Inactive

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: 02/0... 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: 36C250-23-AP-1612 (1) 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 LTC Charles S. Kettles VA Medical Center (VAMC), located at 2215 Fuller Road, Ann Arbor, MI 48105. 506-23-2-118-0095. (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: 800-892-5352 (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 the Ann Arbor 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. 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. ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT FSS/OM 0001 X Series R Manual Monitor/Defibrillator with 4 trace tri-mode display monitor/defibrillator/ printer LOCAL STOCK NUMBER: 603-0211511-01 15.00 EA FSS 0002 4 Year Factory Warranty LOCAL STOCK NUMBER: 8778-0048 15.00 EA OM 0003 Six-hour rechargeable Smart Battery LOCAL STOCK NUMBER: 8000-0580-01 4.00 EA FSS 0004 SurePower 4 Bay Charging System including 4 Battery Charging adapters LOCAL STOCK NUMBER: 8300-0500-01 3.00 EA FSS 0005 Accessory carry case, Printer Chute with Single Zipper, X Series LOCAL STOCK NUMBER: 8707-000502-01 15.00 EA FSS 0006 CaseReview Subscription, 5 Year, R Series and X Series- In premise. LOCAL STOCK NUMBER: 8400-100015 46.00 EA OM 0007 30520007201310013 R Series R Plus Defibrillator LOCAL STOCK NUMBER: 30520007201310013 46.00 EA FSS 0008 SurePower Rechargeable Lithium lon Battery Pack -5.8 Ah Capacity LOCAL STOCK NUMBER: 8019-0535-01 54.00 EA FSS 0009 R WiFi Card with Clock Sync and FIPS LOCAL STOCK NUMBER: 8005-000103-01 46.00 EA FSS 0010 Base Deployment Setup. Basic Onsite Deployment to enable R Series and X Series WiFi capabilities that allow resuscitation case files and device readiness files to be sent to a secure server automatically. LOCAL STOCK NUMBER: 8400-110001 1.00 EA OM 0011 Cable Sleeve, Propaq / X Series, ZOLL Blue LOCAL STOCK NUMBER: 8000-002005-01 15.00 EA FSS 0012 ZOLL AED 3 BLS Hospital Package. Includes: Product Documentation and ZOLL AED 3 Battery Pack LOCAL STOCK NUMBER: 8503-001103-01 40.00 EA FSS 0013 CPR Uni-Padz Universal (Adult/Pediatric) Electrodes (5 Shelf Life) LOCAL STOCK NUMBER: 8900-000280-0 80.00 EA FSS 0014 Transducer interface cable with right angle connector - Edwards LOCAL STOCK NUMBER: 8300-0787-01 30.00 EA FSS 0015 Red MNC Patient Cable, X Series LOCAL STOCK NUMBER: 8000-000460 15.00 EA FSS 0016 37120007201310013 Non-Clinical Training R Series R Plus Defibrillator LOCAL STOCK NUMBER: 37120007201310013 1.00 EA OM 0017 Single Bay Charger for the SurePower and SurePower II batteries LOCAL STOCK NUMBER: 8200-0001000-01 1.00 EA FSS 0018 SurePower Rechargeable Lithium-lon Battery Pack 5.8 Ah Capacity High density lithium-ion chemistry RunTime Indicator Automatic calibration ready Stores history of use and maintenance LOCAL STOCK NUMBER: 8019-0535-01 1.00 EA FSS 0019 128 MB Compact Flash Data Card "For use with R Series only" LOCAL STOCK NUMBER: 9143-0001 1.00 EA FSS 0020 R Series Training Kit. Includes AP manikin, See-Thru CPR simulator, OneStep Training Cable and Electrode (training cable with CPR sensor and Y-connector for simulator connection and OneStep training electrode adult and pediatric), Training Manual, In-Service DVD and Replacement OneStep Training Electrodes- (adult and pediatric) (8 per case) LOCAL STOCK NUMBER: 8700-0893-01 1.00 EA FSS 0021 OneStep Complete Resuscitation Electrode 8/case LOCAL STOCK NUMBER: 8900-0214-01 17.00 EA FSS 0022 OneStep Pediatric CPR Electrode (8 per case) LOCAL STOCK NUMBER: 8900-000220-01 1.00 EA FSS 0023 Single Patient Use Pediatric/Adult Airway Adapter, Box of 10 LOCAL STOCK NUMBER: 8000-0260-01 7.00 EA FSS 0024 Sterilizable Internal Handle, With Switch, 3.0" spoon, 10' cable; 100 - 120 volt (Domestic) only LOCAL STOCK NUMBER: 8011-0139-04 4.00 EA FSS 0025 Recorder Paper 90mm Fold, 10 packages, BPA-FREE LOCAL STOCK NUMBER: 8000-000877-01 7.00 EA OM 0026 Customer Site Biomed Technical Training (2-day), R Series LOCAL STOCK NUMBER: 8777-005022 1.00 EA OM 0027 ZOLL AED Simulator LOCAL STOCK NUMBER: 8000-000925 2.00 EA FSS 0028 ZOLL AED 3 TRAINER, ENGLISH AHA LOCAL STOCK NUMBER: 8028-000001-01 2.00 EA OM 0029 ZOLL AED 3 Trainer CPR Uni-Padz Electrode LOCAL STOCK NUMBER: 8028-000014 2.00 EA OM (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 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 Ann Arbor 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. The open market items will be determined fair and reasonable based on previous purchases. 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. VetCert was queried under NAICS 334510 and 276 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. Regarding compliance with FAR 8.402(f) for the open market items, to date, an intent to sole source those items was published on the GPE and no responses were received. The Contracting Officer will execute a separate single source justification for the open market items. 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 either made in the US or a TAA compliant country. Because this is a national contract, any BAA/TAA issues regarding the items on contract and use of the contract were addressed at time of award and any subsequent delivery orders would thereby be covered as a result. Therefore, the Contracting Officer has determined that placing an order against this contract would be compliant with any BAA requirements and no further action regarding BAA is required. There are 2 items made in China and 1 item made in Finland that are open market; however, the total of all items is $2,084.87 which is below the micro-purchase threshold and the BAA/TAA is not applicable. (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. (9) 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor s supervisor, fund control point official, chief of service or someone with responsibility and accountability.) Blake Drain Staff Assistant, PCS Ann Arbor VAMC (10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: a. Contracting Officer 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 b. One Level Above the Contracting Officer (Required over the 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 Thomas P. Moore Division Chief, Supply/Prosthetics Network Contracting Office 10 Marie L. Smith Director of Contracting Network Contracting Office 10 HIGHER LEVEL APPROVAL (Required for orders over $750,000): c. VHA RPO HCA Review and Approval (over $750,000 to $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. Terry L. Spitzmiller Executive Director Regional Procurement Office Central (VHA)