Loren Data's SAM Daily™

FBO DAILY ISSUE OF JULY 21, 2007 FBO #2063
SOURCES SOUGHT

65 -- Standardization of Trocars for Pacific Region, TRBO Region 12, a military integrated delivery network (IDN), comprised of Army, Navy, Air Force, and Marine Corps medical treatment facilities in Hawaii, Guam, Korea, Japan and Okinawa

Notice Date

7/19/2007
 

Notice Type

Sources Sought
 

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

W81K02-07-T-3018
 

Response Due

8/10/2007
 

Archive Date

10/9/2007
 

Small Business Set-Aside

N/A
 

Description

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 Request for Regional Incentive Agreement Quotation (RFRIAQ) for the standardization of Trocars - Disposable. This new RFRIAQ supersedes the previous solicitation for Trocars solicitation number W81K02-T-07-3016 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 July 23, 2007 and thi s date is established due to a chance in the clinical evaluation process. The change in the process includes a requirement for clinical in-servicing by the vendor prior to the clinical evaluation. All responses to this solicitation must be resubmitted fres h before the closing date of July 23, 2007. No prior submissions for this product line in any previous FBO will be considered 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 product be obtained through the D oD 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, and the 121st Combat Support Hospital, Korea. 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 Agreemen t (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 products. This RFRIAQ is a s upplement 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 award with three 12-month option periods. Anticipated award date is June 2008. The evaluation will be based on clinical, technical, and pricing factors. The award will be determi ned utilizing Best value/ trade off criteria. Point of Contact Cheryl Janus, TRBO Clinical Analyst, 808-433-7985, cheryl.janus@amedd.army.mil B. Products & Performance Required The Pacific Region is seeking product line items in the category of Trocars-Disposable. For this product line, the yearly estimated total usage/forecasted requirement for this region is $159,465.84. This forecast is based on historical prime vendor sales f or 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 information, prime vendor order numbers, MSDS information, and itemization of brands, types of packaging information of the products offered by the vendor. C. Instructions to Offerors 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 cheryl.janus@amedd.army.mil. Submissions must be received prior to the specified closing date/time of this solicitation. Vendors that fail to meet the submittal deadline will be disqualified. This process will include vendor requirements of electronic responses to technical criteria, no charge samples for clinical evaluation, on-site in-person in-servicing, product literature, education and training materials, and submission of electronic best price offers. Due to the potentia l 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 ad vised 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 clinicians and logisticians from the Military Treatment Facilities within the Pacific Region. They are the deciding officials for this in itiative. 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 tech nical/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 Treatment Facilities (MTFs). Vendors are required to ship samples direct to the designated MTFs. Vendors will be given 15 business days to ship s amples. Samples must be shipped to arrive at the MTF by COB, 4PM local time, on the (15th) business day after the notice to ship. Vendors failing to deliver by the deadline will be disqualified from further consideration in the standardization process. Specific MTFs will evaluate the clinical/performance criteria using a likert type scale, using a one to five rating. One is equal to not acceptable, Three point seven five is equal to acceptable, and five is equal to highly acceptable. All clinical/perform ance criteria are weighted equally. The TPRB has set a 3.75 minimally acceptability threshold for all product groups. Clinical/performance results lower than 3.75 will not be considered acceptable for standardization and will be disqualified from further consideration in the standardization process. The Government reserves the right to conduct evaluations in either a non-clinical or clinical setting 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 Trocar - Disposable products. Vendors who cannot provide on-site, in-person in-servicing to TAMC will be disqualified. 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 representative in the perioperative/invasive procedure setting (A ORN Recommended practices, and Guidelines, 2007). In-service is required to meet the governments minimum need and is normal and customary. Vendors will also be required to provide an on-site, in-person in-service to NH Guam, NH Yokosuka, NH Okinawa, and the 121st CSH OR vendors must send product literature, training aides and teaching materials to these MTFs prior to the clinical evaluation p rocess. Vendors who cannot provide on-site, in-person in-servicing OR product literature, training aides, and teaching materials will be disqualified. The TPRBs rationale for in-servicing of this product group is in compliance with the Association of periO perative Registered Nurses Position Statement The role of the health care industry representative 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 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 prov ide in-servicing to the operating room 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 questions, 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 on-site clinical evaluation process for NH Guam, NH Yokosuka, NH Okinawa and the 121st CSH. 1) Each vendor will provide on-site, in person, in-servicing for a period of one week to the MTF. One vendor per week will be evaluated. 2) Day 1: vendor will provide in-servicing to the operating room 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 questions, 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 clinical evaluation process for NH Guam, NH Yokosuka, NH Okinawa, and the 121st CSH. 1) Each vendor will provide product literature, training aides and teaching material prior to the clinical evaluation. 2) Day 1: t he staff will review all literature and teaching aides provided by a vendor. 3) Day 2-5: clinical evaluations will be conducted. Vendors will be available by telephone for questions, consultations and guidance. Phase III. After the clinical/performance evaluation are completed and analyzed, all vendors in the clinical evaluation group who meet the minimum 3.75 threshold will be asked to submit their best pricing offer 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. Pricing will be evaluated based on best value to the government and will be based on a committed volume for a two-year period with possible one-year option periods (not to exceed 5 years). Vendors that fail to offer an incentive discount from DAPA will be disqualified. 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/company 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 quoters responses, 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 quoter has, or is obtaining a DAPA for the items; 4) the quoter has, or is obtaining, an agreement covering the items, with Cardinal Health, the P rime Vendor for the region; 5) the quoter intends to offer discounts off DAPA for all products included in this standardization initiative (vendors that fail to offer a discount from DAPA will be disqualified); and 6) the quoters information provided is f actually correct (any misrepresentation of information will disqualify the vendor from further consideration.) 1. Does your company manufacture and/or distribute a complete line of Trocars - Disposable? 2. Are your products available through the Prime Vendor, Cardinal Health? 3. What is your DAPA number for this product line? 4. Under what brand(s) does your company manufacture or distribute your product? 5. Under what standards is your product manufactured? 6. Under what regulatory and/or advisory agency are your prod ucts classified? Are your products approved by these agencies? 7. Please provide a list of the products your company offers for this product line. 8. Are your products latex free? 9. What types of educational tools or materials do you have for this product line? 10. Does your company provide 24/7 customer service? 11. Is there any history of backorders, recalls, and/or adverse events for this product line? If yes, please provide dates and duration, cause, and resolution 12. Is the vendor able to provide on-site, in-person in-servicing of the product line prior to the clinical evaluation to Tripler Army Medical Center in Hawaii? Vendors who cannot provide on-site, in-person in-servicing to TAMC prior to the clinical evalua tion will be disqualified. 13. Is the vendor able to provide on-site, in-person in-servicing of the product line prior to the clinical evaluation OR provide product literature, training aids, and teaching materials prior to the clinical evaluation to NH Guam, NH Yokosuka, NH Okinawa , and the 121st CSH?. Vendors who cannot provide on-site, in-person in-servicing or provide product literature, training aids, and teaching materials to NH Guam, NH Yokosuka, NH Okinawa and the 121st CSH prior to the clinical evaluation will be disqualifie d. 14. What size range of instruments will a single trocar accommodate? 15. What procedures do users follow to report product failures, and how does your company respond to them? 2. Clinical/Performance Criteria Evaluation A Clinical Product Team (CPT) comprised of medical professionals from multiple disciplines will evaluate the products based upon on the following evaluation criteria to determine acceptability. 1. Product is easy to identify from package. 2. Product is easy to open. 3. Product allows for aseptic delivery to a sterile field. 4. Product is easy to handle. 5. Penetrates abdominal wall easily 6. Product safety features prevent injury to the patient 7. Product maintained placement with no leakage from entry site. 8. Instruments/scopes fit through the trocar for the size specified. 9. Valves allow adaptability to all size scopes/instruments 10. Valve leaflets are durable and do not break off. 11. Device allows for easy rotation of instruments. 12. Clear portion of device remains clear and provides good visibility
 

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
 

Record

SN01347127-W 20070721/070720002100 (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 |