SOURCES SOUGHT
A -- PATIENT SAFETY MONITORING IN INTERNATIONAL LABORATORIES (SMILE)
- Notice Date
- 4/20/2018
- Notice Type
- Sources Sought
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and 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
- HHS-NIH-NIAID(AI)-SBSS-18-006
- Archive Date
- 5/19/2018
- Point of Contact
- Patrick Finn, Phone: 2406695401, John R. Manouelian, Phone: 2406695152
- E-Mail Address
-
patrick.finn@nih.gov, manouelj@niaid.nih.gov
(patrick.finn@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) supports a global 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 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. NIAID places the highest priority on ensuring the safety and optimal management of individuals who participate in its clinical trials and on obtaining reliable laboratory-based data critical for the meaningful interpretation of study findings. Equally important is the safety of those who perform the laboratory testing. NIAID aims to achieve comparability between U.S. (licensed labs) and non-U.S. generated study results. The purpose of this contract for Patient Safety Monitoring in International Laboratories (SMILE) is to enhance the ability of current and future mostly non-U.S. laboratories participating in NIAID-supported clinical trials to perform tests in accordance with good clinical laboratory practices and produce reliable test results. SMILE will continue to serve current and future NIAID-sponsored clinical trial networks and collaborating study groups (User Groups), as well as individual grantees conducting clinical research. The current contract was awarded to Johns Hopkins University, Baltimore, MD, under Contract No. HHSN272201300004C, on November 15, 2012, for a period of seven years. Currently, SMILE supports approximately 170 non-U.S. laboratories in 15 countries. SMILE will continue to support laboratories that are part of current and future NIAID-sponsored clinical trial networks (https://www.niaid.nih.gov/research/hivaids-clinical-trials-networks). Purpose and Objectives: The purpose of this Patient Safety Monitoring in International Laboratories (SMILE) contract is to provide a comprehensive and uniform approach for evaluating initial and on-going laboratory capability and readiness to carry out NIAID-funded clinical trial protocols by (1) monitoring laboratories compliance with good clinical laboratory practices, (2) monitoring the ability of laboratories to reliably perform protocol-specified tests by evaluating results obtained with panels of coded samples, (3) providing Labs with various means of assistance, guidance and training to address and prevent recurrence of deficiencies in good clinical laboratory practices and/or proficiency testing, and (4) maintaining an existing computerized data management system and document library that include lab performance data and guidance documents. The Government anticipates a potential need to (1) expand the number of laboratories serviced by SMILE during the course of the contract, and (2) enhance existing computer software systems to accommodate documents, similar to those managed by SMILE, received from other NIAID laboratory-supporting contracts. Increases in the level of 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 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 August 15, 2019. The requirement will be the delivery of 13.70 full time equivalents (FTEs) per year for the base period (Year 1) and 13.70 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: 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 10 Labs and the Option will be maintained for the life of the contract. If the Government elects to exercise this Option, the Contractor shall provide an additional 1.10 FTE per Option. 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 Level of Effort will not exceed the term of the Option year in which the Option is exercised. Increased Level of Effort for Additional Electronic Data Management System and Document Library services: During the course of the contract, additional specialized expertise may be needed to enhance existing computer software systems in order to accommodate documents, similar to those managed by SMILE, received from other NIAID laboratory-supporting resource. If the Government elects to exercise this Option, the Contractor shall provide an additional 0.75 FTEs with expertise in software development and administrative support. One (1) Option may be exercised in any year of the contract for a total of seven (7) Options during the life of the contract. Once an Option for the additional specialized expertise is exercised, it is the Government's intent to continue the support for the life of the contract. Other important considerations: The Respondent will be expected to maintain and host the existing computerized data management system and enhance it when necessary. Capability Statement/Information sought: Capability statements submitted as a result of this announcement should demonstrate the offeror's qualification, expertise and experience, specifically providing evidence as to the capability to perform this requirement, with particular attention to the following: 1.Reviewing laboratory audit reports to identify deficiencies in good clinical laboratory practices and providing laboratories with guidance for corrective action. 2.Monitoring laboratories ability to accurately and reliably perform tests used to diagnose viral, fungal, bacterial and parasitic infections, hematology and blood chemistry assays, liver function tests, and drug resistance assays. The contractor must have experience in reviewing and interpreting proficiency testing reports from providers such as the College of American Pathologists. 3.Providing assistance, guidance and training on procedures and Standard Operating Procedures related to laboratory qualify management, instrument and test validation, specimen management, data management, equipment maintenance, personnel safety, test QA/QC. The contractor must have experience with creating and utilizing training tools and must have staff able to travel to various laboratories outside the U.S. to provide training. 4.Maintaining and hosting an existing SMILE computerized data management system and document library to track and make available documents in support of activities performed under the contract. Further enhancement of the system may be necessary. The contractor must have the ability to maintain the computerized system security documentation as required by OMB Circular A-130, Appendix III and the Federal Information Security Management Act (FISMA). 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. 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 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; 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. 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 System for Award Management (SAM) located at https://www.sam.gov/index.html/#1. 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-18-006. 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., May 4, 2018. 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).
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