Description
DEPARTMENT OF VETERANS AFFAIRS Justification and Approval For Exception to Fair Opportunity Memo Acquisition Plan Action ID: 36C245-20-AP-0172 Contracting Activity: Department of Veterans Affairs, VISN 05, Baltimore VA Medical Center (512) 2237: 512-20-1-098-0028 Description of Action: The proposed sole source task order against joint National Acquisition Center (NAC)/Defense Logistics Agency (DLA) contract SPE2D1 17 D 0022 is for a one-year firm-fixed price (FFP) effort for maintenance, support, and repair services for high cost/high tech medical imaging equipment at the VA Maryland Health Care System. Description of Supplies or Services: The proposed action is to provide maintenance, support, and repair services for an Aquilion One Genesis 640 CT at the Baltimore VA Medical Center. The contractor will provide travel, original equipment manufacturer (OEM)-certified parts, and labor to complete scheduled preventive maintenance in accordance with the OEM written specifications as well as unscheduled repair services as-needed. The vendor must provide software and quality updates, technical and clinical application support by telephone, and remote monitoring and support to minimize unexpected equipment downtime and maximize use of the equipment. The total estimated value of the proposed action is $153,940.00 per year. Statutory Authority: The statutory authority permitting an exception to fair opportunity is Section 41 U.S.C. 4106(c) as implemented by the Federal Acquisition Regulation (FAR) Subpart 16.505 Subpart 16.505(b)(2)(i): ( )FAR Subpart 16.505(b)(2)(i)(A): The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays. ( X ) FAR Subpart 16.505(b)(2)(i)(B): Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized. ( ) FAR Subpart 16.505(b)(2)(i)(C): The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order. ( ) FAR Subpart 16.505(b)(2)(i)(D): It is necessary to place an order to satisfy a minimum guarantee. ( ) FAR Subpart 16.505(b)(2)(i)(E): For orders exceeding the simplified acquisition threshold, a statute expressly authorizes or requires that the purchase be made from a specified source . The statutory authority permitting an exception to fair opportunity for this action is 38 U.S.C. 8127(c), known as the Veterans First Contracting Program which provides the authority to directly contract with a Service-Disabled Veteran-Owned Small Business (SDVOSB) or a Veteran-Owned Small Business (VOSB). ( ) FAR Subpart 16.505(b)(2)(i)(F) In accordance with section 1331 of Public Law 111-240 (15 U.S.C. 644(r)), contracting officers may, at their discretion, set aside orders for any of the small business concerns identified in 19.000(a)(3). When setting aside orders for small business concerns, the specific small business program eligibility requirements identified in part 19 apply. Rationale Supporting Use of Authority Cited Above: This requirement is for the support of highly-specialized medical imaging equipment that is regulated by the FDA. The original equipment manufacturer, Canon Medical Systems, has proprietary knowledge of the equipment as well as proprietary access within the equipment software that makes them uniquely capable of supporting this equipment. Only Canon Medical Systems can provide software and quality updates for this equipment. Additionally, only Canon Medical Systems has an MOU-ISA with the Department of Veterans Affairs to provide remote monitoring and support of Canon radiological imaging equipment which allows Canon to anticipate equipment failures before they occur which minimizes equipment downtime and the need to reschedule patients. Canon is also the only vendor that can provide remote procedural assistance on the covered equipment to optimize the use of this equipment and minimize patient dosing. If this is a Brand Name Justification: The discussion shall include how the particular brand-name, product, or feature is essential to the Government s requirements and market research indicates other companies similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet, the agency s needs. Include this sentence in your discussion: 6. Efforts to Obtain Competition: A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable. The original equipment manufacturer, Canon Medical Systems, was contacted to provide a list of authorized service providers for support of Canon Medical equipment. At this time, Canon Medical Systems does not authorize any other provider to perform software and quality updates. Additionally, market research determined that only Canon Medical Systems has an MOU-ISA with the Department of Veterans Affairs for support of Canon Medical Radiology equipment which would enable a vendor to provide remote monitoring and technical support of the covered equipment. 7. Actions to Increase Competition: Describe actions taken, or that will be taken, to remove or overcome any barriers to competition before initiating any subsequent acquisitions for the supplies, or services required, including challenges to restrictive data markings, data rights, preparation of a performance based work statement, and etc. In situations involving highly-specialized medical equipment, it is difficult to remove barriers to competition because the original equipment manufacturer has proprietary knowledge of the equipment and access within the equipment software that makes them uniquely capable of supporting this equipment. The Government will continue to conduct market research to ascertain if there are changes in the market place that would enable future actions to be competed. However, unless the manufacturer authorizes other service providers to maintain Canon Medical equipment, the only alternative to increase competition would be to replace the Canon Medical equipment with equipment from another manufacturer. Replacing the equipment would not be economical at this time but all FDA approved alternatives will be considered with the existing equipment reaches the end of its useful life. 8. Market Research: Provide a description of the market research conducted among the contract holders and the results. If market research was not conducted, the reasons it was not conducted should be stated. When citing 16.505(b)(2(i)(b) or 16.505(b)(2)(i)(e), the only possible way to state in paragraph 5 of the J&A that there is only one contractor who can fulfill the agency s needs is to conduct market research, and it should be summarized here. Due to the high-tech nature of this equipment and the proprietary nature of its software, only providers authorized by the equipment manufacturer, Canon Medical Systems, can provide software and quality updates. The original equipment manufacturer, Canon Medical Systems, was contacted to provide a list of authorized service providers for support of Canon Medical equipment. At this time, Canon does not authorize any other provider to perform software and quality updates. Additionally, a review of the National MOI-ISA repository determined that only Canon Medical Systems has an MOU-ISA with the Department of Veterans Affairs for support of Canon Medical Radiology equipment which would enable a vendor to provide remote monitoring and technical support of the covered equipment. 9. Other Facts: This contract is part of a VA-DoD Direct Sharing Agreement, in accordance with VHA Handbook 1660.04, which is highly encouraged to improve cost effectiveness.