M5-Q52A-04-R6: 65VII Invitro Diagnostics, Reagents, Test Kits, & Test Sets

Solicitation / RFP / RFQ

This document is a standing solicitation for a Worldwide Federal Supply Schedule (FSS) Contract for FSC Group 65, Part VII, specifically for Invitro Diagnostics, Reagents, Test Kits, & Test Sets (FSC Class Product Code: 6550). The Department of Veterans Affairs (VA) National Acquisition Center is issuing this solicitation. It is an open and continuous solicitation, meaning offers can be submitted at any time.

• The solicitation details terms and conditions applicable to goods and services, contract terms, vendor instructions, evaluation factors, and offeror representations and certifications.

• Specific clauses cover inspection/acceptance, changes, disputes, payment terms, termination, warranty, and compliance with laws.

• Vendors must adhere to specific instructions for preparing and submitting offers electronically.

• The contract type is a fixed-price with economic price adjustment, indefinite delivery, indefinite quantity (IDIQ) Multiple Award Schedule contract.

• Contracts awarded under this solicitation are in effect for 5 years from the date of award, with options to extend up to 5 additional years (totaling 10 years).

• The minimum guaranteed order is $2,500.

• Offers must be submitted electronically via eOffer to vafssoffers@va.gov. Paper offers will be returned without consideration.

• Specific formatting and naming conventions for electronic submissions are required.

• Offers are evaluated based on reasonable pricing and being most advantageous to the Government, considering factors such as price, past performance, quality, and delivery terms.

• The solicitation is continuous with no closing date for receipt of offers.

• Offerors must demonstrate responsibility and the ability to fulfill contract obligations.

• Minimum annual sales criteria: $150,000 in commercial sales or $25,000 in government sales.

• New offerors without an existing FSS contract must complete the GSA “Pathway to Success” education seminar.

• Various small business set-aside clauses are incorporated by reference, indicating potential for orders to be set aside for small businesses, HUBZone, SDVOSB, EDWOSB, and WOSB concerns.

• The solicitation includes numerous FAR and GSA clauses, covering a wide range of contractual requirements.

• Vendors are advised to read the entire document thoroughly.

• Significant changes have been made since the previous solicitation (M5-Q52A-04-R5), including additions, deletions, and updates to various clauses and provisions.

Form / Attachment / Pricing Sheet

This document contains pricing information and related data required for proposal preparation. It includes several sheets: 'Price Proposal', 'Figure 515.4-2 CSP-1', 'NonManufacturers', 'Price Analysis', and 'Award'. Bidders must use these sheets to detail their pricing structure, manufacturer information, and country of origin for products offered.

• Price Proposal: Requires listing product details, manufacturer information (for resellers), commercial list price, MFC Net Price, and proposed FSS prices (with and without IFF).
• Figure 515.4-2 CSP-1: Provides instructions for entering dates related to data currency and disclosure limitations. It also outlines columns for Customer, Discount, Quantity/Volume, FOB Terms, and Additional Discounts.
• NonManufacturers: Details SIN, Manufacturer Name, Part Numbers, Product Description, and discount percentages for non-manufacturers.
• Price Analysis: Summarizes pricing data, including commercial list price, MFC Net Price, discounts, and proposed FSS prices.
• Award: Lists awarded SINs, Item #, Product Name, Tracking Ratio, and FSS Prices.
• Country Codes: Provides a reference list of countries and their corresponding codes.

This spreadsheet is critical for bidders to accurately populate their pricing proposals. It dictates the format for submitting price lists, manufacturer details, and country of origin information. Understanding and correctly completing these sections is essential for a compliant and competitive bid.

Amendment / Modification

This amendment (0001) to solicitation M5-Q52A-04-R6, dated 01-16-2018, incorporates several changes:

• Addition of Clauses: Includes "Ordering Contact (Mar 2018)" and "52.204-23 Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018)".

• Revision of Documents: Updates Document 03 (Proposal Price List Preparation, Proposal Checklist, Signatory Authority Form), Small Business Subcontracting Plan Template, FAR clause 52.219-9 Small Business Subcontracting Plan, and Trade Agreements notes/instructions to include Scope of Solicitation and Letter of Supply (I-FSS-644).

• The solicitation's terms and conditions are modified by the additions and revisions listed above.

• Specific documents affected include Document 03, Small Business Subcontracting Plan templates, and various FAR clauses.

• The amendment extends the hour and date specified for receipt of offers.

• Offerors must acknowledge receipt of this amendment.

• Changes may require offerors to update their proposals if they have already been submitted.

Form / Attachment / Pricing Sheet

This Excel file contains pricing information required for the solicitation. It includes several sheets for different aspects of pricing and non-manufacturer information.

• Price Proposal Sheet: Contains columns for SIN#, Item #, Product Name/Description, Country of Origin, Manufacturer Information, Commercial List Price, MFC Net Price, MFC % Off, MFC Name, Proposed Tracking Customer (TC) Name, Proposed TC Net Price, TC % Off, Proposed FSS Price (with and without IFF), and FSS % Off.
• Figure 515.4-2 CSP-1 Sheet: Provides a template for entering customer, discount, quantity/volume, FOB terms, and additional discounts or concessions. It also includes instructions for the date of data currency.
• NonManufacturers Sheet: A template for non-manufacturers to provide Manufacturer Name, Part Numbers, Product Description, Manufacturer List Price, and Dealer/Reseller discount percentages.
• Price Analysis Sheet: Details SIN#, Item #, Commercial List Price, MFC Net Price, MFC Discount, Proposed TC Net Price, TC Discount, Proposed FSS Price (with and without IFF), and FSS Discount.
• Country Codes Sheet: A comprehensive list of countries and their corresponding codes.

Bidders must use these templates to provide detailed pricing information as required by the solicitation. The 'Price Proposal' and 'Price Analysis' sheets are critical for outlining the proposed costs and discounts. The 'Figure 515.4-2 CSP-1' and 'NonManufacturers' sheets provide specific formats for different pricing scenarios and vendor types. The 'Country Codes' sheet is a reference for the 'Country of Origin' field.

Form / Attachment / Pricing Sheet

This document is an Excel file containing various sheets related to pricing, non-manufacturers, country codes, and awards. It appears to be a template or a data collection tool for bidders to provide detailed pricing and product information.

• Price Proposal Sheet: Requires bidders to detail product information, manufacturer details, sales data, commercial list prices, net prices, discounts, tracking customer information, and proposed FSS prices (with and without IFF).
• Figure 515.4-2 CSP-1 Sheet: Provides instructions for entering dates and details regarding customer, discount, quantity/volume, FOB terms, and additional concessions. It references external resources for further guidance.
• NonManufacturers Sheet: A table to list non-manufacturers, including manufacturer name, part numbers, product description, and discount information.
• Country Codes Sheet: A comprehensive list of countries and their corresponding codes, likely for use in the 'Country of Origin' field.
• Price Analysis Sheet: Facilitates the analysis of commercial list prices versus net prices and proposed government prices, including discount percentages and a comparison of government price to MFC price.
• Award Sheet: A section to indicate awarded SINs, item numbers, product names, tracking customer names, FSS prices, and a marker for awarded items.

This document is crucial for bidders to understand the detailed pricing structure and requirements for the opportunity. It outlines the specific data points needed for price proposals, discounts, and potential awards. Bidders must accurately complete the relevant sections of this spreadsheet to submit a compliant and competitive offer.

Amendment / Modification

This amendment (0003) to Solicitation M5-Q52A-04-R6, originally dated 01-16-2018, updates regulations, special language, and templates/forms. Key changes include:

• Addition of Clause: 52.219-33 Nonmanufacturer Rule (Mar 2020) has been added.
• Revisions to Regulations and Documents: Updates have been made to FAR and GSAR regulations, Document 03 – Price Proposal Preparation (Dec 2020), AS5000 Pharmaceutical Prime Vendor Participation (Dec 2020), and the Small Business Subcontracting Plan Template (Oct 2020).
• Updated FAR/GSAR Clauses: Numerous FAR and GSAR clauses have been updated to newer versions, including definitions (52.202-1), restrictions on subcontractor sales (52.203-6), contractor code of business ethics (52.203-13), whistleblower rights (52.203-17), reporting requirements (52.204-10), CAGE code maintenance (52.204-18), telecommunications prohibitions (52.204-25), and various small business program clauses (e.g., 52.219-6, 52.219-9, 52.219-14, 52.219-27, 52.219-28, 52.219-29, 52.219-30).

Specific FAR and GSAR clauses, the Price Proposal Preparation document, AS5000 Pharmaceutical Prime Vendor Participation document, and the Small Business Subcontracting Plan Template have been updated or added.

This amendment does not explicitly state a change to the hour and date for receipt of offers, but bidders should review all updated clauses and documents to ensure their proposals remain compliant with the latest requirements.

Form / Attachment / Pricing Sheet

This document is an Excel file containing several sheets related to pricing and product information for a potential government contract. It includes sections for Price Proposal, Figure 515.4-2 CSP-1, Non-Manufacturers, Country Codes, and Price Analysis. Bidders will use these sheets to provide detailed pricing information, product specifics, and manufacturer data.

• Price Proposal Sheet: Requires product information, manufacturer details, sales data, and various pricing tiers (Commercial List Price, MFC Net Price, Proposed Tracking Customer Net Price, Proposed FSS Price with and without IFF).
• Figure 515.4-2 CSP-1 Sheet: Captures transactional data and commercial agreements, including customer, discount, quantity/volume, FOB terms, and additional discounts. It also includes instructions for entering submission dates and date ranges for the data.
• NonManufacturers Sheet: Details product information for non-manufacturers, including manufacturer name, part numbers, and discount percentages.
• Country Codes Sheet: Provides a reference list of countries and their corresponding codes, used in the "Country of Origin" column.
• Price Analysis Sheet: Summarizes and analyzes the pricing data, comparing commercial prices with various government pricing tiers and calculating discounts.

This document is crucial for bidders to understand the required pricing structure and to accurately populate their proposals. It dictates how pricing should be presented, including specific discounts, government pricing, and manufacturer information. The "Country Codes" sheet is a reference for completing the "Country of Origin" field. The "Figure 515.4-2 CSP-1" and "Price Analysis" sheets provide further detail on how pricing data should be presented and analyzed, directly impacting proposal submission and evaluation.

Amendment / Modification

This amendment revises clause 552.238-80, "Industrial Funding Fee and Sales Reporting (Jul 2020, Tailored – Dec 2023)". The primary change is the reduction of the grace period for reporting sales and remitting the Industrial Funding Fee (IFF) from 60 days to 30 days after the close of the reporting quarter. Fiscal Year 2024, Quarter 1 (FY24 Q1) sales reporting must adhere to this new 30-day timeframe.

• Clause 552.238-80, "Industrial Funding Fee and Sales Reporting (Jul 2020, Tailored – Dec 2023)"

• Bidders must be aware of the shortened 30-day deadline for reporting sales and remitting the IFF, effective for FY24 Q1 reporting.

• The Industrial Funding Fee (IFF) remains 0.5% of total quarterly sales.

• Sales reporting must be submitted electronically via an automated system designated by the VA Federal Supply Service (FSS).

• Failure to comply with reporting and remittance deadlines can result in contract debt and may be grounds for termination for cause.

Amendment / Modification

This document is an amendment to Solicitation M5-Q52A-04-R601-16-2018 XXX1. It approves a class deviation to Federal Acquisition Regulation (FAR) subpart 22.8, Equal Employment Opportunity. This deviation is to stop the enforcement of FAR policies related to the now revoked Executive Order 11246, Equal Employment Opportunity, and to align with Executive Order (E.O.) 14173, which ended illegal discrimination and restored merit-based opportunity.

• FAR subpart 22.8, Equal Employment Opportunity, and associated provisions and clauses.
• Pages 2-13 of the original solicitation contain a summary of changes and updated clauses.

This amendment does not extend the hour and date specified for receipt of offers. Offerors must acknowledge receipt of this amendment. If an offer has already been submitted, changes can be made via letter or electronic communication referencing the solicitation and amendment number, provided it is received prior to the opening hour and date.

Amendment / Modification

This amendment (0006) to solicitation M5-Q52A-04-R6, dated 01-16-2018, updates regulations, special language, and templates/forms. Key changes include:

• Updated FAR Clauses:

  • 52.203-17: Incorporated through FAR 52.212-5 (JAN 2025) (DEVIATION FEB 2025), replacing the June 2020 version.
  • 52.212-3: Updated to the May 2024 version (Deviation Feb 2025), replacing the May 2024 version.
  • 52.212-5: Updated to the JAN 2025 version (DEVIATION FEB 2025), replacing the Nov 2020 version.
  • 52.219-9 (Alternate II): Incorporated through FAR 52.212-5 (JAN 2025) (DEVIATION FEB 2025), replacing the Nov 2020 version.
  • 52.226-8: Incorporated through FAR 52.212-5 (JAN 2025) (DEVIATION FEB 2025), replacing the June 2020 version.

• New Regulations/Language Added:

  • 52.203-17 Contractor Employee Whistleblower Rights (NOV 2023): This clause details contractor obligations regarding informing employees of whistleblower rights.
  • 52.212-3 Offeror Representations and Certifications - Commercial Products and Commercial Services (May 2024) (Deviation Feb 2025): This provision outlines updated representations and certifications required from offerors, particularly regarding electronic completion in SAM.
  • 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Products and Commercial Services (Jan 2025) (Deviation Feb 2025): This clause incorporates various updated FAR clauses.
  • 52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024): This clause encourages contractors to adopt policies prohibiting text messaging while driving.

• New Document: A new Responsibility Evaluation document has been added, which should be completed with options and new offers.

• The document references a table on Page 2 detailing specific changes to regulations, special language, and templates/forms.

• All terms and conditions of the original solicitation remain in effect unless specifically changed by this amendment.

• Offerors must acknowledge receipt of this amendment. Failure to do so may result in rejection of the offer.

• If an offeror desires to change a previously submitted offer due to this amendment, the change must be submitted in writing and received prior to the specified opening hour and date.

Amendment / Modification

This amendment (0007) to solicitation M5-Q52A-04-R6, originally dated 01/16/2018, incorporates the following updates:

• New Clause: GSAM Clause 552.238-120, "Economic Price Adjustment – Federal Supply Schedule Contracts (Tailored)" (September 2024), is added. This clause outlines procedures for adjusting contract pricing based on specified economic conditions, including definitions, general provisions, exceptions, specific methods for FSS contracts (including notes for SIN 42-2A, tracking customers, and price indices like CPI-U and PPI), submission requirements, and contracting officer responsibilities.
• Updated Document: The "Responsibility Evaluation" document has been updated to October 2025. This section details requirements for new Department of Veterans Affairs (VA) Federal Supply Schedule (FSS) offers, focusing on contractor qualifications and financial information necessary to determine responsibility.
• Updated Document: The "Signature Authority" form has been updated to August 2025. This form is used to identify individuals delegated authority to sign FSS offers and contracts on behalf of the firm.

• GSAM Clause 552.238-120 (New)
• Responsibility Evaluation (Updated to Oct 2025)
• Signature Authority form (Updated to Aug 2025)

This amendment does not explicitly state a change to the hour and date specified for receipt of offers. Offerors are reminded to acknowledge receipt of this amendment. The updates to the Responsibility Evaluation and Signature Authority forms may impact how offerors prepare and submit their proposals regarding financial responsibility and signatory authority.

Form / Attachment / Pricing Sheet

This document, "Overseas Delivery Vendor Response," is intended for offerors who are proposing to provide overseas delivery services. It outlines the specific clauses, requirements, and response formats necessary for vendors offering overseas delivery as defined in the solicitation.

• Overseas Delivery Clauses: Lists and provides text for various clauses related to overseas shipments, including language, currency, wood packaging, electric current characteristics, marking, transshipments, and foreign taxes/duties.
• Vendor Response Sections: Includes continuation of SF 1449 (Blocks 19-21) for the Schedule of Items, with specific Special Item Numbers (SINs) related to reagents and controls for various laboratory applications, and glucose monitoring supplies. It also requires designation of geographic areas and F.O.B. shipping terms.
• Certification: Requires a "Certification Regarding Trafficking in Persons Compliance Plan" for contracts exceeding $500,000 for supplies or services acquired or performed outside the United States.
• F.O.B. Terms: Details three F.O.B. shipping terms: Destination, Inland Carrier (Point of Exportation), and Inland Point (Country of Importation), with specific responsibilities for the contractor and ordering activity under each.
• Delivery Schedule: Requires offerors to specify delivery times (ARO) for both standard and expedited delivery, including commercial and proposed government terms.
• Parts and Service: Requires offerors to certify availability of parts and services at overseas destinations or the establishment of such facilities.
• Proposed Pricing: Outlines the required format for submitting overseas delivery pricing, including an Excel spreadsheet with specific columns for product information, Most Favored Customer (MFC) details, Tracking Customer (TC) information, and FSS pricing. It emphasizes that proposed pricing must be inclusive of shipping costs.
• Commercial Sales Practices (CSP-1): Requires detailed information on commercial sales practices, including sales to the general public, projected annual sales to the government, and a comparison of discounts and concessions offered to the government versus commercial customers.

This document is critical for any vendor intending to offer overseas delivery. It dictates the specific clauses that will govern such contracts, the required format for itemized offerings, the shipping terms that must be considered in pricing, and the detailed pricing and commercial sales practice information that must be submitted. Failure to comply with these requirements may result in rejection of the offer.

Form / Attachment / Pricing Sheet

This document, "02_VendorResponse_65VII_R6_1162018.docx", is a comprehensive vendor response package for a Federal Supply Schedule (FSS) solicitation. It requires offerors to complete various sections, including signatory authority, agent authorization, SF-1449 form, commercial sales practices, past performance (for new offerors), and small business subcontracting plans (if applicable). It also includes detailed information on the scope of the solicitation, product categories (SINs), delivery terms, order limitations, and specific clauses related to hazardous materials, medical devices, and trade agreements.

• Vendor Response Sections: Requires completion of forms for signatory authority, agent authorization, SF-1449, ACH payment enrollment, business size determination, and more.
• Schedule of Items: Details specific Special Item Numbers (SINs) for In-Vitro Diagnostic Substances, Reagents, Test Kits, and Sets, with estimated annual sales for each.
• Scope of Solicitation: Outlines the FSS program, eligible ordering activities, delivery requirements (domestic and overseas), and limitations on commercial items.
• Clauses and Provisions: Includes numerous standard and tailored clauses covering delivery schedules, order limitations, hazardous materials, medical device compliance, place of performance, authorized negotiators, and more.
• Commercial Sales Practices: Requires detailed information on proposed pricing, discounts, concessions, and commercial sales data.
• Past Performance & Subcontracting: Sections for new offerors to provide past performance references and for "other than small businesses" to submit subcontracting plans.

This document is critical for potential bidders as it contains all the necessary forms, instructions, and contractual requirements for responding to the solicitation. It details the specific products/services sought (SINs), pricing structures, delivery expectations, compliance obligations (e.g., TAA, FDA regulations), and submission requirements. Offerors must carefully review and complete all applicable sections to ensure a compliant and competitive proposal.

Amendment / Modification

This amendment (0002) to Solicitation M5-Q52A-04-R6, dated 01-16-2018, makes several updates:

• Item 1: Revises sections related to "New Items, Refurbished Items, and 'Grey Market Goods" within the "Electronic Acceptance of Offers (Mar 2020)" and "Scope of Solicitation (Jan 2020)" documents.
• Item 2: Adds, removes, and revises various Federal Acquisition Regulation (FAR) and General Services Acquisition Regulation (GSAR) clauses and provisions, as well as solicitation-specific language.
• Item 3: Updates the "Small Business Subcontracting Plan Template (April 2019)", "Signatory Authority Form (Jan 2020)", and "Proposal Checklist (Mar 2020)".
• Item 4: Revises "Document 03 – Price Proposal Preparation (Dec 2019)". Refer to the attached Excel file for details.

• "Electronic Acceptance of Offers (Mar 2020)"
• "Scope of Solicitation (Jan 2020)"
• Various FAR and GSAR clauses and provisions
• "Small Business Subcontracting Plan Template (April 2019)"
• "Signatory Authority Form (Jan 2020)"
• "Proposal Checklist (Mar 2020)"
• "Document 03 – Price Proposal Preparation (Dec 2019)"

This amendment extends the hour and date for receipt of offers. Specific details regarding the new deadline are not provided in this amendment text but are implied by the extension. Offerors must acknowledge receipt of this amendment. Changes to previously submitted offers are permitted if received prior to the new opening hour and date.

Amendment / Modification

This amendment (0007) to solicitation M5-Q52A-04-R6, originally dated 01/16/2018, introduces the following updates:

• Incorporation of GSAM Clause: GSAM Clause 552.238-120, "Economic Price Adjustment – Federal Supply Schedule Contracts (Tailored) (Sep 2024)", is added. This clause outlines procedures for economic price adjustments (EPA) to contract pricing, including definitions, general provisions, exceptions, specific methods for FSS contracts (including notes for SIN 42-2A, tracking customer prices, and indices for Schedule 621 I and 66 III), submission requirements, contracting officer responsibilities, and effective dates.
• Update to Responsibility Evaluation: The "Responsibility Evaluation" section, dated October 2025, has been updated. For new VA Federal Supply Schedule (FSS) offers, it requires offerors to complete the "Contractor’s Qualifications and Financial Information Form" or provide two years of financial statements (audited if available) to determine financial responsibility. It specifies acceptable alternative documentation for new contractors with less than two years of experience and prohibits the submission of tax returns.
• Update to Signature Authority Form: The "Signature Authority" form, dated August 2025, has been updated. This form is used to identify individuals delegated authority to sign FSS offers or contracts. It requires listing company officers and other authorized signatories, along with their roles and contact information.

• GSAM Clause (newly incorporated)
• Responsibility Evaluation section
• Signature Authority form

This amendment does not explicitly extend the hour and date for receipt of offers. Offerors must acknowledge receipt of this amendment. The updates to the Responsibility Evaluation and Signature Authority forms may impact proposal preparation and submission requirements for new offerors.

Amendment / Modification

This amendment modifies the solicitation by incorporating the following:

• GSAM Clause 552.238-120 Economic Price Adjustment – Federal Supply Schedule Contracts (Tailored) (Sep 2024).

• An update to the Responsibility Evaluation dated October 2025.

• An update to the Signature Authority form dated August 2025.

• GSAM Clause 552.238-120 is added.

• Responsibility Evaluation section is updated.

• Signature Authority form is updated.

This amendment does not explicitly state changes to proposal deadlines or submission requirements. Offerors are reminded to acknowledge receipt of this amendment as per the instructions in Item 14 of the Standard Form 30.