65--Stryker Endoscopy Package

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >$150K to $700K OFOC SOP Revision 06 Page 4 of 4 Original Date: 03/22/11 Revision 06 Date: 08/30/2017 DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>$150K to $700K) Brand Name Acquisition Plan Action ID: VA260-18-AP-4535/648-18-2-9961-0077 Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 20 on behalf of the VA Portland Medical Center. Nature and/or Description of the Action Being Processed: This is a new requirement to replace and supplement existing surgical camera equipment used in Operative Care at the Portland VA Medical Center. This is a brand-name procurement that 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 $567,567.20. This is a brand-name justification for the following: Stryker 1488 HD 3-Chip Camera Control Unit (CCU) 11 ea Stryker 1488 HD 3-Chip Camera Head and 18MM Coupler kit 29 ea Statutory Authority Permitting Other than Full and Open Competition: The Authority permitting Other than Full and Open Competition is 41 USC §3304(a), as implemented by FAR 6.302. (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 requirement is to upgrade components of an existing system (cameras and camera controllers), and not the entire video system. The required components must seamlessly integrate into the existing Stryker video towers and, most critically, work directly and seamlessly with the Stryker SDC (Stryker Digital Capture), a key component of the system. This is required so that the systems will continue to function on the VA network. No other manufacturer has equivalent equipment that will integrate into this existing system. To purchase these items from another manufacturer would require the replacement of much more equipment including capture devices, existing surgical cameras and endoscopes. This would represent an excessive duplication of costs to the Government. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research identified that this equipment is available through SDVOSB OEM authorized sources. A sources-sought was issued on FBO from July 19, 2018 through July 24, 2018. I received eight responses, of which one was the OEM, providing a list of authorized distributors, two were SDVOSB authorized distributors, one was a SB authorized distributor, and four were distributors of other manufacturers. Because two OEM authorized SDVOSBs confirmed interest, offers will be solicited on FBO as a SDVOSB set-aside IAW 38 U.S.C. 8127. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost is 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: Market research was conducted to determine if there are any authorized retailers 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 OEM authorized sources. As described in Section 6 above, in accordance with FAR Part 10, market research was conducted by soliciting inquiries from interested parties. Two SDVOSB OEM authorized distributors indicated interest. A review of the OEM s list of authorized vendors indicate that they capable of performing. Therefore, it is expected that there are two or more verified SDVOSB sources that can 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: OEM Authorized Beacon Point Associates, LLC 1216 SW 4th Street, Suite 4 Cape Coral, FL 33991 +1 (555) 000-0000 SDVOSB American Medical Depot (AMD) 10315 USA Today Way Miramar, FL 33025 +1 (555) 000-0000 x 6814 SB TrillaMed, LLC 30100 Telegraph Road Suite 366 Bingham Farms, MI 48025 +1 (555) 000-0000 SDVOSB Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 +1 (555) 000-0000 LG OEM Other Manufacturers Alliant Healthcare 333 Bridge St NW Suite 1125 Grand Rapids, MI 49504 +1 (555) 000-0000 SDVOSB - Olympus ERA Health LLC dba Veterans Health Medical Supply 777 Main Street, Suite 770 Fort Worth TX 76102 (866)-771-7052 SDVOSB Richard Wolf NITOR, Inc. 11140 Rockville Pike, Suite 400 Rockville, MD 20852 +1 (555) 000-0000 SDVOSB - DSCOPE systems L1 Enterprises, Inc. 340 West Patrick St. Frederick, MD 21701 +1 (555) 000-0000 SDVOSB Karl Storz 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: See attached PDF