LRI+CLIA+Compliance+Tool+Software+Requirements+Specification

include component="page" wikiName="siframework" page="LRI Header" toc =**1. Introduction**=

__**1.1 Purpose**__
The purpose of this Software Requirements Specification (SRS) is to define and narrow the scope and purpose of the LRI CLIA Compliance Tool. The intended audience for this SRS are the members and participants of the ONC S&I Initiative LRI Validation Suite WG.

__**1.2 Scope**__
(1) The name of the software product described herein is the “LRI CLIA Compliance Tool”. (2) The LRI CLIA Compliance Tool will be able to ascertain whether LIS <==> EHR HL7 v2 messaging occurs in a CLIA-compliant fashion. The results of this ascertainment will be displayed visually. (3) For paperless EHRs, the LRI CLIA Compliance Tool will be able to examine the text displayed on the computer monitor of the EHR, and programmatically ascertain whether the displayed text string contains all of the terms required by the CLIA regulations.

__**1.3 Definitions, Acronyms, and Abbreviations**__

 * CLIA || Clinical Laboratory Improvement Amendments ||
 * HL7 || Health Level 7 ||
 * LIS || Lab information System ||
 * LRI || Lab Results Interface ||
 * MLLP || Minimal Lower Layer Protocol ||
 * NHIN || Nationwide Health Information Network ||
 * ONC || Office of the National Coordinator ||
 * S&I || Standards and Interoperability ||

__**1.4 References**__

 * **Reference** || **Date Added** || **Reference Description** ||
 * [] || 8/1/2011 || CLIA memo:Revised Interpretive Guidelines for EHRs ||
 * [|42 CFR §493.1291] || 8/1/2011 || CLIA Lab Test Report Standard ||
 * [|CLIA Update with EHR’s & Personnel --2011] || 8/1/2011 || Slide presentation by Judith Yost, Dir., Div. Lab Services CMS(CLIA) ||
 * [|HAPI - Free and open-source HL7 Java Parser and Library] || 8/3/2011 || Java API that may be useful in the tool design ||

__**1.5 Overview**__
The LRI Initiative is an ONC-NHIN S&I Initiative that will deliver a ballotable HL7 v2 Implementation Guide (IG). Once the LRI is approved, it is expected that usage of it will be made a part of Stage 2 Meaningful Use.

=**2. The Overall Description**=

__2.1.1 System Interfaces__
The LRI CLIA Compliance Tool will interface with LIS software systems and EHR software systems.

__2.1.2 Interfaces__
The LRI CLIA Compliance Tool will interface with its end users through the production of CLIA Compliance reports. These reports will be viewable by the end-user as PDF report documents, which will summarize in a check-list which of the CLIA requirements have been met.

__2.1.3 Hardware Interfaces__
The LRI CLIA Compliance Tool is designed to be deployable to a dedicated server. Inasmuch as it's expected to be 100% Java, any server capable of hosting Java 6 will be sufficient.

__2.1.4 Software Interfaces__
The LRI CLIA Compliance Tool is expected to be 100% Java.

__2.1.5 Communications Interfaces__
The LRI CLIA Compliance Tool is designed to communicate with LISs and EHRs under test using the MLLP protocol (both as sender and receiver). Standard MLLP ports will need to be opened to the Internet.

__2.1.6 Memory Constraints__
None. Standard default Java memory settings should suffice.

__2.1.7 Operations__
LRI CLIA Compliance Tool is designed to operate as a service. Running the service as a daemon will be an option.

__2.1.8 Site Adaptation Requirements__
None

__**2.2 Product Functions**__
The LRI CLIA Compliance Tool will have a string search function, that will be capable of searching an EHR visual display text string for CLIA-required elements. The LRI CLIA Compliance Tool will have a CLIA requirement extraction function, which will take as input an HL7 v2 ORU R01 message (e.g., one received from an LIS through MLLP), and will be able to generate a set of CLIA required data strings. The LRI CLIA Compliance Tool will be able to determine whether the set of CLIA required data strings are present in the EHR visual display text string.

__**2.3 User Characteristics**__
The LRI CLIA Compliance Tool will have a web-based graphical user interface. It will also provide a PDF user interface, through the ability to display LRI CLIA Compliance Reports as PDF documents (either displayed in a browser, or displayed in a standalone PDF viewer such as Acrobat Reader).

__**2.4 Constraints**__
Since the LRI CLIA Compliance Tool will communicate with LISs and EHRs using HL7 v2 messaging, it will be constrained to send and receive only valid HL7 v2 messages, and will need to comply with the Messaging Standard Version 2.5.1.

__**2.5 Assumptions and Dependencies**__
It is assumed the the LIS under test will be designed or customized to have the ability to send HL7 v2 messages to the LRI CLIA Compliance Tool, and will have the capability of constructing the appropriate custom HL7 v2 messages for the LRI CLIA Compliance Tool.

It is assumed the the EHR under test will be designed or customized to have the ability to send HL7 v2 messages to the LRI CLIA Compliance Tool, and will have the capability of contructing the appropriate custom HL7 v2 messages for the LRI CLIA Compliance Tool (e.g., HL7 v2 messages containing the EHR visual display text string).

=**3. Specific Requirements**=

__**3.1 External Interfaces**__
The LRI CLIA Compliance Tool will interface with the LIS and EHR under test through the MLLP protocol (both as sender and receiver). The LRI CLIA Compliance Tool will interface with the end-user through a web-interface, and through the generation of PDF files.

__**3.2 Functions**__
TBD

__**3.3 Performance Requirements**__
There may be performance issues if the LRI CLIA Compliance Tool undergoes heavy server load (e.g., if 1000s of HL7 messages are sent and received). Standard Java load tools (e.g., JMeter) will be used to determine whether there should exist specific perfomance requirements.

__**3.4 Logical Database Requirements**__
The current design envisions a database persistence layer off the LRI CLIA Compliance Tool.

__**3.5 Design Constraints**__
TBD

__3.5.1 Standards Compliance__
The LRI CLIA Compliance Tool will have to comply with HL7 Messaging Standard v2, and with the LRI Implementation Guide. The GUI will need to be 508-compliant.

__**3.6 Software System Attributes**__
TBD

__3.6.1 Reliability__
The LRI CLIA Compliance Tool is not expected to be mission critical: it needs to be accurate in its reporting. Software QA will test and ensure this reliability.

__3.6.2 Availability__
The LRI CLIA Compliance Tool is not expected to be mission critical: high levels of ensured availability will not be required.

__3.6.3 Security__
The LRI CLIA Compliance Tool may send and receive PHI. If actual HIPAA covered PHI data is handled (as opposed to dummy data), then appropriate security will be required.

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