SAMDaily.us | PRESOL | 65 | SURGICAL MESH, SYNTHETIC, SELF-FIXATING

SAMDAILY.US - ISSUE OF DECEMBER 10, 2023 SAM #8048
SOLICITATION NOTICE

65 -- SURGICAL MESH, SYNTHETIC, SELF-FIXATING

Notice Date: 12/8/2023 4:45:58 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-2211-03
Response Due: 11/2/2023 2:00:00 PM
Archive Date: 12/17/2023
Point of Contact: MMESO West Clinical Analyst Contractor Mr. Riley Whittlesey, MMESO West Team Leader Contractor Ms. Gabrielle Burns
E-Mail Address: riley.w.whittlesey.ctr@health.mil, gabrielle.m.burns2.ctr@mail.mil
(riley.w.whittlesey.ctr@health.mil, gabrielle.m.burns2.ctr@mail.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 Surgical Mesh, Synthetic, Self-Fixating. This is not a request for a price quote. The MMESO West is the lead MMESO for this project. These Surgical Mesh, Synthetic, Self-Fixating 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 Surgical Mesh, Synthetic, Self-Fixating in accordance with (IAW) FAR 9.2. The QSL for Surgical Mesh, Synthetic, Self-Fixating 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 Surgical Mesh, Synthetic, Self-Fixating. 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 Surgical Mesh, Synthetic, Self-Fixating. 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 Surgical Mesh, Synthetic, Self-Fixating 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 Surgical Mesh, Synthetic, Self-Fixating. Within the MHS MTFs and operational procurement this product line has an estimated annual sales volume of $869,004.23. 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. Thirteen items are required for addition to the QSL and account for 95.4% ($829,368) of the total volume in sales $869,004.23. 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: � 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. 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 SURGICAL MESH, SYNTHETIC, SELF FIXATING, POLYESTER, RECTANGLE, LEFT ANATOMICAL ORIENTED, 10 CM X 15 CM /352 5.2 SURGICAL MESH, SYNTHETIC, SELF FIXATING, POLYESTER, RECTANGLE, RIGHT ANATOMICAL ORIENTED, 10 CM X 15 CM /�371 5.3 SURGICAL MESH, SYNTHETIC, SELF FIXATING, POLYESTER, RECTANGLE, (1) RIGHT ANATOMICAL ORIENTED AND (1) LEFT ANATOMICAL ORIENTED, 10 CM X 15 CM /�50 5.4 SURGICAL MESH, SYNTHETIC, SELF FIXATING, POLYESTER, RECTANGLE, NON-ANATOMICAL ORIENTED, 10 CM X 15 CM /�379 5.5 SURGICAL MESH, SYNTHETIC, SELF FIXATING, POLYESTER, (2) RECTANGLE, NON-ANATOMICAL ORIENTED, 10 CM X 15 CM /�24 5.6 SURGICAL MESH, SYNTHETIC, SELF FIXATING, POLYESTER, RECTANGLE, NON-ANATOMICAL ORIENTED, 12 CM X 16 CM /�83 5.7 SURGICAL MESH, SYNTHETIC, SELF FIXATING, POLYESTER, ELLIPTICAL, RIGHT ANATOMICAL ORIENTED, PRE-CUT WITH FLAP, 12 CM X 8 CM /�167 5.8 SURGICAL MESH, SYNTHETIC, SELF FIXATING, POLYESTER, ELLIPTICAL, LEFT ANATOMICAL ORIENTED, PRE-CUT WITH FLAP, 12 CM X 8 CM /�142 5.9 SURGICAL MESH, SYNTHETIC, SELF FIXATING, POLYESTER, ELLIPTICAL, RIGHT ANATOMICAL ORIENTED, PRE-CUT WITH FLAP, 9 CM X 14 CM /�31 5.10 SURGICAL MESH, SYNTHETIC, SELF FIXATING, POLYESTER, ELLIPTICAL, LEFT ANATOMICAL ORIENTED, PRE-CUT WITH FLAP, 9 CM X 14 CM /�38 5.11 SURGICAL MESH, SYNTHETIC, SELF FIXATING, POLYESTER, RECTANGLE, NON-ANATOMICAL ORIENTED, 9 CM X 15 CM /�79 5.12 SURGICAL MESH, SYNTHETIC, SELF FIXATING, POLYESTER, SQUARE, NON-ANATOMICAL ORIENTED, 15 CM X 15 CM /�77 5.13 SURGICAL MESH, SYNTHETIC, SELF FIXATING, POLYESTER, RECTANGLE, NON-ANATOMICAL ORIENTED, 15 CM X 20 CM /�34 6. Vendor must provide Surgical Mesh, Synthetic, Self-Fixating products that are latex free and provide documentation to support this with initial submittal. 7. Vendor must provide Surgical Mesh, Synthetic, Self-Fixating products that are cleared by the FDA and provide the FDA 510(k) to support this with initial submittal. 8. Vendor must provide Surgical Mesh, Synthetic, Self-Fixating products with resorbable polylactic acid (PLA) grips and provide documentation to support this with initial submittal. 9. Vendor must provide Surgical Mesh, Synthetic, Self-Fixating products that are macroporous and provide documentation to support this with initial submittal. 10. Vendor must provide Surgical Mesh, Synthetic, Self-Fixating products that are tailorable (trim to size) and provide documentation to support this with initial submittal. Vendor Instructions: Vendors must provide with initial submittal in support of requirements 11, 12, and 13 documentation that includes a list of part numbers for required items stating the offered products are all packaged and labeled in the same manner. 11. Vendor must provide Surgical Mesh, Synthetic, Self-Fixating products with an Instructions for Use (IFU) packaged with each individual product. 12. Vendor must provide Surgical Mesh, Synthetic, Self-Fixating products with individual packaging that includes the following information: a. Size b. Image of product shape c. Reference number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 reference number symbol d. Lot number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 lot number 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 g. Sterile as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 sterile symbol h. Unique Device Identification (UDI) information. 13. Vendor must provide individually packaged Surgical Mesh, Synthetic, Self-Fixating products that contain at a minimum four (4) product identification stickers with the following information listed on each sticker: a. Product Name b. Reference number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 reference number symbol c. Lot number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 lot number symbol d. Expiration date as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 use-by date symbol. Vendor Instructions: Vendor MAY provide any or all of the optional items listed below, following the same format as for requirement number 5. Vendor must provide a letter of attestation, INCLUDING a list of part numbers for the submitted optional items, stating that the offered products meet requirements 6-13. Optional Products 1. SURGICAL MESH, SYNTHETIC, SELF FIXATING, POLYESTER, RECTANGLE, RIGHT ANATOMICAL ORIENTED, 12 CM X 16 CM 2. SURGICAL MESH, SYNTHETIC, SELF FIXATING, POLYESTER, RECTANGLE, LEFT ANATOMICAL ORIENTED, 12 CM X 16 CM 3. SURGICAL MESH, SYNTHETIC, SELF FIXATING, POLYESTER, RECTANGLE, NON-ANATOMICAL ORIENTED, 15 CM X 30 CM 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. Riley Whittlesey Lead MMESO West Clinical Analyst Contractor riley.w.whittlesey.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/4f3da9cad6ff49d18e9320395a408078/view)
Place of Performance: Address: Frederick, MD 21702, USA; Zip Code: 21702; Country: USA
Record: SN06907203-F 20231210/231208230427 (samdaily.us)
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65 -- SURGICAL MESH, SYNTHETIC, SELF-FIXATING