Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF APRIL 12, 2023 SAM #7806
SOURCES SOUGHT

Q -- Turnkey Stem Cell Processing Software

Notice Date

4/10/2023 12:29:20 PM
 

Notice Type

Sources Sought
 

NAICS

541519 — Other Computer Related Services
 

Contracting Office

249-NETWORK CONTRACT OFFICE 9 (36C249) MURFREESBORO TN 37129 USA
 

ZIP Code

37129
 

Solicitation Number

36C24923Q0242
 

Response Due

4/28/2023 7:00:00 AM
 

Archive Date

05/13/2023
 

Point of Contact

Tina Parker, Turnkey Stem Cell Processing Software, Phone: NO PHONE CALL, Fax: NO FAX
 

E-Mail Address

tina.parker1@va.gov
(tina.parker1@va.gov)
 

Awardee

null
 

Description

This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. Background: The Department of Veterans Affairs Medical Center, NCO 9 Network Contracting Office, on behalf of Nashville VA Medical Center is conducting market research through this source sought notice to seek sources to identify potential experienced businesses that are capable of meeting the requirements per the Statement of Work (SOW) below. Purpose and Objectives: Your responses to the information requested will assist the Government in determining the appropriate acquisition method. NAICS code: 541519 and has a size standard of 150 employees. NOTE: Respondent claiming SDVOSB and VOSB status must be registered and CVE verified in VetBiz Registry www.vetbiz.gov. The anticipated period of performance: is 12 months after the award. Capability statement /information sought: Response to this announcement shall not to exceed 10 pages and should include the following information: (1) A tailored capability statement indicating the firm s ability to provide a product and related services; (2) The respondents UIE number, organization name, address, point of contact, and size and type of business (e.g., SDVOSB/VOSB, etc,) pursuant to the applicable NAICS code; (3) Information should be provided electronically in a Microsoft Word or Adobe PDF format. Please e-mail your response with the above information to tina.parker1@va.gov with the subject line ""Sources Sought Notice # 36C24923Q0242 by 10:00 a.m. CST on 05/28/2023. Any question should be emailed to tina.parker1@va.gov Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). 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. ----------------------------------------------------------------------------------------------------------------- Statement of Work (SOW) Tennessee Valley Healthcare System (TVHS) Contract Title: TVHS Procurement of a Stem Cell Processing Laboratory Information System (LIS). 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 in order for TVHS to stand up the stem cell processing lab and in order to maintain FACT (Foundation for the Accreditation of Cellular Therapy) accreditation. TVHS is seeking to procure a Cell Processing LIS in Fiscal Year 2023 in order 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. 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 in order 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. Additional equipment requirements and required Contractor tasks/ requirements are detailed in subsequent sections of this SOW. 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. 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. 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. 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. Information manager level Health care professional level Technical staff level Manager/supervisor level Laboratory director level 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. 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)). 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). 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. 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: Order acknowledged by laboratory. Accession(s) activated in laboratory. 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. Analysis completed. Results verified. Results reported; order completed. Product issued. Product administered to patient. The Cell Processing LIS shall be able to track and analyze lab performance and identify improvement areas in order to help lab managers make informed decisions about improving operations and increasing efficiency. 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. 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. 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. 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. The Cell Processing LIS shall allow for customizable system workflows. The system shall be capable of thorough chain of custody tracking and traceability. 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. The Cell Processing LIS shall allow TVHS to maintain compliance with FACT. Software Requirements (Technical Requirements): 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: Compatibility with Microsoft Edge Compatibility with Google Chrome Port 443/ HTTPS utilization. Server Requirements: TVHS requires a complete on-premise software solution that can function completely without requiring external connections outside of the VA network. Software solution shall allow for the use of virtual machines (hosted by VA) for any and all servers required to support the software solution. Server Operating System (all servers): Windows Server 2019 Required (x64) 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. Database Requirements: On-premise database solution required (database hosted within VHA). Database Software: Microsoft SQL Server 2019 (x 64) 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. 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. Application Requirements: Application software shall be web-based software that is compatible with Microsoft Edge and Google Chrome. Application shall be able to run/ function on workstations (clients) with Windows 10 Operating System (OS) with 8 GB of RAM. Browser Requirements: Contractors shall detail (list) any specific browsers settings that may be required in order for the application to run properly (for example, Javascript setting, cookie settings, etc.). Remote via GFE Laptop via Cisco VPN Application shall be able to run on VA laptops operating over a Cisco VPN (while not at a VHA site). Web Application shall support HTTPS (via port 443), utilizing SSL or TLS to encrypt data in transit. Software Licensing 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: 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). 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). Additional Years of Licensing: 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. Contractors shall note when licensing starts within the proposal (after installation, after implementation, after signing of contract) for TVHS awareness. 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). HL7 Interfaces and Functionality (Integration). Contractor shall be able to interface with an Electronic Medical Record (EMR) system using an HL7 version from the list below: 2.1 2.2 2.3 2.4 2.5 2.6 2.3.1 2.5.1 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 -    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. Contractor shall be able to accept ADT data from Vista/ CPRA (EMR used by Nashville VAMC). 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. Observation Result (ORU): Software platform shall be able to accept unsolicited ORU results (for example, blood type results or infectious disease markers). 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 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. HL7 interfaces shall be vendor neutral/ agnostic. 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. Active Directory: Cell Processing LIS shall be able to interface with Active Directory. TVHS utilizes Active Directory in Windows 2016 Forest/ Domain mode. Antivirus and Windows Updates: Proposed software platform (cell manufacturing management system) shall be able to: Run on VA servers running VA baseline antivirus (AV) softwares. Contractor shall note if provided system cannot work with certain AV softwares. Contractor shall note if any AV scanning exclusions are required for system operation. All servers shall be able to be connected to a Windows Update Server. Hardware Requirements 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. 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. 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. Contractor Tasks/ Requirements: 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 in order to determine system requirements and compatibility with VHA technical requirements. 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. Training/ Education: 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 (ie: online courses, materials to be provided, on-site education, etc.). The Contractor shall provide an education plan. End-user education is required to be provided during the go-live/ implementation process. Contractor shall provide an Education Plan as detailed in Section H, part 5 of this SOW. Project Management: Contractor shall include estimated labor and project management hours needed to stand up the new software platform for cell manufacturing management. 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. Contractor shall provide any labor hours needed for remote software installation and testing support. Contractor shall provide any labor hours needed for technical setup of the ADT HL7 interface in the proposal. Contractor shall provide an Installation, Testing, Validation, and Implementation Plan as detailed in Section H, part 4 of this SOW. Design/ Clinical Configuration: Contractor shall include project management hours/ labor hours necessary to work with TVHS staff on software configuration and design (workflow designs, report configurations) requirements. Installation and Testing: Contractor shall provide/ include the resources necessary to support system installation and testing, to include the elements below: Server setup and software installation (for both a production and test environment). SQL Database setup. ADT/ ORU Interface setup and testing. Overall software system testing and Quality Assurance required prior to system implementation. Go-Live/ Implementation Support: Contractor shall provide (include) four (4) days of on-site support for the go-live/ implementation of the newly provided cell manufacturing management system. Contractor shall also include remote support for the go-live/ implementation process. 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. 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. Contractor shall provide an Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ) processes/ services. 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). Contractor responsible for providing any required programs/ scripts for IQ, OQ, PQ processes. 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. Requirements for Award Consideration: Contractor shall provide a completed, accurate Special Purpose System (SPS) Questionnaire. A copy of a blank (template) may be requested from VHA. Software Demonstration: Contractor shall be able to provide a brief software demonstration (virtual demo) prior to bid evaluations. Past Performance: Contractor is required to provide at least two (2) examples/ references of on-premise installations of their Cell LIS (systems that function without any external connections/ VPN connections). Installation, Testing, Validation, and Implementation Plan: In order to be considered for award, potential Contractor shall provide a detailed plan for how they will install, test, validate, and implement the provided Cell Processing LIS. The plan shall include the following: Projected Project Timeline (to include key milestones). Estimated Number of Professional Hours necessary to complete installation, testing, validation, HL7 interface setup/ testing, and implementation (Go-Live). The estimated number of hours and required Contractor resources (Titles, numbers) shall be detailed for key milestones, to minimally include the following: Overall Project Management, to include kickoff call and regularly scheduled meetings. Server Installation and Configuration (for both Test and Production environments). HL7 Interface builds and testing (for both ADT and ORU) Custom Report Building Validation Services Go-Live (Implementation) Services, on-site Follow-up visits (two), on-site Education Plan: In order to be considered for award, potential Contractor shall provide a detailed Education plan for how they will train TVHS clinical staff. Contractor shall detail the number of estimated hours required for training at three super users (system admins) and shall detail the types of education provided (remote, on-site, education documents to be provided, etc.). Terms and Conditions: This procurement is for new cell manufacturing management system platform. All proposed softwares shall be FDA approved Laboratory Information Systems. 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. Place of Performance: Nashville VA Medical Center, located at: 1310 24th Avenue South Nashville, TN 37212 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.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/94610bfde04c40cbb416a83366a214f2/view)
 

Place of Performance

Address: VA Tennessee Valley Medical Center 1310 24th Ave S, Nashville 37212

Zip Code: 37212
 

Record

SN06646005-F 20230412/230410230112 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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