SOURCES SOUGHT
A -- Patient Safety Monitoring in International Laboratories (SMILE)
- Notice Date
- 9/7/2011
- 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
- HHS-NIH-NIAID(AI)-SBSS-11-129
- Archive Date
- 10/6/2011
- Point of Contact
- Ashlety Virts, Phone: 301-402-7084, John Manouelian,
- E-Mail Address
-
virtsa@niaid.nih.gov, manouelj@niaid.nih.gov
(virtsa@niaid.nih.gov, manouelj@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction This notice is for information and planning purposes only. This is not a request for proposal and does not commit the government to award a contract now or in the future. No solicitation is available at this time. Based on capability statements received in response to this sources sought announcement, this acquisition may be solicited as a 100% small business set-aside. All small business organizations (sb, sdb, wosb, hubzone, vosb, and sdvosb) are encouraged to respond to this notice. Small business organizations must have their size status certified by the Small Business Administration. All small businesses are encouraged to respond. The NAICS code is 541712 with a size standard of 500 employees. 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. 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. Purpose and Objectives 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. The initial Patient Safety Monitoring in International Laboratories (SMILE) contract was awarded to Johns Hopkins University, Baltimore, MD on November 16, 2004 for a period of seven years. 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 ). The Government anticipates a potential need to (1) expand the number of laboratories serviced by SMILE during the course of the contract, (2) enhance existing computer software systems, and (3) acquire proficiency testing oversight services when commercial proficiency testing materials are not available. 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 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 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. 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. 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. 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 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, drug resistance assays, histopathology and cytopathology. 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 development 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 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, September 21, 2011. 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 Ashley Virts, Contract Specialist. She 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-11-129. 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: Ashley Virts Email Address: virtsa@niaid.nih.gov Contracting Officer: John R. Manouelian Email Address: manouelj@niaid.nih.gov
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