A. General Information The Southwest & Pacific Regions, two of the three Regions that form the Logistical Support Area (LSA-West), a military integrated delivery network, comprised of Army, Navy, and Air Force medical treatment facilities in California, Guam, Japan, Okinawa, and Korea announce a Request for Regional Incentive Agreement Quotation (RFRIAQ) for the standardization of Safety Lancets. The regions recognize vendors may manufacture and/or distribute subsets of the category. A multiple selection is only a possibility if no single vendor can meet the total requirement of the Regions and would be based on a combination of MTF preference and product availability. In order to meet the total requirements of the Regions a vendor must be able to offer a comprehensive product line (all items within a product category) available in the necessary quantities to meet all of the DoD MTFs? needs. That is, the required products must be available in the required quantities. As stated previously, it is not the preference of this standardization to make a multiple selection, however, if necessary due to non-availability from a single source, a multiple selection would be made based on a combination of Regional Clinical preference as determined by the Clinical Product Team (CPT) and vendor product availability. The product category includes finger and heel lancets with a safety feature to prevent a needlestick injury and subsequent exposure to blood borne pathogens. The primary objective of this standardization initiative is to achieve a best value determination that represents the clinically preferred product or source at the best possible price. It is also intended that standardized product be obtained through the DoD Prime Vendor Program. The secondary objective of this standardization initiative is the potential of decreasing the existing Stock Keeping Unit?s (SKUs) and thus dollars held as inventory. The below item detail of the products being purchased within the region will be used to target and cross-match product lists submitted by the vendor. This process will ensure the minimum requirements of the Region are met and help identify possible candidates (i.e. like product items) for elimination, as well as potentially minimizing the number of SKUs included in a subsequent incentive agreement. The major facilities in these Regions include but are not limited to Naval Medical Center San Diego; David Grant Medical Center, Travis AFB; Naval Hospital Camp Pendleton; Robert E. Bush Hospital, Twenty-Nine Palms; Weed Army Community Hospital, Ft. Irwin; Naval Hospital Lemoore; 9th Medical Group, Beale AFB; 30th Medical Group, Vandenberg AFB; 61st Medical Squadron, Los Angeles AFB; 95th Medical Group, Edwards AFB, Tripler Army Medical Center, U.S. Naval Hospital Okinawa, U.S. Naval Hospital Guam, U.S. Naval Hospital Yokosuka, 121st Combat Support Hospital Seoul, 374th Medical Group, Yokota AB, and 18th Medical Group Kadena AB. This standardization action is part of the Medical/Surgical Prime Vendor program executed by the Defense Supply Center Philadelphia, Directorate of Medical Materiel. In order to participate, your company must have a Distribution and Pricing Agreement (DAPA) and a separate commercial agreement with the Prime Vendor of the program. This is pursuant to the DAPA clause by which DAPA holders agree to the Standardization process and to allow Prime Vendors to distribute their items. This is a supplement to the Prime Vendor Program and it is not a contract. For additional information regarding DSCP?s Prime vendor program please access our web site at: https://dmmonline.dscp.dla.mil. The Tri-Service Regional Business Office (TRBO) will provide anticipated volume (quantity) based on historical usage/forecasted requirements. The agreement will be for a base period of two (2) years (24 months) from date of award with three (3) 12-month option periods. Anticipated award date is June 2008. The evaluation will be based on technical, clinical and pricing factors. 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 based on a combination of MTF preference and product availability. Point of Contact: Cindy Ingrao, RN, MSN at (619) 532-8517; Email- [email protected] B. Products & Performance Required The Southwest and Pacific Regions are seeking product line items in the category of Safety Lancets. The product category includes finger and heel lancets with a safety feature to prevent a needlestick injury and subsequent exposure to blood borne pathogens. Within these 2 Regions, this product line has an estimated annual dollar requirement of $174,200. This forecast is based on historical prime vendor sales during a recent 12-month period. At the request of the Southwest & Pacific Regions Military Treatment Facilities vendors will provide on-site support and in-servicing, educational resources and tools for clinical use of the product, conversion information, prime vendor order numbers, MSDS information, and itemization of the brands, types and packaging information of the products offered by the vendor. Vendors may be asked to provide on-site, in-person in-servicing to Southwest Region test sites and to Tripler Army Medical Center. This option is used to support the government?s minimum need and is normal and customary. All vendors will be required to provide training materials to US Army Health Clinic Schofield Barracks, NH Guam, NH Okinawa, and NH Yokosuka Barracks and Southwest Region test sites. These training aides will address the safe and acceptable method of using the device. The training/guidance materials may be in the form of a DVD, product literature or other instructional methods that the vendor believes will assist the clinician. These training items must arrive prior to the clinical evaluation period. Failure to provide training/instructional materials will result in exclusion from the standardization process. C. Instructions to Vendors If you are interested in participating in this standardization initiative, email your (1) Company name and address, (2) POC (Name and Phone Number, Fax Number, E-mail address, your answers to the technical questions/criteria below and product literature electronically to [email protected] no later than April 9, 2008. All e-mail communications between vendors and the region will be digitally signed. Submissions must be received by 4:00 PM EST on the specified closing date/time of this sources sought notice. Vendors that fail to meet the submittal deadline will be disqualified. If your product literature is more than 4MB in size, please mail your product literature to: Cindy Ingrao, RN, MSN Tri-Service Regional Business Office MSMMO - Southwest Region 34800 Bob Wilson Drive, Suite 110 San Diego, CA 92134 Phone: (619) 532-8517 Cheryl A. Janus RN, MBA Tricare Pacific Lead Agency (TPLA) 1 Jarrett White Road, MCHK-LA Tripler, HI 96859 Phone: (808)433-7985 This process will include vendor requirements of electronic responses to technical criteria, no charge samples for clinical evaluation, and submission of electronic best price offers. Due to the potential for email to become lost in transmission due to network security, etc., the vendor is strongly encouraged to confirm with the Region that its quote and literature actually arrived at the Region via email. We strongly recommend that each submitting vendor confirm receipt, allowing enough time for re-submission before the due date, if a problem should occur with the first transmission. 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 all of the Military Treatment Facilities (MTFs) within the Southwest and Pacific Regions. They are the decision makers for this initiative. Phase I - Technical/Company Evaluation Process Vendors will be required to provide responses to the technical/company criteria. Amplifying information about your products may be requested by the Government. The responses will be reviewed under the purview of the TPRB to determine acceptability. All technical/company criteria are weighted equally. After review of the technical/company criteria, those vendors who meet these criteria will be invited to participate in the clinical/performance evaluation. The TPRB will review the responses from the vendors and determine which vendors meet the criteria and determine acceptability. Acceptability for purposes of evaluation of technical/company criteria: Generally, responses to all questions in this section demonstrate: (1) the vendor is a distributor or manufacturer of a complete line of the subject medical/surgical consumables; (2) based on the vendor?s 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; (3) the vendor has, or is obtaining a DAPA for the items (vendors that fail to have a DAPA will be disqualified); (4) the vendor has, or is obtaining, an agreement covering the items, with Cardinal, the Prime Vendor for the region (vendors whose products are not available through the regional PV will be disqualified); (5) the vendor intends to provide discounts off DAPA for all products included in this standardization initiative (vendors that fail to provide a discount from DAPA will be disqualified); and (6) the vendor?s information provided is factually correct. Any misrepresentation of information will disqualify the vendor from further consideration. Technical/Company Criteria 1. Vendors must provide Safety Lancets for adult, pediatric and neonatal patients for fingers and/or heels with a safety feature to prevent a needlestick injury and subsequent exposure to blood borne pathogens. Vendors must provide a list of the products they supply in this product line and the brand name to include the type, material used, size and how the sizes identified. A complete line of product' is defines as the MTF's 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. 2. Vendors must have a separate agreement with the Prime Vendor supporting our Region, Cardinal Health or will be disqualified. 3. Vendors must have a DAPA number or is in the process of obtaining a DAPA or will be disqualified. 4. Your product line must be latex free and this must be indicated on the packaging of the product. 5. Your products must be single use and disposable. 6. Your products must be sterile. 7. Your products must have a safety feature that is an integral part of the device and not an accessory. 8. The safety feature of the device must require the user?s hands to remain behind the sharp at all times. 9. The safety feature must be activated passively and not be able to be reactivated. 10. Activation of the safety feature must not create any noise that may startle the patient or user. 11. Vendors must provide product literature for this product line. 12. Vendors must provide 24/7 customer support and identify company resources for such support with their initial submittals. 13. Vendors must submit prices lower than their DAPA or will be disqualified. Where lower FSS prices are available, DAPA holders are required by previous agreement to provide the FSS price as their DAPA price. Therefore, FSS prices do not represent a discount off the DAPA. 14. Your products must meet the FDA requirements for medical devices. 15. Vendors must provide electronic and hard copy proposed pricing and a competitive product cross-reference in electronic excel format upon request. 16. Vendors must provide any history of back orders and/or recalls/alerts that occurred during the most recent 24-month period for Safety Lancets including dates, duration, cause, and resolution with their initial submittals. This represents your sole opportunity to present this information. Provide any mitigating factors that you may have in order to provide a proper context for the cited back orders, recalls, etc. 17. Vendors may be asked to provide on-site, in-person in-servicing to Southwest Region test sites. 18. Vendor is required to provide product literature, training aids, and teaching materials prior to the clinical evaluation to the Pacific Region and Southwest Region test sites. Vendors, who cannot provide product literature, training aids, and teaching materials to these MTFs, prior to the clinical evaluations, will be disqualified. Phase II - Clinical/Performance Evaluation Process The TPRB will request samples from the product group to be clinically evaluated at selected Military Treatment Facilities. Vendors are required to ship samples directly to the designated MTFs. Vendors will be given 21 calendar days to receive samples. Samples must arrive at the MTF by COB, 4PM local time, on the 21st calendar day after the notice to ship. Vendors failing to deliver by the deadline will be disqualified from further consideration in the standardization process (all vendors must send TRBO verification regarding date of shipment). The MTFs will evaluate the clinical/performance criteria using a scale from one (1) to five (5) where 1 = Not Acceptable, 2 = Minimally Acceptable, 3 = Neutral, 4 = Acceptable, and 5 = Highly Acceptable. All clinical/performance criteria are weighted equally. The Government reserves the right to conduct evaluations in either a non-clinical or clinical setting or both. The CPT has established a target threshold of 3.0 for clinical acceptability of product for standardization. The CPT will analyze acceptability as being at or near 3.0 depending on the ?break?, in the average scores and how closely the scores are clustered near the Acceptability Target Threshold of 3.0. Subject to this review, products below this threshold will be clinically unacceptable and be disqualified from further consideration for standardization. A Clinical Product Team (CPT) comprised of medical professionals from several disciplines will evaluate the products based upon on the following evaluation criteria to determine acceptability. Clinical/Performance Criteria Evaluation 1. The safety feature activates passively and creates minimal noise that may startle the patient or end user. 2. The safety feature can?t be activated unless the user?s hands remain behind the sharp device at all times to prevent a needlestick injury. 3. The safety device is easily used with either hand so left and right-handed users can use the device as intended. 4. Activation of the safety feature is obvious to the end user so activation is insured before disposal. 5. The safety feature cannot be activated more than once and remains in effect after disposal to prevent a needlestick injury. 6. The device cannot be reused once the safety feature is activated to prevent a needlestick injury. 7. The device can be easily and exactly placed on the desired puncture site (heel or finger) to avoid unnecessary multiple punctures and distress to the patient. 8. The device allows for an adequate blood volume to be drawn with one puncture because multiple punctures will distress the patient. 9. The safety device minimizes the risk of blood exposure because it withdraws the sharp end away from the user. 10. The device is simple and easy to use and requires little training so anyone can use it effectively. 11. The size and type of the device is easily identified from the packaging to avoid opening the package unnecessarily. Phase III ? Pricing Analysis Process All vendors who provide samples for clinical evaluation will be asked to submit best value pricing for analysis. Vendors will be given 14 calendar days from the date of request to submit their best pricing, in a prescribed format, based upon the total requirements of the Southwest Region. Failure to respond within the timeframe will result in disqualification. The Region intends to evaluate pricing and select a vendor or vendor(s), without discussions. Vendor pricing should contain the vendor's best product matches for the products or product lines requested in this announcement. Vendor pricing should contain the vendor's 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 Region). Additionally, the Region reserves the right to conduct discussions and request revised pricing, if it is determined to be necessary. Pricing will be evaluated based on best value to the government and will be based on a committed volume for a two-year period with possible one-year option periods (not to exceed 5 years). The following elements will be considered in the pricing analysis: (1) Impact of RIA prices on the Region (Post-Standardization Costs), (2) Potential Cost Avoidance, (3) Impact of Unmatched Lines, and (4) Consideration of stockage keeping units (SKUs) by each vendor. Due to the potential for Base DAPA prices to be inflated, the Impact of RIA prices on the Region is considered more important than other pricing elements. Clinical/performance and technical/company factors will be weighted more heavily than price. As the evaluation results become more technically equal, price will become more important. Vendors who fail to offer discounted prices will be excluded from RIA award consideration.

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