CUI//PROCURE

Department of Defense Defense Health Agency

Statement of Requirement

Point of Care Testing Middleware

12 May 2026

Naval Medical Center Camp Lejeune

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide: a data management middleware system for Point of Care Testing (POCT) that supports the Roche Accu-chek Inform II and Abbbott i-STAT 1 devices.

1.1.1 Description of services/introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to provide a middleware solution for Point of Care Testing (POCT) connectivity that can transmit patient test results into the hospital’s current laboratory information system for Roche Accu-Chek Inform II and Abbbott i-STAT 1 devices as defined in this Statement of Requirement (SOR).

1.1.2 Background/Scope: The middleware hardware and software solution (including servers if necessary) will allow the end user to monitor patient and quality control testing done via POCT and help the laboratory meet numerous accreditation requirements for POCT. It will allow the Laboratory department to accomplish its objective of backing up, storing, and transmitting essential data from POCT equipment into the patient electronic health record. This supports the mission of the DoD to provide timely, accurate, and appropriate laboratory services in support of patient care by allowing data transmission from instrumentation into the laboratory information database and patient electronic health record. This is essential for reduction of patient safety events such as clerical errors and delayed test result availability to clinicians.

This software should be specific for instrumentation and processes used for laboratory POCT. The middleware solution will be used to post patient results to the permanent record from POCT sites at the facility’s main campus and building NH-200 located on the main campus. Virtual servers are required and must be capable of using Windows Server 2022 and be capable of handling security updates in accordance with DoD specifications.

1.1.3 Period of Performance (PoP): The requested period of performance is 12 May 2026 – 30 September 2026 with 4 option years.

1.2 Administrative specifications

1.2.1 Place of performance: The work shall be performed at Naval Medical Center Camp Lejeune Main Hospital and building NH-200 on the main campus at 100 Brewster Blvd, Camp Lejeune, NC 28547

1.2.2 Recognized Federal holidays: The performance of this middleware solution must be available on all holidays.

The contractor provides 24 hour, 7 days a week Technical Support through phone by calling a toll-free number.

1.2.3 Hours of operation: The performance of this middleware solution must be available 24 hours a day, 7 days a week, 365 days a year including all holidays, nights, and weekends.

The contractor provides 24 hour, 7 days a week Technical Support through phone by calling a toll-free number. The contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this SOR.

1.3 Contractor Identification

1.3.1 Contractor personnel performing services in a contractor capacity in a Government facility are required to possess and wear an identification badge that displays his or her name and the name of their company. Ensure all those with whom the person interacts in any face-to-face dealings while supporting the Governemnt understands that the person is contractor support personnel.

2.0 SPECIFIC TASKS

2.1 Middleware Requirements

2.1.1 System shall interface, providing data handling and management for twenty-eight Roche Accu-chek Inform II and four Abbott i-STAT 1 POCT devices.

2.1.2 System will allow connection to solicited or unsolicited fully configurable interface.

Terminal host should be able to be transitioned if needed.

2.1.3 In addition to the current instruments, system will have the ability to interface and accommodate alternate POCT devices and an increased number of current devices in the event that POCT increases or a change is made with POCT instruments. System should be able to interface at minimum of 100 mb/s.

2.1.4 System shall allow for a single program point of contact for point of care administrators.

The point of care administrator will be able to manage the instruments connected as well as all of the point of care users from one program.

2.1.5 The middleware system must be capable of generating reports such as, but not limited to, reagent lot number specific statistics (mean, standard deviation, coefficient of variation) with Levey Jennings graphs, linearity graphs, Quality Control (QC) outlier results, patient outlier critical test results.

2.1.6 System should be able to add additional testing locations within each facility at no additional cost.

2.1.7 System should provide secure email functionality within its software.

2.1.8 The system must allow for manual entry of non-instrument test results to include documentation of information for each test entry such as reagent lot numbers, expiration dates and internal quality control results in the middleware system. The system will support entry of non-instrument results by operators directly into the middleware and from POCT instruments with the capacity and feature of manual test entry.

2.1.9 Must be able to provide historical quality control and patient test result data without loss of reagent lot specific information.

2.1.10 Middleware must provide a means of managing quality control including patient testing lock out for failed quality control or quality control not performed at the programmed frequency and be able to display, in Levey-Jennings charts, all results of quality control in use.

2.1.11 Must allow customer to remotely configure from one program any instrument settings options furnished within the point of care instrument by the manufacturer.

2.1.12 Must support successful implementation and a non-manual method of uploading historical data, i.e. operators and meters/analyzers in the transition from a different system.

2.2 Connectivity and Conformance Standards

2.2.1 The middleware system must be compliant with all Office of Information and Technology and Information Security directives.

2.2.2 The hardware must meet all DoD minimum specifications and the software version must be approved for use on the DoD network (Windows 11 and Server 2022).

2.2.3 Must be capable of connecting to an HL7 interface.

2.2.4 The contractor’s performance must be in compliance with all applicable state, federal and local laws and regulations.

2.3 Support/Training Features

2.3.1 The contractor provides 24 hour, 7 days a week Technical Support by calling a toll-free number.

2.3.2 Any reference range, reporting units, abnormal value flags or critical value flags and any other updates will be at no cost to the medical center.

2.3.3 The Contractor provides documentation of services performed.

2.3.4 The Contractor shall provide a warranty for all items and services provided and all associated delivery orders.

2.3.5 Training, instruction, and consultation must be provided by the contractor for both initial installation and post installation operations.

2.3.6 Contractor shall at minimum provide on-site training for up to 8 hours per site as requested by the facility.

2.3.7 Contractor will provide example policies and procedures such as standard operating procedure templates for the system.

2.3.8 The Contractor shall provide a training program that is coordinated with and timely to the equipment installation. Training shall include initial setup and user training; onsite training for go-live support, super user training and follow-up training.

2.3.9 The system will provide the customer a means of managing operator identification information and ongoing training and competency assessment dates, with analyzer lockout when not complete.

2.3.10 User and Service Manuals: The Contractor shall provide downloadable PDF versions of operator manuals, service manuals, electronic schematics, troubleshooting guides, diagnostic software and tools. Additionally, any upgrades to these documents shall be provided by the Contractor free of charge. These manuals shall include all components and subsystems, including those not manufactured by the Contractor. These manuals and documentation shall be identical to the ones supplied to the manufacturer’s service representatives and shall contain the diagnostic codes, commands, and passwords utilized in maintenance, repair and calibration of the equipment/software and provided for the life of the system at no additional cost.

2.4 Updates/Upgrades

2.4.1 The Contractor shall provide updates to both the equipment hardware and software in order to maintain the integrity of the system and the state-of-the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system updates” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, update offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc.

3.0 Qualifications/Considerations

3.1 Special Qualifications/Considerations: Software and/or hardware must be an approved product by the Defense Health Agency (DHA), and authorized to be used on the DHA network.

4.0 Points of Contact

4.1 Points of Contact:

Kat Arroyo (POCT Supervisor) Email: Katherine.L.Arroyo.civ@health.mil Phone: 910-450-3494 or 910-450-4621

Erin Wagner (Laboratory Admin Director) Email: Erin.M.Wagner2.civ@health.mil Phone: 910-450-3370 or 910-450-4621 mailto:Katherine.L.Arroyo.civ@health.mil mailto:Erin.M.Wagner2.civ@health.mil