QSL Package Worksheet MN-2311-09 FECAL INCONTINENCE PRODUCTS.xlsx
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- Fecal Incontinence Products
- Solicitation number
- MN-2311-09
About this file
This document appears to be a Sources Sought notification for the creation of a Qualified Suppliers Listing (QSL) for Fecal Incontinence Products. The Defense Health Agency (DHA) Medical Logistics Division and the Defense Logistics Agency (DLA) Troop Support Medical Prime Vendor Program are seeking vendors to provide two required items: an Indwelling Fecal Management System and a Fecal Collection Bag with Connector.
Vendors interested in qualifying for the QSL must submit a QSL Package Worksheet and supporting documentation by October 10, 2024. Requirements include having a Distribution and Pricing Agreement (DAPA), agreements with the current Prime Vendors, an active SAM registration, and meeting various technical specifications for the products. The QSL is anticipated to be established by November 1, 2024 and will be the basis for a subsequent Standardization Action. Only vendors on the QSL will be eligible to submit pricing quotes and enter into an Incentive Agreement. The Government reserves the right to standardize or not standardize on these Fecal Incontinence Products.
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| QSL Announcement MN-2311-09 Fecal Incontinence Products.docx | DOCX document |
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QSL Package Worksheet
| Requirements to Qualify for the QSL | MN-2311-09 FECAL INCONTINENCE PRODUCTS |
| 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. | 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. | |
| 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 INDWELLING FECAL MANAGEMENT SYSTEM | 936 | ||||||||||||
| 5.2 FECAL COLLECTION BAG WITH CONNECTOR, MINIMUM CAPACITY 1 LITER, WITH GRADUATION MARKINGS | 2,390 | ||||||||||||
| 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 Fecal Incontinence 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 Fecal Incontinence 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 Fecal Incontinence Products that are cleared by the FDA and comply with FDA General Controls and must submit supporting documentation with initial submittal that includes FDA Establishment Registration, Medical Device listing, and 510(k). | 2 | Vendor must provide Fecal Incontinence Products that are cleared by the FDA and comply with FDA General Controls and must submit supporting documentation with initial submittal that includes FDA Establishment Registration, Medical Device listing, and 510(k). | 7 | 12 | VENDOR RESPONSE: |
| 8. Vendor must provide Fecal Incontinence Products for single patient use only and provide documentation to support this with initial submittal. | 3 | Vendor must provide Fecal Incontinence Products for single patient use only and provide documentation to support this with initial submittal. | 8 | 13 | VENDOR RESPONSE: |
| 9. Vendor must provide Fecal Incontinence Products designed to allow the collection bag to be hung and provide documentation to support this with initial submittal. | 4 | Vendor must provide Indwelling Fecal Management System with contents listed on the individual product packaging and provide documentation to support this with initial submittal. | 9 | 14 | VENDOR RESPONSE: |
| VENDOR INSTRUCTIONS |
The following requirements 10-19 only pertain to required item 5.1. Indwelling Fecal Management System.
| 10. Vendor must provide Indwelling Fecal Management System with contents listed on the individual product packaging and provide documentation to support this with initial submittal. | 6 | Vendor must provide Indwelling Fecal Management System with odor control barrier property and provide documentation to support this with initial submittal. | 11 | 16 | VENDOR RESPONSE: | |||||
| 11. Vendor must provide a closed system Indwelling Fecal Management System that includes at a minimum the following items and provide documentation to support this with initial submittal: | ||||||||||
| a. | Indwelling rectal catheter | |||||||||
| b. | Inflatable retention balloon/cuff on the proximal end of the catheter | |||||||||
| c. | Drainage tubing assembly with access ports and connector for attaching the collection bag to the tubing assembly | |||||||||
| d. | Luer lock syringe for balloon inflation | |||||||||
| e. | Fecal collection bag – at minimum one collection bag with 1 liter capacity with graduation markings at minimum every 100mL | |||||||||
| f. | Pinching clamp for occluding the drainage tube | |||||||||
| g. | Manufacturer’s written instructions for use of the product and insertion guide | 5 | Vendor must provide a closed system Indwelling Fecal Management System that includes at a minimum the following items and provide documentation to support this with initial submittal: | |||||||
| a. | Indwelling rectal catheter | |||||||||
| b. | Inflatable retention balloon/cuff on the proximal end of the catheter | |||||||||
| c. | Drainage tubing assembly with access ports and connector for attaching the collection bag to the tubing assembly | |||||||||
| d. | Luer lock syringe for balloon inflation | |||||||||
| e. | Fecal collection bag – at minimum one collection bag with 1 liter capacity with graduation markings at minimum every 100mL | |||||||||
| f. | Pinching clamp for occluding the drainage tube | |||||||||
| g. | Manufacturer’s written instructions for use of the product and insertion guide | 10 | 15 | VENDOR RESPONSE: | ||||||
| 12. Vendor must provide Indwelling Fecal Management System with odor control barrier property and provide documentation to support this with initial submittal. | 6 | Vendor must provide Indwelling Fecal Management System with odor control barrier property and provide documentation to support this with initial submittal. | 11 | 16 | VENDOR RESPONSE: | |||||
| 13. Vendor must provide Indwelling Fecal Management System with manufacturer’s recommended volume for balloon inflation and provide documentation to support this with initial submittal. | 7 | Vendor must provide Indwelling Fecal Management System with manufacturer’s recommended volume for balloon inflation and provide documentation to support this with initial submittal. | 12 | 17 | VENDOR RESPONSE: | |||||
| 14. Vendor must provide Indwelling Fecal Management System with catheter position indicator-marked on the proximal end of the drain tube and provide documentation to support this with initial submittal. | 8 | Vendor must provide Indwelling Fecal Management System with catheter position indicator-marked on the proximal end of the drain tube and provide documentation to support this with initial submittal. | 13 | 18 | VENDOR RESPONSE: | |||||
| 15. Vendor must provide Indwelling Fecal Management System with the maximum length of consecutive days of indwelling time listed and provide documentation to support this with initial submittal. | 9 | Vendor must provide Indwelling Fecal Management System with the maximum length of consecutive days of indwelling time listed and provide documentation to support this with initial submittal. | 14 | 19 | VENDOR RESPONSE: | |||||
| 16. Vendor must provide Indwelling Fecal Management System with access port for catheter tube irrigation and provide documentation to support this with initial submittal. | 10 | Vendor must provide Indwelling Fecal Management System with access port for catheter tube irrigation and provide documentation to support this with initial submittal. | 15 | 110 | VENDOR RESPONSE: | |||||
| 17. Vendor must provide Indwelling Fecal Management System with access port designated for rectal medication delivery and provide documentation to support this with initial submittal. | 11 | Vendor must provide Indwelling Fecal Management System with access port designated for rectal medication delivery and provide documentation to support this with initial submittal. | 16 | 111 | VENDOR RESPONSE: | |||||
| 18. Vendor must provide Indwelling Fecal Management System that allows for stool sampling while the indwelling system is in place and provide documentation to support this with initial submittal. | 12 | Vendor must provide Indwelling Fecal Management System that allows for stool sampling while the indwelling system is in place and provide documentation to support this with initial submittal. | 17 | 112 | VENDOR RESPONSE: | |||||
| 19. | Vendor must provide Indwelling Fecal Management System with translucent drainage tubing and provide documentation to support this with initial submittal. | 13 | Vendor must provide Indwelling Fecal Incontinence Management System with translucent drainage tubing and provide documentation to support this with initial submittal. | 18 | 113 | VENDOR RESPONSE: | ||||
| VENDOR INSTRUCTIONS |
In support of requirement 20, vendor must provide photographic images of the product packaging with initial submittal for both required items 5.1 and 5.2. Photographic images of graphic templates of product labeling are not acceptable supporting documentation.
| 20. | Vendor must provide Fecal Incontinence Products with individual packaging that includes the following information: | ||||
| a. | Expiration date or manufacturing date as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 use-by date symbol | ||||
| b. | Lot number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 lot symbol | ||||
| c. | Reference number or part number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 reference symbol | 15 | Vendor must provide Indwelling Fecal Management System with individual packaging that includes the following information: | ||
| a. | Expiration date or manufacturing date as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 use-by date symbol | ||||
| b. | Lot number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 lot symbol | ||||
| c. | Reference number or part number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 reference symbol | 20 | In support of requirement 20, vendor must provide photographic images of the product packaging with initial submittal for required items 5.1 and 5.2. Photographic images of graphic templates of product labeling are not acceptable supporting documentation. | 115 | VENDOR RESPONSE: |
SA_IPP_EVAL_REQS_OUTPUT
| REQ_TYPE_SEQ | REQ_TYPE | SA_REQ_ID | REQ_DESC | OUTPUT_REQ_NUM | VENDOR_INSTRUCTIONS | ROWID | CLIN_REQ_RATIONALE | CLIN_REQ_EVAL_METHOD | |
| 1 | TECHNICAL REVIEW | 1 | Vendor must provide Fecal Incontinence 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 | ||||
| 1 | TECHNICAL REVIEW | 2 | Vendor must provide Fecal Incontinence Products that are cleared by the FDA and comply with FDA General Controls and must submit supporting documentation with initial submittal that includes FDA Establishment Registration, Medical Device listing, and 510(k). | 7 | 12 | ||||
| 1 | TECHNICAL REVIEW | 3 | Vendor must provide Fecal Incontinence Products for single patient use only and provide documentation to support this with initial submittal. | 8 | 13 | ||||
| 1 | TECHNICAL REVIEW | 4 | Vendor must provide Indwelling Fecal Management System with contents listed on the individual product packaging and provide documentation to support this with initial submittal. | 9 | 14 | ||||
| 1 | TECHNICAL REVIEW | 5 | Vendor must provide a closed system Indwelling Fecal Management System that includes at a minimum the following items and provide documentation to support this with initial submittal: | ||||||
| a. | Indwelling rectal catheter | ||||||||
| b. | Inflatable retention balloon/cuff on the proximal end of the catheter | ||||||||
| c. | Drainage tubing assembly with access ports and connector for attaching the collection bag to the tubing assembly | ||||||||
| d. | Luer lock syringe for balloon inflation | ||||||||
| e. | Fecal collection bag – at minimum one collection bag with 1 liter capacity with graduation markings at minimum every 100mL | ||||||||
| f. | Pinching clamp for occluding the drainage tube | ||||||||
| g. | Manufacturer’s written instructions for use of the product and insertion guide | 10 | 15 | ||||||
| 1 | TECHNICAL REVIEW | 6 | Vendor must provide Indwelling Fecal Management System with odor control barrier property and provide documentation to support this with initial submittal. | 11 | 16 | ||||
| 1 | TECHNICAL REVIEW | 7 | Vendor must provide Indwelling Fecal Management System with manufacturer’s recommended volume for balloon inflation and provide documentation to support this with initial submittal. | 12 | 17 | ||||
| 1 | TECHNICAL REVIEW | 8 | Vendor must provide Indwelling Fecal Management System with catheter position indicator-marked on the proximal end of the drain tube and provide documentation to support this with initial submittal. | 13 | 18 | ||||
| 1 | TECHNICAL REVIEW | 9 | Vendor must provide Indwelling Fecal Management System with the maximum length of consecutive days of indwelling time listed and provide documentation to support this with initial submittal. | 14 | 19 | ||||
| 1 | TECHNICAL REVIEW | 10 | Vendor must provide Indwelling Fecal Management System with access port for catheter tube irrigation and provide documentation to support this with initial submittal. | 15 | 110 | ||||
| 1 | TECHNICAL REVIEW | 11 | Vendor must provide Indwelling Fecal Management System with access port designated for rectal medication delivery and provide documentation to support this with initial submittal. | 16 | 111 | ||||
| 1 | TECHNICAL REVIEW | 12 | Vendor must provide Indwelling Fecal Management System that allows for stool sampling while the indwelling system is in place and provide documentation to support this with initial submittal. | 17 | 112 | ||||
| 1 | TECHNICAL REVIEW | 13 | Vendor must provide Indwelling Fecal Incontinence Management System with translucent drainage tubing and provide documentation to support this with initial submittal. | 18 | 113 | ||||
| 1 | TECHNICAL REVIEW | 14 | Vendor must provide Indwelling Fecal Incontinence Products designed to allow the collection bag to be hung and provide documentation to support this with initial submittal. | 19 | 114 | ||||
| 1 | TECHNICAL REVIEW | 15 | Vendor must provide Indwelling Fecal Management System with individual packaging that includes the following information: | ||||||
| a. | Expiration date or manufacturing date as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 use-by date symbol | ||||||||
| b. | Lot number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 lot symbol | ||||||||
| c. | Reference number or part number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 reference symbol | 20 | In support of requirement 20, vendor must provide photographic images of the product packaging with initial submittal for required items 5.1 and 5.2. Photographic images of graphic templates of product labeling are not acceptable supporting documentation. | 115 |
SA_IPP_SAMPLE_PRODS
| PRODUCT DESCRIPTION | SAMPLE_REQUESTED | SAMPLE QTY | CLUSTER_SEQ_ID |
| FECAL COLLECTION BAG WITH CONNECTOR, MINIMUM CAPACITY 1 LITER, WITH GRADUATION MARKINGS | 2 | ||
| INDWELLING FECAL MANAGEMENT SYSTEM | 1 |
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