attach 1_assay biomarkers_sow.docx

Attachment 1: Statement Of Work

STATEMENT OF WORK

Assay Serum Biomarkers for Clinical chemistry panel in West Africans

Background:

National Human Genome Research Institute (NHGRI)/Division of Intramural Research (DIR)/Metabolic, Cardiovascular and Inflammatory Disease Genomics Branch. The mission of the Center for Research on Genomics and Global Health (CRGGH) is to advance research into the role of culture, lifestyle, genetics and genomics in health disparities. The CRGGH will develop genetic epidemiology models and conduct population genetics research that explores the patterns and determinants of common complex diseases, such as Type 2 Diabetes, hypertension and obesity in the US, Africa and China. The CRGGH will give particular thought to ways in which scientists’ document and describe the non-random pattern of human genetic variation and its link to disease risks in different populations.

CRGGH has ongoing large-scale genetic epidemiology studies globally. As part of these studies CRGGH lab continuously accrue new serological samples from Nigeria. In continuity with the previous research work, samples are assayed by the same analysis pipeline to ensure accuracy and comparability of the results across data sets.

Purpose:

The purpose of the procurement is to carry out biochemical assays that include key markers mainly fasting glucose, sodium, chloride, potassium, triglycerides, HDL-C, LDL-C, Total cholesterol, albumin, urea (BUN), cortisol, creatinine, AST, ALTL, ALPL, total bilirubin, uric acid, insulin, fructosamine, hsCRP. These markers are necessary not only to properly characterize the samples in our studies but also to serve as defined quantitative phenotypes in the studies conducted by the center. One of the center’s objectives is to understand the association between these clinical biomarkers and genetic variations. In order to fulfill the later objective, the center must have an accurate measurement of the biomarkers by using techniques and methods clinically validated.

Period of Performance:

Contractor Requirements:

1. The Contractor Study Set-Up includes:

· Preparation of a study specific database; and

· Review of testing and requirements by clinical pathologist.

2. The Contractor shall provide Logistic Support:

· Tracking of samples in transit.

3. The Contractor shall provide Clinical Lab Testing:

· Analysis of the requested tests under stringent quality control (Measurement serum level of biomarkers (fasting glucose, triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol, hs-CRP, sodium, chloride, potassium, albumin, fructosamine, BUN, uric acid, insulin, creatinine, cortisol, AST, ALTL, ALPL, and total bilirubin); and

· Flagging and reporting out-of-range values to CRGGH.

4. The contractor shall return remaining samples to CRGGH on dry-ice after completion of testing.

Government Requirements:

· The Government will ship samples to the Contractor in IATA650 compliant shipping materials with dry-ice to maintain sample integrity.

· The Government samples will be stored on site of the Contractor at -20 degrees Celsius until testing and for a period of 6 months after testing should retesting be required.

· The Government will adhere to clinical testing, well-conserved specimens are required.

· The Government will ensure serum or plasma samples should be frozen after separation from the whole blood and kept frozen during transportation. Conventionally, anti-coagulated peripheral blood collected in EDTA, Na-Citrate, or Heparin-containing vacutainers are the sources of serum or plasma.

Government Responsibilities:

· The contractor shall provide all results to the NIH will be provided to the NIH (CRGGH) via data transfer upon completion of testing.

· The Government will not provide government furnished equipment to perform the study.

· The Government will provide samples and associate sample documentation (sample ID numbers, descriptions) is provided to the Contractor. Government authorized personnel will be required to review the label information prior to finalization.

· The Government will review and enter receiving for invoices.

Reporting Requirements and Deliverables:

The deliverable from the Contractor is to provide a database containing all the measured biomarkers. The Contractor can provide the following reports, upon request or using a predetermined scheduled from CRGGH:

· Sample inventory reports (database);

· Shipping reports;

· Receiving reports;

· Invoices;

· Upload electronical data manifest; and

· Result transmission to CRGGH via email and excel spreadsheets.

Inspection and Acceptance Requirements:

Thawed samples will be reported to the NIH and tested:

· Sample runs are accepted based on Quality Control checks;

· If re-testing is required it will be communicated to the NIH; and

· Final results to be inspected/accepted by the NIH (namely by CRGGH Data Manager and Staff scientist).

FAR 52.217-8 Option to Extend the Services:

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 1 Day.

FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000):

(a)The Government may extend the term of this contract by written notice to the Contractor within 1 day provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 1 day before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed three years.