QSL Package Worksheet MD-2409-56 HEAT REFLECTIVE SHELL - HYPOTHERMIA PREVENTION.xlsx
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- Heat Reflective Shell – Hypothermia Prevention
- Solicitation number
- MD-2409-56
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This is a Qualified Suppliers List (QSL) Package Worksheet and related Sources Sought notification for Heat Reflective Shell - Hypothermia Prevention products issued by the Defense Health Agency (DHA) Medical Logistics Directorate and Defense Logistics Agency (DLA) Troop Support Medical. The opportunity requires vendors to supply two types of hypothermia prevention shells: active (with heat source) and passive (no heat source), with estimated annual usage of 935 and 18,221 units respectively and total estimated annual sales of $728,562.
The technical requirements specify that products must be latex-free, FDA compliant, weigh under 5 lbs, be wind/fluid resistant, minimum 78 inches long, support 250 lbs minimum load, and feature subdued colored scratch-resistant outer shells with heat reflective inner layers. The active version must include heating panels providing 8 hours continuous heat, torso blanket with four heat elements, and safety features including heat injury warnings. Vendor responses are due by March 20, 2025 at 5:00 PM Philadelphia time, with the QSL to be established by April 3, 2025 and subsequent Incentive Agreement invitations around May 1, 2025. Vendors must have or be obtaining a DAPA number and agreements with prime vendors Cardinal Health and Owens & Minor. The products must comply with Trade Agreements Act requirements unless granted an exception.
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| QSL Announcement MD-2409-56 Heat Reflective Shell - Hypothermia Prevention.docx | DOCX document |
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QSL Package Worksheet
| Requirements to Qualify for the QSL | MD-2409-56 HEAT REFLECTIVE SHELL – HYPOTHERMIA PREVENTION |
| Company Name: | |
| Company Address: | |
| Company Point of Contact (POC): |
Name Phone Number
| E-Mail Address | Complete 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 Description | Estimated DoD Purchase Units | Manufacturer's Product Description | Manufacturer Part Number | Distributor Part Number | Manufacturer Name | Unit of Measure (UOM) | QTY in UOM | Unit of Inner Packaging (UOP) | QTY of UOM in UOP | Unit of Sale (UOS) | QTY of UOM in UOS | Product Country of Origin | Vendor Response |
| E.g. 0 12-18in COATED VICRYL VIO BRD TIES | Z123-ABC | 123ABC | COMPANY A | EA | 1 | PK | 12 | CA | 24 | USA | See Product Catalog pg. 109 | ||
| 5.1 HEAT REFLECTIVE SHELL - HYPOTHERMIA PREVENTION, ACTIVE (WITH HEAT SOURCE) | 935 | ||||||||||||
| 5.2 HEAT REFLECTIVE SHELL - HYPOTHERMIA PREVENTION, PASSIVE (NO HEAT SOURCE) | 18,221 | ||||||||||||
| 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 Heat Reflective Shell – Hypothermia Prevention, both Active (with heat source) and Passive (without heat source) 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." | 1 | Vendor must provide Heat Reflective Shell – Hypothermia Prevention, both Active (with heat source) and Passive (without heat source) 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." | 6 | 11 | VENDOR RESPONSE: | ||
| 7. Vendors must provide Heat Reflective Shell – Hypothermia Prevention, both Active (with heat source) and Passive (without heat source) 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. | |||||||
| a. | 5.1 Heat Reflective Shell, Active (with heat source) | ||||||
| b. | 5.2 Heat Reflective Shell, Passive (without heat source). | 2 | Vendors must provide Heat Reflective Shell – Hypothermia Prevention, both Active (with heat source) and Passive (without heat source) 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. | ||||
| a. | 5.1 Heat Reflective Shell, Active (with heat source) | ||||||
| b. | 5.2 Heat Reflective Shell, Passive (without heat source). | 7 | 12 | VENDOR RESPONSE: | |||
| 8. Vendor must provide Heat Reflective Shell – Hypothermia Prevention, both Active (with heat source) and Passive (without heat source) products with the following characteristics on specified sides of the product and provide documentation to support this with initial submittal: | |||||||
| a. | Outer Side of product a subdued color, (e.g., olive drab, coyote, etc.) that is scratch resistant | ||||||
| b. | Inner Side of the product covered with heat reflective layer. | 3 | Vendor must provide Heat Reflective Shell – Hypothermia Prevention, both Active (with heat source) and Passive (without heat source) products with the following characteristics on specified sides of the product and provide documentation to support this with initial submittal: | ||||
| a. | Outer Side of product a subdued color, (e.g., olive drab, coyote, etc.) that is scratch resistant | ||||||
| b. | Inner Side of the product covered with heat reflective layer. | 8 | 13 | VENDOR RESPONSE: | |||
| 9. Vendor must provide Heat Reflective Shell – Hypothermia Prevention, both Active (with heat source) and Passive (without heat source) products that weigh 5 lbs. or less and provide documentation to support this requirement with initial submittal. | 4 | Vendor must provide Heat Reflective Shell – Hypothermia Prevention, both Active (with heat source) and Passive (without heat source) products that weigh 5 lbs. or less and provide documentation to support this requirement with initial submittal. | 9 | 14 | VENDOR RESPONSE: | ||
| 10. Vendor must provide Heat Reflective Shell – Hypothermia Prevention, both Active (with heat source) and Passive (without heat source) products that are resistant to wind and fluids and provide documentation to support this requirement with initial submission. | 5 | Vendor must provide Heat Reflective Shell – Hypothermia Prevention, both Active (with heat source) and Passive (without heat source) products that are resistant to wind and fluids and provide documentation to support this requirement with initial submission. | 10 | 15 | VENDOR RESPONSE: | ||
| 11. Vendor must provide Heat Reflective Shell – Hypothermia Prevention, both Active (with heat source) and Passive (without heat source) products with a minimum length of 78 inches and provide documentation to support this requirement with initial submittal. | 6 | Vendor must provide Heat Reflective Shell – Hypothermia Prevention, both Active (with heat source) and Passive (without heat source) products with a minimum length of 78 inches and provide documentation to support this requirement with initial submittal. | 11 | 16 | VENDOR RESPONSE: | ||
| 12. Vendor must provide Heat Reflective Shell – Hypothermia Prevention, both Active (with heat source) and Passive (without heat source) products with the minimum load requirement of 250 lbs. and provide documentation to support this requirement with initial submittal. | 7 | Vendor must provide Heat Reflective Shell – Hypothermia Prevention, both Active (with heat source) and Passive (without heat source) products with the minimum load requirement of 250 lbs. and provide documentation to support this requirement with initial submittal. | 12 | 17 | VENDOR RESPONSE: | ||
| 13. Vendor must provide Heat Reflective Shell - Hypothermia Prevention, Active (with heat source) products with Heating Panels that provide continuous heating for a minimum of 8 hours and provide supporting documentation with initial submission. | 8 | Vendor must provide Heat Reflective Shell - Hypothermia Prevention, Active (with heat source) products with Heating Panels that provide continuous heating for a minimum of 8 hours and provide supporting documentation with initial submission. | 13 | 18 | VENDOR RESPONSE: | ||
| 14. Vendors must provide the Safety Data Sheet (SDS) for all Heat Reflective Shell - Hypothermia Prevention, Active (with heat source) products and provide documentation with initial submission. | 9 | Vendors must provide the Safety Data Sheet (SDS) for all Heat Reflective Shell - Hypothermia Prevention, Active (with heat source) products and provide documentation with initial submission. | 14 | 19 | VENDOR RESPONSE: | ||
| 15. Vendor must provide Heat Reflective Shell - Hypothermia Prevention, Active (with heat source) products with Heating Panels that have instructions for use (IFU) with each product and provide documentation to support this requirement with initial submittal. | 10 | Vendor must provide Heat Reflective Shell - Hypothermia Prevention, Active (with heat source) products with Heating Panels that have instructions for use (IFU) with each product and provide documentation to support this requirement with initial submittal. | 15 | 110 | VENDOR RESPONSE: | ||
| 16. Vendor must provide Heat Reflective Shell - Hypothermia Prevention, Active (with heat source) products with Heating Panels that have a Heat Injury Warning and provide supporting documentation with initial submission. | 11 | Vendor must provide Heat Reflective Shell - Hypothermia Prevention, Active (with heat source) products with Heating Panels that have a Heat Injury Warning and provide supporting documentation with initial submission. | 16 | 111 | VENDOR RESPONSE: | ||
| 17. Vendor must provide Heat Reflective Shell - Hypothermia Prevention, Active (with heat source) products that meet the following and provide documentation to support this requirement with initial submittal. | |||||||
| a. | One (1) Torso blanket with four (4) heat elements sealed in pockets/pouches. | ||||||
| b. | Torso Blanket with minimum dimensions of 22” x 26”. | 12 | Vendor must provide Heat Reflective Shell - Hypothermia Prevention, Active (with heat source) products that meet the following and provide documentation to support this requirement with initial submittal. | ||||
| a. | One (1) Torso blanket with four (4) heat elements sealed in pockets/pouches. | ||||||
| b. | Torso Blanket with minimum dimensions of 22” x 26”. | 17 | 112 | VENDOR RESPONSE: | |||
| VENDOR INSTRUCTIONS |
In support of requirement #18 vendor must provide with initial submittal photographic images of the individual product packaging for required items #5.1. Photographic images of non-part number graphic templates of product labeling are not acceptable supporting documentation.
| 18. Vendor must provide Heat Reflective Shell - Hypothermia Prevention, Active (with heat source) products with Heating Panels that indicate on the individual product packaging the following: | |||||
| a. | Lot Number in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 lot number symbol | ||||
| b. | Expiration date as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 use-by date symbol | ||||
| c. | Single-use as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 single-use symbol. | 13 | Vendor must provide Heat Reflective Shell - Hypothermia Prevention, Active (with heat source) products with Heating Panels that indicate on the individual product packaging the following: | ||
| a. | Lot Number in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 lot number symbol | ||||
| b. | Expiration date as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 use-by date symbol | ||||
| c. | Single-use as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 single-use symbol. | 18 | In support of requirement #18 vendor must provide with initial submittal photographic images of the individual product packaging for required items #5.1. Photographic images of non-part number graphic templates of product labeling are not acceptable supporting documentation. | 113 | VENDOR RESPONSE: |
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