| 65 -- Safety Scalpels and Blades |
| Program Summary |
 |
| Description |
|
General Information
| Document Type: |
Sources Sought Notice |
| Solicitation Number: |
APP9-10-0712-005 |
| Posted Date: |
Mar 11, 2008 |
| Original Response Date: |
Apr 02, 2008 |
| Current Response Date: |
Apr 02, 2008 |
| Original Archive Date: |
Apr 03, 2008 |
| Current Archive Date: |
Apr 03, 2008 |
| Classification Code: |
65 -- Medical, dental & veterinary equipment & supplies |
| Naics Code: |
339113 -- Surgical Appliance and Supplies Manufacturing |
Contracting Office Address
Department of the Navy, Bureau of Medicine and Surgery, NMC San Diego, Bldg 1 38400 Bob Wilson Drive, San Diego, CA, 92134-5000, UNITED STATES
Description
A. General Information
The Southwest Region is standardizing for a possible multi-vendor award for Safety Scalpels and Blades. This is a 5 year re-evaluation of this product group. The region recognizes this is a specialized category in which 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 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 scalpel blades of various sizes (both safety and non-safety), knife handles of various sizes and lengths (reusable, disposable and surgical grade) and single unit safety blade/handle devices.
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.
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; 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 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 Jun 2008. 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 Scalpels and Blades. The product category includes scalpel blades of various sizes (both safety and non-safety), knife handles of various sizes and lengths (reusable, disposable and surgical grade) and single unit safety blade/handle devices. Within this region, this product line has an estimated annual dollar requirement of $40K. 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 April 2, 2008. Submissions must be received by 4:00 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
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 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. 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. Your company must manufacture and/or distribute a complete line of safety and non-safety, weighted and non-weighted scalpels and blades. At a minimum, line must include blade sizes 10, 11, 12 and 15, reusable handle sizes 3, 3L, 4, and 4L, and disposable single unit blade/handle devices. Please list the brands (both safety and non-safety), sizes of blades, and lengths of handles available from your company.
2. Your products must be available through the Prime Vendor, Cardinal Health or you will be disqualified from the standardization process. Please acknowledge and identify that you have such an agreement with Cardinal Health.
3. 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.
4. Your company must offer volume 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 the DAPA. Vendors that fail to offer a discount off the DAPA price will be disqualified.
5. 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.
6. Your company must provide staff training for this product line. Please state how your company will meet this requirement.
7. Please provide a list of product representatives for each account in the Southwest Region.
8. Please provide your company?s returned goods policy.
9. Please provide an implementation plan for servicing the supply requirements of the Southwest Region.
10. 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.
11. 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 scenarios and their effects. If your company has not had any of the above, so state.
12. Due to the increasing number of latex sensitive beneficiaries in our health system, our region requires latex-free versions of products in this product line where available. Additionally, products must be clearly labeled as latex free.
13. Provide the brand(s) under which your company manufactures or distributes your products.
14. Provide the size for each type of product and how the sizes are identified. (The size and type [safety, non-safety] of scalpel must be easily identified from the packaging.)
15. In the reusable knife handle category, a handle that is ?flash? or steam autoclavable is desired. Please state whether or not your company can provide a handle that is steam autoclavable.
16. For safety products, the safety feature of the scalpel must be an integral part of the safety scalpel and not an accessory. Please explain how your company?s products meet this requirement.
17. Handles have a slip-resistant feature. Please explain how your company?s products meet this requirement.
18. The device cannot be reused once the safety feature is activated. Please explain how your company?s products meet this requirement.
19. Blades must be able to be placed on the handle without touching the blade itself. Please explain how your company?s products meet this requirement.
20. Blades must be able to be disengaged from the handle without touching the blade itself. Please explain how your company?s products meet this requirement.
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 14 calendar days to ship samples. Samples must arrive at the MTF by COB, 4PM local time, 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 = 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
1. Ergonomically designed, comfortable to hold.
2. Device is lightweight when held.
3. Device can be used in either hand.
4. Activation of the safety feature is obvious and easily identified by the user.
5. Safety mechanism can be activated using only one hand.
6. Easy to use with minimal training required.
7. Blade maintains its sharpness throughout use on the procedure.
8. The safety device does not activate passively.
9. Blade position is fully visible at all times on the sterile field.
10. The package is easy to open and allows for aseptic delivery to 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 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 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. Clinical/performance and technical/company factors will be weighted more heavily than 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.
Point of Contact
Cindy Ingrao, Clinical Consultant, Phone 619-532-8517, Fax 619-532-5439, Email cynthia.ingrao@med.navy.mil
|
|
