6515--Supplies - Defibrillators - Indianapolis

VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT VHAPG Part 808.405-6 Limiting Sources Page 1 of 4 Original Date: 08/30/2017 Last updated: 02/01/2022 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID: 36C250-22-AP-2034 (1) Contracting Activity: Department of Veterans Affairs, NCO 10, located at 2215 Fuller Road, Ann Arbor, MI 48105, in support of VISN 10 Richard L. Roudebush VA Medical Center, 1481 W. 10th Street, Indianapolis, IN 46202. 2237: 583-22-2-997-0172. (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). New purchase request for defibrillators for the entire medical center. Order against: FSS Contract Number: V797D-40111 (Expiration date: 2/14/2024) Name of Proposed Contractor: After Action Medical and Dental Supply Street Address: 4444 Decatur Blvd, Suite 100 City, State, Zip: Indianapolis, IN 46241 Phone: +1 (555) 000-0000 (3) Description of Supplies or Services: 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 Richard L. Roudebush VAMC Indianapolis are at end-of-life (FY 2022) and 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 90 days after receipt of order. No options will be included in the order. As stated in the table below, there are some items that are open market (OM) that will be included in this purchase. Per FAR 8.402(f) this is allowable as long as it meets the following: - - - - - - (1) All applicable acquisition regulations pertaining to the purchase of the items not on the Federal Supply Schedule have been followed (e.g., publicizing ( part 5), competition requirements ( part 6), acquisition of commercial products or commercial services ( part 12), contracting methods ( parts 13, 14, and 15), and small business programs ( part 19)); - - - - - - (2) The ordering activity contracting officer has determined the price for the items not on the Federal Supply Schedule is fair and reasonable; - - - - - - (3) The items are clearly labeled on the order as items not on the Federal Supply Schedule and they conform to the rules for numbering line items at subpart 4.10; and - - - - - - (4) All clauses applicable to items not on the Federal Supply Schedule are included in the order. (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. FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays: 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; 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. FAR 8.405-6(b): Items peculiar to one manufacturer: A patent, copyright or proprietary data limits competition. The proprietary data is: Zoll is the only manufacturer whose product complies with all security requirements of the Federal Government s VA s Office of Information Technology. The analytics software is approved in the Office of Information Technology s Technical Resource Manual (TRM). The defibrillators are FIPS 140-2 compliant. The system supports Windows server 2016 or higher. The system has been approved to communicate with the VA network. 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. 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. (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: The Zoll R Series defibrillators have technological features above and beyond that of any other defibrillators. They have been determined to be the devices which provide the best value for Indianapolis VAMC for the following reasons: Integrated Cardiopulmonary Resuscitation (CPR) guidance regarding compressions without adding extra components which minimizes the risk of losing extra parts. Capability of resuscitation/CPR performance monitoring via defibrillator and/or compatible electrodes through audio and visual advisory indicators, warnings, prompts and feedback. Real-time audio/visual feedback for depth, rate, and chest recoil is possible with use of One Step CPR electrodes (pads). This feature confirms high-quality CPR is being delivered by medical staff during cardiac resuscitation to ensure our patients the best patient outcome post cardiac arrest. External pacing (non-invasive): Seamless multi-functional use without the need for additional electrodes or cables. This can be accomplished with the One Step Complete pads & One Step therapy cable without requiring additional leads or wires. Wireless System that automatically communicates defibrillator equipment status back to biomedical engineering through a FIPS 140.2 wireless network in accordance with VHA Directive 6550. Vendor has a FIPs 140.2 certificate in accordance with VA Directive 6550. The defibrillators will be able to work on the VA network environment. The capability enables the VA to provide data in real time and directly improves patient care. FIPs 140.2 certification that meets the VHA encryption requirements. FIPS compliance is approved at the national level to work with VA systems. Acquiring this type of compliance can take months to get and in many cases is denied. Stryker also manufactures defibrillators; however, they do not meet the technical requirements listed above. Pricing is in accordance with FSS Contract Number V797D-40111. The pricing has already been determined fair and reasonable by the NAC Contracting Officer. Based on the information provided in this paragraph, it has been determined that this order represents the best value to the Government. Additionally, in accordance with FAR 8.405-4, the Contracting Officer will seek any additional discounts available prior to award. (6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. VIP was queried under NAICS 334510 and 201 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 for 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. 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 819.7007. As noted in section 3, some of the items are open market. Appropriate measures will be taken to make sure that FAR 8.402(f) is followed and that the open market portion is publicized to the GPE through an intent to sole source. The open market prices will be reviewed to confirm they are fair and reasonable. This will be done by comparing the prices to the vendor s current price list and a market research quote received from the manufacturer. The HCA has approved use of the SBA class waiver and sole source under 38 U.S.C. § 8127. (7) Any Other Facts Supporting the Justification: There are no additional supporting facts. (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: For any forthcoming procurements of this nature, market research will be conducted to identify comparable, compatible, and competitive products in the commercial marketplace.