Closed_System_IV_Catheters

Agency: Defense Logistics Agency
State: Texas
Type of Government: Federal
FSC Category:
  • 65 - Medical, Dental, and Veterinary Equipment and Supplies
NAICS Category:
  • 339113 - Surgical Appliance and Supplies Manufacturing
Posted Date: Jul 18, 2019
Due Date:
Solicitation No: MS-1902-01
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Opportunity History
Solicitation Number :
MS-1902-01
Notice Type :
Combined Synopsis/Solicitation
Synopsis :
Added: Jun 17, 2019 8:27 am
The Defense Health Agency (DHA) Medical Logistics (MEDLOG) Division Medical Materiel Enterprise Standardization Office (MMESO) and the Defense Logistics Agency (DLA) Troop Support Medical Prime Vendor (PV) Program announce a Sources Sought notification for the creation of a Qualified Suppliers Listing (QSL) for Closed System IV Catheters. This is not a request for a price quote. The MMESO South is the lead MMESO for this project.

These Closed System IV Catheters products are for purchase by the Military Treatment Facilities (MTFs) of the Military Health System (MHS) and for the operational assemblages of the Army, Navy, Air Force, Marine Corps, and Naval Expeditionary Medical Support Command (NEMSCOM) and managed regionally by MMESOs North, South, West, Pacific and Europe, hereafter referred to as MMESOs. For information regarding DLA Troop Support Medical's PV program please access the DMMOnline web site at https://www.medical.dla.mil .

This Sources Sought notification is intended to solicit information and products for evaluation in order to create a QSL for Closed System IV Catheters in accordance with (IAW) FAR 9.2. The QSL for Closed System IV Catheters will be established approximately 02 November 2019 and is anticipated to be the basis of a Standardization Action. All medical consumable items on this QSL must be on a Distribution and Pricing Agreement (DAPA) for the DLA Troop Support Medical/Surgical Prime Vendor (MSPV) Program. All participating vendors must complete the registration in the DAPA Management System (DMS) at https://www.medical.dla.mil/Portal/DapaMS/DapaMS.aspx and include either their DAPA number or their Defense Medical Materiel (DMM) number as part of their FBO worksheet submission. Receiving a DMM number allows access to the DMS and is the first step to becoming a DAPA holder. DAPA holders must be prepared to ship items to the PVs, so that the PVs may carry inventory and MTFs may designate items as usage; therefore, standardized items may not be coded in the DMS as "drop ship only." Note: It is recommended that new participants contact each PV prior to adding items to DAPA, in order to gain a full understanding of the PV's requirements and any potential costs associated with PV handling of those items.

If you qualify as a vendor on the QSL, you will then be invited, approximately 02 December 2019, to submit pricing quotes and a separate screenshot of your submitted DAPA Log submission or existing DAPA base uncommitted pricing for all required items to the MMESO POCs. Both pricing quotes and substantiating DMS documentation will be required for eligibility to enter into an Incentive Agreement (IA) for Closed System IV Catheters. Only those vendors with an established DAPA will be eligible to enter into the subsequent IA. The Government reserves the right to standardize or not standardize on Closed System IV Catheters.

The MSPV Program requires that all items be manufactured in a Trade Agreements Act (TAA) Compliant Country (see DFARS 252.225-7020 AND 252.225-7021), unless it is determined that no functionally equivalent item is available from a compliant source. To be eligible for inclusion in the proposed QSL, all vendors are required to provide country of origin information in the QSL FBO Package Worksheet. In addition, according to the DAPA Terms and Conditions, vendors must complete the DAPA TAA Certification for each item quoted. If a quoted item is a TAA Non-Compliant End Product, the Government can use this information to determine whether or not a non-availability determination exists or if the Government will make a non-availability determination for the item. Unless a non-availability determination is made or a waiver is obtained, TAA Non-Compliant Country End Products cannot be added to the QSL and/or DAPA. Any questions concerning TAA may be directed to Donna Raday at DLA Troop Support, donna.raday@dla.mil, 215-737-7885.

A. Products & Performance Required
The MMESOs are seeking product line items in the category of Closed System IV Catheters. Within the MHS MTFs and operational procurement this product line has an estimated annual sales volume of $1,080,899. This forecast is based on historical usage data during a recent 12-month period. Ten items are required for addition to the QSL and account for 61.98% ($669,915) of the total volume in sales ($1,080,899). The specifications for this project are shown in the "Requirements to Qualify for QSL" section below.

B. Instructions to Vendors
Vendors interested in qualifying for inclusion in the QSL must respond to this QSL FBO Sources Sought notification by sending the appropriate FBO worksheet and all supporting documentation via e-mail to the lead MMESO POCs below. The vendor's submission must include all detailed information requested in the "Requirements to Qualify for QSL" section below and must also include: (1) Company name and address; (2) Company POC (Name and Phone Number, Fax Number, and E-mail address); (3) Commercial and Government Entity (CAGE) Code; (4) Identification of the Sources Sought notification to which the vendor is responding, and (5) DAPA or DMM number. Due to the potential for e-mail to be lost in transmission, from network security, etc., vendors are strongly encouraged to confirm with the lead MMESO that their e-mail submission has arrived. Each submitting vendor is advised to confirm receipt allowing adequate time for resubmission before the due date and time. As part of the "Requirements to Qualify for QSL," vendors must complete and submit the QSL FBO Package Worksheet. Any vendor experiencing difficulty opening the Worksheet may contact the MMESO POCs. The MMESO POC will provide a Worksheet copy via an alternate method (fax, e-mail or hard copy).

Vendors that do not meet the deadline of COB 5:00 PM Central Standard Time (CST) on the response date above for this QSL FBO Sources Sought notification will not be included in the lead MMESO's review to establish the QSL and thus will not be able to participate in the subsequent Standardization Action.

Requirements to Qualify for QSL

The requirements for this product line are outlined below. Complete answers and all supporting documentation must be provided with the vendor's submittal by the response date stated in this QSL FBO 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. Vendors must provide responses to this Sources Sought notification via the QSL FBO Package Worksheet.
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.
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.
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.
4. Vendor must have a government issued Commercial and Government Entity (CAGE) code assigned for products contained within the specific product group or be in the process of obtaining one. 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/portal/public/SAM/.
5. Vendor quoted products shall be TAA compliant. End-items quoted shall be manufactured or substantially transformed either in the U.S. or in Designated or Qualifying countries, unless source non-availability determination is made. Therefore, the vendor at the item level must provide country of origin for all required items and any optional items offered. Vendor must provide product catalog & literature for any items offered in response to this Sources Sought notification. Vendor must submit the following information via QSL FBO Package Worksheet for each offered product: Full item description, Distributor Part Number, Manufacturer Part Number, Manufacturer Name, Number of eaches in Unit of Sale, and country of origin. Only ONE Vendor Part Number (PN) should be provided for each item/sample. Vendor must send the same part number(s) for evaluation(s) as provided in response to this QSL FBO announcement and as noted in the QSL FBO Package Worksheet.

Required Products Annual Usage in Units
5.1 CLOSED SYSTEM IV CATHETER DUAL PORT EXTENSION TUBING NORMAL FLOW RATE 18 GAUGE BY 1.25 INCH CATHETER / 30,560 /
5.2 CLOSED SYSTEM IV CATHETER DUAL PORT EXTENSION TUBING NORMAL FLOW RATE 20 GAUGE BY 1 INCH CATHETER / 38,720 /
5.3 CLOSED SYSTEM IV CATHETER DUAL PORT EXTENSION TUBING NORMAL FLOW RATE 20 GAUGE BY 1.25 INCH CATHETER / 11,860 /
5.4 CLOSED SYSTEM IV CATHETER DUAL PORT EXTENSION TUBING NORMAL FLOW RATE 22 GAUGE BY 1 INCH CATHETER / 19,660 /
5.5 CLOSED SYSTEM IV CATHETER DUAL PORT EXTENSION TUBING NORMAL FLOW RATE 24 GAUGE BY 0.75 INCH CATHETER / 8,840 /
5.6 CLOSED SYSTEM IV CATHETER SINGLE PORT EXTENSION TUBING NORMAL FLOW RATE 18 GAUGE BY 1.25 INCH CATHETER / 3,660 /
5.7 CLOSED SYSTEM IV CATHETER SINGLE PORT EXTENSION TUBING NORMAL FLOW RATE 20 GAUGE BY 1 INCH CATHETER / 13,360 /
5.8 CLOSED SYSTEM IV CATHETER SINGLE PORT EXTENSION TUBING NORMAL FLOW RATE 20 GAUGE BY 1.25 INCH CATHETER / 1,100 /
5.9 CLOSED SYSTEM IV CATHETER SINGLE PORT EXTENSION TUBING NORMAL FLOW RATE 22 GAUGE BY 1 INCH CATHETER / 11,240 /
5.10 CLOSED SYSTEM IV CATHETER SINGLE PORT EXTENSION TUBING NORMAL FLOW RATE 24 GAUGE BY 0.75 INCH CATHETER / 2,800 /

6. Vendor must provide Closed System IV Catheters that are not made with natural rubber latex indicated in either a statement or by an accepted ISO BS EN 15223-1: 2016 symbol and provide documentation to support this with initial submittal.
7. Vendor must provide documentation that all Closed System IV Catheters have been approved by the FDA through Class II Medical Devices 510K requirements.
8. Vendor must provide Closed System IV Catheters that are individually packaged and provide documentation to support this with initial submittal.
9. Vendor must provide Closed System IV Catheters, whose packaged contents are sterile and is indicated as such on the individual product packaging; whether in printed language or by an accepted ISO BS EN ISO 15223-1: 2012 sterile symbol, and provide documentation to support this with initial submittal.
10. Vendor must provide Closed System IV Catheters that are single-use and provide documentation to support this with initial submittal.
11. Vendor must provide Closed System IV Catheters that are preassembled, ready-for-use and provide documentation to support this with initial submittal.
12. Vendor must provide Closed System IV Catheters that have an integrated extension tubing and provide documentation to support this with initial submittal.
13. Vendor must provide Closed System IV Catheters that have an integrated needle stabilization platform (e.g. Winged Hub) and provide documentation to support this with initial submittal.
14. Vendor must provide Closed System IV Catheters that have a clamp (e.g. squeeze, slide) on the integrated extension tubing and provide documentation to support this with initial submittal.
15. Vendor's single port Closed System IV Catheters must include a Luer Lock connection and provide documentation to support this with initial submittal.
16. Vendor's dual port Closed System IV Catheters must include a "split-Y" that has a Luer Lock connection on one end and needleless port connection on the other and provide documentation to support this with initial submittal.
17. Vendor must provide Closed System IV Catheters that have a transparent blood flash chamber/hub or equivalent and provide documentation to support this with initial submittal.
18. Vendor must provide Closed System IV Catheters that have individual product package labeling that indicates the needle gauge and length of catheter, Lot number and expiration date and provide documentation to support this with initial submittal.
19. Vendor must provide Closed System IV Catheters that have a minimum pressure rating of 300 psi and provide documentation to support this with initial submittal.

Vendor may provide any or all of the additional items listed below, following the same format as for requirement number 5.

Optional products
1 - CLOSED SYSTEM IV CATHETER DUAL PORT EXTENSION TUBING HIGH FLOW RATE 24 GAUGE BY 0.56 INCH CATHETER /
2 - CLOSED SYSTEM IV CATHETER DUAL PORT EXTENSION TUBING NORMAL FLOW RATE 18 GAUGE BY 1.75 INCH CATHETER /
3 - CLOSED SYSTEM IV CATHETER DUAL PORT EXTENSION TUBING NORMAL FLOW RATE 20 GAUGE BY 1.75 INCH CATHETER /
4 - CLOSED SYSTEM IV CATHETER SINGLE PORT EXTENSION TUBING HIGH FLOW RATE 18 GAUGE BY 1.25 INCH CATHETER /
5 - CLOSED SYSTEM IV CATHETER SINGLE PORT EXTENSION TUBING HIGH FLOW RATE 20 GAUGE BY 1 INCH CATHETER /
6 - CLOSED SYSTEM IV CATHETER SINGLE PORT EXTENSION TUBING HIGH FLOW RATE 20 GAUGE BY 1.25 INCH CATHETER /
7 - CLOSED SYSTEM IV CATHETER SINGLE PORT EXTENSION TUBING HIGH FLOW RATE 22 GAUGE BY 1 INCH CATHETER /
8 - CLOSED SYSTEM IV CATHETER SINGLE PORT EXTENSION TUBING HIGH FLOW RATE 24 GAUGE BY 0.56 INCH CATHETER /
9 - CLOSED SYSTEM IV CATHETER SINGLE PORT EXTENSION TUBING HIGH FLOW RATE 24 GAUGE BY 0.75 INCH CATHETER /
10 - CLOSED SYSTEM IV CATHETER SINGLE PORT EXTENSION TUBING NORMAL FLOW RATE 18 GAUGE BY 1.75 INCH CATHETER /
11 - CLOSED SYSTEM IV CATHETER SINGLE PORT EXTENSION TUBING NORMAL FLOW RATE 20 GAUGE BY 1.75 INCH CATHETER /

Evaluation

Evaluations for this product line will be done by a panel of experts as a document review.

Points of Contact (POCs):

MMESO South Team Leader Mr. David Sheaffer, 210-536-6075, david.v.sheaffer.ctr@mail.mil, and MMESO South Clinical Analyst Dr. Jim Quinn, james.e.quinn28.ctr@mail.mil, 210-536-6071. DLA Troop Support Medical Contracting Officer: Tara J. Perrien, tara.perrien@dla.mil, 215-737-8307.
Added: Jul 18, 2019 3:29 pm
The purpose of this Modification to the QSL FBO is to inform vendors on the QSL List that the Incentive Agreement FBO has now been posted. Only Vendors on the QSL for this product line can be considered for an IA. All solicitation information is available electronically on the Federal Business Opportunities website.

Solicitation External Reference:
https://www.fbo.gov/spg/DLA/J3/DSCP-M/IAS-1907-19/listing.html

Solicitation External Reference To Packages:
https://www.fbo.gov/spg/DLA/J3/DSCP-M/IAS-1907-19/packages.html
Please consult the list of document viewers if you cannot open a file.
QSL FBO Package Worksheet
Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Label:
QSL FBO Package Worksheet
Posted Date:
June 17, 2019
QSL_FBO_Package_Worksheet_MS-1902-01_Closed_System_I... (20.15 Kb)
Download/View QSL_FBO_Package_Worksheet_MS-1902-01_Closed_System_IV_Catheters_-_Vendor_Name.xlsx
Description: Complete answers and all supporting documentation must be provided with the vendor's submittal by the response date stated in the QSL FBO 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 FBO Package Worksheet.
Contracting Office Address :
700 Robbins Avenue
Philadelphia, Pennsylvania 19111-5096
United States
Place of Performance :
Medical Materiel Enterprise Standardization Offices (MMESO)
7800 IH-10 West, Suite 220
San Antonio, Texas 78230-4768
United States
Primary Point of Contact. :
Mr. David V. Sheaffer,
MMESO South Team Leader
Phone: 210-536-6075
Secondary Point of Contact :
Dr. Jim Quinn,
MMESO South Clinical Analyst
Phone: 210-536-6071
All Files
QSL FBO Package Worksheet
Jun 17, 2019
QSL_FBO_Package_Work...
Download/View QSL_FBO_Package_Worksheet_MS-1902-01_Closed_System_IV_Catheters_-_Vendor_Name.xlsx
General Information
Notice Type:
Combined Synopsis/Solicitation
Original Posted Date:
June 17, 2019
Posted Date:
July 18, 2019
Response Date:
-
Original Response Date:
Jun 27, 2019 5:00 pm Central
Archiving Policy:
Automatic, on specified date
Original Archive Date:
-
Archive Date:
July 28, 2019
Original Set Aside:
N/A
Set Aside:
N/A
Classification Code:
65 -- Medical, dental & veterinary equipment & supplies
NAICS Code:
339 -- Miscellaneous Manufacturing/339113 -- Surgical Appliance and Supplies Manufacturing

Related Document

Jun 17, 2019[Combined Synopsis/Solicitation] Closed_System_IV_Catheters

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