PWS_metabolic_profiling_Elsasser.docx

United States Department of Agriculture

Research, Education, and Economics Agricultural Research Service

PERFORMANCE WORK STATEMENT

PREPARED BY

U.S DEPARTMENT OF AGRICULTURE (USDA)

AGRICULTURAL RESEARCH SERVICES (ARS)

(ABBL)

FOR

METABOLOMIC ANALYSES SERVICES

SECTION 1 –GENERAL INFORMATION

segments of the gastrointestinal tract be analyzed on a quantitative as well as a qualitative basis for the types, classes and functionality of the different types of nutrients present in these samples representing these different GIT areas. There are thousands of possible metabolites present in the gut and these need to be identified through the use of mass spectroscopy and gas chromatography. Larger generalizations about metabolic processes as well as these host – microbe interactions can be distilled out of this complex data by subjecting the data to forest analysis as well as specific statistical rubrics that facilitate metabolite grouping via metabolic profiling. Most specifically, the data need to be able to very accurately evaluate the nature of the fatty acid profiles in the metabolite milieu.

1.3 QUALITY ASSURANCE

In accordance with the Inspection of Services clause [FAR Clause 52.246-4, Inspection of Services –Fixed Price (AUG 1996). The Government will inspect and evaluate the Contractor’s performance to ensure services are received in accordance with the requirements set forth in this contract. The Government Point of Contact may inspect actual task performance, physically checking an attribute of the task, checking a report, investigating customer complaint or otherwise inspecting the task or its results to determine whether or not performance meets the standards contained in this PWS. The Government Point of Contact will use the Contractor’s work schedule or modified version thereof, to record surveillance results. Results of surveillance then become the official USNA record of the Contractor’s performance. When a performance threshold has not been met or Contractor performance has not been accomplished, the Government Point of Contact will initiate and provide the Contracting Officer a Corrective Action Report (CAR) for issuance to the Contractor. The contractor shall respond to the CAR instructions provided and return it to the Government Point of Contact and the Contracting Officer within 10 days of receipt.

1.3-1 SURVEILLANCE METHOD(S):

· 100% SURVEILLANCE; This method requires the Government to inspect the service each time it occurs. Results shall be annotated on the inspection schedule. Any deficiency shall be documented and the Contractor shall re-perform service immediately, if appropriate, or within a reasonable time period at no increase in contract amount. Any unsatisfactory inspection identified but re-performed acceptably shall still be counted as an unsatisfactory inspection for trending purposes. Receiving two or more unsatisfactory 100% surveillances within a 12 month period may result in unsatisfactory past performance documentation.

· RANDOM SAMPLING; Random sampling is an appropriate method for frequently recurring tasks. The Government Point of Contact will evaluate randomly selected samples of the activity to determine the acceptability of the entire requirement. Any unsatisfactory inspection (defect) result shall be recorded, and the Contractor shall re-perform the service after notification by the Government Point of Contact. Failure to meet performance in any one month period as outlined in the Performance Summary-Technical Exhibit 1 shall result in a warning or letter of concern from the Contracting Officer. Failure to meet performance in any combination for any two, or more consecutive or no-consecutive months during the contract period shall constitute an immediate Progress Meeting with the designated Government Point of Contact and the Contracting Officer. All remedies shall be in accordance with the contract terms and conditions.

· CUSTOMER COMPLAINTS; The Government Point of Contact will receive and investigate complaints and will be responsible for initially validating customer complaints. The Contracting Officer shall make the final determination of the validity of customer compliant(s) in cases of disagreement with the Government Point of Contact and the Contractor. Exceeding the performance threshold in any one (1) month period shall result in a warning or letter of concern from the Contracting Officer. Exceeding the performance threshold for any two (2) or more consecutive or non-consecutive months during a contract period shall constitute an immediate Progress Meeting with the designated Government Point of Contact and the Contracting Officer. All remedies shall be in accordance with the contract terms and conditions.

· PERIODIC SURVEILLANCES; This method requires the Government to employ a “spot check” style of evaluation based on the Contractor’s schedule. Periodic surveillances will be conducted on a scheduled basis (daily, weekly, monthly, quarterly, semi-annual or annually) and may be adjusted, based on quality trends. Any unsatisfactory inspection (defect) result shall be recorded, and the Contractor shall re-perform the service after notification by the Government Point of Contact. Failure to meet performance in any one month period as outlined in the Performance Summary-Technical Exhibit 1 shall result in a warning or letter of concern from the Contracting Officer. Failure to meet performance in any combination for any two, or more consecutive or no-consecutive months during the contract period shall constitute an immediate Progress Meeting with the designated Government Point of Contact and the Contracting Officer. All remedies shall be in accordance with the contract terms and conditions.

1.4 PERIOD OF PERFORMANCE – One year from date of award.

SECTION 2 – SPECIFIC TASK

Research in the ABBL requires a full metabolic profile of tissue and gut contents samples capable of generating an association map of metabolic pathway components as a function of treatment groupings that can further be analyzed for establishing differences in nutrient biomarkers representative of novel and desirable health traits in chickens. Specifically, the need is to analyze samples of digesta, gut cell scrapings and liver via mass spectroscopy and gas and liquid chromatography and identify the types and concentrations/relative abundance of metabolites present in the samples as obtained from the duodenum, ileum, cecum, and liver as well as gut digesta. From these data, bio-infomatic association and metabolic profiling maps are to be generated as a function of treatment effects and statistical comparisons derived by statistical association algorithms. The work needs to be performed with an error rate of less than 5% in order that the nature of the biological effects be able to be concluded from the data with 95% assurance.

2.0 PERFORMANCE REQUIREMENTS – Contractor shall provide the following

· Provide all labor and materials to perform analyses of samples within specified time frames.

· Submit report to designated Government point of contact within 7 business days after service.

SECTION 3 – DEVLIVERABLES AND DELIVERY SECHDULE

All deliverable products shall be submitted in [state desired format] for the government point of contact’s review and comment.

3.1 DELIVERY SCHEDULE

The ABBL will deliver to the analytical company the needed samples of cell scrapings, tissues and digesta, correctly labeled and identified and preweighed at the time of collection. The samples will be accompanied by a file identifying each sample and the exact wet weight of the sammple at the time of collection.

TECHNICAL EXHIBIT 1

Method of Surveillance

AQL: 98%

Marker quality control samples as blinded samples in triplicate will be added to the total samples sent; the coefficient of variation between these samples must be <5% Random Sampling

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