SOLICITATION NOTICE
65 -- Topical Liquid Skin Adhesive, Ampoule or Vial , Single Application, Steril - Technical / Company Requirement Response Document
- Notice Date
- 12/1/2011
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 423450
— Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers
- 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
- MW-1105-38_Topical_Liquid_Skin_Adhesiv
- Archive Date
- 1/6/2012
- Point of Contact
- Ricardo Orias, Phone: 619-532-8537, Cheryl Janus, Phone: (619) 532-7554
- E-Mail Address
-
ricardo.orias.ctr@med.navy.mil, cheryl.janus.ctr@med.navy.mil
(ricardo.orias.ctr@med.navy.mil, cheryl.janus.ctr@med.navy.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 Topical Liquid Skin Adhesive. The Medical Materiel Enterprise Standardization Office (MMESO) West 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 preferred threshold, best price will determine selection. 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 is seeking a single award 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, 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 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 TS 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 February 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: Ricardo Orias, MMESO West Team Leader, Ricardo.orias.ctr@med.navy.mil, (619) 532-8537; Cheryl Janus, MMESO West Clinical Analyst, Cheryl.janus.ctr@med.navy.mil, (619) 532-7554. B. Products & Performance Required The MMESOs are seeking product line items in the category of Topical Liquid Skin Adhesive. Within the MMESOs this product line has an estimated annual dollar requirement of $3,688,304.00. This forecast is based on historical usage data during a recent 12-month period. Based on usage data, two (2) line items of the total eleven (11) line items represent the top two (2) products and account for 95.6% ($3,525,738) of the total volume in sales ($3,688,304) 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 Ricardo Orias, MMESO West Team Leader, ricardo.orias.ctr@med.navy.mil and Ms. Cheryl Janus, Clinical Analyst, Cheryl.janus.ctr@med.navy.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., vendors are strongly encouraged to confirm with the MMESO West that their initial submissions, quote and literature arrived at the MMESO West 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 who do not meet the deadline of COB 5:00 PM Pacific Daylight Savings Time (PDST) 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 West 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. 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 acquisition planning process, the CPT approved the technical/company requirements outlined below. The twelve (12) 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 line of Topical Liquid Skin Adhesive products that includes at a minimum the specific products identified below for latex free/safe Topical Liquid Skin Adhesive as follows: a. Topical Liquid Skin Adhesive, Ampoule or Vial, Single Application, Sterile * Operational usage items are included in this list of Topical Liquid Skin Adhesive. b. Vendor must provide a complete itemized list of products supplied (manufacture and/or distribute by brands and descriptions) via Microsoft Excel spread sheet, and a product catalog and literature in response to this RFIAQ. Vendors are required to supply all items listed in all sizes and device type. 2. Vendor must provide comprehensive instructions on the recommended storage conditions of the product to include temperature, humidity and light. 3. Vendor must provide latex safe/free and hypoallergenic, occlusive barrier, Topical Liquid Skin Adhesive products. Vendor must provide a list of all latex safe/free hypoallergenic items, supplied via catalog or like-material in response to this RFIAQ with initial submittal. 4. Vendor must provide a product that is water resistant. 5. Vendor must provide a product that does not visibly erode catheters, tubing or other venous, arterial and spinal access devices. 6. 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 Topical Liquid Skin Adhesive 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. 7. Vendor must provide a skin/wound simulation application device with the Topical Liquid Skin Adhesive samples to each evaluation site. 8. 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. A vendor whose products cannot identify these features or a vendor who does not provide documents to support this with initial submittal will be disqualified in Phase I. 9. Vendor must have a DAPA or be in the process of obtaining a DAPA for the Topical Liquid Skin Adhesive product line. Vendor must provide DAPA number or provide documentation that DAPA has been applied for. 10. Vendor must have agreements with the current Med/Surg Prime Vendors for each MMESO AOR, i.e. Cardinal Health and Owens & Minor for Topical Liquid Skin Adhesive or be in the process of obtaining Prime Vendor agreements. 11. Vendor 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 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. A vendor who does not provide discounts off DAPA for in Phase III for all products will be disqualified. 12. 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. Phase II Acceptability Evaluation Clinical Performance Clinical Performance Requirements 1. Following acceptability of the technical/company requirements, the MMESO West 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 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 West 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. One (1) box of 6 vials of the item listed below is to be provided as samples to each of the evaluation sites as identified in the letters of invitation. Topical Liquid Skin Adhesive, Ampoule or Vial, Single Application, Sterile 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. Each evaluator will evaluate or trial each participating vendor's product line. The clinical/performance acceptability evaluation period will last for fourteen (14) 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. 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 completion of the standardization selection. 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 West and results will be forwarded to the MMESO CPT for final review. There will be nine (9) 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. FDA- Medical Devices, Device Regulation and Guidance. Product Code: OMD - Class II 21 CFR 878.4011- It is easy to identify the type, size, latex content, and expiration date and storage requirements of product from the packaging. The product must be labeled in a way that identifies its type, size, latex content, and storage requirements easily and quickly to reduce the amount of time needed for staff to select the appropriate size and determine if the product is usable. 2. FDA- Medical Devices, Device Regulation and Guidance. Product Code: OMD - Class II 21 CFR 878.4011- The product applicator is easy to open/activate and use. The product flows well out of the applicator for application to the simulated incision site without dripping. The product applicator must be easy to open/activate and use and the product must flow well out of the applicator for application to the simulated incision site for clinicians to adequately secure the simulated skin together. 3. FDA- Medical Devices, Device Regulation and Guidance. Product Code: OMD - Class II 21 CFR 878.4011; ASTM F2458-05- The product is strong enough to adhere to the simulated tissue without the use of adhesive strips or cover dressings. Clinicians require a product that is strong enough to be able to adhere the tissue on its own without the use of adhesive strips or a cover dressing. 4. FDA- Medical Devices, Device Regulation and Guidance. Product Code: OMD - Class II 21 CFR 878.4011; and, product wastage/cost for medical devices - The package is easy to open and allows for aseptic delivery to the sterile field. The package must be designed in a way that allows the clinician to open it and remove the product from the packaging and deliver it to a sterile field without risk of contamination of the product or the sterile field. 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 West and must be received by 5:00 PM PDST, 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. Among the products and sources that were determined to be clinically preferred, the best price Aggregate Post-Standardization Cost will be selected.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DLA/J3/DSCP-M/MW-1105-38_Topical_Liquid_Skin_Adhesiv/listing.html)
- Place of Performance
- Address: Medical Materiel Enterprise Standardization Office (MMESO) West, 34960 Bob Wilson Dr., San Diego, California, 92134, United States
- Zip Code: 92134
- Zip Code: 92134
- Record
- SN02632132-W 20111203/111201235302-4c1c30c8b350e1563216d0badf8188be (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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