SOLICITATION NOTICE
A -- Patient Safety Monitoring In International Laboratories (SMILE)
- Notice Date
- 12/1/2011
- Notice Type
- Presolicitation
- 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
- RFP-NIAID-DAIDS-NIHAI2011-129
- Archive Date
- 12/30/2011
- Point of Contact
- Ashley Virts, Phone: 301-402-7084, John R. Manouelian, Phone: 301-496-0612
- E-Mail Address
-
virtsa@mail.nih.gov, manouelj@niaid.nih.gov
(virtsa@mail.nih.gov, manouelj@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of AIDS has a requirement for a comprehensive and uniform approach to evaluate initial and on-going laboratory capability and readiness to carry out NIAID-funded clinical trial protocols outside the U.S. NIAID places the highest priority on ensuring the safety and optimal management of subjects 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. Clinical laboratories in the U.S. are required to meet Clinical Laboratory Improvement Amendments (CLIA) performance standards and participate in a variety of external proficiency testing programs. Though non-U.S. accreditation organizations and providers of proficiency testing programs exist, these vary significantly in their requirements and level of oversight of clinical laboratories. The purpose of the Patient Safety Monitoring in International Laboratories (SMILE) contract is to provide a comprehensive and uniform approach to evaluate 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 (GCLP), (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 GCLP and/or proficiency testing, and (4) maintaining a computerized data management system and document library that include lab performance data and guidance documents. Currently, SMILE supports approximately 150 non-U.S. laboratories in 19 countries. SMILE will continue to support laboratories that are part of current and future NIAID-sponsored clinical trial networks (http://www.niaid.nih.gov/about/organization/daids/networks/pages/daidsnetworks.aspx). It is anticipated that a level of effort type contact will be awarded. The period of performance will be for one year beginning approximately November 15, 2012 through November 14, 2013. The requirement will be the delivery of 11.70 full time equivalents (FTEs) per year for the base period (Year 1) and 11.70 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 10 Labs. If the Government elects to exercise this Option, the Contractor shall provide an additional 0.65 FTE. Up to two (2) Options may be exercised in year 1, year 3, and/or year 5 for a total of 30 Options during the life of the contract. Once an Option for additional Labs is exercised, it is the Government's intent to continue the support for the life of the contract. Therefore, when an Option to extend the term of the contract is exercised, Options to extend the support for the Labs will also be 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. If the Government elects to exercise this Option, the Contractor shall provide an additional 1.25 FTEs with expertise in software development and 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. Therefore, when an Option to extend the terms of the contract is exercised, Options to extend support for the additional specialized expertise will also be exercised. Increased Expertise for Proficiency Testing Oversight Services: During the course of the contract, it may be necessary to acquire Proficiency Testing (PT) Oversight Services when commercial products are not available to monitor Lab proficiency in performing novel Protocol-specified tests (e.g., quantitative TB cultures). If the Government elects to exercise this Option, the Contractor shall provide an additional 2.55 FTEs. One (1) Option may be activated for the acquisition of proficiency testing services in any year of the contract for a total of seven (7) Options during the life of the contract. Once an Option for new PT oversight services is exercised, it is the Government's intent to continue the support for the life of the contract. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about December 15, 2011, and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIAID/RFP-NIAID-DAIDS-NIHAI2011-129/listing.html)
- Record
- SN02631790-W 20111203/111201234829-3ff025909fccc8d6bd9e82ef73f59a8a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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