VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT VHAPM Part 808.405-6 Limiting Sources Page 1 of 4 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID: VA250-18-AP-5883 Contracting Activity: Department of Veterans Affairs, NC0 10, Northern Indian Healthcare System (NIHCS), 610-19-1-025-0002 Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 251 and 40 U.S.C. 501). New Requirement for a base plus four-year FSS BPA. Order against: FSS Contract Number: 36F79718D0454 Name of Proposed Contractor: Carefusion Solutions, LLC Street Address: 3750 Torrey View Court City, State, Zip: San Diego, CA 92130 Phone: (858) 617-4824 Description of Supplies or Services: This requirement is for a base plus four-year lease for equipment/software to update the VA Northern Indiana Health Care Systems (NIHCS) Medication Management System. This includes Automated Dispensing Cabinets, logistical software for inventory management and workflow optimization, automated packaging interface for workflow optimization, carousel interface for workflow optimization, medication diversion software, and sterile compounding product administration interface for workflow optimization and patient safety data review. Upgrade includes replacing existing ADM system (Pyxis 4000) to Pyxis ES. Currently NIHCS is in the process of installing the following components of purchased hardware/software; BD PharmoPack w/336 and w/405, BD Pyxis Carousel 165 Pharmaceutical Carousel Storage and Pyxis Logistics. The following software will need to be purchased to allow for workflow optimization as defined below: BD HealthSight, BD Pyxis MedStation ES, Alaris Infusion Viewer. POP: Base plus four years from date of award (4) IDENTIFY THE AUTHORITY AND SUPPORTING RATIONALE (see 8.405-6(a)(1)(i)(A), (B), and (C) or 8.405-6(b)), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED CONTRACTOR S UNIQUE QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE. An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays. 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; Based on the requirements of NIHCS and the fact that the current requirement is to lease items that must be compatible with the existing equipment, Carefusion Solutions LLC is the only capable vendor for this contract. Carefusion Solutions, LLC is the sole manufacturer and exclusive provider of Pyxis equipment leases and support services. NIHCS recently purchased over $1 million of equipment that is proprietary to Carefusion Solutions, LLC and only interfaces with the Pyxis Medication Management System manufactured by Carefusion Solutions, LLC. Replacing the previously purchased equipment is not currently a need for the VA and the cost involved in replacing it would create substantial duplication of cost to the Government that would not be recovered through competition. No other company can meet VA s needs without also requiring the VA to procure new existing equipment, which isn t part of the current requirement. 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. Items peculiar to one manufacturer: A patent, copyright or proprietary data limits competition. The proprietary data is: (If FAR 8.405-6(a)(2)iii before posting. Do not include specific proprietary data. Only mention the type of equipment, procedure, etc. to show that proprietary supplies or services are being procured.) 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. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system. (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 last five-year contract was competed and was awarded to Carefusion Solutions, LLC under VA251-13-F-0311. During this period, NIHCS purchased over $1 million of equipment that interfaced with the Pyxis (Carefusion) Medication Management System that they have in place. Based on the requirements of NIHCS and the fact that the current requirement is to lease items that must be compatible with the existing equipment, Carefusion Solutions LLC is the only capable vendor for this contract. Compatibility is required to maintain workflow, sustain and provide additional data analytics and to improve patient care. Carefusion Solutions, LLC is the sole manufacturer and exclusive provider of Pyxis equipment leases and support services. The following equipment (manufactured by Carefusion Solutions, LLC) has already been purchased and utilizes proprietary software provided for use with the Pyxis Medication Management System: BD PharmoPack w/336 and w/405 were purchased. The PharmoPack performs many functions on a daily basis. It prints and packs medications in a sophisticated communication by transferring data to and from a Carefusion Database located off-site. The following are critical functions performed by the PharmoPack; daily patient medication strips for all active inpatient orders, automated dispensing machine (ADM) replenishment orders, and first dose orders upon processing a new medication order. When communicating to the central off-site database, updates to the drug database from the primary source will filter out to the remaining connected systems. NIHCS relies on automation to package the majority of active orders in an organized manner at both Marion and Fort Wayne sites. When this system is not functioning properly the majority of staff are redirected to assist in the manual picking of the needed daily medication. This is unsustainable for an extended period of time causing employees to become fatigued and urgently rushing to dispense medications. Thereby resulting in an increase in risk in potential errors and a risk to delays in patient care. No other vendor has been able to demonstrate the capabilities to interface with this government owned equipment. RxFramework VISTA Interface Software (licensed for BD CareFusion) This Transmits HL7 messages for active orders to Pyxis Logistics to facilitate cart exchange orders. KnowledgePortal has also been purchased and installed. It is a drug diversion and ADM optimization software that drills down reporting capabilities, patented drug audit processes, monthly reports, server to hold up to 10 years of data, and retrieves data from ADMs, devices utilized in surgical suite, controlled substance pharmacy storage device and inventory management software. Three BD Pyxis Carousel 165 s were purchased for pharmaceutical carousel storage. They are currently purchased and waiting on installation. Implantation of the BD Pyxis Carousel will improve workflow efficiencies and increase patient safety. The Carousel will communicate what medications are not within the BD PharmoPak and que the proper medication from the Carousel. This will reduce the risk of dispensing an incorrect medication to the inpatient units. The carousel automatically evaluates medications that are not loaded in BD PharmoPack and que said medications to the workflow within the Carousel, utilizes BarCode scanning from the printed BD PharmoPack, and updates drug database from primary source when entered Pyxis Logistics. The automated dispensing machines that VA will procure must interface with the above described equipment because loss of integration between these systems will degrade NINHCS ability to maintain workflow, utilize data analytics to optimize medication dispensing, and to provide quality patient care. No other vendor has been able to demonstrate the capabilities to interface with this government owned equipment. When injectable medications are administered NIHCS uses currently owned Alaris (model 8100 series) pumps to safely and reliably administer these medications. Carefusion Solutions has a tracking software Pyxis Logistics Alaris Infusion Viewer that NIHCS will be implementing as well to further promote patient safety. The software that runs these pumps is Guardrails and acts as a safety component to the infusion process by ensuring these medications are administered under preset guidelines. What NIHCS does not receive from Guardrails is the following information: Patient ID, Patient Name, Location, Medication, Start Time, Dose, Rate, Volume Remaining. As long as the medication is infused at the correct rate Guardrails will not alert. This creates a vulnerability in the system where NIHCS does not know if the medication was infused at the right time, right dose, right rate, or to completion. By installing Alaris Infusion Viewer NIHCS will be able to track infusions in real time improving both the above patient safety concerns but also allow employees to be better aware of infusion status and optimize workflow accordingly. BD Carefusion is the only vendor that offers a software solution for integrating and transferring data from the Alaris Pump to perform the above requirement. Replacing the previously purchased equipment is not currently a need for the VA and the cost involved in replacing it would create substantial duplication of cost to the Government that would not be recovered through competition. Along with the substantial duplication of cost to the government, the VA would have an excess of $1 million dollars worth of obsolete equipment onsite. (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 339112 and 323 concerns were found. A keyword search of medstation was conducted and zero concerns were found. In July 2018, a Sources Sought was posted to FBO. Four responses were received, 1 SDVOSB, 1 SB, 2 LB. The SDVOSB and SB were considered unresponsive. The SDVOSB was attempting to get an agreement in place with a large business but was unsuccessful. The small business did not answer the questions requested from the sources sought. Both large businesses (Carefusion Solutions, LLC and Omnicell, Inc.) were medstation manufacturers and the leases were found on their NAC contracts. These two vendors are also the only vendors that can interface with Vista/CPRS. Due to the non-manufacture rule, this buy cannot be set aside as there are no small business manufacturers available. This procurement was originally competed on eBuy unrestricted as it was not clear if Omnicell would be able to meet the requirement of interfacing with the currently owned Pyxis equipment. Upon receiving the initial quotes, Omnicell simply stated they would be able to interface with it. However, they were not able to answer in detail how this would happen. The RFQ was then amended to provide more detailed requirements. Omnicell then protested, alleging that VA s requirements were too restrictive and amounted to an improper sole source procurement. They requested that VA change the requirement to allow them to replace the owned equipment (over $1 million dollars of new equipment) so they could propose their equal equipment that will meet the requirements. However, the VA has already expended over $1 Million on this equipment and is not willing to lose the funds and time and effort already put into these procurements. Therefore, this procurement will be sole sourced to Carefusion Solutions, LLC as they are the only vendor that can meet the interface requirements. NIHCS has concluded that based upon Omnicell s response above they would be unable to meet the VA s requirements. (7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION: N/A (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 future acquisitions, market research will be performed to determine if there are other sources available. However, until the current equipment reaches the end of its useful life and/or is replaced and a procurement for new equipment is needed, the proprietary nature of the acquisition dictates a single source for the items.