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FBO DAILY ISSUE OF SEPTEMBER 02, 2011 FBO #3569
MODIFICATION

65 -- Manual Resuscitators - MODIFIED ATTACHMENT to respond to FBO

Notice Date
8/31/2011
 
Notice Type
Modification/Amendment
 
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
MP-1105-42_Manual_Resuscitators
 
Archive Date
10/7/2011
 
Point of Contact
Mary Summers, Phone: 808-433-3686, Wendy Sprouse, Phone: 808-433-7985
 
E-Mail Address
mary.summers1@us.army.mil, wendy.a.sprouse.ctr@us.army.mil
(mary.summers1@us.army.mil, wendy.a.sprouse.ctr@us.army.mil)
 
Small Business Set-Aside
N/A
 
Description
Provide all responses to FBO via this document. 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 Manual Resuscitators. The MMESO Pacific 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 standardization initiative. 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 MMESOs 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 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 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. Points of Contact: Mary Summers, MMESO Pacific, Team Leader, mary.summers1@us.army.mil and Wendy Sprouse, Clinical Analyst, wendy.a.sprouse.ctr@us.army.mil. B. Products & Performance Required The MMESOs, are seeking product line items in the category of Manual Resuscitators. Within the MMESOs, this product line has an estimated annual dollar requirement of $1,018,952.95. 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 one-hundred twenty-three (123) line items of the total one-hundred twenty-eight (128) line items, account for 97% ($987,424.85) of the total volume in sales ($1,018,952.95) 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 124 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 Ms. Mary Summers, MMESO Pacific, Team Leader, mary.summers1@us.army.mil and Wendy Sprouse, Clinical Analyst, wendy.a.sprouse.ctr@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 Pacific that its initial submission, quote and literature actually arrived at the MMESO Pacific 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 5:00PM Hawaii Standard Time (HST) 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 based on committed volume of 80% of the total requirements of the MTFs in the MMESOs. The MMESO Pacific 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. 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 process, the MMESO CPT 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 does not submit documentation to support these requirements with initial submittal will be disqualified in Phase I. 1. Vendor must provide a line of Manual Resuscitators products. a. At a minimum the vendor must provide the following: Manual Resuscitators, disposable/single-use or reusable, latex-free/safe with configuration options available in a range of bag volume sizes (adult, pediatric, and infant), and that are PEEP valve compatible, with swivel patient adapter and oxygen reservoir bag. The resuscitation bag must have a slip resistant surface such as textured finish. Packaging should clearly indicate size of the resuscitator for appropriate age group. (Appropriate sized mask should be included within the package.) The resuscitator must be in conformity with the following standard: ISO 10651-4:2009 (Lung Ventilators - Part 4: Particular Requirements for Operator- powered Resuscitators). All manual resuscitators must have available configuration options to include oxygen tubing, manometer port, pressure relief valve, and adjustable PEEP valve. Adult manual resuscitators must be fully assembled, be self-inflating, and be available with a medium face mask. Pediatric manual resuscitators must be fully assembled, be self-inflating, and be available with a toddler face mask. Infant manual resuscitators must be fully assembled, be self-inflating, and be available with a neonate face mask. REQUIRED ITEMS 1. ADULT DISPOSABLE RESUSCITATOR W/OXYGEN TUBING AND RESERVOIR BAG W/MEDIUM MASK 2. ADULT REUSABLE RESUSCITATOR W/OXYGEN TUBING AND RESERVOIR BAG W/ MEDIUM MASK 3. PEDIATRIC DISPOSABLE RESUSCITATOR W/OXYGEN TUBING AND RESERVOIR BAG W/TODDLER MASK 4.PEDIATRIC REUSABLE RESUSCITATOR W/OXYGEN TUBING AND RESERVOIR BAG W/TODDLER MASK 5. INFANT DISPOSABLE RESUSCITATOR W/OXYGEN TUBING AND RESERVOIR BAG W/NEONATE MASK *Operational usage items are included in this list of Manual Resuscitators. b. Vendor must provide a complete itemized list of products supplied (manufactured and/or distributed by brands) via Microsoft Excel spread sheet, and a product catalog & literature, in response to this RFIAQ. Vendors are required to supply all items listed in all types and sizes. 2. Vendor must provide literature indicating that the products' packaging promotes/allows for quick and easy identification of the appropriate age group for size of the resuscitator and states that the resuscitator is in conformity with the following standard: ISO 10651-4:2009 (Lung Ventilators - Part 4: Particular Requirements for Operator-powered Resuscitators) with initial submittal. 3. Vendor must have a DAPA or be in the process of applying for a DAPA for Manual Resuscitators. Vendor must provide DAPA number or provide documentation the DAPA has been applied for. 4. Vendor must have agreements with the current Med/Surg Prime Vendors for each MMESO AOR, i.e. Cardinal Health and Owens & Minor for Manual Resuscitators, or be in the process of obtaining Prime Vendor agreements. 5. 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 III for all products will be disqualified. 6. 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 Pacific, 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 MMESOs Pacific and South 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 Pacific 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. (Samples will not be returned). One (1) sample of each of the Manual Resuscitators listed below is to be provided to each of the evaluation sites as identified in the letters of invitation. SAMPLE SET 1.ADULT DISPOSABLE RESUSCITATOR W/OXYGEN TUBING AND RESERVOIR BAG W/MEDIUM MASK 2. PEDIATRIC DISPOSABLE RESUSCITATOR W/OXYGEN TUBING AND RESERVOIR BAG W/TODDLER MASK 3. INFANT DISPOSABLE RESUSCITATOR W/OXYGEN TUBING AND RESERVOIR BAG W/NEONATE MASK Each evaluator will evaluate each Manual Resuscitator 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 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 (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 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 Pacific and results will be forwarded to the MMESO CPT for final review. There will be approximately eleven (11) 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. (Clinician Efficiency of Care/American Heart Association Guideline - Resuscitation bag must be compressed firmly with one hand to deliver adequate tidal volume that causes patient's chest to rise.) Resuscitation bag design has slip-resistant texture and allows for one-handed operation. One-handed operation frees the operator's other hand to hold a firm seal on the mask or stabilize the endotracheal or tracheotomy tube. 2. (American Heart Association Guideline - Manual adult ventilations should be performed at 12 breaths per minute.) Resuscitation bag is self-inflating. Self-inflating feature allows the required ventilations per minute and does not require compressed oxygen to provide adequate manual ventilation. 3. (American Heart Association Guideline -Provides high quality CPR with minimized interruptions due to repositioning) Manual resuscitator has 360-degree swivel patient adapter. The swivel adapter allows for access to the patient from all angles and facilitates easy position change without interrupting ventilation. 4. (American Heart Association Guideline - Good continuous face mask seal during both ventilation and compressions is critical) Mask is transparent with inflatable mask air bladder. Transparent mask allows for observation of patient skin color changes as well as visualization of tongue obstruction or vomitus, while the inflatable mask air bladder allows the operator to tighten the seal when necessary. 5. (Efficiency of Use and Patient Safety - FDA Standard for Device Labeling - 21 CFR 820.120) Packaging promotes/allows for quick and easy identification of appropriate age group for size of the resuscitator (Adult, Pediatric, or Infant). Packaging will be clearly and boldly labeled with the product type and size to enable/ensure quick and easy identification regarding appropriateness of age group for size of the resuscitator (Adult, Pediatric, or Infant) in order to avoid errors that could lead to potential harm of a patient or inadequate ventilation (A picture, word, or color coded system is acceptable.) 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 Pacific and must be received by 5:00 PM HST, 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/MP-1105-42_Manual_Resuscitators/listing.html)
 
Place of Performance
Address: Tripler Army Medical Center, 1 Jarrett White Road, Honolulu, Hawaii, 96859-5000, United States
Zip Code: 96859-5000
 
Record
SN02556853-W 20110902/110831235330-2ed015facce4ab4603a834f7b7fec7ab (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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