Pregnancy_Test_Devices

The Defense Medical Materiel Program Office (DMMPO) 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 Pregnancy Test Devices. This is not a request for quote or proposal. The MMESO West is the lead MMESO for this project. These Pregnancy Test Devices 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 its 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 in accordance with (IAW) FAR 9.2 for Pregnancy Test Devices. All items proposed to be included in this QSL must be on DAPA for the DLA Troop Support Medical/Surgical Prime Vendor (MSPV) Program. The MSPV Program requires that all items be manufactured in a Trade Agreements Act Compliant Country (as defined by FAR 52.225-5), 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 complete the DAPA TAA Certification. Any questions concerning TAA may be directed to Bill Woltjen at DLA Troop Support, William.woltjen@dla.mil, 215-737-7124. The QSL for Pregnancy Test Devices will be established approximately April 2014 and is anticipated to be the basis of a Standardization Action. Qualified vendors will be invited approximately May 2014 to submit pricing proposals to enter into an Incentive Agreement for Pregnancy Test Devices. The government reserves the right to standardize or not standardize on Pregnancy Test Devices. A. Products & Performance Required. The MMESOs are seeking product line items in the category of Pregnancy Test Devices. Within the MHS MTFs and operational procurement this product line has an estimated annual sales volume of $1,606,427.00. This forecast is based on historical usage data during a recent 12-month period. Five product groupings were found to be relevant to the scope of this standardization action. Of the five product groups, two represent the clinically significant product groups, are considered the minimum requirement for the addition to the QSL, and account for 99.6% of the total volume in sales ($1,606,427.00). The specifications for this project are shown in "Requirements to Qualify for QSL" section below. B. Instructions to Vendors Vendors interested in qualifying for inclusion in the QSL must provide an e-mail response to this QSL FBO Sources Sought notification to the lead MMESO POCs below. The vendor's responses 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; and (4) Identification of the Sources Sought notification to which the vendor is responding. 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 should a problem occur with the first submission. As part of the "Requirements to Qualify for QSL", vendors must complete and submit the QSL FBO Package Worksheet. 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, email or hard copy). Vendors that do not meet the deadline of COB 5:00 PM Pacific Standard Time (PST) on the date listed for closing in this QSL FBO Sources Sought notification will not be included in the lead MMESO's review to establish the instant QSL and thus will not be able to participate in the subsequent Standardization Action. C. Source Selection Procedures The MMESO Joint Product Review Board (JPRB) will serve as the forum for clinical recommendations for product selection and coordinate logistics efforts in support of DoD Components. The board is chaired by Designated Senior Logisticians (DSLs) and co-chaired by Designated Senior Clinicians (DSCs) in the MMESO Areas of Responsibility (AORs) and includes clinicians and logisticians for MTFs within each MMESO. The Clinical Advisory Committee (CAC) members are the deciding officials for this initiative. The MMESO DSLs and DSCs intend to review responses and evaluate products for selection to the QSL IAW FAR 9.2. Requirements to Qualify for QSL Pregnancy Test Devices requirements 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 FBO 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 FBO Package Worksheet. 1. Vendor must have a Distribution and Pricing Agreement (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 documentation and date the DAPA number was applied for. Vendors who do not continue to process application for a DAPA number will not be considered for continued participation. 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. 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. 4. Vendor must have a government issued Commercial and Government Entity (CAGE) code assigned for products contained within the specific product group or be in the process of obtaining one. Vendors who previously had an active record in Central Contractor Registration (CCR) must validate that their account is Active in the System for Award Management (SAMs) and provide Cage Code. Vendors in the process of obtaining a Cage Code must provide documentation to support that they have registered in SAMs. Vendor's who do not continue to process application for a CAGE Code and/or a SAMs account, will not be considered for continued participation. See https://www.sam.gov/portal/public/SAM/. 5. Vendor MUST provide the following items. Vendor must provide product catalog & literature for any items offered in response to this Sources Sought Notification. Vendor must submit the following information via QSL FBO Package Worksheet for each offered product: Full item description, Distributor Part Number, Manufacturer Part Number, Manufacturer Name, and Number of eaches in Unit of Sale. Only ONE Vendor Part Number (PN) should be provided for each item/sample. Required Products / Annual Usage in Units /Units of Sale (EACH) Human Chorionic Gonadotropin Serum/Urine Test Device / 749,506 25 Human Chorionic Gonadotropin Urine Test Device / 18,830 / 25 6. Vendor must provide FDA approved products for professional in vitro use only that are CLIA waived for urine and CLIA moderate complexity for serum. Vendor must provide documentation to support this requirement with their initial submittal. 7. Vendor must provide test device system that includes all supplies needed to perform the test including a disposable pipette to aspirate the sample volume required for the test. Vendor must provide documentation to support this requirement with their initial submittal. 8. Vendor must provide products that test for the qualitative measurement of Human Chorionic Gonadotropin (hCG) levels in; urine, and a combination device that tests either a urine sample or a serum sample and gives results by visual color comparison. Vendor must provide documentation to support this requirement with their initial submittal. 9. Vendor must provide products that give final results within three minutes for urine sample and within five minutes for serum sample. Vendor must provide documentation to support this requirement with their initial submittal. 10. Vendor must provide products that have a sensitivity level of at least 10 mIU/mL for serum and at least 20 mIU/ml for urine. Vendor must provide documentation to support this requirement with their initial submittal. 11. Vendor must provide products that include internal procedural controls in the device. Vendor must provide documentation to support this requirement with their initial submittal. 12. Vendor must provide products that are individually pouched/packaged. Vendor must provide documentation to support this requirement with their initial submittal. 13. Vendor must provide the method/procedure code for their College of American Pathologists (CAP) surveys for both urine and serum which must demonstrate at least two years history of acceptable performance (80% or greater) on the participant summary. Vendor must provide documentation to support this requirement with their initial submittal. 14. Vendor must provide products that can be stored at room temperature and have a shelf life of eighteen (18) months or more. Vendor must provide documentation to support this requirement with their initial submittal. 15. Vendor must provide a copy of the product's packaging that identifies the product's use, storage requirements, expiration date, and lot number. Vendor must provide documentation to support this requirement with their initial submittal. 16. Vendor's printed product insert must include an English version and must provide instructions for the proper performance of the product's test procedure. Product insert must illustrate explanation/interpretation of test results. Vendor must provide documentation to support this requirement with their initial submittal. 17. The Pregnancy Test Device's results can be accurately determined by visual color comparison. 18. The disposable pipette included with the product allows the evaluator to aspirate in a single draw and dispense the volume of sample required, by manufacturer's instructions, to accurately perform the test. 19. The product produces accurate results. 20. Vendor may provide any or all of the additional items listed below, following the same format as for requirement number 5. Additional Item Description Units of Sale (Each) Human Chorionic Gonadotropin Basic Test Urine Stick 25 Reference Standard Human Chorionic Gonadotropin Test Urine 25 Reference Standard Human Chorionic Gonadotropin Test Serum 25 Evaluation After the lead MMESO receives all information required above, they will send each vendor making a complete and approved submission a written request to provide product samples to Clinical Product Team (CPT) members at the participating MTFs. MTF "Ship to" Addresses will be provided as part of the request. To ensure your eligibility to participate, all products required for evaluation must be shipped no later than 14 calendar days from issuance of the MMESO's request and must arrive at all designated MTFs no later than 5:00 PM local time at delivery location, 30 calendar days from issuance of the MMESO's request. Any products received beyond the stated date and time will not be included in the Clinical Process Teams' (CPT) reviews to establish the instant QSL and to participate in the subsequent Standardization Action, but will be destroyed upon receipt. Vendor will provide only the following products for evaluation. The products will be provided at no cost to the government for products or delivery, and unused products will not be returned. One box (25 each) of the required items listed is to be provided as product samples to each of the evaluation sites as requested by the Lead MMESO. Vendor will be required to supply the same part number(s) submitted in the QSL FBO Package Worksheet. Item for Evaluation Human Chorionic Gonadotropin Serum/Urine Test Cassette There will be approximately 13 MTFs enterprise-wide that will be evaluating products. Each evaluator will evaluate the vendor submissions in the Pregnancy Test Devices product line. The MMESO CPT will review the responses from the vendors and the results from the product evaluations and determine which vendors meet the requirements. A vendor who provides all requested information and meets all requirements will be selected for inclusion in the QSL. Vendors will be notified of whether they met or did not meet the QSL requirements by approximately April 2014. Points of Contact (POCs): Mr. Ricardo Orias, MMESO West Team Leader, ricardo.orias.ctr@med.navy.mil, (619) 532-8537; and Ms. Cindy Ingrao, CNM, MSN, MMESO West Clinical Analyst, cynthia.ingrao.ctr@med.navy.mil, (619) 532-8517. DLA Troop Support Medical Contracting Officer: Tara J. Perrien, tara.perrien@dla.mil (215) 737-8307.