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FBO DAILY ISSUE OF NOVEMBER 01, 2008 FBO #2532
SOLICITATION NOTICE

65 -- Airways - Endotracheal Tubes

Notice Date

10/30/2008
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

423450 — Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers
 

Contracting Office

Department of the Army, U.S. Army Medical Command, European Regional Contracting Office, European Regional Contracting Office, ATTN:MCAA E, Building 3705, Landstuhl, Germany APO, AE 09180
 

ZIP Code

09180
 

Solicitation Number

W9114F-09-T-9997
 

Response Due

12/4/2008
 

Archive Date

2/2/2009
 

Point of Contact

Ashley Taylor, 49 6371 868358<br />
 

Small Business Set-Aside

N/A
 

Description

A.General Information The Tri-Service Europe Region, a military integrated delivery network, comprised of 44 Army, Navy, and Air Force medical commands and medical treatment facilities (MTFs) in the countries Germany, Italy, Portugal, Spain, Turkey, United Kingdom announces a Request for Regional Incentive Agreement Quotation (REFRIAQ) for the standardization of Airways-Endotracheal Tubes in all sizes as detailed in 1A of the Technical Criteria below. The primary objective of this standardization initiative is to standardize the quality of care across this Region 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 (PV) Program. The major facilities in the Region include but are not limited to Landstuhl Regional Medical Center, U. S. Army Medical Activity Heidelberg, U. S. Army Medical Activity Bavaria, U. S. Army Health Center - Vicenza, 48th Medical Group RAF Lakenheath, 31st Medical Group Aviano, 52nd Medical Group Spangdahlem, 86th Medical Group Ramstein, 39th Medical Group Incirlik, U. S. Naval Hospital Naples, U. S. Naval Hospital Rota, and U. S. Naval Hospital Sigonella. This standardization action is part of the Medical/Surgical PV program executed by the Defense Supply Center Philadelphia (DSCP), 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 PV for the Europe Region (Owens & Minor). This is pursuant to the DAPA clause by which DAPA holders agree to the Standardization process and to allow PVs to distribute their items. This is a supplement to the PV Program and it is not a contract. For additional information regarding DSCPs PV program please access our web site at https://dmmonline.dscp.dla.mil The Europe Tri-Service Regional Business Office (TRBO) will provide anticipated volume (quantity) based on historical usage. 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 February 2009. The evaluation will be based on clinical, technical, and pricing factors. The Clinical/Performance evaluation factors 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. Point of Contact is Mrs. Marcee Whisenant, phone: 011-49-6221-172109, and e-mail marcee.whisenant@us.army.mil B.Products & Performance Required Vendors MUST provide a complete list of items supplied (catalog, etc.), product literature, and answers to the technical/company criteria below in response to this Request for Quotation (RFQ). Vendors are required to supply all items listed below under 1A, Technical Criteria, in all sizes and styles. (Vendors who do not have a complete product line as outlined above will be disqualified in Phase I). Stock Keeping Unit (SKU) Review and High Volume Lines: Based on recent 12-month usage data, the lines include: Detailed DescriptionSale Amount $ Nasal/Oral Cuffed Size 8.0 mm ID Murphy$41,537.96 Nasal Cuffed 7.5mm ID Murphy$33,630.27 Nasal/Oral Cuffed Size 7.0 mm ID Murphy$31,455.41 Nasal/Oral Cuffed Size 7.5 mm ID Murphy$20,765.89 Nasal/Oral Uncuffed Size 6.0 mm ID Murphy$15,145.37 Nasal/Oral Cuffed Size 6.0 mm ID Murphy$7,940.49 Nasal/Oral Cuffed Size 8.5 mm ID Murphy$6,065.25 Nasal/Oral Cuffed Size 6.5 mm ID Murphy$5,116.19 Oral Cuffed Size 7.5 mm ID RAE$4,959.73 Nasal Cuffed Size 6.5mm ID RAE$4,565.52 The estimated total annual demand for Airways-Endotracheal Tubes is approximately $229,798.00 based on PV usage data over 12 months of recent usage. The overall evaluation will be based upon clinical, technical and pricing factors. The final award recommendation will be determined by utilizing the best value and trade off criteria. At the request of the Europe Region MTFs, vendors will provide on-site support and in-servicing, educational resources and tools for clinical use of these products, conversion information, prime vendor order numbers, Material Safety Data Sheets (MSDS) information, and itemization of the brands, types, and packaging information of the products offered by the vendor. C.Instructions to Vendors DAPA holders interested in participating in this standardization initiative e-mail your response to marcee.whisenant@us.army.mil and provide: (1) Company name and address, (2) point of contact information (Name and Phone Number, Fax Number, and E-mail Address), (3) your companys DAPA number and (4) your companys responses to the questions under Technical/Company Criteria below. Your e-mail will include your agreement to provide for your products necessary technical criteria, no charge samples for clinical evaluation, and submission of electronic best price offers that represent a discount from your companies base uncommitted DAPA pricing. Only e-mail responses will be accepted and must be received no later than Close of Business (COB) on the specified closing date/time of this RFQ Federal Business Opportunity (FBO) Notice. Failure to respond within this timeframe will result in your company being excluded from participation in this standardization effort. This process will include vendor requirements to provide electronic responses to technical criteria, no charge samples for clinical evaluation, and submission of electronic best price quotes. Due to the potential for e-mail to be lost in transmission, from network security, etc., vendors are strongly encouraged to confirm with the Region that its initial submission, quote and literature actually arrived at the Region via e-mail. 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. Vendors that do not meet the deadline of COB on the date listed for closing (per the FBO Request for Quotation) will be disqualified from further consideration in the standardization initiative. All email communications between vendors and the Region will be digitally signed by the issuer. Emails and correspondence may be sent to marcee.whisenant@us.army.mil. D. Evaluation Criteria The Tri-Service Product Review Board (TPRB) is the governing board of the standardization process. This board includes clinicians and logisticians from all of the MTFs within the Europe Region. They are the decision makers for this initiative. The Region intends to evaluate price quotes and select a vendor or vendor(s), without discussions. When requested, vendor quotes should contain the vendor's best product matches for the products or product lines requested in the product and pricing request. Vendor quotes should contain the vendor's best responses to all technical and/or company questions listed in this announcement. Vendor quotes 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). If a down-selection is made during the evaluation process, the Region may limit the number of quotes to the greatest number that will permit an efficient competition among vendors. Phase I - Technical/Company Evaluation Process: 1.Vendors will provide an initial response to the FBO posted RFQ. The vendors initial responses must include information requested in the technical/company criteria listed in the FBO RFQ. 2.The Tri-Service Regional Business Office (TRBO) will compile and review the technical/company criteria responses and forward to the Clinical Product Team (CPT) for review. The technical/company criteria are weighted equally. 3.The TRBO and CPT will review the responses from the vendors and determine which vendors meet the technical/company criteria and determine acceptability. a.In general, acceptability for purposes of evaluation of technical/company criteria is defined as follows: (1) Based on the vendors responses, the evaluators have reasonable confidence that the line of products and/or services submitted meet the medical standards of care of the community, applicable to such products or services; (2) The vendors information provided is factually correct. Any misrepresentation of information will disqualify the vendor from further consideration. NOTE: Specific technical/company criteria will require an additional, more-specific definition of technical acceptability. The specific standard for technical acceptability will be set forth with the individual statement of each criterion, as required. b. The vendors who meet the following technical /company criteria will be qualified/invited to participate in the clinical/performance evaluation process via an e-mail communication with each vendor. All communication of significant acquisition milestones must be digitally signed. Vendors are required to provide responses to the technical/company criteria stated below. The responses will be reviewed under the purview of the CPT to determine the acceptability of each vendor. After review of the technical/company criteria, the Region will eliminate those vendors who fail to meet the criteria. Vendors who fail to meet the criteria will be notified in writing. Technical/Company Criteria: Vendors must provide a response to the twelve (12) Technical/Company criteria below with the vendors initial submittal by the response date of the FBO announcement. 1.Vendors must provide a complete line of Airways-Endotracheal Tube products for single or repeat use. A complete line of product is defined as the MTFs requirements for usage items in the product line. Usage items are defined for this report as items used in the Europe Theater within a twelve month period. At a minimum, a complete product line includes (range of sizes are internal diameter and includes the half (1/2) sizes): A. Usage Items: 1.Endotracheal Tubes Nasal Cuffed Sizes 6mm-8mm 2.Endotracheal Tubes Oral Cuffed Sizes 5mm-9mm 3.Endotracheal Tubes Nasal/Oral Cuffed Sizes 5mm-9.5mm 4.Endotracheal Tubes Nasal Uncuffed Sizes 3.0mm6.0 mm 5.Endotracheal Tubes Oral Uncuffed Sizes 3.0mm6.0mm 6.Endotracheal Tubes Nasal/Oral Uncuffed Sizes 3.0mm6.0mm 7.Endotracheal Tubes Oral Cuffed Reinforced - Sizes 5mm-9mm 8.Endotracheal Tubes Flexible-tip - Sizes 5mm-9mm B. Vendor must provide a complete list of items supplied (catalog, etc.) and product literature in response to this RFQ. Vendors are required to supply all items listed above in all sizes and styles listed. Vendors who do not have a complete product line as above will be disqualified in Phase I. 2.Vendor must have a DAPA or be in the process of applying for a DAPA number for the Airways-Endotracheal Tube product line. Provide the DAPA number or proof of the application process in response to this RFQ. (Note that vendors that fail to have a DAPA by the invitation to Phase II, Clinical/Performance Evaluation and Pricing Process, will be disqualified). Your DAPA number is: __________________. 3.Vendor must have a separate agreement with the PV Owens & Minor for distribution in the Europe Region. (Note a vendor whose products are not available through the regional PV will be disqualified.) 4.Vendor must provide contact information (Name, phone number, and e-mail address) for a local vendor representative in the Europe Region in response to this RFQ. 5.Vendor must submit discounts off DAPA for all products included in this standardization initiative. Where lower uncommitted Federal Supply Schedule (FSS) prices are available, DAPA holders are required by previous agreement to provide the uncommitted FSS price as the DAPA price. Vendors shall NOT quote uncommitted FSS prices as the discounted price for purposes of this standardization initiative. Vendors are to provide a quote on discounts upon Phase II notification. Vendors who do not provide discounts off DAPA for ALL products in Phase II will be disqualified. 6.Vendor must provide electronic and hard copy proposed pricing and a competitive product cross-reference in electronic Microsoft Excel format upon request of Phase II notification. 7.Vendor must provide a statement confirming their products meet the industry production and safety standards (i.e. meets OSHA Standard Industrial Classification {SIC} description for 3842: Orthopedic, Prosthetic, and Surgical Appliances and Supplies and are manufactured in controlled Good Manufacturing Process (GMP) environments with Quality Management - ISO 9001/EN 13485 certification, and hold FDA Marketing Approval notification-510(k) clearance and European Directive for marketing a medical device -CE Mark approval) used in manufacturing Airways-Endotracheal Tube products in response to this RFQ. 8.Vendor must provide any history of back orders and/or recalls that occurred during the most recent 24-month period for the Airways-Endotracheal Tube products including dates, duration, cause (product line failures), and resolution in response to this RFQ. Vendors will not have the opportunity to provide additional information on back orders and recalls during any subsequent stage in this evaluation. Vendors are encouraged to submit all information deemed relevant (i.e., positive resolutions, etc.) in response to this RFQ. The Government will not contact any points of contact provided in response to this question. Vendors should not provide point of contact information in response to this question. 9.Vendor, in response to this RFQ, must provide statement revealing all products containing synthesized polymer (plastic/rubber) are clearly labeled as latex-free. 10.Vendor must provide documentation your products are radiopaque explaining what feature makes the product radiopaque in response to this RFQ. 11.Vendor must provide documentation your products are available sterile and/or non-sterile (re-usable); if sterile, have expiration dates on the packaging and the contents of the package can be delivered to a sterile field. 12.Vendor must be able to ship samples necessary for evaluation via United States Postal Service (USPS) with a copy of the customs form, PS form 2976-A, sent to the TRBO showing the stamped date the package was shipped to the TRBO eliminating delays that occur with Europes Custom Offices. Provide acknowledgement of this issue in response to this RFQ. Phase II - Clinical/Performance Evaluation and Pricing Analysis Process: Upon completion of the Phase I Technical/Company Criteria Evaluation, vendors who are selected to progress to clinical/performance evaluations will be requested to provide product samples concurrent with their best product and price discount quotes being requested. Clinical Evaluation Process 1.For those companies that meet the requirements above, the CPT will request samples from the product group to be clinically evaluated at select MTFs. To avoid shipping delays caused by Europes Customs Offices vendors are required to ship samples to the TRBO via USPS to the following APO address: Commander, Europe Regional Medical Command Attn: G-4 TriService Standardization Mr. Rob Halliday, (011-49-6221-172108) CMR 442 APO AE 09042 2. Vendors will be given 14 calendar days from the issue of the notice to ship samples for the clinical evaluation at Phase II. Vendors who do not meet the deadline for the shipment of samples by COB on the 14th calendar day after the issue date of the notice to supply samples will be disqualified from the standardization process. NOTE: All vendors must send TRBO Point of Contact (POC) verification regarding the date of shipment from the vendor and the anticipated delivery date via e-mail digitally signed. Verification of shipment is defined as sending the TRBO a copy of the USPS PS form 2976-A customs form. The PS form 2976-A will have a stamped date the package was accepted by USPS. Vendors whose packages have a stamped date after the established notification to ship deadline date will be disqualified from this standardization process. The samples to be provided will include 5 of each (size as stated with each product line below) per MTF (6 MTFs) to be provided as follows: 1.Endotracheal Tubes Nasal Cuffed Size 7 or 8mm 2.Endotracheal Tubes Oral Cuffed Size 4 or 4.5mm 3.Endotracheal Tubes Nasal/Oral Cuffed Size 7 or 8mm 4.Endotracheal Tubes Nasal Uncuffed Size 4 or 4.5mm 5.Endotracheal Tubes Oral Uncuffed Size 4 or 4.5mm 6.Endotracheal Tubes Nasal/Oral Uncuffed Size 4 or 4.5mm 7.Endotracheal Tubes Oral Cuffed Reinforced - Size 7 or 8mm 8.Endotracheal Tubes Flexible-tip - Sizes 4 or 4.5mm and 7 or 8mm Samples are to be shipped to the Europe Region TRBO. NOTE: The USPS TRBO address is written in item #1 above. The TRBO requests sample orders be separated by MTF. The TRBO will have the responsibility of forwarding the samples to the participating MTFs. Vendors are not allowed to send any other product samples sets or materials other than what the CPT has requested. Failure to abide by this request will disqualify the vendor from further consideration in this standardization process. 3. To determine acceptability, a CPT comprised of medical professionals from the MTFs will evaluate the products based on the evaluation criteria stated below. It is intended that clinical evaluations shall be conducted in a clinical (patient) setting. 4. The CPT will evaluate the products provided with the clinical/performance criteria identified in this announcement below. All clinical/performance criteria are weighted equally. The clinical/performance evaluation period will last for forty-two (42) calendar days. CPT teams will evaluate the product against the clinical/performance criteria. The evaluation responses will be in a Likert scale format with a 1-5 scoring range. The scale descriptors are: one (1) not acceptable, two (2) minimally acceptable, three (3) acceptable, four (4) more acceptable, and five (5) highly acceptable. The CPT has established a target threshold of 3.00 for the clinical acceptability of products for standardization. The CPT will determine the actual acceptability threshold for this standardization initiative at or near 3.00 depending on the location of any break in vendors average scores (i.e., a gap between vendors average scores). In addition, the CPT may consider how closely scores are clustered near the acceptability target threshold of 3.00, in determining the actual acceptability threshold. Vendors scoring below the actual acceptability threshold will be determined to be clinically unacceptable, and be disqualified from further consideration for this standardization initiative. Clinical/Performance Criteria: 1.Patient Safety - The product is durable. 2.Patient Safety - The product has an opening/channel that allows a smooth passage of a catheter for suctioning. 3.Patient Safety The products balloon mechanism is functional. 4.Safety in urgent care setting - Packaging identifies the size and style of the endotracheal tube. Pricing Analysis Process: 1.Upon completion of Phase I Technical/Company Criteria Evaluation, vendors who are selected to progress to clinical/performance evaluations will be requested to provide their best product and price discount quotes concurrent with product samples being requested. Vendors will be given 14 calendar days from the date of pricing requests, to submit RIA pricing quotes, in a prescribed electronic spreadsheet format, based upon the requirements of the Europe Region. Pricing must be received at the TRBO by COB, fourteen (14) calendar days after the issue date of the vendor notice to submit best product and price quotes. The Region intends to evaluate quotes and select a vendor on initial submissions/quotes. Vendor quotes should contain the vendors best product matches for the products or product lines requested in this announcement. Vendor quotes should contain the vendors best tiered-pricing discounts off of the vendors DAPA pricing (based on committed volume of 80% of the total requirements of the MTFs in the Region). 2.Vendors will forward pricing to the TRBO, and the TRBO will prepare a pricing analysis to be reviewed by the CPT. The CPT will then make a recommendation to the TPRB with the selected vendor giving the best overall value both clinically and financially for the Region. Pricing will be based on a committed volume for a two-year period with possible one-year option periods (not to exceed 5 years). 3.The Clinical/Performance evaluation factors are considered significantly more important than cost or price. As the evaluation results become more clinically equal, price will become more important. 4.The following elements will be considered in the pricing analysis: a.Impact of RIA prices on the Region (Post-Standardization Costs) is considered more important than the other pricing elements. b.Impact of Unmatched Lines; i.e., do the unmatched lines make it difficult to compare the prices of the various vendors, because the evaluator cannot compare similar product lines for each vendor? c.Consideration of SKUs by each vendor. The Region intends to reduce the number of SKUs that must be handled per period. Vendors that can supply the complete range of clinically required product, without unnecessary numbers of SKUs for minimally differentiated products, will be more likely to provide the best-value solution for the Government in this standardization initiative. The Region reserves the right to limit the number of quotes to the greatest number that will permit an efficient competition among vendors. The Region reserves the right to make a down-selection during the evaluation process based on considerations of efficient competition. Non-Selected Vendors will be notified in writing regarding selection/non-selection at the conclusion of the completed product evaluation process.
 

Web Link

FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=c5e2c601c460119ccf583ccb113f713a&tab=core&_cview=1)
 

Place of Performance

Address: European Regional Contracting Office ATTN:MCAA E, Building 3705 Landstuhl, Germany APO AE<br />

Zip Code: 09180<br />
 

Record

SN01698867-W 20081101/081030215627-c5e2c601c460119ccf583ccb113f713a (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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