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FBO DAILY ISSUE OF SEPTEMBER 01, 2011 FBO #3568
SOLICITATION NOTICE

66 -- Justification and Approval for Solicitation No.: 11-009138

Notice Date

8/30/2011
 

Notice Type

Justification and Approval (J&A)
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
 

ZIP Code

20892-5480
 

Solicitation Number

11-009138
 

Archive Date

9/29/2011
 

Point of Contact

Douglas H. Reed, Phone: 301-594-5919, Barbara Taylor, Phone: 301-594-5915
 

E-Mail Address

douglas.reed@nih.gov, barbara.taylor@nih.gov
(douglas.reed@nih.gov, barbara.taylor@nih.gov)
 

Small Business Set-Aside

N/A
 

Award Number

HHSN269201100227P
 

Award Date

8/30/2011
 

Description

JUSTIFICATION AND APPROVAL FOR SOLICITATION NO.: 11-009138 (POSTED AFTER INTENT TO SOLE SOURCE NOTICE PERIOD) 1. AGENCY IDENTIFICATION AND CONTRACTING ACTIVITY The National Institutes of Health (NIH), Clinical Center (CC), Transfusion Services Lab (TSL) has a need to approve a "Justification for Other Than Full and Open Competition" requirement IAW with FAR 6.3, Other Than Full and Open Competition. The quality of product required for ongoing experiments (clinical research) procurement action IAW FAR 6.302-1 is based on the need to purchase instrumentation to be used primarily in patient care testing. 2. NATURE AND/OR DESCRIPTION OF THE ACQUISITION BEING APPROVED Approval of a purchase order for the Applied Biosystems, Inc. is needed for the purchase and trade in of an ABI 3500XL Genetic Analyzer (Sequencer), which performs DNA sequencing and fragment analysis on human DNA samples. This is for patient care testing and will permit staff to better match red blood cell donors to patient blood recipients. 3.DESCRIPTION OF THE SUPPLIES AND SERVICES REQUIRED TO MEET THE AGENCY'S NEEDS This instrumentation is used in the detection of mutations that can cause gene and antigen variants. We will use this sequencer to detect and analyze potentially new or novel alleles in RBC (red blood cell) blood groups that may allow us to better match red blood cell donors to patient blood recipients. An allele is a pair of genes located at the same position on both members of a pair of chromosomes and conveying characters that are inherited. The ABI 3500XL Genetic Analyzer (Sequencer) is specifically designed to support the demanding performance needs of validated and regulated environments (such as blood banks), while retaining unsurpassed versatility of applications related to: Resequencing, fragment analysis, integrated software for instrument control, data collection, quality control, and auto-analysis of sample files for basecalling (sequencing) and fragment analysis. The sequencer also runs cool and needs only standard voltage power sources. This feature is very unique and critical to our research mission, as there have been instances where voltage power has been incompatible with the voltage power of the NIH Clinical Center. This can lead to major electrical changes, if possible at all, regarding our power for the laboratories. The line items to be procured for the equipment are attached (see Schedule of Supplies). The estimated value of this obligation will be $200,000. It is projected to be awarded by September 5, 2011 to ensure no disruption in providing testing for the NIH Clinical Center patient care and research community. 4. IDENTIFICATION OF STATUTORY AUTHORITY The requirement will be solicited under citation 10 U.S.C. 2304(c) (2), 41 U.S.C. 253(c) (2) and FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements; quality of product required for on-going experiments (clinical research). 5. DEMONSTRATION THAT THE PROPOSED CONTRACTOR'S UNIQUE QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES USE OF THE AUTHORITY CITED The proposed vendor is Applied Biosystems, Inc., Rockville, MD (ABI). Primers and other consumables for this instrument are designed in ready-to-use, load and run pouches which make operation simple for laboratory staff, who are not necessarily seasoned researchers. In addition, this instrument will serve in tandem with another Applied Biosystems (ABI) 3500XL Genetic Analyzer (Sequencer) that was recently purchased by our HLA laboratory. Having the interchangeable pouches for consumables and the same technology means less cost associated with maintaining dual inventories of consumables and additional training of staff on multiple instrument platforms. If one instrument is down for repair, we can simply move to the other machine to complete work in progress without wasting work hours or reagents. However, if we receive a sequencer from another company, it will require us to maintain an additional inventory of reagents and disposables at added cost; it will require additional employee training and the development and maintenance of additional standard operating procedures. These extra tasks will overwhelm an already over-burdened staff. Furthermore, a different instrument would also need to be validated to show that it is capable of providing the same quality of results we obtain with the current ABI 3500XL Genetic Analyzer (Sequencer) in HLA laboratory (again with additional work for our staff). This may have adverse impact on research that has already been performed if the other instrument isn't capable of performing the same analysis at the same level of detail. Finally, this purchase is linked to a trade-in credit of $39,000 for another ABI instrument, the 7900HT Fast Real-Time PCR System, which would not be possible if we purchase from another vendor. The ABI ViiA 7 Real Time PCR instrument performs PCR used in the analysis of DNA. This instrument draws 77% less energy when idling and 70% less energy to process one sample plate compared to other Fast Real-Time PCR systems. It uses less raw material and is less hazardous for disposal than competitors because it is free of lead, mercury, cadmium, and other hazardous materials found in electronic products. It has 44% smaller space needs, which is very important in labs where space is very tight, such as ours. This "green" instrument is being purchased with a $39,500.00 trade-in credit for an older ABI PCR machine, the ABI 3730 XL DNA Analyzer, which is not energy efficient due to its age, and is bundled with the ABI 3500XL instrument for performing DNA analysis of blood group genes. 6. A DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE SOLICITED FROM AS MANY POTENTIAL SOURCES AS PRACTIABLE At this current time, it is not practicable to solicit offers, as this instrumentation is similar to our ABI other instrument so there will be one testing platform and hence consistency and reliability between the test results. Also, there will be less cost associated with consumables and a single inventory for all the consumables and pouches. Also, the vendor is permitting trade-in credits, resulting in lower costs to the Government. However, to ensure fair opportunity for possible alternate vendors providing/carrying brand name or equal products (as listed on Schedule of Supplies) to emerge, an Intent to Sole Source notice will be posted to www.fbo.gov. Vendors will be given an opportunity to submit capability statements and/or product literature/materials to program staff to see if it would address our unique departmental needs. 7. DEMONSTRATION THAT THE ANTICIPATED COST WILL BE FAIR AND REASONABLE The Government anticipates that the proposed cost will be fair and reasonable in accordance with FAR 15.404-1(b)(ii). 8.DESCRIPTION OF MARKET RESEARCH CONDUCTED AND THE RESULTS OR STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED Due to the need for consistency in testing and results, market research was not conducted. It is not anticipated that the NIH CC will submit a request for contract for this one-time acquisition. 9.OTHER FACTS SUPPORTING In accordance with FAR 6.302-2 (b) (2), the nature of harm that would be brought to NIH CC TSL is that if NIH does not have this in place, NIH CC patients could expire (die) or have their health severely impacted due to inaccurate assessment/testing. Many of these patients are here at the NIH CC on research/testing due to their unique conditions/diseases. 10. ADMINISTRATIVE OFFICER/PROGRAM OFFICIAL CERTIFICATION "I certify that the facts and representations under my cognizance and which are included in this Justification and Approval are accurate and complete to the best of my knowledge and belief." /s/ _________________________ Lacey Gholson Administrative Officer 11. CONTRACTING OFFICER'S CERTIFICATION "I certify that the facts and representations under my cognizance and which are included in this Justification and Approval are accurate and complete to the best of my knowledge and belief." /s/ _________________________ Barbara Taylor Contracting Officer
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/11-009138/listing.html)
 

Place of Performance

Address: NIH Clinical Center, Transfusion Services Laboratory (TSL), Building 10, 9000 Rockville Pike, Bethesda, Maryland, 20892, United States

Zip Code: 20892
 

Record

SN02555595-W 20110901/110831000054-261716c2e06b9898f5de55f490806a19 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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