SPECIAL NOTICE
A -- J&A6.302-1 SKELETAL MUSCLE TISSUE ANALYSIS Beth Israel Deaconess Medical Center
- Notice Date
- 4/3/2009
- Notice Type
- Special Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Veterans Affairs;VA Boston Healthcare System;Contracting Officer (90C);940 Belmont Street;Brockton MA 02301
- ZIP Code
- 02301
- Archive Date
- 4/18/2009
- Point of Contact
- Tracey Bissonnette<br />
- Small Business Set-Aside
- N/A
- Description
- The Department of Veterans Affairs, VA Boston Healthcare System, has awarded a sole source contract for a molecular biologist to complete skeletal muscle and blood assessments of tissue samples collected from heart failure patients and health controls to Beth Israel Deaconess Medical Center. A fixed price contract with a base of March 30, 2009 through September 30, 2009 with two (2) 1-year options was awarded. It is the Government's belief that only Beth Israel Deaconess Medical Center (BIDMC) possessed the required capabilities to successfully meet this requirement. Please refer to the Sole Source Justification. This is not a solicitation or a request for information; it is notice of a sole source contract award. JUSTIFICATION AND APPROVAL VA241-P-1148 SKELETAL MUSCLE ANALYSIS SOLE SOURCE AWARD 1.Identification of the service/department and the transaction/requisition #: Department Veterans Affairs, Boston Healthcare System, Geriatric Research, Education, and Clinical Center, 150 South Huntington Avenue, Boston, MA 02130 Solicitation No: VA-241-09-RQ-0019, Contract No: VA241-P-1148 2.Nature and/or description of the action being approved: General requirements: Molecular biologist to complete skeletal muscle and blood assessments of tissues samples collected from heart failure patients and healthy controls. Assessments will include light microscopy as well as assessments of gene signaling patterns in the acquired human muscle biopsy samples. In particular, the molecular biologist must be qualified to complete highly specialized assessments of atrogenes (genes regulating proteolysis) as well as anabolic signaling patterns. Moreover, the molecular biologist must be disposed to work closely with Dr., in frequent meetings during data acquisition and throughout data analysis. This is a newly funded award that was specifically formulated and premised on the synergy of Dr. (principal investigator) and Dr. (co-investigator), incorporating novel analytic methods developed by Dr. in prior animal studies. Dr. played a key role in the development of this project, building upon and extending his seminal work in animals. The synergy created by the combination of Dr. and Dr. unique fields of expertise are felt to be major strengths of this study. In particular Dr. (and his staff) will be responsible for molecular assessment of muscle and blood samples collected in this study. Light microscopy will be used to complete histological analyses of tissue samples. Technically difficult and specialized real-time PCR techniques will be used to assess transcriptional patterns underlying the histological findings in these samples. The molecular assessments are especially novel, and constitute the basis of sole source contracting with Dr.. Genes regulating atrophy (atrogenes) will be identified as well as anabolic skeletal muscle transcriptional coactivators (PGC-1, and IGF-1). Dr. is uniquely qualified for these collaborations as he was one of the investigators that originally identified the concept of muscle atrogenes he has completed seminal research on atrogenes function (see below). He has also refined a systematic method of assessing atrogenes comprehensively and in aggregate with anabolic signaling patterns using real-time PCR techniques. Signaling assessments will include: 1. Protein degeneration atrogenes: atrogin-1/MAFb, MuRF1, Polyubiquitin (UbB), E3a-II, proteasome subunits (PSMA1), cathepsin L. 2.Growth factors (molecular signaling related to growth): PGC-la, IGF-1, IGFBP5, Fox01, TGFa, myostatin, follistatin, P311. 3.Structural atrogenes. MyHC, troponin I, Collagens (Co11A). 4.Metabolic atrogenes. enolase, pyruvate dehydrogenase, lactate dehydrogenase, glutamine synthase, creatine kinase, metallothionein. Dr. has been focused on issues of gene regulation in skeletal muscle for 12 years, and has published at length as this field (see below). Dr. will also regularly participate in acquisition and analysis of data, working closely with Dr. to correlate muscle biological indices to functional assessments completed by Dr.. Dr. will meet regularly with Dr. at the VA Jamaica Plain campus to achieve these objectives. 3.Description of the supplies/services required to meet the agency's needs (including the estimated value): To perform these analyses, Dr. will assess mRNA using real-time PCR techniques that are currently available and being utilized in his laboratory at BIDMC. Total skeletal muscle mRNA will be extracted from muscle biopsies using well established protocols. mRNA levels will be determined by real-time PCR using an Applied Biosystems OneStepPlus real-time PCR analyzer. For histological assessments, standard light microscopy techniques will be employed to analyze cross-sectional area of muscle fibers, as well as damage, inflammation, and atrophy. Histochemistry to differentiate type I and type II fibers will be performed (cytochrome C oxidase activity), and the histomorphometric and enzymatic features will be correlated to atrogenes expression, IGF-1, and PGC-la levels. Standard measures of aerobic enzymes (citrate synthase) will also be completed to establish additional correlations to molecular signaling patterns. Dr. also works proximately to the JP VA Boston Healthcare campus. He will work directly with Dr. as samples are collected and analyzed, and correlated to the comprehensive functional assessments that will be completed by Dr. at the VA campus. Dr. will regularly travel to the JP campus to achieve these objectives. 4.Identification of the statutory authority permitting other than full and open competition: FAR 6.302.1 Only one responsible source 5.Demonstration that the proposed contractor's unique qualifications or the nature of the acquisition requires use of the authority cited: Dr. is a molecular biologist and nephrologist with a combined MD-PhD degree, based at the Beth Israel Deaconess Medical Center and Harvard Medical School in Boston, MA. For the past twelve years, he has been involved in basic research to understand the molecular mechanisms that underlie muscle atrophy and has identified both the atrogene network that will be measured in this study as well as being a co-discoverer of atrogin-1 itself. He has extensive experience measuring changes in gene expression of atrogenes in muscle tissue (see below). 6.Describe the efforts that have been made to ensure that offers are solicited from as many potential sources as is practicable, including whether a Commerce Business Daily notice was or will be publicized as required by Subpart 5.2 (copy attached) and, if not, which exception under 5.202 applies: Dr. is uniquely qualified to complete these analyses. In the process of refining this project, Dr. discussed the techniques with several preeminent molecular biologists (at Duke University and University of Vermont, both major centers of skeletal muscle research), with all concurring that Dr. is uniquely suited to this investigation. Not only was his seminal work in atrogenes formative to this proposal, but Dr. has also refined the atrogene and anabolic gene transcription assessments that are critical in achieving the goals of this proposal. In fact, Dr. worked closely with Dr. as the generation of this proposal, and consequently, the proposal's methods are precisely those which Dr. has matured and advanced. 7.Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable: The Contracting Officer determined that the price proposed of $138,151.00 was fair and reasonable. 8.Description of the market survey that was conducted (i.e. names of firms and the date(s) the firms were contacted) and the results or a statement of the reasons a market survey was not conducted: As mentioned in question 6, Dr. is uniquely qualified to complete the analyses required to achieve the goals of this proposal. Over the years in which this proposal matured, Dr. has discussed this proposal with several preeminent investigators in the field, particularly _____ and ______ (U of Vermont). These investigators specifically corroborated the unique aspects of the analyses of this proposal; work that only Dr. can perform. Based on the scientific merits of the study, Dr. is the right person to do the muscle analyses. The proposal builds on his seminal work, methods, and insights. 9.Any other facts supporting the use of other than full and open competition, such as an explanation as to why technical data packages, specifications, engineering descriptions, statement of work, or purchase descriptions suitable for competition have not been developed or are not available. This contracting activity seeks to maximize competition whenever possible. However, Research requirements are often very specific and there is truly only one responsible source available to meet the Government's needs. Seeking competition under these circumstances would serve no useful purpose. 10. A Listing of the sources, if any, that expressed an interest in the acquisition: None to date 11. A statement of the actions, if any, that the department/service may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies/services is required in the future: This acquisition is truly a sole source requirements and there were no barriers to competition to remove.
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