Inactive Service-Disabled Veteran-Owned Small Business (SDVOSB) Set-Aside (FAR 19.14)

RFQ 36C25019Q0243 Alaris Infusion Pumps Dayton VA Medical Center, Dayton, OH This is a combined synopsis/solicitation for commercial items prepared in accordance with (IAW) the format in Subpart 12.6,... RFQ 36C25019Q0243 Alaris Infusion Pumps Dayton VA Medical Center, Dayton, OH This is a combined synopsis/solicitation for commercial items prepared in accordance with (IAW) the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The Government reserves the right to make no award from this solicitation. This is a request for quote (RFQ) and the solicitation number is 36C25019Q0243. The Government anticipates awarding a firm-fixed price contract resulting from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circulars 2005-101, effective 10/26/2018. The associated NAICS Code is 339113, Surgical Appliance and Supplies Manufacturing; Small Business Size Standard is 750 Employees. This is a 100% set aside for Service-Disabled Veteran-Owned Small Business (SDVOSB). The Department of Veterans Affairs, Network Contracting Office 10, is soliciting quotes from SDVOSB sources to supply the Dayton VA Medical Center with new Alaris Infusion Pumps. Respondents to this solicitation must fully demonstrate their capability by supplying detailed quote information, along with any other documents necessary to support the requirements below. Quotes are to be provided to Angie Carpenter, Contract Specialist, via email at angie.carpenter@va.gov, no later than Wednesday, 23 January 2019, by 4:00PM EST. No telephone calls will be accepted. No submission received after the above-mentioned date and time will be accepted. REQUIREMENTS: This combined synopsis/solicitation is for exact match, Brand Name Only, items listed in the table below: Schedule Item # Manufacturer/Description/Part/Model Number* Qty Unit Unit Price Ext. Price 1 8015 Next Generation Alaris PC Unit 180 EA 2 8100 Alaris Pump Module 200 EA 3 8120 Alaris PCA Module 35 EA 4 8300 Alaris EtCO2 Module 35 EA 5 Equipment Check-In Services 1 JB 6 Project Management Support 1 JB 7 Maintenance and Support Fees - Software Management Services Alaris System (Level 3) 1 YR New Equipment ONLY; NO remanufactured or "GRAY MARKET" items. All items must be covered by the manufacturer's warranty. No telephone requests for information will be accepted. Only emailed requests received directly from the Offeror are acceptable. It is the Offeror s responsibility to ensure the quote is received. Salient Characteristics Next Generation Alaris PC Unit: Shall have 5.7 LCD Display Shall have wireless connectivity enabling easy download and upload of key infusion drug and IV therapy data System shall use Guardrails software to help identify trends and measure IV formula data Shall have the capability to run four (4) separate infusions concurrently Alaris Pump Module: Shall have large volume infusion pump providing both continuous or intermittent delivery of fluids, mediation, blood, and blood products Alaris PCA Module: Shall have syringed-based, patient-controlled analgesia device with large volume pump Alaris EtCO2 Module: Shall have continuous respiratory monitoring Shall pause PCA infusion when patient status dictates Delivery Contractor shall deliver all equipment to the Dayton VA Medical Center, 4100 West Third Street, Dayton, Ohio 45428-9000, no later than 60 Days ARO. FOB Destination. The selected Offeror must comply with the following commercial item terms and conditions. Clauses FAR 52.212-1, Instructions to Offerors Commercial; FAR 52.212-4, Contract Terms and Conditions - Commercial Items; FAR 52.203-17, Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights; FAR 52.204-4, Printed or copied Double-sided on Postconsumer Fiber Content Paper; FAR 52.204-13, System for Award Management Maintenance; FAR 52.204-18, Commercial and Government Entity Code Maintenance; FAR 52.209-7, Information Regarding Responsibility Matters; FAR 52.232-40, Providing Accelerated Payments to Small Business Subcontractors; and 52.233-2, Service of Protest, apply to this acquisition. The selected Offeror must submit a completed copy of the provision at 52.212-3, Offeror Representations and Certifications - Commercial Items. The following FAR clauses in paragraph (b) of FAR clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, will apply: 52.203-6, 52.204-10, 52.209-6, 52.209-9, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.222-40, 52.222-50, 52.222-55, 52.223-18, 52.225-13, 52.232-33. The full text of a FAR clause may be accessed electronically at http://www.acquisition.gov/far/index.html. The following VAAR Clauses will apply: 852.203-70, Commercial Advertising; 852.219-10, VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside (Jul 2016) (DEVIATION); 852.232-72, Electronic Submission of Payment Requests; 852.233-70, Protest Content/Alternate Dispute Resolution; 852.233-71, Alternate Protest Procedure, and 852.246-71, Rejected Goods. The full text of a VAAR clause may be accessed electronically at http://www.va.gov/oal/library/vaar/. OFOC SOP Revision 08 Page 6 of 7 Original Date: 03/22/11 Revision 08 Date: 04/18/2018 EVALUATION CRITERIA/ SUBMISSION OF OFFER: Evaluation Process: Any award resulting from this solicitation will be completed using the procedures under FAR 13. Offerors will be evaluated utilizing Best Value Determination to the Government. To be considered technically acceptable, offers must be determined by the Government to fully meet or exceed all salient characteristics specified in this solicitation on a pass-fail basis. Quotes must be good for 60 calendar days after close of this combined synopsis solicitation. Quotes shall be sent by email only to: angie.carpenter@va.gov no later than Wednesday, 23 January 2019, at 4:00PM EST. Telephone inquiries will not be accepted. Questions pertaining to this solicitation shall be sent by email only to: angie.carpenter@va.gov no later than Friday, 18 January 2019, by 2:00PM EST. No late submissions will be accepted. Set-Aside Requirement: Only verified SDVOSB firms are eligible to submit an offer or receive an award of a VA contract that is set-aside for SDVOSBs in accordance with VAAR Part 819. A non-verified vendor that submits a quote should be rejected as non-responsive or technically unacceptable as listing in VIP is not self-correctable as a minor informality as, for example, a listing in SAM. All other purported SDVOSBs must apply for and receive verified status in accordance with 38 CFR Part 74 and be listed in VIP prior to submitting a quote on an acquisition conducted in accordance with VAAR Part 819. The VIP database will be checked both upon receipt of an offer and prior to award. Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID: 36C250-19-AP-1329 Contracting Activity: The Department of Veterans Affairs, Dayton VA Medical Center, Dayton, OH; and Network Contracting Office (NCO) 10, Kettering, OH. The purchase request number is 552-18-4-325-0136. Nature and/or Description of the Action Being Processed: Network Contracting Office 10 intends to award a new, firm-fixed price purchase order for mandatory upgrade to the CareFusion Alaris Infusion Pump equipment located at the Dayton VA Medical Center. This brand-name requirement will be competed as a SDVOSB set-aside among the four SDVOSB authorized distributors of CareFusion. This procurement is 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: An infusion pump is a complex medical device that delivers fluids, such as nutrients and medications, into a patient's body in controlled amounts. The Medical Center Infusion Drug-Delivery platform is set-up on CareFusion Alaris infusion pump systems and infusion software (Guardrail). The entire system platform consists of Point-of-Care (PC) units (which is the controller or brain of the system), end tidal carbon dioxide modules (EtCO2), general large volume infusion modules (LVP), patient controlled analgesia modules (PCA), syringe modules, and peripheral capillary oxygen saturation modules (SPo2). This requirement is to upgrade and augment additional units to match our existing inventory of equipment and to replace the main controller PC modules. The PC units need to be replaced because the manufacturer has issued an end-of-life notice. Because infusion pumps are frequently used to administer critical fluids, including high-risk medications, the PC units need to be the same brand and manufacturer to match and be fully interoperable with our extensive inventory of existing system components, consumables, and software. The FSC code for this procurement is 6515 and the NAICS code is 339113. The total estimated cost of this procurement is $_________, with an estimated delivery date of 30 days after receipt of order. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(1), as implemented by FAR 6.302-1. The specific paragraph must be cited. Most likely, only the -1 or -2 authorities will be cited. Please be aware that failure to adequately plan for future requirements does not constitute appropriate use of the unusual and compelling urgency statutory authority. ( ) (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 FAR 13.501(a)(1)(ii) 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): The rationale for replacing the PC units with the same brand is two-fold. First, the Infusion system components that the VA currently utilizes are extensive. In addition to the main PC units going end-of-life, the additional augmenting accessory modules spread across the medical center are also nearing the end of their life expectancy. Secondly, and more importantly, the procurement needs to be limited to the same brand/manufacturer for patient safety. The need for standardization is critical for certain medical devices. Infusion pumps have long been associated with persistent safety problems. From 2005 through 2009, FDA received approximately 56,000 reports of adverse events associated with the use of infusion pumps, including numerous injuries and deaths. Reference is made to the published article Evaluating and Predicting Patient Safety for Medical Devices with Integral Information Technology, sponsored by the Agency for Healthcare Research and Quality, the Department of the Army, and the National Aeronautics and Space Administration, asserts that medical device use errors where multiple types of equipment are used in a clinical environment are a common source of patient injury and death and that there is a clear link between usability problems and user error. This study concludes that standardization of medical devices is essential to reducing patient risk. A similar brand-name equipment procurement was protested (GAO case 8-411904 [2015]) and was denied by GAO because of the need for standardization for patient safety. Another argument for patient safety is the necessity of integration with existing components, such as the EtCO2. Respiratory depression from the administration of pain medication is a leading cause of preventable death in hospitals, and the EtCO2 monitor can provide an early warning of an impending respiratory crises. It shuts down the infusion pump when the EtCO2 device is in the alarm mode, and the VA National Patient Safety Center (NPSC) recognizes that this integration greatly enhances patient safety. It has been found (root cause analyses and published clinical review literature) that more than 60 percent of adverse events related to infusion pumps could be prevented with infusion pumps with an integrated end tidal CO2 monitor. For this procurement, upgrading the PC units with a different brand/manufacturer will result in compatibility with all current system components to be lost, including the EtCO2 modules. Furthermore, competitor equipment does not offer integration with an EtCO2 component. Another consideration is that the CareFusion platform offers the ability to infuse up to four different drugs simultaneously using a single controller source. It is critical for the VA to retain a system with this capability to provide the needed care for our unique patient population, especially those receiving care in critical areas such as the Emergency Department, Surgery, and Intensive Care Units. Having a system that would deviate from this capability would place an unnecessary risk on the current level of care the VISN 10 medical facilities provide to its Veterans. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research was conducted IAW FAR Part 10. A search was conducted on mandatory sourcing which resulted in no sources. A search was conducted on FSS which was found by one source, the OEM, a large business. The OEM identified four SDVOSB sources who could provide the equipment on the open market. A Sources Sought Notice was submitted to the four SDVOSB authorized distributors via email on 21 December 2018 requesting the capability of providing the Alaris equipment for the Dayton VA Medical Center, which resulted in three SDVOSB providing capability statements and product information. Due to the estimated cost of procurement being over SAT, a Non-Manufacturer Rule (NMR) waiver was requested and granted by SBA on 06/21/2018. Additionally, a previous solicitation was submitted under RFQ #36C24618Q0110 which resulted in one response for an or equal system; however, that system did not offer an integrated EtCO2 module. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The offeror will be evaluated In accordance with (IAW) FAR 13.106-1, Brand Name Purchases: A determination of price fairness and reasonableness will be determined IAW FAR Part 13.106-3(a)(1), a comparison of competitive quotations or offers. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted IAW FAR Part 10. A search was conducted on mandatory sourcing which resulted in no sources identified. A search was conducted on FSS which was found by one source, the OEM a large business. The OEM identified four SDVOSB sources who could provide the equipment on the open market. A Sources Sought Notice was submitted to determine the capabilities of each SDVOSB source which resulted in three SDVOSB responses. Due to the estimated cost of procurement being over SAT, a NMR waiver was requested and granted by SBA on 06/21/2018. Additionally, a previous solicitation was submitted under RFQ #36C24618Q0110 which resulted in one response for an or equal system; however, that system did not offer an integrated EtCO2 module. Any Other Facts Supporting the Use of Other than Full and Open Competition: Replacement of the PC units with newer-version PC units of the same brand and manufacturer will guarantee that all the other existing platform modules will fully integrate and communicate with each other. In addition, the CareFusion platform offers the ability to infuse up to 4 different drugs simultaneously using a single controller source. It is critical for the VA to retain a system with this capability to ensure we can provide the needed care for our unique patient population - especially those receiving care in critical areas such as the Emergency Department, Surgery, and Intensive Care Units. Having a system that would deviate from this capability would place an unnecessary risk on the care Dayton VAMC provides to its Veterans. Lastly, Dayton VAMC already has invested a substantial amount in existing CareFusion Alaris Infusion Pump platform modules and FTEE training. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Redacted. 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: Due to the specific needs of this requirement, only one brand of equipment was identified through current market research methods. If a future requirement for the same solution is identified, full and open competition shall be promoted amongst all manufacturers capable of meeting the agency s needs.