QSL Package Worksheet MD-2409-55 EMERGENCY THERMAL BLANKET - HYPOTHERMIA PREVENTION.xlsx

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Emergency Thermal Blankets - Hypothermia Prevention
Solicitation number
MD-2409-55
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This is a QSL Package Worksheet for Emergency Thermal Blanket - Hypothermia Prevention products, accompanied by a Sources Sought notification from the Defense Health Agency (DHA) and Defense Logistics Agency (DLA) Troop Support Medical. The worksheet outlines requirements for vendors to qualify for inclusion on a Qualified Suppliers List (QSL) that will be established by March 13, 2025.

The technical requirements specify emergency thermal blankets that must be: minimum size 48" x 84" when unfolded, made of Polyethylene terephthalate film with a subdued colored outer side and heat reflective inner layer, packaged within 3"x5"x5" dimensions, weighing ≤1 lb, latex-free, single-use, and FDA compliant. Vendors must have or be obtaining a Distribution and Pricing Agreement (DAPA), agreements with prime vendors Cardinal Health and Owens & Minor, and active SAM registration. The estimated annual usage is 35,001 units with projected sales of $180,035. Responses are due by February 20, 2025 at 5:00 PM Philadelphia time. This is not a request for pricing, though qualified vendors will be invited to submit pricing around April 10, 2025 for potential Incentive Agreements.

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QSL Package Worksheet

Requirements to Qualify for the QSLMD-2409-55 EMERGENCY THERMAL BLANKET - HYPOTHERMIA PREVENTION
Company Name:
Company Address:
Company Point of Contact (POC):

Name Phone Number

E-Mail AddressComplete answers and all supporting documentation must be provided with the vendor’s submittal by the response date stated in the QSL Announcement, Sources Sought notification. A vendor who does not meet all these requirements, or who does not submit documentation to support these requirements as requested, will not be qualified for the QSL. Vendors must provide responses to the Sources Sought notification via this QSL Package Worksheet.
****PLEASE READ THE FOLLOWING BEFORE CONTINUING WITH YOUR SUBMISSION BELOW***

Product requirements are outlined below. Complete answers and all supporting documentation MUST be provided with the vendor’s submittal by the response date stated in the Sources Sought notification. A vendor who does not meet all of these requirements or who does not submit documentation to support these requirements as requested will not be qualified for the QSL. Vendor must provide responses to the Sources Sought notification via the QSL Package Worksheet.

SUPPLIER REQUIREMENTS
VENDOR INSTRUCTIONS

UNDER "VENDOR RESPONSE" ENTER YOUR DAPA NUMBER OR THE DATE YOU APPLIED FOR A DAPA ALONG WITH DAPA LOG NUMBER.

1. Vendor must have a DAPA or be in the process of applying for a DAPA number for the product line listed. Vendor must provide their DAPA number or provide date of application and DMM number proving access to the DMS, as the subsequent Standardization Action requires vendors to have all required items on DAPA.VENDOR RESPONSE:
VENDOR INSTRUCTIONS

UNDER "VENDOR RESPONSE" ENTER

YES - IF YOU HAVE AN AGREEMENT

OR

NO - IF YOU DO NOT HAVE AN AGREEMENT AND INDICATE THAT YOU ARE WORKING WITH PRIME VENDOR TO INITIATE AN AGREEMENT.

2. Vendor must have an agreement with the current DoD Medical/Surgical Prime Vendor CARDINAL HEALTH, or must work with CARDINAL HEALTH to initiate an agreement, as standardized items from this QSL will be distributed via the MSPV program.VENDOR RESPONSE:
3. Vendor must have an agreement with the current DoD Medical/Surgical Prime Vendor OWENS & MINOR, or must work with OWENS & MINOR to initiate an agreement, as standardized items from this QSL will be distributed via the MSPV program.VENDOR RESPONSE:
VENDOR INSTRUCTIONS

UNDER "VENDOR RESPONSE" ENTER YOUR CAGE CODE OR THE DATE YOU APPLIED FOR A CAGE CODE ALONG WITH THE CURRENT STATUS.

4. Vendors must validate that their account is Active in the System for Award Management (SAM) and provide CAGE Code. Vendors in the process of obtaining a CAGE Code must provide documentation to support that they have registered in SAM. Vendors without a CAGE Code and/or a SAM account will not be considered for participation in the subsequent Standardization Action. See https://www.sam.gov/SAM/.VENDOR RESPONSE:
REQUIRED PRODUCTS
VENDOR INSTRUCTIONS

UNDER "VENDOR RESPONSE" for EACH REQUIRED ITEM IDENTIFY SUPPORTING DOCUMENTATION(S) (i.e. catalogs, brochures, website screen shots with date, product pictures, packaging pictures, etc.). WITHIN DOCUMENTATION, ANNOTATE SECTION(S) THAT SUPPORT SPECIFIC REQUIREMENT.

5. Vendor must provide manufacturer part numbers that meet the product descriptions below. Vendor must submit the following information via QSL Response Worksheet for each offered product: Vendor Part Number, Manufacturer Part Number, Manufacturer Name, Full Item Description, Unit of Measure (UOM), Quantity (QTY) in UOM, Unit of Inner Packaging (UOP), QTY of UOM in UOP, Unit of Sale (UOS), and QTY of UOM in UOS. Vendor must provide product catalog and literature for any items offered in response to this Sources Sought notification. Only ONE Vendor Part Number should be provided for each item/sample. Vendor must send the same reference number(s) for evaluation(s) as provided in response to this QSL Announcement and as noted in the QSL Package Worksheet. The vendor must provide country of origin for all required items and any optional items offered.
Required Product DescriptionEstimated DoD Purchase UnitsManufacturer's Product DescriptionManufacturer Part NumberDistributor Part NumberManufacturer NameUnit of Measure (UOM)QTY in UOMUnit of Inner Packaging (UOP)QTY of UOM in UOPUnit of Sale (UOS)QTY of UOM in UOSProduct Country of OriginVendor Response
E.g. 0 12-18in COATED VICRYL VIO BRD TIESZ123-ABC123ABCCOMPANY AEA1PK12CA24USASee Product Catalog pg. 109
5.1 EMERGENCY THERMAL BLANKET - HYPOTHERMIA PREVENTION35,001
PRODUCT SPECIFIC REQUIREMENTS - TECHNICAL REVIEW
VENDOR INSTRUCTIONS

UNDER "VENDOR RESPONSE" IDENTIFY SUPPORTING DOCUMENTATION(S) (i.e. catalogs, brochures, website screen shots with date, product pictures, packaging pictures, etc.). WITHIN DOCUMENTATION, ANNOTATE SECTION(S) THAT SUPPORT SPECIFIC REQUIREMENT.

E.g. See ENCL 3 - Suture + Ties Reels Memo Natural Rubber Latex

6. Vendor must provide Emergency Thermal Blanket – Hypothermia Prevention products that are not made with natural rubber latex. Vendor must also provide submittal documentation establishing that the offered products are not made with natural rubber latex. The vendor must meet this requirement in one of three ways: 1) demonstrating that the labeling for the offered products contains the FDA recommended statement "Not made with natural rubber latex," 2) demonstrating that the ISO BS EN 15223-1:2021 symbol [reference number 5.4.5] is on the labeling for the offered products, or 3) if the product labeling does not contain the FDA recommended statement or the ISO BS EN 15223-1:2021 symbol [reference number 5.4.5], the vendor must provide a signed letter stating that the offered products are "not made with natural rubber latex."1Vendor must provide Emergency Thermal Blanket – Hypothermia Prevention products that are not made with natural rubber latex. Vendor must also provide submittal documentation establishing that the offered products are not made with natural rubber latex. The vendor must meet this requirement in one of three ways: 1) demonstrating that the labeling for the offered products contains the FDA recommended statement "Not made with natural rubber latex," 2) demonstrating that the ISO BS EN 15223-1:2021 symbol [reference number 5.4.5] is on the labeling for the offered products, or 3) if the product labeling does not contain the FDA recommended statement or the ISO BS EN 15223-1:2021 symbol [reference number 5.4.5], the vendor must provide a signed letter stating that the offered products are "not made with natural rubber latex."611VENDOR RESPONSE:
7. Vendors must provide Emergency Thermal Blanket – Hypothermia Prevention products that meet FDA General Controls and Special Controls as applicable and must submit supporting documentation with initial submittal to include FDA Establishment Registration, Medical Device listing, and 510(k) as applicable.2Vendors must provide Emergency Thermal Blanket – Hypothermia Prevention products that meet FDA General Controls and Special Controls as applicable and must submit supporting documentation with initial submittal to include FDA Establishment Registration, Medical Device listing, and 510(k) as applicable.712VENDOR RESPONSE:
8. Vendor must provide Emergency Thermal Blanket – Hypothermia Prevention products that are single use items. The vendor must meet this requirement in one of three ways: 1) demonstrating that the labeling or product information for the offered products contains the recommended statement "single use”, "use only once”, “do not re-use” or “do not re-sterilize”, 2) demonstrating that the ISO BS EN 15223-1:2021 symbol [reference number 5.4.2] single-use symbol is on the labeling or product information for the offered products, or 3) if the labeling or product information do not contain the ISO BS EN 15223-1:2021 symbol [reference number 5.4.2], the vendor must provide a signed letter stating that the offered products are single use.3Vendor must provide Emergency Thermal Blanket – Hypothermia Prevention products that are single use items. The vendor must meet this requirement in one of three ways: 1) demonstrating that the labeling or product information for the offered products contains the recommended statement "single use”, "use only once”, “do not re-use” or “do not re-sterilize”, 2) demonstrating that the ISO BS EN 15223-1:2021 symbol [reference number 5.4.2] single-use symbol is on the labeling or product information for the offered products, or 3) if the labeling or product information do not contain the ISO BS EN 15223-1:2021 symbol [reference number 5.4.2], the vendor must provide a signed letter stating that the offered products are single use.813VENDOR RESPONSE:
9. Vendor must provide Emergency Thermal Blanket – Hypothermia Prevention products with a minimum size of 48” x 84” when completely unfolded and documentation to support this requirement with initial submittal.4Vendor must provide Emergency Thermal Blanket – Hypothermia Prevention products with a minimum size of 48” x 84” when completely unfolded and documentation to support this requirement with initial submittal.914VENDOR RESPONSE:
10. Vendor must provide Emergency Thermal Blanket – Hypothermia Prevention products with the following material and characteristics on specified sides of the product and provide documentation to support this with initial submittal:
a.Both sides of product made of Polyethylene terephthalate film (e.g., Mylar, Melinex and Hostaphan).
b.Outer Side of product a subdued color, (e.g., olive drab, coyote, etc.) that is scratch resistant.
c.Inner Side of the product covered with heat reflective layer.5Vendor must provide Emergency Thermal Blanket – Hypothermia Prevention products with the following material and characteristics on specified sides of the product and provide documentation to support this with initial submittal:
a.Both sides of product made of Polyethylene terephthalate film (e.g., Mylar, Melinex and Hostaphan).
b.Outer Side of product a subdued color, (e.g., olive drab, coyote, etc.) that is scratch resistant.
c.Inner Side of the product covered with heat reflective layer.1015VENDOR RESPONSE:
11. Vendor must provide Emergency Thermal Blanket – Hypothermia Prevention products with individual packaging dimensions less than or equal to 3” x 5” x 5” and documentation to support this requirement with initial submittal.6Vendor must provide Emergency Thermal Blanket – Hypothermia Prevention products with individual packaging dimensions less than or equal to 3” x 5” x 5” and documentation to support this requirement with initial submittal.1116VENDOR RESPONSE:
12. Vendor must provide Emergency Thermal Blanket – Hypothermia Prevention products that weigh less than or equal to1 lb. and documentation to support this requirement with initial submittal.7Vendor must provide Emergency Thermal Blanket – Hypothermia Prevention products that weigh less than or equal to1 lb. and documentation to support this requirement with initial submittal.1217VENDOR RESPONSE:

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