SOLICITATION NOTICE
65 -- Needles - Technical / Company Requirement Response Documen
- Notice Date
- 8/5/2011
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Defense Logistics Agency, DLA Acquisition Locations, DLA Troop Support - Medical, 700 Robbins Avenue, Philadelphia, Pennsylvania, 19111-5096, United States
- ZIP Code
- 19111-5096
- Solicitation Number
- MN-1104-16_Needles
- Archive Date
- 9/10/2011
- Point of Contact
- Toni Massenburg, Phone: 202 782-3666, Varnia Bryant, Phone: 202-782-4494
- E-Mail Address
-
toni.massenburg@us.army.mil, varnia.c.bryant.ctr@us.army.mil
(toni.massenburg@us.army.mil, varnia.c.bryant.ctr@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- Responses to this RFIAQ should include all the information as indicated in the FBO. Use this document for all your responses. The Defense Medical Materiel Program Office (DMMPO) Medical Materiel Enterprise Standardization Office (MMESO) announces a Request for Incentive Agreement Quotation (RFIAQ) for the standardization of Needles. The MMESO North is the lead MMESO for this project. The primary objective of this program is to standardize the quality of care across the MMESO North, South, West, Pacific, Europe (hereafter referred to as MMESOs) areas of responsibility (AOR) and operational assemblages based on the critical balance of clinical efficacy and value. This Standardization Action (SA) will apply to all MMESOs. It is intended for this initiative to result in the standardization of a technically and clinically preferred product (s) and source for institutional and operational medicine requirements at the best possible price. It is intended for this initiative to result in the reduction of Stock Keeping Units (SKUs) and National Stock Numbers (NSN). It is also intended that standardized products be obtained through the Department of Defense (DoD) Prime Vendor (PV) Program. As an enterprise-wide clinically driven program, vendors and products must meet specific technical requirements plus products must meet or exceed specific clinical performance requirements as a primary consideration. Among vendors who meet the technical requirements and the products that meet or exceed the clinical the clinical preferred threshold, best price will determine selection by MMESO Area of Responsibility (AOR). It is intended that the selected vendor (s) for this SA support the enterprise goal of medical materiel standardization that combines operational and institutional requirements. The Government will make a single selection for each of the following MMESO AORs: 1. MMESO North 2. MMESO South 3. MMESO West 4. MMESO Pacific 5. MMESO Europe The major facilities in the MMESOs include, but are not limited to MMESO North: Walter Reed Army Medical Center, National Naval Medical Center, Naval Medical Center Portsmouth, Wright-Patterson Medical Center; MMESO South: Wilford Hall Medical Center, Brooke Army Medical Center, Naval Hospital Jacksonville, Martin Army Community Hospital; MMESO West: Naval Medical Center San Diego, Madigan Army Medical Center, Irwin Army Community Hospital, Mike O'Callaghan Federal Hospital; MMESO Pacific: Tripler Army Medical Center, Honolulu, HI, 18th Medical Group, Kadena AB, Okinawa, US Naval Hospital, Yokosuka, Japan; MMESO Europe: Landstuhl Regional Medical Center, Landstuhl, GE, US Naval Hospital, Naples, Italy, the 48th Medical Group, Lakenheath, UK; and Operational U.S. Forces. This standardization action is part of the Medical/Surgical PV program executed by the Defense Logistics Agency (DLA) Troop Support, Directorate of Medical Materiel. To participate, your company must have a Distribution and Pricing Agreement (DAPA) and a separate commercial agreement with the current Med-Surg PV for each MMESO Area of Responsibility (AOR) for which a quote is submitted, i.e., Cardinal Health, and Owens & Minor. This requirement is pursuant to the DAPA clause by which DAPA holders agree to the standardization process and agree to allow PVs to distribute their products. The Incentive Agreement (IA) resulting from this RFIAQ is a supplement to the PV Program and is not a contract. For additional information regarding DLA Troop Support Medical's PV program please access its web site at https://dmmonline.dscp.dla.mil. This IA standardization initiative will be a Three Phase IPP Process: vendor (s) who meets the technical / company requirements in Phase I will be invited to advance and participate Phase II where no-charge products will be provided for clinical evaluation and Phase III where pricing will be required for submittal. Phase II and Phase III will be run concurrently. The resulting IA will be for a base period of two (2) years (24 months) from date of selection with three (3) 12-month "option" periods not to exceed a total of 5 years. Anticipated selection date is Oct 2011. The selection will be based on the product and vendor that provides the Best Value to the enterprise. Products and vendors that meet or exceed the technical and clinical performance requirements will be considered clinically preferred products and sources. Among vendors who meet the technical requirements and the products that meet or exceed the clinically preferred standard, best price (i.e. lowest Aggregate Post Standardization Cost) will determine selection for each MMESO AOR. Point of Contact: Ms. Toni Massenburg, MMESO North, Team Leader, toni.massenburg@us.army.mil, 202-782-3663, or Ms. Varnia Bryant, MMESO North Clinical Analyst, varnia.c.bryant.ctr@us.army.mil. 202-782-3666. B. Products & Performance Required The MMESOs, are seeking product line items in the category of Needles. Within MMESOs, this product line has an estimated annual dollar requirement of $2,060,178.75. Estimated annual demand per Area of Responsibility is approximately MMESO North: $411.868.79; MMESO South: $561,463.40; MMESO West: $571,662.35; MMESO Europe: $319,315.83; and MMESO Pacific: $195,868.38. This forecast is based on historical Prime Vendor sales during a recent 12-month period. Based on the recent 12-month usage data, the top fifty four (54) line items of the total one hundred and seventy eight (178) line items, account for 82.9% ($1,707,119.43) of the total volume in sales ($2,060,178.75) in the MMESOs and are procurement significant. The top high volume usage lines for this project are shown in the Technical/Company Requirements below, consolidated by product type to reduce duplication within the top 5 products. This represents the line item, or SKU, reduction that is an additional objective of this program. C. Instructions to Vendors Vendors interested in participating in this standardization initiative will provide an initial response to the FBO-posted RFIAQ to Ms. Toni Massenburg, Team Leader, toni.massenburg@us.army.mil or Ms. Varnia Bryant, varnia.c.bryant.ctr@us.army.mil. The vendor's initial responses will include detailed information requested in the technical/company requirements listed in the FBO RFIAQ and must also include: (1) Company name and address; (2) Company Point of Contact (POC) (Name and Phone Number, Fax Number, and E-mail address); and (3) Identification of the RFIAQ to which the vendor is responding. Due to the potential for e-mail to be lost in transmission, from network security, etc., vendor is strongly encouraged to confirm with the MMESO North that its initial submission, quote and literature actually arrived at the MMESO North via email. Each submitting vendor is advised to confirm receipt, allowing adequate time for resubmission before the due date/time, should a problem occur with the first submission. Vendor who does not meet the deadline of COB 5:00PM Eastern Standard Time (EST) on the date listed for closing will be disqualified from further consideration in the standardization initiative. D. Source Selection Procedures The MMESO Joint Product Review Board (JPRB) will serve as the forum for clinical recommendations for product selection, seeking and evaluating opportunities for committed volume purchase agreements, and coordinating logistics efforts in support of DoD Components. The boards are chaired by Designated Senior Logisticians (DSLs) and co-chaired by Designated Senior Clinicians (DSCs) in the MMESO AORs and include clinicians and logisticians for Medical Treatment Facilities (MTFs) within each MMESO. The Clinical Advisory Committee (CAC) members are the deciding officials for this initiative. The MMESO DSLs and DSCs intend to evaluate quotes and select a vendor on initial submissions/quotes. Vendor quotes should contain the vendor's best discounts off of the vendor's DAPA pricing for each MMESO AOR based on committed volume of 80% of the total requirements of the MTFs in the MMESOs. The MMESO North reserves the right to conduct discussions and request revised quotes, if determined necessary. Phase I Technical / Company Requirements The MMESO CPT will review the responses from the vendors and determine which vendors meet the technical/company requirements and determine acceptability. A vendor must meet the technical requirements for continued consideration in this initiative. A vendor who does not meet the requirements will be disqualified. Failure to provide any requested information or meet any of the technical requirements will disqualify the vendor from further consideration. The vendors who meet the following technical/company requirements will be qualified/invited to participate in the clinical/performance selection and will be requested to submit their best product/price discount quotes via an email communication. All communications of significant acquisition milestones (such as invitations to participate, or notices of disqualification) should be digitally signed. Technical/Company Requirements: During the acquisition planning process, the MMESO CPT validated/approved the technical/company requirements outlined below. The fourteen (14) requirements below must be answered with the vendor's initial submittal by the response date stated in the FBO announcement. A vendor who does not meet these requirements or who does not submit documentation to support these requirements with initial submittal will be disqualified in Phase I. 1. Vendor must provide a line of Needles products that includes at a minimum the specific products identified below for disposable, sterile, single-use, disposable Conventional and Safety Needles appropriate for all age patients including a variety of gauge sizes and lengths as follows: gauges ranging from 18G to 25G, lengths from 5/8 to 1 ½ inches; regular, short, and intradermal bevels as follows: a. ITEM DESCRIPTION 18G X 1 ½" SAFETY NEEDLE 21GX 1 ½" SAFETY NEEDLE 22GX 1" SAFETY NEEDLE 23GX1" SAFETY NEEDLE 25GX 5/8" SAFETY NEEDLE * Operational usage items are included in this list of Conventional and Safety Needles b. Vendor must provide a complete itemized list of items supplied (manufacture and/or distribute by brands and descriptions) via excel sheet, and product catalog & literature in response to this RFIAQ with initial submittal. Vendor is required to supply all items listed in all sizes and device type. 2. Vendor must provide literature that clearly identifies that the products' packaging are clearly labeled, has manufacturing lot number and expiration date on packaging with initial submittal. 3. Vendor must provide Safety and Conventional Needles products that adhere to the Federal Needle stick Safety and Prevention Act (Public Law 106-430 (2000)), OSHA Blood borne Pathogens Standard (29 CFR 1910.1030), the Centers for Disease Control and Prevention, National Institute for Occupation Safety and Health (NIOSH) and other regulatory guidelines in the prevention of exposure to blood-borne pathogens and needle stick and other sharps injuries. 4. Vendors must identify these safety features of their Safety Needle products and provide literature to support this in response to this RFIAQ with initial submittal. 5. Vendor must achieve a high standard of manufacturing quality for medical Needles to ensure patient comfort and enable practitioners to accurately deploy and extract fluids with a syringe. During the product development process, needles are subjected to flexure, tensile, and puncture tests to reach this required level of production consistency. 6. Vendors must have Needles that adhere to the International Organization for Standardization (ISO): 7864:1993 Sterile needles for single use requirements and provide documentation that the products are sterile, have expiration dates on the packaging, and the contents of the package can be aseptically delivered to a sterile field. 7. Vendor must provide Safety Needles that can be activated with a one-handed technique and be of such a design that the safety feature cannot be deactivated /disabled before, during or after activation. 8. Vendors must have package labeling of the Needle product line that clearly indicates the size, gauge and length. 9. Vendor must provide Needles with a standard hub that will fit all luer lock and luer slip syringes creating leak proof seals, and that have a semi-transparent needle-hub for easy visualization of flashback per standards. 10. Vendor must provide needles that are ground and honed with a double-bevel design to provide a comfortable and accurate injection. The thin and ultra-thin walled design insures the needles provide more comfort with an increased flow rate. 11. Vendor must have an identified customer service representative available for on-site assessment, on-site instructional sessions (in-services), and on-going clinical support as required at no cost to the government for the Needles product line. A vendor must provide a list of customer service representatives with initial submittal. A vendor who cannot provide representatives to support these requirements will be disqualified in Phase I. 12. Vendor must have a DAPA or be in the process of obtaining a DAPA for the Needles product line. Vendor must provide DAPA number with initial submittal or provide documentation that DAPA has been applied for with response submittal. 13. Vendor must have agreements with the current Med/Surg Prime Vendors for each MMESO AOR for which a quote is submitted, i.e. Cardinal Health and Owens & Minor for Needles or be in the process of obtaining Prime Vendor agreements. Vendor must provide documentation to support agreements with initial submittal. 14. Vendor must submit discounts off of DAPA for all products included in this standardization initiative. Where lower FSS prices are available, DAPA holders are required by previous agreement to provide the FSS price as the DAPA price. A vendor shall not quote FSS prices as the discounted price for purposes of this standardization initiative. Vendor is not required to provide a quote for all MMESO AORs. 15. Vendor must identify with initial submittal which MMESO AOR(s) they intend to submit quotes for. Vendor will not have an opportunity to change MMESO AOR(s) during any subsequent stage in this evaluation. Phase II Acceptability Evaluation Clinical Performance Clinical Performance Requirements Following acceptability of the technical/company requirements, the MMESO North, on behalf of the CPT, will request product sample sets from the product group to be sent to the CPT members at the participating MTFs. Vendor will be given 30 calendar days from the issue of the notice in which to deliver the product samples for clinical evaluation at Phase II. Product samples must be shipped to arrive at the designated addresses by 5:00PM local time for each MTF on the 30th calendar day after the notice to ship. Vendor MUST be able to deliver product literature, training materials and evaluation samples to the MMESO North via FedEx or UPS AND to the MMESO Europe via United States Postal Service (USPS) and throughout the United States when requested in Phase II. Vendor who cannot or does not meet this requirement will be disqualified from the standardization process. All vendors must send the MMESO North verification regarding the shipment of literature and samples. This information will include the date of shipment, final delivery date, tracking numbers and the carrier used by the vendor. Vendor will provide only the following no cost product samples for the clinical/performance evaluation. Unused samples will not be returned. One box of safety needles (minimum 50 each) of sizes and lengths listed below are to be provided as samples to each of the evaluation sites as identified in the letters of invitation. ITEM DESCRIPTION 18G X 1 ½" SAFETY NEEDLE 21GX 1 ½" SAFETY NEEDLE 23GX1" SAFETY NEEDLE The clinical/performance acceptability evaluation period will last for fourteen (14) calendar days. Each evaluator will evaluate each Needle product sample from each vendor against the established requirements. A trial will consist of evaluating all sample products from a single vendor, evaluated against the requirements and recorded on a single evaluation form per vendor. Each evaluator will evaluate or trial each participating vendor's product line. The acceptability evaluation responses will be in a Likert scale format with a one (1) through five (5) scoring range. The scale descriptors are: one (1)- Completely Unacceptable, two (2)- Overwhelmingly Unacceptable, three (3)- Partially Unacceptable, four (4)- Acceptable, and five (5)- Highly Acceptable. The MMESO JPRB has established a 4.0 as the Clinically Preferred threshold of products for standardization. Vendor scoring below the clinically preferred threshold will be disqualified from selection for this standardization initiative. Of those Vendors who are qualified as clinically preferred, selection for each MMESO AOR will be based on best price. Vendor who has been disqualified will be notified in writing upon disqualification. Clinical /performance acceptability evaluations by the participating CPT facilities will be tabulated resulting in one score per participating MMESO per vendor. The participating MMESOs' scores by vendor will then be combined resulting in one final vendor performance evaluation score. All clinical/performance acceptability evaluations will be tabulated by the MMESO North, and results will be forwarded to the MMESO CPT for final review. There will be approximately twelve (12) MTFs enterprise wide that will be evaluating products. Clinical/Performance Requirements: During the acquisition planning process, the CPT validated/approved the clinical/performance requirements outlined below. 1. Clinician Safety - (OSHA Blood borne Pathogens Standard 29CFR 1910.1030). The safety feature is an integral part of the device built into the needle, activates easily and automatically and is not an accessory. This feature of the device provides prevention of accidental needle sticks. 2. Clinician Safety - (OSHA Blood borne Pathogens Standard 29CFR 1910.1030).The safety feature allows or requires the worker's hands to remain behind the needle at all times. This feature of the device provides prevention of accidental needle sticks. 3. Clinician Safety and Patient Safety - (OSHA Blood borne Pathogens Standard 29CFR 1910.1030) There is a clear and unmistakable change (audible or visible) that occurs when the safety feature is activated. This safety feature is in effect before disassembly and remains in effect after disposal. This feature of the device provides prevention of accidental needle sticks. 4. Clinician Safety - (OSHA Blood borne Pathogens Standard 29CFR 1910.1030). The needle's hub fits evenly/equally to all luer lock and luer slip syringes. This feature of the needle hub fits all luer lock and luer slip syringes without the need to purchase a special syringe. 5. Patient Safety and Comfort - (OSHA Blood borne Pathogens Standard 29CFR 1910.1030). The bevel of the needle is sharp enough to penetrate the area of the body or the object intended and prevents drag. The device must have minimal penetration and drag force to reduce pain and provide a quick and easy injection. 6. Clinical Safety - (OSHA Blood borne Pathogens Standard 29CFR 1910.1030). The design of the needle safety feature enables comfortable, safe clinical use including use while wearing gloves. The design of the safety feature must be safe, and easy to handle while wearing gloves for provider comfort and effective use. Phase III Pricing Analysis Price Analysis Upon completion of the Phase I - Technical/Company Requirements, vendors who are found technically acceptable will be qualified /invited to provide their product samples and price discount quotes concurrently. Vendor will be given 30 calendar days from the date of pricing requests, to submit IA pricing quotes, in a prescribed electronic spreadsheet format, based upon the requirements of the MMESOs. Pricing must be received at the MMESO North by 5:00 PM EST, thirty (30) calendar days after the issue date of the vendor notice to submit best price quotes. Vendor quotes should contain the vendor's best product matches for the specific products requested in this announcement. Pricing should be provided for each MMESO AOR based on a committed volume of 80% of the total volume in sales of the MTFs in that MMESO AOR. Vendor quotes will contain separate pricing for each MMESO AOR(s) that was identified in Technical / Company Requirements above. Vendor is not required to provide a quote for each MMESO AOR. Price will be analyzed based on the projected Aggregate Post-Standardization costs for each vendor. Aggregate Post-Standardization Cost will be calculated for each vendor by applying the vendor's offered prices to the anticipated annual usage of the enterprise. Unmatched items will be represented in the Post-Standardization Cost at a baseline non-discounted price (current DAPA price of product with highest procurement). Among the products and sources that were determined to be clinically preferred, the best price Aggregate Post-Standardization Cost will be selected for each MMESO AOR.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DLA/J3/DSCP-M/MN-1104-16_Needles/listing.html)
- Place of Performance
- Address: Walter Reed AMC, 6900 Georgia Ave N.W., ATTN: WR-NARMC, Bldg 1 Rm C330, Washington, District of Columbia, 20307, United States
- Zip Code: 20307
- Zip Code: 20307
- Record
- SN02523332-W 20110807/110805234624-477043881a09dd11297ddbc5d4796319 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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