SOLICITATION NOTICE
65 -- OR Drapes (Disposable) - Technical/Company Requirements Response Document
- Notice Date
- 6/28/2011
- 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
- ME-1104-19_OR_Drapes
- Point of Contact
- Robert Halliday, Phone: 011-49-6221-172109, Thomas Winkel, Phone: 011-49-6221-172106
- E-Mail Address
-
Robert.halliday@us.army.mil, tom.winkel@us.army.mil
(Robert.halliday@us.army.mil, tom.winkel@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- Responses to this RFIAQ should include all the information as indicated in the FBO. Please 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 OR Drapes. The MMESO Europe 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) and operational assemblages based on the critical balance of clinical efficacy and value. 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 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 award for this SA. 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 MMESOs Area of Responsibility (AOR), 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 September 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. Point of Contact: Mr. Robert Halliday, MMESO Europe Clinical Analyst, Robert.halliday@us.army.mil and 011-49-6221-172109 or Mr. Tom Winkle, MMESO Europe Team Leader, tom winkel@us.army.mil and 011-49-6221-172106. B. Products & Performance Required. The MMESOs are seeking product line items in the category of OR Drapes. Within the MMESOs this product line has an estimated annual dollar requirement of $1,552,522.09. 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 fifteen (15) cluster groups of the total sixty-two (62) clustered groups accounts for 81.10% ($1,259,214.52) of the total volume in sales ($1,552,522.09) 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 15 lines. 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 Mr. Robert Halliday, MMESO Europe, Clinical Analyst, Robert.halliday@us.army.mil and Mr. Tom Winkle, Team Leader, tom.winkle@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., vendors are strongly encouraged to confirm with the MMESO Europe that its initial submission, quote and literature actually arrived at the MMESO Europe via e-mail. 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 that do not meet the deadline of COB 5:00PM Eastern Standard Time (EST) on the date listed for closing (per the FBO RFIAQ), 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 based on committed volume of 80% of the total requirements of the MTFs in the MMESOs. The MMESO Europe reserves the right to conduct discussions and request revised quotes, if determined necessary. Technical 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 procedures the MMESO CPT validated/approved the company/technical requirements outlined below. The twelve (12) requirements below must be answered and supporting documentation submitted 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. A vendor must provide a complete line of disposable OR Drapes. The disposable OR Drapes must be strong, durable, have sound drape ability, and be flame and abrasion resistant. 1. This product line includes sterile and non-sterile, single use, disposable, latex-free operating room drapes in various sizes (sizes are approximate understanding that companies manufacture slightly different sized product items), styles, and levels of protection: 1) drapes surgical sheets fanfold, 2) drapes surgical u-drape, 3) drapes surgical towel, 4) drapes surgical split, 5) drapes surgical laparotomy, 6) drapes surgical extremity, 7) back table covers, 8) Mayo stand covers, 9) drapes surgical utility, 10) drapes surgical isolation, 11) drapes stockinette, 12) drapes surgical under buttock, 13) drapes leggings, 14) drapes surgical shoulder, and 15) drapes hand to include at a minimum the specific products listed. Drape surgical sheet approximately 60x76inches reinforced, fanfold Drape surgical U-drape approximately 60x70inches impervious Drape surgical split approximately 77x120inches reinforced, tube holder Drape towel surgical approximately 17x23inches adhesive strip Drape surgical laparotomy approximately 104x76x120inches fenestrated adhesive Drape surgical extremity approximately 106x129inches fenestrated reinforced Back table covers approximately 44x88inches reinforced Mayo stand covers approximately 23inches reinforced Drape surgical utility approximately 15x26inches adhesive strip fenestrated Drape surgical isolation, pouch, drain, tube holder Drape stockinette approximately 12x48inches impervious Drape surgical under buttock approximately 38x48inches pouch with drain Drape leggings clear approximately 31x48inches Drape surgical shoulder approximately 160x105inches adhesive strip, pouch w/drain Drape hand fenestrated approximately 76x150inches tube holder table extension *Operational usage items are included in this list of OR Drapes. 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. Vendors are required to supply all items listed in all sizes. (Vendors who do not have a complete product line as stated above will be disqualified in Phase I). 2. Vendor must provide supporting documentation that all OR Drapes that are manufactured must be in compliance with the guidelines established by the Center for Disease Control and Prevention (CDC) which involves the Healthcare Infection Control Practices Advisory Committee (HIPAC) and the Department's Steering Committee for the Prevention of Healthcare Associated Infections (HAIs) recommended infection control technology that is proven to reduce infections at the same time providing patient comfort and clinical performance, and provide supporting documentation to support this requirements with the initial submittal. Products will conform to the levels of barrier protection by the Association for the Advancement of Medical Instrumentation (AAMI) PB70:2003 guidelines for Liquid Barrier Performance and Classification of Protection Apparel and Drapes Intended for use in Health Care Facilities. 3. Vendor must provide OR Drapes that are non-toxic and have non-fast dyes. Provide supporting documentation with initial submittal. 4. Vendor must provide OR Drapes that have minimal lint. Provide supporting documentation with initial submittal. 5. Vendors must provide OR Drapes that have the maximum rating for flame resistance (CPSC: 16 CFR Part 1610; Class I. Standard for flammability of clothing and textiles). 6. Vendor must provide OR Drapes that withstand rubbing and abrasion throughout a procedure decreasing the generation of particulate contaminants and airborne bacterial transmission. 7. Vendor must provide OR Drapes that have a barrier material which is impermeable to liquids and microorganisms. 8. Vendor must provide OR Drapes with packaging that easily identifies the drape which includes the size and other product descriptions for the drape. 9. Vendor must provide placement and unfolding directions that are visible and understandable for all specialty OR Drapes. 10. Vendor must have a Distribution and Pricing Agreement (DAPA) for OR Drapes or be in the process of applying for a DAPA number for the OR Drapes product line. Vendor must provide the DAPA number or provide documentation that DAPA has been applied for with response submittal. Your DAPA number is: __________________. 11. Vendor must have agreements with the current Med/Surg prime vendors for each MMESO AOR, i.e. Cardinal Health and Owens & Minor for OR Drapes or be in the process of obtaining Prime Vendor agreements. 12. Vendor must submit discounts off DAPA for all products included in this standardization initiative. (Note: vendors that fail to submit a discount from DAPA will be disqualified. Where lower uncommitted Federal Supply Schedule (FSS) prices are available, DAPA holders are required by previous agreement to provide the FSS price as the DAPA price. Vendors shall not quote FSS prices as the discounted price for purposes of this standardization initiative. Vendors who do not provide discounts off DAPA for all products in Phase II will be disqualified. Phase II Acceptability Evaluation Clinical Performance Clinical Performance Requirements Following acceptability of the technical/company requirements, the MMESO Europe, 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 EST 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 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 who cannot or does not meet this requirement will be disqualified from the standardization process. Vendor must send the MMESO Europe 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. Five (5) samples of each type/size sterile drape listed below are to be provided as samples to each of the evaluation sites as identified in the letters of invitation. 1. Drape surgical U-drape (disposable) adhesive strip impervious, sterile, approximately 60 x 70inches 2. Drape surgical extremity fenestrated reinforced/impervious tube holder, sterile, approximately 106 x 129inches 3. Drape surgical laparotomy fenestrated adhesive strip, sterile, approximately 104x76x120inches fenestrated adhesive 4. Drape surgical shoulder fenestrated adhesive strip pouch with drain, sterile, approximately 160 x 105inches, 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. Each evaluator will evaluate each OR Drape 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 in a non-clinical/non-patient care setting. A 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 will be based on best price. A 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 Europe, and results will be forwarded to the MMESO CPT for final review. There will be approximately twenty-two (22) MTFs enterprise wide that will be evaluating products. Clinical/Performance Requirements: During the acquisition planning procedures the MMESO CPT validated/approved the clinical/performance requirements outlined below: 1. AST Standard of Practice VI - Drape material and performance - The OR drape's folding, draping, and flexibility allows the product to function properly in the operating room. The OR drape material must be flexible in order to conform to the contour of the patient and OR table during the operating procedure without compromising sterility. 2. AST Standard of Practice III - Drapes must be resistant to fluid penetration - The OR drape resists saturation and any penetration of liquids. The OR drape must effectively resist saturation and /or any liquid penetration to maintain sterility during the operating procedure. 3. AST Standard of Practice II - A compromise in the integrity of the microbial barrier results in contamination - The OR drape does not tear and/or perforate during the surgical procedure. The OR drape must effectively resist tears and/or perforations to maintain sterility during the operating procedure. 4. AST Standard of Practice VI - Drape material and performance - The construction of the OR drape is of good quality. The OR drape's construction must have the correct fenestration size for the surgical procedure, critical areas around the fenestration must be reinforced, and the construction must have the lowest lint particles possible. 5. AST Standard of Practice VI - Drape material and performance - Drape placement and unfolding directions must be clearly visible and understandable. The directions for OR drape's must be clearly visible and understandable reducing any error in placement reducing contamination of the surgical site. 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 Europe and must be received 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. 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 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 vendors' 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/ME-1104-19_OR_Drapes/listing.html)
- Place of Performance
- Address: ERMC HQ, CMR 442, Dept G4, Bldg 3613, Rm 0055, Heidelberg,Nachrichten Kaserne, Non-U.S., APOAE09042, Germany
- Record
- SN02483743-W 20110630/110628234301-20523d8ea4693f095d7bf8c77e6795aa (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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