SOLICITATION NOTICE
65 -- Mask_Particulate_Respirator (N95) - Technical Requirement Documents
- Notice Date
- 2/13/2012
- 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-1108-55_Mask_Particulate_Respirator_(N95)
- 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
- 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. The Defense Medical Materiel Program Office (DMMPO) announces a Request for Incentive Agreement Quotation (RFIAQ) for the standardization of Mask Particulate Respirator (N95). The Medical Materiel Enterprise Standardization Office (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 lowest price. 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. 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 vendor selection for this SA. 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 Ambulatory Surgical 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 SA is part of the Medical/Surgical Prime Vendor program executed by the Defense Logistics Agency (DLA) Troop Support, Directorate of Medical Materiel. To participate in this SA your company must have or be in the process of obtaining 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 initiative and agree to allow PVs to distribute their products. The 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 participate in 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 July 2012. 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 011-49-6221-172109 and Mr. Tom Winkel, Team Leader, Tom.winkel@us.army.mil 011-49-6221-172106. B. Products & Performance Required. The MMESOs are seeking product line items in the category of Mask Particulate Respirator (N95). Within the MMESOs this product line has an estimated annual dollar requirement of $10,358,864.65. This forecast is based on historical usage data during a recent 12-month period. Based on usage data, nineteen (19) of the total thirty one (31) line items represent the top two (2) products and account for 99.57% ($10,314,587) of the total volume in sales $10,358,864 in the MMESOs and are clinically significant. 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. Rob Halliday, Clinical Analyst, at robert.halliday@us.army.mil and 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 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 email to be lost in transmission, from network security, etc., vendors are strongly encouraged to confirm with the MMESO Europe that their initial submissions, quote and literature 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. 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 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 MTFs within each MMESO. The Clinical Advisory Committee (CAC) members are the deciding officials for this initiative. 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. Phase I Technical/Company Evaluation The MMESO CPT will review the responses from the vendors and determine which vendors meet the technical/company requirements. A vendor must meet the technical requirements for continued consideration in this initiative. 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 process and will be requested to submit products for testing and their best price discount quotes via an e-mail 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 pre-source selection procedures, the CPT approved the technical/company requirements outlined below. The requirements below must be answered with the vendor's initial submittal and required documents 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 Mask Particulate Respirator (N95) products. a. This product line, Mask Particulate Respirator (N95), includes disposable, latex-free/safe, particulate respirator masks to include at a minimum the specific products listed. 1) N95 Respirator, disposable, fluid resistant (160mmHg), size medium/large or regular 2) N95 Respirator, disposable, fluid resistant (160mmHg), size small *Operational usage items are included in this list of Mask Particulate Respirator (N95). 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 above. 2. Vendor must provide documentation or a statement revealing all products containing a synthesized polymer (plastic/rubber) are clearly labeled as latex-free/safe. 3. Vendor must provide Mask Particulate Respirators (N95) that provide the highest ASTM level of fluid resistance (160 mm/Hg), meets CDC guidelines for protection against TB, the NIOSH certified particle filter efficiency (PFE) of 95% or greater, and bacterial filtration efficiency (BFE) greater than 99% 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 disposable Mask Particulate Respirators (N95) meaning they are NIOSH approved and have the TC-Approval Number labeled on the product as required (September 2008 requirement). 5. Vendor must provide supporting documentation indicating their product line of Mask Particulate Respirators (N95) is non-toxic and has colorfast dyes that do not run. 6. Vendor must provide supporting documentation indicating their product line of Mask Particulate Respirators (N95) PFE, BFE, and ASTM level of fluid resistance accompanies the box of masks and/or is easily identifiable on the mask packaging. 7. Vendor must provide supporting documentation indicating their product line of Mask Particulate Respirators (N95) has two straps for securing the respirator to the face. The straps should be attached to the respirator so one strap allows securement across the upper part of the back of the head (occipital) and the other secures across the back of the neck. The straps should be made of elastic material (non-latex) and be of sufficient length to create an adequate seal against the face. 8. Vendor must provide, per OSHA 1910.134 Appendix B-1, the recommended procedure (positive or negative pressure check) by the manufacturer of the Mask Particulate Respirator (N95) explaining how the user performs a seal check. 9. Vendor must have a DAPA or be in the process of applying for a DAPA number for the Mask Particulate Respirators (N95). Vendor must provide their DAPA number or provide documentation and the date the DAPA number was applied for. 10. Vendor must have agreements with the current Med/Surg Prime Vendors for each MMESO AOR, i.e. Cardinal Health and Owens & Minor for Mask Particulate Respirators (N95), or be in the process of obtaining Prime Vendor agreements. 11. 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 terms of the DAPA 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. A vendor who does not provide discounts off DAPA in Phase III for all products will be disqualified. 12. 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. Phase II Clinical Performance Evaluation 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 specific 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 in 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 EST before the 30th calendar day. Vendor must be able to deliver product literature, training materials and evaluation samples as requested to the MMESO Pacific via FedEx or UPS AND to the MMESO Europe via United States Postal Service (USPS) Express Mail or Priority Mail with delivery confirmation service 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. Unused samples will not be returned. Twenty (20) respirators of each Mask Particulate Respirator (N95) listed below is to be provided to each of the evaluation sites as identified in the letters of invitation. 1 box equals approximately 20 respirators. 1) N95 Respirator, disposable, fluid resistant (160mmHg), size medium/large or regular, 20 respirators per MTF test site 2) N95 Respirator, disposable, fluid resistant (160mmHg), size small, 20 respirators per MTF test site Each evaluator will evaluate each 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. 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 who has been disqualified will be notified in writing upon completion of the standardization selection. Of those vendors that are qualified as clinically preferred, selection will be based on best price. 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. A Fit Test is a test protocol conducted to verify that a respirator is both comfortable and correctly fits the user. Fit testing each model of respirator the employee is to use in workplace tasks before their use is important (OSHA Regulation 29 CFR 1910.134) to assure the expected level of protection is provided by minimizing the total amount of contaminant leakage into the facepiece. Each vendor's mask to be evaluated will be Fit Tested for each participating evaluator prior to the clinical evaluation in a patient setting. Each MTF participating on the CPT will use their current Fit Test protocol and be responsible for the expense needed to Fit Test the participating vendor's mask particulate respirators. The time allotted for each MTF to conduct the Fit Test for each evaluator involving each participating vendor's mask particulate respirator (N95) is fourteen (14) calendar days. There will be approximately fourteen (14) MTFs enterprise wide that will be evaluating products. Clinical/Performance Requirements During the acquisition planning process, the CPT approved the clinical/ performance requirements outlined below. 1. FDA/CDRH Safety and effectiveness of medical devices - The Mask Particulate Respirator (N95) is comfortable, does not inhibit breathing, and does not get hot during use. The Mask Particulate Respirator's (N95) construction must allow the user a proper fit but at the same time not be so tight as to inhibit breathing and does not get hot during use making the respirator uncomfortable. 2. OSHA Regulation 29 CFR 1910.134 - The Mask Particulate Respirator (N95) does not hinder speech. The Mask Particulate Respirator (N95) must not hinder speech enough to interfere with the clinician-to-patient or peer-to-peer communication process depriving quality of care for a patient. 3. Health Care Personnel Preference/Patient Safety - The Mask Particulate Respirator (N95) does not obstruct the user's vision due to fogging of the protective eye-wear. The Mask Particulate Respirator (N95) must be fog free to provide a clear field of vision for health care personnel wearing eye-protection. 4. Health Care Personnel Preference/Patient Safety - The Mask Particulate Respirator (N95) does not obstruct the user's field of vision. The Mask Particulate Respirator (N95) must provide the health care provider a clear field of vision in all directions. Phase III Pricing 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 (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 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DLA/J3/DSCP-M/ME-1108-55_Mask_Particulate_Respirator_(N95)/listing.html)
- Place of Performance
- Address: ERMC HQ, CMR 442, Dept G4, Bldg 3613, Rm 0055, Heidelberg,Nachrichten Kaserne,, Non-U.S., APOAE0904, Germany
- Record
- SN02674050-W 20120215/120213235558-c8a18d2c1ffdf98747b3fc6bab077568 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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