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 Chest Drain Valves, One-Way. This is not a request for a price quote. The MMESO South is the lead MMESO for this project.
These Chest Drain Valves, One-Way 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 DMM Online 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 Chest Drain Valves, One-Way in accordance with (IAW) FAR 9.2. The QSL for Chest Drain Valves, One-Way will be established approximately 22 December 2023 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 QSL Package 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 19 January 2024, 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 Chest Drain Valves, One-Way. 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 Chest Drain Valves, One-Way. The resulting IA will not be a contract and will not constitute a guarantee of a specific volume of sales dollars.
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 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.
NOTE: The Contracting Officer will review submissions in response to the subsequent IA for Chest Drain Valves, One-Way for country of origin purposes. Only vendors on the QSL who offer items which are US made, designated country, or qualifying country end products will be considered for an IA, unless the Contracting Officer determines that no functional equivalent item is available from a compliant source in accordance with DFARS 225.403(c)(i). Vendors are advised to keep this in mind when submitting their response to this Sources Sought notification.
A. Products & Performance Required
The MMESOs are seeking product line items in the category of Chest Drain Valves, One-Way. Within the MHS MTFs and operational procurement this product line has an estimated annual sales volume of $748,236. This forecast is a good faith estimate based on historical usage data during a recent 12-month period and does not constitute a guarantee of a specific volume of sales dollars. One item is required for addition to the QSL and account for 100% ($748,236) of the total volume in sales. The specifications for this project are shown in the “Requirements to Qualify for QSL” section below.
B. Instructions to Vendors to Qualify for the QSL
Vendors interested in qualifying for inclusion in the QSL must respond to this QSL Sources Sought notification by sending the appropriate QSL Package Worksheet and all supporting documentation via e-mail to the lead MMESO and DLA POCs below. The QSL requirements are outlined under Requirements to Qualify for QSL outlined below.
Vendors that do not meet the deadline of COB 5:00 PM local Philadelphia time for this QSL 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 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 Package Worksheet.
Technical Review
Supplier Requirements:
Required Products:
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 part 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 Products/Annual Usage in Units
5.1 CHEST DRAIN VALVES, ONE-WAY, BILATERAL CONICAL/TAPERED CONNECTORS / 14,535
6. Vendor must provide Chest Drain Valve, One-Way 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."
7. Vendor must provide Chest Drain Valve, One-Way products constructed of plastic (e.g., polypropylene) and provide documentation to support this with initial submittal.
8. Vendor must provide Chest Drain Valve, One-Way products with Instructions for Use (IFU) in each box/package and provide documentation to support this with initial submittal.
9. Vendor must provide Chest Drain Valve, One-Way products with a length of 4.00 inches – 4.75 inches (or equivalent in millimeters) and provide documentation to support this with initial submittal.
10. Vendor must provide Chest Drain Valve, One-Way products with a circumference of 2.25 inches – 3.00 inches (or equivalent in millimeters) and provide documentation to support this with initial submittal.
Vendor Instructions: In support of requirements 11 and 12, vendor must provide with initial submittal photographic images of the individual product for required item 5.1.
11. Vendor must provide Chest Drain Valve, One-Way products with ribbed proximal and distal conical/tapered connectors.
12. Vendor must provide Chest Drain Valve, One-Way products with unidirectional flow indicators (e.g., arrows, color coded connectors, etc.).
Vendor Instructions: In support of requirement 13, vendor must provide with initial submittal photographic images of the individual packaging for required item 5.1. Photographic images of non-part number graphic templates of product labeling are not acceptable supporting documentation.
13. Vendor must provide Chest Drain Valve, One-Way products with the following information on the individual product packaging:
a. Product description
b. Part number/Reference number
c. Expiration date as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 use-by date symbol
d. Lot number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 lot symbol
e. Single-use as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 single-use symbol
f. Sterile as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 sterile symbol.
Evaluation
Evaluations for this product line will be done by a panel of experts as a technical review to determine which vendors meet the requirements. Vendors who provide all requested information and meet the requirements will be selected for inclusion on the QSL. Vendors will be notified of whether they met or did not meet the QSL requirements by approximately 22 December 2023.
RESPONSE INFORMATION:
Responses to this QSL Announcement must be submitted via email to the MMESO Clinical Analyst, MMESO Team Lead, and DLA KO listed below.
Vendor questions regarding this QSL Announcement are due no later than 5:00 pm local Philadelphia time 2 business days before solicitation closes. Vendor responses to this QSL Announcement are due no later than 5:00 pm local Philadelphia time on 02 November 2023.
All vendor correspondence should be emailed to all of the following:
Mr. Elbridge (Eb) Merritt
MMESO South Clinical Analyst Contractor
Mr. David Sheaffer
MMESO South Team Leader Contractor
Ms. Tara Perrien
DLA Troop Support Medical Contracting Officer
The Contracting Officer will address any issues/questions pertaining to Incentive Agreements, TAA questions, and extension requests.