6550--NEW - STX Core Lab QC Consumables

Form / Attachment / Pricing Sheet

This document, Attachment 2, outlines the "Salient Characteristics" for in-vitro diagnostic (IVD) quality control (QC) materials and QC data-management software. It establishes the minimum physical, functional, and performance requirements that any "equal" product must meet to be considered technically acceptable for Solicitation No. 36C25726Q0381. It also details requirements for offerors proposing brand-name products.

QC Reagents:

• Common Characteristics: Must have FDA clearance, use human-derived matrix, be in ready-to-use liquid format, meet specified stability windows (closed/open vial), have appropriate package/fill volumes, cover specified analytes, provide commutability/validation documentation, and meet traceability and labeling requirements.
• Product-Specific Characteristics: Details specific requirements for various QC reagents (e.g., Multiqual, Liquichek Immunoassay, Ethanol/Ammonia, Cardiac Marker, Diabetes, Urine Chemistry, Immunology, Spinal Fluid, Toxicology) including matrix, stability, and analyte coverage for specific analyzers (Beckman Coulter AU 5800, DxI 800, and Tosoh HbA1c). QC Data-Management Software (Unity Real Time or equal):
• Deployment: Must be local/on-premises, not cloud-only or SaaS-only.
• Interfaces: Native bidirectional interface with Data Innovations Instrument Manager and direct interface with Tosoh HbA1c analyzer.
• Features: Multi-rule/Multi-Levey-Jennings statistical QC, interlaboratory peer-group program, multi-site reporting (Audie L. Murphy and Kerrville sites), and security/accessibility compliance (VA TRM, Section 508/VPAT).
• Data Continuity: Must preserve historical QC data or provide a transition plan.
• Licensing: Twelve (12)-month subscription, renewable. Delivery and Service:
• Next-business-day delivery (ARO) to both San Antonio and Kerrville sites.
• Same-day order confirmation with tracking.
• Lot sequestration for 12-month ordering periods.
• 24-hour emergency replacement capability.
• Written technical alert and recall notification procedures.
• Temperature-controlled shipping for refrigerated materials.
• Specific packing slip and labeling requirements.

Offerors proposing an "equal" product must complete and submit a Compliance Matrix (Part VI) and provide supporting documentation (Part VII), including FDA clearance, package inserts, commutability documentation, and software compliance details. Failure to meet any salient characteristic may result in the offer being deemed technically unacceptable. Offerors proposing brand-name products must still meet software, delivery, and service characteristics.

Solicitation / RFP / RFQ

This document is a Brand Name or Equal Justification for Solicitation No. 36C25726Q0381. It outlines the government's need for in-vitro diagnostic (IVD) quality control (QC) materials and renewal of Unity Real Time QC data-management software for the Core Laboratory at the South Texas Veterans Health Care System (STVHCS). The procurement is for Beckman Coulter AU 5800, DxI 800, and Tosoh HbA1c analyzers.

• FDA-approved, ready-to-use IVD QC materials.

• QC data-management software subscription (Unity Real Time).

• Materials must be compatible with specific laboratory analyzers (Beckman Coulter AU 5800, DxI 800, Tosoh HbA1c).

• Specific requirements include:

  • FDA clearance or approval for specific analytes.
  • Human serum-, whole-blood-, or human urine-based matrices.
  • Ready-to-use liquid format.
  • Specified closed-vial and open-vial stability windows.
  • Specified package and fill volumes.
  • Analyte coverage matching or exceeding enumerated panels.
  • Commutability and validation documentation for CLIA QC requirements.

• Software requirements include:

  • Local, non-web-based deployment.
  • Native interfacing with laboratory middleware and analyzers.
  • Interlaboratory peer-group program participation.
  • Multi-rule / Multi-Levey-Jennings (Westgard) statistical QC capability.
  • Site-to-site comparison reporting.

• Delivery and Service Characteristics:

  • Next-business-day delivery to specified sites.
  • Same-day order confirmation.
  • Lot sequestration.
  • 24-hour emergency replacement capability.
  • Technical alert and recall notification procedures.

• Proposed Contract Vehicle: Single-award Firm-Fixed-Price IDIQ.

• Contract Period: 1 base ordering period + 4 option ordering periods (not to exceed 5 years total).

• Estimated Maximum Value: $1,310,704.58 (inclusive of base and all option periods).

• This is a competitive "Brand Name or Equal" solicitation.

• Offerors may propose Bio-Rad products or any "equal" product that meets every salient characteristic in Attachment 2.

• The solicitation includes FAR 52.211-6, Brand Name or Equal.

• Evaluation includes a factor giving preference to SDVOSB and VOSB offerors.

• The acquisition strategy supports small-business participation.

• Multiple SDVOSB and VOSB distributors are capable of supplying products.

• The solicitation applies VAAR 852.215-70 / 852.215-71 evaluation factor for SDVOSB and VOSB offerors.

• The justification is posted with Solicitation No. 36C25726Q0381 on SAM.gov as a separate document.

• Attachment 2 (Salient Characteristics) is the authoritative reference for "equal" product requirements.

• Brand names referenced: Bio-Rad Laboratories, Inc. ("Liquichek," "Multiqual," and "Unity Real Time" product lines).

Solicitation / RFP / RFQ

This solicitation is for the procurement of FDA-approved, brand-name quality control materials and renewal support for the Unity Real Time Software. These materials are required for the Core Laboratory of Pathology & Laboratory Medicine Service at Audie L. Murphy VA Hospital and Kerrville VA. The goal is to ensure compliance with CLIA standards and detect systematic errors.

• Ready-to-use Quality Control materials compatible with Beckman Coulter AU 5800, DXI 800, and Tosoh HgbA1c instrumentation.

• Material to cover all listed analytes.

• Local, non-web-based expert quality control program utilizing data from Beckman Coulter instruments.

• Reporting capabilities for interlaboratory peer group comparisons and comparison with affiliated hospitals and clinics.

• Monthly peer data download to local software.

• Support for Multi Levey Jennings for QC result comparison.

• Next-day delivery to Audie L. Murphy VA Hospital and Kerrville VA.

• Same-day order confirmation and tracking information.

• Emergency Contingency Plan for defective supplies or delivery failures.

• Specific product requirements for Multiqual Level 1, 2, and 3, Liquichek Immunoassay Plus Level 1, 2, and 3, Liquichek Ethanol/Ammonia Control Level 1, 2, and 3, Liquichek Cardiac Marker Plus Control LT Level 1, 2, and 3, Liquichek Diabetes Control Level 1, 2, and 3, Liquichek Urine Chemistry Control Level 1 and 2, Liquichek Immunology Control Level 1, 2, and 3, Liquichek Spinal Fluid Control Level 1 and 2, Liquichek Urine Toxicology Screen Control Level S1E Low Opiate and S2E Low Opiate, and Unity Real Time software subscriptions/support.

• Contract Type: Single-award Indefinite Delivery, Indefinite Quantity (IDIQ) with Firm-Fixed-Price delivery orders.

• Period of Performance: Base ordering period (June 15, 2026 - June 14, 2027) plus four (4) option ordering periods, each 12 months, for a total of up to five (5) years.

• Guaranteed Minimum Obligation: $13,000.00.

• Maximum Contract Ceiling: $1,300,000.00.

• Proposal Due Date: May 8, 2026, 10:00 AM CT.

• Questions Due Date: May 4, 2026, 10:00 AM CT.

• Proposals to be submitted via email to the Contract Specialist.

• Evaluation Factors: Technical Acceptability, Past Performance, SDVOSB/VOSB Participation, and Price.

• Award Basis: Lowest Price Technically Acceptable (LPTA).

• This acquisition is unrestricted.

• NAICS Code: 325413 (In-Vitro Diagnostic Substance Manufacturing).

• Size Standard: 1250 Employees.

• The solicitation is a "Brand Name or Equal" solicitation. Offerors may propose "equal" products that meet all salient characteristics.

• All attachments referenced are posted on SAM.gov.

• Offerors are responsible for monitoring SAM.gov for amendments.

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation for in-vitro diagnostic (IVD) quality-control (QC) reagents, consumables, and associated QC data-management software for the South Texas Veterans Health Care System (STVHCS) Core Laboratory. The materials support patient testing on Beckman Coulter AU 5800, DxI 800, and Tosoh HbA1c analyzers.

• IVD QC reagents and consumables.

• Renewal of QC data-management software (Bio-Rad Unity Real Time or equal).

• Next-business-day delivery to Audie L. Murphy VA Hospital (San Antonio, TX) and Kerrville VA Medical Center (Kerrville, TX).

• Lot sequestration throughout each 12-month ordering period.

• 24-hour emergency replacement capability for defective shipments or delivery failures.

• Contract Type: Single-Award Indefinite-Delivery, Indefinite-Quantity (IDIQ) with Firm-Fixed-Price delivery orders.

• Ordering Period: Base of 12 months plus four 12-month option periods (5 years total).

• Estimated Maximum Ceiling: $1,310,704.58.

• Response Date: Friday, May 8, 2026, 10:00 AM Central Time (CT).

• Submission Method: Email to ognian.ivanov@va.gov with subject line "RFQ 36C25726Q0381 — Quotation — [Offeror Name]".

• Questions Due: Friday, May 1, 2026, 2:00 PM Central Time (CT).

• Evaluation Basis: Lowest Price Technically Acceptable (LPTA), considering Technical Acceptability, Past Performance, SDVOSB/VOSB Participation, and Price.

• Procurement Vehicle: Open Market — Full and Open Competition.

• Set-Aside: Unrestricted. SDVOSB/VOSB participation will be evaluated as a non-price factor.

• Registration: Offerors must be registered and active in SAM.gov.

• Acquisition is solicited on a Brand Name or Equal basis (Bio-Rad Laboratories, Inc. referenced). Offerors quoting "equal" must submit a Compliance Matrix (Attachment 5) and substantiating documentation (Attachment 2).

• Key attachments include SOW, Salient Characteristics, Brand Name or Equal Justification, Pricing Schedule, Compliance Matrix, and Clauses/Provisions.