SOLICITATION NOTICE
65 -- Internal Staplers & Clip Appliers
- Notice Date
- 5/15/2011
- 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
- MP-1102-11_Internal_Staplers_Clip_Appliers
- Archive Date
- 6/24/2011
- Point of Contact
- Wendy Sprouse, Phone: 808-433-7985, Mary Summers, Phone: 808-433-3686
- E-Mail Address
-
wendy.a.sprouse.ctr@us.army.mil, mary.summers1@us.army.mil
(wendy.a.sprouse.ctr@us.army.mil, mary.summers1@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- 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 Internal Staplers & Clip Appliers. The MMESO Pacific 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 expectations 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 by MMESO Area of Responsibility (AOR). Vendor is not required to quote for each MMESO 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, Brook 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 MMESOs Area of Responsibility (AOR), i.e., Cardinal Health and/or 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 August 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. Mary Summers, MMESO Pacific, Team Leader, mary.summers1@us.army.mil and 808-433-3686 and Ms. Wendy Sprouse, Clinical Analyst, wendy.a.sprouse.ctr@us.army.mil. B. Products & Performance Required The MMESOs, are seeking product line items in the category of Internal Staplers & Clip Appliers. Within the MMESOs, this product line has an estimated annual dollar requirement of $10,880,055.54. Estimated annual demand per Area of Responsibility is approximately MMESO North: $1,414,340.80; MMESO South: $3,462,702.98; MMESO West: $2,086,534.91; MMESO Europe: $2,038,712.40; and MMESO Pacific: $1,877,764.45. This forecast is based on historical Prime Vendor sales during a recent 12-month period. Based on the recent 12-month usage data, sixty-six (66) line items of the total seven thousand two hundred seventy four (7,274) line items represent the top five (5) products and account for 71% ($7,704,286.99) of the total volume in sales of $10,880,055.54 in the MMESOs, and are procurement significant. The five (5) products listed in Technical/Company Requirements below, represent the products that a participating vendor must be able to supply. C. Instructions to Vendors Vendors interested in participating in this standardization initiative will provide an initial response to the FBO-posted RFIAQ to Ms. Mary Summers, MMESO Pacific, Team Leader, mary.summers1@us.army.mil and Ms. Wendy Sprouse, MMESO Pacific Clinical Analyst, wendy.a.sprouse.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 Pacific that its initial submission, quote and literature actually 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. Vendors who do not meet the deadline of COB 5:00PM 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 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 that MMESO AOR. The MMESO Pacific 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. A vendor who meets 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 six (6) requirements below must be answered and all supporting documentation provided with the vendor's initial submittal by the response date stated. 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 Internal Staplers & Clip Appliers products that includes at a minimum the specific products identified below for sterile, latex-free/safe, single patient use Internal Staplers & Clip Appliers with packaging that displays the size and type of product, and must allow for aseptic delivery to a sterile field. The device is ergonomically designed and fits comfortably in the right or left hand. The device is ergonomically designed and fits comfortably in the right or left hand. Staplers that have adjustable or selectable staple heights give the efficiency of several closed staple heights in one cartridge, resulting in up to 50% fewer SKUs. If available, these higher efficiency staplers should be listed in the vendors' full line of products. The vendor must be able to supply a full line of products to include at a minimum:: a. Required Items OPEN STAPLER ReLOAD STAPLER UNIT BLUE 12S 1.5MM OPEN STAPLER STAPLER SURGICAL 3S OPEN STAPLER ReLOAD CUTTER LINEAR 75MM 12S 2.0MM CLIP APPLIERS APPLIER CLIP LIGAMAX 5MM ENDOSCOPIC ARTICULATING STAPLER STAPLER ETS FLEX 45 3S ARTICULATING STAPLER ReLOAD STAPLER ENDO CART 12S ARTICULATING STAPLER ReLOAD STAPLER ENDO CARTRIGE GIA ROTICULATOR 45 ARTICULATING STAPLER STAPLER ENDO INTERNAL GIA 30/4 ENDOSCOPIC STAPLER ReLOAD RELOAD CUTTER 35MM 1.0MM ENDOSCOPIC STAPLER 35MM ENDO STAPLER CIRCULAR STAPLER CIRCULAR STAPLER, 25MM W/4 HEAD DIAMETER SIZES 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. A vendor is required to supply all items listed in all sizes and device type. 2. Vendor MUST have a DAPA or be in the process of obtaining a DAPA for the Internal Staplers & Clip Appliers product line. Vendor MUST provide DAPA number with initial submittal or provide documentation that DAPA has been applied for with response submittal. 3. 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/or Owens & Minor, for Internal Staplers & Clip Appliers or be in the process of obtaining Prime Vendor agreements. Vendor must provide documentation to support agreements with initial submittal. 4. 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. Vendor shall not quote FSS prices as the discounted price for purposes of this standardization initiative). 5. 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. 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 Internal Staplers & Clip Appliers product line. A vendor must provide a list of customer service representatives with initial submittal. Phase II Acceptability Evaluation Clinical Performance Clinical Performance Requirements 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 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 or hand delivered 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 who ships products to arrive at MTFs prior to in-servicing MUST be able to deliver product literature, training materials and evaluation samples to the MMESOs Pacific & South via FedEx or UPS AND to the MMESO Europe via United States Postal Service (USPS) and to the continental United States when requested in Phase II. A vendor who cannot or does not meet this requirement will be disqualified from the standardization process. 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). The specific products of each type and size specified below are to be provided as samples in the quantities listed to each of the evaluation sites as identified in the letters of invitation. Sample Set 1 box OPEN STAPLER ReLOAD STAPLER UNIT BLUE 12S 1.5MM 1 unit OPEN STAPLER STAPLER SURGICAL 3S 2 units CLIP APPLIERS APPLIER CLIP LIGAMAX 5MM ENDOSCOPIC 1 unit ARTICULATING STAPLER STAPLER Endo Articulating 45 1 box ARTICULATING STAPLER ReLOAD STAPLER ENDO CART 1.0MM 1 box ENDOSCOPIC STAPLER ReLOAD RELOAD CUTTER 35MM 1.0MM 1 unit ENDOSCOPIC STAPLER 35MM ENDO STAPLER 2 units CIRCULAR STAPLER CIRCULAR STAPLER, 25MM W/4 HEAD DIAMETER SIZES 1. Vendor WILL BE required to demonstrate their products, as requested above, utilizing foam or other materials which approximate the performance in actual clinical usage, as part of the evaluation. Vendor will be given a specific date and time at each of the participating MTFs in which they will demonstrate each of the samples, answer questions, and allow participants to handle and manipulate the sample products so the participants can assess the defined clinical requirements. As required in the CPT signed Non-Disclosure agreements, no discussions of the actual criteria results are to take place between the vendor and the evaluators. If the vendor cannot have a representative on site, then they must provide an instructional DVD and be present on a Video Conference at the scheduled time for their demonstration to the CPT for each evaluating site. A vendor who does not make the before mentioned arrangements for their scheduled demonstration at each evaluating site will be disqualified from this standardization initiative. Note: vendor must send the MMESO Pacific confirmation regarding the method (In Person or Video Conference) and scheduled demonstration dates at each participating MTF before COB 30 calendar days from the issue of the notice in which to deliver the product samples for clinical evaluation at Phase II. 2. Vendor WILL DEMONSTRATE their products using the sample set as requested during the scheduled time. Once the vendor presentation time period is complete, the vendor must leave the facility. 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. 3. Once the vendor leaves the room, the MMESO CPT, comprised of medical professionals from multiple disciplines, will begin the evaluation process and complete the evaluation forms for the vendors' products using the Likert scale format as defined below. 4. Each evaluator will evaluate each 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. 5. The clinical/performance evaluations will be scheduled over a fourteen (14) calendar day period. 6. 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. 7. 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. 8. Of those vendors who are qualified as clinically preferred, selection for each MMESO AOR will be based on best price. 9. A vendor who has been disqualified or has not been selected will be notified in writing upon disqualification. 10. 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. 11. 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 ten (10) MTFs enterprise wide that will be evaluating products. Clinical/Performance Requirements: During the acquisition planning process, the MMESO CPT validated/approved the clinical/performance requirements outlined below. 1. Device is ergonomically designed to fit comfortably in either hand and is slip-resistant. (Non-slip grip provides improved control and efficiency.) (Clinician Efficiency of Care/Patient Safety - NPSG 07.02.01). Instrument handles will fit comfortably in either left or right hand and will remain securely positioned (without slipping) in clinician's gloved hand throughout procedure, under both wet and dry conditions, in order to avoid patient injury. 2. The product has no sharp or rough edges which may interfere with or impede insertion of the various devices via trocars. (Patient Safety - NPSG 07.05.01) There must be no sharp or rough edges which would interfere with or impede insertion of the various devices via trocars and which could in turn lead to extended time under anesthesia, jeopardizing patient safety. 3. The product is easy to use and is durable. (Patient Safety - NPSG 07.02.01) Stapler and clip applier handles will easily compress when gripped, and staples or clips will deploy with ease. The product will perform as designed the first time and not have a failure which could necessitate keeping the patient under anesthesia longer than necessary. The instrument will continue to function properly throughout the duration of the procedure. 4. Product packaging is easy to open and allows for aseptic delivery to a sterile field. (Pull-apart segments or tear-away tabs do not damage packaging or expose contents.) (Patient Safety; Prevent hospital acquired infection - NPSG 07.02.01) Product packaging must be easy to open and allow for aseptic delivery to a sterile field because compromising the sterile field could lead to patient infection. In addition, a contaminated product could delay the surgical procedure and lead to extended time under anesthesia. 5. Staplers provide consistent staple formation, minimizing tissue trauma and achieving hemostasis by supporting tissue closure. (Patient Safety/Comfort; NPSG 07.05.01) Staple formation must be consistent to indicate that the stapler is functioning properly and will achieve the desired goal of hemostasis, control bleeding and prevent hemorrhage. 6. The packaging is easily identifiable as to size and type of product. (Efficiency of Use and Patient Safety - FDA Standard for Device Labeling - 21 CFR 820.120 and NPSG 07.02.01) Instrument containers (packaging) will be clearly and boldly labeled with the product type and size in order to avoid errors and waste in the O.R. Phase III Pricing Analysis Price 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 5:00 PM 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. Pricing should be provided for each MMESO area of responsibility (AOR) based on committed volume of 80% of the total volume in sales of the MTFs in that MMESO AOR. 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 vendors' 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/MP-1102-11_Internal_Staplers_Clip_Appliers/listing.html)
- Place of Performance
- Address: Tripler Army Medical Center, 1 Jarrett White Road, United States, Honolulu, Hawaii, 96859-5000, United States
- Zip Code: 96859-5000
- Zip Code: 96859-5000
- Record
- SN02448290-W 20110517/110515233024-7e3840232a8258ff2f4a2fcff67c3446 (fbodaily.com)
- Source
-
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