MODIFICATION
68 -- LRN Proficiency Testing Program Vendor Procurement
- Notice Date
- 12/4/2012
- Notice Type
- Modification/Amendment
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2013-54091
- Archive Date
- 1/4/2013
- Point of Contact
- Maria S Shamburger,
- E-Mail Address
-
HEG9@cdc.gov
(HEG9@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- LRN Proficiency Testing Program Vendor Procurement Laboratory Preparedness and Response Branch(LRN), Division of Preparedness and Emerging Infections Background: This is a SOURCES SOUGHT NOTICE to determine the availability of potential small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) in accordance with FAR 7.104(d). The potential small business will need to demonstrate the ability to produce and distribute samples for a limited number of LRN Proficiency Testing challenges for biological threat agents to prepare clinical samples to be used for validation of LRN assays. History: The Laboratory Response Network (LRN) was established by the Department of Health and Human Services, Centers for Disease Control and Prevention (CDC) in accordance with Presidential Decision Directive 39, which outlined national anti-terrorism policies and assigned specific missions to federal departments and agencies. The LRN's mission is to maintain an integrated national and international network of laboratories that can respond to acts of biological or chemical terrorism and other public health emergencies. The biological component of the Laboratory Response Network (LRN) is managed by the LRN program office in the Laboratory Preparedness and Response Branch (LPRB), Division of Preparedness and Emerging Infections (DPEI), National Center for Zoonotic and Emerging Infectious Diseases (NCEZID), Office of Infectious Diseases (OID), Centers for Disease Control and Prevention. In order to ensure preparedness and competency with LRN procedures, LRN Member Laboratories must participate in the Proficiency Testing (PT) Program provided by LPRB. The LRN PT Program is designed to simulate real-world scenarios involving potential bioterrorism agents; requiring the preparation, packaging, and distribution of prepared biological samples in a variety of sample matrices. LRN PT challenges are distributed one to four times a year to as many as 200 LRN member laboratories. In addition, the LRN program also provides opportunities for laboratories to exercise capabilities, capacities, and testing policies through simulated exercises involving samples spoke with biological threat agents. Futhermore, LRN assays undergo a rigorous validation process and large numbers of clinical samples (positive and negative) will need to be created to support this project. The LPRB does not have the capacity or production capabilities to produce sufficient sample quantities to meet LRN PT Challenge, exercise or validation sample requirements. Describe the work: NAICS Code 541990 All Other Professional, Scientific, and Technical Services. Production of samples for PT Challenges and exercises involves the spiking of designated environmental or clinical matrices with agents of bioterrorism, including bacteria, viruses, and toxins. Each Challenge panel contains no more than five samples and production of as many as 200 panels may be required for a PT Challenge. Each panel may contain up to 3 agents. In addition, twenty percent of the panels produced must be stored by the vendor for shipment as remediation up to 6 months after the initial PT Challenge. Vendor is responsible for shipping PT panels to participating laboratories as directed by individual task orders issued under this contract. Exercises may involve production of a large volume of samples and shipping to one or multi laboratories for testing. Samples we generally be a mix of 30% positive and 70% negative. The same biological threat agents could be spiked into clinical or environmental matrices. The range of samples needed for exercise is unknown but could be anywhere from 200-2000. Preparation of clinical samples to be used in multi-center validation studies includes procurement or fabrication of clinical samples. Some of these samples will then be spiked with agents of bioterrorism, including bacteria, viruses, and toxins. Up to 300 samples per clinical sample type may be needed. Vendor is responsible for shipping PT panels, exercise samples and clinical samples for multi-center studies to participating laboratories as directed by individual task orders issued under this contract. The contract will include the following requirements: • Sign and abide by nondisclosure agreement provided by the CDC to protect sensitivity of LRN member information, agent and testing capabilities. • Provide verification that all personnel working under this contract have passed a background check equivalent to the clearance required for Select Agent certification • Abide by all relevant federal regulations • Follow safety practices for the manipulation of biological agents as outlined in the Biosafety in Microbiological and Biomedical Laboratories, 5th ed., published by the CDC, HHS, NIH • Maintain Select Agent Certification and allow only those personnel included on the Select Agent permit to participate in LRN PT Program sample and panel or Clinical sample production • Provide all raw materials, excluding biological agents, as instructed by the LPRB, for PT panel, exercise or clinical sample production • Provide all packaging materials for shipment • Package and ship PT Challenge panels, exercise samples and clinical samples to LRN Member Laboratories, nationally and potentially internationally, on date specified by the LPRB Program Officer at specified temperature (e.g. frozen, room temperature) following all shipping regulations (HHS - Select Agent Regulations 42 CFR Part 73, DOC - Export Administration Regulations 15 CFR Parts 730-744, IATA Regulations, and DOT Regulations) • Culture and propagate biological agent samples provided by the LPRB • Spike designated matrices or Clinical samples with appropriate biological agents at concentrations defined by LPRB • Produce number of panels for PT challenge, exercise or Clinical samples as directed by LPRB and store until designated ship date. • Ship sample panels to the LPRB QC Laboratory or other appointed laboratory at designated points during production for Quality Control (QC) testing • Reproduce PT Challenge, exercsise or Clinical samples or panels that do not pass QC testing as instructed by LPRB • Store 20% of PT panels produced as directed by LPRB for up to 6 months after initial PT Challenge shipment • Ship panels, exercise or Clinical samples as directed by LPRB to national labs for receipt next business day • Maintain a Quality System throughout all production steps List Contractor Requirements: Contractors must respond to all the following points, by indicating your experience and ability to provide: (1) Biosafety level 3 facilities (2) Clinical Laboratory Improvement Amendments (CLIA) certification (3) ISO 9001 certification (4) Select Agent registration Interested parties having the capabilities necessary to perform the stated requirements may submit capability statements via email to Maria Shamburger, Contracting Specialist, heg9@cdc.gov. CAPABILITY STATEMENTS MUST DEMONSTRATE THE MINIMUM REQUIREMENTS OUTLINED ABOVE. Please address each in order listed above. Teaming Arrangements: All teaming arrangements shall include the above-cited information and certifications for each entity on the proposed team. Teaming arrangements are encouraged. Responses must be submitted not later than (12/20/2012) Capability statements will not be returned and will not be accepted after the due date. This is not an invitation for bid, request for proposal or other solicitation and in no way obligates the CDC to award a contract. The sole intent of this Sources Sought Notice is to obtain capabilities for set-aside and procurement planning purposes. Please provide the follow Business information: 1. DUNS Number 2. Company Name 3. Company Address. 4. Company Point of Contact, phone number and email address 5. Type of company under NAICS, as validated via the Central Contractor Registration (CCR). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the CCR located at http://www.ccr.gov/index.asp. 6. Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); 7. Current GSA Schedules appropriate to this Sources Sought 8. Current Government Wide Agency Contracts (GWACs) 9. Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses. 10. Responders should also include a statement about whether or not they have an approved Federal audited accounting system. If the responder has an approved accounting system, please provide the certification in which the accounting system was deemed adequate (e.g. the name of the audit agency and audit number). You may submit as an attachment, which will not count towards the overall page limit. All capability statements can be submitted via e-mail, facsimile, or regular mail to the point of contact listed below. Responses shall be limited to 5 pages. Responses must be submitted no later than 12/20/2012. Documentation should be sent to: Maria Shamburger, Contract Specialist 2920 Brandywine Road, Mailstop K14 Atlanta, Ga 30341 or Heg9@cdc.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2013-54091/listing.html)
- Place of Performance
- Address: Contractor's facility, United States
- Record
- SN02942315-W 20121206/121204235523-8ea8e127b0ab0cfa735992bafd027411 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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