Inactive Service-Disabled Veteran-Owned Small Business (SDVOSB) Set-Aside (FAR 19.14)

Combined Synopsis-Solicitation for Commercial Items VHAPM Part 813.106 SAP: Soliciting Competition & Evaluation of Quotations SOP Page 3 of 5 Original Date: 10/12/17 Revision 04 Date: 06/10/20 Descrip... Combined Synopsis-Solicitation for Commercial Items VHAPM Part 813.106 SAP: Soliciting Competition & Evaluation of Quotations SOP Page 3 of 5 Original Date: 10/12/17 Revision 04 Date: 06/10/20 Description This is a combined synopsis/solicitation for 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; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-04. This solicitation is set-aside for SDVOSB in accordance with VAAR 852.215-70. Offerors are cautioned that they must be registered and verified in Vendor Information Pages (VIP) Database (http://www.vetbiz.gov). The associated North American Industrial Classification System (NAICS) code for this procurement is 333314 with a small business size standard of 500 Employees. The FSC/PSC is 6515. The VA Maine Health Care System requires One Ophthalmic Ultrasound Scanner (Ellex Eye Cube) for the Eye Clinic in the new Portland CBOC located at 141 W. Commercial St. Portland, ME 04120. THIS EQUIPMENT NEEDS TO BE DELIVED and INSTALLED NO EARLIER THAN NOVEMBER 12, 2021 AND NOT TO EXCEED 30 DAYS AFTER THIS DATE. All interested companies shall provide quotations for the following: Supplies/Services Line Item Description Quantity EyeCubed V4 Console EyeCubed V4 Console 1 A - Biometry A-Scan Probe A - Biometry A-Scan Probe Only 1 B - 10 MHz Posterior Segment Probe B - 10 MHz Posterior Segment Probe 1 D - Diagnostic A-Mode Probe D - Diagnostic A-Mode Probe Only 1 U - 40MHz UBM Wide Field Anterior Segment 40MHz UBM Wide Field Anterior Segment Probe Only 1 DICOM Digital Imaging and Communications in Medicine Software 1 EyeCubed Cart SI EyeCubed Ultrasound SI Cart 1 Service/Schematics Manual Service/Schematics Manual 1 Performance Work Statement (PWS) MAINE VA HEALTHCARE SYSTEM Introduction The VA Maine Health Care System requires One Ophthalmic Ultrasound Scanner (Ellex Eye Cube) for the Eye Clinic in the new Portland CBOC located at 141 W. Commercial St Portland ME 04120. THIS EQUIPMENT NEEDS TO BE DELIVED and INSTALLED NO EARLIER THAN NOVEMBER 12, 2021 AND NOT TO EXCEED 30 DAYS AFTER THIS DATE. Background The EyeCubed allows increased resolution over previous technology, thus increasing diagnostic value. It enhances surgical outcomes and obtains multiple sets of data at one acquisition point. It has the capability to also aid in the treatment and management of many nonsurgical cases. Being able to obtain the most advanced data allows providers to serve VA patients to the highest standards and decreases outside referrals. The EyeCubed is used reputable referral sites. The EyeCubed enhances surgical outcomes and thus decreases complications and adverse outcomes. It also allows for continuity of care within the VA system which leads to better patient satisfaction and improved quality of care. Scope (Provide an overview of the PWS emphasizing the most important aspects of your requirement and defining the boundaries of the contractor s performance responsibilities). This project will provide one Ophthalmic Ultrasound Scanner (Ellex Eye Cube) for the Eye Clinic department in Portland. Ultrasonography s unique imaging capability makes it a critically important diagnostic tool in ophthalmology. High-resolution ultrasound enables the interpretation of certain structures that cannot be seen as clearly with lower resolution ultrasound systems. For clearer and sharper imaging, and better accuracy, high resolution is vital. Further, the detection of disorders like posterior vitreous detachment (PVD) in opaque ocular media is easily achieved with B-Scan ultrasound. With the additional capability of video capturing, advanced ultrasound systems can be used to determine ocular structures more clearly with the additional benefit that patients are able to better understand their condition. This is the standard of care outside the VA and with essential features as: Customized Configuration- Customized configuration of A-Scan and B-Scan modes ensures that Eye Cubed meets all your needs for both the posterior and anterior segments. 40 MHz UBM B-Scan- mode delivers accurate measurement and evaluation of the iris, angle, and ciliary body, including sulcus-to-sulcus (ICL sizing) and IOL haptic placement. Biometry A-Scan- delivers ultra-precise axial length measurement with faster, easier image acquisition in real-time movie mode. 10 MHz Posterior B-Scan- mode produces the subtlest vitreous echoes, offering unparalleled distinction between the retina, choroid and sclera, as well as the vitreo retinal junction. Standardized Diagnostic A-Scan- enables precision tissue differentiation. Advanced Movie Technology- Eye Cubed s advanced movie technology greatly improves the diagnostic capability and speed of each exam, allowing you to capture movies of up to 20 seconds in duration. Review movies frame-by-frame to reveal greater detail or play them back in full movie mode. High Speed Imaging for Real Time Display- With an image acquisition rate of up to 25 frames per second, Eye Cubed provides the fastest image-sampling rate available. This speed creates a real time view of detailed ocular activity, including blood cell movement and membrane behavior. The EyeCubed Systems shall adhere to all VA Privacy & Security, the Privacy Act and HIPAA requirements when obtaining and reviewing diagnostic information. This includes all log files, error traps, screen capture images and database query results used to aid Technical and Installation in their troubleshooting activities. Applicable Directives (List all documents referenced in the next section 5.0, Performance Requirements, with which the contractor will have to comply in performance of the contract effort. If only portions of a given document apply, specifically identify the applicable portions). The system must meet the manufacturer s specifications and be designed and implemented within the vendors 510K system design as an FDA regulated medical device/system. Performance Requirements (Identify what the contractor is required to do (major tasks and subtasks). The vendor will as part of their project plan outline a timeline for implementing the project for the Eye Clinic in the Portland VA Maine Healthcare System. Deliverables (List all data required to manage or monitor contractor performance). The vendor as part of the quote, will include the following: A - Biometry A-Scan Probe Only B - 10 MHz Posterior Segment Probe Only D - Diagnostic A-Mode Probe Only 40MHz UBM Wide Field Anterior Segment Probe Only Digital Imaging and Communications in Medicine Software EyeCubed Ultrasound SI Cart Service/Schematics Manual Laser Printer flat screen monitor keyboard, mouse and/or touch pad double footswitch dust cover operator s manual, DVD Burner Thorough on-site complete in-service training (provided at time of installation - USA Installations Only). Standard manufacturer s warranty Each Eye Cubed System carries a full 2-YEAR WARRANTY on all components including peripheral accessories included in the Eyecubed System purchase. Peripheral accessories typically included in the original purchase and thereby included in the 2-year warranty include: A-scan probes, B-scan probes, printer, monitor, equipment cart, keyboard, mouse, power transformer, scleral shells, and footswitch. If warranty service is required, Ellex Inc. will pay all shipping charges to repair or replace defective equipment. One (1) Preventive Maintenance visit per year (to be scheduled by customer). There are no fees for loaner components required while under warranty. All Eye Cubed peripheral accessories purchased individually or separately from an Eye Cubed System carry a 1-year warranty. This project will include all and any peripheral items to ensure a fully functional system. (misc. hardware or req. hardware upgrades, network switches, video cards, KVM switches, cabling, mouse, keyboards etc.) to ensure the functionality of the final product. Equipment to be procured: Delivery and installation shall be provided no earlier than NOVEMBER 12, 2021 after receipt of order (ARO). Products must in stock and available for delivery and installation. Vendor MUST be able to provide delivery, implementation, training, and manuals for this equipment. Place of Performance/Place of Delivery Address: 141 W. Commercial St Portland, ME Postal Code: 04120 Country: UNITED STATES The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Items FAR 52.212-3, Offerors Representations and Certifications Commercial Items Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal 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 2021-05 FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders 2021-05 The following subparagraphs of FAR 52.212-5 are applicable: 52.204-7, 52.204-16, 52.211-6, 52.212-2 52.212-3, 852.212-70 to include 852.212-71, 852.215-70, 852.219-10 All quoters shall submit the following: Quote All quotes shall be sent to the Contract Specialist, Divianna.Mathurin@va.gov. Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government. The following are the decision factors: Price, past performance, meeting delivery and installation dates in November 2021, items available in stock. THIS EQUIPMENT NEEDS TO BE DELIVED and INSTALLED NO EARLIER THAN NOVEMBER 12, 2021 AND NOT TO EXCEED 30 DAYS AFTER THIS DATE. The award will be made to the response most advantageous to the Government. Responses should contain your best terms, conditions. ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL ITEMS 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 provisions are incorporated into 52.212-1 as an addendum to this solicitation: FAR 52.212-1 INSTRUCTIONS TO QUOTERS COMMERCIAL ITEMS (a) North American Industry Classification System (NAICS) code and small business size standard are stated in the combined synopsis/solicitation. (b) Submission of quotations. Submit quotations to the office specified in this solicitation at or before the exact time specified in this solicitation. Quotations may be submitted on letterhead stationery, or as otherwise specified in the solicitation. As a minimum, quotations must show- (1) The solicitation numbers. (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 than mailing address. (8) A completed copy of the representations and certifications at FAR 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the quoter shall complete electronically). (9) Acknowledgment of Solicitation Amendments. (10) Past performance information, when included as an evaluation factor, to include recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information); and (11) If the quotation is not submitted on the SF 1449, include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Quotations that fail to furnish required representations or information or reject the terms and conditions of the solicitation may be excluded from consideration. (c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 30 calendar days from the date specified for receipt of offers unless another time period is specified in an addendum to the solicitation. (d) Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for receipt of quotations. Unless otherwise specified in this solicitation, these samples shall be submitted at no expense to the Government, and returned at the sender s request and expense, unless they are destroyed during testing. (e) Multiple quotations. Quoters are encouraged to submit multiple quotations presenting alternative terms and conditions or commercial items for satisfying the requirements of this solicitation. Each quotation submitted will be evaluated separately. (f) Late submissions (1) Quoters are responsible for submitting quotations so as 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 p.m., local time, for the designated Government office on the date that quotations are due. (2) Any quotation received at the Government office designated in the solicitation after the exact time specified for receipt of quotations is late and will not be considered unless it is received before purchase order issuance and the Contracting Officer 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 quotations by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of quotations 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. Quotations should contain the quoter s best technical and price terms. The Contracting Officer may reject any or all quotations. The Contracting Officer may issue a purchase order to other than the quoter with the lowest priced quotation. After the evaluation of quotations, the Contracting Officer may negotiate final terms with one or more quoters of the Government s choice before issuing any purchase order. The Contracting Officer will not negotiate with any quoters other than those of the Government s choice and will not use the formal source selection procedures described in FAR part 15. (h) Multiple purchase orders. 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 a quantity less than the quantity quoted, at the unit prices quoted, unless the quoter specifies otherwise in the quotation. (i) Availability of requirements documents cited in the solicitation. (1) (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) Most unclassified Defense specifications and standards may be downloaded from the following ASSIST websites: (i) ASSIST (https://assist.dla.mil/online/start/). (ii) Quick Search (http://quicksearch.dla.mil/). (iii) ASSISTdocs.com (http://assistdocs.com). (3) Documents not available from ASSIST may be ordered from the Department of Defense Single Stock Point (Doss) by- (i) Using the ASSIST Shopping Wizard (https://assist.dla.mil/wizard/index.cfm). (ii) Phoning the DoDSSP Customer Service Desk (215) 697-2179, Mon-Fri, 0730 to 1600 EST; or (iii) Ordering from DoDSSP, Building 4, Section D, 700 Robbins Avenue, Philadelphia, PA 19111-5094, Telephone (215) 697-2667/2179, Facsimile (215) 697-1462. (4) Nongovernment (voluntary) standards must be obtained from the organization responsible for their preparation, publication, or maintenance. (j) Data Universal Numbering System (DUNS) Number. (Applies to all quotations exceeding the Micro-Purchase Threshold (MPT), and quotations of MPT or less if the solicitation requires the Contractor to be registered in the System for Award Management (SAM) database.) The quoter shall enter, in the block with its name and address on the cover page of its quotation, the annotation DUNS or DUNS+4 followed by the DUNS or DUNS+4 number that identifies the quoter s name and address. The DUNS+4 is the DUNS number plus a 4-character suffix that may be assigned at the discretion of the quoter to establish additional SAM records for identifying alternative Electronic Funds Transfer (EFT) accounts (see FAR Subpart 32.11) for the same concern. If the quoter does not have a DUNS number, it should contact Dun and Bradstreet directly to obtain one. A quoter within the United States may contact Dun and Bradstreet by calling 1-866-705-5711 or via the internet at http://fedgov.dnb.com/webform. A quoter located outside the United States must contact the local Dun and Bradstreet office for a DUNS number. The quoter should indicate that it is a quoter for a Government contract when contacting the local Dun and Bradstreet office. (k) [Reserved]. (l) Requests for information. The contracting officer will not notify unsuccessful quoters that responded to this solicitation. Quoters may request information on purchase order(s) resulting from this solicitation from the contracting officer. 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. Submission of your response shall be received not later than May 7, 2021 at 12:00PM Divianna.Mathurin@va.gov. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below. Point of Contact Contract Specialist Divianna Mathurin Divianna.Mathurin@va.gov (203) 932-5711 x 8748

Inactive

Performance Work Statement (PWS) Design and Content MAINE VA HEALTHCARE SYSTEM Introduction The VA Maine Health Care System requires One Ophthalmic Ultrasound Scanner (Ellex Eye Cube) for the Eye Clin... Performance Work Statement (PWS) Design and Content MAINE VA HEALTHCARE SYSTEM Introduction The VA Maine Health Care System requires One Ophthalmic Ultrasound Scanner (Ellex Eye Cube) for the Eye Clinic in the new Portland CBOC located at 141 W. Commercial St Portland ME 04120. THIS EQUIPMENT NEEDS TO BE DELIVED NO EARLIER THAN NOVEMBER 12, 2021 AND NOT TO EXCEED 30 DAYS AFTER THIS DATE. Background The EyeCubed allows increased resolution over previous technology, thus increasing diagnostic value. It enhances surgical outcomes and obtains multiple sets of data at one acquisition point. It has the capability to also aid in the treatment and management of many nonsurgical cases. Being able to obtain the most advanced data allows providers to serve VA patients to the highest standards and decreases outside referrals. The EyeCubed is used reputable referral sites. The EyeCubed enhances surgical outcomes and thus decreases complications and adverse outcomes. It also allows for continuity of care within the VA system which leads to better patient satisfaction and improved quality of care. Scope (Provide an overview of the PWS emphasizing the most important aspects of your requirement and defining the boundaries of the contractor s performance responsibilities). This project will provide one Ophthalmic Ultrasound Scanner (Ellex Eye Cube) for the Eye Clinic department in Portland. Ultrasonography s unique imaging capability makes it a critically important diagnostic tool in ophthalmology. High-resolution ultrasound enables the interpretation of certain structures that cannot be seen as clearly with lower resolution ultrasound systems. For clearer and sharper imaging, and better accuracy, high resolution is vital. Further, the detection of disorders like posterior vitreous detachment (PVD) in opaque ocular media is easily achieved with B-Scan ultrasound. With the additional capability of video capturing, advanced ultrasound systems can be used to determine ocular structures more clearly with the additional benefit that patients are able to better understand their condition. This is the standard of care outside the VA and with essential features as; Customized Configuration- Customized configuration of A-Scan and B-Scan modes ensures that Eye Cubed meets all your needs for both the posterior and anterior segments. 40 MHz UBM B-Scan- mode delivers accurate measurement and evaluation of the iris, angle, and ciliary body, including sulcus-to-sulcus (ICL sizing) and IOL haptic placement. Biometry A-Scan- delivers ultra-precise axial length measurement with faster, easier image acquisition in real-time movie mode. 10 MHz Posterior B-Scan- mode produces the subtlest vitreous echoes, offering unparalleled distinction between the retina, choroid and sclera, as well as the vitreo retinal junction. Standardized Diagnostic A-Scan- enables precision tissue differentiation. Advanced Movie Technology- Eye Cubed s advanced movie technology greatly improves the diagnostic capability and speed of each exam, allowing you to capture movies of up to 20 seconds in duration. Review movies frame-by-frame to reveal greater detail or play them back in full movie mode. High Speed Imaging for Real Time Display- With an image acquisition rate of up to 25 frames per second, Eye Cubed provides the fastest image-sampling rate available. This speed creates a real time view of detailed ocular activity, including blood cell movement and membrane behavior. The EyeCubed Systems shall adhere to all VA Privacy & Security, the Privacy Act and HIPAA requirements when obtaining and reviewing diagnostic information. This includes all log files, error traps, screen capture images and database query results used to aid Technical and Installation in their troubleshooting activities. Applicable Directives (List all documents referenced in the next section 5.0, Performance Requirements, with which the contractor will have to comply in performance of the contract effort. If only portions of a given document apply, specifically identify the applicable portions). The system must meet the manufacturer s specifications and be designed and implemented within the vendors 510K system design as an FDA regulated medical device/system. Performance Requirements (Identify what the contractor is required to do (major tasks and subtasks). The vendor will as part of their project plan outline a timeline for implementing the project for the Eye Clinic in the Portland VA Maine Healthcare System. Deliverables (List all data required to manage or monitor contractor performance). The vendor as part of the quote, will include the following: A - Biometry A-Scan Probe Only B - 10 MHz Posterior Segment Probe Only D - Diagnostic A-Mode Probe Only 40MHz UBM Wide Field Anterior Segment Probe Only Digital Imaging and Communications in Medicine Software EyeCubed Ultrasound SI Cart Service/Schematics Manual Laser Printer flat screen monitor keyboard, mouse and/or touch pad double footswitch dust cover operator s manual, DVD Burner Thorough on-site complete in-service training (provided at time of installation - USA Installations Only). Standard manufacturer s warranty Each Eye Cubed System carries a full 2-YEAR WARRANTY on all components including peripheral accessories included in the Eyecubed System purchase. Peripheral accessories typically included in the original purchase and thereby included in the 2-year warranty include: A-scan probes, B-scan probes, printer, monitor, equipment cart, keyboard, mouse, power transformer, scleral shells, and footswitch. If warranty service is required, Ellex Inc. will pay all shipping charges to repair or replace defective equipment. One (1) Preventive Maintenance visit per year (to be scheduled by customer). There are no fees for loaner components required while under warranty. All Eye Cubed peripheral accessories purchased individually or separately from an Eye Cubed System carry a 1-year warranty. This project will include all and any peripheral items to ensure a fully functional system. (misc. hardware or req. hardware upgrades, network switches, video cards, KVM switches, cabling, mouse, keyboards etc.) to ensure the functionality of the final product. Equipment to be procured: