SOLICITATION NOTICE
65 -- LSA West Regional Announcement for Holding Chambers
- Notice Date
- 11/24/2009
- Notice Type
- Presolicitation
- Contracting Office
- Western Regional Contracting Office, ATTN: MCAA W BLDG 9902, 9902 Lincoln Street, Tacoma, WA 98431-1110
- ZIP Code
- 98431-1110
- Solicitation Number
- W91YU0R11-9-10-12-0911-002HOLDINGCHAMBERS
- Response Due
- 12/15/2009
- Archive Date
- 2/13/2010
- Point of Contact
- Shannon Ford, 253-968-0878
- E-Mail Address
-
Western Regional Contracting Office
(shannon.ford2@amedd.army.mil)
- Small Business Set-Aside
- N/A
- Description
- Tri-Service Northwest, Southwest and Pacific Regions, collectively referred to as Logistical Support Area West (LSA-West), initiate the standardization process for Holding Chamber products for its 35 Army, Navy, and Air Force medical facilities in Washington, Alaska, California, Hawaii and Pacific islands. The product line consists of holding chambers with caps in neonatal, pediatric, and adult sizes. This is new product line initiative for the LSA West Region. The primary objective of this program is to standardize products or product lines obtaining the clinically preferred product or source(s) at the best possible price based on volume pricing discounts utilizing a best value determination process. Standardized products will be obtained through the DoD Prime Vendor Program. The secondary objective of this standardization initiative is the potential of decreasing the existing Stock Keeping Units (SKUs) and thus dollars held as inventory. The below item detail of the products being purchased within the LSA-West 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 (i.e. like product items) for elimination, as well as potentially minimizing the number of SKUs included in a subsequent incentive agreement. The Military Treatment Facilities (MTFs) in the LSA West Region include but are not limited to: Region 11: Bassett Army Community Hospital, Fort Wainwright, AK; Bremerton Naval Hospital, Bremerton, WA; Fairchild AFB Clinic, Fairchild AFB, WA; 354th Medical Group, Eielson Air Force Base, AK; 3rd Medical Group, Elmendorf AFB, AK; Madigan Army Medical Center, Tacoma, WA; Oak Harbor Naval Hospital, Oak Harbor, WA Region 9/10: Naval Medical Center-San Diego, CA; 9th Medical Group Beale AFB, CA; 60th Medical Group Travis AFB, CA; Naval Hospital-Lemoore, CA; Weed Army Community Hospital, CA; 95th Medical Group Edwards AFB, CA; Naval Hospital-29 Palms, CA; 30th Medical Group Vandenberg AFB, CA; 61st Medical Squadron Los Angeles AFB, CA; Naval Hospital-Camp Pendleton, CA Region 12: Med. Co. CLC-3, Kaneohe Bay, HI; 15th Medical Group Hickam AFB, HI; Naval Health Clinic Hawaii, HI; Tripler Army Medical Center, HI; U.S. Army Health Clinic Schofield Barracks, HI; 35th Medical Group Misawa AB, Japan; 374th Medical Group Yokota AB; Japan; Naval Hospital Yokosuka; Japan; U.S. Army Health Clinic Camp Zama, Japan; 3rd MLG, Camp Kinser, Okinawa, Japan; 18th Medical Group, Kadena AB, Okinawa, Japan; Naval Hospital Okinawa, Japan; 8th Medical Support Squadron Kunsan ABM, Korea; 16th MEDLOG BN, Waegwan, Korea; 51st Medical Group, Osan AB, Korea; 121st Combat Support Hospital, Korea; 36th Medical Group Andersen AB, Guam; Naval Hospital (NH) Guam (Agana), Guam This standardization action is part of the Medical/Surgical PV program executed by the Defense Supply Center Philadelphia (DSCP), Directorate of Medical Materiel. To participate, your company must have a Distribution and Pricing Agreement (DAPA) and a separate commercial agreement with the PVs for the program. 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 RFQ will result in Regional Incentive Agreements (RIAs) that supplement the PV Program. The RFQ will not result in a contract award. For additional information regarding DSCPs PV program, please access their web site at https://dmmonline.dscp.dla.mil. The resulting 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 01/10. 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 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. The Point of Contact is Rosa Crumpton, phone: 253-968-0898, and e-mail rosa.crumpton@amedd.army.mil Products & Performance Required The LSA West Region is seeking Holding Chamber Products which at a minimum include the product lines below. Within these regions, this product line has an estimated annual demand of $232,660. This forecast is based on historical PV sales during a recent 12-month period. The top high volume usage lines for this project include: Manufacturer Part Number Description MONAGHAN MEDICAL 78810 AEROCHAMBER MAX WITH MASK MEDIUM 10EA/CS MONAGHAN MEDICAL 78710 AEROCHAMBER PLUS ZSTAT WITH MED MASK MONAGHAN MEDICAL 79850 AEROCHAMBER MAX WITH FLOW VU 50EA/CS MONAGHAN MEDICAL 79750 AEROCHAMBER PLUS ZSTAT 50EA/CS MONAGHAN MEDICAL 80810 AEROCHAMBER MAX WITH MASK LARGE 10EA/CS MONAGHAN MEDICAL 88810 AEROCHAMBER MAX WITH MASK SMALL 10EA/CS RESPIRONICS HS80050-050 OPTICHAMBER (IN BAG) 50/CS MONAGHAN MEDICAL 79810 AEROCHAMBER MAX WITH FLOW VU 10EA/CS MONAGHAN MEDICAL 88710 AEROCHAMBER PLUS ZSTAT WITH SMALL MASK MONAGHAN MEDICAL 96510 METER PEAK FLOW TRUZONE 10EA/CS At the request of the Regional MTFs, vendors will provide on-site support and in-servicing during implementation, educational resources and tools for clinical use of the product, conversion information, PV order numbers, MSDS information, and itemization of the brands, types and packaging information of the products supplied by the vendor Instructions to Vendors DAPA holders interested in participating in this standardization initiative should email their (1) Company name and address, (2) POC (Name and Phone Number, Fax Number, and E-mail address) to rosa.crumpton@amedd.army.mil. All e-mail communication between vendors and the 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 4:00 PM PST 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 have actually arrived at the Northwest 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. Evaluation Criteria The Tri-Service Product Review Board (TPRB) is the governing board of the standardization process. This board includes clinicians and logisticians from the MTFs within the LSA West Regions. They are the deciding officials for this initiative. The TPRB 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 Region). Additionally, the TPRB 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 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 intent to participate to the above POC by the required response date.The vendors initial responses will include information requested in the technical/company criteria listed in the FBO RFQ. 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 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. 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. The following Technical/Company Evaluation Criteria have been established for the standardization initiative: 1. Vendors must provide a complete line of Holding Chamber products for neonatal, pediatric and adult patients that are FDA approved and latex free. A complete line of product is defined as the MTFs requirements for usage items in the product line. 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. Valved Holding Chamber Products required by the LSA-West (at a minimum) are valved holding chambers which are latex-free and anti-static. These items are for use with metered dose inhalers to administer aerosolized medication to asthmatic patients. NOTE: Vendors: Please state that you can provide a complete product line and provide a complete list of items supplied (catalog, etc.). In addition, send any applicable product literature in response to this RFQ. 2. The valved Holding Chamber product line must be designed to meet the needs of the following groups: a. Older child with neurodevelopmental delay - large adult-sized mask for clients that have difficulty obtaining an effective seal with a standard mouthpiece device b. Infants, child and adult mask designed of soft material that will mold to face with an expiratory valve with low resistance for comfort with minimal deadspace. c. Tracheostomy tube patient - chamber for delivery of medication d. Mechanical ventilator patient - chamber for in line delivery of medication 3. Vendors must have a DAPA, or be in the process of applying for a DAPA, for the Valved Holding Chamber Product Line. Provide the DAPA number or proof of the application process with the initial submittal. (Note that vendors that fail to have a DAPA or show a lack of progress in obtaining a DAPA will be disqualified.) 4. Vendors must have a separate agreement with LSA-Wests Prime Vendor (currently, Cardinal Health is the PV for distribution in LSA-West.) Please provide documentation of your companys agreement with Prime Vendor. (Note that vendors whose products are not available through the Regional PV will be disqualified.) 5. Vendors 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. 6. Vendors products must have been tested using USP methods normalizing the dose for the following pMDI formulations: All current pMDI medications are HFA formulations; except for Combivent CFC. a. Advair HFA b. Albuterol HFA formulations ProAir HFA Proventil HFA Ventolin HFA Xopenex HFA c. Albuterol / Atrovent [Combivent] formulation d. Atrovent HFA e. Flovent HFA f. Qvar HFA 7. Instructions for use of this product must be consistent with recommendations for Holding Chambers according to the AARC Clinical Practice Guideline: Selection of an Aerosol Delivery Device for Neonatal and Pediatric Patients as published in Respiratory Care 1995; 40(12):1325-1335. Vendor will provide this information in the response to this solicitation. 8. Vendors mouthpiece and large masked products must have a flow signal to indicate when inspiration is too fast. 9. The valved holding chamber products must have an inspiratory flow valve to indicate the beginning of inspiration. 10. Vendor must provide a valved holding chamber designed specifically for children, not an adult holding chamber modified for pediatric use. 11. The design of the chamber must minimize the need for hand-breath coordination. 12. The chamber must have a one-way valve between the chamber and the patient to protect and hold the dose of medication before inhalation. 13. The mouthpiece of the chamber must come with a cap attached to the chamber by a tether for safety and cleanliness between patients own use. 14. The inspiratory valve of the chamber must be designed with low resistance to enhance opening and drug delivery and be secured in place for safety and proper function. 15. The chamber must have a baffle in the holding chamber to maximize a fine particle dose. 16. The chamber must have a universal back piece that will accept all MDIs (metered dose inhalers). 17. The chamber must be capable of being cleaned and air dried and not manually dried. 18. The chamber must be assembled in a way that prevents the parts from being lost or broken during disassembly and cleaning. Please provide a copy of the procedure for cleaning your product that includes: a. How often your company recommends the product be cleaned b. Patient friendly instructions in various languages with a list of the languages 19. Vendor must provide educational tools or materials for this product line. Please list the tools available to staff and patients in response to this solicitation. 20. Vendors must have a local vendor representative in the Northwest Region, Southwest Region & Pacific Region that can provide assistance at regional facility locations. Provide contact information, i.e. name, address, phone number, and e-mail address. 21. Vendors must provide any history of back orders and/or recalls that occurred during the most recent 12-month period for items in their Holding Chamber product line, including dates, duration, cause, and resolution. a. Vendors will not have an opportunity to provide additional information on back orders and recalls during any subsequent stage in this evaluation. b. Vendors are encouraged to submit all information deemed relevant (i.e., positive resolutions, etc.) in response to this RFQ. c. Vendors should not provide point of contact information in response to this question. Additionally, the Government will not contact any points of contact that are provided in response to this question. Phase II - Clinical/Performance Evaluation and Price Analysis Process: Vendors determined to be acceptable based upon evaluation of their Technical/Company Criteria response will be asked to provide samples and their price discount quotes. The request for samples (see the sample set identified below and that appears in the FBO) will be concurrent with the request for price discount quotes (which will include the vendors full product line) 1. In the pre-source selection procedures above, the CPT developed a list of items from the product group to evaluate. The determination of the sample set was based on advances in technology, patient safety, and on historical usage for the product line. The CPT also determined that the clinical/performance evaluation will be performed in a non-clinical setting. 2. The following procedures will apply: a. The TRBO office will request a no charge clinical evaluation sample set from each of the vendors with a required delivery date 14 days from date of request. b. Each vendor will send the samples directly to the participating MTFs at the addresses listed at the end of this announcement. c. All email communications between vendors and the LSA-West concerning sample set shipment will be digitally signed. d. Vendors who do not meet the deadline for sample arrival will be disqualified from the standardization process. e. Due to the potential for samples to become lost or delayed in shipping, all vendors must send the TRBO verification regarding the date of shipment from the vendor, and anticipated delivery date. The samples to be provided are as follows: Mouthpiece Valved Holding Chamber with cap (Latex-free, anti-static, valved): Quantity (5) Optional mask pediatric size: Quantity (5) Optional mask adult size: Quantity (5) 3. The CPTs will evaluate each product against the clinical/performance criteria. All criteria will carry equal weight. The evaluations will take place in a clinical setting. 4. The evaluation responses will represent a clinical value judgment placed in a Likert-like scale with a 1 to 5 scoring format (1 = Strongly Disagree; 2 = Disagree or no; 3 = Undecided; 4 = Agree or yes; 5 = Strongly Agree). Comments will be invited and recorded on the evaluations. 5. The CPTs have set a clinical acceptability threshold target at 3.1. The CPTs will determine the actual acceptability threshold for this standardization initiative at or near 3.1 depending on the location of any break (or gap) in vendors average scores. In addition, the CPT may consider how closely scores are clustered near the acceptability target threshold of 3.1 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: During the pre-source selection procedures, the CPT developed, validated, and approved the following equally weighted clinical/performance criteria. Criteria will be evaluated one time in a non-clinical setting by at least one clinical product team member at each participating facility. 1. Clear, easy to follow instructions are provided for assembly and operation of the product in both English and Spanish. a. Rationale: Due to our beneficiaries varying educational levels and products that are used in both home and medical treatment facility environments, clear and easy to follow instructions for proper assembly and operation of devices are required. b. Evaluators will read the insert provided with the product and evaluate whether instructions are clear and easy to follow. 2. The product furnishes a good oral seal for inhalation. a. Rationale: A good oral seal is required for proper and effective administration of medication. b. Evaluators will simulate an oral seal using their forearm and evaluate whether a good seal is obtainable. 3. Product can be easily cleaned/maintained in a home environment. a. Rationale: Due to varying home and field training environments of our patient beneficiary population, products that can be easily cleaned and maintained are required. b. Evaluators will read cleaning/maintenance instructions accompanying the product and evaluate whether products can be cleaned/maintained in any setting. Pricing Analysis: Upon completion of the Phase I Technical/Company Criteria Evaluation, vendors who are selected to progress to clinical/performance evaluations will be asked to provide their price discount quotes as well as product cross-reference data based on a committed volume of 80% of the total LSA West Regional requirement concurrent with product sample request. 1. 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 LSA West Region. Pricing must be received at the TRBO by 4:00 PM (PST), fourteen (14) calendar days or as described 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 vendor's best product matches for the products or product lines requested in this announcement. Vendor quotes should also contain the vendor's best responses to any other technical and/or company questions listed in this request. Vendor quotes should contain the vendor's best tiered-pricing discounts off of the vendor's DAPA pricing. 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. The impact of RIA prices on the Region is considered more important than the other pricing elements. 2. The following elements will be considered in the pricing analysis: a. Impact of RIA prices on the Region (Post-Standardization Costs); b. Potential Cost Avoidance, (representing the discount offered by the company from their DAPA and FSS pricing with cost avoidance being the difference between DAPA pricing and RIA pricing multiplied by the number of items purchased over time). c. Impact of Unmatched Lines [i.e., unmatched lines require the Region to either substitute a less than optimal item or pay DAPA or possibly open market prices to obtain the item]; and d. Consideration of SKUs by each vendor 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. Those vendors that fail to respond as required will be disqualified from further consideration. 4. Vendors will forward pricing to the Lead TRBO, and the Lead TRBO will prepare a pricing analysis to be reviewed by the individual Region TPRB. Pricing will be based on a committed volume for a two-year period with possible one-year option periods (not to exceed 5 years). 5. 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 and clinically equal, price will become more important. 6. The individual Regions TPRB reviews the data to support a selection of the best-value, lowest-overall-cost quote. The individual Regions TPRB votes for the best-value, lowest-overall-cost alternative for a single vendor selection. The DSLs review the basis for the selection and approves the selection. Rules of Engagement: a. Standardization Evaluations will be conducted in areas designated by the TRBO. b. Clinicians will use an evaluation tool, which will be collected by the TRBO. c. CPT members can have no invested personal interest in the outcome in a standardization effort. d. CPT members will be familiar with the specific guidelines for accepting gifts and incentive type items from vendors. Any violations of the guidelines will be reported to the appropriate officials. e. The TRBO will perform statistical analysis of data obtained from the evaluations. f. Vendors will deliver products to designated location and specified time as agreed upon by the vendors and the TRBO. g. Vendors presence will not be required during this evaluation. h. When participating in a standardization effort, vendors must contact the TRBO prior to contacting any clinical personnel in reference to the product being considered for standardization. i. Additional education or training on the selected products will be at the vendors expense. j. All evaluation methods will have a start and stop date set by the CPT that will be strictly enforced. k. The government is not responsible for cost of sample items, shipping of these items, or any costs associated with the clinical evaluations. l. Only products selected by the CPT will be reviewed during an evaluation. All other products presented during the evaluation will be rejected. m. Unless specifically requested by the TRBO, NO COMPANY REPRESENTATIVE SHOULD SPEAK TO ANY HOSPITAL STAFF MEMBER OR TPRB MEMBER REGARDING PRICE OR PRICE-RELATED FACTORS. Failure to comply with any of the rules of engagement described above may result in disqualification of your company from further consideration. Please do not hesitate to contact our Clinical Analyst at 253-968-0898 for questions.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/MEDCOM/DADA13/W91YU0R11-9-10-12-0911-002HOLDINGCHAMBERS/listing.html)
- Place of Performance
- Address: Western Regional Contracting Office ATTN: MCAA W BLDG 9902, 9902 Lincoln Street Tacoma WA
- Zip Code: 98431-1110
- Zip Code: 98431-1110
- Record
- SN02010832-W 20091126/091124235559-9608f5921f7e6871a6e16cef7b53ae40 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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