QSL Package Worksheet MS-2407-43 KNEE SLEEVES HINGED.xlsx
XLSX spreadsheet 17 KB Posted
- Attached to
- Knee Sleeves, Hinged
- Solicitation number
- MS-2407-43
About this file
This document is a Qualified Suppliers Listing (QSL) Package Worksheet for Knee Sleeves, Hinged, issued by the Defense Health Agency and Defense Logistics Agency Troop Support Medical. The solicitation seeks vendors to qualify for a Standardized Item List for 12 specific hinged knee sleeve configurations, with sizes ranging from XS to 2XL, covering left, right, and universal knee applications. The total estimated annual sales volume is $222,362, and vendors must meet extensive technical requirements including FDA compliance, latex-free manufacturing, specific product features like adjustable closures and hinged design, and packaging specifications.
Key vendor requirements include having a Distribution and Pricing Agreement (DAPA), agreements with prime vendors Cardinal Health and Owens & Minor, active System for Award Management (SAM) registration, and submission of comprehensive product documentation. Vendors must provide detailed product information, country of origin, and supporting materials demonstrating compliance with technical specifications. The QSL will be established around 15 May 2025, with vendor responses due by 17 April 2025. Vendors meeting all requirements will be invited to submit pricing quotes approximately 12 June 2025, with the goal of establishing an Incentive Agreement for standardized knee sleeve products for Military Treatment Facilities and operational procurement.
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|---|---|---|
| QSL Announcement MS-2407-43 Knee Sleeves Hinged.docx | DOCX document |
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QSL Package Worksheet
| Requirements to Qualify for the QSL | MS-2407-43 KNEE SLEEVES, HINGED |
| 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 HINGED KNEE SLEEVE, OPEN PATELLA, LEFT KNEE, SMALL, ( 15-17 ½” ) CIRCUMFERENCE | 45 | ||||||||||||
| 5.2 HINGED KNEE SLEEVE, OPEN PATELLA, LEFT KNEE, MEDIUM, ( 18 - 20" ) CIRCUMFERENCE | 60 | ||||||||||||
| 5.3 HINGED KNEE SLEEVE, OPEN PATELLA, LEFT KNEE, LARGE, ( 20 ½ -23” ) CIRCUMFERENCE | 166 | ||||||||||||
| 5.4 HINGED KNEE SLEEVE, OPEN PATELLA, RIGHT KNEE, SMALL, ( 15-17 ½” ) CIRCUMFERENCE | 39 | ||||||||||||
| 5.5 HINGED KNEE SLEEVE, OPEN PATELLA, RIGHT KNEE, MEDIUM, ( 18 -20” ) CIRCUMFERENCE | 217 | ||||||||||||
| 5.6 HINGED KNEE SLEEVE, OPEN PATELLA, RIGHT KNEE, LARGE, ( 20 ½ -23” ) CIRCUMFERENCE | 68 | ||||||||||||
| 5.7 HINGED KNEE SLEEVE, OPEN PATELLA, LEFT AND RIGHT KNEE USE, XS, ( 13-14 ½” ) CIRCUMFERENCE | 251 | ||||||||||||
| 5.8 HINGED KNEE SLEEVE, OPEN PATELLA, LEFT AND RIGHT KNEE USE, SMALL, ( 15-17 ½” ) CIRCUMFERENCE | 584 | ||||||||||||
| 5.9 HINGED KNEE SLEEVE, OPEN PATELLA, LEFT AND RIGHT KNEE USE, MEDIUM, ( 18 - 20" ) CIRCUMFERENCE | 1,153 | ||||||||||||
| 5.10 HINGED KNEE SLEEVE, OPEN PATELLA, LEFT AND RIGHT KNEE USE, LARGE, ( 20 ½ -23” ) CIRCUMFERENCE | 1,472 | ||||||||||||
| 5.11 HINGED KNEE SLEEVE, OPEN PATELLA, LEFT AND RIGHT KNEE USE, XL, ( 23 ½ -25 1/6”) CIRCUMFERENCE | 421 | ||||||||||||
| 5.12 HINGED KNEE SLEEVE, OPEN PATELLA, LEFT AND RIGHT KNEE USE, 2XL, ( 26 ½-29 ½” ) CIRCUMFERENCE | 183 | ||||||||||||
| 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 Knee Sleeve Hinged 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 or product information 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 with Annex B.2 Negation Symbol] is on the labeling or product information for the offered products, or 3) if the labeling or product information do not contain the FDA recommended statement or the ISO BS EN 15223-1:2021 symbol [reference number 5.4.5 with Annex B.2 Negation Symbol], the vendor must provide a signed letter stating that the offered products are "not made with natural rubber latex. | 1 | Vendor must provide Knee Sleeve Hinged 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 or product information 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 with Annex B.2 Negation Symbol] is on the labeling or product information for the offered products, or 3) if the labeling or product information do not contain the FDA recommended statement or the ISO BS EN 15223-1:2021 symbol [reference number 5.4.5 with Annex B.2 Negation Symbol], the vendor must provide a signed letter stating that the offered products are "not made with natural rubber latex. | 6 | 11 | VENDOR RESPONSE: |
| 7. Vendor must provide Knee Sleeve Hinged 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. | 2 | Vendor must provide Knee Sleeve Hinged 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. | 7 | 12 | VENDOR RESPONSE: |
| 8. Vendor must provide Knee Sleeve Hinged products with measurements that fit the required product groupings measuring 5 - 8 inches ( “ ) above the mid-patella and provide documentation to support this with initial submittal. | 3 | Vendor must provide Knee Sleeve Hinged products with measurements that fit the required product groupings measuring 5 - 8 inches ( “ ) above the mid-patella and provide documentation to support this with initial submittal. | 8 | 13 | VENDOR RESPONSE: |
| 9. Vendor must provide Knee Sleeve Hinged products that have an adjustable closure feature to ensure the end-user can customize the fit and provide documentation to support this with initial submittal. | 4 | Vendor must provide Knee Sleeve Hinged products that have an adjustable closure feature to ensure the end-user can customize the fit and provide documentation to support this with initial submittal. | 9 | 14 | VENDOR RESPONSE: |
| 10. Vendor must provide Knee Sleeve Hinged that can be donned as a pull-on or wraparound item and provide documentation to support this with initial submittal. | 5 | Vendor must provide Knee Sleeve Hinged that can be donned as a pull-on or wraparound item and provide documentation to support this with initial submittal. | 10 | 15 | VENDOR RESPONSE: |
| 11. Vendor must provide Knee Sleeve Hinged products that include cleaning instructions with each item and provide documentation to support this with initial submittal. | 6 | Vendor must provide Knee Sleeve Hinged products that include cleaning instructions with each item and provide documentation to support this with initial submittal. | 11 | 16 | VENDOR RESPONSE: |
| 12. Vendor must provide Knee Sleeve Hinged products that includes medial and lateral hinges and provide documentation to support this with initial submittal. | 7 | Vendor must provide Knee Sleeve Hinged products that includes medial and lateral hinges and provide documentation to support this with initial submittal. | 12 | 17 | VENDOR RESPONSE: |
| 13. Vendor must provide Knee Sleeve Hinged products that includes hinges made of metal or plastic and provide documentation to support this with initial submittal. | 8 | Vendor must provide Knee Sleeve Hinged products that includes hinges made of metal or plastic and provide documentation to support this with initial submittal. | 13 | 18 | VENDOR RESPONSE: |
| VENDOR INSTRUCTIONS |
In support of requirement 14, vendor must provide with initial submittal a photographic image for product’s individual packaging (front and back) for required items 5.3, 5.5, and 5.10 and provide a letter of attestation stating the other required items meet the requirement. Photographic images of graphic templates are not acceptable supporting documentation.
| 14. Vendor must provide Knee Sleeve Hinged products with individual packaging that includes the following information: | |||||
| a. | Product Size (Small, Medium, Large, XL) | ||||
| b. | Instructions for Use (IFU) provided by either a product insert, QR Code, or printed on packaging | ||||
| c. | Identification that the product is designed to be worn exclusively on the right or left knee or on either knee | ||||
| d. | Part Number | 9 | Vendor must provide Knee Sleeve Hinged products with individual packaging that includes the following information: | ||
| a. | Product Size (Small, Medium, Large, XL) | ||||
| b. | Instructions for Use (IFU) provided by either a product insert, QR Code, or printed on packaging | ||||
| c. | Identification that the product is designed to be worn exclusively on the right or left knee or on either knee | ||||
| d. | Part Number | 14 | In support of requirement 14, vendor must provide with initial submittal a photographic image for product’s individual packaging (front and back) for required items 5.3, 5.5, and 5.10 and provide a letter of attestation stating the other required items meet the requirement. Photographic images of graphic templates are not acceptable supporting documentation. | 19 | VENDOR RESPONSE: |
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