Inactive

This QSL Announcement is cancelled. A new QSL Announcement is now active under MN-2001-07 Needles, Hypodermic with Safety Feature, on this website. The Defense Health Agency (DHA) Medical Logistics (M... This QSL Announcement is cancelled. A new QSL Announcement is now active under MN-2001-07 Needles, Hypodermic with Safety Feature, on this website. 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 Needles, Hypodermic with Safety Feature. This is not a request for a price quote. The MMESO North is the lead MMESO for this project. These Needles, Hypodermic with Safety Feature 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 Needles, Hypodermic with Safety Feature in accordance with (IAW) FAR 9.2. The QSL for Needles, Hypodermic with Safety Feature will be established approximately 07 March 2020 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 07 April 2020, 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 Needles, Hypodermic with Safety Feature. 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 Needles, Hypodermic with Safety Feature. 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. 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 Needles, Hypodermic with Safety Feature. Within the MHS MTFs and operational procurement this product line has an estimated annual sales volume of $2,239,691. This forecast is based on historical usage data during a recent 12-month period. Eleven items are required for addition to the QSL and account for 98.62 % ($2,208,837) of the total volume in sales ($2,239,691). 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 Sources Sought notification by sending the appropriate QSL Package 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 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 Eastern Standard Time (EST) on the response date above 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. 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 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 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 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/. 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 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 Announcement and as noted in the QSL Package Worksheet. Required Products / Annual Usage in Units / 5.1 - NEEDLE, HYPODERMIC WITH SAFETY FEATURE 18 G X 1.5 INCH / 1,364,500 / 5.2 - NEEDLE, HYPODERMIC WITH SAFETY FEATURE 20 G X 1.5 INCH / 129,750 / 5.3 - NEEDLE, HYPODERMIC WITH SAFETY FEATURE 21 G X 1.0 INCH / 108,500 / 5.4 - NEEDLE, HYPODERMIC WITH SAFETY FEATURE 21 G X 1.5 INCH / 609,500 / 5.5 - NEEDLE, HYPODERMIC WITH SAFETY FEATURE 22 G X 1.0 INCH / 291,053 / 5.6 - NEEDLE, HYPODERMIC WITH SAFETY FEATURE 22 G X 1.5 INCH / 331,750 / 5.7 - NEEDLE, HYPODERMIC WITH SAFETY FEATURE 23 G X 1.0 INCH / 3,387,900 / 5.8 - NEEDLE, HYPODERMIC WITH SAFETY FEATURE 25 G X 1.0 INCH / 2,410,550 / 5.9 - NEEDLE, HYPODERMIC WITH SAFETY FEATURE 25 G X 1.5 INCH / 217,400 / 5.10 - NEEDLE, HYPODERMIC WITH SAFETY FEATURE 25 G X 5/8 INCH / 1,164,900 / 5.11 - NEEDLE, HYPODERMIC WITH SAFETY FEATURE 27 G X 0.5 INCH / 57,200 / Vendor must provide Needles, Hypodermic with Safety Feature 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 for the offered products contains the FDA recommended statement "Not made with natural rubber latex," 2) demonstrating that the ISO BS EN 15223-1:2016 symbol [reference number 5.4.5] is on the labeling for the offered products, or 3) if the product labeling does not contain the FDA recommended statement or the ISO BS EN 15223-1:2016 symbol [reference number 5.4.5], the vendor must provide a signed letter stating that the offered products are "not made with natural rubber latex." Vendor must provide Needles, Hypodermic with Safety Feature products cleared via FDA 510(k) submission and provide the FDA 510(k) document to support this with initial submittal. Vendor must provide Needles, Hypodermic with Safety Feature products that are sterile and indicated as such in a statement or with the appropriate ISO BS EN 15223-1:2016 symbol [reference number 5.2] and provide documentation to support this with initial submittal. Vendor must provide Needles, Hypodermic with Safety Feature products that are single use and indicated as such in a statement or with the ISO BS EN 15223-1:2016 symbol [reference number 5.4.2] and provide documentation to support this with initial submittal. Vendors must provide Needles, Hypodermic with Safety Feature products with the needle gauge and length indicated on the individual product packaging and provide documentation to support this with initial submittal. Vendor must provide Needles, Hypodermic with Safety Feature products that are color coded according to ISO 6009:2016 and provide documentation to support this with initial submittal. Vendor must provide Needles, Hypodermic with Safety Feature products made with medical grade stainless steel and provide documentation to support this with initial submittal. Vendor must provide Needles, Hypodermic with Safety Feature products that are compatible with syringes having 6 % Luer conical fitting and provide documentation to support this with initial submittal. Vendor’s Hypodermic Safety Needles must include an integrated safety feature that once activated irreversibly shields the needle, and provide documentation to support this with initial submittal. Vendor must provide documentation with initial submittal stating they agree to provide in-service training in a method(s) required by the government. The government may require any of the following training method(s): in-person training sessions, DVD, web-based training and/or materials or written materials (i.e. user manual, package inserts and literature). Vendor may provide any or all of the additional items listed below, following the same format as for requirement number 5. OPTIONAL ITEMS / NEEDLE, HYPODERMIC WITH SAFETY FEATURE 18 G X 1.0 INCH / NEEDLE, HYPODERMIC WITH SAFETY FEATURE 23 G X 5/8 INCH / Evaluation Evaluations for this product line will be done by a panel of experts as a document review. Points of Contact (POCs): MMESO North Team Leader Contractor Ms. Vivian Alexander, 571-231-5451, vivian.r.alexander.ctr@mail.mil and MMESO North Clinical Analyst Contractor Mr. Harris Satari, harris.satari.ctr@mail.mil, 571-231-5456. DLA Troop Support Medical Contracting Officer: Tara J. Perrien, tara.perrien@dla.mil, 215-737-8307. This QSL Announcement is cancelled. A new QSL Announcement is now active under MN-2001-07 Needles, Hypodermic with Safety Feature, on this website.