SOURCES SOUGHT
65 -- Electrodes and Defibrillator Pads
- Notice Date
- 10/8/2008
- 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
- APP9-10-0809-01
- Archive Date
- 11/14/2008
- Point of Contact
- Cindy Ingrao,, Phone: 619-532-8517
- E-Mail Address
-
cynthia.ingrao@med.navy.mil
- Small Business Set-Aside
- N/A
- Description
- A. General Information The Southwest Region will be standardizing Electrodes and Defibrillator Pads. This is a re-evaluation of this product group. A multiple selection is only a possibility if no single vendor can meet the total requirement 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 ECG monitoring electrodes and resting EKG electrodes for adult, pediatric and neonatal patients in various styles (snap, tab, wired, unwired, chest, back, limb, round, square, radiotranslucent and any other types currently available on the market) and with various adhesives (standard, gel, diaphoretic and any other types currently available on the market) and defibrillator pads for adult, pediatric and neonatal patients that are multipurpose and have translucent qualities. The entire category of Electrodes and Defibrillator Pads has an annual demand of over $130,000. 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. 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 December 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 Electrodes. The product category includes ECG monitoring electrodes and resting EKG electrodes for adult, pediatric and neonatal patients in various styles (snap, tab, wired, unwired, chest, back, limb, round, square, radiotranslucent and any other types currently available on the market) and with various adhesives (standard, gel, diaphoretic and any other types currently available on the market) and defibrillator pads for adult, pediatric and neonatal patients that are multipurpose and have translucent qualities. Within this region, this product line has an estimated annual dollar requirement of $130,000. 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 October 30, 2008. Submissions must be received by 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 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. Your company must manufacture and/or distribute a complete line of electrodes/defibrillator pads. At a minimum, the line must include ECG monitoring electrodes and resting EKG electrodes for adult, pediatric and neonatal patients in various styles (snap, tab, wired, unwired, chest, back, limb, round, square, radiotranslucent and any other types currently available on the market) and with various adhesives (standard, gel, diaphoretic and any other types currently available on the market) and defibrillator pads for adult, pediatric and neonatal patients that are multipurpose and have translucent qualities to meet the needs of the facilities. 2. Provide the brand(s) under which your company manufactures or distributes your products. 3. Provide the size for each type of product, the type of conductive material, whether creams or gels are required for operation, is it suitable for the field setting, how the product is packaged to avoid the adhesive from drying out once the package is opened and how the sizes are identified. 4. Your electrodes/defibrillator pads must be packaged in quantities that service departments that are large users as well as small users for purposes such as crash carts. 5. Your electrodes/defibrillator pads must meet federal standards (FDA and AAMI). Please provide documentation stating that they meet the standards. 6. Your electrodes/defibrillator pads must be used with any manufacturer's equipment. 7. Your electrodes/defibrillator pads must be used for both short and long-term applications. 8. Your electrodes/defibrillator pads must be used for adult, pediatric, and neonatal populations. 9. 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. 10. 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. 11. 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. 12. 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. 13. 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. 14. Your company must provide staff training for this product line. Please state how your company will meet this requirement. 15. Please provide a list of product representatives for each account in the Southwest Region. 16. Please provide your company's returned goods policy. 17. Please provide an implementation plan for servicing the supply requirements of the Southwest region. 18. 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. 19. 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 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, 5PM 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 = Strongly Disagree, 2 = Disagree, 3 = Neutral, 4 = Agree and 5 = Strongly Agree. All clinical/performance criteria are weighted equally. The clinical evaluation will be conducted in 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. Electrode/defibrillator pad packaging allows for simple and quick electrode application and prevention of the adhesive from drying out. a. Clinicians require packaging that allows for easy opening and long term storage to prevent the electrodes/defibrillator pads from drying out and for handling of electrodes/defibrillator pads for quick application and lead attachment leading to timely assessment of patient status and prevention of lead malfunction. b. This criterion will be evaluated in the clinical setting by use of electrodes/defibrillator pads on at least (3) patients. c. Evaluator will open/remove electrode from packaging, apply to patient skin and attach wire leads (unless pre-wired), and will observe for ease of application process. Evaluator will also read the label packaging to assess if the packaging prevents the electrode from drying out after the package is opened. 2. Electrode/defibrillator pad adhesive backing (or attachment strap for limb lead electrodes/defibrillator pads) assures full skin contact through use. a. Clinicians require that the electrodes/defibrillator pads remain in full contact with skin to assure a constant and accurate electronic signal to monitor/record patient status. b. This criterion will be evaluated in the clinical setting by use of electrodes/defibrillator pads on at least (3) patients. c. After applying the electrode to patients' skin, the evaluator will gently pull/tug on connecting lead wire and will observe for quality of electrode adhesive contact (or limb lead attachment strap) with skin. 3. Electrode-lead/defibrillator pad wire connection remains intact through use. a. Clinicians require that the electrode-lead wire remain in constant connection to assure a constant and accurate electronic signal to monitor/record patient status. b. This criterion will be evaluated in the clinical setting by use of electrodes/defibrillator pads on at least (3) patients. c. After applying the electrode to patients' skin and attaching lead wires (unless pre-wired), the evaluator will gently pull/tug on connecting lead wire (including pre-wired electrodes/defibrillator pads) and will observe for the quality of the electrode-lead wire connection. 4. Electrodes/defibrillator pads remain in full contact with dry as well as moist skin. a. Clinicians require that electrodes/defibrillator pads remain in full contact with skin under all circumstances including when patient is diaphoretic (sweating) due to changes in physical status. b. This criterion will be evaluated in the clinical setting by use of electrodes/defibrillator pads on at least (3) patients. c. After applying electrode to patients' skin, evaluator will observe the quality of electrode-skin contact when skin moisture is present (if patient's skin is dry, moisture is added by water spray mist or moistened towel applied to the patient' skin around area of electrode). 5. Electrode/defibrillator pad adhesive surface is non-irritating/damaging to the skin during use or during removal. a. Clinicians require that the electrode does not cause skin breakdown during use or skin breakdown upon electrode removal from skin. b. This criterion will be evaluated in the clinical setting by use of electrodes/defibrillator pads on at least (3) patients. c. Evaluator will observe the condition of the patient skin during electrode removal and after electrode removal for compromise too skin integrity. 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 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 (2) years (24 months) with possible three (3) 12-month 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. 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.
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