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FBO DAILY ISSUE OF MARCH 05, 2010 FBO #3023
SOURCES SOUGHT

65 -- Skin Staples and Staple Removers - Southwest and Northwest Regions

Notice Date
3/3/2010
 
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
APP9-10-11-1002-01
 
Archive Date
4/8/2010
 
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 and Northwest Regions will initiate the standardization process for Skin Staplers and Staple Removers for the Army, Navy, and Air Force medical facilities in California, Washington and Alaska. In the Southwest Region this is a re-evaluation for 2 separate expired RIAs with Covidien for the Skin Staplers and with 3M for the Staple Removers. This is also a re-evaluation for the Northwest Region who also has an expired RIA with Covidien for the Skin Staplers and Staple Removers. A multiple selection is only a possibility if no single vendor can meet the total requirements 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 Skin Staplers and Staple Removers in various sizes for the approximation of the skin. The entire category of Skin Staplers and Staple Removers has an annual demand of over $78,000. The primary objective of this program is to standardize the quality of care across the Southwest and Northwest Regions 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. 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 Southwest and Northwest Regions 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; 9th Medical Group, Beale AFB; 30th Medical Group, Vandenberg AFB; 61st Medical Squadron, Los Angeles AFB; 95th Medical Group, Edwards AFB. The major facilities in the Northwest Regions include but are not limited to Bassett Army Community Hospital, Fort Wainwright, AK; Bremerton Naval Hospital, Bremerton, WA; Fairchild AFB Clinic, Fairchild AFB, WA; 354th Medical Group, Eielson Air Force Base, AK; 3rd Medical Group, Elmendorf AFB, AK; Madigan Army Medical Center, Tacoma, WA; Oak Harbor Naval Hospital, Oak Harbor, WA. 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 July 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. 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. Points of Contact: Cindy Ingrao, RN, MSN at (619) 532-8517; Email- cynthia.ingrao@med.navy.mil Rosa Crumpton at (253) 968-0898; Email - rosa.crumpton@us.army.mil B.Products & Performance Required The Southwest and Northwest Regions is seeking product line items in the category of Skin Staplers and Staple Removers. The product category includes Skin Staplers and Staple Removers in various sizes for the approximation of the skin. Within this region, this product line has an estimated annual dollar requirement of $78,000. 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 and Northwest 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. 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 March 24, 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 and Northwest Regions 34800 Bob Wilson Drive, Suite 110 San Diego, CA 92134 Phone: (619) 532-8517 Rosa Crumpton Tri-service Regional Business Office - Northwest Region General Dynamics Information Technology Army Solutions Division Madigan Army Medical Center 9040A Fitzsimmons Ave., Room G-07-09 Tacoma, WA 98431-1100 Phone: (253) 968-0898 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 be lost in transmission, due to network security/firewalls, etc., vendors are strongly encouraged to confirm with the Regions that its initial submission, quote and literature actually arrived at the Regions 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. All email communications between vendors and the Regions are to be digitally signed by the issuer. 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.Vendors must provide a line of Skin Staplers and Staple Removers that are FDA approved and latex free. A ‘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.’ Skin Staplers and Staple Removers required by the region are latex-free. Please state that you can provide the product line and provide a complete list of items supplied including sizes, lengths and specifications for use (catalog, etc.). In addition, send any applicable product literature in response to this RFQ. 2.Vendors must have a DAPA, or be in the process of applying for a DAPA, for the Skin Staplers and Staple Removers Product Line. 3.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.) 4.Vendors must have a separate agreement with the Region’s Prime Vendor, Cardinal Health. Please provide documentation of your company’s agreement with Prime Vendor. (Note that vendors whose products are not available through the Regional PV will be disqualified.) 5.Vendors 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. 6.Vendors must provide the brand(s) that their company manufactures or distributes. 7.Vendors must state under what standards their products are manufactured. 8.Vendors must state if there is an expiration date on the packaging. 9.Vendors must state under what regulatory and/or advisory agency their products are classified and whether their products are approved by these agencies. 10.Vendors must state if their products are recyclable and/or environmentally friendly to discard in landfills. 11.Vendors must provide educational tools or materials for this product line. Vendors must list the tools and training available to staff and patients in response to this solicitation. 12.Vendors must have a local representative in the Southwest and Northwest Regions that can provide assistance at regional facility locations. Vendors must provide contact information, i.e. name, address, phone number, and e-mail address. 13.Vendors must provide all history of back orders and/or recalls that occurred during the most recent 12-month period for items in their Skin Staplers and Staple Removers product line, including dates, duration, cause, and resolution. a.Vendors will not have an opportunity to provide additional information on back orders and recalls during any subsequent stage in this evaluation. b.Vendors are encouraged to submit all information deemed relevant (i.e., positive resolutions, etc.) in response to this RFQ. c.Vendors should not provide point of contact information in response to this question. Additionally, the Government will not contact any points of contact that are provided in response to this question. 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 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 clinical evaluation responses are scored using a Likert scale with a range from 1-5. The scale descriptors are 1 = Does Not Meet Criteria, 2 = Partially Meets Criteria, 3 = Meets Criteria, 4 = Exceeds Criteria and 5 = Exceptionally Exceeds Criteria. All clinical/performance criteria are weighted equally. The score of each criterion will be analyzed. If the score of the clinical/performance criterion partially meets or does not meet criteria, that vendor will be ineligible for RIA award consideration. 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 Clinicians will use each vendor’s products on at least 2 patients in order to evaluate the criteria. Skin Staplers: 1.The product performs without misfires or jams. a.Rationale: clinicians require product to perform rapidly and precisely without misfiring or jamming to insure proper placement on the skin and approximation of wound edges. b.Method: the clinician will perform skin closure with product and determine whether misfire or jam occurs. 2.The type of product/size/rust free status are easy to identify from the package. a.Rationale: clinicians require the product type and size be easily identified from the package to increase time efficiency and avoid the time wasted in performing a long detailed examination of the product in its package. b.Method: the clinician will determine if type/size/rust free status can be seen by quickly glancing at the package. 3.The product is ergonomically designed for use with both hands and comfort. a.Rationale: product must be lightweight, ergonomically and comfortable to hold in either hand to reduce hand fatigue. b.Method: the clinician will use the product as directed and determine if it caused hand fatigue and/or discomfort. 4.Easy to use with minimal training required. a.Rationale: clinicians require the product be easy to use with minimal training required to reduce clinician’s time and effort of use. b.Method: the clinician will determine if the product is easy to use by reviewing written instructions of use and/or in-service training of the product by the manufacturer. 5.The package is easy to open & allows for aseptic delivery to a sterile field. a.Rationale: package must be designed to allow the product to remain sterile during opening and placement onto the sterile field to prevent contamination and potential patient infection. b.Method: the clinician will open the sealed package and note whether or not the packaging is easy to open and the product remains in the sterile section of the package while being placed on the sterile field. Staple Removers: 1.The product performs without misfires or jams. a.Rationale: clinicians require product to perform rapidly and precisely without misfiring or jamming to insure proper placement on the skin and approximation of wound edges. b.Method: the clinician will perform skin closure with product and determine whether misfire or jam occurs. 2.The type of product/size/rust free status are easy to identify from the package. a.Rationale: clinicians require the product type and size be easily identified from the package to increase time efficiency and avoid the time wasted in performing a long detailed examination of the product in its package. b.Method: the clinician will determine if type/size/rust free status can be seen by quickly glancing at the package. 3.The staple is easily extracted from the skin with the staple remover. a.Rationale: staples must be inserted in the skin in a manner that allows them to be easily removed preventing skin and tissue damage. b.Method: clinician will use a staple remover to remove the staples and determine the ease of removal. 4.The product is ergonomically designed for use with both hands and comfort. a.Rationale: product must be lightweight, ergonomically and comfortable to hold in either hand to reduce hand fatigue. b.Method: the clinician will use the product as directed and determine if it caused hand fatigue and/or discomfort. 5.Easy to use with minimal training required. a.Rationale: clinicians require the product be easy to use with minimal training required to reduce clinician’s time and effort of use. b.Method: the clinician will determine if the product is easy to use by reviewing written instructions of use and/or in-service training of the product by the manufacturer. 6.The package is easy to open & allows for aseptic delivery to a sterile field. a.Rationale: package must be designed to allow the product to remain sterile during opening and placement onto the sterile field to prevent contamination and potential patient infection. b.Method: the clinician will open the sealed package and note whether or not the packaging is easy to open and the product remains in the sterile section of the package while being placed on the sterile field. 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 and Northwest Regions. The Regions intend 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 Regions 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. 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/APP9-10-11-1002-01/listing.html)
 
Record
SN02081758-W 20100305/100303234802-2ccd9c9b98d65fe785d743aba419bb7d (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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