Lab Reaserch Asistant Support Services

Statement of Work
Research Assistant Support
CDC/NCHHSTP/DHAP/Lab Branch

I PROJECT IDENTIFICATION AND PURPOSE

Effective and efficient diagnosis of HIV infection is a cornerstone of HIV prevention strategies. The DHAP Laboratory Branch has developed new assays for HIV diagnosis and incidence testing both independently and in collaboration with test manufacturers. Furthermore, the Laboratory branch has collaborated both within CDC and with external partners to evaluate new diagnostic/incidence technology currently in the pipeline for FDA approval (diagnostics assays) or implementation for HIV surveillance (incidence assays). The purpose of this project is to continue this work with new protocols and technology.

II SCOPE OF WORK

An experienced research assistant support is needed to perform the following tasks:

1. Process, catalogue and store human biological specimens including whole blood, serum, plasma and dried blood spots to be used for diagnostic assays.
2. Explore alternative storage options for human biological specimens that eliminate the need for costly freezer storage and also maintain sample integrity.
3. Perform a variety of serologic diagnostic assays including multi-analyte Bio-plex assays, EIAs, and rapid tests to evaluate test performance.
4. Construct and perform quality assurance of in house developed rapid HIV tests for diagnosis or incidence determination.
5. Perform HIV Viral load assays such as the Roche or Abbott real-time assays.
6. Calibrate and maintain laboratory instruments and equipment and documents for QMS related activities.
7. Maintain experiment records, prepare and present oral and written reports within CDC, and help prepare results for manuscripts and presentations.
The contractor key personnel must be very enthusiastic and have the appropriate technical expertise in the biological sciences to greatly enhance our investigations related to HIV diagnostic and incidence research. The key personnel is expected to have:
• A minimum of 2 years of laboratory experience working with HIV diagnostic or incidence assay development or evaluation (this includes competency in assay design, format optimization and evaluation of HIV diagnostic or incidence rapid tests or Enzyme Immunoassays (EIAs)
• Experience with multi-analyte equipment formats such as Bio-Plex/Luminex
• Experience working human sample types such as whole blood, serum/plasma and dried blood spots
• A working knowledge of HIV viral load platforms is desirable
• Competence in the operation of all standard lab equipment (centrifuges, plate washers, plate readers, rapid test readers and Bio-plex instruments)

Many of these activities involve cooperation and communication with other team or branch members within CDC and academic collaborators outside of CDC. The candidate should therefore be proficient in:
• Microsoft Word, Powerpoint and Excel.

The contractor key personnel shall perform tasks in 40 hours per week for 1 year with CDC personnel and shall adhere to administrative guidelines established in the contract and policy of the contractor company.

III HOURS OF OPERATION

The core hours of operation for the contractor shall be Monday through Friday. The work day shall consist of eight duty hours and a thirty-minute lunch period. As long as the eight duty hours are met, the start and end times may be adjusted by the program as deemed necessary to accommodate required support in the organization. However, the initial schedule shall be 8:00a.m.- 4:30p.m., excluding federal holidays (listed below) and weekends.
*In case of government shutdown or closure for any reason, make-up time can be performed (no more than two hours per business day) to work on tasks affected by shutdown. Payment can be made for a shutdown period.

Federal Holidays are:

New Year's Day Labor Day
Martin Luther King's B-day Columbus Day
President's Day Veteran's Day
Memorial Day Thanksgiving Day
Independence Day Christmas Day

IV GOVERNMENT FURNISHED FACILITIES AND EQUIPMENT

The Government shall provide a workspace area with computer access, telephone, fax and copy machines, and general office supplies (paper, pens, etc.) for the contractor's use in performing the required services at:

1600 Clifton Road
Building 17
Atlanta, GA 30329

Adequate parking is available on-site.

V PROGRAM MANAGEMENT

The Contractor shall ensure the quality of work performed by the research assistant associated with the performance of this procurement. The Contractor shall evaluate the entire scope of operations, and implement an effective quality control program. This includes providing up-front costs necessary for vaccinations, medical tests, blood draws, and any expected work related screening and items required for access to and work in the lab.

The Contractor shall provide program management and supervision of services performed by research assistant to satisfy the requirements of this procurement. The Contractor shall manage any make-up time for days affected by Government shut down. The program management functions shall include the handling of all employment matters including health and leave benefits related to Contractor's employee/research assistant.
The Contractor's employees shall adhere to government's policies and rules that are applicable to contractors and complete mandatory trainings as required in a timely manner.

Neither the Contractor nor any of its employees shall disclose or cause to be disseminated, any information concerning government operations, including those performed by contractors for the government, which could result in or increase the likelihood of the possibility of a breach of security and/or failure to safeguard any restricted information that may come to the Contractor in connection with work under this procurement.

VI PERIOD OF PERFORMANCE

The period of performance shall be one year: 9/25/2016 - 9/24/2017.

VII DELIVERABLES

The Contractor shall submit monthly reports and invoices to the COR, and the Contracting Officer simultaneously. The monthly report will contain at a minimum, a summary statement of services, progress report and financial forecasting and budget information. This monthly report is a mandatory deliverable. Invoices will not be paid until a complete monthly report is received by the Contracting Officer and/or his/her designated representative. The Contracting Officer may return incomplete and/or inaccurate reports for correction prior to payment of invoices.

Deliverables Frequency
Process, catalogue and store human biological specimens 1000 specimens per month; 12,000 within the year
Explore alternative storage options for human biological specimens Conducts 5 literature searches per month; 60 per year; order approved alternative storage options and test biological specimens for viability
Perform a variety of serologic diagnostic assays Perform 10,000 specimens per month using various serologic diagnostic assay equipment
Perform quality assurance of in house developed rapid HIV tests for diagnosis or incidence determination Perform 1,000 specimens quality assurance tests per month
Perform HIV Viral load assays Perform 5,000 specimens per month using automated process
Calibrate and maintain laboratory instruments and equipment and documents for QMS related activities Perform daily on all lab instruments and equipment used and maintain documents for QMS relate activities
Maintain experiment records Record experiment procedures daily - at least 365 entries per year

VIII. KEY PERSONNEL
The key personnel specified in this contract (Research assistant) is considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the contractor or Government.

No fromal soliciation will sent out.