SOLICITATION NOTICE
65 -- MP-1106-43_Functional_Hinged_Knee_Braces - Technical Requirement Documents
- Notice Date
- 3/15/2012
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 339113
— Surgical Appliance and Supplies 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
- MP-1106-43_Functional_Hinged_Knee_Braces
- Point of Contact
- Mary Summers, Phone: 808-433-3686, Corazon Toledo, Phone: 808.433.2894
- E-Mail Address
-
mary.summers1@us.army.mil, corazon.M.Toledo.ctr@us.army.mil
(mary.summers1@us.army.mil, corazon.M.Toledo.ctr@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- Use this document for all your responses. Fill in the attachment and provide with your initial submittal to this FBO RFIAQ. *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. *Vendor who does not meet the deadline of COB on the date/time listed in the FBO, will be disqualified from further consideration in the standardization initiative. *Please remember to attach your product literature and catalogs required in the Federal Business Opportunity. The Defense Medical Materiel Program Office (DMMPO) announces a Request for Incentive Agreement Quotation (RFIAQ) for the standardization of Functional Hinged Knee Braces. The Medical Materiel Enterprise Standardization Office (MMESO) Pacific is the lead MMESO for this project. The primary objective of this effort is to standardize the quality of care across the Military Treatment Facilities (MTFs) and operational assemblages based on the critical balance of clinical efficacy and value. The intent for this initiative is the standardization of a clinically preferred product(s) and source for institutional and operational medicine requirements at the lowest price. It is also intended for this initiative to result in the reduction of Stock Keeping Units (SKUs) and National Stock Numbers (NSN). Standardized products must 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 expectations as a primary consideration. Among vendors who meet the technical requirements and the products that meet or exceed the clinical acceptability, then clinically preferred, best value will determine selection. It is intended that the selected standardized vendor(s) for this Standardization Action (SA) support the enterprise goal of medical materiel standardization that combines operational and institutional requirements. The government is seeking a single vendor selection for this SA. The major facilities in the MMESOs North, South, West, Pacific and Europe (hereafter referred to as MMESOs) include but are not limited to MMESO North: Walter Reed National Military Medical Center, Portsmouth Naval Hospital, Womack Army Medical Center, Wright-Patterson Medical Center; MMESO South: Wilford Hall Ambulatory Surgical Center, Brooke Army Medical Center, Eisenhower Army Medical Center, Darnall Army Medical Center, Keesler Medical Center, Naval Hospital Jacksonville, Martin Army Community Hospital, Fort Benning, GA; MMESO West: Madigan Army Medical Center, William Beaumont Army Medical Center, Naval Medical Center San Diego, Irwin Army Community Hospital, Mike O'Callaghan Federal Hospital; MMESO Pacific: Tripler Army Medical Center, 18th Medical Group, Kadena AB, Okinawa, US Naval Hospital, Yokosuka, Japan; MMESO Europe: Landstuhl Regional Medical Center, Landstuhl, GE, US Naval Hospital, Naples, Italy, and 48th Medical Group, RAF Lakenheath; and Operational U.S. Forces. This SA is part of the Medical/Surgical Prime Vendor program executed by the Defense Logistics Agency (DLA) Troop Support, Directorate of Medical Materiel. To participate in this SA your company must have, or be in the process of obtaining, a Distribution and Pricing Agreement (DAPA) and a separate commercial agreement with the current Med-Surg PV for each MMESO Region, i.e., Cardinal Health, and Owens & Minor. This requirement is pursuant to the DAPA clause by which DAPA holders agree to the standardization initiative and agree to allow PVs to distribute their products. The 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://www.medical.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 participate in 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 August 2012. 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. Points of Contact: Mary Summers, MMESO Pacific, Team Leader, mary.summers1@us.army.mil 808-433-3686 and Cora Toledo, Clinical Analyst, corazon.m.toledo.ctr@us.army.mil. 808-433-2894. B. Products & Performance Required. The MMESOs are seeking product line items in the category of Functional Hinged Knee Braces. Within the MMESOs this product line has an estimated annual dollar requirement of $609,773.36. This forecast is based on historical usage data during a recent 12-month period. Based on usage data, one hundred fifty six (156) of the total one hundred fifty six (156) line items represent the top forty (40) products and account for 100% ($609,773.36) of the total volume in sales $609,773.36 in the MMESOs and are clinically significant. The top high volume usage lines for this project are shown in the Technical/Company Requirements below. C. Instructions to Vendors Vendors interested in participating in this standardization initiative will provide an initial response to the FBO-posted RFIAQ to Mary Summers, MMESO Pacific, Team Leader, mary.summers1@us.army.mil and Cora Toledo, Clinical Analyst, corazon.m.toledo.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 email to be lost in transmission, from network security, etc., vendors are strongly encouraged to confirm with the MMESO Pacific that their initial submissions, quote and literature arrived at the MMESO Pacific 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 should complete and submit the attached document. A vendor who cannot open the attachments, may contact the POC as noted in the FBO RFIAQ and a copy will be provided via an alternate method (fax, email or hard copy). Vendors that do not meet the deadline of COB 5:00 PM Hawaii Standard Time (HST) 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 MTFs within each MMESO. The Clinical Advisory Committee (CAC) members are the deciding officials for this initiative. Vendor quotes should contain the vendor's best discounts off of the vendor's DAPA pricing based on committed volume of 80% of the total requirements of the MTFs in the MMESOs. The MMESO Pacific reserves the right to conduct discussions and request revised quotes, if determined necessary. Phase I Technical/Company Evaluation The MMESO CPT will review the responses from the vendors and determine which vendors meet the technical/company requirements. A vendor must meet the technical requirements for continued consideration in this initiative. Failure to provide any requested information or meet any of the technical requirements will disqualify the vendor from further consideration. A vendor who meets the following technical/company requirements will be qualified and invited to participate in the clinical/performance selection process and will be requested to submit products for testing and their best price discount quotes via an e-mail 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 pre-source selection procedures, the CPT approved the company/technical requirements outlined below. The requirements below must be answered with the vendor's initial submittal and required documents 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 complete line of Functional Hinged Knee Braces. a. At a minimum the vendor must provide the following: latex-free/safe, lightweight material and construction, with rust proof and well padded metal components, breathable fabric material, adjustable Velcro straps, comprised of washable material that is compatible with readily available household cleaning agents or detergents without decreasing the structural integrity of the brace/support, and available in various sizes. FUNCTIONAL HINGED KNEE BRACES; 1. Incremental range of motion control of flexion and extension, and hinges with stop locks. 2. Functional hinged knee braces to be available in standard lengths (ranges 5-7 inches above knee, 5-7 inches below knee), range of sizes small to 2x-large, and custom fit by measurement or to cast. Available in the configurations of multi-ligament (ACL/PCL or ACL, MCL, LCL, PCL), combined instability (CI); and available for Osteoarthritis. 3. Must have devices for Right and Left Knee OR be universal. FUNCTIONAL HINGED KNEE BRACES Styles REQUIRED ITEMS ACL/PCL Small, right knee or universal Small, left knee or universal Medium, right knee or universal Medium, left knee or universal Large, right knee or universal Large, left knee or universal X Large, right knee or universal X Large, left knee or universal 2 X Large, right knee or universal 2 X Large, left knee or universal Multiligament (ACL/MCL /LCL/PCL) Small, right knee or universal Small, left knee or universal Medium, right knee or universal Medium, left knee or universal Large, right knee or universal Large, left knee or universal X Large, right knee or universal X Large, left knee or universal 2 X Large, right knee or universal 2 X Large, left knee or universal Combined Instability Small, right knee or universal Small, left knee or universal Medium, right knee or universal Medium, left knee or universal Large, right knee or universal Large, left knee or universal X Large, right knee or universal X Large, left knee or universal 2 X Large, right knee or universal 2 X Large, left knee or universal Osteoarthritis Small, right knee or universal Small, left knee or universal Medium, right knee or universal Medium, left knee or universal Large, right knee or universal Large, left knee or universal X Large, right knee or universal X Large, left knee or universal 2 X Large, right knee or universal 2 X Large, left knee or universal *Operational usage items are included in this list of Functional Hinged Knee Braces. b. Vendor must provide a complete itemized list of products (manufactured and/or distributed by brands) via Microsoft Excel spread sheet, and a product catalog and literature in response to this RFIAQ. Vendors must be able to supply all the items in the sizes, and types, as identified in the required items list. 2. Vendor must have a DAPA, or be in the process of obtaining a DAPA, for the Functional Hinged Knee Braces product line. Vendor must provide their DAPA number or provide documentation and the date the DAPA number was applied for. 3. Vendor must have agreements with the current Med/Surg prime vendors for each MMESO AOR, i.e. Cardinal Health and Owens & Minor for Functional Hinged Knee Braces, or be in the process of obtaining Prime Vendor agreements. 4. Vendors will be required to submit discounts off of DAPA for all products included in this standardization initiative when pricing is requested in Phase III. Where lower FSS prices are available, DAPA holders are required by the terms of the DAPA 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. A vendor who does not provide discounts off DAPA in Phase III for ALL products will be disqualified. 5. Vendor must indicate country from which each line item is an end product, IAW Trade Agreements Act. Vendors having existing DAPA numbers must also ensure that all DAPA line items/end products in the subject product line list the proper Trade Agreements Act country in the DAPA Management System. 6. Vendor must provide a statement confirming their products meet the industry and safety standards set forth by the Occupational Safety and Health Administration (OSHA) North American Industry Classification System (NAICS) description for 339113 (Surgical Appliances and Supplies Manufacturing) which involves Orthopedic, Prosthetic, Surgical Appliances and Supplies used in manufacturing Functional Hinged Knee Braces product items. 7. Vendor must state the type of rustproof metal, and the type of lightweight washable fabric that is used for the Functional Hinged Knee Braces. The specific type of metal and washable fabric is not a requirement; however failure to provide this information will result in disqualification. Phase II Clinical Performance Evaluation Following acceptability of the technical/company requirements, the MMESO Pacific, on behalf of the CPT, will request product sample sets from the product group to be sent to the specific 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 in Phase II. Product samples must be shipped no later than fourteen (14) calendar days after issue of notice, and arrive at the designated addresses for each MTF by 5:00PM local time before the 30th calendar day. Vendor must be able to deliver product literature, training materials and evaluation samples as requested to the MMESO Pacific via FedEx or (United Parcel Service) UPS, AND to the MMESO Europe via United States Postal Service (USPS) Express Mail AND throughout the United States by selected shipping method when requested in Phase II. Vendor must send the MMESO Pacific 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 clinical/performance evaluation. Unused samples will not be returned. Two (2) samples of each of the Functional Hinged Knee Braces listed below are to be provided to each of the evaluation sites as identified in the letters of invitation. Sample Set FUNCTIONAL HINGED KNEE BRACE FOR MULTI- LIGAMENT INSTABILITY, (ACL/MCL/LCL/PCL), Right OR UNIVERSAL KNEE, SIZE LARGE Each evaluator will evaluate each product sample from each vendor against the established requirements. A trial will consist of evaluating sample products from a single vendor, evaluated against the requirements and recorded on a single evaluation form per vendor. The clinical/performance acceptability evaluation period will last for twenty-one (21) calendar days. 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. Vendors will be required for in-servicing prior to the evaluations. Vendors will be given 14 calendar days from the invitation to participate in which to make demonstration/in-service arrangements/ appointments with the participating MTFs so that the instructions are available prior to the start of the clinical evaluation in Phase II. Arrangements must be made for product samples to be delivered to participating MTFs by the scheduled in-service date. Vendors who do not make the before mentioned arrangements by the deadline will be disqualified from this standardization initiative. Vendor must send the MMESO Pacific verification regarding the dates of the in-services for the participating MTFs. The vendor must coordinate all in-services so that all MTFs are in-serviced before the evaluation starts. Vendor will be allowed to be present during the in-servicing. Vendor will not be allowed to be present during the actual evaluation process of their products or their competitor's products. Vendor will not be allowed to speak to any hospital staff member regarding the product evaluation, product pricing or price related factors. A vendor who speaks and/or attempts to speak to hospital staff members regarding the product evaluations, pricing or price related factors will be disqualified from this evaluation process. A vendor scoring below the clinically preferred threshold will be disqualified from selection for this standardization initiative. A vendor who has been disqualified will be notified in writing upon disqualification. Of those vendors that are qualified as clinically preferred, selection will be based on best price. 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 Pacific 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 approved the clinical/performance requirements outlined below. The Functional Hinged Knee Braces will be worn by the evaluator for a 5 day period. 1. Patient Comfort and Safety - NPSG 09 - Functional Hinged Knee Brace will be lightweight and the construction will promote patient comfort. The Functional Hinged Knee Brace must be lightweight to provide comfort, support, stability, and not feel so heavy that it is uncomfortable to wear. 2. Patient Comfort and Safety - NPSG 09 - Metal reinforcements are fully padded and covered. The metal reinforcements that are in contact with the skin must be fully covered to prevent skin injury, provide protection and comfort, and reduce potential chafing. 3. Patient Safety and Product Performance - NPSG 09 - Functional Hinged Knee Brace Hinge adjustment should allow for quick adjustments and is easily reached. The Hinged Knee Brace hinge design must allow for quick and simple access, with a hinge adjustment that is easy to reach and use allowing for patient comfort and continued usage. 4. Patient Safety and Product Performance - NPSG 09 - Functional Hinged Knee braces provide stability when ambulating, standing or when performing range of motion exercises. The knee braces must provide stability during ambulation, standing, or during the motions of exercises in order to prevent injury to the knee. 5. Patient Safety and Product Performance - NPSG 9 - The Functional Hinged Knee Brace has adjustable straps which are easy to apply and provide stability. The adjustable straps must be easily applied by the patient, and provide the stability required to maintain support to the affected knee. 6. Patient Safety and Product Performance - NPSG 14 and NPSG 07 - The fabric material is breathable and wicks moisture to control temperature inside the brace. The product must have lightweight and breathable padding that will reduce moisture between the knee and device to control temperature inside the brace, making it comfortable to wear, preventing skin break down, surgical site infection and/or potential pressure ulcers. Phase III Pricing Analysis Upon completion of the Phase I - Technical/Company Requirements, a vendor who is found technically acceptable will be qualified / invited to provide product samples and price discount quotes concurrently. A 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 will be submitted to MMESO Pacific and must be received by 5:00PM HST, 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. Vendor quotes should contain the vendor's best discounts off of the vendor's DAPA pricing for the products identified in this announcement (based on committed volume of 80% of the total requirements of the MTFs in the MMESOs). 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. The selected Vendor of Choice will have an opportunity to provide other items beyond the minimum required product line that you would like to be considered for addition to the Incentive Agreement with a discount from DAPA. All additions will be at the discretion of the Government.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DLA/J3/DSCP-M/MP-1106-43_Functional_Hinged_Knee_Braces/listing.html)
- Place of Performance
- Address: Tripler Army Medical Center, 1 Jarrett White Road, Honolulu, Hawaii, 96859-5000, United States
- Zip Code: 96859-5000
- Zip Code: 96859-5000
- Record
- SN02697322-W 20120317/120315234432-237113137c0bac68c6941e1a4575749d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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