A. General Information The Heartland Region, TRBO Region 5, a military integrated delivery network, comprised of 5 Army, Navy, and Air Force, medical treatment facilities in Ohio, Illinois, and Kentucky announces a Request for Regional Incentive Agreement Quotation (RFRIAQ) for the standardization of Surgical Drapes. This product line includes, but is not limited to U-Drapes, 71X85 Drape Sheets, Three Quarter Drape Sheets, Extremity Drapes, Arthroscopy Drapes with Fluid Control Pouches & Laparotomy Drape Sheets. 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 products be obtained through the DoD Prime Vendor Program. A single selection is intended in this project; however, the Heartland Region acknowledges the possibility of a multiple selection if no single vendor can meet the total requirements of the region. The major facilities in the area include but are not limited to Wright Patterson Air Force Base Ohio, Scott Air Force Base Illinois, Naval Health Clinics of Great Lakes Illinois, Blanchfield Army Community Hospital Ft Campbell Kentucky, and Ireland Army Community Hospital Ft Knox Kentucky. 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 Vendors for 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 products. This RFRIAQ 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 their web site at https://dmmonline.dscp.dla.mil The resulting Regional Incentive Agreement (RIA) will be for a base period of two (2) years (24 months) from date of selection with three (3) 12-month option periods. Anticipated selection date is June 2008. The evaluation will be based on clinical, technical, 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. Point of Contact Phyllis Targett 937-257-9075 [email protected] B. Products & Performance Required The Heartland Region is seeking product line items in the category of Surgical Drapes, which at a minimum includes the high volume lines below. Within this region, this product line has an estimated annual dollar requirement of $44,835.40. This forecast is based on historical prime vendor sales for a 12-month period. The top high volume usage lines for this project include: 3M STERI-DRAPE U-DRAPE: ADHESI 45 Cases/$10,385.24; $3,103.89; DRAPE SHEET, 71 X 85 55 Cases/$4,551.37; PROXIMA THREE QUARTER DRAPE, E 77 Cases/$3,103.89; EXTREMITY DRAPE 86X128 34 Cases/$3,091.49; PROXIMA ARTHROSCOPY SHEET WITH 13 Cases/$3,031.53; PROXIMA LAPAROTOMY DRAPE WITH 29 Cases/$3,026.44; KIMBERLY-CLARK COMPONENTS (STE) 9 Cases/$2,973.39; 3M IOBAN 2 ANTIMICROBIAL INCIS 37 Cases/$2,870.27; 3M STERI-DRAPE IRRIGATION POUC 24 Cases/$2,480.00; KIMBERLY-CLARK COMPONENTS (STE ) 19 Cases/$2,099.01. At the request of the Heartland Region 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 provided by the vendor. C. Instructions to Vendors DAPA holders interested in participating in this standardization initiative should email their (1) Company name and address, (2) POC (Name and Phone Number, Fax Number, and E-mail address) to [email protected] (937) 257-9075. Submissions must be received by 5:00 P.M. EST on the specified closing date/time of this sources sought notice. Failure of the vendor to meet the submittal deadline will result in exclusion. This process will include vendor requirements of electronic responses to technical criteria, no charge samples for clinical evaluation, and submission of electronic best price quotes. Due to the potential for email to be lost in transmission from network security, etc., vendors are strongly encouraged to confirm with the Region that its initial submission, quote and literature actually arrived at the Regional Tri-Service Business Office (TRBO) 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. Failure of the vendor to meet the submittal deadline will result in exclusion. All e-mail communication between vendors and the region will be digitally signed by the issuer. D. Evaluation Criteria The Tri-Service Product Review Board (TPRB) is the governing body of the standardization process. This board includes clinicians and logisticians from all of the Military Treatment Facilities within the Heartland Region. They are the deciding officials for this initiative. The Region intends to evaluate price quotes and select a vendor without discussions. Vendor quotes should contain the vendor's best product matches for the products or product lines requested in this announcement. Vendor quotes should contain the vendor's best responses to all technical and/or company questions listed in this announcement. Vendor quotes 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 MTF?s in the Region). Additionally, the Region reserves the right to conduct discussions and request revised quotes, if it is determined to be necessary. If a down-selection is made during the evaluation process, the Region may limit the number of quotes to the greatest number that will permit an efficient competition among vendors. Phase I-Technical/Company Evaluation Process. Interested vendors are to respond to this FBO announcement by emailing their ?intent to participate? to the above POC by the required response date. Based on vendor responses, the TRBO POC will request detailed responses to the technical/company criteria from each vendor. 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 by the Clinical Product Team, to determine the acceptability of each vendor. After the review of the technical/company criteria, those vendors who meet the technical/company criteria will be qualified/invited to participate in the clinical/performance evaluation process via e-mail communication with each vendor. All communications of significant milestones, such as invitations to participate, notices of disqualification, etc. must be digitally signed. Acceptability for purposes of evaluation of technical/company criteria: Generally, responses to all questions in this section demonstrate: (1) the business concern submitting the quote 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 Owens & Minor, 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. The following equally weighted Technical/Company Evaluation Criteria have been established for this standardization initiative: 1. Vendors must have a DAPA or be in the process of applying for a DAPA number for the Surgical Drapes product line. Provide the DAPA number or proof of the application process with the initial submittal. (Note that vendors that fail to have a DAPA or show a lack of progress in obtaining a DAPA will be disqualified.) 2. Products must be available through the current Prime Vendor, Owens & Minor. Provide documentation to support with initial submittal. 3. Vendors must identify the brand(s) that your company manufacture and/or distribute your product. . Provide documentation to support with initial submittal. 4. Vendors products must meet the industry production and safety standards used in manufacturing drapes and must provide these standards and the independent studies and efficacy test results that certify that your products meet these standards with their initial submittals. These must include, but not limited to the American Association of Operating Room Nurses (AORN) standards. Provide documentation with initial submittal. 5. Vendors? products must be latex free/safe. Provide documentation to support with initial submittal. 6. Vendors? drapes must have barrier protection against particulate matter and fluids. Identify if this barrier protection is dependent on the number of layers the fabric has. List the levels of protection. 7. The impervious regions of your drapes must be labeled or indicated in some way on the item. Identify what is the method of labeling or indication. 8. Vendors must manufacture or distribute a complete line of drapes for all types of surgical procedures that include but are not limited to the high usage items listed above.. Please provide a complete list by identifying all brands, sizes, and types of your drapes with the initial submittal. 9. Vendors drapes must be packaged with labeling that clearly identifies the expiration date. Please confirm 10. Vendors drapes, (where applicable), must have instrument pads with a non-slip surface Provide documentation to support with initial submittal. 11. Vendors? drapes must be labeled/printed with the directions of placement. Provide documentation to support with initial submittal. 12. Vendors must identify what type of adhesive your company uses for the incision areas of your drapes. 13. Vendors must identify the ASTM International test method used (and the score) for assessing your drape propensity to lint (i.e., flexing in air, Helmke drum test etc). 14. Vendors must identify the ASTM International test method used to determine breaking strength for your drapes (grab or strip tensile strength, burst strength, etc.) and provide the test result score for your product. 17. Vendors must identify the ASTM International tear strength test method (and score) used for your drapes. 18. Vendors must provide information about how your company?s fabrics used in your drapes perform in a surgical fire, i.e., Meets Consumer Product Safety Commission Standard for Flammability of Clothing Textiles (CPSC 16 CFR 1610). 19. Vendors must provide information on how your company?s drapes are constructed, i.e., spun-lace, spunbond, wet laid etc? 20. Vendors must provide the recommended disposal guidelines for your drapes (If products are incinerated for disposal, what are the potential byproducts?) 21. Vendors must identify if company has history of backorders and /or recalls for the product line in the past five (5) years Explaining the a) dates and duration, b) cause, c) resolution. Vendors should provide a context to include any mitigating factors for these situations, and any relief of resolution which may have been provided, since there will be no further opportunity to explain these scenarios and their effects. 1. Phase II ? Clinical/Performance Evaluation Process. The multi-disciplinary Clinical Product Team (CPT) formed by the TPRB will request samples (no charge) from the product line to be clinically evaluated at select Military Treatment Facilities. Vendors are required to ship their no cost samples directly to the designated MTF?s and will be allowed 3 weeks (21 calendar days) from the date of notification to complete the delivery. Samples must be shipped to arrive at the MTF by COB, 5PM EST, 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. The samples to be provided are as follows: U Drape (Sterile-Disposable-plastic w/ adhesive around opening) 48 x 52-5 each facility Drape Sheet (Sterile-Disposable) 71 X 85-5 each facility ? Drape Sheet (Sterile-Disposable-Economy) 53X77- 5 each facility Extremity Drape (Sterile-Disposable) 89X128-5 each facility Arthroscopy Drape w/Fluid Control Pouch (Sterile/Disposable) Specific MTF?s will evaluate the clinical/performance criteria using a Likert like scale, with a one to five rating. 1 = strongly disagree, 2=disagree, 3=neutral, 4=agree and 5 = strongly agree. All clinical/performance criteria are equally weighted. The CPT has established a target threshold of 3.75 for the clinical acceptability of products for standardization. The CPT will analyze this acceptability as being at or 3.75 depending on the "break" in the average scores and how closely scores are clustered near the Acceptability Target Threshold of 3.75. Subject to this review, products below this threshold will be clinically unacceptable and will be disqualified from further consideration for standardization. To determine acceptability, a Clinical Product Team (CPT) comprised of medical professionals will evaluate the products based on the evaluation criteria below. The CPT intends that clinical evaluations be conducted in a clinical setting. The following equally weighted Clinical/Performance Evaluation Criteria have been established for this standardization initiative: Clinical Acceptability Target Threshold: 3.75 1. Product size and folding allows item to be easily applied to the operative site (sterile drapes should be handled as little as possible) 2. Product is flexible enough to conform loosely to the patient?s contour.(flexibility allows the patient to be draped smoothly and closely which allows for placement of surgical instruments on field) 3. Product has limited memory (drape stays unfolded and in place when applied). 4. Product is lint-free during use (lint can contaminate surgical site and increases the chance for infection) 5. Product does not tear and/or perforate easily during use (tears increase the chance of contaminating the sterile field) 6. Product fenestration size is adequate for the type of procedure (allows for easy access to surgical site) 7. Reinforced areas on the drape prevent strikethrough (critical areas are reinforced). 8. The edge of the incision opening has good adhesion (the incision opening will not come loose if moist or wet). Phase III ? Pricing Analysis Process. After the clinical/performance evaluation is completed and analyzed, all vendors in the clinical evaluation group who met the minimum 3.75 threshold (depending on the "break" in the average scores and how closely scores are clustered near the Acceptability Target Threshold as determined by the CPT) will be contacted to submit their lowest pricing quotes (as well as product cross-reference data) based on committed volume of 80% of the total Regional requirement. Vendors will be provided 2 weeks (14 calendar days) to submit their price quotes in a prescribed format via email. Price quotes must be received by 5:00 PM EST on the 14th calendar day. Failure to respond within this timeframe or failure to submit incentive discounts from their DAPA prices will result in the vendor being disqualified from further consideration/ participation. The Region intends to evaluate quotes and select a vendor, without discussion as noted above. However, the Region reserves the right to conduct discussions and request revised pricing, if determined to be necessary. A multiple selection is only a possibility if no single vendor can meet the total requirement of the Region and would be based on a combination of MTF preference and product availability. Clinical/performance and technical/company factors will be weighted more heavily than price. As the technical and clinical evaluation results become more equal, price will become more important. 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 a total of 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.

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