SOLICITATION NOTICE
B -- Cortisol Saliva Analysis and Saliva Collection Supplies - Statement of Work
- Notice Date
- 3/31/2014
- Notice Type
- Presolicitation
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions-Treatment and Support Branch, Bldg 244, Room 112, Frederick, Maryland, 21702
- ZIP Code
- 21702
- Solicitation Number
- N02AT44410-11
- Archive Date
- 4/30/2014
- Point of Contact
- Brenda Oberholzer, Phone: 301-624-8750
- E-Mail Address
-
oberholzerb@mail.nih.gov
(oberholzerb@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Statement of Work General Information Title: Cortisol Saliva Analysis and Saliva Collection Supplies Document Type: Presolicitation Notice Solicitation Number: N02AT44410-11 Posted Date: 03/31/2014 Response Date: 04/15/2014 Classification Code: Q301 Laboratory Testing Services NAICS Code: 621511 Medical Laboratories Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, Riverside Five, Suite 400, Room 4032, 8490 Progress Drive, Frederick, MD 21701, UNITED STATES. A. Background In clinical protocol 14-AT-0054, we are measuring group differences in baseline salivary cortisol levels over time, as well as salivary cortisol levels in response to experimental tasks. Both measures are important for understanding hypothalamo-pituitary axis function in yoga practitioners versus control subjects. For this project, we will collect 35 saliva samples/person for the baseline cortisol measure and 7 saliva samples/person during the experimental task. We will be testing a maximum of 98 subjects, and therefore will collect and analyze up to a total of 4116 saliva samples. In the event that our primary outcome reaches significance before all 98 participants have been tested, we may terminate the study early. The services herein are being procured in accordance with the simplified acquisition procedures as authorized by FAR Part 13.106-1 (b)(1). The North American Industry Classification System code is 621511 and the business size standard is $30 million. The National Center of Complementary and Alternative Medicine (NCCAM) is anticipating to award a firm-fixed price competitive purchase order for the necessary supplies and cortisol saliva analysis of 4,116 samples over a two-year period. Period of Performance shall be 24 months from date of award (est. 05/15/2014-05/14/2016). B. Purpose and Objectives of the Procurement Provide a source of clinical grade supplies and equipment and provide a qualified testing facility capable of analyzing a large volume of samples (4,116) over a period of 2 years while maintaining a high level of accuracy in testing and reliable and repeatable analysis. The contractor shall be required to; 1. Provide supplies (swabs, storage tubes with coded labels, cryogenic storage boxes and dry-ice shipment boxes). Swabs are preferred over passive drool sampling as the latter often leads to under-sampling and inaccuracies. Passive sampling is particularly problematic when the samples are acquired at home, like most of the samples in the current study, as the researcher cannot correct the participant if under-sampling has occurred. 2. Be able to perform testing on samples received in multiple shipments, as the samples can be altered if frozen for long periods of time. Saliva samples will be stored at the NIH in -80 C freezers. Collection tubes can only survive in the freezer for 6 months, therefore it is extremely important that we have flexibility in how many samples we can send for out testing services at a time. 3. Provide the highest accuracy in testing: Cortisol is assayed using a highly sensitive enzyme immunoassay and the samples should be assayed in duplicate for at least part of the sampling to determine accuracy. We need the samples tested at least to include 85% singlet testing and 15% in duplicate testing (i.e. two test results per sample), (see attached Granger paper, Incorporating Salivary Biomarkers Into Nursing Research: An Overview and Review of Best Practices). We need the company to provide an average intra-assay coefficient of variation <5%, and because testing of 4,116 samples will require numerous assays, we need the company to provide an average inter-assay coefficient of variation <6%. The higher the coefficients the less accurate the testing. 4. Provide a CLIA (Clinical Laboratory Improvement Amendments) certified testing facility. U.S. regulations created to provide quality standards for laboratory testing to ensure accuracy, reliability and timeliness of test results. C. Contractor Requirements To be deemed capable of providing the current need the organization must submit a written tailored capability statement. Organizations that submit capability statements in response to this notice will be evaluated against the following technical areas of experience and expertise: Personnel/Experience: a. Proven organizational and past experience in salivary cortisol analysis. b. The organization shall provide the name of the Principal Investigator, his/her professional qualifications and specific experience as a key investigator in cortisol saliva analysis. c. The organization shall demonstrate that the proposed team and staff have previous successful experience in carrying out the requirements of the services stated herein. Facilities: Adequacy of facilities for performing the Statement of Work. The organization shall provide evidence of CLIA certification and testing accuracy standards. 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 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. This is not a solicitation for competitive quotations. However, if any interested party believes they can meet the above requirement, they may submit a statement of capabilities. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. An original and one copy of the capability statement must be received in the NCI Office of Acquisitions on or before 12:00 PM EST on April 15, 2014. No electronic capability statements will be accepted (i.e. email or fax). An original and one copy must be sent to the NCI Office of Acquisitions at the address stated above. All questions must be in writing and can be emailed to Brenda Oberholzer, Contracting Officer, at oberholzerb@mail.nih.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must have valid registration and certification, and reps and certs in the System for Award Management (www.sam.gov). No collect calls will be accepted. Please reference solicitation number N02AT44410-11 on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF2/N02AT44410-11/listing.html)
- Place of Performance
- Address: TBD, United States
- Record
- SN03324820-W 20140402/140331234639-9a4bfa58629b72defc83758118856402 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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