Syringes with Permanently Attached Safety Needles

Active

Contract Opportunity

The Defense Health Agency (DHA) Medical Logistics (MEDLOG) Directorate 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 Syringes with Permanently Attached Safety Needles. This is not a request for a price quote.

These Syringes with Permanently Attached Safety Needles 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 Syringes with Permanently Attached Safety Needles in accordance with (IAW) FAR 9.2. The QSL for Syringes with Permanently Attached Safety Needles will be established approximately 12 December 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 16 January 2025, 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 Syringes with Permanently Attached Safety Needles. 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 Syringes with Permanently Attached Safety Needles. 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 Syringes with Permanently Attached Safety Needles 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 Syringes with Permanently Attached Safety Needles. Within the MHS MTFs and operational procurement this product line has an estimated annual sales volume of $268,297. 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. Six items are required for addition to the QSL and account for 100% of the total volume in sales $268,297. 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.

1. Vendor must complete the QSL Package Worksheet in full and submit it 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.


2. Only ONE Manufacturer Part Number may be provided for each product description listed in Requirement 5 per submitted response.


3. Vendors may provide multiple responses/submissions to the QSL Source Sought notification.


4. Vendor must offer commercially available products for all items offered in response to this Sources Sought notification.


5. 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.).


6. Due to the potential for e-mail to be lost in transmission, from network security, etc., vendors are strongly encouraged to confirm with the MMESO POCs 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.


7. Any vendor experiencing difficulty opening the Worksheet may contact the MMESO POCs. The MMESO POC will provide a Worksheet copy via e-mail.

Instructions for Submitting Product Samples.

1. Vendor must send the same part number(s) for validation and/or evaluation(s) as provided in response to this QSL Source Sought notification and as noted in the QSL Response Worksheet.


2. The Vendor submissions must submit the specified quantity of each product.


3. The Vendor is required to ship products to the MMESO POCs by the date and time stated on the QSL Sources Sought notification.


4. “Ship to” addresses and deadlines for shipping and receiving samples are outlined under Evaluation below. The Vendor is required to ship samples to all required evaluation locations. The Vendor may ship by the Vendor’s preferred shipment method to CONUS MTFs.


5. Products received after the stated date and time will not be included in the evaluation for addition to the QSL nor will these products participate in the subsequent Standardization Action.


6. The late arrival products will be destroyed upon receipt.

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 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 Product(s), Annual Usage in Units, and Samples Required for Evaluation(Qty required)

5.1 SYRINGE WITH PERMANENTLY ATTACHED SAFETY NEEDLE, STERILE, 1 ML VOLUME, 27 GAUGE X 1/2 INCH LONG NEEDLE / 190,672 - 1 box of product samples

5.2 SYRINGE WITH PERMANENTLY ATTACHED SAFETY NEEDLE, STERILE, 1 ML VOLUME, 25 GAUGE X 5/8 INCH LONG NEEDLE / 112,900

5.3 SYRINGE WITH PERMANENTLY ATTACHED SAFETY NEEDLE, STERILE, 1 ML VOLUME, 25 GAUGE X 1 INCH LONG NEEDLE / 76,800

5.4 SYRINGE WITH PERMANENTLY ATTACHED SAFETY NEEDLE, STERILE, 3 ML VOLUME, 25 GAUGE X 5/8 INCH LONG NEEDLE / 78,300

5.5 SYRINGE WITH PERMANENTLY ATTACHED SAFETY NEEDLE, STERILE, 3 ML VOLUME, 25 GAUGE X 1 INCH LONG NEEDLE / 117,200

5.6 SYRINGE WITH PERMANENTLY ATTACHED SAFETY NEEDLE, STERILE, 3 ML VOLUME, 23 GAUGE X 1 INCH LONG NEEDLE / 420,200 - 1 box of product samples

6. Vendor must provide Syringes with Permanently Attached Safety Needles 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 Syringes with Permanently Attached Safety Needles products that are cleared by the FDA and comply with FDA General Controls and must submit supporting documentation with initial submittal that includes FDA Establishment Registration, Medical Device listing, and 510(k)

8. Vendor must provide Syringes with Permanently Attached Safety Needles products with the following characteristics and provide documentation to support this with initial submittal:

a. Stainless steel needles, for medical use, in accordance with ISO 9626:2016

b. Plastic syringe barrels and plungers

c. Color coded syringes in accordance with ISO 6009:2016

d. Graduation markings on the barrel, for Required Items 5.1-5.3, in 0.01 mL or cc increments

e. Graduation markings on the barrel, for Required Items 5.4-5.6, in 0.1 mL or cc increment

9. Vendor must provide Syringes with Permanently Attached Safety Needles products with documentation upon initial submittal stating they provide training materials in the form of, but is not limited to: DVD, web-based training and/or materials or written materials (i.e. user manual, package inserts and literature).

Technical Review with Product Sample Validation:

Vendor Instructions in support of requirements 10 and 11: with initial submittal vendor must provide one box each of product samples for Required Items 5.1 and 5.6, Instructions for Use (in print or digitally accessible), and a signed letter of attestation stating the offered products for Required Items 5.2 -5.5 meet requirements 10 and 11.

10. Vendor must provide Syringes with Permanently Attached Safety Needles products with individual packaging that includes the following information:

a. Expiration date as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 use-by date symbol

b. Lot number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 lot symbol

c. Single-use as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 single-use symbol

d. Sterile as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 Sterile symbol

e. Syringe volume indicated in milliliter (ML) or cubic centimeter (CC)

f. Needle internal diameter indicated in gauge (G)

g. Needle length indicated in inches (IN)

11. Vendor must provide Syringes with Permanently Attached Safety Needles products with a safety mechanism which activates in accordance with the Manufacturer’s Instructions for Use; a single-handed activation of the safety mechanism preventing exposure to contamination and rendering the needle permanently non-usable. Vendor provided product samples and Instructions for Use will be used for validation of the product safety mechanism.

Evaluation

Technical Review with Product Sample Validation

To ensure your eligibility to participate, you must provide tracking information for products required for evaluation to MMESO POCs by the close date of this QSL Announcement and products must arrive at addresses below no later than 5:00 PM local time at delivery location, 5 calendar days from the close date of the QSL Announcement.

The products will be provided at no cost to the government for products or delivery, and unused products will not be returned. Vendors are to provide 1 box each of the commercially packaged products as identified above and one manufacturer’s instructions to the evaluation site (identified below) as requested by the MMESO. Vendor will be required to supply the same part number(s) submitted in the QSL Package Worksheet.

Products received after the stated date and time will not be included in review to establish the QSL nor will these products participate in the subsequent Standardization Action. Products arriving after stated deadline will be destroyed upon receipt.

Please complete the checklist below, to ensure your eligibility to participate in the product evaluations:

☐ The tracking number(s) and the carriers used must be provided to MMESO POCs by the close date of this QSL Announcement, 21 November 2024.

☐ The deadline for product delivery (see addresses below) is 5 days after the close date of this QSL Announcement, 26 November 2024, no later than 5:00 PM local time.

☐ Your company is required to send the same part number(s), as provided in the response to the QSL Announcement, and as noted in the QSL Package Worksheet

Your company representatives will:

• Not be required for in-servicing prior to, or during the evaluations


• Not be allowed to be present during the actual evaluation process of their products or their competitors’ products


• Not be allowed to speak to any hospital staff member regarding the product evaluation, product pricing or price-related factors

Your company representatives who speak or attempt to speak to hospital staff members regarding the product evaluations, pricing, or price related factors will not be eligible for this evaluation process.

• The vendor may select the shipping method for the evaluation sites that are CONUS

Evaluation Site for Technical Review with Product Sample Validation and E-mail

Mailing Address for Product Samples

FORT DETRICK

CPT Mellisa Barnswell

693 Neiman Street, 3rd Floor

Ft Detrick, MD 21702

ATTN: DHA MEDLOG MMESO CPT Barnswell/ Ms. Kathleen Harne

(Standardization Evaluation Samples)

E-mail information: mellisa.t.barnswell.mil@health.mil

kathleen.m.harne.ctr@health.mil

Evaluations for this product line will be done by a panel of experts as a technical review with product sample validation 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 12 December 2024.

RESPONSE INFORMATION:

Responses to this QSL Announcement must be submitted via email to the MMESO Clinical Analyst, MMESO Project Manager, 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 21 November 2024.

All vendor correspondence should be emailed to all of the following:

Ms. Kathleen Harne

Lead MMESO Clinical Analyst Contractor

kathleen.m.harne.ctr@health.mil

Mr. David Sheaffer

MMESO Project Manager Contractor

David.v.sheaffer.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.

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