SSJ_LIMS_Redacted.pdf

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FAR Part 13 Justification and Approval for Sole-Source

1. Contracting activity: The Defense Health Agency (DHA), Healthcare Contracting Division - Central (HCD-C), Colorado Springs.

2. Description of Action: Sole-source contract with MediaLab Solutions LLC for the 88th Medical Group at Wright-Patterson AFB (WPAFB) Clinical Laboratory under simplified acquisition procedures. Estimated value is under the simplified acquisition threshold.

3. Period of Performance and Estimated Price: Base Year plus four (4) Option Years with an estimated value of .

Base Year: 16 December 2024 to 15 December 2025 Option Year 1: 16 December 2025 to 15 December 2026 Option Year 2: 16 December 2026 to 15 December 2027 Option Year 3: 16 December 2027 to 15 December 2028 Option Year 4: 16 December 2028 to 15 December 2029

4. Description of Supplies/Services: A sole source requirement to award a sole source contract to Medialab Solutions LLC. This requirement is to procure an annual subscription to utilize a web-based Laboratory Management Software via a Laboratory Information Management System accessible by username and password that was developed specifically to meet medical laboratory requirements. The platform must contain all laboratory operating instructions that are updated, approved, and available real-time to lab technicians; training, and competency assessments to ensure current skills are maintained; exam simulators for laboratory students and staff;

accreditation standards for regulatory compliance; nonconforming event reporting for trend analysis and corrective action; and continuing education resources for required certification maintenance. Below are the required platform modules:

Compliance & CE [1 site, 100 users] Histology CE [10 users] Document Control [1 site, 125 users] Inspection Proof [1 site] Compass [1 site, 125 users] IQE [1 site] Exam Simulator (MLS, MT, MLT) [20 seats]

4. Authority Cited: Acquisition of commercial items conducted pursuant to FAR Subpart 13.106-1(b)(1)(i) in accordance with 41 U.S.C. 1901 Simplified Acquisition Procedures.

5. Reason for Authority Cited: The 88th MDG Laboratory has relied on MediaLab Solutions LLC since 2019 as the only quality management platform providing immediate access and real-time updates to all essential laboratory documentation. Before 2022, individual modules were purchased via GPC. To ensure uninterrupted access to the full range of required quality management systems, a contract for MediaLab software was awarded in 2022, as a base contract plus several option years. The current contract does not include all required modules. The

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platform currently houses critical operational documentation, including 700 operating instructions, 1.2K forms, 140 continuing education courses, 17 accreditation checklists with 1.4K regulatory standards, 35 training and competency assessments, and 5 national certification preparation exams. Discontinuing MediaLab and transitioning to another platform would severely disrupt operations and compromise accreditation compliance. The Defense Health Agency Center for Laboratory Medicine Services is working to establish a centralized MediaLab contract for all laboratories, with 27 laboratories in the Network Continental (DHN-9) already using the platform.

6. Efforts to Obtain Competition: We thoroughly explored and researched a variety of potential alternatives to meet the laboratory's quality management needs. This included reviewing several platforms such as Decoto Regulator, Thermo Scientific Sample Manager LIMS, Benchling, and Labguru. Despite our efforts to find a suitable alternative, none of these platforms fully met the extensive requirements outlined in the Market Research and Statement of Work. MediaLab Solutions LLC, however, was the only platform that met all of the specified criteria. This is the only Laboratory Information Management System that can maintain the current certifications and the additional modules not previously included on our current Media Lab contract FA860123P0015. This new requirement will ensure that all modules are covered via contract.

7. Actions to Increase Competition: Posting Notice of Intent to Sole Source on SAM.gov.

8. Market Research: Market research was conducted through a comprehensive process that involved obtaining detailed documentation from various potential vendors. We evaluated each platform’s capabilities based on the specific needs outlined in our requirements, which include document control, training and competency records, nonconforming event management, continuing education course management, national certification exam simulators, and regulatory standard compliance certification. Through this process, we requested technical specifications, product demonstrations, and documentation from multiple vendors to assess their ability to meet these critical requirements. After careful review, it was determined that no other quality management software, including Decoto Regulator, Thermo Scientific SampleManager LIMS, Benchling, or Labguru, could fulfill all WPAFB’s laboratory operations and compliance requirements. MediaLab Solutions LLC is the only platform that will fully satisfy all the necessary criteria.

9. A statement of any actions the agency will take to remove or overcome any future barriers to competition.

WPAFB Lab will take proactive steps to continuously monitor the market for new and emerging quality management software solutions to remove or overcome any future barriers to competition. This will involve regularly reviewing industry trends, attending relevant conferences, and engaging with vendors to stay informed about potential alternatives.

Additionally, the agency will work closely with the Defense Health Agency Center for Laboratory Medicine Services to establish a centralized contract for MediaLab Solutions LLC, ensuring more streamlined and competitive procurement processes for all laboratories within the network. Furthermore, the agency will maintain an open line of communication with current and