SOURCES SOUGHT
65 -- Topical Oxygen Wound Treatment Delivery Devices
- Notice Date
- 5/21/2008
- 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-V-TRBO
- Response Due
- 6/10/2008
- Point of Contact
- Walter Holt, 2023560796
- Small Business Set-Aside
- N/A
- Description
- 65-Medical Supplies-Request for RIA 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 Topical Oxygen Wound Treatment Delivery Devices. 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 or vendors 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 Topical Oxygen Wound Treatment Delivery Devices, which at a minimum includes the product lines below. Within this region, this product line has a projected annual dollar estimated requirement of $74,572. This forecast is based on historical PV sales during a recent 3-month period and includes the following top high volume usage lines for this project: PART # DESCRIPTION 02S001Wound Care Device For Head, Neck, Torso & Upper Leg, Delivers Topical Hyperbaric Oxygen To Wounds 02B001Wound Care Device For Arm, Hand & Lower Leg. Delivers Topical Hyperbaric Oxygen To Difficult Wounds 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 10, 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 Topical Oxygen Wound Treatment Delivery Devices. 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 Disposable Topical Oxygen Wound Treatment delivery devices appropriate for adult and pediatric patients in extremity and torso 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/body area. 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 Topical Oxygen Wound Treatment System and Device 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 from 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 Topical Oxygen Wound Treatment delivery devices 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 Topical Oxygen Wound Treatment delivery devices 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 Topical Oxygen Wound Treatment delivery 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 these standards in the literature. 11. Vendors must provide products that are latex-free. 12. Vendors must provide samples and descriptions of the labeling which includes labeling of lot number in response to this RFRIAQ. 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-cost 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. No cost sample sets must be received by COB 4:00 PM EDT on the 10th calendar day. Those vendors who do not meet the deadline to deliver the no cost sample sets required by COB 4:00 PM 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) week (7 calendar days). Specific CPT members will evaluate the vendors product sample sets against the clinical/performance criteria in a clinical (patient care) 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. [Care Efficiency] Disposable Topical Oxygen Wound Treatment Delivery Device application and complete skin contact/adhesion seal including Device edge-seal continuity (to both torso areas and extremities) is effortless. a. Device must fully adhere to patients skin during treatment to assure a continuous therapeutic oxygen concentration level for effective wound treatment and healing. b. Evaluator places Device on skin/extremity observes for ease of application and adequacy of initial skin contact/adhesion seal including edge-seal continuity. 2. [Continuity of Therapy] Disposable Topical Oxygen Wound Treatment Delivery Device maintains complete skin contact/adhesion seal including Device edge-seal continuity during treatment use. a. Device must fully adhere to patients skin during treatment to assure a continuous therapeutic oxygen concentration level for effective wound treatment and healing. b. Evaluator observes device in place on patients skin for breaks in seal and observes any loosening of seal with patient movement or gentle manipulation of the device. 2. [Patient Comfort and Patient Safety] Disposable Topical Oxygen Wound Treatment Delivery Device does not impair blood circulation or sensation to extremities during use. a. Impaired circulation or nerve function in extremities further compromises wound healing and patient health during the length of each recommended 90-minute treatment. b. Evaluator will observe patients extremity for discoloration and/or any patient complaints of numbness/tingling/discomfort in the extremity during use. 3. [Patient Comfort and Patient Safety] Disposable Topical Oxygen Wound Treatment Delivery Device is easily removed from skin contact without causing injury to tissue. a. Injury to tissue surrounding wound further compromises healing process and patient health. b. Evaluator will observe for difficulty in removing Delivery Device after completed treatment, and evaluator will observe for injury to tissue from adhesive contact to skin both during removal and after removal. 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
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