36C24125Q0857.docx

Combined Synopsis/Solicitation Notice

GENERAL INFORMATION

Network Contracting Office 1 (NCO 1) Contracting Officer (90C) 1 VA Center Augusta ME 04330

POINT OF CONTACT*

Contracting Specalist Todd Hanson todd.hanson@va.gov

PLACE OF PERFORMANCE

830 Chalkstone Avenue

Providence RI

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

DESCRIPTION

Combined Synopsis/Solicitation Notice Combined Synopsis Intent to Compete/RFQ OEM-Authorized SB Distributors Omni Hysteroscope Standard Sets/Omni Instrument Trays

Combined Synopsis/Solicitation Notice

DESCRIPTION

Combined Synopsis/Solicitation Notice

Page 1 of

Combined Synopsis/Solicitation Notice

Page 1 of STRAIGHT SB SET-ASIDE AMONGST HOLOGIC-AUTHORIZED SB DISTRIBUTORS FOR TWO (2) HOLOGIC OMNI STANDARD SETS AND (2) HOLOGIC OMNI INSTRUMENT REAYS

GENERAL INFORMATION: This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in FAR 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested, and a written solicitation will not be issued.

This solicitation: 36C24125Q0857 is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2025-05, August 7th, 2025.

This combined synopsis is being solicited with the intent to award via a FAR 19.502-2(a) Straight SB (Small Business) Set-Aside competition at Contract Opportunities, amongst the two (2) designated Hologic OEM (Original Equipment Manufacturer)-authorized SB Class Distributors for a one-time, purchase of two (2) OMNI Instrument Tray and (2) Hologic OMNI Hysteroscope Standard Set for VAMC Providence RI.

This is a brand-name-only solicitation for Hologic’s OMNI Hysteroscope, listed on the Product List below. VAMC Providence has standardized to the Hologic Fluent and Hysteroscopy Systems. The quotes will be submitted via email. The competition will be among the two known Hologic’s OMNI Hysteroscope OEM-authorized SB Class distributors: DGA Medical LLC and Sustainment Technologies, LLC.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339113, with a small business size standard of 800 employees. The FSC/PSC is 6515. The competition will be an SB set-aside amongst the OEM-authorized distributors IAW FAR 19.502-2(a):

Document Type: Combined Solicitation Synopsis

VISN 1 New England is seeking to purchase two (2) OMNI Instrument Trays and two (2) Hologic OMNI Hysteroscope Standard Sets for VAMC Providence, RI

Hologic has identified (2) Hysteroscope SB class distributors: DGA Medical LLC and Sustainment Technologies, LLC. All Hologic OMNI-authorized distributors shall provide quotations for the required Hologic OMNI Instrument Tray and Hologic OMNI Hysteroscope Standard Set for VAMC, Providence, RI.

The quotations shall be for two (2) Hologic OMNI Instrument Trays and two (2) Hologic OMNI Hysteroscope Standard Sets listed below, and as described in detail in the combined synopsis solicitation, Intent to Compete/ RFQ to be posted on Contract Opportunities. The product is manufactured in the USA. The FOB point is “Destination.”

Hologic OMNI Instrument SB Class Distributors: DGA Medical and Sustainment Technologies shall submit the following: Submit a quote for (4) OMNI Instruments as listed in the Product List above.

Please follow the solicitation provisions, clauses, and the addendum to offerors stated below:

The following solicitation provisions apply to this acquisition:

1. FAR 52.212-1” Instructions to Offerors–Commercial Items” (SEP 2023)

· Awards shall be made to the OEM-authorized SB Class distributor/quoter, who holds whose quotation, is determined to be the lowest price.

· Pricing shall be entered into for each line item as listed in the PRODUCT LIST above.

· The requirement is for two (2) Hologic OMNI Instrument Tray and (2) Hologic OMNI Hysteroscope Standard Set product VAMC Providence RI

· The respondent must be verifiable as a SB in SAM and on the SBA (Small Business Administration) DSBS website.

· All other quoters not authorized by the OEM to distribute the Hologic OMNI will not be considered.

· Distributors will need to submit a LOA (Letter of Authorization) from Hologic OMNI designating that distributor as an authorized distributor for Hologic.

· No substitutions. Due to standardization to Hologic OMNI equipment and the Fluent technology systems, the hysteroscopy equipment purchased must be Hologic OMNI brand to ensure full system integration and compatibility: fit, form, and function.

The following solicitation provisions apply to this acquisition:

2. FAR 52.212-2 (NOV 2021) The government will evaluate information based on the following evaluation criteria:

(1) Full capability to supply all Line-Item requirements listed above, at the lowest price.

3. FAR 52.212-3: “Offerors Representations and Certifications–Commercial Items” [FAR Overhaul Reserved at 52.212-3.] Offerors must complete annual representations and certifications on-line at https://www.sam.gov/portal/SAM/#1, in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items.” If paragraph (j) of the provision is applicable, a written submission is required.

The following contract clauses apply to this acquisition:

· FAR 52.212-4, “Contract Terms and Conditions–Commercial Items” Nov 2023

· FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive Orders” Jan 2025 (DEVIATION FEB 2025)

The following subparagraphs of FAR 52.212-5 (JAN 2025) are applicable:

· 52.204-10, 52.209-6, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-50, 52.223-1 (MAY 2024) (DEV FEB 2025); 52.223-10 (MAY 2024) (DEV FEB 2025), 52.223-23 (MAY 2024) (DEV FEB 2025), 52.223-18, 52.225-13, 52.232-33.

· FSS Schedule products satisfy Trade Agreement requirements.

VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB 2023)

(a) No used, refurbished, or remanufactured supplies or equipment/parts shall be provided. This procurement is for new Original Equipment Manufacturer (OEM) items only. No gray market items shall be provided. Gray market items are OEM goods intentionally or unintentionally sold outside an authorized sales territory or sold by non-authorized dealers in an authorized sales territory.

VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB 2023) (Cont’d):

(b) No counterfeit supplies or equipment/ parts shall be provided. Counterfeit items include unlawful or unauthorized reproductions, substitutions, or alterations that have been mismarked, misidentified, or otherwise misrepresented to be an authentic, unmodified item from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer. Unlawful or unauthorized substitutions include used items represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics.

(c) Vendor shall be an OEM, authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

(End of Clause)

VAAR 852.212-72 GRAY MARKET AND COUNTERFEIT ITEMS— INFORMATION TECHNOLOGY MAINTENANCE ALLOWING OTHER-THAN-NEW PARTS (FEB 2023)

(a) No used, refurbished, or remanufactured supplies or equipment/parts shall be provided. This procurement is for new Original Equipment Manufacturer (OEM) items only. No gray market items shall be provided. Gray market items are OEM goods intentionally or unintentionally sold outside an authorized sales territory or sold by non-authorized dealers in an authorized sales territory.

(b) No counterfeit supplies or equipment/ parts shall be provided. Counterfeit items include unlawful or unauthorized reproductions, substitutions, or alterations that have been mismarked, misidentified, or otherwise misrepresented to be an authentic, unmodified item from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer.

Unlawful or unauthorized substitutions include used items represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics.

(c) Vendor shall be an OEM, authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

(End of Clause)

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (SEP 2023): Provisions that are incorporated by reference (by Citation Number, Title, and Date) have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The version of FAR 52.212-1 in the addendum is tailored for Simplified Acquisition Procedures and supersedes the current version of FAR 52.212-1 contained in the FAR.

The following provision is incorporated into 52.212-1 as an addendum to this solicitation:

52.212-1 Instructions to Offerors – Commercial Products and Commercial Services (SEP 2023) (a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code(s) and small business size standard(s) for this acquisition appear elsewhere in the Request for Quote (RFQ). However, the small business size standard for a concern that submits a quote, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce, is 500 employees if the acquisition—

The following provision is incorporated into 52.212-1 as an addendum to this solicitation (Cont’d):

(1) Is set aside for small businesses and has a value above the simplified acquisition threshold;

Or

(2) Uses the HUBZone price evaluation preference regardless of dollar value, unless The quoter waives the price evaluation preference; or

(3) Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award, regardless of dollar value.

(b) Submission of Quotes. Submit signed and dated quotes to the office specified in this Request for Quote (RFQ) at or before the exact time specified. Quotes may be submitted on letterhead stationery or as otherwise specified in the RFQ. As a minimum, quotes must show—

(1) The solicitation number;

(2) The time specified in the solicitation for receipt of quotations;

(3) The name, address, and telephone number of the quoter;

(4) A technical description of the items being quoted in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature or other documents, if necessary.

(5) Terms of any express warranty;

(6) Price and any discount terms;

(7) "Remit to" address, if different from the mailing address;

(8) A completed copy of the representations and certifications of the Federal Acquisition Regulation (FAR) 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that The quoter shall complete electronically.;

(b) Submission of Quotes (cont’d):

(9) Acknowledgment Request for Quotation amendments;

(10) Past performance will not be considered in simplified acquisition procurements.

(11) Quote should include a statement specifying the extent of agreement with all terms, conditions, and provisions contained in the solicitation. Quotes that fail to furnish required representations and certifications, information requested in (1) to (9), and accept the terms and conditions of the solicitation may be excluded from consideration.

(c) Period for acceptance of Quotes. The quoter agrees to hold the prices in its quote firm for 30 calendar days from the date specified for receipt of quotes unless another time period is specified in an addendum to the solicitation.

(d) Product samples. NA

(e) Multiple Quotes. Quoters are requested to submit one (1) quote presenting the best discounted price for the required Hologic OMNI Hysteroscopes.

(f) Late submissions, revisions, and withdrawals of quotes.

(1) Quoters are responsible for submitting quotes to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 PM, local time, for the designated Government office on the date that quotes are due. (Time specified is 09/25/25 16:30 (EDT))

(2) Any quotation received at the Government office designated in the solicitation after the exact time specified for receipt of quotes is "late" and may not be considered unless it is received before purchase order issuance and the Contracting Officer (CO) determines that accepting the late quotation would not unduly delay the acquisition.

(3) If an emergency or unanticipated event interrupts normal Government processes so that quotations cannot be received at the Government office designated for receipt of quotes by the exact time specified in the solicitation, and urgent Government requirements preclude a notice of an extension of the closing date, the time specified for receipt of quotes will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

(g) Issuance of Purchase Order. The Government may issue a purchase order to one or more quoters as identified in the Request for Quote (RFQ). Therefore, the quoter’s initial quote should contain the best terms and the best FSS Schedule discounted price. All service packages from OEM are set per OEM Part Number. The Government may reject any or all quotes if such action is in the public’s best interest.

(h) Multiple awards. The Government may issue a purchase order for any item or group of items of a quotation, unless the quoter qualifies the quotation by specific limitations. Unless otherwise provided in the schedule, quotations may not be submitted for quantities less than those specified. The Government reserves the right to issue a purchase order for an amount less than the quantity quoted, at the unit prices quoted, unless the quoter specifies otherwise in the quotation.

(1) Availability of requirements documents cited in the solicitation.

(i) The GSA Index of Federal Specifications, Standards and Commercial Item Descriptions, FPMR Part 101-29, and copies of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained for a fee by submitting a request to- GSA Federal Supply Service Specifications Section Suite 8100 470 East L’Enfant Plaza, SW Washington, DC 20407 Telephone (202) 619-8925, Facsimile (202) 619-8978.

(ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a single copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained free of charge by submitting a request to the addressee in paragraph (i)(1)(i) of this provision. Additional copies will be issued for a fee.

(2) NA: Applies to DoD.

(3) NA: Applies to DoD.

(4) Nongovernment (voluntary) standards must be obtained from the organization responsible for their preparation, publication, or maintenance.

(j) Unique entity identifier (UEI). Applies to all quotes that exceed the micro-purchase threshold, and quotes at or below the micro-purchase threshold if the solicitation requires the contractor to be registered in the System for Award Management (SAM).)

· The quoter must enter, in the block with its name and address on the cover page of its quote, the annotation "Unique Entity Identifier" followed by the unique entity identifier that identifies the quoter's name and address. The quoter also must enter its Electronic Funds Transfer (EFT) indicator, if applicable.

· The EFT indicator is a four-character suffix to the UEI. The suffix is assigned at the discretion of the quoter to establish additional SAM records for identifying alternative EFT accounts (see FAR subpart 32.11) for the same entity.

· If the quoter does not have a UEI, it should contact the entity designated at www.sam.gov for UEI establishment directly to obtain one. The quoter should indicate that it is a quoter for a Government contract when contacting the entity designated at www.sam.gov for establishing the UEI.

(k) [Reserved]

(l) Requests for information. The CO will not notify unsuccessful quoters that responded to this Request for Quotation (RFQ). However, quoters may request information on purchase order(s) resulting from this solicitation with the CO.

(End of Provision)

To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoters shall list exception(s) and rationale for the exception(s), if any.

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below.

All quotations shall be emailed to: todd.hanson@va.gov

The lowest price will be the sole determining factor. Please submit your best price with the best discount applied. The award will be made to the pricing response most advantageous to the Government.

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

This is an open-market combined synopsis/solicitation for products as defined herein. The government intends to award a one-time contract/purchase order as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein.

E-mailed quotes will be accepted. Submission shall be received no later than 16:30 EDT 09/25/25.

Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C241-25-AP-4763

1. Contracting Activity: US Department of Veterans Affairs, VISN 01, VAMC White River Junction, VT, 215 North Main Street, White River Junction, VT.

Funding document: 650-25-4-5090-0049

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

Two (2) Hologic OMNI Instrument Trays and two (2) Hologic OMNI Instrument Trays and two (2) Hologic OMNI Hysteroscopes at Women's Health Care, VAMC, Providence, RI

· (2) Hologic OMNI Instrument Tray

· (2) two (2) Hologic OMNI Hysteroscopes

3. Unique characteristics that limit availability to only one source, with the reason that no other supplies or services can be used. Two (2) Hologic OMNI Instrument Trays and two (2) Hologic OMNI Hysteroscopes at Women's Health Care, Providence VAMC has standardized on many Hologic brand environmental control and power regulation products.

4. Description of market research conducted and results or statement why it was not performed: Market research was conducted IAW FAR 10.001. Contracting conducted market research to determine if the required VFDs could be sourced from mandatory sources, to determine if SDVOSBs could be provided first opportunity via VFCP, or if any other set-aside opportunities could be applied, and whether the VFDs could be sourced from any non-mandatory GSA or GWAC contracts.

· VFCP (Veterans First Contracting Program): An SBA DSBS search under NAICS 339113 revealed four capable SD/VOSB class distributors within the Environmental Control Manufacturing group. None of the SD/VISBs listed are authorized to distribute for Hologic. There are (3) OEM-authorized Hologic distributors within the SD/VOSB class; they were not listed in the SBA DSBS search.

· Mandatory Sources: The VFDs are not available through mandatory sources such as VA Inventories, Other Agencies, or AbilityOne. There were no mandatory contract vehicles for the VFDs located on the SAC (Strategic Acquisition Center) or the SCMC (Supply Chain Master Catalog). The SCMC search yielded zero results when searching for Variable and via search by part number. There are no IDVs for this requirement.

· NAC (National Acquisition Center): There were no results for Hysteroscope in the NAC.

· GSA Advantage: The search term "Hysteroscope" results in GSA Advantage. Hysteroscopes are an open market procurement.

· GSA e-Library: A GSA e-Library search also produced zero results when using search terms for NAICS 339113, and Hysteroscope

· FPDS: FPDS was searched using the keywords: Hysteroscope and NAICS 339113. There were no results in FPDS.

· Nonmanufacturer Rule (NMR) Findings: The required hysteroscopes are domestically manufactured by the large business (LB) OEM. Market research has determined that there are at least two SDVOSBs (non-manufacturers) and 1 SB (Non-manufacturer) that sells the required VFDs. There is no NMR Waiver; therefore, the VA Rule of Two requirement cannot be met due to the OEM being an LB. The NMR decision tree indicates that an SB Set-Aside can be leveraged IAW FAR 19.502-2. It is anticipated that the requirement can be completed between (3) (2) SB class distributors.

Recommendation: The recommendation for this requirement is a SB Set-Aside IAW FAR 19.502-2 (a). The Hysteroscope is required to ensure system integrity through its fit, form, and function, thereby providing optimal power stabilization to the VAMC in Providence, RI. Hologic distributes its products through its authorized distributors, who are assigned according to geographic location. The requirement will fall below SAT; there is no NMR waiver to leverage VFCP. The NMR Exception applies; there are at least (2) SB class Hologic-authorized distributors. The Rule of (2) will be met. The recommendation for an SB Set-Aside will afford competition to the maximum extent practicable.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR 13.106-1 (b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Deidra Thomas Contracting Officer VAMC White River Junction, VT, NC1 RPOE

STATEMENT OF WORK

Hologic OMNI Hysteroscopy System VAMC Providence RI

SCOPE OF WORK: The Contractor shall provide all labor, personnel, equipment, tools, materials, supervision and other items and services necessary to provide a fully functional system that meets the following characteristics:

1. EQUIPMENT: Two Omni Hysteroscope Standard Sets and two Omni Rod Lens Hysteroscope Instrument Trays. These sets will allow women’s health providers to do more D&C (Dilation and Curettage) hysteroscopy procedures to meet the veteran demand and decrease wait times for these procedures. Currently, only two procedures can be booked per day due to SPS reprocessing times, and this purchase would allow 3-4 to be booked. The scopes need to be of the same brand name (Hologic) to achieve standardization of equipment – this will allow standard setup in the OR for the providers.

2. SALIENT CHARACTERISTICS

QTY 2: Omni Hysteroscope Standard Set (60-250-1)

· (1) 60-200 2.9 mm mm 0º Operative Hysteroscope, 45º Offset

· (1) 60-201 Diagnostic Sheath 3.7mm

· (1) 60-202 Operative Sheath 5.5mm

· (1) 60-203 Operative Sheath 6.0mm

· (1) 40-201 MyoSure XL 6.25 mm Outflow Sheath

· (1) 50-201XL MyoSure XL 7.25 mm Outflow Sheath

· (1) Light Cable Adaptor

QTY 2: Omni Rd Lens Hysteroscope Instrument Tray

· A sterilization tray that encloses, protects and organizes the Omni Hysteroscopes, Sheaths, and Removable Outflow Channels (all included in the Hysteroscope Standard Set) for sterilization and storage

2. AREAS TO BE SERVICED

Department of Veterans Affairs Providence VA Medical Center 830 Chalkstone Ave Providence, RI 02908

3. INSTALLATION

NA

4. TRAINING

NA

5. INSPECTION AND ACCEPTANCE

a) The Contractor shall conduct a joint inspection with the COR upon delivery of equipment.

b) Contractor shall provide dates of completion of punch list items and replacement parts and/or short ship items from the manufacturer(s).

c) The COR shall ensure all work is completed satisfactorily prior to acceptance. Disputes shall be resolved by the Contracting Officer.

6. WARRANTY

a) The contractor shall provide a one-year manufacturer’s warranty on all parts and labor.

b) The warranty shall include all travel and shipping costs associated with any warranty repair.

7. TASK FREQUENCY AND INSTRUCTIONS

NA

8. SPECIAL WORK REQUIREMENTS: The Contractor shall comply with any and all Infection Control Risk Assessment requirements deemed appropriate by the Providence VA Medical Center during all portions of the work set forth in the Scope of Work.

The Contractor must comply with security, privacy, and safety issues in accordance to VA standards, policies, and directives set forth at all times while providing the work outlined in the Scope of Work.

9. PROPERTY DAMAGE: The contractor shall take all necessary precautions to prevent damage to any government property. The contractor shall report any damages immediately and shall be assessed current replacement costs for property damaged by the contractor, unless corrective action is taken. Any damaged material (e.g. trees, shrubs, lawn/turf, curbs, gutters, sidewalks, etc.) will be replaced in a timely manner or corrected by the contractor with like materials, at no extra cost to the government, upon approval of the Contracting Officer.

10. ATTACHMENTS: None.

11. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA REGULATIONS

The contractor's employees shall wear visible identification at all times while on the premises of the VA property. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service. The VA will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited inside any buildings at the VA. Cellular phones and two-way radios are not to be used within six feet of any medical equipment. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in a citation answerable in the United States (Federal) District Court, not a local district state, or municipal court.

12. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD

The contractor shall comply with the Federal OSHA Blood borne Pathogens Standard. The contractor shall:

13. INFORMATION SECURITY LANGUAGE

14. Records Management Language for Statement of Work (SOW):

The following standard items relate to records generated in executing the contract and should be included in a typical procurement contract:

1. Citations to pertinent laws, codes, and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information

The RFQ will be dispatched via email to the two (2) Hologic-authorized SB Class Distributors for competition to the maximum extent practicable.

RFQ 36C241Q0857: Hologic OMNI Standard Sets and Hologic OMNI Instrument Trays

Good morning, VAMC Providence RI is looking to purchase two (2) Hologic OMNI Standard Sets and (2) Hologic Instrument Trays as listed in the Product List below:

The items quoted must be the Hologic brand product and must be identical to the brand Name Part Number and Description as listed below.

Please note that shipping costs should be included in Line-Item Costs and not listed as a separate Line Item.

· Lowest Price will be the final determining criteria.

· Please submit your best offer; please consider including all available discounts.

· Please list any contracts that may apply.

· Please note that the Scope of Work (SOW) is attached above in the Combined Synopsis.

· The product will be delivered to VAMC Providence, 830 Chalkstone Ave., Providence RI, 02908-4734.

Product List Hologic OMNI Standard Sets and Hologic Instrument Trays:

We are looking to process this order by 09/26/25. Please respond to RFQ by 09/25/25 at 16:30 PM EDT

· Please let me know if you have any questions.

· Please let me know if the due date and time will not work for your schedule.

Thank you in advance for submitting a quote via email to todd.hanson@va.gov

Please copy the Contracting Officer Deidra Thomas: deidra.thomas@va.gov on all emails.

Combined Synopsis: Intent to Compete/RFQ Straight SB Set-Aside Between OEM-Authorized Distributors

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Combined Synopsis/Solicitation Notice image1.emf image2.emf

Appendix C 6500 ISO Info 2024.pdf

MARCH 12, 2010 VA HANDBOOK 6500.6

APPENDIX C

C-1

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR

INCLUSION INTO CONTRACTS, AS APPROPRIATE

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontrator shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S.

to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

VA HANDBOOK 6500.6 MARCH 12, 2010

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3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data

- General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

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f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold

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g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R.

Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy

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Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COTR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration.

Information technology staff must also use the Windows Installer Service for installation to the default “program files” directory and silently install and uninstall.

d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

g. The contractor/subcontractor agrees to:

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

(a) The Systems of Records (SOR); and

(b) The design, development, or operation work that the contractor/subcontractor is to perform;

(2) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and

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(3) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a

SOR.

h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.

(1) “Operation of a System of Records” means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

(2) “Record” means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person’s name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

(3) “System of Records” means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as “Systems”), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than ____ days.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within ____ days.

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l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor’s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR and approved by VA Privacy Service prior to operational approval.