SOURCES SOUGHT
65 -- Safety IV Catheters
- Notice Date
- 4/22/2010
- 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, 34800 Bob Wilson Drive, San Diego, California, 92134-5000, United States
- ZIP Code
- 92134-5000
- Solicitation Number
- APP-9-10-1004-01
- Archive Date
- 5/28/2010
- 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 The Southwest Region will be standardizing Safety IV Catheters. This is a re-evaluation of this product group since the Regional Incentive Agreements have expired. A multiple selection is only a possibility if no single vendor can meet the total requirements of the Region and would be based on a combination of MTF preference and product availability. In order to meet the total requirements of the Region 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 Safety IV Catheters for adult and pediatric patients. The entire category of Safety IV Catheters has an annual demand of over $500,000. 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 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 for elimination (i.e. like product items), as well as potentially minimizing the number of SKUs included in a subsequent incentive agreement. 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; 9 th Medical Group, Beale AFB; 30 th Medical Group, Vandenberg AFB; 61 st Medical Squadron, Los Angeles AFB; 95 th 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 August 2010. 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 Safety IV Catheters. The product category includes Safety IV Catheters for adult and pediatric patients. Within this region, this product line has an estimated annual dollar requirement of $500,000. This is a re-evaluation of this product group. A multiple selection is only a possibility if no single vendor can meet the total requirements of the Region and would be based on a combination of MTF preference and product availability. 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 May 13, 2010. Submissions must be received by COB, 5:00 PM PST 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 - 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 FDA approved Safety IV Catheters (known as product(s)) for adult and pediatric patients. 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, the following products in the following sizes are required: Safety IV Catheters are to be available with and/or without wings for all sizes listed except 20 and 24 gauge are required to be available with and without wings. •· Safety IV Catheter - 16 gauge with an approximate length range of 1.0 to 2.0 inches •· Safety IV Catheter - 18 gauge with an approximate length range of 1.0 to 2.0 inches •· Safety IV Catheter - 20 gauge with an approximate length range of 0.5 to 2.0 inches •· Safety IV Catheter - 22 gauge with an approximate length range of 0.5 to 2.0 inches •· Safety IV Catheter - 24 gauge with an approximate length range of 0.75 to 2.0 inches 2. Vendors must have a DAPA or be in the process of applying for a DAPA number for the Safety IV Catheters 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. Please provide your DAPA number. 3. 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. 4. 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. 5. Vendors must provide the product brand(s) your company manufactures or distributes. 6. Vendors must provide 24/7 customer service and identify company resources for such support with your initial submittals. 7. Vendors must provide product literature for this product line with your initial submittals both electronically and hard copy. 8. Vendors are required to provide on-site, in-person in-servicing, CD/DVD, and/or product literature training if requested. Vendors who cannot provide on-site, in-person in servicing, CD/DVD and/or product literature training if requested will be disqualified. 9. Vendors must provide products and packaging that are latex free and indicated on the packaging and in the product literature. 10. Vendors must provide products that have a safety feature that is easily identified, remains activated during disconnection of the needle from the catheter and after disposal. A feature which does not require the user to do anything differently than use the device as an intravenous catheter, using the percutaneous route of entry. The safety mechanism will be activated during the normal use of the device. Vendors that cannot provide such products will be disqualified. 11. Vendors must provide products that are single use, disposable, radio-opaque and compatible with all IV tubing currently on the market. Vendors that cannot provide such products will be disqualified. 12. Vendors must provide products whose access ports are needle-free. Vendors that cannot provide such products will be disqualified. 13. Vendors must provide a product which is clearly marked with the size of the safety catheter length and gauge. Provide specific information whether this information is provided on the device, or on the packaging or on both. Vendors that cannot provide such products will be disqualified. 14. Vendors must list the types of educational tools or materials they have for this product line and the type of staff training provided. 15. 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. Vendors will not have an opportunity to provide additional information on back orders and recalls during any subsequent stage in this evaluation. 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, 5:00 PM PST, on the 14 th 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 and individually. The evaluations are conducted in a non-clinical setting. 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. It is easy to identify the type and size of product from the packaging. •a. The product must be identified easily and quickly to reduce the amount of time needed for staff to select the appropriate size for patient care needs. •b. This criterion will be evaluated in a clinical setting by use of the product at least 2 times. •c. The evaluator will examine the packaging and assess if it is easy to identify the type and size of the product. 2. The bevel of the needle is sharp enough to penetrate the skin and blood vessel and prevent drag. •a. A sharp bevel will penetrate the skin and blood vessel easily and prevent repeated sticking of the patient because of failed attempts and or piercing through the vessel causing bleeding under the skin and subjecting the patient to unnecessary trauma and pain. •b. This criterion will be evaluated in a clinical setting by use of the product at least 2 times. •c. Evaluator will perform a venipuncture with the safety IV catheter by examining the bevel of the needle and then performing the venipuncture assessing the ease or difficulty of penetrating the skin and blood vessel. 3. The catheter allows visualization of flashback in the chamber and or catheter. •a. Visualizing flashback confirms the clinician has entered the blood vessel. •b. This criterion will be evaluated in a clinical setting by use of the product at least 2 times. •c. Evaluator will perform a venipuncture with the safety IV catheter and watch for visualization of blood in the chamber or catheter. 4. The catheter hub is luer-lock compatible and attaches to tubing securely. •a. Attachment to tubing securely prevents tubing from accidental disconnection. •b. This criterion will be evaluated in a clinical setting by use of the product at least 2 times. •c. Evaluator will attempt to connect the catheter hub to the IV tubing and inspect whether the connection is secure. 5. The catheter sheath moves freely on the needle to facilitate advancement of the catheter into the blood vessel and disconnects from the needle easily. •a. Causes less manipulation at insertion site to prevent damage to the skin and/or blood vessel. Easy disconnection of the catheter from the needle prevents the catheter from being dislodged from the blood vessel requiring another venipuncture. •b. This criterion will be evaluated in a clinical setting by use of the product at least 2 times. •c. After performing the venipuncture, the evaluator will attempt to advance the catheter into the blood vessel and take note of the ease or difficulty in performing the advancement. The evaluator will attempt to disconnect the catheter from the needle and take note of the ease or difficulty in performing the disconnection. 6. The catheter recovers from kinking to its original form easily. •a. Ki nk recovery is essential during catheter advancement to insure the catheter floats in the blood vessel with smooth edges preventing damage to the blood vessel and fluid from flowing easily. •b. This criterion will be evaluated in a clinical setting by use of the product at least 2 times. •c. The evaluator will remove the catheter from the needle and kink it manually and observe whether the catheter restores itself to its original form. 7. The safety feature is an integral part of the device, activates passively and automatically and is not an accessory. •a. The safety feature must be an integral part of the device to insure it is available for deployment at every use to prevent accidental needle stick injury and exposure to blood borne pathogens to the end user. •b. This criterion will be evaluated in a clinical setting by use of the product at least 2 times. •c. The evaluator will examine the device to confirm the safety feature is part of the device and not an accessory. 8. The safety feature allows or requires the end user's hands to remain behind the needle at all times, is in effect before disassembly and remains in effect after disposal. •a. The safety feature requiring the end user's hands remain behind the needle and being in effect before disassembly and after disposal insures prevention of accidental needle stick injury and exposure to blood borne pathogens. •b. This criterion will be evaluated in a clinical setting by use of the product at least 2 times. •c. The evaluator will examine the device and confirm whether the safety feature requires the end user's hands remain behind the needle or not and confirm whether the safety feature is in effect before disassembly and remains in effect after disposal. 9. The catheter design allows for single-handed technique. •a. The ease of being able to insert the catheter with one hand is imperative during emergent situations of patient care. •b. This criterion will be evaluated in a clinical setting by use of the product at least 2 times. •c. The evaluator will attempt to perform a venipuncture with one hand assess the ease or difficulty in doing so. 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N00259/APP-9-10-1004-01/listing.html)
- Record
- SN02130412-W 20100424/100422235736-5dfb3d2655242b3979dcb7ae45eaeea4 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |