddiagnoses that require physician review

• Lab results – results received via aninterface requiring review and approvalwith the ability to identify and filterresults based on the person or source ofordering to focus the result set toreview.

1.10.3 Correspondence management

• List of notes to be sent to physicianseither by fax or printed and mailed

1.10.4 Transcription

• List of dictation sound files that requiretranscription

• Ability to count the amount of typedtext for accounting purposes

1.10.5 Physician orders

• List of approved physician orders thatare ready to be transcribed

1.10.6 Operations

• Task Monitoring – ability to monitor avariety of tasks for completion across allpatients scheduled for a visit (e.g., areall expected doses marked asadministered)

• Billing Review – ability to monitor allcharges across all patients scheduled fora visit on a date to review and approvecharges

1.10.7 Reports

The ARIA for Medical Oncology reportlibrary currently consists of more than1,500 reports that are organized bycategories, including:

• Financial: insurance listing, revenue,and costing, and super bills / fee tickets

• Operational: auditing, data completion,workload measures, QA, referralpatterns, and form letters

• Charting: chart print and patientdocumentation

• Clinical / outcomes: toxicity, treatmentpatterns, treatment responses,population reporting, and survival

• Scheduling: institution, provider,patient, department, location, andclinic levels

• Lab: tests and results, facilitycalibration, face sheets, and labstatistics


• Pharmacy: drug inventoryrequirements, worksheets, prescriptions,drug administration, and dispensingreports

• Clinical trials: Case Report Forms,adverse event listings, variance reporting

Reports can be exported in a variety ofdifferent formats including: PDF, Excel,HTML, RTF, and text formats.

1.11 Patient engagement

Capabilities have been added to facilitatecommunication with patients in a variety ofways. This also includes methods of providingclinical information.

1.11.1 Patient communication

Using different communication methods,sites can send messages to patients forvarious clinical needs and for follow-up.

• Define communication criteria andmessages to send to patients

• Send reminders to patients via e-mail orprinted content for patients who meetpredefined criteria

1.11.2 Clinical summaries

Different clinical summaries can beprovided using a continuity of caredocument (CCD).

• CCDs can be produced that containclinical data, consisting ofdemographics, medications, allergies,problems/diagnoses, and lab results.Those saved electronically are encryptedusing a patient-supplied password.

• Visit summaries can be created forselected visits.

• Care summaries can be created forselected date ranges.

1.12 Compliance monitoring

• Dashboard that provides individualprovider’s compliance rates forindividual Meaningful Use criteria for areporting period.

• A patient listing that identifies thoseeligible patients who are missingindividual data elements.

1.13 Privacy and auditing

ARIA includes capabilities and features that willhelp oncology healthcare providers achievecompliance with HIPAA (US) or other privacylaws. Varian Medical Systems is a HIPAABusiness Associate. Specific capabilities include:

• Tracking of all successful and unsuccessful loginattempts

• Expiration durations for passwords

• Non-trivial passwords

• Auto-lock after customizable idle times

• Ability to control access to patient charts on auser-by-user basis

• Track patient chart access, patient screenviewed, and patient information printed

• Ability to define day of week and time of daylogon access

1.14 Clinical trials and decision support

1.14.1 Clinical trials support

Medical Oncology providescomprehensive clinical trials support asimbedded 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 allrequired data

• Automated toxicity management

• Variance detection and tracking

1.14.2 Decision support

Using sophisticated “If/Then” logic,Manager offers rules-based processingcapabilities that are used to providedecision support to a variety of tasks atthe point-of-care.

• Specific tasks include:

- Toxicity management for clinical trials

- Symptom detection and management

- Drug order monitoring


• 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 forsuccessful rules:

- Dose modifications, omissions, anddosing

- Treatment delays and stoppages

- Inclusion of questionnaires to answer

- Textual notification

2.0 PlannerPlanner provides the functionality necessary to createall treatment guideline capabilities for Manager.

2.1 Drug regimens

Planner provides the capabilities to definechemotherapy regimens and complex clinicaltrials. It also provides the ability to define datacollection forms (questionnaires). Regimens caninclude:

• Classifications – cancer type and categories

• Consent

• Ability to define agents for ordering that can beeither predetermined amounts as straight doses,/m2, /kg, or AUC, or determined based on ageor weight ranges. An agent can be marked toexplicitly have no starting dose.

• An agent can be specified to be given in adiluent, either as a fixed amount, /m2, or /kg.

• When selecting an agent from Multilex, onlythe valid routes and forms for the agent arepresented.

• Schedule of events – medications, hydration,tests, and toxicities

• Rule support to monitor for toxicity andprovide textual recommendations formanagement

• Access control to regimens by clinic andphysician

2.2 Clinical trials

Clinical trials are an extension of chemotherapyregimens. A clinical trial can include differentsections of the trial: eligibility assessment, activetreatment, and follow-up, each section with itsown schedule of events.

• Classifications – stage, intent, line of treatment

• Schedule of events – questionnaires

• Complex rule support

• Access control to regimens by clinic andphysician

2.3 Questionnaires

Questionnaires are dynamic data collection formsthat allow clients to define their own forms tocollect information not already contained withinARIA. Each questionnaire can contain anynumber of questions with responses of thefollowing 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” agentsdefined (e.g., white cell growth factor) thatallow mass replacement of the place holderwith an actual agent definition.

3.0 Configuration ManagementARIA Security provides two general capabilities;defining and managing users and access; and systemadministration support for configuring the variousARIA features.

3.1 Users and user groups

Users and user groups provide the basis fordefining application access and preferences. Eachuser belongs to a user group in which allapplication and clinic access is defined. There areno limits to the number of user groups that canbe defined. Access control includes:


• 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 highlyconfigurable system where many preferences andlists of information that are referenced inManager. This includes:

• Lab requisitions and results

• Scheduling and tracking locations

• Medical history lists

• RoS/PE system wording and problemdescriptions

• Physician orders and sheet definition;

• Label definition

• Treatment decision reasons

• Apply updates to billing codes (CPT© andHCPCS©) and ICD diagnosis codes

• Designate different syringe sizes for variousroutes of administration

Connectivity1.0 Information Exchange Manager (IEM)

IEM supports communication between ARIA andthird-party patient health systems. IEM is designedusing the HL7 standards as its baseline, allowing foropen system functionality that provides effectivecommunication between patient health systems. UsingIEM, both outbound and inbound interfaces can beimplemented. 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 intoHL7 format for importing and fromHL7 format to a file format acceptableto the hospital system for exporting

1.2 Demographics (ADT) and provider interface

1.2.1 The IEM inbound demographicsinterface is designed to provide a meansfor keeping the OIS data up to date withpatient information provided by outsidesystems. In response to HL7 messagesreceived through the interface, the IEMinterface will add and/or update patientinformation.

1.2.2 The Demographics (ADT) interfaceprovides inbound (to ARIA) andoutbound (from ARIA) processing ofpatient demographic data.

1.2.3 The Demographics (ADT) interfaceeliminates the need for duplicate patientregistration in ARIA and the hospital’sregistration/ADT system.

1.2.4 IEM supports inbound and outboundprovider interfaces using HL7 MFNmessage format.

1.2.5 The provider interface, sometimes calledthe master file upload, imports referringphysician information into the OISusing HL7 MFN messages.

1.2.6 The provider interface updates ARIAwith provider information.

More detailed information is available in theIEM Demographics (ADT) and the ProviderInterface Guides. Contact your local salesrepresentative to receive a copy of the IEMDemographics (ADT) and Provider InterfaceGuides.

1.3 Billing (financial) interface

1.3.1 The IEM billing interface exportsclinical activity data to a billing systemto be processed for payment. Thetransaction messages can be sent on ascheduled or manually initiated basis.

1.3.2 The billing interface provides:

• CPT© (Current ProceduralTerminology) support as the default(other procedure code sets may beimplemented)


• Multiple billing systems to be defined,which allows for split charge exports todifferent systems

• Controls to ensure all this interactionaccording to strict rules so that chargesare always submitted correctly.

• Batch message delivery, grouped on avariety of criteria

• Supports professional, technical andglobal charges

More detailed specifications are available in theIEM Financial (DFT) Interface Guide. Contactyour local sales representative to receive a copy ofthe IEM Financial (DFT) Interface Guide.

1.4 Lab results interface

1.4.1 The IEM lab results interface importslaboratory test results that are completedand released from the defined laboratorysystems. HL7 messages are generatedcontaining patient identifier and the labresults information to ensure the properinformation is imported into ARIA.

1.4.2 The lab results interface provides:

• Lab results data import into ARIA

• Configuration capability to eitherignore the results or report them as anerror when a patient does not existwithin the Varian Systems databases

• Message logs if/when an importproblem is encountered to facilitatetroubleshooting

• Log files for administrator review

- Detailed specifications are available inthe Lab Results Interface Guide.Contact your local sales representativeto receive a copy of the IEM LabResults Interface Guide.

1.5 Query/response interface – Demographics(ADT)

1.5.1 The query/response interface allows onesystem to request patient updates fromanother.

1.5.2 The query interface provides:

• Outbound (send query) from ARIA

• Inbound (receive query and sendresponse) for ARIA

More detailed specifications are available in theQuery/Response Interface Guide. Contact yourlocal sales representative to receive a copy of theQuery/Response Interface Guide.

1.6 Document interface

1.6.1 IEM supports inbound and outboundprocessing of transcriptions for ARIAusing HL7’s MDM message formats.

1.6.2 The document interface provides:

• Importing of transcribed health careprofessional’s documentation (progressnotes) into ARIA

• View of the transcriptions informationin ARIA

• Exporting of transcribed health careprofessional documentation (progressnotes) from ARIA to another system

• Exporting CCDs and importingCCD/continuity of care records(CCRs) either to/from a hospitalinformation system (HIS), healthinformation exchange (HIE) orregional health informationorganization (RHIO)

1.7 Pharmacy interface

1.7.1 The pharmacy interface supports ARIAfor Medical Oncology communicationto pharmacy systems using two forms ofHL7 messages: ORM-O01 andRDE/RXE.

• Available interface: pharmacy ordersoutbound from ARIA

• Available interface: agent formularyinbound to ARIA

• Available interface: drug administrationoutbound from ARIA


1.8 Lab orders

1.8.1 IEM supports an outbound ordersinterface using HL7’s ORM messageformat. Users can create lab orders forpatient blood work and other tests inARIA for medical oncology.

1.8.2 The lab orders interface provides:

• Approved outbound order is messageexport to third-party system

• Support for order modifications andcancellations

• Support for integration to lab devices,such as chemistry or blood analyzers

1.9 Scheduling interface

IEM supports inbound and outbound patientscheduling information using the HL7 SIUmessage format. Users can share schedulinginformation between ARIA and other patientscheduling 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 forscheduled appointment

1.10 Ordering/images out of medical oncology -Image orders that are entered and approved inMedical Oncology are converted to an HL7format and sent to the receiving system.

1.11 Results/image report into ARIA - Image reportsare sent to ARIA, the patient is located, and thereport is updated to the ARIA database.

1.12 Results/pathology report into ARIA - Pathologyreports 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 resultingimage file may be imported into a patient's chart

Notes may be automatically faxed from oursystem to other patient providers

1.14 Public health submission

Submission based on reportable diagnoses as partof the U.S. HITECH Act. Demographic anddiagnosis information are included using an HL7ADT message format.

1.15 Immunization

Submission based on identifiable immunizationsas part of the U.S. HITECH Act. Demographicand immunization information are includedusing an HL7 VXU message format.

1.16 Custom interfaces

1.16.1 Custom interfaces can be created whenIEM and the hospital system cannotcommunicate using HL7 either becausethe hospital system does not supportHL7 and cannot be enhanced to do so,or the information being exchanged isnot supported in HL7. In some cases, itis possible to extend the HL7 formats toaccommodate unsupported data therebyallowing a modified version of a standardinterface to be used.

1.17 Interface connectivity

1.17.1 IEM can communicate with hospitalsystems through a TCP/IP sockets-basedinterface engine or by exchanging filesacross a network. In somecircumstances, a manual file transfermethod can also be accommodated.

• Using TCP/IP sockets: Directly (pointto point) or through a centralizedinterface engine (such as Datagate orCloverLeaf). IEM supports datatransfers through TCP/IP sockets usingthe HL7 minimum lower levelprotocol.

• Using file exchange: Shared networkdirectories are set up with multiplesystem access. Systems exchange filesby writing and reading from pre-determined directories. Files can beexchanged with Windows or UNIXservers using protocols such asNetwork File System (NFS) or FileTransfer Protocol (FTP).


Data Protection Solution1.0 Data Protection

1.1 Warm standby database server (Optional)

• Continuous replication of database databetween production and backup databaseservers

• Configurable replication frequency

• Rapid failover to backup system

• Minimal loss of data in case of a database serverfailure during replication (<1 hour worth ofdata)

• Certified for Windows 2003 Server

System Information1.0 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 arespread evenly among server resources when not inrecovery

2.0 Minimum Hardware RecommendationsUp-to-date hardware recommendations can be foundat www.varian.com/ARIA

3.0 Available ConfigurationsARIA application licenses are available on per systemand per user or per physician basis. A user license isdefined as a concurrent floating license. In addition,ARIA for Medical Oncology offers ProfessionalServices and Multi-Year Software Support Agreement(SSA) contracts. See list below for specificconfigurations.

3.1 System licenses (one per database)

• ARIA for Medical Oncology Server License

• Information Exchange Manager (IEM)

- ARIA for Medical Oncology InterfaceLicense(s) (quantity and type varies dependenton customer preferred connectivity).

3.2 User licenses

• ARIA for Medical Oncology ComprehensiveWorkstation License

• ARIA for Medical Oncology Physician Licensefor one (1) physician and up to a maximum ofnine supporting staff. This license is forconcurrent usage

The ARIA for Medical OncologyComprehensive Workstation License andPhysician 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 TrainingServices

• Custom work

3.4 Software Support Agreement

• Software Support Agreement contracts

Specifications subject to change without notice.


USA HeadquartersCaliforniaVarian Medical SystemsPalo Alto, CA Tel: 650.424.5700 800.544.4636Fax: 650.493.5637www.varian.com

USA Regional OfficesCaliforniaVarian Medical SystemsCorona, CATel: 951.280.4401Fax: 951.280.4300

GeorgiaVarian Medical SystemsMarietta, GATel: 770.955.1367Fax: 678.255.3850

European HeadquartersSwitzerlandVarian Medical Systems International AGZug, SwitzerlandTel: 41.41.749.8844Fax: 41.41.740.3340

AustriaVarian Medical Systems Gesellschaft m.b.H.Brunn am Gebirge, AustriaTel: 43.1.698.56.56Fax: 43.1.698.56.59

BelgiumVarian Medical Systems Belgium N.V./S.A.Diegem, BelgiumTel: 32.2.720.10.08Fax: 32.2.720.77.07

FinlandVarian Medical Systems Finland OyHelsinki, FinlandTel: 358.9.430.771Fax: 358.9.455.4585

FranceVarian Medical Systems FranceBuc, FranceTel: 33.1.30.83.83.83Fax: 33.1.30.83.83.00

GermanyVarian Medical Systems Deutschland GmbHDarmstadt, GermanyTel: 49.61.51.73130Fax: 49.61.51.731313

IndiaVarian Medical Systems International (India) Pvt LtdMumbai, IndiaTel: 91.22.6785.22.52Fax: 91.22.2838.56.14

Varian Medical Systems International (India) Pvt LtdChennai, IndiaTel: 91.44.28295970Fax: 91.44.28295980

ItalyVarian Medical SystemsItalia, S.p.A.Cernusco s/N (MI), ItalyTel: 39.02.921.351Fax: 39.02.921.35240

NetherlandsVarian Medical Systems Nederland B.V.Houten, NetherlandsTel: 31.30.634.0506Fax: 31.30.636.2466

ScandinaviaVarian Medical Systems Scandinavia ASHerlev, DenmarkTel: 45.44.500.100Fax: 45.44.500.190

Spain/PortugalVarian Medical Systems Ibérica, S.L.Madrid, SpainTel: 34.91.33.44.800Fax: 34.91.33.44.801

UK/IrelandVarian Medical Systems UK Ltd.Crawley, West Sussex, UKTel: 44.1293.601.200Fax: 44.1293.510.260

Asian HeadquartersHong KongVarian Medical Systems Pacific, Inc.Kowloon, Hong KongTel: 85.22.724.2836Fax: 85.22.369.4280

ChinaVarian Medical Systems China Ltd.Beijing, P.R. ChinaTel: 8610.8785.8785Fax: 8610.8785.8960

JapanVarian Medical Systems K.K.Chuo-ku, Tokyo, JapanTel: 81.3.3639.9700Fax: 81.3.3639.9623

Latin American HeadquartersBrazilVarian Medical Systems do Brasil Ltda. São Paulo, BrazilTel: 55.11.3457.2655Fax: 55.11.3286.0034

Australian HeadquartersAustraliaVarian Medical Systems Australasia Pty Ltd.Sydney, AustraliaTel: 61.2.9485.0111Fax: 61.2.9485.0119

Oncology Systems3 1 0 0 H a n s e n W a yP a l o A l t o , C A 9 4 3 0 4 - 1 0 3 8t e l 6 5 0 . 4 2 4 . 5 7 0 0 t e l 8 0 0 . 5 4 4 . 4 6 3 6w w w . v a r i a n . c o m

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Varian, Varian Medical Systems, and ARIA are registered trademarks of Varian Medical Systems, Inc. All other trademarks are the property of their respective owners.