36C24923Q0308.pdf

PAGE 1 OF1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C24923Q0308 05-25-2023

Tina Parker 615-255-6454 06-30-2023

10:00 AM CDT

Department of Veterans Affairs Network Contracting Office 9 (90C)

NCO 9

1639 Medical Center Parkway, Suite 400 Murfreesboro TN 37129

X

541519

$34 Million

NET 30 N/A

X

Department of Veterans Affairs VA Medical Center, Nashville Campus 1310 24th Avenue South

Nashville TN 37129

90C

Network Contracting Office 9 Department of Veterans Affairs Network Contracting Office (90C) 1639 Medical Center Parkway Suite 400 Murfreesboro TN 37129

90C

FSC e-Invoicing Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 Invoice must be submitted electronically

Setup 1-877-489-6135

See CONTINUATION Page

1 year contract for a Turnkey Stem Cell Processing Software for Nashville VA Medical Center, Nashville Campus 1310 24th Avenue South Nashville, TN 37212-2637.

Period of Performance 08-1-2023 to 7-31-2024.

Contractors MUST be registered in Vendor Information Page at time quotes are received AND at the time of Contract Award.

See CONTINUATION Page

X X

36C24923Q0308

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES

A.2 CONTRACT ADMINISTRATION DATA

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 PRICE/COST SCHEDULE

ITEM INFORMATION

B.2 Statement of Work

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (DEC 2022)

C.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

C.3 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.4 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

C.5 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018)

C.6 VAAR 852.239-70 SECURITY REQUIREMENTS FOR INFORMATION TECHNOLOGY RESOURCES

(FEB 2023)

C.7 VAAR 852.239-71 INFORMATION SYSTEM SECURITY PLAN AND ACCREDITATION (FEB 2023)

C.8 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.9 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAR 2023)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (MAR 2023)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.4 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

ADDENDUM to 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (DEC 2022)

A.2 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C249

Department of Veterans Affairs

Network Contracting Office 9 (90C)

NCO 9

1639 Medical Center Parkway, Suite 400

Murfreesboro TN 37129

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[X] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly in arrears.

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1.00 EA __________________ ________________

Biotherapies Lab Full System - Initial Site License PRINCIPAL NAICS CODE: 541519 - Other Computer Related Services PRODUCT/SERVICE CODE: Q702 - Technical Medical Support - Medical logistics, biomedical equipment, occupational/public health, medical supply, medical readiness.

LOCAL STOCK NUMBER: N/A

0002 1.00 EA __________________ ________________

Biotherapies Lab System Validation Scripts PRINCIPAL NAICS CODE: 541519 - Other Computer Related Services PRODUCT/SERVICE CODE: Q702 - Technical Medical Support - Medical logistics, biomedical equipment, occupational/public health, medical supply, medical readiness.

LOCAL STOCK NUMBER: N/A

0003 3.00 EA __________________ ________________

Biotherapies Software Concurrent User Licenses PRINCIPAL NAICS CODE: 541519 - Other Computer Related Services PRODUCT/SERVICE CODE: Q702 - Technical Medical Support - Medical logistics, biomedical equipment, occupational/public health, medical supply, medical readiness.

LOCAL STOCK NUMBER: N/A

0004 1.00 EA __________________ ________________

Intelligent Integration HL7 Interface - Includes Single instance of: - Lab:

Inbound ADT & Results PRINCIPAL NAICS CODE: 541519 - Other Computer Related Services

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

PRODUCT/SERVICE CODE: Q702 - Technical Medical Support - Medical logistics, biomedical equipment, occupational/public health, medical supply, medical readiness.

LOCAL STOCK NUMBER: N/A

0005 1.00 EA __________________ ________________

Quality and Compliance Document and Compliance System - 10 Named Q&C System User Licenses - 10 Quality Management Module User Licenses PRINCIPAL NAICS CODE: 541519 - Other Computer Related Services PRODUCT/SERVICE CODE: Q702 - Technical Medical Support - Medical logistics, biomedical equipment, occupational/public health, medical supply, medical readiness.

LOCAL STOCK NUMBER: N/A

0006 1.00 EA __________________ ________________

Implementation Services - Lab PRINCIPAL NAICS CODE: 541519 - Other Computer Related Services PRODUCT/SERVICE CODE: Q702 - Technical Medical Support - Medical logistics, biomedical equipment, occupational/public health, medical supply, medical readiness.

LOCAL STOCK NUMBER: N/A

0007 1.00 EA __________________ ________________

Quality & Compliance Implementation and Training Services PRINCIPAL NAICS CODE: 541519 - Other Computer Related Services PRODUCT/SERVICE CODE: Q702 - Technical Medical Support - Medical logistics, biomedical equipment, occupational/public health, medical supply, medical readiness.

LOCAL STOCK NUMBER: N/A

0008 1.00 EA __________________ ________________

Data Import Services - Lab PRINCIPAL NAICS CODE: 541519 - Other Computer Related Services PRODUCT/SERVICE CODE: Q702 - Technical Medical Support - Medical logistics, biomedical equipment, occupational/public health, medical supply, medical readiness.

LOCAL STOCK NUMBER: N/A

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0009 1.00 EA __________________ ________________

Validation Services - Lab PRINCIPAL NAICS CODE: 541519 - Other Computer Related Services PRODUCT/SERVICE CODE: Q702 - Technical Medical Support - Medical logistics, biomedical equipment, occupational/public health, medical supply, medical readiness.

LOCAL STOCK NUMBER: N/A

0010 1.00 EA __________________ ________________

Extended Go-live Support (Onsite) - Lab (per week) PRINCIPAL NAICS CODE: 541519 - Other Computer Related Services PRODUCT/SERVICE CODE: Q702 - Technical Medical Support - Medical logistics, biomedical equipment, occupational/public health, medical supply, medical readiness.

LOCAL STOCK NUMBER: N/A

0011 1.00 EA __________________ ________________

Mid Project Upgrade - Lab PRINCIPAL NAICS CODE: 541519 - Other Computer Related Services PRODUCT/SERVICE CODE: Q702 - Technical Medical Support - Medical logistics, biomedical equipment, occupational/public health, medical supply, medical readiness.

LOCAL STOCK NUMBER: N/A

0012 1.00 EA __________________ ________________

Rhapsody Integration Engine for Hospitals >/= 100 Beds PRINCIPAL NAICS CODE: 541519 - Other Computer Related Services PRODUCT/SERVICE CODE: Q702 - Technical Medical Support - Medical logistics, biomedical equipment, occupational/public health, medical supply, medical readiness.

LOCAL STOCK NUMBER: N/A

0013 1.00 EA __________________ ________________

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

Digi-Trax Hematrax-CT (HT-TCP-CT) - Integrated PRINCIPAL NAICS CODE: 541519 - Other Computer Related Services PRODUCT/SERVICE CODE: Q702 - Technical Medical Support - Medical logistics, biomedical equipment, occupational/public health, medical supply, medical readiness.

LOCAL STOCK NUMBER: N/A

0014 3.00 EA __________________ ________________

Sato Printer (Model: CT-CT4-LX) PRINCIPAL NAICS CODE: 541519 - Other Computer Related Services PRODUCT/SERVICE CODE: Q702 - Technical Medical Support - Medical logistics, biomedical equipment, occupational/public health, medical supply, medical readiness.

LOCAL STOCK NUMBER: N/A

0015 3.00 EA __________________ ________________

Digi-Trax Handheld Scanner CR1500 (Corded) PRINCIPAL NAICS CODE: 541519 - Other Computer Related Services PRODUCT/SERVICE CODE: Q702 - Technical Medical Support - Medical logistics, biomedical equipment, occupational/public health, medical supply, medical readiness.

LOCAL STOCK NUMBER: N/A

0016 1.00 EA __________________ ________________

Annual Software and Support Fees PRINCIPAL NAICS CODE: 541519 - Other Computer Related Services PRODUCT/SERVICE CODE: Q702 - Technical Medical Support - Medical logistics, biomedical equipment, occupational/public health, medical supply, medical readiness.

LOCAL STOCK NUMBER: N/A

0017 1.00 EA __________________ ________________

Rhapsody Annual Maintenance and Support PRINCIPAL NAICS CODE: 541519 - Other Computer Related Services PRODUCT/SERVICE CODE: Q702 - Technical Medical Support - Medical logistics, biomedical equipment, occupational/public health, medical supply, medical readiness.

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

LOCAL STOCK NUMBER: N/A

0018 1.00 EA __________________ ________________

HemaTrax Support PRINCIPAL NAICS CODE: 541519 - Other Computer Related Services PRODUCT/SERVICE CODE: Q702 - Technical Medical Support - Medical logistics, biomedical equipment, occupational/public health, medical supply, medical readiness.

LOCAL STOCK NUMBER: N/A

GRAND TOTAL ________________

B.2 Statement of Work

Statement of Work (SOW)

Tennessee Valley Healthcare System (TVHS)

A. Contract Title: TVHS Procurement of a Stem Cell Processing Laboratory Information System (LIS).

B. Overview: TVHS Pathology and Laboratory Service (P&L) is preparing to stand up an on-site cell processing laboratory at the Nashville VA Medical Center (VAMC) and is seeking to procure a Stem Cell Processing Laboratory Information System (Cell Processing LIS) to support that effort. Currently, TVHS utilizes a stem cell processing laboratory situated at Vanderbilt University Medical Center and does not have a Cell Processing LIS. P&L service estimates a volume of 120 stem cell transplants each year to be completed once the new stem cell processing lab is up and running. P&L expects the number of transplants per year to steadily rise over time as the Nashville VAMC will be the only VHA facility with an in-house stem cell processing lab. TVHS will mainly be conducting autologous transplants (majority of workload) but will also need to be able to support allogeneic transplants and CAR T-cell therapy, the latter of which is anticipated to increase over the next three years in volume.

TVHS requires a Cell Processing LIS to support the new stem cell processing lab at the Nashville VAMC. A Cell Processing LIS is needed to track cell manufacturing and inventory, support document retention, track critical supplies and reagents, support label printing and compliance, and help TVHS maintain compliance with respect to cell manufacturing processes. The Cell Processing LIS is critical for TVHS to stand up the stem cell processing lab and to maintain FACT (Foundation for the Accreditation of Cellular Therapy) accreditation.

TVHS is seeking to procure a Cell Processing LIS in Fiscal Year 2023 to support the effort of standing up a new stem cell processing laboratory at the Nashville VAMC.

Note: TVHS already has an Apheresis clinic operating at the Nashville VAMC.

C. Scope: The scope of this procurement contract is to provide a complete Stem Cell LIS software solution that meets the needs of the TVHS P&L service. The scope of this contract includes the provisioning of all software, licensing, interfaces required to meet the clinical and technical requirements set forth within this SOW. Software installation service (time and labor) and project management services are required to support the implementation of the provided Stem Cell LIS software solution.

The scope also includes required implementation (go-live) services, educational and training services, and validation services as detailed in this SOW. The scope includes the provisioning of any ancillary hardware required to allow the system to function as required by TVHS in this SOW.

NOTE: Respondent claiming SDVOSB and VOSB status shall be registered and Center for Veterans Enterprise (CVE) verified in VetBiz Registry www.vetbiz.gov. BASED ON THE

RESPONSES TO THIS SOURCES SOUGHT NOTICE/MARKET RESEARCH, THIS

REQUIREMENT MAY BE SET-ASIDE FOR SDVOSB, VOSB, SMALL BUSINESSES OR PROCURED

THROUGH FULL AND OPEN COMPETITION.

Additional equipment requirements and required Contractor tasks/ requirements are detailed in subsequent sections of this SOW.

D. Software Requirements/ Salient Characteristics (Laboratory Functionality): Proposed stem cell software solution shall be able to meet the following requirements:

LIS systems have been an integral part of laboratories since the 1970s. An LIS’s main goal is to improve a laboratory’s overall efficiency and productivity by streamlining data management and reporting. Proposed stem cell software solution shall be able to meet the following basic requirements. The idealized stem cell processing LIS system has multiple points of data entry to optimize functionality.

1. The VA Cell Processing Laboratory Information System (LIS) shall be a turn-key system (software, hardware, professional services for setup/ implementation) capable of providing the laboratory with automated daily functionality. The LIS should be able to immediately access clinical data, including name, medical record number, date of birth, product inventory, and historical information pertaining to product availability.

2. The Cell Processing LIS shall ensure secure registration of test ordering/clinical product ordering, production of specimen collection sheets and identification labels, confirmation of specimen/product collection, ISBT 128 label production, workload inquiries, worksheet production, result inquiries, preliminary reports, final reports, daily activities reports, statistical reports, and billing/charge capture. The LIS system should also report date and time of specimen collection and result reporting. The Cell Processing LIS shall provide accurate and timely workload assessments, interpretive comment capabilities, and accurate information retrieval functions.

3. The Cell Processing LIS must be able to maintain information security, preventing unauthorized internal and external access to data by implementing user access controls and data encryption. The cell processing LIS shall be able to provide secure data streams and maintain confidentiality of records in accordance with applicable law and regulations. Individuals involved in assessing quality of care (VA QA team) shall have access to certain information on all patients and cell therapy products. Different levels of security should be available, and the system should allow users to establish workgroups with user-specific sets of functions and access to data.

i. Information manager level

ii. Health care professional level

iii. Technical staff level

iv. Manager/supervisor level

v. Laboratory director level

4. The Cell Processing LIS should be compatible with VA log-in capabilities, including but not limited to PIV card access and/or local directory of secure users.

5. Test/Product ordering functionality: Immediate, accurate functionality for inquiries shall provide users timely feedback (computerized provider order entry within the laboratory for product changes (e.g., red blood cell reduction)).

6. Ability to establish notification criteria by institutional, departmental, or other group policy is required. Ability to select notification media, including health information system overriding alert, health information system alert on patient record and e-mail (smtp).

7. The Cell Processing LIS shall have a user-friendly display of the test catalog (to include testing performed by external reference laboratories), with available alternative groupings, for example, alphabetically, by discipline (e.g., sterility testing of cell therapy products), by clinical situation (e.g., autologous peripheral blood stem cells versus bone marrow stem cells versus CAR T-cells). The menus must be consistent, complete, regularly updated to maintain currency, and with standard nomenclature, including the nomenclature of our accreditation bodies (e.g., the terms used in FACT standards can change or new therapies come to market, the LIS needs to be adaptable to these updated products). The LIS shall facilitate compliance with regulatory standards, thus ensuring the validity of data in case of any audits. The LIS should allow for easy traceability of data and samples, which is essential for maintaining the integrity of laboratory operations.

8. The VA EMR (VistA/ CPRS) should receive real-time feedback from the Cell Processing LIS and notify the ordering providers about the status of the order, including the following steps:

i. Order acknowledged by laboratory.

ii. Accession(s) activated in laboratory.

1. Best case scenario if a cell therapy order is placed, the cell therapy LIS should be optimized to split the order as some products may require multiple steps to execute the order.

iii. Analysis completed.

iv. Results verified.

v. Results reported; order completed. Product issued. Product administered to patient.

9. The Cell Processing LIS shall be able to track and analyze lab performance and identify improvement areas to help lab managers make informed decisions about improving operations and increasing efficiency.

10. The Cell Processing LIS shall be capable of managing laboratory inventory, such as tracking and ordering reagents, and supplies. This is needed to improve efficiency and reduce costs by ensuring that the laboratory always has the necessary materials on hand.

11. The Cell Processing LIS system shall be capable of generating reports and statistics that can be used to demonstrate a laboratory’s performance. The Cell Processing LIS shall allow for custom configuration of any forms/ documents/ reports generated by the system. Eligibility determination criteria shall be able to be included/ customized on system generated forms.

12. Batch Record: The Cell Processing LIS shall be capable of ensuring the complete and accurate data capture throughout the entire process, to include the ability to associate equipment and equipment used and the ability to manage orders from interfaced analyzers/ instruments.

13. System shall allow for the manual entry of results, such as infectious disease markers (in the absence of a working/ configured HL7 interface(s)). System shall allow for manual entry of demographics.

14. The Cell Processing LIS shall allow for customizable system workflows. The system shall be capable of thorough chain of custody tracking and traceability.

15. Quality Assurance/ Management: The Cell LIS shall allow VHA to monitor quality processes. The Cell Processing LIS shall allow VHA staff to prepare for regulatory audits/ inspections.

16. The Cell Processing LIS shall allow TVHS to maintain compliance with FACT.

E. Software Requirements (Technical Requirements):

1. Application Software/ Access: Software application shall be a web-based application (zero-footprint). TVHS requires an application that does not require installation of software directly onto client workstations. The software shall be powered by a web server (virtual machine(s)) hosted on premise. The application software shall be compatible with the following web browsers:

a. Compatibility with Microsoft Edge

b. Compatibility with Google Chrome

c. Port 443/ HTTPS utilization.

2. Server Requirements:

a. TVHS requires a complete on-premise software solution that can function completely without requiring external connections outside of the VA network.

b. Software solution shall allow for the use of virtual machines (hosted by VA) for all servers required to support the software solution.

c. Server Operating System (all servers):

i. Windows Server 2019 Required (x64)

d. Contractor shall detail the number of servers needed to power their software solution. Contractor shall provide servers to produce both a production environment and test environment for their software solution.

3. Database Requirements:

a. On-premise database solution required (database hosted within VHA).

b. Database Software: Microsoft SQL Server 2019 (x 64)

c. Contractor shall allow for a SQL server database to be hosted on a VHA managed consolidated SQL server. VHA consolidated SQL servers host a multitude of databases to support different systems.

d. Contractor is responsible for detailing the required SQL Licensing requirements (such as server plus cal, core licensing, etc.) if a dedicated SQL server is required.

4. Application Requirements:

a. Application software shall be web-based software that is compatible with Microsoft Edge and Google Chrome.

b. Application shall be able to run/ function on workstations (clients) with Windows 10 Operating System (OS) with 8 GB of RAM.

c. Browser Requirements: Contractors shall detail (list) any specific browsers settings that may be required for the application to run properly (for example, Javascript setting, cookie settings, etc.).

d. Remote via GFE Laptop via Cisco VPN

i. Application shall be able to run on VA laptops operating over a Cisco VPN (while not at a VHA site).

e. Web Application shall support HTTPS (via port 443), utilizing SSL or TLS to encrypt data in transit.

5. Software Licensing

a. Contractor shall provide at least one year of licensing needed to support their software product for VA use. Contractor shall meet either of the requirements below:

i. Concurrent User Licensing: Provide six (6) concurrent user licenses.

This would allow for six VHA personnel to utilize the system at the same time. There shall be no limit to the number of personnel that can access the system in general. Licensing time frame shall take effect one the system is implemented (officially in use).

ii. Site License: Contractor may provide a site wide license (for one year). This would allow an unlimited of users to access the system (whether simultaneously or not). Licensing time frame shall take effect one the system is implemented (officially in use).

b. Additional Years of Licensing:

i. VHA requires two additional years of licensing to be added to the proposal (in additional to the first year). A total of three years of software licensing shall be included in the proposals.

ii. Contractors shall note when licensing starts within the proposal (after installation, after implementation, after signing of contract) for TVHS awareness.

6. Usage/ Batch Licensing (if applicable to Contractor Proposal): The VA plans on executing approximately 120 peripheral stem cell transplants a year. Contractor proposal shall accommodate this volume of treatments for the first year of the system use (and two additional years).

7. HL7 Interfaces and Functionality (Integration).

a. Contractor shall be able to interface with an Electronic Medical Record (EMR) system using an HL7 version from the list below:

i. 2.1

ii. 2.2

iii. 2.3

iv. 2.4

v. 2.5

vi. 2.6

vii. 2.3.1

viii. 2.5.1

b. Contractor shall be able to successfully interface with the EMR used by the Nashville VAMC, which is VistA/ CPRS. Contractor can refer to the VA HL7 technical manual to determine VA requirements for HL7 interfacing, which can be accessed via the VA Software Document Library.

VA Software Document Library -

c. Admission Transfer Discharge (ADT): Interfacing licensing for ADT is required in the proposal. Contractor shall include any project management/ labor time required to setup ADT interfaces for both the test and production environment.

i. Contractor shall be able to accept ADT data from Vista/ CPRA (EMR used by Nashville VAMC).

ii. Contractor shall be able to setup an interface server (both test and production) with appropriate HL7 software/ interface engine to accept ADT data from VistA/ CPRS.

d. Observation Result (ORU): Software platform shall be able to accept unsolicited ORU results (for example, blood type results or infectious disease markers).

i. Contractor shall include any licensing required to support ORU interfacing in the proposal. Contracting shall include any project management/ labor time required to setup interfaces for accepting ORUs

e. Device Integration: TVHS does not want device integration licensing/ labor included in the proposal, TVHS does require a software platform that can interface with laboratory devices, such as flow cytometers and hematology analyzers, via HL7. System shall be able to interface with Data Innovations Instrument Manager.

f. HL7 interfaces shall be vendor neutral/ agnostic.

8. Data Migration: TVHS requires a software platform that can accept existing data from another cell manufacturing management system. Contractor shall be able to migrate data from another cell manufacturing management system into the newly provided cell manufacturing management system software for TVHS.

9. Active Directory: Cell Processing LIS shall be able to interface with Active Directory.

TVHS utilizes Active Directory in Windows 2016 Forest/ Domain mode.

10. Antivirus and Windows Updates: Proposed software platform (cell manufacturing management system) shall be able to:

a. Run on VA servers running VA baseline antivirus (AV) software. Contractor shall note if provided system cannot work with certain AV software.

Contractor shall note if any AV scanning exclusions are required for system operation.

b. All servers shall be able to be connected to a Windows Update Server.

F. Hardware Requirements

1. Printing: Software platform shall support the printing of ISBT-128 compliant labels.

Software platform shall be able to associate equipment, reagents, collection kits, and consumables with the batch record.

2. Contractor shall provide three (3) total printers capable of processing ISBT-128 compliant labels. Providing printing hardware is required. Contractor shall provide any required third-party software/ drivers required to support, install, and implement the printers.

3. Contractor shall provide three (3) scanners capable of scanning 2D and 3D barcodes.

Providing scanner hardware is required. Contractor shall provide any required third-party software/ drivers required to support, install, and implement the scanners.

G. Contractor Tasks/ Requirements:

1. Contractor shall fully complete the Special Purpose System (SPS) Questionnaire during the bid process (shall be included in proposal). The SPS Questionnaire is critical for TVHS to determine system requirements and compatibility with VHA technical requirements.

a. Upon award, Contractor shall complete a VHA Enterprise Risk Assessment (ERA) for their software. Contractor will be required to fill out additional Risk Assessment documentation and meet with VHA personnel to complete the required ERA process.

2. Training/ Education:

a. Contractor shall include super user training for three (3) super users in the proposal. Contractor shall detail the education that will be provided to the super users in the proposal (i.e.: online courses, materials to be provided, on-site education, etc.). The Contractor shall provide an education plan.

b. End-user education is required to be provided during the go-live/ implementation process.

c. Contractor shall provide an Education Plan as detailed in Section H, part 5 of this SOW.

3. Project Management:

a. Contractor shall include estimated labor and project management hours needed to stand up the new software platform for cell manufacturing management.

b. Contractor shall provide project management hours needed for technical support during the installation and testing of the new software platform. A dedicated project manager is required. The dedicated project manager shall be responsible for scheduling a project kickoff call and for scheduling regularly occurring project tracking calls, to include general project status calls, technical setup calls, and validation/ testing calls.

c. Contractor shall provide any labor hours needed for remote software installation and testing support.

d. Contractor shall provide any labor hours needed for technical setup of the ADT HL7 interface in the proposal.

e. Contractor shall provide an Installation, Testing, Validation, and Implementation Plan as detailed in Section H, part 4 of this SOW.

4. Design/ Clinical Configuration:

a. Contractor shall include project management hours/ labor hours necessary to work with TVHS staff on software configuration and design (workflow designs, report configurations) requirements.

5. Installation and Testing: Contractor shall provide/ include the resources necessary to support system installation and testing, to include the elements below:

a. Server setup and software installation (for both a production and test environment).

b. SQL Database setup.

c. ADT/ ORU Interface setup and testing.

d. Overall software system testing and Quality Assurance required prior to system implementation.

6. Go-Live/ Implementation Support:

a. Contractor shall provide (include) four (4) days of on-site support for the go-live/ implementation of the newly provided cell manufacturing management system.

b. Contractor shall also include remote support for the go-live/ implementation process.

c. Contractor shall detail the number of personnel (and type, technical, clinical, educational), hours, and days of support being proposed to support the go-live/ implementation of the newly provided Cell Processing LIS system.

7. Validation Support and Process: Contractor shall support a validation process to ensure the installed system is fully functional prior to go-live. Contractor shall ensure all system operations are validated/ qualified prior to go-live. Contractor shall provide TVHS a validation process guide/ document.

a) Contractor shall provide an Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ) processes/ services.

b) Contractor shall develop and provide a comprehensive IQ, OQ, PQ validation plan to VHA. Contractor is responsible for completing all required validation processes as part of this contract (IQ, OQ, PQ).

c) Contractor responsible for providing any required programs/ scripts for IQ, OQ, PQ processes.

8. Follow up Progress Visits: Contractor shall provide two follow-up visits for one clinical consultant. Two four (4) day on-site follow-up visits are required.

H. RESERVED

I. Terms and Conditions:

1. This procurement is for new cell manufacturing management system platform. All proposed software shall be FDA approved Laboratory Information Systems.

2. If additional equipment, parts, labor, travel, and/or repairs are necessary outside the scope and pricing of the original contract, the Contractor shall contact the COR before completing/ providing such work. The Contractor shall be liable for any additional parts, labor, travel, and/or repairs (including labor hours) provided that are outside the scope and pricing of the original contract unless 1) the COR has been contacted about the additional parts and/or repairs required and 2) a corresponding contract modification has been put in place to cover and account for the additional parts and/ or work required.

J. Place of Performance:

Nashville VA Medical Center, located at:

1310 24th Avenue South Nashville, TN 37212

K. Period of Performance:

TVHS anticipates an entire year (365 days) for the Period of Performance due to the complexity of the installation and implementation requirements.

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference.

The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by

EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 4701 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause)

C.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY

REFERENCE (FEB 1998)

This solicitation incorporates one or more…