Middleware for Point of Care Testing

Amendment / Modification

This amendment (0001) to Solicitation HT940626QE019, dated 25 Mar 2026, is issued to respond to questions received from the RFQ.

• A "Q and A" document has been added as an attachment.
• The "Q and A" document is titled "Q and A HT940626QE019".
• An additional attachment, "HT940626QE0190001", has also been added.

This amendment does not explicitly state if proposal deadlines, requirements, or evaluation factors were modified. However, the addition of Q&A suggests potential clarification of existing requirements.

Questions & Answers / Clarifications

This document provides responses to vendor questions regarding the solicitation.

• Incumbent Contract: The contract is a recompete. The current contract number is N6809321P0041.
• Submission Instructions: For requirements related to iSTAT connectivity and AccuChecks, ensure offers/quotes are submitted in accordance with ADDENDUM TO 52.212-1, INSTRUCTIONS TO OFFERORS – COMMERCIAL, SECTION III, and Volume II: Pricing Sheet.

No specific impact on requirements, due dates, or submission rules was noted beyond the clarification of submission instructions.

Solicitation / RFP / RFQ

This solicitation (HT940626QE019) is for "Middleware" services, specifically related to Point of Care Testing Middleware. The North American Industry Classification Standard (NAICS) code is 541512, with a size standard of USD 34,000,000.00.

• The primary requirement is for Point of Care Testing Middleware.

• CLINs (Contract Line Item Numbers) will be broken out at the time of award based on the awardee's pricing breakdown.

• The document incorporates FAR clauses by reference, including those related to contracting officer's representative, electronic submission of payment requests, and Wide Area WorkFlow (WAWF) payment instructions.

• DFARS clauses are also incorporated, including those related to item unique identification and valuation.

• The contract type is not explicitly stated but is indicated as a Request for Quote (RFQ) or Request for Proposal (RFP).

• The estimated award amount is not specified, but the NAICS size standard is $34,000,000.00.

• The period of performance for the base CLIN is May 12, 2026, to September 30, 2026.

• Option periods extend the performance through September 30, 2030.

• The solicitation issue date is March 25, 2026.

• The offer due date is April 06, 2026, at 08:00 PM.

• Evaluation factors for award are not detailed in the provided pages, but the document references "ADDENDUM TO 52.212-2, BASIS FOR AWARD."

• Payment requests and receiving reports are to be submitted electronically via the Wide Area WorkFlow (WAWF) system.

• The acquisition is listed as "UNRESTRICTED."

• The document includes several addenda to FAR clauses, including "ADDENDUM TO 52.212-1, INSTRUCTIONS TO OFFERORS – COMMERCIAL" and "ADDENDUM TO 52.212-2, BASIS FOR AWARD."

• Inspection and acceptance will occur at NAVMEDCEN CAMP LEJEUNE NC.

• The document also details requirements for Item Unique Identification and Valuation (IUID).

Amendment / Modification

This addendum clarifies the basis for award for the solicitation. The primary change is the confirmation that the award will be made on a Lowest Priced, Technically Acceptable (LPTA) basis.

• Basis of Award: Explicitly states the award will be made to the Lowest Priced, Technically Acceptable offer.
• Non-Price Evaluation Factors: Details the Technical Capability Factor and its subfactor (Technical Capability Subfactor), emphasizing the requirement for a current Authority to Operate (ATO) or the ability to obtain one prior to the period of performance. It also outlines the technical ratings (Acceptable/Unacceptable).
• Price Evaluation Factor: States that price reasonableness will be evaluated.
• Basis of Award (Detailed): Reaffirms that quotes will be evaluated technically first, and among technically acceptable quotes, award will go to the lowest-priced offer. The Government may make an award decision based on initial quotes without requesting additional information.

Offerors must ensure their proposals meet all technical requirements to be considered technically acceptable. The Government intends to make award without discussions, so offerors should submit their most favorable prices in their initial offers. A current ATO or demonstrated ability to obtain one is a critical requirement for technical acceptability.

Amendment / Modification

This document is an addendum to FAR 52.212-1, Instructions to Offerors – Commercial, for the Data Management Middleware System for Point of Care Testing (POCT) opportunity.

• Section I: Clarifies that offerors shall submit only one quote. Emphasizes that incomplete quotes may not be considered and that falsification can lead to prosecution. States the government is not liable for costs incurred in proposal preparation. Requires compliance with FAR 52.204-7 (SAM) and completion of all representations and certifications in SAM.
• Section II: Specifies the requirement is for commercial, non-personal services for a Data Management Middleware System supporting Roche Accu-chek Inform II and Abbott i-STAT 1 devices at Naval Medical Center Camp Lejeune, NC. It will result in a Firm Fixed-Price contract. The Statement of Requirement (SOR) provides detailed requirements. The Period of Performance includes a base period (12 May 2026 – 30 September 2026) and four option periods. The NAICS code is 541512 with a $34.0M small business size standard. Competition is Full and Open.
• Quote Submission Instructions: Provides Points of Contact (POCs) for contracting matters. Questions must be submitted in writing by 2:00 PM ET on March 31, 2026, with a specific subject line. No phone calls are accepted. Answers will be provided via amendment. Quotes are due no later than 8:00 PM ET on April 6, 2026, with a specific subject line.
• Section III: Details submittal instructions, requiring one quote via email. Quotes must be clear and comprehensive.
  • Volume I (Technical Capability): Limited to three (3) pages, excluding cover page, title page, POC sheet, table of contents, and acronyms page. Pages exceeding the limit will be removed. The POC sheet must include specific company contact details.
  • Volume II (Pricing Sheet): Must be submitted in MS Excel format, including annual and total contract prices.
  • Volume III (Redacted Technical Capability): Must include only the Technical Capability portion of Volume I, with company-specific information, personnel details, and logos redacted. This volume is also subject to page limitations.
• Formatting: Volume I and III in MS Word or searchable PDF; Volume II in MS Excel. Zip files are not accepted. No classified data or hyperlinks. Submissions should have three attachments titled: Volume I: TC_Company Name; Volume II: Pricing_Company Name; and Volume III: Redacted_Company Name.
• Technical Capability: Offerors must provide a written technical approach demonstrating understanding of tasks and methodology. If partnering, explain the arrangement, scope of services, and payment division.
• Price: Pricing must be in accordance with the SOR. Quotes must remain valid for at least 120 calendar days.
• Redacted Technical Capability: All company-identifying information must be redacted.

This addendum provides critical details on submission requirements, format, page limitations, content for technical and pricing volumes, and deadlines for questions and quotes. Offerors must ensure compliance with all specified instructions, including SAM registration and the redaction of sensitive information in Volume III.

Statement of Requirement (SOR)

To provide a data management middleware system for Point of Care Testing (POCT) that supports Roche Accu-chek Inform II and Abbott i-STAT 1 devices, enabling transmission of patient test results into the hospital's current laboratory information system.

• Provide all personnel, equipment, supplies, and services for a middleware solution.

• Allow end-users to monitor patient and quality control testing via POCT.

• Facilitate the backing up, storing, and transmitting of POCT data into the patient electronic health record.

• Support the mission of the DoD to provide timely and accurate laboratory services.

• Ensure reduction of patient safety events related to clerical errors and delayed test results.

• The middleware solution will be used at Naval Medical Center Camp Lejeune Main Hospital and building NH-200.

• Virtual servers are required, capable of using Windows Server 2022 and handling security updates.

• Period of Performance: 12 May 2026 – 30 September 2026 with 4 option years.

• Place of Performance: Naval Medical Center Camp Lejeune Main Hospital and building NH-200, 100 Brewster Blvd, Camp Lejeune, NC 28547.

• Availability: 24 hours a day, 7 days a week, 365 days a year, including all holidays, nights, and weekends.

• Technical Support: 24/7 toll-free phone support.

• Contractor Identification: Personnel must wear identification badges.

• Middleware Requirements:

  • Interface with 28 Roche Accu-chek Inform II and 4 Abbott i-STAT 1 POCT devices.
  • Allow connection to configurable interfaces and accommodate alternate POCT devices.
  • Interface at a minimum of 100 mb/s.
  • Allow a single point of contact for point of care administrators to manage instruments and users.
  • Generate reports including reagent lot statistics, QC outlier results, and patient critical test results.
  • Support additional testing locations at no additional cost.
  • Provide secure email functionality.
  • Allow manual entry of non-instrument test results.
  • Provide historical quality control and patient test result data.
  • Manage quality control, including lockout for failed QC.
  • Allow remote configuration of instrument settings.
  • Support non-manual historical data uploading.

• Connectivity and Conformance Standards:

  • Compliant with Office of Information and Technology and Information Security directives.
  • Hardware must meet DoD minimum specifications; software approved for DoD network (Windows 11 and Server 2022).
  • Capable of connecting to an HL7 interface.
  • Compliance with all applicable laws and regulations.

• Support/Training Features:

  • 24/7 Technical Support.
  • Updates to reference ranges, reporting units, and flags at no cost.
  • Provide documentation of services.
  • Provide warranty for all items and services.
  • Provide initial installation and post-installation training, including up to 8 hours on-site per site.
  • Provide example SOP templates.
  • Training program coordinated with equipment installation.
  • System to manage operator identification and training dates.
  • Provide downloadable PDF versions of manuals (operator, service, schematics, etc.) and upgrades free of charge.

• Updates/Upgrades: Provide hardware and software updates at no additional charge to maintain state-of-the-art technology.

• Qualifications: Software/hardware must be approved by the Defense Health Agency (DHA) and authorized for the DHA network.

• Kat Arroyo (POCT Supervisor)

• Erin Wagner (Laboratory Admin Director)