SAMDaily.us | PRESOL | 65 | Tracheostomy Tubes

SAMDAILY.US - ISSUE OF JULY 13, 2024 SAM #8264
SOLICITATION NOTICE

65 -- Tracheostomy Tubes

Notice Date: 7/11/2024 4:18:27 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: MS-2401-03
Response Due: 8/1/2024 2:00:00 PM
Archive Date: 01/11/2025
Point of Contact: Mr. Elbridge Merritt, MMESO South Clinical Analyst Contractor, Moises Soto
E-Mail Address: elbridge.a.merritt.ctr@mail.mil, moises.soto1.ctr@health.mil
(elbridge.a.merritt.ctr@mail.mil, moises.soto1.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 Tracheostomy Tubes. This is not a request for a price quote. The MMESO South is the lead MMESO for this project. These Tracheostomy Tubes 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 to create a QSL for Tracheostomy Tubes in accordance with (IAW) FAR 9.2. The QSL for Tracheostomy Tubes will be established approximately 01 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, 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 01 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 Tracheostomy Tubes. 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 Tracheostomy Tubes. 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 Tracheostomy Tubes 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 Tracheostomy Tubes. Within the MHS MTFs and operational procurement this product line has an estimated annual sales volume of $142,507. 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. Twenty-one items are required for addition to the QSL and account for 100% of the total volume in sales $142,507. The specifications for this project are shown in the �Requirements to Qualify for QSL� section below. 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 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 ITEMS / Annual usage in units 5.1� TRACHEOSTOMY TUBE, 62 MM TO 65 MM LONG, DISPOSABLE 6.0 MM TO 6.5 MM INNER CANNULA SET, CUFFED, PVC / 316 5.2� TRACHEOSTOMY TUBE, 68 MM TO 70 MM LONG, DISPOSABLE 7.0 MM INNER CANNULA SET, CUFFED, PVC / 60 5.3� TRACHEOSTOMY TUBE, 73 MM TO 74 MM LONG, DISPOSABLE 7.5 MM INNER CANNULA SET, CUFFED, PVC / 690 5.4� TRACHEOSTOMY TUBE, 75 MM TO 77 MM LONG, DISPOSABLE 8.0 MM INNER CANNULA SET, CUFFED, PVC / 64 5.5� TRACHEOSTOMY TUBE, 78 MM TO 79 MM LONG, DISPOSABLE 8.5 MM INNER CANNULA SET, CUFFED, PVC / 532 5.6� TRACHEOSTOMY TUBE, 79� MM TO 81 MM LONG, DISPOSABLE 9.0 MM INNER CANNULA SET, CUFFED, PVC / 35 5.7� TRACHEOSTOMY TUBE, 79 MM BY 88 MM LONG, DISPOSABLE 10.0 MM INNER CANNULA SET, CUFFED, PVC / 67 5.8� TRACHEOSTOMY TUBE, 62 MM TO 65 MM LONG, DISPOSABLE 6.0 MM TO 6.5 MM INNER CANNULA SET, UNCUFFED, PVC / 98 5.9� TRACHEOSTOMY TUBE, 68 MM TO 70 MM LONG, DISPOSABLE 7.0 MM INNER CANNULA SET, UNCUFFED, PVC / 11 5.10� TRACHEOSTOMY TUBE, 73 MM TO 74 MM LONG, DISPOSABLE 7.5 MM INNER CANNULA SET, UNCUFFED, PVC / 211 5.11� TRACHEOSTOMY TUBE, 75 MM TO 77 MM LONG, DISPOSABLE 8.0 MM INNER CANNULA SET, UNCUFFED, PVC / 38 5.12� TRACHEOSTOMY TUBE, 78 MM TO 79 MM LONG, DISPOSABLE 8.5 MM INNER CANNULA SET, UNCUFFED, PVC / 61 5.13� TRACHEOSTOMY TUBE, 79� MM TO 81 MM LONG, DISPOSABLE 9.0 MM INNER CANNULA SET, UNCUFFED, PVC / 10 5.14� TRACHEOSTOMY TUBE, 79 MM BY 88 MM LONG, DISPOSABLE 10.0 MM INNER CANNULA SET, UNCUFFED, PVC / 21 5.15� TRACHEOSTOMY TUBE, INNER CANNULA, DISPOSABLE 6.0 MM TO 6.5 MM, PVC / 200 5.16� TRACHEOSTOMY TUBE, INNER CANNULA, DISPOSABLE 7.0 MM, PVC / 90 5.17� TRACHEOSTOMY TUBE, INNER CANNULA, DISPOSABLE 7.5 MM, PVC / 2085 5.18� TRACHEOSTOMY TUBE, INNER CANNULA, DISPOSABLE 8.0 MM, PVC / 270 5.19� TRACHEOSTOMY TUBE, INNER CANNULA, DISPOSABLE 8.5 MM, PVC / 1030 5.20� TRACHEOSTOMY TUBE, INNER CANNULA, DISPOSABLE 9.0 MM, PVC / 160 5.21� TRACHEOSTOMY TUBE, INNER CANNULA, DISPOSABLE 10.0 MM, PVC / 630 6. Vendor must provide Tracheostomy Tube 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 Tracheostomy Tube products that are cleared by the FDA and provide the FDA 510(k) with products listed by manufacturer to support this with initial submittal. 8. Vendor must provide Tracheostomy Tube products that are not made with Di (2-ethylhexyl) phthalate (DEHP) and provide submittal documentation establishing that the offered products are not made with DEHP. The vendor must meet this requirement in one of two ways: 1) demonstrating that the labeling or product information for the offered products contains the statement ""Not made with DEHP,"" or 2) if the labeling or product information does not contain the statement, the vendor must provide a signed letter stating that the offered products are ""Not made with DEHP.� 9. Vendor must provide Tracheostomy Tube products that have an integrated 15mm male conical connector on the proximal end of the Tracheostomy tube and provide documentation to support with initial submittal. 10. Vendor must provide Tracheostomy Tube products with the following information identified on the proximal end (flange) of the Tracheostomy Tube and provide documentation to support this with initial submittal: �� a. Manufacturer and/or Product name � � � � �b. Size (i.e., dimensional information (in mm) to include inner diameter (ID), outer diameter (OD)) �� c. Color coded sizing indicator 11. Vendor must provide Tracheostomy Tube products that contain Instructions for Use (IFU) and� �� provide documentation to support this with initial submittal. 12. Vendor must provide Tracheostomy Tube products that contain Magnetic Resonance Imaging� �� (MRI) safety labeling and/or instructions and provide documentation to support this with initial �� submittal. Vendor Instructions: In support of Requirements 13a-e and 14a-h, vendor must provide with initial submittal photographic images of the individual product packaging for submitted Required Products 5.3, 5.8 and 5.17. Photographic images of non-part number products and graphic templates of product labeling are not acceptable supporting documentation. Vendor must provide a letter of attestation, including a list of part numbers for the required items 5.1 � 5.2, 5.4 � 5.7, 5.9 � 5.16, and 5.18 � 5.21, stating that the offered products meet requirements #13a-e and 14a-h.� 13. Vendor must provide Tracheostomy Tube products with individual outer packaging that includes �� the following information: �� a. Manufacturer and product name �� b. Part / reference number �� c. Size (i.e., in mm and/or color-coded indicator) �� d. Lot number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 lot symbol �� e. Expiration date as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 use-by date symbol �14. Vendor must provide Tracheostomy Tube products with individual inner packaging that includes �� the following information: �� a.�� Manufacturer and product name �� b.�� Part / reference number �� c.�� Size (i.e., in mm and/or color coded indicator) �� d.�� Lot number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 lot symbol �� e.�� Expiration date as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 use-by date symbol �� f.�� Single-use as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 �� single-use symbol, unless otherwise indicated in the product description �� g.�� Sterile as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 sterile symbol �� h.�� Packaging that facilitates aseptic presentation to a sterile field (e.g., peel package) 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 01 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 01 August 2024. All vendor correspondence should be emailed to all of the following: Mr. Elbridge (Eb) Merritt Lead MMESO DHA Clinical Analyst Contractor Elbridge.a.merritt@health.mil Mr. Moises Soto Lead MMESO DHA Team Leader Contractor moises.soto1.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/8460c98b2e994f6398f3e768fbd89796/view)
Place of Performance: Address: Frederick, MD 21702, USA; Zip Code: 21702; Country: USA
Record: SN07125543-F 20240713/240711230122 (samdaily.us)
Source: SAM.gov Link to This Notice
(may not be valid after Archive Date)

| FSG Index | This Issue's Index | Today's SAM Daily Index Page |

Loren Data's SAM Daily™

65 -- Tracheostomy Tubes