QSL Package Worksheet MW-2206-93 CENTRAL VENOUS CATHETER TRAYS TRIPLE LUMEN.xlsx
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This document is a Sources Sought notification for the creation of a Qualified Suppliers Listing (QSL) for Central Venous Catheter Trays, Triple Lumen. The Defense Health Agency (DHA) Medical Logistics (MEDLOG) Division and the Defense Logistics Agency (DLA) Troop Support Medical Prime Vendor Program are seeking product line items in this category. The estimated annual sales volume is $937,139. Vendors must meet several requirements to qualify for the QSL, including having a Distribution and Pricing Agreement (DAPA), agreements with the current DoD Medical/Surgical Prime Vendors, an active SAM registration, and providing products that are FDA-cleared and not made with natural rubber latex. Vendors must submit detailed information about offered products, including manufacturer part numbers, item descriptions, and country of origin. Vendor responses are due by 5:00 PM local Philadelphia time on July 5, 2024. The QSL for Central Venous Catheter Trays, Triple Lumen is anticipated to be established on September 5, 2024 and may be the basis of a subsequent Standardization Action.
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QSL Package Worksheet
| Requirements to Qualify for the QSL | MW-2206-93 CENTRAL VENOUS CATHETERS, TRIPLE LUMEN |
| 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.
The Defense Logistics Agency has been granted an exception to allow submissions of TAA non-compliant products for the following Dressing Sponge products within the product line: SPONGE, DRESSING, NON-STERILE, COTTON, WOVEN, 2IN X 2IN, 12-PLY; SPONGE, DRESSING, NON-STERILE, COTTON, WOVEN, 2IN X 2IN, 8-PLY; and SPONGE, DRESSING, NON-STERILE, COTTON, WOVEN, 4IN X 4IN, 12-PLY.
The Defense Logistics Agency has been granted an exception for synthetic medical exam gloves manufactured in Malaysia or Thailand. As a result of that exception, this Sources Sought notification is being modified to allow submissions of TAA non-compliant synthetic medical exam gloves manufactured in Malaysia or Thailand.
| Required Product Description | Tray Components | 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 CENTRAL VENOUS CATHETER, MAXIMAL STERILE BARRIER TRAY, WITH ANTIMICROBIAL 7 FR X 20 CM TRIPLE LUMEN CATHETER | 3,190 | |||||||||||||
| a. One (1) Indwelling Catheter, triple lumen: 7 FR X 20 cm, antimicrobial coated, pressure injectable, radiopaque, with cm depth markings | ||||||||||||||
| b. One (1) Echogenic Introducer needle: 18 Ga X 5 cm – 7 cm | ||||||||||||||
| c. One (1) Catheter introducer needle : 18 Ga X 6.35 cm - 7 cm over 18 Ga or 20 Ga needle | ||||||||||||||
| d. One (1) Stainless steel Guidewire with cm depth indicator markings: 0.32 IN X 60 cm | ||||||||||||||
| e. One (1) Tissue Dilator (8.5 FR X 10 CM - 11 CM) | ||||||||||||||
| f. Two (2) Luer lock syringe, 3 mL – 6 mL | ||||||||||||||
| g. One (1) 5 mL ampule 1% lidocaine and One (1) Filter straw (5 micron) OR One (1) 5 mL vial 1% lidocaine and One (1) blunt fill needle (18 Ga X 1.5 IN) | ||||||||||||||
| h. One (1) Hypodermic safety needle, 25 Ga X 0.625 IN - 1 IN | ||||||||||||||
| i. One (1) Hypodermic safety needle, 22 Ga X 1.5 IN | ||||||||||||||
| j. One (1) Sharps safety system (e.g., locking vise, locking cup) | ||||||||||||||
| k. Two (2) Site Skin Prep, 3 mL applicator with 2% chlorhexidine gluconate (CHG) and 70% isopropyl alcohol (IPA) solution | ||||||||||||||
| l. Two (2) Gauze sponge, 2 IN x 2 IN (minimum 4 ply) | ||||||||||||||
| m. Five (5) Gauze sponge, 4 IN x 4 IN (minimum 4 ply) | ||||||||||||||
| n. One (1) Safety scalpel, #11 blade | ||||||||||||||
| o. One (1) Suture, silk non-absorbable with curved needle | ||||||||||||||
| p. One (1) Needle holder/driver: 5 IN – 6 IN | ||||||||||||||
| q. One (1) Primary catheter stabilization device (e.g., clamp/fastener with suture eyelets/holes) |
| r. One (1) Secondary catheter stabilization device (e.g., sutureless securement) | ||
| s. Three (3) Pre-filled Luer lock syringe, normal saline 0.9% NaCl, 10 mL | ||
| t. Three (3) Luer Activated Needleless Connectors, neutral fluid displacement, clear, non-tinted housing | ||
| u. One (1) Ultrasound/Transducer probe cover, universal size (5 IN - 6 IN X 48 IN – 58 IN) | ||
| v. Two (2) rubber bands | ||
| w. One (1) Packet, ultrasound transmission media | ||
| x. One (1) Central venous catheter securement dressing (Contour 3 IN - 4 IN X 4 IN - 5 IN), transparent face, impregnated/integrated with CHG OR One (1) Central venous catheter securement dressing, transparent face, with One (1) protective CHG disk | ||
| y. One (1) Drape, full body 54 IN – 70 IN Width X 90 IN – 125 IN Length with or without fenestration | ||
| z. One (1) Bouffant or Surgical Cap, universal size | ||
| aa. One (1) Surgical Gown, AAMI/ANSI:PB70 Level 4 (Large or X-Large) | ||
| bb. One (1) ASTM level 3, Mask with anti-fog resistant Eye Shield | ||
| cc. One (1) Pair of Medium or Large Powder Free Exam Gloves, Nitrile | ||
| 5.2 CENTRAL VENOUS CATHETER, MAXIMAL STERILE BARRIER TRAY, WITH NON-COATED 7 FR X 20 CM TRIPLE LUMEN CATHETER | 348 | |
| a. One (1) Indwelling Catheter, triple lumen: 7 FR X 20 cm, non-coated, polyurethane pressure injectable, radiopaque, with cm depth markings | ||
| b. One (1) Echogenic Introducer needle: 18 Ga X 5 cm – 7 cm | ||
| c. One (1) Catheter introducer needle : 18 Ga X 6.35 cm - 7 cm over 18 Ga or 20 Ga needle | ||
| d. One (1) Stainless steel Guidewire with cm depth indicator markings: 0.32 IN X 60 cm | ||
| e. One (1) Tissue Dilator (8.5 FR X 10 CM - 11 CM) | ||
| f. Two (2) Luer lock syringe, 3 mL – 6 mL | ||
| g. One (1) 5 mL ampule 1% lidocaine and One (1) Filter straw (5 micron) OR One (1) 5 mL vial 1% lidocaine and One (1) blunt fill needle (18 Ga X 1.5 IN) | ||
| h. One (1) Hypodermic safety needle, 25 Ga X 0.625 IN - 1 IN | ||
| i. One (1) Hypodermic safety needle, 22 Ga X 1.5 IN | ||
| j. One (1) Sharps safety system (e.g., locking vise, locking cup) | ||
| k. Two (2) Site Skin Prep, 3 mL applicator with 2% chlorhexidine gluconate (CHG) and 70% isopropyl alcohol (IPA) solution | ||
| l. Two (2) Gauze sponge, 2 IN x 2 IN (minimum 4 ply) | ||
| m. Five (5) Gauze sponge, 4 IN x 4 IN (minimum 4 ply) | ||
| n. One (1) Safety scalpel, #11 blade | ||
| o. One (1) Suture, silk non-absorbable with curved needle | ||
| p. One (1) Needle holder/driver: 5 IN – 6 IN | ||
| q. One (1) Primary catheter stabilization device (e.g., clamp/fastener with suture eyelets/holes) |
| r. One (1) Secondary catheter stabilization device (e.g., sutureless securement) | ||
| s. Three (3) Pre-filled Luer lock syringe, normal saline 0.9% NaCl, 10 mL | ||
| t. Three (3) Luer Activated Needleless Connectors, neutral fluid displacement, clear, non-tinted housing | ||
| u. One (1) Ultrasound/Transducer probe cover, universal size (5 IN - 6 IN X 48 IN – 58 IN) | ||
| v. Two (2) rubber bands | ||
| w. One (1) Packet, ultrasound transmission media | ||
| x. One (1) Central venous catheter securement dressing (Contour 3 IN - 4 IN X 4 IN - 5 IN), transparent face, impregnated/integrated with CHG OR One (1) Central venous catheter securement dressing, transparent face, with One (1) protective CHG disk | ||
| y. One (1) Drape, full body 54 IN – 70 IN Width X 90 IN – 125 IN Length with or without fenestration | ||
| z. One (1) Bouffant or Surgical Cap, universal size | ||
| aa. One (1) Surgical Gown, AAMI/ANSI:PB70 Level 4 (Large or X-Large) | ||
| bb. One (1) ASTM level 3, Mask with anti-fog resistant Eye Shield | ||
| cc. One (1) Pair of Medium or Large Powder Free Exam Gloves, Nitrile | ||
| 5.3 CENTRAL VENOUS CATHETER TRAY, WITH ANTIMICROBIAL 7 FR X 20 CM TRIPLE LUMEN CATHETER, WITHOUT PPE | 1,467 | |
| a. One (1) Indwelling Catheter, triple lumen: 7 FR X 20 cm, antimicrobial coated, pressure injectable, radiopaque, with cm depth markings | ||
| b. One (1) Echogenic Introducer needle: 18 Ga X 5 cm – 7 cm | ||
| c. One (1) Catheter introducer needle : 18 Ga X 6.35 cm - 7 cm over 18 Ga or 20 Ga needle | ||
| d. One (1) Stainless steel Guidewire with cm depth indicator markings: 0.32 IN X 60 cm | ||
| e. One (1) Tissue Dilator (8.5 FR X 10 CM - 11 CM) | ||
| f. Two (2) Luer lock syringe, 3 mL – 6 mL | ||
| g. One (1) 5 mL ampule 1% lidocaine and One (1) Filter straw (5 micron) OR One (1) 5 mL vial 1% lidocaine and One (1) blunt fill needle (18 Ga X 1.5 IN) | ||
| h. One (1) Hypodermic safety needle, 25 Ga X 0.625 IN - 1 IN | ||
| i. One (1) Hypodermic safety needle, 22 Ga X 1.5 IN | ||
| j. One (1) Sharps safety system (e.g., locking vise, locking cup) | ||
| k. Two (2) Site Skin Prep, 3 mL applicator with 2% chlorhexidine gluconate (CHG) and 70% isopropyl alcohol (IPA) solution | ||
| l. Two (2) Gauze sponge, 2 IN x 2 IN (minimum 4 ply) | ||
| m. Five (5) Gauze sponge, 4 IN x 4 IN (minimum 4 ply) | ||
| n. One (1) Safety scalpel, #11 blade | ||
| o. One (1) Suture, silk non-absorbable with curved needle | ||
| p. One (1) Needle holder/driver: 5 IN – 6 IN | ||
| q. One (1) Primary catheter stabilization device (e.g., clamp/fastener with suture eyelets/holes) |
| r. One (1) Secondary catheter stabilization device (e.g., sutureless securement) | ||
| s. Three (3) Pre-filled Luer lock syringe, normal saline 0.9% NaCl, 10 mL | ||
| t. Three (3) Luer Activated Needleless Connectors, neutral fluid displacement, clear, non-tinted housing | ||
| u. One (1) Ultrasound/Transducer probe cover, universal size (5 IN - 6 IN X 48 IN – 58 IN) | ||
| v. Two (2) rubber bands | ||
| w. One (1) Packet, ultrasound transmission media | ||
| x. One (1) Central venous catheter securement dressing (Contour 3 IN - 4 IN X 4 IN - 5 IN), transparent face, impregnated/integrated with CHG OR One (1) Central venous catheter securement dressing, transparent face, with One (1) protective CHG disk | ||
| y. One (1) Drape, full body 54 IN – 70 IN Width X 90 IN – 125 IN Length with or without fenestration | ||
| 5.4 CENTRAL VENOUS CATHETER TRAY, WITH NON-COATED 7 FR X 20 CM TRIPLE LUMEN CATHETER, WITHOUT PPE | 371 | |
| a. One (1) Indwelling Catheter, triple lumen: 7 FR X 20 cm, non-coated, polyurethane pressure injectable, radiopaque, with cm depth markings | ||
| b. One (1) Echogenic Introducer needle: 18 Ga X 5 cm – 7 cm | ||
| c. One (1) Catheter introducer needle : 18 Ga X 6.35 cm - 7 cm over 18 Ga or 20 Ga needle | ||
| d. One (1) Stainless steel Guidewire with cm depth indicator markings: 0.32 IN X 60 cm | ||
| e. One (1) Tissue Dilator (8.5 FR X 10 CM - 11 CM) | ||
| f. Two (2) Luer lock syringe, 3 mL – 6 mL | ||
| g. One (1) 5 mL ampule 1% lidocaine and One (1) Filter straw (5 micron) OR One (1) 5 mL vial 1% lidocaine and One (1) blunt fill needle (18 Ga X 1.5 IN) | ||
| h. One (1) Hypodermic safety needle, 25 Ga X 0.625 IN - 1 IN | ||
| i. One (1) Hypodermic safety needle, 22 Ga X 1.5 IN | ||
| j. One (1) Sharps safety system (e.g., locking vise, locking cup) | ||
| k. Two (2) Site Skin Prep, 3 mL applicator with 2% chlorhexidine gluconate (CHG) and 70% isopropyl alcohol (IPA) solution | ||
| l. Two (2) Gauze sponge, 2 IN x 2 IN (minimum 4 ply) | ||
| m. Five (5) Gauze sponge, 4 IN x 4 IN (minimum 4 ply) | ||
| n. One (1) Safety scalpel, #11 blade | ||
| o. One (1) Suture, silk non-absorbable with curved needle | ||
| p. One (1) Needle holder/driver: 5 IN – 6 IN | ||
| q. One (1) Primary catheter stabilization device (e.g., clamp/fastener with suture eyelets/holes) |
| r. One (1) Secondary catheter stabilization device (e.g., sutureless securement) | |
| s. Three (3) Pre-filled Luer lock syringe, normal saline 0.9% NaCl, 10 mL | |
| t. Three (3) Luer Activated Needleless Connectors, neutral fluid displacement, clear, non-tinted housing | |
| u. One (1) Ultrasound/Transducer probe cover, universal size (5 IN - 6 IN X 48 IN – 58 IN) | |
| v. Two (2) rubber bands | |
| w. One (1) Packet, ultrasound transmission media | |
| x. One (1) Central venous catheter securement dressing (Contour 3 IN - 4 IN X 4 IN - 5 IN), transparent face, impregnated/integrated with CHG OR One (1) Central venous catheter securement dressing, transparent face, with One (1) protective CHG disk | |
| y. One (1) Drape, full body 54 IN – 70 IN Width X 90 IN – 125 IN Length with or without fenestration | |
| 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 Central Venous Catheter Trays, Triple Lumen 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 Central Venous Catheter Trays, Triple Lumen 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 Central Venous Catheter Trays, Triple Lumen, Indwelling Catheters 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 | Vendor must provide Central Venous Catheter Trays, Triple Lumen, Indwelling Catheters (component) that are cleared by the FDA and provide the FDA 510(k) to support this with initial submittal. | 7 | 17 | VENDOR RESPONSE: |
| VENDOR INSTRUCTIONS |
In support of requirement 8, vendor must provide with initial submittal a signed letter of attestation, INCLUDING a list of part numbers for required items, stating that the offered products meet requirement 8.
8. Vendor must provide Central Venous Catheter Trays, Triple Lumen products for each tray packaging that includes the following information:
a. Catheter French Size
b. Length of Catheter (CM)
c. Number of Lumens
d. List of tray components
e. Reference number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 reference number symbol
f. Lot number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 lot number symbol
g. Expiration date as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 use-by date symbol
h. Single-use as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 single-use symbol
| i. Sterile as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 sterile symbol. | 8 | Vendor must provide Central Venous Catheter Trays, Triple Lumen products for each tray packaging that includes the following information: | ||
| a. | Catheter French Size | |||
| b. | Length of Catheter (CM) | |||
| c. | Number of Lumens | |||
| d. | List of tray components | |||
| e. | Reference number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 reference number symbol | |||
| f. | Lot number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 lot number symbol | |||
| g. | Expiration date as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 use-by date symbol | |||
| h. | Single-use as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 single-use symbol | |||
| i. | Sterile as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 sterile symbol. | 8 | 18 | VENDOR RESPONSE: |
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