SOURCES SOUGHT
A -- NIAID Virology Quality Assurance
- Notice Date
- 12/7/2010
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 6700 B Rockledge Room 3214 MSC7612, Bethesda, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- HHSN-NIH-NIAID(AI)-SBSS-10-106
- Archive Date
- 1/6/2011
- Point of Contact
- Cecil Butler, Phone: 301-496-0612, John Manouelian, Phone: 301-496-0612
- E-Mail Address
-
butlerce@mail.nih.gov, manouelj@mail.nih.gov
(butlerce@mail.nih.gov, manouelj@mail.nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; women-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Background The mission of the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) is to help ensure an end to the HIV/AIDS epidemic by increasing basic knowledge of the pathogenesis and transmission of the human immunodeficiency virus (HIV), supporting the development of therapies for HIV infection and its complications and co-infections, and supporting the development of vaccines and other prevention strategies Purpose and Objectives The purpose of the NIAID Virology Quality Assurance (VQA) program is to provide a comprehensive quality assessment program for virologic assays for HIV, and HIV-related viral co-pathogens, performed on samples from subjects enrolled in NIAID-sponsored multi-site clinical studies. The VQA program ensures the validity and inter- and intra-laboratory comparability of virologic laboratory data obtained from NIAID-supported clinical trials and HIV natural history studies by providing laboratories with proficiency testing panels and real time assay run controls, and analyzing proficiency panel and assay run data from each laboratory. The VQA program also implements standards of performance for existing and state-of-the-art new virologic assays, develops and tests biostatistical methods relating to the assays, and acquires, tests, stores and dispenses quality control materials and reagents. Thus, the VQA program is critical to the scientific integrity of on-going and future studies concerning HIV diagnosis, disease progression, assessment of treatments, vaccine efficacy and other preventive measures. The VQA has been in operation since 1988 and has developed and standardized quality control procedures for approximately 25 virologic assays used in DAIDS-sponsored clinical trials. The current contract is entitled "DAIDS Virology Quality Assurance" and is with the Rush Presbyterian St. Luke's Medical Center, Chicago, Illinois. Project Requirements The Division of AIDS (DAIDS), of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is seeking capability statements from qualified organizations to act as a contractor to provide a comprehensive quality assessment program for virologic assays for HIV, and HIV-related viral co-pathogens (HCV, HBV, CVM, KSHV). The program must ensure the validity and inter-and intra-laboratory comparability of virologic laboratory data obtained from NIAID-supported clinical trials by providing laboratories with validation and proficiency testing panels and real time assay run controls, and analyzing proficiency panel and assay run data from each laboratory. The contractor must also plan and execute single and multi-laboratory studies for the evaluation and development of new and existing virologic assays and supporting statistical methodologies, implement standards of performance for existing and new virologic assays, develop and test biostatistical methods relating to the assays, and acquire, test, store and dispense all quality control materials and reagents required for this program, including specimens collected from HIV-infected and-uninfected human subjects. The contractor will serve laboratories associated with current and future NIAID-sponsored clinical trial networks and collaborating study groups. Currently, the contract serves approximately 110 laboratories, with 55 international laboratories in 22 countries. The Government anticipates a potential need to expand the number of laboratories serviced by the Program during the course of the contract and also anticipates a potential need for similar services that address viral disease agents other than HIV and related viral co-pathogens. Increases in effort for these services would be implemented through the exercise of contract options, at the discretion of the Government. Anticipated Period of Performance It is anticipated that a level of effort type contact will be awarded. The period of performance will be for one year beginning approximately June 1, 2012 through May 31, 2013. The requirement will be the delivery of 9.10 full time equivalents (FTE) per year for the base period (Year 1) and 9.10 FTE per year for Options 1-6 (Years 2-7). In addition, the Government may exercise options for an increased level of effort that may result from unanticipated increases in demand for the activities supported by the base requirements of this contract. Options for increased services may include: Increased Level of Effort for Additional Labs: During the course of the contract it may be necessary to incorporate additional Labs to support new NIAID-supported clinical trials. Such an increase would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an option. Each option of this type will implement work commensurate with the addition of 5 Labs. More than one (1), but not more than three (3), Options may be exercised in any one year. It is estimated that an additional 0.20 full time equivalents (FTEs) will be needed to accommodate these additional Labs during the first year of activation. If the options for these Labs are exercised for continuation in subsequent years, 0.10 FTE/year will be needed. Options to add new Labs will not be exercised in the last year of the contract (Year 7). Addition of Expertise: Addition of a Quality Assessment Program for viral disease agents other than HIV and related co-pathogens. During the course of the contract it may be necessary to develop a quality assessment program for assays associated with viral disease agents other than HIV that were not anticipated at the time this solicitation was initiated, and that would directly support high priority NIAID research programs. During the contract period, one option could be activated for the addition of a Quality Assessment Program. The option may be activated in any year of the contract. Additional options to extend the Quality Assessment Program for subsequent years may be exercised as well. It is estimated that 3.10 full time equivalents (FTEs) will be needed for this Option in the first year, and in subsequent years if options are exercised for continuation. Capability Statement/Information Sought Potential sources must demonstrate and document the following in their capability statements: The program will require the ability to obtain quality control materials to be used in proficiency panels and assay run controls. This will require the ability to grow HIV in cell culture and will also require access to domestic and international populations of HIV-infected and -uninfected individuals for donation of blood and other clinical specimens to be processed for use as quality control materials in validation and proficiency panels and in panels used for the evaluation of new and existing virologic assays. The contractor must have the ability to provide multiple domestic and international laboratories with validation and proficiency testing panels and reagents and controls, and must be able to retrieve and analyze data from all laboratories. This program will require experience in the areas of HIV virology, HIV-associated viral co-pathogens, medical technology/pathology, statistical modeling, data management, quality assurance, and safety and ethics regulations. The prospective contractor must have a Principal Investigator and staff with the experience and expertise to carry out a project of this size and complexity, must understand cultural sensitivity issues relevant to resource-constrained countries, and must have the flexibility to address emerging needs and expansion. Capability statements submitted as a result of this announcement should demonstrate the offerors' qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to the following: Acquisition of quality control materials: Interested parties must demonstrate the ability to acquire quality control materials and process them for shipping to domestic and international laboratories as validation and proficiency panels and assay controls. This must include the ability to acquire specimens from HIV-infected and-uninfected human subjects both domestically and internationally. Provision of test panels to laboratories: Interested parties must demonstrate the ability to provide multiple domestic and international laboratories with validation and proficiency panels and must demonstrate the ability to retrieve and analyze data from multiple laboratories. Personnel/Management: Interested parties must demonstrate adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity. Past Performance: Past performance is considered essential. In addition to demonstrating that they have met the above qualifications, interested parties must identify at least three other projects of similar size and complexity. Capability Statements should clearly convey information regarding the respondents capabilities, including: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information; Interested contractors must submit a capability statement (five page limitation, excluding resumes) describing their company's experience and ability to perform this effort which includes the following: (1) a summary list of similar work previously performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Principal Investigator/co-PI, which reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; and (5) demonstrated ability to carry out the work. Each response should include the following Business Information: a. DUNS b. Company Name c. Company Address d. Company Points of Contact (both technical and administrative), including names, titles, addresses, telephone and fax numbers and Email addresses e. Current GSA Schedule appropriate to this Sources Sought. f. Do you have a Government approved accounting system? If so, please identify the agency that approved the system. g. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration (CCR). All offerors must be registered in CCR which is located at http://www.ccr.gov/ Teaming Arrangements: All teaming arrangements should also include the above-cited information and certification for each entity on the proposed team. Teaming arrangements are encouraged. NIAID recognizes that no single organization or institution may have the expertise and facilities required to perform all of the tasks mentioned above. Therefore, the Contractor may need to utilize the expertise and resources of subcontractors and specialized consultants to provide the full spectrum of requested activities. The Contractor shall be responsible for ALL work performed under this contract including that performed by any subcontractors and consultants. The Contractor will ensure that any and all processes meet international, federal, local and state regulations to ensure the continuity and validity of the resulting product. Responses must be submitted no later than 4:00 PM, December 22, 2010. Capability statements will not be returned and will not be accepted after the due date. These statements may be submitted by e-mail or paper copy to Cecil Butler, Contract Specialist. He can be emailed at the address provided below. Electronic submissions should be submitted in PDF format, however, Microsoft Word or Corel WordPerfect will be accepted. In the subject line, please reference: HHS-NIH-NIAID (AI)-SBSS-10-106. A paper copy can be sent via regular mail at the address provided below. If sending a paper copy, please send an original and one copy. Cecil Butler Contract Specialist Office of Acquisitions National Institute of Allergy and Infectious Diseases National Institutes of Health 6700 B Rockledge Drive, Room 3214, MSC 7612 Bethesda, Maryland 20892-7612 Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a Presolicitation synopsis and solicitation may be published in the Federal Business Opportunities. Respondents will be added to the prospective offerors list for any subsequent solicitation. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation. The Government will not entertain questions regarding this Market Research; however, general questions may be emailed to the following addresses: Contract Specialist: Cecil Butler Email Address: butlerce@niaid.nih.gov Contracting Officer: John Manouelian Email Address: manouelj@niaid.nih.gov
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