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FBO DAILY ISSUE OF DECEMBER 15, 2006 FBO #1845
SOLICITATION NOTICE

65 -- Supplies and Reagents that have been Optimized for 51 Highly Specialized Items of Medical Equipment

Notice Date
12/13/2006
 
Notice Type
Solicitation Notice
 
NAICS
334516 — Analytical Laboratory Instrument Manufacturing
 
Contracting Office
US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
 
ZIP Code
21702-5014
 
Solicitation Number
W81XWH-07-D-0001
 
Response Due
12/28/2006
 
Archive Date
2/26/2007
 
Small Business Set-Aside
N/A
 
Description
The U.S. Army Medical Research Acquisition Activity (USAMRAA) intends to award a contract to Applied BioSystems, Foster City, CA for supplies and reagents that have been optimized for 51 highly specialized items of equipment at the Armed Forces Insti tute of Pathology, Armed Forces DNA Identification Laboratory, Washington, DC. The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302. The r eagents are equipment-specific for DNA sequencing, quantitation, typing and amplification with primers, polymerases, terminators, and the like. Contract award is expected January 2007. The total estimated value of the contract, including a base year and f our one-year option periods is $3,826,272.61. Interested persons may identify their interest and capability to respond to the requirement by contacting Ms. Cheryl Lowery at Cheryl.Lowery@us.army.mil. This notice of intent is not a request for competitive proposals. A determination by the Government not to compete with this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of dete rmining whether to conduct a competitive procurement. Control No. 07-004 Justification and Approval for Other than Full and Open Competition Justification 1. Requiring Activity: Armed Forces Institute of Pathology (AFIP), Washington, DC; Contracting Agency: U.S. Army Medical Research Acquisition Activity, Fort Detrick, MD 21702-5014. The Contracting Activity responsible for this action is the U.S. Army Me dical Research Acquisition Activity in support of the AFIP (DNA Identification Laboratory), Washington, DC. 2. Description of Action: This approval is being requested to award a new firm fixed price requirements contract using Operation and Maintenance-Army (OMA) funds to Applera (d.b.a. Applied Biosystems (AB). 3. Description of Supplies/Services: The Armed Forces DNA Identification Laboratory (AFDIL) requires supplies and reagents that have been optimized for 51 highly specialized items of equipment at AFDIL. The reagents must be equipment-specific for DNA se quencing, quantitation, typing and amplification with primers, polymerases, terminators, and the like. The total estimated value of the contract, including four one-year option periods is $3,826,272.61. 4. Authority Cited: The statutory authority permitting other than full and open competition is 10 U.S.C. 2304(c) (1). The FAR citation is 6.302-1(a) (2) (ii), and the FAR citation title is only one responsible source and no other supplies or services wi ll satisfy agency requirements and FAR 6.302-1(a)(2)(ii), Only One Responsible Source and No Other Supplies or Services will Satisfy the Agency Requirements. 5. Reason for Authority Cited: AFIPs mission requires consistent and standardization of testing to accomplish their overall mission and to maintain credibility, therefore, accuracy is critical to AFIP's mission. The AFDIL is equipped with 51 instrument s that are optimized to specifically operate with AB reagents, some of which are protected by patents and trademarks. Vital to the DNA identification mission is the need for reproducible and accurate test results with no lot to lot variability as determi ned through extensive internal validation studies. The sequencing, typing, amplification, quantitation, and other stages of DNA identification process are performed using reagents compatible with the specific analysis laboratory equipment/instruments. Comparable products with even the very slightest differences would compromise the compatibility and consistency of DNA identification, void instrument warrantees, and shut down the laboratory for 6-12 months while new reagents are tested and validated. Ad ditionally, SOPs would have to be re-written for 51 pieces of Gove rnment-owned equipment critical for AFIP to execute its mission. Competition would involve substantial duplication of cost to the Government that would not be recovered through competition. 6. Efforts to Obtain Competition: Not applicable. No effort will be made to solicit offers from as many potential sources as practicable as there is only one source capable of providing the supplies and reagents for 51 highly specialized scientific inst ruments. The use of any other manufacturers reagents requires various validation procedures involving significant man-hours and efforts lasting approximately 6 to 8 months, during which time the normal daily operation of Identification of US service memb ers using DNA will be suspended. Bringing competitor products online would also involve rewriting of Standard Operating Procedures (SOPs) and Quality Control procedures. AFDIL is an American Society of Crime Laboratory Directors (ASCLD) accredited forens ic lab, which means the FBIs Quality Assurance Document is followed. Based on accreditation adherence (section IV of the Master Operating Plan and the FBIs QAS document), all reagents and equipment must be developmentally validated by the company and in ternally validated by the laboratory as well as pass a stringent quality control before being released for casework. 7. Actions to Increase Competition: Because of the mandate that amplification and extraction reagents be acquired from the same firm who manufactured the DNA sequencing, quantifying, typing and amplifying with primers, polymerases, terminators, etc. equi pment, there can be no effective competition for subsequent acquisitions. 8. Market Research: Prior to the decision to implement a product into the laboratory at AFDIL, extensive validation studies are performed to determine which product possesses the desired properties. Reagents and consumables are compared and tested for s ensitivity, ease of use, consistency, cost, and compatibility with the existing instrumentation used in the lab. Since AFDIL not only works on identification cases but also on evidence to be presented in criminal trials in courts nationwide, as well as in ternationally, all the reagents and consumables used in the laboratory need to be approved for use in processing forensic casework based on Fry and Dalbert Hearings. Although similar products are on the market, not all products have the ability to be uphe ld in the courts and have the general acceptance of the forensic community. In addition, the use of products which are not recommended by the manufacturer of the instrumentation used will void all warranties on the respective equipment and invalidate the service contracts. AFDIL tests and compares each product used and makes its decision based on its internal studies and on the studies of international forensic community. 9. Interested Sources: In accordance with FAR 5.207(c) (14), a notice was published in FEDBIZOPPS announcing the Government's intent to acquire the amplification and extraction reagents from Applera on a non-competitive basis. The announcement identifie d the Government's reasoning for accomplishing this award without competition. After appearing for fifteen (15) calendar days, no sources indicated any interest in pursuing this requirement. 10. Other Facts: Procurement History: A previous requirements contract for these reagents was administered and issued by NARCO-WRAMC. The contract number was DADA1501D0064. It expired September 30, 2006. It was awarded in a non-competitive manner. That contract w as also awarded citing the authority of 10 U.S.C. 2304(c) (1 and utilizing the same rationale as is contained in this document.
 
Place of Performance
Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
Zip Code: 21702-5014
Country: US
 
Record
SN01195946-W 20061215/061213221025 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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