SOURCES SOUGHT
A -- Mycobacterium tuberculosis (Mtb) Quality Assessment Program (TBQA)
- Notice Date
- 8/18/2015
- 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, 5601 Fishers Lane, 3rd Floor, MSC 9821, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- NIH-NIAID-SBSS-15048
- Archive Date
- 9/17/2015
- Point of Contact
- Patrick Finn, Phone: 240-669-5401, John R. Manouelian, Phone: 240-669-5152
- E-Mail Address
-
patrick.finn@niaid.nih.gov, manouelj@niaid.nih.gov
(patrick.finn@niaid.nih.gov, manouelj@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction 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; woman-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 Division of AIDS (DAIDS) develops and supports the research infrastructure and biomedical research needed to: 1) halt the spread of HIV through the development of an effective vaccine and biomedical prevention strategies that are safe and desirable; 2) develop novel approaches for the treatment and cure of HIV infection; 3) treat and/or prevent HIV co-infections and co-morbidities of greatest significance; and 4) partner with scientific and community stakeholders to efficiently implement effective interventions. DAIDS accomplishes its mission through the funding of clinical studies conducted by networks (e.g., the Adult AIDS Clinical Trials Group), clinical cohorts (e.g., the India Regional Prospective Observational Research for Tuberculosis), and individual research grantees. The development and implementation of shorter, more effective, less toxic treatment regimens for drug-sensitive and drug-resistant Mycobacterium tuberculosis (Mtb) is of high priority for advancing public health. As these treatments are developed and studied in NIAID-supported trials, there is a need for laboratory-based tests that shorten the time to evaluate the efficacy of such treatments. Additionally, the World Health Organization has identified a critical need to develop and implement tests for rapid diagnosis of active Mtb, tests to predict and diagnose latent Mtb, non-sputum based tests to detect childhood Mtb and extra-pulmonary Mtb, reliable tests to diagnose Mtb/HIV co-infected subjects and next generation drug-susceptibility tests. Such tests will have to be optimized and standardized prior to implementation in NIAID-supported clinical studies, and once implemented in studies, there will be a need to monitor the ability of laboratories (Labs) to reliably and accurately perform these tests. Currently, the ability of Labs to perform Acid Fast Bacillus testing as well as qualitative Mtb cultures and resistance testing is being assessed by another NIAID contract. Purpose and Objectives The purpose of the proposed Mtb Quality Assessment Program (TBQA) contract will be to: (1) evaluate the ability of Labs to accurately and reliably perform study-specified Mtb tests; (2) advise and train laboratories and clinical site staff when deficiencies are identified; (3) evaluate Mtb technologies and specimen processes to be ultimately used in NIAID-supported clinical investigations, and (4) disseminate TBQA technical and scientific data. It is expected that the TBQA will support 25 to 30 Labs, a few in the U.S. and most in various countries around the world where Mtb is an endemic disease. Project requirements Specifically, the TBQA contract will be responsible for the following: 1. Monitoring Labs' ability to perform accurately and reliably study-specified Mtb tests (e.g. next-generation bacterial DNA and RNA sequencing, serial sputum colony count on solid media, time to positivity in liquid culture, minimal inhibitory concentration assessment, and host-based assays). This will include preparation of proficiency testing panels (or acquisition from commercial and non-commercial sources), distribution to participating laboratories, capture and statistical analysis of test results obtained from Labs, determination of performance acceptability, and generation of Lab-specific performance reports. 2. Providing assistance, guidance and training in corrective action when Labs' test performance is unacceptable, including assistance with procedures and Standard Operating Procedures related to Mtb specimen processes and testing, laboratory quality management and instrument/test validation. 3. Evaluating and comparing sample preparation parameters (e.g., specimen collection, storage and shipping) and assay procedures of existing and novel Mtb methodologies (e.g., point-of-care tests for active Mtb and tests to diagnose extra-pulmonary Mtb) by conducting in-house preliminary studies as well as facilitating multi-Lab studies for ultimate inclusion in studies. This will require statistical support for designing the evaluations and for determining within-lab and between-lab magnitude and sources of variability 4. Obtaining, characterizing (e.g., complete phenotypic and genotypic drug susceptibility testing), storing and distributing materials and reagents needed for the preparation of quality control materials (QCMs) used to prepare proficiency testing panels and for method evaluation studies. Examples of QCMs include a collection of distinct clinical Mtb isolates from geographically diverse Mtb-endemic regions obtained from adult and pediatric individuals with and without HIV infection. Isolates shall represent drug-sensitive and -resistant strains from various lineages and genetic diversity. Other QCMs may include extra-pulmonary samples, such as urine, blood and saliva. 5. Disseminating TBQA scientific and technical data through publications and presentations at meetings. Anticipated period of performance It is anticipated that one (1) cost reimbursement, level-of-effort (term) type contract will be awarded. The period of performance will be for one (1) year (Base Period) plus six (6) one year options (terms) that may be exercised by the Government unilaterally, for a total possible performance period of seven (7) years, beginning on or about December 15, 2016. The requirement will be for the delivery of 5.4 full time equivalents (FTEs) per year for the Base Period (Year 1) and each option period (Years 2 through 7). In addition, the Government may unilaterally 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: (1) Increased Level of Effort for Additional Labs: During the course of the contract it may be necessary to incorporate additional U.S. and non-U.S. Labs to support clinical trials and participate in proficiency testing evaluation. Such an increase would require an increase in the Respondent 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. If the Government elects to exercise this Option, the Contractor shall provide an additional 0.5 FTE per option. More than one (1), but not more than six (6) options may be exercised in any one year. The period of performance of an Option for Increased Services will not exceed the term of the Base year or Option year in which the Option is exercised. (2) Increased Level of Effort for Additional Evaluation of Mtb Assay and Specimen Processing Methodologies. During the course of the contract, it may be necessary to conduct in-house and/or facilitate multi-Lab studies to evaluate/compare Mtb assay and specimen processing methodologies. Such an increase would require an increase in the Respondent'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 one multi-Lab evaluation of a novel Mtb assay. If the Government elects to exercise this Option, the Respondent shall provide an additional 0.55 FTE. The period of performance of an Option for Increased Services will not exceed the term of the base year or Option year in which the Option is exercised. Other important considerations It is expected that Respondent's staff will have education, training, experience and expertise with respect to: clinical Mtb research, clinical microbiology, Mtb immunology, Mtb method evaluation studies, statistical methods, good clinical laboratory practices, creating and utilizing training tools and customer service. The Respondent must have staff able to travel to various Labs in and outside the U.S. to provide training and trouble shooting. QCM-related activities will require: access to BSL-3 facilities, availability of appropriate equipment (e.g., fluorescent microscope, GeneXpert MTB/RIF technology, gene sequencing, C02 incubators, and BACTEC MGIT960 system), and knowledge and expertise in shipping QCMs with appropriate permits and in accordance with IATA/ICAO dangerous goods shipping regulations and other relevant shipping regulations. Capability Statement/Information Sought Capability Statements submitted as a result of this announcement should demonstrate the Respondent's qualifications, expertise and experience, specifically providing evidence as to the capability to perform this requirement. Capability Statements should clearly convey the following information: (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; (5) corporate experience and management capability; (6) examples of prior completed Government contracts, references, and other related information; and (7) demonstrated ability to carry out the work. 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 Respondent may need to utilize the expertise and resources of subcontractors and specialized consultants to provide the full spectrum of requested activities. The Respondent shall be responsible for ALL work performed under this contract, including any work performed by any subcontractors and consultants. The Respondent shall ensure that any and all processes meet international, federal, local and state regulations to ensure the continuity and validity of the resulting product. Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 5 pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such. Required Business Information: • DUNS. • Company Name. • Company Address. • Company Point of Contact, Phone and Email address • Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought. • Do you have a Government approved accounting system? If so, please identify the agency that approved the system. • Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration (CCR) located at http://www.ccr.gov/index.asp. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern's name and address). Number of Copies: Please submit one (1) electric copy of your response as follows: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Patrick Finn, Contract Specialist, at patrick.finn@nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify HHS-NIH-NIAID-SBSS-15048. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:30 PM local time on September 2, 2015. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. 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 pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. 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(s)."
- Web Link
-
FBO.gov Permalink
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- Record
- SN03843455-W 20150820/150818235743-4c2284a7e72009453099987342c0304d (fbodaily.com)
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