36C10G18R0003-008.xlsx

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A The offeror shall provide descriptive product literature (prefer hyperlink to access vendors web site. "Descriptive literature," as used in this provision, means information (e.g., cuts, illustrations, drawings, and brochures) that is submitted as part of an offer. Descriptive literature is required to establish, for the purpose of evaluation and award, details of the product offered that are specified elsewhere in the solicitation and pertain to significant elements such as: (1) materials; (2) components; and (3) performance characteristics. The literature will be used to evaluate the depth & breadth of the offerors product line.

Product Line (Provide product literature that demonstrates the breadth and depth of each product line, including but not limited to: size options, materiel options, preferable to be available with access on the vendor’s web site).

B Descriptive literature, required elsewhere in this solicitation, should be (1) identified to show the item(s) of the offer to which it applies and (2) received by the time specified in this solicitation for receipt of offers.

C The offeror shall provide a completed Attachment 7 - Technically Acceptability Spreadsheet to ensure each technical item has been addressed. If response is a “No” the comments must be provide a justification.

D Provide a response if National and/or VISN Coverage is available and provide a listing to display location(s) of vendor representatives and demonstrate how national and/or VISN coverage will be provided to VA, if applicable. Demonstrate how the representatives will provide timely delivery for just-in-time or consignment to individual facilities; reps availability for consultations during surgery and provide other implant support needed as determined by physician.

E Qualifications and Certification of Representatives (Address company's requirements for representatives to provide support in the hospital and operating room. Narrative shall include educational requirements, specific product training and continuing education. Must demonstrate that the reps are technically qualified and experience in supporting their product line, since they will be the ones teaching VA Operating Room (OR) staff).

F Ability and commitment to train operating room and hospital personnel (Outline a proposed on-going training program over life of the contract for hospital OR personnel and the frequency of such a program. The program shall include product features and surgical procedure training to support the surgeon.

G Trends of Failure (Describe the procedures and policies on tracking Trends of Failure on products offered to VA and how that information is communicated to VA).

H The offeror shall provide documentation (i.e., certificate, letter, etc.) that verifies registration as required by the Food and Drug Administration (FDA) under subpart B of part 1271 of title 21, Code of Federal Regulations, or any successor regulation.

I The offeror must provide a copy of the Centers for Medicare and Medicaid Services (CMS) Clinical Laboratory Improvement Amendment (CLIA) certificate for the facility that will be performing FDA required testing for allografts and xenografts during the contract period. (If Applicable).

J The offeror shall provide a copy of American Association of Tissue Banks (AATB) accreditation

K The offeror shall submit a copy of the FDA 3356: Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps) for their supplier facility.

L The offeror must hold a state license (if supplier is located in a state requiring licensure). Copy of state license shall be submitted with offer.

M The offeror shall submit a copy of their Biological License, if manufacture of product intended for introduction into interstate commerce as defined by 21 CFR 601.2.

P Authorized Distributor: The offeror shall provide authorized distributor letter from the manufacture for each product proposed authorizing the offeror to be a distributor for the contract period including options, if exercised. The letter shall be on the manufacturer letterhead and contain signature of authorized official of the manufacturer. The letter shall identify the specific product(s) authorized to distribute on behalf of the manufacturer.

Q Do you have any pending litigation? If so, what is the status of that litigation?

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