QSL Package Worksheet MS-2407-46 CLOTH CHLORHEXIDINE GLUCONATE PRE-OP PREP.xlsx
XLSX spreadsheet 16 KB Posted
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- Cloth, Chlorhexidine Gluconate Pre-Op Prep
- Solicitation number
- MS-2407-46
About this file
This is a Qualified Suppliers Listing (QSL) Package Worksheet for Cloth, Chlorhexidine Gluconate Pre-Op Prep medical supplies. The Defense Health Agency and Defense Logistics Agency are seeking vendors to establish a Mission Essential Medical-Surgical Materiel Qualified Suppliers Listing for two specific chlorhexidine gluconate pre-op prep cloth products: a 2-cloth package and a 6-cloth package, with an estimated annual sales volume of $379,896. Vendors must meet extensive technical requirements, including having a Distribution and Pricing Agreement (DAPA), agreements with prime vendors Cardinal Health and Owens & Minor, an active SAM account, and providing detailed product documentation demonstrating compliance with FDA regulations, latex-free manufacturing, packaging specifications, and Trade Agreements Act country of origin requirements.
Key response dates include a vendor response deadline of 5:00 PM local Philadelphia time on 10 April 2025, with vendor notification of QSL qualification expected by 01 May 2025. Vendors who are selected will be invited to submit pricing quotes on 22 May 2025, with the potential to enter an Incentive Agreement. The solicitation (MS-2407-46) is not a price quote request but a sources sought notification to create a qualified suppliers list for Military Treatment Facilities and operational medical units across Army, Navy, Air Force, Marine Corps, and Naval Expeditionary Medical Support Command.
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| File | Type | Posted |
|---|---|---|
| QSL Announcement MS-2407-46 Cloth Chlorhexidine Gluconate Pre-Op Prep.docx | DOCX document |
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QSL Package Worksheet
| Requirements to Qualify for the QSL | MS-2407-46 CLOTH, CHLORHEXIDINE GLUCONATE PRE-OP PREP |
| 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 CLOTH, CHLORHEXIDINE GLUCONATE (2% CHG) PRE-OP PREP, 2 CLOTHS PER PACKAGE | 19,906 | ||||||||||||
| 5.2 CLOTH, CHLORHEXIDINE GLUCONATE (2% CHG) PRE-OP PREP, 6 CLOTHS PER PACKAGE | 280,824 | ||||||||||||
| 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 Cloth, Chlorhexidine Gluconate Pre-Op Prep 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 Cloth, Chlorhexidine Gluconate Pre-Op Prep 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 Cloth, Chlorhexidine Gluconate Pre-Op Prep 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 Cloth, Chlorhexidine Gluconate Pre-Op Prep 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 Cloth, Chlorhexidine Gluconate Pre-Op Prep products that have an approved New Drug Application (NDA) by the FDA and provide documentation to support this with initial submittal. | 3 | Vendor must provide Cloth, Chlorhexidine Gluconate Pre-Op Prep products that have an approved New Drug Application (NDA) by the FDA and provide documentation to support this with initial submittal. | 8 | 13 | VENDOR RESPONSE: |
| 9. Vendor must provide Cloth, Chlorhexidine Gluconate Pre-Op Prep products with minimum size of 7.5 IN by 7.5 IN and provide documentation to support this with initial submittal. | 4 | Vendor must provide Cloth, Chlorhexidine Gluconate Pre-Op Prep products with minimum size of 7.5 IN by 7.5 IN and provide documentation to support this with initial submittal. | 9 | 14 | VENDOR RESPONSE: |
| 10. Vendor must provide Cloth, Chlorhexidine Gluconate Pre-Op Prep products with a Safety Data Sheet (SDS) and provide documentation to support this with initial submittal. | 5 | Vendor must provide Cloth, Chlorhexidine Gluconate Pre-Op Prep products with a Safety Data Sheet (SDS) and provide documentation to support this with initial submittal. | 10 | 15 | VENDOR RESPONSE: |
| VENDOR INSTRUCTIONS |
In support of requirement 11, vendor must provide with initial submittal photographic images of the individual product packaging for required items 5.1 and 5.2. Photographic images of graphic templates of product labeling are not acceptable supporting documentation.
| 11. Vendor must provide Cloth, Chlorhexidine Gluconate Pre-Op Prep products with individual packaging that includes the following information identified: | |||||
| a. | Reference number or part number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 reference 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. | Lot number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 lot symbol | ||||
| d. | Single-use as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 single-use symbol | ||||
| e. | Do not flush as indicated in a statement or a symbol | ||||
| f. | Do not microwave | ||||
| g. | Allergy alert | ||||
| h. | Rinse-free | ||||
| i. | For external use only | ||||
| j. | Storage instructions | ||||
| k. | Instructions for use | 6 | Vendor must provide Cloth, Chlorhexidine Gluconate Pre-Op Prep products with individual packaging that includes the following information identified: | ||
| a. | Reference number or part number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 reference 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. | Lot number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 lot symbol | ||||
| d. | Single-use as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 single-use symbol | ||||
| e. | Do not flush as indicated in a statement or a symbol | ||||
| f. | Do not microwave | ||||
| g. | Allergy alert | ||||
| h. | Rinse-free | ||||
| i. | For external use only | ||||
| j. | Storage instructions | ||||
| k. | Instructions for use | 11 | In support of requirement 11, vendor must provide with initial submittal photographic images of the individual product packaging for required items 5.1 and 5.2. Photographic images of graphic templates of product labeling are not acceptable supporting documentation. | 16 | VENDOR RESPONSE: |
| VENDOR INSTRUCTIONS |
Vendor MAY provide any or all of the additional items listed below following the same format as for Requirement number 5.
Vendor must provide a letter of attestation, INCLUDING a list of part numbers for the submitted optional items, stating that the offered products meet all requirements after requirement 6.
| Item Descriptions | 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 | ||
| 1. CLOTH, CHLORHEXIDINE GLUCONATE (2% CHG) PRE-OP PREP, 2 CLOTHS PER PACKAGE (SET OF 3) |
File details come from the government source that posted it. Updated .