6515--NX EQ Capsule Endoscopy (VA-26-00006488)

Description

{"description":"\nCombined Synopsis/Solicitation Notice\n\n\nCombined Synopsis/Solicitation Notice\n\n\n\nPage 8 of 8\n\n*= Required Field\nCombined Synopsis/Solicitation Notice\n\n\nPage 1 of 11\nSolicitation Number: \n36C10G26Q0024\nNotice Type: \nCombined Synopsis/Solicitation Synopsis: COMBINED SYNOPSIS/SOLICITATION\nThis is a combined synopsis/solicitation for brand name or equal commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; offers are being requested, and a written solicitation will not be issued. \nSolicitation number 36C10G26Q0024 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Quote (RFQ). This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2025-06, dated August 27, 2025. This award will be made pursuant to 38 U.S.C. 8127, which authorizes the Department of Veterans Affairs to award sole-source contract to verified Service-Disabled Veteran-Owned or (Veteran-Owned) Small Businesses. Per Federal Acquisition Regulation Part 6.103-5(e), no justification and approval is required for contracts awarded under this statutory authority (except 8(a) sole source awards over $25 million, which is not applicable here. \nRequirement Description:\nVA has a requirement to purchase NX EQ CAPSULE ENDOSOPY to deliver patient care to its VA Medical Centers Nationwide and in outlying territories. Capsule Endoscopy systems are designed to examine various points along the intestinal tract using images captured with a tiny ingestible video camera. These systems typically consist of three components: a disposable ingestible camera pill/capsule that is swallowed by the patient and that transmits video images as it passes through the gastrointestinal tract, a recorder used by the patient (e.g., worn on a belt around the waist) that receives the signals transmitted by the camera, and a workstation appropriate for processing and displaying the images from the recorder. Ingestible camera endoscopic video systems are used to detect abnormalities (e.g., angioectasia, ulcers, tumors) especially in areas of the small intestine that are difficult or impossible to reach using endoscopes.\nA single award Requirements contract will be awarded IAW FAR 52.211-6 Brand Name in accordance with all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Offers shall contain the terms for cost/price and technical capabilities of the brand name or equal equipment. The Government reserves the right to award without discussions. \nThe associated North American Industrial Classification System (NAICS) code for this procurement is 334510 Endoscopic equipment, electromedical (e.g., bronchoscopes, colonoscopes, cystoscopes), manufacturing, Product Service Code: 6515 Medical and Surgical Instruments, Equipment, and Supplies. and the associated size standard is 750 employees. This procurement action is issued as a Sole Source award to verified Service-Disabled Veteran-Owned (or Veteran-Owned) Small Business.\nThis acquisition is for a single award Requirements contract in accordance with FAR Part 16.03 for Medtronic brand name NX EQ CAPSULE ENDOSCOPY and related equipment and accessories as identified in ATTACHMENT A PRICE COST SCHEDULE - NX EQ CAPSULE ENDOSOPY. All interested companies shall provide an offer for all Contract Line-Item Numbers (CLINs) listed in ATTACHMENT A PRICE COST SCHEDULE NX EQ CAPSULE ENDOSOPY and paragraph 2 below. \nThe ordering period is for one 12-month base year with four 12-month option years. Delivery is FOB destination.\nFirm-Fixed Price Orders will be placed against this contract in writing and will provide the delivery locations, delivery dates and exact quantities. \nThe FAR provision at 52.212-1, Instructions to Offerors Commercial Products and Commercial Services, applies to this acquisition including attached addenda (ATTACHMENT D) to the provision.\nThe FAR provision at 52.212-2, Evaluation -- Commercial Products and Commercial Services, and the specific evaluation criteria as attached addenda (ATTACHMENT D) also applies to this acquisition.\nThe Offeror is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Products and Commercial Services, with its offer.\nClause at 52.212-4, Contract Terms and Conditions -- Commercial Products and Commercial Services, applies to this acquisition and a statement regarding any addenda to the clause. Addendum is attached (ATTACHMENT C).\nClause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Products and Commercial Services, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to the acquisition. Addendum is attached (ATTACHMENT C).\nAll interested offerors must be registered in the System for Award Management (SAM) prior to submitting an offer. You may access SAM at https://sam.gov/SAM/.\nQuestions regarding this combined synopsis/solicitation are due via email by 11:59 PM ET on December 22, 2025, to Contracting Officer, Hosea Berkley at Hosea.Berkley@va.gov. No calls will be accepted.\nOffers are due via email by 11:59 PM ET on December 29, 2025, to Contracting Officer, Hosea Berkley at Hosea.Berkley@va.gov.\n1. SCOPE OF WORK: \n\nThe Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Capsule Endoscopy product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract award. \n\nThe Veterans Health Administration (VHA) Non-Expendable Equipment National Program is seeking offerors that can provide Capsule Endoscopy. The Capsule Endoscopy systems are designed to examine various points along the intestinal tract using images captured with a tiny ingestible video camera. These systems typically consist of three components: a disposable ingestible camera pill/capsule that is swallowed by the patient and that transmits video images as it passes through the gastrointestinal tract, a recorder used by the patient (e.g., worn on a belt around the waist) that receives the signals transmitted by the camera, and a workstation appropriate for processing and displaying the images from the recorder. Ingestible camera endoscopic video systems are used to detect abnormalities (e.g., angioectasia, ulcers, tumors) especially in areas of the small intestine that are difficult or impossible to reach using endoscopes.\n\nThe Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Capsule Endoscopy to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for a base of 12-months with four 12-month option periods.\n\n\n\n2. REQUIREMENT\n\nThis requirement will be IAW FAR clause 6.103, Brand Name which requires the quoter indicate that the product being offered is a Capsule Endoscopy. \n\n\nContract Line Items\nManufacturer\nPart Number\nDescription\n0001\nMedtronic\nFGS-0504\nUSBC 2PK\n0002\nMedtronic\nFGS-0688\nPillCam® GENIUS SB 1 PK US\n0003\nMedtronic\nFGS-0802\nSOFTWARE PillCam® 9.7 US\n0004\nMedtronic\nFGS-0806\nGenius Sync Agent (GSA) OFFLINE PillCam® US\n0005\nMedtronic\nFGS-0808\nBARCODE SCANNER\n0006\nMedtronic\nFGS-0668\nPillCam® Patency Capsule 5-Pack\n0007\nMedtronic\nFGS-0347\nPillCam® RECORDER DR3 X1\n0008\nMedtronic\nFGS-0355\nPillCam® RECORDER CRADLE DR3X1\n0009\nMedtronic\nFGS-0362\nPillCam® RECORD ACCESSORIESDR3\n0010\nMedtronic\nFGS-0498\nPillCam® SB 3-EX CAPSULE 5-PACK\n0011\nMedtronic\nFGS-0499\nPillCam® SB 3-EX CAPSULE 10-PK\n0012\nMedtronic\nFGS-0590\nPillCam® SENSOR BELT MS SB\n0013\nMedtronic\nFGS-0591\nPillCam® SENSOR ARRAY MS\n0014\nMedtronic\nFGS-0453\nPillCam® SENSOR SLEEVES 10-PACK\n\nThe Department of Veterans Affairs (VA) is seeking vendors who can provide the Capsule Endoscopy as listed above which meet all the following salient characteristics: Vendors must quote product solutions that meet the salient characteristics. Products quoted in the technical volume must be captured on the Vendor s pricing volume (Attachment A, Price Cost Schedule) of the solicitation. Vendors may quote any additional ancillary products which they deem to be essential to the functionality of the proposed solution; these items must be captured in the Vendor s pricing volume with a quantity of zero.\n***** LOCATION IN TECHNICAL LITERATURE WHERE SC IS MET MUST BE COMPLETED IN THE FOLLOWING TABLE (NO EXCEPTIONS):******\n\n\nSC #\nSALIENT CHARACTERISTICS\nApplicable CLIN\nMETHOD OF EVALUATION\nSC Literature Map\nSC 1\nAllow for direct visualization of small bowel via the paired recorder\n0010, 0011\nLiterature Review\nMedtronic \nPage #39, 57\nSC 2\nAdaptive frame technology allows the capsule to capture images faster if the capsule is moving faster and slower if the capsule is moving slower and produces quality images \n0002, 0010, 0011\nLiterature Review\nMedtronic \nPage #40\nSC 3\nSoftware for enhanced reading capabilities and reduced reading time\n0003\nLiterature Review\nMedtronic \nPage #67\nSC4\nOptimized optics that deliver clear images and provide greater diagnostic ability\n0002, 0010, 0011\nLiterature Review\nMedtronic \nPage #67 - 70\nSC 5\nRecorder which actively communicates with the capsule and indicates when paired with capsule\n0002\nLiterature Review\nMedtronic \nPage #9\nSC 6\nPillcam does not need to be retrieved to read data.\n0002, 0010, 0011\nLiterature Review\nMedtronic \nPage #14, 40\nSC 7\nSystem must have FDA 510 K Approval\nAll\nLiterature Review\nMedtronic \nPage #56 - 66\nSC 8\nThe Recorder system must have the ability to take video and still images.\n0010, 0011\nLiterature Review\nMedtronic \nPage #57\nSC 9\nPatency capsule that can be used to verify an unobstructed small bowel prior to capsule endoscopy procedure\n0002, 0010, 0011\nLiterature Review\nMedtronic \nPage #41\nSC 10\nCapable of remote ingestion\n0002, 0010, 0011\nLiterature Review\nMedtronic \nPage #40\nSC 11\nSystem does not require capital equipment\n0002\nLiterature Review\nMedtronic\nPage #40\n\n\nThe following attachments are incorporated by reference. All criteria outlined in the attachments are applicable to this Combined Synopsis/Solicitation Notice.\n"} Solicitation Number: 36C10G26Q0024 Type: Combined Synopsis/Solicitation Base Type: Combined Synopsis/Solicitation NAICS: 334510 Classification Code: 6515 Response Deadline: 2025-12-04T23:59:00-05:00 Office Address: FREDERICKSBURG, VA POC: Hosea Berkley, hosea.berkley@va.gov, 540-479-8450 {"description":"\nCombined Synopsis/Solicitation Notice\n\n\nCombined Synopsis/Solicitation Notice\n\n\n\nPage 8 of 8\n\n*= Required Field\nCombined Synopsis/Solicitation Notice\n\n\nPage 1 of 11\nSolicitation Number: \n36C10G26Q0024\nNotice Type: \nCombined Synopsis/Solicitation Synopsis: COMBINED SYNOPSIS/SOLICITATION\nThis is a combined synopsis/solicitation for brand name or equal commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; offers are being requested, and a written solicitation will not be issued. \nSolicitation number 36C10G26Q0024 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Quote (RFQ). This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2025-06, dated August 27, 2025. This award will be made pursuant to 38 U.S.C. 8127, which authorizes the Department of Veterans Affairs to award sole-source contract to verified Service-Disabled Veteran-Owned or (Veteran-Owned) Small Businesses. Per Federal Acquisition Regulation Part 6.103-5(e), no justification and approval is required for contracts awarded under this statutory authority (except 8(a) sole source awards over $25 million, which is not applicable here. \nRequirement Description:\nVA has a requirement to purchase NX EQ CAPSULE ENDOSOPY to deliver patient care to its VA Medical Centers Nationwide and in outlying territories. Capsule Endoscopy systems are designed to examine various points along the intestinal tract using images captured with a tiny ingestible video camera. These systems typically consist of three components: a disposable ingestible camera pill/capsule that is swallowed by the patient and that transmits video images as it passes through the gastrointestinal tract, a recorder used by the patient (e.g., worn on a belt around the waist) that receives the signals transmitted by the camera, and a workstation appropriate for processing and displaying the images from the recorder. Ingestible camera endoscopic video systems are used to detect abnormalities (e.g., angioectasia, ulcers, tumors) especially in areas of the small intestine that are difficult or impossible to reach using endoscopes.\nA single award Requirements contract will be awarded IAW FAR 52.211-6 Brand Name in accordance with all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Offers shall contain the terms for cost/price and technical capabilities of the brand name or equal equipment. The Government reserves the right to award without discussions. \nThe associated North American Industrial Classification System (NAICS) code for this procurement is 334510 Endoscopic equipment, electromedical (e.g., bronchoscopes, colonoscopes, cystoscopes), manufacturing, Product Service Code: 6515 Medical and Surgical Instruments, Equipment, and Supplies. and the associated size standard is 750 employees. This procurement action is issued as a Sole Source award to verified Service-Disabled Veteran-Owned (or Veteran-Owned) Small Business.\nThis acquisition is for a single award Requirements contract in accordance with FAR Part 16.03 for Medtronic brand name NX EQ CAPSULE ENDOSCOPY and related equipment and accessories as identified in ATTACHMENT A PRICE COST SCHEDULE - NX EQ CAPSULE ENDOSOPY. All interested companies shall provide an offer for all Contract Line-Item Numbers (CLINs) listed in ATTACHMENT A PRICE COST SCHEDULE NX EQ CAPSULE ENDOSOPY and paragraph 2 below. \nThe ordering period is for one 12-month base year with four 12-month option years. Delivery is FOB destination.\nFirm-Fixed Price Orders will be placed against this contract in writing and will provide the delivery locations, delivery dates and exact quantities. \nThe FAR provision at 52.212-1, Instructions to Offerors Commercial Products and Commercial Services, applies to this acquisition including attached addenda (ATTACHMENT D) to the provision.\nThe FAR provision at 52.212-2, Evaluation -- Commercial Products and Commercial Services, and the specific evaluation criteria as attached addenda (ATTACHMENT D) also applies to this acquisition.\nThe Offeror is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Products and Commercial Services, with its offer.\nClause at 52.212-4, Contract Terms and Conditions -- Commercial Products and Commercial Services, applies to this acquisition and a statement regarding any addenda to the clause. Addendum is attached (ATTACHMENT C).\nClause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Products and Commercial Services, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to the acquisition. Addendum is attached (ATTACHMENT C).\nAll interested offerors must be registered in the System for Award Management (SAM) prior to submitting an offer. You may access SAM at https://sam.gov/SAM/.\nQuestions regarding this combined synopsis/solicitation are due via email by 11:59 PM ET on December 22, 2025, to Contracting Officer, Hosea Berkley at Hosea.Berkley@va.gov. No calls will be accepted.\nOffers are due via email by 11:59 PM ET on December 29, 2025, to Contracting Officer, Hosea Berkley at Hosea.Berkley@va.gov.\n1. SCOPE OF WORK: \n\nThe Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Capsule Endoscopy product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract award. \n\nThe Veterans Health Administration (VHA) Non-Expendable Equipment National Program is seeking offerors that can provide Capsule Endoscopy. The Capsule Endoscopy systems are designed to examine various points along the intestinal tract using images captured with a tiny ingestible video camera. These systems typically consist of three components: a disposable ingestible camera pill/capsule that is swallowed by the patient and that transmits video images as it passes through the gastrointestinal tract, a recorder used by the patient (e.g., worn on a belt around the waist) that receives the signals transmitted by the camera, and a workstation appropriate for processing and displaying the images from the recorder. Ingestible camera endoscopic video systems are used to detect abnormalities (e.g., angioectasia, ulcers, tumors) especially in areas of the small intestine that are difficult or impossible to reach using endoscopes.\n\nThe Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Capsule Endoscopy to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for a base of 12-months with four 12-month option periods.\n\n\n\n2. REQUIREMENT\n\nThis requirement will be IAW FAR clause 6.103, Brand Name which requires the quoter indicate that the product being offered is a Capsule Endoscopy. \n\n\nContract Line Items\nManufacturer\nPart Number\nDescription\n0001\nMedtronic\nFGS-0504\nUSBC 2PK\n0002\nMedtronic\nFGS-0688\nPillCam® GENIUS SB 1 PK US\n0003\nMedtronic\nFGS-0802\nSOFTWARE PillCam® 9.7 US\n0004\nMedtronic\nFGS-0806\nGenius Sync Agent (GSA) OFFLINE PillCam® US\n0005\nMedtronic\nFGS-0808\nBARCODE SCANNER\n0006\nMedtronic\nFGS-0668\nPillCam® Patency Capsule 5-Pack\n0007\nMedtronic\nFGS-0347\nPillCam® RECORDER DR3 X1\n0008\nMedtronic\nFGS-0355\nPillCam® RECORDER CRADLE DR3X1\n0009\nMedtronic\nFGS-0362\nPillCam® RECORD ACCESSORIESDR3\n0010\nMedtronic\nFGS-0498\nPillCam® SB 3-EX CAPSULE 5-PACK\n0011\nMedtronic\nFGS-0499\nPillCam® SB 3-EX CAPSULE 10-PK\n0012\nMedtronic\nFGS-0590\nPillCam® SENSOR BELT MS SB\n0013\nMedtronic\nFGS-0591\nPillCam® SENSOR ARRAY MS\n0014\nMedtronic\nFGS-0453\nPillCam® SENSOR SLEEVES 10-PACK\n\nThe Department of Veterans Affairs (VA) is seeking vendors who can provide the Capsule Endoscopy as listed above which meet all the following salient characteristics: Vendors must quote product solutions that meet the salient characteristics. Products quoted in the technical volume must be captured on the Vendor s pricing volume (Attachment A, Price Cost Schedule) of the solicitation. Vendors may quote any additional ancillary products which they deem to be essential to the functionality of the proposed solution; these items must be captured in the Vendor s pricing volume with a quantity of zero.\n***** LOCATION IN TECHNICAL LITERATURE WHERE SC IS MET MUST BE COMPLETED IN THE FOLLOWING TABLE (NO EXCEPTIONS):******\n\n\nSC #\nSALIENT CHARACTERISTICS\nApplicable CLIN\nMETHOD OF EVALUATION\nSC Literature Map\nSC 1\nAllow for direct visualization of small bowel via the paired recorder\n0010, 0011\nLiterature Review\nMedtronic \nPage #39, 57\nSC 2\nAdaptive frame technology allows the capsule to capture images faster if the capsule is moving faster and slower if the capsule is moving slower and produces quality images \n0002, 0010, 0011\nLiterature Review\nMedtronic \nPage #40\nSC 3\nSoftware for enhanced reading capabilities and reduced reading time\n0003\nLiterature Review\nMedtronic \nPage #67\nSC4\nOptimized optics that deliver clear images and provide greater diagnostic ability\n0002, 0010, 0011\nLiterature Review\nMedtronic \nPage #67 - 70\nSC 5\nRecorder which actively communicates with the capsule and indicates when paired with capsule\n0002\nLiterature Review\nMedtronic \nPage #9\nSC 6\nPillcam does not need to be retrieved to read data.\n0002, 0010, 0011\nLiterature Review\nMedtronic \nPage #14, 40\nSC 7\nSystem must have FDA 510 K Approval\nAll\nLiterature Review\nMedtronic \nPage #56 - 66\nSC 8\nThe Recorder system must have the ability to take video and still images.\n0010, 0011\nLiterature Review\nMedtronic \nPage #57\nSC 9\nPatency capsule that can be used to verify an unobstructed small bowel prior to capsule endoscopy procedure\n0002, 0010, 0011\nLiterature Review\nMedtronic \nPage #41\nSC 10\nCapable of remote ingestion\n0002, 0010, 0011\nLiterature Review\nMedtronic \nPage #40\nSC 11\nSystem does not require capital equipment\n0002\nLiterature Review\nMedtronic\nPage #40\n\n\nThe following attachments are incorporated by reference. All criteria outlined in the attachments are applicable to this Combined Synopsis/Solicitation Notice.\n"}