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FBO DAILY ISSUE OF JUNE 30, 2011 FBO #3505
SOLICITATION NOTICE

65 -- OR Equipment Drapes - Responses to Technical Requirements

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-1104-20_OR_Equipment_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 Equipment 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 MMESO 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. Points of Contact: Mr. Robert Halliday, Clinical Analyst, Robert.halliday@us.army.mil and COM 011-49-6221-172109 or Mr. Tom Winkel, Team Leader, Tom.winkel@us.army.mil and COM 011-49-6221-172106. B. Products & Performance Required. The MMESOs, are seeking product line items in the category of OR Equipment Drapes. Within the MMESOs this product line has an estimated annual dollar requirement of $482,744.93. This forecast is based on historical prime vendor sales during a recent 12-month period. Based on the recent 12-month usage data, seventy-two (72) of the total one hundred and thirty-six (136) line items represent the top twenty-one (21) products and accounts for 80.10% ($386,772.06) of the total volume in sales ($482,744.93) 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 10 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 RFIAQ to Mr. Robert Halliday, Clinical Analyst, Robert.halliday@us.army.mil or Mr. Tom Winkel, Team Leader, Tom.winkel@us.army.mil. The vendor's initial responses will include detailed information requested in the technical/company requirements 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 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 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 eleven (11) requirements below must be answered with the vendor's initial submittal and any required documentation provided by the response date. Vendors who do not meet these requirements and provide supporting documentation will be disqualified during Phase I. 1. Vendors must provide a complete line of disposable OR Equipment Drapes. The disposable OR Equipment Drapes must be strong, durable, have sound drape ability, and be flame and abrasion resistant. a. This product line includes sterile, single use, disposable, latex-free operating room equipment drapes in various approximate sizes (sizes are approximate understanding that companies manufacture slightly different clinically equivalent sized product items) and styles: 1) drapes solution slush, 2) drapes x-ray C-arm, 3) drapes camera/laser, 4) drapes microscope, 5) drapes x-ray mini C-arm, 6) drapes ultrasound probe, 7) drapes x-ray cassette, 8) banded bags to include at a minimum the specific products listed. Drape x-ray C-arm, approximately 41x72 inches Drape x-ray C-arm, approximately 60x105 inches Drape slush, approximately 44x66 inches Drape camera/laser, approximately 5x96 inches Drape microscope, approximately 52x154 inches Drape microscope, approximately 46x80 inches Drape x-ray mini C-arm, approximately 54x84 inches Drape ultrasound probe, approximately 5x96 inches Cover footswitch, approximately 14x30 inches Banded bag, approximately 30x36 inches * Operational usage items are included in this list of OR Equipment 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. 2. Vendors MUST provide supporting documentation that all OR Equipment Drapes are in compliance with the Association of Peri-Operative Registered Nurses; Standards and Recommended Practices. "Non-sterile equipment (e.g., Mayo stands, microscopes, C-arms) should be covered with sterile barrier material(s) before being introduced to or brought over a sterile field. Only sterile items should touch sterile surfaces. The equipment should be covered with a barrier material on the top, bottom, and all sides. Sterile barrier material also should be applied to the portion of the equipment that will be positioned immediately adjacent to the sterile field". The standards are also located with the Joint Commission Accreditation Program: Hospital-National Patient Safety Goal (NPSG) 07.05.01; Implement evidence-based practices for preventing surgical site infections. The Consumer Product Safety Commission (CPSC): 16 CFR Part 1610; Class I, Standard for flammability of clothing and textiles; when evaluating an equipment drape, the surgical team members should confirm that the manufacturer's information includes the statement, "The basic fabric meets the Class 1Flammability Requirements for CPSC 16 CFR Part 1610. 3. Vendors must provide OR Equipment Drapes that are non-toxic and have non-fast dyes. 4. Vendor must provide camera/laser OR Equipment Drapes that are available in sizes to be used with Zeiss and Leica manufactured microscope models. 5. Vendor must provide microscope OR Equipment Drapes that feature observer tubes, poly straps and easy-to-use closures to provide a custom fit around the ocular aspect of the microscope. Provide supporting documentation with initial submittal. 6. Vendors must provide OR Equipment Drapes with packaging that easily identifies the drape which includes the size and other product descriptions for the drape. 7. Vendors must provide OR Equipment Drapes that have the maximum rating for flame resistance (CPSC: 16 CFR Part 1610; Class I, Standard for flammability of clothing and textiles). 8. Vendor must provide OR Equipment Drapes that have a barrier material which is impermeable to liquids. 9. Vendors must have a Distribution and Pricing Agreement (DAPA) for OR Equipment Drapes or be in the process of applying for a DAPA number for the OR Equipment Drapes product line. Vendor must provide the DAPA number with initial submittal or provide documentation that DAPA has been applied for with response submittal. Your DAPA number is: __________________. 10. Vendor must have agreements with the current Med/Surg prime vendors for each MMESO AOR, i.e. Cardinal Health and/or Owens & Minor for OR Equipment Drapes or be in the process of obtaining Prime Vendor agreements. Vendor must provide documentation to support agreements with initial submittal. 11. Vendors 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. 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 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 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). Two (2) samples of each type/size listed below are to be provided to each of the evaluation sites as identified in the letters of invitation. 1. Drape slush approximately, approximately 44x66 inches - 2 per MTF/CPT member 2. Drape X-ray C-arm, approximately 41x72 inches - 2 per MTF/CPT member 3. Drape camera, approximately 5x96 inches - 2 per MTF/CPT member 4. Drape microscope, approximately 17x23inches - 2 per MTF/CPT member The clinical/performance acceptability evaluation period will last for fourteen (14) calendar days. The acceptability evaluation will be conducted using the below listed requirements with responses as either a "YES" (meets/passes requirements) or "NO" (does not/fails to meet requirements) answers. The MMESO JPRB has established that the Clinically Preferred threshold of products for standardization will be eighty percent (80%) of the requirements questions answered as "YES" (meets/passes requirements). Vendor scoring below the clinically preferred threshold will be disqualified from selection for this standardization initiative. 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. Each evaluator will evaluate each OR Equipment Drape 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. There will be approximately sixteen (16) 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. AORN Standards and Recommended Practices - The equipment drape must allow visibility of equipment. The OR equipment drape must be made of clear plastic (synthetic polymer) allowing the OR personnel to maintain visibility of the device for operational purposes without compromising sterility. 2. AORN Recommended Standards & Joint Commission NPSG.07.05.01- The equipment drape accurately and efficiently covers the OR equipment device maintaining the shape of the device and provides sterile barrier between the equipment and the sterile field. The OR equipment drape must provide a sterile barrier for the equipment it is covering before being introduced to or brought over a sterile field. Only sterile items should touch sterile surfaces. 3. Joint Commission NPSG.07.05.01 - The equipment drape must be made from heavy gauge material to help reduce the possibility of pinholes or tears. The OR equipment drape must be resistant to punctures and tears to prevent microbial contamination of the sterile field. 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. 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.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/DLA/J3/DSCP-M/ME-1104-20_OR_Equipment_Drapes/listing.html)
 
Place of Performance
Address: ERMC HQ, CMR 442, Dept G4, Bldg 3613, Rm 0055, Heidleberg, Nachrichten Kaserne, Non-U.S., APOAE09042, Germany
 
Record
SN02483757-W 20110630/110628234309-8e6737441e040df6a0a88d1968c9aee0 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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