SOURCES_SOUGHT_SYNOPSIS_final_1.docx

SOURCES SOUGHT SYNOPSIS

Synopsis:

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: (1) the availability and capability of qualified small business sources: (2) whether they are small businesses; service-disabled veteran owned small businesses; woman-owned small businesses; 8(a) small businesses; veteran owned small businesses; HUBZone small businesses; woman owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your 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. This requirement is assigned a code of 541715 in the NAICS, and the small business size standard for such requirements is 1,000 employees or less.

Background:

The goal is to seek to obtain the services of a biomedical laboratory to provide validated, clinical analyses of biospecimens as well as to modify and/or develop new analyses as needed to measure biological specimens collected as part of the Division’s intramural and collaborative research activities. It is anticipated that the resultant contract will be an Indefinite Delivery Indefinite Quantity (IDIQ) type contract.

Potential sources must demonstrate and document experience of both the oversight of receiving and maintaining a large number (typically on average about 1,000) of specimens including blood (plasma, serum, WBC, etc.), urine, saliva, adipose tissue, follicular fluid, seminal fluid, and other biologic material relevant for specific research initiatives in addition to conducting analysis including but not limited to: Measurement of inflammatory markers (e.g. isoprostanes, leukotrienes), DNA extraction from whole blood, DNA extraction from pre-washed newborn blood spots, DHEA, DHEAS, and cortisol, Female and male reproductive hormones including estrogen, progesterone, luteinizing hormone, follicle-stimulating hormone, testosterone, serum hormone binding globulin, inhibin-B, estradiol, anti-mullerian hormone, and gluconated metabolites of the above where appropriate C-reactive protein, Markers of angiogenesis including soluble fms-like tyrosine kinase 1 (sFlt-1), placental growth factor, and soluble endoglin, Markers of adipogenesis, lipolysis, and lipogenesis including lipid and fatty acid profiles, C1q/TNF-related proteins (CTRPs 1, 3, 5, 6, 7, 9, and 15), adiponectin, high molecular weight adiponectin, leptin, soluble leptin receptor, vaspin, omentin-1, triglycerides, HDL, LDL, VLDL, and total cholesterol, Measurements of glucose metabolism including HbA1c, C-peptide, insulin, and glucose, Measurements of renal function including creatinine, urea nitrogen, cystatin-C, and the urine albumin to creatinine ratio (ACR), Antioxidants, including ascorbic acid, tocopherols, and carotenoids, Measurement of thyroid function including thyroid stimulating hormone, triiodothyronine free (FT3), thyroxine free (FT4), and thyroid peroxidase antibodies (TPO-Ab), Pro- and anti-inflammatory cytokines, Vitamins including 25-(OH) Vitamin D2 and D3, Vitamin B6 and B12, Other biomarkers including ferritin, transferrin receptor, hepcidin, insulin-like growth factor and binding proteins, uric acid, F2 isoprostanes, acylcarnities, and amino acids, LC/MS measurement of caffeine, theobromine, and paraxanthine, Quantification of semen parameters including but not limited to motility, morphology, and DNA fragmentation, Whole exome and targeted sequencing using DNA isolated from buffy coat and serum, RNA isolation and expression array analysis, and DNA extraction from rectal swabs and microbiome analysis

Requirements:

To be deemed capable of performing this requirement, the potential offerors must submit a capability statement that clearly demonstrates their experience and ability to provide the following capabilities:

1. Documentation of CLIA (Clinical Laboratory Improvement Amendments 1988) certification and a CLIA-approved proficiency testing program in accordance with 42CFR part 493 as amended, should such certification exist for the above listed analytes.

2. Documentation of capability and previous experience preforming the assays noted above.

3. An understanding of adherence to Federal regulations pertaining to human research, and requirements for security and confidentiality of research records, as documented by reporting to a responsible IRB.

4. Documentation illustrating soundness of procedures for measurement of specific standards for quality assurance and quality control, including proficiency testing and application of Westgard rules violations.

5. Experience and expertise of a doctoral - level laboratory scientist as evidenced by peer review publications, which demonstrate active participation of research closely related to the assays described above, particularly those relevant to human health.

6. Demonstrated relevant qualifications and experience of key research staff in successfully conducting all analyses.

7. Documentation of the ability to process, handle, and track shipments of human biospecimens that are stored in bar-coded vials.

Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. The Government reserves the right to use information provided by the 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.

Confidentiality: Any proprietary information included must be marked as such.

Responses: Small businesses that believe they possess the capabilities necessary to undertake this project should send an electronic copy of their capability statement addressing the listed areas above. Please state clearly in the subject line of the email that it is in response to 75N94022R00006. Please limit responses to no more than 15 pages, exclusive of resumes. Electronic capability statements should be received by the Contracting Officer no later than 2:00 PM Eastern time on February 25, 2022. Capability statements must identify the small business of their organization. No phone calls will be accepted. Respondents must submit their capability statement via electronic submission only.

Information submitted must be pertinent and specific in the technical areas under consideration, on each of the following qualifications (1) Experience: an outline of previous projects, specific work previously performed or being performed and any in house research and development effort; (2) Personnel: Name, professional qualifications and specific experience of scientist, and technical personnel who may be assigned as a principal investigator and/or project officer; (3) Facilities: Availability and description of facilities required to perform the work. Any other specific and pertinent information as it pertains to this area of procurement that would enhance our consideration and evaluation of the information submitted.

The designated NAICS code for this effort is 541715 and the size standard is 1,000 employees or less. Please send your capability statement to the attention of Megan Gnall at megan.gnall@nih.gov and Ty Main at ty.main@nih.gov