Inactive

VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT Effective Date: 02/01/2022 Page 1 of 4 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405... VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT Effective Date: 02/01/2022 Page 1 of 4 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID:_36C263-22-AP-5584__________ (1) Contracting Activity: Department of Veterans Affairs, Network/Program Contracting Office 23, located at 4801 Veterans Dr, St Cloud MN, in support of VISN 23 VA Health Care System at all locations. (2) Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). Binax- NOW Covid Tests for all sites in VISN 23. Order against: FSS Contract Number: _36F79721D0073__ Name of Proposed Contractor: Abbott Rapids DX North American Street Address: 30 S Keller Rd STE 100 City, State, Zip: Orlando FL 32810 Phone: Â Â Â Â Â 210-426-1174 (3) Description of Supplies or Services: The estimated value of the proposed action is $ 678,408.75 Binax NOW Covid Tests 195-000 for all sites in VISN 23. No other brand of COVID tests provide what is required when testing. (4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor s unique qualifications to provide the required supply or service. (CHECK THE APPLICABLE AUTHORITY BELOW AND COMPLETE) FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays: The current contract for BINAX NOW COVID tests expired 12/31/2022 and they are available from one source on GSA that will meet the demand of all of NCO 23 sites. FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; Specific characteristics of the material or service that limit the availability to a sole source (unique features, function of the item, etc.). Describe in detail why only this suggested source can furnish the requirements to the exclusion of other sources. FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures. Specify how the new work is a logical follow-on to the original order and confirm that the original order was not issued under sole source or limited source procedures. FAR 8.405-6(b): Items peculiar to one manufacturer: A patent, copyright or proprietary data limits competition. The proprietary data is: (If FAR 8.405-6(a)(2)iii before posting. Do not include specific proprietary data. Only mention the type of equipment, procedure, etc. to show that proprietary supplies or services are being procured.) These are direct replacements parts/components for existing equipment. The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system. (5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination: A three year BPA is being issued off of an already established contract, therefore the prices are already considered fair and reasonable. (6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. Limited market research was conducted due to the availability on an already established GSA contract. (7) Any Other Facts Supporting the Justification: N/A (8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: N/A (9) Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor s supervisor, fund control point official, chief of service or someone with responsibility and accountability.) Jill Johnson VISN 23 (10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: a. Contracting Officer s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _____ WENDY HOESCHEN DATE Contracting Officer b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition. _____ SIGNATURE DATE JAMESON SCHWARTZ NCO23 Branch Chief SST2

Inactive

Statement of Work- VISN 23 Binax NOW® SARS-CoV-2 Antigen Test Kit (BRAND NAME ONLY) 1. Introduction The purpose of this Statement of Work (SOW) is to detail salient characteristics for Binax NOW® SA... Statement of Work- VISN 23 Binax NOW® SARS-CoV-2 Antigen Test Kit (BRAND NAME ONLY) 1. Introduction The purpose of this Statement of Work (SOW) is to detail salient characteristics for Binax NOW® SARS-CoV-2 Antigen Test Kit (BRAND NAME ONLY) and define the tasks and responsibilities of the successful offeror for the procurement of an FDA-approved or Emergency Use Authorization (EUA) Binax NOW® SARS-CoV-2 Antigen (BRAND NAME ONLY) Test Kit for thirteen (13) VA Midwest Health Care Network (VISN 23) laboratories. 3. Scope Network Contracting Office 23 (NCO23) intends to award a single agreement to the overall best-value contractor capable of meeting the requirements outlined herein for Binax NOW® SARS-CoV-2 Antigen Test Kit for clinical laboratories located at the following VA facilities: Black Hills Health Care System, Hot Springs, SD Black Hills Health Care System, Fort Meade, SD Black Hills Health Care System, Rapid City, SD Central Iowa Health Care System, Des Moines, IA VA Medical Center, Fargo, ND Royal C. Johnson VA Medical Center, Sioux Falls, SD VA Medical Center, Iowa City, IA VA Medical Center, Minneapolis, MN Twin Ports Community Based Outpatient Clinic, Superior, WI Nebraska-Western Iowa Health Care System, Omaha, NE Nebraska-Western Iowa Health Care System, Grand Island, NE Nebraska-Western Iowa Health Care System, Lincoln, NE VA Medical Center, St. Cloud, MN General Requirements: This section defines minimum requirements that must be met or exceeded by this acquisition. Narrative descriptions shall be provided of how these requirements will be met or exceeded: Technical The science of the Abbott Binax NOW® SARS-CoV-2 Antigen test shall be lateral flow immunoassay for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in direct nasal swab collections. The Abbott Binax NOW® SARS-CoV-2 Antigen test kit and specimen type(s) must minimally have Emergency Use Authorization (EUA) issued by the Food and Drug Administration (FDA) pursuant to Section 564 of the Federal Food, Drug and Cosmetic Act for high complexity and moderate complexity designated laboratories. The Abbott Binax NOW® SARS-CoV-2 Antigen assay shall also be authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The analytical sensitivity of the Abbott Binax NOW® SARS-CoV-2 antigen test shall be 200 TCID50/ml or lower.    The Abbott Binax NOW® SARS-CoV-2 antigen test result must be available for result reporting within fifteen (15) minutes or less.    The Abbott Binax NOW® SARS-CoV-2 Antigen test system Reagents and collection swabs are included within the test kit.   The Abbott Binax NOW® SARS-CoV-2 collection sample shall be stable for 1 hour or longer at room temperature.  The Abbott Binax NOW® Antigen test system shall not require the use of a biosafety cabinet to process sample or perform testing.  Internal quality control material must be specific and proprietary to the Abbott Binax NOW® SARS-CoV-2 antigen test system offered and within the scope of the FDA EUA authorization. Abbott Binax NOW® SARS-CoV-2 External positive and negative quality control material must be compatible for use with the proprietary Abbott Binax NOW® reagent test system. The products in the Abbott Binax NOW® SARS-CoV-2 reagent test system must not require a storage temperature of less than 8 degrees centigrade. Room temperature storage is preferred.  Hardware and Software Equipment or instrumentation required for the performance of the testing or interpretation/reading of the test result of the proposed equal test system, shall be provided as part of the antigen test kit pricing. If equipment or instrumentation is required for the performance of the testing or interpretation/reading of the test result of the proposed equal test system, an approved VA Enterprise Risk Assessment (ERA) for medical devices is required. The ERA number and a copy of the approved ERA report shall be provided, upon request.   If equipment or instrumentation is required for the performance of the testing or interpretation/reading of the test result of the proposed equal test system, a copy of a completed MDS2 and 6550 shall be submitted with proposal.  Network Security and Integration Requirements If equipment or instrumentation is required for the performance of the testing or interpretation/reading of the test result of the proposed equal test system, compliance of all hardware and software with VA network security, and Enterprise Risk Analysis requirements. The Contractor shall supply responses to required documents for connection of medical devices to the VA network including but not limited to the VA Form 6550, Access Control List (ACL) Communication ports and protocols, services and application inventory, network diagram, and MSD2. Contractor shall have a Memorandum of Understanding/Information Security Agreement (MOU/ISA) with the VA or the capability to obtain an MOU/ISA without creating significant implementation delays. https://vaww.portal2.va.gov/sites/infosecurity/FY15CRISPAudit/CRISPRemediationContract/WorkSite/SitePages/MOU-ISA_Version2.aspx The hardware must meet all VA minimum specifications and the software version must be approved for use on the VA network. termination. Troubleshooting Troubleshooting and assistance with the use of the Abbott Binax NOW® SARS-CoV-2 reagent test system must minimally be available through telephone hotline support. In accordance with 5 U.S.C. 6103, Executive Order 11582 and Public Law 94-97 the following national holidays are observed and for the purpose of this contract are defined as Legal Federal official holidays . New Year s Day January 1st Martin Luther King s Birthday Third Monday in January President s Day Last Monday in January Memorial Day Last Monday in January Juneteenth June 19th Independence Day July 4th Labor Day First Monday in September Columbus Day Second Monday in October Veteran s Day November 11th Thanksgiving Day Fourth Thursday in November Christmas Day December 25th When a holiday falls on a Sunday, the following Monday will be observed as a National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by U.S. Government Agencies.