65--BK ULTRASOUND

Other Than Full and Open Competition (OFOC) Brand Name DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) Brand Name For Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID: VA260-18-AP-3751/648-18-2-9961-0032 Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 20 on behalf of the VA Portland Healthcare System. Nature and/or Description of the Action Being Processed: This is a new requirement to replace BK Ultrasounds with BK3000 Ultrasounds for the Portland VA Medical Center Operative Care. The procurement will be set-aside for SDVOSBs. FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for commercially available medical equipment in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. Description of Supplies/Services Required to Meet the Agency s Needs: The estimated value of the proposed action is $649,760.10. This is a brand-name justification for the following: Item Qty Item Qty BK3000 Ultrasound 2 Reprocessing Tray for E14CL4b 1 URO Super Application Pack 2 Reprocessing Tray for E14C4t 20 DICOM Option 2 Reprocessing Tray for 6C2 1 Elastography License 2 Needle Guide 8802/20e/23/30 Transducer 1 Triplane Endocavity Transducer 20 Disposable Biplane Guides for 8808e/8818 Disposable 14g Biplane guides for 10 Curved Array Transducer 1 8808e/8818 1 Biplane Endocavity Transducer 1 Disposable Dual Guides for 8818 2 High Frequency Linear Array 1 Sterile CIV-Flex Transducer Cover 1 bkFusion Transrectal w/ Leakage Test Kit 2 Software/licenses/controls/generator 1 Multi-modality Prostate Phantom 1 EM Sensor 1 Flex Cart Basket 2 EM Sensor Clamp 1 Printer shelf 2 MIM Symphony DX- Software 1 Flexible Endotransucer Holder 2 MIM Installation 1 Reprocessing Tray for 9C2 1 MRI & US Prostate Phantom for bkFusion 1 Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(1), as implemented by FAR 6.302-1. (x) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1; ( ) (2) Unusual and Compelling Urgency per FAR 6.302-2; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3; ( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5; ( ) (6) National Security per FAR 6.302-6; ( ) (7) Public Interest per FAR 6.302-7; FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2). Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): This requirement is for specialized surgical equipment which has been approved for use by the facility Clinical Products Review Committee (CPRC). Per VHA Directive 1761 (1), the CPRC is responsible for reviewing and approving all new Reusable Medical Equipment (RME) prior to their use for direct patient care so that compatibility with current processes and equipment is ensured. This unit will be used in Operative Care/OR in urology. The level of care being performed requires high level ultrasound equipment designed for use in a urological/surgical setting. It must have several modes of operation and be capable of using in conjunction with MRI images. Other ultrasound units do not have the combination of probes, hardware, software, characteristics, functionality or capabilities that meet the need of the Portland VA Operative Care department. Furthermore, the VA Portland clinicians are trained and experienced using existing BK ultrasound units and require the BK3000 in order to ensure continuity of care with minimal user training. The need for standardizing operative equipment is critical as different models have slightly different operating procedures and user interfaces. A mixture of different models in a the operative theater increases the risk of user error, significantly increasing the risk to patient safety. Standardizing operative equipment is a recognized best-practice for reducing the risk of errors, increasing uniformity of practice and patient safety. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research identified that there is a NMR class waiver for NAICS 334510, FSC/PSC 6525. Therefore, a search was conducted to determine if there are any authorized retailers of the required equipment. Market research identified that this equipment is available through SDVOSB OEM authorized sources. Therefore, offers will be solicited on FBO as a SDVOSB set-aside IAW 38 U.S.C. 8127. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost to the Government will be Fair and Reasonable based on competition. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: As described in Section 5 above, in accordance with FAR Part 10, market research was conducted to determine if there are any authorized SDVOSB sources of the required equipment. This includes a search on VIP, strategic source listings, GSA s eLibrary and FPDS for past acquisitions with similar requirements. Market research identified that this equipment is available through SDVOSB sources. Therefore, it is expected that there are two or more verified SDVOSB sources that are able to meet the requirement. Any Other Facts Supporting the Use of Other than Full and Open Competition: The operating rooms are not designated for use by a single physician or surgical team; physicians schedule the use of one or more rooms as needed and can be working out of any of the suites. Therefore, the VA has a legitimate need to standardize the equipment it uses in the Operative Care Service to achieve the highest possible reliability and effectiveness. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Four Points Technology 14900 Conference Center Dr. Ste 100 Chantilly, VA 20151 +1 (555) 000-0000 DUNS: 089896737 SDVOSB A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: Standardized medical equipment is a bona fide clinical need for patient safety. Future changes in available technologies or standards will require review and approval from the facility Clinical Products Review Committee (CPRC). However, market research will continue to be completed for all subsequent acquisitions to ensure to promote competition from authorized sources. 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 and belief. See attached PDF