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Surgical Masks

Solicitation Number: ME-1105-41_Surgical_Masks
Agency: Defense Logistics Agency
Office: DLA Acquisition Locations
Location: DLA Troop Support - Medical
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ME-1105-41_Surgical_Masks
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Combined Synopsis/Solicitation
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Added: Nov 03, 2011 3:04 pm
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 Surgical Masks. The MMESO Europe is the lead MMESO for this project.

The primary objective of this effort is to standardize the quality of care across the Military Treatment Facilities (MTFs) and operational assemblages based on the critical balance of clinical efficacy and value. The intent for this initiative is the standardization of a clinically preferred product(s) and source for institutional and operational medicine requirements at the best price for each MMESO Area of Responsibility (AOR). It is also intended for this initiative to result in the reduction of Stock Keeping Units (SKUs) and National Stock Numbers (NSN). Standardized products must 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 for each MMESO AOR. 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. 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 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 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 or be in the process of obtaining a DAPA and a separate commercial agreement with the current Med-Surg PV for each MMESO AOR for which a quote is submitted, 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://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 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 December 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. Points of Contact: Mr. Robert Halliday, Clinical Analyst, Robert.halliday@us.army.mil and COM 011-49-6221-172108 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 Surgical Masks. Within the MMESOs this product line has an estimated annual dollar requirement of $1,971,522.19. This forecast is based on historical usage data during a recent 12-month period. Based on usage data, one eighty-four (84) of the total one hundred and fifty-three (153) line items represent the top six (6) products and accounts for 75.8% ($1,495,329.98) of the total volume in sales, $1,971,522.19, in the MMESOs and are clinically significant. Estimated annual demand per AOR is approximately MMESO North $455,791.04, MMESO South $524,702.06, MMESO West $474,480.00, MMESO Europe $352,783.78, MMESO Pacific $156,683.28, and Non-MMESO purchases $7,082.03. 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 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 criteria 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. 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 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 for each MMESO AOR based on committed volume of 80% of the total requirements of the MTFs in that MMESO AOR. The MMESO Europe reserves the right to conduct discussions and request revised quotes, if determined necessary.


Technical/Company Evaluation
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 and 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 ten (10) 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 Surgical Masks products.
a. This product line, Surgical Masks, includes latex-free, fog free, flat masks (both procedure and surgical); and specialty masks (both high-filtration flat masks and cone masks), to include at a minimum the specific products listed.
1) Procedure Mask, pleated, fluid resistant, with eye shield
2) Procedure Mask, pleated, fluid resistant, sub-micron particulate filtration efficiency (PFE) > 95%
3) Surgical Mask, fluid resistant, pleated with eye shield
4) Surgical Mask, pleated, fluid resistant, bacterial filtration efficiency (BFE) > 95%
5) Procedure Mask, pleated, PFE > 95%
6) Cone Mask, cone, standard
*Operational usage items are included in this list of Surgical Masks.
b. Vendor must provide a complete itemized list of items supplied (manufactured and/or distributed 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 styles.
2. Vendor must provide documentation or a statement revealing all products containing a synthesized polymer (plastic/rubber) are clearly labeled as latex-fee/safe; all products are nontoxic and contain non-fast dyes.
3. Vendor must provide masks that are available with fluid penetration resistance (APIC recommends160 mm/Hg), the ability to filter aerosol particles, and a BFE greater than 95% in accordance with (IAW) the American Society for Testing and Materials (ASTM) F 1862, ASTM F 2299, and ASTM F 2101 respectively.
4. Vendor must provide supporting documentation that all products meet the industry production and safety standards used in manufacturing Surgical Masks.
5. Vendor must provide supporting documentation indicating their product line of Surgical Masks' fluid penetration resistance, bacterial filtration efficiency (BFE), and sub-micron particulate filtrations efficiency (PFE) accompanies the box of masks and/or is easily identifiable on the mask packaging.
6. Vendor must have a DAPA or be in the process of applying for a DAPA number for the Surgical Masks. Vendor must provide the DAPA number or provide documentation the DAPA number has been applied for.
7. 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 Owens & Minor for Surgical Masks, or be in the process of obtaining Prime Vendor agreements.
8. 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. Vendor is not required to provide a quote for all MMESO AORs. A vendor who does not provide discounts off DAPA in Phase III for all products will be disqualified.
9. 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.
10. Vendor must identify with initial submittal which MMESO AOR(s) they intend to submit quotes for. Vendor will not have an opportunity to change MMESO AOR(s) during any subsequent stage in this evaluation.

Phase II Phase II Clinical/Performance Evaluation Acceptability


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 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/catalog, 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 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. The unused samples will not be returned. One (1) box (approximately 25-50 masks) of the items per MTF listed below are to be provided as samples to each of the evaluation sites as identified in the letters of invitation.
1. Procedure Mask, pleated, fluid resistant, fog free with eye shield, BFE > 95%
2. Surgical Mask, pleated, fluid resistant, fog free with eye shield, BFE > 95%
3. Surgical mask, pleated, fluid resistant, fog free, BFE > 95%


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 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 or has not been selected will be notified in writing upon completion of the standardization selection. 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 procedures the MMESO CPT validated/approved the clinical/performance requirements outlined below:
1. FDA/CDRH Safety and effectiveness of medical devices- The surgical/procedure mask is comfortable, does not inhibit breathing and does not get hot during the procedure. The surgical/procedure mask's construction must allow the user a proper fit, but at the same time not being so tight as to inhibit breathability; and it should not get "hot" over long periods of time.
2. Health Care Personnel Preference/Patient Safety - The surgical/procedure mask fog-free device is functional. The surgical/procedure mask fog-free device maintains a clear field of vision for health care personnel wearing eye-protection.
3. AORN Recommendation III, Recommended Practices for Surgical Attire - The surgical/procedure mask prevents venting. Masks are intended to contain and filter droplets of microorganisms expelled from the mouth and nasopharynx during talking, sneezing, and coughing.
4. OSHA Bloodborne Pathogen Standard Reduce the exposure to blood or other infectious materials - The surgical/procedure mask resists penetration of liquids (fluid strike-throughs). The surgical/procedure mask must effectively resist any liquid penetration to protect health care personnel during the operating procedure or procedures performed outside the operating room.

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 5:00PM 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. 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 AOR based on a committed volume of 80% of the total volume in sales of the MTFs in that MMESO AOR. Vendor quotes will contain separate pricing for each MMESO AOR(s) that was identified in Technical / Company Requirements above. 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 vendor's 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.

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Technical / Company Requirement Response Document

Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Label:
Technical / Company Requirement Response Document
Posted Date:
November 3, 2011
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.
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700 Robbins Avenue
Philadelphia, Pennsylvania 19111-5096
United States
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ERMC HQ
CMR 442
Dept G4, Bldg 3613, Rm 0055

Heidelberg, Nachrichten Kaserne, APOAE09042
Germany
:
Robert Halliday,
Clinical Analyst
Phone: 011-49-6221-172109
:
Thomas Winkel,
Team Leader/Logistician
Phone: 011-49-6221-172106