SOLICITATION NOTICE
A -- Sample 8,600 Samples for HLA-A, -B, -C, and Exon 4 by a Dual Method High Resolution SSOP typing and Sequence Based Typing (SBT)
- Notice Date
- 10/4/2011
- Notice Type
- Justification and Approval (J&A)
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, NMLC, 693 Neiman Street, FT Detrick, Maryland, 21702-9203, United States
- ZIP Code
- 21702-9203
- Solicitation Number
- N3239811RCEA079
- Archive Date
- 10/29/2011
- Point of Contact
- Thomas L. Hood, Phone: 3016198894
- E-Mail Address
-
thomas.hood@med.navy.mil
(thomas.hood@med.navy.mil)
- Small Business Set-Aside
- N/A
- Award Number
- n62645-11-C-4045
- Award Date
- 9/29/2011
- Description
- JUSTIFICATION AND APPROVAL FOR USE OF OTHER THAN FULL AND OPEN COMPETITION 1. Contracting Activity. Contracting Activity: Naval Medical Logistics Command (NMLC), Acquisition Management Directorate, Code 02, 693 Neiman Street, Fort Detrick, MD 21702, is acquiring on behalf of the requesting agency: Naval Medical Research Center (NMRC), 503 Robert Grant Avenue, Silver Spring, MD 20901. 2. Description of the Action Being Approved. Approval is requested to award a single contract to Histogenetics Inc., 300 Executive Boulevard, Ossining, NY 10562 for medical support services to process all sample and HLA typing requests with state-of-the art large volume high resolution typing. 3. Description of Supplies/Services The NMRC has a critical need for medical support services to process all samples and typing requests with state-of-the-art automated instrumentation and bio-informatic tools. Accuracy of allele level typing is further assured by a dual method-high resolution sequence specific oligonucleotide probe (SSOP) typing and Sequence Based Typing (SBT) with further laboratory validation. The contractor's facility must be certified by American Society for Histocompatibility and Immunogentics (ASHI) accreditation which is mandatory for the NMRC Bone Marrow Program laboratory. Typing will be performed to allele resolution genetic typing using the July 2010 World Health Organization (WHO) definitions with complete resolution for all alleles defined in exon 2 and 3 for HLA- A, -B, and -C (and for selected samples for exon 4 where required by the Government to resolve ambiguity) and all alleles defined by exon 2 for HLA- DRB1 using DNA sequence-based method requirements. During the base year (and option years if exercised);8,600 samples will be sent to the contractor over a two month period to be typed. Samples must be typed and returned to NMRC within 30 days from receipt of each sample for 95% of the samples (8,170) and the remaining 5% (430) must be completed within 60 days from receipt of each sample. The period of performance for this contract is anticipated to be a base period of 12-months, followed by two 12-month option periods for a total of 36-months. The type of funds being utilized in the base period are FY2011 Research, Development, Test and Evaluation (RDT&E). 4. Statutory Authority Permitting Other Than Full and Open Competition. 10 U.S.C. 2304(c)(1), One source or limited sources. 5. Rationale Justifying Use of Cited Statutory Authority. The C. W. Bill Young/Department of Defense (DoD) Marrow Donor Program and the National Marrow Donor Program (NMDP) perform allele level testing on a large number (8,600) of volunteer donors at the time of initial recruitment as potential marrow donor volunteers. This results in a significant increase in the number of completely resolved allele typed donors on the DoD and NMDP donor files. The data will also be used for additional scientific studies of the genetics of marrow transplant matching. Typing donors at the time of initial recruitment also allows for the ability to more rapidly find donors and the ability to better determine the percentage of newly entering donors that have novel HLA alleles. Histogenetics is the only company that has demonstrated the capability and experience to perform the number of unambiguous allele level HLA types required. Buccal swabs from 8,600 donors will be sent to the contractor in shipments over a two month period. Samples must be typed and returned within 30 days from receipt of each sample for 95% of the samples (8,170) and the remaining 5% (430) must be completed within 60 days from receipt of each sample. Histogenetics successfully typed 15,000 samples at the unambiguous allele level under Contract N62645-10-C-4067 and 11,000 samples under Contract N62645-08-P-2152. Both contracts were awarded on a sole source basis. To complete the DNA typing, the laboratory and personnel must be certified at the unambiguous allele Level by the ASHI. The required certification is the most difficult certification level to obtain and means that each nucleic acid that codes for the HLA molecule is precisely defined without ambiguity. Histogenetics possesses the required certification. Awarding this follow-on contract to Histogenetics will reduce the start-up time involved in training the laboratory technicians and time allotted for adjustments in performing the services. The start-up cost is estimated at $20,000.00 for this fiscal year. A follow-on contract award to the contractor provides for continuity of services as the key personnel resources that are capable of starting work immediately after contract award are already in place. An award to a new contractor may delay the performance of services up to six months and prevent the typing of donors at the time of initial recruitment. This significantly slows the ability to find donors and the ability to better determine the percentage of newly entering donors that have novel HLA alleles. 6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable. The proposed contract was synopsized on the FedBizOpps website on 1 August 2011. No other known sources have expressed an interest in allele resolution genetic typing. Previous notices of intent have been placed on FedBizOpps for prior contracts for this service (N62645-10-C-4067 and N62645-08-P-2152) and no interested parties have come forward. 7. Determination of Fair and Reasonable Cost. The Contracting Officer will perform a price analysis in order to determine that the anticipated cost to the Government of the services covered by this J&A will be fair and reasonable. The Independent Government Cost Estimate (IGCE) and past purchase history will form the basis of the price analysis. 8. Actions to Remove Barriers to Future Competition. For the reasons set forth in Paragraph 5, NMLC has no plans at this time to compete future contracts for the type of services covered by this document. If another potential source emerges, NMLC will assess whether competition for future requirements is feasible.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N3239811RCEA079/listing.html)
- Place of Performance
- Address: Naval Medical Research Center, Silver Spring, Maryland, 20910, United States
- Zip Code: 20910
- Zip Code: 20910
- Record
- SN02602266-W 20111006/111004235315-0e726d913c70107aac6bc476775b7354 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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