SOURCES SOUGHT
Q -- Thyroid Profile Analysis for NHANES 2018-2023 - Draft Statement of Work
- Notice Date
- 9/10/2018
- 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
- CDC-2019-26148-SBSS-EDS
- Archive Date
- 10/9/2018
- Point of Contact
- Eric D. Sullivan, Phone: 4123865290
- E-Mail Address
-
lrv4@cdc.gov
(lrv4@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- Draft Statement of Work for NHANES Thyroid Profile Requirement 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 measure thyroid profiles from biologic samples collected at the NHANES mobile examination center (MEC), and develop a laboratory procedure manual in accordance with the Statement of Work. 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 minimum qualifications that a laboratory will have to meet to be considered as capable of successfully performing this work. Capability submittals must document the following qualifications: 1.The laboratory has in place CLIA-compliant processes for tracking receipt and processing of NHANES samples from receipt in the lab, to output of the analysis product which includes the date of receipt, date of analysis, run/batch number, and the technician who completed these tasks. 2.The ability to analyze a thyroid profile (TP) to include eight measurements using current industry standard immunoassays for total and free thyroxine (T3), total and free triiodothyronine (T4), thyroglobulin, thyroglobulin antibodies, thyroid peroxidase antibodies, and thyroid stimulating hormone. Thyroid profile assays must be FDA-approved or FDA-cleared, current, stable, and available. 3.Provide documentation that verifies performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1) accuracy; (2) precision; (3) the reportable range of test results; and (4) the manufacturer's reference intervals (normal values) for each of the eight analytes requested in this thyroid profile requirement. 4.The laboratory has in place a storage facility (-70 degrees C for sera) for samples upon receipt and to store for at least one year any excess sera specimen remaining in vials after analyzing the samples. 5.Provide acceptable alternative methods or analytical test systems (backup instrumentation) and recommended storage conditions including optimal and maximum storage time for sample retention. 6. 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. 7.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. 8.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. 9.Proof of Clinical Laboratory Improvement Amendment (CLIA) certification and ability to 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 $32.5 M. - Point(s) of contact - Emails for contacts - Telephone numbers for contacts Response Due Date. Submit information regarding the above to Eric D. Sullivan, Contracting Officer via email at LRV4@cdc.gov and Reference: CDC-2019-26148-SBSS-EDS. Responses are due no later than 3:00 PM Eastern Time on September 24, 2018. Responses must be submitted via email addressed to LRV4@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/CDC-2019-26148-SBSS-EDS/listing.html)
- Record
- SN05081645-W 20180912/180910231535-b47dc006ea36efc8af68fe15599c584c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |