MODIFICATION
65 -- Modification for Standardization of Endo Surgery Devices for the Pacific Region
- Notice Date
- 12/17/2007
- Notice Type
- Modification
- NAICS
- 423450
— Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers
- Contracting Office
- Pacific Regional Contr Ofc TAMC, ATTN: MCAA PC BLDG 160, 160 Krukowski Road, Honolulu, HI 96859-5000
- ZIP Code
- 96859-5000
- Solicitation Number
- W81K02-08-T-3007
- Response Due
- 1/8/2008
- Archive Date
- 3/8/2008
- Point of Contact
- Susan Hwang, 808-433-3686
- E-Mail Address
-
Email your questions to Pacific Regional Contr Ofc TAMC
(susan.hwang@amedd.army.mil)
- Small Business Set-Aside
- N/A
- Description
- A. General Information The Pacific Region-TRBO Region 12, a military integrated delivery network, comprised of 18 Army, Navy, Air Force, and Marine Corps medical treatment facilities in Hawaii, Guam, Japan, Okinawa, and Korea announces a Requ est for Regional Incentive Agreement Quotation (RFRIAQ) for the standardization of Endo-Surgery Devices (Disposable). This new RFRIAQ supersedes the previous announcement for Endo Mechanical announcement number W81K02-07-T-3015 which was posted on April 30, 2007, closed on May 21, 2007, and cancelled on June 14, 2007. The new closing date for this posting is January 7, 2007 and this date is established due to a change in the clinical evaluation process. The change in the process includes a requireme nt for clinical in-servicing by the vendor prior to the clinical evaluation. All responses to this announcement must be resubmitted fresh before the closing date of January 7, 2007. No prior submissions for this product line in any previous FBO will be con sidered or evaluated. 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 prod uct be obtained through the Department of Defense Prime Vendor Program. The major facilities in the region include Tripler Army Medical Center, U.S. Naval Hospital Okinawa, U.S. Naval Hospital Guam, U.S. Naval Hospital Yokosuka, 121st Combat Support Hospital Seoul, 374th Medical Group, Yokota AB, and 18th Medical Group Kadena AB. This standardization action is part of the Medical/Surgical Prime Vendor program executed by the Defense Supply Center Philadelphia (DSCP), Directorate of Medical Mat eriel. 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 Standardi zation process and to allow Prime Vendors to distribute their products. This RFRIAQ is a supplement to the Prime Vendor Program and is not a contract. For additional information regarding DSCPs Prime vendor program please access their web site at https:/ /dmmonline.dscp.dla.mil The agreement will be for a base period of two years (24 months) from date of selection with three 12-month option periods. Anticipated selection date is December 2008. The evaluation will be based on clinical, technical, and pricing factors. The selection will be determined utilizing Best value/ trade off criteria. Point of Contact: Cheryl Janus, RN, TRBO Clinical Analyst 808-433-7985, cheryl.janus@amedd.army.mil B. Products & Performance Re quired The Pacific Region is seeking product line items in the category of Endo-Surgery Devices (Disposable). For this product line, the yearly estimated total usage/forecasted requirement for this region is $565,297. This forecast is based on histo rical prime vendor sales for a 12-month period. At the request of the Pacific Region Military Treatment Facilities, vendors will provide on-site support and in-servicing, educational resources and tools for clinical use of the product, conversion i nformation, 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 DAPA holders interested in participating in this standa rdization initiative should email their (1) Company name and address, (2) POC (Name and Phone Number, Fax Number, and E-mail address) to cheryl.janus@amedd.army.mil. Submissions must be received prior to the specified closing date/time of this announcement . Failure to meet the submittal deadline will result in exclusion. This process will include vendor requirements of electronic responses to technical c riteria, no charge samples for clinical evaluation, on-site in-person in-servicing, product literature, education and training materials, and submission of electronic best price quote. Due to the potential for email to be lost in transmission from network security, etc., vendors are strongly encouraged to confirm with the Regional POC that their initial submission, quote, and literature actually arrived at the Region via email. 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. D. Evaluation Criteria The Tri-Service Product Review Board (TPRB) is the governing board of the standardization process. This board includes clinici ans and logisticians from the Military Treatment Facilities within the Pacific Region. They are the deciding officials for this initiative. The Region intends to evaluate quotes and select a vendor or vendor(s), without discussions. Vendor quotes should contain the vendor's best product matches for the products or product lines requested in this announcement. 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 Pacific Region). Additionally, the Region reserves the right to conduct discussions a nd 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: Vendors will be required to provide responses to the technical/company criteria. The responses will be reviewed under the purview of the TPRB to determine acceptability. All technical/company criteria are weighted equally. After review of the technica l/company criteria, those vendors who meet these criteria will be invited to participate in the clinical/performance evaluation. Phase II: The TPRB will request samples from the product group to be clinically evaluated at select Military Treatme nt Facilities (MTFs). Vendors are required to ship samples direct to the designated MTFs. Vendors will be given 15 business days to ship samples. Samples must be shipped to arrive at the MTF by COB, 4PM local time, on the (15th) business day after the not ice to ship. Failure to deliver samples by the requested deadline will result in exclusion from the standardization process. Specific MTFs will evaluate the clinical/performance criteria using a Likert type scale, using a one to five rating. The sca le descriptors are; One (1) = not acceptable, Three (3) = acceptable, Five (5) = highly acceptable. All clinical/performance criteria are weighted equally. The Government reserves the right to conduct evaluations in either a non-clinical or clinical setti ng or both. All vendors will be required to provide an on-site, in-person in-service to Tripler Army Medical Center (TAMC), prior to the use of their Endo-Surgery Devices (Disposable). Failure to provide on-site, in-person in-servicing to TAMC will result in exclusion from the standardization process. The TPRBs rationale for in-servicing of this product group is in compliance with the Association of PeriOperative Registered Nurses Position Statement The role of the health care industry representat ive in the perioperative/invasive procedure setting (AORN Recommended practices, and Guidelines, 2007). In-service is required to meet the governments minimum need and is normal and customary. The surgical staff at TAMC is represented by physicians in su rgical residency and internship programs. Vendors will also be required to provide NH Guam, NH Yokosuka, and NH Okinawa with product literature, trainin g aides and teaching materials, prior to the clinical evaluation process. Failure to provide product literature, training aides, and teaching materials will result in exclusion from the standardization process. The TPRBs rationale for in-servicing of this product group, utilizing this option, is a reflection of the stability of the clinical staff at these MTFs. This in-service is required to meet the governments minimum need and is normal and customary. The following steps are the on-site clinical evaluation process for Tripler Army Medical Center: 1. Each vendor will provide on-site, in-person, in-servicing for a period of one week to TAMC. One vendor per week will be evaluated. 2. Day 1: vendor will provide in-servicing to the operating roo m staff. A presentation reviewing the technical aspects of the device, the indications for use of the device, and how to use the device will be addressed. 3. Day 2-5: clinical evaluations will be conducted. The vendor will be available for any questi ons, consultations, or guidance regarding the product. 4. All vendors will be required to meet the standards of conduct in accordance with facility policies, local, state, and federal regulations. The following steps are the training aid clinica l evaluation process for NH Guam, NH Yokosuka, NH Okinawa. 1. Each vendor will provide product literature, training aides and teaching material prior to the clinical evaluation. 2. Day 1: the staff will review all literature and teaching aides provi ded by a vendor. 3. Day 2-5: clinical evaluations will be conducted. 4. Vendors will be available by telephone for questions, consultations and guidance. Phase III: After the clinical/performance evaluation are completed and analyzed, all vendors will be asked to submit their best pricing quote based on committed volume of 80% of the total requirements of the MTFs in the Pacific Region. Clinical/performance and technical/company factors will be weighted more heavily than price. Prici ng 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 provide a discount off the DAPA price will result in exclusio n from the standardization process. 1. Technical/Company Criteria Evaluation The TPRB will review the following technical criteria responses from each vendor and determine acceptability. Acceptability for purposes of evaluation of technical/compa ny criteria: Generally responses to all questions in this section demonstrate that: 1) the business concern offering the quote is a distributor or manufacturer of a complete line of the subject medical/surgical consumables; 2) based on the vendors response s, the evaluators have reasonable confidence that the line or products and/or services offered 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; 4) the ven dor has, or is obtaining, an agreement covering the items, with Cardinal Health, the Prime Vendor for the region; 5) the vendor intends to offer discounts off DAPA for all products included in this standardization initiative (vendors that fail to offer a d iscount from DAPA will be disqualified); and 6) the vendors information provided is factually correct (any misrepresentation of information will disqualify the vendor from further consideration.) 1. Vendor must manufacture and/or distribute a compl ete product line of Endo Surgery Devices. 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. At a minimum, the following items are required: " Titanium clips: provide list of sizes " Linear cutters: provide list of millimeter sizes " Reloads for cutters: provide list of sizes. " Internal staplers: provide list of sizes. " Babcock graspers: provide list of millimeter sizes " Dissectors: provide list of sizes " Stainless steel cl ips: provide list of sizes " Clip appliers with rotating shafts: provide list of sizes " Peanuts for Endo-Surgery " Reload apparatus for staplers: provide list of devices " Scissors: provide list of sizes " Specimen pouches: provide list " Electrodes: provide list " Suturing devices: provide list " Retractors: provide list Provide certification of all brands of this product line that you manufacturer or distribute with the initial submittal. 2. Vendors must have a DAPA or be in the process of applying for a DAPA number for the Endo Surgery Devices product line. Provided 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 obtaini ng a DAPA will be disqualified). 3. Vendors must have a separate agreement with the regional prime vendor Cardinal Health for distribution in this Region and provide certification of this with the initial submittal. (Note that vendors whose products are not available through the regional PV will be disqualified). 4. Vendors must provide discounts off DAPA for all products included in this standardization initiative. (Note that vendors that fail to provide a discount from DAPA will be disqualified).<B R>5. Vendors must provide electronic and hard copy pricing quotes and competitive product cross-reference in electronic MS Excel format upon request. 6. Vendor must provide educational tools, product literature, and materials for Endo Surgery Devices as well as no cost samples for the evaluation. Describe your available company educational tools and material resources with the initial submittal. 7. Vendor must provide customer service (telephonic and e-mail) for regional facilities. Identify company r esources and capabilities for such support with the initial submittal. 8. Vendors must have a local vendor representative available in the region. Provide contact information, i.e. name, address, phone number, and e-mail address with the initial submitt al. 9. Vendors product line must be latex free and indicated on the packaging and in the product literature. 10. Vendor is required to provide on-site, in-person in-servicing to Tripler Army Medical Center prior to the clinical evaluation. Vendors, who cannot provide on-site, in-person in-servicing to TAMC, prior to the clinical evaluation, will be disqualified. 11. Vendor is required to provide product literature, training aids, and teaching materials prior to the clinical evaluation to NH Guam, NH Yokosuka, and NH Okinawa. Vendors, who cannot provide product literature, training aids, and teaching materials toNH Guam, NH Yokosuka, and NH Okinawa, prior to the clinical evaluation, will be disqualified. 12. Vendors product line are single use and disposable. 2. Clinical/Performance Criteria Evaluation A Clinical Product Team (CPT) comprised of medical professionals from multiple disciplines will evaluate the products based upon the following evaluation criteria to determine accep tability. 1. Product is easy to identify from package. (Distinct identification of contents avoids costly errors when setting up for a case or supplementing an existing instrumentation set) 2. The package is easy to open and allows for aseptic d elivery to the sterile field. (Pull apart segments or tear away tabs do not damage packaging or expose contents) 3. Ergonomically designed, lightweight, and comfortable to hold. (No sharp or rough edges, insertion of various devices via trocars is done smoothly without resistance; device surfaces move through converters w/out resistance devices can be held as any similar currently used endo-surgical device). 4. Product is easy to handle. (Devices with jaws a-traumatically hold the correct amount and type of tissues; devices with cutting edges cut tissue evenly w/out tearing tissue; retractors can be maneuvered to allow for maximum visibility product per forms the surgical application for which is designed) 5. Product features prevent injury to the patient. (Devices with jaws do not passively close, cutting edges approximate completely, clip devices do not fire passively, ligation site has adequate visi bility to avoid misplacement of ligation, and retractor devices do not slip off site)
- Place of Performance
- Address: Pacific Regional Contr Ofc TAMC ATTN: MCAA PC BLDG 160, 160 Krukowski Road Honolulu HI
- Zip Code: 96859-5000
- Country: US
- Zip Code: 96859-5000
- Record
- SN01471306-W 20071219/071217224037 (fbodaily.com)
- Source
-
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