Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF APRIL 17, 2025 SAM #8543
SPECIAL NOTICE

Q -- Intent to Sole Source Molecular Testing Reagent Rental | HCV, HIV, HPV, and CMV Cobas 6800 VA Pittsburgh Healthcare System

Notice Date

4/15/2025 5:36:04 AM
 

Notice Type

Special Notice
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

244-NETWORK CONTRACT OFFICE 4 (36C244) PITTSBURGH PA 15215 USA
 

ZIP Code

15215
 

Solicitation Number

36C24425Q0574
 

Response Due

4/18/2025 7:00:00 AM
 

Archive Date

05/18/2025
 

Point of Contact

Christa Stine, Contract Specialist, Phone: 570-824-3521
 

E-Mail Address

christa.stine@va.gov
(christa.stine@va.gov)
 

Awardee

null
 

Description

Page 3 of 6 INTENT TO SOLE SOURCE The Department of Veterans Affairs, Network Contracting Office 4 (NCO4) intends to sole source a contract for Molecular Testing of HCV, HIV, HPV, and CMV testing, including Quality control, reagents, and the cost of all reagents of molecular testing of HCV, HIV, HPV, and CMV for the Cobas 6800. All work is to be completed in accordance with the Performance Work Statement. This sole source contract will be solicited and negotiated with Roche Diagnostics, 9115 Hague Road, Indianapolis, IN under the authority of FAR 13.106-1 Single Source Justification. See attached Draft Statement of Work (SOW). The North American Industry Classification System (NAICS) code for this procurement is 334516. The Small Business Administration (SBA) size standard is 1000 employees. Interested vendors that can meet this requirement, shall identify their interest and capability, and respond to this notice by 04/18/2025 by 10:00 AM EST. Interested vendors must send a capability statement, no more than one page in length; to include Company Name, ueiSAM Number, Socioeconomic Category, brief description of your business entities capability to handle this project at the Lebanon VA Medical Center. This Special Notice of Intent to Sole Source is for planning purposes only. No solicitation will be made available. This is not a request for quotations. All information shall be provided at no cost or obligation to the Government. Responses must be sent via email to the Contracting Specialist at christa.stine@va.gov. Responses received will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon the responses to this notice is solely at the discretion of the Government. If no responses are received, Contracting will proceed with the sole source negotiation with Pharmacy OneSource, INC. PERFORMANCE WORK STATEMENT (PWS) DEPARTMENT OF VETERANS AFFAIRS VA Pittsburgh Health System 1.0 INTRODUCTION AND SCOPE OVERVIEW The purpose of the VA Pittsburgh Healthcare System requirement is to provide best value professional and healthcare for molecular testing of HCV, HIV, HPV, and CMV. 1.2 SCOPE The contractor shall provide all resources necessary to accomplish the deliverables described in this Performance Work Statement (PWS) for molecular testing of HCV, HIV, HPV, and CMV testing, including Quality control, reagents, and the cost all reagents of molecular testing of HCV, HIV, HPV, and CMV. Shipping and handling charges would be factored into the cost of the reagents. The molecular testing must be compatible with the Cobas 6800 which is our current analyzer for molecular testing. 2.0 GENERAL INFORMATION 2.1 Type of Contract The U.S. Department of Veterans Affairs, Pittsburgh VA Medical Center anticipates a Reagent Rental Usage Agreement from this Request for Quote using FAR Part 12 Commercial Item procedures. Pittsburgh VAMC will issue a reagent usage (Reagent Rental) for instrument use, supplies, installation, training, and servicing of the equipment (for the life of agreement). 2.2 Contract Ordering Period The Reagent Usage Agreement will consist of a 12-months base period with four (4), 12-months options. The performance period will commence upon the Contracting Officer s signature and will expire within one (1) year unless canceled, terminated, or extended. 2.3 Place of Performance The place of performance will be VA Pittsburgh Healthcare System, University Drive C, Pittsburgh, PA 15240. 2.4 Travel Travel may be required from contractor to implement and deploy reagent rental contract of molecular testing of HCV, HIV, HPV, and CMV which may include testing, training, installation, and servicing of equipment. 2.5 Hours of Contractor Operations (Government-Provided Work Site) Work performed on molecular testing of HCV, HIV, HPV, and CMV instrumentation is issued under this contract are anticipated to occur Monday through Friday, within the hours of 0600 Eastern Standard Time (EST) and 1700 EST, except as authorized by the COR. VA observes all federal holidays as recognized by the Office of Personnel Management (http://www.opm.gov/fedhol/index.htm). Services performed at the Government s site must not occur on Federal holidays or weekends, unless authorized in advance by the COR, or anytime the Government offices are closed. These parameters may be the contractor may be required to provide back-up coverage during periods of extended absences of assigned contractor personnel (five or more workdays) to ensure continuity of services. 2.6 Government-Furnished Information, Equipment, and Facilities Government-Furnished Information (GFI), Government-Furnished Equipment (GFE), and Government- Furnished Facilities (GFF), if applicable, will be specified as necessary by each individual task order. VA implements and enforces, two-factor authentication (2FA) for all remote access to its networks. Network access through the Citrix Access Gateway (CAG) will require the use of a personal identity verification (PIV) card to complete the login process. The only method for users to access the VA network is with a PIV card. The Contractor shall request other Government documentation deemed pertinent to the work accomplishment directly from the Government officials with whom the Contractor has contact. The Contractor shall consider the COR as the final source for needed Government documentation when the Contractor fails to secure the documents by other means. The Contractor is expected to use common knowledge and resourcefulness and when in doubt, shall ask the COR. 3.0 SERVICE GROUPS AND LABOR CATEGORIES 3.1 General Requirements Contractor personnel shall have the level of experience necessary to accomplish the requirements of this PWS. In addition, contractor personnel shall be acceptable to the Government in terms of personal and professional conduct, and in technical knowledge. Furthermore, contractor personnel are expected to be proficient in using office automation equipment and software and have sufficient written and verbal communication skills to support VA program offices, their customers, and any other VA organizations. Should any contractor personnel be determined to be unacceptable in terms of technical competency or unacceptable conduct or behavior while on-site or while working on contract activities, the contractor shall immediately remove and replace the unacceptable on-site personnel at no additional cost to the Government. Contractor personnel are to serve in a support role; therefore, final decisions regarding inherently governmental functions will always be made by Government personnel. General and technical requirements: General Specifications: The cost of the molecular analyzer would be factored into the cost of the reagents. The contractor must provide reagents and quality control for molecular testing of HCV, HIV, HPV, and CMV. Materials with the longest outdates will be shipped when the order is placed. Materials will be scheduled for shipment according to the needs of the Microbiology/Molecular department. All reagents including quality control material, validation, and linearity reagents must be compatible with Cobas 6800. The Microbiology/Molecular supervisor/designee will be the individuals designated to order against this contract. All reagents will be delivered to the dock area of : VA Pittsburgh Healthcare System University Drive Pittsburgh, PA 15240 Materials will be shipped within 3 business days of ordering. Monthly updates of materials shipped from the vendor will be sent via email to the Microbiology/Molecular contact at VA Pittsburgh. Printed MSDS/SDS will be available upon request. Continuing educational opportunities will be offered by the contractor. Shipping, handling, and freight charges will be the responsibility of the contractor. Technical Requirements: Reagents must be compatible with Cobas 6800 and Cobas 6800 proprietary software. Storage of patient results on the analyzer 3.2 Service Requirements Services performed shall be of a non-personal nature. VA organizations will not provide supervision of contractor personnel. Contractor personnel shall at no time allow an employer-employee relationship to develop with VA organizations or their staff. VA organizations will refrain from any activities that create the appearance of such a relationship. Contractors shall not perform inherently governmental functions including decision-making, supervision of Government employees, supervision of other contractors on other contracts, and activities that create the appearance of performing such functions. Service requirements are as follows: Technical service shall be provided by telephone 8am-5pm EST (Mon-Fri) Field service shall be provided within 24 hours of notification. Hours of service shall be 8am-5pm EST (Mon-Fri) Analyzers shall be covered under warranty during the entire contracted period to include service, repair and/or replacement. 3.3 Service Groups The proposed contractor shall provide services, labor categories, and solutions necessary to fulfill the scope of service groups one (1) and two (2) and at least one (1) other group. The entire contractor team shall collectively provide services, labor categories, and solutions necessary to fulfill the scope of all service groups. 3.3.1 Group 1 - Program and Project Management and Integration The contractor shall provide services facilitation as they relate to program and project management, strategic planning, and performance measurement in a healthcare environment, as outlined below. Critical to the success of this work is an integrated approach, encompassing all lines of effort. 3.3.1.1 Program and Project Management The contractor will provide support to assist the Government in implementing disciplined, comprehensive, and flexible program and project management processes, including monitoring of project metrics, rigorous risk management, and prompt reporting on Government-approved cost, schedule, performance, and risk baseline. When needed the approach must incorporate large integrated (to include governmental) healthcare project management best practices. Program and project management must integrate all functions required for a success. 3.3.1.2 Business Requirements Development The contractor shall support the development of healthcare business requirements to support strategic implementation of new technology solutions that improve business efficiency while meeting programmatic goals. Tasks may include gathering customer input, identifying measures, assumptions, or dependencies, integrating process into larger systems requirements, defining non-universal terms, and interfacing with information technology staff to communicate requirements. Strategic Planning The contractor shall provide support of healthcare strategic planning, including development of strategic goals, objectives, strategies, performance measures, targets, improved programmatic outcomes, succession plans, and linkages to programming, budgeting, and evaluation. 3.3.1.4 Performance Measurement. The contractor shall provide support of strategic performance measurement development based upon healthcare industry standards, including improved linkage between VA-wide strategic goals and VA programmatic outcomes; and implementation of the Government Performance and Results Act (GPRA) Modernization Act (GPRAMA). 3.3.1.5 Program Evaluation The contractor will employ a systematic method for collecting, analyzing, and leveraging information to evaluate healthcare projects, policies and programs for effectiveness and efficiency. 3.3.1.6 Acquisitions Support The Contractor shall provide acquisition subject matter expert services to support development of acquisition packages that address portfolio, program, and project-level product and service requirements. See paragraph 8.1 for potential OCI restrictions related to this task area. Tasks may include the development of a Strategic Acquisition Plan that identifies required acquisitions, corresponding budgets, and gaps, risks, and issues that may impact success and support to the Government in the development of acquisition packages to address program goals. 3.3.2 Group 2 Improvement and Change Management The contractor shall provide services and facilitation as they relate to large integrated healthcare business process reengineering, business process improvement, business process management, and change management and transition, as outlined below. 3.3.2.1 Business Process Reengineering, Improvement and Management The contractor shall conduct studies in support of healthcare system redesign and business process reengineering, improvement, and management. The contractor shall develop implementation plan and support the process of implementing and sustaining improvements. The contractor shall use a healthcare system engineering approach to conduct organizational studies that specifically assess and analyze current organizational states and management systems and perform gap analyses of differences between current and targeted states, including findings and recommendations. Contractor shall provide all business architecture deliverables in accordance with VHA Standards as mandated by VHA Business Architecture. 3.3.2.2 Change Management and Transition The contractor shall support all activities associated with organizational change, including but not limited to, transition management, implementation of major initiatives, communications associated with major initiatives, risk assessment, and organizational transformation and culture change, to include assessment of organizational health. 3.3.2.3 Quality Management The contractor shall provide support of quality management systems, tools, and techniques to help organizations transform, including, but not limited to, CMMI, Lean Six Sigma (LSS), ISO 9000/9001, and the Malcolm Baldrige Quality Award criteria. Group 3 Data and Analyses The contractor shall provide services as they relate to studies and analyses, information and records management, and surveys and research, as outlined below. 3.3.3.1 Studies and analyses The contractor shall provide healthcare studies as they relate to staffing, evaluation, human resources, organization, leadership, efficiency, effectiveness, gap analyses, organization development, timeliness and quality of care, and emergency preparedness. The contractor shall also conduct surveys, focus groups, conjoint analyses, and other VHA accepted techniques for data collection in support of transformation initiatives. Among myriad potential healthcare related study subjects, tasks may include studies of advanced healthcare methodologies and technology (to include the use of Artificial Intelligence in healthcare) and the study and utilization of emerging (disruptive) models in healthcare. The contractor shall conduct organizational studies and evaluations, design systems and procedures, conduct work simplification and measurement studies, and prepare operations and procedures manuals to assist management in operating more efficiently and effectively. 3.3.3.2 Information and Records Management The contractor shall evaluate and recommend solutions to compile, evaluate, analyze, control, secure, and disseminate timely, relevant, objective, and accurate data and information to VHA and VHA stakeholders, including, but not limited to, web-based designs, data governance, operational systems, document storage, applications, models, and assessment of existing legacy systems. These services may include the digitization of hard records to electronic media, disposition of records, and storage of records in accordance with specific regulations. Approaches shall include healthcare industry standards. 3.3.3.3 Data Governance The contractor shall support in the management of the availability, usability, integrity, and security of the VHA s healthcare data. Services may include consultations, and process improvements. 3.3.4 Group 4 Training The contractor shall design, conduct, and evaluate training in support of projects and programs. Training tasks may require development of web-based and in-person training integrated with work performed across all other service groups and may require healthcare expertise. 3.3.4.1 Training Development The contractor will create training in various mediums for delivery to desired audience. 3.3.4.2 Training Delivery The contractor will deliver training in various mediums to include face to face, online, or hybrid formats. 3.3.5. Group 5 Strategic Communications and Implementation The contractor shall provide services as they relate to outreach, promotional materials, and advertising for internal and external customers. Communications support will be integrated with work performed across all other service groups and may require healthcare expertise. 3.3.5.1 Strategic The contractor shall provide support to assist in defining, implementing, and executing a communications strategy that establishes consistent messaging, public relations management, and structured internal and external communication practices. Plans will be related to VHA initiatives, priorities, healthcare operations and services and may include inter-agency collaboration, the integration of multiple programs, and national level campaigns. Additionally, the contractor shall assess the return on investment (ROI), effectiveness, and performance of the communication or marketing plan using industry standard best practices and comprehensive metrics/analytics tools and techniques. The communications strategy should closely align with the overall change management approach (Service Group 2), reflected in its target audiences, modalities, and timing of internal and external communications. 3.3.5.2 Executive Support Contractor shall provide planning, design, organization and management of healthcare executive correspondence and documentation. Tasks may include the development and preparation of presentation materials and business correspondence for Government approval, to include but not limited to PowerPoint, speeches, and virtual presentations, brochures, posters, templates, Web graphics, fact sheets, talking points, e-Mail blast content and other materials. Tasks may also include the tracking and reviewing of the status and progress of actions related to the correspondence to ensure the timeliness of responses. 3.3.5.3 Advertising Services The contractor shall develop materials to promote the public and private awareness of the VHA s mission, goals, initiatives, and objectives to ensure complete understanding of the complex and technical aspects and social issues of the VHA. Additionally, to disseminate information to industry, consumer advocacy groups, and Veteran Service Organizations and engage in recruitment campaigns. Services may include the following healthcare related components: advertising objective determination, message decision / creation, media selection, outdoor marketing and media services, broadcast media (radio, TV, and public service announcements), direct mail services, web-based media services, media planning, media placement services, advertising evaluation, and related activities to advertising services. 3.3.5.4 Media Buying The contractor shall assist in the procurement of healthcare related advertising and outreach activities that can be in the form of television stations time, periodicals ads, internet advertisement, radio, social media, billboards, public transportation, etc. for the VHA. The contractor shall provide support in negotiating media in accordance with research and analysis and purchasing paid advertising to impact targeted healthcare markets and audiences; generating excitement and awareness of VHA benefits, healthcare, and services. 3.3.5.5 Public Relations Services/Outreach The contractor shall assist in the healthcare related strategic communication plan that builds beneficial relationships between the VHA, the public, and other entities. The Contractor shall provide support to assist in developing plans for various Department-wide outreach campaigns and recommending the most effective way of communicating a message in print, electronic format, or both, including social media and web-based outreach. Other related services may fall under the following categories: executing healthcare related media programs, conducting press conferences, scheduling broadcast and/or print interviews, public relations, and crisis communications media training, such as, training of agency healthcare personnel to deal with media and media responses, media alerts and press clipping services related activities to public relations services. 3.3.5.6 Conference, Events, and Planning Services The contractor shall develop and support the VHA in preparation of healthcare related conferences, seminars, and events planning services by providing materials that can be presented and/or provided to participants of these events. Services may include the following components for an event and/or booth: project management, coordination and implementation of third party participation, collection management of third party payment for participation, liaison support with venue, audiovisual and information technology support, topic and speaker identification, site location research, reservation of facilities, on-site meeting and registration support, editorial services, automation and telecommunications support, design and editing productions; and mailing and other communication with attendees including pre/post meeting mailings/travel support and computer database creation. 3.3.5.7 Healthcare Related Promotional Materials The contractor shall develop healthcare related promotional materials in multiple medium. This type of medium can include pamphlets, posters, brochures, etc. Services may include the following components: developing conceptual design and layouts, providing copywriting and technical writing services, creating sketches, drawings, publication designs, and typographic layouts; and furnishing custom or stock artwork (including electronic artwork). 3.3.5.8 Video/Film Production The contractor shall develop healthcare related video and/or film materials in multiple mediums to include digital media for the use by the VHA. Services may include final editing, copyrights and editing to fit various formats, i.e. High-Definition, streaming, Moving Picture Experts Group (MPEG), etc. 3.3.5.9 Graphics Design The contractor shall support in the development of healthcare related visual communication for internal and external facing using photography, illustration, visual arts, page layout, etc. Services may include logo design, periodical design, web design, and signage. 3.3.6 Group 6 Supply Chain The contractor shall provide services as they relate to the discipline of healthcare supply chain management concepts to include process improvement, cold chain management, delivery and storage of goods, and cost benefit analytical studies. 3.3.6.1 Supply Chain and Healthcare Logistics Analysis The contractor shall provide support in the analysis of healthcare supply chain efficiency and improvement measures. The services include all phases of planning, acquisition, and management of logistics systems. These services may include planning, acquisition, design, development, testing, production, fielding, management, operation, maintenance, sustainment, improvement, modification, and disposal. 3.3.6.2 Supply Chain Management The contractor shall provide support in the management and analysis of the system of the VA, personnel, and resources involved in the moving and procurement of healthcare supplies from the supplier to the VA. These activities may include analysis of the transformation of raw materials to the finished product, the coordination and collaboration with channel partners, and responsibility for linking business functions and processes. 3.3.6.3 Supply Chain Planning The contractor shall provide support in the process of predicting future healthcare requirements to balance supply and demand of the VA. Services may include the analysis of supply stock, future forecast, etc. 3.3.6.4 Inventory Management and Operation The contractor shall provide support in the practice of overseeing and controlling the systemic ordering, storage, and use of resources in stock of healthcare supplies and inventory for the VA. These activities may include the analysis of mitigating risks to increase value from the vendors used in the procurement process, cost control processes, and analysis of quality measurements of consumables, expendables, and supplies. 3.3.6.5 Supply Chain Optimization The contractor shall provide support in the analytical study of identifying efficiencies or lack of efficiencies in the healthcare supply chain of the VA. Services may include providing consultation on process improvements of the supply chain, presentation of best practices by industry, quality management and assessment of supply chain. 3.3.7 Group 7 - Financial Management The contractor shall provide services as they relate to financial services management. Financial management support may be integrated with work performed across all other service groups and may require healthcare finance expertise. 3.3.7.1 Modernization The contractor shall support program office efforts to modernize the VA s Financial Management System (FMS) and multiple workstreams centered around healthcare financial business processes. The contractor shall provide technical, systems engineering, planning, programmatic support, and resourcing recommendations to support financial management modernization. 3.3.7.2 Internal Controls The contractor shall support with increasing the efficiency of organizations, detecting, and eliminating fraud, and ensuring compliance with relevant regulation. Support may include monitoring and measuring organizational resources, policies and procedures and delivering relevant artifacts. 3.3.7.3 Management and Operations The Contractor shall provide budget and financial management support to include budget tracking, forecasting, analysis, execution, reporting, and actuarial services. Tasks may include analyses to develop recommendations specifically aimed at cost control/cost reduction, support for the Government s budget planning and formulation activities for future year funding needs, and creation of standard operating procedures related to healthcare financial management. 3.3.8 Group 8 - Policy 3.3.8.1 Policy Research and Development The contractor shall perform tasks related to healthcare policy and regulation analysis and the development of policy recommendations. Tasks may include the analysis of specific issues, identification of alternatives, white paper development, development of policy review papers, development of policy directives and handbooks, and other analytical tasks focused on VA policy. Public Health related policy tasks may require the contractor to complete quantitative predictive modeling to address future needs in the design of a Veteran-centered health system. All recommendations for policy will be reviewed and approved by Government employees. 3.3.8.2 Policy Management The contractor shall perform tasks related to the management, review, and revision of existing healthcare policy documents. Tasks may include databasing, indexing, revision scheduling, tracking, supporting SME review panels, standardization, and periodic review and analysis of existing policies and procedures for continued applicability, effectiveness, and compliance. All recommendations for policy changes will be reviewed and approved by Government employees. 3.3.9 Group 9 Other Task Areas 3.3.9.1 Research and Development Administration Support The contractor shall perform tasks related to the administration of healthcare research and Institutional Review Board support. Tasks may include support for the peer review process, literature reviews, Federal Advisory Committee Act (FACA), meeting preparation, travel for non-VA reviewers, portfolio analyses, and other administrative and analytical tasks in support of the VA intramural healthcare research and development program. 3.3.9.2 Human Resources Support The contractor shall provide human resources and staffing solutions as they relate to supporting development of healthcare position descriptions for Government approval, conduct manpower surveys, and provide workforce consulting in the support of human capital management. The contractor shall provide support in the development of position description and qualification documents for human resource activities specific to the healthcare industry to include document generation for hiring officials and amendments to position description and responsibility documents, by utilizing Office of Personnel Management (OPM) and the Department of Veterans Affairs policies. The contractor shall provide support in the design and analysis of manpower and healthcare staffing studies for the VA. This support is not inclusive of temporary staffing services. 3.4 Labor Categories Attachment A, Labor Categories, provides a comprehensive list of labor categories, descriptions, minimum education and experience requirements, as well as identification for which service groups the labor categories are applicable. Individual Task Orders may provide additional requirements for experience or education, including certifications. It is expected that the minimum education and experience will be in a field or specialty that directly relates to the labor category and task order requirements. The CO reserves the right to grant waivers for the education and experience requirements. Waivers for education may be based on additional years of experience, industry certifications, or equivalent trainings. Waivers for experience may be based on additional years of education and exceptionally specialized experience. Individual task orders may cite additional equivalencies that will be recognized. Contractor s request for waiver must be provided in writing to the CO, and the CO s authorization must be provided in writing to the contractor. 4.0 MANDATORY TASKS AND DELIVERABLES In addition to any specific groups awarded to the contractor, the base contract and any subsequent task orders require general management to manage schedules; monitor costs; assure quality of services, performance, and deliverables; and maintain a proper level of oversight. The contractor may be asked to attend virtual meetings, provide meeting minutes, prepare agendas, review deliverables, and participate in ad hoc communication to discuss contract or task order status. In addition to tasks and deliverables defined in individual task orders, the contractor shall perform the following tasks and provide the following deliverables throughout the performance period. All tasks and deliverables listed in this section shall not be separately priced, nor will separate task orders be issued. 4.1 Management of the Reagent Rental Contract The contractor shall institute and maintain a management process that effectively manages the base contract and subsequent option years and all contractor personnel and financial resources used to perform the services required by the base contract and subsequent option years. As part of the management process described above, the contractor shall: 4.1.1 Employ a management approach that is consistent with project management best practices (e.g., PMBOK). 4.1.2 Clearly identify all personnel involved in the management and performance of the contract and clearly define their roles, responsibilities, and interaction with the Government. 4.1.3 Ensure that all services are compliant with applicable Federal regulations and guidelines. 4.1.4 Adhere to the security regulations, policies, and procedures set forth in the base contract and subsequent option years. 4.1.5 Attend a post-award kickoff meeting. The contractor shall ...
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/9a5040b2425f40588d5836ead9b1256d/view)
 

Record

SN07408746-F 20250417/250415230041 (samdaily.us)
 

Source

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

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