SAMDaily.us | PRESOL | 65 | Urine Specimen Collection and Transfer Products

SAMDAILY.US - ISSUE OF DECEMBER 03, 2020 SAM #6944
SOLICITATION NOTICE

65 -- Urine Specimen Collection and Transfer Products

Notice Date: 12/1/2020 12:45:39 PM
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: MN-2003-20
Response Due: 12/16/2020 2:00:00 PM
Archive Date: 12/20/2021
Point of Contact: Ms. Vivian Alexander, Phone: 5712315451, Mr. Harris Satari, Phone: 5712315456
E-Mail Address: vivian.r.alexander.ctr@mail.mil, harris.satari.ctr@mail.mil
(vivian.r.alexander.ctr@mail.mil, harris.satari.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 Urine Specimen Collection and Transfer Products. This is not a request for a price quote. The MMESO North is the lead MMESO for this project. These Urine Specimen Collection and Transfer 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 Medicalï¿½s 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 Urine Specimen Collection and Transfer Products in accordance with (IAW) FAR 9.2. The QSL for Urine Specimen Collection and Transfer Products will be established approximately 04 May 2021 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 04 June 2021, 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 Urine Specimen Collection and Transfer Products. 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 Urine Specimen Collection and Transfer Products. 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 Urine Specimen Collection and Transfer Products 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 Urine Specimen Collection and Transfer Products. Within the MHS MTFs and operational procurement this product line has an estimated annual sales volume of $310,422. This forecast is based on historical usage data during a recent 12-month period. Two items are required for addition to the QSL and account for 75.2% ($233,306) of the total volume in sales $310,422. The specifications for this project are shown in the ï¿½Requirements to Qualify for QSLï¿½ 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 vendorï¿½s submission must include all detailed information requested in the ï¿½Requirements to Qualify for QSLï¿½ 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.).ï¿½ 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). Instructions for Submitting Product Samples. 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. The Vendor submissions must submit the specified quantity of each product. The Vendor is required to ship products to the Lead MMESO by the date and time stated on the QSL Sources Sought notification.ï¿½ ï¿½Ship toï¿½ 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 Vendorï¿½s preferred shipment method to CONUS MTFs. The Vendor must ship by FedEx or United Parcel Service (UPS) to OCONUS MTFs. 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. The late arrival products will be destroyed upon receipt. 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 MMESOï¿½s 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 vendorï¿½s 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 (PN), Manufacturer PN, 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. The vendor 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. 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 - Required Minimum Components - Annual Usage in Units -ï¿½Samples Required for Evaluation (Qty required) 5.1 URINE SPECIMEN COLLECTION CONTAINER WITH INTEGRATED TRANSFER DEVICE, 100 mL/cc - 120 mL/cc CAPACITY, STERILE - NA - ï¿½271,000 - 15 Urine Specimen Collection Containers 5.2 URINE SPECIMEN COLLECTION KIT Required Minimum Components: a. (1) Specimen collection container with integrated transfer device, sterile, 100 mL/cc - 120 mL/cc capacity b. (1) Specimen tube without preservative for urinalysis, sterile, 8 mL/cc - 10 mL/cc capacity c. (1) Specimen tube with preservative for urine culture, sterile, 4 mL/cc capacity Annual Uage in Units - 74,600 Samples Required for Evaluation (Qty required) - 15 Urine Specimen Collection Kits 6. Vendor must provide Urine Specimen Collection and Transfer 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 15223-1:2016 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 15223-1:2016 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 Urine Specimen Tubes with Preservative for urine culture and sensitivity cleared by FDA and submit the FDA 510(k) to support this with initial submittal. 8. Vendor must provide single-use Urine Specimen Collection and Transfer Products indicated as such in a statement or by the ISO BS EN 15223-1: 2016 symbol [reference number 5.4.2] on the individual product or product package. Vendor must provide documentation with initial submittal to support this requirement. 9. Vendor must provide Urine Specimen Collection Containers products containing no more than 200 individual containers per case and provide documentation to support this with initial submittal. 10. Vendor must provide Urine Specimen Collection Kit products containing no more than 50 individual kits per case and provide documentation to support this with initial submittal. 11. Vendor must provide evacuated urine specimen tube(s). Vendor must provide documentation with initial submittal to support this requirement. 12. Vendor must provide Urine Specimen Collection Containers and Specimen Collection Tube products that are sterile and indicated as such on the individual product whether in a statement or the appropriate ISO BS EN ISO 15223-1:2016 sterile symbol [reference number 5.2]. Vendors must provide a photographic image of the individual product and/or component for each required item in support of this requirement with initial submittal. 13. Vendor must provide assembled Urine Specimen Container products with a threaded container/receptacle and a threaded lid with screw cap closure. Vendors must provide a photographic image of the individual product for each required item in support of this requirement with initial submittal. 14. Vendor must provide Urine Specimen Collection Container products with a peel off safety sticker on the specimen collection container lid covering the integrated transfer mechanism. Vendor must provide a photographic image of the individual product for each required item in support of this requirement with initial submittal. 15. Vendor must provide graduated Urine Specimen Collection Container products with marked increments at a minimum every 10 mL/cc up to maximum container capacity. Vendor must provide a photographic image of the individual product for each required item in support of this requirement with initial submittal. 16. Vendor must provide Urine Specimen Collection Kit containing a specimen tube with preservative that comes with minimum fill line marked on the specimen tube. Vendor must provide documentation including a photographic image of each specimen tube product for required item 5.2 with initial submittal to support this requirement. 17. Vendor must provide Urine Specimen Tube products with preservatives that are mercury free Vendor must provide documentation with initial submittal to support this requirement. 18. Vendor must provide Urine Specimen Collection Tube products with preservative that maintain specimen integrity for up to 48 hours at room temperature/without refrigeration. Vendor must provide documentation with initial submittal to support this requirement. Clinical Product Performance Evaluation Each requirement below for this product line will be evaluated in a non-patient treatment setting. Evaluation is to be completed in 14 calendar days. 19. Vendor must provide Urine Specimen Collection Container products with integrated transfer devices which come with secure lids/closures that do not leak during handling. 20. Vendor must provide Urine Specimen Collection Container products with integrated transfer mechanisms which do not leak during transfer of urine samples directly from the specimen collection container to a vacuum sample tube. Vendor may provide any or all of the additional items listed below, following the same format as for requirement number 5. Optional Products and Required Components 1. URINE SPECIMEN COLLECTION KIT (1) Specimen collection container with integrated transfer device, sterile,100 mL/cc - 120 mL/cc capacity (1) Specimen tube without preservative for urinalysis, sterile, 8 mL/cc - 10 mL/cc capacity 2. URINE SPECIMEN COLLECTION KIT (1) Specimen collection container with integrated transfer device, sterile,100 mL/cc - 120 mL/cc capacity (1) Specimen tube with preservative for urinalysis, sterile, 8 mL/cc - 10 mL/cc capacity (1) Specimen tube with preservative for urine culture, sterile, 4 mL/cc capacity 3. URINE SPECIMEN TUBE WITH PRESERVATIVE FOR URINE CULTURE Evaluation Clinical Product Performance Evaluation 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, 15 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 15 of each of the commercially packaged products identified above and one manufacturerï¿½s instructions to each of the evaluation sites (identified below) as requested by the Lead 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, 16 December 2020. ? The deadline for product delivery (see addresses below) is 19 days after the close date of this QSL Announcement,ï¿½4ï¿½January 2021, 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 competitorsï¿½ 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 Clinical Product Performance Evaluationï¿½ï¿½ VENDOR MAY SHIP BY VENDOR'S PREFERRED SHIPPING METHOD TO CONUS MTFs Participating Clinical Evaluation Sites MMESO North POC Nameï¿½Vivian Alexander, Team Lead & Harris Satari, Clinical Analyst Mailing Address Sample to be shipped to MMESO North POC - Vivian Alexander 9275 Doerr Rd. Bldg 1221 Fort Belvoir, VA 22060 ATTN:ï¿½Vivian Alexander/Harris Satari - STANDARDIZATION EVALUATION SAMPLES E-Mail vivian.r.alexander.ctr@mail.mil harris.satari.ctr@mail.mil Evaluation for this product line will be done by a panel of experts as a clinical product performance evaluation 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 04 May 2021. 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.
Web Link: SAM.gov Permalink
(https://beta.sam.gov/opp/4293d3a565774efd8415421602ef55ec/view)
Place of Performance: Address: Fort Belvoir, VA 22060, USA; Zip Code: 22060; Country: USA
Record: SN05863827-F 20201203/201201230141 (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 -- Urine Specimen Collection and Transfer Products