SOURCES SOUGHT
65 -- One-Step Surgical Skin Prep with 2% Chlorhexidine and 70% Isopropyl Alcohol
- Notice Date
- 5/30/2009
- 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
- APP9-10-0902-02
- Archive Date
- 7/7/2009
- Point of Contact
- Cynthia Ingrao, Phone: 619-532-8517
- E-Mail Address
-
cynthia.ingrao@med.navy.mil
(cynthia.ingrao@med.navy.mil)
- Small Business Set-Aside
- N/A
- Description
- A. General Information Southwest Region seeks approval to standardize One-Step Surgical Skin Prep with 2% Chlorhexidine and 70% Isopropyl Alcohol for its 10 Army, Navy, and US Air Force medical facilities in California. This standardization action for this product line is a new initiative for the Southwest Region. 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. This product line includes the following products in the following sizes: 1) an applicator sponge device which delivers a range of 0.5 to 3 ml of solution which contains 2% Chlorhexidine Gluconate with 70% Isopropyl Alcohol; 2) an applicator sponge device which delivers a range of 10 to 15 ml of solution which contains 2% Chlorhexidine Gluconate with 70% Isopropyl Alcohol and 3) an applicator sponge device which delivers a range of 25 to 30 ml of solution which contains 2% Chlorhexidine Gluconate with 70% Isopropyl Alcohol in clear and tinted versions appropriate for the application of use. 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, Cardinal, currently serving the Southwest Region. The major facilities in the area 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 obtaining 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 October 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 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- cynthia.ingrao@med.navy.mil B. Products & Performance Required The Southwest Region is seeking product line items in the category of One-Step Surgical Skin Prep with 2% Chlorhexidine and 70% Isopropyl Alcohol. Within this region, this product line has an estimated annual dollar requirement of $96,000. This is a new product line, which addresses the newer standards of care in the prevention of Surgical Site Infections and the prevention of nosocomial infections. This forecast is based on historical prime vendor sales during a recent 12-month period. At the request of the Southwest 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 offered by the vendor. 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 to cynthia.ingrao@med.navy.mil no later than June 22, 2009. 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 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. All e-mail communication between vendors and the region will be digitally signed by the issuer. 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 Phase I - Technical/Company Evaluation Process. Vendors will be required to provide detailed responses to the technical/company criteria and product literature. 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. The vendors who meet the following 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. 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. Vendor must manufacture and/or distribute a complete product line of One Step Surgical Prep 2% Chlorhexidine With 70% Isopropyl Alcohol. A ‘complete line of product' is defined as the 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. At a minimum, a complete product line includes the following products in the following sizes: 1) an applicator sponge device which delivers a range of 0.5 to 3 ml of solution which contains 2% Chlorhexidine Gluconate with 70% Isopropyl Alcohol; 2) an applicator sponge device which delivers a range of 10 to 15 ml of solution which contains 2% Chlorhexidine Gluconate with 70% Isopropyl Alcohol and 3) an applicator sponge device which delivers a range of 25 to 30 ml of solution which contains 2% Chlorhexidine Gluconate with 70% Isopropyl Alcohol in clear and tinted versions appropriate for the application of use. 2. Vendor must provide CDC certification, for clinical efficacy in skin asepsis and the microbial control of coagulase-negative Staphylococcus (CoNS), S. aureaus, Enterococcus species, Escherichia coli and Pseudomonas aeruginosa; as well as, effectiveness against multi-drug resistant microorganisms including, but not limited to MRSA, VRE, C.Difficil, Acinetobacter, Candida and Pseudomonas species, for all itemized brand(s) and styles that are manufactured and/or distributed for One Step Surgical Skin Prep products. 3. Vendors must have a DAPA or be in the process of applying for a DAPA number for the One Step Surgical Skin Prep product line. Provide the DAPA number or proof of the application process with the initial submission. Vendors that fail to have a DAPA or show a lack of progress in obtaining a DAPA will be disqualified. 4. Vendors must have a separate agreement with the prime vendor Cardinal Health for distribution in the Southwest Region. Vendors whose products are not available through Cardinal Health will be disqualified. 5. Vendors must provide discounts off DAPA for all products included in this standardization initiative. 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 DAPA. Vendors that fail to provide a discount from DAPA will be disqualified. 6. Vendors must have a vendor representative(s) available in the Southwest Region. Please provide contact information, i.e. name, address, phone number, and e-mail address with the initial submission. 7. Vendors must provide proof of corrective actions(s)/ resolution for any history of back orders and/or recalls that occurred during the most recent 12-month period for One Step Surgical Skin Prep with at least 2% chlorhexidine and at least 70% isopropyl alcohol products, 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. 8. Vendors must provide the MSDS literature for each product offered. 9. Vendors must provide in-service staff training and identify company resources for such requirements with the initial submissions. 10. Vendors must provide educational tools and materials for One Step Surgical Skin Prep with at least 2% chlorhexidine and at least 70% isopropyl alcohol products, and provide evidence of this with the initial submission. For instance, provide a written description of the tools/materials available. 11. Vendors must identify if there is any latex component in the device or packaging of the One Step Surgical Skin Prep product. 12. Vendors must provide products with visible expiration dates and product description on the labeling/packaging. Phase II - Clinical/Performance Evaluation Process. The TPRB will request samples and product literature 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 14 calendar days to ship samples. Samples must arrive at the MTF by COB, 5:00PM PDST, on the 14th 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 MTFs will evaluate the clinical/performance criteria using a scale from one (1) to five (5) where 1 = Strongly Disagree, 2 = Disagree, 3 = Neutral, 4 = Agree and 5 = Strongly Agree. All clinical/performance criteria are weighted equally. The evaluations are conducted a clinical setting. 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 1. The product container & wrapping are durable and intact and ensure no leakage of the prep solution. This ensures the product's sterility is maintained and eliminates the potential for degradation of the product. The wrapping alerts users of latex or non-latex content and expiration date. a. The product container & wrapping are free of holes, punctures, splits in the heat sealed edges and does not leak solution from any of the seams or edges. The wrapping states the latex content and expiration date. b. This criterion will be evaluated in the clinical setting by use of the product at least 3 times. c. The evaluators will carefully scrutinize the entire package for any punctures, tears or compromise to the sealed edges, latex content, & expiration date. The expectation is that no evidence of breaks in the barrier of the packaging or evidence of liquid seepage will be found and the user would be alerted of latex content and expiration date. 2. The sponge applicator is constructed in a way that ensures an even, controlled application of solution onto the skin. a. The sponge applicator controls the amount of solution delivered as it is applied to the skin area. No surges in the amount of liquid or leakage from the applicator will occur. b. This criterion will be evaluated in the clinical setting by use of the product at least 3 times. c. The clinicians using this product on the patient's skin will closely observe the applicator for any evidence of an uneven delivery of solution. The expectation is that the applicator will control the amount of solution delivered during use. 3. The device's container holds an adequate amount of solution to prepare the patient's skin for surgery. There is sufficient variety in the volumes available to completely cover the surgical site area without need to open a second container. a. A second applicator is not required to complete the skin prep. b. This criterion will be evaluated in the clinical setting by use of the product at least 3 times. c. The clinicians using this product will directly observe the adequacy of the amount of solution provided. The expectation is that the device will contain the adequate amount of prep solution. 4. The solution, when applied to the surgical site, will leave an easily identified landmark. Visualization of the prepped skin area is clearly distinguishable from other skin areas to avoid wrong site errors. a. The prepped area of the skin will transition from a very shiny wet appearance to a dull matted appearance for clear solution or will be tinted with the color of the solution. b. This criterion will be evaluated in the clinical setting by use of the product at least 3 times. c. The clinicians will directly observe for this critical characteristic of having prepped the surgical site. The expectation is that this transition from a shiny skin appearance to a dull matted skin appearance or resulting tinted color will occur. 5. The drying time of the solution is within the time stated by the manufacturer. Excessive drying time interferes with the standard of initiating the application of surgical drapes and protective barriers to the patient. a. The prep solution will dry in accordance with the stated drying time. b. This criterion will be evaluated in the clinical setting by use of the product at least 3 times. c. The clinicians will directly observe for the anticipated drying time. The expectation is that the solution will dry in accordance with the product literature. 6. The solution does not have an unpleasant or irritating odor and is not irritating to the skin. An odor that is unpleasant or irritating to the user and patient may cause physical reactions to both. Irritation to the skin of the patient will cause skin breakdown and increase the risk of infection. a. The prep solution will not have an unpleasant or irritating odor and not be irritating to the skin. b. This criterion will be evaluated in the clinical setting by use of the product at least 3 times. c. The clinicians will directly observe for odor that is unpleasant and/or irritating and for skin irritation. The expectation is that there will be no unpleasant or irritating odor or skin irritation to the patient. 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. 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 SKUs by each vendor. The impact of RIA prices on the Region is considered more important than other pricing elements. 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 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). Failure to submit a discount off the DAPA price will result in exclusion.
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