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FBO DAILY ISSUE OF JUNE 12, 2010 FBO #3122
SOURCES SOUGHT

65 -- Anesthesia Breathing Circuits

Notice Date
6/10/2010
 
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-9-10-1006-01
 
Archive Date
7/16/2010
 
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 Anesthesia Breathing Circuits. This is a re-evaluation of this product group since the Regional Incentive Agreement has 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 Anesthesia Breathing Circuits for adult and pediatric patients. The entire category of Anesthesia Breathing Circuits has an annual demand of over $110,000. 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; 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 November 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 Anesthesia Breathing Circuits. The product category includes Anesthesia Breathing Circuits for adult and pediatric patients. Within this region, this product line has an estimated annual dollar requirement of $110,000. 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 July 1, 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 sterile, single-use, Adult, Pediatric and Jackson-Reese Anesthesia Breathing Circuits with single coaxial corrugated tubing with separate inner tube for expiratory gases (known as product(s)). 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. The following products in the following sizes are required. Vendors that cannot meet all of the requirements below are to indicate what requirements they can meet and include product literature describing those requirements. Vendors that fail to provide product literature in response to this criterion will be disqualified. Pediatric Breathing Circuit a.Elbow with gas port b.Pedi wye c.Approximately 75 inch expandable hose d.1L bag e.Male/Male gas line Hyperinflation System a.2L bag with tail-end valve that allows CPAP/PEEP without add-on adapter b.Approximately 10 inch hose c.Fresh gas elbow General Anesthesia System a.Tubing approximately 72 inches with separate inner tube for expiratory gases b.Elbow with gas port c.3L bag d.Adult flex mask e.Male/Male gas line f.Yankauer g.Approximately 10 foot suction tubing General Anesthesia a.Parallel wye with gas sampling port b.Elbow with sampling port c.Approximately 108 inches Accessories a.Breathing circuit extensions b.Gas sampling elbows c.Large volume patient vent filter, disposable, bacterial/viral removal efficiency of 99.999%, cross contamination prevention for use distal to the gas sampling elbow Pediatric/Adult Heated/Humidified Circuits a.Heated/humidified wick, wired breathing circuit b.Approximately 48/60/72 inches c.Pressure line for pediatric d.28V Infant Hyperinflation System a.1L bag b.Adjustable airway pressure valve, 60 cmH20 with bleed vent that allows CPAP/PEEP without add-on adapter c.Pressure monitoring tubing 2.Vendors must provide standard circuit configurations and a full line of single-use anesthesia breathing circuit components in both adult and pediatric sizes, regular and expandable lightweight coaxial tubing, as well as adult and pediatric single-limb circuits, HME/HEPA filters, bags, masks, connectors, gas sampling lines, tubing, and any other products in this category. 3.Vendor must provide products that are utilized in the safe and effective delivery of oxygen and anesthetic gases to the patient and are safe, reliable, and meet ISO and ASTM standards. Vendors must identify these features of their products that provide for patient safety and provide literature to support this with initial submittal. 4.Vendors must provide products that are compatible with all anesthesia machines currently on the market. Vendor must submit the brand/manufacturer of all anesthesia machines your products are compatible with. 5.Vendors must have a DAPA or be in the process of applying for a DAPA number for the Anesthesia Breathing Circuit 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. 6.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. 7.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. 8.Vendors must provide the product brand(s) your company manufactures or distributes. 9.Vendors must provide 24/7 customer service and identify company resources for such support with your initial submittals. 10.Vendors must be able to provide in-service training if requested. Vendors that cannot provide in-service training if requested will be disqualified. 11.Vendors must provide product literature for this product line with your initial submittals both electronically and hard copy. 12.Vendors must provide products and packaging that are latex free and indicated on the packaging and in the product literature. 13.Vendors must provide a product which is clearly marked with the size/type of circuit. Provide specific information whether this information is provided on the product, 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 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 and individually. The evaluations are conducted in a 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.The light weight corrugated and expandable tubing is of adequate length and retains memory when extended for ideal positioning. a.Clinicians require the product to resist cracking, ripping, and tearing; expand to allow for a turn of 180 degrees; and retain memory for ideal positioning. b.This criterion will be evaluated in a clinical setting by use of the product on at least (3) patients. c.Evaluator will open/remove product from packaging, easily extend the tubing into proper position, and check for any signs of cracking, ripping, or tearing; observe that the tubing retains its memory and that it extends to allow the operating platform to be turned at least 180 degrees. 2.The soft, air-inflatable cushion of the mask is ergonomically designed, has a clear body for superior view, and has an inflation valve that allows the cushion to be easily adjusted to provide a safe and comfortable fit. a.Clinicians require that the product is engineered with a secure-fit air cushion mask to provide an optimal seal with minimum pressure. b.This criterion will be evaluated in the clinical setting by use of the product on at least (3) patients. c.After applying the mask securely over the mouth and nose with the adjustable strap, the evaluator will examine for any leakage. 3.The product’s single limb swivel connector eliminates kinking problems and helps reduce torque at the patient end. a.Clinicians require that the product effectively prevents kinking problems, making repositioning of the circuits easier. b.This criterion will be evaluated in the clinical setting by use of the product on at least (3) patients. c.The evaluator will examine the swivel connector with the naked eye and determine if there is any torque or kinks. 4.The product is easy to set up and connect to the anesthesia gas machine and endotracheal tube. a.Clinicians require that product come in a complete kit reducing the necessity to gather and assemble extra components and that the tubing is easy to connect to the gas outflow of the machine and the patient. b.This criterion will be evaluated in a clinical setting by use of the product on at least (3) patients. c.The evaluator will open/remove products from the packaging without having to assemble any of the components and attach to the anesthesia gas machine and endotracheal tube. Evaluator will observe the ease of performing the task. 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-9-10-1006-01/listing.html)
 
Record
SN02173712-W 20100612/100610234726-1a5467d55cfbd34f4426a99981bf334d (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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