Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF JULY 20, 2024 SAM #8271
SOLICITATION NOTICE

65 -- CHEST SEALS, NON-VENTED

Notice Date

7/18/2024 10:24:06 AM
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

339113 — Surgical Appliance and Supplies Manufacturing
 

Contracting Office

DLA TROOP SUPPORT PHILADELPHIA PA 19111 USA
 

ZIP Code

19111
 

Solicitation Number

MW-2404-19
 

Response Due

8/8/2024 2:00:00 PM
 

Archive Date

01/18/2025
 

Point of Contact

MMESO Pacific Clinical Analyst Contractor Ms. Tammie Morton, MMESO West Team Leader Contractor Ms. Gabrielle Burns
 

E-Mail Address

tammie.w.morton.ctr@health.mil, gabrielle.m.burns2.ctr@health.mil
(tammie.w.morton.ctr@health.mil, gabrielle.m.burns2.ctr@health.mil)
 

Description

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 Seals, Non-Vented. This is not a request for a price quote. The MMESO West is the lead MMESO for this project. These Chest Seals, Non-Vented 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 Seals, Non-Vented in accordance with (IAW) FAR 9.2. The QSL for Chest Seals, Non-Vented will be established approximately 10 October 2024 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 08 November 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 Seals, Non-Vented. 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 Seals, Non-Vented. 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 Seals, Non-Vented 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 Seals, Non-Vented. Within the MHS MTFs and operational procurement this product line has an estimated annual sales volume of $807,629. 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 38.8% ($313,551) of the total volume in sales $807,629. 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. Vendor must complete the QSL Package Worksheet in full to the MMESO POCs and DLA POC as listed in the QSL Source Sought notification by the above response date. 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. Only ONE Manufacturer Part Number may be provided for each product description listed in Requirement 5 per submitted response. Vendors may provide multiple responses/submissions to the QSL Source Sought notification. Vendor must offer commercially available products for all items offered in response to this Sources Sought notification. Supporting documentation must be in form of commercially available catalogs and product literature (e.g. brochures, user manuals, product packaging, product specification sheets, product images, etc.).� 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. 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 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: � 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. 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/. 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 SEAL, NON-VENTED (OCCLUSIVE DRESSING), 1 PER PACK / 34,551 6. Vendor must provide Chest Seals, Non-Vented 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 Seals, Non-Vented products with hydrogel adhesive that adheres to the wound area in the presence of fluids, e.g., blood and/or sweat and provide documentation to support this with initial submittal. 8. Vendor must provide Chest Seals, Non-Vented products with a tab(s) designed to aid in placement during low light visibility situations, e.g., visual differences (such as color contrast, printing on the tab, etc.) and/or tactile surface differences (use of tape, textured surface, etc.) and provide documentation to support this with initial submittal. 9. Vendor must provide Chest Seals, Non-Vented products with tear notches on the package and provide documentation to support this with initial submittal. 10. Vendor must provide Chest Seals, Non-Vented products with a minimum shelf life of five (5) years and provide documentation to support this with initial submittal. 11. Vendor must provide Chest Seals, Non-Vented products that have instructions/directions for use printed on the individual package and provide documentation to support this with initial submittal. Vendor Instructions: In support of requirement 12, vendor must provide with initial submittal photographic images or other documentation (i.e., brochure or catalog pictures) of the individual product packaging for the required item. Photographic images of graphic templates of product labeling are not acceptable supporting documentation. 12. Vendor must provide Chest Seals, Non-Vented required products with individual packaging that includes the following information: a.� Product identification and/or intended use as a Chest Seal and/or an occlusive dressing. b. Expiration�date as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 use-by date symbol. c. Lot�number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 lot symbol. d. Quantity�of chest seals in the package as indicated by a number or the term (e.g., �individual� or �one�). e. Single use as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 lot symbol. 13. Vendor must provide Chest Seals, Non-Vented products that meet FDA General Controls and Special Controls as applicable and must submit supporting documentation with initial submittal to include FDA Establishment Registration, Medical Device listing, and 510(k) as applicable. Vendor Instructions: Vendor MAY provide the optional item listed below, following the same format as for requirement number 5. Vendor must provide a letter of attestation, INCLUDING the part number for the submitted optional item, stating that the offered product meets requirements 6-13. Optional Product CHEST SEALS, NON-VENTED (OCCLUSIVE DRESSING), 2 PER PACK 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 08 October 2024. 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 08 August 2024. All vendor correspondence should be emailed to all of the following: Ms. Tammie Morton Lead MMESO West Clinical Analyst Contractor tammie.w.morton.ctr@health.mil Ms. Gabrielle Burns Lead MMESO West Team Leader Contractor gabrielle.m.burns2.ctr@health.mil Ms. Tara Perrien DLA Troop Support Medical Contracting Officer tara.perrien@dla.mil The Contracting Officer will address any issues/questions pertaining to Incentive Agreements, TAA questions, and extension requests.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/62d176f95e2a4d95ae628bf26460e0ef/view)
 

Place of Performance

Address: Frederick, MD 21702, USA

Zip Code: 21702

Country: USA
 

Record

SN07134944-F 20240720/240718230122 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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