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Implementation Guide

Unity RIS/CVIS/PACS

Contents

1. Getting Started ... 3

2. Safety Guidelines and Data Compression ... 24

3. DR Systems Unity v|Series Introduction ... 32

4. Clinical Implementation ... 41

5. Technical Implementation ... 53

6. Quality Assurance and Disaster Preparedness ... 81

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Implementation Guide Unity RIS/CVIS/PACS

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Copyright and Notice | Contacting DR Systems | Certification

Copyright

Copyright © 1997-2012 DR Systems, Inc. All rights reserved.

Various DR Systems product modules are protected by one or more of U.S. Patent # 5,452,416; 7,660,488; 7,885,440; 7,787,672; 7,953,614; 7,970,625; 8,019,138; 8,094,901 and other patents pending. Other trademarks used herein are the property of their respective owners.

Specifications are subject to change without notice.

Contacting DR Systems

10140 Mesa Rim Road | San Diego, CA 92121 www.drsys.com  Phone: 1-800-794-5955  Fax: 1-858-625-3337  E-mail: Sales [email protected] Info [email protected] Support [email protected]

 Customer Support Online: www.drsys.com

Click Customer Support Login

Displaying Online Help

 Display a comprehensive Help program:

 Press F1 or click Help Topics from the Help menu.

Accessing the Resource Center

To view and download white papers, user guides, quick start guides, TechNotes, technical specifications, and other documents:

 Go to www.drsys.com.

 Click the Resource Center button.

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1.

Getting Started

About this Guide

Welcome

DR Systems has provided automated image and information management for hospitals and imaging centers since 1992. Today, our solutions encompass the entire imaging workflow process in one unified system--From web scheduling to registration, to PACS, reporting, tracking, Peer Review, Management Reporting, and regulatory compliance.

DR Systems automated solutions enable healthcare imaging providers to succeed clinically and economically. DR Systems Unity™ Imaging and Information Management Systems scale from small imaging centers to large integrated healthcare networks, and include solutions for all imaging modalities and specialties, such as cardiology, radiology, pathology, and orthopedics.

The purpose of this Implementation Guide is to help you prepare for installation. To ensure a successful implementation, DR Systems works closely with you during the entire process of planning, site

preparation, and installation.

Who should use this guide

The following staff should use this guide as a reference:  Radiology administrator

 System administrators  Reading physicians  Technologists

 Information Technology (IT) staff

Transition to DR Systems Unity RIS/CVIS/PACS

Vision, planning, commitment, and communication

Whether you are converting from film-based workflow or another RIS, CVIS, or PACS system, you can now achieve a higher level of accuracy, service, and cost-effectiveness. Your success depends on your vision, planning, commitment, and communication. You must communicate with us, with your own employees, and with your referring physicians to optimize the success of your implementation. We will communicate with you frequently to help you choose appropriate configurable settings and to evaluate the success of your system implementation.

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Implementation is in a series of stages

Each DR Systems implementation progresses through a series of stages. We must work together as partners to complete our homework assignments for each stage of implementation. We will review your task list with you and report on status and any issues we encounter.

Your primary contact – the DR Systems Project Manager

After the purchase order is issued, DR Systems assigns a project manager to supervise the entire project from beginning to end. The project manager becomes your primary contact when you have any

questions about the project.

The project manager sends you this Implementation Guide so you can learn about the requirements for a successful installation of your system.

Exchange of information

Your project manager will guide you through documenting all required information. DR Systems has data templates and surveys to make this process as efficient as possible.

A successful implementation depends on you, and any third-party companies involved, to provide required information. The following list is a brief example of some of the information required:

 Number of sites, name of sites, and location of sites.  List of HL7 interfaces.

 Numbering schemes for Reading Physicians, Referring Doctors and Patients.  Current systems installed for RIS, CVIS, HIS and/or Billing.

 Interface considerations for ADT, Orders, and Billing documented.  Network considerations.

Commitment to safety

As much as we want an on-time implementation, we are even more committed to a safe implementation. DR Systems will delay an implementation when we all agree that safety or performance concerns require more time to resolve.

DR Systems equipment, services, and solutions

At DR Systems, we specialize in unified technologies, services, and training aimed at enhancing your clinical and financial success in medical imaging.

DR Systems provides modular and fully integrated solutions for:

Feature Description

PACS Picture Archival and Communication System.

RIS/CVIS Radiology /Cardiovascular Information Systems, with form management.

Data conversion From historical systems.

HL7, DICOM, and IHE Compliant interfaces using all of these standards.

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Feature Description

Reporting Dictation, speech recognition, report templates, storage, and faxing.

Patient record maintenance Editing, patient merge, look-up.

Mammography Display, reporting, outcomes, breast history and tracking.

Document scanning™ Scan documents associated with one or more other exams.

Advanced image processing Color, MIPs, MPRs, 3D, surface shading, and volume rendering.

Web-based access Diagnostic reading, transcription, scheduling, and image viewing.

Charge capture Includes billing output interfaces.

Management Reports™ Administrative reports on collective data.

Mammography tracking Integration with DR Mammography Tracking. Also allows output to third-party solutions.

Critical Results Define and track critical tests and results. Peer Review Secure and confidential analyses of exam

interpretations.

The quantifiable benefits

When the implementation is complete, the system provides financial and professional benefits:

 Improving staff efficiency and communication for reading physicians, technologists, and support staff.

 Improving efficiency and satisfaction of the referring physicians. This improves the accuracy of communication between the interpreting physician and the referring physician.

 Improving image processing and review capabilities.

 Expediting patient care within the facility and local community.  Decreasing operating costs.

 Creating clear, structured reports of image interpretation.  Eliminating or reducing film and film-related expenses.

 Eliminating the problem of lost or inaccessible records, while improving access to images and results.

Using DR Systems Management Reports, you can measure these benefits and show continuous improvement.

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Competitive advantages

You can now market your competitive advantages because your facility is characterized by:  Outstanding service.

 Reduced RIS/CVIS/PACS costs with leaner hardware, software, interface, and maintenance requirements.

 Efficient doctors and staff.

 Measurable improvements in quality.

 Improved communication with referring physicians. Every time referring physicians access imaging results, they can also access marketing and educational information that you make available through your website.

 Economies of scale in networking with other medical imaging sites.

About Your Implementation Project

Defining the overall success formula

The success formula is a high-level guide to your RIS/CVIS/PACS implementation. It is DR Systems proven formula for implementing the RIS/CVIS/PACS system in your facility.

An important part of a successful RIS/CVIS/PACS implementation is the planning and preparation stage. DR Systems works with your site to understand and communicate all of the requirements of the

RIS/CVIS/PACS System implementation so you can define your own mission and goals.

Goals

 Plan to communicate effectively and frequently - with DR Systems and within your own leadership team.

 Set clinical and financial goals.  Appoint leadership.

 Identify a Need-to-Know list that the DR Systems project manager will use for all communications regarding the project.

 Document current workflow.

 Document desired workflow: clearly define goals and workflow changes.  Write a Project Mission Statement.

 Start preparing marketing efforts - to market the new system to referring physicians.  Start preparing a PACS roll-out plan.

 Start preparing a disaster preparedness plan.

 Identify the scope of construction, cosmetic, and environmental projects (such as lighting, painting, demolition).

 Identify the scope of network and electrical projects.  Anticipate and define potential changes in personnel.

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Developing a project team

Moving to a new RIS/CVIS/PACS system requires vision, goals, careful planning and a great team to implement the change.

Your RIS/CVIS/PACS team will include key individuals from both your facility - and from DR Systems.

Your team members

Your team members should include leaders from the following areas:  Reading physicians

 Technologists  IT staff

 Administration

Team members from DR Systems

DR Systems team members include:

 Your project manager  Lead Installation Engineer  HL7 Specialist

 Lead Applications Engineer

Developing a detailed project plan

The project team kickoff meeting and walkthrough of your facilities will result in a detailed project plan with a complete list of milestones, tasks, resources allocated to complete the tasks, and deadlines for when the tasks must be completed.

Implementation Process

What to expect after you place an order

After you place an order from DR Systems, the implementation progresses through the following stages: Stage Details

1 Initial

Contact The DR Systems project manager assigned to your site contacts you to discuss the project and timelines and to schedule the Site Visit. You must provide a complete contact list of your implementation team including participating physicians. The DR Systems team uses this contacts list to continuously keep the entire team informed throughout the implementation.

2 Site Visit The project manager visits your site to review your technical requirements, to ensure that the installation schedule is on track.

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Stage Details

3 Planning and Site Preparation

The project manager works with you to plan and prepare for installation. 4 Installation A DR Systems Installation Engineer arrives on site to begin installing the system. 5 Validation

Testing Your installation team and training staff will work with you to complete validation testing using checklists for each component as well as the overall system. Review the validation checklists in advance and allocate appropriate staff for complete testing.

6 Training After the system is installed, a DR Systems Applications Specialist arrives on site to begin training.

7 Support The Customer Support team is available 24 hours a day, 7 days a week.

Initial contact stage

During the initial contact, the project manager assigned to your site contacts you to discuss your installation and timelines.

During the first contact, the project manager:

 Schedules a preinstallation site visit. Before your project manager visits your site to go over the technical requirements, including current network layout and configuration, to ensure that installation is on time and efficient.

 Asks you for staff contacts for the site visit, including:

 Radiology administrator or other staff who make decisions regarding workflow.  Facilities staff, to review electrical and networking requirements.

 Information Technology (IT) staff, to review networking requirements.  Vendors responsible for modalities.

 Vendors responsible for the HIS/RIS system at your facility.

Site visit stage

The site visit agenda includes the following steps:  Review system requirements.

 Receive reading physician and staff lists.  Determine DICOM modalities to support.

 Define the filmless workflow environment for your site.

 Review interface requirements to other systems: HIS, RIS, CVIS, DICOM archives.  Review technical and network requirements:

 Review your current network layout and configuration.  Review shipping and receiving conditions.

 Walk through your site to identify physical layout.

Note: For details on technical requirements, see Chapter 5, “Technical Implementation“ on page 53.

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Reviewing system requirements

During the site visit, the project manager will review the following: Review item Details

Power General network and power requirements.

DICOM modalities Requirements for DICOM modalities. Determines if the DICOM Modality Worklist feature is supported on each scanner. Video capture modalities Connection requirements for non-DICOM modalities, if any still

exist at your site.

Web access requirements Requirements for reading physicians and referring doctors to access exam information from remote locations.

Workflow Site workflow for the RIS/CVIS/PACS. Data compression Compression needs for modalities.

User rights and roles Default roles and additional roles needed for the implementation. Expected exchange of

information with HIS/RIS system

Data shared with the HIS/RIS/CVIS. Expected exchange of

information with HIS/RIS and DR Scheduler™

Scheduling data shared between HIS/RIS/CVIS and DR Scheduler. Recommended placement

of equipment Furniture required for your implementation. Dedicated phone line for

support A dedicated phone line is needed for DR Systems to support your system remotely.

Receiving templates to provide staff lists and exam codes

To prepare for the installation and configuration, you receive the DR Systems template files to complete your current configuration of exam, billing, and referring doctor definitions. Each form includes

instructions for all fields to help you complete the form accurately and completely. DR Systems imports the data into your system so you do not need to manually enter information about staff, referring doctors, and exam types.

Templates DR Systems provides include:

 Sample job description for system administrators.  Sample notice for clerks and technologists.  Sample letter to physician staff committee.  Surveys during transition.

 Sample physician and office staff survey.  Recommended website content.

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Staff lists

Staff lists are required so that DR Systems can add the reading physician and referring physicians to the database before Applications Training. This saves you time because Customer Service populates the database in advance.

 Information for reading physicians includes:  First name.

 Last name.  Specialty.

 Office phone numbers.

 Information for referring doctors includes:  Last name.

 Recommended: First name, specialty, offices, and office phone numbers.

Exam codes

Exam codes are also required before an installation. The codes can be CPT codes, or codes customized for the facility. DR Systems enters the codes during system integration, so that the technologists can choose from a set of standard selections. This ensures that the database has consistent entries.

DR Systems requests that you provide exam codes. We need the following information regarding exam codes:

 Exam code.  Exam description.  Service codes (optional).  Modality.

 Duration.

Example: Exam code information

Exam Code Exam Description Modality Duration

71021 Chest, 2 views with apical lordotic XR 40

71120 Sternum XR 30

The following is an example template for exam types.

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Defining the workflow environment for your site

The project manager will discuss your current workflow and volume and will work with you to design the best transition to a filmless environment.

Tasks involved in designing the transition

 Customize a mission statement for your facility.

 Assign the system administrators. For details on identifying system administrators, see “Selecting the system administrators on page 11.”

 Redefine job descriptions.

 Discuss workflow management for:  Case notes.

 Restoring previous exams.  Legacy film jackets.

 Recorded audio conclusion.  Requisitions and film buckets.  Set expectations for the go-live day.

Planning and site preparation stage

During this stage, DR Systems guides you through: Phases Description

1 Creating the Project Plan 2 Selecting the Administrators

3 Receiving a demo machine, if you choose to receive one.

4 Completing HIS/RIS testing, if you purchased the HL7 Gateway option or Dedicated Test System.

Creating the Project Plan

Based on the site visit information and your Success Formula, the project manager builds a detailed project plan with all tasks to be completed for your RIS/CVIS/PACS implementation. The project manager will review the list of tasks with you.

Note: Completing the tasks lists at this phase is critical to successfully completing the installation and training on time.

Selecting the system administrators

The system administrators can be one or more key staff members depending on the size and complexity of your configuration. These administrators are responsible for:

 PACS  Networking  Physicians

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 Technologists

 RIS  CVIS

System administrator

System administrators typically come from your Information Technology (IT) group, reading physicians, and technologists. System administrators are more than a RIS/CVIS/PACS administrator. They need to understand:

 Network configuration  DICOM

 HL7

 HIPAA standards

Physician system administrators

Your physician system administrators are the central point of communication between your physician associates and DR Systems.

Roles of physician system administrators

The physician system administrators have the responsibility and authority to:

 Remain available full-time with no other responsibilities during initial training.

 Communicate with DR Systems to keep current with new developments, keep us informed of any problems, and to immediately report any perceived hazards.

 Train and supervise other reading physicians and referring physicians in using DR Systems RIS, CVIS, PACS, and Reporting.

 Participate in the development and implementation of local security, confidentiality, data compression, and back-up policies.

 Implement image and data entry policies, working with administration and technical staff.  Communicate with referring staff and appropriate supervisory committees at the facility.

Technologist system administrators

Your technologist system administrators are the central point of communication between the

technologists and DR Systems. By understanding DR Systems and the system configuration options, the technologist system administrators can help you improve productivity.

Roles of technologist system administrators

Technologist system administrators have the responsibility and authority to:

 Remain available full-time with no other responsibilities during initial training.

 Communicate with DR Systems to keep current with new developments, to keep us informed of any problems, and to immediately report any perceived hazards.

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 Train and supervise other technologists and clerks, as well as participate in the ongoing training

of nurses and referring physicians.

 Participate in the development and implementation of local security, confidentiality, data compression, and back-up policies.

 Implement image and data entry policies, working with administration, reading physicians, and technical staff.

 Communicate with reading physicians and referring staff.

Receiving a demo machine

DR Systems can send you a demo machine, if you want to demonstrate DR Systems equipment before installation. This can be useful to introduce your referring physicians to the new system prior to installation.

HIS/RIS/CVIS testing

The HL7 Gateway or Dedicated Test System (DTS) option provides a communication interface between HIS/RIS/CVIS and PACS. DR Systems participates in configuring and testing the interface before and during installation.

Test orders received from HIS/RIS/CVIS

External HIS/RIS/CVIS. Test orders received from external HIS/RIS/CVIS, for customers without DR Scheduler or RIS/CVIS.

DR Scheduler. Test orders generated by DR Scheduler. Test interfaces after changes in the HIS/RIS/CVIS interfaces

External HIS/RIS/CVIS. Test orders after changes in external HIS/RIS/CVIS interface.  DR Scheduler. Test orders after configuring changes in DR Scheduler/PACS.

Installation stage

The goal of installation is to ensure a successful implementation of your RIS/CVIS/PACS systems and to transition your site through the Installation, Training, and Support stages to achieve the goals of each stage in the least amount of time.

Teams of authorized technicians from DR Systems travel to your site and install all components in the DR Systems RIS/CVIS/PACS. Each team has focused tasks to complete their phase of the installation with you and handoff to the next team with planned integration.

Note: Third-party vendors must be present during our installation.

Installation phases

Installation is a phased process that includes about one week each for: 1. Preinstallation

2. Installation

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Preinstallation phase

In preparation for preinstallation, the project manager checks that all identified tasks have been completed.

Site requirements

Site requirements may include:

 Purchasing tables and other furniture.  Adding additional power outlets.

 Ensuring that network cable and T1/DSL lines are in place and tested.

 Ensuring that a dedicated phone line is in place and available for the Messenger modem.  Ensuring that phone lines or a T1 line are available for faxing.

Note: For details on installation requirements, see Chapter 5 “Technical Implementation” on page 53.

The Preinstallation Team consists of one or more DR Systems installation engineers. They provide you with the preinstallation checklist that they will use to verify that your site is ready for installation.

Preinstallation checks

Review of the Preinstallation Checklist. The Preinstallation Team provides you the Checklist to prepare you for the tasks the preinstallation, installation, and validation teams accomplish. The Preinstallation Team meets with you to review the Checklist and identify the process.

Final walkthrough. The final walkthrough is to ensure the infrastructure is in place, such as the furniture for the RIS/CVIS/PACS equipment, and all items on the checklist are completed.  Network validation. The network validation is to ensure the network is functional.

Installation phase

Installation usually proceeds in this order by installation technologists:

1. Set up and connect the server rack, including the AGS (Application Gateway Server, HL7 Gateway, Dedicated Test System, and Messenger.

2. Connect Catapults to DICOM-compliant equipment.

3. Connect Catapults to non-DICOM-compliant equipment for video capture. 4. Connect the following equipment:

 Laser Camera Interface  Dominator™ DC workstations  Ambassador™ DC workstations  Install the Guardian™ archive device. 5. Test all equipment by DR Systems staff.

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Validation testing stage

The validation testing stage is to verify the core installation is complete and running. The phases in the validation stage include:

1. The Installation Team provides you a checklist of test items in advance to help with your preparation for both new installations and future upgrades.

2. The Applications team participates in the validation step as a handoff to the next implementation stage, training.

Training stage

For DR Systems customers, training starts from the first day. Our goal is for your staff to become productive quickly. The first training segment is conducted before installation at our corporate training headquarters in San Diego, California. After the installation is complete, the Applications Specialists provide training at your facility.

Training is tailored to your facility’s unique requirements. DR Systems training staff works with you to assess your workflow and suggest ways to optimize the Unity RIS/CVIS/PACS technology for improved workflow efficiency. The trainers apply their knowledge of the Unity RIS/CVIS/PACS to your workflow. Because DR Systems training staff incorporates your requirements into the on-site training program to optimize the Unity RIS/CVIS/PACS technology for your facility, the result is that you see immediate improvements in workflow efficiency, enhancing your clinical and financial success.

Blended approach

DR Systems offers a blended approach to training:

 Classroom and lab training at DR Systems for system administrators and key staff.

 On-site, customized classroom and hands-on training for hospital or imaging center staff.  Web-based training.

Certified training

DR Systems training is certified by the American Society of Radiological Technologists (ASRT) to offer Class A Continuing Education Units on successful completion of training.

Training stage phases

The training phases include:

1. Initial planning.

2. Preinstallation system administration training. 3. On-site staff training.

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Initial planning

Establishing the training schedule

Training is provided to all staff involved with imaging:  System administrators

 Front desk staff  Technologists  Reading physicians  Transcriptionists  Schedulers  Back office staff

The project manager asks for your list of staff to be trained. Based on this list, the project manager works with the DR Systems training manager to assign trainers. A member of the training team contacts you to discuss the training stage and schedule of your installation.

For more details on the training schedule, see “A sample training implementation schedule,” on page 17.

Importance of the system administrator's availability and participation

The DR Systems Unity RIS/CVIS/PACS is a strategic and tactical medical imaging information system critical to the clinical and financial success of your business. It is important that you identify the system administrators and ensure that these people complete training on all aspects of the system.

Responsibilities of system administrators

System administrators gain expertise of the Unity RIS/CVIS/PACS, and take responsibility for system operation, implementation, communication with DR Systems, and ongoing new employee training.

Preinstalla

t

ion training for system administrators

Before your RIS/CVIS/PACS system is installed, system administrators and/or other key personnel have the opportunity to attend the PACS Administrator class offered monthly at DR Systems headquarters.

On-site staff training

After the Unity RIS/CVIS/PACS installation and validation, the DR Systems Applications Specialists start training your key staff at your facility.

Follow-up and advanced training

As your imaging enterprise grows, DR Systems Training is there to support your needs with a variety of follow-up and advanced training programs including:

Web-based basic and advanced training courses. The DR Systems Training and Applications department provides webinars on various topics that are helpful in increasing proficiency on DR Systems RIS/CVIS/PACS features. The Marketing department periodically sends email messages about topics and dates.

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Sample topics include:

 Latest software upgrades  Management Reports  Instant Reporter™

 Basic Universal Manager™ operations  Universal Manager for referring doctors

Teleconference application training. As required, DR Systems provides solutions to ongoing training needs by scheduling teleconferences to supplement and reinforce training for your staff.

Additional on-site training. On-site training of new hires, new RIS/CVIS/PACS features, and enhancements is available at your facility for an additional charge.

The Communicator newsletter. DR Systems distributes a quarterly newsletter, The Communicator, that includes topics for training on specific features.

Previous Communicator newsletters described:  Microsoft® Word templates.

 System monitoring.

 Continuing an exam when connectivity is lost.  Exam notes.

A sample training implementation schedule

 The project manager contacts the DR Systems Training Manager with list of students and tentative dates for training.

 The Training Manager assigns the appropriate number of applications staff to provide training. One Applications Specialist is assigned as the Lead Trainer. The number of Applications

Specialists assigned depends on the staff size and number of facilities.  The Lead Trainer contacts the designated site staff to prepare the training.  DR Systems trainers provide the following training:

System administrator training. System administrators attend the System Administration class at DR Systems corporate headquarters before the system is installed.

Reading physician training. Individual, on-site training is provided for all reading physicians.  Technologist training. The applications trainers provide on-site training to technologists

typically in 2 hour classroom sessions followed by 2 hour hands-on training. Training is in groups by modality and is customized to the needs of your department.

Transcriptionist training. DR Systems provides transcriptionist training to use the automatic features and toolbar shortcuts for inserting text from the reading physician’s dictation.  DR Scheduler training. DR Systems provides schedulers training to use DR Scheduler to

make appointments that appear on the Schedule tab for technologists, referring physicians, and reading physicians.

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Super-user training. DR Systems offers super-user training for large implementations or

sites with multiple facilities. The DR Systems Applications Specialist works one-on-one with the designated super-user to train that person to train your remaining staff. By training the trainer, staff can be trained at your convenience.

The approximate duration of training for each group or individual is identified in the following table:

Who Training Schedule

System administrators Half-day

Physicians 2-4 hours

Can also be individually tutored.

Technologists 2-4 hours trained in groups or by the super-user. Transcriptionists 2-4 hours

Schedulers 2-4 hours

Information Systems Training is handled before and during installation. We work closely with this group to install and launch the wide area network (WAN).

Training needs assessment

Applications Specialists work daily with the system administrators to assess on-going needs and provide solutions to the needs. DR Systems highly recommends a daily meeting of the site training coordinators and the following DR Systems.

Training objectives

During training, your staff learns to complete the following sample tasks:

Training Task Syst em A dm in istr ato rs Fil e R oo m Te ch no lo gis ts R ea din g Ph ysi ci an s Tra ns cri pti on ists Sch ed uler

Identify the purpose of all system components.  Enter cases from each individual Catapult and

DICOM Gateway.

 

Operate Dominator, including worklist

management, creation of a montage, and dictation of an audio file.

 

Print a case entered from each Universal Manager.    Use Catapult Technologist QC Workstation (if this

option was purchased) to do advanced image processing, 3D color, MPRs, MIPs, volume rendering,

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Training Task Syst em A dm in istr ato rs Fil e R oo m Te ch no lo gis ts R ea din g Ph ysi ci an s Tra ns cri pti on ists Sch ed uler

volume measurement, and surface shading.

Operate print modules and the LCI (Laser Camera Interface).

 

Use the Universal Manager to enter staff and referring physician information, restore a case, and modify a record.

 

Use and restart the HL7 Gateway. 

Use the Communicator module.  

Use the Guardian module to create a DVD or Centera archive.

 

Use the Archive feature for reports on the Reports

Server. 

Create reports from the reading physician’s dictation. 

Speech recognition 

Scheduling appointments 

Dominator I+  

Transcription I+  

Support stage

The Customer Support team

When a problem occurs, the Customer Support team at DR Systems determines as quickly as possible where the problem originates and determines the best solution for the problem.

Phases of the support stage

DR Systems provides support in phases:

1. Post-installation Support 2. Service

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Post-installation Support phase

DR Systems assigns a Post-installation Support team of experienced DR Systems staff to help your staff use RIS/CVIS/PACS to its fullest potential. This team reinforces training to ensure complete confidence in using the system.

The Post-installation Support team provides intensive support for the first 30 days after an installation. The objective is to verify that all items on the checklist were completed and that staff are prepared for the RIS/CVIS/PACS.

Post-installation Support training

In addition to reinforcing RIS/CVIS/PACS training, the Post-installation Team trains your staff on using DR Systems support services. For example, the team provides training on:

 Notifying Customer Support of an issue.  Submitting a ticket for support.

 Using self-service.

 Getting service requests escalated.  Contacting Customer Support.  Setting up referring physicians.

 Using features of the system to elevate staff from novice users to expert users.

Post-installation Support approaches

Post-installation support includes multiple approaches to support on a daily basis:

 Help Desk support by multiple staff members to provide immediate attention to your issues during 6:00 AM to 6:00 PM Pacific Time.

 Help Desk after-hours support provides a Help Desk staff member and a Technical Support staff member 24 hours per day.

 Conference calls to solve your issues with one or more experts at DR Systems.

Post-installation Support transition to Service

After 30 days and a level of confidence in completing exam tasks, the Post installation Team hands off support to DR Systems Customer Support to provide service.

Service phase

The levels of service include:

Help Desk

DR Systems provides telephone support for software problems and for all application questions. These account for a large percentage of all service calls. The Help Desk staff attempts to solve your problems as quickly as possible and submits a ticket to track your issues.

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Help Desk hours:

 6 AM to 6 PM Pacific Time / Monday through Friday

We have staff available in our office to answer your calls immediately during the hours of 6 AM to 6 PM Pacific Time.

 24 hours / 7 days a week

After standard work hours, we have Help Desk and Technical Support personnel on call 24 hours a day, 7 days a week.

If the Help Desk cannot solve your problem, they escalate the problem to a Technical Support expert.

Technical Support

The Technical Support expert attempts to solve your problem. If that isn’t possible, the Technical Support expert escalates the problem to a higher level of expertise, such as:

 Development for feature experts.  Systems engineering.

 RMA (Returned Material Authorization).

Field Service

If the subject matter expert can’t solve the problem or the problem requires someone on-site, a regional field service engineer is assigned the issue for resolution. For service issues that require a hardware fix, DR Systems provides on-site local service.

Approaches to providing service

Remote access

When required during a support call, the Customer Support team can dial into the site to analyze the problem. By using this method of remote access control, the Customer Support team can provide solutions to most problems faster than a local engineer could drive to your location.

Initial warranty period

Note: Support Services are provided at no charge during the initial warranty period (12 months). At the expiration of the one-year warranty, the customer has the option of purchasing an Annual Service Contract.

Annual service contract

DR Systems offers a one-year Service Contract, renewable annually. The Service Contract includes  Application (software) support.

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 Hardware and platform service, which will include parts, labor and services so as to maintain the

system in proper working order in accordance with the terms of this Agreement. During the term of a service agreement, DR Systems provides maintenance releases,

enhancements/improvements updates, bug fixes, and workarounds at no charge to the customer.

Purchase of additional components

If you need to purchase additional components as your DR Systems network increases in scope, please contact the DR Systems sales representative assigned to your site to obtain pricing information.

Marketing communications

When you submit comments to DR Systems, you can sign up to receive product information. This keeps you informed of new products and upgrade.

Customer surveys

DR Systems conducts surveys to evaluate the effectiveness of the product, services, training, documentation, and support. We use the results of these surveys as an assessment to continuously improve products and services.

Related Documents and Training Materials

DR Systems provides a library of documents and training materials supporting the family of RIS/CVIS/PACS products.

On the Resource Center:

Type of Material Description

Implementation Guides Information about preparing for system

installation and setup Full-length books

Quick Start Guides Brief document with keyboard shortcuts and

tools to bring you up to speed quickly Brief document Technical Specifications Details on hardware components and software

requirements Brief document

TechNotes Brief technical instructions on a single topic,

targeted for a specific set of users Brief document Tutorials Online self-paced instruction demonstrating how

to use a feature or product Up to 30 minutes Videos Full-motion movies demonstrating workflow 30 minutes to 1 hour White papers An explanation of an architecture, framework, or

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Accessing related documents on the Resource Center

1. Go to the DR Systems website, at: www.drsys.com

2. Click Resource Center. 3. Log in.

4. Do one of the following:

 Search for the title of the item.  Search by role.

 Use the navigation bars at the top of the window to go to the Document Library, Online Tutorials, or White Papers.

Note: New training materials are added and updated frequently. Check the Resource Center for the latest versions and new titles.

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2.

Safety Guidelines and Data

Compression

Safety Guidelines

General requirements

Required training

All personnel, including physicians and technologists, who plan to use any DR Systems product must receive training before using the system. This can include training at DR Systems headquarters, at the customer site, via the web, and/or thorough review of DR Systems official training materials and manuals.

Note: Please carefully review the cautions and warnings described in this section.

System of supervision, peer review, and periodic training

You must develop a system of supervision, peer review, and periodic employee training to ensure that the equipment is properly and safely used.

Quality assurance and system maintenance

Routine assurance and system maintenance must be performed. A dedicated phone line must be available to DR Systems for software service.

If hardware or software problems occur

If hardware or software problems occur that prevent the transmission of images, or result in the inability to acquire or display images properly, immediately cease operation of the system and inform the

responsible physician or supervisor. Promptly contact DR Systems Customer Support. See the copyright page for contact information.

Image enhancements

Image enhancements quality must be used with care, as it is possible to obfuscate data by improper use of processing tools. You must exercise professional judgment in the manipulation of images.

Cautions regarding electrical equipment

Adhere to the standard safety precautions employed when operating electrical equipment.

Ergonomics to avoid fatigue or injury

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Operating environment

Temperature and power characteristics of the environment are very important. See the following related topics:

 Air temperature and circulation requirements  Voltage and power requirements

 Dedicated power circuit

Air temperature and circulation requirements

The system components must be located in an air-conditioned environment with adequate air

circulation around each of the components so that the air intake and exhaust vents for each component are not blocked.

Voltage and power requirements

The system components should be protected from:  Over voltage and under voltage

 Transient power fluctuation  Power failure

Protect against these conditions by using:  Line conditioners

 Surge protectors

 UPS (uninterruptible power supply)

Dedicated power circuit

Ideally, the system components should have a dedicated power circuit. If it is necessary to share a circuit, efforts should be made to avoid sharing a circuit with any of the following equipment:

 Copy machines.  Power tools.  Air conditioners.

 Motorized machines or equipment.  Laser printers.

 Space heaters.  Facsimile machines.

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Security

Maintaining security and confidentiality

Maintaining secure, confidential patient records should be a prime objective of your organization. DR Systems provides tools to accomplish this. DR Systems urges you to establish the following:

Written policy. Maintain and update a written patient confidentiality and security policy. Adhere to the policy, and periodically review it with all new and existing employees.

Restricted access. Physically locate each component so that authorized employees, but not the general public, can access them.

Confidentiality agreements. Develop and maintain confidentiality agreements with all referring physicians, employees, and appropriate third-party vendors or consultants who are given access to any system component.

Personal security. Use the logon and password security provided with all system components. Do not attempt to override security warnings.

User Roles and Rights. Carefully implement user roles and rights to appropriately restrict access. Audit activities periodically using DR Systems Audit Trail and Management Reports to verify appropriate use. Institute policies to discipline inappropriate users. For those using DR Systems document scanning and notes, consider carefully which types of documents and notes you wish to classify as Confidential to limit viewing to only those users who have the appropriate rights.  State and federal security. Keep current with state and federal security regulations and ensure

compliance with these regulations. Regulatory adherence is your responsibility. Requirements may vary at different locales.

Security and backup plans

DR Systems urges you to develop a written security plan, and written procedures for back up, technology failure, and disaster planning. The DR Systems Resource Center (available at www.drsys.com) provides several documents on this topic.

Failure to develop and implement appropriate security, training, and backup plans inevitably lead to:  Improper image import, display, or transmission.

 Inadvertent loss or mislabeling of medical records.  Unintended breaches in patient confidentiality.

Specific Cautions

For reading physicians

Image labels. Images are always labeled if they are compressed, clipped, magnified, or displayed at less than maximum resolution. You must understand these labels and warnings to avoid inadvertently viewing an image in a less than optimal way. Check images for their fiduciary marks and labels to be certain you understand image orientation correctly.

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Mammography images. Images that are lossy compressed display a warning:

Not for primary reading or primary archive.

Image edits. Whenever you edit images, such as altering window/level settings on the

Dominator, the system asks if you want to save these edits when you exit the displayed exam. If you choose to save edits, the images will subsequently be displayed and printed according to your new settings. After an exam is marked as Read, images are presented by default according to your last saved edits.

Audio recordings. Your voice clip and montage become part of a patient’s medical record. If you purchase Instant Reporter, your dictation and transcription also are part of the medical record. Exercise care and medical prudence at all times.

Ergonomics. Be certain that lighting and other ergonomic conditions are optimized to maximize image quality and prevent fatigue or injury.

Warnings. If you attempt to mark a case Read without displaying all images or dictating a digital voice file, you will receive a warning. Do not override these warnings without careful

consideration.

Patient demographics. Always verify that patient demographic data is correct.

Color images. A color monitor must be used to view color images. This can be accomplished using a color Dominator I+, Dominator DC, Ambassador I+, or Ambassador DC. You can use these devices to colorize monochrome images in a variety of different ways.

Large matrix images. When viewing large matrix images, such as computed radiographs or digital radiographs, be sure to view the images at full resolution, using one of multiple software options.

Measurements: Linear and area measurements can be made on nearly all DICOM format images without additional calibration.

Calibration. Calibration is required before you can measure non-DICOM images. In some cases, calibration may be required for DICOM images that lack sufficient information.

Caution: For projection images (such as radiographs, digitized film), be aware that

measurements are always affected by geometric magnification. DR Systems provides calibration technologies that can be used to account for geometric magnification in such images. Such technologies require training for proper use—do not ignore warnings that appear.

For technologists

The following are specific cautions you must carefully consider:

Review images and data. Always review imported images and associated data for accuracy, completeness, and image quality prior to completing the import process.

Review notes and documents. Always review appropriate documents, notes, and allergies before imaging the patient. When appropriate, add notes, indications, history, and allergies.  Delete cautiously. Never delete a case that has not been archived without the utmost care and

consideration. Do not override warnings unless specifically authorized to do so.

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Be discrete. Recognize that any comments about the patient (such as the patient's reaction to

contrast media), or notes specific to the exam, become a part of the patient’s medical record. Exercise discretion and judgment in preparing these notes.

Preserve quality when editing images. You may be given the responsibility to window, level, crop, flip orientation, label, and sort images, as well as enter or alter patient demographic data. Please exercise the utmost care in monitoring and verifying accuracy, while maximizing image quality. When images are cropped, be absolutely sure to maintain proper placement of left and right markers, and verify the accuracy of all labels.

Tracking changes. You may be asked to modify existing medical records when a patient changes name or medical record number. Name changes are automatically tracked. Changing a patient’s medical record number requires great care, particularly when the patient already has old archived records. DR Systems provides a warning whenever you attempt to change a medical record number so that new records are not inadvertently isolated from old records.

Adverse reactions. Check the Allergy field for any past allergies. The field can be customized per site and per modality to require allergy or adverse reaction notification confirmation. That means the technologist must view and acknowledge the alert before the exam is available to the scanner via DICOM Modality Worklist.

Preventing Data Loss

Archiving and backups

DR Systems offers a variety of options for disaster recovery and long term storage for exams, images and report data, including:

 Single or replicated EMC Centera Content Address Storage (CAS) solutions.  Single or replicated Storage Area Network (SAN) solutions.

For details on archiving and backups, see the System Administration online Help.

Responding to network or server failure

You will be taught how to operate system components even in the event of a serious network or server failure. Please review this training periodically.

At the time of installation, you will be instructed on monitoring the fault-tolerant PACS Server™ for non-fatal failures that might otherwise go undetected. You must monitor the PACS Server at least daily as instructed.

Caution: Call DR Systems immediately if the appropriate indicator lights are not readily visible, or if failure indicators are lit.

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Data Compression

The decision to use compression

Whether and how you compress data is your responsibility and should be based on physician supervision, as well as periodic review of appropriate standards and the scientific literature.

Compression may or may not alter diagnostic ability. We recommend that you adopt a written policy, review it periodically, and adhere to it.

White papers regarding this topic are available at the DR Systems online Resource Center at www.drsys.com.

Note: While we can share information about the experiences of our other customers, we do not specifically endorse any data compression, because DR Systems is not in the practice of medicine.

Where compression is used

Compression can be used:

 At the time of image acquisition from various capture devices.  For archiving.

 For web distribution.

You can apply different compression ratios for each of these activities and for each exam modality and/or per connected imaging device. The project manager provides a form to specify compression levels.

How compression is configured

After your facility makes a decision regarding the use of compression, the system administrator works with DR Systems to set the configuration defaults for your facility.

In some cases, you can set compression options for a specific action, as in DICOM Send or Image Copy.

Compression formats

DR Systems supports the following types of compression, when specifically authorized by physicians. All of the following formats are DICOM-compliant:

JPEG. Compression formats that are part of the DICOM Standard. Available as JPEG Lossy or Lossless format.

JPEG 2000. A wavelet-based international (ISO) image compression standard that can provide either true lossless or lossy image compression. It has been added as an official part of the DICOM Standard as Supplement 61 - "JPEG 2000 Transfer Syntaxes,” published in January, 2002. DR Systems supports the following forms of JPEG 2000:

JPEG 2000 lossy. A compression format that produces image compression ratios comparable to JPEG. However, JPEG 2000 is better suited to compression of images with more than 12

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bits/pixel. Another advantage is that you can specify the desired compression ratio when using

JPEG 2000 Lossy compression.

JPEG 2000 lossless. A compression format that produces image compression ratios between 2.5:1 and 4:1 on most images. The actual image compression ratios vary based on the modality and the amount of image detail in each image.

Setting defaults

You can set:

 A default compression type (JPEG, JPEG 2000 Lossless, and JPEG 2000 Lossy).

 A desired quality/compression level for all modalities, or for specific modalities (for JPEG and JPEG 2000 Lossy).

Note: All compression formats supported by DR Systems are standard DICOM

implementations, which can be read by other DICOM-compliant viewers. The JPEG 2000 formats are compliant with the DICOM Standard Supplement #61.

Guidelines for setting a compression level

The compression level determines the quality of the compressed image. The following are examples of image compression parameters.

JPEG Lossless

Files compressed without loss of data. No compression levels set.

JPEG Lossy

We specify JPEG compression in terms of a Quality Factor (QFactor). Compression levels include:

JPEG (Q = NN) = Compresses at NN on a scale of 100, where 100 has the least compression. For example: Your system may display the following image compression options:

JPEG (Q = 60) = Compresses at 60 on a scale of 100.

JPEG (Q = 70) = Compresses at 70 on a scale of 100. This compressed image would be higher quality than JPEG 60.

JPEG 2000 lossless

No compression levels can be set. JPEG 2000 lossless compresses files without any loss in data.

JPEG 2000 lossy

DR Systems specifies JPEG 2000 lossy compression in terms of a compression ratio (X:1).

JPEG2000_X:1 = Compresses x bytes to 1 byte, where x = a number from 1 to 100. The file size of the resulting image is 1/x the size of the original.

Examples:

JPEG2000_5:1 = The file size of the resulting image is 1/5 the size of the original. This compressed image would be higher quality than JPEG2000_10:1.

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Patient Editing Warning

Exercise caution in editing patient information. If you modify the Patient ID, you can lose association with other exams for the patient.

Before creating a new patient, verify that this patient does not have a record in the Unity system. These measures avoid duplicating patient entries, which will interfere with proper comparison of exams over time.

You can use Patient Merge to integrate records for a patient with more than one Medical Record Number. For details, see the System Administration Help.

Safety Summary

Careful training and implementation of the technology will improve your success. If you have any questions or concerns about the system’s operation or safety, please call us immediately. For details on contacting DR Systems Customer Support, see the copyright page.

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3.

DR Systems Unity v|Series Introduction

v|Series solutions for the entire workflow

The DR System Unity v|Series applications provide the full range of front desk, technologist/QC, reading physician, referring physician, and back office workflow solutions.

v|Series allows you to:

 Supply their own hardware and configure their systems. OR

 Purchase hardware configured by DR Systems.

v|Series product families

The v|Series product families comprise:  I+ (Internet Plus) Series

 DC (Direct Connect) Series  MD (Mapped Drive) Series

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Systems Provided and Configured by Customers

I+ Series

The I+ (Internet Plus) Series is a Web-based, modular, virtualization-capable RIS, CVIS, PACS, and Reporting platform. The I+ Series provides full-range applications for installations on workstations connected to the AGS™ (Application Gateway Server) through the Internet for users’ home or office workstations or through the intranet for hospital or imaging center workstations.

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Unique to the I+ Series configuration, the AGS allows system administrators to download and maintain

their Unity applications via the web, supporting both local and remote workstations.

 HTTP connection through AGS (Application Gateway Server) database through the Internet or intranet.

 Hardware provided by customer.  Products include:

 Diagnostic Reading and Reporting PACS Dominator I+  Technologist QC Catapult I+

 Clinical Review Ambassador I+  Dictation Report Review I+  Transcription I+

 z|Series (Zero Download) - ZDS Scheduling

- ZDA Ambassador Clinical Review

DC (Direct Connect) Series

The DC (Direct Connect) Series provides full-range applications for installation on workstations that connect to the PACS Server. This product series was previously called CS Series.

 WAN or LAN connection to the PACS Server at the imaging center or hospital.  Hardware provided by customer.

 Products include:

- Diagnostic Reading and Reporting PACS Dominator DC - Technologist QC Catapult DC

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- Clinical Review Ambassador DC

- Dictation Report Review DC - Transcription DC

Systems Provided and Configured by DR Systems

MD (Mapped Drive) Series

The MD (Mapped Drive) Series include hardware, third-party applications, and full-range solutions configured on the server and workstations for customers.

 ODBC/TCPIP connection to the PACS Server database for imaging centers or hospitals.  Hardware provided and configured by DR Systems.

 Products include:

- Diagnostic Reading and Reporting PACS Dominator - Technologist QC Catapult

- Clinical Review Ambassador - Dictation Report Review - Transcription

The Universal Manager

The Universal Manager is the software interface common to all DR Systems components. Preregistration staff, reading physicians, technologists, transcriptionists, referring physicians, and IT personnel all access their respective DR Systems components through this same interface.

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Unity v|Series Product Components

Unity v|Series product components provide workflow solutions for:  Referring physicians  Front desk  Technologists  Reading physicians  Transcriptionists  Back office  System administrators

Referring physician

 ZDS (Zero Download Scheduler)  Order exams.

 Schedule exams, resources, and facilities.  Web-based - no software to download or set up.  ZDA (Zero Download Ambassador)

 Clinical review of images, reports, documents, and audio.  Robust, intuitive, secure viewer.

 Web-based - no software to download or set up.

Front-desk

 DR Scheduler  Order exams.

 Schedule exams, staff, and resources.

 Web-based ordering and scheduling by referring physicians available.  Preregistration and registration

 Receive and process patients.

 Enter or update patient insurance, verify eligibility, record authorization, track phone confirmations.

 Document Scanning

 Scan printed items or photographs, such as patient identification cards, insurance cards, sketches, and prior radiology reports.

 Apply security levels to restrict who can view scanned documents.  HL7 Gateway

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 Media Ambassador™

 Create CDs or DVDs that contain patient exam images, both current and prior exams, and the reading physician's recorded audio conclusion.

 Anonymize patient data for training and education.

Technologist

 Technologist QC (Quality Control) Catapult™

 Technologist DICOM Catapult or Video Capture Catapult workstation.  Input images from an array of imaging devices.

 Supports Vidar CAD PRO Advantage® and ClinicalExpress® for digitizing mammograms.  Advanced Image Processing

 Import images with advanced image processing, 3D modeling reconstruction in color, volume rendering, and volume measurement.

 DICOM Gateway

 Digital communication between diagnostic and therapeutic equipment and the DR Systems RIS/CVIS/PACS.

 Digitizer Technologist Workstation Catapult  Input scanned films in DICOM format.  User-selectable DICOM data compression.

 Supports the Vidar Diagnostic Pro Advantage digitizer.

Reading physician

Reading solutions for radiology, cardiology, mammography, pathology, and advanced image processing  Diagnostic Reading and Reporting Dominator

 The Gold Standard diagnostic reading station.

 Interpret and display all types of medical imaging exams.  Rapid and flexible image review and comparison.

 Consolidate information sources: patient data, workflow and dataflow, tools, productivity, and multimodality image viewer.

 DR Mammography Tracking™

 Track follow-up tasks and outcomes.  Critical Results

 Define and track critical tests and results.

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 Peer Review

 Allow reading physicians to review each other's exam interpretations.  Continuously improve patient care.

 Provide support for confidentiality, security, and fairness.

Reporting solutions

 Report Manager™

 Provide permanent report storage for all versions of a report.

 Store reports generated by the DR Systems RIS/CVIS/PACS or by third-party reports sent through a HIS or RIS.

 Instant Reporter

 Integrate dictation, report display, and transcription.

 Provide mammography assessment and recommendations reporting.  Speech Recognition

 Allow recognition of natural and continuous speech.  Convert speech to text on the screen.

 Dictation and Report Review Workstation  Dictate and review patient exam reports.  Report Review Workstation

 Review and approve patient exam reports.

Transcriptionist

 Transcription

 Integrated with Instant Reporter.

 Provide automation tools for optimizing transcription productivity.  Use included templates, dictation controls, and work lists.

Back office

 RIS Charge Capture and Insurance/Billing Interface

 Collect costs for billing through the HL7 interface as they occur in the workflow.  Capture diagnosis codes (ICD-9), service codes (CPT, HCPCS), and supply codes.  Allow modifications to ICD-9 diagnosis codes.

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 Billing out

 Send insurance/billing information to a third-party billing company.

 Include charge information, insurance type, insurance plan, employer information, and payments.

 Management Reports  Gather statistical data.

 Generate productivity and usage reports.  Perform workflow and practice analysis.

System administrator

Monitoring

 Sentinel™

 Monitor system performance and workflow.

 Accessed by DR Systems Customer Support for proactive service.

Remote diagnostics

 Messenger™

 Communications system for DR Systems Customer Support to access Unity servers remotely.

Writing exam data to media

 Network Media Ambassador™

 A network-based station that receives media-production requests from any configured Unity workstation.

 The requesting workstation can perform other tasks while the Network Media Ambassador creates the CD or DVD media.

Online storage

 Storage Area Network (SAN)

 High-speed, short-term network for the active files among facilities.  Provide backup, restore, and archives functions.

 Network Attached Storage (NAS)  Integrated IP storage.

 Consolidate file systems for backup to disk and for recovery.  Automated online storage processing

 Purge Online and Scheduled exams and reports exceeding their purge dates.  Track application status.

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Guardian long-term archives

 Spinning Disk Technologies  NAS.

 SAN.  DICOM.

 Content Addressed Storage (CAS) and options.  Replicated to remote CAS or replicated to Disk Array.

References

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