Mycobacterium tuberculosis (MTB) Quality Assessment Program (TBQA)

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; 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 Division of AIDS (DAIDS) supports a comprehensive research portfolio to advance biological knowledge of HIV/AIDS, its related co-infections, and co-morbidities. With the ultimate goal of creating an - AIDS-free Generation, the Division 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. Tuberculosis (TB), caused by the bacterium Mycobacterium tuberculosis (MTB), continues to be a significant public health burden and global threat. In 2019 alone, there were over 10 million new cases of TB infection world-wide, with 1.2 million new cases in People with HIV (PWH). TB is the leading cause of death among PWH. PWH are 15-22 times more likely to develop active TB, with fatality rates 16-25% greater than those without HIV, and are the most vulnerable to drug-resistant TB. In recent years, significant research efforts have focused on evaluating novel approaches for TB prevention, diagnosis and treatment in pregnant and postpartum women, infants, children, and adolescents, with and without HIV. These efforts have led to the development of shorter, safer treatment regimens for drug-susceptible and drug-resistant TB disease; identification of optimal TB preventive therapy for drug-susceptible latent TB infection and household contacts exposed to multi-drug resistant TB (MDR-TB); and optimization of treatments for TB meningitis. However, despite these efforts, approximately 30% of all new cases of TB go undiagnosed each year. Ending the TB epidemic relies in great part on the early, accurate, and rapid diagnosis of MTB infection to facilitate screening and triage, improve case detection, and initiate effective treatment regimens. The primary purpose of the Mycobacterium tuberculosis Quality Assessment (TBQA) contract is to support and promote access to quality-assured MTB laboratory diagnosis and testing across laboratories participating in DAIDS-supported clinical trials. MTB laboratories play a critical role in generating data that determine primary and secondary endpoints for TB clinical trials. The harmonization of methodologies among the various testing laboratories (Labs) ensures comparability of test results across multiple trial-supporting labs and comparability of data between trials. The use of appropriate methodologies and reliable test results ensures the safety of study participants and supports product advancement and approval by U.S. and non-U.S. regulatory entities. The TBQA will continue to serve current and future NIAID-sponsored clinical trial networks, cohorts, and collaborating study groups (User Groups), as well as individual grantees conducting clinical research. The current contract is held by MRIGlobal, Kansas City, MO, under contract number HHSN272201700001C. The period of performance of the current contract is January 1, 2017 through December 31, 2023. Purpose and Objectives: The purpose of the proposed contract will be to provide a Mycobacterium tuberculosis (MTB) Quality Assessment Program (TBQA), a resource to: (1) support the ability of laboratories (Labs) to reliably perform study-specified MTB tests; (2) evaluate MTB technologies and specimen processes for use in clinical investigations; and (3) disseminate technical and scientific data. This contract also includes Options to increase level of effort in support of: (1) unanticipated increases in demand related to support of additional Labs; (2) performance of late-stage assay validation and/or MTB assay testing of clinical samples in a CLIA-certified laboratory; and (3) public health emergency needs. The TBQA will serve NIAID-sponsored and collaborating clinical trial networks and cohorts as well as individual grantees conducting research in and outside the U.S. Examples of NIAID-sponsored Networks include the Adult AIDS Clinical Trials Group (ACTG), the International Maternal Pediatric and Adolescent AIDS Clinical Trials Group (IMPAACT) and the HIV Vaccine Trials Network (HVTN). Examples of NIAID-sponsored TB cohorts include the India and Brazil Regional Prospective Observational Research for Tuberculosis (RePORT). Anticipated Period of Performance: It is anticipated that a cost reimbursement, term/level of effort, type contact will be awarded. The period of performance will be for one year (Base Period) plus six (6) one-year options to extend the term of the contract that may be exercised by the Government unilaterally, for a total possible period of performance of seven (7) years, beginning approximately October 16, 2023 The requirement will be the delivery of 5.0 full time equivalents (FTEs) per year for the Base Period (Year 1) and 5.0 FTEs 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: Options 1 through 6, to Extend the Term of the Contract: The Government may exercise options to extend the period of the contract beyond the Base Period (Year 1), annually, for a total contract period of up to 7 years. The scope and types of activities as outlined for Year 1 of the contract would be continued for each succeeding annual contract period, up to 7 total years. The percentage of effort includes the effort of subcontracts and consultants. Options 7 through 27, to Increase Level of Effort for Additional Labs: 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. During the course of the contract, it may be necessary to incorporate additional Labs to support NIAID-supported clinical trials. Such an increase would require an increase in the Contractor's effort 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 1.0 FTE. One Option for adding new Labs may be exercised once per year during any year of the contract, beginning with Year 2 of the contract, to a total of 21 options during the life of the contract, as follows: Year 2 (Option 7), Year 3 (Options 8 & 9), Year 4 (Options 10, 11, 12), Year 5 (Options 13, 14, 15, 16), Year 6 (Options 17, 18, 19, 20, 21), and Year 7 (Options 22, 23, 24, 25, 26, 27). The period of performance of an Option for Increased Services will not exceed the term of the base year or the Option year in which the Option is exercised. Options 28 through 33, to Increase Level of Effort for Use of a CLIA Certified Lab: During the course of the contract, it may become necessary to use new and novel MTB assays in clinical trials where results will be used for clinical decisions within the trial. This will necessitate the use of a CLIA certified laboratory for late-stage validation of the assay and for clinical sample testing. If necessary, this will be provided through the exercise of options to this contract. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 1.0 FTE for each option exercised. One option may be exercised per year in years 2 through 7. The period of performance of an Option for increased level of effort for this purpose will not exceed the term of Option year in which the Option is exercised. The percentage of effort includes the effort of subcontracts and consultants. Options 34 through 40, for Increase Level of Effort for Additional Expertise: During the course of the contract, it may be necessary to provide contract services for non-MTB pathogens that were not anticipated at the time this solicitation was initiated and would directly support NIAID research on high priority public health emergency needs. Such services may include the development of new, or optimization of existing, diagnostic tests and sample collection techniques, development of SOPs and training materials, and testing of study samples. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 1.2 FTE for each option exercised. One option may be exercised per year in years 1 through 7. The period of performance of an Option for increased level of effort for this purpose will not exceed the term of Option year in which the Option is exercised. The percentage of effort includes the effort of subcontracts and consultants. Capability Statement/Information sought: Capability statements submitted as a result of this announcement should demonstrate the Offeror's qualifications, expertise and experience, specifically providing evidence as to the capability to perform this requirement, with particular attention to the following: Obtaining or creating proficiency testing (PT) panels to monitor the ability of laboratories to reliably perform a variety of study-specified MTB testing, statistically analyzing test performance results, and providing laboratories with assistance, guidance and training when performance is unacceptable. Propose an approach for providing proficiency testing of Labs ability to accurately perform the Nipro Genoscholar PZA-TB II assay. Supporting assay validations (e.g., Minimum Inhibitory Concentration of MTB drugs) at MTB testing laboratories, including provision of guidance materials, drugs (e.g., Bedaquiline), and MTB strains (e.g., strains resistant to Moxifloxacin); as well as review of assay validation data obtained from laboratories and further guidance to laboratories. Monitoring study longitudinal endpoint MTB test results generated by Labs that provide testing for a clinical study Assessing the ability of new and established Labs to conduct tests reliably and in accordance with Good Clinical Laboratory Practices (GCLP), providing capacity building and other needed assistance, guidance and training. Conducting preliminary studies in-house (at Contractor's laboratory) and facilitating single- and/or multi-laboratory studies to: a) evaluate and/or compare existing or newly developed MTB assays, assay kits, or reagents to determine their performance characteristics (e.g., Alere DETERMINE TB LAM Ag; and b) evaluate and/or compare specimen collection, processing, storage and shipping conditions/procedures. To support the above activities, the Offeror will create or obtain, characterize, store and distribute quality control materials (QCMs) to include: Establishing, as needed, and maintaining a dynamic collection of distinct clinical MTB isolates representing drug-sensitive and drug-resistant strains from various lineages and genetic diversity. The collection should consist primarily of cultures isolated from sputum samples from HIV-infected and non HIV-infected individuals. Isolates will be characterized at the Contractor's laboratory by various methodologies Obtaining non-sputum samples, including whole blood, serum, plasma, peripheral blood mononuclear cells (PBMCs), urine and saliva from MTB-infected and uninfected adult and pediatric individuals, with or without HIV infection, vaccinated and not vaccinated with BCG, and individuals with non-MTB respiratory diseases. Shipping QCMs to US and non-US laboratories under appropriate shipping conditions (e.g., temperature monitoring) and in accordance with IATA/ICAO dangerous goods shipping regulations and other relevant shipping regulations; executing agreements with receiving institutions regarding relevant standards for safe handling and authorized use of QCM as well as obtaining the appropriate interstate, intrastate and foreign shipping licenses and permits for transporting biohazardous materials and arrange overnight (or fastest possible) delivery of shipments to the Labs. 7. Reviewing unidentifiable longitudinal study MTB test results captured by data center across all enrolling sites to assess quality indicators, inform on laboratory performance and needs for additional assistance, training or in-person visits for assessment 8. Disseminating scientific and technical data and making available to the public, including presentations at scientific and investigator meetings, publications in peer-reviewed journals, and presentation of data through conference calls and meetings with relevant parties. 8.Maintaining knowledge of, and access to, MTB instruments/methodologies (e.g., GeneXpert platforms), as well as access to Biosafety Level 3 facilities. Capability statements submitted as a result of this announcement should demonstrate the Offeror's qualifications, expertise, and experience, specifically providing evidence as to the capability to perform this requirement. Capability Statements should clearly convey information regarding the Respondent's 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. Required Business Information: Unique Entity Identifier (UEI) number Company Name Company Address Company Points of Contact (both technical and administrative), including names, titles, addresses, telephone and fax numbers and Email addresses Current GSA Schedule 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 System for Award Management (SAM). All offerors must be registered in the SAM, located at http://www.sam.gov/ 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. Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed five (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. 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 Robert Corno, Contracting Officer at cornorj@niaid.nih.gov. The capability statements should be submitted Adobe Portable Document Format (PDF); however, capability statements in Microsoft Word will also be accepted. The e-mail subject line must specify SBSS75N93022R00015. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:00 p.m., EST., JUNE 22, 2022. 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. The Government will not entertain questions regarding this Market Research; however, general questions may be emailed to the following address: Contracting Officer: Robert Corno Email Address: cornorj@niaid.nih.gov 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).