QSL Package Worksheet MS-2401-03 TRACHEOSTOMY TUBES.xlsx
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- Tracheostomy Tubes
- Solicitation number
- MS-2401-03
About this file
This document is a Sources Sought notification for the creation of a Qualified Suppliers Listing (QSL) for Tracheostomy Tubes. The Defense Health Agency (DHA) Medical Logistics Division Medical Materiel Enterprise Standardization Office (MMESO) and the Defense Logistics Agency (DLA) Troop Support Medical Prime Vendor (PV) Program are seeking vendors to provide 21 specific tracheostomy tube products for annual estimated sales of $142,507. Vendors must meet various supplier requirements, including having a Distribution and Pricing Agreement (DAPA), agreements with the current Prime Vendors, and an active SAM registration. Vendors must provide documentation demonstrating their products meet technical specifications, such as being latex-free, DEHP-free, FDA-cleared, and having specific labeling and packaging requirements. Responses are due by August 1, 2024, and the QSL is anticipated to be established by October 1, 2024, potentially leading to a Standardization Action.
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| QSL Announcement MS-2401-03 Tracheostomy Tubes.docx | DOCX document |
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QSL Package Worksheet
| Requirements to Qualify for the QSL | MS-2401-03 TRACHEOSTOMY TUBES |
| Company Name: | |
| Company Address: | |
| Company Point of Contact (POC): |
Name Phone Number E-Mail Address
****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 TRACHEOSTOMY TUBE, 62 MM TO 65 MM LONG, DISPOSABLE 6.0 MM TO 6.5 MM INNER CANNULA SET, CUFFED, PVC | 316 | ||||||||||||
| 5.2 TRACHEOSTOMY TUBE, 68 MM TO 70 MM LONG, DISPOSABLE 7.0 MM INNER CANNULA SET, CUFFED, PVC | 60 | ||||||||||||
| 5.3 TRACHEOSTOMY TUBE, 73 MM TO 74 MM LONG, DISPOSABLE 7.5 MM INNER CANNULA SET, CUFFED, PVC | 690 | ||||||||||||
| 5.4 TRACHEOSTOMY TUBE, 75 MM TO 77 MM LONG, DISPOSABLE 8.0 MM INNER CANNULA SET, CUFFED, PVC | 64 | ||||||||||||
| 5.5 TRACHEOSTOMY TUBE, 78 MM TO 79 MM LONG, DISPOSABLE 8.5 MM INNER CANNULA SET, CUFFED, PVC | 532 | ||||||||||||
| 5.6 TRACHEOSTOMY TUBE, 79 MM TO 81 MM LONG, DISPOSABLE 9.0 MM INNER CANNULA SET, CUFFED, PVC | 35 | ||||||||||||
| 5.7 TRACHEOSTOMY TUBE, 79 MM BY 88 MM LONG, DISPOSABLE 10.0 MM INNER CANNULA SET, CUFFED, PVC | 67 | ||||||||||||
| 5.8 TRACHEOSTOMY TUBE, 62 MM TO 65 MM LONG, DISPOSABLE 6.0 MM TO 6.5 MM INNER CANNULA SET, UNCUFFED, PVC | 98 | ||||||||||||
| 5.9 TRACHEOSTOMY TUBE, 68 MM TO 70 MM LONG, DISPOSABLE 7.0 MM INNER CANNULA SET, UNCUFFED, PVC | 11 | ||||||||||||
| 5.10 TRACHEOSTOMY TUBE, 73 MM TO 74 MM LONG, DISPOSABLE 7.5 MM INNER CANNULA SET, UNCUFFED, PVC | 211 | ||||||||||||
| 5.11 TRACHEOSTOMY TUBE, 75 MM TO 77 MM LONG, DISPOSABLE 8.0 MM INNER CANNULA SET, UNCUFFED, PVC | 38 | ||||||||||||
| 5.12 TRACHEOSTOMY TUBE, 78 MM TO 79 MM LONG, DISPOSABLE 8.5 MM INNER CANNULA SET, UNCUFFED, PVC | 61 | ||||||||||||
| 5.13 TRACHEOSTOMY TUBE, 79 MM TO 81 MM LONG, DISPOSABLE 9.0 MM INNER CANNULA SET, UNCUFFED, PVC | 10 | ||||||||||||
| 5.14 TRACHEOSTOMY TUBE, 79 MM BY 88 MM LONG, DISPOSABLE 10.0 MM INNER CANNULA SET, UNCUFFED, PVC | 21 | ||||||||||||
| 5.15 TRACHEOSTOMY TUBE, INNER CANNULA, DISPOSABLE 6.0 MM TO 6.5 MM, PVC | 200 | ||||||||||||
| 5.16 TRACHEOSTOMY TUBE, INNER CANNULA, DISPOSABLE 7.0 MM, PVC | 90 | ||||||||||||
| 5.17 TRACHEOSTOMY TUBE, INNER CANNULA, DISPOSABLE 7.5 MM, PVC | 2,085 | ||||||||||||
| 5.18 TRACHEOSTOMY TUBE, INNER CANNULA, DISPOSABLE 8.0 MM, PVC | 270 | ||||||||||||
| 5.19 TRACHEOSTOMY TUBE, INNER CANNULA, DISPOSABLE 8.5 MM, PVC | 1,030 | ||||||||||||
| 5.20 TRACHEOSTOMY TUBE, INNER CANNULA, DISPOSABLE 9.0 MM, PVC | 160 | ||||||||||||
| 5.21 TRACHEOSTOMY TUBE, INNER CANNULA, DISPOSABLE 10.0 MM, PVC | 630 | ||||||||||||
| 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 Tracheostomy Tube 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 | Vendor must provide Tracheostomy Tube 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 | 16 | VENDOR RESPONSE: | ||||||
| 7. Vendor must provide Tracheostomy Tube products that are cleared by the FDA and provide the FDA 510(k) to support this with initial submittal. | 7 | Vendor must provide Tracheostomy Tube products that are cleared by the FDA and provide the FDA 510(k) to support this with initial submittal. | 7 | 17 | VENDOR RESPONSE: | ||||||
| 8. | Vendor must provide Tracheostomy Tube products that are not made with Di (2-ethylhexyl) phthalate (DEHP) and provide submittal documentation establishing that the offered products are not made with DEHP. The vendor must meet this requirement in one of two ways: 1) demonstrating that the labeling or product information for the offered products contains the statement "Not made with DEHP," or 2) if the labeling or product information does not contain the statement, the vendor must provide a signed letter stating that the offered products are "Not made with DEHP.” | 8 | Vendor must provide Tracheostomy Tube products that are made with flexible non-Di (2-ethylhexyl) phthalate (DEHP) polyvinyl chloride (PVC) and provide submittal documentation establishing that the offered products are not made with DEHP. The vendor must meet this requirement in one of two ways: 1) demonstrating that the labeling or product information for the offered products contains the statement "Not made with DEHP," or 2) if the labeling or product information does not contain the statement, the vendor must provide a signed letter stating that the offered products are "Not made with DEHP.” | 8 | 18 | VENDOR RESPONSE: | |||||
| 9. Vendor must provide Tracheostomy Tube products that have an integrated 15mm male conical connector on the proximal end of the Tracheostomy tube and provide documentation to support with initial submittal. | 9 | Vendor must provide Tracheostomy Tube products that have an integrated 15mm male conical connector on the proximal end of the Tracheostomy tube and provide documentation to support with initial submittal. | 9 | 19 | VENDOR RESPONSE: | ||||||
| 10. Vendor must provide Tracheostomy Tube products with the following information identified on the proximal end (flange) of the Tracheostomy Tube and provide documentation to support this with initial submittal: | |||||||||||
| a. Manufacturer and or Product name | |||||||||||
| b. Sizing / dimensional information (in mm) to include inner diameter (ID), outer | |||||||||||
| diameter (OD) | |||||||||||
| c. Color coded sizing indicato | 10 | Vendor must provide Tracheostomy Tube products with the following information identified on the proximal end (flange) of the Tracheostomy Tube and provide documentation to support this with initial submittal: | |||||||||
| a. Manufacturer and or Product name | |||||||||||
| b. Sizing / dimensional information (in mm) to include inner diameter (ID), outer | |||||||||||
| diameter (OD) | |||||||||||
| c. Color coded sizing indicato | 10 | 110 | VENDOR RESPONSE: | ||||||||
| 11. Vendor must provide Tracheostomy Tube products that contain Instructions for Use (IFU) and provide documentation to support this with initial submittal. | 11 | Vendor must provide Tracheostomy Tube products that contain Instructions for Use (IFU) and provide documentation to support this with initial submittal. | 11 | 111 | VENDOR RESPONSE: | ||||||
| 12. Vendor must provide Tracheostomy Tube products that contain Magnetic Resonance Imaging (MRI) safety labeling / instructions and provide documentation to support this with initial submittal. | 12 | Vendor must provide Tracheostomy Tube products that contain Magnetic Resonance Imaging (MRI) safety labeling / instructions and provide documentation to support this with initial submittal. | 12 | Vendor Instructions: In support of Requirements 13 and 14, vendor must provide with initial submittal photographic images of the individual product packaging for submitted Required Products 5.1, 5.8 and 5.15. Photographic images of non-part number products and graphic templates of product labeling are not acceptable supporting documentation. | |||||||
| Vendor must provide a letter of attestation, including a list of part numbers for the required items 5.2 – 5.7, 5.9 – 5.14, 5.16 – 5.21, stating that the offered products meet requirements #13 and 14. | 112 | VENDOR RESPONSE: | |||||||||
| VENDOR INSTRUCTIONS: In support of Requirements 13a-e and 14a-h, vendor must provide with initial submittal photographic images of the individual product packaging for submitted Required Products 5.3, 5.8 and 5.17. Photographic images of non-part number products and graphic templates of product labeling are not acceptable supporting documentation. |
Vendor must provide a letter of attestation, including a list of part numbers for the required items 5.1 – 5.2, 5.4 – 5.7, 5.9 – 5.16, and 5.18 – 5.21, stating that the offered products meet requirements #13a-e and 14a-h.
13. Vendor must provide Tracheostomy Tube products with individual outer packaging that includes the following information:
| a. Manufacturer and product name | ||
| b. Part / reference number | ||
| c. Size (i.e., in mm and/or color-coded indicator) | ||
| d. Lot number as indicated in a statement or with the appropriate ISO BS EN ISO 15223- | ||
| 1:2021 lot symbol | ||
| e. Expiration date as indicated in a statement or with the appropriate ISO BS EN ISO 15223- | ||
| 1:2021 use-by date symbol | 13 | Vendor must provide Tracheostomy Tube products with individual outer packaging that includes the following information: |
a. Manufacturer and product name
b. Part / reference number
c. Sizing / dimensional information / color coded sizing indicator
d. Lot number as indicated in a statement or with the appropriate ISO BS EN ISO 15223- 1:2021 lot symbol
e. Expiration date as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 use-by date symbol
f. Single-use as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 single-use symbol
| g. Sterile as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 Sterile symbol | 13 | 113 | VENDOR RESPONSE: |
| 14. Vendor must provide Tracheostomy Tube products with individual inner packaging that includes |
the following information:
| a. Manufacturer and product name | ||
| b. Part / reference number | ||
| c. Size (i.e., in mm and/or color coded indicator) | ||
| d. Lot number as indicated in a statement or with the appropriate ISO BS EN ISO 15223- | ||
| 1:2021 lot symbol | ||
| e. Expiration date as indicated in a statement or with the appropriate ISO BS EN ISO 15223- | ||
| 1:2021 use-by date symbol | ||
| f. Single-use as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 | ||
| single-use symbol, unless otherwise indicated in the product description | ||
| g. Sterile as indicated in a statement or with the appropriate ISO BS EN ISO 15223- | ||
| 1:2021 sterile symbol | ||
| h. Packaging that facilitates aseptic presentation to a sterile field (e.g., peel package) | 14 | Vendor must provide Tracheostomy Tube products with individual inner packaging that includes the following information: |
a. Manufacturer and product name
b. Part / reference number
c. Sizing / dimensional information / color coded sizing indicator
d. Lot number as indicated in a statement or with the appropriate ISO BS EN ISO 15223- 1:2021 lot symbol
e. Expiration date as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 use-by date symbol
f. Single-use as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 single-use symbol
g. Sterile as indicated in a statement or with the appropriate ISO BS EN ISO 15223- 1:2021 Sterile symbol.
h. Packaging that facilitates aseptic presentation to a sterile field (e.g., peel package 14 114 VENDOR RESPONSE:
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