Drafted SOW.docx

STATEMENT OF WORK

Location: Palo Alto HCS 3801 Miranda Avenue Palo Alto, CA 94304

PraediGene H5N1 Module

1. Requirements:

The VHA public health reference laboratory (PHRL) has a requirement for the purchase of one (1) license for twelve months of PraediGene H5N1 Module to add to our existing, PraediGene Bronze COTS product.

The PHSR has been providing clinical laboratory testing for Veterans since 2014, and public health investigation laboratory services since 2009. PHRL is located at the VA Palo Alto Health Care System and is a high-complexity, CLIA-licensed laboratory offering validated assays for clinical care and public health investigations. PHRL participates in College of American Pathologists (CAP) proficiency testing and is accredited by CAP. PHRL also participates in proficiency testing through the CDC (e.g., influenza, dengue or norovirus testing) and is aligned with the CDC-sponsored Laboratory Response Network (LRN) that support the nation’s public health efforts. PHRL is the VA National COVID-19 Sequencing Laboratory.

PHRL serves as the VA’s primary reference microbiology laboratory to test for, and aid in the diagnosis of unusual pathogens; confirm atypical laboratory test results; test epidemiologically significant specimens with potential public health implications; and test for infectious diseases of public health consequence that are too rare or unusual for other laboratories to maintain testing capacity. In March of 2016, PHRL became a member of the VA National Reference Laboratory Network (NRLN).

Laboratory Workflow Add On Module

The PraediGene H5N1 Module is an optional module seamlessly integrated with Bitscopic's PraediGene Laboratory Workflow Tool.

As with all tools in the PraediGene Library, once entered into the PraediGene H5N1 Module, work items are immediately available to all users for tracking, DNA analysis, report generation, and generic workflow activities. With PraediGene, the H5N1 Module has the ability to associate and retrieve patient information directly from EHR systems. The DNA analysis features automatically predict and report resistance mutations given the organism’s genetic sequence. To ease reporting and transcription requirements, it is also able to generate “EHR friendly” input.

This is a Non-IT procurement Item Number 41, Direct Medical Diagnostic or Treatment System (Purchased Commercial Off The Shelf [COTS] Software used for purposes of direct patient care), VA Directive 6008, Appendix A, November 2, 2017.

The PraediGene H5N1 Module includes:

· Rules-based, configurable resistance sequence analysis (oncology)

· PIV & Active Directory login integration

· Role-Based Access Control

· Web-based installation, cloud-ready, modest hardware requirements

· TRM approval / running in VA

· VistA R/W capability

· Can run stand-alone (i.e. no EMR integration – H5N1 features only)

· HL7 support, integration with VistA HL7, etc.

· Financial components:

· granular invoicing capabilities (site, VISN, user-definable accounting, etc)

· generate "master invoices" per VA requirements

· commercial lab cost comparison feature

· Quality Control checks on results

· Configurable workflow support (e.g. new test -> pending -> results available -> completed)

· Advanced analytics & querying capabilities w/ mapping support

· Print & download/export functionality

· Bulk import functionality

· Ability to Integrate with clinical trials tools

· Lab performance measure reports (e.g. Turn-Around-Time)

· Barcode scan

· Integration with PraediGene

· 508 compliance

Purchase of PraediGene H5N1 Module will allow the PHRL to receive software patches and updates, licensing, and software maintenance as needed. The contractor shall provide support in accordance with its GSA Schedule for the PraediGene COTS software which is as follows:

Twelve months of (1) PraediGene H5N1 Module

2. Type of Contract: Firm Fixed Price (FFP)

3. Period of Performance for Base Year: The Period of Performance shall estimate to begin August 30, 2024.

4. Shipping Instructions:

The Contractor shall deliver all software maintenance no later than 30 days from receipt of order.

Inspection: Destination Acceptance: Destination Free on Board (FOB): Destination

Ship To :