QSL Package Worksheet MS 2401-01 Specimen Container Peel.xlsx
XLSX spreadsheet 16 KB Posted
- Attached to
- Specimen Container Peel Pack
- Solicitation number
- MS-2401-01
About this file
This document is a Sources Sought notification for the creation of a Qualified Suppliers Listing (QSL) for Specimen Container - Peel Pack products for the Military Health System (MHS). The Defense Health Agency (DHA) Medical Logistics Division and Defense Logistics Agency (DLA) Troop Support Medical Prime Vendor Program are seeking vendors to provide one required product - Specimen Container - Peel Pack, 90 to 120 ML PVC. Vendors must meet technical requirements such as not being made with natural rubber latex, having threaded containers and lids, being sterile and single-use, and meeting FDA regulations. Vendors must have a DAPA or be in the process of obtaining one, have agreements with the current DoD Medical/Surgical Prime Vendors, and be active in the System for Award Management (SAM). Vendor responses are due by 5:00 pm local Philadelphia time on 01 August 2024. The QSL is anticipated to be established around 01 October 2024 and may form the basis of a future Standardization Action.
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| File | Type | Posted |
|---|---|---|
| QSL Announcement MS-2401-01 Specimen Container Peel Pack.docx | DOCX document |
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QSL Package Worksheet
| Requirements to Qualify for the QSL | MS 2401-01 Specimen Container, Peel Pack |
| 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 SPECIMEN CONTAINER - PEEL PACK, 90 TO 120 ML PVC | 892,944 | ||||||||||||
| 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 Specimen Container - Peel Pack 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 Specimen Container - Peel Pack 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 Instructions: In support of Requirements 7, 8, 9, 11, & 15 vendor must provide with initial submittal photographic images of the individual product packaging for submitted required product 5.1. Photographic images of non-part number products and graphic templates of product labeling are not acceptable supporting documentation. | ||||
| Vendor must provide letter of attestation, including a list of part numbers for the required item 5.1, stating that the offered product meets requirements #7, 8, 9, 11, & 1 | 16 | VENDOR RESPONSE: | ||||||
| 7. Vendor must provide Specimen Container - Peel Pack products that have a threaded container/receptacle and a threaded lid with screw cap closure and provide documentation to support this with initial submittal. | 7 | Vendor must provide Specimen Container - Peel Pack products that have a threaded container/receptacle and a threaded lid with screw cap closure and provide documentation to support this with initial submittal. | 7 | 17 | VENDOR RESPONSE: | |||
| 8. Vendor must provide Specimen Container - Peel Pack products that are packed together with the threaded lid and provide documentation to support this with initial submittal. | 8 | Vendor must provide Specimen Container - Peel Pack products that are packed together with the threaded lid and provide documentation to support this with initial submittal. | 8 | 18 | VENDOR RESPONSE: | |||
| 9. Vendor must provide Specimen Container - Peel Pack products with a container and lid that are made of Polyvinyl chloride (PVC) and provide documentation to support this with initial submittal. | 9 | Vendor must provide Specimen Container - Peel Pack products with a container and lid that are made of Polyvinyl chloride (PVC) and provide documentation to support this with initial submittal. | 9 | 19 | VENDOR RESPONSE: | |||
| 10. Vendor must provide Specimen Container – Peel Pack products that are packaged to facilitate aseptic presentation to a sterile field and provide documentation to support this with initial submittal. | 10 | Vendor must provide Specimen Container – Peel Pack products that are packaged to facilitate aseptic presentation to a sterile field and provide documentation to support this with initial submittal. | 10 | 110 | VENDOR RESPONSE: | |||
| 11. Vendor must provide Specimen Container - Peel Pack products with graduation marks identified in milliliters (mL) or cubic centimeters (cc) and provide documentation to support this with initial submittal. | 11 | Vendor must provide Specimen Container - Peel Pack products with graduation marks identified in milliliters (mL) or cubic centimeters (cc) and provide documentation to support this with initial submittal. | 11 | 111 | VENDOR RESPONSE: | |||
| VENDOR INSTRUCTIONS |
Vendor Instructions: In support of requirements 12-14, vendor must provide with initial submittal photographic images of the individual product for each required item. Photographic images of graphic templates of product labeling are not acceptable supporting documentation.
| 12. Vendor must provide Specimen Container - Peel Pack products which are sterile and indicated as such on the individual product packaging; whether in printed language or by an accepted ISO BS EN ISO 15223-1: 2021 sterile symbol [reference number 5.4.2] and provide documentation to support this with initial submittal. | 12 | Vendor must provide Specimen Container - Peel Pack products which are sterile and indicated as such on the individual product packaging; whether in printed language or by an accepted ISO BS EN ISO 15223-1: 2021 sterile symbol [reference number 5.4.2] and provide documentation to support this with initial submittal. | 12 | Vendor Instructions: In support of requirements 12-14, vendor must provide with initial submittal photographic images of the individual product for each required item. Photographic images of graphic templates of product labeling are not acceptable supporting documentation. | 112 | VENDOR RESPONSE: |
| 13. Vendor must provide Specimen Container – Peel Pack 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. | 13 | Vendor must provide Specimen Container – Peel Pack 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. | 13 | 113 | VENDOR RESPONSE: | |
| 14. Vendor must provide Specimen Container - Peel Pack products with packaging that include the Lot number as indicated in a statement or with the ISO BS EN ISO 15223-1:2021 lot symbol | 14 | Vendor must provide Specimen Container - Peel Pack products with packaging that include the Lot number as indicated in a statement or with the ISO BS EN ISO 15223-1:2021 lot symbol | 14 | 114 | VENDOR RESPONSE: | |
| 15. Vendors must provide Specimen Container Peel Pack 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. | 15 | Vendors must provide Specimen Container Peel Pack 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. | 15 | 115 | VENDOR RESPONSE: |
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