Project :Industry: Security, Manufacturing, Human Resources, Research and Development Services Provided: Project Management, Organizational Change Management Company: The client is a global leader in

Business Requirements Document

Clinical Archive Viewer

Document Information

Revision History

Version #

Date

Description

1.0

1.1

2.0

3.0

9/16/2014

9/19/2014

9/22/2014

9/23/2014

Initial Draft – Karen Treska

Lahey Amendments

Revision of last bullet point of section 5.2

Added ECMS_to_FairWarning_Interface.doc

EMC accepted amendments to requirements: AV-3.01, AV-3.02 and AV-5.02

EMC accepted amendments to requirement AV-3.01 for new attribute Amended Record Flag.

Document Release and Approval

Name	Title	Organization	Date

Table of Contents

1.Introduction 4

1.1Purpose of this document 4

1.2Document Scope 4

1.3Techniques used 4

1.4Intended Audience 4

2.Management Summary 5

3.Information Sources and References 6

3.1Stakeholder List 6

3.2References 7

4.Background 8

4.1Business Drivers 8

4.2Business Benefits 8

5.Archive Viewer Requirements Analysis 9

5.1Assumptions 9

5.2Business Objectives 9

5.3In-Scope Requirements for Archive Viewer 9

5.4Out-of-Scope Requirements for Archive Viewer 9

6.Use Cases 11

6.1UC-AV-01: Pass Patient MRN and User Info 12

6.2UC-AV-02: View Patient Archived Data and Content 12

6.3UC-AV-03: View Patient Images 14

7.Requirements 17

7.1Patient Identity 17

7.2Launch Archive Viewer 17

7.3Archive Viewer Display 17

7.4User Actions 19

7.5 Security 20

7.6Privacy 20

7.7Performance 20

7.8Interoperability 21

7.9Look and Feel 21

8.Conditional Requirements 22

9.Requirements Traceability Matrix 23

10.Glossary of Terms 32

11.Appendix Exhibits 33

11.1Exhibit A. Patients with No Archived Records 33

11.2Exhibit B. Archive Viewer Wireframe 34

11.3Exhibit C. Tab Contents 35

11.4Exhibit D. Archive Viewer Wireframe #2 36

11.5Exhibit E. Metadata for Filtering and Sorting 37

11.6Exhibit F. Quick Tips 40

11.7Exhibit G. Fair Warning File Structure 41

11.8Exhibit H. Lahey Marketing Guidelines 42

11.9Exhibit I. Integration Specifications with EPIC Hyperspace 43

Introduction
1. Purpose of this document

The purpose of the document is to define the business requirements for the development of the Clinical Archive Viewer by EMC for Lahey Health.

1. Document Scope

This document encompasses the business requirements identified by Lahey Health as they pertain to the Archive Viewer.

1. Techniques used

The contents of this document were derived from the requirements gathering workshops and follow up review sessions between Lahey Health and EMC project teams.

1. Intended Audience

This document is intended as a guide for end users, system architects and developers when authoring a detailed technical Solution Design Document. As such, this document provides the justification necessary on which to base design criteria. Keeping in mind that these requirements were captured during several iterative discussions between Lahey Health and EMC, reference to technical terms and language will be expanded upon where appropriate.

All the intended parties, especially the subject matter experts, should review and comment on the requirements listed in later sections of this document to ensure that all the business needs are addressed in this document.

Management Summary

Lahey Health has initiated a strategic program to migrate their existing outpatient and inpatient medical record management functions to the Epic EHR platform. The migration to Epic’s EHR platform will support Lahey Health’s goal to unify and simplify the medical record management functions employed by the hospitals affiliated with the Lahey Health system of care. Key to the success of Lahey’s Epic EHR implementation is the requirement to ensure that Lahey has the capability to retain, organize, and access the historical clinical patient data and documents as part of its application rationalization process. In order to achieve that goal, Lahey Health has selected EMC’s InfoArchive platform as its strategic data and document archive platform. To effectively implement EMC’s InfoArchive platform, Lahey will partner with EMC through efforts defined to:

Install, configure, and deploy a scalable, flexible, reliable archiving solution that can efficiently store disparate data and documents loaded in from heterogeneous legacy application systems.
Design, build, test, and deploy applications that can extract, transform, and load in-scope data and documents from legacy application systems and import the in-scope data and documents into the InfoArchive platform
Design, build, test, and deploy a clinically relevant, flexible, scalable, secure, reliable, and auditable user interface (Archive Viewer) to enable the viewing of data and documents that will be stored within the InfoArchive platform.

This document addresses business requirements for the Archive Viewer only (third bullet point).

Information Sources and References
1. Stakeholder List

Stakeholder	Category	Role	Contact Details
Dr. Hongsermeier, Dr. Finkel, Dr. Napolitana, Dr. Esakof	Clinicians / Primary	Primary end users
Joyce Spiegel	IT PMO	Project Management	[email protected]
Patrick Gilman	Lahey IT Infrastructure	Server production, system architecture
Jim Drewett	Lahey IT Security	Ensures that Lahey’s IT security policies are adhered to
Lore Chapman	Epic Project Team	Integration of Archive with Epic
Christine Scott	Epic Data Conversion Team	Extraction of data from source systems
Deb Ash	All Scripts Team	Extraction of patient level data and historical notes
Marianne Rhoades	LCMC Team	Extraction of historical results and notes Extraction of lab results
Paul Reed	ECMS Team	Assist EMC in the extraction, transform, and load of historical data from DCTM Transform and load data from LCMC, Sunquest, IatriScan, and Docutrack
Sue Burgess	Meditech Team	Assist in the ETL process
IatriScan Team	Assist vendor in extraction of historical documents
Lesley Bailey	Centricity Team	Assist in the ETL process
Docutrack Team	Assist in the ETL process
Kathy Morel	Lahey Home Health	Assist in the ETL process
Theresa Pirie, David Murphy, Shelly Graham	HIM Team	Provide guidance on HIM requirements for Release 2
Karen M. Treska	IT PMO	Sr Business Analyst	[email protected]

1. References

Following documents are used as reference or as a basis for deriving the business requirements listed in this document.

Ref Number	Title	Status	Source
1	Archive Viewer Requirements Doc 090914_Version1.1.docx		Lahey Health
2	AV Requirements 2014-09-17.xlsx		EMC
3

Background
1. Business Drivers

Ensure that Lahey has the capability to retain, organize, and access the historical clinical patient data and documents as part of its application rationalization process.

1. Business Benefits

Users are able to access and view historical information from patient’s medical record without logging out of the EPIC system and manually abstracting information from legacy systems
Provide patient-context aware integration with the EPIC system
Present to the clinician patient level historical summary document in CCDA format

Archive Viewer Requirements Analysis

Following is a list of persons who attended the initial requirements gathering workshops conducted at Lahey Health offices August 21st, 2014.

Name	User Group represented
Joyce A. Spiegel	Lahey Health PMO IT
Karen M. Treska	Lahey Health PMO IT
Paul Reed	Lahey Health PMO IT
Stephen Pagana	EMC IIG
Laury Verner	EMC IIG
Madhu Machireddy	EMC IIG
Srinivasa Ravula	EMC IIG
Gani Cortez	EMC IIG

1. Assumptions

Lahey Health Subject Matter Experts and Administrators will provide information/data as required for the analysis, design and development of the Archive Viewer.
Lahey Health will provide a complete wireframe for Archive Viewer that includes all filters, search and sort criteria, columns and tabs and expected behavior.
Lahey Health will provide style guidelines and documentation for the Archive Viewer.
Key personnel will attend relevant workshops and will provide decisions on all matters pertaining to the Archive Viewer.

1. Business Objectives

The Archive Viewer shall integrate with Lahey's E.H.R system, Epic, to provide context-aware patient information.
The Archive Viewer shall present structured and unstructured data.
The Archive Viewer shall organize data and documents in a manner that is easy for the clinician to quickly locate.
The Archive Viewer shall adhere to Lahey Health’s security and privacy standards listed in section 7.5 Security and section 7.6 Privacy of this document and provided that EMC receives in a timely fashion the required specifications for such.

1. In-Scope Requirements for Archive Viewer

Patient identification process
Archive Viewer user interface
Clinical user requirements such as filtering and sorting, etc. that are detailed in the use cases and list of requirements.

1. Out-of-Scope Requirements for Archive Viewer

Extract, Transfer and Load (ETL) of legacy systems
Conversion of both structured and unstructured data and content
Single-Sign-On and URL Obfuscation to launch Archive Viewer.

Viewing of document content which is handled by applications and systems outside of the Archive Viewer. Downloading and viewing of document content are handled by plugins made available by the external applications.
User actions and operations that are performed within the viewed content and not within the Archive Viewer. These operations, examples of which include copying of text, highlighting and printing are operations provided natively by the external applications.
Other requirements listed in the Lahey Health list of requirements that are not listed in this document due to the following:

Unsupported features in the current release of Archive Viewer
Requirements that will affect the timely delivery of the Archive Viewer as per project schedule. These requirements were agreed to be pushed to future release of the Archive Viewer.

Use Cases

Use cases are developed to help derive the requirements of how the Archive Viewer is to be configured and/or customized for Lahey Clinic to display structured and unstructured information kept in the InfoArchive database/repository. Each use case is an operation that needs to be performed in relation to the system, mostly within the system. The use case diagram below describes the interaction between an actor (person, group, role, or external system) and the Archive Viewer use cases. The system boundary box indicates the scope of the system (Archive Viewer). The Pass Patient MRN and User Info is really not in the scope of the Archive Viewer as this is a function of EPIC. It is depicted in the use case diagram below to provide a background of what are required to launch the Archive Viewer. The Download / View Content is a function of the computer operating system and/or third-party application system and thus are not within the scope of the Archive Viewer.

Project :Industry: Security, Manufacturing, Human Resources, Research and Development Services Provided: Project Management, Organizational Change Management Company: The client is a global leader in 1

UC-AV-01: Pass Patient MRN and User Info

Description	Initiate Archive Viewer and passing to the Archive Viewer the patient MRN (or the Enterprise Patient Id) and the details about the EPIC user (such as the EPIC Hyperspace User Id).
Actors	EPIC
Pre-Condition	A patient is selected in EPIC
Post-Condition	Archive Viewer is launched in a separate Internet Explorer browser window
Main Flow	EPIC assembles a URL to launch Archive Viewer with patient MRN and user id The system launches Internet Explorer (or the browser) Internet Explorer invokes Archive Viewer Archive Viewer extracts patient MRN and user id See Alternate Flow 4a. No patient MRN extracted from URL See Alternate Flow 4b. No user id extracted from URL Use case ends
Alternate Flow	4a. No patient MRN extracted from URL Archive Viewer displays a message Use case ends 4b. Archive Viewer unable to extract user id Archive Viewer displays a message Use case ends
Requirements	See Requirements traceability matrix

UC-AV-02: View Patient Archived Data and Content

Description	Use case to search for and view structured (metadata) and unstructured (content) data for a specific patient
Actors	Clinician EMPI InfoArchive System Svcs – Computer application package that opens the document content for viewing
Pre-Condition	Archive Viewer is launched with patient enterprise id (MRN) and the EPIC user’s id
Post-Condition	A clinician is able to search for a patient’s structured and unstructured data from the archive, identify the content s/he is looking for, and view the content. Archive Viewer did not find archived data in InfoArchive and presents a message to the Clinician
Main Flow	Archive Viewer extracts patient MRN and user id Archive Viewer searches for patient legacy ids Archive Viewer queries patient demographic information Archive Viewer queries patient archived information Archive Viewer displays the default active tab and page - ‘Legacy E.H.R. Snapshot’ page See Alternate Flow 5a. No archived information for patient See Alternate Flow 5b. Clinician selects a different tab to search for a document Archive Viewer displays in table form the structured metadata for the selected tab See Alternate Flow 6a. Clinician applies filters to the results See Alternate Flow 6b. Clinician sorts the results See Alternate Flow 6c. Clinician pages through the results Clinician double-click on a document title to view the document See Alternate Flow 7a. Document content is restricted or sensitive See Alternate Flow 7b. Cancel the viewing of the document content System Svcs downloads the content file to the Clinicians computer System Svcs opens the content file for viewing See Alternate Flow 9a. Unable to open the document file Clinician views the content file Clinician closes the content file Clinician is brought back to the Archive Viewer See Alternate Flow 12a. Archive Viewer is not the active window Clinician closes Archive Viewer Archive Viewer prompts the Clinician with message of confirmation to close Archive Viewer Clinician confirms to close Archive Viewer See Alternate Flow 15a. Clinician cancels closing of Archive Viewer System Svcs closes the Archive Viewer and Epic is made the active window See Alternate Flow 16a. Epic is not made the active window Use case ends
Alternate Flow	5a. No archived information for patient Archive Viewer displays a message Use case jumps to step 13 5b. Clinician selects a different tab to search for a document Clinician hovers the mouse over a particular tab to search for a particular document or patient record Archive Viewer displays a brief description of the data included in the particular tab Clinician clicks on a particular tab to select it and make it the active tab Use case continues 6a. Clinician applies filters to the results table Clinician selects a filter criteria from the dynamic filtering options Archive Viewer refreshes the results table to show filtered results Use case continues 6b. Clinician sorts the results Clinician clicks a column heading Archive Viewer re-sorts the results table based on the selected column heading in ascending (default) or descending order. Use case continues 6c. Clinician pages through the results Clinician clicks a page control to view desired page (first, previous, next, last) Archive Viewer refreshes the results table to display rows of data for page Use case continues 7a. Document content is restricted or sensitive Archive Viewer prompts a message that the content is restricted or sensitive and that the attempt is being logged and asks Clinician to enter his/her Lahey employee number Clinician enters his/her employee number Clinician clicks the OK button Use case jumps to step 8 7b. Cancel the viewing of the document content Archive Viewer prompts a message that the content is restricted or sensitive and that the attempt is being logged and asks Clinician to enter his/her Lahey employee number Clinician cancels the viewing of the document content Use case jumps to step 6 9a. Unable to open the document file System Svcs displays a message that no application is configured to open the file Clinician acknowledges the message Use case jumps to step 12 12a. Archive Viewer is not the active window Clinician selects the Archive Viewer browser window in the Windows task bar. System Svcs make Archive Viewer the active window Use case continues 15a. Clinician cancels closing of Archive Viewer Use case jumps to step 6. 16a. Epic is not made the active window Clinician selects Epic browser window in the Windows task bar. Use case continues.
Requirements	See Requirements traceability matrix

1. UC-AV-03: View Patient Images

Description	Use case to search for and view patient clinical images
Actors	Clinician EMPI InfoArchive PACS System System Svcs – Computer application package that downloads and opens the images for viewing
Pre-Condition	Archive Viewer is launched with patient enterprise id (MRN) and the EPIC user’s id Link to the image is available in metadata Radiology report is stored in InfoArchive PACS System is available and online
Post-Condition	A clinician is able to search for a patient’s structured and unstructured data from the archive, identify the content s/he is looking for, and view the content. Archive Viewer did not find archived data in InfoArchive and presents a message to the Clinician
Main Flow	Archive Viewer extracts patient MRN and user id Archive Viewer searches for patient legacy ids Archive Viewer queries patient demographic information Archive Viewer queries patient archived information Archive Viewer displays the default active tab and page - ‘Legacy E.H.R. Snapshot’ See Alternate Flow 5a. No archived information for patient Clinician selects the Imaging tab Archive Viewer displays in table form the structured metadata for the Imaging tab See Alternate Flow 7a. Clinician applies filters to the results See Alternate Flow 7b. Clinician sorts the results See Alternate Flow 7c. Clinician pages through the results Clinician clicks on a document title to view the document See Alternate Flow 8a. Document content is restricted or sensitive See Alternate Flow 8b. Cancel the viewing of the document content System Svcs downloads the content file to the Clinicians computer System Svcs opens the content file for viewing See Alternate Flow 10a. Unable to open the document file Clinician views the content file Clinician closes the content file Clinician is brought back to the Archive Viewer See Alternate Flow 13a. Archive Viewer is not the active window System Svcs displays the Archive Viewer with the Imaging tab as the active tab Clinician double-clicks the image icon System Svcs launches a separate IE browser window to launch the PACS System and display the image Clinician closes the PACS System browser window System Svcs brings the clinician back to the Archive Viewer window Clinician closes Archive Viewer Archive Viewer prompts the Clinician with message of confirmation to close Archive Viewer Clinician confirms to close Archive Viewer See Alternate Flow 21a. Clinician cancels closing of Archive Viewer System Svcs closes the Archive Viewer and Epic is made the active window See Alternate Flow 22a. Epic is not made the active window Use case ends
Alternate Flow	5a. No archived information for patient Archive Viewer displays a message Use case jumps to step 19 7a. Clinician applies filters to the results table Clinician selects a filter criteria from the dynamic filtering options Archive Viewer refreshes the results table to show filtered results Use case continues 7b. Clinician sorts the results Clinician clicks a column heading Archive Viewer re-sorts the results table based on the selected column heading in ascending (default) or descending order. Use case continues 7c. Clinician pages through the results Clinician clicks a page control to view desired page (first, previous, next, last) Archive Viewer refreshes the results table to display rows of data for the page Use case continues 8a. Document content is restricted or sensitive Archive Viewer prompts a message that the content is restricted or sensitive and that the attempt is being logged and asks Clinician to enter his/her Lahey employee number Clinician enters his/her employee number Clinician clicks the OK button Use case jumps to step 9 8b. Cancel the viewing of the document content Archive Viewer prompts a message that the content is restricted or sensitive and that the attempt is being logged and asks Clinician to enter his/her Lahey employee number Clinician cancels the viewing of the document content Use case jumps to step 7 10a. Unable to open the document file System Svcs displays a message that no application is configured to open the file Clinician acknowledges the message Use case jumps to step 13 13a. Archive Viewer is not the active window Clinician selects the Archive Viewer browser window in the Windows task bar. System Svcs make Archive Viewer the active window Use case continues 21a. Clinician cancels closing of Archive Viewer Use case jumps to step 13. 22a. Epic is not made the active window Clinician selects Epic browser window in the Windows task bar. Use case continues.
Requirements	See Requirements traceability matrix

Requirements
1. Patient Identity

Related Requirements
AV-1.01	The archive shall have the ability to search historical medical records containing site-specific patient medical record numbers using the updated enterprise medical record numbers in Epic.
AV-1.02*	The archive shall have the ability to reference an alias table in order to identify patients that have been merged post ingestion.	Requires a post-ETL alias table that indicates for each MRN the alias MRN's. The Archive Search will have to be repeated for each alias. May affect performance. Lahey will create and maintain this alias mapping table. Note that there are two tables needed: one for pre-ETL and one for post-ETL. The Merge comes from EPIC.

1. Launch Archive Viewer

Related Requirements
AV-2.01	End-users shall be required to select a patient in Epic prior to launching the Archive Viewer.
AV-2.02	End-users shall be required to select a new patient in Epic and then re-launch the Archive Viewer. They shall not be permitted to change patients within the Archive Viewer.	AV does not provide a way to enter a new patient ID and open a new session for that patient.
AV-2.03	For patients with no data in the archive, the Archive Viewer shall open to display a message reading, “This patient does not have any archived records.” Please see Exhibit A: Patients with No Archived Records.	Note that this requirement implies that all data must be stored in on-line storage. Finalize content of message

1. Archive Viewer Display

Related Requirements
AV-3.01*	The Archive Viewer shall display a header containing the Lahey Health logo and patient demographics including: 1. Patient Name 2. Patient Medical Record Number 3. Patient Date of Birth 4. Patient Address Line 1 5. Patient Address Line 2 6. Patient City, State and Zip 7. Patient Country 8. Secure Data Flag 9. Amended Record Flag Please see Exhibit B : Archive Viewer Wireframe	Ok, provided that this data is made available to the viewer. Integration spec with EMPI is missing
AV-3.02	Documents shall be arranged in a tabular structure consisting of 14 tabs including: 1. Legacy E.H.R. Snapshot 2. Past Visits 3. Notes 4. Operating/Procedure Notes 5. Labs 6. Pathology 7. Imaging 8. Cardiology 9. Diagnostic Procedures 10. Orders 11. Outside Records 12. Historical Abstracts 13. Admin/Legal 14. Other
AV-3.03	The Archive Viewer shall display the document count on each tab. The document count shall be in parenthesis following the tab name as shown in Exhibit B : Archive Viewer Wireframe	This requirement incurs two types of risk. The first is schedule risk, as this feature introduces additional complexity into the architecture and will have to be designed, developed, and tested. The second is performance risk. since these counts will have to be dynamically calculated. The tab counts cannot be cached.
AV-3.04	The Archive Viewer shall indicate that there are no records in a tab by displaying the tab name followed by a 0 in parenthesis. For example: Notes (0).
AV-3.05	Documents within each tab shall be organized into a table in which each row contains consists of metadata and a document link (see Exhibit D: Archive Viewer Wireframe #2).
AV-3.06	Users shall have the ability to open a document by selecting the document title.
AV-3.07	The Archive Viewer shall display various filters utilizing key metadata (Exhibit D: Archive Viewer Wireframe #2) on the left side of the Archive Viewer.
AV-3.08	The metadata available for filtering shall be different for each tab as specified in Exhibit E: Metadata for Filtering & Sorting.
AV-3.09	Any filter options associated with a date (encounter date of service or scan date) shall be presented by year rather than the actual date.
AV-3.10	Users shall have the ability to expand or collapse filter categories.	Initial state will be collapsed
AV-3.11	Users shall have the ability to sort documents by clicking on column titles.	Default sort order will be Date of Service. Lahey will specify any exceptions to this rule.
AV-3.12	The columns available for sorting data shall be different on each tab as specified in Exhibit E: Metadata for Filtering & Sorting.
AV-3.13	The Archive Viewer shall default to the “Legacy EHR Snapshot” tab upon launch of the viewer.
AV-3.14	Within each tab the user will be able to navigate to the First page, the Last page, the Next page, or the Previous page.
AV-3.15	The Archive Viewer shall display “Quick Tips” when the end-user hovers over a tab as shown in Exhibit E: Quick Tips. Lahey will provide the text for Quick Tips.

1. User Actions

Related Requirements
AV-4.01	When the user clicks on a tab, a table of documents along with meta-data shall be displayed (See Exhibit D: Archive Viewer Wireframe #2).
AV-4.02	When the user clicks on the document title, the document shall be displayed.
AV-4.03	Users shall have the ability to open archived links; for example, to view medical images in external applications	Will also support URL composition at runtime (thereby allowing servers to be changed)
AV-4.04	Users shall have the ability to dynamically filter data rows based on key metadata as predefined for each tab (See Exhibit E: Metadata for Filtering & Sorting).	Filtering is applied on the rows of the results table.
AV-4.05	Users shall have the ability to re-sort rows by clicking on a column title.
AV-4.06	When a user filters data within a tab, the data shall remain filtered until the user removes the filter.	Only applies within a single client session, if the user closes the browser or the application is reloaded within the same browser the filters will not be retained.
AV-4.07	When a user sorts data within a tab, the data shall remain sorted, even if the user leaves and then re-enters the tab, until the user re-sorts the data.	Only applies within a single client session, if the user closes the browser or the application is reloaded within the same browser the sort orders will not be retained.
AV-4.08	A user shall have the ability to open more than one document within the Archive Viewer.	Depending on the capability of the third-party application used for viewing the content, they must be able to display multiple documents.

Security

Related Requirements
AV-5.01	Users shall be restricted to read-only access to documents.
AV-5.02	The Archive Viewer session shall time-out after a period of non-activity. This time period shall be configurable.	Default time-out period is 15 minutes.
AV-5.03	If a user attempts to access the Archive Viewer after it has timed-out, the Archive Viewer shall display a message reading, “Your Archive session has timed-out. Please re-launch the Archive Viewer.”
AV-5.04	Lahey Health shall have the ability to add High Availability to the Archive Viewer at any time.

Privacy

Related Requirements
AV-6.01	The Archive Viewer shall audit user activity at the patient and document level.
AV-6.02*	The Archive Viewer shall provide a text file of the audit log data consistent with the file layout required by the Fair Warning system (See Exhibit F: Fair Warning File Structure).	Pending EMC review of Fair Warning File Structure Need Fair Warning File Structure
AV-6.03	The audit log file shall be generated on a daily basis.	Schedule will be configurable
AV-6.04*	Specific data and documents shall be identified as “sensitive” based on criteria to be provided by Lahey. Sensitive data will include any data related to behavioral health or treatment provided to Lahey colleagues.	Lahey to specify criteria for which documents are sensitive.
AV-6.05	Upon opening a document identified as sensitive or restricted, the Archive Viewer shall display a warning to the user reading, “Caution. You are about to view sensitive patient information.”	Will be applied for each sensitive document Clinician will know from Epic that a patient is a colleague. Will it be necessary for AV to remind the clinician of that fact?
AV-6.06	Upon opening a document identified as sensitive or restricted, the Archive Viewer shall request entry of the user’s Lahey employee number and reason for viewing the document.	Note that Lahey Employee Number is different from MRN.
AV-6.07	The user’s reason for viewing a restricted document shall be limited to 100 characters.

Performance

Related Requirements
AV-7.01	Upon selection of the Lahey Archive button, the Archive Viewer shall launch within 5 seconds.	EMC will strive to achieve these performance goals. However, actual performance values depend on how fast Epic generates the url, how fast the browser launches, how fast the network is. EMC cannot take responsibility for those aspects of the performance.
AV-7.02	Documents shall be re-sorted upon user selection of the column title within 3 seconds	EMC will strive to achieve these performance goals. However, actual performance values depend on the hardware of both servers and clients and how fast the network is. EMC cannot take responsibility for those aspects of the performance.
AV-7.03	Filtered search results shall be displayed within 3 seconds of filter criteria selection.	EMC will strive to achieve these performance goals. However, actual performance values depend on on the hardware of both servers and clients and how fast the network is. EMC cannot take responsibility for those aspects of the performance.

1. Interoperability

Related Requirements
AV-8.01	The archive application shall be compatible with IE10
AV-8.02	The archive application must be compatible with Citrix XenApp

1. Look and Feel

Related Requirements

AV-9.01

The design of the Archive Viewer will use the color palette and text styles approved by Lahey Health's marketing department.

See attached document, “Lahey Marketing Guidelines.”

* Conditional requirement.

Conditional Requirements

The following requirements are conditionally accepted pending the availability and release of relevant documentation by Lahey Health to the EMC project team. EMC realizes the importance of these requirements but they are dependent on specifications unknown to the EMC project team and may contain additional complexities that affects the design and development of the Archive Viewer.

Requirement			Missing Relevant Documentation
AV-1.02	The archive shall have the ability to reference an alias table in order to identify patients that have been merged post ingestion.	Integration specifications with the patient id merge table (alias table).
AV-3.01	The Archive Viewer shall display a header containing the Lahey Health logo and patient demographics including: 1. Patient Name 2. Patient Medical Record Number 3. Patient Date of Birth 4. Patient Address Line 1 5. Patient Address Line 2 6. Patient City, State and Zip 7. Patient Country 8. Secure Data Flag 9. Amended Record Flag Please see Exhibit B : Archive Viewer Wireframe	Integration specifications with EMPI or applicable sources of patient demographic details.
AV-6.02	The Archive Viewer shall provide a text file of the audit log data consistent with the file layout required by the Fair Warning system (See Exhibit F: Fair Warning File Structure).	Fair Warning File Structure
AV-6.04	Specific data and documents shall be identified as “sensitive” based on based on criteria to be provided by Lahey. Sensitive data will include any data related to behavioral health or treatment provided to Lahey colleagues.	Lahey to specify the criteria for which documents are sensitive

Requirements Traceability Matrix

APPLICABLE
USE CASES

REQ
NUMBER

DEFINED REQUIREMENTS FOR ARCHIVE VIEWER

LAHEY SOURCE REQUIREMENTS

CONFIGURED
/ CODED

TEST SCRIPT
DEVELOPED

TESTED /
DEMO'ED

COMMENTS AND NOTES

UC-AV-01

UC-AV-02

UC-AV-03

PATIENT IDENTITY

AV-1.01

The archive shall have the ability to search historical medical records containing site-specific patient medical record numbers using the updated enterprise medical record numbers in Epic.

1.01

AV-1.02

The archive shall have the ability to reference an alias table in order to identify patients that have been merged post ingestion.

1.02

Requires a post-ETL alias table that indicates for each MRN the alias MRN's. The Archive Search will have to be repeated for each alias. May affect performance.
Lahey will create and maintain this alias mapping table. Note that there are two tables needed: one for pre-ETL and one for post-ETL.
The Merge comes from EPIC.

LAUNCH ARCHIVE VIEWER

AV-2.01

End-users shall be required to select a patient in Epic prior to launching the Archive Viewer.

2.02

AV-2.02

End-users shall be required to select a new patient in Epic and then re-launch the Archive Viewer. They shall not be permitted to change patients within the Archive Viewer.

2.03

AV does not provide a way to enter a new patient ID and open a new session for that patient.

AV-2.03

For patients with no data in the archive, the Archive Viewer shall open to display a message reading, “This patient does not have any archived records.” Please see Exhibit A: Patients with No Archived Records.

2.05

Note that this requirement implies that all data must be stored in on-line storage.
Finalize content of message

ARCHIVE VIEWER DISPLAY

AV-3.01*

The Archive Viewer shall display a header containing the Lahey Health logo and patient demographics including:
1. Patient Name
2. Patient Medical Record Number
3. Patient Date of Birth
4. Patient Address Line 1
5. Patient Address Line 2
6. Patient City, State and Zip
7. Patient Country

8. Secure Data Flag

9. Amended Record Flag
Please see Exhibit B : Archive Viewer Wireframe

3.01

Ok, provided that this data is made available to the viewer. Integration spec with EMPI is missing

AV-3.02

Documents shall be arranged in a tabular structure consisting of 14 tabs including:
1. Legacy E.H.R. Snapshot
2. Past Visits
3. Notes
4. Operating/Procedure Notes
5. Labs
6. Pathology
7. Imaging
8. Cardiology
9. Diagnostic Procedures
10. Orders
11. Outside Records
12. Historical Abstracts
13. Admin/Legal
14. Other

3.02

AV-3.03

AV-3.03 The Archive Viewer shall display the document count on each tab. The document count shall be in parenthesis following the tab name as shown in Exhibit B : Archive Viewer Wireframe

3.03

This requirement incurs two types of risk. The first is schedule risk, as this feature introduces additional complexity into the architecture and will have to be designed, developed, and tested. The second is performance risk. since these counts will have to be dynamically calculated. The tab counts cannot be cached.

AV-3.04

The Archive Viewer shall indicate that there are no records in a tab by displaying the tab name followed by a 0 in parenthesis. For example: Notes (0).

3.04

AV-3.05

Documents within each tab shall be organized into a table in which each row contains consists of metadata and a document link (see Exhibit D: Archive Viewer Wireframe #2).

3.05

AV-3.06

Users shall have the ability to open a document by selecting the document title.

3.06

AV-3.07

The Archive Viewer shall display various filters utilizing key metadata (Exhibit D: Archive Viewer Wireframe #2) on the left side of the Archive Viewer.

3.07

AV-3.08

The metadata available for filtering shall be different for each tab as specified in Exhibit E: Metadata for Filtering & Sorting.

3.08

AV-3.09

Any filter options associated with a date (encounter date of service or scan date) shall be presented by year rather than the actual date.

3.09

AV-3.10

Users shall have the ability to expand or collapse filter categories.

3.10

Initial state will be collapsed

AV-3.11

Users shall have the ability to sort documents by clicking on column titles.

3.11

Default sort order will be Date of Service. Lahey will specify any exceptions to this rule.

AV-3.12

The columns available for sorting data shall be different on each tab as specified in Exhibit E: Metadata for Filtering & Sorting.

3.12

AV-3.13

The Archive Viewer shall default to the “Legacy EHR Snapshot” tab upon launch of the viewer.

3.13

AV-3.14

Within each tab the user will be able to navigate to the First page, the Last page, the Next page, or the Previous page.

3.14

AV-3.15

The Archive Viewer shall display “Quick Tips” when the end-user hovers over a tab as shown in Exhibit E: Quick Tips. Lahey will provide the text for Quick Tips.

3.15

USER ACTIONS

AV-4.01

When the user clicks on a tab, a table of documents along with meta-data shall be displayed (See Exhibit D: Archive Viewer Wireframe #2).

5.01

AV-4.02

When the user clicks on the document title, the document shall be displayed.

5.02

AV-4.03

Users shall have the ability to open archived links; for example, to view medical images in external applications

5.07

Will also support URL composition at runtime (thereby allowing servers to be changed)

AV-4.04

Users shall have the ability to dynamically filter data rows based on key metadata as predefined for each tab (See Exhibit E: Metadata for Filtering & Sorting).

5.08

Filtering is applied on the rows of the results table.

AV-4.05

Users shall have the ability to re-sort rows by clicking on a column title.

5.09

AV-4.06

When a user filters data within a tab, the data shall remain filtered until the user removes the filter.

5.10

Only applies within a single client session, if the user closes the browser or the application is reloaded within the same browser the filters will not be retained.

AV-4.07

When a user sorts data within a tab, the data shall remain sorted, even if the user leaves and then re-enters the tab, until the user re-sorts the data.

5.11

Only applies within a single client session, if the user closes the browser or the application is reloaded within the same browser the sort orders will not be retained.

AV-4.08

A user shall have the ability to open more than one document within the Archive Viewer.

5.12

Depending on the capability of the third-party application used for viewing the content, they must be able to display multiple documents.

SECURITY

AV-5.01

Users shall be restricted to read-only access to documents.

6.03

AV-5.02

The Archive Viewer session shall time-out after a period of non-activity. This time period shall be configurable.

6.05

Default time-out period is 15 minutes.

AV-5.03

If a user attempts to access the Archive Viewer after it has timed-out, the Archive Viewer shall display a message reading, “Your Archive session has timed-out. Please re-launch the Archive Viewer.”

6.06

AV-5.04

Lahey Health shall have the ability to add High Availability to the Archive Viewer at any time.

6.08

PRIVACY

AV-6.01

The Archive Viewer shall audit user activity at the patient and document level.

7.01

AV-6.02*

The Archive Viewer shall provide a text file of the audit log data consistent with the file layout required by the Fair Warning system (See Exhibit F: Fair Warning File Structure).

7.02

Pending EMC review of Fair Warning File Structure
Need Fair Warning File Structure

AV-6.03

The audit log file shall be generated on a daily basis.

7.03

Schedule will be configurable

AV-6.04*

Specific data and documents shall be identified as “sensitive” based on criteria to be provided by Lahey. Sensitive data will include any data related to behavioral health or treatment provided to Lahey colleagues.

7.04

Lahey to specify criteria for which documents are sensitive.

AV-6.05

Upon opening a document identified as sensitive or restricted, the Archive Viewer shall display a warning to the user reading, “Caution. You are about to view sensitive patient information.”

7.05

Will be applied for each sensitive document
Clinician will know from Epic that a patient is a colleague. Will it be necessary for AV to remind the clinician of that fact?

AV-6.06

Upon opening a document identified as sensitive or restricted, the Archive Viewer shall request entry of the user’s Lahey employee number and reason for viewing the document.

7.06

Note that Lahey Employee Number is different from MRN.

AV-6.07

The user’s reason for viewing a restricted document shall be limited to 100 characters.

7.07

PERFORMANCE

AV-7.01

Upon selection of the Lahey Archive button, the Archive Viewer shall launch within 5 seconds.

8.01

EMC will strive to achieve these performance goals. However, actual performance values depend on how fast Epic generates the url, how fast the browser launches, how fast the network is. EMC cannot take responsibility for those aspects of the performance.

AV-7.02

Documents shall be re-sorted upon user selection of the column title within 3 seconds

8.02

AV-7.03

Filtered search results shall be displayed within 3 seconds of filter criteria selection.

8.03

INTEROPERABILITY

AV-8.01

The archive application shall be compatible with IE10

9.01

AV-8.02

The archive application must be compatible with Citrix XenApp

9.02

LOOK AND FEEL

AV-9.01

The design of the Archive Viewer shall adhere to the color palette and text styles approved by Lahey Health's marketing department.
See attached document, “Lahey Marketing Guidelines.”

10.01

NUMBER OF
REQUIREMENTS

*Note that these requirements are conditionally accepted pending the availability and release of relevant documentation by Lahey Health to the EMC project team. EMC realizes the importance of these requirements but they are dependent on specifications unknown to the EMC project team and may contain additional complexities that affects the design and development of the Archive Viewer.

Glossary of Terms

Term	Definition / Context
InfoArchive	EMC software that archives data
Archive Viewer	Browser-based application that presents archived information to the user
EPIC	EPIC Hyperspace
EMPI
Clinician	A user of the EPIC Hyperspace and Archive Viewer applications
System Svcs	Third-party application software that provides services. This include, but not limited to, operating system services, services provided by hardware, network, application packages installed in the computer such as MS Office, Acrobat Reader, etc.

Appendix Exhibits
1. Exhibit A. Patients with No Archived Records

1. Exhibit B. Archive Viewer Wireframe

Exhibit C. Tab Contents

Cnt	Tab	Contents
01	Legacy EHR Snapshot	Current and Past Medical Problems, Surgical History, Medications, Immunizations, Allergies, Family History, Social History and Vitals.
02	Past Visits	List of past inpatient admissions, outpatient visits, and emergency room visits
03	Notes	Assessments, Consults, Discharge Reports, Nursing Notes, Other Notes.
04	Operating/Procedural Notes	Operating Notes, Procedural Notes
05	Labs	Hematology, Microbiology, Chemistry, Immunology, Urinalysis, Endocrine Tests
06	Pathology	Anatomical pathology, cytology
07	Imaging	CT Scans, Diagnostic Radiology, MRI/MRA, Nuclear Med, Ultrasounds
08	Cardiology	EKG, Echo, EP Lab, Other Cardiac
09	Diagnostic Procedures	Pulmonary Results, Neurology results, Other Diagnostic Testing
10	Orders	Scanned Orders
11	Outside Records	Outside Records
12	Historical Archives	Abstracted Archives
13	Legal/Administrative	Advance Directives, DNR, Consents
14	Other	Correspondence, Flow Sheets, Patient Instructions, Plan of Care,

Exhibit D. Archive Viewer Wireframe #2

Exhibit E. Metadata for Filtering and Sorting

Tab Name	Filter Options	Columns Titles (Sorting)
Legacy EHR Snapshot	Location	Document Title Location Practice
Past Visits	Visit Type Provider Name Department/Specialty Visit DOS (By year) Location Practice Location	Visit Type Provider Name Department/Specialty Visit Date of Service Location Practice Location
Notes	Location Note Type Department Encounter DOS (By Year) Provider	Note Title Note Type Department Encounter DOS Provider Location
Operating/Procedure Notes	Location Note Type Department Encounter DOS (By Year) Provider	Note Title Note Type Department Encounter DOS Provider Location
Labs	Location Lab Type Specimen Type Encounter DOS (By Year) Ordering Provider	Lab Title Lab Type Specimen Type Encounter DOS Ordering Provider Location
Pathology	Location Lab Type Specimen Type Encounter DOS (By Year) Ordering Provider	Lab Title Lab Type Specimen Type Encounter DOS Ordering Provider Location
Imaging	Location Image Type Encounter DOS (By Year) Provider	Report Title Image Type Encounter DOS Provider Location Image Link (If needed)
Cardiology	Location Report Type Encounter DOS (By Year) Provider	Report Title Report Type Encounter DOS Provider Location Image Link (If needed)
Diagnostic Procedures	Location Report Type Department Encounter DOS (By Year) Provider	Report Title Report Type Department Encounter DOS Provider Location
Orders	Location Department Scan Date (By Year) Provider	Document Title Department Scan Date Provider Location
Outside Records	Location Encounter Date (By Year) Scan Date (By Year)	Document Title Encounter Date Scan Date Location
Historical Archives	Location Document Type (Child Folder) Encounter Date (By Year) Scan Date (By Year)	Document Title Document Type (Child Folder) Encounter Date Scan Date Location
Admin/Legal	Location Document Type (Child Folder) Scan Date (By Year)	Document Title Document Type (Child Folder) Scan Date Location
Other	Location NoteType Department Encounter DOS (By Year) Provider	Note Title Note Type Department Encounter DOS Provider Location

Exhibit F. Quick Tips

1. Exhibit G. Fair Warning File Structure

1. Exhibit H. Lahey Marketing Guidelines

1. Exhibit I. Integration Specifications with EPIC Hyperspace