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FBO DAILY ISSUE OF APRIL 07, 2011 FBO #3421
SOLICITATION NOTICE

65 -- Operating Room (OR) Gowns

Notice Date
4/5/2011
 
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_1011-10_OR_Gowns
 
Archive Date
5/12/2011
 
Point of Contact
Mr 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
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 Gowns. 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) 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 (s) for institutional and operational medicine requirements at the best possible price for each MMESO AOR. 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 the clinical preferred threshold, best price will determine selection 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. Vendor is not required to quote for each MMESO AOR. 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 MMESO Area of Responsibility (AOR) for which a quote is submitted, 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 conducted 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 July 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: Mr. Robert Halliday, MMESO Europe Clinical Analyst, Robert.halliday@us.army.mil and 011-49-6221-172109. B. Products & Performance Required. The MMESOs, are seeking product line items in the category of OR Gowns. Within the MMESOs, this product line has an estimated annual dollar requirement of $1,454,747.62. Estimated annual demand per Area of Responsibility is approximately MMESO North $349,264.16, MMESO South $406,839.31, MMESO West $311,564.51, MMESO Europe $229,102.33, MMESO Pacific $159,071.14, and Non-MMESO purchases $1,098.87. This forecast is based on historical Prime Vendor sales during a recent 12-month period. Based on the recent 12-month usage data, the forty-four (44) line items of the total seventy-nine (79) line items, account for 83% ($1,212,155.74) of the total volume in sales ($1,454,747.62) in the MMESOs and are procurement significant. The top high volume usage lines for this project are shown in the Technical/Company Requirements, consolidated by product type to reduce duplication within the top usage 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, Clinical Analyst, robert.halliday@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 Europe that its initial submission, quote and literature actually arrived at the MMESO Europe 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. A vendor who does not meet the deadline of COB 5:00PM 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 Tri-Service Product Review Board (TPRB) 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 the Designated Senior Logisticians (DSLs) and co-chaired by a Designated Senior Clinician (DSC) in the MMESOs AOR 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 (s) 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 a committed volume of 80% of the total volume in sales of the MTFs in that MMESO AOR. The MMESO Europe 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. 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 company/technical requirements outlined below. The twelve (12) requirements below must be answered and all supporting documentation provided 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. Vendor must provide a complete line of disposable OR Gowns. a. At a minimum sterile, single use, disposable, latex-free operating room gowns in the following sizes, styles, and levels of protection: 1) reinforced sizes large (LG) and extra-large (XL), 2) non-reinforced size LG, 3) impervious size XL, and 4) reinforced impervious sizes LG, and double-extra-large (2XL). GOWN SURGICAL DISPOSABLE IMPERVIOUS XL GOWN SURGICAL DISPOSABLE REINFORCED XL GOWN SURGICAL DISPOSABLE REINFORCED IMPERVIOUS 2XL GOWN SURGICAL DISPOSABLE LG GOWN SURGICAL DISPOSABLE REINFORMED IMPERVIOUS LG GOWN SURGICAL DISPOSABLE REINFORMCED LG * Operational usage items are included in this list of OR Gowns. 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. Vendor is required to supply all items listed in all sizes. Vendor who does not have a complete product line as stated above will be disqualified in Phase I. 2. Vendor must provide supporting documentation that all OR Gowns are 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, 3. Vendor must provide OR Gowns and supporting documentation indicating that these items conform to the levels of barrier protection stated in 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. 4. Vendor must provide OR Gowns and supporting documentation indicating that these items are non-toxic and have non-fast dyes. 5. Vendor must provide OR Gowns and supporting documentation indicating that these items have Minimal/Low lint. 6. Vendor must provide OR Gowns and supporting documentation indicating that these items have maximum rating for flame resistance and the basic fabric meets the Class 1 Flammability Requirements in accordance with Consumer Product Safety Commission (CPSC): 16 CFR Part 1610, Standard for the Flammability of Clothing Textiles. 7. Vendor must provide OR Gowns and supporting documentation indicating that these items are resistant to the generation of particulate contaminants and airborne bacterial transmission due to rubbing and abrasion during use. 8. Vendor must provide OR Gowns and supporting documentation indicating that these itmes have a barrier material along the front side and sleeves which is impermeable to liquids and microorganisms. 9. Vendor must provide OR Gowns and supporting documentation indicating that these items have the OR gown's level of barrier protection easily identifiable on the gown and gown packaging. 10. Vendor must have a Distribution and Pricing Agreement (DAPA) for OR Gowns or be in the process of applying for a DAPA number for the OR Gowns product line. Vendor MUST provide the DAPA number with initial submittal or provide documentation that DAPA has been applied for with response submittal. Vendor without a DAPA number or who has not applied for a DAPA will be disqualified in Phase I. DAPA number is: __________________. 11. 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 OR Gowns or be in the process of obtaining Prime Vendor agreements. Vendor must provide documentation to support agreements with initial submittal. Vendor whose products are not available through the Prime Vendors or who has not applied for PV distribution will be disqualified in Phase I. 12. Vendor must submit discounts off DAPA for all products included in this standardization initiative. (Note: vendor who fails to submit a discount from DAPA will be disqualified. Where lower uncommitted Federal Supply Schedule (FSS) prices are available, DAPA holder is 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. Vendor is not required to provide a quote for all line items (MMESO). Vendor who does not provide discounts off DAPA for all products in Phase II will be disqualified. Phase II Acceptability Evaluation Clinical Performance Clinical Performance Evaluations 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 Europe via FedEx or UPS AND to the MMESO Europe via United States Postal Service (USPS) and throughout the United States 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, and 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 disposable operating room gown listed below are to be provided to each of the evaluation sites that will be identified in the letters of invitation. 1. Surgical gown (disposable & sterile), Gown surgical disposable impervious, size XL - 2 per MTF/CPT member 2. Surgical gown (disposable & sterile), Gown surgical disposable reinforced, size XL - 2 per MTF/CPT member 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 TPRB 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. 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 fourteen (14) 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. The OR gown must have barrier protection and resist saturation and any penetration of liquids (fluid strike-throughs) in order to maintain sterility and protect the clinician during an operating procedure in accordance with the Joint Commission National Patient Safety Goal (NPSG) 07.01.01 - Reduce the risk of health care associated infections. a. The ORgown will be wet with water and inspected during and after the simulated surgical procedure process cycle for visual signs of moisture and/or wetness (fluid strike-throughs). 2. The OR gown must resist tears and/or perforations in order to maintain sterility and protect the clinician during an operating procedure in accordance with the Joint Commission NPSG 07.01.01 - Reduce the risk of health care associated infections. a. The OR gown will be manipulated in a way that simulates events during a surgical procedure and inspected during and after the simulated surgical procedure process cycle for visual signs of tears or perforations. 3. The OR gown's construction must have limited memory, be flexible enough to conform loosely to the clinician's body, be lightweight, have breathability, and have a pleasant odor in accordance with AAMI PB70:2003 Product Performance Standards. a. Each OR gown will be donned according to the manufacturer's guidelines and examined for comfort, breathability, weight, conformity to the clinician's body, and any unpleasant odor. 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 and invited to provide product samples and price discount quotes concurrently. 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 the MMESO Europe by 5:00 PM EST, thirty (30) calendar days after the issue date of the vendor notice to submit best product and price quotes. 1. Vendor quotes should contain the vendor's best product matches for the specific products requested in this announcement. 2. Vendor quotes should contain the vendor's best discounts off of the vendor's DAPA pricing for the products identified in this announcement. 3. Pricing should be provided for each MMESO area of responsibility (AOR) based on a committed volume of 80% of the total volume in sales of the MTFs in that MMESO AOR. 4. Vendor is not required to provide a quote for each MMESO AOR The MMESO DSLs and DSCs intend to evaluate quotes and select a vendor (s) on initial submissions/quotes. Price will be analyzed based on the vendor's anticipated post-standardization costs. Post-standardization cost will be calculated for each vendor by applying the vendor's offered prices to the anticipated annual usage of each MMESO. 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/ME_1011-10_OR_Gowns/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
SN02416990-W 20110407/110405234423-06405f390e6ee36d429af6fe2ae6aa42 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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