SOURCES SOUGHT
Q -- Lab Services for QFT Gold Plus Assay for NHANES - Draft Statement of Work
- Notice Date
- 9/6/2018
- Notice Type
- Sources Sought
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Acquisition and Assistance Field Branch (Pittsburgh), Post Office Box 18070, Cochrans Mill Road, Pittsburgh, Pennsylvania, 15236-0070
- ZIP Code
- 15236-0070
- Solicitation Number
- HHS-CDC-NCHS(FB)-SBSS-19-001
- Archive Date
- 9/24/2018
- Point of Contact
- Florence P Black,
- E-Mail Address
-
fpblack@cdc.gov
(fpblack@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- Draft Statement of Work for Laboratory Services to measure infection with Mycobacterium tuberculosis by QuantiFERON-TB Gold Plus assay from samples collected at NHANES mobile examination centers. 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 the availability and capability of all qualified sources to perform a potential requirement. The Centers for Disease Control and Prevention (CDC), National Center for Health Statistics (NCHS) seeks to contract with a CLIA - certified laboratory to obtain laboratory to indirectly measure infection with Mycobacterium tuberculosis by QuantiFERON-TB Gold Plus (QFT Gold Plus) assay from Qiagen from biologic samples collected at the NHANES mobile examination center (MEC). Blood samples are collected from participants ages 6 years and older, and this test will be measured on all participants in all sessions. The contractor will also develop a laboratory procedures manual. The contractor shall provide all labor, equipment, supplies, services, permits, and licenses necessary to perform these measurements and develop the manual. The attached draft statement of work (SOW) contains more details about the work. 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 NAICS code 621511 for the potential acquisition. 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. Additionally, organizations submitting information must have an active registration in the System for Award Management (SAM). Anticipated period of performance is 56 months. Capability statement /information sought. Respondents believing that they possess the expertise and experience to meet the government's needs described in the SOW are invited to submit technical and management capabilities addressing those requirements. These may include but are not limited to: (a) staff expertise, including staff availability, experience, and formal and other training and (b) examples of prior completed Government contracts, references, and other related information. Below are the six (6) minimum qualifications that a laboratory will have to meet to be considered as potentially capable of successfully performing this work. Capability submittals must document these qualifications. 1) The laboratory shall have applicable knowledge and at least 3 years' combined experience measuring and reporting results of infection with Mycobacterium tuberculosis by the QuantiFERON TB Gold (QFT Gold) ( discontinued in July 2018), and the new QuantiFERON TB Gold Plus (QFT Gold Plus) assay test. Offerors must use the FDA-approved QFT Gold Plus assay as approved and intended. Offerors shall provide documentation that verifies performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1) accuracy; (2) precision; and (3) the reportable range of test results. 2) The laboratory must show experience handling large numbers of samples each week. The requirement to transmit the results to NCHS within 3 weeks of receipt of the samples requires a high throughput. 3) The laboratory must have systems for receiving, analyzing, storing, and transmitting data, and a secure location and space available for performance of the contract analyses. The description will include the capability of transmitting data in a computer readable and secure format for electronic transmission. A secure transmission format is required since maintaining the confidentiality of participant data is critical. 4) All NHANES TB laboratory data must be comparable throughout the survey. This will be assessed by reviewing the quality control data. The contractor shall utilize QFT Gold Plus Analysis Software or other applicable spreadsheet program, such as Microsoft® Excel®, to determine the standard curve and sample IU/mL values to calculate and report quality control parameters. 5) The laboratory must be enrolled in a proficiency-testing program through independent laboratories such as the College of American Pathologists (CAP) or a comparable program, and be able and willing to report the results of the proficiency testing to the COR in the quarterly reports. 6) The laboratory must provide proof of Clinical Laboratory Improvement Amendment (CLIA) certification and maintain CLIA certification throughout the life of the contract. Additionally, a respondent must include in its capability statement: - Organization name, - Address, - DUNS number, - Business size and Classification (e.g., 8(a), HUBZone, etc.) pursuant to the applicable NAICS code of 621511 with a size standard of $35.5 M. - Points of contact, - Emails for contacts, - Telephone numbers for contacts. Response Due Date. Submit information above to Florence P. Black, Contract Specialist -Contractor, CDC- OFR - OAS, 626 Cochrans Mill Road, Pittsburgh, PA 15236, and Reference: HHS-CDC-NCHS(FB)-SBSS-19-001. Responses are due no later than 1:00 PM, September 20, 2018, Eastern Time. Responses must be submitted via email addressed to fpblack@cdc.gov. Any information received by the government will not be returned. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response to this notice. 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/CMBP/HHS-CDC-NCHS(FB)-SBSS-19-001/listing.html)
- Place of Performance
- Address: Contractor's facility, United States
- Record
- SN05076508-W 20180908/180906232316-645c7da5b4c34d5fecc936ade72c5246 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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