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VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5 Effective Date: 02/01/2022 Page 1 ... VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5 Effective Date: 02/01/2022 Page 1 of 9 DEPARTMENT OF VETERANS AFFAIRS SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5 Acquisition Plan Action ID: 36C250-23-AP-2858 Contracting Activity: Department of Veterans Affairs, NCO 10, located at 24 Frank Lloyd Wright Drive, Lobby M, Suite M2200, Ann Arbor, MI 48105, in support of the John D. Dingell VA Medical Center (VAMC), located at 4646 John R. Street. 553-23-2-063-0187. Nature and/or Description of the Action Being Processed: This procurement is for defibrillators 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. This is a new requirement to replace all of the defibrillators at the Detroit VA Medical Center. The procurement will be completed using FAR 8 procedures; however, there are line items that are open market included. IAW FAR 8.402(f), we are able to add the line items to the purchase if we have met the requirements. Description of Supplies/Services Required to Meet the Agency s Needs: Defibrillators are devices that administer electrical shock to the heart to restore a normal heartbeat. These devices are on all crash carts used to respond to emergent situations. Many of the defibrillators at the Detroit VAMC are at end-of-life or will be at end-of-life by the end of this year. Several are in need of repair or consistent maintenance to maintain full functionality. This has created a need to replace all the life saving devices for standardization across the facility. These products are peculiar to one manufacturer, Zoll Medical Corporation. Delivery is 160 days after receipt of order. No options will be included in the order. Delivery will be 160 days after receipt of order. Item # Description/Part Number* QTY FSS/OM 2 R Series ® ALS Defibrillator (30750005201310012) 13 OM 10 Paper, Thermal, BPA Free (box of 6) (8000-000875-01) 8 OM 14 X Series Carry Case, Premium (8000-000393-01) 11 OM 18 CPR Uni-padz Universal (Adult/Pediatric) Electrodes (8900-000280-01) 36 OM 19 TRAINING BLS PACKAGE, ZOLL AED 3, ENGLISH, AHA (8593-001103-01) 4 OM 20 CaseReview Subscription, 5 Year, R Series and XSeries (8400-100015) 61 OM 21 Defib Dashboard Subscription, 5 Year, R Seriesanqdq X Series. (8400-100005) 61 OM 22 CaseReview Subscription, 5 Year, AED 3- Inpremise (8400-100115) 18 OM 23 Base Deployment Setup (8400-110001) 1 OM 26 CPR Training Kit (8700-0060-01) 4 OM Statutory Authority Permitting Restricted Competition: FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement.  Competition is restricted on this procurement for the reason below:        ( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements        ( ) Unusual and Compelling Urgency        ( )  Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services        ( ) International Agreement        ( ) Authorized or Required by Statute        ( ) National Security        ( ) Public Interest Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Zoll is the only manufacturer whose product complies with all security requirements of the Federal Government s VA Office of Information Technology. The defibrillators are FIPS 140-2 compliant. The system supports Windows server 2016 or higher. Technological Features proprietary to the Zoll Defibrillators include: CPR Dashboard: The CPR Dashboard affords the capability to provide feedback on the quality of CPR (Cardio-Pulmonary Resuscitation) during the resuscitation event and during post event review. The feedback is automatically activated upon deployment of the defibrillation electrodes with a CPR sensor. The CPR Dashboard displays real-time measures which improve training quality by ensuring that staff achieve a compression depth of 2 to 2.4 inches at a rate of 100-120 compressions per minute. The main objective is to deliver a higher-quality compression for an increased number of successful resuscitations. See-Thru CPR®: The See-Thru CPR® safety feature is peculiar to Zoll and the R Series Defibrillators. The See-Thru CPR® proprietary filter removes chest compression artifacts from the ECG signal, allowing staff to see the patient s underlying heart rhythm without pausing chest compressions. The filter minimizes the need to pause compressions which enables VA clinicians to align advanced life-saving techniques with the AHA Guidelines. The outcome is minimized pause times and increased patient survival rates. One-Step Complete Electrode: The One-Step Complete Electrode is a key safety feature used exclusively with the R Series defibrillator. This technology allows the clinician to rapidly initiate compression pacing. This electrode incorporates a three lead ECG into the front Electrode PA. The direct connection eliminates the need to connect the three-lead cable and electrodes, separately. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: The open market portion was publicized to the GPE through an intent to sole source. No responses were received. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The open market items will be determined fair and reasonable based on previous purchases. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: VetCert was queried under NAICS 334510 and 285 concerns were found. VIP was queried under NAICS 334510 and 180 concerns were found. A keyword search of Zoll along with the NAICS was then completed and 1 concern was found. The VA Rule of Two cannot be met. However, the NAICS is on the NMR Waiver list and therefore the procurement can be set aside or sole sourced to SDVOSB. The manufacturer was contacted and they confirmed they have one FSS SDVOSB distributor. GSA Advantage was searched and there were two vendors that were found, the large business manufacturer and one SDVOSB distributor (one other distributor was found as well, but Zoll confirmed they were no longer a distributor). Since there is one SDVOSB available on FSS and there is a NMR waiver in place, this can be sole sourced to After Action Medical and Dental Supply, LLC, the SDVOSB distributor, in accordance with VAAR 819.7008. Some line items are open market and appropriate measures were taken to make sure that FAR 8.402(f) is followed. The open market portion was publicized to the GPE through an intent to sole source. No responses were received. The open market prices will be reviewed to confirm they are fair and reasonable. This will be done by comparing the prices to past purchases for the same or similar equipment. Items that are found on After Action Medical and Dental Supplies, LLC s NAC contract, are made in the USA. There is 1 item made in Vietnam and 1 item made in Finland that are open market; however, the total of all items is below the MPT and the BAA/TAA is not applicable. Any Other Facts Supporting the Use of Other than Full and Open Competition: The Zoll defibrillators only require compliance with VA Directive 6550 and must be FIPS 140-2 compliant. FITARA approval is not required for defibrillators. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: After Action Medical and Dental Supply, LLC 4444 Decatur Blvd. Suite 100 Indianapolis, IN 46241 317-508-5927 Shelby Winton Shelby@afteractionmedical.com 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: For any forthcoming procurements of this nature, market research will be conducted to identify comparable, compatible, and competitive products in the commercial marketplace. 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. Juanita Oleson Administrative Officer Detroit VAMC Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: Contracting Officer or Designee s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Kellie Konopinski Contracting Officer, Supplies Team 3 Network Contracting Office 10 One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition. Diana J. Pittman Branch Chief, Supplies Team 3 Network Contracting Office 10