36C25726Q0381_Brand_Name_or_Equal_Justification-CO signed.pdf

Brand Name or Equal Justification — 36C25726Q0381

BRAND NAME OR EQUAL JUSTIFICATION

Pursuant to FAR 11.105 and VAAR 811.104 Posted with Solicitation No. 36C25726Q0381 under FAR 5.102(a)(6) and FAR 11.105(b)

Government Pre-Award Determination — Not an Attachment to the Solicitation or Resulting Contract

Requiring Activity South Texas Veterans Health Care System (STVHCS) — Pathology & Laboratory Medicine Service; Audie L. Murphy VA Hospital (San Antonio, TX) and Kerrville VA Medical Center (Kerrville, TX)

Contracting Activity Department of Veterans Affairs, Network Contracting Office17, 5441 Babcock Road, Ste. 302, San Antonio, TX 78240

Solicitation No. 36C25726Q0381

Description of Supplies In-vitro diagnostic (IVD) quality control (QC) materials and renewal of Unity Real Time QC data-management software for the Core Laboratory (Beckman Coulter AU 5800, DxI 800, and Tosoh HbA1c analyzers).

Proposed Contract Vehicle Single-award Firm-Fixed-Price IDIQ under FAR Subpart 16.504; 1 base + 4 option ordering periods; not to exceed 5 years.

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

Brand Name Referenced Bio-Rad Laboratories, Inc. (Hercules, CA) — "Liquichek," "Multiqual," and "Unity Real Time" product lines

Extent of Competition Competitive — "Brand Name or Equal" under FAR 11.104;

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

Justification Authority FAR 11.105 (restrictive purchase description); FAR 11.104 (brand-name-or-equal purchase description); VAAR 811.104

Scope of This Justification This is NOT a FAR 6.303 / 13.501 limited-source (sole-source) justification. Because the Government is soliciting competitively on a "brand name or equal" basis under FAR 11.104 — allowing any responsible source to propose an equal product that meets the salient characteristics in Attachment 2 — the restriction documented here is the use of a brand name within an otherwise competitive purchase description, which is governed by FAR 11.105. If the agency were instead limiting the source to Bio-Rad only, a separate limited-source justification under FAR 6.302-1 (simplified acquisition: FAR 13.106-1(b)(1) / 13.501(a) for SAP; FAR 6.303 for above SAT) would be required and would be documented in a different form.

1. Agency and Contracting Activity The requiring activity is the South Texas Veterans Health Care System (STVHCS), Pathology & Laboratory Medicine Service, supporting the Core Laboratories at Audie L. Murphy VA Hospital, San Antonio, Texas, and the Kerrville VA Medical Center, Kerrville, Texas. The contracting activity is the Department of Veterans Affairs, VISN 17 Network Contracting Office (NCO 17), San Antonio, Texas.

2. Nature and Description of the Action Being Approved Approval is requested to issue a competitive "Brand Name or Equal" solicitation (FAR 11.104) that references the Bio-Rad Laboratories, Inc. Multiqual, Liquichek, and Unity Real Time product lines, and to award a single-award Firm-Fixed-Price Indefinite-Delivery, Indefinite-Quantity (IDIQ) contract with one (1) base ordering period and four (4) twelve-month option ordering periods (not to exceed five (5) years total ordering time under FAR 17.204(e)). The maximum contract ceiling is $1,300,000.00. A minimum guaranteed obligation (stated in Section B) will be satisfied by an initial delivery order upon award.

3. Description of the Supplies Required STVHCS requires a continuous supply of FDA-approved, ready-to-use IVD QC materials and a QC data-management software subscription (the Bio-Rad Unity Real Time program) sufficient to maintain regulatory compliance with the Clinical Laboratory Improvement Amendments (CLIA) and with VHA Directive / VHA Handbook 1106.01 (Pathology and Laboratory Medicine Service Procedures). Materials must be compatible with the laboratory’s installed analyzer fleet:

Beckman Coulter AU 5800 (clinical chemistry), Beckman Coulter DxI 800 (immunoassay), and Tosoh (HbA1c). Specific line items with salient characteristics are set forth in the Statement of Work (Attachment 1) and the Salient Characteristics (Attachment 2), and include 28 QC reagent product lines plus the Unity Real Time software renewal.

4. Identification of the Brand Name and Manufacturer

Brand Name Manufacturer Product Family

Multiqual Bio-Rad Laboratories, Inc.

Tri-level human serum chemistry QC (Products 697 / 698 / 699)

Liquichek Bio-Rad Laboratories, Inc.

Multi-level QC panels: Immunoassay Plus, Ethanol/Ammonia, Cardiac Markers Plus LT, Diabetes (HbA1c), Urine Chemistry, Immunology, Spinal Fluid, Urine Toxicology, Specialty Immunoassay Plus

Unity Real Time Bio-Rad Laboratories, Inc.

Local (non-web-based) QC data-management software with interlaboratory peer-group comparison program (Product 804-1)

5. Salient Physical, Functional, and Performance Characteristics (FAR 11.104(b); FAR 52.211-6) The characteristics that an "equal" product must satisfy are set forth in full in Attachment 2 (Salient Characteristics), incorporated herein by reference. The characteristics below are summarized; Attachment 2 controls in the event of any conflict.

5.1 Product (Reagent) Characteristics Common to All Line Items

● FDA clearance or approval for use as an IVD quality-control material for the specific analytes on each panel.

● Human serum-, whole-blood-, or human urine-based matrices as specified for each panel — non-human / synthetic matrices do not match the commutability required for the listed methods.

● Ready-to-use (no reconstitution) liquid format to minimize preanalytical error and to eliminate lot-to-lot reconstitution variability.

● Closed-vial and open-vial stability windows as specified per panel (for example, 30-day unopened / 14-day open-vial at 2–8 °C for Multiqual; 14-day open-vial at 2–8 °C for Liquichek Immunoassay Plus with Folate 7-day; at least 2-year shelf life for Ethanol/Ammonia; at least 3-year shelf life for Urine Toxicology).

● Package and fill volume specified per panel (for example, 12 × 10 mL for Multiqual; 12 × 5 mL or 6 × 5 mL for immunoassay panels; 6 × 3 mL for cardiac and immunology panels;

6 × 1 mL for diabetes HbA1c).

● Analyte coverage matching or exceeding each enumerated panel in Attachment 2 (for example, the full Multiqual chemistry analyte list including Acid Phosphatase, ALT/AST, Alkaline Phosphatase, Amylase (including Pancreatic), Bilirubin (Total/Direct/Neonatal), Calcium, Chloride, Cholesterol (Total/HDL/LDL), Cholinesterase, CK, Creatinine, GGT, Glucose, Iron, Lactic Acid, LDH, Lipase, Magnesium, Osmolality, Phosphorus, Potassium, Protein (Total), Sodium, TIBC/UIBC, Triglycerides, Urea Nitrogen, Uric Acid).

● Commutability and validation documentation sufficient to meet 42 C.F.R. § 493.1256 (CLIA QC requirements) for the Beckman Coulter AU 5800, DxI 800, and Tosoh HbA1c method families.

5.2 Software (Data-Management) Characteristics

● Local (on-premises, non-web-based) deployment architecture, consistent with VA information-security and Technical Reference Model (TRM) constraints.

● Native interfacing with the laboratory’s Data Innovations Instrument Manager middleware to ingest results from the Beckman Coulter AU 5800 and DxI 800, and interfacing with the Tosoh HbA1c analyzer.

● Participation in an interlaboratory peer-group program with monthly peer-data download and report generation.

● Multi-rule / Multi-Levey-Jennings (Westgard) statistical QC capability for cross-instrument comparison.

● Capability to generate site-to-site comparison reports across the Audie L. Murphy and Kerrville sites (multi-site affiliate reporting).

● Listing on, or documented compliance with, the VA TRM; delivery of Section 508 conformance documentation (Attachment 8).

5.3 Delivery and Service Characteristics

● Next-business-day delivery to both the Audie L. Murphy (San Antonio, TX) and Kerrville

(Kerrville, TX) sites.

● Same-day order confirmation with tracking and estimated delivery time.

● Lot sequestration: the contractor shall sequester QC lots so the lot numbers remain constant throughout each 12-month ordering period.

● 24-hour emergency replacement capability if delivered supplies are defective or routine delivery fails, with sufficient quantity to support one week of normal Government test-load volume at no additional cost to the Government.

● Technical alert and recall notification procedures consistent with 21 C.F.R. Part 806 and VHA Handbook 1106.01.

6. Reasons Why the Particular Brand Name Is Cited in the Purchase Description (FAR 11.105(a)) FAR 11.105(a)(1) permits the use of a brand name in a purchase description only when the particular brand name, product, or feature is essential to the Government’s requirements, and market research indicates other companies’ similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet, the agency’s needs. The following facts support that determination for this acquisition:

6.1 Incumbent Validation History Under CLIA

Under 42 C.F.R. § 493.1256, each clinical laboratory must establish and follow written policies and procedures for quality control that, at minimum, "monitor the accuracy and precision of the complete analytic process." STVHCS Core Laboratory has performed, and maintains on file, the method-validation studies required by 42 C.F.R. § 493.1253 using the Bio-Rad Multiqual, Liquichek, and specialty QC materials listed in the SOW. Citing the brand in the purchase description permits continuity of the validated QC program while preserving the opportunity for an "equal" proposal from any responsible source whose product matches the salient characteristics.

6.2 Analyte-Specific Coverage and Commutability

The enumerated analyte lists in the SOW (Attachment 1) and the Salient Characteristics (Attachment 2) reflect the complete analyte menu run on the STVHCS Core Laboratory analyzer fleet. Bio-Rad panels were selected because they provide the broadest single-vendor commutable coverage of that menu on the installed methods; however, the purchase description is written around those analyte lists and package configurations — not around Bio- Rad as a sole source — so any manufacturer able to meet the stated analyte coverage, matrix, stability, and package specifications is eligible to compete.

6.3 Unity Real Time Software — Data-Continuity Consideration

The Unity Real Time QC data-management application is the incumbent system of record for the Core Laboratory’s QC history, Levey-Jennings charts, Westgard rule configurations, peer-group assignments, and site-to-site comparisons. The solicitation permits an "equal" QC data-management product, but any equal solution must replicate the local (non-web-based) deployment, the native DI Instrument Manager interface, the peer-group program, and the multi-site reporting described in Attachment 2. The brand is cited to define the functional baseline; it is not being used to restrict the source.

6.4 Package Insert and Package-Size Alignment

The package configurations (for example, 12 × 10 mL; 12 × 5 mL; 6 × 3 mL; 6 × 1 mL) align with the laboratory’s established open-vial schedule, inventory rotation practice, and 14-day / 30-day open-vial stability windows. These package sizes drive realistic run-rate and waste economics;

the salient characteristics therefore express package size explicitly so that any equal product can be evaluated on equal footing.

7. Market Research (FAR Part 10; FAR 11.105(a)(1)(ii))

7.1 Methodology

Market research was conducted consistent with FAR Part 10 and included: (i) review of the incumbent contract 36C25721D0093 (Government Scientific Source, Inc., PoP 06/15/2021– 06/14/2026, $1,100,140) and its performance history; (ii) searches of the GSA eLibrary and GSA Advantage! for MAS 65 VII, SIN 555-2 schedule holders listing equivalent IVD QC products; (iii) review of the FDA 510(k) database to identify additional cleared QC material manufacturers compatible with the installed method families; (iv) review of clinical-laboratory peer publications and proficiency-testing (CAP, API) vendor lists; (v) review of the SBA VetCert database for SDVOSB/VOSB distributors able to supply the referenced products; and (vi) consultation with Pathology & Laboratory Medicine Service subject-matter experts regarding the validation burden associated with changing control material on the installed analyzers.

7.2 Sources Identified

Market research confirmed that multiple manufacturers produce multi-analyte IVD QC materials (for example, Bio-Rad Laboratories, Inc.; Thermo Fisher Scientific, Inc. (MAS); Randox Laboratories Ltd. (Acusera / Acusera 24·7); Technopath Clinical Diagnostics (Multichem)).

Because several manufacturers are active in this market, a competitive "brand name or equal" solicitation is appropriate. An "equal" proposal that meets every salient characteristic in Attachment 2 is eligible for award on identical footing with a brand-name Bio-Rad proposal.

Competitive distribution. Market research further confirmed that multiple authorized distributors, including SDVOSB- and VOSB-certified small businesses, are capable of supplying Bio-Rad products and of supplying at least some qualifying "equal" products. Evidence of active SDVOSB/VOSB distributor coverage in MAS 65 VII, SIN 555-2 supports continued set-aside consideration and the Factor 3 (VAAR 852.215-70) evaluation factor used in Section E.5.

8. Rationale for Brand Name or Equal (Not Sole Source) The Contracting Officer determined that a competitive "brand name or equal" purchase description under FAR 11.104 is the least restrictive means of meeting the Government’s requirement. A brand-name-only approach would have required a limited-source justification under FAR 6.302-1 (or, if under SAT, FAR 13.106-1(b)(1) / 13.501(a)). Market research did not support a sole-source restriction because multiple manufacturers and multiple distributors can compete. Accordingly, a brand-name-or-equal approach satisfies FAR 11.002 (describing agency needs in a manner that promotes full and open competition) while preserving the technical rigor necessary for CLIA-compliant QC.

9. Determination Under FAR 11.105 Based on the foregoing, the Contracting Officer determines that (a) the brand names cited (Multiqual, Liquichek, Unity Real Time — all Bio-Rad Laboratories, Inc.) are necessary to describe the agency’s minimum needs with sufficient precision to enable meaningful competition; (b) the salient physical, functional, and performance characteristics that an "equal" product must satisfy are fully stated in Attachment 2; (c) FAR 52.211-6, Brand Name or Equal (AUG 1999), is included in the solicitation (Section E.3); and (d) this justification is available with the solicitation for public inspection on SAM.gov (see FAR 11.105(b) and, when applicable, VAAR 811.104).

10. Impact on Small-Business Participation The acquisition strategy supports small-business participation. Multiple SDVOSB and VOSB distributors carry the Bio-Rad product family and are listed on the SBA VetCert database;

additional small businesses distribute potential equal products through MAS 65 VII (SIN 555-2).

The solicitation applies the VAAR 852.215-70 / 852.215-71 evaluation factor to give a meaningful preference to SDVOSB and VOSB offerors, consistent with the "Vets First" Contracting Program (38 U.S.C. § 8127) and SBA Small Business Act priorities.

11. Publication and Availability In accordance with FAR 5.102(a)(6) and FAR 11.105(b), this justification is made available to the public. It is posted with Solicitation No. 36C25726Q0381 on SAM.gov as a separate document (not as an attachment to the solicitation) and will remain publicly accessible for the life of the solicitation. The signed original is retained in the official contract file in accordance with FAR 4.802 and the VA Contract File Content Checklist.

12. Certification and Approvals I certify that the facts and rationale set forth above are accurate and complete to the best of my knowledge and belief, and that the use of a brand name in the purchase description for this acquisition is justified under FAR 11.105.

C. Approved (Contracting Officer, FAR 11.105):

Signature: ______________________________

Name: Jose Campa Title: Contracting Officer, NCO 17

Appendix A — Regulatory Authorities Checklist

Authority Applicability to This Acquisition

FAR 11.002 Describe agency needs in a manner designed to promote full and open competition. — Satisfied through brand-name-or-equal approach.

FAR 11.104 Use of brand name or equal purchase descriptions. — Primary authority.

FAR 11.105 Items peculiar to one manufacturer; justification required when a brand name is cited. — Primary authority for this document.

FAR 52.211-6 Brand Name or Equal (AUG 1999). — Included in Section E.3 of the solicitation.

FAR Part 10 Market research. — Documented in Section 7 above.

FAR 5.102(a)(6) Public availability of the justification. — Posted on SAM.gov with the solicitation as a separate document.

FAR 6.302-1 / 13.106-

1(b)(1) / 13.501(a)

Limited-source justification. — Not invoked; the action is competitive brand-name-or-equal. Listed here solely to document the road not taken.

VAAR 811.104 VA supplemental guidance on brand-name purchase descriptions.

— Observed.

38 U.S.C. § 8127 "Vets First" — supports the VAAR 852.215-70/-71 evaluation factor applied to this competitive acquisition.

42 C.F.R. § 493.1253 /

CLIA method-validation and quality-control requirements supporting the salient characteristics.

VHA Handbook 1106.01

VA Pathology & Laboratory Medicine Service procedures referenced in the SOW (Attachment 1).

Appendix B — Reference Crosswalk (Salient Characteristics ↔ SOW Line Items) The following table cross-references the salient-characteristic categories in Attachment 2 to the SOW product-line numbering in Attachment 1. It is included to allow an "equal" offeror to align its Compliance Matrix (Attachment 5) entries to the correct salient-characteristic sub-section. In the event of any conflict between this appendix and Attachment 2, Attachment 2 controls.

SOW

Item(s)

Product / Family Package Salient-Char. Section

1 – 3 Multiqual Levels 1 / 2 / 3 (clinical chemistry, tri-level)

12 × 10 mL II — Chemistry Reagents

4 – 6 Liquichek Immunoassay Plus Levels 1 / 2 / 3

12 × 5 mL II — Immunoassay Reagents

7 – 9 Liquichek Ethanol / Ammonia Control Levels 1 / 2 / 3

6 × 3 mL II — Specialty Chemistry

10 – 12 Liquichek Cardiac Marker Plus LT Levels 1 / 2 / 3

6 × 3 mL II — Cardiac Markers

13 – 15 Liquichek Diabetes (HbA1c) Levels 1 / 2 / 3

6 × 1 mL IV — HbA1c (Tosoh)

16 – 17 Liquichek Urine Chemistry Levels 1 / 2

12 × 10 mL II — Urine Chemistry

18 – 20 Liquichek Immunology Levels 1 / 2 /

6 × 3 mL II — Immunology

21 – 22 Liquichek Spinal Fluid Levels 1 / 2 6 × 3 mL II — Body Fluids

23 – 24 Liquichek Urine Toxicology Screen S1E / S2E Low Opiate

10 × 10 mL II — Toxicology

25 Liquichek Cardiac Markers Plus LT Level 1B

6 × 3 mL II — Cardiac Markers

26 – 28 Liquichek Specialty Immunoassay Plus Levels 1 / 2 / 3

6 × 5 mL II — Specialty Immunoassay

29 Unity Real Time — 1-Year Subscription (Prod. 804-1)

Software III — QC Data Management

(End of Brand Name or Equal Justification)