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FBO DAILY ISSUE OF MAY 14, 2008 FBO #2361
SOURCES SOUGHT

65 -- Disposable Electrosurgical Grounding Pads

Notice Date
5/12/2008
 
Notice Type
Sources Sought
 
NAICS
423450 — Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers
 
Contracting Office
Department of the Army, U.S. Army Medical Command, MEDCOM, North Atlantic Regional Contracting Office, Medcom Contracting Center North Atlantic, ATTN: MCAA NA Bldg T20, 6900 Georgia Avenue NW, Washington, DC 20307-5000
 
ZIP Code
20307-5000
 
Solicitation Number
W91YTZ-08-T-TRBO
 
Response Due
6/2/2008
 
Point of Contact
Walter Holt, 2023560796
 
Small Business Set-Aside
N/A
 
Description
65-Medical Supplies-Request for Quotation A.General Information. The Northeast Region, Tri-Service Regional Business Office (TRBO) REG 1, a military integrated delivery network, comprised of 47 Army, Navy, Air Force, Marine Corps, and U.S. Coast Guard Medical Treatment Facilities (MTFs) in the states of Maine, New Hampshire, Massachusetts, Rhode Island, Connecticut, New York, Pennsylvania, New Jersey, Delaware, Maryland, District of Columbia, and Virginia seeks to initiate the standardization process for Disposable Electrosurgical Grounding Pads. The primary objective of this program is to standardize the quality of care across this region based on a best value determination that represents the clinically preferred product or source(s) at the best possible price. It is also intended that standardized product be obtained through the DoD Prime Vendor (PV) Program. The major facilities in the Northeast Region include, but are not limited to Walter Reed Army Medical Center, Washington, DC; National Naval Medical Center, Bethesda, MD; Malcolm Grow Medical Center, Andrews AFB, MD; Dewitt Healthcare System, FT Belvoir, VA; Keller Army Community Hospital, Westpoint, NY; and Kimbrough Ambulatory Care Center, FT Meade, MD. This standardization action is part of the Medical/Surgical PV program executed by the Defense Supply Center Philadelphia (DSCP), Directorate of Medical Materiel. To participate, your company must have a Distribution and Pricing Agreement (DAPA) and a separate commercial agreement with the PVs for the program. This is pursuant to the DAPA clause by which DAPA holders agree to the standardization process and to allow PV to distribute their items. This RFRIAQ will result in Regional Incentive Agreements that supplement the PV Program. The RFRIAQ will not result in a contract award. For additional information regarding DSCP PV program, please access their web site at https://dmmonline.dscp.dla.mil. The resulting RIA will be for a base period of two (2) years (24 months) from date of selection with three (3) 12-month option periods for a maximum of five (5) years. Anticipated selection date is July 2008. The Technical/Company and Clinical/Performance evaluation factors, when combined, are considered significantly more important than cost or price. As the technical and clinical evaluation results become more equal, price will become more important. The selection will be determined utilizing best value/trade off criteria. The selection of a single vendor is anticipated. However, if no single vendor can meet the total requirement of the region, the Government reserves the right to make two or more selections for RIAs. In this event, selection would be cased on a combination of MTF preference and product availability. The selected vendor(s) of the standardization initiative are to submit a copy of the signed RIA along with the DAPA log number to both the TRBO lead logistician and the DSCP COR when submitting the log. Point of Contact is Tracy Martin-Tilghman, Team Logistician, Phone: 202-782-3663, and email: tracy.martin-tilghman@amedd.army.mil. B.Products & Performance Required. The Northeast Region is seeking product line items in the category of Disposable Electrosurgical Grounding Pads, which at a minimum includes the product lines below. Within this region, this product line has an estimated annual dollar requirement of $65,945. This forecast is based on historical PV sales during a recent 12-month period and include the following top high volume usage lines for this project: PART # DESCRIPTION 402-2204MACROLYTE ADULT DUAL DISPERSIVE ELECTRODES, SINGLE-USE E7507DISPOSABLE REM POLYHESIVE II RETURN ELECTRODE 51-7310THERMOGARD, AD, DUAL, CABLE 9165UNIVERSAL PAD W/SAFETY RING SPLIT PAD WITH CORD 425-2508PEDIATRIC REM GR PAD 7-382THERMOGARD, ABC, AD, DUAL, CABLE E7506DISPOSABLE POLYHESIVE RETURN ELECTRODE 450-2300MACROLYTE, INFANT, SINGLE, CABLE E751025DISPOSABLE INFANT REM POLYHESIVE II RETURN ELECTRODE 440-2400MACROLYTE, PREMIE, SINGLE, CABLE 400-2100ADULT DISPERSIVE ELECTROD 10' CABLE MACROLYTE ADH 7-383B-GUARD PLUS INFANT DUAL- CONDUCTOR MONITOR ELECT 1149PAT.PLATE, LG, NOCORD, 25/BX 4BX/ C.Instructions to Vendors. DAPA holders interested in participating in this standardization initiative should email their detailed electronic responses to the technical/company criteria with accompanying electronic product literature, and the following information--(1) Company name and address, (2) Company Point of Contact (POC Name and Phone Number, Fax Number, and E-mail address) to the following Northeast Region POC: larry.shaughnesy@amedd.army.mil (202-782-3666). All email communication between vendors and the region must be digitally signed. All communications of significant acquisition milestones (such as invitations to participate, or notices of disqualification) must be digitally signed as well. Submissions must be received by 4:00 PM EDT on June 2, 2008. Vendors that fail to meet the submittal deadline will be disqualified from participating. This process will include the above vendor requirements to provide electronic responses to technical/company criteria, electronic product literature, no-cost samples for clinical evaluation when requested, and submission of electronic best value price quotes when requested. Due to the potential for email to be lost in transmission, from network security, etc., vendors are strongly encouraged to confirm with the Northeast Region POC stated above that their initial submission, product literature, and best price submissions when requested actually arrived at the Northeast Regional Tri-Service Business Office (TRBO) POC 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. All email communications between vendors and the Northeast Region must be digitally signed by the issuer. D. Evaluation Criteria. The Tri-Service Product Review Board (TPRB) is the governing board of the standardization process. This board includes clinicians and logisticians from the MTFs within the Northeast Region. They are the deciding officials for this initiative. Phase I Technical/Company Evaluation Process. Interested vendors are to respond to this FBO announcement by emailing their intent to participate, the required company/company POC information, electronic product literature, and detailed responses to the technical/company criteria listed below to the above POC by the required response date. Vendors are required to meet/provide responses to the technical/company criteria stated below. All technical/company criteria are weighted equally. The responses will be reviewed under the purview of the TPRB and the Clinical Product Team (CPT) to determine the acceptability of each vendor. After review of the technical/company criteria responses, those vendors who meet these criteria will be qualified/invited to participate in the clinical/performance evaluation. 1. In general, acceptability for purposes of evaluation of technical/company criteria is defined as follows: a. Based on the vendors responses, the evaluators have reasonable confidence that the line or products and/or services submitted meet the medical standards of care of the community, applicable to such products or services. b. The vendors information provided is factually correct. Any misrepresentation of information will disqualify the vendor from further consideration. 2. Each technical/company criteria below requires additional, more specific definition of technical acceptability. This specific standard for technical acceptability will be sent forth with the individual criterion. 3. The vendors who meet the following technical/company criteria will be qualified/invited to participate in the clinical/performance evaluation process via an email communication with each vendor. The following Technical/Company Evaluation Criteria have been established for the standardization initiative: 1. Vendor must provide a complete line of Disposable Electrosurgical Grounding Pads. A complete line of product is defined as the Military Treatment Facilities (MTFs) requirements for usage items in the product line. Usage items are defined in the Medical/Surgical Prime Vendor contract statement of work, as DAPA items ordered at least once per month, and at least one unit per order. a. At a minimum, a complete product line includes adult, pediatric, infant/neonate sizes. Vendors are to provide a complete list of items supplied (catalog, etc.) and product literature in response to this RFRIAQ. b. Individual products packaging must be clearly labeled as to size/size range or weight/weight/range. 2. Vendors must have a Distribution and Pricing Agreement (DAPA) with Defense Supply Center Philadelphia (DSCP) or be in the process of applying for a DAPA number for the Disposable Electrosurgical Grounding Pad product line. Provide the DAPA number or proof of the application process in response to this RFRIAQ. Vendors that fail to have a DAPA or show a lack of progress in obtaining a DAPA will be disqualified. 3. Vendors must have a separate agreement with the prime vendor (PV) (currently the Prime Vendor for the Northeast Region is Owens-Minor) for distribution within the Northeast Region. Vendors whose products are not available through the current regional PV will be disqualified. Provide documentation of agreement with PV in response to this RFRIAQ. 4. Vendors must submit discounts off DAPA for all products included in this standardization initiative. Vendors that fail to submit a discount form DAPA will be disqualified. Where lower uncommitted FSS prices are available, DAPA holders are required by previous agreement to provide the uncommitted FSS price as the DAPA price. Vendors shall not quote uncommitted FSS prices as the discounted price for purposes of this standardization initiative. Vendors are to provide quote on discounts, in response to this RFRIAQ. 5. Vendors must provide a local vendor representative for the Northeast Region. Provide contact information, i.e. name, address, phone number, and email address in response to this RFRIAQ. 6. Vendors must provide any history of back orders and/or recalls that occurred during the most recent 12-month period for the Disposable Electrosurgical Grounding Pads product line, including dates, duration, cause, and resolution. Vendors will not have an opportunity to provide additional information on back orders and recalls during any subsequent stage in this evaluation. Vendors are encouraged to submit all information deemed relevant, i.e. positive resolutions, etc., in response to this RFRIAQ. The Government will not contact any points of contact provided in response to this question. Vendors should not provide point of contact information in response to this question. 7. Vendors must supply instructions/directions for use for all Disposable Electrosurgical Grounding Pads to be supplied. Provide this electronic information with the product literature submitted in response to this RFRIAQ. Provide information explaining whether or not the instructions/directions are supplied with the individual item packaging, or are provided with the larger units of packaging only, i.e. per case, etc. 8. Vendors must provide inservice/implementation and ongoing educational support as needed by Regional MTFs. Vendors must identify company resources for such requirements in response to this RFRIAQ. Provide electronic literature, if available, describing this support. 9. Vendor must provide Customer Service during routine business hours (Monday-Friday 9:00AM-5:00PM) and identify company resources for such support in response to this RFRIAQ. 10. Vendors must provide a list of vendor production and product safety standards under which all itemized brand(s) and styles are manufactured and/or distributed for Disposable Electrosurgical Grounding Pads including the Association for the Advancement of Medical Instrumentation (AAMI) Standard HF-18 for high-frequency electrosurgical devices. Vendors must provide a complete list of these standards and the vendors mechanism to assure that all quoted products meet these standards in response to this RFRIAQ. The vendor will clearly state the compliance with AAMI Standard HF-18 including applicable Revisions, in the literature. 11. Vendors must provide products that are latex-free and hypoallergenic (including dyes used in manufacturing). Vendors must ensure that all individual products are clearly labeled as latex-free and hypoallergenic (including dyes used in manufacturing). Vendors must provide samples and descriptions of the labeling in response to this RFRIAQ. 12. Vendors must provide Disposable Electrosurgical Grounding Pads that have a universal plug for connection to the Electrosurgical Unit (ESU) generator, and Disposable Electrosurgical Grounding Pads that have a pre-attached cord. Vendors must provide a list of ESU generator brands name with which their Disposable Electrosurgical Grounding Pads are compatible. Vendors must provide a list of available pre-attached pad-generator cord lengths. 13. Vendors must provide packaging for Disposable Electrosurgical Grounding Pads that includes labeling of lot number and expiration date. 14. Vendors must provide Disposable Electrosurgical Grounding Pads of such a design as to be an integral part of an ESU safety return electrode contact quality monitor (RECQM) or similarly operating safety system. Phase II Clinical/Performance Evaluation Process Following acceptability of the technical/company criteria, the TRBO, on behalf of the Clinical Product Team (CPT), will request product sample sets from the product group at no cost to the Government or the TRBO POC recipient, to be sent to the TRBO, Clinical Analyst for dissemination to the CPT members for evaluation in a non-clinical setting. Vendors will be given ten (10) calendar days from the issue of the notice requesting the no-cast product sample sets in which to deliver the no-cost sample sets to the TRBO Clinical Analyst. Requested no-cost product sample sets must be shipped to arrive at the TRBO Clinical Analyst address no later than the 10th calendar day after the date of the notice requesting no-cost product sample sets. Vendors who do not deliver the no-cost product samples by 4:00PM EDT on the 10th calendar day after the date of the notice requesting no-cost product sample sets will be disqualified from this standardization initiative. NOTE: all vendors must send the TRBO verification regarding the quantity, products, description of items, and date of shipment from the vendor, anticipated delivery date and individual who signed for no-cost product sample sets. Vendors presence will not be required for in-servicing prior to the evaluations. The clinical/performance evaluation period will last for one (1) calendar day. Specific CPT members will evaluate the vendors product sample sets against the clinical/performance criteria in a non-clinical setting. The evaluation responses will be recorded using a Likert scale format with a 1-5 scoring range. The scale descriptors are: One (1)Extremely Poor; Two (2)Below Average; Three (3)Average; Four (4)Above Average; and Five (5)Excellent. All clinical/performance criteria are weighted equally. The CPT has established a target threshold of 3.75 Vendor Total Averaged Score. The CPT will determine the actual Clinical Acceptability threshold for this standardization initiativeat or near the 3.75 Vendor Total Averaged Score target thresholddepending on the location of any break: in vendors Total Averaged Scores ((i.e. a gap between vendors Total Averaged Scores). In addition, the CPT may consider how closely scores are clustered near the 3.75 Vendor Total Averaged Score Clinically Acceptability target threshold in determining the actual Clinically Acceptability threshold. Vendors whose Total Averaged Scores are below the actual Clinically Acceptability threshold will be determined to be Clinically Unacceptable, and be disqualified from further consideration for this standardization initiative. To determine acceptability, the CPT will evaluate the products based on the evaluation criteria below. The CPT intends that clinical evaluations be conducted in a non-clinical setting. The following Clinical/Performance Evaluation Criteria have been established for this standardization initiative with Clinical Acceptability Target Threshold3.75 Vendor Total Averaged Score: 1. Disposable Electrosurgical Grounding Pad adhesive provides complete skin contact including pad edge continuity. [Addresses patient and environmental safety]. a. Grounding pad must adhere to patients skin with edge-attachment continuity for safe electrical conduction and to avoid pooling of body fluids/irrigation fluids under the Pad. b. The evaluation team will review the literature and documentation provided by the vendors and evaluate criterion in a non-clinical setting. c. The products will be evaluated by CPT members applying electrodes to simulated skin or on each others skin and observe that the pad completely contacts the surface including uniformity of pad edge adherence. The expectation is that the electrosurgical pad provides good skin contact and the edges will be firmly intact against the skin, will provide uniform adherence even over hair and body contours. 2. Disposable Electrosurgical Grounding Pad is flexible adhered to the skin and maintains skin-contact integrity over body contours during body part repositioning and during tension on the pad-generator connecting cord. [Addresses patient and environmental safety]. a. Grounding pad must adhere to patients skin with edge-attachment continuity during patient repositioning including during periods of tension on connection cord for safe electrical conduction. b. The evaluation team will review the literature and documentation provided by the vendors and evaluate criterion in a non-clinical setting. c. The products will be evaluated by CPT members by manipulating another members body part or simulated body part with attached grounding pad to simulate patient repositioning and will apply tension on the connecting cord and observe that the pad completely contacts the surface including uniformity of pad edge adherence. The expectation is that the product will adhere to the skin/simulated skin surface and not lose contact with movement/tension on connection cord. 3. Disposable Electrosurgical Grounding Pad is easily removed from contact without causing injury to tissue. [Addresses patient safety/discomfort and infection control]. a. Grounding pad must remove easily and completely without injury to underlying body tissue. b. The evaluation team will review the literature and documentation provided by the vendors and evaluate criterion in a non-clinical setting. c. The products will be evaluated by CPT members by removing a grounding pad adhered to another members body part and observe that the pad removes easily, completely and without injury to the body tissue (redness, swelling, blistering or any open break in the skin. Phase III Pricing Analysis Process. 1. The following elements will be considered in the pricing analysis: (1) Impact of RIA prices (Post-Standardization Costs) on the Northeast Regionrepresents the new estimated total annual cost including matched and unmatched productsand reflects the amount the Region would pay using the RIA pricing. (2) Impact of Unmatched Linesunmatched products make vendor comparisons difficult and those in the high usage category has higher impact for post-standardization costs. (3) Consideration of SKUs by each vendorreduction of the number of SKUs handled per period is the intent of the Region; therefore, vendors supplying the complete range of clinically-required product, without unnecessary numbers of SKUs for minimally-differentiated products, is more likely to provide the best-value solution for the Government in this standardization initiative. Due to the potential for Base DAPA prices to be inflated, the impact of RIA prices is considered more important than the other pricing elements. 2. Vendors that are determined to be Acceptable after review of their responses to the technical/company criteria, are qualified/invited to participate in the clinical/performance evaluation and meet the Clinically Acceptability target threshold of 3.75 Vendor Total Averaged Scoredepending on the location of any break in vendors Total Averaged Score (i.e., a gap between vendors Total Averaged Score) as determined by the CPT will be requested to submit best value pricing, a competitive product cross reference, and value-adds based on a committed volume of 80% of the total requirements of the Northeast Region. The quote will be requested to be in a prescribed electronic spreadsheet format. Those vendors who do not meet the technical/company criteria and are not qualified/invited to participate in the clinical/performance evaluation will not be requested to submit pricing quotes and will be disqualified form further consideration. Vendors that have been disqualified will be notified in writing at the conclusion of the standardization process. 3. Vendors will be given fourteen (14) calendar days from the date of the notice to submit RIA pricing quotes, the competitive product cross reference, and value adds. in a proscribed electronic spreadsheet format. Price quotes, cross reference, and value adds must be received by 4:00 PM EDT on the 14th calendar day after the date of the notice to submit. Those vendors that fail to respond by the deadline date/time will be disqualified from further consideration. Vendors that have been disqualified will be notified in writing at the conclusion of the standardization process. 4. The Northeast Region intends to evaluate quotes and select a vendor or vendor(s), on initial submissions/quotes. Vendor quotes should contain the vendor's best product matches for the products or product lines requested I the notice to submit RIA pricing. Vendors quotes should contain the vendors best tiered-pricing discounts off of the vendor's DAPA pricing (based on committed volume of 80% of the total requirements of the MTFs in the Northeast Region). The Northeast Region reserves the right to conduct discussions and request revised quotes, if determined necessary. The Northeast Region reserves the right to limit the number of quotes to the greatest number that will permit an efficient competition among vendors. The Northeast Region reserves the right to make a down selection during the evaluation process based on considerations of efficient competition. 5. The Technical/Company and Clinical/Performance evaluation factors, when combined, are considered significantly more important than cost or price. As the evaluation results become more technically/clinically equal, price will become more important. Pricing will be evaluated based on a best-value, lowest-overall-cost alternative to the Government and will be based on a committed volume for a two (2) years (24 months) from date of selection with three (3) 12-month option periods not to exceed a total of five (5) years. _____________________________________________________________________________ END
 
Web Link
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=94ed5c6664cb9a227043deba5f61d327&tab=core&_cview=1)
 
Place of Performance
Address: Triservices Regional Business Office (TRBO) C/O Commander North Atlantic Regional Medical Command, ATTN: ACSLA (MCAT-LA), 6900 Georgia Avenue NW Washington DC
Zip Code: 20307-5001
 
Record
SN01571218-W 20080514/080512220016-94ed5c6664cb9a227043deba5f61d327 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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