SRCSGT | 65 | Airways - Oral and Nasopharyngeal Products for Standardization

FBO DAILY ISSUE OF MAY 31, 2009 FBO #2743
SOURCES SOUGHT

65 -- Airways - Oral and Nasopharyngeal Products for Standardization

Notice Date: 5/29/2009
Notice Type: Sources Sought
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-9984
Response Due: 6/19/2009
Archive Date: 8/18/2009
Point of Contact: Gina A Barto, 011496371866021<br />
E-Mail Address: European Regional Contracting Office
(gina.p.alfonso@us.army.mil)
Small Business Set-Aside: N/A
Description: A.General Information The Tri-Service Standardization Europe Region announces the standardization initiative for Airways- Oral and Nasopharyngeal for its 44 Army, Navy, and US Air Force medical treatment facilities (MTF) in Germany, Italy, Portugal, Spain, Turkey, and the United Kingdom. Standardization for this product line, Airways-Oral and Nasopharyngeal, represents a new or first time standardized product line initiative for the Europe Region. This product line includes a full line of oral (Guedel and Berman styles) and nasopharyngeal airways. At a minimum this product line includes the following products in the following styles and sizes: 1) Airway Nasopharyngeal PVC Sterile Sizes 24, 26, 36 (Fr), 2) Airway Nasopharyngeal Latex Sterile Sizes 26, 28, 30, (Fr), 3) Airway Nasopharyngeal Latex non-Sterile Sizes 28, 32 (Fr), 4) Airway Oral Guedel Sizes 80, 90,100 (mmL), and 5) Airway Oral Berman Sizes 80, 100 (mmL). This RIA initiative will be a Two Phase RIA Process: vendor(s) who meet the technical/company criteria in Phase I will be invited to advance and participate in Phase II; where pricing will be required for submittal along with no charge product literature and/or samples. Vendors 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 detailed below in usage items, will be disqualified in Phase I). The primary objective of this standardization initiative is to standardize the quality of care across the Europe 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, via the United States Army Medical Material Center, Europe (USAMMCE). The major facilities in the Europe 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, 65th Medical Group Portugal (Azores), U. S. Naval Hospital Naples, U. S. Naval Hospital Rota, and U. S. Naval Hospital Sigonella, U. S. Army 30th Medical Command (MEDCOM), and U. S. Army Central Command (CENTCOM). This standardization action is part of the Medical/Surgical Prime Vendor 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 Prime Vendors for 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 Request for Quotes (RFQ) will result in Regional Incentive Agreements that supplement the Prime Vendor Program. The RFQ will not result in a contract award. For additional information regarding DSCPs Prime vendor program, please access their web site at https://dmmonline.dscp.dla.mil. The resulting Regional Incentive Agreement RIA will be for a base period of two (2) years (24 months) from date of selection with three (3) 12-month option periods for a maximum of 5 years. Anticipated selection date is September 2009. The evaluation will be based on clinical, technical, 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 Europe 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 Military Treatment Facility (MTF) preference and product availability. Point of Contact is Mr. Robert Halliday, phone: 011-49-6221-172108, and e-mail robert.halliday@us.army.mil B.Products & Performance Required 1.The Europe Region is seeking product line items in the category of Airways-Oral & Nasopharyngeal, which at a minimum, includes the product lines below. Within this region, this product line has an estimated annual dollar requirement of $497,150.00. This forecast is based on historical prime vendor sales during a recent 12-month period. The top high volume usage line items for this project include but are not limited to Airways-Oral & Nasopharyngeal in following items in different styles and sizes (sizes are in French (Fr) units or mmL units of measurement). a.Airway Nasopharyngeal PVC Sterile Sizes 24, 26, 36 (Fr) b.Airway Nasopharyngeal Latex Sterile Sizes 26, 28, 30, (Fr) c.Airway Nasopharyngeal Latex non-Sterile Sizes 28, 32 (Fr) d.Airway Oral Guedel Sizes 80, 90,100 (mmL) e.Airway Oral Berman Sizes 80, 100 (mmL) 2.Vendors 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 (sizes are approximate) listed above. Vendors who do not have a complete product line as listed above will be disqualified in Phase I. 3.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 must e-mail your response to robert.halliday@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) the company DAPA number and (4) the company detailed responses to the questions under Technical/Company Criteria below. All e-mail communication between vendors and the Europe Region must be digitally signed. All communications of significant acquisition milestones (such as invitations to participate, or notices of disqualification) must be digitally signed as well. Submissions must be received by close of business (COB) on the specified closing date of this RFQ. Vendors that fail to meet this submittal deadline will be disqualified from participating. This process will include vendor requirements for providing electronic responses to technical criteria, no charge literature 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 Regional POC stated above their initial submission, best price submissions, and literature or other requested information has actually arrived at the Europe Regional Tri-Service Business Office (TRBO) 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 RFQ); will be disqualified from further consideration in the standardization initiative. All e-mail communications between vendors and the Europe Region must be digitally signed by the issuer. D.Evaluation Criteria The Europe 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 Europe Region intends to evaluate price quotes and select a vendor or vendors, without discussions. 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 responses to all technical and/or company questions listed 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 Europe Region). (Note: vendors that fail to submit a discount from DAPA will be disqualified. Note: Where lower FSS prices are available, DAPA holders are required by previous agreement to provide the FSS price as the DAPA price. Vendors shall not quote FSS prices as the discounted price for purposes of this standardization initiative.) Additionally, the Europe Region reserves the right to conduct discussions and request revised quotes, if it is determined to be necessary. If a down selection is made during the evaluation process, the Europe 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 Interested vendors are to respond to this FBO announcement by emailing their detailed responses and required documentation to robert.halliday@us.army.mil by the required response date. Vendors are required to meet/provide responses to the technical/company criteria stated below. All technical/company criteria are weighted equally. The responses will be reviewed under the purview of the Europe TPRB and the Clinical Product Team (CPT) to determine acceptability of each vendor. After review of the technical/company criteria, those vendors who meet these criteria will be qualified/invited to participate in the clinical/performance evaluation process as well as the price analysis process and will be requested to submit their best product/price discount quotes via an email communication with each vendor. 1. In general, acceptability for purposes of evaluation of technical/company criteria is defined as follows: a. Based on the vendors 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. b. The vendors information provided is factually correct. Any misrepresentation of information will disqualify the vendor from further consideration. 2. Each technical/company criteria below requires additional, more specific definition of technical acceptability. This specific standard for technical acceptability will be set forth with the individual criterion. 3. 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. 4. The following eleven (11) equally weighted Technical/Company Evaluation Criteria have been established for this standardization initiative and vendors must provide a response to the following criteria by the closing date of the FBO. a.Vendors must provide a complete line of Airways-Oral & Nasopharyngeal 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. i.At a minimum, a complete product line includes but is not limited to Airways-Oral & Nasopharyngeal for the following items in different styles and sizes (sizes are in French (Fr) units or mmL units of measurement). 1)Airway Nasopharyngeal PVC Sterile Sizes 24, 26, 36 (Fr) 2)Airway Nasopharyngeal Latex Sterile Sizes 26, 28, 30, (Fr) 3)Airway Nasopharyngeal Latex non-Sterile Sizes 28, 32 (Fr) 4)Airway Oral Guedel Sizes 80, 90,100 (mmL) 5)Airway Oral Berman Sizes 80, 100 (mmL) ii.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 identified above will be disqualified in Phase I. b.Vendor must have a DAPA or be in the process of applying for a DAPA number for the Airways-Oral & Nasopharyngeal 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 or show a lack of progress in obtaining a DAPA will be disqualified.) Your DAPA number is: __________________. c.Vendor must have a separate agreement with the Prime Vendor (PV), Owens & Minor, for Airways-Oral and Nasopharyngeal distribution in the Europe Region. (Note a vendor whose products are not available through the regional PV will be disqualified.) Vendor must provide supporting documentation (four digit code) of agreement with Prime Vendor with initial submittal. d.Vendor must submit discounts off DAPA for all products included in this standardization initiative. Note: vendors that fail to submit a discount from DAPA will be disqualified. 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. e.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. f.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. g.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-Oral & Nasopharyngeal products in response to this RFQ. h.Vendor, in response to this RFQ, must provide products that are latex-free and all labeling must indicate the item is latex-free. Vendor must provide list with initial submittal. i.Vendor must provide documentation your products are available sterile and 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. j.Vendors must be able to ship samples necessary for evaluation via United States Postal Service (USPS) to the Europe TRBO eliminating delays that occur with Europes Custom Offices. Proof of vendor shipment via USPS prior to the established deadline must be scanned and sent via digitally signed e-mail to the Europe TRBO. Provide acknowledgement of this requirement in response to this RFQ. k.Vendors must provide, the only following no cost product samples for clinical or performance evaluation (Unused samples will not be returned.) i.The Airways-Oral and Nasopharyngeal samples (latex-free only) to be provided will include 5 of each (size as stated with each product line below) per MTF (6 MTFs) and 1 of each size for the Europe TRBO to be provided as follows: 1) Nasopharyngeal 30 Fr 2) Nasopharyngeal 32 Fr 3) Nasopharyngeal 34 Fr 4) Oropharyngeal 80mmL 5) Oropharyngeal 90mmL 6) Oropharyngeal 100mmL ii.Samples are to be shipped to the Europe Region TRBO. The Europe TRBO requests sample orders be separated by MTF. The Europe 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 Europe CPT has requested. Failure to abide by this request will disqualify the vendor from further consideration in this standardization process. Phase II - Clinical/Performance Evaluation and Pricing Analysis Process Clinical Evaluation Process The Europe CPT determined/approved the product samples sets are required for the evaluation in a clinical (patient care) setting. Requested samples will only include high-volume products. Based on this determination, the following procedures will apply. 1.To avoid shipping delays caused by Europes Customs Offices, the Europe Region TRBO office requires sample sets from each qualifying vendor to be sent directly to the Europe Region TRBO via e-mail address robert.halliday@us.army.mil or USPS to the following APO address: Commander, Europe Regional Medical Command Attn: G-4 TriService Standardization Mr. Robert 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 product samples / literature 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 Europe Region 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 Europe Region 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. 3.Vendors must provide, the only following no cost product samples for clinical or performance evaluation (Unused samples will not be returned.) a.The Oral and Nasopharyngeal samples (latex-free only) to be provided will include 5 of each (size as stated with each product line below) per MTF (6 MTFs) and 1 of each size for the Europe TRBO to be provided as follows. 1)Nasopharyngeal 30Fr 2)Nasopharyngeal 32Fr 3)Nasopharyngeal 34Fr 4)Oropharyngeal 80mmL 5)Oropharyngeal 90mmL 6)Oropharyngeal 100mmL b.Samples are to be shipped to the Europe Region TRBO. NOTE: The Europe Region TRBO shipping address is written in item #1 above. The Europe Region TRBO requests sample orders be separated by MTF. The Europe Region 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 Europe CPT has requested. Failure to abide by this request will disqualify the vendor from further consideration in this standardization process. 4.Specific Rules of Engagement for this standardization initiative: a.Vendors will only provide sample products of the items that are requested and being evaluated. Vendors that bring in other product samples or literature on items that are not part of the evaluation process will be disqualified from the evaluation process. b.Vendors presence will not be required for in-servicing prior to or during the evaluations. c.Vendors will not be allowed to be present during the actual evaluation process of their products or their competitors products. d.Vendors will not be allowed to speak to any hospital staff member regarding the product evaluation, product pricing or pricerelated factors. Vendors that speak to hospital staff members regarding the product evaluation; pricing or pricerelated factor will be disqualified from this evaluation process. e.Each of the clinical criteria will be evaluated 5 times by each participating MTF. The clinical/performance evaluation period will last for thirty (30) calendar days. 5.The Europe CPT will evaluate each vendors sample sets against the clinical/performance criteria in a clinical (patient care) setting. 6.All clinical/performance criteria are weighted equally. 7.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 Europe CPT has established a target threshold of 3.0 for the clinical acceptability of products for standardization. The Europe CPT will determine the actual acceptability threshold for this standardization initiative at or near 3.0 depending on the location of any break in vendors average scores. In addition, the Europe CPT may consider how closely scores are clustered near the Acceptability Target Threshold of 3.0, 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. Vendors that have been disqualified will be notified in writing at the conclusion of the evaluation process (DSCP approval). 8.To determine acceptability, a Europe CPT comprised of medical professionals from the MTFs will evaluate the products based on the evaluation criterion stated below. It is intended that clinical evaluations shall be conducted in a clinical (patient care) setting. 9.Clinical/performance evaluations will be tabulated by the Europe Region TRBO, and results will be forwarded to the Europe CPT for final review. Clinical/Performance Criteria: During the pre-source selection procedures, the Europe CPT validated/approved the equally weighted clinical/performance criteria outlined below. 1.Patient Safety - The product is durable. a.An oropharyngeal or nasopharyngeal airway needs to be durable due to use in a body cavity where the possibility of the item breaking down would cause harm to the patient. b.The evaluator will visually inspect the product, confirming the quality of the material used to construct the item is acceptable. 2.Patient Safety - The oropharyngeal airway provides or has an opening/channel that allows a smooth passage of a catheter for suctioning. a.An oropharyngeal airway must allow or provide an opening allowing the patients airway to be adequately suctioned. b.The valuator will visually inspect the product, confirming the capability of using suction when the need arises. 3.Safety in urgent care setting Packaging and or color identifies the size and style of the oropharyngeal or nasopharyngeal airway. a.The package identification reduces the amount of time needed for staff to select the appropriate size for urgent patient care. b.The evaluator will visually inspect the package label, making sure the color, size, and style information properly identifies the respective oropharyngeal or nasopharyngeal airway. 4.The two airway evaluation forms, one for the nasopharyngeal airways and the second for the oropharyngeal airways, will be evaluated by using a combination, not all, of the approved clinical/performance criteria as above. The airway evaluation forms will use the following clinical/performance criteria. a.The nasopharyngeal airway evaluation form Criteria 1, 2, &3 b.The oropharyngeal airway evaluation form Criteria 1 & 3 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 Europe Region TRBO by COB, fourteen (14) calendar days after the issue date of the vendor notice to submit best product and price quotes. The Europe 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 Europe MTFs.). a.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, lowest overall cost factors, with pricing being least 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 three (3) one-year option periods. b.Vendors will forward pricing to the Europe Regional TRBO, and the Europe Regional TRBO will prepare a pricing analysis to be reviewed by the Europe TPRB. The Europe TPRB will select the vendor giving the best overall value both clinically and financially for the Europe Region. 2.The following elements will be considered in the pricing analysis and are listed in order of importance: a.Impact of RIA prices on the Europe Region. (Post-Standardization Costs). This represents the new estimated annual cost or the total cost post standardization and includes the vendors products, and the products that could not be matched. It reflects the amount the Europe Region would pay the vendor using the RIA pricing. This is the most important pricing element. b.Impact of Unmatched Lines. 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. Those items that are considered in the high usage category will have a higher impact to the Europe Region for the unmatched product line and the end post-standardization costs. c.Potential Cost Avoidance. Cost avoidance is calculated by subtracting the RIA price from the Distribution and Pricing Agreement (DAPA) price and multiplying by 12-months of usage. This is included as a reporting matrix. d.Consideration of SKUs by each vendor. The Europe 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. 3.The Europe Region reserves the right to conduct discussions and request revised quotes, if determined necessary. The Europe Region reserves the right to limit the number of quotes to the greatest number that will permit an efficient competition among vendors. The Europe Region reserves the right to make a down-selection during the evaluation process based on considerations of efficient competition.
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/USA/MEDCOM/DADA19/W9114F-09-T-9984/listing.html)
Place of Performance: Address: Europe Tri-Service Regional Business Office (TRBO) CMR 442 Attn: G-4 Tri-Services Standardization APO AE<br />; Zip Code: 09042<br />
Record: SN01831653-W 20090531/090530001304-2c663b6755f3d6296a59a1aeebd2dfbb (fbodaily.com)
Source: FedBizOpps Link to This Notice
(may not be valid after Archive Date)

| FSG Index | This Issue's Index | Today's FBO Daily Index Page |

Loren Data's SAM Daily™

65 -- Airways - Oral and Nasopharyngeal Products for Standardization