Attachment_2_Salient_Characteristics_36C25726Q0381.docx

Solicitation 36C25726Q0381 — Attachment 2 (Salient Characteristics)

ATTACHMENT 2

SALIENT CHARACTERISTICS

Brand Name or Equal — FAR 11.104 / FAR 11.105 / FAR 52.211-6

1. Purpose and Scope This Attachment 2 establishes the salient physical, functional, and performance characteristics that any "equal" product proposed under Solicitation No. 36C25726Q0381 must satisfy in order to be considered technically acceptable in accordance with FAR 52.211-6, Brand Name or Equal (AUG 1999). The characteristics stated herein describe the Government's minimum needs for the acquisition of in-vitro diagnostic (IVD) quality-control (QC) materials and a QC data-management software subscription supporting the South Texas Veterans Health Care System (STVHCS) Core Laboratory at Audie L. Murphy VA Hospital (San Antonio, TX) and Kerrville VA Medical Center (Kerrville, TX).

Offerors proposing the referenced Bio-Rad Laboratories, Inc. brand-name products (Multiqual, Liquichek, and Unity Real Time) need not separately demonstrate compliance with each reagent-level characteristic in Part II, but shall still demonstrate compliance with the software characteristics in Part III and the delivery and service characteristics in Part V. Offerors proposing an "equal" product shall complete and submit the Compliance Matrix in Part VI with their quotation.

In the event of any conflict between this Attachment 2 and the Statement of Work (Attachment 1), this Attachment 2 controls for purposes of determining whether an "equal" product meets the Government's minimum needs.

2. Part I — Reagent Characteristics Common to All Line Items In addition to the product-specific characteristics listed in Part II below, every QC reagent proposed under this solicitation shall meet the following common characteristics:

1. FDA 510(k) clearance or FDA approval for use as an IVD quality-control material for the specific analytes on the applicable panel.

1. Human-derived matrix (human serum, human whole blood, human urine, or human cerebrospinal fluid) as specified for each panel. Non-human and synthetic matrices do not provide the commutability required for the installed Beckman Coulter and Tosoh method families and therefore do not meet the Government's minimum needs.

1. Ready-to-use liquid format. Lyophilized (freeze-dried) or reconstitute materials that require user reconstitution do not meet the minimum needs because of preanalytical error and lot-to-lot reconstitution variability on the installed methods.

1. Closed-vial and open-vial stability windows as specified for each panel in Part II (for example, 30-day unopened and 14-day open-vial at 2–8 °C for Multiqual; 14-day open-vial at 2–8 °C for Liquichek Immunoassay Plus, except Folate at 7 days; minimum 2-year shelf life for Ethanol / Ammonia; minimum 3-year shelf life for Urine Toxicology).

1. Package / fill-volume configuration as specified for each panel in Part II.

1. Analyte coverage that matches or exceeds the full analyte list enumerated for each panel in Part II.

1. Commutability and method-validation documentation sufficient to satisfy 42 C.F.R. § 493.1253 (method establishment / verification) and 42 C.F.R. § 493.1256 (quality control) on the Beckman Coulter AU 5800 (clinical chemistry), Beckman Coulter DxI 800 (immunoassay), and Tosoh HbA1c analyzers as applicable.

1. Traceability, where applicable, to recognized reference systems (for example, IFCC / NGSP for HbA1c; CDC / CRMLN for lipids; IRMM / NIST SRMs for chemistry).

1. Labeling consistent with 21 C.F.R. Part 809 (IVD labeling), including lot number, expiration date, storage conditions, and target-value / range assignments for each analyte and each level.

3. Part II — Product-Specific Characteristics (QC Reagents) The following table enumerates the product-specific salient characteristics for each reagent line item in the Statement of Work (Attachment 1). Package sizes, matrices, stability windows, and analyte menus reflect the Government's minimum needs based on the installed Beckman Coulter AU 5800, Beckman Coulter DxI 800, and Tosoh HbA1c analyzer fleet and the laboratory's established open-vial schedule, inventory rotation practice, and CLIA method-validation history.

Where a panel insert specifies a stability, storage, or analyte value that differs from the characteristics above, the more protective (shorter open-vial, lower expiration) value controls.

4. Part III — QC Data-Management Software Characteristics The QC data-management software renewed under SOW Item 29 (Unity Real Time or equal) shall satisfy each of the following characteristics. These characteristics describe a functional baseline; any "equal" software product shall meet or exceed each item below.

5. Part IV — Additional HbA1c (Tosoh) Characteristics QC materials for the Tosoh HbA1c analyzer (SOW Items 13–15) shall additionally meet:

1. Whole-blood-based matrix appropriate for HPLC / cation-exchange HbA1c methodology.

1. NGSP-certified and IFCC-traceable assigned values at three clinically meaningful decision levels (approximately normal, elevated, and diabetic ranges).

1. Fill volume of 6 × 1 mL (or equal) consistent with the Tosoh analyzer on-board QC cup footprint.

1. Documented performance verification on the Tosoh HbA1c method family consistent with 42 C.F.R. § 493.1256 and current CAP / CLSI guidance.

6. Part V — Delivery and Service Characteristics The following delivery and service characteristics apply to all line items on the solicitation regardless of whether a brand-name or an "equal" product is proposed:

7. Part VI — Compliance Matrix (Offeror-Completed) Offerors proposing an "equal" product shall complete the following Compliance Matrix and submit it with their quotation (Attachment 5, Compliance Matrix, may be used in lieu of this table at the offeror's option). For each characteristic, indicate Yes, No, or Partial; identify the manufacturer and part / catalog number of the offered product; and provide a reference (page and paragraph) to the product literature, 510(k) summary, package insert, or other documentation that substantiates the entry.

Solicitation 36C25726Q0381 — Attachment 2 (Salient Characteristics)

8. Part VII — Documentation Required with an "Equal" Offer Offerors proposing an "equal" product shall submit with their quotation, at a minimum, the following documentation to enable the Contracting Officer to determine technical acceptability:

1. FDA 510(k) clearance letter or FDA approval documentation for each proposed IVD QC product.

1. Manufacturer package insert / Instructions for Use (IFU) for each proposed product, including assigned values, stability, storage conditions, and analyte list.

1. Commutability / method-validation documentation on the applicable analyzer platform (AU 5800, DxI 800, Tosoh HbA1c).

1. A completed Compliance Matrix (Part VI above, or Attachment 5).

1. For any proposed "equal" QC data-management software: (i) VA TRM listing or VA TRM decision reference; (ii) Section 508 / VPAT conformance documentation; (iii) data-migration / transition plan addressing preservation of historical QC data and CLIA method-validation continuity.

1. A statement of commercial availability and lead time supporting the delivery characteristics in Part V.

9. Part VIII — Evaluation Note The Contracting Officer, in consultation with the Chief, Pathology & Laboratory Medicine Service, STVHCS, will evaluate each "equal" offer against the characteristics in Parts I through V of this Attachment 2. Failure to meet any single salient characteristic may, at the Contracting Officer's discretion, render the offer technically unacceptable. The Government reserves the right (but is not obligated) to request clarifications under FAR 15.306(a) or to conduct exchanges consistent with the evaluation procedures identified in Section E of the solicitation.

— End of Attachment 2 —