ATTACHMENT 1 - PPE Questionaire.pdf

PPE Source Questionnaire

The purpose of this document is to ascertain information necessary to execute an award with your company, if you are not able to adequately respond to each item herein, the process will stop and no further consideration will be given to your company regarding a potential contract. Please complete all fields below and provide attachments with the response to support your responses below.

Question Contractor Response

1. Company legal name, address, point of contact information

2. Has your company done business with the Federal government previously? If yes, please provide contract number for reference

3. Company DUNS

4. Are you registered in System for Award Management (SAM)? If so, are there any exclusions? Link below:

https://www.sam.gov/SAM/pages/public/samStatusTracker.jsf

5. Any proposed payment terms (Standard Federal payment terms are NET30)

6. Any unique terms and conditions being proposed

7. Are products being proposed completed correctly on Attachment 2 with OEM (Manufacturer) name, OEM number, etc? (Yes/No)

8. Is product literature attached to response, and does product literature clearly identify the product(s) being proposed meet the mandatory technical requirements as detailed in the Statement of Work? (Yes/No)

Complete the Exam Glove Mandatory Technical Requirement Chart at the end of this questionnaire for EACH glove proposed.

9. Confirmation the product being proposed is not gray market or counterfeit in accordance with Veterans Affairs Acquisition Regulation Clause 852.212-72 below.

852.212-72 Gray Market and Counterfeit Items

(MAR 2020) (DEVIATION)

GRAY MARKET AND COUNTERFEIT ITEMS (MAR 2020)

(a) No used, refurbished, or remanufactured supplies or equipment/parts shall be provided. This procurement is for new Original Equipment Manufacturer (OEM) items only. No gray market items shall be provided.

Gray market items are OEM goods intentionally or unintentionally sold outside an authorized sales territory or sold by non-authorized dealers in an authorized sales territory.

https://www.sam.gov/SAM/pages/public/samStatusTracker.jsf

(b) No counterfeit supplies or equipment/parts shall be provided. Counterfeit items include unlawful or unauthorized reproductions, substitutions, or alterations that have been mismarked, misidentified, or otherwise misrepresented to be an authentic, unmodified item from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer.

Unlawful or unauthorized substitutions include used items represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics.

(c) Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

10. Are all applicable FDA, ASTIM, AMMI NIOSH Certifications, and supporting testing reports, for products being offered provided as separate attachments? (Yes/No)

11. How will you ensure quality of the product? (i.e. SGS Inspection)

12. If already produced, where is product located now?

13. Are you able to provide a letter from the manufacturer stating they will allocate a quantity to you as a distributor? If so, provide letter with quote.

14. Quantity on hand (in-stock and available for immediate delivery)

15. Estimated shipping and delivery information.

- Shipping terms (FOB Origin or Destination)

16. Provide summary of logistics chain (i.e. they are buying from the manufacture or are they buying from another wholesaler/importer and reselling again (how many hand exchanges before delivery)

17. Recent (during COVID19) experience providing this specific product to the Federal government and/or US hospital. If so, provide contract number and Government POC name and contact information.

Complete the following Exam Glove Mandatory Technical Requirement Chart for EACH glove proposed.

Exam Glove Mandatory Technical Requirement (MTR) Chart Brand Name or Equal To: Bosma Enterprises, Nitrile Textured Exam Glove (OEM# 72-10501, 72-10502, 72-10503, 72-10504) Brand Name (OEM) Offered:

Specific Model/Product (OEM Product Number) Glove Offered: _________________________ Item Description:

FDA 510K Number:

TECHNICAL SPECIFICATIONS –

Mandatory Technical Requirement (MTR)

SUPPLIER RESPONSE –

Identify specific document name and page number within the provided technical literature which identifies the product meets the requirement.

NOTE: Ensure the page numbers are identified on the pages themselves.

MTR 1

Meets ASTM D6319 standard for nitrile examination gloves for medical application. NOTE: All claims of ASTM certifications must include the actual test report that produced those results to obtain certification.

MTR 2 Sizes: Small, Medium, Large, X-Large

MTR 3

No Latex – Product must not contain latex. Product identified as “not made with natural rubber latex”, “latex-free”, or “does not contain latex”.

MTR 4

No Powder. Residual Powder Test: The amount of powder allowed on powdered gloves is 120mg. Powder free gloves may only contain a maximum of 2mg per glove.

MTR 5 Glove material is nitrile

MTR 6 Non-sterile

MTR 7 Single use

MTR 8 Ambidextrous

MTR 9

Puncture Resistant. Tensile Test: at least 14 MPa and a minimum of 500% elongation