D--Element Laboratory Information Management System ( 68HERD25Q0033

Upon the basis of the following justification, prepared in accordance with Federal Acquisition Regulation (FAR) 8.405-6(c), I, as the Contracting Officer, hereby approve the use of sources limited to fewer than those required in FAR 8.405-3 pursuant to the authority of 41 U.S. Code (USC) 251 as implemented by FAR 8.405-6(a)(1)(i)(B). This acquisition is conducted under the authority of the Multiple Award Schedule program (41 USC 251, et seq. and 40 USC 501). 1. Identification of agency and the contracting activity. Contracting Office: United States Environmental Protection Agency (EPA) Information Technology Acquisition Division (ITAD) Information Technology Infrastructure, Development, and Operations Branch (ITIDOB) Development and Operations Section (DOS) Regions and Program Offices: EPA Regions 2,3,4,5,6,7,8, and 9 x National Enforcement Investigations Center (NEIC) x National Analytical Radiation Environmental Laboratory (NAREL) 2. Nature and/or description of the action being approved. This limited source justification is for the establishment of a single-award BPA for the maintenance and support services for EPA perpetually owned software licenses. EPA perpetually owns Clinisys Element LIMS software licenses, and these licenses are used by EPA regions and two program offices: EPA Regions 2,3,4,5,6,7,8, and 9; the National Enforcement Investigations Center (NEIC); and the National Analytical Radiation Environmental Laboratory (NAREL). A single-award BPA is planned to be awarded on a Firm Fixed Price (FFP) basis with a Statement of Work (SOW) to Clinisys utilizing their GSA MAS Contract Schedule for volume discounts. 3. A complete description of the supplies and/or services required to meet the agency s needs. Eight EPA regions and two EPA program offices perpetually own Element LIMS software licenses. This acquisition for services is for the on-going maintenance and support of these licenses. The maintenance and support of the licenses includes, non-custom bug fixes, minor/major upgrades, technical support, remote diagnostics and corrective actions, online trouble ticketing and online help resources. Element LIMS has been used by EPA laboratories for over twenty years to effectively manage laboratory samples, tests, data management, automation, and federal regulatory requirements. Element LIMS increases the operational efficiency of the laboratory by automating and streamlining the workflows, thus eliminating the need for maintaining information manually. Element LIMS facilitates record keeping and reporting assisting with the risks of human errors and improving the overall turnaround time of submission of results to the client. A single-award BPA is expected to be awarded to Clinisys. The Independent Government Cost Estimate (IGCE) is estimated at ; therefore, it is expected that the total value of all orders placed under the BPA will be close in value to the IGCE. The period of performance for the BPA is expected to be a base period for one year and four option periods each for one year. Proposed Contractor: Clinisys, Inc. 3300 E Sunrise DR Tucson, Arizona 85718-3208 4. An identification of the LSJ rationale, and if applicable, a demonstration of the contractor s unique qualifications to provide the required supply or service. In accordance with FAR 8.405-6(a)(1)(i)(B), it is the Government s position that this requirement can only be satisfied by awarding a single-award BPA to the incumbent, Clinisys. The EPA owns perpetual software licenses for Clinisys Element LIMS. This software is used amongst laboratories across eight EPA regions and two program offices. Competing the maintenance and support services for these licenses would require EPA to switch to a new LIMS system which would result in a loss of time as well as an increase in cost to the agency. The native code to Element LIMS is owned and copyrighted by Clinisys. Other vendors do not have access to the code to compete for maintenance and support efforts for the EPA perpetually owned Element LIMS software licenses. The Contracting Officer confirmed there were no authorized resellers, or partnerships, and/or subcontractors to compete the maintenance and support work while performing marketing research (please see Marketing Research Report). If EPA were to switch to a new LIMS system, it is estimated that is would cost per laboratory. This cost would be applied to the ten laboratory that currently use Element LIMS totaling Establishing a single-award BPA from Clinisys s GSA MAS would save the agency over the course of five-year period. Transitioning to a new LIMS system would increase the risk for potential litigation issues and schedule delays. The Element LIMS software is used to handle laboratory data gathered for the analysis of contaminants in the air, drinking water, non-portable water, solid and chemical materials governed by acts, including the Resource Conservation and Recovery Act (RCRA). The EPA is required to hold on to both current and historical lab samples for litigation purposes and criminal investigation. There is no known tool to migrate the current database, resulting in a risk of losing laboratory samples. Migrating the database would result in schedule delays, as the users would need to adapt to a new system and ensure no data was lost during the migration process. If migration was possible, the process would need to be slow to ensure no data was lost, and that each lab doesn t lose functionality along the way which also adds to potential schedule risks. In addition to the cost and schedule delay risk, Clinisys poses unique qualifications. The engineers at Clinisys are well versed in the proprietary features of the Element LIMS software operating system. The engineers have extensive training and expertise, and this allows them to quickly troubleshoot 3 software malfunctions. The engineers also have real time access to any proprietary software upgrades pertaining to this system and this is critical for troubleshooting potential system malfunctions. Since the native code is owned and copyrighted by Clinisys, Clinisys is the only vendor that can provide the maintenance and support to the EPA perpetually owned licenses for Element LIMS. The EPA laboratories are open to competing the maintenance and support work for LIMS, and have developed a workgroup, to discuss the possibility of competition in the future. Prior to deciding that a single-award BPA was in the Government s best interest from both a schedule and cost perspective, the workgroup met up to discuss the possibility of competing this acquisition. During their discussions, it was decided that the migration of the database would be too time consuming and cost the agency close to per lab to migrate. The workgroup plans to continue to meet to discuss switching to a new LIMS system in the future. The follow-on work, after the establishment of the BPA, has the potential to competed in the future, however the EPA would need to strategically migrate the current database and ensure that the price is fair and reasonable prior to switching to an entirely new LIMS system. 5. A determination by the ordering activity contracting officer that the order represents the best value consistent with FAR 8.404(d). The anticipated cost to the Government is determined to be fair and reasonable by the Contracting Officer for this award. The IGCE not to exceed value for this award is The acquisition strategy is to award a single-award BPA to Clinisys, utilizing their GSA MAS. In accordance with FAR 8.404(d) prices on the GSA MAS are determined to be fair and reasonable. 6. A description of the market research conducted among schedule holders and the results, or a statement why market research was not conducted. A statement must be made that the supplies and services are available from the MAS. Marketing research was conducted by the Contracting Officer s Representative (COR) in April of 2024, and updated by the Contracting Officer in September of 2024. An internal EPA workgroup was established to assist with knowledge gathering for marketing research. During the knowledge gathering phase of marketing research, it was determined that no other LIMS system is compatible with Element LIMS. To add, as of right now, there are no known tools that could migrate the current database (Element LIMS) to a new LIMS database, and the EPA is required to keep laboratory samples for both litigation and criminal investigations. The marketing research also determined that there were no authorized resellers or partnership arrangements for Clinisys Element LIMS for competition. The marketing research report determined that establishing a single-award BPA would save the Agency financial resources. Currently, there are ten smaller purchase orders for the maintenance and support for the EPA Element licenses one for each region and program office that uses the software. Establishing a single-award BPA and awarding to the incumbent, Clinisys, would save the agency in maintenance and support costs over a period of five years. The marketing research showed that there are other companies that offer LIMS software systems, 4 however, none of these vendors can provide maintenance and support specific to the EPA perpetually owned software licenses. The EPA would need to switch to a new LIMS system to compete the requirement, and the cost estimation is about per laboratory to migrate the current Element LIMS system to a new LIMS system. 7. Any other facts supporting the limited source justification. There are no additional facts to support this LSJ. As previously stated, the EPA owns perpetual software licenses for Element LIMS. The native code is not available and is copyrighted by the incumbent, Clinisys. Since the native code is copyrighted, and Clinisys does not have any authorized resellers, there is no other vendor that can perform maintenance and support services for the EPA perpetually owned software licenses. To add, it is estimated that it could cost per lab to switch to a new LIMS system, while establishing a single-award BPA utilizing Clinisys s GSA MAS would save the Government over a period of five years. 8. A statement of the actions, if any, the agency will take to remove or overcome any barriers that led to restricted consideration before any subsequent acquisition for supplies and services is made. No actions are currently available to remove or overcome any barriers that preclude the Agency from meeting the requirements of FAR 8.405-3. The agency will continue to examine the possibility of switching to a new LIMS system in the future and has already established internal workgroups to continually research future possibilities. 9. The ordering activity contracting officer s certification that the justification is accurate and complete to the best of the contracting officer s knowledge and belief, and evidence that the supporting data that form a basis for the justification have been certified as complete and accurate by technical/program personnel. Certification Program Manager: I certify that the facts and representations under my cognizance, which are included in this justification and form a basis for this justification, are complete and accurate. _____________________________ Michael Spiegel Date Contracting Officer s Representative (COR) Region 09 Reviews and Approvals Reviewed By: _____________________________ Kareen C. Mansfield Date Contracting Officer Development and Operations Section (DOS) Information Technology Infrastructure, Development, and Operations Branch (ITIDOB) Information Technology Acquisition Division (ITAD) Contracting Officer Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief. The approving official certifies that this justification is accurate and complete in accordance with FAR 8.405-6(a)(1)(i)(C) as noted by their signature below. _____________________________ Darren J. Gann Date Contracting Officer / Section Manager Development and Operations Section (DOS) Information Technology Infrastructure, Development, and Operations Branch (ITIDOB) Information Technology Acquisition Division (ITAD)

PSC: DA10 Element Laboratory Information Management System (LIMS)- Maintenance and Support Blank Purchase Agreement (BPA) This is a post-award synopsis for a single-award Blanket Purchase Agreement (BPA) made in accordance with the procedures in Federal Acquisition Regulations (FAR) 8.405-3 under the authority of the Multiple Award Schedule program (41 USC 251, et seq. and 40 USC 501). One single-award BPA was awarded to Clinisys, Inc. on July 1, 2025. This single-award BPA was made under an approved Limited Sources Justification (LSJ) in accordance with FAR 8.405-6(a)(1)(i)(B). The BPA was awarded with a base period and four option periods, and the estimated total value for all performance periods is $474,912.00. Work performed under the BPA order(s) will be performed at the contractor’s facility in Tucson, Arizona. This BPA was established to provide the Environmental Protection Agency (EPA) with maintenance and support for the Agency’s perpetually owned Element Laboratory Information Management System (LIMS) software licenses.