SOURCES SOUGHT
65 -- BRUSHLESS SURGICAL HAND SCRUB
- Notice Date
- 3/27/2009
- Notice Type
- Sources Sought
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, NMC San Diego, Bldg 1, 38400 Bob Wilson Drive, San Diego, California, 92134-5000
- ZIP Code
- 92134-5000
- Solicitation Number
- APP-1-9-10-0901-01
- Archive Date
- 5/2/2009
- Point of Contact
- Cynthia Ingrao, Phone: 619-532-8517
- E-Mail Address
-
cynthia.ingrao@med.navy.mil
- Small Business Set-Aside
- N/A
- Description
- A. General Information The Northeast & Southwest Regions comprised of Army, Navy, and Air Force medical treatment facilities in Maine, New Hampshire, Massachusetts, Rhode Island, Connecticut, New York, Pennsylvania, New Jersey, Delaware, Maryland, District of Columbia, Virginia and California announce a Request for Regional Incentive Agreement Quotation (RFRIAQ) for the standardization of Brushless Surgical Hand Scrub. 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 brushless surgical hand scrub that does not require the use of a brush or sponge. The scrub must contain ingredients that significantly reduce microorganisms on intact skin; contain a nonirritating, antimicrobial preparation; be broad spectrum; be fast acting, and have a persistent effect per methodology specified by the Food and Drug Administration's (FDA) Tentative Final Monograph (TFM) Protocol for Healthcare Antiseptic Drug Products (21 CFR Parts 333 and 369, Tentative Final Monograph for Healthcare Antiseptic Drug Products; Proposed Rule). 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, Owens & Minor and Cardinal, currently serving the Northeast Region and Southwest Region, respectively. 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 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 Network, FT Belvoir, VA; Keller Army Community Hospital, Westpoint, NY; and Kimbrough Ambulatory Care Center, FT Meade, MD. The major facilities in the Southwest Region 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. 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 and how to obtain a DAPA 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 2009. 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 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- cynthia.ingrao@med.navy.mil B. Products & Performance Required The Northeast and Southwest Regions are seeking product line items in the category of Brushless Surgical Hand Scrub. The product category includes brushless surgical hand scrub that does not require the use of a brush or sponge. The scrub must contain ingredients that significantly reduce microorganisms on intact skin; contain a nonirritating, antimicrobial preparation; be broad spectrum; be fast acting, and have a persistent effect per methodology specified by the Food and Drug Administration's (FDA) Tentative Final Monograph (TFM) Protocol for Healthcare Antiseptic Drug Products (21 CFR Parts 333 and 369, Tentative Final Monograph for Healthcare Antiseptic Drug Products; Proposed Rule). Within these two Regions, this product line has an estimated annual dollar requirement of $68,595. This forecast is based on historical prime vendor sales during a recent 12-month period. At the request of the Northeast & Southwest 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 the test sites. These training aides will address the safe and acceptable method of using the product. 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 cynthia.ingrao@med.navy.mil no later than April 17, 2009. All e-mail communications between vendors and the region will be digitally signed. Submissions must be received by COB, 5:00 PM PDST 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 Toni Massenberg, RN Walter Reed Army Medical Center Tri-Service Regional Business Office Building 1, Suite C330 6900 Georgia Avenue, NW Washington, DC 20307-5001 Phone: (202) 782-3666 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 Northeast and Southwest 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. Your company must manufacture and/or distribute a complete line of brushless surgical hand scrub that does not require the use of a brush or sponge. The scrub must contain ingredients that significantly reduce microorganisms on intact skin; contain a nonirritating, antimicrobial preparation; be broad spectrum; be fast acting, and have a persistent effect. 2. Your product must meet FDA requirements as outlined in the Tentative Final Monograph. The FDA requires that products for surgical hand scrubs provide a one-log reduction on day one, a two-log reduction on day two, a three-log reduction on day five, and show persistent activity for at least six hours on each of the three test days. 3. Provide the brand(s) under which your company manufactures or distributes your products. 4. Provide the volumes your product is available and how the product is packaged to avoid contamination of the unused product and prevent fire hazards if your product contains a flammable ingredient. 5. Your product must be non-irritating, significantly reduce microorganisms on intact skin, be broad spectrum, be fast-acting and have a persistent effect. Please provide documentation supporting these features. 6. Your product must have cumulative activity. Please provide the documentation supporting this feature. 7. If your product contains alcohol, it must be 60% - 95% by volume. 8. Your product must not change in consistency or deteriorate over time. 9. The package must allow for easy, hands-free dispensing. 10. Your product containers must be designed to prevent "topping off". 11. Your product must be easily cleaned off surfaces and equipment should accidental exposure to those surfaces occur. 12. Your product must not cause damage of any surfaces found in a hospital operating room suite. Please provide literature stating the surfaces (including equipment) your product does not cause damage to if it accidentally comes in contact with it and that repair or replacement of the damaged property will be completed at no cost to the facility. 13. Your company must submit MSDS information in PDF format for distribution with your product. 14. Your product must be compatible with latex and non-latex surgical gloves. 15. Your product must be compatible with skin moisturizers should your product not have a moisturizing ingredient. 16. Your products must be available through the Prime Vendors, Cardinal Health and Owens & Minor, or you will be disqualified from the standardization process. Please acknowledge and identify that you have such an agreement with Cardinal Health and Owens & Minor. 17. Your company must have a DAPA number for this product line or you will be disqualified from the standardization process. Please provide the DAPA number for this product line. 18. Your company must offer volume discounts off DAPA for all products included in this standardization initiative. Where 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. Vendors that fail to offer a discount off the DAPA price will be disqualified. 19. Educational tools or materials in the form of written, audio and/or visual must be provided for this product line. Please state how your company will meet this requirement. 20. Your company must provide staff training for this product line. Please state how your company will meet this requirement. 21. During in-service training the following points must be covered: a. The amount of time it takes to achieve antimicrobial protection after application of the product. b. If an initial brush scrub is required before application of the product. c. If subsequent scrubs are required during the same day. d. The method your product is applied. e. If water is required for use with your product. f. The time it takes for your product to dry. g. If your product is compatible with iodine, CHG, and latex. 22. The instructions for use of your product must be consistent with recommendations for surgical hand antisepsis in the 2002 CDC Guideline for Hand Hygiene in Health-Care Settings. Please provide the instructions for use of your product. 23. Please provide a list of product representatives for each account in the Southwest and Northeast Regions. 24. Please provide your company's returned goods policy. 25. Please provide an implementation plan for servicing the supply requirements of the Southwest and Northeast Regions including a list of all costs, if applicable, if not state so, that would be incurred by the Medical Treatment Facilities to convert to your product and your company's ability to minimize wall damage when mounting dispensers. 26. Please annotate the hours that customer service support is accessible via a toll-free number. 24 hours/day, 7 days/week support is preferable. If your company does not provide preferable level of support, state the hours support is provided. 27. Please provide any history of backorders, recalls, and/or adverse events for this product line stating dates and duration, cause, and resolution. Vendors should put their best foot forward, that is, provide a context to include any mitigating factors for these situations and any relief or resolution which may have been provided since there will be no further opportunity to explain these incidents. If your company has not had any of the above, so state. 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 from the issue of the notice to deliver literature and samples. Samples must arrive at the MTF by COB, 5:00 PM 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 method of product dispensing is acceptable and the solution is easily dispensed from the dispenser. Clinicians need the product to be dispensed in a method that is hands free and does not involve handling bottles to prevent contamination of the dispenser by the clinician's hands and vice versa. The product needs to dispense easily from the dispenser to prevent contamination and assist in completing the surgical scrub quickly. a. The product is removed from the dispenser easily and quickly without the clinician having to touch the dispenser. b. This criterion will be evaluated in the clinical setting by use of the dispenser at least 2 times. c. The evaluator using the dispenser will obtain product from the dispenser without touching it and the product will be dispensed quickly. 2. The dispenser does not leak. Clinicians do not want a dispenser that leaks the product on table top surfaces, sinks or floors. Product that is leaked on a working surface or the floor can be unsightly and hazardous to health and safety because of possible chemical exposure in the form of vapors. a. The dispenser will be mounted to a wall in the evaluation area or to a manufacturer designed floor stand for a period long enough to determine if the dispenser leaks. b. This criterion will be evaluated in the clinical setting for a minimum of 36 hours. c. The evaluator will directly observe the dispenser and examine it for leaks as evidenced by product being outside of the dispenser and in the immediate area or on the dispenser. 3. The manufacture's instructions for use are easy to understand and prevent confusion. Clinicians need easy to understand instructions of use to insure the product is used correctly and they get the results they expect. a. The manufacture's instructions for use are clearly written on the product dispenser in easy to use steps. b. This criterion will be evaluated in the clinical setting by use of the product at least 2 times. c. The evaluator will carefully read the product label for the manufacturer's instructions of use. The expectation is that the instructions will be easily and clearly understood and the evaluator will get the expected result from the product. 4. The drying time of the product is within the time stated by the manufacturer and acceptable to the clinician. Excessive drying time interferes with the donning of surgical gloves and subsequent commencement of the surgical procedure. a. The product will dry in accordance with the stated drying time and be acceptable to the clinician. b. This criterion will be evaluated in the clinical setting by use of the product and a timer, watch or clock at least 2 times. c. The evaluator will directly observe for the anticipated drying time. The expectation is that the product will dry in accordance with the product literature and be acceptable to the evaluator. 5. The product does not have an unpleasant odor. Clinicians require the products they use have a pleasant odor or no odor at all. Odors and fragrances can be irritating and sometimes cause allergic reactions. a. The product will not give off an unpleasant odor as perceived by the clinician. b. This criterion will be evaluated in the clinical setting by use of the product at least 1 time. c. The evaluator will dispense the product, use it as directed and then note if there is an unpleasant odor. The expectation is that the product will not initiate an allergic reaction to the evaluator. 6. The product does not leave an unpleasant residue. Clinicians require the product not leave an unpleasant residue on the skin. Residues can be irritating to the skin or cause interaction reactions with gloves. Residues also create a sense of discomfort that compels the clinician to wash with water to remove it, which negates the intended use. a. The product will not leave an unpleasant residue on the skin of the clinician. b. This criterion will be evaluated in the clinical setting by use of the product at least 2 times. c. The evaluator will dispense the product, use it as directed and then note if there is an unpleasant residue. The expectation is that the product will not leave or build up an unpleasant residue on the skin of the evaluator. The evaluator will not be compelled to wash the skin with water. 7. The product does not dry; cause irritation to or breakdown the skin. Clinicians do not want a product that dries the skin, causes irritation to the skin or breaks the skin down. Compromise of skin integrity makes it easy for microbes to enter the system and cause infection. a. The product will not dry the skin, cause irritation to the skin or breakdown the skin of the clinician. b. This criterion will be evaluated in the clinical setting by use of the product at least 2 times. c. The evaluator will dispense the product, use it as directed and then note if the skin is dry, irritated or becoming fragile which make cause skin breakdown. The expectation is that the product will not cause any discomfort to the skin of the evaluator. 8. It is easy to don surgical gloves after use of the product. Clinicians require the donning of surgical gloves after use of a surgical scrub be smooth and fast taking only seconds to complete from start to finish. a. The product, after it is dried, allows the clinician to don surgical gloves in a smooth and efficient manner. b. This criterion will be evaluated in the clinical setting after the product has been applied according to manufacture's instructions and donning a pair of surgical gloves at least 1 time. c. The evaluator will dispense the product, use it as directed and then don a pair of surgical gloves. The expectation is that the product will not cause the surgical gloves to adhere or catch on the skin of the evaluator thereby making the donning of the gloves cumbersome and inefficient. 9. The product cleans off surfaces easily. During use, products can fall or be splashed on surfaces near the dispenser or the clinician using the product. Clinicians prefer products that do not damage the surfaces of counters, sinks, floors or equipment. a. The product will not damage the surfaces of counters, sinks, floors or equipment. b. This criterion will be evaluated in the clinical setting by reviewing literature and the manufacturer's warranty on the use of the product for information that states the product is safe on all surfaces and if damage occurs to the surface, the manufacturer will replace the damaged surface. c. The evaluator will read literature provided by the manufacturer and determine if the desired warranty information is included. The expectation is that the literature will contain the needed information that the product is safe for all surfaces. 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 Northeast 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. 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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