SOLICITATION NOTICE
65 -- Exam Gloves (Non-Sterile) - Technical/Company Requirements Response Document
- Notice Date
- 7/12/2011
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 339112
— Surgical and Medical Instrument 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
- MW-1104-17_Exam_Gloves
- Point of Contact
- Cheryl Janus, Phone: (619) 532-7554, Ricardo Orias, Phone: 619-532-8537
- E-Mail Address
-
cheryl.janus.ctr@med.navy.mil, ricardo.orias.ctr@med.navy.mil
(cheryl.janus.ctr@med.navy.mil, ricardo.orias.ctr@med.navy.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 Exam Gloves. The MMESO West 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 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 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. 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. 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 Prime Vendor 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 Prime Vendor for each MMESO Region, 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 Prime Vendors to distribute their products. The Incentive Agreement (IA) resulting from this RFIAQ is a supplement to the Prime Vendor Program and is not a contract. For additional information regarding DLA Troop Support Medical's Prime vendor 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 November 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: Ricardo Orias, MMESO West Team Leader, Ricardo.orias.ctr@med.navy.mil,(619) 532-8537; and Cheryl Janus, MMESO West Clinical Analyst, Cheryl.janus.ctr@med.navy.mil,(619) 532-7554. B. Products & Performance Required. The MMESO North, South, West, Pacific and Europe, are seeking product line items in the category of Exam Gloves. Within MMESO North, South, West, Pacific, and Europe, this product line has an estimated annual dollar requirement of $10,912,528. 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 two hundred fifty-eight (258) lines items of the total five hundred nine (509) line items, account for 82.8% ($9,036,598) of the total volume in sales ($10,912,528) in the MMESO North, South, West, Pacific, and Europe and are statistically 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 Ricardo Orias, MMESO West Team Leader, ricardo.orias.ctr@med.navy.mil, and Ms. Cheryl Janus, Clinical Analyst, cheryl.janus.ctr@med.navy.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 West that its initial submission, quote and literature actually arrived at the MMESO West 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. Vendors who do not meet the deadline of COB 5:00 PM Pacific Daylight Savings Time (PDST) 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 West 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. Vendors must meet the technical requirements for continued consideration in this initiative. Vendors who do 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. The vendors who meet 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 technical/company requirements outlined below. The six (6) requirements below must be answered with the vendor's initial submittal by the response date stated in the FBO announcement. A vendor who does not meet these requirements or those who do not submit documentation to support these requirements with initial submittal will be disqualified in Phase I. 1. Vendor MUST provide a line of Exam Gloves products that includes at a minimum the specific products identified below. Exam Gloves are to be non-sterile synthetic powder-free and latex-free/safe. a. GLOVE EXAM NON-STERILE SYNTHETIC POWDER-FREE BEADED CUFF NITRILE LG TEXTURED LATEX-FREE GLOVE EXAM NON-STERILE SYNTHETIC POWDER-FREE BEADED CUFF NITRILE MED TEXTURED LATEX-FREE GLOVE EXAM NON-STERILE SYNTHETIC POWDER-FREE BEADED CUFF NITRILE SM TEXTURED LATEX-FREE GLOVE EXAM NON-STERILE SYNTHETIC POWDER-FREE BEADED CUFF POLYVINYL CHLORIDE MED GLOVE EXAM NON-STERILE SYNTHETIC POWDER-FREE BEADED CUFF POLYVINYL CHLORIDE LARGE GLOVE EXAM NON-STERILE SYNTHETIC POWDER-FREE NITRILE LG LATEX-FREE CHEMICAL RESISTANT GLOVE EXAM NON-STERILE SYNTHETIC POWDER-FREE NITRILE MED LATEX-FREE CHEMICAL RESISTANT GLOVE EXAM NON-STERILE SYNTHETIC POWDER-FREE NITRILE SM LATEX-FREE CHEMICAL RESISTANT * Operational usage items are included in this list of Exam Gloves. 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 and device type. 2. Vendor MUST provide product literature which lists the sizes and the type of the Exam Gloves. The type of literature is not a disqualifier; however, the failure to disclose this information will result in disqualification in Phase I. 3. Vendor MUST provide a list of all the brands vendor is currently distributing. The list may be provided as an attachment in excel format. 4. Vendor MUST have a DAPA or be in the process of obtaining a DAPA for the Exam Gloves product line. Vendor MUST provide DAPA number with initial submittal or provide documentation that DAPA has been applied for. 5. 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 Exam Gloves or be in the process of obtaining Prime Vendor agreements. 6. 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. A vendor who does not provide discounts off DAPA in Phase II for all products will be disqualified. Phase II Acceptability Evaluation Clinical Performance Clinical Performance Requirements Following acceptability of the technical/company requirements, the MMESO West, 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 5:00 PM 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) 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 West 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. A box of 100 each of the items listed below is to be provided as samples to each of the evaluation sites as identified in the letters of invitation. GLOVE EXAM NON-STERILE SYNTHETIC POWDER-FREE BEADED CUFF NITRILE LARGE TEXTURED LATEX-FREE GLOVE EXAM NON-STERILE SYNTHETIC POWDER-FREE BEADED CUFF NITRILE MEDIUM TEXTURED LATEX-FREE GLOVE EXAM NON-STERILE SYNTHETIC POWDER-FREE NITRILE LARGE LATEX-FREE CHEMICAL RESISTANT GLOVE EXAM NON-STERILE SYNTHETIC POWDER-FREE NITRILE MEDIUM LATEX-FREE CHEMICAL RESISTANT GLOVE EXAM NON-STERILE SYNTHETIC POWDER-FREE BEADED CUFF POLYVINYL CHLORIDE LARGE GLOVE EXAM NON-STERILE SYNTHETIC POWDER-FREE BEADED CUFF POLYVINYL CHLORIDE MEDIUM 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 disqualification. Of those vendors who 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 West, and results will be forwarded to the MMESO CPT for final review. Each evaluator will evaluate each 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. There will be approximately eighteen (18) 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 glove is donned with ease in the evaluator's selected size and does not tear. (Addresses User Safety - User Manual Dexterity: CFR 1910.138; FDA Industry-Medical Glove Guidance 2008. Exam glove will have a fit which covers the digits without extra material at the finger tips and allows for flexing of fingers and movement of palm without restriction. 2. The glove allows the clinical evaluator to have optimal dexterity and flexibility during use. (Addresses User Hand Fatigue and Efficiency of Usage - OSHA 29 CFR 1910.1030; FDA Industry-Medical Glove Guidance 2008) Exam glove will allow for maximum movement of fingers and hand without constricting and causing any limitation of motion. 3. The exam glove allows for maximum gripping abilities, both wet and dry. (Addresses User Safety and Environment Safety and Efficiency of Usage - OSHA 29 CFR 1910.1030(d) (3) Exam gloves gripping surfaces - finger tips and palm of hand - will allow for secure grasping and gripping of any materials both wet and dry. 4. The glove maintains a barrier without leakage (Addresses User Safety and Environmental Safety and Patient safety - OSHA Standard 29 CFR 1910.1030(d) (3), CDC HICPAC Guidelines Isolation 2007; FDA Industry- Medical Glove Guidance 2008) Exam gloves will provide the mandated barrier between user and environment/patient in the performance of activities. 5. Tape/labels can be easily removed from the glove. (Addresses Efficiency of Use and User Safety: OSHA Standard 29 CFR 1910.1030(d) (3) Exam glove should be durable and flexible to allow for this basic clinical function. 6. Any odor from the unused glove does not elicit an olfactory reaction or discomfort. (Addresses Patient Safety/Comfort and User Safety: FDA Industry-Medical Glove Guidance 2008) Exam glove will be odor free to avoid patient or user olfactory reactivity and discomfort. 7. The evaluator's skin is not irritated by the glove. (Addresses User Safety: OSHA Standard CFR 1910.1030(d)(3), CFT 1910.138 Personal Protective Equipment, Hand Protection; FDA Industry-Medical Glove Guidance 2008) Exam glove will not cause any redness or break in the skin of the user; avoiding any damage to the user's first barrier of protection - the skin. 8. The glove packaging allows for easy and safe identification of size, type, and latex content of the product (Addresses Efficiency of Use and User Safety: OSHA Standard 29 CFR 1910.1030(d) (3); FDA Industry-Medical Glove Guidance 2008) Exam glove containers will be labeled clearly and boldly with the size of the glove and the material/composition of the glove; reducing wastage and exposure to latex materials if appropriate. Price Analysis Upon completion of the Phase I - Technical/Company Requirements Evaluation, vendors who are found technically acceptable will be qualified/invited to provide their product samples and price discount quotes concurrently. Vendors will be given 30 calendar days from the date of pricing requests, to submit Incentive Agreement pricing quotes, in a prescribed electronic spreadsheet format, based upon the requirements of the MMESOs. Pricing will be submitted to MMESO West and must be received by 5:00 PM PDST 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 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/MW-1104-17_Exam_Gloves/listing.html)
- Place of Performance
- Address: Medical Materiel Enterprise Standardization Office (MMESO) West, 34960 Bob Wilson Dr., San Diego, California, 92134, United States
- Zip Code: 92134
- Zip Code: 92134
- Record
- SN02496846-W 20110714/110712235720-cbfbae891a0e00cfc47defab6b18bf72 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |